Bill Summary
This legislation aims to protect patients from surprise medical bills and out-of-network deductibles in emergency situations by amending the Public Health Service Act. It also includes provisions for notice and consent before receiving non-emergency services from an out-of-network provider at an in-network facility, and prohibits facilities or practitioners from billing more than an in-network rate. The legislation also includes amendments to the Federal Food, Drug, and Cosmetic Act related to drug pricing, generic drug access, and requirements for disclosing patent information. It also prohibits anticompetitive terms in healthcare contracts and requires accurate provider directory information. Additionally, the legislation adds a new section to the Public Health Service Act related to making health claims, network, and cost information available to individuals upon request. This section also focuses on the recognition of security practices for potential violations of the HIPAA Security rule and includes provisions for a GAO study on privacy and security risks of electronic transmission of health information.
Possible Impacts
1. Patients will be protected from out-of-network deductibles in emergency situations, and surprise medical bills will be prohibited. This will provide peace of mind and financial stability for individuals in need of emergency care.
2. The legislation requires disclosure of compensation for brokers and consultants in group health plans and individual market plans. This will increase transparency in the healthcare industry and help individuals make informed decisions about their health coverage.
3. The segment also includes a new section that requires group health plans and health insurance issuers to make certain health claims, network, and cost information available to individuals upon request. This will give patients access to important information to help them understand their medical costs and make informed decisions about their healthcare.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1895 Reported in Senate (RS)]
<DOC>
Calendar No. 133
116th CONGRESS
1st Session
S. 1895
To lower health care costs.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 19, 2019
Mr. Alexander (for himself and Mrs. Murray) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
July 8, 2019
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To lower health care costs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>
<DELETED> (a) Short Title.--This Act may be cited as the ``Lower
Health Care Costs Act''.</DELETED>
<DELETED> (b) Table of Contents.--The table of contents for this Act
is as follows:</DELETED>
<DELETED>Sec. 1. Short title; table of contents.
<DELETED>TITLE I--ENDING SURPRISE MEDICAL BILLS
<DELETED>Sec. 101. Protecting patients against out-of-network
deductibles in emergencies.
<DELETED>Sec. 102. Protection against surprise bills.
<DELETED>Sec. 103. Benchmark for payment.
<DELETED>Sec. 104. Effective date.
<DELETED>Sec. 105. Ending surprise air ambulance bills.
<DELETED>Sec. 106. Report.
<DELETED>TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS
<DELETED>Sec. 201. Biological product patent transparency.
<DELETED>Sec. 202. Orange book modernization.
<DELETED>Sec. 203. Ensuring timely access to generics.
<DELETED>Sec. 204. Protecting access to biological products.
<DELETED>Sec. 205. Preventing blocking of generic drugs.
<DELETED>Sec. 206. Education on biological products.
<DELETED>Sec. 207. Biological product innovation.
<DELETED>Sec. 208. Clarifying the meaning of new chemical entity.
<DELETED>Sec. 209. Streamlining the transition of biological products.
<DELETED>Sec. 210. Orphan drug clarification.
<DELETED>Sec. 211. Prompt approval of drugs related to safety
information.
<DELETED>Sec. 212. Conditions of use for biosimilar biological
products.
<DELETED>Sec. 213. Modernizing the labeling of certain generic drugs.
<DELETED>TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE
<DELETED>Sec. 301. Increasing transparency by removing gag clauses on
price and quality information.
<DELETED>Sec. 302. Banning anticompetitive terms in facility and
insurance contracts that limit access to
higher quality, lower cost care.
<DELETED>Sec. 303. Designation of a nongovernmental, nonprofit
transparency organization to lower
Americans' health care costs.
<DELETED>Sec. 304. Protecting patients and improving the accuracy of
provider directory information.
<DELETED>Sec. 305. Timely bills for patients.
<DELETED>Sec. 306. Health plan oversight of pharmacy benefit manager
services.
<DELETED>Sec. 307. Government Accountability Office study on profit-
and revenue-sharing in health care.
<DELETED>Sec. 308. Disclosure of direct and indirect compensation for
brokers and consultants to employer-
sponsored health plans and enrollees in
plans on the individual market.
<DELETED>Sec. 309. Ensuring enrollee access to cost-sharing
information.
<DELETED>Sec. 310. Strengthening parity in mental health and substance
use disorder benefits.
<DELETED>Sec. 311. Technical amendments.
<DELETED>Sec. 312. Third-party administrators.
<DELETED>TITLE IV--IMPROVING PUBLIC HEALTH
<DELETED>Sec. 401. Improving awareness of disease prevention.
<DELETED>Sec. 402. Grants to address vaccine-preventable diseases.
<DELETED>Sec. 403. Guide on evidence-based strategies for public health
department obesity prevention programs.
<DELETED>Sec. 404. Expanding capacity for health outcomes.
<DELETED>Sec. 405. Public health data system modernization.
<DELETED>Sec. 406. Innovation for maternal health.
<DELETED>Sec. 407. Training for health care providers.
<DELETED>Sec. 408. Study on training to reduce and prevent
discrimination.
<DELETED>Sec. 409. Perinatal quality collaboratives.
<DELETED>Sec. 410. Integrated services for pregnant and postpartum
women.
<DELETED>Sec. 411. Extension for community health centers, the National
Health Service Corps, and teaching health
centers that operate GME programs.
<DELETED>Sec. 412. Other programs.
<DELETED>TITLE V--IMPROVING THE EXCHANGE OF HEALTH INFORMATION
<DELETED>Sec. 501. Requirement to provide health claims, network, and
cost information.
<DELETED>Sec. 502. Recognition of security practices.
<DELETED>Sec. 503. GAO study on the privacy and security risks of
electronic transmission of individually
identifiable health information to and from
entities not covered by the Health
Insurance Portability and Accountability
Act.
<DELETED>Sec. 504. Technical corrections.
<DELETED>TITLE I--ENDING SURPRISE MEDICAL BILLS</DELETED>
<DELETED>SEC. 101. PROTECTING PATIENTS AGAINST OUT-OF-NETWORK
DEDUCTIBLES IN EMERGENCIES.</DELETED>
<DELETED> Section 2719A(b) of the Public Health Service Act (42
U.S.C. 300gg-19a) is amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in the matter preceding subparagraph
(A), by inserting ``or a freestanding emergency room''
after ``hospital''; and</DELETED>
<DELETED> (B) in subparagraph (C)--</DELETED>
<DELETED> (i) in clause (ii)(I), by
inserting ``or emergency room'' after
``emergency department''; and</DELETED>
<DELETED> (ii) in subparagraph (C)(ii)(II),
by adding, ``a deductible,'' after ``(expressed
as''; and</DELETED>
<DELETED> (2) in paragraph (2)(B)--</DELETED>
<DELETED> (A) in clause (i)--</DELETED>
<DELETED> (i) by inserting ``or freestanding
emergency room'' after ``hospital'';
and</DELETED>
<DELETED> (ii) by inserting ``or emergency
room'' after ``emergency department'';
and</DELETED>
<DELETED> (B) in clause (ii), by inserting ``or
emergency room'' after ``hospital''.</DELETED>
<DELETED>SEC. 102. PROTECTION AGAINST SURPRISE BILLS.</DELETED>
<DELETED> (a) PHSA.--Section 2719A of the Public Health Service Act
(42 U.S.C. 300gg-19a) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(e) Coverage of Certain Out-of-Network Services.--
</DELETED>
<DELETED> ``(1) In general.--Subject to subsection (h), in
the case of an enrollee in a group health plan or group or
individual health insurance coverage who receives out-of-
network, ancillary, non-emergency services at an in-network
facility, including any referrals for diagnostic services--
</DELETED>
<DELETED> ``(A) the cost-sharing requirement
(expressed as a copayment amount, coinsurance rate, or
deductible) with respect to such services shall be the
same requirement that would apply if such services were
provided by an in-network practitioner, and any
coinsurance or deductible shall be based on in-network
rates; and</DELETED>
<DELETED> ``(B) such cost-sharing amounts shall be
counted towards the in-network deductible and in-
network out-of-pocket maximum amount under the plan or
coverage for the plan year.</DELETED>
<DELETED> ``(2) Definition.--For purposes of this
subsection, the term `facility' has the meaning given the term
`health care facility' in section 2729A(c).</DELETED>
<DELETED> ``(f) Coverage of Out-of-Network Services for Enrollees
Admitted After Emergency Services.--</DELETED>
<DELETED> ``(1) Notice and consent.--Subject to subsection
(h), in the case of an enrollee in a group health plan or group
or individual health insurance coverage who receives emergency
services, or maternal care for a woman in labor, in the
emergency department of an out-of-network facility and has been
stabilized (within the meaning of subsection (b)(2)(C)), if the
patient is subsequently admitted to the out-of-network facility
for care, the cost-sharing requirement (expressed as a
copayment amount, coinsurance rate, or deductible) with respect
to any out-of-network services is the same requirement that
would apply if such services were provided by a participating
provider, unless the enrollee, once stable and in a condition
to receive such information, including having sufficient mental
capacity--</DELETED>
<DELETED> ``(A) has been provided by the facility,
prior to the provision of any post-stabilization, out-
of-network service at such facility, with--</DELETED>
<DELETED> ``(i) paper and electronic
notification that the practitioner or facility
is an out-of-network health care provider and
the out-of-network rate of the provider, as
applicable, and the option to affirmatively
consent to receiving services from such
practitioner or facility; and</DELETED>
<DELETED> ``(ii) the estimated amount that
such provider may charge the participant,
beneficiary, or enrollee for such items and
services involved;</DELETED>
<DELETED> ``(B) has been provided by the plan or
coverage, prior to the provision of any post-
stabilization, out-of-network service at such facility,
with--</DELETED>
<DELETED> ``(i) paper and electronic
notification that the practitioner or facility
is an out-of-network health care provider and
the out-of-network rate of the provider, as
applicable, and the option to affirmatively
consent to receiving services from such
practitioner or facility;</DELETED>
<DELETED> ``(ii) a list of in-network
practitioners or facilities that could provide
the same services, and an option for a referral
to such providers; and</DELETED>
<DELETED> ``(iii) information about whether
prior authorization or other care management
limitations may be required in advance of
receiving in-network care at the facility;
and</DELETED>
<DELETED> ``(C) has acknowledged that the out-of-
network treatment may not be covered or may be covered
at an out-of-network cost-sharing amount, requiring
higher cost-sharing obligations of the enrollee than if
the service were provided at an in-network facility,
and has assumed, in writing, full responsibility of
out-of-pocket costs associated with services furnished
after the enrollee has been stabilized, from the out-
of-network practitioner or facility, as
applicable.</DELETED>
<DELETED> ``(2) Requirements of notice.--The notice under
paragraph (1) shall be in a format determined by the Secretary
to give a reasonable layperson clear comprehension of the terms
of the agreement, including all possible financial
responsibilities, including the requirements that the notice--
</DELETED>
<DELETED> ``(A) does not exceed one page in
length;</DELETED>
<DELETED> ``(B) is readily identifiable for its
purpose and as a contract of consent;</DELETED>
<DELETED> ``(C) clearly states that consent is
optional;</DELETED>
<DELETED> ``(D) includes an estimate of the amount
that such provider will charge the participant,
beneficiary, or enrollee for such items and services
involved; and</DELETED>
<DELETED> ``(E) be available in the 15 most common
languages in the facility's geographic area, with the
facility making a good faith effort to provide oral
notice in the enrollee's primary language if it is not
one of such 15 languages.</DELETED>
<DELETED> ``(g) Prohibition on Billing More Than an In-Network Rate
Under Certain Circumstances.--</DELETED>
<DELETED> ``(1) In general.--A facility or practitioner
furnishing--</DELETED>
<DELETED> ``(A) emergency services, as defined in
subsection (b)(2), regardless of the State in which the
patient resides;</DELETED>
<DELETED> ``(B) services at an in-network facility
described in subsection (e); or</DELETED>
<DELETED> ``(C) out-of-network services furnished
after the enrollee has been stabilized (within the
meaning of subsection (b)(2)(C)), where the notice and
option for referral required under subsection (f)(1)
have not been provided to the enrollee and the
assumption of responsibility for out-of-pocket costs
under subsection (f)(2) has not been
obtained,</DELETED>
<DELETED>may not bill an enrollee in a group health plan or
group or individual health insurance coverage for amounts
beyond the cost-sharing amount that would apply under
subsection (b)(1)(C)(ii)(II), (e), or (f), as
applicable.</DELETED>
<DELETED> ``(2) Notice.--A facility furnishing services
described in paragraph (1) shall provide enrollees in a group
health plan or group or individual health insurance coverage
with a one-page notice, in 16-point font, upon intake at the
emergency room or being admitted at the facility of the
prohibition on balance billing under paragraph (1) and who to
contact for recourse if they are sent a balance bill in
violation of such paragraph. The facility shall be responsible
for obtaining the signature from the enrollee on such notice.
The Secretary shall issue regulations within 6 months of the
date of enactment of the Lower Health Care Costs Act on the
requirements for the notice under this paragraph.</DELETED>
<DELETED> ``(3) Enforcement.--</DELETED>
<DELETED> ``(A) In general.--Subject to subparagraph
(B), a facility or practitioner that violates a
requirement under paragraph (1) shall be subject to a
civil monetary penalty of not more than $10,000 for
each act constituting such violation.</DELETED>
<DELETED> ``(B) Procedure.--The provisions of
section 1128A of the Social Security Act, other than
subsections (a) and (b) and the first sentence of
subsection (c)(1) of such section, shall apply to civil
money penalties under this subsection in the same
manner as such provisions apply to a penalty or
proceeding under section 1128A of the Social Security
Act.</DELETED>
<DELETED> ``(C) Safe harbor.--The Secretary shall
waive the penalties described under subparagraph (A)
with respect to a facility or, practitioner who
unknowingly violates paragraph (1) with respect to an
enrollee, if such facility or practitioner, within 30
days of the violation, withdraws the bill that was in
violation of paragraph (1), and, as applicable,
reimburses the group health plan, health insurance
issuer, or enrollee, as applicable, in an amount equal
to the amount billed in violation of paragraph (1),
plus interest, at an interest rate determined by the
Secretary.</DELETED>
<DELETED> ``(h) Maintaining State Surprise Billing Protections.--
</DELETED>
<DELETED> ``(1) In general.--Notwithstanding section 514 of
the Employee Retirement Income Security Act of 1974, except
with respect to self-insured group health plans, nothing in
this section shall prevent a State from establishing or
continuing in effect an alternate method under State law for
determining the appropriate compensation for services described
in subsection (b), (e), or (f).</DELETED>
<DELETED> ``(2) Additional application.--In the case of
group health plans or health insurance coverage in the
individual or group market offered in a State that has not
enacted an alternate method described in paragraph (1), such as
arbitration or a benchmark, or for services described in
subsection (b), (e), or (f) that are not covered by such
State's alternate method described in paragraph (1), the
provisions of this section shall apply.</DELETED>
<DELETED> ``(3) Self-insured plans.--Subsections (b), (e),
and (f) shall apply to a self-insured group health plan that is
not subject to State insurance regulation.''.</DELETED>
<DELETED> (b) Coverage Under Federal Employees Health Benefits
Program.--Section 8904 of title 5, United States Code, is amended by
adding at the end the following:</DELETED>
<DELETED> ``(c) Any health benefits plan offered under this chapter
shall be treated as a group health plan or group or individual health
insurance coverage for purposes of subsections (e) through (g) of
section 2719A of the Public Health Service Act (42 U.S.C. 300gg-19a)
(except for paragraph (3) of such subsection (g)).''.</DELETED>
<DELETED>SEC. 103. BENCHMARK FOR PAYMENT.</DELETED>
<DELETED> (a) In General.--Subpart II of part A of title XXVII of
the Public Health Service Act (42 U.S.C. 300gg-11 et seq.) is amended
by adding at the end the following:</DELETED>
<DELETED>``SEC. 2729A. BENCHMARK FOR PAYMENT.</DELETED>
<DELETED> ``(a) Establishment of Benchmark.--A group health plan or
health insurance issuer offering group or individual health insurance
coverage shall pay facilities or practitioners furnishing services for
which such facilities and practitioners are prohibited from billing
enrollees under section 2719A(g), the median in-network rate, using a
methodology determined under subsection (b) for the same or similar
services offered by the group health plan or health insurance issuer in
that geographic region.</DELETED>
<DELETED> ``(b) Median In-Network Rate.--</DELETED>
<DELETED> ``(1) In general.--For purposes of this section,
the term `median in-network rate' means, with respect to health
care services covered by a group health plan or group or
individual health insurance coverage, the median negotiated
rate under the applicable plan or coverage recognized under the
plan or coverage as the total maximum payment for the service
minus the in-network cost-sharing for such service under the
plan or coverage, for the same or a similar service that is
provided by a provider in the same or similar specialty and in
the geographic region in which the service is
furnished.</DELETED>
<DELETED> ``(2) Rulemaking.--Not later than 1 year after the
date of enactment of the Lower Health Care Costs Act, the
Secretary shall, through rulemaking, determine the methodology
a group health plan or health insurance issuer is required to
use to determine the median in-network rate described in
paragraph (1), differentiating by business line, the
information the plan or issuer shall share with the
nonparticipating provider involved when making such a
determination, and the geographic regions applied for purposes
of this subparagraph. Such rulemaking shall take into account
payments that are made by health insurance issuers that are not
on a fee-for-service basis.</DELETED>
<DELETED> ``(3) Certain insurers.--If a group health plan or
health insurance issuer offering group or individual health
insurance coverage does not have sufficient information to
calculate a median in-network rate for this service or provider
type, or amount of, claims for services (as determined by the
applicable State authority, in the case of health insurance
coverage, or by the Secretary of Labor, in the case of a self-
insured group health plan) covered under the list of out-of-
network services set by the State authority or Secretary of
Labor, as applicable, in a particular geographic area, such
plan or issuer shall demonstrate that it will use a database
free of conflicts of interest that has sufficient information
reflecting allowed amounts paid to individual health care
providers for relevant services provided in the applicable
geographic region, and that such plan or issuer will use that
database to determine a median in-network rate. The group
health plan or health insurance issuer shall cover the cost of
accessing the database.</DELETED>
<DELETED> ``(4) Rule of construction.--Nothing in this
subsection shall prevent a group health plan or health
insurance issuer from establishing separate calculations of a
median in-network rate under paragraph (1) for services
delivered in nonhospital facilities, including freestanding
emergency rooms.</DELETED>
<DELETED> ``(c) Facility.--For purposes of this section, the term
`health care facility' includes hospitals, hospital outpatient
departments, critical access hospitals, ambulatory surgery centers,
laboratories, radiology clinics, and any other facility that provides
services that are covered under a group health plan or health insurance
coverage, including settings of care subject to section
2719A(b).''.</DELETED>
<DELETED> (b) Non-Federal Governmental Plans.--Section 2722(a)(2)(E)
of the Public Health Service Act (42 U.S.C. 300gg-21(a)(2)(E)) is
amended by inserting ``, except that such election shall be available
with respect to section 2729A'' before the period.</DELETED>
<DELETED>SEC. 104. EFFECTIVE DATE.</DELETED>
<DELETED> The amendments made by sections 101, 102, and 103 shall
take effect beginning in the second plan year that begins after the
date of enactment of this Act.</DELETED>
<DELETED>SEC. 105. ENDING SURPRISE AIR AMBULANCE BILLS.</DELETED>
<DELETED> (a) In General.--Part A of title XXVII of the Public
Health Service Act is amended by inserting after section 2719A (42
U.S.C. 300gg-19a) the following:</DELETED>
<DELETED>``SEC. 2719B. ENDING SURPRISE AIR AMBULANCE BILLS.</DELETED>
<DELETED> ``(a) In General.--In the case of an enrollee in a group
health plan or group or individual health insurance coverage who
receives air ambulance services from an out-of-network provider--
</DELETED>
<DELETED> ``(1) the cost-sharing requirement (expressed as a
copayment amount, coinsurance rate, or deductible) with respect
to such services shall be the same requirement that would apply
if such services were provided by an in-network practitioner,
and any coinsurance or deductible shall be based on in-network
rates; and</DELETED>
<DELETED> ``(2) such cost-sharing amounts shall be counted
towards the in-network deductible and in-network out-of-pocket
maximum amount under the plan or coverage for the plan
year.</DELETED>
<DELETED> ``(b) Payment Rate.--A group health plan or health
insurance issuer shall pay for air ambulance services for purposes of
subsection (a) at the median in-network as defined in subsection
(c).</DELETED>
<DELETED> ``(c) Median In-Network Rate.--</DELETED>
<DELETED> ``(1) In general.--For purposes of this section,
the term `median in-network rate' means, with respect to air
ambulance services covered by a group health plan or group or
individual health insurance coverage, the median negotiated
rate under the applicable plan or coverage recognized under the
plan or coverage as the total maximum payment for the service,
minus the in-network cost-sharing for such service under the
plan or coverage, for the same or a similar service that is
provided by a provider in the same or similar specialty, and in
the geographic region in which the service is
furnished.</DELETED>
<DELETED> ``(2) Rulemaking.--Not later than 6 months after
the date of enactment of the Lower Health Care Costs Act, the
Secretary shall, through rulemaking, determine the methodology
a group health plan or health insurance issuer is required to
use to determine the median in-network rate described in
paragraph (1), the information the plan or issuer shall share
with the non-participating provider involved when making such a
determination, and the geographic regions applied for purposes
of this subsection. Such rulemaking shall take into account
payments that are made by issuers that are not on a fee-for-
service basis.</DELETED>
<DELETED> ``(3) Certain insurers.--If a group health plan or
health insurance issuer offering group or individual health
insurance coverage does not have sufficient information to
calculate a median in-network rate for this service or provider
type, or amount of, claims for services (as determined by the
applicable State authority, in the case of health insurance
coverage, or by the Secretary of Labor, in the case of a self-
insured group health plan) covered under the list of out-of-
network services set by the State authority or Secretary of
Labor, as applicable, in a particular geographic area, such
plan or issuer shall demonstrate that it will use a database
free of conflicts of interest that has sufficient information
reflecting allowed amounts paid to individual health care
providers for relevant services provided in the applicable
geographic region, and that such plan or issuer will use that
database to determine a median in-network rate. The group
health plan or health insurance issuer shall cover the cost of
accessing the database.</DELETED>
<DELETED> ``(4) Clarification.--For purposes of this
subsection, the Secretary may define geographic regions that
are different from the geographic regions identified for
purposes of section 2729A(b) to ensure that an adequate number
of air ambulance services are in-network in each geographic
region so that a median in-network rate for air ambulance
services may be calculated for each such region.</DELETED>
<DELETED> ``(d) Cost-Sharing Limitation.--An air ambulance service
provider may not bill an enrollee in a group health plan or group or
individual health insurance coverage for amounts beyond the cost-
sharing amount that applies under subsection (a).</DELETED>
<DELETED> ``(e) Enforcement.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), an
air ambulance service provider that violates subsection (d)
shall be subject to a civil monetary penalty of not more than
$10,000 for each act constituting such violation.</DELETED>
<DELETED> ``(2) Procedure.--The provisions of section 1128A
of the Social Security Act, other than subsections (a) and (b)
and the first sentence of subsection (c)(1) of such section,
shall apply to civil money penalties under this subsection in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A of the Social Security
Act.</DELETED>
<DELETED> ``(3) Safe harbor.--The Secretary shall waive the
penalties described under paragraph (1) with respect to an air
ambulance service provider who unknowingly violates subsection
(d) with respect to an enrollee, if such air ambulance service
provider within 30 days of the violation, withdraws the bill
that was in violation of subsection (d), and, as applicable,
reimburses the group health plan, health insurance issuer, or
enrollee, as applicable, in an amount equal to the amount
billed in violation of subsection (d), plus interest, at an
interest rate determined by the Secretary.''.</DELETED>
<DELETED> (b) Effective Date.--Section 2719B of the Public Health
Service Act, as added by subsection (a), shall take effect on the date
that is 1 year after the date of enactment of this Act.</DELETED>
<DELETED>SEC. 106. REPORT.</DELETED>
<DELETED> Not later than 1 year after the effective date described
in section 104, and annually for the following 4 years, the Secretary
of Health and Human Services, in consultation with the Federal Trade
Commission and the Attorney General, shall--</DELETED>
<DELETED> (1) conduct a study on--</DELETED>
<DELETED> (A) the effects of the amendments made by
sections 101, 102, and 103, including any patterns of
vertical or horizontal integration of health care
facilities, providers, group health plans, or health
insurance issuers;</DELETED>
<DELETED> (B) the effects of the amendments made by
sections 101, 102, and 103 on overall health care
costs; and</DELETED>
<DELETED> (C) recommendations for effective
enforcement of 2729A as added by section 103, including
potential challenges to addressing anti-competitive
consolidation by health care facilities, providers,
group health plans, or health insurance issuers;
and</DELETED>
<DELETED> (2) submit a report on such study to the Committee
on Health, Education, Labor, and Pensions, the Committee on
Commerce, Science, and Transportation, the Committee on
Finance, and the Committee on the Judiciary of the Senate and
the Committee on Education and Labor, the Committee on Energy
and Commerce, the Committee on Ways and Means, and the
Committee on the Judiciary of the House of
Representatives.</DELETED>
<DELETED>TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS</DELETED>
<DELETED>SEC. 201. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.</DELETED>
<DELETED> (a) In General.--Section 351 of the Public Health Service
Act (42 U.S.C. 262) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(o) Additional Requirements With Respect to Patents.--
</DELETED>
<DELETED> ``(1) Approved application holder listing
requirements.--</DELETED>
<DELETED> ``(A) In general.--Beginning on the date
of enactment of the Lower Health Care Costs Act, within
60 days of approval of an application under subsection
(a) or (k), the holder of such approved application
shall submit to the Secretary a list of each patent
required to be disclosed (as described in paragraph
(3)).</DELETED>
<DELETED> ``(B) Previously approved or licensed
biological products.--</DELETED>
<DELETED> ``(i) Products licensed under
section 351 of the phsa.--Not later than 30
days after the date of enactment of the Lower
Health Care Costs Act, the holder of a
biological product license that was approved
under subsection (a) or (k) before the date of
enactment of such Act shall submit to the
Secretary a list of each patent required to be
disclosed (as described in paragraph
(3)).</DELETED>
<DELETED> ``(ii) Products approved under
section 505 of the ffdca.--Not later than 30
days after March 23, 2020, the holder of an
approved application for a biological product
under section 505 of the Federal Food, Drug,
and Cosmetic Act that is deemed to be a license
for the biological product under this section
on March 23, 2020, shall submit to the
Secretary a list of each patent required to be
disclosed (as described in paragraph
(3)).</DELETED>
<DELETED> ``(C) Updates.--The holder of a biological
product license that is the subject of an application
under subsection (a) or (k) shall submit to the
Secretary a list that includes--</DELETED>
<DELETED> ``(i) any patent not previously
required to be disclosed (as described in
paragraph (3)) under subparagraph (A) or (B),
as applicable, within 30 days of the earlier
of--</DELETED>
<DELETED> ``(I) the date of issuance
of such patent by the United States
Patent and Trademark Office;
or</DELETED>
<DELETED> ``(II) the date of
approval of a supplemental application
for the biological product;
and</DELETED>
<DELETED> ``(ii) any patent, or any claim
with respect to a patent, included on the list
pursuant to this paragraph, that the Patent
Trial and Appeal Board of the United States
Patent and Trademark Office determines in a
decision to be invalid or unenforceable, within
30 days of such decision.</DELETED>
<DELETED> ``(2) Publication of information.--</DELETED>
<DELETED> ``(A) In general.--Within 1 year of the
date of enactment of the Lower Health Care Costs Act,
the Secretary shall publish and make available to the
public a single, easily searchable, list that
includes--</DELETED>
<DELETED> ``(i) the official and proprietary
name of each biological product licensed under
subsection (a) or (k), and of each biological
product application approved under section 505
of the Federal Food, Drug, and Cosmetic Act and
deemed to be a license for the biological
product under this section on March 23,
2020;</DELETED>
<DELETED> ``(ii) with respect to each
biological product described in clause (i),
each patent submitted in accordance with
paragraph (1);</DELETED>
<DELETED> ``(iii) the date of approval and
application number for each such biological
product;</DELETED>
<DELETED> ``(iv) the marketing status,
dosage form, route of administration, strength,
and, if applicable, reference product, for each
such biological product;</DELETED>
<DELETED> ``(v) the licensure status for
each such biological product, including whether
the license at the time of listing is approved,
withdrawn, or revoked;</DELETED>
<DELETED> ``(vi) with respect to each such
biological product, any period of any
exclusivity under paragraph (6), (7)(A), or
(7)(B) of subsection (k) of this section or
section 527 of the Federal Food, Drug, and
Cosmetic Act, and any extension of such period
in accordance with subsection (m) of this
section, for which the Secretary has determined
such biological product to be eligible, and the
date on which such exclusivity
expires;</DELETED>
<DELETED> ``(vii) information regarding any
determination of biosimilarity or
interchangeability for each such biological
product; and</DELETED>
<DELETED> ``(viii) information regarding
approved indications for each such biological
product, in such manner as the Secretary
determines appropriate.</DELETED>
<DELETED> ``(B) Updates.--Every 30 days after the
publication of the first list under subparagraph (A),
the Secretary shall revise the list to include--
</DELETED>
<DELETED> ``(i)(I) each biological product
licensed under subsection (a) or (k) during the
30-day period; and</DELETED>
<DELETED> ``(II) with respect to each
biological product described in subclause (I),
the information described in clauses (i)
through (viii) of subparagraph (A);
and</DELETED>
<DELETED> ``(ii) any updates to information
previously published in accordance with
subparagraph (A).</DELETED>
<DELETED> ``(C) Noncompliance.--Beginning 18 months
after the date of enactment of the Lower Health Care
Costs Act, the Secretary, in consultation with the
Director of the United States Patent and Trademark
Office, shall publish and make available to the public
a list of any holders of biological product licenses,
and the corresponding biological product or products,
that failed to submit information as required under
paragraph (1), including any updates required under
paragraph (1)(C), in such manner and format as the
Secretary determines appropriate. If information
required under paragraph (1) is submitted following
publication of such list, the Secretary shall remove
such holders of such biological product licenses from
the public list in a reasonable period of
time.</DELETED>
<DELETED> ``(3) Patents required to be disclosed.--In this
section, a `patent required to be disclosed' is any patent for
which the holder of a biological product license approved under
subsection (a) or (k), or a biological product application
approved under section 505 of the Federal Food, Drug, and
Cosmetic Act and deemed to be a license for a biological
product under this section on March 23, 2020, believes a claim
of patent infringement could reasonably be asserted by the
holder, or by a patent owner that has granted an exclusive
license to the holder with respect to the biological product
that is the subject of such license, if a person not licensed
by the holder engaged in the making, using, offering to sell,
selling, or importing into the United States of the biological
product that is the subject of such license.''.</DELETED>
<DELETED> (b) Disclosure of Patents.--Section 351(l)(3)(A)(i) of the
Public Health Service Act (42 U.S.C. 262(l)(3)(A)(i)) is amended by
inserting ``included in the list provided by the reference product
sponsor under subsection (o)(1)'' after ``a list of
patents''.</DELETED>
<DELETED> (c) Review and Report on Noncompliance.--Not later than 30
months after the date of enactment of this Act, the Secretary shall--
</DELETED>
<DELETED> (1) solicit public comments regarding appropriate
remedies, in addition to the publication of the list under
subsection (o)(2)(C) of section 351 of the Public Health
Service Act (42 U.S.C. 262), as added by subsection (a), with
respect to holders of biological product licenses who fail to
timely submit information as required under subsection (o)(1)
of such section 351, including any updates required under
subparagraph (C) of such subsection (o)(1); and</DELETED>
<DELETED> (2) submit to Congress an evaluation of comments
received under paragraph (1) and the recommendations of the
Secretary concerning appropriate remedies.</DELETED>
<DELETED> (d) Regulations.--The Secretary of Health and Human
Services may promulgate regulations to carry out subsection (o) of
section 351 of the Public Health Service Act (42 U.S.C. 262), as added
by subsection (a).</DELETED>
<DELETED> (e) Rule of Construction.--Nothing in this Act, including
an amendment made by this Act, shall be construed to require or allow
the Secretary of Health and Human Services to delay the licensing of a
biological product under section 351 of the Public Health Service Act
(42 U.S.C. 262).</DELETED>
<DELETED>SEC. 202. ORANGE BOOK MODERNIZATION.</DELETED>
<DELETED> (a) Submission of Patent Information for Brand Name
Drugs.--</DELETED>
<DELETED> (1) In general.--Paragraph (1) of section 505(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b))
is amended to read as follows:</DELETED>
<DELETED> ``(b)(1)(A) Any person may file with the Secretary an
application with respect to any drug subject to the provisions of
subsection (a). Such persons shall submit to the Secretary as part of
the application--</DELETED>
<DELETED> ``(i) full reports of investigations which have
been made to show whether or not such drug is safe for use and
whether such drug is effective in use;</DELETED>
<DELETED> ``(ii) a full list of the articles used as
components of such drug;</DELETED>
<DELETED> ``(iii) a full statement of the composition of
such drug;</DELETED>
<DELETED> ``(iv) a full description of the methods used in,
and the facilities and controls used for, the manufacture,
processing, and packing of such drug;</DELETED>
<DELETED> ``(v) such samples of such drug and of the
articles used as components thereof as the Secretary may
require;</DELETED>
<DELETED> ``(vi) specimens of the labeling proposed to be
used for such drug;</DELETED>
<DELETED> ``(vii) any assessments required under section
505B; and</DELETED>
<DELETED> ``(viii) the patent number and expiration date, of
each patent for which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug, and
that--</DELETED>
<DELETED> ``(I) claims the drug for which the
applicant submitted the application and is a drug
substance patent or a drug product patent; or</DELETED>
<DELETED> ``(II) claims the method of using the drug
for which approval is sought or has been granted in the
application.</DELETED>
<DELETED> ``(B) If an application is filed under this subsection for
a drug, and a patent of the type described in subparagraph (A)(viii)
that claims such drug or a method of using such drug is issued after
the filing date but before approval of the application, the applicant
shall amend the application to include such patent
information.</DELETED>
<DELETED> ``(C) Upon approval of the application, the Secretary
shall publish the information submitted under subparagraph
(A)(viii).''.</DELETED>
<DELETED> (2) Guidance.--The Secretary of Health and Human
Services shall, in consultation with the Director of the
National Institutes of Health and with representatives of the
drug manufacturing industry, review and develop guidance, as
appropriate, on the inclusion of women and minorities in
clinical trials required under subsection (b)(1)(A)(i) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by paragraph (1).</DELETED>
<DELETED> (b) Conforming Changes to Requirements for Subsequent
Submission of Patent Information.--Section 505(c)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended--
</DELETED>
<DELETED> (1) by inserting before the first sentence the
following: ``Not later than 30 days after the date of approval
of an application under subsection (b), the holder of the
approved application shall file with the Secretary the patent
number and the expiration date of any patent described in
subclause (I) or (II) of subsection (b)(1)(A)(viii), except
that a patent that claims a method of using such drug shall be
filed only if approval for such use has been granted in the
application. The holder of the approved application shall file
with the Secretary the patent number and the expiration date of
any patent described in subclause (I) or (II) of subsection
(b)(1)(A)(viii) that is issued after the date of approval of
the application, not later than 30 days of the date of issuance
of the patent, except that a patent that claims a method of
using such drug shall be filed only if approval for such use
has been granted in the application.'';</DELETED>
<DELETED> (2) by inserting after ``the patent number and the
expiration date of any patent which'' the following: ``fulfills
the criteria in subsection (b) and'';</DELETED>
<DELETED> (3) by inserting after the third sentence (as
amended by paragraph (1)) the following: ``Patent information
that is not the type of patent information required by
subsection (b)(1)(A)(viii) shall not be submitted under this
paragraph.''; and</DELETED>
<DELETED> (4) by inserting after ``could not file patent
information under subsection (b) because no patent'' the
following: ``of the type required to be submitted in subsection
(b)''.</DELETED>
<DELETED> (c) Listing of Exclusivities.--Subparagraph (A) of section
505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)) is amended by adding at the end the following:</DELETED>
<DELETED> ``(iv) For each drug included on the list, the Secretary
shall specify any exclusivity period that is applicable, for which the
Secretary has determined the expiration date, and for which such period
has not yet expired under--</DELETED>
<DELETED> ``(I) clause (ii), (iii), or (iv) of subsection
(c)(3)(E) of this section;</DELETED>
<DELETED> ``(II) clause (iv) or (v) of paragraph (5)(B) of
this subsection;</DELETED>
<DELETED> ``(III) clause (ii), (iii), or (iv) of paragraph
(5)(F) of this subsection;</DELETED>
<DELETED> ``(IV) section 505A;</DELETED>
<DELETED> ``(V) section 505E;</DELETED>
<DELETED> ``(VI) section 527(a); or</DELETED>
<DELETED> ``(VII) section 505(u)''.</DELETED>
<DELETED> (d) Orange Book Updates With Respect to Invalidated
Patents.--</DELETED>
<DELETED> (1) In general.--</DELETED>
<DELETED> (A) Amendments.--Section 505(j)(7)(A) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)(A)), as amended by subsection (c), is further
amended by adding at the end the following:</DELETED>
<DELETED> ``(v) In the case of a listed drug for which the
list under clause (i) includes a patent or patent claim for the
drug, or a patent or a patent claim for the use of such drug,
and where the Under Secretary of Commerce for Intellectual
Property and Director of the United States Patent and Trademark
Office has canceled any claim of the patent relating to such
drug or such use pursuant to a decision by the Patent Trial and
Appeal Board in an inter partes review conducted under chapter
31 of title 35, United States Code, or a post-grant review
conducted under chapter 32 of that title, and from which no
appeal has been taken, or can be taken, the holder of the
applicable approved application shall notify the Secretary, in
writing, within 14 days of such cancellation, and, if the
patent has been deemed wholly inoperative or invalid, or if a
patent claim has been canceled, the revisions required under
clause (iii) shall include striking the patent or information
regarding such patent claim from the list with respect to such
drug.''.</DELETED>
<DELETED> (B) Application.--The amendment made by
subparagraph (A) shall not apply with respect to any
determination with respect to a patent or patent claim
that is made prior to the date of enactment of this
Act.</DELETED>
<DELETED> (2) No effect on first applicant exclusivity
period.--Section 505(j)(5)(B)(iv)(I) is amended by adding at
the end the following: ``This subclause shall apply even if a
patent is stricken from the list under paragraph (7)(A),
pursuant to paragraph (7)(A)(v), provided that, at the time
that the first applicant submitted an application under this
subsection containing a certification described in paragraph
(2)(A)(vii)(IV), the patent that was the subject of such
certification was included in such list with respect to the
listed drug.''.</DELETED>
<DELETED>SEC. 203. ENSURING TIMELY ACCESS TO GENERICS.</DELETED>
<DELETED> Section 505(q) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(q)(1)) is amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A)(i), by inserting
``, 10.31,'' after ``10.30'';</DELETED>
<DELETED> (B) in subparagraph (E)--</DELETED>
<DELETED> (i) by striking ``application
and'' and inserting ``application
or'';</DELETED>
<DELETED> (ii) by striking ``If the
Secretary'' and inserting the
following:</DELETED>
<DELETED> ``(i) In general.--If the
Secretary''; and</DELETED>
<DELETED> (iii) by striking the second
sentence and inserting the following:</DELETED>
<DELETED> ``(ii) Primary purpose of
delaying.--</DELETED>
<DELETED> ``(I) In general.--For
purposes of this subparagraph, a
petition or supplement to a petition
may be considered to be submitted with
the primary purpose of delaying an
application under subsection (b)(2) or
(j) of this section or section 351(k)
of the Public Health Service Act, if
the petitioner has the purpose of
setting aside, delaying, rescinding,
withdrawing, or preventing submission,
review, or the approval of such an
application.</DELETED>
<DELETED> ``(II) Factors.--In
determining whether a petition was
submitted with the primary purpose of
delaying an application, the Secretary
may consider the following
factors:</DELETED>
<DELETED> ``(aa) Whether the
petition was submitted in
accordance with paragraph
(2)(B), based on when the
petitioner knew or reasonably
should have known the relevant
information relied upon to form
the basis of such
petition.</DELETED>
<DELETED> ``(bb) Whether the
petitioner has submitted
multiple or serial petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or
petitions.</DELETED>
<DELETED> ``(cc) Whether the
petition was submitted close in
time to a known, first date
upon which an application under
subsection (b)(2) or (j) of
this section or section 351(k)
of the Public Health Service
Act could be
approved.</DELETED>
<DELETED> ``(dd) Whether the
petition was submitted without
any relevant data or
information in support of the
scientific positions forming
the basis of such
petition.</DELETED>
<DELETED> ``(ee) Whether the
petition raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.</DELETED>
<DELETED> ``(ff) Whether the
petition requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
applicable to the listed drug,
reference product, or
petitioner's version of the
same drug.</DELETED>
<DELETED> ``(gg) The
petitioner's record of
submitting petitions to the
Food and Drug Administration
that have been determined by
the Secretary to have been
submitted with the primary
purpose of delay.</DELETED>
<DELETED> ``(hh) Other
relevant and appropriate
factors, which the Secretary
shall describe in
guidance.</DELETED>
<DELETED> ``(III) Guidance.--The
Secretary may issue or update guidance,
as appropriate, to describe factors the
Secretary considers in accordance with
subclause (II).'';</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(iii) Referral to the federal
trade commission.--The Secretary shall
establish procedures for referring to the
Federal Trade Commission any petition or
supplement to a petition that the Secretary
determines was submitted with the primary
purpose of delaying approval of an application.
Such procedures shall include notification to
the petitioner and an opportunity for judicial
review after the issuance of an order by the
Federal Trade Commission.'';</DELETED>
<DELETED> (D) by striking subparagraph
(F);</DELETED>
<DELETED> (E) by redesignating subparagraphs (G)
through (I) as subparagraphs (F) through (H),
respectively; and</DELETED>
<DELETED> (F) in subparagraph (H), as so
redesignated, by striking ``submission of this
petition'' and inserting ``submission of this
document'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) by redesignating subparagraphs (A)
through (C) as subparagraphs (C) through (E),
respectively;</DELETED>
<DELETED> (B) by inserting before subparagraph (C),
as so redesignated, the following:</DELETED>
<DELETED> ``(A) In general.--A person shall submit a
petition to the Secretary under paragraph (1) before
filing a civil action in which the person seeks to set
aside, delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.</DELETED>
<DELETED> ``(B) Timely submission of citizen
petition.--A petition and any supplement to a petition
shall be submitted within 60 days after the person
knew, or reasonably should have known, the information
that forms the basis of the request made in the
petition or supplement.'';</DELETED>
<DELETED> (C) in subparagraph (C), as so
redesignated, by--</DELETED>
<DELETED> (i) in the heading, striking
``within 150 days'';</DELETED>
<DELETED> (ii) in clause (i), striking
``during the 150-day period referred to in
paragraph (1)(F),''; and</DELETED>
<DELETED> (iii) amending clause (ii) to read
as follows:</DELETED>
<DELETED> ``(ii) on or after the date that
is 151 days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';</DELETED>
<DELETED> (D) by amending subparagraph (D), as so
redesignated, to read as follows:</DELETED>
<DELETED> ``(D) Dismissal of certain civil
actions.--</DELETED>
<DELETED> ``(i) Petition.--If a person files
a civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (A), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.</DELETED>
<DELETED> ``(ii) Timeliness.--If a person
files a civil action against the Secretary in
which a person seeks to set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.</DELETED>
<DELETED> ``(iii) Final response.--If a
civil action is filed against the Secretary
with respect to any issue raised in a petition
timely filed under paragraph (1) in which the
petitioner requests that the Secretary take any
form of action that could, if taken, set aside,
delay, rescind, withdraw, or prevent
submission, review, or approval of an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act before the Secretary
has issued a final response to any such
petition submitted, the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.'';
and</DELETED>
<DELETED> (E) in subparagraph (E), as so
redesignated--</DELETED>
<DELETED> (i) in clause (ii), by striking
``, if issued''; and</DELETED>
<DELETED> (ii) in clause (iii), by striking
``final agency action as defined under
subparagraph (2)(A)'' and inserting ``the final
response to the petitioner''; and</DELETED>
<DELETED> (3) in paragraph (4)--</DELETED>
<DELETED> (A) by striking ``Exceptions'' and all
that follows through ``This subsection does'' and
inserting ``Exceptions--This subsection
does'';</DELETED>
<DELETED> (B) by striking subparagraph (B);
and</DELETED>
<DELETED> (C) by redesignating clauses (i) and (ii)
as subparagraphs (A) and (B), respectively, and
adjusting the margins accordingly.</DELETED>
<DELETED>SEC. 204. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS.</DELETED>
<DELETED> Section 351(k)(7) of the Public Health Service Act (42
U.S.C. 262(k)(7)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(D) Deemed licenses.--</DELETED>
<DELETED> ``(i) No additional exclusivity
through deeming.--An approved application that
is deemed to be a license for a biological
product under this section pursuant to section
7002(e)(4) of the Biologics Price Competition
and Innovation Act of 2009 shall not be treated
as having been first licensed under subsection
(a) for purposes of subparagraphs (A) and
(B).</DELETED>
<DELETED> ``(ii) Limitation on
exclusivity.--Subparagraph (C) shall apply to
any reference product, without regard to
whether--</DELETED>
<DELETED> ``(I) such product was
first licensed under subsection (a);
or</DELETED>
<DELETED> ``(II) the approved
application for such product was deemed
to be a license for a biological
product as described in clause
(i).</DELETED>
<DELETED> ``(iii) Applicability.--Any
unexpired period of exclusivity under section
527 or section 505A(c)(1)(A)(ii) of the Federal
Food, Drug, and Cosmetic Act with respect to a
biological product shall continue to apply to
such biological product after an approved
application for the biological product is
deemed to be a license for the biological
product as described in clause
(i).''.</DELETED>
<DELETED>SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS.</DELETED>
<DELETED> Section 505(j)(5)(B)(iv)(I) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)(I)) is amended--</DELETED>
<DELETED> (1) by striking ``180 days after the date'' and
inserting ``180 days after the earlier of the
following:</DELETED>
<DELETED> ``(aa) The date''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(bb) The date on which all of
the following conditions are first
met:</DELETED>
<DELETED> ``(AA) An application for
the drug submitted by an applicant
other than a first applicant could
receive approval, if no first applicant
were eligible for 180-day exclusivity
under this clause.</DELETED>
<DELETED> ``(BB) Thirty-three months
have passed since the date of
submission of an application for the
drug by one first applicant, if there
is only one first applicant, or, in the
case of more than one first applicant,
33 months have passed since the date of
submission of all such
applications.</DELETED>
<DELETED> ``(CC) Approval of an
application for the drug submitted by
at least one first applicant would not
be precluded under clause
(iii).</DELETED>
<DELETED> ``(DD) No application for
the drug submitted by any first
applicant is approved at the time the
conditions under subitems (AA), (BB),
and (CC) are all met, regardless of
whether such an application is
subsequently approved.''.</DELETED>
<DELETED>SEC. 206. EDUCATION ON BIOLOGICAL PRODUCTS.</DELETED>
<DELETED> Subpart 1 of part F of title III of the Public Health
Service Act (42 U.S.C. 262 et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.</DELETED>
<DELETED> ``(a) Internet Website.--</DELETED>
<DELETED> ``(1) In general.--The Secretary may establish,
maintain, and operate an internet website to provide
educational materials for health care providers, patients, and
caregivers, regarding the meaning of the terms, and the
standards for review and licensing of, biological products,
including biosimilar biological products and interchangeable
biosimilar biological products.</DELETED>
<DELETED> ``(2) Content.--Educational materials provided
under paragraph (1) may include explanations of--</DELETED>
<DELETED> ``(A) key statutory and regulatory terms,
including `biosimilar' and `interchangeable', and
clarification regarding the appropriate use of
interchangeable biosimilar biological
products;</DELETED>
<DELETED> ``(B) information related to development
programs for biological products, including biosimilar
biological products and interchangeable biosimilar
biological products and relevant clinical
considerations for prescribers, which may include, as
appropriate and applicable, information related to the
comparability of such biological products;</DELETED>
<DELETED> ``(C) the process for reporting adverse
events for biological products, including biosimilar
biological products and interchangeable biosimilar
biological products; and</DELETED>
<DELETED> ``(D) the relationship between biosimilar
biological products and interchangeable biosimilar
biological products licensed under section 351(k) and
reference products (as defined in section 351(i)),
including the standards for review and licensing of
each such type of biological product.</DELETED>
<DELETED> ``(3) Format.--The educational materials provided
under paragraph (1) may be--</DELETED>
<DELETED> ``(A) in formats such as webinars,
continuing medical education modules, videos, fact
sheets, infographics, stakeholder toolkits, or other
formats as appropriate and applicable; and</DELETED>
<DELETED> ``(B) tailored for the unique needs of
health care providers, patients, caregivers, and other
audiences, as the Secretary determines
appropriate.</DELETED>
<DELETED> ``(4) Other information.--In addition to the
information described in paragraph (2), the internet website
established under paragraph (1) shall include the following
information, as a single, searchable database:</DELETED>
<DELETED> ``(A) The action package of each
biological product licensed under subsection (a) or
(k), within 30 days of licensure, or, in the case of a
biological product licensed before the date of
enactment of the Lower Health Care Costs Act, not later
than 1 year after such date of enactment.</DELETED>
<DELETED> ``(B) The summary review of each
biological product licensed under subsection (a) or
(k), within 7 days of licensure, except where such
materials require redaction by the Secretary, or, in
the case of a biological product licensed before the
date of enactment of the Lower Health Care Costs Act,
not later than 1 year after such date of
enactment.</DELETED>
<DELETED> ``(5) Confidential and trade secret information.--
This subsection does not authorize the disclosure of any trade
secret, confidential commercial or financial information, or
other matter described in section 552(b) of title 5.</DELETED>
<DELETED> ``(b) Continuing Medical Education.--The Secretary shall
advance education and awareness among health care providers regarding
biological products, including biosimilar biological products and
interchangeable biosimilar biological products, as appropriate,
including by developing or improving continuing medical education
programs that advance the education of such providers on the
prescribing of, and relevant clinical considerations with respect to
biological products, including biosimilar biological products and
interchangeable biosimilar biological products.''.</DELETED>
<DELETED>SEC. 207. BIOLOGICAL PRODUCT INNOVATION.</DELETED>
<DELETED> Section 351(j) of the Public Health Service Act (42 U.S.C.
262(j)) is amended--</DELETED>
<DELETED> (1) by striking ``except that a product'' and
inserting ``except that--</DELETED>
<DELETED> ``(1) a product'';</DELETED>
<DELETED> (2) by striking ``Act.'' and inserting ``Act;
and''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(2) no requirement under such Act regarding an
official compendium (as defined in section 201(j) of such Act),
or other reference in such Act to an official compendium (as so
defined), shall apply with respect to a biological product
subject to regulation under this section.''.</DELETED>
<DELETED>SEC. 208. CLARIFYING THE MEANING OF NEW CHEMICAL
ENTITY.</DELETED>
<DELETED> Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended--</DELETED>
<DELETED> (1) in section 505 (21 U.S.C. 355)--</DELETED>
<DELETED> (A) in subsection (c)(3)(E)--</DELETED>
<DELETED> (i) in clause (ii), by striking
``active ingredient (including any ester or
salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in
section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations))'';
and</DELETED>
<DELETED> (ii) in clause (iii), by striking
``active ingredient (including any ester or
salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in
section 314.3 of title 21, Code of Federal
Regulations (or any successor
regulations))'';</DELETED>
<DELETED> (B) in subsection (j)(5)(F)--</DELETED>
<DELETED> (i) in clause (ii), by striking
``active ingredient (including any ester or
salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in
section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations))'';
and</DELETED>
<DELETED> (ii) in clause (iii), by striking
``active ingredient (including any ester or
salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in
section 314.3 of title 21, Code of Federal
Regulations (or any successor
regulations))'';</DELETED>
<DELETED> (C) in subsection (l)(2)(A)(i), by
striking ``active ingredient (including any ester or
salt of the active ingredient)'' and inserting ``active
moiety (as defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any successor
regulations))'';</DELETED>
<DELETED> (D) in subsection (s), in the matter
preceding paragraph (1), by striking ``active
ingredient (including any ester or salt of the active
ingredient)'' and inserting ``active moiety (as defined
by the Secretary in section 314.3 of title 21, Code of
Federal Regulations (or any successor regulations))'';
and</DELETED>
<DELETED> (E) in subsection (u)(1), in the matter
preceding subparagraph (A)--</DELETED>
<DELETED> (i) by striking ``active
ingredient (including any ester or salt of the
active ingredient)'' and inserting ``active
moiety (as defined by the Secretary in section
314.3 of title 21, Code of Federal Regulations
(or any successor regulations))'';
and</DELETED>
<DELETED> (ii) by striking ``same active
ingredient'' and inserting ``same active
moiety'';</DELETED>
<DELETED> (2) in section 512(c)(2)(F) (21 U.S.C.
360b(c)(2)(F))--</DELETED>
<DELETED> (A) in clause (i), by striking ``active
ingredient (including any ester or salt of the active
ingredient)'' and inserting ``active moiety (as defined
by the Secretary in section 314.3 of title 21, Code of
Federal Regulations (or any successor
regulations))'';</DELETED>
<DELETED> (B) in clause (ii), by striking ``active
ingredient (including any ester or salt of the active
ingredient)'' and inserting ``active moiety (as defined
by the Secretary in section 314.3 of title 21, Code of
Federal Regulations (or any successor regulations))'';
and</DELETED>
<DELETED> (C) in clause (v), by striking ``active
ingredient (including any ester or salt of the active
ingredient)'' and inserting ``active moiety (as defined
by the Secretary in section 314.3 of title 21, Code of
Federal Regulations (or any successor
regulations))'';</DELETED>
<DELETED> (3) in section 524(a)(4)(C) (21 U.S.C.
360n(a)(4)(C)), by striking ``active ingredient (including any
ester or salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in section 314.3
of title 21, Code of Federal Regulations (or any successor
regulations))'';</DELETED>
<DELETED> (4) in section 529(a)(4)(A)(ii) (21 U.S.C.
360ff(a)(4)(A)(ii)), by striking ``active ingredient (including
any ester or salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in section 314.3
of title 21, Code of Federal Regulations (or any successor
regulations))''; and</DELETED>
<DELETED> (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb-
4a(a)(4)(D)), by striking ``active ingredient (including any
ester or salt of the active ingredient)'' and inserting
``active moiety (as defined by the Secretary in section 314.3
of title 21, Code of Federal Regulations (or any successor
regulations))''.</DELETED>
<DELETED>SEC. 209. STREAMLINING THE TRANSITION OF BIOLOGICAL
PRODUCTS.</DELETED>
<DELETED> Section 7002(e)(4) of the Biologics Price Competition and
Innovation Act of 2009 (Public Law 111-148) is amended by adding at the
end the following: ``With respect to an application for a biological
product under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) with a filing date that is not later than September 23,
2019, the Secretary shall continue to review and approve such
application under section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355), even if such review and approval process continues
after March 23, 2020. Effective on the later of March 23, 2020, or the
date of approval of such application under such section 505, such
approved application shall be deemed to be a license for the biological
product under section 351 of the Public Health Service
Act.''.</DELETED>
<DELETED>SEC. 210. ORPHAN DRUG CLARIFICATION.</DELETED>
<DELETED> Section 527(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360cc(c)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(3) Applicability.--This subsection applies to
any drug designated under section 526 that was approved under
section 505 of this Act or licensed under section 351 of the
Public Health Service Act after the date of enactment of the
FDA Reauthorization Act of 2017, regardless of the date of on
which such drug was designated under section 526.''.</DELETED>
<DELETED>SEC. 211. PROMPT APPROVAL OF DRUGS RELATED TO SAFETY
INFORMATION.</DELETED>
<DELETED> Section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(z) Prompt Approval of Drugs When Safety Information Is
Added to Labeling.--</DELETED>
<DELETED> ``(1) General rule.--A drug for which an
application has been submitted or approved under subsection
(b)(2) or (j) shall not be considered ineligible for approval
under this section or misbranded under section 502 on the basis
that the labeling of the drug omits safety information,
including contraindications, warnings, precautions, dosing,
administration, or other information pertaining to safety, when
the omitted safety information is protected by exclusivity
under clause (iii) or (iv) of subsection (j)(5)(F), clause
(iii) or (iv) of subsection (c)(3)(E), or section 527(a), or by
an extension of such exclusivity under section 505A or
505E.</DELETED>
<DELETED> ``(2) Labeling.--Notwithstanding clauses (iii) and
(iv) of subsection (j)(5)(F), clauses (iii) and (iv) of
subsection (c)(3)(E), or section 527, the Secretary shall
require that the labeling of a drug approved pursuant to an
application submitted under subsection (b)(2) or (j) that omits
safety information described in paragraph (1) include a
statement of any appropriate safety information that the
Secretary considers necessary to assure safe use.</DELETED>
<DELETED> ``(3) Availability and scope of exclusivity.--This
subsection does not affect--</DELETED>
<DELETED> ``(A) the availability or scope of
exclusivity or an extension of exclusivity described in
subparagraph (A) or (B) of section
505A(o)(3);</DELETED>
<DELETED> ``(B) the question of the eligibility for
approval under this section of any application
described in subsection (b)(2) or (j) that omits any
other aspect of labeling protected by exclusivity
under--</DELETED>
<DELETED> ``(i) clause (iii) or (iv) of
subsection (j)(5)(F);</DELETED>
<DELETED> ``(ii) clause (iii) or (iv) of
subsection (c)(3)(E); or</DELETED>
<DELETED> ``(iii) section 527(a);
or</DELETED>
<DELETED> ``(C) except as expressly provided in
paragraphs (1) and (2), the operation of this section
or section 527.''.</DELETED>
<DELETED>SEC. 212. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGICAL
PRODUCTS.</DELETED>
<DELETED> Section 351(k)(2)(A)(iii) of the Public Health Service Act
(42 U.S.C. 262(k)(2)(A)(iii)) is amended--</DELETED>
<DELETED> (1) in subclause (I), by striking ``; and'' and
inserting a semicolon;</DELETED>
<DELETED> (2) in subclause (II), by striking the period and
inserting ``; and''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(III) may include
information to show that the conditions
of use prescribed, recommended, or
suggested in the labeling proposed for
the biological product have been
previously approved for the reference
product.''.</DELETED>
<DELETED>SEC. 213. MODERNIZING THE LABELING OF CERTAIN GENERIC
DRUGS.</DELETED>
<DELETED> Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 503C the
following:</DELETED>
<DELETED>``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN
DRUGS.</DELETED>
<DELETED> ``(a) Definitions.--For purposes of this
section:</DELETED>
<DELETED> ``(1) The term `covered drug' means a drug
approved under section 505(c)--</DELETED>
<DELETED> ``(A) for which there are no unexpired
patents included in the list under section 505(j)(7)
and no unexpired period of market
exclusivity;</DELETED>
<DELETED> ``(B) for which the approval of the
application has been withdrawn for reasons other than
safety or effectiveness; and</DELETED>
<DELETED> ``(C) for which, with respect to the
labeling--</DELETED>
<DELETED> ``(i) new scientific evidence is
available regarding the conditions of use of
the drug;</DELETED>
<DELETED> ``(ii) there is a relevant
accepted use in clinical practice that is not
reflected in the approved labeling;
or</DELETED>
<DELETED> ``(iii) the labeling of such drug
does not reflect current legal and regulatory
requirements.</DELETED>
<DELETED> ``(2) The term `period of market exclusivity',
with respect to a drug approved under section 505(c), means any
period of market exclusivity under clause (ii), (iii), or (iv)
of section 505(c)(3)(E), clause (ii), (iii), or (iv) of section
505(j)(5)(F), or section 505A, 505E, or 527.</DELETED>
<DELETED> ``(3) The term `generic version' means a drug
approved under section 505(j) whose reference drug is a covered
drug.</DELETED>
<DELETED> ``(4) The term `relevant accepted use' means a use
for a drug in clinical practice that is supported by scientific
evidence that appears to the Secretary to meet the standards
for approval under section 505.</DELETED>
<DELETED> ``(5) The term `selected drug' means a covered
drug for which the Secretary has determined through the process
under subsection (c) that the labeling should be
changed.</DELETED>
<DELETED> ``(b) Identification of Covered Drugs.--The Secretary may
identify covered drugs for which labeling updates would provide a
public health benefit. To assist in identifying covered drugs, the
Secretary may do one or both of the following:</DELETED>
<DELETED> ``(1) Enter into cooperative agreements or
contracts with public or private entities to review the
available scientific evidence concerning such drugs.</DELETED>
<DELETED> ``(2) Seek public input concerning such drugs,
including input on whether there is a relevant accepted use in
clinical practice that is not reflected in the approved
labeling of such drugs or whether new scientific evidence is
available regarding the conditions of use for such drug, by--
</DELETED>
<DELETED> ``(A) holding one or more public
meetings;</DELETED>
<DELETED> ``(B) opening a public docket for the
submission of public comments; or</DELETED>
<DELETED> ``(C) other means, as the Secretary
determines appropriate.</DELETED>
<DELETED> ``(c) Selection of Drugs for Updating.--If the Secretary
determines, with respect to a covered drug, that the available
scientific evidence meets the standards under section 505 for adding or
modifying information to the labeling or providing supplemental
information to the labeling regarding the use of the covered drug, the
Secretary may initiate the process under subsection (d).</DELETED>
<DELETED> ``(d) Initiation of the Process of Updating.--If the
Secretary determines that labeling changes are appropriate for a
selected drug pursuant to subsection (c), the Secretary shall provide
notice to the holders of approved applications for a generic version of
such drug that--</DELETED>
<DELETED> ``(1) summarizes the findings supporting the
determination of the Secretary that the available scientific
evidence meets the standards under section 505 for adding or
modifying information or providing supplemental information to
the labeling of the covered drug pursuant to subsection
(c);</DELETED>
<DELETED> ``(2) provides a clear statement regarding the
additional, modified, or supplemental information for such
labeling, according to the determination by the Secretary
(including, as applicable, modifications to add the relevant
accepted use to the labeling of the drug as an additional
indication for the drug); and</DELETED>
<DELETED> ``(3) states whether the statement under paragraph
(2) applies to the selected drug as a class of covered drugs or
only as to a specific drug product.</DELETED>
<DELETED> ``(e) Response to Notification.--Within 30 days of receipt
of notification provided by the Secretary pursuant to subsection (d),
the holder of an approved application for a generic version of the
selected drug shall--</DELETED>
<DELETED> ``(1) agree to change the approved labeling to
reflect the additional, modified, or supplemental information
the Secretary has determined to be appropriate; or</DELETED>
<DELETED> ``(2) notify the Secretary that the holder of the
approved application does not believe that the requested
labeling changes are warranted and submit a statement detailing
the reasons why such changes are not warranted.</DELETED>
<DELETED> ``(f) Review of Application Holder's Response.--</DELETED>
<DELETED> ``(1) In general.--Upon receipt of the application
holder's response, the Secretary shall promptly review each
statement received under subsection (e)(2) and determine which
labeling changes pursuant to the Secretary's notice under
subsection (d) are appropriate, if any. If the Secretary
disagrees with the reasons why such labeling changes are not
warranted, the Secretary shall provide opportunity for
discussions with the application holders to reach agreement on
whether the labeling for the covered drug should be updated to
reflect current scientific evidence, and if so, the content of
such labeling changes.</DELETED>
<DELETED> ``(2) Changes to labeling.--After considering all
responses from the holder of an approved application under
paragraph (1) or (2) of subsection (e), and any discussion
under paragraph (1), the Secretary may order such holder to
make the labeling changes the Secretary determines are
appropriate. Such holder of an approved application shall--
</DELETED>
<DELETED> ``(A) update its paper labeling for the
drug at the next printing of that labeling;</DELETED>
<DELETED> ``(B) update any electronic labeling for
the drug within 30 days; and</DELETED>
<DELETED> ``(C) submit the revised labeling through
the form, `Supplement--Changes Being
Effected'.</DELETED>
<DELETED> ``(g) Violation.--If the holder of an approved application
for the generic version of the selected drug does not comply with the
requirements of subsection (f)(2), such generic version of the selected
drug shall be deemed to be misbranded under section 502.</DELETED>
<DELETED> ``(h) Limitations; Generic Drugs.--</DELETED>
<DELETED> ``(1) In general.--With respect to any labeling
change required under this section, the generic version shall
be deemed to have the same conditions of use and the same
labeling as a reference drug for purposes of clauses (i) and
(v) of section 505(j)(2)(A). Any labeling change so required
shall not have any legal effect for the applicant that is
different than the legal effect that would have resulted if a
supplemental application had been submitted and approved to
conform the labeling of the generic version to a change in the
labeling of the reference drug.</DELETED>
<DELETED> ``(2) Supplemental applications.--Changes to
labeling made in accordance with this paragraph shall not be
eligible for an exclusivity period under this Act.</DELETED>
<DELETED> ``(i) Drug Product Classes.--In the case of a selected
drug for which the labeling changes ordered by the Secretary under
subsection (d)(2) are required for a class of covered drugs, such
labeling changes shall be made for generic versions of such drug in
that class.</DELETED>
<DELETED> ``(j) Rules of Construction.--</DELETED>
<DELETED> ``(1) Approval standards.--This section shall not
be construed as altering the applicability of the standards for
approval of an application under section 505. No order shall be
issued under this subsection unless the evidence supporting the
changed labeling meets the standards for approval applicable to
any change to labeling under section 505.</DELETED>
<DELETED> ``(2) Removal of information.--Nothing in this
section shall be construed to give the Secretary additional
authority to remove approved indications for drugs, other than
the authority to remove certain indications from the labels of
certain covered drugs, as described in this section.</DELETED>
<DELETED> ``(k) Reports.--Not later than 4 years after the date of
the enactment of the Lower Health Care Costs Act and every 4 years
thereafter, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, a report that--
</DELETED>
<DELETED> ``(1) describes the actions of the Secretary under
this section, including--</DELETED>
<DELETED> ``(A) the number of covered drugs and
description of the types of drugs the Secretary has
selected for labeling changes and the rationale for
such recommended changes; and</DELETED>
<DELETED> ``(B) the number of times the Secretary
entered into discussions concerning a disagreement with
an application holder or holders and a summary of the
decision regarding a labeling change, if any;
and</DELETED>
<DELETED> ``(2) includes any recommendations of the
Secretary for modifying the program under this
section.''.</DELETED>
<DELETED>TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE</DELETED>
<DELETED>SEC. 301. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES ON
PRICE AND QUALITY INFORMATION.</DELETED>
<DELETED> Subpart II of part A of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-11 et seq.), as amended by section 103, is
amended by adding at the end the following:</DELETED>
<DELETED>``SEC. 2729B. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES
ON PRICE AND QUALITY INFORMATION.</DELETED>
<DELETED> ``(a) Increasing Price and Quality Transparency for Plan
Sponsors and Consumers.--</DELETED>
<DELETED> ``(1) Group health plans.--A group health plan or
a health insurance issuer offering group health insurance
coverage may not enter into an agreement with a health care
provider, network or association of providers, third-party
administrator, or other service provider offering access to a
network of providers that would directly or indirectly restrict
a group health plan or health insurance issuer from--</DELETED>
<DELETED> ``(A) providing provider-specific cost or
quality of care information, through a consumer
engagement tool or any other means, to referring
providers, the plan sponsor, enrollees, or eligible
enrollees of the plan or coverage;</DELETED>
<DELETED> ``(B) electronically accessing de-
identified claims and encounter data for each enrollee
in the plan or coverage, upon request and consistent
with the privacy regulations promulgated pursuant to
section 264(c) of the Health Insurance Portability and
Accountability Act, the amendments to this Act made by
the Genetic Information Nondiscrimination Act of 2008,
and the Americans with Disabilities Act of 1990, with
respect to the applicable health plan or health
insurance coverage, including, on a per claim basis--
</DELETED>
<DELETED> ``(i) financial information, such
as the allowed amount, or any other claim-
related financial obligations included in the
provider contract;</DELETED>
<DELETED> ``(ii) provider information,
including name and clinical
designation;</DELETED>
<DELETED> ``(iii) service codes;
or</DELETED>
<DELETED> ``(iv) any other data element
normally included in claim or encounter
transactions when received by a plan or issuer;
or</DELETED>
<DELETED> ``(C) sharing data described in
subparagraph (A) or (B) with a business associate as
defined in section 160.103 of title 45, Code of Federal
Regulations (or successor regulations), consistent with
the privacy regulations promulgated pursuant to section
264(c) of the Health Insurance Portability and
Accountability Act, the amendments to this Act made by
the Genetic Information Nondiscrimination Act of 2008,
and the Americans with Disabilities Act of
1990.</DELETED>
<DELETED> ``(2) Individual health insurance coverage.--A
health insurance issuer offering individual health insurance
coverage may not enter into an agreement with a health care
provider, network or association of providers, or other service
provider offering access to a network of providers that would,
directly or indirectly restrict the health insurance issuer
from--</DELETED>
<DELETED> ``(A) providing provider-specific price or
quality of care information, through a consumer
engagement tool or any other means, to referring
providers or the plan sponsor, enrollees, or eligible
enrollees of the plan or coverage; or</DELETED>
<DELETED> ``(B) sharing data described in
subparagraph (A) with a business associate as defined
in section 160.103 of title 45, Code of Federal
Regulations (or successor regulations), consistent with
the privacy regulations promulgated pursuant to section
264(c) of the Health Insurance Portability and
Accountability Act, the amendments to this Act made by
the Genetic Information Nondiscrimination Act of 2008,
and the Americans with Disabilities Act of 1990, for
plan design, plan administration, and plan, financial,
legal, and quality improvement activities.</DELETED>
<DELETED> ``(3) Clarification regarding public disclosure of
information.--Nothing in paragraph (1)(A) or (2)(A) prevents a
health care provider, network or association of providers, or
other service provider from placing reasonable restrictions on
the public disclosure of the information described in such
paragraphs (1) and (2).</DELETED>
<DELETED> ``(4) Attestation.--A group health plan or a
health insurance issuer offering group or individual health
insurance coverage shall annually submit to, as applicable, the
applicable authority described in section 2723 or the Secretary
of Labor, an attestation that such plan or issuer is in
compliance with the requirements of this subsection.</DELETED>
<DELETED> ``(5) Rule of construction.--Nothing in this
section shall be construed to otherwise limit group health plan
or plan sponsor access to data currently permitted under the
privacy regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability Act, the
amendments to this Act made by the Genetic Information
Nondiscrimination Act of 2008, and the Americans with
Disabilities Act of 1990.''.</DELETED>
<DELETED>SEC. 302. BANNING ANTICOMPETITIVE TERMS IN FACILITY AND
INSURANCE CONTRACTS THAT LIMIT ACCESS TO HIGHER QUALITY,
LOWER COST CARE.</DELETED>
<DELETED> (a) In General.--Section 2729B of the Public Health
Service Act, as added by section 301, is amended by adding at the end
the following:</DELETED>
<DELETED> ``(b) Protecting Health Plans Network Design
Flexibility.--</DELETED>
<DELETED> ``(1) In general.--A group health plan or a health
insurance issuer offering group or individual health insurance
coverage shall not enter into an agreement with a provider,
network or association of providers, or other service provider
offering access to a network of service providers if such
agreement, directly or indirectly--</DELETED>
<DELETED> ``(A) restricts the group health plan or
health insurance issuer from--</DELETED>
<DELETED> ``(i) directing or steering
enrollees to other health care providers;
or</DELETED>
<DELETED> ``(ii) offering incentives to
encourage enrollees to utilize specific health
care providers;</DELETED>
<DELETED> ``(B) requires the group health plan or
health insurance issuer to enter into any additional
contract with an affiliate of the provider as a
condition of entering into a contract with such
provider;</DELETED>
<DELETED> ``(C) requires the group health plan or
health insurance issuer to agree to payment rates or
other terms for any affiliate not party to the contract
of the provider involved; or</DELETED>
<DELETED> ``(D) restricts other group health plans
or health insurance issuers not party to the contract,
from paying a lower rate for items or services than the
contracting plan or issuer pays for such items or
services.</DELETED>
<DELETED> ``(2) Additional requirement for self-insured
plans.--A self-insured group health plan shall not enter into
an agreement with a provider, network or association of
providers, third-party administrator, or other service provider
offering access to a network of providers if such agreement,
directly or indirectly requires the group health plan to
certify, attest, or otherwise confirm in writing that the group
health plan is bound by the terms of the contract between the
service provider and a third-party administrator that the group
health plan is not party to and is not allowed to
review.</DELETED>
<DELETED> ``(3) Exception for certain group model issuers.--
Paragraph (1)(A) shall not apply to a group health plan or a
health insurance issuer offering group or individual health
insurance coverage with respect to a health maintenance
organization (as defined in section 2791(b)(3)) if such health
maintenance organization operates primarily through exclusive
contracts with multi-specialty physician groups, nor to any
arrangement between such a health maintenance organization and
its affiliates.</DELETED>
<DELETED> ``(4) Attestation.--A group health plan or a
health insurance issuer offering group or individual health
insurance coverage shall annually submit to, as applicable, the
applicable authority described in section 2723 or the Secretary
of Labor, an attestation that such plan or issuer is in
compliance with the requirements of this subsection.</DELETED>
<DELETED> ``(c) Maintenance of Existing HIPAA, GINA, and ADA
Protections.--Nothing in this section shall modify, reduce, or
eliminate the existing privacy protections and standards provided by
reason of State and Federal law, including the requirements of parts
160 and 164 of title 45, Code of Federal Regulations (or any successor
regulations).</DELETED>
<DELETED> ``(d) Regulations.--The Secretary, in coordination with
the Secretary of Labor and the Secretary of the Treasury, not later
than 1 year after the date of enactment of the Lower Health Care Costs
Act, shall promulgate regulations to carry out this section.</DELETED>
<DELETED> ``(e) Rule of Construction.--Nothing in this section shall
be construed to limit network design or cost or quality initiatives by
a group health plan or health insurance issuer, including accountable
care organizations, exclusive provider organizations, networks that
tier providers by cost or quality or steer enrollees to centers of
excellence, or other pay-for-performance programs.''.</DELETED>
<DELETED> (b) Effective Date.--Section 2729B of the Public Health
Service Act (as added by section 301 and amended by subsection (a))
shall apply with respect to any contract entered into after the date of
enactment of this Act. With respect to an applicable contract that is
in effect on the date of enactment of this Act, such section 2729B
shall apply on the earlier of the date of renewal of such contract or 3
years after such date of enactment.</DELETED>
<DELETED>SEC. 303. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT
TRANSPARENCY ORGANIZATION TO LOWER AMERICANS' HEALTH CARE
COSTS.</DELETED>
<DELETED> (a) In General.--Subpart C of part 7 of subtitle B of
title I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1191 et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 735. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT
TRANSPARENCY ORGANIZATION TO LOWER AMERICANS' HEALTH CARE
COSTS.</DELETED>
<DELETED> ``(a) In General.--The Secretary, in consultation with the
Secretary of Health and Human Services, not later than 6 months after
the date of enactment of the Lower Health Care Costs Act, shall have in
effect a contract with a nonprofit entity to support the establishment
and maintenance of a database that receives and utilizes health care
claims information and related information and issues reports that are
available to the public and authorized users, and are submitted to the
Department of Labor.</DELETED>
<DELETED> ``(b) Requirements.--</DELETED>
<DELETED> ``(1) In general.--The database established under
subsection (a) shall--</DELETED>
<DELETED> ``(A) improve transparency by using de-
identified health care data to--</DELETED>
<DELETED> ``(i) inform patients about the
cost, quality, and value of their
care;</DELETED>
<DELETED> ``(ii) assist providers and
hospitals, as they work with patients, to make
informed choices about care;</DELETED>
<DELETED> ``(iii) enable providers,
hospitals, and communities to improve services
and outcomes for patients by benchmarking their
performance against that of other providers,
hospitals, and communities;</DELETED>
<DELETED> ``(iv) enable purchasers,
including employers, employee organizations,
and health plans, to develop value-based
purchasing models, improve quality, and reduce
the cost of health care and insurance coverage
for enrollees;</DELETED>
<DELETED> ``(v) enable employers and
employee organizations to evaluate network
design and construction, and the cost of care
for enrollees;</DELETED>
<DELETED> ``(vi) facilitate State-led
initiatives to lower health care costs and
improve quality; and</DELETED>
<DELETED> ``(vii) promote competition based
on quality and cost;</DELETED>
<DELETED> ``(B) collect medical claims, prescription
drug claims, and remittance data consistent with the
protections and requirements of subsection
(d);</DELETED>
<DELETED> ``(C) be established in such a manner that
allows the data collected pursuant to subparagraph (B)
to be shared with any State all-payer claims database
or regional database operated with authorization from
States, at cost, using a standardized format, if such
State or regional database also submits claims data to
the database established under this section;
and</DELETED>
<DELETED> ``(D) be available to--</DELETED>
<DELETED> ``(i) the Director of the
Congressional Budget Office, the Comptroller
General of the United States, the Executive
Director of the Medicare Payment Advisory
Commission, and the Executive Director of the
Medicaid and CHIP Payment Advisory Commission,
upon request, subject to the privacy and
security requirements of authorized users under
subsection (e)(2); and</DELETED>
<DELETED> ``(ii) authorized users, including
employers, employee organizations, providers,
researchers, and policymakers, subject to
subsection (e).</DELETED>
<DELETED> ``(2) Privacy and security.--The entity receiving
a contract under subsection (a) shall--</DELETED>
<DELETED> ``(A) be subject to the breach
notification rule under subpart D of part 164 of title
45, Code of Federal Regulations (or any successor
regulations), the security rule under part 160 and
subparts A and C of part 164 of title 45, Code of
Federal Regulations (or any successor regulations), and
the privacy rule under part 160 and subparts A and E of
part 164 of title 45, Code of Federal Regulations (or
any successor regulations); and</DELETED>
<DELETED> ``(B) consistent with the requirements and
prohibitions in the regulations promulgated under
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996--</DELETED>
<DELETED> ``(i) ensure that the database
under subsection (a) is capable of--</DELETED>
<DELETED> ``(I) receiving data under
subsection (d);</DELETED>
<DELETED> ``(II) providing data
access to authorized users;
and</DELETED>
<DELETED> ``(III) storing data on
secure servers in a manner that is
consistent with the privacy, security,
and breach notification requirements
under section 13402 of the HITECH Act
and under the regulations promulgated
under section 264(c) of the Health
Insurance Portability and
Accountability Act of 1996;</DELETED>
<DELETED> ``(ii) not disclose to the public
any individually identifiable health
information or proprietary financial
information;</DELETED>
<DELETED> ``(iii) strictly limit staff
access to the data to staff with appropriate
training, clearance, and background checks and
require regular privacy and security
training;</DELETED>
<DELETED> ``(iv) maintain effective security
standards for transferring data or making data
available to authorized users;</DELETED>
<DELETED> ``(v) develop a process for
providing access to data to authorized users,
in a secure manner that maintains privacy and
confidentiality of data;</DELETED>
<DELETED> ``(vi) adhere to current best
security practices with respect to the
management and use of such data for health
services research, in accordance with
applicable Federal privacy law; and</DELETED>
<DELETED> ``(vii) report on the security
methods of the entity to the Secretary, the
Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on
Education and Labor of the House of
Representatives.</DELETED>
<DELETED> ``(3) Consultation.--</DELETED>
<DELETED> ``(A) Advisory committee.--Not later than
180 days after the date of enactment of the Lower
Health Care Costs Act, the Secretary shall convene an
Advisory Committee (referred to in this section as the
`Committee'), consisting of 11 members, to advise the
Secretary, the contracting entity, and Congress on the
establishment, operations, and use of the database
established under this section.</DELETED>
<DELETED> ``(B) Membership.--</DELETED>
<DELETED> ``(i) Appointment.--In accordance
with clause (ii), the Secretary, in
consultation with the Secretary of Health and
Human Services, and the Comptroller General of
the United States shall, not later than 1 year
after the date of enactment of the Lower Health
Care Costs Act, appoint members to the
Committee who have distinguished themselves in
the fields of health services research, health
economics, health informatics, or the
governance of State all-payer claims databases,
or who represent organizations likely to submit
data to or use the database, including
patients, employers, or employee organizations
that sponsor group health plans, health care
providers, health insurance issuers, and third-
party administrators of group health plans.
Such members shall serve 3-year terms on a
staggered basis. Vacancies on the Committee
shall be filled by appointment consistent with
this subsection not later than 3 months after
the vacancy arises.</DELETED>
<DELETED> ``(ii) Composition.--In accordance
with clause (i)--</DELETED>
<DELETED> ``(I) the Secretary, in
consultation with the Secretary of
Health and Human Services, shall
appoint to the Committee--</DELETED>
<DELETED> ``(aa) 1 member
selected by the Secretary, in
coordination with the Secretary
of Health and Human Services,
to serve as the chair of the
Committee;</DELETED>
<DELETED> ``(bb) the
Assistant Secretary for
Planning and Evaluation of the
Department of Health and Human
Services;</DELETED>
<DELETED> ``(cc) 1
representative of the Centers
for Medicare & Medicaid
Services;</DELETED>
<DELETED> ``(dd) 1
representative of the Agency
for Health Research and
Quality;</DELETED>
<DELETED> ``(ee) 1
representative of the Office
for Civil Rights of the
Department of Health and Human
Services with expertise in data
privacy and security;
and</DELETED>
<DELETED> ``(ff) 1
representative of the National
Center for Health Statistics;
and</DELETED>
<DELETED> ``(II) the Comptroller
General of the United States shall
appoint to the Committee--</DELETED>
<DELETED> ``(aa) 1
representative of an employer
that sponsors a group health
plan;</DELETED>
<DELETED> ``(bb) 1
representative of an employee
organization that sponsors a
group health plan;</DELETED>
<DELETED> ``(cc) 1 academic
researcher with expertise in
health economics or health
services research;</DELETED>
<DELETED> ``(dd) 1 patient
advocate; and</DELETED>
<DELETED> ``(ee) 2
additional members.</DELETED>
<DELETED> ``(C) Duties.--The Committee shall--
</DELETED>
<DELETED> ``(i) assist and advise the
Secretary on the management of the contract
under subsection (a);</DELETED>
<DELETED> ``(ii) assist and advise the
entity receiving the contract under subsection
(a) in establishing--</DELETED>
<DELETED> ``(I) the scope and format
of the data to be submitted under
subsection (d);</DELETED>
<DELETED> ``(II) the appropriate
uses of data by authorized users,
including developing standards for the
approval of requests by organizations
to access and use the data;
and</DELETED>
<DELETED> ``(III) the appropriate
formats and methods for making reports
and analyses based on the database to
the public;</DELETED>
<DELETED> ``(iii) conduct an annual review
of whether data was used according to the
appropriate uses as described in clause
(ii)(II), and advise the designated entity on
using the data for authorized
purposes;</DELETED>
<DELETED> ``(iv) report, as appropriate, to
the Secretary and Congress on the operation of
the database and opportunities to better
achieve the objectives of this
section;</DELETED>
<DELETED> ``(v) establish additional
restrictions on researchers who receive
compensation from entities described in
subsection (e)(2)(B)(ii), in order to protect
proprietary financial information;
and</DELETED>
<DELETED> ``(vi) establish objectives for
research and public reporting.</DELETED>
<DELETED> ``(4) State requirements.--A State may require
health insurance issuers and other payers to submit claims data
to the database established under this section, provided that
such data is submitted in a form and manner established by the
Secretary, and pursuant to subsection (d)(4)(B).</DELETED>
<DELETED> ``(5) Sanctions.--The Secretary shall take
appropriate action to sanction users who attempt to re-identify
data accessed pursuant to paragraph (1)(D).</DELETED>
<DELETED> ``(c) Contract Requirements.--</DELETED>
<DELETED> ``(1) Competitive procedures.--The Secretary shall
enter into the contract under subsection (a) using full and
open competition procedures pursuant to chapter 33 of title 41,
United States Code.</DELETED>
<DELETED> ``(2) Eligible entities.--To be eligible to enter
into a contract described in subsection (a), an entity shall--
</DELETED>
<DELETED> ``(A) be a private nonprofit entity
governed by a board that includes representatives of
the academic research community and individuals with
expertise in employer-sponsored insurance, research
using health care claims data and actuarial
analysis;</DELETED>
<DELETED> ``(B) conduct its business in an open and
transparent manner that provides the opportunity for
public comment on its activities; and</DELETED>
<DELETED> ``(C) agree to maintain an active
certification as a qualified entity under section
1874(e) of the Social Security Act (or any successor
program) throughout the contract period.</DELETED>
<DELETED> ``(3) Considerations.--In awarding the contract
under subsection (a), the Secretary shall consider an entity's
experience in--</DELETED>
<DELETED> ``(A) health care claims data collection,
aggregation, quality assurance, analysis, and
security;</DELETED>
<DELETED> ``(B) supporting academic research on
health costs, spending, and utilization for and by
privately insured patients;</DELETED>
<DELETED> ``(C) working with large health insurance
issuers and third-party administrators to assemble a
national claims database;</DELETED>
<DELETED> ``(D) effectively collaborating with and
engaging stakeholders to develop reports;</DELETED>
<DELETED> ``(E) meeting budgets and timelines,
including in connection with report generation;
and</DELETED>
<DELETED> ``(F) facilitating the creation of, or
supporting, State all-payer claims databases.</DELETED>
<DELETED> ``(4) Contract term.--A contract awarded under
this section shall be for a period of 5 years, and may be
renewed after a subsequent competitive bidding process under
this section.</DELETED>
<DELETED> ``(5) Transition of contract.--If the Secretary,
following a competitive process at the end of the contract
period, selects a new entity to maintain the database, all data
shall be transferred to the new entity according to a schedule
and process to be determined by the Secretary. Upon termination
of a contract, no entity may keep data held by the database or
disclose such data to any entity other than the entity so
designated by the Secretary. The Secretary shall include
enforcement terms in any contract with an organization chosen
under this section, to ensure the timely transfer of all data
to a new entity in the event of contract termination.</DELETED>
<DELETED> ``(d) Receiving Health Information.--</DELETED>
<DELETED> ``(1) Requirements.--</DELETED>
<DELETED> ``(A) In general.--An applicable self-
insured group health plan shall, through its health
insurance issuer, third-party administrator, pharmacy
benefit manager, or other entity designated by the
group health plan, electronically submit all claims
data with respect to the plan, pursuant to subparagraph
(B).</DELETED>
<DELETED> ``(B) Scope of information and format of
submission.--The entity awarded the contract under
subsection (a), in consultation with the Committee
described in subsection (b)(3), and pursuant to the
privacy and security requirements of subsection (b)(2),
shall--</DELETED>
<DELETED> ``(i) specify the data elements
required to be submitted under subparagraph
(A), which shall include all data related to
transactions described in subparagraphs (A) and
(E) of section 1173(a)(2) of the Social
Security Act, including all data elements
normally present in such transactions when
adjudicated, and enrollment
information;</DELETED>
<DELETED> ``(ii) specify the form and manner
for such submissions, and the historical period
to be included in the initial submission;
and</DELETED>
<DELETED> ``(iii) offer an automated
submission option to minimize administrative
burdens for entities required to submit
data.</DELETED>
<DELETED> ``(C) De-identification of data.--The
entity awarded the contract under subsection (a)
shall--</DELETED>
<DELETED> ``(i) establish a process under
which data is de-identified in accordance with
section 164.514(a) of title 45, Code of Federal
Regulations (or any successor regulations),
while retaining the ability to link data
longitudinally for the purposes of research on
cost and quality, and the ability to complete
risk adjustment and geographic
analysis;</DELETED>
<DELETED> ``(ii) ensure that any third-party
subcontractors who perform the de-
identification process described in clause (i)
retain the minimum necessary information to
perform such a process, and adhere to effective
security and encryption practices in data
storage and transmission;</DELETED>
<DELETED> ``(iii) store claims and other
data collected under this subsection only in
de-identified form, in accordance with section
164.514(a) of title 45, Code of Federal
Regulations (or any successor regulations);
and</DELETED>
<DELETED> ``(iv) ensure that data is
encrypted, in accordance with the regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of
1996.</DELETED>
<DELETED> ``(2) Applicable self-insured group health plan.--
For purposes of paragraph (1), a self-insured group health plan
is an applicable self-insured group health plan if such plan is
self-administered, or is administered by a health insurance
issuer or third-party administrator that meets one or both of
the following criteria:</DELETED>
<DELETED> ``(A) Administers health benefits for more
than 50,000 enrollees.</DELETED>
<DELETED> ``(B) Is one of the 5 largest
administrators or issuers of self-insured group health
plans in a State in which such administrator operates,
as measured by the number of enrollees.</DELETED>
<DELETED> ``(3) Issuers and third-party administrators.--In
the case of a health insurance issuer or third-party
administrator that is required under this subsection to submit
claims data with respect to an applicable self-insured group
health plan, such issuer or administrator shall submit claims
data with respect to all self-insured group health plans that
the issuer or administrator administers, including such plans
that are not applicable self-insured group health plans, as
described in paragraph (2).</DELETED>
<DELETED> ``(4) Receiving other information.--</DELETED>
<DELETED> ``(A) Medicare data.--The entity awarded
the contract under subsection (a) shall maintain active
certification as a qualified entity pursuant to section
1874(e) of the Social Security Act for the term of the
contract awarded under subsection (a).</DELETED>
<DELETED> ``(B) State data.--The entity awarded the
contract under subsection (a) shall collect data from
State all-payer claims databases that seek access to
the database established under this section.</DELETED>
<DELETED> ``(5) Availability of data.--An entity required to
submit data under this subsection may not place any
restrictions on the use of such data by authorized
users.</DELETED>
<DELETED> ``(e) Uses of Information.--</DELETED>
<DELETED> ``(1) In general.--The entity awarded the contract
under subsection (a) shall make the database available to users
who are authorized under this subsection, at cost, and reports
and analyses based on the data available to the public with no
charge.</DELETED>
<DELETED> ``(2) Authorization of users.--</DELETED>
<DELETED> ``(A) In general.--An entity may request
authorization by the entity awarded the contract under
subsection (a) for access to the database in accordance
with this paragraph.</DELETED>
<DELETED> ``(B) Application.--An entity desiring
authorization under this paragraph shall submit to the
entity awarded the contract an application for such
access, which shall include--</DELETED>
<DELETED> ``(i) in the case of an entity
requesting access for research purposes--
</DELETED>
<DELETED> ``(I) a description of the
uses and methodologies for evaluating
health system performance using such
data; and</DELETED>
<DELETED> ``(II) documentation of
approval of the research by an
institutional review board, if
applicable for a particular plan of
research; or</DELETED>
<DELETED> ``(ii) in the case of an entity
such as an employer, health insurance issuer,
third-party administrator, or health care
provider, requesting access for the purpose of
quality improvement or cost-containment, a
description of the intended uses for such
data.</DELETED>
<DELETED> ``(C) Requirements.--</DELETED>
<DELETED> ``(i) Research.--Upon approval of
an application for research purposes under
subparagraph (B)(i), the authorized user shall
enter into a data use and confidentiality
agreement with the entity awarded the contract
under subsection (a), which shall include a
prohibition on attempts to reidentify and
disclose protected health information and
proprietary financial information.</DELETED>
<DELETED> ``(ii) Quality improvement and
cost-containment.--In consultation with the
Committee described in subsection (b)(3), the
Secretary shall, through rulemaking, establish
the form and manner in which authorized users
described in subparagraph (B)(ii) may access
data. Data provided to such authorized users
shall be provided in a form and manner such
that users may not obtain individually
identifiable price information with respect to
direct competitors. Upon approval, such
authorized user shall enter into a data use and
confidentiality agreement with the
entity.</DELETED>
<DELETED> ``(iii) Customized reports.--
Employers and employer organizations may
request customized reports from the entity
awarded the contract under subsection (a), at
cost, subject to the requirements of this
section with respect to privacy, security, and
proprietary financial information.</DELETED>
<DELETED> ``(iv) Non-customized reports.--
The entity awarded the contract under
subsection (a), in consultation with the
Committee, shall make available to all
authorized users aggregate data sets, free of
charge.</DELETED>
<DELETED> ``(f) Funding.--</DELETED>
<DELETED> ``(1) Initial funding.--There are authorized to be
appropriated, and there are appropriated, out of monies in the
Treasury not otherwise appropriated, $20,000,000 for fiscal
year 2020, for the implementation of the initial contract and
establishment of the database under this section.</DELETED>
<DELETED> ``(2) Ongoing funding.--There are authorized to be
appropriated $15,000,000 for each of fiscal years 2021 through
2025, for purposes of carrying out this section (other than the
grant program under subsection (h)).</DELETED>
<DELETED> ``(g) Annual Report.--</DELETED>
<DELETED> ``(1) Submission.--Not later than March 1, 2021,
and March 1 of each year thereafter, the entity receiving the
contract under subsection (a) shall submit to Congress, the
Secretary of Labor, and the Secretary of Health and Human
Services, and publish online for access by the general public,
a report containing a description of--</DELETED>
<DELETED> ``(A) trends in the price, utilization,
and total spending on health care services, including a
geographic analysis of differences in such
trends;</DELETED>
<DELETED> ``(B) limitations in the data
set;</DELETED>
<DELETED> ``(C) progress towards the objectives of
this section; and</DELETED>
<DELETED> ``(D) the performance by the entity of the
duties required under such contract.</DELETED>
<DELETED> ``(2) Public reports and research.--The entity
receiving a contract under subsection (a) shall, in
coordination with authorized users, make analyses and research
available to the public on an ongoing basis to promote the
objectives of this section.</DELETED>
<DELETED> ``(h) Grants to States.--</DELETED>
<DELETED> ``(1) In general.--The Secretary, in consultation
with the Secretary of Health and Human Services, may award
grants to States for the purpose of establishing and
maintaining State all-payer claims databases that improve
transparency of data in order to meet the goals of subsection
(a)(1).</DELETED>
<DELETED> ``(2) Requirement.--To be eligible to receive the
funding under paragraph (1), a State shall submit data to the
database as described in subsection (b)(1)(C), using the format
described in subsection (d)(1).</DELETED>
<DELETED> ``(3) Funding.--There is authorized to be
appropriated $100,000,000 for the period of fiscal years 2020
through 2029 for the purpose of awarding grants to States under
this subsection.</DELETED>
<DELETED> ``(i) Exemption From Public Disclosure.--</DELETED>
<DELETED> ``(1) In general.--Claims data provided to the
database, and the database itself shall not be considered
public records and shall be exempt from public disclosure
requirements.</DELETED>
<DELETED> ``(2) Restrictions on uses for certain
proceedings.--Data disclosed to authorized users shall not be
subject to discovery or admission as public information, or
evidence in judicial or administrative proceedings without
consent of the affected parties.</DELETED>
<DELETED> ``(j) Definitions.--</DELETED>
<DELETED> ``(1) Protected health information.--The term
`protected health information' has the meaning given such term
in section 160.103 of title 45, Code of Federal Regulations (or
any successor regulations).</DELETED>
<DELETED> ``(2) Proprietary financial information.--The term
`proprietary financial information' means data that would
disclose the terms of a specific contract between an individual
health care provider or facility and a specific group health
plan, Medicaid managed care organization or other managed care
entity, or health insurance issuer offering group or individual
coverage.</DELETED>
<DELETED> ``(k) Rule of Construction.--Nothing in this section shall
be construed to affect or modify enforcement of the privacy, security,
or breach notification rules promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996 (or
successor regulations).''.</DELETED>
<DELETED> (b) GAO Report.--</DELETED>
<DELETED> (1) In general.--The Comptroller General of the
United States shall conduct a study on--</DELETED>
<DELETED> (A) the performance of the entity awarded
a contract under section 735(a) of the Employee
Retirement Income Security Act of 1974, as added by
subsection (a), under such contract;</DELETED>
<DELETED> (B) the privacy and security of the
information reported to the entity; and</DELETED>
<DELETED> (C) the costs incurred by such entity in
performing such duties.</DELETED>
<DELETED> (2) Reports.--Not later than 2 years after the
effective date of the first contract entered into under section
735(a) of the Employee Retirement Income Security Act of 1974,
as added by subsection (a), and again not later than 4 years
after such effective date, the Comptroller General of the
United States shall submit to Congress a report containing the
results of the study conducted under paragraph (1), together
with recommendations for such legislation and administrative
action as the Comptroller General determines
appropriate.</DELETED>
<DELETED> (c) Clerical Amendment.--The table of contents in section
1 of the Employee Retirement Income Security Act of 1974 is amended by
inserting after the item relating to section 734 the following new
item:</DELETED>
<DELETED>``Sec. 735. Designation of a nongovernmental, nonprofit
transparency organization to lower
Americans' health care costs.''.
<DELETED>SEC. 304. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF
PROVIDER DIRECTORY INFORMATION.</DELETED>
<DELETED> Subpart II of part A of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-11 et seq.), as amended by sections 301
and 302, is further amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE ACCURACY
OF PROVIDER DIRECTORY INFORMATION.</DELETED>
<DELETED> ``(a) Network Status of Providers.--</DELETED>
<DELETED> ``(1) In general.--Beginning on the date that is
one year after the date of enactment of this section, a group
health plan or a health insurance issuer offering group or
individual health insurance coverage shall--</DELETED>
<DELETED> ``(A) establish business processes to
ensure that all enrollees in such plan or coverage
receive proof of a health care provider's network
status--</DELETED>
<DELETED> ``(i) through a written electronic
communication from the plan or issuer to the
enrollee, as soon as practicable and not later
than 1 business day after a telephone inquiry
is made by such enrollee for such information;
and</DELETED>
<DELETED> ``(ii) in real-time through an
online health care provider directory search
tool maintained by the plan or issuer;
and</DELETED>
<DELETED> ``(B) include in any print directory a
disclosure that the information included in the
directory is accurate as of the date of the last data
update and that enrollees or prospective enrollees
should consult the group health plan or issuer's
electronic provider directory on its website or call a
specified customer service telephone number to obtain
the most current provider directory
information.</DELETED>
<DELETED> ``(2) Group health plan and health insurance
issuer business processes.--Beginning on the date that is one
year after the date of enactment of the Lower Health Care Costs
Act, a group health plan or a health insurance issuer offering
group or individual health insurance coverage shall establish
business processes to--</DELETED>
<DELETED> ``(A) verify and update, at least once
every 90 days, the provider directory information for
all providers included in the online health care
provider directory search tool described in paragraph
(1)(A)(ii); and</DELETED>
<DELETED> ``(B) remove any provider from such online
directory search tool if such provider has not verified
the directory information within the previous 6 months
or the plan or issuer has been unable to verify the
provider's network participation.</DELETED>
<DELETED> ``(b) Cost-Sharing Limitations.--</DELETED>
<DELETED> ``(1) In general.--A group health plan or a health
insurance issuer offering group or individual health insurance
coverage shall not apply, and shall ensure that no provider
applies cost-sharing to an enrollee for treatment or services
provided by a health care provider in excess of the normal
cost-sharing applied for in-network care (including any balance
bill issued by the health care provider involved), if such
enrollee, or health care provider referring such enrollee,
demonstrates (based on the electronic information described in
subsection (a)(1)(A)(i) or a copy of the online provider
directory described in subsection (a)(1)(A)(ii) on the date the
enrollee attempted to obtain the provider's network status)
that the enrollee relied on the information described in
subsection (a)(1), if the provider's network status or
directory information on such directory was incorrect at the
time the treatment or services involved was provided.</DELETED>
<DELETED> ``(2) Refunds to enrollees.--If a health care
provider submits a bill to an enrollee in violation of
paragraph (1), and the enrollee pays such bill, the provider
shall reimburse the enrollee for the full amount paid by the
enrollee in excess of the in-network cost-sharing amount for
the treatment or services involved, plus interest, at an
interest rate determined by the Secretary.</DELETED>
<DELETED> ``(c) Provider Business Processes.--A health care provider
shall have in place business processes to ensure the timely provision
of provider directory information to a group health plan or a health
insurance issuer offering group or individual health insurance coverage
to support compliance by such plans or issuers with subsection (a)(1).
Such providers shall submit provider directory information to a plan or
issuers, at a minimum--</DELETED>
<DELETED> ``(1) when the provider begins a network agreement
with a plan or with an issuer with respect to certain
coverage;</DELETED>
<DELETED> ``(2) when the provider terminates a network
agreement with a plan or with an issuer with respect to certain
coverage;</DELETED>
<DELETED> ``(3) when there are material changes to the
content of provider directory information described in
subsection (a)(1); and</DELETED>
<DELETED> ``(4) every 90 days throughout the duration of the
network agreement with a plan or issuer.</DELETED>
<DELETED> ``(d) Enforcement.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), a
health care provider that violates a requirement under
subsection (c) or takes actions that prevent a group health
plan or health insurance issuer from complying with subsection
(a)(1) or (b) shall be subject to a civil monetary penalty of
not more than $10,000 for each act constituting such
violation.</DELETED>
<DELETED> ``(2) Safe harbor.--The Secretary may waive the
penalty described under paragraph (1) with respect to a health
care provider that unknowingly violates subsection (b)(1) with
respect to an enrollee if such provider rescinds the bill
involved and, if applicable, reimburses the enrollee within 30
days of the date on which the provider billed the enrollee in
violation of such subsection.</DELETED>
<DELETED> ``(3) Procedure.--The provisions of section 1128A
of the Social Security Act, other than subsections (a) and (b)
and the first sentence of subsection (c)(1) of such section,
shall apply to civil money penalties under this subsection in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A of the Social Security
Act.</DELETED>
<DELETED> ``(e) Savings Clause.--Nothing in this section shall
prohibit a provider from requiring in the terms of a contract, or
contract termination, with a group health plan or health insurance
issuer--</DELETED>
<DELETED> ``(1) that the plan or issuer remove, at the time
of termination of such contract, the provider from a directory
of the plan or issuer described in subsection (a)(1);
or</DELETED>
<DELETED> ``(2) that the plan or issuer bear financial
responsibility, including under subsection (b), for providing
inaccurate network status information to an enrollee.</DELETED>
<DELETED> ``(f) Definition.--For purposes of this section, the term
`provider directory information' includes the names, addresses,
specialty, and telephone numbers of individual health care providers,
and the names, addresses, and telephone numbers of each medical group,
clinic, or facility contracted to participate in any of the networks of
the group health plan or health insurance coverage involved.</DELETED>
<DELETED> ``(g) Rule of Construction.--Nothing in this section shall
be construed to preempt any provision of State law relating to health
care provider directories or network adequacy.''.</DELETED>
<DELETED>SEC. 305. TIMELY BILLS FOR PATIENTS.</DELETED>
<DELETED> (a) In General.--</DELETED>
<DELETED> (1) Amendment.--Part P of title III of the Public
Health Service Act (42 U.S.C. 280g et seq.) is amended by
adding at the end the following:</DELETED>
<DELETED>``SEC. 399V-7. TIMELY BILLS FOR PATIENTS.</DELETED>
<DELETED> ``(a) In General.--The Secretary shall require--</DELETED>
<DELETED> ``(1) health care facilities, or in the case of
practitioners providing services outside of such a facility,
practitioners, to provide to patients a list of services
rendered during the visit to such facility or practitioner,
and, in the case of a facility, the name of the provider for
each such service, upon discharge or by postal or electronic
communication as soon as practicable and not later than 5
calendar days after discharge; and</DELETED>
<DELETED> ``(2) health care facilities and practitioners to
send all adjudicated bills to the patient as soon as
practicable, but not later than 45 calendar days after
discharge.</DELETED>
<DELETED> ``(b) Payment After Billing.--No patient may be required
to pay a bill for health care services any earlier than 30 calendar
days after receipt of a bill for such services.</DELETED>
<DELETED> ``(c) Effect of Violation.--</DELETED>
<DELETED> ``(1) Notification and refund requirements.--
</DELETED>
<DELETED> ``(A) Provider lists.--If a facility or
practitioner fails to provide a patient a list as
required under subsection (a)(1), such facility or
practitioner shall report such failure to the
Secretary.</DELETED>
<DELETED> ``(B) Billing.--If a facility or
practitioner bills a patient after the 45-calendar-day
period described in subsection (a)(2), such facility or
practitioner shall--</DELETED>
<DELETED> ``(i) report such bill to the
Secretary; and</DELETED>
<DELETED> ``(ii) refund the patient for the
full amount paid in response to such bill with
interest, at a rate determined by the
Secretary.</DELETED>
<DELETED> ``(2) Civil monetary penalties.--</DELETED>
<DELETED> ``(A) In general.--The Secretary may
impose civil monetary penalties of up to $10,000 a day
on any facility or practitioner that--</DELETED>
<DELETED> ``(i) fails to provide a list
required under subsection (a)(1) more than 10
times, beginning on the date of such tenth
failure;</DELETED>
<DELETED> ``(ii) submits more than 10 bills
outside of the period described in subsection
(a)(2), beginning on the date on which such
facility or practitioner sends the tenth such
bill;</DELETED>
<DELETED> ``(iii) fails to report to the
Secretary any failure to provide lists as
required under paragraph (1)(A), beginning on
the date that is 45 calendar days after
discharge; or</DELETED>
<DELETED> ``(iv) fails to send any bill as
required under subsection (a)(2), beginning on
the date that is 45 calendar days after the
date of discharge or visit, as
applicable.</DELETED>
<DELETED> ``(B) Procedure.--The provisions of
section 1128A of the Social Security Act, other than
subsections (a) and (b) and the first sentence of
subsection (c)(1) of such section, shall apply to civil
money penalties under this subsection in the same
manner as such provisions apply to a penalty or
proceeding under section 1128A of the Social Security
Act.</DELETED>
<DELETED> ``(3) Safe harbor.--The Secretary may exempt a
practitioner or facility from the penalties under paragraph
(2)(A) or extend the period of time specified under subsection
(a)(2) for compliance with such subsection if a practitioner or
facility--</DELETED>
<DELETED> ``(A) makes a good faith attempt to send a
bill within 30 days but is unable to do so because of
an incorrect address; or</DELETED>
<DELETED> ``(B) experiences extenuating
circumstances (as defined by the Secretary), such as a
hurricane or cyberattack, that may reasonably delay
delivery of a timely bill.''.</DELETED>
<DELETED> (2) Rulemaking.--Not later than 1 year after the
date of enactment of this Act, the Secretary shall promulgate
final regulations to define the term ``extenuating
circumstance'' for purposes of section 399V-7(c)(3)(B) of the
Public Health Service Act, as added by paragraph (1).</DELETED>
<DELETED> (b) Group Health Plan and Health Insurance Issuer
Requirements.--Subpart II of part A of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-11), as amended by section 304, is further
amended by adding to the end the following:</DELETED>
<DELETED>``SEC. 2729D. TIMELY BILLS FOR PATIENTS.</DELETED>
<DELETED> ``(a) In General.--A group health plan or health insurance
issuer offering group or individual health insurance coverage shall
have in place business practices with respect to in-network facilities
and practitioners to ensure that claims are adjudicated in order to
facilitate facility and practitioner compliance with the requirements
under section 399V-7(a).</DELETED>
<DELETED> ``(b) Clarification.--Nothing in subsection (a) prohibits
a provider and a group health plan or health insurance issuer from
establishing in a contract the timeline for submission by either party
to the other party of billing information, adjudication, sending of
remittance information, or any other coordination required between the
provider and the plan or issuer necessary for meeting the deadline
described in section 399V-7(a)(2).''.</DELETED>
<DELETED> (c) Effective Date.--The amendments made by subsections
(a) and (b) shall take effect 6 months after the date of enactment of
this Act.</DELETED>
<DELETED>SEC. 306. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER
SERVICES.</DELETED>
<DELETED> Subpart II of part A of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-11 et seq.), as amended by section 305, is
further amended by adding at the end the following:</DELETED>
<DELETED>``SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT
MANAGER SERVICES.</DELETED>
<DELETED> ``(a) In General.--A group health plan or health insurance
issuer offering group or individual health insurance coverage or an
entity or subsidiary providing pharmacy benefits management services
shall not enter into a contract with a drug manufacturer, distributor,
wholesaler, subcontractor, rebate aggregator, or any associated third
party that limits the disclosure of information to plan sponsors in
such a manner that prevents the plan or coverage, or an entity or
subsidiary providing pharmacy benefits management services on behalf of
a plan or coverage from making the reports described in subsection
(b).</DELETED>
<DELETED> ``(b) Reports to Group Plan Sponsors.--</DELETED>
<DELETED> ``(1) In general.--Beginning with the first plan
year that begins after the date of enactment of the Lower
Health Care Costs Act, not less frequently than once per plan
quarter, a health insurance issuer offering group health
insurance coverage or an entity providing pharmacy benefits
management services on behalf of a group health plan shall
submit to the plan sponsor (as defined in section 3(16)(B) of
the Employee Retirement Income Security Act of 1974) of such
group health plan or health insurance coverage a report in
accordance with this subsection and make such report available
to the plan sponsor in a machine-readable format. Each such
report shall include, with respect to the applicable group
health plan or health insurance coverage--</DELETED>
<DELETED> ``(A) information collected from drug
manufacturers by such issuer or entity on the total
amount of copayment assistance dollars paid, or
copayment cards applied, that were funded by the drug
manufacturer with respect to the enrollees in such plan
or coverage;</DELETED>
<DELETED> ``(B) a list of each covered drug
dispensed during the reporting period, including, with
respect to each such drug during the reporting period--
</DELETED>
<DELETED> ``(i) the brand name, chemical
entity, and National Drug Code;</DELETED>
<DELETED> ``(ii) the number of enrollees for
whom the drug was filled during the plan year,
the total number of prescription fills for the
drug (including original prescriptions and
refills), and the total number of dosage units
of the drug dispensed across the plan year,
including whether the dispensing channel was by
retail, mail order, or specialty
pharmacy;</DELETED>
<DELETED> ``(iii) the wholesale acquisition
cost, listed as cost per days supply and cost
per pill, or in the case of a drug in another
form, per dose;</DELETED>
<DELETED> ``(iv) the total out-of-pocket
spending by enrollees on such drug, including
enrollee spending through copayments,
coinsurance, and deductibles; and</DELETED>
<DELETED> ``(v) for any drug for which gross
spending of the group health plan or health
insurance coverage exceeded $10,000 during the
reporting period--</DELETED>
<DELETED> ``(I) a list of all other
available drugs in the same therapeutic
category or class, including brand name
drugs and biological products and
generic drugs or biosimilar biological
products that are in the same
therapeutic category or class;
and</DELETED>
<DELETED> ``(II) the rationale for
preferred formulary placement of a
particular drug or drugs in that
therapeutic category or
class;</DELETED>
<DELETED> ``(C) a list of each therapeutic category
or class of drugs that were dispensed under the health
plan or health insurance coverage during the reporting
period, and, with respect to each such therapeutic
category or class of drugs, during the reporting
period--</DELETED>
<DELETED> ``(i) total gross spending by the
plan, before manufacturer rebates, fees, or
other manufacturer remuneration;</DELETED>
<DELETED> ``(ii) the number of enrollees who
filled a prescription for a drug in that
category or class;</DELETED>
<DELETED> ``(iii) if applicable to that
category or class, a description of the
formulary tiers and utilization mechanisms
(such as prior authorization or step therapy)
employed for drugs in that category or
class;</DELETED>
<DELETED> ``(iv) the total out-of-pocket
spending by enrollees, including enrollee
spending through copayments, coinsurance, and
deductibles; and</DELETED>
<DELETED> ``(v) for each therapeutic
category or class under which three or more
drugs are marketed and available--</DELETED>
<DELETED> ``(I) the amount received,
or expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--</DELETED>
<DELETED> ``(aa) to be paid
by drug manufacturers for
claims incurred during the
reporting period; or</DELETED>
<DELETED> ``(bb) that is
related to utilization of
drugs, in such therapeutic
category or class;</DELETED>
<DELETED> ``(II) the total net
spending by the health plan or health
insurance coverage on that category or
class of drugs; and</DELETED>
<DELETED> ``(III) the net price per
dosage unit or course of treatment
incurred by the health plan or health
insurance coverage and its enrollees,
after manufacturer rebates, fees, and
other remuneration for drugs dispensed
within such therapeutic category or
class during the reporting
period;</DELETED>
<DELETED> ``(D) total gross spending on prescription
drugs by the plan or coverage during the reporting
period, before rebates and other manufacturer fees or
remuneration;</DELETED>
<DELETED> ``(E) total amount received, or expected
to be received, by the health plan or health insurance
coverage in drug manufacturer rebates, fees,
alternative discounts, and all other remuneration
received from the manufacturer or any third party
related to utilization of drug or drug spending under
that health plan or health insurance coverage during
the reporting period;</DELETED>
<DELETED> ``(F) the total net spending on
prescription drugs by the health plan or health
insurance coverage during the reporting period;
and</DELETED>
<DELETED> ``(G) amounts paid directly or indirectly
in rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's or health
insurance issuer's business to the pharmacy benefit
manager.</DELETED>
<DELETED> ``(2) Privacy requirements.--Health insurance
issuers offering group health insurance coverage and entities
providing pharmacy benefits management services on behalf of a
group health plan shall provide information under paragraph (1)
in a manner consistent with the privacy, security, and breach
notification regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of 1996
(or successor regulations), and shall restrict the use and
disclosure of such information according to such privacy
regulations.</DELETED>
<DELETED> ``(3) Disclosure and redisclosure.--</DELETED>
<DELETED> ``(A) Limitation to business associates.--
A group health plan receiving a report under paragraph
(1) may disclose such information only to business
associates of such plan as defined in section 160.103
of title 45, Code of Federal Regulations (or successor
regulations).</DELETED>
<DELETED> ``(B) Clarification regarding public
disclosure of information.--Nothing in this section
prevents a health insurance issuer offering group
health insurance coverage or an entity providing
pharmacy benefits management services on behalf of a
group health plan from placing reasonable restrictions
on the public disclosure of the information contained
in a report described in paragraph (1).</DELETED>
<DELETED> ``(c) Limitations on Spread Pricing.--</DELETED>
<DELETED> ``(1) Prescription drug transactions with
pharmacies independent of the issuer or pharmacy benefits
manager.--If the pharmacy that dispenses a prescription drug to
an enrollee in a group health plan or group or individual
health insurance coverage is not wholly or partially owned by
such plan, such issuer, or an entity providing pharmacy benefit
management services under such plan or coverage, such plan,
issuer, or entity shall not charge the plan, issuer, or
enrollee a price for such prescription drug that exceeds the
price paid to the pharmacy, excluding penalties paid by
pharmacies to such plan, issuer, or entity.</DELETED>
<DELETED> ``(2) Intra-company prescription drug
transactions.--If the mail order, specialty, or retail pharmacy
that dispenses a prescription drug to an enrollee in a group
health plan or health insurance coverage is wholly or partially
owned by such health insurance issuer or an entity providing
pharmacy benefit management services under a group health plan
or group or individual health insurance coverage, the price
charged for such drug by such pharmacy to such group health
plan or health insurance issuer offering group or individual
health insurance coverage may not exceed the lesser of--
</DELETED>
<DELETED> ``(A) the wholesale acquisition cost of
the drug paid by the pharmacy, plus clearly documented
dispensing costs, including pharmacy profit;
or</DELETED>
<DELETED> ``(B) the median price charged to the
group health plan or health insurance issuer when the
same drug is dispensed to enrollees in the plan or
coverage by other similarly situated pharmacies not
wholly or partially owned by the health insurance
issuer or entity providing pharmacy benefits management
services, as described in paragraph (1).</DELETED>
<DELETED> ``(3) Supplementary reporting for intra-company
prescription drug transactions.--A health insurance issuer of
group health insurance coverage or an entity providing pharmacy
benefits management services under a group health plan or group
health insurance coverage that conducts transactions with a
wholly or partially owned pharmacy, as described in paragraph
(2), shall submit, together with the report under subsection
(b), a supplementary quarterly report to the plan sponsor that
includes--</DELETED>
<DELETED> ``(A) an explanation of any benefit design
parameters that encourage enrollees in the plan or
coverage to fill prescriptions at mail order,
specialty, or retail pharmacies that are wholly or
partially owned by that issuer or entity;</DELETED>
<DELETED> ``(B) the percentage of total
prescriptions charged to the plan, coverage, or
enrollees in the plan or coverage, that were dispensed
by mail order, specialty, or retail pharmacies that are
wholly or partially owned by the issuer or entity
providing pharmacy benefits management services;
and</DELETED>
<DELETED> ``(C) a list of all drugs dispensed by
such wholly or partially owned pharmacy and charged to
the plan or coverage, or enrollees of the plan or
coverage, during the applicable quarter, and, with
respect to each drug--</DELETED>
<DELETED> ``(i) the amount charged per
dosage unit or course of treatment with respect
to enrollees in the plan or coverage, including
amounts charged to the plan or coverage and
amounts charged to the enrollee;</DELETED>
<DELETED> ``(ii) the median amount charged
to the plan or coverage, per dosage unit or
course of treatment, and including amounts paid
by the enrollee, when the same drug is
dispensed by other pharmacies that are not
wholly or partially owned by the issuer or
entity and that are included in the pharmacy
network of that plan or coverage;</DELETED>
<DELETED> ``(iii) the interquartile range of
the costs, per dosage unit or course of
treatment, and including amounts paid by the
enrollee, when the same drug is dispensed by
other pharmacies that are not wholly or
partially owned by the issuer or entity and
that are included in the pharmacy network of
that plan or coverage; and</DELETED>
<DELETED> ``(iv) the lowest cost per dosage
unit or course of treatment, for such drug,
including amounts charged to the plan or issuer
and enrollee, that is available from any
pharmacy included in the network of the plan or
coverage.</DELETED>
<DELETED> ``(d) Full Rebate Pass-Through to Plan.--</DELETED>
<DELETED> ``(1) In general.--A pharmacy benefits manager, a
third-party administrator of a group health plan, a health
insurance issuer offering group health insurance coverage, or
an entity providing pharmacy benefits management services under
such health plan or health insurance coverage shall remit 100
percent of rebates, fees, alternative discounts, and all other
remuneration received from a pharmaceutical manufacturer,
distributor or any other third party, that are related to
utilization of drugs under such health plan or health insurance
coverage, to the group health plan.</DELETED>
<DELETED> ``(2) Form and manner of remittance.--Such
rebates, fees, alternative discounts, and other remuneration
shall be--</DELETED>
<DELETED> ``(A) remitted to the group health plan in
a timely fashion after the period for which such
rebates, fees, or other remuneration is calculated, and
in no case later than 90 days after the end of such
period;</DELETED>
<DELETED> ``(B) fully disclosed and enumerated to
the group health plan sponsor, as described in (b)(1);
and</DELETED>
<DELETED> ``(C) available for audit by the plan
sponsor, or a third-party designated by a plan sponsor
no less than once per plan year.</DELETED>
<DELETED> ``(e) Enforcement.--</DELETED>
<DELETED> ``(1) Failure to provide timely information.--A
health insurance issuer or an entity providing pharmacy benefit
management services that violates subsection (a), fails to
provide information required under subsection (b), engages in
spread pricing as defined in subsection (c), or fails to comply
with the requirements of subsection (d), or a drug manufacturer
that fails to provide information under subsection (b)(1)(A),
in a timely manner shall be subject to a civil monetary penalty
in the amount of $10,000 for each day during which such
violation continues or such information is not disclosed or
reported.</DELETED>
<DELETED> ``(2) False information.--A health insurance
issuer, entity providing pharmacy benefit management services,
or drug manufacturer that knowingly provides false information
under this section shall be subject to a civil money penalty in
an amount not to exceed $100,000 for each item of false
information. Such civil money penalty shall be in addition to
other penalties as may be prescribed by law.</DELETED>
<DELETED> ``(3) Procedure.--The provisions of section 1128A
of the Social Security Act, other than subsections (a) and (b)
and the first sentence of subsection (c)(1) of such section
shall apply to civil monetary penalties under this subsection
in the same manner as such provisions apply to a penalty or
proceeding under section 1128A of the Social Security
Act.</DELETED>
<DELETED> ``(f) Definitions.--In this section--</DELETED>
<DELETED> ``(1) the term `similarly situated pharmacy'
means, with respect to a particular pharmacy, another pharmacy
that is approximately the same size (as measured by the number
of prescription drugs dispensed), and that serves patients in
the same geographical area, whether through physical locations
or mail order; and</DELETED>
<DELETED> ``(2) the term `wholesale acquisition cost' has
the meaning given such term in section 1847A(c)(6)(B) of the
Social Security Act.''.</DELETED>
<DELETED>SEC. 307. GOVERNMENT ACCOUNTABILITY OFFICE STUDY ON PROFIT-
AND REVENUE-SHARING IN HEALTH CARE.</DELETED>
<DELETED> (a) Study.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United States
shall conduct a study to--</DELETED>
<DELETED> (1) describe what is known about profit- and
revenue-sharing relationships in the commercial health care
markets, including those relationships that--</DELETED>
<DELETED> (A) involve one or more--</DELETED>
<DELETED> (i) physician groups that practice
within a hospital included in the profit- or
revenue-sharing relationship, or refer patients
to such hospital;</DELETED>
<DELETED> (ii) laboratory, radiology, or
pharmacy services that are delivered to
privately insured patients of such
hospital;</DELETED>
<DELETED> (iii) surgical services;</DELETED>
<DELETED> (iv) hospitals or group purchasing
organizations; or</DELETED>
<DELETED> (v) rehabilitation or physical
therapy facilities or services; and</DELETED>
<DELETED> (B) include revenue- or profit-sharing
whether through a joint venture, management or
professional services agreement, or other form of gain-
sharing contract;</DELETED>
<DELETED> (2) describe Federal oversight of such
relationships, including authorities of the Department of
Health and Human Services and the Federal Trade Commission to
review such relationships and their potential to increase costs
for patients, and identify limitations in such oversight;
and</DELETED>
<DELETED> (3) as appropriate, make recommendations to
improve Federal oversight of such relationships.</DELETED>
<DELETED> (b) Report.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United States
shall prepare and submit a report on the study conducted under
subsection (a) to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Education and Labor and the
Committee on Energy and Commerce of the House of
Representatives.</DELETED>
<DELETED>SEC. 308. DISCLOSURE OF DIRECT AND INDIRECT COMPENSATION FOR
BROKERS AND CONSULTANTS TO EMPLOYER-SPONSORED HEALTH
PLANS AND ENROLLEES IN PLANS ON THE INDIVIDUAL
MARKET.</DELETED>
<DELETED> (a) Group Health Plans.--Section 408(b)(2) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) is
amended--</DELETED>
<DELETED> (1) by striking ``(2) Contracting or making'' and
inserting ``(2)(A) Contracting or making''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(B)(i) No contract or arrangement for services
between a covered plan and a covered service provider, and no
extension or renewal of such a contract or arrangement, is
reasonable within the meaning of this paragraph unless the
requirements of this clause are met.</DELETED>
<DELETED> ``(ii)(I) For purposes of this
subparagraph:</DELETED>
<DELETED> ``(aa) The term `covered plan' means a
group health plan as defined section 733(a).</DELETED>
<DELETED> ``(bb) The term `covered service provider'
means a service provider that enters into a contract or
arrangement with the covered plan and reasonably
expects $1,000 (or such amount as the Secretary may
establish in regulations to account for inflation since
the date of enactment of the Lower Health Care Costs
Act, as appropriate) or more in compensation, direct or
indirect, to be received in connection with providing
one or more of the following services, pursuant to the
contract or arrangement, regardless of whether such
services will be performed, or such compensation
received, by the covered service provider, an
affiliate, or a subcontractor:</DELETED>
<DELETED> ``(AA) Brokerage services, for
which the covered service provider, an
affiliate, or a subcontractor reasonably
expects to receive indirect compensation or
direct compensation described in item (dd),
provided to a covered plan with respect to
selection of insurance products (including
vision and dental), recordkeeping services,
medical management vendor, benefits
administration (including vision and dental),
stop-loss insurance, pharmacy benefit
management services, wellness services,
transparency tools and vendors, group
purchasing organization preferred vendor
panels, disease management vendors and
products, compliance services, employee
assistance programs, or third-party
administration services.</DELETED>
<DELETED> ``(BB) Consulting, for which the
covered service provider, an affiliate, or a
subcontractor reasonably expects to receive
indirect compensation or direct compensation
described in item (dd), related to the
development or implementation of plan design,
insurance or insurance product selection
(including vision and dental), recordkeeping,
medical management, benefits administration
selection (including vision and dental), stop-
loss insurance, pharmacy benefit management
services, wellness design and management
services, transparency tools, group purchasing
organization agreements and services,
participation in and services from preferred
vendor panels, disease management, compliance
services, employee assistance programs, or
third-party administration services.</DELETED>
<DELETED> ``(cc) The term `affiliate', with respect
to a covered service provider, means an entity that
directly or indirectly (through one or more
intermediaries) controls, is controlled by, or is under
common control with, such provider, or is an officer,
director, or employee of, or partner in, such
provider.</DELETED>
<DELETED> ``(dd)(AA) The term `compensation' means
anything of monetary value, but does not include non-
monetary compensation valued at $250 (or such amount as
the Secretary may establish in regulations to account
for inflation since the date of enactment of the Lower
Health Care Costs Act, as appropriate) or less, in the
aggregate, during the term of the contract or
arrangement.</DELETED>
<DELETED> ``(BB) The term `direct compensation'
means compensation received directly from a covered
plan.</DELETED>
<DELETED> ``(CC) The term `indirect compensation'
means compensation received from any source other than
the covered plan, the plan sponsor, the covered service
provider, or an affiliate. Compensation received from a
subcontractor is indirect compensation, unless it is
received in connection with services performed under a
contract or arrangement with a subcontractor.</DELETED>
<DELETED> ``(ee) The term `responsible plan
fiduciary' means a fiduciary with authority to cause
the covered plan to enter into, or extend or renew, the
contract or arrangement.</DELETED>
<DELETED> ``(ff) The term `subcontractor' means any
person or entity (or an affiliate of such person or
entity) that is not an affiliate of the covered service
provider and that, pursuant to a contract or
arrangement with the covered service provider or an
affiliate, reasonably expects to receive $1,000 (or
such amount as the Secretary may establish in
regulations to account for inflation since the date of
enactment of the Lower Health Care Costs Act, as
appropriate) or more in compensation for performing one
or more services described in item (bb) under a
contract or arrangement with the covered
plan.</DELETED>
<DELETED> ``(II) For purposes of this subparagraph, a
description of compensation or cost may be expressed as a
monetary amount, formula, or a per capita charge for each
enrollee or, if the compensation or cost cannot reasonably be
expressed in such terms, by any other reasonable method,
including a disclosure that additional compensation may be
earned but may not be calculated at the time of contract if
such a disclosure includes a description of the circumstances
under which the additional compensation may be earned and a
reasonable and good faith estimate if the covered service
provider cannot otherwise readily describe compensation or cost
and explains the methodology and assumptions used to prepare
such estimate. Any such description shall contain sufficient
information to permit evaluation of the reasonableness of the
compensation or cost.</DELETED>
<DELETED> ``(III) No person or entity is a `covered service
provider' within the meaning of subclause (I)(bb) solely on the
basis of providing services as an affiliate or a subcontractor
that is performing one or more of the services described in
subitem (AA) or (BB) of such subclause under the contract or
arrangement with the covered plan.</DELETED>
<DELETED> ``(iii) A covered service provider shall disclose
to a responsible plan fiduciary, in writing, the
following:</DELETED>
<DELETED> ``(I) A description of the services to be
provided to the covered plan pursuant to the contract
or arrangement.</DELETED>
<DELETED> ``(II) If applicable, a statement that the
covered service provider, an affiliate, or a
subcontractor will provide, or reasonably expects to
provide, services pursuant to the contract or
arrangement directly to the covered plan as a fiduciary
(within the meaning of section 3(21)).</DELETED>
<DELETED> ``(III) A description of all direct
compensation, either in the aggregate or by service,
that the covered service provider, an affiliate, or a
subcontractor reasonably expects to receive in
connection with the services described in subclause
(I).</DELETED>
<DELETED> ``(IV)(aa) A description of all indirect
compensation that the covered service provider, an
affiliate, or a subcontractor reasonably expects to
receive in connection with the services described in
subclause (I)--</DELETED>
<DELETED> ``(AA) including compensation from
a vendor to a brokerage firm based on a
structure of incentives not solely related to
the contract with the covered plan;
and</DELETED>
<DELETED> ``(BB) not including compensation
received by an employee from an employer on
account of work performed by the
employee.</DELETED>
<DELETED> ``(bb) A description of the arrangement
between the payer and the covered service provider, an
affiliate, or a subcontractor, as applicable, pursuant
to which such indirect compensation is paid.</DELETED>
<DELETED> ``(cc) Identification of the services for
which the indirect compensation will be received, if
applicable.</DELETED>
<DELETED> ``(dd) Identification of the payer of the
indirect compensation.</DELETED>
<DELETED> ``(V) A description of any compensation
that will be paid among the covered service provider,
an affiliate, or a subcontractor, in connection with
the services described in subclause (I) if such
compensation is set on a transaction basis (such as
commissions, finder's fees, or other similar incentive
compensation based on business placed or retained),
including identification of the services for which such
compensation will be paid and identification of the
payers and recipients of such compensation (including
the status of a payer or recipient as an affiliate or a
subcontractor), regardless of whether such compensation
also is disclosed pursuant to subclause (III) or
(IV).</DELETED>
<DELETED> ``(VI) A description of any compensation
that the covered service provider, an affiliate, or a
subcontractor reasonably expects to receive in
connection with termination of the contract or
arrangement, and how any prepaid amounts will be
calculated and refunded upon such
termination.</DELETED>
<DELETED> ``(iv) A covered service provider shall disclose
to a responsible plan fiduciary, in writing a description of
the manner in which the compensation described in clause (iii),
as applicable, will be received.</DELETED>
<DELETED> ``(v)(I) A covered service provider shall disclose
the information required under clauses (iii) and (iv) to the
responsible plan fiduciary not later than the date that is
reasonably in advance of the date on which the contract or
arrangement is entered into, and extended or renewed.</DELETED>
<DELETED> ``(II) A covered service provider shall disclose
any change to the information required under clauses (iii) and
(iv) as soon as practicable, but not later than 60 days from
the date on which the covered service provider is informed of
such change, unless such disclosure is precluded due to
extraordinary circumstances beyond the covered service
provider's control, in which case the information shall be
disclosed as soon as practicable.</DELETED>
<DELETED> ``(vi)(I) Upon the written request of the
responsible plan fiduciary or covered plan administrator, a
covered service provider shall furnish any other information
relating to the compensation received in connection with the
contract or arrangement that is required for the covered plan
to comply with the reporting and disclosure requirements under
this Act.</DELETED>
<DELETED> ``(II) The covered service provider shall disclose
the information required under clause (iii)(I) reasonably in
advance of the date upon which such responsible plan fiduciary
or covered plan administrator states that it is required to
comply with the applicable reporting or disclosure requirement,
unless such disclosure is precluded due to extraordinary
circumstances beyond the covered service provider's control, in
which case the information shall be disclosed as soon as
practicable.</DELETED>
<DELETED> ``(vii) No contract or arrangement will fail to be
reasonable under this subparagraph solely because the covered
service provider, acting in good faith and with reasonable
diligence, makes an error or omission in disclosing the
information required pursuant to clause (iii) (or a change to
such information disclosed pursuant to clause (v)(II)) or
clause (vi), provided that the covered service provider
discloses the correct information to the responsible plan
fiduciary as soon as practicable, but not later than 30 days
from the date on which the covered service provider knows of
such error or omission.</DELETED>
<DELETED> ``(viii)(I) Pursuant to subsection (a),
subparagraphs (C) and (D) of section 406(a)(1) shall not apply
to a responsible plan fiduciary, notwithstanding any failure by
a covered service provider to disclose information required
under clause (iii), if the following conditions are
met:</DELETED>
<DELETED> ``(aa) The responsible plan fiduciary did
not know that the covered service provider failed or
would fail to make required disclosures and reasonably
believed that the covered service provider disclosed
the information required to be disclosed.</DELETED>
<DELETED> ``(bb) The responsible plan fiduciary,
upon discovering that the covered service provider
failed to disclose the required information, requests
in writing that the covered service provider furnish
such information.</DELETED>
<DELETED> ``(cc) If the covered service provider
fails to comply with a written request described in
subclause (II) within 90 days of the request, the
responsible plan fiduciary notifies the Secretary of
the covered service provider's failure, in accordance
with subclauses (II) and (III).</DELETED>
<DELETED> ``(II) A notice described in subclause (I)(cc)
shall contain--</DELETED>
<DELETED> ``(aa) the name of the covered
plan;</DELETED>
<DELETED> ``(bb) the plan number used for the annual
report on the covered plan;</DELETED>
<DELETED> ``(cc) the plan sponsor's name, address,
and employer identification number;</DELETED>
<DELETED> ``(dd) the name, address, and telephone
number of the responsible plan fiduciary;</DELETED>
<DELETED> ``(ee) the name, address, phone number,
and, if known, employer identification number of the
covered service provider;</DELETED>
<DELETED> ``(ff) a description of the services
provided to the covered plan;</DELETED>
<DELETED> ``(gg) a description of the information
that the covered service provider failed to
disclose;</DELETED>
<DELETED> ``(hh) the date on which such information
was requested in writing from the covered service
provider; and</DELETED>
<DELETED> ``(ii) a statement as to whether the
covered service provider continues to provide services
to the plan.</DELETED>
<DELETED> ``(III) A notice described in subclause (I)(cc)
shall be filed with the Department not later than 30 days
following the earlier of--</DELETED>
<DELETED> ``(aa) the covered service provider's
refusal to furnish the information requested by the
written request described in subclause (I)(bb);
or</DELETED>
<DELETED> ``(bb) 90 days after the written request
referred to in subclause (I)(cc) is made.</DELETED>
<DELETED> ``(IV) If the covered service provider fails to
comply with the written request under subclause (I)(bb) within
90 days of such request, the responsible plan fiduciary shall
determine whether to terminate or continue the contract or
arrangement under section 404. If the requested information
relates to future services and is not disclosed promptly after
the end of the 90-day period, the responsible plan fiduciary
shall terminate the contract or arrangement as expeditiously as
possible, consistent with such duty of prudence.</DELETED>
<DELETED> ``(ix) Nothing in this subparagraph shall be
construed to supersede any provision of State law that governs
disclosures by parties that provide the services described in
this section, except to the extent that such law prevents the
application of a requirement of this section.''.</DELETED>
<DELETED> (b) Applicability of Existing Regulations.--Nothing in the
amendments made by subsection (a) shall be construed to affect the
applicability of section 2550.408b-2 of title 29, Code of Federal
Regulations (or any successor regulations), with respect to any
applicable entity other than a covered plan or a covered service
provider (as defined in section 408(b)(2)(B)(ii) of the Employee
Retirement Income Security Act of 1974, as amended by subsection
(a)).</DELETED>
<DELETED> (c) Individual Market Coverage.--Subpart 1 of part B of
title XVII of the Public Health Service Act (42 U.S.C. 300gg-41 et
seq.) is amended by adding at the end the following:</DELETED>
<DELETED>``SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL MARKET
COVERAGE.</DELETED>
<DELETED> ``(a) In General.--A health insurance issuer offering
individual health insurance coverage shall make disclosures to
enrollees in such coverage, as described in subsection (b), and reports
to the Secretary, as described in subsection (c), regarding direct or
indirect compensation provided to an agent or broker associated with
enrolling individuals in such coverage.</DELETED>
<DELETED> ``(b) Disclosure.--A health insurance issuer described in
subsection (a) shall disclose to an enrollee the amount of direct or
indirect compensation provided to an agent or broker for services
provided by such agent or broker associated with plan selection and
enrollment. Such disclosure shall be--</DELETED>
<DELETED> ``(1) made prior to the individual finalizing plan
selection; and</DELETED>
<DELETED> ``(2) included on any documentation confirming the
individual's enrollment.</DELETED>
<DELETED> ``(c) Reporting.--A health insurance issuer described in
subsection (a) shall report to the Secretary any direct or indirect
compensation provided to an agent or broker associated with enrolling
individuals in such coverage.</DELETED>
<DELETED> ``(d) Rulemaking.--Not later than 1 year after the date of
enactment of the Lower Health Care Costs Act, the Secretary shall
finalize, through notice-and-comment rulemaking, the form and manner in
which issuers described in subsection (a) are required to make the
disclosures described in subsection (b) and the reports described in
subsection (c).''.</DELETED>
<DELETED> (d) Transition Rule.--No contract executed prior to the
effective date described in subsection (e) by a group health plan
subject to the requirements of section 408(b)(2)(B) of the Employee
Retirement Income Security Act of 1974 (as amended by subsection (a))
or by a health insurance issuer subject to the requirements of section
2746 of the Public Health Service Act (as added by subsection (c))
shall be subject to the requirements of such section 408(b)(2)(B) or
such section 2746, as applicable.</DELETED>
<DELETED> (e) Effective Date.--The amendments made by subsections
(a) and (c) shall take effect 2 years after the date of enactment of
this Act.</DELETED>
<DELETED>SEC. 309. ENSURING ENROLLEE ACCESS TO COST-SHARING
INFORMATION.</DELETED>
<DELETED> (a) In General.--Subpart II of part A of title XXVII of
the Public Health Service Act (42 U.S.C. 300gg-11 et seq.), as amended
by section 306, is further amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 2729F. PROVISION OF COST-SHARING INFORMATION.</DELETED>
<DELETED> ``(a) Provider Disclosures.--A provider that is in-network
with respect to a group health plan or a health insurance issuer
offering group or individual health insurance coverage shall provide to
an enrollee in the plan or coverage who submits a request for the
information described in paragraph (1) or (2), together with accurate
and complete information about the enrollee's coverage under the
applicable plan or coverage--</DELETED>
<DELETED> ``(1) as soon as practicable and not later than 2
business days after the enrollee requests such information, a
good faith estimate of the expected enrollee cost-sharing for
the provision of a particular health care service (including
any service that is reasonably expected to be provided in
conjunction with such specific service); and</DELETED>
<DELETED> ``(2) as soon as practicable and not later than 2
business days after an enrollee requests such information, the
contact information for any ancillary providers for a scheduled
health care service.</DELETED>
<DELETED> ``(b) Insurer Disclosures.--A group health plan or a
health insurance issuer offering group or individual health insurance
coverage shall provide an enrollee in the plan or coverage with a good
faith estimate of the enrollee's cost-sharing (including deductibles,
copayments, and coinsurance) for which the enrollee would be
responsible for paying with respect to a specific health care service
(including any service that is reasonably expected to be provided in
conjunction with such specific service), as soon as practicable and not
later than 2 business days after receiving a request for such
information by an enrollee.</DELETED>
<DELETED> ``(c) Enforcement.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), a
health care provider that violates a requirement under
subsection (a) shall be subject to a civil monetary penalty of
not more than $10,000 for each act constituting such
violation.</DELETED>
<DELETED> ``(2) Procedure.--The provisions of section 1128A
of the Social Security Act, other than subsections (a) and (b)
and the first sentence of subsection (c)(1) of such section,
shall apply to civil money penalties under this subsection in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A of the Social Security
Act.''.</DELETED>
<DELETED> (b) Effective Date.--Section 2729G of the Public Health
Service Act, as added by subsection (a), shall apply with respect to
plan years beginning on or after January 1, 2021.</DELETED>
<DELETED>SEC. 310. STRENGTHENING PARITY IN MENTAL HEALTH AND SUBSTANCE
USE DISORDER BENEFITS.</DELETED>
<DELETED> Section 2726 of the Public Health Service Act (42 U.S.C.
300gg-26) is amended--</DELETED>
<DELETED> (1) in subsection (a), by adding at the end the
following:</DELETED>
<DELETED> ``(8) Compliance requirements.--</DELETED>
<DELETED> ``(A) Nonquantitative treatment limitation
(nqtl) requirements.--In the case of a group health
plan or a health insurance issuer offering group or
individual health insurance coverage that provides both
medical and surgical benefits and mental health or
substance use disorder benefits, the plan or coverage
shall perform comparative analyses about the design and
application of nonquantitative treatment limitations
(referred to in this paragraph as the `NQTL') in
accordance with the following process, and make
available to the Secretary upon request within 60 days
beginning January 1, 2020, and within 30 days beginning
January 1, 2021, the following information:</DELETED>
<DELETED> ``(i) The specific plan or
coverage language regarding the NQTL, that
applies to such plan or coverage, and a
description of all mental health or substance
use disorder and medical/surgical services to
which it applies in each respective benefits
classification.</DELETED>
<DELETED> ``(ii) The factors used to
determine that an NQTL will apply to mental
health or substance use disorder benefits and
medical/surgical benefits.</DELETED>
<DELETED> ``(iii) The evidentiary standard
(both identified and deidentified) for the
factors identified in clause (ii) and any other
evidence relied upon to design and apply the
NQTL to mental health or substance use disorder
benefits and medical/surgical
benefits.</DELETED>
<DELETED> ``(iv) The comparative analyses
demonstrating that the processes and strategies
used to design the NQTL, as written and in
operation, and the as written processes and
strategies used to apply the NQTL for mental
health or substance use disorder benefits are
comparable to, and are applied no more
stringently than, the processes and strategies
used to design the NQTL, as written and in
operation, and the as written processes and
strategies used to apply the NQTL to medical/
surgical benefits.</DELETED>
<DELETED> ``(v) A disclosure of the specific
findings and conclusions reached by the plan or
coverage that the results of the analyses
described in this subparagraph indicate that
the plan or coverage is in compliance with this
section.</DELETED>
<DELETED> ``(B) Secretary request process.--
</DELETED>
<DELETED> ``(i) Submission upon complaint.--
The Secretary shall request that a group health
plan or a health insurance issuer offering
group or individual health insurance coverage
submit the comparative analyses described in
subparagraph (A) if the Secretary has received
any complaints from plan participants or
participating providers about such a plan or
coverage that involve mental health or
substance use disorder benefits.</DELETED>
<DELETED> ``(ii) Random submissions.--The
Secretary shall request the comparative
analyses described in subparagraph (A) from no
fewer than 50 plans or coverages selected at
random, annually, and such plans or coverages
shall not--</DELETED>
<DELETED> ``(I) be the same plans or
coverages for which the comparative
analyses are requested under clause
(i);</DELETED>
<DELETED> ``(II) be the same plan or
coverage being investigated by the
Department regarding NQTLs or that has
been investigated by the Department
regarding NQTLs within the last 5
years; and</DELETED>
<DELETED> ``(III) be the same plan
or coverage that has been selected
under clause (i) or (ii) within the
last 5 years.</DELETED>
<DELETED> ``(iii) Additional information.--
In instances in which the Secretary has
concluded that the plan or coverage has not
submitted sufficient information for the
Secretary to review the comparative analyses
described in subparagraph (A), as requested
under clauses (i) and (ii), the Secretary shall
specify to the plan or coverage the information
the plan or coverage must submit to be
responsive to the request under clauses (i) and
(ii) for the Secretary to review the
comparative analyses described in subparagraph
(A) for compliance with this section.</DELETED>
<DELETED> ``(iv) Required action.--In
instances in which the Secretary has reviewed
the comparative analyses described in
subparagraph (A), as requested under clauses
(i) and (ii), and determined that the plan or
coverage is not in compliance with this
section, the Secretary shall specify to the
plan or coverage the actions the plan or
coverage must take to be in compliance with
this section. Documents or communications
produced in connection with the Secretary's
recommendations to the plan or coverage shall
not be subject to disclosure pursuant to
section 552 of title 5, United States
Code.</DELETED>
<DELETED> ``(v) Report.--Not later than 1
year after the date of enactment of this
paragraph, and annually thereafter, the
Secretary shall submit to the Committee on
Education and Labor of the House of
Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a
report that contains--</DELETED>
<DELETED> ``(I) each of the
comparative analyses requested under
clauses (i) and (ii), except that the
identity of each plan or coverage and
any contracted entity of a plan or
coverage shall be redacted;</DELETED>
<DELETED> ``(II) the Secretary's
conclusions as to whether each plan or
coverage submitted sufficient
information for the Secretary to review
the comparative analyses requested
under clauses (i) and (ii) for
compliance with this section;</DELETED>
<DELETED> ``(III) for each plan or
coverage that did submit sufficient
information for the Secretary to review
the comparative analyses requested
under clause (i), the Secretary's
conclusions as to whether and why the
plan or coverage is in compliance with
this section;</DELETED>
<DELETED> ``(IV) the Secretary's
specifications described in clause
(iii) for each plan or coverage that
the Secretary determined did not submit
sufficient information for the
Secretary to review the comparative
analyses requested under clauses (i)
and (ii) for compliance with this
section; and</DELETED>
<DELETED> ``(V) the Secretary's
specifications described in clause (iv)
of the actions each plan or coverage
that the Secretary determined is not in
compliance with this section must take
to be in compliance with this section,
including the reason why the Secretary
determined the plan or coverage is not
in compliance.</DELETED>
<DELETED> ``(C) Compliance program guidance document
update process.--</DELETED>
<DELETED> ``(i) In general.--The Secretary
shall include select instances of noncompliance
that the Secretary discovers upon reviewing the
comparative analyses requested under clauses
(i) and (ii) of subparagraph (B) in the
compliance program guidance document described
in section 2726(a)(6), as it is updated every 2
years, except that all instances shall be
deidentified and such instances shall not
disclose any protected health information or
individually identifiable
information.</DELETED>
<DELETED> ``(ii) Guidance and regulations.--
Not later than 18 months after the date of
enactment of this paragraph, the Secretary
shall finalize any draft or interim guidance
and regulations relating to mental health
parity under this section.</DELETED>
<DELETED> ``(iii) State.--Any instances of
noncompliance the Secretary discovers upon
reviewing the comparative analyses requested
under clauses (i) and (ii) of subparagraph (B)
shall be shared with a State for coverage
offered by a health insurance issuer in the
group market, in accordance with section
2726(a)(6)(B)(iii)(II).''.</DELETED>
<DELETED>SEC. 311. TECHNICAL AMENDMENTS.</DELETED>
<DELETED> (a) ERISA.--Section 715 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185d) is amended--</DELETED>
<DELETED> (1) in subsection (a)(1), by striking ``(as
amended by the Patient Protection and Affordable Care Act)''
and inserting ``(including any subsequent amendments to such
part)''; and</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) by striking ``(as amended by the
Patient Protection and Affordable Care Act)'' and
inserting ``(including any subsequent amendments to
such part)''; and</DELETED>
<DELETED> (B) by striking ``(as so
amended)''.</DELETED>
<DELETED> (b) IRC.--Section 9815 of the Internal Revenue Code of
1986 is amended--</DELETED>
<DELETED> (1) in subsection (a)(1), by striking ``(as
amended by the Patient Protection and Affordable Care Act)''
and inserting ``(including any subsequent amendments to such
part)''; and</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) by striking ``(as amended by the
Patient Protection and Affordable Care Act)'' and
inserting ``(including any subsequent amendments to
such part)''; and</DELETED>
<DELETED> (B) by striking ``(as so
amended)''.</DELETED>
<DELETED> (c) Applicability.--The amendments made by subsections (a)
and (b) shall take effect as though included in the enactment of the
Patient Protection and Affordable Care Act (Public Law 111-
148).</DELETED>
<DELETED>SEC. 312. THIRD-PARTY ADMINISTRATORS.</DELETED>
<DELETED> Any obligation on a third-party administrator under this
Act (including the amendments made by this Act) shall not affect any
other direct or indirect requirement under any other provision of
Federal law that applies to third-party administrators offering
services to group health plans.</DELETED>
<DELETED>TITLE IV--IMPROVING PUBLIC HEALTH</DELETED>
<DELETED>SEC. 401. IMPROVING AWARENESS OF DISEASE PREVENTION.</DELETED>
<DELETED> The Public Health Service Act is amended by striking
section 313 of such Act (42 U.S.C. 245) and inserting the
following:</DELETED>
<DELETED>``SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE OF
VACCINATIONS.</DELETED>
<DELETED> ``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention and in
coordination with other offices and agencies, as appropriate, shall
award competitive grants to one or more public or private entities to
carry out a national, evidence-based campaign to increase awareness and
knowledge of the safety and effectiveness of vaccines for the
prevention and control of diseases, combat misinformation about
vaccines, and disseminate scientific and evidence-based vaccine-related
information, with the goal of increasing rates of vaccination across
all ages, as applicable, particularly in communities with low rates of
vaccination, to reduce and eliminate vaccine-preventable
diseases.</DELETED>
<DELETED> ``(b) Consultation.--In carrying out the campaign under
this section, the Secretary shall consult with appropriate public
health and medical experts, including the National Academy of Medicine
and medical and public health associations and nonprofit organizations,
in the development, implementation, and evaluation of the evidence-
based public awareness campaign.</DELETED>
<DELETED> ``(c) Requirements.--The campaign under this section
shall--</DELETED>
<DELETED> ``(1) be a national, evidence-based
initiative;</DELETED>
<DELETED> ``(2) include the development of resources for
communities with low rates of vaccination, including culturally
and linguistically appropriate resources, as
applicable;</DELETED>
<DELETED> ``(3) include the dissemination of vaccine
information and communication resources to public health
departments, health care providers, and health care facilities,
including such providers and facilities that provide prenatal
and pediatric care;</DELETED>
<DELETED> ``(4) be complementary to, and coordinated with,
any other Federal, State, or local efforts, as appropriate;
and</DELETED>
<DELETED> ``(5) assess the effectiveness of communication
strategies to increase rates of vaccination.</DELETED>
<DELETED> ``(d) Additional Activities.--The campaign under this
section may--</DELETED>
<DELETED> ``(1) include the use of television, radio, the
internet, and other media and telecommunications
technologies;</DELETED>
<DELETED> ``(2) be focused to address specific needs of
communities and populations with low rates of vaccination;
and</DELETED>
<DELETED> ``(3) include the dissemination of scientific and
evidence-based vaccine-related information, such as--</DELETED>
<DELETED> ``(A) advancements in evidence-based
research related to diseases that may be prevented by
vaccines and vaccine development;</DELETED>
<DELETED> ``(B) information on vaccinations for
individuals and communities, including individuals for
whom vaccines are not recommended by the Advisory
Committee for Immunization Practices, and the effects
of low vaccination rates within a community on such
individuals;</DELETED>
<DELETED> ``(C) information on diseases that may be
prevented by vaccines; and</DELETED>
<DELETED> ``(D) information on vaccine safety and
the systems in place to monitor vaccine
safety.</DELETED>
<DELETED> ``(e) Evaluation.--The Secretary shall--</DELETED>
<DELETED> ``(1) establish benchmarks and metrics to
quantitatively measure and evaluate the awareness campaign
under this section;</DELETED>
<DELETED> ``(2) conduct qualitative assessments regarding
the awareness campaign under this section; and</DELETED>
<DELETED> ``(3) prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives an evaluation of the awareness campaign under
this section.</DELETED>
<DELETED> ``(f) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section and section
317(k) such sums as may be necessary for fiscal years 2020 through
2024.''.</DELETED>
<DELETED>SEC. 402. GRANTS TO ADDRESS VACCINE-PREVENTABLE
DISEASES.</DELETED>
<DELETED> Section 317(k)(1) of the Public Health Service Act (42
U.S.C. 247b(k)(1)) is amended--</DELETED>
<DELETED> (1) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;</DELETED>
<DELETED> (2) in subparagraph (D), by striking the period
and inserting a semicolon; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(E) planning, implementation, and evaluation of
activities to address vaccine-preventable diseases, including
activities to--</DELETED>
<DELETED> ``(i) identify communities at high risk of
outbreaks related to vaccine-preventable diseases,
including through improved data collection and
analysis;</DELETED>
<DELETED> ``(ii) pilot innovative approaches to
improve vaccination rates in communities and among
populations with low rates of vaccination;</DELETED>
<DELETED> ``(iii) reduce barriers to accessing
vaccines and evidence-based information about the
health effects of vaccines;</DELETED>
<DELETED> ``(iv) partner with community
organizations and health care providers to develop and
deliver evidence-based interventions, including
culturally and linguistically appropriate
interventions, to increase vaccination rates;</DELETED>
<DELETED> ``(v) improve delivery of evidence-based
vaccine-related information to parents and others;
and</DELETED>
<DELETED> ``(vi) improve the ability of State,
local, tribal, and territorial public health
departments to engage communities at high risk for
outbreaks related to vaccine-preventable diseases;
and</DELETED>
<DELETED> ``(F) research related to strategies for improving
awareness of scientific and evidence-based vaccine-related
information, including for communities with low rates of
vaccination, in order to understand barriers to vaccination,
improve vaccination rates, and assess the public health
outcomes of such strategies.''.</DELETED>
<DELETED>SEC. 403. GUIDE ON EVIDENCE-BASED STRATEGIES FOR PUBLIC HEALTH
DEPARTMENT OBESITY PREVENTION PROGRAMS.</DELETED>
<DELETED> (a) Development and Dissemination of an Evidence-Based
Strategies Guide.--The Secretary of Health and Human Services (referred
to in this section as the ``Secretary''), acting through the Director
of the Centers for Disease Control and Prevention, not later than 2
years after the date of enactment of this Act, shall--</DELETED>
<DELETED> (1) develop a guide on evidence-based strategies
for State, territorial, and local health departments to use to
build and maintain effective obesity prevention and reduction
programs, and, in consultation with stakeholders that have
expertise in Tribal health, a guide on such evidence-based
strategies with respect to Indian Tribes and Tribal
organizations for such Indian Tribes and Tribal organizations
to use for such purpose, both of which guides shall--</DELETED>
<DELETED> (A) describe an integrated program
structure for implementing interventions proven to be
effective in preventing and reducing the incidence of
obesity; and</DELETED>
<DELETED> (B) recommend--</DELETED>
<DELETED> (i) optimal resources, including
staffing and infrastructure, for promoting
nutrition and obesity prevention and reduction;
and</DELETED>
<DELETED> (ii) strategies for effective
obesity prevention programs for State and local
health departments, Indian Tribes, and Tribal
organizations, including strategies related
to--</DELETED>
<DELETED> (I) the application of
evidence-based and evidence-informed
practices to prevent and reduce obesity
rates;</DELETED>
<DELETED> (II) the development,
implementation, and evaluation of
obesity prevention and reduction
strategies for specific communities and
populations;</DELETED>
<DELETED> (III) demonstrated
knowledge of obesity prevention
practices that reduce associated
preventable diseases, health
conditions, death, and health care
costs;</DELETED>
<DELETED> (IV) best practices for
the coordination of efforts to prevent
and reduce obesity and related chronic
diseases;</DELETED>
<DELETED> (V) addressing the
underlying risk factors and social
determinants of health that impact
obesity rates; and</DELETED>
<DELETED> (VI) interdisciplinary
coordination between relevant public
health officials specializing in fields
such as nutrition, physical activity,
epidemiology, communications, and
policy implementation, and
collaboration between public health
officials and community-based
organizations; and</DELETED>
<DELETED> (2) disseminate the guides and current research,
evidence-based practices, tools, and educational materials
related to obesity prevention, consistent with the guide, to
State and local health departments, Indian Tribes, and Tribal
organizations.</DELETED>
<DELETED> (b) Technical Assistance.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention, shall
provide technical assistance to State and local health departments,
Indian Tribes, and Tribal organizations to support such health
departments in implementing the guide developed under subsection
(a)(1).</DELETED>
<DELETED> (c) Indian Tribes; Tribal Organizations.--The terms
``Indian Tribe'' and ``Tribal organization'' have the meanings given
the terms ``Indian tribe'' and ``tribal organization'', respectively,
in section 4 of the Indian Self-Determination and Education Assistance
Act (25 U.S.C. 5304).</DELETED>
<DELETED>SEC. 404. EXPANDING CAPACITY FOR HEALTH OUTCOMES.</DELETED>
<DELETED> Title III of the Public Health Service Act is amended by
inserting after section 330M (42 U.S.C. 254c-19) the
following:</DELETED>
<DELETED>``SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUTCOMES.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Eligible entity.--The term `eligible entity'
means an entity providing health care services in rural areas,
frontier areas, health professional shortage areas, or
medically underserved areas, or to medically underserved
populations or Native Americans, including Indian tribes or
tribal organizations.</DELETED>
<DELETED> ``(2) Health professional shortage area.--The term
`health professional shortage area' means a health professional
shortage area designated under section 332.</DELETED>
<DELETED> ``(3) Indian tribe.--The terms `Indian tribe' and
`tribal organization' have the meanings given such terms in
section 4 of the Indian Self-Determination and Education
Assistance Act.</DELETED>
<DELETED> ``(4) Medically underserved population.--The term
`medically underserved population' has the meaning given the
term in section 330(b)(3).</DELETED>
<DELETED> ``(5) Native americans.--The term `Native
Americans' has the meaning given such term in section 736 and
includes Indian tribes and tribal organizations.</DELETED>
<DELETED> ``(6) Technology-enabled collaborative learning
and capacity building model.--The term `technology-enabled
collaborative learning and capacity building model' means a
distance health education model that connects specialists with
multiple other health care professionals through simultaneous
interactive videoconferencing for the purpose of facilitating
case-based learning, disseminating best practices, and
evaluating outcomes.</DELETED>
<DELETED> ``(b) Program Established.--The Secretary shall, as
appropriate, award grants to evaluate, develop, and, as appropriate,
expand the use of technology-enabled collaborative learning and
capacity building models, to increase access to health care services,
such as those to address chronic diseases and conditions, mental
health, substance use disorders, prenatal and maternal health,
pediatric care, pain management, palliative care, and other specialty
care in medically underserved areas and for medically underserved
populations.</DELETED>
<DELETED> ``(c) Use of Funds.--</DELETED>
<DELETED> ``(1) In general.--Grants awarded under subsection
(b) shall be used for--</DELETED>
<DELETED> ``(A) the development and acquisition of
instructional programming, and the training of health
care providers and other professionals that provide or
assist in the provision of services through such
models;</DELETED>
<DELETED> ``(B) information collection and
evaluation activities to study the impact of such
models on patient outcomes and health care providers,
and to identify best practices for the expansion and
use of such models; or</DELETED>
<DELETED> ``(C) other activities consistent with
achieving the objectives of the grants awarded under
this section, as determined by the Secretary.</DELETED>
<DELETED> ``(2) Other uses.--In addition to any of the uses
under paragraph (1), grants awarded under subsection (b) may be
used for--</DELETED>
<DELETED> ``(A) equipment to support the use and
expansion of technology-enabled collaborative learning
and capacity building models, including for hardware
and software that enables distance learning, health
care provider support, and the secure exchange of
electronic health information; or</DELETED>
<DELETED> ``(B) support for health care providers
and other professionals that provide or assist in the
provision of services through such models.</DELETED>
<DELETED> ``(d) Length of Grants.--Grants awarded under subsection
(b) shall be for a period of up to 5 years.</DELETED>
<DELETED> ``(e) Application.--An eligible entity that seeks to
receive a grant under subsection (b) shall submit to the Secretary an
application, at such time, in such manner, and containing such
information as the Secretary may require. Such application criteria
shall include an assessment of the effect of technology-enabled
collaborative learning and capacity building models on patient outcomes
and health care providers.</DELETED>
<DELETED> ``(f) Technical Assistance.--The Secretary shall provide
(either directly through the Department of Health and Human Services or
by contract) technical assistance to eligible entities, including
recipients of grants under subsection (b), on the development, use, and
evaluation of technology-enabled collaborative learning and capacity
building models in order to expand access to health care services
provided by such entities, including for medically underserved areas
and to medically underserved populations.</DELETED>
<DELETED> ``(g) Report by Secretary.--Not later than 4 years after
the date of enactment of this section, the Secretary shall prepare and
submit to the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives, and post on the internet website of the Department of
Health and Human Services, a report including, at minimum--</DELETED>
<DELETED> ``(1) a description of any new and continuing
grants awarded to entities under subsection (b) and the
specific purpose and amounts of such grants;</DELETED>
<DELETED> ``(2) an overview of--</DELETED>
<DELETED> ``(A) the evaluations conducted under
subsections (b) or (f); and</DELETED>
<DELETED> ``(B) technical assistance provided under
subsection (f); and</DELETED>
<DELETED> ``(3) a description of any significant findings or
developments in patient outcomes and health care providers and
best practices for eligible entities expanding, using, or
evaluating technology-enabled collaborative learning and
capacity building models.</DELETED>
<DELETED> ``(h) Authorization of Appropriations.--There is
authorized to be appropriated to carry out this section, such sums as
may be necessary for each of fiscal years 2020 through
2024.''.</DELETED>
<DELETED>SEC. 405. PUBLIC HEALTH DATA SYSTEM MODERNIZATION.</DELETED>
<DELETED> Subtitle C of title XXVIII of the Public Health Service
Act (42 U.S.C. 300hh-31 et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 2822. PUBLIC HEALTH DATA SYSTEM MODERNIZATION
GRANTS.</DELETED>
<DELETED> ``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, shall--
</DELETED>
<DELETED> ``(1) award grants to State, local, Tribal, and
territorial public health departments for the expansion and
modernization of public health data systems, to assist public
health departments in--</DELETED>
<DELETED> ``(A) assessing current data
infrastructure capabilities and gaps to improve and
increase consistency in data collection, storage,
analysis, and, as appropriate, to improve dissemination
of public health-related information;</DELETED>
<DELETED> ``(B) improving secure public health data
collection, transmission, exchange, maintenance, and
analysis;</DELETED>
<DELETED> ``(C) simplifying and supporting reporting
by health care providers, as applicable, pursuant to
State law, including through the use of health
information technology, to State, local, Tribal, and
territorial public health departments, including public
health officials in multiple jurisdictions within such
State, as appropriate;</DELETED>
<DELETED> ``(D) enhancing interoperability of public
health data systems (including systems created or
accessed by public health departments) with health
information technology, including certified health
information technology;</DELETED>
<DELETED> ``(E) supporting earlier disease and
health condition detection, such as through near real-
time data monitoring, to support rapid public health
responses; and</DELETED>
<DELETED> ``(F) supporting activities within the
applicable jurisdiction related to the expansion and
modernization of electronic case reporting;</DELETED>
<DELETED> ``(2) as appropriate, conduct activities related
to the interoperability and improvement of applicable public
health data systems used by the Centers for Disease Control and
Prevention, and, in coordination with the Office of the
National Coordinator for Health Information Technology, the
designation of data and technology standards for health
information systems of the public health infrastructure with
deference given to standards published by standards development
organizations and voluntary consensus-based standards bodies;
and</DELETED>
<DELETED> ``(3) develop and utilize public-private
partnerships for technical assistance and related
implementation support for State, local, Tribal, and
territorial public health departments, and the Centers for
Disease Control and Prevention, on the expansion and
modernization of electronic case reporting and public health
data systems, as applicable.</DELETED>
<DELETED> ``(b) Requirements.--</DELETED>
<DELETED> ``(1) In general.--The Secretary may not award a
grant under subsection (a)(1) unless the applicant supports
standards endorsed by the National Coordinator for Health
Information Technology pursuant to section 3001(c)(1) or
adopted by the Secretary under section 3004.</DELETED>
<DELETED> ``(2) Waiver.--The Secretary may waive the
requirement under paragraph (1) with respect to an applicant if
the Secretary determines that the activities under subsection
(a) cannot otherwise be carried out within the applicable
jurisdiction.</DELETED>
<DELETED> ``(3) Application.--A State, local, Tribal, or
territorial health department applying for a grant under this
section shall submit an application to the Secretary at such
time and in such manner as the Secretary may require. Such
application shall include information describing--</DELETED>
<DELETED> ``(A) the activities that will be
supported by the grant; and</DELETED>
<DELETED> ``(B) how the modernization of such public
health data systems will support or impact the public
health infrastructure of the health department,
including a description of remaining gaps, if any, and
the actions needed to address such gaps.</DELETED>
<DELETED> ``(c) Use of Funds.--An entity receiving a grant under
this section may use amounts received under such grant for one or both
of the following:</DELETED>
<DELETED> ``(1) Carrying out activities described in
subsection (a)(1) to support public health data systems
(including electronic case reporting), which may include
support for, and training of, professionals with expertise in
contributing to and using such systems (including public health
data scientists).</DELETED>
<DELETED> ``(2) Developing and disseminating information
related to the use and importance of public health
data.</DELETED>
<DELETED> ``(d) Strategy and Implementation Plan.--Not later than
180 days after the date of enactment of the Lower Health Care Costs
Act, the Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, a coordinated
strategy and an accompanying implementation plan that identifies and
demonstrates the steps the Secretary will carry out to--</DELETED>
<DELETED> ``(1) update and improve applicable public health
data systems used by the Centers for Disease Control and
Prevention; and</DELETED>
<DELETED> ``(2) carry out the activities described in this
section to support the improvement of State, local, Tribal, and
territorial public health data systems.</DELETED>
<DELETED> ``(e) Consultation.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, shall
consult with State, local, Tribal, and territorial health departments,
professional medical and public health associations, associations
representing hospitals or other health care entities, health
information technology experts, and other appropriate entities
regarding the plan and grant program to modernize public health data
systems pursuant to this section. Such activities may include the
provision of technical assistance related to the exchange of
information by such public health data systems used by relevant health
care and public health entities at the local, State, Federal, Tribal,
and territorial levels.</DELETED>
<DELETED> ``(f) Report to Congress.--Not later than 1 year after the
date of enactment of this section, the Secretary shall submit a report
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives that includes--</DELETED>
<DELETED> ``(1) a description of any barriers to--</DELETED>
<DELETED> ``(A) public health authorities
implementing electronic case reporting and
interoperable public health data systems; or</DELETED>
<DELETED> ``(B) the exchange of information pursuant
to electronic case reporting;</DELETED>
<DELETED> ``(2) an assessment of the potential public health
impact of implementing electronic case reporting and
interoperable public health data systems; and</DELETED>
<DELETED> ``(3) a description of the activities carried out
pursuant to this section.</DELETED>
<DELETED> ``(g) Electronic Case Reporting.--In this section, the
term `electronic case reporting' means the automated identification,
generation, and bilateral exchange of reports of health events among
electronic health record or health information technology systems and
public health authorities.</DELETED>
<DELETED> ``(h) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be appropriated such
sums as may be necessary for fiscal years 2020 through
2024.''.</DELETED>
<DELETED>SEC. 406. INNOVATION FOR MATERNAL HEALTH.</DELETED>
<DELETED> (a) In General.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary''), in
consultation with experts representing a variety of clinical
specialties, State, tribal, or local public health officials,
researchers, epidemiologists, statisticians, and community
organizations, shall establish a program to award competitive grants to
eligible entities for the purpose of--</DELETED>
<DELETED> (1) identifying, developing, or disseminating best
practices to improve maternal health care quality and outcomes,
eliminate preventable maternal mortality and severe maternal
morbidity, and improve infant health outcomes, which may
include--</DELETED>
<DELETED> (A) information on evidence-based
practices to improve the quality and safety of maternal
health care in hospitals and other health care settings
of a State or health care system, including by
addressing topics commonly associated with health
complications or risks related to prenatal care, labor
care, birthing, and postpartum care;</DELETED>
<DELETED> (B) best practices for improving maternal
health care based on data findings and reviews
conducted by a State maternal mortality review
committee that address topics of relevance to common
complications or health risks related to prenatal care,
labor care, birthing, and postpartum care;
and</DELETED>
<DELETED> (C) information on addressing determinants
of health that impact maternal health outcomes for
women before, during, and after pregnancy;</DELETED>
<DELETED> (2) collaborating with State maternal mortality
review committees to identify issues for the development and
implementation of evidence-based practices to improve maternal
health outcomes and reduce preventable maternal mortality and
severe maternal morbidity;</DELETED>
<DELETED> (3) providing technical assistance and supporting
the implementation of best practices identified in paragraph
(1) to entities providing health care services to pregnant and
postpartum women; and</DELETED>
<DELETED> (4) identifying, developing, and evaluating new
models of care that improve maternal and infant health
outcomes, which may include the integration of community-based
services and clinical care.</DELETED>
<DELETED> (b) Eligible Entities.--To be eligible for a grant under
subsection (a), an entity shall--</DELETED>
<DELETED> (1) submit to the Secretary an application at such
time, in such manner, and containing such information as the
Secretary may require; and</DELETED>
<DELETED> (2) demonstrate in such application that the
entity has a demonstrated expertise in data-driven maternal
safety and quality improvement initiatives in the areas of
obstetrics and gynecology or maternal health.</DELETED>
<DELETED> (c) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated such sums as may be
necessary for each of fiscal years 2020 through 2024.</DELETED>
<DELETED>SEC. 407. TRAINING FOR HEALTH CARE PROVIDERS.</DELETED>
<DELETED> Title VII of the Public Health Service Act is amended by
striking section 763 (42 U.S.C. 294p) and inserting the
following:</DELETED>
<DELETED>``SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS.</DELETED>
<DELETED> ``(a) Grant Program.--The Secretary shall establish a
program to award grants to accredited schools of allopathic medicine,
osteopathic medicine, and nursing, and other health professional
training programs for the training of health care professionals to
reduce and prevent discrimination (including training related to
implicit biases) in the provision of health care services related to
prenatal care, labor care, birthing, and postpartum care.</DELETED>
<DELETED> ``(b) Eligibility.--To be eligible for a grant under
subsection (a), an entity described in such subsection shall submit to
the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require.</DELETED>
<DELETED> ``(c) Reporting Requirement.--Each entity awarded a grant
under this section shall periodically submit to the Secretary a report
on the status of activities conducted using the grant, including a
description of the impact of such training on patient outcomes, as
applicable.</DELETED>
<DELETED> ``(d) Best Practices.--The Secretary may identify and
disseminate best practices for the training of health care
professionals to reduce and prevent discrimination (including training
related to implicit biases) in the provision of health care services
related to prenatal care, labor care, birthing, and postpartum
care.</DELETED>
<DELETED> ``(e) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated such sums as may be
necessary for each of fiscal years 2020 through 2024.''.</DELETED>
<DELETED>SEC. 408. STUDY ON TRAINING TO REDUCE AND PREVENT
DISCRIMINATION.</DELETED>
<DELETED> Not later than 2 years after date of enactment of this
Act, the Secretary of Health and Human Services (referred to in this
section as the ``Secretary'') shall, through a contract with an
independent research organization, study and make recommendations for
accredited schools of allopathic medicine, osteopathic medicine, and
nursing, and other health professional training programs on best
practices related to training to reduce and prevent discrimination,
including training related to implicit biases, in the provision of
health care services related to prenatal care, labor care, birthing,
and postpartum care.</DELETED>
<DELETED>SEC. 409. PERINATAL QUALITY COLLABORATIVES.</DELETED>
<DELETED> Section 317K(a)(2) of the Public Health Service Act (42
U.S.C. 247b-12(a)(2)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(E)(i) The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention and in coordination with other offices and
agencies, as appropriate, shall establish or continue a
competitive grant program for the establishment or
support of perinatal quality collaboratives to improve
perinatal care and perinatal health outcomes for
pregnant and postpartum women and their infants. A
State or Indian Tribe may use funds received through
such grant to--</DELETED>
<DELETED> ``(I) support the use of evidence-
based or evidence-informed practices to improve
outcomes for maternal and infant
health;</DELETED>
<DELETED> ``(II) work with clinical teams;
experts; State, local, and, as appropriate,
tribal public health officials; and
stakeholders, including patients and families,
to identify, develop, or disseminate best
practices to improve perinatal care and
outcomes; and</DELETED>
<DELETED> ``(III) employ strategies that
provide opportunities for health care
professionals and clinical teams to collaborate
across health care settings and disciplines,
including primary care and mental health, as
appropriate, to improve maternal and infant
health outcomes, which may include the use of
data to provide timely feedback across hospital
and clinical teams to inform responses, and to
provide support and training to hospital and
clinical teams for quality improvement, as
appropriate.</DELETED>
<DELETED> ``(ii) To be eligible for a grant under
clause (i), an entity shall submit to the Secretary an
application in such form and manner and containing such
information as the Secretary may require.''.</DELETED>
<DELETED>SEC. 410. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM
WOMEN.</DELETED>
<DELETED> (a) Grants.--Title III of the Public Health Service Act is
amended by inserting after section 330N of such Act, as added by
section 404, the following:</DELETED>
<DELETED>``SEC. 330O. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM
WOMEN.</DELETED>
<DELETED> ``(a) In General.--The Secretary may award grants for the
purpose of establishing or operating evidence-based or innovative,
evidence-informed programs to deliver integrated health care services
to pregnant and postpartum women to optimize the health of women and
their infants, including to reduce adverse maternal health outcomes,
pregnancy-related deaths, and related health disparities (including
such disparities associated with racial and ethnic minority
populations), and as appropriate, by addressing issues researched under
subsection (b)(2) of section 317K.</DELETED>
<DELETED> ``(b) Integrated Services for Pregnant and Postpartum
Women.--</DELETED>
<DELETED> ``(1) Eligibility.--To be eligible to receive a
grant under subsection (a), a State or Indian Tribe (as defined
in section 4 of the Indian Self-Determination and Education
Assistance Act) shall work with relevant stakeholders that
coordinate care (including coordinating resources and referrals
for health care and social services) to develop and carry out
the program, including--</DELETED>
<DELETED> ``(A) State, tribal, and local agencies
responsible for Medicaid, public health, social
services, mental health, and substance use disorder
treatment and services;</DELETED>
<DELETED> ``(B) health care providers who serve
pregnant women; and</DELETED>
<DELETED> ``(C) community-based health organizations
and health workers, including providers of home
visiting services and individuals representing
communities with disproportionately high rates of
maternal mortality and severe maternal morbidity, and
including those representing racial and ethnicity
minority populations.</DELETED>
<DELETED> ``(2) Terms.--</DELETED>
<DELETED> ``(A) Limitation.--The Secretary may award
a grant under subsection (a) to up to 10
States.</DELETED>
<DELETED> ``(B) Period.--A grant awarded under
subsection (a) shall be made for a period of 5
years.</DELETED>
<DELETED> ``(C) Prioritization.--In awarding grants
under subsection (a), the Secretary shall prioritize
applications from States or Indian Tribes with the
highest rates of maternal mortality and severe maternal
morbidity, and shall consider health disparities
related to maternal mortality and severe maternal
morbidity, including such disparities associated with
racial and ethnic minority populations.</DELETED>
<DELETED> ``(D) Evaluation.--The Secretary shall
require grantees to evaluate the outcomes of the
programs supported under the grant.</DELETED>
<DELETED> ``(c) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such sums as
may be necessary for each of fiscal years 2020 through
2024.''.</DELETED>
<DELETED> (b) Report on Grant Outcomes and Dissemination of Best
Practices.--</DELETED>
<DELETED> (1) Report.--Not later than April 1, 2025, the
Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report that describes--</DELETED>
<DELETED> (A) the outcomes of the activities
supported by the grants awarded under the amendments
made by this section on maternal and child
health;</DELETED>
<DELETED> (B) best practices and models of care used
by recipients of grants under such amendments;
and</DELETED>
<DELETED> (C) obstacles identified by recipients of
grants under such amendments, and strategies used by
such recipients to deliver care, improve maternal and
child health, and reduce health disparities.</DELETED>
<DELETED> (2) Dissemination of best practices.--Not later
than October 1, 2025, the Secretary of Health and Human
Services shall disseminate information on best practices and
models of care used by recipients of grants under the
amendments made by this section (including best practices and
models of care relating to the reduction of health disparities,
including such disparities associated with racial and ethnic
minority populations, in rates of maternal mortality and severe
maternal morbidity) to relevant stakeholders, which may include
health providers, medical schools, nursing schools, relevant
State, tribal, and local agencies, and the general
public.</DELETED>
<DELETED>SEC. 411. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE NATIONAL
HEALTH SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT
OPERATE GME PROGRAMS.</DELETED>
<DELETED> (a) Community Health Centers Funding.--Section
10503(b)(1)(F) of the Patient Protection and Affordable Care Act (42
U.S.C. 254b-2(b)(1)(F)) is amended by striking ``fiscal year 2019'' and
inserting ``each of fiscal years 2019 through 2024''.</DELETED>
<DELETED> (b) National Health Service Corps.--Section 10503(b)(2)(F)
of the Patient Protection and Affordable Care Act (42 U.S.C. 254b-
2(b)(2)(F)) is amended by striking ``and 2019'' and inserting ``through
2024''.</DELETED>
<DELETED> (c) Teaching Health Centers That Operate Graduate Medical
Education Programs.--Section 340H(g)(1) of the Public Health Service
Act (42 U.S.C. 256h(g)(1)) is amended by striking ``and 2019'' and
inserting ``through 2024''.</DELETED>
<DELETED> (d) Application of Provisions.--Amounts appropriated
pursuant to this section for each of fiscal years 2019 through 2024
shall be subject to the requirements contained in Public Law 115-245
for funds for programs authorized under sections 330 through 340 of the
Public Health Service Act.</DELETED>
<DELETED> (e) Conforming Amendments.--Paragraph (4) of section
3014(h) of title 18, United States Code, as amended by section 50901 of
Public Law 115-123, is amended by striking ``and section 50901(e) of
the Advancing Chronic Care, Extenders, and Social Services Act'' and
inserting ``, section 50901(e) of the Advancing Chronic Care,
Extenders, and Social Services Act, and section 411(d) of the Lower
Health Care Costs Act''.</DELETED>
<DELETED>SEC. 412. OTHER PROGRAMS.</DELETED>
<DELETED> (a) Type I.--Section 330B(b)(2)(D) of the Public Health
Service Act (42 U.S.C. 254c-2(b)(2)(D)) is amended by striking ``and
2019'' and inserting ``through 2024''.</DELETED>
<DELETED> (b) Indians.--Subparagraph (D) of section 330C(c)(2) of
the Public Health Service Act (42 U.S.C. 254c-3(c)(2)(D)) is amended by
striking ``and 2019'' and inserting ``through 2024''.</DELETED>
<DELETED>TITLE V--IMPROVING THE EXCHANGE OF HEALTH
INFORMATION</DELETED>
<DELETED>SEC. 501. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND
COST INFORMATION.</DELETED>
<DELETED> (a) In General.--Part A of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg et seq.) is amended by inserting
after section 2715A the following:</DELETED>
<DELETED>``SEC. 2715B. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK,
AND COST INFORMATION.</DELETED>
<DELETED> ``(a) In General.--A group health plan or a health
insurance issuer offering group or individual health insurance coverage
shall make available for access, exchange, or use without special
effort, through application programming interfaces (or successor
technology or standards), the information described in subsection (b),
in the manner described in subsection (b) and otherwise consistent with
this section.</DELETED>
<DELETED> ``(b) Information.--The following information is required
to be made available, in such form and manner as the Secretary may
specify, as described in subsection (a):</DELETED>
<DELETED> ``(1) Historical claims, provider encounter, and
payment data for each enrollee, which shall--</DELETED>
<DELETED> ``(A) include adjudicated medical and
prescription drug claims and equivalent encounters,
including all data elements contained in such
transactions--</DELETED>
<DELETED> ``(i) that were adjudicated by the
group health plan or health insurance issuer
during the previous 5 years or the enrollee's
entire period of enrollment in the applicable
plan or coverage if such period is less than 5
years;</DELETED>
<DELETED> ``(ii) that involve benefits
managed by any third party, such as a pharmacy
benefits manager or radiology benefits manager
that manages benefits or adjudicates claims on
behalf of the plan or coverage; and</DELETED>
<DELETED> ``(iii) from any other health plan
or health insurance coverage issued or
administered by the same insurance issuer, in
which the same enrollee was enrolled during the
previous 5 years; and</DELETED>
<DELETED> ``(B) be available--</DELETED>
<DELETED> ``(i) in a single, longitudinal
format that is easy to understand and secure,
and that may update automatically, including by
using the standards adopted for implementation
of section 3001(c)(5)(D)(iv);</DELETED>
<DELETED> ``(ii) as soon as practicable, and
in no case later than the period of time
determined by the Secretary, after the claim is
adjudicated or the data is received by the
health plan or health insurance issuer;
and</DELETED>
<DELETED> ``(iii) to the enrollee, and any
providers or third-party applications or
services authorized by the enrollee, for 5
years after the end date of the enrollee's
enrollment in the plan or in any coverage
offered by the health insurance
issuer.</DELETED>
<DELETED> ``(2) Identifying directory information for all
in-network providers, including facilities and practitioners,
that participate in the plan or coverage, which shall--
</DELETED>
<DELETED> ``(A) include--</DELETED>
<DELETED> ``(i) the national provider
identifier for in-network facilities and
practitioners; and</DELETED>
<DELETED> ``(ii) the name, address, phone
number, and specialty for each such facility
and practitioner, based on the most recent
interaction between the plan or coverage and
that facility or practitioner;</DELETED>
<DELETED> ``(B) be capable of returning a list of
participating in-network facilities and practitioners,
in a given specialty or at a particular facility type,
within a specified geographic radius; and</DELETED>
<DELETED> ``(C) be capable of returning the network
status, when presented with identifiers for a given
enrollee and facility or practitioner.</DELETED>
<DELETED> ``(3) Estimated patient out-of-pocket costs,
including costs expected to be incurred through a deductible,
copayment, coinsurance, or other form of cost-sharing, for--
</DELETED>
<DELETED> ``(A) a designated set of common services
or episodes of care, to be established by the Secretary
through rulemaking, including, at a minimum--</DELETED>
<DELETED> ``(i) in the case of services
provided by a hospital, the 100 most common
diagnosis-related groups, as used in the
Medicare Inpatient Prospective Patient System
(or successor episode-based reimbursement
methodology) at that hospital, based on claims
data adjudicated by the group health plan or
health insurance issuer;</DELETED>
<DELETED> ``(ii) in the case of services
provided in an outpatient setting, including
radiology, lab tests, and outpatient surgical
procedures, any service rendered by the
facility or practitioner, and reimbursed by the
health plan or health insurance issuer;
and</DELETED>
<DELETED> ``(iii) in the case of post-acute
care, including home health providers, skilled
nursing facilities, inpatient rehabilitation
facilities, and long-term care hospitals, the
patient out-of-pocket costs for an episode of
care, as the Secretary may determine, which
permits users to reasonably compare costs
across different facility and service types;
and</DELETED>
<DELETED> ``(B) all prescription drugs currently
included on any tier of the formulary of the plan or
coverage.</DELETED>
<DELETED> ``(c) Availability and Access.--The application
programming interfaces, including all data required to be made
available through such interfaces, shall--</DELETED>
<DELETED> ``(1) be made available by the applicable group
health plan or health insurance issuer, at no charge, to--
</DELETED>
<DELETED> ``(A) enrollees in the group health plan
or health insurance coverage;</DELETED>
<DELETED> ``(B) third parties authorized by the
enrollee;</DELETED>
<DELETED> ``(C) facilities and practitioners who are
under contract with the plan or coverage; and</DELETED>
<DELETED> ``(D) business associates of such
facilities and practitioners, as defined in section
160.103 of title 45, Code of Federal Regulations (or
any successor regulations);</DELETED>
<DELETED> ``(2) be available to enrollees in the group
health plan or health insurance coverage, and to third-party
applications or services facilitating such access by enrollees,
during the enrollment process and for a minimum of 5 years
after the end date of the enrollee's enrollment in the plan or
in any coverage offered by the health insurance
issuer;</DELETED>
<DELETED> ``(3) permit persistent access by third-party
applications or services authorized by the enrollee, for a
reasonable period of time, consistent with current security
practices;</DELETED>
<DELETED> ``(4) employ the applicable content, vocabulary,
and technical standards, including, as appropriate, such
standards adopted by the Secretary pursuant to title XXX;
and</DELETED>
<DELETED> ``(5) employ security and authentication
standards, as the Secretary determines appropriate.</DELETED>
<DELETED> ``(d) Rule of Construction Regarding Privacy.--Nothing in
this section shall be construed to alter existing obligations under the
privacy, security, and breach notification rules promulgated under
section 264(c) of the Health Insurance Portability and Accountability
Act (or successor regulations), under part 2 of title 42, Code of
Federal Regulations (or successor regulations), under section 444 of
the General Education Provisions Act (20 U.S.C. 1232g) (commonly
referred to as the `Family Educational Rights and Privacy Act of
1974'), under the amendments made by the Genetic Information
Nondiscrimination Act, or under State privacy law.''.</DELETED>
<DELETED> (b) Effective Date.--Section 2715B of the Public Health
Service Act, as added by subsection (a), shall take effect 1 year after
the date of enactment of this Act.</DELETED>
<DELETED>SEC. 502. RECOGNITION OF SECURITY PRACTICES.</DELETED>
<DELETED> Part 1 of subtitle D of the Health Information Technology
for Economic and Clinical Health Act (42 U.S.C. 17931 et seq.) is
amended by adding at the end the following:</DELETED>
<DELETED>``SEC. 13412. RECOGNITION OF SECURITY PRACTICES.</DELETED>
<DELETED> ``(a) In General.--Consistent with the authority of the
Secretary under sections 1176 and 1177 of the Social Security Act, when
making determinations relating to fines under section 13410, decreasing
the length and extent of an audit under section 13411, or remedies
otherwise agreed to by the Secretary, the Secretary shall consider
whether the entity or business associate had, for not less than the
previous 12 months, recognized security practices in place that may--
</DELETED>
<DELETED> ``(1) mitigate fines under section
13410;</DELETED>
<DELETED> ``(2) result in the early, favorable termination
of an audit under section 13411; and</DELETED>
<DELETED> ``(3) limit the remedies that would otherwise be
agreed to in any agreement between the entity or business
associate and the Department of Health and Human
Services.</DELETED>
<DELETED> ``(b) Additional Consideration.--At the election of the
entity or business associate, the Secretary may provide further
consideration to an entity or business associate that can adequately
demonstrate that such recognized security practices were in place, as
determined by the Secretary.</DELETED>
<DELETED> ``(c) Definition and Miscellaneous Provisions.--</DELETED>
<DELETED> ``(1) Recognized security practices.--The term
`recognized security practices' means the standards,
guidelines, best practices, methodologies, procedures, and
processes developed under section 2(c)(15) of the National
Institute of Standards and Technology Act, the approaches
promulgated under section 405(d) of the Cybersecurity
Information Sharing Act of 2015, and any other program or
processes that are equivalent to such requirements as may be
developed through regulations. Such practices shall be
determined by the entity or business associate, except where
additional consideration is requested under subsection
(b).</DELETED>
<DELETED> ``(2) Limitation.--Nothing in this section shall
be construed as providing the Secretary authority to--
</DELETED>
<DELETED> ``(A) increase fines under section 13410,
or the length, extent or quantity of audits under
section 13411, due to a lack of compliance with the
recognized security practices; or</DELETED>
<DELETED> ``(B) mandate, direct, or condition the
award of any Federal grant, contract, or purchase, on
compliance with such recognized security
practices.</DELETED>
<DELETED> ``(3) No liability for nonparticipation.--Nothing
in this section shall be construed to subject an entity or
business associate to liability for electing not to engage in
the recognized security practices defined by this
section.</DELETED>
<DELETED> ``(4) Rule of construction.--Nothing in this
section shall be construed to limit the Secretary's authority
to enforce the HIPAA Security rule (part 160 of title 45, Code
of Federal Regulations, and subparts A and C of part 164 of
such title), or to supersede or conflict with an entity or
business associate's obligations under the HIPAA Security
rule.''.</DELETED>
<DELETED>SEC. 503. GAO STUDY ON THE PRIVACY AND SECURITY RISKS OF
ELECTRONIC TRANSMISSION OF INDIVIDUALLY IDENTIFIABLE
HEALTH INFORMATION TO AND FROM ENTITIES NOT COVERED BY
THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY
ACT.</DELETED>
<DELETED> (a) In General.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United States
shall conduct a study to--</DELETED>
<DELETED> (1) describe the roles of Federal agencies and the
private sector with respect to protecting the privacy and
security of individually identifiable health information
transmitted electronically to and from entities not covered by
the regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C.
1320d-2 note);</DELETED>
<DELETED> (2) identify recent developments regarding the use
of application programming interfaces to access individually
identifiable health information, and implications for the
privacy and security of such information;</DELETED>
<DELETED> (3) identify practices in the private sector, such
as terms and conditions for use, relating to the privacy,
disclosure, and secondary uses of individually identifiable
health information transmitted electronically to or from
entities, selected by an individual, that are not subject to
the regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996;
and</DELETED>
<DELETED> (4) identify steps the public and private sectors
can take to improve the private and secure access to and
availability of individually identifiable health
information.</DELETED>
<DELETED> (b) Report.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United States
shall submit to Congress a report concerning the findings of the study
conducted under subsection (a).</DELETED>
<DELETED>SEC. 504. TECHNICAL CORRECTIONS.</DELETED>
<DELETED> (a) In General.--Section 3022(b) of the Public Health
Service Act (42 U.S.C. 300jj-52(b)) is amended by adding at the end the
following new paragraph:</DELETED>
<DELETED> ``(4) Application of authorities under inspector
general act of 1978.--In carrying out this subsection, the
Inspector General shall have the same authorities as provided
under section 6 of the Inspector General Act of 1978 (5 U.S.C.
App.).''.</DELETED>
<DELETED> (b) Effective Date.--The amendment made by subsection (a)
shall take effect as if included in the enactment of the 21st Century
Cures Act (Public Law 114-255).</DELETED>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Lower Health Care
Costs Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--ENDING SURPRISE MEDICAL BILLS
Sec. 101. Protecting patients against out-of-network deductibles in
emergencies.
Sec. 102. Protection against surprise bills.
Sec. 103. Benchmark for payment.
Sec. 104. Effective date.
Sec. 105. Ending surprise air ambulance bills.
Sec. 106. Report.
TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS
Sec. 201. Biological product patent transparency.
Sec. 202. Orange Book modernization.
Sec. 203. Ensuring timely access to generics.
Sec. 204. Protecting access to biological products.
Sec. 205. Preventing blocking of generic drugs.
Sec. 206. Education on biological products.
Sec. 207. Biological product innovation.
Sec. 208. Clarifying the meaning of new chemical entity.
Sec. 209. Streamlining the transition of biological products.
Sec. 210. Orphan drug clarification.
Sec. 211. Prompt approval of drugs related to safety information.
Sec. 212. Conditions of use for biosimilar biological products.
Sec. 213. Modernizing the labeling of certain generic drugs.
Sec. 214. Actions for delays of generic drugs and biosimilar biological
products.
Sec. 215. Reducing the price of prescription drugs.
TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE
Sec. 301. Increasing transparency by removing gag clauses on price and
quality information.
Sec. 302. Banning anticompetitive terms in facility and insurance
contracts that limit access to higher
quality, lower cost care.
Sec. 303. Designation of a nongovernmental, nonprofit transparency
organization to lower Americans' health
care costs.
Sec. 304. Protecting patients and improving the accuracy of provider
directory information.
Sec. 305. Timely bills for patients.
Sec. 306. Health plan oversight of pharmacy benefit manager services.
Sec. 307. Government Accountability Office study on profit- and
revenue-sharing in health care.
Sec. 308. Disclosure of direct and indirect compensation for brokers
and consultants to employer-sponsored
health plans and enrollees in plans on the
individual market.
Sec. 309. Ensuring enrollee access to cost-sharing information.
Sec. 310. Strengthening parity in mental health and substance use
disorder benefits.
Sec. 311. Technical amendments.
Sec. 312. Third-party administrators.
Sec. 313. Group health plan reporting requirements.
Sec. 314. Study by Comptroller General of United States.
TITLE IV--IMPROVING PUBLIC HEALTH
Sec. 401. Improving awareness of disease prevention.
Sec. 402. Grants to address vaccine-preventable diseases.
Sec. 403. Guide on evidence-based strategies for public health
department obesity prevention programs.
Sec. 404. Expanding capacity for health outcomes.
Sec. 405. Public health data system modernization.
Sec. 406. Innovation for maternal health.
Sec. 407. Training for health care providers.
Sec. 408. Study on training to reduce and prevent discrimination.
Sec. 409. Perinatal quality collaboratives.
Sec. 410. Integrated services for pregnant and postpartum women.
Sec. 411. Extension for community health centers, the national health
service corps, and teaching health centers
that operate GME programs.
Sec. 412. Other programs.
Sec. 413. Native American suicide prevention.
Sec. 414. Minimum age of sale of tobacco products.
Sec. 415. Sale of tobacco products to individuals under the age of 21.
TITLE V--IMPROVING THE EXCHANGE OF HEALTH INFORMATION
Sec. 501. Requirement to provide health claims, network, and cost
information.
Sec. 502. Recognition of security practices.
Sec. 503. GAO study on the privacy and security risks of electronic
transmission of individually identifiable
health information to and from entities not
covered by the Health Insurance Portability
and Accountability Act.
Sec. 504. Technical corrections.
Sec. 505. Public meeting.
TITLE I--ENDING SURPRISE MEDICAL BILLS
SEC. 101. PROTECTING PATIENTS AGAINST OUT-OF-NETWORK DEDUCTIBLES IN
EMERGENCIES.
Section 2719A(b) of the Public Health Service Act (42 U.S.C. 300gg-
19a) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
inserting ``or a freestanding emergency room'' after
``hospital''; and
(B) in subparagraph (C)--
(i) in clause (ii)(I), by inserting ``or
freestanding emergency room'' after ``emergency
department''; and
(ii) in subparagraph (C)(ii)(II), by
adding, ``a deductible,'' after ``(expressed
as''; and
(2) in paragraph (2)(B)--
(A) in clause (i)--
(i) by inserting ``or freestanding
emergency room'' after ``hospital''; and
(ii) by inserting ``or freestanding
emergency room'' after ``emergency
department''; and
(B) in clause (ii), by inserting ``or freestanding
emergency room'' after ``hospital''.
SEC. 102. PROTECTION AGAINST SURPRISE BILLS.
(a) PHSA.--Section 2719A of the Public Health Service Act (42
U.S.C. 300gg-19a) is amended by adding at the end the following:
``(e) Out-of-network Ancillary Services.--
``(1) Coverage of services.--Subject to subsection (h), in
the case of an enrollee in a group health plan or group or
individual health insurance coverage who receives out-of-
network ancillary services at an in-network facility, including
any referrals for diagnostic services, and such services would
be covered under such plan or coverage if provided in-network--
``(A) the cost-sharing requirement (expressed as a
copayment amount, coinsurance rate, or deductible) with
respect to such services shall be the same requirement
that would apply if such services were provided by an
in-network practitioner, and any coinsurance or
deductible shall be based on in-network rates; and
``(B) amounts paid toward such cost-sharing shall
be counted towards the in-network deductible and in-
network out-of-pocket maximum amount, as applicable,
under the plan or coverage for the plan year.
``(2) Notice before providing non-emergency services.--
Subject to subsection (h), in the case of an enrollee in a
group health plan or group or individual health insurance
coverage who receives out-of-network, non-emergency services
that are not ancillary services, from an out-of-network
provider at an in-network facility, and such services would be
covered under such plan or coverage if provided in-network, the
cost-sharing requirement (expressed as a copayment amount,
coinsurance rate, or deductible) with respect to such services
shall be the same requirement that would apply if such services
were provided by an in-network practitioner, and any
coinsurance or deductible shall be based on in-network rates,
unless, as soon as practicable, and in no case later than 48
hours prior to providing non-emergency services that are not
ancillary services--
``(A) the in-network facility provides to the
enrollee who is scheduled to receive such services
notice that--
``(i) is provided in paper or electronic
form (and including electronic notification
whenever practicable);
``(ii) states that such service will be
provided out-of-network;
``(iii) includes the estimated amount that
such practitioner or facility may charge the
enrollee for such services; and
``(iv) provides the option to affirmatively
consent to receiving such services from such
practitioner or facility;
``(B) such enrollee signs such notice consenting to
receive such services from an out-of-network provider
at an in-network facility, and acknowledging that the
out-of-network services may be covered at an out-of-
network cost-sharing amount, requiring higher cost-
sharing obligations of the enrollee than if the service
were provided by an in-network practitioner or
facility; and
``(C) such facility maintains documentation of the
enrollee's signature or confirmation of receipt of such
information under subparagraph (B) in the enrollee's
patient record for 2 years after the date of services.
``(3) Definition.--For purposes of this subsection, the
term `facility' has the meaning given the term `health care
facility' in section 2729A(c).
``(f) Coverage of Out-of-network Services for Enrollees Admitted
After Emergency Services.--
``(1) Protection for enrollees admitted to the hospital for
emergency services prior to stabilization.--In the case of an
enrollee in a group health plan or group or individual health
insurance coverage who receives emergency services, or maternal
care for a woman in labor, in the emergency department of an
out-of-network facility and has not been stabilized (within the
meaning of subsection (b)(2)(C)), if the patient is
subsequently admitted to the out-of-network facility for care,
the cost-sharing requirement (expressed as a copayment amount,
coinsurance rate, or deductible) with respect to any out-of-
network services provided to the enrollee prior to being stable
and in a condition to receive information under (2), is the
same requirement that would apply as under subsection
(b)(2)(C)(ii)(II).
``(2) Notice and consent.--
``(A) In general.--Subject to subsection (h), in
the case of an enrollee in a group health plan or group
or individual health insurance coverage who receives
emergency services, or maternal care for a woman in
labor, in the emergency department of an out-of-network
facility and has been stabilized (within the meaning of
subsection (b)(2)(C)), if the patient is subsequently
admitted to the out-of-network facility for care, the
cost-sharing requirement (expressed as a copayment
amount, coinsurance rate, or deductible) with respect
to any out-of-network services is the same requirement
that would apply if such services were provided by an
in-network provider, unless the enrollee, once stable
and in a condition to receive such information,
including having sufficient mental capacity--
``(i) has been provided by the facility,
prior to the provision of any post-
stabilization, out-of-network service at such
facility, with--
``(I) paper or electronic
notification that the practitioner or
facility is an out-of-network health
care provider and the out-of-network
rate of the provider, as applicable,
and the option to affirmatively consent
to receiving services from such
practitioner or facility; and
``(II) the estimated amount that
such provider may charge the
participant, beneficiary, or enrollee
for such services involved;
``(ii) has been provided by the plan or
coverage, prior to the provision of any post-
stabilization, out-of-network service at such
facility, with--
``(I) paper or electronic
notification (and including electronic
notification whenever practicable) that
the practitioner or facility is an out-
of-network health care provider, and
the option to affirmatively consent to
receiving services from such
practitioner or facility;
``(II) a list of in-network
practitioners or facilities in the
relevant geographic area that could
provide the same services, and an
option for a referral to such
providers; and
``(III) information about whether
prior authorization or other care
management limitations may be required
in advance of receiving in-network
services at the facility;
``(iii) has acknowledged, in writing, that
the out-of-network services provided after the
individual has been stabilized may not be
covered or may be covered at an out-of-network
cost-sharing amount, requiring higher cost-
sharing obligations of the enrollee than if the
service were provided at an in-network
facility.
``(B) Requirements of notice.--The notice under
subparagraph (A) shall be in a format determined by the
Secretary to give a reasonable layperson clear
comprehension of the terms of the agreement, including
all possible financial responsibilities, including the
requirements that the notice--
``(i) does not exceed one page in length;
``(ii) is readily identifiable for its
purpose and as a contract of consent;
``(iii) clearly states that consent to
potential out-of-network charges is optional
and that the enrollee has the choice to
transfer to an in-network facility;
``(iv) includes an estimate of the amount
that such provider will charge the participant,
beneficiary, or enrollee for such services
involved; and
``(v) be available in the 15 most common
languages in the facility's geographic area,
with the facility making a good faith effort to
provide oral notice in the enrollee's primary
language if it is not one of such 15 languages.
``(C) Maintenance of records.--A facility shall
maintain documentation of notice given to an enrollee
pursuant to this subsection and the enrollee's
confirmation of receipt of such information in the
enrollee's patient record for 2 years after the date of
services.
``(3) Rulemaking.--Not later than 6 months after the date
of enactment of the Lower Health Care Costs Act, the Secretary
shall issue regulations to carry out this subsection, which
shall include clarification on how to determine whether an
individual is stabilized and the timing of the notice required
under this paragraph.
``(g) Prohibition on Billing More Than an In-network Rate Under
Certain Circumstances.--
``(1) In general.--A facility or practitioner furnishing--
``(A) emergency services, as defined in subsection
(b)(2), regardless of the State in which the patient
resides;
``(B) out-of-network services at an in-network
facility described in subsection (e)(1);
``(C) out-of-network services at an in-network
facility described in subsection (e)(2), where the
notice and consent for receiving such services out-of-
network did not meet the requirement of such
subsection;
``(D) services furnished by an out-of-network
provider after an enrollee has been admitted to the
hospital for emergency services but prior to
stabilization, as described in subsection (f)(1); or
``(E) out-of-network services furnished after the
enrollee has been stabilized (within the meaning of
subsection (b)(2)(C)), where the notice and option for
receiving care at an alternate facility required under
subsection (f)(2) have not been provided to the
enrollee and the enrollee did not give consent under
subsection (f)(3),
may not bill an enrollee in a group health plan or group or
individual health insurance coverage for amounts beyond the
cost-sharing amount that would apply under subsection
(b)(1)(C)(ii)(II), (e)(1), (e)(2), or (f), as applicable.
``(2) Notice.--A facility furnishing services described in
paragraph (1) shall provide enrollees in a group health plan or
group or individual health insurance coverage with a one-page
notice, in 16-point font, upon intake at the emergency room or
being admitted at the facility of the prohibition on balance
billing under paragraph (1) and who to contact for recourse if
they are sent a balance bill in violation of such paragraph.
The facility shall be responsible for obtaining the signature
from the enrollee on such notice. The Secretary shall issue
regulations within 6 months of the date of enactment of the
Lower Health Care Costs Act on the requirements for the notice
under this paragraph.
``(h) Maintaining State Surprise Billing Protections.--
``(1) In general.--Nothing in this section shall prevent a
State from establishing or continuing in effect, with respect
to health insurance issuers, facilities, or practitioners, an
alternate method under State law for determining the
appropriate compensation for services described in subsection
(b), (e), or (f).
``(2) Additional application.--In the case of group health
plans or group or individual health insurance coverage offered
in a State that has not established an alternate method
described in paragraph (1), such as arbitration or a benchmark,
or for services described in subsection (b), (e), or (f) that
are not covered by such State's alternate method described in
paragraph (1), the provisions of this section shall apply.
``(3) Self-insured plans.--Subsections (b), (e), and (f)
shall apply to a self-insured group health plan that is not
subject to State insurance regulation.
``(i) Definitions.--In this section:
``(1) In-network.--The term `in-network', with respect to a
group health plan or health insurance coverage means a provider
that has a contractual relationship with the plan.
``(2) Enrollee.--The term `enrollee', with respect to
health insurance coverage or a group health plan, includes a
participant, dependent, or beneficiary.
``(3) Ancillary services.--The term `ancillary services'
means non-emergency care that is--
``(A) provided by anesthesiologists, pathologists,
emergency medicine providers, intensivists,
radiologists, neonatologists, hospitalists, and
assistant surgeons, whether the care is provided by a
physician or non-physician practitioner;
``(B) a diagnostic service (including radiology and
lab services); or
``(C) provided by such other specialty practitioner
not typically selected by the patients receiving the
care, which the Secretary may add periodically to such
definition through rulemaking.''.
(b) Enforcement of Balance Billing Prohibitions.--Part C of title
XXVII of the Public Health Service Act (42 U.S.C. 300gg-91 et seq.) is
amended by adding at the end the following:
``SEC. 2795. ENFORCEMENT OF BALANCE BILLING PROHIBITIONS.
``(a) In General.--Subject to subsection (b), a facility or
practitioner that violates a requirement under section 2719A(g)(1) or
fails to provide notice or obtain consent as required under subsection
(e)(2) or (f)(2) shall be subject to a civil monetary penalty of not
more than $10,000 for each act constituting such violation.
``(b) Procedure.--The provisions of section 1128A of the Social
Security Act, other than subsections (a) and (b) and the first sentence
of subsection (c)(1) of such section, shall apply to civil money
penalties under this subsection in the same manner as such provisions
apply to a penalty or proceeding under section 1128A of the Social
Security Act.
``(c) Safe Harbor.--
``(1) In general.--The Secretary shall waive the penalties
described under subsection (a) with respect to a facility or,
practitioner who does not knowingly violate, and should not
have reasonably known it violated, section 2719A(g)(1) with
respect to an enrollee, if such facility or practitioner,
within 30 days of the violation, withdraws the bill that was in
violation of section 2719A(g)(1), and, as applicable,
reimburses the group health plan, health insurance issuer, or
enrollee, in an amount equal to the difference between the
amount billed and the amount allowed to be billed under section
2719A(g)(1), plus interest, at an interest rate determined by
the Secretary.
``(2) Hardship exemption.--The Secretary may establish a
hardship exemption to the penalties under this section.
``(3) State enforcement.--The Secretary shall waive
penalties under this section with respect to a facility or
practitioner that has already been subject to enforcement
action under State law for a violation described in subsection
(a).''.
(c) Application to Grandfathered Plans.--Section 1251(a) of the
Patient Protection and Affordable Care Act (42 U.S.C. 18011(a)) is
amended by adding at the end the following:
``(5) Application of additional provisions.--Subsections
(b) through (h) of section 2719A of the Public Health Service
Act (42 U.S.C. 300gg-19a) shall apply to grandfathered health
plans for plan years beginning with the second plan year that
begins after the date of enactment of the Lower Health Care
Costs Act.''.
(d) Coverage Under Federal Employees Health Benefits Program.--
Section 8904 of title 5, United States Code, is amended by adding at
the end the following:
``(c) Any health benefits plan offered under this chapter shall be
treated as a group health plan or group or individual health insurance
coverage for purposes of subsections (e) through (g) of section 2719A
of the Public Health Service Act (42 U.S.C. 300gg-19a) (except for
paragraph (3) of such subsection (g)).''.
SEC. 103. BENCHMARK FOR PAYMENT.
(a) In General.--Subpart II of part A of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-11 et seq.) is amended by adding at
the end the following:
``SEC. 2729A. BENCHMARK FOR PAYMENT.
``(a) Establishment of Benchmark.--A group health plan or health
insurance issuer offering group or individual health insurance coverage
shall pay providers, including facilities and practitioners, furnishing
services for which such facilities and practitioners are prohibited
under section 2719A(g) from billing enrollees for amounts beyond the
cost-sharing amount that would apply under subsection
(b)(1)(C)(ii)(II), (e), or (f) of section 2719A,the median in-network
rate for such services provided to enrollees, using a methodology
determined under subsection (b) for the same or similar services
offered by the group health plan or health insurance issuer in that
geographic region. Such payment shall be made in a timely fashion in
order to ensure compliance with sections 399V-7 and 2729D.
``(b) Median In-network Rate.--
``(1) In general.--For purposes of this section, the term
`median in-network rate' means, with respect to health care
services covered by a group health plan or group or individual
health insurance coverage, the median contracted rate under the
applicable plan or coverage recognized under the plan or
coverage as the total maximum payment for the service minus the
in-network cost-sharing for such service under the plan or
coverage, for the same or a similar service that is provided by
a provider in the same or similar specialty and in the
geographic region in which the service is furnished.
``(2) Rulemaking.--
``(A) In general.--Not later than 1 year after the
date of enactment of the Lower Health Care Costs Act,
the Secretary shall, through rulemaking, determine the
methodology a group health plan or health insurance
issuer is required to use to determine the median in-
network rate described in paragraph (1),
differentiating by business line, the information the
plan or issuer shall share with the out-of-network
provider involved when making such a determination, and
the geographic regions applied for purposes of this
subsection. Such rulemaking shall take into account
payments that are made by health insurance issuers that
are not on a fee-for-service basis.
``(B) Geographic regions.--In establishing
geographic regions under subparagraph (A), the
Secretary shall consider adequate access to services in
rural areas and health professional shortage areas, as
defined in section 332. The Secretary shall consult
with the National Association of Insurance
Commissioners in establishing the geographic regions.
The Secretary shall update the geographic regions
periodically, as appropriate, taking into account the
findings of the report under section 106 of the Lower
Health Care Costs Act.
``(3) Certain insurers.--If a group health plan or health
insurance issuer offering group or individual health insurance
coverage does not have sufficient information to calculate a
median in-network rate for this service or provider type, or
amount of, claims for services (as determined by the applicable
State authority, in the case of health insurance coverage, or
by the Secretary of Labor, in the case of a self-insured group
health plan) covered under the list of out-of-network services
set by the State authority or Secretary of Labor, as
applicable, in a particular geographic area, such plan or
issuer shall demonstrate that it will use a database free of
conflicts of interest that has sufficient information
reflecting allowed amounts paid to individual health care
providers for relevant services provided in the applicable
geographic region, and that such plan or issuer will use that
database to determine a median in-network rate. The group
health plan or health insurance issuer shall cover the cost of
accessing the database.
``(4) Rule of construction.--Nothing in this subsection
shall prevent a group health plan or health insurance issuer
from establishing separate calculations of a median in-network
rate under paragraph (1) for services delivered in nonhospital
facilities, including freestanding emergency rooms.
``(c) Facility.--For purposes of this section, the term `health
care facility' or `facility' includes hospitals, hospital outpatient
departments, critical access hospitals, ambulatory surgery centers,
laboratories, radiology clinics, freestanding emergency rooms, and any
other facility that provides services that are covered under a group
health plan or health insurance coverage, including settings of care
subject to section 2719A(b).''.
(b) Non-Federal Governmental Plans.--Section 2722(a)(2)(E) of the
Public Health Service Act (42 U.S.C. 300gg-21(a)(2)(E)) is amended by
inserting ``, except that such election shall be available with respect
to section 2729A'' before the period.
SEC. 104. EFFECTIVE DATE.
The amendments made by sections 101, 102, and 103 shall take effect
beginning in the second plan year that begins after the date of
enactment of this Act.
SEC. 105. ENDING SURPRISE AIR AMBULANCE BILLS.
(a) In General.--Part A of title XXVII of the Public Health Service
Act is amended by inserting after section 2719A (42 U.S.C. 300gg-19a)
the following:
``SEC. 2719B. ENDING SURPRISE AIR AMBULANCE BILLS.
``(a) In General.--In the case of an enrollee in a group health
plan or group or individual health insurance coverage who receives air
ambulance services from an out-of-network provider, if such services
would be covered if provided by an in-network provider--
``(1) the cost-sharing requirement (expressed as a
copayment amount, coinsurance rate, or deductible) with respect
to such services shall be the same requirement that would apply
if such services were provided by an in-network practitioner,
and any coinsurance or deductible shall be based on in-network
rates; and
``(2) such cost-sharing amounts shall be counted towards
the in-network deductible and in-network out-of-pocket maximum
amount under the plan or coverage for the plan year.
``(b) Payment Rate.--A group health plan or health insurance issuer
shall pay for air ambulance services for purposes of subsection (a) at
the median in-network as defined in subsection (c).
``(c) Median In-network Rate.--
``(1) In general.--For purposes of this section, the term
`median in-network rate' means, with respect to air ambulance
services covered by a group health plan or group or individual
health insurance coverage, the median contracted rate under the
applicable plan or coverage recognized under the plan or
coverage as the total maximum payment for the service, minus
the in-network cost-sharing for such service under the plan or
coverage, for the same or a similar service that is provided by
a provider in the same or similar specialty, and in the
geographic region in which the service is furnished.
``(2) Rulemaking.--
``(A) In general.--Not later than 6 months after
the date of enactment of the Lower Health Care Costs
Act, the Secretary shall, through rulemaking, determine
the methodology a group health plan or health insurance
issuer is required to use to determine the median in-
network rate described in paragraph (1), the
information the plan or issuer shall share with the
out-of-network provider involved when making such a
determination, and the geographic regions applied for
purposes of this subsection. Such rulemaking shall take
into account payments that are made by issuers that are
not on a fee-for-service basis.
``(B) Geographic regions.--In establishing
geographic regions as described in subparagraph (A),
the Secretary shall consider adequate access to
services in rural areas. The Secretary shall consult
with the National Association of Insurance
Commissioners in establishing the geographic regions.
The Secretary shall update the geographic regions
periodically, as appropriate, taking into account the
findings of the report under section 106 of the Lower
Health Care Costs Act.
``(3) Certain insurers.--If a group health plan or health
insurance issuer offering group or individual health insurance
coverage does not have sufficient information to calculate a
median in-network rate for this service or provider type, or
amount of, claims for services (as determined by the applicable
State authority, in the case of health insurance coverage, or
by the Secretary of Labor, in the case of a self-insured group
health plan) covered under the list of out-of-network services
set by the State authority or Secretary of Labor, as
applicable, in a particular geographic area, such plan or
issuer shall demonstrate that it will use a database free of
conflicts of interest that has sufficient information
reflecting allowed amounts paid to individual health care
providers for relevant services provided in the applicable
geographic region, and that such plan or issuer will use that
database to determine a median in-network rate. The group
health plan or health insurance issuer shall cover the cost of
accessing the database.
``(4) Clarification.--For purposes of this subsection, the
Secretary may define geographic regions that are different from
the geographic regions identified for purposes of section
2729A(b) to ensure that an adequate number of air ambulance
services are in-network in each geographic region so that a
median in-network rate for air ambulance services may be
calculated for each such region.
``(d) Cost-sharing Limitation.--An air ambulance service provider
may not bill an enrollee in a group health plan or group or individual
health insurance coverage for amounts beyond the cost-sharing amount
that applies under subsection (a).
``(e) Enforcement.--
``(1) In general.--Subject to paragraph (2), an air
ambulance service provider that violates subsection (d) shall
be subject to a civil monetary penalty of not more than $10,000
for each act constituting such violation.
``(2) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsections (a) and (b) and the
first sentence of subsection (c)(1) of such section, shall
apply to civil money penalties under this subsection in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A of the Social Security Act.
``(3) Safe harbor.--The Secretary shall waive the penalties
described under paragraph (1) with respect to a air ambulance
service provider who unknowingly violates subsection (d) with
respect to an enrollee, if such air ambulance service provider
within 30 days of the violation, withdraws the bill that was in
violation of subsection (d), and, as applicable, reimburses the
group health plan, health insurance issuer, or enrollee, as
applicable, in an amount equal to the amount billed in
violation of subsection (d), plus interest, at an interest rate
determined by the Secretary.''.
(b) Effective Date.--Section 2719B of the Public Health Service
Act, as added by subsection (a), shall take effect on the date that is
1 year after the date of enactment of this Act.
SEC. 106. REPORT.
Not later than 1 year after the effective date described in section
104, and annually for the following 4 years, the Secretary of Health
and Human Services, in consultation with the Federal Trade Commission
and the Attorney General, shall--
(1) conduct a study on--
(A) the effects of the amendments made by sections
101, 102, 103, and 105, including any patterns of
vertical or horizontal integration of health care
facilities, providers, group health plans, or health
insurance issuers;
(B) the effects of the amendments made by sections
101, 102, 103, and 105 on overall health care costs;
(C) the effects of the amendments made by sections
101, 102, 103, and 105 on access to services, including
specialty services, in rural areas and health
professional shortage areas as defined in section 332;
and
(D) recommendations, made in consultation with the
Secretary of Labor and the Secretary of the Treasury,
for effective enforcement of 2729A of the Public Health
Service Act, as added by section 103, including
potential challenges to addressing anti-competitive
consolidation by health care facilities, providers,
group health plans, or health insurance issuers; and
(2) submit a report on such study to the Committee on
Health, Education, Labor, and Pensions, the Committee on
Commerce, Science, and Transportation, the Committee on
Finance, and the Committee on the Judiciary of the Senate and
the Committee on Education and Labor, the Committee on Energy
and Commerce, the Committee on Ways and Means, and the
Committee on the Judiciary of the House of Representatives.
TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS
SEC. 201. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.
(a) In General.--Section 351 of the Public Health Service Act (42
U.S.C. 262) is amended by adding at the end the following:
``(o) Additional Requirements With Respect to Patents.--
``(1) Approved application holder listing requirements.--
``(A) In general.--Beginning on the date of
enactment of the Lower Health Care Costs Act, within 60
days of approval of an application under subsection (a)
or (k), the holder of such approved application shall
submit to the Secretary a list of each patent required
to be disclosed (as described in paragraph (3)).
``(B) Previously approved or licensed biological
products.--
``(i) Products licensed under section 351
of the phsa.--Not later than 30 days after the
date of enactment of the Lower Health Care
Costs Act, the holder of a biological product
license that was approved under subsection (a)
or (k) before the date of enactment of such Act
shall submit to the Secretary a list of each
patent required to be disclosed (as described
in paragraph (3)).
``(ii) Products approved under section 505
of the ffdca.--Not later than 30 days after
March 23, 2020, the holder of an approved
application for a biological product under
section 505 of the Federal Food, Drug, and
Cosmetic Act that is deemed to be a license for
the biological product under this section on
March 23, 2020, shall submit to the Secretary a
list of each patent required to be disclosed
(as described in paragraph (3)).
``(C) Updates.--The holder of a biological product
license that is the subject of an application under
subsection (a) or (k) shall submit to the Secretary a
list that includes--
``(i) any patent not previously required to
be disclosed (as described in paragraph (3))
under subparagraph (A) or (B), as applicable,
within 30 days of the earlier of--
``(I) the date of issuance of such
patent by the United States Patent and
Trademark Office; or
``(II) the date of approval of a
supplemental application for the
biological product; and
``(ii) any patent, or any claim with
respect to a patent, included on the list
pursuant to this paragraph, that the Patent
Trial and Appeal Board of the United States
Patent and Trademark Office determines in a
written decision to cancel as unpatentable,
within 30 days of such decision.
``(2) Publication of information.--
``(A) In general.--Within 1 year of the date of
enactment of the Lower Health Care Costs Act, the
Secretary shall publish and make available to the
public a single, easily searchable list that includes--
``(i) the official and proprietary name of
each biological product licensed, or deemed to
be licensed, under subsection (a) or (k);
``(ii) with respect to each biological
product described in clause (i), each patent
submitted in accordance with paragraph (1);
``(iii) the date of licensure and
application number for each such biological
product;
``(iv) the marketing status, dosage form,
route of administration, strength, and, if
applicable, reference product, for each such
biological product;
``(v) the licensure status for each such
biological product, including whether the
license at the time of listing is approved,
withdrawn, or revoked;
``(vi) with respect to each such biological
product, any period of exclusivity under
paragraph (6), (7)(A), or (7)(B) of subsection
(k) of this section or section 527 of the
Federal Food, Drug, and Cosmetic Act, and any
extension of such period in accordance with
subsection (m) of this section, for which the
Secretary has determined such biological
product to be eligible, and the date on which
such exclusivity expires;
``(vii) any determination of biosimilarity
or interchangeability for each such biological
product; and
``(viii) information regarding approved
indications for each such biological product,
in such manner as the Secretary determines
appropriate.
``(B) Updates.--Every 30 days after the publication
of the first list under subparagraph (A), the Secretary
shall revise the list to include--
``(i)(I) each biological product licensed
under subsection (a) or (k) during the 30-day
period; and
``(II) with respect to each biological
product described in subclause (I), the
information described in clauses (i) through
(viii) of subparagraph (A); and
``(ii) any updates to information
previously published in accordance with
subparagraph (A).
``(C) Noncompliance.--Beginning 18 months after the
date of enactment of the Lower Health Care Costs Act,
the Secretary, in consultation with the Director of the
United States Patent and Trademark Office, shall
publish and make available to the public a list of any
holders of biological product licenses, and the
corresponding biological product or products, that
failed to submit information as required under
paragraph (1), including any updates required under
paragraph (1)(C), in such manner and format as the
Secretary determines appropriate. If information
required under paragraph (1) is submitted following
publication of such list, the Secretary shall remove
such holders of such biological product licenses from
the public list in a reasonable period of time.
``(3) Patents required to be disclosed.--In this section, a
`patent required to be disclosed' is any patent for which the
holder of a biological product license approved under
subsection (a) or (k), or a biological product application
approved under section 505 of the Federal Food, Drug, and
Cosmetic Act and deemed to be a license for a biological
product under this section on March 23, 2020, believes a claim
of patent infringement could reasonably be asserted by the
holder, or by a patent owner that has granted an exclusive
license to the holder with respect to the biological product
that is the subject of such license, if a person not licensed
by the owner engaged in the making, using, offering to sell,
selling, or importing into the United States of the biological
product that is the subject of such license.''.
(b) Disclosure of Patents.--Section 351(l)(3)(A)(i) of the Public
Health Service Act (42 U.S.C. 262(l)(3)(A)(i)) is amended by inserting
``included in the list provided by the reference product sponsor under
subsection (o)(1)'' after ``a list of patents''.
(c) Review and Report on Noncompliance.--Not later than 30 months
after the date of enactment of this Act, the Secretary shall--
(1) solicit public comments regarding appropriate remedies,
in addition to the publication of the list under subsection
(o)(2)(C) of section 351 of the Public Health Service Act (42
U.S.C. 262), as added by subsection (a), with respect to
holders of biological product licenses who fail to timely
submit information as required under subsection (o)(1) of such
section 351, including any updates required under subparagraph
(C) of such subsection (o)(1); and
(2) submit to Congress an evaluation of comments received
under paragraph (1) and the recommendations of the Secretary
concerning appropriate remedies.
(d) Regulations.--The Secretary of Health and Human Services may
promulgate regulations to carry out subsection (o) of section 351 of
the Public Health Service Act (42 U.S.C. 262), as added by subsection
(a).
(e) Rule of Construction.--Nothing in this Act, including an
amendment made by this Act, shall be construed to require or allow the
Secretary of Health and Human Services to delay the licensing of a
biological product under section 351 of the Public Health Service Act
(42 U.S.C. 262).
SEC. 202. ORANGE BOOK MODERNIZATION.
(a) Submission of Patent Information for Brand Name Drugs.--
(1) In general.--Paragraph (1) of section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is
amended to read as follows:
``(b)(1)(A) Any person may file with the Secretary an application
with respect to any drug subject to the provisions of subsection (a).
Such persons shall submit to the Secretary as part of the application--
``(i) full reports of investigations which have been made
to show whether or not such drug is safe for use and whether
such drug is effective in use;
``(ii) a full list of the articles used as components of
such drug;
``(iii) a full statement of the composition of such drug;
``(iv) a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing,
and packing of such drug;
``(v) such samples of such drug and of the articles used as
components thereof as the Secretary may require;
``(vi) specimens of the labeling proposed to be used for
such drug;
``(vii) any assessments required under section 505B; and
``(viii) the patent number and expiration date, of each
patent for which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug, and
that--
``(I) claims the drug for which the applicant
submitted the application and is a drug substance
patent or a drug product patent; or
``(II) claims the method of using the drug for
which approval is sought or has been granted in the
application.
``(B) If an application is filed under this subsection for a drug,
and a patent of the type described in subparagraph (A)(viii) that
claims such drug or a method of using such drug is issued after the
filing date, the applicant shall amend the application to include such
patent information.''.
(2) Guidance.--The Secretary of Health and Human Services
shall, in consultation with the Director of the National
Institutes of Health and with representatives of the drug
manufacturing industry, review and develop guidance, as
appropriate, on the inclusion of women and minorities in
clinical trials required under subsection (b)(1)(A)(i) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by paragraph (1).
(b) Conforming Changes to Requirements for Subsequent Submission of
Patent Information.--Section 505(c)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)(2)) is amended--
(1) by inserting before the first sentence the following:
``Not later than 30 days after the date of approval of an
application under subsection (b), the holder of the approved
application shall file with the Secretary the patent number and
the expiration date of any patent described in subclause (I) or
(II) of subsection (b)(1)(A)(viii), except that a patent that
is identified as claiming a method of using such drug shall be
filed only if the patent claims a method of use approved in the
application. The holder of the approved application shall file
with the Secretary the patent number and the expiration date of
any patent described in subclause (I) or (II) of subsection
(b)(1)(A)(viii) that is issued after the date of approval of
the application, not later than 30 days after the date of
issuance of the patent, except that a patent that claims a
method of using such drug shall be filed only if approval for
such use has been granted in the application.'';
(2) by inserting after ``the patent number and the
expiration date of any patent which'' the following: ``fulfills
the criteria in subsection (b) and'';
(3) by inserting after the third sentence (as amended by
paragraph (1)) the following: ``Patent information that is not
the type of patent information required by subsection
(b)(1)(A)(viii) shall not be submitted under this paragraph.'';
and
(4) by inserting after ``could not file patent information
under subsection (b) because no patent'' the following: ``of
the type required to be submitted in subsection
(b)(1)(A)(viii)''.
(c) Listing of Exclusivities.--Subparagraph (A) of section
505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)) is amended by adding at the end the following:
``(iv) For each drug included on the list, the Secretary shall
specify any exclusivity period that is applicable, for which the
Secretary has determined the expiration date, and for which such period
has not yet expired under--
``(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E)
of this section;
``(II) clause (iv) or (v) of paragraph (5)(B) of this
subsection;
``(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of
this subsection;
``(IV) section 505A;
``(V) section 505E;
``(VI) section 527(a); or
``(VII) subsection (u)''.
(d) Orange Book Updates With Respect to Invalidated Patents.--
(1) In general.--
(A) Amendments.--Section 505(j)(7)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)(A)), as amended by subsection (c), is further
amended by adding at the end the following:
``(v) In the case of a listed drug for which the list under
clause (i) includes a patent for such drug, and where the Under
Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office have cancelled
any claim of the patent pursuant to a decision by the Patent
Trial and Appeal Board in an inter partes review conducted
under chapter 31 of title 35, United States Code, or a post-
grant review conducted under chapter 32 of that title, and from
which no appeal has been taken, or can be taken, the holder of
the applicable approved application shall notify the Secretary,
in writing, within 14 days of such cancellation, and, if the
patent has been deemed wholly inoperative or invalid, or if a
patent claim has been cancelled, the revisions required under
clause (iii) shall include striking the patent or information
regarding such patent claim from the list with respect to such
drug, as applicable, except that the Secretary shall not remove
a patent from the list before the expiration of any 180-day
exclusivity period under paragraph (5)(B)(iv) that relies on a
certification described in paragraph (2)(A)(vii)(IV) with
respect to such patent.''.
(B) Application.--The amendment made by
subparagraph (A) shall not apply with respect to any
determination with respect to a patent or patent claim
that is made prior to the date of enactment of this
Act.
(2) No effect on first applicant exclusivity period.--
Section 505(j)(5)(B)(iv)(I), as amended by section 205, is
amended by adding at the end the following: ``This subclause
shall apply even if a patent is stricken from the list under
paragraph (7)(A), pursuant to paragraph (7)(A)(v), provided
that, at the time that the first applicant submitted an
application under this subsection containing a certification
described in paragraph (2)(A)(vii)(IV), the patent that was the
subject of such certification was included in such list with
respect to the listed drug.''.
SEC. 203. ENSURING TIMELY ACCESS TO GENERICS.
Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)(i), by inserting ``,
10.31,'' after ``10.30'';
(B) in subparagraph (E)--
(i) by striking ``application and'' and
inserting ``application or'';
(ii) by striking ``If the Secretary'' and
inserting the following:
``(i) In general.--If the Secretary''; and
(iii) by striking the second sentence and
inserting the following:
``(ii) Primary purpose of delaying.--
``(I) In general.--In determining
whether a petition was submitted with
the primary purpose of delaying an
application, the Secretary may consider
the following factors:
``(aa) Whether the petition
was submitted in accordance
with paragraph (2)(B), based on
when the petitioner knew or
reasonably should have known
the relevant information relied
upon to form the basis of such
petition.
``(bb) Whether the
petitioner has submitted
multiple or serial petitions or
supplements to petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or petitions.
``(cc) Whether the petition
was submitted close in time to
a known, first date upon which
an application under subsection
(b)(2) or (j) of this section
or section 351(k) of the Public
Health Service Act could be
approved.
``(dd) Whether the petition
was submitted without relevant
data or information in support
of the scientific positions
forming the basis of such
petition.
``(ee) Whether the petition
raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.
``(ff) Whether the petition
requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
the Secretary has determined to
be applicable to the listed
drug, reference product, or
petitioner's version of the
same drug.
``(gg) The petitioner's
record of submitting petitions
to the Food and Drug
Administration that have been
determined by the Secretary to
have been submitted with the
primary purpose of delay.
``(hh) Other relevant and
appropriate factors, which the
Secretary shall describe in
guidance.
``(II) Guidance.--The Secretary may
issue or update guidance, as
appropriate, to describe factors the
Secretary considers in accordance with
subclause (II).'';
(C) by adding at the end the following:
``(iii) Referral to the federal trade
commission.--The Secretary shall establish
procedures for referring to the Federal Trade
Commission any petition or supplement to a
petition that the Secretary determines was
submitted with the primary purpose of delaying
approval of an application. Such procedures
shall include notification to the petitioner by
the Secretary.'';
(D) by striking subparagraph (F);
(E) by redesignating subparagraphs (G) through (I)
as subparagraphs (F) through (H), respectively; and
(F) in subparagraph (H), as so redesignated, by
striking ``submission of this petition'' and inserting
``submission of this document'';
(2) in paragraph (2)--
(A) by redesignating subparagraphs (A) through (C)
as subparagraphs (C) through (E), respectively;
(B) by inserting before subparagraph (C), as so
redesignated, the following:
``(A) In general.--A person shall submit a petition
to the Secretary under paragraph (1) before filing a
civil action in which the person seeks to set aside,
delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.
``(B) Timely submission of citizen petition.--A
petition and any supplement to a petition shall be
submitted within 60 days after the person knew, or
reasonably should have known, the information that
forms the basis of the request made in the petition or
supplement.'';
(C) in subparagraph (C), as so redesignated--
(i) in the heading, by striking ``within
150 days'';
(ii) in clause (i), by striking ``during
the 150-day period referred to in paragraph
(1)(F),''; and
(iii) by amending clause (ii) to read as
follows:
``(ii) on or after the date that is 151
days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';
(D) by amending subparagraph (D), as so
redesignated, to read as follows:
``(D) Dismissal of certain civil actions.--
``(i) Petition.--If a person files a civil
action against the Secretary in which a person
seeks to set aside, delay, rescind, withdraw,
or prevent submission, review, or approval of
an application submitted under subsection
(b)(2) or (j) of this section or section 351(k)
of the Public Health Service Act without
complying with the requirements of subparagraph
(A), the court shall dismiss without prejudice
the action for failure to exhaust
administrative remedies.
``(ii) Timeliness.--If a person files a
civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.
``(iii) Final response.--If a civil action
is filed against the Secretary with respect to
any issue raised in a petition timely filed
under paragraph (1) in which the petitioner
requests that the Secretary take any form of
action that could, if taken, set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act before the Secretary has taken final agency
action on the petition within the meaning of
subparagraph (C), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.''; and
(E) in clause (iii) of subparagraph (E), as so
redesignated, by striking ``as defined under
subparagraph (2)(A)'' and inserting ``within the
meaning of subparagraph (C)''; and
(3) in paragraph (4)--
(A) by striking ``Exceptions'' and all that follows
through ``This subsection does'' and inserting
``Exceptions.--This subsection does'';
(B) by striking subparagraph (B); and
(C) by redesignating clauses (i) and (ii) as
subparagraphs (A) and (B), respectively, and adjusting
the margins accordingly.
SEC. 204. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS.
Section 351(k)(7) of the Public Health Service Act (42 U.S.C.
262(k)(7)) is amended by adding at the end the following:
``(D) Deemed licenses.--
``(i) No additional exclusivity through
deeming.--An approved application that is
deemed to be a license for a biological product
under this section pursuant to section
7002(e)(4) of the Biologics Price Competition
and Innovation Act of 2009 shall not be treated
as having been first licensed under subsection
(a) for purposes of subparagraphs (A) and (B).
``(ii) Application of limitations on
exclusivity.--Subparagraph (C) shall apply with
respect to a reference product referred to in
such subparagraph that was the subject of an
approved application that was deemed to be a
license pursuant to section 7002(e)(4) of the
Biologics Price Competition and Innovation Act
of 2009.
``(iii) Applicability.--The exclusivity
periods described in section 527, section
505A(b)(1)(A)(ii), and section
505A(c)(1)(A)(ii) of the Federal Food, Drug,
and Cosmetic Act shall continue to apply to a
biological product after an approved
application for the biological product is
deemed to be a license for the biological
product under subsection (a) pursuant to
section 7002(e)(4) of the Biologics Price
Competition and Innovation Act of 2009.''.
SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS.
(a) In General.--Section 505(j)(5)(B)(iv)(I) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)(I)) is amended--
(1) by striking ``180 days after the date'' and inserting
``180 days after the earlier of the following:
``(aa) The date''; and
(2) by adding at the end the following:
``(bb) The date on which all of the
following conditions are first met, provided no
application submitted by any first applicant is
approved on or before such date:
``(AA) An application for the drug
submitted by an applicant other than a
first applicant has received tentative
approval and could receive approval, if
no first applicant were eligible for
180-day exclusivity under this clause,
and such applicant has not entered into
an agreement that would prevent
commercial marketing upon approval and
has submitted a notification to the
Secretary documenting that it has not
entered into an agreement that would
prevent commercial marketing.
``(BB) Thirty-three months have
passed since the date of submission of
an application for the drug by one
first applicant, if there is only one
first applicant, or, in the case of
more than one first applicant, 33
months have passed since the date of
submission of all such applications.
``(CC) Approval of an application
for the drug submitted by at least one
first applicant would not be precluded
under clause (iii).''.
(b) Information.--Not later than 60 days of the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this subsection as the ``Secretary'') shall publish, as appropriate and
available, information sufficient to allow applicants to assess whether
the conditions described in subitems (AA) through (CC) of section
505(j)(5)(B)(iv)(I)(bb) of the Federal Food, Drug, and Cosmetic Act (as
amended by subsection (a)) have been or will be satisfied for all
applications where the exclusivity period under (iv)(I) of section
505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act (as so
amended) has not expired, and shall provide updates to reflect the most
recent information available to the Secretary.
SEC. 206. EDUCATION ON BIOLOGICAL PRODUCTS.
Subpart 1 of part F of title III of the Public Health Service Act
(42 U.S.C. 262 et seq.) is amended by adding at the end the following:
``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.
``(a) Internet Website.--
``(1) In general.--The Secretary may maintain and operate
an internet website to provide educational materials for health
care providers, patients, and caregivers, regarding the meaning
of the terms, and the standards for review and licensing of,
biological products, including biosimilar biological products
and interchangeable biosimilar biological products.
``(2) Content.--Educational materials provided under
paragraph (1) may include--
``(A) explanations of key statutory and regulatory
terms, including `biosimilar' and `interchangeable',
and clarification regarding the use of interchangeable
biosimilar biological products;
``(B) information related to development programs
for biological products, including biosimilar
biological products and interchangeable biosimilar
biological products and relevant clinical
considerations for prescribers, which may include, as
appropriate and applicable, information related to the
comparability of such biological products;
``(C) an explanation of the process for reporting
adverse events for biological products, including
biosimilar biological products and interchangeable
biosimilar biological products; and
``(D) an explanation of the relationship between
biosimilar biological products and interchangeable
biosimilar biological products licensed under section
351(k) and reference products (as defined in section
351(i)), including the standards for review and
licensing of each such type of biological product.
``(3) Format.--The educational materials provided under
paragraph (1) may be--
``(A) in formats such as webinars, continuing
medical education modules, videos, fact sheets,
infographics, stakeholder toolkits, or other formats as
appropriate and applicable; and
``(B) tailored for the unique needs of health care
providers, patients, caregivers, and other audiences,
as the Secretary determines appropriate.
``(4) Other information.--In addition to the information
described in paragraph (2), the Secretary shall continue to
publish the following information:
``(A) The action package of each biological product
licensed under subsection (a) or (k).
``(B) The summary review of each biological product
licensed under subsection (a) or (k).
``(5) Confidential and trade secret information.--This
subsection does not authorize the disclosure of any trade
secret, confidential commercial or financial information, or
other matter described in section 552(b) of title 5.
``(b) Continuing Education.--The Secretary shall advance education
and awareness among health care providers regarding biological
products, including biosimilar biological products and interchangeable
biosimilar biological products, as appropriate, including by developing
or improving continuing medical education programs that advance the
education of such providers on the prescribing of, and relevant
clinical considerations with respect to, biological products, including
biosimilar biological products and interchangeable biosimilar
biological products.''.
SEC. 207. BIOLOGICAL PRODUCT INNOVATION.
Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j))
is amended--
(1) by striking ``except that a product'' and inserting
``except that--
``(1) a product'';
(2) by striking ``Act.'' and inserting ``Act; and''; and
(3) by adding at the end the following:
``(2) no requirement under such Act regarding an official
compendium (as defined in section 201(j) of such Act), or other
reference in such Act to an official compendium (as so
defined), shall apply with respect to a biological product
subject to regulation under this section.''.
SEC. 208. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 505 (21 U.S.C. 355)--
(A) in subsection (c)(3)(E), by striking ``active
ingredient (including any ester or salt of the active
ingredient)'' each place it appears and inserting
``active moiety (as defined by the Secretary in section
314.3 of title 21, Code of Federal Regulations (or any
successor regulations))'';
(B) in subsection (j)(5)(F), by striking ``active
ingredient (including any ester or salt of the active
ingredient)'' each place it appears and inserting
``active moiety (as defined by the Secretary in section
314.3 of title 21, Code of Federal Regulations (or any
successor regulations))'';
(C) in subsection (l)(2)(A)--
(i) by amending clause (i) to read as
follows:
``(i) not later than 30 days after the date of
approval of such applications--
``(I) for a drug, no active moiety (as
defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any
successor regulations)) of which has been
approved in any other application under this
section; or
``(II) for a biological product, no active
ingredient of which has been approved in any
other application under section 351 of the
Public Health Service Act; and''; and
(ii) in clause (ii), by inserting "or
biological product" before the period;
(D) by amending subsection (s) to read as follows:
``(s) Referral to Advisory Committee.--The Secretary shall--
``(1) refer a drug or biological product to a Food and Drug
Administration advisory committee for review at a meeting of
such advisory committee prior to the approval of such drug or
biological if it is--
``(A) a drug, no active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) of which
has been approved in any other application under this
section; or
``(B) a biological product, no active ingredient of
which has been approved in any other application under
section 351 of the Public Health Service Act; or
``(2) if the Secretary does not refer a drug or biological
product described in paragraph (1) to a Food and Drug
Administration advisory committee prior to such approval,
provide in the action letter on the application for the drug or
biological product a summary of the reasons why the Secretary
did not refer the drug or biological product to an advisory
committee prior to approval.''; and
(E) in subsection (u)(1), in the matter preceding
subparagraph (A)--
(i) by striking ``active ingredient
(including any ester or salt of the active
ingredient)'' and inserting ``active moiety (as
defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any
successor regulations))''; and
(ii) by striking ``same active ingredient''
and inserting ``same active moiety'';
(2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)), by
striking ``active ingredient (including any ester or salt of
the active ingredient)'' each place it appears and inserting
``active moiety (as defined by the Secretary in section 314.3
of title 21, Code of Federal Regulations (or any successor
regulations))'';
(3) in section 524(a)(4) (21 U.S.C. 360n(a)(4)), by
amending subparagraph (C) to read as follows:
``(C) is for--
``(i) a human drug, no active moiety (as
defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any
successor regulations)) of which has been
approved in any other application under section
505(b)(1); or
``(ii) a biological product, no active
ingredient of which has been approved in any
other application under section 351 of the
Public Health Service Act.'';
(4) in section 529(a)(4) (21 U.S.C. 21 U.S.C. 360ff(a)(4)),
by striking subparagraphs (A) and (B) and inserting the
following:
``(A) is for a drug or biological product that is
for the prevention or treatment of a rare pediatric
disease;
``(B)(i) is for such a drug--
``(I) that contains no active moiety (as
defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any
successor regulations)) that has been
previously approved in any other application
under subsection (b)(1), (b)(2), or (j) of
section 505; and
``(II) that is the subject of an
application submitted under section 505(b)(1);
or
``(ii) or is for such a biological product--
``(I) that contains no active ingredient
that has been previously approved in any other
application under section 351(a) or 351(k) of
the Public Health Service Act; and
``(II) that is the subject of an
application submitted under section 351(a) of
the Public Health Service Act;''; and
(5) in section 565A(a)(4) (21 U.S.C. 360bbb-4a(a)(4)), by
amending subparagraph (D) to read as follows:
``(D) is for--
``(i) a human drug, no active moiety (as
defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any
successor regulations)) of which has been
approved in any other application under section
505(b)(1); or
``(ii) a biological product, no active
ingredient of which has been approved in any
other application under section 351 of the
Public Health Service Act.''.
(b) Technical Corrections.--Chapter V of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351 et seq) is amended--
(1) in section 505 (21 U.S.C. 355)--
(A) in subsection (c)(3)(E), by repealing clause
(i); and
(B) in subsection (j)(5)(F), by repealing clause
(i); and
(2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C.
355a(c)(1)(A)(i)), by striking ``(c)(3)(D)'' and inserting
``(c)(3)(E)''.
SEC. 209. STREAMLINING THE TRANSITION OF BIOLOGICAL PRODUCTS.
Section 7002(e)(4) of the Biologics Price Competition and
Innovation Act of 2009 (Public Law 111-148) is amended by adding at the
end the following: ``With respect to an application for a biological
product submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)) with a filing date that is not later
than September 23, 2019, and that does not receive final approval on or
before March 23, 2020, such application shall be deemed to be withdrawn
and the Secretary shall refund the fee paid under section 736(a)(1)(B)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)(B)).
Notwithstanding any such withdrawal of the drug application, the
Secretary shall consider any previously conducted scientific review and
accelerate review of any such subsequent application with respect to
such biological product under section 351 of the Public Health Service
Act (42 U.S.C. 262). The Secretary shall provide additional assistance
to the sponsor or manufacturer of such application.''.
SEC. 210. ORPHAN DRUG CLARIFICATION.
Section 527(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360cc(c)) is amended by adding at the end the following:
``(3) Applicability.--This subsection applies to any drug
designated under section 526 for which an application was
approved under section 505 of this Act or licensed under
section 351 of the Public Health Service Act after the date of
enactment of the FDA Reauthorization Act of 2017, regardless of
the date of on which such drug was designated under section
526.''.
SEC. 211. PROMPT APPROVAL OF DRUGS RELATED TO SAFETY INFORMATION.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended by adding at the end the following:
``(z) Prompt Approval of Drugs When Safety Information Is Added to
Labeling.--
``(1) General rule.--A drug for which an application has
been submitted or approved under subsection (b)(2) or (j) shall
not be considered ineligible for approval under this section or
misbranded under section 502 on the basis that the labeling of
the drug omits safety information, including contraindications,
warnings, precautions, dosing, administration, or other
information pertaining to safety, when the omitted safety
information is protected by exclusivity under clause (iii) or
(iv) of subsection (j)(5)(F), clause (iii) or (iv) of
subsection (c)(3)(E), or section 527(a), or by an extension of
such exclusivity under section 505A or 505E.
``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of
subsection (j)(5)(F), clauses (iii) and (iv) of subsection
(c)(3)(E), or section 527, the Secretary shall require that the
labeling of a drug approved pursuant to an application
submitted under subsection (b)(2) or (j) that omits safety
information described in paragraph (1) include a statement of
any appropriate safety information that the Secretary considers
necessary to assure safe use.
``(3) Availability and scope of exclusivity.--This
subsection does not affect--
``(A) the availability or scope of exclusivity or
an extension of exclusivity described in subparagraph
(A) or (B) of section 505A(o)(3);
``(B) the question of the eligibility for approval
under this section of any application described in
subsection (b)(2) or (j) that omits any other aspect of
labeling protected by exclusivity under--
``(i) clause (iii) or (iv) of subsection
(j)(5)(F);
``(ii) clause (iii) or (iv) of subsection
(c)(3)(E); or
``(iii) section 527(a); or
``(C) except as expressly provided in paragraphs
(1) and (2), the operation of this section or section
527.''.
SEC. 212. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGICAL PRODUCTS.
Section 351(k)(2)(A)(iii) of the Public Health Service Act (42
U.S.C. 262(k)(2)(A)(iii) is amended--
(1) in subclause (I), by striking ``; and'' and inserting a
semicolon;
(2) in subclause (II), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(III) may include information to
show that the conditions of use
prescribed, recommended, or suggested
in the labeling proposed for the
biological product have been previously
approved for the reference product.''.
SEC. 213. MODERNIZING THE LABELING OF CERTAIN GENERIC DRUGS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 503C the following:
``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN DRUGS.
``(a) Definitions.--For purposes of this section:
``(1) The term `covered drug' means a drug approved under
section 505(c)--
``(A) for which there are no unexpired patents
included in the list under section 505(j)(7) and no
unexpired period of exclusivity;
``(B) for which the approval of the application has
been withdrawn for reasons other than safety or
effectiveness; and
``(C) for which, with respect to the labeling--
``(i) new scientific evidence is available
regarding the conditions of use of the drug;
``(ii) there is a relevant accepted use in
clinical practice that is not reflected in the
approved labeling; or
``(iii) the labeling of such drug does not
reflect current legal and regulatory
requirements.
``(2) The term `period of exclusivity', with respect to a
drug approved under section 505(c), means any period of
exclusivity under clause (ii), (iii), or (iv) of section
505(c)(3)(E), clause (ii), (iii), or (iv) of section
505(j)(5)(F), or section 505A, 505E, or 527.
``(3) The term `generic version' means a drug approved
under section 505(j) whose reference drug is a covered drug.
``(4) The term `relevant accepted use' means a use for a
drug in clinical practice that is supported by scientific
evidence that appears to the Secretary to meet the standards
for approval under section 505.
``(5) The term `selected drug' means a covered drug for
which the Secretary has determined through the process under
subsection (c) that the labeling should be changed.
``(b) Identification of Covered Drugs.--The Secretary may identify
covered drugs for which labeling updates would provide a public health
benefit. To assist in identifying covered drugs, the Secretary may do
one or both of the following:
``(1) Enter into cooperative agreements or contracts with
public or private entities to review the available scientific
evidence concerning such drugs.
``(2) Seek public input concerning such drugs, including
input on whether there is a relevant accepted use in clinical
practice that is not reflected in the approved labeling of such
drugs or whether new scientific evidence is available regarding
the conditions of use for such drug, by--
``(A) holding one or more public meetings;
``(B) opening a public docket for the submission of
public comments; or
``(C) other means, as the Secretary determines
appropriate.
``(c) Selection of Drugs for Updating.--If the Secretary
determines, with respect to a covered drug, that the available
scientific evidence meets the standards under section 505 for adding or
modifying information to the labeling or providing supplemental
information to the labeling regarding the use of the covered drug, the
Secretary may initiate the process under subsection (d).
``(d) Initiation of the Process of Updating.--If the Secretary
determines that labeling changes are appropriate for a selected drug
pursuant to subsection (c), the Secretary shall provide notice to the
holders of approved applications for a generic version of such drug
that--
``(1) summarizes the findings supporting the determination
of the Secretary that the available scientific evidence meets
the standards under section 505 for adding or modifying
information or providing supplemental information to the
labeling of the covered drug pursuant to subsection (c);
``(2) provides a clear statement regarding the additional,
modified, or supplemental information for such labeling,
according to the determination by the Secretary (including, as
applicable, modifications to add the relevant accepted use to
the labeling of the drug as an additional indication for the
drug); and
``(3) states whether the statement under paragraph (2)
applies to the selected drug as a class of covered drugs or
only to a specific drug product.
``(e) Response to Notification.--Within 30 days of receipt of
notification provided by the Secretary pursuant to subsection (d), the
holder of an approved application for a generic version of the selected
drug shall--
``(1) agree to change the approved labeling to reflect the
additional, modified, or supplemental information the Secretary
has determined to be appropriate; or
``(2) notify the Secretary that the holder of the approved
application does not believe that the requested labeling
changes are warranted and submit a statement detailing the
reasons why such changes are not warranted.
``(f) Review of Application Holder's Response.--
``(1) In general.--Upon receipt of the application holder's
response, the Secretary shall promptly review each statement
received under subsection (e)(2) and determine which labeling
changes pursuant to the Secretary's notice under subsection (d)
are appropriate, if any. If the Secretary disagrees with the
reasons why such labeling changes are not warranted, the
Secretary shall provide opportunity for discussions with the
application holders to reach agreement on whether the labeling
for the covered drug should be updated to reflect current
scientific evidence, and if so, the content of such labeling
changes.
``(2) Changes to labeling.--After considering all responses
from the holder of an approved application under paragraph (1)
or (2) of subsection (e), and any discussion under paragraph
(1), the Secretary may order such holder to make the labeling
changes the Secretary determines are appropriate. Such holder
of an approved application shall--
``(A) update its paper labeling for the drug at the
next printing of that labeling;
``(B) update any electronic labeling for the drug
within 30 days; and
``(C) submit the revised labeling through the form,
`Supplement--Changes Being Effected'.
``(g) Violation.--If the holder of an approved application for the
generic version of the selected drug does not comply with the
requirements of subsection (f)(2), such generic version of the selected
drug shall be deemed to be misbranded under section 502.
``(h) Limitations; Generic Drugs.--
``(1) In general.--With respect to any labeling change
required under this section, the generic version shall be
deemed to have the same conditions of use and the same labeling
as a reference drug for purposes of clauses (i) and (v) of
section 505(j)(2)(A). Any labeling change so required shall not
have any legal effect for the applicant that is different than
the legal effect that would have resulted if a supplemental
application had been submitted and approved to conform the
labeling of the generic version to a change in the labeling of
the reference drug.
``(2) Supplemental applications.--Changes to labeling made
in accordance with this paragraph shall not be eligible for an
exclusivity period under this Act.
``(i) Drug Product Classes.--In the case of a selected drug for
which the labeling changes ordered by the Secretary under subsection
(d)(2) are required for a class of covered drugs, such labeling changes
shall be made for generic versions of such drug in that class.
``(j) Rules of Construction.--
``(1) Approval standards.--This section shall not be
construed as altering the applicability of the standards for
approval of an application under section 505. No order shall be
issued under this subsection unless the evidence supporting the
changed labeling meets the standards for approval applicable to
any change to labeling under section 505.
``(2) Removal of information.--Nothing in this section
shall be construed to give the Secretary additional authority
to remove approved indications for drugs, other than the
authority described in this section.
``(k) Reports.--Not later than 4 years after the date of the
enactment of the Lower Health Care Costs Act and every 4 years
thereafter, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, a report that--
``(1) describes the actions of the Secretary under this
section, including--
``(A) the number of covered drugs and description
of the types of drugs the Secretary has selected for
labeling changes and the rationale for such recommended
changes; and
``(B) the number of times the Secretary entered
into discussions concerning a disagreement with an
application holder or holders and a summary of the
decision regarding a labeling change, if any; and
``(2) includes any recommendations of the Secretary for
modifying the program under this section.''.
SEC. 214. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL
PRODUCTS.
(a) Definitions.--In this section--
(1) the term ``commercially reasonable, market-based
terms'' means--
(A) a nondiscriminatory price for the sale of the
covered product at or below, but not greater than, the
most recent wholesale acquisition cost for the drug, as
defined in section 1847A(c)(6)(B) of the Social
Security Act (42 U.S.C. 1395w-3a(c)(6)(B));
(B) a schedule for delivery that results in the
transfer of the covered product to the eligible product
developer consistent with the timing under subsection
(b)(2)(A)(iv); and
(C) no additional conditions are imposed on the
sale of the covered product;
(2) the term ``covered product''--
(A) means--
(i) any drug approved under subsection (c)
or (j) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or
biological product licensed under subsection
(a) or (k) of section 351 of the Public Health
Service Act (42 U.S.C. 262);
(ii) any combination of a drug or
biological product described in clause (i); or
(iii) when reasonably necessary to support
approval of an application under section 505 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), or section 351 of the Public
Health Service Act (42 U.S.C. 262), as
applicable, or otherwise meet the requirements
for approval under either such section, any
product, including any device, that is marketed
or intended for use with such a drug or
biological product; and
(B) does not include any drug or biological product
that appears on the drug shortage list in effect under
section 506E of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356e), unless--
(i) the drug or biological product has been
on the drug shortage list in effect under such
section 506E continuously for more than 6
months; or
(ii) the Secretary determines that
inclusion of the drug or biological product as
a covered product is likely to contribute to
alleviating or preventing a shortage.
(3) the term ``device'' has the meaning given the term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321);
(4) the term ``eligible product developer'' means a person
that seeks to develop a product for approval pursuant to an
application for approval under subsection (b)(2) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or for licensing pursuant to an application under
section 351(k) of the Public Health Service Act (42 U.S.C.
262(k));
(5) the term ``license holder'' means the holder of an
application approved under subsection (c) or (j) of section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
the holder of a license under subsection (a) or (k) of section
351 of the Public Health Service Act (42 U.S.C. 262) for a
covered product;
(6) the term ``REMS'' means a risk evaluation and
mitigation strategy under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1);
(7) the term ``REMS with ETASU'' means a REMS that contains
elements to assure safe use under section 505-1(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f));
(8) the term ``Secretary'' means the Secretary of Health
and Human Services;
(9) the term ``single, shared system of elements to assure
safe use'' means a single, shared system of elements to assure
safe use under section 505-1(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355-1(f)); and
(10) the term ``sufficient quantities'' means an amount of
a covered product that the eligible product developer
determines allows it to--
(A) conduct testing to support an application
under--
(i) subsection (b)(2) or (j) of section 505
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355); or
(ii) section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)); and
(B) fulfill any regulatory requirements relating to
approval of such an application.
(b) Civil Action for Failure To Provide Sufficient Quantities of a
Covered Product.--
(1) In general.--An eligible product developer may bring a
civil action against the license holder for a covered product
seeking relief under this subsection in an appropriate district
court of the United States alleging that the license holder has
declined to provide sufficient quantities of the covered
product to the eligible product developer on commercially
reasonable, market-based terms.
(2) Elements.--
(A) In general.--To prevail in a civil action
brought under paragraph (1), an eligible product
developer shall prove, by a preponderance of the
evidence--
(i) that--
(I) the covered product is not
subject to a REMS with ETASU; or
(II) if the covered product is
subject to a REMS with ETASU--
(aa) the eligible product
developer has obtained a
covered product authorization
from the Secretary in
accordance with subparagraph
(B); and
(bb) the eligible product
developer has provided a copy
of the covered product
authorization to the license
holder;
(ii) that, as of the date on which the
civil action is filed, the product developer
has not obtained sufficient quantities of the
covered product on commercially reasonable,
market-based terms;
(iii) that the eligible product developer
has submitted a written request to purchase
sufficient quantities of the covered product to
the license holder, and such request--
(I) was sent to a named corporate
officer of the license holder;
(II) was made by certified or
registered mail with return receipt
requested;
(III) specified an individual as
the point of contact for the license
holder to direct communications related
to the sale of the covered product to
the eligible product developer and a
means for electronic and written
communications with that individual;
and
(IV) specified an address to which
the covered product was to be shipped
upon reaching an agreement to transfer
the covered product; and
(iv) that the license holder has not
delivered to the eligible product developer
sufficient quantities of the covered product on
commercially reasonable, market-based terms--
(I) for a covered product that is
not subject to a REMS with ETASU, by
the date that is 31 days after the date
on which the license holder received
the request for the covered product;
and
(II) for a covered product that is
subject to a REMS with ETASU, by 31
days after the later of--
(aa) the date on which the
license holder received the
request for the covered
product; or
(bb) the date on which the
license holder received a copy
of the covered product
authorization issued by the
Secretary in accordance with
subparagraph (B).
(B) Authorization for covered product subject to a
rems with etasu.--
(i) Request.--An eligible product developer
may submit to the Secretary a written request
for the eligible product developer to be
authorized to obtain sufficient quantities of
an individual covered product subject to a REMS
with ETASU.
(ii) Authorization.--Not later than 120
days after the date on which a request under
clause (i) is received, the Secretary shall, by
written notice, authorize the eligible product
developer to obtain sufficient quantities of an
individual covered product subject to a REMS
with ETASU for purposes of--
(I) development and testing that
does not involve human clinical trials,
if the eligible product developer has
agreed to comply with any conditions
the Secretary determines necessary; or
(II) development and testing that
involves human clinical trials, if the
eligible product developer has--
(aa)(AA) submitted
protocols, informed consent
documents, and informational
materials for testing that
include protections that
provide safety protections
comparable to those provided by
the REMS for the covered
product; or
(BB) otherwise satisfied
the Secretary that such
protections will be provided;
and
(bb) met any other
requirements the Secretary may
establish.
(iii) Notice.--A covered product
authorization issued under this subparagraph
shall state that the provision of the covered
product by the license holder under the terms
of the authorization will not be a violation of
the REMS for the covered product.
(3) Affirmative defense.--In a civil action brought under
paragraph (1), it shall be an affirmative defense, on which the
defendant has the burden of persuasion by a preponderance of
the evidence--
(A) that, on the date on which the eligible product
developer requested to purchase sufficient quantities
of the covered product from the license holder--
(i) neither the license holder nor any of
its agents, wholesalers, or distributors was
engaged in the manufacturing or commercial
marketing of the covered product; and
(ii) neither the license holder nor any of
its agents, wholesalers, or distributors
otherwise had access to inventory of the
covered product to supply to the eligible
product developer on commercially reasonable,
market-based terms;
(B) that--
(i) the license holder sells the covered
product through agents, distributors, or
wholesalers;
(ii) the license holder has placed no
restrictions, explicit or implicit, on its
agents, distributors, or wholesalers to sell
covered products to eligible product
developers; and
(iii) the covered product can be purchased
by the eligible product developer in sufficient
quantities on commercially reasonable, market-
based terms from the agents, distributors, or
wholesalers of the license holder; or
(C) that the license holder made an offer to the
individual specified pursuant to paragraph
(2)(A)(iii)(III), by a means of communication
(electronic, written, or both) specified pursuant to
such paragraph, to sell sufficient quantities of the
covered product to the eligible product developer at
commercially reasonable market-based terms--
(i) for a covered product that is not
subject to a REMS with ETASU, by the date that
is 14 days after the date on which the license
holder received the request for the covered
product, and the eligible product developer did
not accept such offer by the date that is 7
days after the date on which the eligible
product developer received such offer from the
license holder; or
(ii) for a covered product that is subject
to a REMS with ETASU, by the date that is 20
days after the date on which the license holder
received the request for the covered product,
and the eligible product developer did not
accept such offer by the date that is 10 days
after the date on which the eligible product
developer received such offer from the license
holder.
(4) Remedies.--
(A) In general.--If an eligible product developer
prevails in a civil action brought under paragraph (1),
the court shall--
(i) order the license holder to provide to
the eligible product developer without delay
sufficient quantities of the covered product on
commercially reasonable, market-based terms;
(ii) award to the eligible product
developer reasonable attorney's fees and costs
of the civil action; and
(iii) award to the eligible product
developer a monetary amount sufficient to deter
the license holder from failing to provide
eligible product developers with sufficient
quantities of a covered product on commercially
reasonable, market-based terms, if the court
finds, by a preponderance of the evidence--
(I) that the license holder delayed
providing sufficient quantities of the
covered product to the eligible product
developer without a legitimate business
justification; or
(II) that the license holder failed
to comply with an order issued under
clause (i).
(B) Maximum monetary amount.--A monetary amount
awarded under subparagraph (A)(iii) shall not be
greater than the revenue that the license holder earned
on the covered product during the period--
(i) beginning on--
(I) for a covered product that is
not subject to a REMS with ETASU, the
date that is 31 days after the date on
which the license holder received the
request; or
(II) for a covered product that is
subject to a REMS with ETASU, the date
that is 31 days after the later of--
(aa) the date on which the
license holder received the
request; or
(bb) the date on which the
license holder received a copy
of the covered product
authorization issued by the
Secretary in accordance with
paragraph (2)(B); and
(ii) ending on the date on which the
eligible product developer received sufficient
quantities of the covered product.
(C) Avoidance of delay.--The court may issue an
order under subparagraph (A)(i) before conducting
further proceedings that may be necessary to determine
whether the eligible product developer is entitled to
an award under clause (ii) or (iii) of subparagraph
(A), or the amount of any such award.
(c) Limitation of Liability.--A license holder for a covered
product shall not be liable for any claim under Federal, State, or
local law arising out of the failure of an eligible product developer
to follow adequate safeguards to assure safe use of the covered product
during development or testing activities described in this section,
including transportation, handling, use, or disposal of the covered
product by the eligible product developer.
(d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the
following new subsection:
``(l) Provision of Samples Not a Violation of Strategy.--The
provision of samples of a covered product to an eligible product
developer (as those terms are defined in section 214(a) of the Lower
Health Care Costs Act) shall not be considered a violation of the
requirements of any risk evaluation and mitigation strategy that may be
in place under this section for such drug.''.
(e) Rule of Construction.--
(1) Definition.--In this subsection, the term ``antitrust
laws''--
(A) has the meaning given the term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12); and
(B) includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent that such
section applies to unfair methods of competition.
(2) Antitrust laws.--Nothing in this section shall be
construed to limit the operation of any provision of the
antitrust laws.
(f) REMS Approval Process for Subsequent Filers.--Section 505-1 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), as amended
by subsection (d), is further amended--
(1) in subsection (g)(4)(B)--
(A) in clause (i) by striking ``or'' after the
semicolon;
(B) in clause (ii) by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(iii) accommodate different, comparable
aspects of the elements to assure safe use for
a drug that is the subject of an application
under section 505(j), and the applicable listed
drug.'';
(2) in subsection (i)(1), by striking subparagraph (C) and
inserting the following:
``(C)(i) Elements to assure safe use, if required
under subsection (f) for the listed drug, which,
subject to clause (ii), for a drug that is the subject
of an application under section 505(j) may use--
``(I) a single, shared system with the
listed drug under subsection (f); or
``(II) a different, comparable aspect of
the elements to assure safe use under
subsection (f).
``(ii) The Secretary may require a drug that is the
subject of an application under section 505(j) and the
listed drug to use a single, shared system under
subsection (f), if the Secretary determines that no
different, comparable aspect of the elements to assure
safe use could satisfy the requirements of subsection
(f).'';
(3) in subsection (i), by adding at the end the following:
``(3) Shared rems.--If the Secretary approves, in
accordance with paragraph (1)(C)(i)(II), a different,
comparable aspect of the elements to assure safe use under
subsection (f) for a drug that is the subject of an abbreviated
new drug application under section 505(j), the Secretary may
require that such different comparable aspect of the elements
to assure safe use can be used with respect to any other drug
that is the subject of an application under section 505(j) or
505(b) that references the same listed drug.''; and
(4) by adding at the end the following:
``(m) Separate REMS.--When used in this section, the terms
`different, comparable aspect of the elements to assure safe use' or
`different, comparable approved risk evaluation and mitigation
strategies' means a risk evaluation and mitigation strategy for a drug
that is the subject of an application under section 505(j) that uses
different methods or operational means than the strategy required under
subsection (a) for the applicable listed drug, or other application
under section 505(j) with the same such listed drug, but achieves the
same level of safety as such strategy.''.
(g) Rule of Construction.--Nothing in this section, the amendments
made by this section, or in section 505-1 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355-1), shall be construed as--
(1) prohibiting a license holder from providing an eligible
product developer access to a covered product in the absence of
an authorization under this section; or
(2) in any way negating the applicability of a REMS with
ETASU, as otherwise required under such section 505-1, with
respect to such covered product.
SEC. 215. REDUCING THE PRICE OF PRESCRIPTION DRUGS.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by adding at the end the following:
``PART W--DRUG PRICE REPORTING; DRUG VALUE FUND
``SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG PRICE INCREASES.
``(a) Definitions.--In this section:
``(1) Manufacturer.--The term `manufacturer' means the
person--
``(A) that holds the application for a drug
approved under section 505 of the Federal Food, Drug,
and Cosmetic Act or the license issued under section
351 of this Act; or
``(B) who is responsible for setting the price for
the drug.
``(2) Qualifying drug.--The term `qualifying drug' means
any drug that is approved under subsection (c) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act or
licensed under subsection (a) or (k) of section 351 of this
Act--
``(A) that has a wholesale acquisition cost of $100
or more per month supply, or per a course of treatment
that lasts less than a month, and is--
``(i)(I) subject to section 503(b)(1) of
the Federal Food, Drug, and Cosmetic Act; or
``(II) commonly administered by hospitals
(as determined by the Secretary); and
``(ii) not designated by the Secretary as a
vaccine; and
``(B) for which, during the previous calendar year,
at least 1 dollar of the total amount of sales were for
individuals enrolled under the Medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.) or under a State Medicaid plan under title XIX
of such Act (42 U.S.C. 1396 et seq.) or under a waiver
of such plan.
``(3) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given that term in section
1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(6)(B)).
``(b) Report.--
``(1) Report required.--The manufacturer of a qualifying
drug shall submit a report to the Secretary for each price
increase of a qualifying drug that will result in an increase
in the wholesale acquisition cost of that drug that is equal
to--
``(A) 10 percent or more over a 12-month period; or
``(B) 25 percent or more over a 36-month period.
``(2) Report deadline.--Each report described in paragraph
(1) shall be submitted to the Secretary not later than 30 days
prior to the planned effective date of such price increase.
``(c) Contents.--A report under subsection (b) shall, at a minimum,
include--
``(1) with respect to the qualifying drug--
``(A) the percentage by which the manufacturer will
raise the wholesale acquisition cost of the drug on the
planned effective date of such price increase;
``(B) a justification for, and description of, each
manufacturer's price increase that will occur during
the 12-month period described in subsection (b)(1)(A)
or the 36-month period described in subsection
(b)(1)(B), as applicable;
``(C) the identity of the initial developer of the
drug;
``(D) a description of the history of the
manufacturer's price increases for the drug since the
approval of the application for the drug under section
505 of the Federal Food, Drug, and Cosmetic Act or the
issuance of the license for the drug under section 351,
or since the manufacturer acquired such approved
application or license;
``(E) the current list price of the drug;
``(F) the total expenditures of the manufacturer
on--
``(i) materials and manufacturing for such
drug; and
``(ii) acquiring patents and licensing for
such drug;
``(G) the percentage of total expenditures of the
manufacturer on research and development for such drug
that was derived from Federal funds;
``(H) the total expenditures of the manufacturer on
research and development for such drug that is used
for--
``(i) basic and preclinical research;
``(ii) clinical research;
``(iii) new drug development;
``(iv) pursuing new or expanded indications
for such drug through supplemental applications
under section 505 of the Federal Food, Drug,
and Cosmetic Act or section 351 of this Act;
and
``(v) carrying out postmarket requirements
related to such drug, including those under
section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act;
``(I) the total revenue and the net profit
generated from the qualifying drug for each calendar
year since the approval of the application for the drug
under section 505 of the Federal Food, Drug, and
Cosmetic Act or the issuance of the license for the
drug under section 351, or since the manufacturer
acquired such approved application or license; and
``(J) the total costs associated with marketing and
advertising for the qualifying drug;
``(2) with respect to the manufacturer--
``(A) the total revenue and the net profit of the
manufacturer--
``(i) for the 12-month period preceding the
date of the report, in the case of a report
based on an increase described in subsection
(b)(1)(A); or
``(ii) for the 36-month period preceding
the date of the report, in the case of a report
based on an increase described in subsection
(b)(1)(B);
``(B) all stock-based performance metrics used by
the manufacturer to determine executive compensation--
``(i) for the12-month period preceding the
date of the report, in the case of a report
based on an increase described in subsection
(b)(1)(A); or
``(ii) for the 36-month period preceding
the date of the report, in the case of a report
based on an increase described in subsection
(b)(1)(B); and
``(C) any additional information the manufacturer
chooses to provide related to drug pricing decisions,
such as total expenditures on--
``(i) drug research and development; or
``(ii) clinical trials on drugs that failed
to receive approval by the Food and Drug
Administration; and
``(3) such other related information as the Secretary
considers appropriate, as specified through notice and comment
rulemaking.
``(d) Civil Penalty.--Any manufacturer of a qualifying drug that
fails to submit a report for the drug as required by this section shall
be subject to a civil penalty of $100,000 for each day on which the
violation continues.
``(e) Public Posting.--
``(1) In general.--Subject to paragraph (3), not later than
30 days after the submission of a report under subsection (b),
the Secretary shall post the report on the public website of
the Department of Health and Human Services.
``(2) Format.--In developing the format of such report for
public posting, the Secretary shall consult stakeholders,
including beneficiary groups, and shall seek feedback on the
content and format from consumer advocates and readability
experts to ensure such public reports are user-friendly to the
public and are written in plain language that consumers can
readily understand.
``(3) Trade secrets and confidential information.--In
carrying out this section the Secretary shall enforce current
law concerning the protection of confidential commercial
information and trade secrets.''.
``SEC. 399OO-1. USE OF CIVIL PENALTY AMOUNTS.
``The Secretary shall, without further appropriation, collect civil
penalties under section 399OO and use the funds derived from such civil
penalties, in addition to any other amounts available to the Secretary,
to carry out activities described in this part and to improve consumer
and provider information about drug value and drug price transparency.
``SEC. 399OO-2. ANNUAL REPORT TO CONGRESS.
``(a) In General.--Subject to subsection (b), the Secretary shall
submit to Congress, and post on the public website of the Department of
Health and Human Services in a way that is easy to find, use, and
understand, an annual report--
``(1) summarizing the information reported pursuant to
section 399OO; and
``(2) including copies of the reports and supporting
detailed economic analyses submitted pursuant to such section.
``(b) Trade Secrets and Confidential Information.--In carrying out
this section the Secretary shall enforce current law concerning the
protection of confidential commercial information and trade secrets.''.
TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE
SEC. 301. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES ON PRICE AND
QUALITY INFORMATION.
Subpart II of part A of title XXVII of the Public Health Service
Act (42 U.S.C. 300gg-11 et seq.), as amended by section 103, is amended
by adding at the end the following:
``SEC. 2729B. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES ON PRICE
AND QUALITY INFORMATION.
``(a) Increasing Price and Quality Transparency for Plan Sponsors
and Group and Individual Market and Consumers.--
``(1) Group health plans.--A group health plan or health
insurance issuer offering group health insurance coverage may
not enter into an agreement with a health care provider,
network or association of providers, third-party administrator,
or other service provider offering access to a network of
providers that would directly or indirectly restrict a group
health plan or health insurance issuer from--
``(A) providing provider-specific cost or quality
of care information, through a consumer engagement tool
or any other means, to referring providers, the plan
sponsor, enrollees, or eligible enrollees of the plan
or coverage;
``(B) electronically accessing de-identified claims
and encounter data for each enrollee in the plan or
coverage, upon request and consistent with the privacy
regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability
Act, the amendments to this Act made by the Genetic
Information Nondiscrimination Act of 2008, and the
Americans with Disabilities Act of 1990, with respect
to the applicable health plan or health insurance
coverage, including, on a per claim basis--
``(i) financial information, such as the
allowed amount, or any other claim-related
financial obligations included in the provider
contract;
``(ii) provider information, including name
and clinical designation;
``(iii) service codes; or
``(iv) any other data element normally
included in claim or encounter transactions
when received by a plan or issuer; or
``(C) sharing data described in subparagraph (A) or
(B) with a business associate as defined in section
160.103 of title 45, Code of Federal Regulations (or
successor regulations), consistent with the privacy
regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability
Act, the amendments to this Act made by the Genetic
Information Nondiscrimination Act of 2008, and the
Americans with Disabilities Act of 1990.
``(2) Individual health insurance coverage.--A health
insurance issuer offering individual health insurance coverage
may not enter into an agreement with a health care provider,
network or association of providers, or other service provider
offering access to a network of providers that would directly
or indirectly restrict the health insurance issuer from--
``(A) providing provider-specific price or quality
of care information, through a consumer engagement tool
or any other means, to referring providers, enrollees,
or eligible enrollees of the plan or coverage; or
``(B) sharing, for plan design, plan
administration, and plan, financial, legal, and quality
improvement activities, data described in subparagraph
(A) with a business associate as defined in section
160.103 of title 45, Code of Federal Regulations (or
successor regulations), consistent with the privacy
regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability
Act, the amendments to this Act made by the Genetic
Information Nondiscrimination Act of 2008, and the
Americans with Disabilities Act of 1990.
``(3) Clarification regarding public disclosure of
information.--Nothing in paragraph (1)(A) or (2)(A) prevents a
health care provider, network or association of providers, or
other service provider from placing reasonable restrictions on
the public disclosure of the information described in such
paragraphs (1) and (2).
``(4) Attestation.--A group health plan or a health
insurance issuer offering group or individual health insurance
coverage shall annually submit to, as applicable, the
applicable authority described in section 2723 or the Secretary
of Labor, an attestation that such plan or issuer is in
compliance with the requirements of this subsection.
``(5) Rule of construction.--Nothing in this section shall
be construed to otherwise limit group health plan, plan
sponsor, or health insurance issuer access to data currently
permitted under the privacy regulations promulgated pursuant to
section 264(c) of the Health Insurance Portability and
Accountability Act, the amendments to this Act made by the
Genetic Information Nondiscrimination Act of 2008, and the
Americans with Disabilities Act of 1990.''.
SEC. 302. BANNING ANTICOMPETITIVE TERMS IN FACILITY AND INSURANCE
CONTRACTS THAT LIMIT ACCESS TO HIGHER QUALITY, LOWER COST
CARE.
(a) In General.--Section 2729B of the Public Health Service Act, as
added by section 301, is amended by adding at the end the following:
``(b) Protecting Health Plans Network Design Flexibility.--
``(1) In general.--A group health plan or a health
insurance issuer offering group or individual health insurance
coverage shall not enter into an agreement with a provider,
network or association of providers, or other service provider
offering access to a network of service providers if such
agreement, directly or indirectly--
``(A) restricts the group health plan or health
insurance issuer from--
``(i) directing or steering enrollees to
other health care providers; or
``(ii) offering incentives to encourage
enrollees to utilize specific health care
providers; or
``(B) requires the group health plan or health
insurance issuer to enter into any additional contract
with an affiliate of the provider, such as an affiliate
of the provider, as a condition of entering into a
contract with such provider;
``(C) requires the group health plan or health
insurance issuer to agree to payment rates or other
terms for any affiliate not party to the contract of
the provider involved; or
``(D) restricts other group health plans or health
insurance issuers not party to the contract from paying
a lower rate for items or services than the contracting
plan or issuer pays for such items or services.
``(2) Additional requirement for self-insured plans.--A
self-insured group health plan shall not enter into an
agreement with a provider, network or association of providers,
third-party administrator, or other service provider offering
access to a network of providers if such agreement directly or
indirectly requires the group health plan to certify, attest,
or otherwise confirm in writing that the group health plan is
bound by restrictive contracting terms between the service
provider and a third-party administrator that the group health
plan is not party to, without a disclosure that such terms
exist.
``(3) Exception for certain group model issuers.--Paragraph
(1)(A) shall not apply to a group health plan or health
insurance issuer offering group or individual health insurance
coverage with respect to--
``(A) a health maintenance organization (as defined
in section 2791(b)(3)), if such health maintenance
organization operates primarily through exclusive
contracts with multi-specialty physician groups, nor to
any arrangement between such a health maintenance
organization and its affiliates; or
``(B) a value-based network arrangement, such as an
exclusive provider network, accountable care
organization, center of excellence, a provider
sponsored health insurance issuer that operates
primarily through aligned multi-specialty physician
group practices or integrated health systems, or such
other similar network arrangements as determined by the
Secretary through rulemaking.
``(4) Attestation.--A group health plan or health insurance
issuer offering group or individual health insurance coverage
shall annually submit to, as applicable, the applicable
authority described in section 2723 or the Secretary of Labor,
an attestation that such plan or issuer is in compliance with
the requirements of this subsection.
``(c) Maintenance of Existing HIPAA, GINA, and ADA Protections.--
Nothing in this section shall modify, reduce, or eliminate the existing
privacy protections and standards provided by reason of State and
Federal law, including the requirements of parts 160 and 164 of title
45, Code of Federal Regulations (or any successor regulations).
``(d) Regulations.--The Secretary, not later than 1 year after the
date of enactment of the Lower Health Care Costs Act, shall promulgate
regulations to carry out this section.
``(e) Rule of Construction.--Nothing in this section shall be
construed to limit network design or cost or quality initiatives by a
group health plan or health insurance issuer, including accountable
care organizations, exclusive provider organizations, networks that
tier providers by cost or quality or steer enrollees to centers of
excellence, or other pay-for-performance programs.
``(f) Clarification With Respect to Antitrust Laws.--Compliance
with this section does not constitute compliance with the antitrust
laws, as defined in subsection (a) of the first section of the Clayton
Act (15 U.S.C. 12(a)).''.
(b) Effective Date.--Section 2729B of the Public Health Service Act
(as added by section 301 and amended by subsection (a)) shall apply
with respect to any contract entered into on or after the date that is
18 months after the date of enactment of this Act. With respect to an
applicable contract that is in effect on the date of enactment of this
Act, such section 2729B shall apply on the earlier of the date of
renewal of such contract or 3 years after such date of enactment.
SEC. 303. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT TRANSPARENCY
ORGANIZATION TO LOWER AMERICANS' HEALTH CARE COSTS.
(a) In General.--Subpart C of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-91 et seq.), as amended by section 102, is
further amended by adding at the end the following:
``SEC. 2796. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT TRANSPARENCY
ORGANIZATION TO LOWER AMERICANS' HEALTH CARE COSTS.
``(a) In General.--The Secretary, in consultation with the
Secretary of Labor, not later than 1 year after the date of enactment
of the Lower Health Care Costs Act, shall enter into a contract with a
nonprofit entity to support the establishment and maintenance of a
database that receives and utilizes health care claims information and
related information and issues reports that are available to the public
and authorized users, and are submitted to the Department of Health and
Human Services.
``(b) Requirements.--
``(1) In general.--The database established under
subsection (a) shall--
``(A) improve transparency by using de-identified
health care data to--
``(i) inform patients about the cost,
quality, and value of their care;
``(ii) assist providers and hospitals, as
they work with patients, to make informed
choices about care;
``(iii) enable providers, hospitals, and
communities to improve services and outcomes
for patients by benchmarking their performance
against that of other providers, hospitals, and
communities;
``(iv) enable purchasers, including
employers, employee organizations, and health
plans, to develop value-based purchasing
models, improve quality, and reduce the cost of
health care and insurance coverage for
enrollees;
``(v) enable employers and employee
organizations to evaluate network design and
construction, and the cost of care for
enrollees;
``(vi) facilitate State-led initiatives to
lower health care costs and improve quality;
and
``(vii) promote competition based on
quality and cost;
``(B) collect medical claims, prescription drug
claims, and remittance data consistent with the
protections and requirements of subsection (d);
``(C) be established in such a manner that allows
the data collected pursuant to subparagraph (B) to be
shared with any State all-payer claims database or
regional database operated with authorization from
States, at cost, using a standardized format, if such
State or regional database also submits claims data to
the database established under this section; and
``(D) be available to--
``(i) the Director of the Congressional
Budget Office, the Comptroller General of the
United States, the Executive Director of the
Medicare Payment Advisory Commission, and the
Executive Director of the Medicaid and CHIP
Payment Advisory Commission, upon request,
subject to the privacy and security
requirements of authorized users under
subsection (e)(2); and
``(ii) authorized users, including
employers, employee organizations, providers,
researchers, and policymakers, subject to
subsection (e).
``(2) Privacy and security; breach notifications.--
``(A) Regulations.--
``(i) In general.--The Secretary shall
issue regulations prescribing the extent to
which, and the manner in which, the following
rules (and any successors of such rules) shall
apply to the activities under this section of
an entity receiving a contract under subsection
(a):
``(I) The Privacy Rule under part
160 and subparts A and E of part 164 of
title 45, Code of Federal Regulations
(or any successor regulations).
``(II) The Security Rule under part
160 and subparts A and C of part 164 of
such title 45 (or any successor
regulations).
``(III) The Breach Notification
Rule under part 160 and subparts A and
D of part 164 of such title 45 (or any
successor regulations).
``(ii) Supplemental regulations.--In order
to ensure data privacy and security and the
notification of breaches, the Secretary may
issue such supplemental regulations on the
subjects of the rules listed under clause (i)
as the Secretary determines appropriate to
address differences between the activities
described by this section and the activities
covered by such rules.
``(B) Enforcement.--Section 1176 of Social Security
Act shall apply with respect to a violation of this
paragraph in the same manner such section 1176 applies
to a violation of part C of title XI of the Social
Security Act, and the Secretary may include in the
regulations promulgated under this section provisions
to apply such section to this paragraph.
``(C) Procedure.--
``(i) Timing.--The Secretary shall issue
the initial set of regulations under this
paragraph not later than 1 year after the date
of enactment of the Lower Health Care Costs
Act.
``(ii) Authority to use interim final
procedures.--The Secretary may make such
initial set of regulations effective and final
immediately upon issuance, on an interim basis,
and provide for a period of public comment on
such initial set of regulations after the date
of publication.
``(D) Requirements of entity.--The entity receiving
the contract under this section shall--
``(i) not disclose to the public any
individually identifiable health information or
proprietary financial information;
``(ii) strictly limit staff access to the
data to staff with appropriate training,
clearance, and background checks and require
regular privacy and security training;
``(iii) maintain effective security
standards for transferring data or making data
available to authorized users;
``(iv) develop a process for providing
access to data to authorized users, in a secure
manner that maintains privacy and
confidentiality of data; and
``(v) adhere to current best security
practices with respect to the management and
use of such data for health services research,
in accordance with applicable Federal privacy
law
``(3) Consultation.--
``(A) Advisory committee.--Not later than 180 days
after the date of enactment of the Lower Health Care
Costs Act, the Secretary shall convene an Advisory
Committee (referred to in this section as the
`Committee'), consisting of 13 members, to advise the
Secretary, the contracting entity, and Congress on the
establishment, operations, and use of the database
established under this section.
``(B) Membership.--
``(i) Appointment.--In accordance with
clause (ii), the Secretary, in consultation
with the Secretary of Labor and the Comptroller
General of the United States shall, not later
than 180 days after the date of enactment of
the Lower Health Care Costs Act, appoint
members to the Committee who have distinguished
themselves in the fields of health services
research, health economics, health informatics,
or the governance of State all-payer claims
databases, or who represent organizations
likely to submit data to or use the database,
including patients, employers, or employee
organizations that sponsor group health plans,
health care providers, health insurance
issuers, or third-party administrators of group
health plans. Such members shall serve 3-year
terms on a staggered basis. Vacancies on the
Committee shall be filled by appointment
consistent with this subsection not later than
3 months after the vacancy arises.
``(ii) Composition.--In accordance with
clause (i)--
``(I) the Secretary, in
consultation with the Secretary of
Labor, shall appoint to the Committee--
``(aa) 1 member selected by
the Secretary, in coordination
with the Secretary of Labor, to
serve as the chair of the
Committee;
``(bb) the Assistant
Secretary for Planning and
Evaluation of the Department of
Health and Human Services, or a
designee of such Assistant
Secretary;
``(cc) 1 representative of
the Centers for Medicare &
Medicaid Services;
``(dd) 1 representative of
the Agency for Health Research
and Quality;
``(ee) 1 representative of
the Office for Civil Rights of
the Department of Health and
Human Services with expertise
in data privacy and security;
``(ff) 1 representative of
the National Center for Health
Statistics; and
``(gg) 1 representative of
the Employee Benefits and
Security Administration of the
Department of Labor; and
``(II) the Comptroller General of
the United States shall appoint to the
Committee--
``(aa) 1 representative of
an employer that sponsors a
group health plan;
``(bb) 1 representative of
an employee organization that
sponsors a group health plan;
``(cc) 1 academic
researcher with expertise in
health economics or health
services research;
``(dd) 1 consumer advocate;
and
``(ee) 2 additional
members.
``(C) Duties.--The Committee shall--
``(i) advise the Secretary on the
management of the contract under subsection
(a);
``(ii) assist and advise the entity
receiving the contract under subsection (a) in
establishing--
``(I) the scope and format of the
data to be submitted under subsection
(d);
``(II) best practices with respect
to de-identification of data, as
appropriate;
``(III) the appropriate uses of
data by authorized users, including
developing standards for the approval
of requests by organizations to access
and use the data; and
``(IV) the appropriate formats and
methods for making reports and analyses
based on the database to the public;
``(iii) conduct an annual review of whether
data was used according to the appropriate uses
as described in clause (ii)(II), and advise the
designated entity on using the data for
authorized purposes;
``(iv) report, as appropriate, to the
Secretary and Congress on the operation of the
database and opportunities to better achieve
the objectives of this section;
``(v) establish additional restrictions on
researchers who receive compensation from
entities described in subsection (e)(2)(B)(ii),
in order to protect proprietary financial
information; and
``(vi) establish objectives for research
and public reporting.
``(4) State requirements.--A State may require health
insurance issuers and other payers to submit claims data to the
database established under this section, provided that such
data is submitted to the entity awarded the contract under this
section in a form and manner established by the Secretary, and
pursuant to subsection (d)(4)(B).
``(5) Sanctions.--The Secretary shall take appropriate
action to sanction users who attempt to re-identify data
accessed pursuant to paragraph (1)(D).
``(c) Contract Requirements.--
``(1) Competitive procedures.--The Secretary shall enter
into the contract under subsection (a) using full and open
competition procedures pursuant to chapter 33 of title 41,
United States Code.
``(2) Eligible entities.--To be eligible to enter into a
contract described in subsection (a), an entity shall--
``(A) be a private nonprofit entity governed by a
board that includes representatives of the academic
research community and individuals with expertise in
employer-sponsored insurance, research using health
care claims data and actuarial analysis;
``(B) conduct its business in an open and
transparent manner that provides the opportunity for
public comment on its activities; and
``(C) agree to comply with any requirements imposed
under the rulemaking described in subsection (d)(4)(A).
``(3) Considerations.--In awarding the contract under
subsection (a), the Secretary shall consider an entity's
experience in--
``(A) health care claims data collection,
aggregation, quality assurance, analysis, and security;
``(B) supporting academic research on health costs,
spending, and utilization for and by privately insured
patients;
``(C) working with large health insurance issuers
and third-party administrators to assemble a national
claims database;
``(D) effectively collaborating with and engaging
stakeholders to develop reports;
``(E) meeting budgets and timelines, including in
connection with report generation; and
``(F) facilitating the creation of, or supporting,
State all-payer claims databases.
``(4) Contract term.--A contract awarded under this section
shall be for a period of 5 years, and may be renewed after a
subsequent competitive bidding process under this section.
``(5) Transition of contract.--If the Secretary, following
a competitive process at the end of the contract period,
selects a new entity to maintain the database, all data shall
be transferred to the new entity according to a schedule and
process to be determined by the Secretary. Upon termination of
a contract, no entity may keep data held by the database or
disclose such data to any entity other than the entity so
designated by the Secretary. The Secretary shall include
enforcement terms in any contract with an organization chosen
under this section, to ensure the timely transfer of all data,
and any associated code or algorithms, to a new entity in the
event of contract termination.
``(d) Receiving Health Information.--
``(1) Requirements.--
``(A) In general.--The Secretary of Labor shall
ensure that the applicable self-insured group health
plan, through its third-party administrator, pharmacy
benefit manager, or other entity designated by the
group health plan, as applicable, electronically
submits all claims data with respect to the plan,
pursuant to subparagraph (B).
``(B) Scope of information and format of
submission.--The entity awarded the contract under
subsection (a), in consultation with the Committee
described in subsection (b)(3), and pursuant to the
privacy and security requirements of subsection (b)(2),
shall--
``(i) specify the data elements required to
be submitted under subparagraph (A), which
shall include all data related to transactions
described in subparagraphs (A) and (E) of
section 1173(a)(2) of the Social Security Act,
including all data elements normally present in
such transactions when adjudicated, and
enrollment information;
``(ii) specify the form and manner for such
submissions, and the historical period to be
included in the initial submission; and
``(iii) offer an automated submission
option to minimize administrative burdens for
entities required to submit data.
``(C) De-identification of data.--The entity
awarded the contract under subsection (a) shall--
``(i) establish a process under which data
is de-identified consistent with the de-
identification requirements under section
164.514 of title 45, Code of Federal
Regulations (or any successor regulations),
while retaining the ability to link data
longitudinally for the purposes of research on
cost and quality, and the ability to complete
risk adjustment and geographic analysis;
``(ii) ensure that any third-party
subcontractors who perform the de-
identification process described in clause (i)
retain only the minimum necessary information
to perform such a process, and adhere to
effective security and encryption practices in
data storage and transmission;
``(iii) store claims and other data
collected under this subsection only in de-
identified form, in accordance with section
164.514 of title 45, Code of Federal
Regulations (or any successor regulations); and
``(iv) ensure that individually
identifiable data is encrypted, in accordance
with guidance issued by the Secretary under
section 13402(h)(2) of the HITECH Act.
``(2) Applicable self-insured group health plan.--For
purposes of paragraph (1), a self-insured group health plan is
an applicable self-insured group health plan if such plan is
self-administered, or is administered by a third-party plan
administrator that meets 1 or both of the following criteria:
``(A) Administers health, medical, or pharmacy
benefits for more than 50,000 enrollees.
``(B) Is one of the 5 largest administrators or
issuers of self-insured group health plans in a State
in which such administrator operates, as measured by
the aggregate number of enrollees in plans administered
by such administrator in such State, as determined by
the Secretary.
``(3) Third-party administrators.--In the case of a third-
party administrator that is required under this subsection to
submit claims data with respect to an applicable self-insured
group health plan, such administrator shall submit claims data
with respect to all self-insured group health plans that the
administrator administers, including such plans that are not
applicable self-insured group health plans, as described in
paragraph (2).
``(4) Receiving other information.--
``(A) Medicare data.--The Secretary, through
rulemaking, shall ensure that the data made available
to such entity is available to qualified entities under
section 1874(e) of the Social Security Act is made
available to the entity awarded a contract under
subsection (a).
``(B) State data.--The entity awarded the contract
under subsection (a) shall collect data from State all
payer claims databases that seek access to the database
established under this section.
``(5) Availability of data.--An entity required to submit
data under this subsection may not place any restrictions on
the use of such data by authorized users.
``(e) Uses of Information.--
``(1) In general.--The entity awarded the contract under
subsection (a) shall make the database available to users who
are authorized under this subsection, at cost, and reports and
analyses based on the data available to the public with no
charge.
``(2) Authorization of users.--
``(A) In general.--An entity may request
authorization by the entity awarded the contract under
subsection (a) for access to the database in accordance
with this paragraph.
``(B) Application.--An entity desiring
authorization under this paragraph shall submit to the
entity awarded the contract an application for such
access, which shall include--
``(i) in the case of an entity requesting
access for research purposes--
``(I) a description of the uses and
methodologies for evaluating health
system performance using such data; and
``(II) documentation of approval of
the research by an institutional review
board, if applicable for a particular
plan of research; or
``(ii) in the case of an entity such as an
employer, health insurance issuer, third-party
administrator, or health care provider,
requesting access for the purpose of quality
improvement or cost-containment, a description
of the intended uses for such data.
``(C) Requirements.--
``(i) Research.--Upon approval of an
application for research purposes under
subparagraph (B)(i), the authorized user shall
enter into a data use and confidentiality
agreement with the entity awarded the contract
under subsection (a), which shall include a
prohibition on attempts to reidentify and
disclose individually identifiable health
information and proprietary financial
information.
``(ii) Quality improvement and cost-
containment.--In consultation with the
Committee described in subsection (b)(3), the
Secretary shall, through rulemaking, establish
the form and manner in which authorized users
described in subparagraph (B)(ii) may access
data. Data provided to such authorized users
shall be provided in a form and manner such
that users may not obtain individually
identifiable price information with respect to
direct competitors. Upon approval, such
authorized user shall enter into a data use and
confidentiality agreement with the entity.
``(iii) Customized reports.--Employers and
employer organizations may request customized
reports from the entity awarded the contract
under subsection (a), at cost, subject to the
requirements of this section with respect to
privacy, security, and proprietary financial
information.
``(iv) Non-customized reports.--The entity
awarded the contract under subsection (a), in
consultation with the Committee, shall make
available to all authorized users aggregate
data sets, free of charge.
``(f) Funding.--
``(1) Initial funding.--There are authorized to be
appropriated, and there are appropriated, out of monies in the
Treasury not otherwise appropriated, $20,000,000 for fiscal
year 2020, for the implementation of the initial contract and
establishment of the database under this section.
``(2) Ongoing funding.--There are authorized to be
appropriated $15,000,000 for each of fiscal years 2021 through
2025, for purposes of carrying out this section (other than the
grant program under subsection (h)).
``(g) Annual Report.--
``(1) Submission.--On each of the dates described in
paragraph (2), the entity receiving the contract under
subsection (a) shall submit to Congress, the Secretary of
Health and Human Services, and the Secretary of Labor and
publish online for access by the general public, a report
containing a description of--
``(A) trends in the price, utilization, and total
spending on health care services, including a
geographic analysis of differences in such trends;
``(B) limitations in the data set;
``(C) progress towards the objectives of this
section; and
``(D) the performance by the entity of the duties
required under such contract.
``(2) Dates described.--The reports described in paragraph
(1) shall be submitted--
``(A) not later than 3 years after the date of
enactment of the Lower Health Care Costs Act;
``(B) the later of 1 year after the date that is 3
years after such date of enactment or March 1 of the
year after the date that is 3 years after such date of
enactment; and
``(C) March 1 of each year thereafter.
``(3) Public reports and research.--The entity receiving a
contract under subsection (a) shall, in coordination with
authorized users, make analyses and research available to the
public on an ongoing basis to promote the objectives of this
section.
``(h) Grants to States.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor, may award grants to States for the purpose
of establishing and maintaining State all-payer claims
databases that improve transparency of data in order to meet
the goals of subsection (a)(1).
``(2) Requirement.--To be eligible to receive the funding
under paragraph (1), a State shall submit data to the database
as described in subsection (b)(1)(C), using the format
described in subsection (d)(1).
``(3) Funding.--There is authorized to be appropriated
$100,000,000 for the period of fiscal years 2020 through 2029
for the purpose of awarding grants to States under this
subsection.
``(i) Exemption From Public Disclosure.--
``(1) In general.--Claims data provided to the database,
and the database itself shall not be considered public records
and shall be exempt from public disclosure requirements.
``(2) Restrictions on uses for certain proceedings.--Data
disclosed to authorized users shall not be subject to discovery
or admission as public information, or evidence in judicial or
administrative proceedings without consent of the affected
parties.
``(j) Definitions.--
``(1) Individually identifiable health information.--The
term `individually identifiable health information' has the
meaning given such term in section 1171(6) of the Social
Security Act.
``(2) Proprietary financial information.--The term
`proprietary financial information' means data that would
disclose the terms of a specific contract between an individual
health care provider or facility and a specific group health
plan, Medicaid managed care organization or other managed care
entity, or health insurance issuer offering group or individual
coverage.
``(k) Rule of Construction.--Nothing in this section shall be
construed to affect or modify enforcement of the privacy, security, or
breach notification rules promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996 (or
successor regulations).''.
(b) GAO Report.--
(1) In general.--The Comptroller General of the United
States shall conduct a study on--
(A) the performance of the entity awarded a
contract under section 2795(a) of the Public Health
Service Act, as added by subsection (a), under such
contract;
(B) the privacy and security of the information
reported to the entity; and
(C) the costs incurred by such entity in performing
such duties.
(2) Reports.--Not later than 2 years after the effective
date of the first contract entered into under section 2795(a)
of the Public Health Service Act, as added by subsection (a),
and again not later than 4 years after such effective date, the
Comptroller General of the United States shall submit to
Congress a report containing the results of the study conducted
under paragraph (1), together with recommendations for such
legislation and administrative action as the Comptroller
General determines appropriate.
SEC. 304. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF PROVIDER
DIRECTORY INFORMATION.
(a) In General.--Subpart II of part A of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-11 et seq.), as amended by sections
301 and 302, is further amended by adding at the end the following:
``SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF
PROVIDER DIRECTORY INFORMATION.
``(a) Network Status of Providers.--
``(1) In general.--Beginning on the date that is one year
after the date of enactment of this section, a group health
plan or a health insurance issuer offering group or individual
health insurance coverage shall--
``(A) establish business processes to ensure that
all enrollees in such plan or coverage receive proof of
a health care provider's network status, based on what
a plan or issuer knows or could reasonably know--
``(i) through a written electronic
communication from the plan or issuer to the
enrollee, as soon as practicable and not later
than 1 business day after a telephone inquiry
is made by such enrollee for such information;
``(ii) through an oral confirmation,
documented by such issuer or coverage, and kept
in the enrollee's file for a minimum of 2
years; and
``(iii) in real-time through an online
health care provider directory search tool
maintained by the plan or issuer; and
``(B) include in any print directory a disclosure
that the information included in the directory is
accurate as of the date of the last data update and
that enrollees or prospective enrollees should consult
the group health plan or issuer's electronic provider
directory on its website or call a specified customer
service telephone number to obtain the most current
provider directory information.
``(2) Group health plan and health insurance issuer
business processes.--Beginning on the date that is one year
after the date of enactment of the Lower Health Care Costs Act,
a group health plan or a health insurance issuer offering group
or individual health insurance coverage shall establish
business processes to--
``(A) verify and update, at least once every 90
days, the provider directory information for all
providers included in the online health care provider
directory search tool described in paragraph
(1)(A)(iii); and
``(B) remove any provider from such online
directory search tool if such provider has not verified
the directory information within the previous 6 months
or the plan or issuer has been unable to verify the
provider's network participation.
``(b) Cost-sharing Limitations.--
``(1) In general.--A group health plan or a health
insurance issuer offering group or individual health insurance
coverage shall not apply, and shall ensure that no provider
applies cost-sharing to an enrollee for treatment or services
provided by a health care provider in excess of the normal
cost-sharing applied for in-network care (including any balance
bill issued by the health care provider involved), if such
enrollee, or health care provider referring such enrollee,
demonstrates (based on the electronic, written information
described in subsection (a)(1)(A)(i), the oral confirmation
described in subsection (a)(1)(A)(ii), or a copy of the online
provider directory described in subsection (a)(1)(A)(iii) on
the date the enrollee attempted to obtain the provider's
network status) that the enrollee relied on the information
described in subsection (a)(1), if the provider's network
status or directory information on such directory was incorrect
at the time the treatment or services involved was provided.
``(2) Refunds to enrollees.--If a health care provider
submits a bill to an enrollee in violation of paragraph (1),
and the enrollee pays such bill, the provider shall reimburse
the enrollee for the full amount paid by the enrollee in excess
of the in-network cost-sharing amount for the treatment or
services involved, plus interest, at an interest rate
determined by the Secretary.
``(c) Provider Business Processes.--A health care provider shall
have in place business processes to ensure the timely provision of
provider directory information to a group health plan or a health
insurance issuer offering group or individual health insurance coverage
to support compliance by such plans or issuers with subsection (a)(1).
Such providers shall submit provider directory information to a plan or
issuers, at a minimum--
``(1) when the provider begins a network agreement with a
plan or with an issuer with respect to certain coverage;
``(2) when the provider terminates a network agreement with
a plan or with an issuer with respect to certain coverage;
``(3) when there are material changes to the content of
provider directory information described in subsection (a)(1);
and
``(4) every 90 days throughout the duration of the network
agreement with a plan or issuer.
``(d) Enforcement.--
``(1) In general.--Subject to paragraph (2), a health care
provider that violates a requirement under subsection (c) or
takes actions that prevent a group health plan or health
insurance issuer from complying with subsection (a)(1) or (b)
shall be subject to a civil monetary penalty of not more than
$10,000 for each act constituting such violation.
``(2) Safe harbor.--The Secretary may waive the penalty
described under paragraph (1) with respect to a health care
provider that unknowingly violates subsection (b)(1) with
respect to an enrollee if such provider rescinds the bill
involved and, if applicable, reimburses the enrollee within 30
days of the date on which the provider billed the enrollee in
violation of such subsection.
``(3) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsections (a) and (b) and the
first sentence of subsection (c)(1) of such section, shall
apply to civil money penalties under this subsection in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A of the Social Security Act.
``(e) Savings Clause.--Nothing in this section shall prohibit a
provider from requiring in the terms of a contract, or contract
termination, with a group health plan or health insurance issuer--
``(1) that the plan or issuer remove, at the time of
termination of such contract, the provider from a directory of
the plan or issuer described in subsection (a)(1); or
``(2) that the plan or issuer bear financial
responsibility, including under subsection (b), for providing
inaccurate network status information to an enrollee.
``(f) Definition.--For purposes of this section, the term `provider
directory information' includes the names, addresses, specialty, and
telephone numbers of individual health care providers, and the names,
addresses, and telephone numbers of each medical group, clinic, or
facility contracted to participate in any of the networks of the group
health plan or health insurance coverage involved.
``(g) Rule of Construction.--Nothing in this section shall be
construed to preempt any provision of State law relating to health care
provider directories or network adequacy.''.
(b) Effective Date.--Section 2729C of the Public Health Service
Act, as added by subsection (a), shall take effect with respect to plan
years beginning on or after the date that is 18 months after the date
of enactment of this Act.
SEC. 305. TIMELY BILLS FOR PATIENTS.
(a) In General.--
(1) Amendment.--Part P of title III of the Public Health
Service Act (42 U.S.C. 280g et seq.) is amended by adding at
the end the following:
``SEC. 399V-7. TIMELY BILLS FOR PATIENTS.
``(a) In General.--The Secretary shall require--
``(1) health care facilities, or in the case of
practitioners providing services outside of such a facility,
practitioners, to provide to patients a list of services
rendered during the visit to such facility or practitioner,
and, in the case of a facility, the name of the provider for
each such service, upon discharge or end of the visit or by
postal or electronic communication as soon as practicable and
not later than 5 calendar days after discharge or date of
visit; and
``(2) health care facilities and practitioners to furnish
all adjudicated bills to the patient as soon as practicable,
but not later than 45 calendar days after discharge or date of
visit.
``(b) Payment After Billing.--No patient may be required to pay a
bill for health care services any earlier than 35 days after the
postmark date of a bill for such services.
``(c) Effect of Violation.--
``(1) Notification and refund requirements.--
``(A) Provider lists.--If a facility or
practitioner fails to provide a patient a list as
required under subsection (a)(1), such facility or
practitioner shall report such failure to the
Secretary.
``(B) Billing.--If a facility or practitioner bills
a patient after the 45-calendar-day period described in
subsection (a)(2), such facility or practitioner
shall--
``(i) report such bill to the Secretary;
and
``(ii) refund the patient for the full
amount paid in response to such bill with
interest, at a rate determined by the
Secretary.
``(2) Civil monetary penalties.--
``(A) In general.--The Secretary may impose civil
monetary penalties of up to $10,000 a day on any
facility or practitioner that--
``(i) fails to provide a list required
under subsection (a)(1) more than 10 times,
beginning on the date of such tenth failure;
``(ii) submits more than 10 bills outside
of the period described in subsection (a)(2),
beginning on the date on which such facility or
practitioner sends the tenth such bill;
``(iii) fails to report to the Secretary
any failure to provide lists as required under
paragraph (1)(A), beginning on the date that is
45 calendar days after discharge or visit; or
``(iv) fails to send any bill as required
under subsection (a)(2), beginning on the date
that is 45 calendar days after the date of
discharge or visit, as applicable.
``(B) Procedure.--The provisions of section 1128A
of the Social Security Act, other than subsections (a)
and (b) and the first sentence of subsection (c)(1) of
such section, shall apply to civil money penalties
under this subsection in the same manner as such
provisions apply to a penalty or proceeding under
section 1128A of the Social Security Act.
``(3) Safe harbor.--The Secretary may exempt a practitioner
or facility from the penalties under paragraph (2)(A) or extend
the period of time specified under subsection (a)(2) for
compliance with such subsection if a practitioner or facility--
``(A) makes a good-faith attempt to send a bill
within 30 days but is unable to do so because of an
incorrect address; or
``(B) experiences extenuating circumstances (as
defined by the Secretary), such as a hurricane or
cyberattack, that may reasonably delay delivery of a
timely bill.''.
(2) Rulemaking.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall promulgate final
regulations to define the term ``extenuating circumstance'' for
purposes of section 399V-7(c)(3)(B) of the Public Health
Service Act, as added by paragraph (1).
(b) Group Health Plan and Health Insurance Issuer Requirements.--
Subpart II of part A of title XXVII of the Public Health Service Act
(42 U.S.C. 300gg-11), as amended by section 304, is further amended by
adding at the end the following:
``SEC. 2729D. TIMELY BILLS FOR PATIENTS.
``(a) In General.--A group health plan or health insurance issuer
offering group or individual health insurance coverage shall have in
place business practices with respect to in-network facilities and
practitioners to ensure that claims are adjudicated in order to
facilitate facility and practitioner compliance with the requirements
under section 399V-7(a).
``(b) Clarification.--Nothing in subsection (a) prohibits a
provider and a group health plan or health insurance issuer from
establishing in a contract the timeline for submission by either party
to the other party of billing information, adjudication, sending of
remittance information, or any other coordination required between the
provider and the plan or issuer necessary for meeting the deadline
described in section 399V-7(a)(2).''.
(c) Effective Date.--The amendments made by subsections (a) and (b)
shall take effect 6 months after the date of enactment of this Act.
SEC. 306. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER SERVICES.
Subpart II of part A of title XXVII of the Public Health Service
Act (42 U.S.C. 300gg-11 et seq.), as amended by section 305(b), is
further amended by adding at the end the following:
``SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER
SERVICES.
``(a) In General.--A group health plan or health insurance issuer
offering group health insurance coverage or an entity or subsidiary
providing pharmacy benefits management services shall not enter into a
contract with a drug manufacturer, distributor, wholesaler,
subcontractor, rebate aggregator, or any associated third party that
limits the disclosure of information to plan sponsors in such a manner
that prevents the plan or coverage, or an entity or subsidiary
providing pharmacy benefits management services on behalf of a plan or
coverage from making the reports described in subsection (b).
``(b) Reports to Group Plan Sponsors.--
``(1) In general.--Beginning with the first plan year that
begins after the date of enactment of the Lower Health Care
Costs Act, not less frequently than once every 6 months, a
health insurance issuer offering group health insurance
coverage or an entity providing pharmacy benefits management
services on behalf of a group health plan shall submit to the
plan sponsor (as defined in section 3(16)(B) of the Employee
Retirement Income Security Act of 1974) of such group health
plan or health insurance coverage a report in accordance with
this subsection and make such report available to the plan
sponsor in a machine-readable format. Each such report shall
include, with respect to the applicable group health plan or
health insurance coverage--
``(A) information collected from drug manufacturers
by such issuer or entity on the total amount of
copayment assistance dollars paid, or copayment cards
applied, that were funded by the drug manufacturer with
respect to the enrollees in such plan or coverage;
``(B) a list of each covered drug dispensed during
the reporting period, including, with respect to each
such drug during the reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of enrollees for whom the
drug was filled during the plan year, the total
number of prescription fills for the drug
(including original prescriptions and refills),
and the total number of dosage units of the
drug dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
enrollees on such drug, including enrollee
spending through copayments, coinsurance, and
deductibles;
``(v) for any drug for which gross spending
of the group health plan or health insurance
coverage exceeded $10,000 during the reporting
period--
``(I) a list of all other available
drugs in the same therapeutic category
or class, including brand name drugs
and biological products and generic
drugs or biosimilar biological products
that are in the same therapeutic
category or class; and
``(II) the rationale for preferred
formulary placement of a particular
drug or drugs in that therapeutic
category or class;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan or
health insurance coverage during the reporting period,
and, with respect to each such therapeutic category or
class of drugs, during the reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of enrollees who filled a
prescription for a drug in that category or
class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
enrollees, including enrollee spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan or coverage--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) to be paid by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan or
health insurance coverage on that
category or class of drugs; and
``(III) the net price per course of
treatment or 30-day supply incurred by
the health plan or health insurance
coverage and its enrollees, after
manufacturer rebates, fees, and other
remuneration for drugs dispensed within
such therapeutic category or class
during the reporting period;
``(D) total gross spending on prescription drugs by
the plan or coverage during the reporting period,
before rebates and other manufacturer fees or
remuneration;
``(E) total amount received, or expected to be
received, by the health plan or health insurance
coverage in drug manufacturer rebates, fees,
alternative discounts, and all other remuneration
received from the manufacturer or any third party,
other than the plan sponsor, related to utilization of
drug or drug spending under that health plan or health
insurance coverage during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan or health insurance coverage during
the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's or health
insurance issuer's business to the pharmacy benefit
manager.
``(2) Privacy requirements.--Health insurance issuers
offering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in a
manner consistent with the privacy, security, and breach
notification regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of 1996
(or successor regulations), and shall restrict the use and
disclosure of such information according to such privacy
regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents a health
insurance issuer offering group health insurance
coverage or an entity providing pharmacy benefits
management services on behalf of a group health plan
from placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such issuer or
entity may not restrict disclosure of such report to
governmental agencies pursuant to an investigation or
enforcement action.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(c) Limitations on Spread Pricing.--
``(1) Prescription drug transactions with pharmacies
independent of the issuer or pharmacy benefits manager.--If the
pharmacy that dispenses a prescription drug to an enrollee in a
group health plan or group or individual health insurance
coverage is not wholly or partially-owned by such plan, such
issuer, or an entity providing pharmacy benefit management
services under such plan or coverage, such plan, issuer, or
entity shall not charge the plan, issuer, or enrollee a price
for such prescription drug that exceeds the price paid to the
pharmacy, excluding penalties paid by pharmacies to such plan,
issuer, or entity.
``(2) Intra-company prescription drug transactions.--If the
mail order, specialty, or retail pharmacy that dispenses a
prescription drug to an enrollee in a group health plan or
health insurance coverage is wholly or partially owned by, and
submits claims to, such health insurance issuer or an entity
providing pharmacy benefit management services under a group
health plan or group or individual health insurance coverage,
the price charged for such drug by such pharmacy to such group
health plan or health insurance issuer offering group or
individual health insurance coverage may not exceed the lesser
of--
``(A) the amount paid to the pharmacy for
acquisition of the drug; or
``(B) the median price charged to the group health
plan or health insurance issuer when the same drug is
dispensed to enrollees in the plan or coverage by other
similarly-situated pharmacies not wholly or partially
owned by the health insurance issuer or entity
providing pharmacy benefits management services, as
described in paragraph (1).
``(3) Supplementary reporting for intra-company
prescription drug transactions.--A health insurance issuer of
group health insurance coverage or an entity providing pharmacy
benefits management services under a group health plan or group
health insurance coverage that conducts transactions with a
wholly or partially-owned pharmacy, as described in paragraph
(2), shall submit, together with the report under subsection
(b), a supplementary report every 6 months to the plan sponsor
that includes--
``(A) an explanation of any benefit design
parameters that encourage enrollees in the plan or
coverage to fill prescriptions at mail order,
specialty, or retail pharmacies that are wholly or
partially-owned by that issuer or entity;
``(B) the percentage of total prescriptions charged
to the plan, coverage, or enrollees in the plan or
coverage, that were dispensed by mail order, specialty,
or retail pharmacies that are wholly or partially-owned
by the issuer or entity providing pharmacy benefits
management services; and
``(C) a list of all drugs dispensed by such wholly
or partially-owned pharmacy and charged to the plan or
coverage, or enrollees of the plan or coverage, during
the applicable quarter, and, with respect to each
drug--
``(i) the amount charged per course of
treatment or 30-day supply with respect to
enrollees in the plan or coverage, including
amounts charged to the plan or coverage and
amounts charged to the enrollee;
``(ii) the median amount charged to the
plan or coverage, per course of treatment or
30-day supply, including amounts paid by the
enrollee, when the same drug is dispensed by
other pharmacies that are not wholly or
partially-owned by the issuer or entity and
that are included in the pharmacy network of
that plan or coverage;
``(iii) the interquartile range of the
costs, per course of treatment or 30-day
supply, including amounts paid by the enrollee,
when the same drug is dispensed by other
pharmacies that are not wholly or partially-
owned by the issuer or entity and that are
included in the pharmacy network of that plan
or coverage;
``(iv) the lowest cost per course of
treatment or 30-day supply, for such drug,
including amounts charged to the plan or issuer
and enrollee, that is available from any
pharmacy included in the network of the plan or
coverage.
``(d) Full Rebate Pass-through to Plan.--
``(1) In general.--A pharmacy benefits manager, a third-
party administrator of a group health plan, a health insurance
issuer offering group health insurance coverage, or an entity
providing pharmacy benefits management services under such
health plan or health insurance coverage shall remit 100
percent of rebates, fees, alternative discounts, and all other
remuneration received from a pharmaceutical manufacturer,
distributor or any other third party, that are related to
utilization of drugs under such health plan or health insurance
coverage, to the group health plan.
``(2) Form and manner of remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--
``(A) remitted to the group health plan in a timely
fashion after the period for which such rebates, fees,
or other remuneration is calculated, and in no case
later than 90 days after the end of such period;
``(B) fully disclosed and enumerated to the group
health plan sponsor, as described in (b)(1);
``(C) available for audit by the plan sponsor, or a
third-party designated by a plan sponsor no less than
once per plan year; and
``(D) returned to the issuer or entity providing
pharmaceutical benefit management services by the group
health plan if audits by such issuer or entity indicate
that the amounts received are incorrect after such
amounts have been paid to the group health plan.
``(3) Audit of rebate contracts.--A pharmacy benefits
manager, a third-party administrator of a group health plan, a
health insurance issuer offering group health insurance
coverage, or an entity providing pharmacy benefits management
services under such health plan or health insurance coverage
shall make rebate contracts with drug manufacturers available
for audit by such plan sponsor or designated third-party,
subject to confidentiality agreements to prevent re-disclosure
of such contracts.
``(e) Enforcement.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor and the Secretary of the Treasury, shall
enforce this section.
``(2) Failure to provide timely information.--A health
insurance issuer or an entity providing pharmacy benefit
management services that violates subsection (a), fails to
provide information required under subsection (b), engages in
spread pricing as defined in subsection (c), or fails to comply
with the requirements of subsection (d), or a drug manufacturer
that fails to provide information under subsection (b)(1)(A),
in a timely manner shall be subject to a civil monetary penalty
in the amount of $10,000 for each day during which such
violation continues or such information is not disclosed or
reported.
``(3) False information.--A health insurance issuer, entity
providing pharmacy benefit management services, or drug
manufacturer that knowingly provides false information under
this section shall be subject to a civil money penalty in an
amount not to exceed $100,000 for each item of false
information. Such civil money penalty shall be in addition to
other penalties as may be prescribed by law.
``(4) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsection (a) and (b) and the
first sentence of subsection (c)(1) of such section shall apply
to civil monetary penalties under this subsection in the same
manner as such provisions apply to a penalty or proceeding
under section 1128A of the Social Security Act.
``(5) Safe harbor.--The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of
this section that has made a good-faith effort to comply with
this section.
``(f) Rule of Construction.--Nothing in this section shall be
construed to prohibit payments to entities offering pharmacy benefits
management services for bona fide services using a fee structure not
contemplated by this section, provided that such fees are transparent
to group health plans and health insurance issuers.
``(g) Definitions.--In this section--
``(1) the term `similarly situated pharmacy' means, with
respect to a particular pharmacy, another pharmacy that is
approximately the same size (as measured by the number of
prescription drugs dispensed), and that serves patients in the
same geographical area, whether through physical locations or
mail order; and
``(2) the term `wholesale acquisition cost' has the meaning
given such term in sectionb1847A(c)(6)(B) of the Social
Security Act.''.
SEC. 307. GOVERNMENT ACCOUNTABILITY OFFICE STUDY ON PROFIT- AND
REVENUE-SHARING IN HEALTH CARE.
(a) Study.--Not later than 1 year after the date of enactment of
this Act, the Comptroller General of the United States shall conduct a
study to--
(1) describe what is known about profit- and revenue-
sharing relationships in the commercial health care markets,
including those relationships that--
(A) involve one or more--
(i) physician groups that practice within a
hospital included in the profit- or revenue-
sharing relationship, or refer patients to such
hospital;
(ii) laboratory, radiology, or pharmacy
services that are delivered to privately
insured patients of such hospital;
(iii) surgical services;
(iv) hospitals or group purchasing
organizations; or
(v) rehabilitation or physical therapy
facilities or services; and
(B) include revenue- or profit-sharing whether
through a joint venture, management or professional
services agreement, or other form of gain-sharing
contract;
(2) describe Federal oversight of such relationships,
including authorities of the Department of Health and Human
Services and the Federal Trade Commission to review such
relationships and their potential to increase costs for
patients, and identify limitations in such oversight; and
(3) as appropriate, make recommendations to improve Federal
oversight of such relationships.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Comptroller General of the United States shall prepare
and submit a report on the study conducted under subsection (a) to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Education and Labor and Committee on Energy and
Commerce of the House of Representatives.
SEC. 308. DISCLOSURE OF DIRECT AND INDIRECT COMPENSATION FOR BROKERS
AND CONSULTANTS TO EMPLOYER-SPONSORED HEALTH PLANS AND
ENROLLEES IN PLANS ON THE INDIVIDUAL MARKET.
(a) Group Health Plans.--Section 408(b)(2) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) is
amended--
(1) by striking ``(2) Contracting or making'' and inserting
``(2)(A) Contracting or making''; and
(2) by adding at the end the following:
``(B)(i) No contract or arrangement for services between a
covered plan and a covered service provider, and no extension
or renewal of such a contract or arrangement, is reasonable
within the meaning of this paragraph unless the requirements of
this clause are met.
``(ii)(I) For purposes of this subparagraph:
``(aa) The term `covered plan' means a group health
plan as defined section 733(a).
``(bb) The term `covered service provider' means a
service provider that enters into a contract or
arrangement with the covered plan and reasonably
expects $1,000 (or such amount as the Secretary may
establish in regulations to account for inflation since
the date of enactment of the Lower Health Care Costs
Act, as appropriate) or more in compensation, direct or
indirect, to be received in connection with providing
one or more of the following services, pursuant to the
contract or arrangement, regardless of whether such
services will be performed, or such compensation
received, by the covered service provider, an
affiliate, or a subcontractor:
``(AA) Brokerage services, for which the
covered service provider, an affiliate, or a
subcontractor reasonably expects to receive
indirect compensation or direct compensation
described in item (dd), provided to a covered
plan with respect to selection of insurance
products (including vision and dental),
recordkeeping services, medical management
vendor, benefits administration (including
vision and dental), stop-loss insurance,
pharmacy benefit management services, wellness
services, transparency tools and vendors, group
purchasing organization preferred vendor
panels, disease management vendors and
products, compliance services, employee
assistance programs, or third party
administration services.
``(BB) Consulting, for which the covered
service provider, an affiliate, or a
subcontractor reasonably expects to receive
indirect compensation or direct compensation
described in item (dd), related to the
development or implementation of plan design,
insurance or insurance product selection
(including vision and dental), recordkeeping,
medical management, benefits administration
selection (including vision and dental), stop-
loss insurance, pharmacy benefit management
services, wellness design and management
services, transparency tools, group purchasing
organization agreements and services,
participation in and services from preferred
vendor panels, disease management, compliance
services, employee assistance programs, or
third party administration services.
``(cc) The term `affiliate', with respect to a
covered service provider, means an entity that directly
or indirectly (through one or more intermediaries)
controls, is controlled by, or is under common control
with, such provider, or is an officer, director, or
employee of, or partner in, such provider.
``(dd)(AA) The term `compensation' means anything
of monetary value, but does not include non-monetary
compensation valued at $250 (or such amount as the
Secretary may establish in regulations to account for
inflation since the date of enactment of the Lower
Health Care Costs Act, as appropriate) or less, in the
aggregate, during the term of the contract or
arrangement.
``(BB) The term `direct compensation' means
compensation received directly from a covered plan.
``(CC) The term `indirect compensation' means
compensation received from any source other than the
covered plan, the plan sponsor, the covered service
provider, or an affiliate. Compensation received from a
subcontractor is indirect compensation, unless it is
received in connection with services performed under a
contract or arrangement with a subcontractor.
``(ee) The term `responsible plan fiduciary' means
a fiduciary with authority to cause the covered plan to
enter into, or extend or renew, the contract or
arrangement.
``(ff) The term `subcontractor' means any person or
entity (or an affiliate of such person or entity) that
is not an affiliate of the covered service provider and
that, pursuant to a contract or arrangement with the
covered service provider or an affiliate, reasonably
expects to receive $1,000 (or such amount as the
Secretary may establish in regulations to account for
inflation since the date of enactment of the Lower
Health Care Costs Act, as appropriate) or more in
compensation for performing one or more services
described in item (bb) under a contract or arrangement
with the covered plan.
``(II) For purposes of this subparagraph, a description of
compensation or cost may be expressed as a monetary amount,
formula, or a per capita charge for each enrollee or, if the
compensation or cost cannot reasonably be expressed in such
terms, by any other reasonable method, including a disclosure
that additional compensation may be earned but may not be
calculated at the time of contract if such a disclosure
includes a description of the circumstances under which the
additional compensation may be earned and a reasonable and good
faith estimate if the covered service provider cannot otherwise
readily describe compensation or cost and explains the
methodology and assumptions used to prepare such estimate. Any
such description shall contain sufficient information to permit
evaluation of the reasonableness of the compensation or cost.
``(III) No person or entity is a `covered service provider'
within the meaning of subclause (I)(bb) solely on the basis of
providing services as an affiliate or a subcontractor that is
performing one or more of the services described in subitem
(AA) or (BB) of such subclause under the contract or
arrangement with the covered plan.
``(iii) A covered service provider shall disclose to a
responsible plan fiduciary, in writing, the following:
``(I) A description of the services to be provided
to the covered plan pursuant to the contract or
arrangement.
``(II) If applicable, a statement that the covered
service provider, an affiliate, or a subcontractor will
provide, or reasonably expects to provide, services
pursuant to the contract or arrangement directly to the
covered plan as a fiduciary (within the meaning of
section 3(21)).
``(III) A description of all direct compensation,
either in the aggregate or by service, that the covered
service provider, an affiliate, or a subcontractor
reasonably expects to receive in connection with the
services described in subclause (I).
``(IV)(aa) A description of all indirect
compensation that the covered service provider, an
affiliate, or a subcontractor reasonably expects to
receive in connection with the services described in
subclause (I)--
``(AA) including compensation from a vendor
to a brokerage firm based on a structure of
incentives not solely related to the contract
with the covered plan; and
``(BB) not including compensation received
by an employee from an employer on account of
work performed by the employee.
``(bb) A description of the arrangement between the
payer and the covered service provider, an affiliate,
or a subcontractor, as applicable, pursuant to which
such indirect compensation is paid.
``(cc) Identification of the services for which the
indirect compensation will be received, if applicable.
``(dd) Identification of the payer of the indirect
compensation.
``(V) A description of any compensation that will
be paid among the covered service provider, an
affiliate, or a subcontractor, in connection with the
services described in subclause (I) if such
compensation is set on a transaction basis (such as
commissions, finder's fees, or other similar incentive
compensation based on business placed or retained),
including identification of the services for which such
compensation will be paid and identification of the
payers and recipients of such compensation (including
the status of a payer or recipient as an affiliate or a
subcontractor), regardless of whether such compensation
also is disclosed pursuant to subclause (III) or (IV).
``(VI) A description of any compensation that the
covered service provider, an affiliate, or a
subcontractor reasonably expects to receive in
connection with termination of the contract or
arrangement, and how any prepaid amounts will be
calculated and refunded upon such termination.
``(iv) A covered service provider shall disclose to a
responsible plan fiduciary, in writing a description of the
manner in which the compensation described in clause (iii), as
applicable, will be received.
``(v)(I) A covered service provider shall disclose the
information required under clauses (iii) and (iv) to the
responsible plan fiduciary not later than the date that is
reasonably in advance of the date on which the contract or
arrangement is entered into, and extended or renewed.
``(II) A covered service provider shall disclose any change
to the information required under clause (iii) and (iv) as soon
as practicable, but not later than 60 days from the date on
which the covered service provider is informed of such change,
unless such disclosure is precluded due to extraordinary
circumstances beyond the covered service provider's control, in
which case the information shall be disclosed as soon as
practicable.
``(vi)(I) Upon the written request of the responsible plan
fiduciary or covered plan administrator, a covered service
provider shall furnish any other information relating to the
compensation received in connection with the contract or
arrangement that is required for the covered plan to comply
with the reporting and disclosure requirements under this Act.
``(II) The covered service provider shall disclose the
information required under clause (iii)(I) reasonably in
advance of the date upon which such responsible plan fiduciary
or covered plan administrator states that it is required to
comply with the applicable reporting or disclosure requirement,
unless such disclosure is precluded due to extraordinary
circumstances beyond the covered service provider's control, in
which case the information shall be disclosed as soon as
practicable.
``(vii) No contract or arrangement will fail to be
reasonable under this subparagraph solely because the covered
service provider, acting in good faith and with reasonable
diligence, makes an error or omission in disclosing the
information required pursuant to clause (iii) (or a change to
such information disclosed pursuant to clause (v)(II)) or
clause (vi), provided that the covered service provider
discloses the correct information to the responsible plan
fiduciary as soon as practicable, but not later than 30 days
from the date on which the covered service provider knows of
such error or omission.
``(viii)(I) Pursuant to subsection (a), subparagraphs (C)
and (D) of section 406(a)(1) shall not apply to a responsible
plan fiduciary, notwithstanding any failure by a covered
service provider to disclose information required under clause
(iii), if the following conditions are met:
``(aa) The responsible plan fiduciary did not know
that the covered service provider failed or would fail
to make required disclosures and reasonably believed
that the covered service provider disclosed the
information required to be disclosed.
``(bb) The responsible plan fiduciary, upon
discovering that the covered service provider failed to
disclose the required information, requests in writing
that the covered service provider furnish such
information.
``(cc) If the covered service provider fails to
comply with a written request described in subclause
(II) within 90 days of the request, the responsible
plan fiduciary notifies the Secretary of the covered
service provider's failure, in accordance with
subclauses (II) and (III).
``(II) A notice described in subclause (I)(cc) shall
contain--
``(aa) the name of the covered plan;
``(bb) the plan number used for the annual report
on the covered plan;
``(cc) the plan sponsor's name, address, and
employer identification number;
``(dd) the name, address, and telephone number of
the responsible plan fiduciary;
``(ee) the name, address, phone number, and, if
known, employer identification number of the covered
service provider;
``(ff) a description of the services provided to
the covered plan;
``(gg) a description of the information that the
covered service provider failed to disclose;
``(hh) the date on which such information was
requested in writing from the covered service provider;
and
``(ii) a statement as to whether the covered
service provider continues to provide services to the
plan.
``(III) A notice described in subclause (I)(cc) shall be
filed with the Department not later than 30 days following the
earlier of--
``(aa) The covered service provider's refusal to
furnish the information requested by the written
request described in subclause (I)(bb); or
``(bb) 90 days after the written request referred
to in subclause (I)(cc) is made.
``(IV) If the covered service provider fails to comply with
the written request under subclause (I)(bb) within 90 days of
such request, the responsible plan fiduciary shall determine
whether to terminate or continue the contract or arrangement
under section 404. If the requested information relates to
future services and is not disclosed promptly after the end of
the 90-day period, the responsible plan fiduciary shall
terminate the contract or arrangement as expeditiously as
possible, consistent with such duty of prudence.
``(ix) Nothing in this subparagraph shall be construed to
supersede any provision of State law that governs disclosures
by parties that provide the services described in this section,
except to the extent that such law prevents the application of
a requirement of this section.''.
(b) Applicability of Existing Regulations.--Nothing in the
amendments made by subsection (a) shall be construed to affect the
applicability of section 2550.408b-2 of title 29, Code of Federal
Regulations (or any successor regulations), with respect to any
applicable entity other than a covered plan or a covered service
provider (as defined in section 408(b)(2)(B)(ii) of the Employee
Retirement Income Security Act of 1974, as amended by subsection (a)).
(c) Individual Market Coverage.--Subpart 1 of part B of title XXVII
of the Public Health Service Act (42 U.S.C. 300gg-41 et seq.) is
amended by adding at the end the following:
``SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL MARKET COVERAGE.
``(a) In General.--A health insurance issuer offering individual
health insurance coverage shall make disclosures to enrollees in such
coverage, as described in subsection (b), and reports to the Secretary,
as described in subsection (c), regarding direct or indirect
compensation provided to an agent or broker associated with enrolling
individuals in such coverage.
``(b) Disclosure.--A health insurance issuer described in
subsection (a) shall disclose to an enrollee the amount of direct or
indirect compensation provided to an agent or broker for services
provided by such agent or broker associated with plan selection and
enrollment. Such disclosure shall be--
``(1) made prior to the individual finalizing plan
selection; and
``(2) included on any documentation confirming the
individual's enrollment.
``(c) Reporting.--A health insurance issuer described in subsection
(a) shall annually report to the Secretary, prior to the beginning of
open enrollment, any direct or indirect compensation provided to an
agent or broker associated with enrolling individuals in such coverage.
``(d) Rulemaking.--Not later than 1 year after the date of
enactment of the Lower Health Care Costs Act, the Secretary shall
finalize, through notice-and-comment rulemaking, the form and manner in
which issuers described in subsection (a) are required to make the
disclosures described in subsection (b) and the reports described in
subsection (c).''.
(d) Transition Rule.--No contract executed prior to the effective
date described in subsection (e) by a group health plan subject to the
requirements of section 408(b)(2)(B) of the Employee Retirement Income
Security Act of 1974 (as amended by subsection (a)) or by a health
insurance issuer subject to the requirements of section 2746 of the
Public Health Service Act (as added by subsection (c)) shall be subject
to the requirements of such section 408( b)(2)(B) or such section 2746,
as applicable.
(e) Effective Date.--The amendments made by subsections (a) and (c)
shall take effect 2 years after the date of enactment of this Act.
SEC. 309. ENSURING ENROLLEE ACCESS TO COST-SHARING INFORMATION.
(a) In General.--Subpart II of part A of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-11 et seq.), as amended by section
306, is further amended by adding at the end the following:
``SEC. 2729F. PROVISION OF COST-SHARING INFORMATION.
``(a) Provider Disclosures.--A provider that is in-network with
respect to a group health plan or a health insurance issuer offering
group or individual health insurance coverage shall provide to an
enrollee in the plan or coverage who submits a request for the
information described in paragraph (1) or (2), together with accurate
and complete information about the enrollee's coverage under the
applicable plan or coverage--
``(1) as soon as practicable and not later than 2 business
days after the enrollee requests such information, a good faith
estimate of the expected enrollee cost-sharing for the
provision of a particular health care service (including any
service that is reasonably expected to be provided in
conjunction with such specific service); and
``(2) as soon as practicable and not later than 2 business
days after an enrollee requests such information, the contact
information for any ancillary providers for a scheduled health
care service.
``(b) Insurer Disclosures.--A group health plan or a health
insurance issuer offering group or individual health insurance coverage
shall provide an enrollee in the plan or coverage with a good faith
estimate of the enrollee's cost-sharing (including deductibles,
copayments, and coinsurance) for which the enrollee would be
responsible for paying with respect to a specific health care service
(including any service that is reasonably expected to be provided in
conjunction with such specific service), as soon as practicable and not
later than 2 business days after a request for such information by an
enrollee.
``(c) Enforcement.--
``(1) In general.--Subject to paragraph (2), a health care
provider that violates a requirement under subsection (a) shall
be subject to a civil monetary penalty of not more than $10,000
for each act constituting such violation.
``(2) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsections (a) and (b) and the
first sentence of subsection (c)(1) of such section, shall
apply to civil money penalties under this subsection in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A of the Social Security Act.''.
(b) Effective Date.--Section 2729G of the Public Health Service
Act, as added by subsection (a), shall apply with respect to plan years
beginning on or after the date that is 18 months after the date of
enactment of this Act.
SEC. 310. STRENGTHENING PARITY IN MENTAL HEALTH AND SUBSTANCE USE
DISORDER BENEFITS.
Section 2726 of the Public Health Service Act (42 U.S.C. 300gg-26)
is amended--
(1) in subsection (a), by adding at the end the following:
``(8) Compliance requirements.--
``(A) Nonquantitative treatment limitation (nqtl)
requirements.--In the case of a group health plan or a
health insurance issuer offering group or individual
health insurance coverage that provides both medical
and surgical benefits and mental health or substance
use disorder benefits and that imposes nonquantitative
treatment limitations (referred to in this section as
`NQTL') on mental health or substance use disorder
benefits, the plan or issuer offering health insurance
coverage in connection with such a plan, shall perform
comparative analyses of the design and application of
NQTLs in accordance with the following process, and
make available to the applicable State authority (or,
as applicable, to the Secretary of Labor with respect
to group health plans or the Secretary of Health and
Human Services with respect to health insurance
coverage), upon request within 60 days beginning 6
months after the date of enactment of the Lower Health
Care Costs Act, the following information:
``(i) The specific plan or coverage terms
regarding the NQTL, that applies to such plan
or coverage, and a description of all mental
health or substance use disorder and medical or
surgical benefits to which it applies in each
respective benefits classification.
``(ii) The factors used to determine that
the NQTL will apply to mental health or
substance use disorder benefits and medical or
surgical benefits.
``(iii) The evidentiary standards used for
the factors identified in clause (ii), when
applicable, provided that every factor shall be
defined and any other source or evidence relied
upon to design and apply the NQTL to mental
health or substance use disorder benefits and
medical or surgical benefits.
``(iv) The comparative analyses
demonstrating that the processes, strategies,
evidentiary standards, and other factors used
to design the NQTL, as written, and the
operation processes and strategies as written
and in operation that are used to apply the
NQTL for mental health or substance use
disorder benefits are comparable to, and are
applied no more stringently than, the
processes, strategies, evidentiary standards,
and other factors used to design the NQTL, as
written, and the operation processes and
strategies as written and in operation that are
used to apply the NQTL to medical or surgical
benefits.
``(v) A disclosure of the specific findings
and conclusions reached by the plan or coverage
that the results of the analyses described in
this subparagraph indicate that the plan or
coverage is in compliance with this section.
``(B) Secretary request process.--
``(i) Submission upon request.--With
respect to group health plans or health
insurance coverage for which the Secretary is
enforcing this section in accordance with
section 2723, the Secretary, in consultation
with the Secretary of Labor and the Secretary
of Treasury, shall request that a group health
plan or a health insurance issuer offering
group or individual health insurance coverage
submit the comparative analyses described in
subparagraph (A) for plans that involve
potential violations of this section concerning
NQTLs and any other instances in which the
Secretary determines appropriate. The Secretary
shall request not fewer than 20 such analyses
per year.
``(ii) Additional information.--In
instances in which the Secretary has concluded
that the plan or coverage has not submitted
sufficient information for the Secretary to
review the comparative analyses described in
subparagraph (A), as requested under clause
(i), the Secretary shall specify to the plan or
coverage the information the plan or coverage
must submit to be responsive to the request
under clause (i) for the Secretary to review
the comparative analyses described in
subparagraph(A) for compliance with this
section. Nothing in this paragraph shall
require the Secretary to conclude that a plan
is in compliance with this section solely based
upon the inspection of the comparative analyses
described in subparagraph (A), as requested
under clause (i).
``(iii) Required action.--In instances in
which the Secretary has reviewed the
comparative analyses described in subparagraph
(A), as requested under clause (i), and
determined that the plan or coverage is not in
compliance with this section, the plan or
coverage shall specify to the Secretary the
actions the plan or coverage will take to be in
compliance with this section. Documents or
communications produced in connection with the
Secretary's recommendations to the plan or
coverage shall not be subject to disclosure
pursuant to section 552 of title 5, United
States Code.
``(iv) Report.--Not later than 1 year after
the date of enactment of this paragraph, and
annually thereafter, the Secretary shall submit
to the Committee on Education and Labor of the
House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the
Senate a report that contains--
``(I) a summary of the comparative
analyses requested under clause (i),
except that the identity of each plan
or coverage and any contracted entity
of a plan or coverage shall be
redacted;
``(II) the Secretary's conclusions
as to whether each plan or coverage
submitted sufficient information for
the Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section;
``(III) for each plan or coverage
that did submit sufficient information
for the Secretary to review the
comparative analyses requested under
clause (i), the Secretary's conclusions
as to whether and why the plan or
coverage is in compliance with the
disclosure requirements under this
section;
``(IV) the Secretary's
specifications described in clause (ii)
for each plan or coverage that the
Secretary determined did not submit
sufficient information for the
Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section; and
``(V) the Secretary's
specifications described in clause
(iii) of the actions each plan or
coverage that the Secretary determined
is not in compliance with this section
must take to be in compliance with this
section, including the reason why the
Secretary determined the plan or
coverage is not in compliance.
``(C) Compliance program guidance document update
process.--
``(i) In general.--The Secretary shall
include select instances of noncompliance that
the Secretary discovers upon reviewing the
comparative analyses requested under
subparagraph (B)(i) in the compliance program
guidance document described in section
2726(a)(6), as it is updated every 2 years,
except that all instances shall be deidentified
and such instances shall not disclose any
protected health information or individually
identifiable information.
``(ii) Guidance and regulations.--Not later
than 18 months after the date of enactment of
this paragraph, the Secretary shall finalize
any draft or interim guidance and regulations
relating to mental health parity under this
section.
``(iii) State.--The Secretary shall share
information on findings of compliance and
noncompliance discovered upon reviewing the
comparative analyses requested under
subparagraph (B)(i) shall be shared with the
State where the group health plan is located or
the State where the health insurance issuer is
licensed to do business for coverage offered by
a health insurance issuer in the group market,
in accordance with section
2726(a)(6)(B)(iii)(II).''.
SEC. 311. TECHNICAL AMENDMENTS.
(a) ERISA.--Section 715 of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1185d) is amended--
(1) in subsection (a)(1), by striking ``(as amended by the
Patient Protection and Affordable Care Act)'' and inserting
``(including any subsequent amendments to such part)''; and
(2) in subsection (b)--
(A) by striking ``(as amended by the Patient
Protection and Affordable Care Act)'' and inserting
``(including any subsequent amendments to such part)'';
and
(B) by striking ``(as so amended)''.
(b) IRC.--Section 9815 of the Internal Revenue Code of 1986 is
amended--
(1) in subsection (a)(1), by striking ``(as amended by the
Patient Protection and Affordable Care Act)'' and inserting
``(including any subsequent amendments to such part)''; and
(2) in subsection (b)--
(A) by striking ``(as amended by the Patient
Protection and Affordable Care Act)'' and inserting
``(including any subsequent amendments to such part)'';
and
(B) by striking ``(as so amended)''.
(c) Applicability.--The amendments made by subsections (a) and (b)
shall take effect as though included in the enactment of the Patient
Protection and Affordable Care Act (Public Law 111-148).
SEC. 312. THIRD-PARTY ADMINISTRATORS.
Any obligation on a third-party administrator under this Act
(including the amendments made by this Act) shall not affect any other
direct or indirect requirement under any other provision Federal law
that applies to third-party administrators offering services to group
health plans.
SEC. 313. GROUP HEALTH PLAN REPORTING REQUIREMENTS.
Part C of title XXVII of the Public Health Service Act (42 U.S.C.
300gg-91 et seq.), as amended by section 303, is further amended by
adding at the end the following:
``SEC. 2797. GROUP HEALTH PLAN REPORTING.
``(a) In General.--A group health plan or health insurance issuer
offering group or individual health insurance coverage shall submit to
the Secretary, not later than March 1 of each year, the following
information with respect to the health plan in the previous plan year:
``(1) The beginning and end dates of the plan year.
``(2) The number of enrollees.
``(3) Each State in which the plan is offered.
``(4) The 50 brand prescription drugs most frequently
dispensed by pharmacies for claims paid by the issuer, and the
total number of paid claims for each such drug.
``(5) The 50 most costly prescription drugs with respect to
the plan by total annual spending, and the annual amount spent
by the plan for each such drug.
``(6) The 50 prescription drugs with the greatest increase
in plan expenditures over the plan year preceding the plan year
that is the subject of the report, and, for each such drug, the
change in amounts expended by the plan in each such plan year.
``(7) Total spending on health care services by such group
health plan, broken down by--
``(A) the type of costs, including--
``(i) hospital costs;
``(ii) health care provider and clinical
service costs;
``(iii) costs for prescription drugs; and
``(iv) other medical costs; and
``(B) spending on prescription drugs by--
``(i) the health plan; and
``(ii) the enrollees.
``(8) The average monthly premium--
``(A) paid by employers on behalf of enrollees; and
``(B) paid by enrollees.
``(9) Any impact on premiums by rebates, fees, and any
other remuneration paid by drug manufacturers to the plan or
its administrators or service providers, with respect to
prescription drugs prescribed to enrollees in the plan,
including--
``(A) the amounts so paid for each therapeutic
class of drugs; and
``(B) the amounts so paid for each of the 25 drugs
that yielded the highest amount of rebates and other
remuneration under the plan from drug manufacturers
during the plan year.
``(10) Any reduction in premiums and out-of-pocket costs
associated with rebates, fees, or other remuneration described
in paragraph (9).
``(b) Report.--Not later than 18 months after the date on which the
first report is required under subsection (a) and biannually
thereafter, the Secretary, acting through the Assistant Secretary of
Planning and Evaluation and in coordination with the Inspector General
of the Department of Health and Human Services, shall make available on
the internet website of the Department of Health and Human Services a
report on prescription drug reimbursements under group health plans,
prescription drug pricing trends, and the role of prescription drug
costs in contributing to premium increases or decreases under such
plans, aggregated in such a way as no drug or plan specific information
will be made public.
``(c) Privacy Protections.--No confidential or trade secret
information submitted to the Secretary under subsection (a) shall be
included in the report under subsection (b).''.
SEC. 314. STUDY BY COMPTROLLER GENERAL OF UNITED STATES.
(a) In General.--The Comptroller General of the United States
(referred to in this section as the ``Comptroller General'') shall, in
consultation with appropriate stakeholders, conduct a study on the role
of pharmacy benefit managers.
(b) Permissible Examination.--In conducting the study required
under subsection (a), the Comptroller General may examine various
qualitative and quantitative aspects of the role of pharmacy benefit
managers, such as the following:
(1) The role that pharmacy benefit managers play in the
pharmaceutical supply chain.
(2) The state of competition among pharmacy benefit
managers, including the market share for the Nation's largest
pharmacy benefit managers.
(3) The use of rebates and fees by pharmacy benefit
managers, including--
(A) the extent to which rebates are passed on to
health plans and whether such rebates are passed on to
individuals enrolled in such plans;
(B) the extent to which rebates are kept by such
pharmacy benefit managers; and
(C) the role of any fees charged by such pharmacy
benefit managers.
(4) Whether pharmacy benefit managers structure their
formularies in favor of high-rebate prescription drugs over
lower-cost, lower-rebate alternatives.
(5) The average prior authorization approval time for
pharmacy benefit managers.
(6) Factors affecting the use of step therapy by pharmacy
benefit managers.
(c) Report.--Not later than 3 years after the date of enactment of
this Act, the Comptroller General shall submit to the Secretary of
Health and Human Services, the Committee on Health, Education, Labor,
and Pensions of the Senate, and the Committee on Energy and Commerce of
the House of Representatives a report containing the results of the
study conducted under subsection (a), including policy recommendations.
TITLE IV--IMPROVING PUBLIC HEALTH
SEC. 401. IMPROVING AWARENESS OF DISEASE PREVENTION.
The Public Health Service Act is amended by striking section 313 of
such Act (42 U.S.C. 245) and inserting the following:
``SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE OF
VACCINATIONS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in coordination with
other offices and agencies, as appropriate, shall award competitive
grants to one or more public or private entities to carry out a
national, evidence-based campaign to increase awareness and knowledge
of the safety and effectiveness of vaccines for the prevention and
control of diseases, combat misinformation about vaccines, and
disseminate scientific and evidence-based vaccine-related information,
with the goal of increasing rates of vaccination across all ages, as
applicable, particularly in communities with low rates of vaccination,
to reduce and eliminate vaccine-preventable diseases.
``(b) Consultation.--In carrying out the campaign under this
section, the Secretary shall consult with appropriate public health and
medical experts, including the National Academy of Medicine and medical
and public health associations and nonprofit organizations, in the
development, implementation, and evaluation of the evidence-based
public awareness campaign.
``(c) Requirements.--The campaign under this section shall--
``(1) be a national, evidence-based initiative;
``(2) include the development of resources for communities
with low rates of vaccination, including culturally- and
linguistically-appropriate resources, as applicable;
``(3) include the dissemination of vaccine information and
communication resources to public health departments, health
care providers, and health care facilities, including such
providers and facilities that provide prenatal and pediatric
care;
``(4) be complementary to, and coordinated with, any other
Federal, State, local, or Tribal efforts, as appropriate; and
``(5) assess the effectiveness of communication strategies
to increase rates of vaccination.
``(d) Additional Activities.--The campaign under this section may--
``(1) include the use of television, radio, the internet,
and other media and telecommunications technologies;
``(2) be focused to address specific needs of communities
and populations with low rates of vaccination; and
``(3) include the dissemination of scientific and evidence-
based vaccine-related information, such as--
``(A) advancements in evidence-based research
related to diseases that may be prevented by vaccines
and vaccine development;
``(B) information on vaccinations for individuals
and communities, including individuals for whom
vaccines are not recommended by the Advisory Committee
for Immunization Practices, and the effects of low
vaccination rates within a community on such
individuals;
``(C) information on diseases that may be prevented
by vaccines; and
``(D) information on vaccine safety and the systems
in place to monitor vaccine safety.
``(e) Evaluation.--The Secretary shall--
``(1) establish benchmarks and metrics to quantitatively
measure and evaluate the awareness campaign under this section;
``(2) conduct qualitative assessments regarding the
awareness campaign under this section; and
``(3) prepare and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and Committee on
Energy and Commerce of the House of Representatives an
evaluation of the awareness campaign under this section.
``(f) Supplement Not Supplant.--Funds appropriated under this
section shall be used to supplement and not supplant other Federal,
State, and local public funds provided for activities described in this
section.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section and section 317(k) such sums as
may be necessary for fiscal years 2020 through 2024.''.
SEC. 402. GRANTS TO ADDRESS VACCINE-PREVENTABLE DISEASES.
(a) In General.--Section 317(k)(1) of the Public Health Service Act
(42 U.S.C. 247b(k)(1)) is amended--
(1) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(2) in subparagraph (D), by striking the period and
inserting a semicolon; and
(3) by adding at the end the following:
``(E) planning, implementation, and evaluation of
activities to address vaccine-preventable diseases, including
activities to--
``(i) identify communities at high risk of
outbreaks related to vaccine-preventable diseases,
including through improved data collection and
analysis;
``(ii) pilot innovative approaches to improve
vaccination rates in communities and among populations
with low rates of vaccination;
``(iii) reduce barriers to accessing vaccines and
evidence-based information about the health effects of
vaccines;
``(iv) partner with community organizations and
health care providers to develop and deliver evidence-
based interventions, including culturally- and
linguistically-appropriate interventions, to increase
vaccination rates;
``(v) improve delivery of evidence-based vaccine-
related information to parents and others; and
``(vi) improve the ability of State, local, tribal,
and territorial public health departments to engage
communities at high risk for outbreaks related to
vaccine-preventable diseases; and
``(F) research related to strategies for improving
awareness of scientific and evidence-based vaccine-related
information, including for communities with low rates of
vaccination, in order to understand barriers to vaccination,
improve vaccination rates, and assess the public health
outcomes of such strategies.''.
(b) Supplemental Grant Funds.--Section 330(d)(1) of the Public
Health Service Act (42 U.S.C. 254b) is amended--
(1) in subparagraph (F), by striking ``and'' at the end;
(2) in subparagraph (G), by striking the period and and
inserting ``; and''; and
(3) by adding at the end the following:
``(H) improving access to recommended
immunizations.''.
SEC. 403. GUIDE ON EVIDENCE-BASED STRATEGIES FOR PUBLIC HEALTH
DEPARTMENT OBESITY PREVENTION PROGRAMS.
(a) Development and Dissemination of an Evidence-based Strategies
Guide.--The Secretary of Health and Human Services (referred to in this
section as the ``Secretary''), acting through the Director of the
Centers for Disease Control and Prevention, not later than 2 years
after the date of enactment of this Act, shall--
(1) develop a guide on evidence-based strategies for State,
territorial, and local health departments to use to build and
maintain effective obesity prevention and reduction programs,
and, in consultation with Indian Tribes and Tribal
organizations, a guide on such evidence-based strategies with
respect to Indian Tribes and Tribal organizations for such
Indian Tribes and Tribal organizations to use for such purpose,
both of which guides shall--
(A) describe an integrated program structure for
implementing interventions proven to be effective in
preventing and reducing the incidence of obesity; and
(B) recommend--
(i) optimal resources, including staffing
and infrastructure, for promoting nutrition and
obesity prevention and reduction; and
(ii) strategies for effective obesity
prevention programs for State, territorial, and
local health departments, Indian Tribes, and
Tribal organizations, including strategies
related to--
(I) the application of evidence-
based and evidence-informed practices
to prevent and reduce obesity rates;
(II) the development,
implementation, and evaluation of
obesity prevention and reduction
strategies for specific communities and
populations;
(III) demonstrated knowledge of
obesity prevention practices that
reduce associated preventable diseases,
health conditions, death, and health
care costs;
(IV) best practices for the
coordination of efforts to prevent and
reduce obesity and related chronic
diseases;
(V) addressing the underlying risk
factors and social determinants of
health that impact obesity rates; and
(VI) interdisciplinary coordination
between relevant public health
officials specializing in fields such
as nutrition, physical activity,
epidemiology, communications, and
policy implementation, and
collaboration between public health
officials, community-based
organizations, and others, as
appropriate; and
(2) disseminate the guides and current research, evidence-
based practices, tools, and educational materials related to
obesity prevention, consistent with the guide, to State,
territorial, and local health departments, Indian Tribes, and
Tribal organizations.
(b) Technical Assistance.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, shall
provide technical assistance to State, territorial, and local health
departments, Indian Tribes, and Tribal organizations to support such
health departments in implementing the guide developed under subsection
(a)(1).
(c) Indian Tribes; Tribal Organizations.--The terms ``Indian
Tribe'' and ``Tribal organization'' have the meanings given the terms
``Indian tribe'' and ``tribal organization'', respectively, in section
4 of the Indian Self-Determination and Education Assistance Act (25
U.S.C. 5304).
SEC. 404. EXPANDING CAPACITY FOR HEALTH OUTCOMES.
Title III of the Public Health Service Act is amended by inserting
after section 330M (42 U.S.C. 254c-19) the following:
``SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUTCOMES.
``(a) Definitions.--In this section:
``(1) Eligible entity.--The term `eligible entity' means an
entity providing health care services in rural areas, frontier
areas, health professional shortage areas, or medically
underserved areas, or to medically underserved populations or
Native Americans, including Indian tribes or tribal
organizations.
``(2) Health professional shortage area.--The term `health
professional shortage area' means a health professional
shortage area designated under section 332.
``(3) Indian tribe.--The terms `Indian tribe' and `tribal
organization' have the meanings given such terms in section 4
of the Indian Self-Determination and Education Assistance Act.
``(4) Medically underserved population.--The term
`medically underserved population' has the meaning given the
term in section 330(b)(3).
``(5) Native americans.--The term `Native Americans' has
the meaning given such term in section 736 and includes Indian
tribes and tribal organizations.
``(6) Technology-enabled collaborative learning and
capacity building model.--The term `technology-enabled
collaborative learning and capacity building model' means a
distance health education model that connects health care
professionals, and particularly specialists, with multiple
other health care professionals through simultaneous
interactive videoconferencing for the purpose of facilitating
case-based learning, disseminating best practices, and
evaluating outcomes.
``(b) Program Established.--The Secretary shall, as appropriate,
award grants to evaluate, develop, and, as appropriate, expand the use
of technology-enabled collaborative learning and capacity building
models, to increase access to health care services, such as those to
address chronic diseases and conditions, mental health, substance use
disorders, prenatal and maternal health, pediatric care, pain
management, palliative care, and other specialty care in rural areas,
frontier areas, health professional shortage areas, or medically
underserved areas and for medically underserved populations or Native
Americans, including Indian Tribes and Tribal organizations.
``(c) Use of Funds.--
``(1) In general.--Grants awarded under subsection (b)
shall be used for--
``(A) the development and acquisition of
instructional programming, and the training of health
care providers and other professionals that provide or
assist in the provision of services through such
models;
``(B) information collection and evaluation
activities to study the impact of such models on
patient outcomes and health care providers, and to
identify best practices for the expansion and use of
such models; or
``(C) other activities consistent with achieving
the objectives of the grants awarded under this
section, as determined by the Secretary.
``(2) Other uses.--In addition to any of the uses under
paragraph (1), grants awarded under subsection (b) may be used
for--
``(A) equipment to support the use and expansion of
technology-enabled collaborative learning and capacity
building models, including for hardware and software
that enables distance learning, health care provider
support, and the secure exchange of electronic health
information; or
``(B) support for health care providers and other
professionals that provide or assist in the provision
of services through such models.
``(d) Length of Grants.--Grants awarded under subsection (b) shall
be for a period of up to 5 years.
``(e) Application.--An eligible entity that seeks to receive a
grant under subsection (b) shall submit to the Secretary an
application, at such time, in such manner, and containing such
information as the Secretary may require. Such application criteria
shall include an assessment of the effect of technology-enabled
collaborative learning and capacity building models on patient outcomes
and health care providers.
``(f) Access to Broadband.--In administering grants under this
section, the Secretary may coordinate with other agencies to ensure
that funding opportunities are available to support access to reliable,
high-speed internet for grantees.
``(g) Technical Assistance.--The Secretary shall provide (either
directly through the Department of Health and Human Services or by
contract) technical assistance to eligible entities, including
recipients of grants under subsection (b), on the development, use, and
evaluation of technology-enabled collaborative learning and capacity
building models in order to expand access to health care services
provided by such entities, including for medically underserved areas
and to medically underserved populations or Native Americans, including
Indian tribes and Tribal organizations.
``(h) Research and Evaluation.--The Secretary, in consultation with
stakeholders with appropriate expertise in such models, shall develop a
strategic plan to research and evaluate the evidence for such models.
The Secretary shall use such plan to inform the activities carried out
under this section.
``(i) Report by Secretary.--Not later than 4 years after the date
of enactment of this section, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives, and post on the Internet website of the Department of
Health and Human Services, a report including, at minimum--
``(1) a description of any new and continuing grants
awarded to entities under subsection (b) and the specific
purpose and amounts of such grants;
``(2) an overview of--
``(A) the evaluations conducted under subsections
(b) or (f); and
``(B) technical assistance provided under
subsection (g); and
``(3) a description of any significant findings or
developments in patient outcomes and health care providers and
best practices for eligible entities expanding, using, or
evaluating technology-enabled collaborative learning and
capacity building models, including through the activities
described in subsection (g).
``(j) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, such sums as may be necessary
for each of fiscal years 2020 through 2024.''.
SEC. 405. PUBLIC HEALTH DATA SYSTEM MODERNIZATION.
Subtitle C of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh-31 et seq.) is amended by adding at the end the following:
``SEC. 2822. PUBLIC HEALTH DATA SYSTEM MODERNIZATION GRANTS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall--
``(1) award grants to State, local, Tribal, and territorial
public health departments for the expansion and modernization
of public health data systems, to assist public health
departments in--
``(A) assessing current data infrastructure
capabilities and gaps to improve and increase
consistency in data collection, storage, analysis, and,
as appropriate, to improve dissemination of public
health-related information;
``(B) improving secure public health data
collection, transmission, exchange, maintenance, and
analysis;
``(C) simplifying and supporting reporting by
health care providers, as applicable, pursuant to State
law, including through the use of health information
technology, to State, local, Tribal, and territorial
public health departments, including public health
officials in multiple jurisdictions within such State,
as appropriate;
``(D) enhancing interoperability of public health
data systems (including systems created or accessed by
public health departments) with health information
technology, including health information technology
certified under section 3001(c)(5);
``(E) supporting earlier disease and health
condition detection, such as through near real-time
data monitoring, to support rapid public health
responses; and
``(F) supporting activities within the applicable
jurisdiction related to the expansion and modernization
of electronic case reporting;
``(2) as appropriate, conduct activities related to the
interoperability and improvement of applicable public health
data systems used by the Centers for Disease Control and
Prevention, and, in coordination with the Office of the
National Coordinator for Health Information Technology, the
designation of data and technology standards for health
information systems of the public health infrastructure with
deference given to standards published by standards development
organizations and voluntary consensus-based standards bodies;
and
``(3) develop and utilize public-private partnerships for
technical assistance and related implementation support for
State, local, Tribal, and territorial public health
departments, and the Centers for Disease Control and
Prevention, on the expansion and modernization of electronic
case reporting and public health data systems, as applicable.
``(b) Requirements.--
``(1) In general.--The Secretary may not award a grant
under subsection (a)(1) unless the applicant uses or agrees to
use standards recognized by the National Coordinator for Health
Information Technology pursuant to section 3001(c)(1) or
adopted by the Secretary under section 3004.
``(2) Waiver.--The Secretary may waive the requirement
under paragraph (1) with respect to an applicant if the
Secretary determines that the activities under subsection (a)
cannot otherwise be carried out within the applicable
jurisdiction.
``(3) Application.--A State, local, Tribal, or territorial
health department applying for a grant under this section shall
submit an application to the Secretary at such time and in such
manner as the Secretary may require. Such application shall
include information describing--
``(A) the activities that will be supported by the
grant; and
``(B) how the modernization of such public health
data systems will support or impact the public health
infrastructure of the health department, including a
description of remaining gaps, if any, and the actions
needed to address such gaps.
``(c) Use of Funds.--An entity receiving a grant under this section
may use amounts received under such grant for one or both of the
following:
``(1) Carrying out activities described in subsection
(a)(1) to support public health data systems (including
electronic case reporting), which may include support for, and
training of, professionals with expertise in contributing to
and using such systems (including public health data
scientists).
``(2) Developing and disseminating information related to
the use and importance of public health data.
``(d) Strategy and Implementation Plan.--Not later than 180 days
after the date of enactment of the Lower Health Care Costs Act, the
Secretary, acting through the Director of the Centers for Disease
Control and Prevention, shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives, a coordinated
strategy and an accompanying implementation plan that identifies and
demonstrates the steps the Secretary will carry out to--
``(1) update and improve applicable public health data
systems used by the Centers for Disease Control and Prevention;
and
``(2) carry out the activities described in this section to
support the improvement of State, local, Tribal, and
territorial public health data systems.
``(e) Consultation.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall consult with
State, local, Tribal, and territorial health departments, professional
medical and public health associations, associations representing
hospitals or other health care entities, health information technology
experts, and other appropriate entities regarding the plan and grant
program to modernize public health data systems pursuant to this
section. Such activities may include the provision of technical
assistance related to the exchange of information by such public health
data systems used by relevant health care and public health entities at
the local, State, Federal, Tribal, and territorial levels.
``(f) Report to Congress.--Not later than 1 year after the date of
enactment of this section, the Secretary shall submit a report to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives
that includes--
``(1) a description of any barriers to--
``(A) public health authorities implementing
interoperable public health data systems and electronic
case reporting;
``(B) the exchange of information pursuant to
electronic case reporting; or
``(C) reporting by health care providers using such
public health data systems, as appropriate, and
pursuant to State law;
``(2) an assessment of the potential public health impact
of implementing electronic case reporting and interoperable
public health data systems; and
``(3) a description of the activities carried out pursuant
to this section.
``(g) Electronic Case Reporting.--In this section, the term
`electronic case reporting' means the automated identification,
generation, and bilateral exchange of reports of health events among
electronic health record or health information technology systems and
public health authorities.
``(h) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for fiscal years 2020 through 2024.''.
SEC. 406. INNOVATION FOR MATERNAL HEALTH.
Title III of the Public Health Service Act is amended by inserting
after section 330N of such Act, as added by section 404, the following:
``SEC. 330O. INNOVATION FOR MATERNAL HEALTH.
``(a) In General.--The Secretary, in consultation with experts
representing a variety of clinical specialties, State, tribal, or local
public health officials, researchers, epidemiologists, statisticians,
and community organizations, shall establish or continue a program to
award competitive grants to eligible entities for the purpose of--
``(1) identifying, developing, or disseminating best
practices to improve maternal health care quality and outcomes,
eliminate preventable maternal mortality and severe maternal
morbidity, and improve infant health outcomes, which may
include--
``(A) information on evidence-based practices to
improve the quality and safety of maternal health care
in hospitals and other health care settings of a State
or health care system, including by addressing topics
commonly associated with health complications or risks
related to prenatal care, labor care, birthing, and
postpartum care;
``(B) best practices for improving maternal health
care based on data findings and reviews conducted by a
State maternal mortality review committee that address
topics of relevance to common complications or health
risks related to prenatal care, labor care, birthing,
and postpartum care; and
``(C) information on addressing determinants of
health that impact maternal health outcomes for women
before, during, and after pregnancy;
``(2) collaborating with State maternal mortality review
committees to identify issues for the development and
implementation of evidence-based practices to improve maternal
health outcomes and reduce preventable maternal mortality and
severe maternal morbidity;
``(3) providing technical assistance and supporting the
implementation of best practices identified in paragraph (1) to
entities providing health care services to pregnant and
postpartum women; and
``(4) identifying, developing, and evaluating new models of
care that improve maternal and infant health outcomes, which
may include the integration of community-based services and
clinical care.
``(b) Eligible Entities.--To be eligible for a grant under
subsection (a), an entity shall--
``(1) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may require; and
``(2) demonstrate in such application that the entity is
capable of carrying out data-driven maternal safety and quality
improvement initiatives in the areas of obstetrics and
gynecology or maternal health.
``(c) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated such sums as may be necessary
for each of fiscal years 2020 through 2024.''.
SEC. 407. TRAINING FOR HEALTH CARE PROVIDERS.
Title VII of the Public Health Service Act is amended by striking
section 763 (42 U.S.C. 294p) and inserting the following:
``SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS.
``(a) Grant Program.--The Secretary shall establish a program to
award grants to accredited schools of allopathic medicine, osteopathic
medicine, and nursing, and other health professional training programs
for the training of health care professionals to reduce and prevent
discrimination (including training related to implicit biases) in the
provision of health care services related to prenatal care, labor care,
birthing, and postpartum care.
``(b) Eligibility.--To be eligible for a grant under subsection
(a), an entity described in such subsection shall submit to the
Secretary an application at such time, in such manner, and containing
such information as the Secretary may require.
``(c) Reporting Requirement.--Each entity awarded a grant under
this section shall periodically submit to the Secretary a report on the
status of activities conducted using the grant, including a description
of the impact of such training on patient outcomes, as applicable.
``(d) Best Practices.--The Secretary may identify and disseminate
best practices for the training of health care professionals to reduce
and prevent discrimination (including training related to implicit
biases) in the provision of health care services related to prenatal
care, labor care, birthing, and postpartum care.
``(e) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated such sums as may be necessary
for each of fiscal years 2020 through 2024.''.
SEC. 408. STUDY ON TRAINING TO REDUCE AND PREVENT DISCRIMINATION.
Not later than 2 years after date of enactment of this Act, the
Secretary of Health and Human Services (referred to in this section as
the ``Secretary'') shall, through a contract with an independent
research organization, conduct a study and make recommendations for
accredited schools of allopathic medicine, osteopathic medicine, and
nursing, and other health professional training programs on best
practices related to training to reduce and prevent discrimination,
including training related to implicit biases, in the provision of
health care services related to prenatal care, labor care, birthing,
and postpartum care.
SEC. 409. PERINATAL QUALITY COLLABORATIVES.
Section 317K(a)(2) of the Public Health Service Act (42 U.S.C.
247b-12(a)(2)) is amended by adding at the end the following:
``(E)(i) The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and
in coordination with other offices and agencies, as
appropriate, shall establish or continue a competitive
grant program for the establishment or support of
perinatal quality collaboratives to improve perinatal
care and perinatal health outcomes for pregnant and
postpartum women and their infants. A State, Indian
Tribe, or Tribal organization may use funds received
through such grant to--
``(I) support the use of evidence-based or
evidence-informed practices to improve outcomes
for maternal and infant health;
``(II) work with clinical teams; experts;
State, local, and, as appropriate, tribal
public health officials; and stakeholders,
including patients and families, to identify,
develop, or disseminate best practices to
improve perinatal care and outcomes; and
``(III) employ strategies that provide
opportunities for health care professionals and
clinical teams to collaborate across health
care settings and disciplines, including
primary care and mental health, as appropriate,
to improve maternal and infant health outcomes,
which may include the use of data to provide
timely feedback across hospital and clinical
teams to inform responses, and to provide
support and training to hospital and clinical
teams for quality improvement, as appropriate.
``(ii) To be eligible for a grant under clause (i),
an entity shall submit to the Secretary an application
in such form and manner and containing such information
as the Secretary may require.''.
SEC. 410. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.
(a) Grants.--Title III of the Public Health Service Act is amended
by inserting after section 330O of such Act, as added by section 406,
the following:
``SEC. 330P. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.
``(a) In General.--The Secretary may award grants for the purpose
of establishing or operating evidence-based or innovative, evidence-
informed programs to deliver integrated health care services to
pregnant and postpartum women to optimize the health of women and their
infants, including to reduce adverse maternal health outcomes,
pregnancy-related deaths, and related health disparities (including
such disparities associated with racial and ethnic minority
populations), and, as appropriate, by addressing issues researched
under subsection (b)(2) of section 317K.
``(b) Integrated Services for Pregnant and Postpartum Women.--
``(1) Eligibility.--To be eligible to receive a grant under
subsection (a), a State, Indian Tribe, or Tribal organization
(as such terms are defined in section 4 of the Indian Self-
Determination and Education Assistance Act) shall work with
relevant stakeholders that coordinate care (including
coordinating resources and referrals for health care and social
services) to develop and carry out the program, including--
``(A) State, Tribal, and local agencies responsible
for Medicaid, public health, social services, mental
health, and substance use disorder treatment and
services;
``(B) health care providers who serve pregnant and
postpartum women; and
``(C) community-based health organizations and
health workers, including providers of home visiting
services and individuals representing communities with
disproportionately high rates of maternal mortality and
severe maternal morbidity, and including those
representing racial and ethnicity minority populations.
``(2) Terms.--
``(A) Period.--A grant awarded under subsection (a)
shall be made for a period of 5 years. Any supplemental
award made to a grantee under subsection (a) may be
made for a period of less than 5 years.
``(B) Preference.--In awarding grants under
subsection (a), the Secretary shall--
``(i) give preference to States, Indian
Tribes, and Tribal organizations that have the
highest rates of maternal mortality and severe
maternal morbidity relative to other such
States, Indian Tribes, or Tribal organizations,
respectively; and
``(ii) shall consider health disparities
related to maternal mortality and severe
maternal morbidity, including such disparities
associated with racial and ethnic minority
populations.
``(C) Priority.--In awarding grants under
subsection (a), the Secretary shall give priority to
applications from up to 15 entities described in
subparagraph (B)(i).
``(D) Evaluation.--The Secretary shall require
grantees to evaluate the outcomes of the programs
supported under the grant.
``(c) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be necessary
for each of fiscal years 2020 through 2024.''.
(b) Report on Grant Outcomes and Dissemination of Best Practices.--
(1) Report.--Not later than February 1, 2026, the Secretary
of Health and Human Services shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report that describes--
(A) the outcomes of the activities supported by the
grants awarded under the amendments made by this
section on maternal and child health;
(B) best practices and models of care used by
recipients of grants under such amendments; and
(C) obstacles identified by recipients of grants
under such amendments, and strategies used by such
recipients to deliver care, improve maternal and child
health, and reduce health disparities.
(2) Dissemination of best practices.--Not later than August
1, 2026, the Secretary of Health and Human Services shall
disseminate information on best practices and models of care
used by recipients of grants under the amendments made by this
section (including best practices and models of care relating
to the reduction of health disparities, including such
disparities associated with racial and ethnic minority
populations, in rates of maternal mortality and severe maternal
morbidity) to relevant stakeholders, which may include health
providers, medical schools, nursing schools, relevant State,
tribal, and local agencies, and the general public.
SEC. 411. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE NATIONAL HEALTH
SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT OPERATE
GME PROGRAMS.
(a) Community Health Centers.--Section 10503(b)(1)(F) of the
Patient Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(1)(F))
is amended by striking ``fiscal year 2019'' and inserting ``each of
fiscal years 2019 through 2024''.
(b) National Health Service Corps.--Section 10503(b)(2)(F) of the
Patient Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(2)(F))
is amended by striking ``and 2019'' and inserting ``through 2024''.
(c) Teaching Health Centers That Operate Graduate Medical Education
Programs.--Section 340H(g)(1) of the Public Health Service Act (42
U.S.C. 256h(g)(1)) is amended by striking ``and 2019'' and inserting
``through 2024''.
(d) Application of Provisions.--Amounts appropriated pursuant to
this section for each of fiscal years 2019 through 2024 shall be
subject to the requirements contained in Public Law 115-245 for funds
for programs authorized under sections 330 through 340 of the Public
Health Service Act.
(e) Conforming Amendments.--Paragraph (4) of section 3014(h) of
title 18, United States Code, as amended by section 50901 of Public Law
115-123, is amended by striking ``and section 50901(e) of the Advancing
Chronic Care, Extenders, and Social Services Act'' and inserting ``,
section 50901(e) of the Advancing Chronic Care, Extenders, and Social
Services Act, and section 411(d) of the Lower Health Care Costs Act''.
SEC. 412. OTHER PROGRAMS.
(a) Type I.--Section 330B(b)(2)(D) of the Public Health Service Act
(42 U.S.C. 254c-2(b)(2)(D)) is amended by striking ``and 2019'' and
inserting ``through 2024''.
(b) Indians.--Subparagraph (D) of section 330C(c)(2) of the Public
Health Service Act (42 U.S.C. 254c-3(c)(2)(D)) is amended by striking
``and 2019'' and inserting ``through 2024''.
SEC. 413. NATIVE AMERICAN SUICIDE PREVENTION.
Section 520E(b) of the Public Health Service Act (42 U.S.C. 290bb-
36(b) is amended by inserting after paragraph (3) the following:
``(4) Consultation.--A State applying for a grant or
cooperative agreement under this section shall, in the
development and implementation of a statewide early
intervention strategy, consult or confer with entities
described in paragraph (1)(C) in such State.''.
SEC. 414. MINIMUM AGE OF SALE OF TOBACCO PRODUCTS.
(a) In General.--Section 906(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 387f(d)) is amended--
(1) in paragraph (3)(A)(ii), by striking ``18 years'' and
inserting ``21 years''; and
(2) by adding at the end the following:
``(5) Minimum age of sale.--It shall be unlawful for any
retailer to sell a tobacco product to any person younger than
21 years of age.''.
(b) Regulations.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall publish in the
Federal Register a final rule to update the regulations issued under
chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387
et seq.) as appropriate, only to carry out the amendments made by
subsection (a), including updating the relevant age verification
requirements under part 1140 of title 21, Code of Federal Regulations
to require age verification for individuals under the age of 30. Such
final rule shall--
(1) take full effect not later than 90 days after the date
on which such final rule is published; and
(2) be deemed to be in compliance with all applicable
provisions of chapter 5 of title 5, United States Code and all
other provisions of law relating to rulemaking procedures.
(c) Notification.--Not later than 90 days after the date of
enactment of this Act, the Secretary shall provide written notification
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives regarding the progress of the Department of Health and
Human Services towards promulgating the final rule under subsection
(b). If, 180 days after the date of enactment of this Act, such rule
has not been promulgated in accordance with subsection (b), the
Secretary shall provide a written notification and a justification for
the delay in rulemaking to such committees.
(d) Penalties for Violations.--
(1) In general.--Section 103(q)(2) of the Family Smoking
Prevention and Tobacco Control Act (Public Law 111-31) is
amended--
(A) in subparagraph (A), in the matter preceding
clause (i), by inserting ``section 906(d)(5) or of''
after ``violations of''; and
(B) in subparagraph (C), by inserting ``section
906(d)(5) or of'' after ``a retailer of''.
(2) Repeated violations.--Section 303(f)(8) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) is amended
by inserting ``section 906(d)(5) or of'' after ``repeated
violations of''.
(3) Misbranded products.--Section 903(a)(7)(B) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387c) is
amended by inserting ``section 906(d)(5) or of'' after
``violation of''.
SEC. 415. SALE OF TOBACCO PRODUCTS TO INDIVIDUALS UNDER THE AGE OF 21.
(a) In General.--Section 1926 of the Public Health Service Act (42
U.S.C. 300x-26) is amended--
(1) in the heading--
(A) by striking ``state law regarding''; and
(B) by striking ``18'' and inserting ``21'';
(2) by striking subsections (a) and (d);
(3) by redesignating subsections (b) and (c) as subsections
(a) and (b), respectively;
(4) by amending subsection (a), as so redesignated, to read
as follows:
``(a) In General.--A funding agreement for a grant under section
1921 is that the State involved will--
``(1) annually conduct random, unannounced inspections to
ensure that retailers do not sell tobacco products to
individuals under the age of 21; and
``(2) annually submit to the Secretary a report
describing--
``(A) the activities carried out by the State to
ensure that retailers do not sell tobacco products to
individuals under the age of 21;
``(B) the extent of success the State has achieved
in ensuring that retailers do not sell tobacco products
to individuals under the age of 21; and
``(C) the strategies to be utilized by the State to
ensure that retailers do not sell tobacco products to
individuals under the age of 21 during the fiscal year
for which the grant is sought.'';
(5) in subsection (b), as so redesignated--
(A) by striking paragraphs (1), (2), (3), and (4);
(B) by striking ``Before making'' and inserting the
following:
``(1) In general.--Before making'';
(C) by striking ``for the first applicable fiscal
year or any subsequent fiscal year'';
(D) by striking ``subsections (a) and (b)'' and
inserting ``subsection (a)'';
(E) by striking ``equal to--'' and inserting ``up
to 10 percent of the amount determined under section
1933 for the State for the applicable fiscal year.'';
and
(F) by adding at the end the following:
``(2) Limitation.--
``(A) In general.--A State shall not have funds
withheld pursuant to paragraph (1) if such State for
which the Secretary has made a determination of
noncompliance under such paragraph--
``(i) certifies to the Secretary by May 1
of the fiscal year for which the funds are
appropriated, consistent with subparagraph (B),
that the State will commit additional State
funds, in accordance with paragraph (1), to
ensure that retailers do not sell tobacco
products to individuals under 21 years of age;
``(ii) agrees to comply with a negotiated
agreement for a corrective action plan that is
approved by the Secretary and carried out in
accordance with guidelines issued by the
Secretary; or
``(iii) is a territory that receives less
than $1,000,000 for a fiscal year under section
1921.
``(B) Certification.--
``(i) In general.--The amount of funds to
be committed by a State pursuant to
subparagraph (A)(i) shall be equal to 1 percent
of such State's substance abuse allocation
determined under section 1933 for each
percentage point by which the State misses the
retailer compliance rate goal established by
the Secretary.
``(ii) State expenditures.--For a fiscal
year in which a State commits funds as
described in clause (i), such State shall
maintain State expenditures for tobacco
prevention programs and for compliance
activities at a level that is not less than the
level of such expenditures maintained by the
State for the preceding fiscal year, plus the
additional funds for tobacco compliance
activities required under clause (i). The State
shall submit a report to the Secretary on all
State obligations of funds for such fiscal year
and all State expenditures for the preceding
fiscal year for tobacco prevention and
compliance activities by program activity by
July 31 of such fiscal year.
``(iii) Discretion.--The Secretary shall
exercise discretion in enforcing the timing of
the State obligation of the additional funds
required by the certification described in
subparagraph (A)(i) as late as July 31 of such
fiscal year.
``(C) Failure to certify.--If a State described in
subparagraph (A) fails to certify to the Secretary
pursuant to subparagraph (A)(i) or enter into, or
comply with, a negotiated agreement under subparagraph
(A)(ii), the Secretary may take action pursuant to
paragraph (1).''; and
(6) by adding at the end the following:
``(c) Implementation of Reporting Requirements.--
``(1) Transition period.--The Secretary shall--
``(A) not withhold amounts under subsection (b) for
the 3-year period immediately following the date of
enactment of the Lower Health Care Costs Act; and
``(B) use discretion in exercising its authority
under subsection (b) during the 2-year period
immediately following the 3-year period described in
subparagraph (A), to allow for a transition period for
implementation of the reporting requirements under
subsection (a)(2).
``(2) Regulations or guidance.--Not later than 180 days
after the date of enactment of the Lower Health Care Costs Act
the Secretary shall update regulations under part 96 of title
45, Code of Federal Regulations or guidance on the retailer
compliance rate goal under subsection (b), the use of funds
provided under section 1921 for purposes of meeting the
requirements of this section, and reporting requirements under
subsection (a)(2).
``(3) Coordination.--The Secretary shall ensure the
Assistant Secretary for Mental Health and Substance Use
coordinates, as appropriate, with the Commissioner of Food and
Drugs in providing technical assistance under this section to
States, related to ensuring retailers do not sell tobacco
products to individuals under the age of 21, that is consistent
with applicable regulations issued by the Food and Drug
Administration.
``(d) Transitional Grants.--
``(1) In general.--The Secretary shall award grants under
this subsection to each State that receives funding under
section 1921 to ensure compliance of each such State with this
section.
``(2) Use of funds.--A State receiving a grant under this
subsection--
``(A) shall use amounts received under such grant
for activities to plan for or ensure compliance in the
State with subsection (a); and
``(B) in the case of a State for which the
Secretary has made a determination under subsection (b)
that the State is prepared to meet, or has met, the
requirements of subsection (a), may use such funds for
tobacco cessation activities, strategies to prevent the
use of tobacco products by individuals under the age of
21, or allowable uses under section 1921.
``(3) Supplement not supplant.--Grants under this
subsection shall be used to supplement and not supplant other
Federal, State, and local public funds provided for activities
under paragraph (2).
``(4) Authorization of appropriations.--To carry out this
subsection, there are authorized to be appropriated $18,580,790
for each of fiscal years 2020 through 2024.
``(5) Sunset.--This subsection shall have no force or
effect after September 30, 2024.
``(e) Technical Assistance.--The Secretary shall provide technical
assistance to States related to the activities required under this
section.''.
(b) Report to Congress.--Not later than 3 years after the date of
enactment of this Act, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report on the
status of implementing the requirements of section 1926 of the Public
Health Service Act (42 U.S.C. 300x-26), as amended by subsection (a),
and a description of any technical assistance provided under subsection
(e) of such section, including the number of meetings requested and
held related to technical assistance.
(c) Conforming Amendment.--Section 212 of division D of the
Consolidated Appropriations Act, 2010 (Public Law 111-117) is repealed.
TITLE V--IMPROVING THE EXCHANGE OF HEALTH INFORMATION
SEC. 501. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND COST
INFORMATION.
(a) In General.--Part A of title XXVII of the Public Health Service
Act (42 U.S.C. 300gg et seq.) is amended by inserting after section
2715A the following:
``SEC. 2715B. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND COST
INFORMATION.
``(a) In General.--A group health plan or a health insurance issuer
offering group or individual health insurance coverage shall make
available for access, exchange, and use without special effort, through
application programming interfaces (or successor technology or
standards), the information described in subsection (b), in the manner
described in subsection (b) and otherwise consistent with this section.
``(b) Information.--The following information is required to be
made available, as the Secretary may specify:
``(1) Historical claims, provider encounter, and payment
data for each enrollee, which shall--
``(A) include adjudicated medical and prescription
drug claims and equivalent encounters, including all
data elements contained in such transactions--
``(i) that were adjudicated by the group
health plan or health insurance issuer during
the previous 5 years or the enrollee's entire
period of enrollment in the applicable plan or
coverage if such period is less than the
previous 5 years;
``(ii) that involve benefits managed by any
third party, such as a pharmacy benefits
manager or radiology benefits manager that
manages benefits or adjudicates claims on
behalf of the plan or coverage; and
``(iii) from any other health plan or
health insurance coverage offered by the same
insurance issuer, in which the same enrollee
was enrolled during the previous 5 years; and
``(B) be available to an enrollee or former
enrollee, the enrollee's providers, and any third-party
applications or services authorized by the enrollee--
``(i) through the application programming
interfaces (or successor technology or
standards) as required by this paragraph, in a
single, longitudinal format that is easy to
understand, secure, and that may update
automatically;
``(ii) as soon as practicable, and in no
case later than the period of time determined
by the Secretary, after the claim is
adjudicated or the data is received by the
health plan or health insurance issuer; and
``(iii) to the enrollee, former enrollee,
and any providers or third-party applications
or services authorized by the enrollee, for 5
years after the end date of the enrollee's
enrollment in the plan or in any coverage
offered by the health insurance issuer.
``(2) Identifying directory information for all in-network
providers, including facilities and practitioners, that
participate in the plan or coverage, which shall--
``(A) include--
``(i) the national provider identifier for
in-network facilities and practitioners; and
``(ii) the name, address, phone number, and
specialty for each such facility and
practitioner, based on the most recent
interaction between the plan or coverage and
that facility or practitioner;
``(B) be capable of returning the information
necessary to establish a list of participating in-
network facilities and practitioners, in a given
specialty or at a particular facility type, within a
specified geographic radius; and
``(C) be capable of returning the network status,
when presented with identifiers for a given enrollee
and facility or practitioner.
``(3) Estimated enrollee out-of-pocket costs, including
costs expected to be incurred through a deductible, co-payment,
coinsurance, or other form of cost-sharing, for--
``(A) a designated set of common services or
episodes of care, to be established by the Secretary
through rulemaking, including, at a minimum--
``(i) in the case of services provided by a
hospital, the 100 most common diagnosis-related
groups, as used in the Medicare Inpatient
Prospective Patient System (or successor
episode-based reimbursement methodology) at
that hospital, based on claims data adjudicated
by the group health plan or health insurance
issuer;
``(ii) in the case of services provided in
an out-patient setting, including radiology,
lab tests, and out-patient surgical procedures,
any service rendered by the facility or
practitioner, and reimbursed by the health plan
or health insurance issuer; and
``(iii) in the case of post-acute care,
including home health providers, skilled
nursing facilities, inpatient rehabilitation
facilities, and long-term care hospitals, the
patient out-of-pocket costs for an episode of
care, as the Secretary may determine, which
permits users to reasonably compare costs
across different facility and service types;
and
``(B) all prescription drugs currently included on
any tier of the formulary of the plan or coverage.
``(4) A list of the categories of providers of ancillary
services, as defined in section 2719(A)(i)(3), for which the
plan or coverage has no in-network providers.
``(c) Availability and Access.--Subject to all applicable Federal
and State privacy, security, and breach notification laws, the
application programming interfaces, including all data required to be
made available through such interfaces, shall--
``(1) be made available by the applicable group health plan
or health insurance issuer, at no charge, to--
``(A) enrollees and prospective enrollees in the
group health plan or health insurance coverage;
``(B) third parties authorized by the enrollee;
``(C) facilities and practitioners who are under
contract with the plan or coverage; and
``(D) business associates of such facilities and
practitioners, as defined in section 160.103 of title
45, Code of Federal Regulations (or any successor
regulations);
``(2) be available to enrollees in the group health plan or
health insurance coverage, and to third-party applications or
services facilitating such access by enrollees, during the
enrollment process and for a minimum of 5 years after the end
date of the enrollee's enrollment in the plan or in any
coverage offered by the health insurance issuer;
``(3) permit persistent access by third party applications
or services authorized by the enrollee, for a reasonable period
of time, consistent with the requirements of the HIPAA Security
rule (part 160 of title 45 Code of Federal Regulations and
subparts A and C of part 164 of such title);
``(4) employ the applicable content, vocabulary, and
technical standards, as determined by the Secretary pursuant to
title XXX; and
``(5) employ security and authentication standards, as the
Secretary determines appropriate.
``(d) Rule of Construction Regarding Privacy.--Nothing in this
section shall be construed to alter existing obligations of a covered
entity or business associate under the privacy, security, and breach
notification rules promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act or section 13402 of the
HITECH Act, or to alter the Secretary's existing authority to modify
such rules, under part 2 of title 42, Code of Federal Regulations (or
successor regulations), under section 444 of the General Education
Provisions Act (20 U.S.C. 1232g) (commonly referred to as the `Family
Educational Rights and Privacy Act of 1974'), under the amendments made
by the Genetic Information Nondiscrimination Act, or under State
privacy law.''.
(b) Effective Date.--Section 2715B of the Public Health Service
Act, as added by subsection (a), shall take effect 18 months after the
date of enactment of this Act.
SEC. 502. RECOGNITION OF SECURITY PRACTICES.
Part 1 of subtitle D of the Health Information Technology for
Economic and Clinical Health Act (42 U.S.C. 17931 et seq.) is amended
by adding at the end the following:
``SEC. 13412. RECOGNITION OF SECURITY PRACTICES.
``(a) In General.--Consistent with the authority of the Secretary
under sections 1176 and 1177 of the Social Security Act, when making
determinations relating to fines under section 13410, decreasing the
length and extent of an audit under section 13411, or remedies
otherwise agreed to by the Secretary, the Secretary shall consider
whether the covered entity or business associate has adequately
demonstrated that it had, for not less than the previous 12 months,
recognized security practices in place that may--
``(1) mitigate fines under section 13410;
``(2) result in the early, favorable termination of an
audit under section 13411; and
``(3) mitigate the remedies that would otherwise be agreed
to in any agreement with respect to resolving potential
violations of the HIPAA Security rule (part 160 of title 45
Code of Federal Regulations and subparts A and C of part 164 of
such title) between the covered entity or business associate
and the Department of Health and Human Services.
``(b) Definition and Miscellaneous Provisions.--
``(1) Recognized security practices.--The term `recognized
security practices' means the standards, guidelines, best
practices, methodologies, procedures, and processes developed
under section 2(c)(15) of the National Institute of Standards
and Technology Act, the approaches promulgated under section
405(d) of the Cybersecurity Act of 2015, and other programs and
processes that address cybersecurity and that are developed,
recognized, or promulgated through regulations under other
statutory authorities. Such practices shall be determined by
the covered entity or business associate.
``(2) Limitation.--Nothing in this section shall be
construed as providing the Secretary authority to increase
fines under section 13410, or the length, extent or quantity of
audits under section 13411, due to a lack of compliance with
the recognized security practices.
``(3) No liability for nonparticipation.--Subject to
paragraph (4), nothing in this section shall be construed to
subject a covered entity or business associate to liability for
electing not to engage in the recognized security practices
defined by this section.
``(4) Rule of construction.--Nothing in this section shall
be construed to limit the Secretary's authority to enforce the
HIPAA Security rule (part 160 of title 45 Code of Federal
Regulations and subparts A and C of part 164 of such title), or
to supersede or conflict with an entity or business associate's
obligations under the HIPAA Security rule.''.
SEC. 503. GAO STUDY ON THE PRIVACY AND SECURITY RISKS OF ELECTRONIC
TRANSMISSION OF INDIVIDUALLY IDENTIFIABLE HEALTH
INFORMATION TO AND FROM ENTITIES NOT COVERED BY THE
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Comptroller General of the United States shall conduct
a study to--
(1) describe the roles of Federal agencies and the private
sector with respect to protecting the privacy and security of
individually identifiable health information transmitted
electronically to and from entities not covered by the
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C.
1320d-2 note);
(2) identify recent developments regarding the use of
application programming interfaces to access individually
identifiable health information, and implications for the
privacy and security of such information;
(3) identify practices in the private sector, such as terms
and conditions for use, relating to the privacy, disclosure,
and secondary uses of individually identifiable health
information transmitted electronically to or from entities,
selected by an individual, that are not subject to the
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996; and
(4) identify steps the public and private sectors can take
to improve the private and secure access to and availability of
individually identifiable health information.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Comptroller General of the United States shall submit to
Congress a report concerning the findings of the study conducted under
subsection (a).
SEC. 504. TECHNICAL CORRECTIONS.
(a) In General.--Section 3022(b) of the Public Health Service Act
(42 U.S.C. 300jj-52(b)) is amended by adding at the end the following
new paragraph:
``(4) Application of authorities under inspector general
act of 1978.--In carrying out this subsection, the Inspector
General shall have the same authorities as provided under
section 6 of the Inspector General Act of 1978 (5 U.S.C.
App.).''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect as if included in the enactment of the 21st Century Cures
Act (Public Law 114-255).
SEC. 505. PUBLIC MEETING.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
convene a public meeting for purposes of discussing and providing input
on patient-matching metrics for the purpose of enabling
interoperability and the exchange of health information across health
care organizations.
(b) Experts.--The public meeting under this section may include--
(1) representatives of relevant Federal agencies (including
representatives from the Office of the National Coordinator for
Health Information Technology);
(2) State, local, Tribal, and territorial public health
officials;
(3) stakeholders with expertise in health information
exchange;
(4) stakeholders with expertise in capabilities relevant to
patient matching, such as experts in informatics and data
analytics;
(5) stakeholders affected by record-matching (including
patients, hospitals, health systems, payers, health information
exchanges, and prescription drug monitoring programs); and
(6) other representatives, as the Secretary determines
appropriate.
(c) Topics.--Such public meeting shall include a discussion of--
(1) standards and processes for assessing the accuracy of
patient-matching algorithms;
(2) performance metrics for health care providers
purchasing patient-matching technology and algorithm
developers;
(3) the development of benchmarks for the accuracy of
patient-matching algorithms;
(4) considerations for State, local, Tribal, and
territorial capabilities and infrastructure related to data
exchange, interoperability, and matching patient records;
(5) opportunities for the incorporation of innovative
technologies to improve patient matching; and
(6) privacy and security protections.
Calendar No. 133
116th CONGRESS
1st Session
S. 1895
_______________________________________________________________________
A BILL
To lower health care costs.
_______________________________________________________________________
July 8, 2019
Reported with an amendment