Bill Summary
This legislation, titled "AN ACT To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities," aims to lower prescription drug costs and stabilize the health insurance market. It includes measures such as bringing low-cost options and competition, protecting consumer access to generic drugs, and conducting a study on federal assistance in drug development. It also addresses penalties for violating FTC rules, defines key terms, and outlines procedures for eligible product developers to bring civil actions against license holders. The legislation also amends sections of existing federal food and drug laws and outlines provisions for outreach and educational activities for the Exchange. Additionally, it includes a provision for preserving state options in implementing health care marketplaces and sets requirements for the navigator program. The legislation also requires reports on the performance of the Federal Exchange, advertising and outreach efforts, and the effects of state-administered health insurance plans and website maintenance.
Possible Impacts
1) The legislation will lower prescription drug costs and increase competition, resulting in savings for patients and improved access to medications.
2) The penalties and remedies outlined in the legislation will hold violators accountable and provide additional protections for consumers.
3) The changes to drug development and approval processes will ultimately benefit Medicare beneficiaries by providing more affordable options and increasing transparency.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 987 Referred in Senate (RFS)]
<DOC>
116th CONGRESS
1st Session
H. R. 987
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 20, 2019
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To amend the Patient Protection and Affordable Care Act to provide for
Federal Exchange outreach and educational activities.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Strengthening Health Care and
Lowering Prescription Drug Costs Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--LOWERING PRESCRIPTION DRUG COSTS
Subtitle A--Bringing Low-Cost Options and Competition While Keeping
Incentives for New Generics
Sec. 101. Change conditions of first generic exclusivity to spur access
and competition.
Subtitle B--Protecting Consumer Access to Generic Drugs
Sec. 111. Unlawful agreements.
Sec. 112. Notice and certification of agreements.
Sec. 113. Forfeiture of 180-day exclusivity period.
Sec. 114. Commission litigation authority.
Sec. 115. Statute of limitations.
Subtitle C--Creating and Restoring Equal Access to Equivalent Samples
Sec. 121. Actions for delays of generic drugs and biosimilar biological
products.
Sec. 122. REMS approval process for subsequent filers.
Sec. 123. Rule of construction.
Subtitle D--Study on Role of Federal Assistance in Drug Development
Sec. 131. Study on role of Federal assistance in drug development.
Subtitle E--Pharmacy School Outreach
Sec. 141. Pharmacy school outreach.
Subtitle F--Reports
Sec. 151. Effects of increases in prescription drug price.
TITLE II--HEALTH INSURANCE MARKET STABILIZATION
Sec. 201. Preserving State option to implement health care
marketplaces.
Sec. 202. Providing for additional requirements with respect to the
navigator program.
Sec. 203. Federal Exchange outreach and educational activities and
annual enrollment targets.
Sec. 204. Short-term limited duration insurance rule prohibition.
Sec. 205. Protection of health insurance coverage in certain Exchanges.
Sec. 206. Sense of Congress relating to the practice of silver loading.
Sec. 207. Consumer outreach, education, and assistance.
Sec. 208. GAO report.
Sec. 209. Report on the effects of website maintenance during open
enrollment.
TITLE III--BUDGETARY EFFECTS
Sec. 301. Determination of budgetary effects.
TITLE I--LOWERING PRESCRIPTION DRUG COSTS
Subtitle A--Bringing Low-Cost Options and Competition While Keeping
Incentives for New Generics
SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLUSIVITY TO SPUR ACCESS
AND COMPETITION.
Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
(1) in subclause (I), by striking ``180 days after'' and
all that follows through the period at the end and inserting
the following: ``180 days after the earlier of--
``(aa) the date of the first
commercial marketing of the drug
(including the commercial marketing of
the listed drug) by any first
applicant; or
``(bb) the applicable date
specified in subclause (III).''; and
(2) by adding at the end the following new subclause:
``(III) Applicable date.--The applicable
date specified in this subclause, with respect
to an application for a drug described in
subclause (I), is the date on which each of the
following conditions is first met:
``(aa) The approval of such an
application could be made effective,
but for the eligibility of a first
applicant for 180-day exclusivity under
this clause.
``(bb) At least 30 months have
passed since the date of submission of
an application for the drug by at least
one first applicant.
``(cc) Approval of an application
for the drug submitted by at least one
first applicant is not precluded under
clause (iii).
``(dd) No application for the drug
submitted by any first applicant is
approved at the time the conditions
under items (aa), (bb), and (cc) are
all met, regardless of whether such an
application is subsequently
approved.''.
Subtitle B--Protecting Consumer Access to Generic Drugs
SEC. 111. UNLAWFUL AGREEMENTS.
(a) Agreements Prohibited.--Subject to subsections (b) and (c), it
shall be unlawful for an NDA or BLA holder and a subsequent filer (or
for two subsequent filers) to enter into, or carry out, an agreement
resolving or settling a covered patent infringement claim on a final or
interim basis if under such agreement--
(1) a subsequent filer directly or indirectly receives from
such holder (or in the case of such an agreement between two
subsequent filers, the other subsequent filer) anything of
value, including a license; and
(2) the subsequent filer agrees to limit or forego research
on, or development, manufacturing, marketing, or sales, for any
period of time, of the covered product that is the subject of
the application described in subparagraph (A) or (B) of
subsection (g)(8).
(b) Exclusion.--It shall not be unlawful under subsection (a) if a
party to an agreement described in such subsection demonstrates by
clear and convincing evidence that the value described in subsection
(a)(1) is compensation solely for other goods or services that the
subsequent filer has promised to provide.
(c) Limitation.--Nothing in this section shall prohibit an
agreement resolving or settling a covered patent infringement claim in
which the consideration granted by the NDA or BLA holder to the
subsequent filer (or from one subsequent filer to another) as part of
the resolution or settlement includes only one or more of the
following:
(1) The right to market the covered product that is the
subject of the application described in subparagraph (A) or (B)
of subsection (g)(8) in the United States before the expiration
of--
(A) any patent that is the basis of the covered
patent infringement claim; or
(B) any patent right or other statutory exclusivity
that would prevent the marketing of such covered
product.
(2) A payment for reasonable litigation expenses not to
exceed $7.5 million in the aggregate.
(3) A covenant not to sue on any claim that such covered
product infringes a patent.
(d) Enforcement by Federal Trade Commission.--
(1) General application.--The requirements of this section
apply, according to their terms, to an NDA or BLA holder or
subsequent filer that is--
(A) a person, partnership, or corporation over
which the Commission has authority pursuant to section
5(a)(2) of the Federal Trade Commission Act (15 U.S.C.
45(a)(2)); or
(B) a person, partnership, or corporation over
which the Commission would have authority pursuant to
such section but for the fact that such person,
partnership, or corporation is not organized to carry
on business for its own profit or that of its members.
(2) Unfair or deceptive acts or practices enforcement
authority.--
(A) In general.--A violation of this section shall
be treated as an unfair or deceptive act or practice in
violation of section 5(a)(1) of the Federal Trade
Commission Act (15 U.S.C. 45(a)(1)).
(B) Powers of commission.--Except as provided in
subparagraph (C) and paragraphs (1)(B) and (3)--
(i) the Commission shall enforce this
section in the same manner, by the same means,
and with the same jurisdiction, powers, and
duties as though all applicable terms and
provisions of the Federal Trade Commission Act
(15 U.S.C. 41 et seq.) were incorporated into
and made a part of this section; and
(ii) any NDA or BLA holder or subsequent
filer that violates this section shall be
subject to the penalties and entitled to the
privileges and immunities provided in the
Federal Trade Commission Act.
(C) Judicial review.--In the case of a cease and
desist order issued by the Commission under section 5
of the Federal Trade Commission Act (15 U.S.C. 45) for
violation of this section, a party to such order may
obtain judicial review of such order as provided in
such section 5, except that--
(i) such review may only be obtained in--
(I) the United States Court of
Appeals for the District of Columbia
Circuit;
(II) the United States Court of
Appeals for the circuit in which the
ultimate parent entity, as defined in
section 801.1(a)(3) of title 16, Code
of Federal Regulations, or any
successor thereto, of the NDA or BLA
holder (if any such holder is a party
to such order) is incorporated as of
the date that the application described
in subparagraph (A) or (B) of
subsection (g)(8) or an approved
application that is deemed to be a
license for a biological product under
section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)) pursuant
to section 7002(e)(4) of the Biologics
Price Competition and Innovation Act of
2009 (Public Law 111-148; 124 Stat.
817) is submitted to the Commissioner
of Food and Drugs; or
(III) the United States Court of
Appeals for the circuit in which the
ultimate parent entity, as so defined,
of any subsequent filer that is a party
to such order is incorporated as of the
date that the application described in
subparagraph (A) or (B) of subsection
(g)(8) is submitted to the Commissioner
of Food and Drugs; and
(ii) the petition for review shall be filed
in the court not later than 30 days after such
order is served on the party seeking review.
(3) Additional enforcement authority.--
(A) Civil penalty.--The Commission may commence a
civil action to recover a civil penalty in a district
court of the United States against any NDA or BLA
holder or subsequent filer that violates this section.
(B) Special rule for recovery of penalty if cease
and desist order issued.--
(i) In general.--If the Commission has
issued a cease and desist order in a proceeding
under section 5 of the Federal Trade Commission
Act (15 U.S.C. 45) for violation of this
section--
(I) the Commission may commence a
civil action under subparagraph (A) to
recover a civil penalty against any
party to such order at any time before
the expiration of the 1-year period
beginning on the date on which such
order becomes final under section 5(g)
of such Act (15 U.S.C. 45(g)); and
(II) in such civil action, the
findings of the Commission as to the
material facts in such proceeding shall
be conclusive, unless--
(aa) the terms of such
order expressly provide that
the Commission's findings shall
not be conclusive; or
(bb) such order became
final by reason of section
5(g)(1) of such Act (15 U.S.C.
45(g)(1)), in which case such
findings shall be conclusive if
supported by evidence.
(ii) Relationship to penalty for violation
of an order.--The penalty provided in clause
(i) for violation of this section is separate
from and in addition to any penalty that may be
incurred for violation of an order of the
Commission under section 5(l) of the Federal
Trade Commission Act (15 U.S.C. 45(l)).
(C) Amount of penalty.--
(i) In general.--The amount of a civil
penalty imposed in a civil action under
subparagraph (A) on a party to an agreement
described in subsection (a) shall be sufficient
to deter violations of this section, but in no
event greater than--
(I) if such party is the NDA or BLA
holder (or, in the case of an agreement
between two subsequent filers, the
subsequent filer who gave the value
described in subsection (a)(1)), the
greater of--
(aa) three times the value
received by such NDA or BLA
holder (or by such subsequent
filer) that is reasonably
attributable to the violation
of this section; or
(bb) three times the value
given to the subsequent filer
(or to the other subsequent
filer) reasonably attributable
to the violation of this
section; and
(II) if such party is the
subsequent filer (or, in the case of an
agreement between two subsequent
filers, the subsequent filer who
received the value described in
subsection (a)(1)), 3 times the value
received by such subsequent filer that
is reasonably attributable to the
violation of this section.
(ii) Factors for consideration.--In
determining such amount, the court shall take
into account--
(I) the nature, circumstances,
extent, and gravity of the violation;
(II) with respect to the violator,
the degree of culpability, any history
of violations, the ability to pay, any
effect on the ability to continue doing
business, profits earned by the NDA or
BLA holder (or, in the case of an
agreement between two subsequent
filers, the subsequent filer who gave
the value described in subsection
(a)(1)), compensation received by the
subsequent filer (or, in the case of an
agreement between two subsequent
filers, the subsequent filer who
received the value described in
subsection (a)(1)), and the amount of
commerce affected; and
(III) other matters that justice
requires.
(D) Injunctions and other equitable relief.--In a
civil action under subparagraph (A), the United States
district courts are empowered to grant mandatory
injunctions and such other and further equitable relief
as they deem appropriate.
(4) Remedies in addition.--Remedies provided in this
subsection are in addition to, and not in lieu of, any other
remedy provided by Federal law.
(5) Preservation of authority of commission.--Nothing in
this section shall be construed to affect any authority of the
Commission under any other provision of law.
(e) Federal Trade Commission Rulemaking.--The Commission may, in
its discretion, by rule promulgated under section 553 of title 5,
United States Code, exempt from this section certain agreements
described in subsection (a) if the Commission finds such agreements to
be in furtherance of market competition and for the benefit of
consumers.
(f) Antitrust Laws.--Nothing in this section shall modify, impair,
limit, or supersede the applicability of the antitrust laws as defined
in subsection (a) of the first section of the Clayton Act (15 U.S.C.
12(a)), and of section 5 of the Federal Trade Commission Act (15 U.S.C.
45) to the extent that such section 5 applies to unfair methods of
competition. Nothing in this section shall modify, impair, limit, or
supersede the right of a subsequent filer to assert claims or
counterclaims against any person, under the antitrust laws or other
laws relating to unfair competition.
(g) Definitions.--In this section:
(1) Agreement resolving or settling a covered patent
infringement claim.--The term ``agreement resolving or settling
a covered patent infringement claim'' means any agreement
that--
(A) resolves or settles a covered patent
infringement claim; or
(B) is contingent upon, provides for a contingent
condition for, or is otherwise related to the
resolution or settlement of a covered patent
infringement claim.
(2) Commission.--The term ``Commission'' means the Federal
Trade Commission.
(3) Covered patent infringement claim.--The term ``covered
patent infringement claim'' means an allegation made by the NDA
or BLA holder to a subsequent filer (or, in the case of an
agreement between two subsequent filers, by one subsequent
filer to another), whether or not included in a complaint filed
with a court of law, that--
(A) the submission of the application described in
subparagraph (A) or (B) of paragraph (9), or the
manufacture, use, offering for sale, sale, or
importation into the United States of a covered product
that is the subject of such an application--
(i) in the case of an agreement between an
NDA or BLA holder and a subsequent filer,
infringes any patent owned by, or exclusively
licensed to, the NDA or BLA holder of the
covered product; or
(ii) in the case of an agreement between
two subsequent filers, infringes any patent
owned by the subsequent filer; or
(B) in the case of an agreement between an NDA or
BLA holder and a subsequent filer, the covered product
to be manufactured under such application uses a
covered product as claimed in a published patent
application.
(4) Covered product.--The term ``covered product'' means a
drug (as defined in section 201(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(g))), including a biological
product (as defined in section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i)).
(5) NDA or bla holder.--The term ``NDA or BLA holder''
means--
(A) the holder of--
(i) an approved new drug application filed
under section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))
for a covered product; or
(ii) a biologics license application filed
under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) with respect to
a biological product;
(B) a person owning or controlling enforcement of
the patent on--
(i) the list published under section
505(j)(7) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(7)) in
connection with the application described in
subparagraph (A)(i); or
(ii) any list published under section 351
of the Public Health Service Act (42 U.S.C.
262) comprised of patents associated with
biologics license applications filed under
section 351(a) of such Act (42 U.S.C. 262(a));
or
(C) the predecessors, subsidiaries, divisions,
groups, and affiliates controlled by, controlling, or
under common control with any entity described in
subparagraph (A) or (B) (such control to be presumed by
direct or indirect share ownership of 50 percent or
greater), as well as the licensees, licensors,
successors, and assigns of each of the entities.
(6) Patent.--The term ``patent'' means a patent issued by
the United States Patent and Trademark Office.
(7) Statutory exclusivity.--The term ``statutory
exclusivity'' means those prohibitions on the submission or
approval of drug applications under clauses (ii) through (iv)
of section 505(c)(3)(E) (5- and 3-year exclusivity), clauses
(ii) through (iv) of section 505(j)(5)(F) (5-year and 3-year
exclusivity), section 505(j)(5)(B)(iv) (180-day exclusivity),
section 527 (orphan drug exclusivity), section 505A (pediatric
exclusivity), or section 505E (qualified infectious disease
product exclusivity) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F),
360cc, 355a, 355f), or prohibitions on the submission or
licensing of biologics license applications under section
351(k)(6) (interchangeable biological product exclusivity) or
section 351(k)(7) (biological product reference product
exclusivity) of the Public Health Service Act (42 U.S.C.
262(k)(6), (7)).
(8) Subsequent filer.--The term ``subsequent filer''
means--
(A) in the case of a drug, a party that owns or
controls an abbreviated new drug application submitted
pursuant to section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) or a new drug
application submitted pursuant to section 505(b)(2) of
the Federal Food, Drug, and Cosmetic Act (21U.S.C.
355(b)(2)) and filed under section 505(b)(1) of such
Act (21 U.S.C. 355(b)(1)) or has the exclusive rights
to distribute the covered product that is the subject
of such application; or
(B) in the case of a biological product, a party
that owns or controls an application filed with the
Food and Drug Administration under section 351(k) of
the Public Health Service Act (42 U.S.C. 262(k)) or has
the exclusive rights to distribute the biological
product that is the subject of such application.
(h) Effective Date.--This section applies with respect to
agreements described in subsection (a) entered into on or after the
date of the enactment of this Act.
SEC. 112. NOTICE AND CERTIFICATION OF AGREEMENTS.
(a) Notice of All Agreements.--Section 1111(7) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (21
U.S.C. 355 note) is amended by inserting ``or the owner of a patent for
which a claim of infringement could reasonably be asserted against any
person for making, using, offering to sell, selling, or importing into
the United States a biological product that is the subject of a
biosimilar biological product application'' before the period at the
end.
(b) Certification of Agreements.--Section 1112 of such Act (21
U.S.C. 355 note) is amended by adding at the end the following:
``(d) Certification.--The Chief Executive Officer or the company
official responsible for negotiating any agreement under subsection (a)
or (b) that is required to be filed under subsection (c) shall, within
30 days of such filing, execute and file with the Assistant Attorney
General and the Commission a certification as follows: `I declare that
the following is true, correct, and complete to the best of my
knowledge: The materials filed with the Federal Trade Commission and
the Department of Justice under section 1112 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, with
respect to the agreement referenced in this certification--
```(1) represent the complete, final, and exclusive
agreement between the parties;
```(2) include any ancillary agreements that are contingent
upon, provide a contingent condition for, were entered into
within 30 days of, or are otherwise related to, the referenced
agreement; and
```(3) include written descriptions of any oral agreements,
representations, commitments, or promises between the parties
that are responsive to subsection (a) or (b) of such section
1112 and have not been reduced to writing.'.''.
SEC. 113. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.
Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting ``section
111 of the Strengthening Health Care and Lowering Prescription Drug
Costs Act or'' after ``that the agreement has violated''.
SEC. 114. COMMISSION LITIGATION AUTHORITY.
Section 16(a)(2) of the Federal Trade Commission Act (15 U.S.C.
56(a)(2)) is amended--
(1) in subparagraph (D), by striking ``or'' after the
semicolon;
(2) in subparagraph (E), by inserting ``or'' after the
semicolon; and
(3) by inserting after subparagraph (E) the following:
``(F) under section 111(d)(3)(A) of the
Strengthening Health Care and Lowering Prescription
Drug Costs Act;''.
SEC. 115. STATUTE OF LIMITATIONS.
(a) In General.--Except as provided in subsection (b), the
Commission shall commence any administrative proceeding or civil action
to enforce section 111 of this Act not later than 6 years after the
date on which the parties to the agreement file the Notice of Agreement
as provided by section 1112(c)(2) and (d) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note).
(b) Civil Action After Issuance of Cease and Desist Order.--If the
Commission has issued a cease and desist order under section 5 of the
Federal Trade Commission Act (15 U.S.C. 45) for violation of section
111 of this Act and the proceeding for the issuance of such order was
commenced within the period required by subsection (a) of this section,
such subsection does not prohibit the commencement, after such period,
of a civil action under section 111(d)(3)(A) against a party to such
order or a civil action under subsection (l) of such section 5 for
violation of such order.
Subtitle C--Creating and Restoring Equal Access to Equivalent Samples
SEC. 121. 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 121(a) of the
Strengthening Health Care and Lowering Prescription Drug 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.
SEC. 122. 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 section 121, 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.''.
SEC. 123. RULE OF CONSTRUCTION.
(a) In General.--Nothing in this subtitle, the amendments made by
this subtitle, 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 subtitle; 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.
(b) Definitions.--In this section, the terms ``covered product'',
``eligible product developer'', ``license holder'', and ``REMS with
ETASU'' have the meanings given such terms in section 121(a).
Subtitle D--Study on Role of Federal Assistance in Drug Development
SEC. 131. STUDY ON ROLE OF FEDERAL ASSISTANCE IN DRUG DEVELOPMENT.
(a) In General.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of the Health and Human Services
shall enter into a contract with the National Academy of Medicine to
conduct a study on, and submit to Congress a report on, the following:
(1) The percentage of drugs developed in the United States
using at least some amount of Federal funding from any Federal
source.
(2) The average cost incurred by a drug developer to
develop a drug.
(3) The average amount of revenue and profits made by drug
developers from the sales of drugs.
(4) The percentage of such revenue and profits that are
reinvested into research and development of new drugs.
(5) The appropriate percentage, if any, of such revenue and
profits the Secretary, in consultation with the National
Academy of Medicine, recommends should be returned to Federal
entities for Federal funding used in the development of the
drugs involved.
(b) Enforcement.--A drug developer shall, as a condition of receipt
of any Federal funding for the development of drugs, comply with any
request for the data necessary to perform the study under subsection
(a).
(c) Confidentiality.--This section does not authorize the
disclosure of any trade secret, confidential commercial or financial
information, or other matter listed in section 552(b) of title 5,
United States Code.
(d) Definitions.--In this section:
(1) The term ``drug'' has the meaning given such term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(2) The term ``drug developer'' means an entity that
submitted, and received 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).
Subtitle E--Pharmacy School Outreach
SEC. 141. PHARMACY SCHOOL OUTREACH.
The Secretary of Health and Human Services and the Secretary of
Education shall make every effort necessary to ensure appropriate
outreach to institutions of higher education to ensure that students
and faculty at schools of pharmacy are provided with materials
regarding generic drugs and biosimilar biological products, including
materials on--
(1) how generic drugs and biosimilar biological products
are equivalent or similar to brand-name drugs;
(2) the approval process at the Food and Drug
Administration for generic drugs and biosimilar biological
products;
(3) how to make consumers aware of the availability of
generic drugs and biosimilar biological products;
(4) requirements for substituting generic drugs and
biosimliar biological products in place of corresponding drugs
products; and
(5) the impacts of generic drugs and biosimilar biological
products on consumer costs.
Subtitle F--Reports
SEC. 151. EFFECTS OF INCREASES IN PRESCRIPTION DRUG PRICE.
Not later than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services shall submit a report to the
Congress on the extent to which increases in prescription drug prices
may have caused Medicare beneficiaries to forego recommended treatment,
including failing to fill prescriptions.
TITLE II--HEALTH INSURANCE MARKET STABILIZATION
SEC. 201. PRESERVING STATE OPTION TO IMPLEMENT HEALTH CARE
MARKETPLACES.
(a) In General.--Section 1311 of the Patient Protection and
Affordable Care Act (42 U.S.C. 18031) is amended--
(1) in subsection (a)--
(A) in paragraph (4)(B), by striking ``under this
subsection'' and inserting ``under this paragraph or
paragraph (1)''; and
(B) by adding at the end the following new
paragraph:
``(6) Additional planning and establishment grants.--
``(A) In general.--There shall be appropriated to
the Secretary, out of any moneys in the Treasury not
otherwise appropriated, $200 million to award grants to
eligible States for the uses described in paragraph
(3).
``(B) Duration and renewability.--A grant awarded
under subparagraph (A) shall be for a period of 2 years
and may not be renewed.
``(C) Limitation.--A grant may not be awarded under
subparagraph (A) after December 31, 2023.
``(D) Eligible state defined.--For purposes of this
paragraph, the term `eligible State' means a State
that, as of the date of the enactment of this
paragraph, is not operating an Exchange (other than an
Exchange described in section 155.200(f) of title 45,
Code of Federal Regulations).''; and
(2) in subsection (d)(5)(A)--
(A) by striking ``operations.--In establishing an
Exchange under this section'' and inserting
``operations.--
``(i) In general.--In establishing an
Exchange under this section (other than in
establishing an Exchange pursuant to a grant
awarded under subsection (a)(6))''; and
(B) by adding at the end the following:
``(ii) Additional planning and
establishment grants.--In establishing an
Exchange pursuant to a grant awarded under
subsection (a)(6), the State shall ensure that
such Exchange is self-sustaining beginning on
January 1, 2025, including allowing the
Exchange to charge assessments or user fees to
participating health insurance issuers, or to
otherwise generate funding, to support its
operations.''.
(b) Clarification Regarding Failure to Establish Exchange or
Implement Requirements.--Section 1321(c) of the Patient Protection and
Affordable Care Act (42 U.S.C. 18041(c)) is amended--
(1) in paragraph (1), by striking ``If'' and inserting
``Subject to paragraph (3), if''; and
(2) by adding at the end the following new paragraph:
``(3) Clarification.--This subsection shall not apply in
the case of a State that elects to apply the requirements
described in subsection (a) and satisfies the requirement
described in subsection (b) on or after January 1, 2014.''.
SEC. 202. PROVIDING FOR ADDITIONAL REQUIREMENTS WITH RESPECT TO THE
NAVIGATOR PROGRAM.
(a) In General.--Section 1311(i) of the Patient Protection and
Affordable Care Act (42 U.S.C. 18031(i)) is amended--
(1) in paragraph (2), by adding at the end the following
new subparagraph:
``(C) Selection of recipients.--In the case of an
Exchange established and operated by the Secretary
within a State pursuant to section 1321(c), in awarding
grants under paragraph (1), the Exchange shall--
``(i) select entities to receive such
grants based on an entity's demonstrated
capacity to carry out each of the duties
specified in paragraph (3);
``(ii) not take into account whether or not
the entity has demonstrated how the entity will
provide information to individuals relating to
group health plans offered by a group or
association of employers described in section
2510.3-5(b) of title 29, Code of Federal
Regulations (or any successor regulation), or
short-term limited duration insurance (as
defined by the Secretary for purposes of
section 2791(b)(5) of the Public Health Service
Act); and
``(iii) ensure that, each year, the
Exchange awards such a grant to--
``(I) at least one entity described
in this paragraph that is a community
and consumer-focused nonprofit group;
and
``(II) at least one entity
described in subparagraph (B), which
may include another community and
consumer-focused nonprofit group in
addition to any such group awarded a
grant pursuant to subclause (I).
In awarding such grants, an Exchange may consider an
entity's record with respect to waste, fraud, and abuse
for purposes of maintaining the integrity of such
Exchange.''.
(2) in paragraph (3)--
(A) by amending subparagraph (C) to read as
follows:
``(C) facilitate enrollment, including with respect
to individuals with limited English proficiency and
individuals with chronic illnesses, in qualified health
plans, State medicaid plans under title XIX of the
Social Security Act, and State child health plans under
title XXI of such Act;'';
(B) in subparagraph (D), by striking ``and'' at the
end;
(C) in subparagraph (E), by striking the period at
the end and inserting a semicolon;
(D) by inserting after subparagraph (E) the
following:
``(F) conduct public education activities in plain
language to raise awareness of the requirements of and
the protections provided under--
``(i) the essential health benefits package
(as defined in section 1302(a)); and
``(ii) section 2726 of the Public Health
Service Act (relating to parity in mental
health and substance use disorder benefits);
and'';
(E) by inserting after subparagraph (F) (as added
by subparagraph (D)) the following new subparagraph:
``(G) provide referrals to community-based
organizations that address social needs related to
health outcomes.''; and
(F) by adding at the end the following flush left
sentence:
``The duties specified in the preceding sentences may be
carried out by such a navigator at any time during a year.'';
(3) in paragraph (4)(A)--
(A) in the matter preceding clause (i), by striking
``not'';
(B) in clause (i)--
(i) by inserting ``not'' before ``be''; and
(ii) by striking ``; or'' and inserting a
semicolon;
(C) in clause (ii)--
(i) by inserting ``not'' before
``receive''; and
(ii) by striking the period and inserting a
semicolon; and
(D) by adding at the end the following new clauses:
``(iii) maintain physical presence in the
State of the Exchange so as to allow in-person
assistance to consumers;
``(iv) receive training on how to assist
individuals with enrolling for medical
assistance under State plans under the Medicaid
program under title XIX of the Social Security
Act or for child health assistance under State
child health plans under title XXI of such Act;
and
``(v) receive opioid specific education and
training that ensures the navigator can best
educate individuals on qualified health plans
offered through an Exchange, specifically
coverage under such plans for opioid health
care treatment.''; and
(4) in paragraph (6)--
(A) by striking ``Funding.--Grants under'' and
inserting ``Funding.--
``(A) State exchanges.--Subject to subparagraph
(C), grants under''; and
(B) by adding at the end the following new
subparagraphs:
``(B) Federal exchanges.--For purposes of carrying
out this subsection, with respect to an Exchange
established and operated by the Secretary within a
State pursuant to section 1321(c), the Secretary shall
obligate $100 million out of amounts collected through
the user fees on participating health insurance issuers
pursuant to section 156.50 of title 45, Code of Federal
Regulations (or any successor regulations) for fiscal
year 2020 and each subsequent fiscal year. Such amount
for a fiscal year shall remain available until
expended.
``(C) State exchanges.--For the purposes of
carrying out this subsection, with respect to an
Exchange operated by a State pursuant to this section,
there is authorized to be appropriated $25 million for
fiscal year 2020 and each subsequent fiscal year. Each
State receiving a grant pursuant to this subparagraph
shall receive a grant in an amount that is not less
than $1 million.''.
(b) Study on Effects of Funding Cuts.--Not later than 1 year after
the date of the enactment of this Act, the Comptroller General of the
United States shall study the effects of funding cuts made for plan
year 2019 with respect to the navigator program (as described in
section 1311(i) of the Patient Protection and Affordable Care Act (42
U.S.C. 18031(i))) and other education and outreach activities carried
out with respect to Exchanges established by the Secretary of Health
and Human Services pursuant to section 1321(c) of such Act. Such study
shall describe the following:
(1) How such funding cuts negatively impacted the ability
of entities under such program to conduct outreach activities
and fulfill duties required under such section 1311(i).
(2) The overall effect on--
(A) the number of individuals enrolled in health
insurance coverage offered in the individual market for
plan year 2019; and
(B) the costs of health insurance coverage offered
in the individual market.
(c) Promote Transparency and Accountability in the Administration's
Expenditures of Exchange User Fees.--For plan year 2020 and each
subsequent plan year, not later than the date that is 3 months after
the end of such plan year, the Secretary of Health and Human Services
shall submit to the appropriate committees of Congress and make
available to the public an annual report on the expenditures by the
Department of Health and Human Services of user fees collected pursuant
to section 156.50 of title 45, Code of Federal Regulations (or any
successor regulations). Each such report for a plan year shall include
a detailed accounting of the amount of such user fees collected during
such plan year and of the amount of such expenditures used during such
plan year for the federally facilitated Exchange operated pursuant to
section 1321(c) of the Patient Protection and Affordable Care Act (42
U.S.C. 18041(c)) on outreach and enrollment activities, navigators,
maintenance of Healthcare.gov, and operation of call centers.
(d) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning on or after January 1, 2020.
SEC. 203. FEDERAL EXCHANGE OUTREACH AND EDUCATIONAL ACTIVITIES AND
ANNUAL ENROLLMENT TARGETS.
(a) In General.--Section 1321(c) of the Patient Protection and
Affordable Care Act (42 U.S.C. 18041(c)), as amended by section
201(b)(2), is further amended by adding at the end the following new
paragraphs:
``(4) Outreach and educational activities.--
``(A) In general.--In the case of an Exchange
established or operated by the Secretary within a State
pursuant to this subsection, the Secretary shall carry
out outreach and educational activities for purposes of
informing individuals about qualified health plans
offered through the Exchange, including by informing
such individuals of the availability of coverage under
such plans and financial assistance for coverage under
such plans. Such outreach and educational activities
shall be provided in a manner that is culturally and
linguistically appropriate to the needs of the
populations being served by the Exchange (including
hard-to-reach populations, such as racial and sexual
minorities, limited English proficient populations,
individuals residing in areas where the unemployment
rates exceeds the national average unemployment rate,
individuals in rural areas, veterans, and young adults)
and shall be provided to populations residing in high
health disparity areas (as defined in subparagraph (E))
served by the Exchange, in addition to other
populations served by the Exchange.
``(B) Limitation on use of funds.--No funds
appropriated under this paragraph shall be used for
expenditures for promoting non-ACA compliant health
insurance coverage.
``(C) Non-aca compliant health insurance
coverage.--For purposes of subparagraph (B):
``(i) The term `non-ACA compliant health
insurance coverage' means health insurance
coverage, or a group health plan, that is not a
qualified health plan.
``(ii) Such term includes the following:
``(I) An association health plan.
``(II) Short-term limited duration
insurance.
``(D) Funding.--Out of any funds in the Treasury
not otherwise appropriated, there are hereby
appropriated for fiscal year 2020 and each subsequent
fiscal year, $100 million to carry out this paragraph.
Funds appropriated under this subparagraph shall remain
available until expended.
``(E) High health disparity area defined.--For
purposes of subparagraph (A), the term `high health
disparity area' means a contiguous geographic area
that--
``(i) is located in one census tract or ZIP
code;
``(ii) has measurable and documented
racial, ethnic, or geographic health
disparities;
``(iii) has a low-income population, as
demonstrated by--
``(I) average income below 138
percent of the Federal poverty line; or
``(II) a rate of participation in
the special supplemental nutrition
program under section 17 of the Child
Nutrition Act of 1966 (42 U.S.C. 1786)
that is higher than the national
average rate of participation in such
program;
``(iv) has poor health outcomes, as
demonstrated by--
``(I) lower life expectancy than
the national average; or
``(II) a higher percentage of
instances of low birth weight than the
national average; and
``(v) is part of a Metropolitan Statistical
Area identified by the Office of Management and
Budget.
``(5) Annual enrollment targets.--For plan year 2020 and
each subsequent plan year, in the case of an Exchange
established or operated by the Secretary within a State
pursuant to this subsection, the Secretary shall establish
annual enrollment targets for such Exchange for such year.''.
(b) Study and Report.--Not later than 30 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
release to Congress all aggregated documents relating to studies and
data sets that were created on or after January 1, 2014, and related to
marketing and outreach with respect to qualified health plans offered
through Exchanges under title I of the Patient Protection and
Affordable Care Act.
SEC. 204. SHORT-TERM LIMITED DURATION INSURANCE RULE PROHIBITION.
(a) Findings.--Congress finds the following:
(1) On August 3, 2018, the Administration issued a final
rule entitled ``Short-Term, Limited-Duration Insurance'' (83
Fed. Reg. 38212).
(2) The final rule dramatically expands the sale and
marketing of insurance that--
(A) may discriminate against individuals living
with preexisting health conditions, including children
with complex medical needs and disabilities and their
families;
(B) lacks important financial protections provided
by the Patient Protection and Affordable Care Act
(Public Law 111-148), including the prohibition of
annual and lifetime coverage limits and annual out-of-
pocket limits, that may increase the cost of treatment
and cause financial hardship to those requiring medical
care, including children with complex medical needs and
disabilities and their families; and
(C) excludes coverage of essential health benefits
including hospitalization, prescription drugs, and
other lifesaving care.
(3) The implementation and enforcement of the final rule
weakens critical protections for up to 130 million Americans
living with preexisting health conditions and may place a large
financial burden on those who enroll in short-term limited-
duration insurance, which jeopardizes Americans' access to
quality, affordable health insurance.
(b) Prohibition.--The Secretary of Health and Human Services, the
Secretary of the Treasury, and the Secretary of Labor may not take any
action to implement, enforce, or otherwise give effect to the rule
entitled ``Short-Term, Limited Duration Insurance'' (83 Fed. Reg. 38212
(August 3, 2018)), and the Secretaries may not promulgate any
substantially similar rule.
SEC. 205. PROTECTION OF HEALTH INSURANCE COVERAGE IN CERTAIN EXCHANGES.
In the case of an Exchange that the Secretary of Health and Human
Services operates pursuant to section 1321(c)(1) of the Patient
Protection and Affordable Care Act (42 U.S.C. 18041(c)(1)), the
Secretary may not implement any process that would terminate the health
insurance coverage of an enrollee solely because such enrollee did not
actively enroll during the most recent open enrollment period.
SEC. 206. SENSE OF CONGRESS RELATING TO THE PRACTICE OF SILVER LOADING.
It is the sense of Congress that the Secretary of Health and Human
Services should not take any action to prohibit or otherwise restrict
the practice commonly known as ``silver loading'' (as described in the
rule entitled ``Patient Protection and Affordable Care Act; HHS Notice
of Benefit and Payment Parameters for 2020'' published on April 25,
2019 (84 Fed. Reg. 17533)).
SEC. 207. CONSUMER OUTREACH, EDUCATION, AND ASSISTANCE.
(a) Open Enrollment Reports.--For plan year 2020 and each
subsequent year, the Secretary of Health and Human Services (referred
to in this section as the ``Secretary''), in coordination with the
Secretary of the Treasury and the Secretary of Labor, shall issue
biweekly public reports during the annual open enrollment period on the
performance of the Federal Exchange. Each such report shall include a
summary, including information on a State-by-State basis where
available, of--
(1) the number of unique website visits;
(2) the number of individuals who create an account;
(3) the number of calls to the call center;
(4) the average wait time for callers contacting the call
center;
(5) the number of individuals who enroll in a qualified
health plan; and
(6) the percentage of individuals who enroll in a qualified
health plan through each of--
(A) the website;
(B) the call center;
(C) navigators;
(D) agents and brokers;
(E) the enrollment assistant program;
(F) directly from issuers or web brokers; and
(G) other means.
(b) Open Enrollment After Action Report.--For plan year 2020 and
each subsequent year, the Secretary, in coordination with the Secretary
of the Treasury and the Secretary of Labor, shall publish an after
action report not later than 3 months after the completion of the
annual open enrollment period regarding the performance of the Federal
Exchange for the applicable plan year. Each such report shall include a
summary, including information on a State-by-State basis where
available, of--
(1) the open enrollment data reported under subsection (a)
for the entirety of the enrollment period; and
(2) activities related to patient navigators described in
section 1311(i) of the Patient Protection and Affordable Care
Act (42 U.S.C. 18031(i)), including--
(A) the performance objectives established by the
Secretary for such patient navigators;
(B) the number of consumers enrolled by such a
patient navigator;
(C) an assessment of how such patient navigators
have met established performance metrics, including a
detailed list of all patient navigators, funding
received by patient navigators, and whether established
performance objectives of patient navigators were met;
and
(D) with respect to the performance objectives
described in subparagraph (A)--
(i) whether such objectives assess the full
scope of patient navigator responsibilities,
including general education, plan selection,
and determination of eligibility for tax
credits, cost-sharing reductions, or other
coverage;
(ii) how the Secretary worked with patient
navigators to establish such objectives; and
(iii) how the Secretary adjusted such
objectives for case complexity and other
contextual factors.
(c) Report on Advertising and Consumer Outreach.--Not later than 3
months after the completion of the annual open enrollment period for
the 2020 plan year, the Secretary shall issue a report on advertising
and outreach to consumers for the open enrollment period for the 2020
plan year. Such report shall include a description of--
(1) the division of spending on individual advertising
platforms, including television and radio advertisements and
digital media, to raise consumer awareness of open enrollment;
(2) the division of spending on individual outreach
platforms, including email and text messages, to raise consumer
awareness of open enrollment; and
(3) whether the Secretary conducted targeted outreach to
specific demographic groups and geographic areas.
SEC. 208. GAO REPORT.
Not later than 1 year after the date of the enactment of this Act,
the Comptroller General of the United States shall submit to Congress a
study that analyzes the costs and benefits of the establishment of
State-administered health insurance plans to be offered in the
insurance market of such States that choose to administer and offer
such a plan.
SEC. 209. REPORT ON THE EFFECTS OF WEBSITE MAINTENANCE DURING OPEN
ENROLLMENT.
Not later than 1 year after the date of the enactment of this Act,
the Comptroller General of the United States shall submit to Congress a
report examining whether the Department of Health and Human Services
has been conducting maintenance on the website commonly referred to as
``Healthcare.gov'' during annual open enrollment periods (as described
in section 1311(c)(6)(B) of the Patient Protection and Affordable Care
Act (42 U.S.C. 18031(c)(6)(B)) in such a manner so as to minimize any
disruption to the use of such website resulting from such maintenance.
TITLE III--BUDGETARY EFFECTS
SEC. 301. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the Congressional
Record by the Chairman of the House Budget Committee, provided that
such statement has been submitted prior to the vote on passage.
Passed the House of Representatives May 16, 2019.
Attest:
CHERYL L. JOHNSON,
Clerk.