[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2408 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 2408
To amend title XVIII of the Social Security Act to update and clarify
the classification of and applicable payment methodology for complex
rehabilitation technology items under the Medicare program, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 30, 2019
Mr. Sensenbrenner (for himself and Mr. Higgins of New York) introduced
the following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Ways and Means, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to update and clarify
the classification of and applicable payment methodology for complex
rehabilitation technology items under the Medicare program, and for
other purposes.
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 ``Ensuring Access to Quality Complex
Rehabilitation Technology Act of 2019''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) There is a small and specific population of Medicare
beneficiaries who have significant disabilities and medical
conditions who require complex and individually configured
medical equipment, items, and technologies. These items and
technologies are referred to as complex rehabilitation
technology (or ``CRT'') and include specialized wheelchairs,
specialized seating and positioning, and other types of
adaptive equipment and items that are uniquely configured and
fitted to the specific individual. Individuals in this
population often qualify for Medicare based on their disability
(rather than their age) and have significant disabilities and
medical conditions that may include, but are not limited to,
cerebral palsy, muscular dystrophy, multiple sclerosis, spinal
cord injury, amyotrophic lateral sclerosis (ALS), traumatic
brain injury, and spina bifida. This small population comprises
less than 15 percent of the Medicare beneficiaries who receive
wheelchairs.
(2) Current provisions addressing Medicare benefit
categories and related definitions do not sufficiently define
certain complex rehabilitation technology items and do not
adequately describe and distinguish these items as compared to
other types of Medicare-covered medical items and equipment.
(3) This current lack of definitional clarity for complex
rehabilitation technology items results in access challenges
for beneficiaries with significant disabilities and medical
conditions, as these items are often grouped with standardized,
nonspecialized products that significantly differ with respect
to the complexity and the individualized configuration
involved, as well as certain evaluation requirements, clinical
coverage criteria, and other considerations.
(4) To provide adequate access for the small population of
Medicare beneficiaries with significant disabilities and
medical conditions who require these complex, specialized, and
individually configured items a distinct Medicare benefit
category for complex rehabilitative technology items is needed.
This will allow for related improvements to clarify applicable
coding, coverage, payment, and supplier standards for such
items. A separate benefit category is needed to ensure
appropriate access to these items for individuals with
significant disabilities and medical conditions, and will help
prevent potential overutilization of CRT by individuals for
whom such items are not medically necessary.
SEC. 3. ESTABLISHING SEPARATE BENEFIT CATEGORY FOR COMPLEX
REHABILITATION TECHNOLOGIES WITHIN MEDICARE.
Section 1861 of the Social Security Act (42 U.S.C. 1395x) is
amended--
(1) in subsection (s)(2)--
(A) in subparagraph (GG), by striking ``and'' at
the end;
(B) in subparagraph (HH), by inserting ``and'' at
the end; and
(C) by inserting after subparagraph (HH) the
following new paragraph:
``(II) complex rehabilitation technology items (as
defined in subsection (kkk));''; and
(2) by adding at the end, the following new subsections:
``(kkk) Complex Rehabilitation Technology Item.--
``(1) The terms `complex rehabilitation technology item'
and `CRT item' mean an item that--
``(A) is designed, manufactured, individually
configured, adjusted, or modified for a specific
individual to meet the individual's unique medical,
physical, or functional needs and capacities;
``(B) is primarily used to serve a medical,
physical, or functional purpose and is generally not
useful to a person in the absence of disability,
illness, injury, or other medical condition; and
``(C) requires certain services to ensure
appropriate use of such item, including one or more of
the following--
``(i) an evaluation of the features and
functions of CRT items to the specific
individual who will use such an item, as
required under section 1834(x)(2)(B)(ii)(II);
or
``(ii) configuring, fitting, programming,
adjusting, or adapting the particular complex
rehabilitation technology item for use by such
individual.
``(2)(A) CRT items shall include--
``(i) complex rehabilitation manual and power
wheelchairs, options, and accessories;
``(ii) specialized seating and positioning items,
options, and accessories;
``(iii) adaptive equipment such as standing frames
and gait trainers and options and accessories; and
``(iv) other items that meet the definition in
subparagraph (1), as determined by the Secretary.
``(B) In determining which items meet the definition of a
CRT item under this subsection, the Secretary shall review
existing and new technologies on at least a yearly basis, and
in a manner that takes into consideration technological
differences in available items and equipment, as well as the
varying clinical needs of individuals who rely on such items
and equipment.
``(3)(A) Not later than six months after the date of
enactment of this subsection, the Secretary shall publish a
list of HCPCS codes that meet the definition of CRT items under
this subsection. In considering and publishing the list of
codes that meet such definition, the Secretary must ensure that
the HCPCS code set provides adequate and appropriate access to
existing and new technologies that may improve medical,
physical, or functional outcomes for beneficiaries with
significant disabilities and medical conditions, taking into
consideration technological differences, clinical application,
and the unique medical, physical, and functional needs of
beneficiaries who rely on medically necessary CRT items.
``(B) In establishing the list under subparagraph (A), the
Secretary shall--
``(i) identify and include existing HCPCS codes
that are exclusively CRT items, including items that,
as of January 1, 2019, were classified within the
following HCPCS codes: E0637, E0638, E0641, E0642,
E0953, E0954, E0986, E1002, E1003, E1004, E1005, E1006,
E1007, E1008, E1009, E1010, E1011, E1012, E1014, E1037,
E1161, E1220, E1228, E1229, E1231, E1232, E1233, E1234,
E1235, E1236, E1237, E1238, E1239, E2209, E2291, E2292,
E2293, E2294, E2295, E2300, E2301, E2310, E2311, E2312,
E2313, E2321, E2322, E2323, E2324, E2325, E2326, E2327,
E2328, E2329, E2330, E2331, E2351, E2373, E2374, E2376,
E2377, E2609, E2610, E2617, E8000, E8001, E8002, K0005,
K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842,
K0843, K0848, K0849, K0850, K0851, K0852, K0853, K0854,
K0855, K0856, K0857, K0858, K0859, K0860, K0861, K0862,
K0863, K0864, K0868, K0869, K0870, K0871, K0877, K0878,
K0879, K0880, K0884, K0885, K0886, K0890, K0891, and
K0898;
``(ii) create and include in the list new HCPCS
codes and appropriate code descriptors for CRT items
that are currently considered to be included in
existing HCPCS codes that include both CRT and non-CRT
items, including CRT items that, as of January 1, 2019,
were classified within the following HCPCS codes:
E0143, E0950, E0951, E0952, E0955, E0956, E0957, E0960,
E0967, E0978, E0990, E0995, E1015, E1016, E1028, E1029,
E1030, E2205, E2208, E2231, E2368, E2369, E2370, E2605,
E2606, E2607, E2608, E2613, E2614, E2615, E2616, E2620,
E2621, E2622, E2623, E2624, E2625, K0004, K0009, K0040,
K0108, and K0669; and
``(iii) create new HCPCS codes for other
miscellaneous, otherwise not classified, or custom CRT
items.
``(C) For each year subsequent to the year during which the
Secretary publishes the list under subparagraph (A), the
Secretary shall publish any necessary updates to such list
(including additions of new CRT items and any changes in
applicable HCPCS codes and/or code descriptors) as needed to
ensure appropriate access to the full range of medically
necessary CRT items and technologies.''.
SEC. 4. PAYMENT RULES.
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is
amended by adding at the end the following:
``(x) Payment for CRT Items.--
``(1) General rule for payment.--
``(A) In general.--Not later than the date that is
one year after the date of the enactment of this
subsection, subject to subparagraph (B), the Secretary
shall establish a fee schedule that shall apply to CRT
items as defined at section 1861(kkk) and shall ensure
that such fee schedule considers the potential impact
on quality, access, and beneficiary liability,
including the likely effects on assignment rates and
participation rates, and facilitates appropriate access
to medically necessary CRT items and technologies.
``(B) Methodology.--In establishing the CRT fee
schedule payment system under subparagraph (A), the
Secretary shall include in such fee schedule, at a
minimum, the allowance of purchase of items identified
at section 1861(kkk)(3) and--
``(i) shall set the CRT fee schedule
payment amounts for CRT items identified by the
codes listed in section 1861(kkk)(3)(B)(i) at a
purchase price derived from payment amounts
from the January 1, 2015 Medicare fee schedule
plus annual Consumer Price Index-Urban All Item
updates for each subsequent year to such items,
as applicable, under this section;
``(ii) shall calculate the payment amounts
for CRT items identified by the codes created
pursuant to section 1861(kkk)(3)(B)(ii) in
accordance with the methodology described in
subparagraph (C);
``(iii) shall permit the payment amounts
for CRT items identified by codes for
miscellaneous, otherwise not classified, or
custom items, created pursuant to section
1861(kkk)(3)(B)(iii), to be calculated based on
the methodology described in subparagraph (C)
applied to the specific item billed under this
subsection; and
``(iv) shall require that payment amounts
for CRT items be adjusted annually by the
increase in the Consumer Price Index-Urban All
Item for the 12-month period ending the
preceding June 30th.
``(C) Payment amount calculation.--For purposes of
subparagraph (B)(ii), the methodology described in this
subparagraph for calculating payment amounts for CRT
items identified by the codes specified in such
subparagraph is as follows:
``(i) Identify commercial price information
(such as manufacturer suggested retail price
lists, but not mail order prices or internet
retail prices) for CRT items in the applicable
code in effect during the base year (which, for
purposes of this subparagraph is the calendar
year ending December 1986), except that if the
only available commercial price information is
from a period other than the base year, the
Secretary shall use the oldest available
pricing for the items and deflate the pricing
data to the mid-point of the base year using
the deflation factors used by the Centers for
Medicare & Medicaid Services for durable
medical equipment at the time of enactment of
this section.
``(ii) Using the base year prices, identify
the median price for all CRT items in the code.
``(iii) Increase the median price by 1.7
percent and inflate to the payment year using
the durable medical equipment fee schedule
update factors required by law through 2005 and
full consumer price index for all urban
consumers update factors starting in 2006 and
for each subsequent year, adjusted to reflect
applicable sales tax circumstances, if
applicable.
``(D) Used equipment.--For used equipment, the
Secretary shall set payment at 75 percent of the CRT
fee schedule amount for the CRT item as determined
pursuant to the methodology set forth in subparagraph
(B).
``(E) Payment for temporary rental.--
``(i) In general.--If a CRT item owned by a
qualified individual needs to be repaired,
payment may be made under this subsection for
the temporary rental of a CRT item while the
CRT item owned by such individual is being
repaired.
``(ii) Basis; limitation.--Payment
permitted under clause (i) shall be made on a
monthly basis, and the period of rental may not
exceed one month.
``(iii) Payment amount.--The amount of
payment allowed under clause (i) for a month
for the rental of a CRT item shall be 10
percent of the purchase price for the CRT item.
``(F) Replacement of items.--
``(i) Establishment of reasonable useful
lifetime.--In accordance with clause (ii), not
later than two years of the date of enactment
of this subsection, the Secretary shall
determine and establish, through a rulemaking
process involving advance public notice and an
opportunity for stakeholder input and public
comments, a reasonable useful lifetime for CRT
items for which payment may be made under this
paragraph.
``(ii) Length of reasonable useful
lifetime.--The reasonable useful lifetime of
items of CRT items under this subsection shall
be established based on the intended use and
continued efficacy, but shall not in any event
exceed five years for any CRT item. The
Secretary shall ensure that the length of
reasonable useful lifetime is appropriate for
each sub-category of items within the CRT
category.
``(G) Exclusive payment rule.--This subsection
shall constitute the exclusive provision under this
title for payment for CRT items under this part.
``(2) Conditions for payment.--
``(A) Limitation on payment.--No payment shall be
made under this subsection for a CRT item unless such
CRT item--
``(i) meets the clinical conditions for
payment set forth under subparagraph (B); and
``(ii) is furnished by a supplier
accredited pursuant to subparagraph (D) and
meets the supplier and quality standards
specified under subparagraph (C).
``(B) Clinical conditions for payment.--
``(i) In general.--The Secretary shall
establish standards for clinical conditions for
payment for CRT items under this subsection.
``(ii) Requirements.--The standards
established under clause (B)(i) shall require
the following:
``(I) Written order.--A qualified
ordering practitioner, as defined in
section 1861(mmm) of the Act, shall
provide a written order for a CRT item
for a specific individual before the
Secretary may provide payment for such
item for such individual under this
subsection.
``(II) CRT evaluation.--In the case
of a CRT item that is categorized by
the Secretary, for purposes of the
program under this title, as a manual
wheelchair or a power wheelchair, the
qualified ordering practitioner may not
provide a written order under subclause
(I) unless the individual has undergone
a CRT evaluation conducted by a
licensed physical therapist or
occupational therapist who has no
financial relationship with the CRT
supplier. The performance of such a CRT
evaluation by a licensed physical or
occupational therapist shall not be
subject (or counted towards) the
limitation on certain therapy services
under section 1833(g).
``(III) Documentation of medical
necessity.--A qualified ordering
practitioner who provides a written
order under subclause (I) shall
maintain documentation of the medical
necessity of such order for a period of
seven years and shall make such
documentation available to the
Secretary upon request. The
documentation of medical necessity
under this clause shall include
evidence that the individual for whom
the order was written has medical,
physical, and/or functional needs and
capacities that require the use of the
prescribed CRT item.
``(IV) Coverage.--In developing the
standards under subparagraph (B), the
coverage of CRT items shall be based on
the individual's specific medical,
physical, or functional needs and
capacities for basic and instrumental
activities of daily living in any
setting in which life activities take
place. For purposes of this subclause,
basic and instrumental activities of
daily living include, but are not
limited to, moving from place to place;
transferring; maintaining or changing
body position; caring for one's self
(such as toileting, bathing, dressing,
eating, housekeeping and household
management); acquiring necessities,
goods and services; engaging in
education, employment and economic
life; or using transportation.
``(V) Coverage requirement.--
Nothing in this subsection or section
1861(s)(2)(II) shall be construed as
requiring the Secretary to provide for
coverage under this title of any item
that would not otherwise be covered
under this title without application of
the amendments made by the Ensuring
Access to Quality Complex
Rehabilitation Technology Act of 2019,
or as changing any coverage
requirements in existence as of the
date of the enactment of this
subsection, including any prior
authorization coverage requirements or
advance determinations of Medicare
coverage requirements that may apply to
CRT items.
``(C) Establishment of supplier and quality
standards for crt.--
``(i) Establishment.--The Secretary shall
establish and implement supplier and quality
standards for suppliers of CRT items to be
applied by recognized independent accreditation
organizations (as designated under subparagraph
(D)), which as set forth below, incorporate
existing standards as well as creating new CRT-
specific standards. Such standards shall be
applied prospectively and shall be published on
the Internet website of the Centers for
Medicare & Medicaid Services.
``(ii) Requirements of standards.--In
establishing the supplier and quality standards
under clause (i), the Secretary shall require
that each supplier of CRT items meets the
following requirements:
``(I) DME and medical equipment and
supplies standards.--The supplier
complies with all of the standards that
are applicable to suppliers of durable
medical equipment under subsection
(a)(20) and suppliers of medical
equipment and supplies under subsection
(j).
``(II) Qualified crt professional
standards.--The supplier of a CRT item
makes available, in each service area
served by such supplier, at least one
qualified CRT professional to analyze
the needs and capacities of individuals
for a CRT item in collaboration with
the clinical team; assist in selecting
any appropriate CRT items for such an
individual, given such needs and
capacities; and provide technology-
related training to such an individual
in the proper use and maintenance of
the CRT items.
``(III) Service and repair
standards.--The supplier of the CRT
item--
``(aa) makes available, in
each service area served by
such supplier, at least one
qualified CRT service
technician to service and
repair CRT items that are
furnished by such supplier; and
``(bb) provides the
individual with written
information on accessing
service and repair for the CRT
item before the CRT item is
ordered for the individual
involved.
``(D) Accreditation for suppliers of crt items.--
``(i) Requirement for provider or supplier
number.--The Secretary shall not provide a
supplier of CRT items with a provider or
supplier number to submit claims for payment
under this subsection unless the supplier is in
compliance with the requirements under this
subparagraph.
``(ii) Application of accreditation
requirement.--In implementing supplier and
quality standards under paragraph (C), the
Secretary shall require suppliers furnishing
CRT items, on or after one year after the
standards are published under such paragraph,
directly or as a subcontractor for another
entity--
``(I) to comply with such
standards; and
``(II) to have submitted to the
Secretary evidence of accreditation by
an accreditation organization
designated under subparagraph (iii)
demonstrating that the supplier is
complying with such standards.
``(iii) Designation of independent
accreditation organizations.--Not later than
the date that is one year after the date on
which the Secretary implements the supplier and
quality standards under subparagraph (C), the
Secretary shall designate and approve one or
more independent accreditation organizations
that--
``(I) are approved under subsection
(a)(20)(B), which set forth the
designation of independent
accreditation organizations for
suppliers of durable medical equipment;
and
``(II) have the capability to
assess whether suppliers of CRT items
meet the supplier and quality standards
established under subparagraph (C).
``(3) Definitions.--For purposes of this subsection:
``(A) Qualified crt professional.--
``(i) In general.--The term `qualified CRT
professional' means an individual who--
``(I) is certified by the
Rehabilitation Engineering and
Assistive Technology Society of North
America as an assistive technology
professional or is certified by another
organization designated by the
Secretary (acting in consultation with
relevant parties, including
manufacturers and suppliers of CRT
items, relevant consumer organizations,
and clinicians with knowledge of CRT
items and direct experience working
with individuals who use CRT items) as
providing a certification that is
equivalent to, or more stringent than,
the assistive technology professional
certification; and
``(II) beginning 2 years after the
establishment of the designation under
clause (ii), subject to clause
(ii)(II), achieves an additional
designation that demonstrates the
individual's competencies and
experience in supplying CRT items.
``(ii) Additional designation.--
``(I) Not later than one year after
the date of the enactment of this
subparagraph, the Secretary, with
stakeholder input, including
manufacturers and suppliers of CRT
items, relevant consumer organizations,
and clinicians with knowledge of CRT
items and direct experience working
with patients who use CRT items, shall
establish the additional designation
under clause (i)(II).
``(II) Until such time as the
additional designation is established,
the term `qualified CRT professional'
shall include an individual meeting the
requirements in clause (i)(I) only.
``(B) Qualified crt service technician.--The term
`qualified CRT service technician' means an individual
who, with respect to a CRT item--
``(i) has successfully completed a training
program approved by the manufacturer of the CRT
item;
``(ii) is trained and educated (including
through on-the-job training) to assemble,
program, adjust, service, and repair CRT items;
and
``(iii) on an annual basis, completes at
least 10 hours of education specific to the
assembly, programming, service, adjusting, and
repairing of CRT items.
``(C) Qualified ordering practitioner.--The term
`qualified ordering practitioner' means a physician (as
defined in section 1861(r)), a physician assistant,
nurse practitioner, or a clinical nurse specialist (as
those terms are defined in section 1861(aa)(5)).''.
SEC. 5. CONFORMING AMENDMENTS.
(a) Exemption From Competitive Acquisition.--Section 1847(a)(7) of
the Social Security Act (42 U.S.C. 1395w-3(a)(7)) is amended by adding
at the end the following new subparagraph:
``(C) CRT items.--For calendar year 2020 and
subsequent years, complex rehabilitation technology
items (as defined in section 1861(kkk)).''.
(b) Payment Exclusions.--Section 1834(a) of the Social Security Act
(42 U.S.C. 1395m(a)) is amended--
(1) in paragraph (4), by adding at the end the following
sentence ``For calendar year 2020 and subsequent years, the
items covered by this paragraph shall not include CRT items (as
defined in section 1861(kkk)), which shall be paid pursuant to
the fee schedule and methodology for CRT items described in
section 1834(x) beginning on January 1, 2020, and in subsequent
years.'';
(2) in paragraph (7)(A), by adding at the end the
following: ``For calendar year 2020 and subsequent years, this
paragraph shall not apply to CRT items under section
1861(kkk).''; and
(3) in paragraph (16), by inserting at the end the
following: ``The Secretary shall impose (and, may, as allowed
by the second sentence of this paragraph, waive) the
requirements of the first sentence of this paragraph to
suppliers of complex rehabilitation technology items, except
that, in order to avoid duplicate bonds, the Secretary shall
not impose such requirements with respect to suppliers of
complex rehabilitation technology items if such suppliers also
participate in the Medicare program as suppliers of durable
medical equipment.''.
(c) Requirements for Suppliers of Medical Equipment and Supplies.--
Section 1834(j)(5) of the Social Security Act (42 U.S.C. 1395m(j)(5))
is amended--
(1) by redesignating subparagraphs (E) and (F) as
subparagraphs (F) and (G), respectively; and
(2) by inserting after subparagraph (D) the following new
subparagraph:
``(E) complex rehabilitation technology items (as
defined in section 1861(kkk));''.
SEC. 6. CONTINUED COVERAGE OF CRT ITEMS.
The amendments made by this Act do not change the availability of
coverage in existence as of the date of the enactment of this Act,
including prior authorization coverage requirements, for CRT items
under title XVIII of the Social Security Act or title XIX of such Act,
or any other payor or program, including in the case in which CRT items
are covered, as of such date of enactment, as durable medical equipment
or under a home health benefit, including the home health benefit under
section 1902 of such Act and the regulations implementing such section;
nor do the amendments made by this Act change the existing definitions
of durable medical equipment or medical equipment and supplies under
such Act or as established by any other payor or program, including
where CRT items may also fit those definitions. In the case that a CRT
item also satisfies the definition of durable medical equipment, or
medical equipment and supplies, or another benefit category as defined
by an applicable payor, the amendments of this Act shall apply only for
purposes of payment of the CRT item under title XVIII of such Act.
SEC. 7. EFFECTIVE DATE.
The amendments made by this Act shall be effective beginning on the
date that is 30 days after the date of the enactment of this Act,
unless otherwise specified in a provision of, including amendment made
by, this Act.
<all>
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2019
#2408 | HR Congress #116
Policy Area: Health
Subjects: Disability and paralysisDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth care costs and insuranceHealth care coverage and accessHealth care qualityHealth technology, devices, suppliesLicensing and registrationsLong-term, rehabilitative, and terminal careMedicareProduct safety and quality
Last Action: Referred to the Subcommittee on Health. (5/1/2019)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text