[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5663 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5663
To amend title XVIII of the Social Security Act to provide coverage of
ALS-related services under the Medicare program for individuals
diagnosed with amyotrophic lateral sclerosis, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 21, 2023
Ms. Schakowsky (for herself, Mr. Quigley, Mr. Fitzpatrick, Mr. Crow,
Mr. Bacon, Mr. Jackson of Illinois, and Mr. Bishop of Georgia)
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 provide coverage of
ALS-related services under the Medicare program for individuals
diagnosed with amyotrophic lateral sclerosis, 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 ``ALS Better Care Act''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Amyotrophic lateral sclerosis (in this section,
referred to as ``ALS'') is a progressive and debilitating
neurodegenerative disease.
(2) Key services that include (but are not limited to)
evidence of providing specialized physician or nurse
practitioner support, occupational therapy support, speech
pathology support, physical therapy, dietary support,
respiratory support, registered nurse support, and coordination
of the furnishing of durable medical equipment are crucial for
managing the complex medical needs of ALS patients.
(3) Studies have shown ALS clinics that provide these key
services to ALS patients extend these patients' lifespans and
improve the quality of their lives.
(4) These key services are furnished by a range of
healthcare professionals.
(5) Facilities providing care to ALS patients currently
face inadequate Medicare reimbursement for the key services
they offer to these patients.
(6) Insufficient reimbursement creates significant
challenges for facilities specializing in ALS care, resulting
in extended wait times for patients in need of crucial services
and hampering the ability of these facilities to innovate and
improve the quality of care provided to ALS patients.
(7) Improved reimbursement rates would encourage facilities
to invest in research, innovation, and technology, leading to
enhanced treatment options for ALS and improved patient
outcomes.
(8) Remote medical management options for individuals
suffering from ALS must be a crucial part of access to care for
such individuals, especially those living in rural areas or
care deserts.
(9) Telehealth is an essential management option referred
to in paragraph (6) and can assist in delivering timely and
comprehensive care, as ALS patients living in rural areas or
care deserts often face challenges in accessing specialized ALS
care and could otherwise be required to travel long travel
distances--often with caregivers or family members.
(10) Telehealth is especially important in maintaining
access to care for ALS patients as the disease progresses and
ALS patients have more limited mobility, which may make it
challenging to attend in-person appointments regularly.
(11) Low funding and difficulty in staffing for ALS
clinical trials delay the development and availability of
potential treatments and therapies for individuals living with
the disease.
(12) Inadequate funding for ALS clinical trials also
impedes the ability to attract and retain qualified
researchers, clinicians, and support staff, limiting the
overall progress and success of these trials.
SEC. 3. PROVIDING FOR COVERAGE OF ALS-RELATED SERVICES UNDER THE
MEDICARE PROGRAM FOR INDIVIDUALS DIAGNOSED WITH
AMYOTROPHIC LATERAL SCLEROSIS.
(a) In General.--Subtitle E of title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.) is amended by inserting after section
1881A the following new section:
``SEC. 1881B. MEDICARE COVERAGE OF ALS-RELATED SERVICES FOR INDIVIDUALS
DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS.
``(a) In General.--In the case of a covered ALS individual, the
Secretary shall establish a supplemental facility-based payment system
described in subsection (d) for ALS-related services provided to such
an individual.
``(b) Covered ALS Individual.--For purposes of this section, the
term `covered ALS individual' means an individual who is medically
determined to have amyotrophic lateral sclerosis (as described in
section 226(h)).
``(c) ALS-Related Services.--For purposes of this section, the term
`ALS-related services' means items and services that are furnished to a
covered ALS individual in an outpatient setting by a qualified provider
(or by others under arrangements with them made by the qualified
provider) for the care and treatment of such an individual with respect
to the progression of amyotrophic lateral sclerosis.
``(d) Payment System.--
``(1) Authority.--The Secretary shall establish a payment
system under which a single payment determined in accordance
with the succeeding paragraphs is made to a qualified provider
for ALS-related services furnished to a covered ALS individual
during a visit beginning on and after January 1, 2025, for the
purpose of reimbursing the qualified provider (or clinic, if
applicable) for furnishing ALS-related services.
``(2) Base payment amount.--
``(A) 2025.--For coverage year 2025, the Secretary
shall establish a single payment amount for ALS-related
services equal to $800 for such services furnished for
each visit during such year.
``(B) 2026.--For coverage year 2026, the Secretary
shall establish a single payment amount for ALS-related
services furnished for each visit during such year that
is the greater of--
``(i) the payment amount recommended by the
Comptroller General in the report described in
subparagraph (D)(i); or
``(ii) the amount specified in subparagraph
(A).
``(C) Subsequent years.--The Secretary shall do
each of the following:
``(i) Annual increase.--For each coverage
year beginning with coverage year 2027, the
Secretary shall annually increase the payment
amount for each visit determined under this
paragraph by an ALS services market basket
percentage increase (as determined by the
Secretary) for the purpose of reflecting the
year-to-year changes in the prices of an
appropriate mix of goods and services that are
ALS-related services.
``(ii) Reestablishment of amount.--For each
coverage year beginning with coverage year
2028, and every three coverage years
thereafter, the Secretary shall reestablish a
single payment amount for ALS-related services
furnished for each visit during such year that
is the greater of--
``(I) the payment amount
recommended by the Comptroller General
in the report described in subclause
(I) or (II) of subparagraph (D)(ii), as
appropriate; or
``(II) the payment amount specified
pursuant to clause (i); for the purpose
of ensuring that the range of ALS-
related services is modernized over
time.
``(D) Report by the comptroller general.--Not later
than January 1, 2025, the Comptroller General shall, in
consultation with qualified providers that are
representative of the types of qualified providers
eligible for payment under this subsection, submit to
the Secretary of Health and Human Services a report
that recommends a single payment amount for ALS-related
services that takes into account the average amount of
payment for each item or service included in ALS-
related services that the Comptroller General estimates
would have been payable--
``(i) under this title for such a service
based on per patient utilization data from
whichever single coverage year from 2021
through 2023 has the highest per patient
utilization of ALS-related services, even if
such service is not payable for a particular
ALS individual because of the application of
section 1862(a)(1)(A) with respect to an item
or service provided to such individual;
``(ii) in the case an estimate is unable to
be determined pursuant to subclause (I), by
health insurance issuers and group health plans
(as such terms are defined in section 2791 of
the Public Health Service Act) and MA plans
under part C for such a service, based on such
data from whichever single coverage year from
2021 through 2023 has the highest per patient
utilization of ALS-related services; and
``(iii) in the case an estimate is unable
to be determined pursuant to subclause (II),
based on the recommendation of the Specialty
Society Relative Value Scale Update Committee
of the American Medical Association or the
estimate of the Comptroller General for such a
service.
``(E) Subsequent reports.--For the purpose of
subparagraph (C)(ii)(I), the Comptroller General shall,
not later than--
``(i) January 1, 2028, submit a report to
the Secretary in accordance with clause (i),
except by substituting `2021 through 2023' for
`2024 through 2026'; and
``(ii) three years after the date specified
in subclause (I), and every three years
thereafter, submit a report to the Secretary in
accordance with such clause (i), except by
substituting the coverage years for the
previous report with coverage years that are
three years later.
``(3) Payment adjustments.--The payment system under this
subsection shall include a payment adjustment--
``(A) for a qualified provider that is
participating in at least one clinical trial identified
on the clinicaltrials.gov database (or any successor
database) of the National Institutes of Health to
account for the increased costs borne by such a
qualified provider during such a clinical trial; and
``(B) for a medical service or technology which is
furnished as a part of ALS-related services for which,
as determined by the Secretary--
``(i) payment for the service or technology
as part of ALS-related services under this
section was not being made in the preceding
coverage year; and
``(ii) the cost of the service or
technology is not insignificant in relation to
the payment amount (as determined under this
subsection) payable for ALS-related services.
``(4) Mechanism for payments.--For purposes of making
payments for ALS-related services, the Secretary shall
establish a mechanism under the payment system under this
subsection which makes payment when a qualified provider
submits a claim for reimbursement which includes, with respect
to a covered ALS individual, an alphanumeric code issued under
the International Classification of Diseases, 10th Revision,
Clinical Modification (`ICD-10-CM') and its subsequent
revisions that is for the treatment of a diagnosis of
amyotrophic lateral sclerosis.
``(5) No cost sharing.--Payment under this subsection shall
be made only on an assignment-related basis without any cost
sharing.
``(6) Qualified provider defined.--In this section, the
term `qualified provider' means a provider of services which--
``(A) is capable of furnishing care to a covered
ALS individual that includes (but is not limited to)
evidence of providing specialized physician or nurse
practitioner support, occupational therapy support,
speech pathology support, physical therapy, dietary
support, respiratory support, registered nurse support,
and coordination of the furnishing of durable medical
equipment; and
``(B) meets requirements as the Secretary
prescribes by regulation to implement subparagraph (A),
in consultation with--
``(i) covered ALS individuals and their
representatives;
``(ii) physicians who provide ALS-related
services and their representatives; and
``(iii) professional and non-profit
organizations with expertise in amyotrophic
lateral sclerosis.
``(e) Clarification.--Payment under subsection (d) shall be in
addition to, and shall not supplant, any payment that would be
otherwise made to a provider of services, physician, practitioner,
supplier, or laboratory under any other provision of this title for an
item or service furnished to a covered ALS individual.
``(f) Implementation.--
``(1) In general.--Except as provided under paragraph (2),
the Secretary may implement the provisions of this section by
program instruction or otherwise.
``(2) Rulemaking.--The Secretary shall implement
subsections (c) and (d)(6) through notice and comment
rulemaking.
``(g) Funding.--For purposes of carrying out this section, subject
to subsection (e), payment under this section shall be made from the
Federal Supplementary Medical Insurance Trust Fund under section 1841
or from the Federal Hospital Insurance Trust Fund under section
1817.''.
(b) Conforming Amendments.--
(1) Section 1833(t) of the Social Security Act (42 U.S.C.
1395(t)) is amended by adding at the end the following new
paragraph:
``(23) Ensuring supplemental payments for als-related
services.--Any covered OPD service furnished to a covered ALS
individual (as defined in section 1881B(b)) that is otherwise
payable to a qualified provider (as defined in section
1881B(d)(6)) pursuant to paragraph (4) shall be payable under
such paragraph notwithstanding any payment made under section
1881B(d).''.
(2) Section 1861(w)(1) of the Social Security Act (42
U.S.C. 1395x(w)(1)) is amended by inserting ``qualified
provider (as defined in section 1881B(d)(6)(A)) with respect to
ALS-related services (as defined in section 1881B(c)),'' before
``or hospice program''.
SEC. 4. REPORT ON CHALLENGES WITH RESPECT TO THE ADMINISTRATION AND
STAFFING OF AMYOTROPHIC LATERAL SCLEROSIS CLINICAL
TRIALS.
Not later than 90 days after the date of the enactment of this Act,
the Secretary of Health and Human Services, acting through the Director
of the National Institute of Neurological Disorders and Stroke of the
National Institutes of Health, shall submit to Congress and publish on
the internet website of the agency a report that identifies--
(1) any challenges with respect to the administration and
staffing of clinical trials for the prevention, diagnosis,
mitigation, treatment, or cure of amyotrophic lateral
sclerosis;
(2) actions that the Director of the National Institute of
Neurological Disorders and Stroke to address such challenges;
and
(3) any legislative recommendations (including requests for
appropriations) to further improve the administration of such
clinical trials.
SEC. 5. EFFECTIVE DATE.
The amendments made by this Act shall take effect on the date of
the enactment of this Act.
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