[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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