II 

118TH CONGRESS 

1ST SESSION S. 3258 

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 SENATE OF THE UNITED STATES 

NOVEMBER 8, 2023 

Mr. COONS (for himself and Ms. MURKOWSKI) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘ALS Better Care Act’’. 

5 SEC. 2. FINDINGS. 

6 Congress makes the following findings: 


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1 (1) Amyotrophic lateral sclerosis (in this sec2 tion, referred to as ‘‘ALS’’) is a progressive and de3 bilitating neurodegenerative disease. 

4 (2) Key services, that include (but are not lim5 ited to) providing specialized physician or nurse 

6 practitioner support, occupational therapy support, 

7 speech pathology support, physical therapy, dietary 

8 support, respiratory support, registered nurse sup9 port, and coordination of the furnishing of durable 

10 medical equipment, are crucial for managing the 

11 complex medical needs of ALS patients. 

12 (3) Studies have shown ALS clinics that pro13 vide these key services to ALS patients extend these 

14 patients’ lifespans and improve the quality of their 

15 lives. 

16 (4) These key services are furnished by a range 

17 of healthcare professionals. 

18 (5) Facilities providing care to ALS patients 

19 currently face inadequate Medicare reimbursement 

20 for the key services they offer to these patients. 

21 (6) Insufficient reimbursement creates signifi22 cant challenges for facilities specializing in ALS 

23 care, resulting in extended wait times for patients in 

24 need of crucial services and hampering the ability of 


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1 these facilities to innovate and improve the quality 

2 of care provided to ALS patients. 

3 (7) Improved reimbursement rates would en4 courage facilities to invest in research, innovation, 

5 and technology, leading to enhanced treatment op6 tions for ALS and improved patient outcomes. 

7 (8) Remote medical management options for in8 dividuals suffering from ALS must be an essential 

9 part of access to care for such individuals, especially 

10 those living in rural areas or care deserts. 

11 (9) Telehealth is one of the essential manage12 ment options referred to in paragraph (8) and can 

13 assist in delivering timely and comprehensive care, 

14 as ALS patients living in rural areas or care deserts 

15 often face challenges in accessing specialized ALS 

16 care and could otherwise be required to travel long 

17 travel distances, often with caregivers or family 

18 members. 

19 (10) Telehealth is especially important in main20 taining access to care for ALS patients as the dis21 ease progresses and causes ALS patients to have 

22 more limited mobility, which may make it chal23 lenging to attend in-person appointments regularly. 

24 (11) Low funding and difficulty in staffing for 

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1 ability of potential treatments and therapies for indi2 viduals living with the disease. 

3 (12) Inadequate funding for ALS clinical trials 

4 also impedes the ability to attract and retain quali5 fied researchers, clinicians, and support staff, lim6 iting the overall progress and success of these trials. 

7 SEC. 3. PROVIDING FOR COVERAGE OF ALS-RELATED SERV8 ICES UNDER THE MEDICARE PROGRAM FOR 

9 INDIVIDUALS DIAGNOSED WITH 

10 AMYOTROPHIC LATERAL SCLEROSIS. 

11 (a) IN GENERAL.—Part E of title XVIII of the Social 

12 Security Act (42 U.S.C. 1395 et. seq.) is amended by in13 serting after section 1881A the following new section: 

14 ‘‘SEC. 1881B. MEDICARE COVERAGE OF ALS-RELATED SERV15 ICES FOR INDIVIDUALS DIAGNOSED WITH 

16 AMYOTROPHIC LATERAL SCLEROSIS. 

17 ‘‘(a) IN GENERAL.—In the case of a covered ALS 

18 individual, the Secretary shall establish a supplemental fa19 cility-based payment system described in subsection (d) 

20 for ALS-related services provided to such an individual. 

21 ‘‘(b) COVERED ALS INDIVIDUAL.—For purposes of 

22 this section, the term ‘covered ALS individual’ means an 

23 individual who is medically determined to have 

24 amyotrophic lateral sclerosis (as described in section 

25 226(h)). 


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1 ‘‘(c) ALS-RELATED SERVICES.—For purposes of this 

2 section, the term ‘ALS-related services’ means items and 

3 services that are furnished to a covered ALS individual 

4 in an outpatient setting by a qualified provider (or by oth5 ers under arrangements with them made by the qualified 

6 provider) for the care and treatment of such an individual 

7 with respect to the progression of amyotrophic lateral scle8 rosis. 

9 ‘‘(d) PAYMENT SYSTEM.— 

10 ‘‘(1) AUTHORITY.—The Secretary shall estab11 lish a payment system under which a single payment 

12 determined in accordance with the succeeding para13 graphs is made to a qualified provider for ALS-re14 lated services furnished to a covered ALS individual 

15 during a visit beginning on or after January 1, 

16 2025, for the purpose of reimbursing the qualified 

17 provider for furnishing ALS-related services. 

18 ‘‘(2) BASE PAYMENT AMOUNT.— 

19 ‘‘(A) 2025.—For coverage year 2025, the 

20 Secretary shall establish a single payment 

21 amount for ALS-related services equal to $800 

22 for such services furnished for each visit during 

23 such year. 

24 ‘‘(B) 2026.—For coverage year 2026, the 

25 Secretary shall establish a single payment 


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1 amount for ALS-related services furnished for 

2 each visit during such year that is the greater 

3 of— 

4 ‘‘(i) the payment amount rec5 ommended by the Comptroller General in 

6 the report described in subparagraph (D); 

7 or 

8 ‘‘(ii) the amount specified in subpara9 graph (A). 

10 ‘‘(C) SUBSEQUENT YEARS.—The Secretary 

11 shall do each of the following: 

12 ‘‘(i) ANNUAL INCREASE.—For each 

13 coverage year beginning with coverage year 

14 2027, the Secretary shall annually increase 

15 the payment amount for each visit deter16 mined under this paragraph by an ALS 

17 services market basket percentage increase 

18 (as determined by the Secretary) for the 

19 purpose of reflecting the year-to-year 

20 changes in the prices of an appropriate 

21 mix of goods and services that are ALS-re22 lated services. 

23 ‘‘(ii) REESTABLISHMENT OF

24 AMOUNT.—For each coverage year begin25 ning with coverage year 2028, and every 3 


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1 coverage years thereafter, for the purpose 

2 of ensuring that the range of ALS-related 

3 services is modernized over time, the Sec4 retary shall reestablish a single payment 

5 amount for ALS-related services furnished 

6 for each visit during such year that is the 

7 greater of— 

8 ‘‘(I) the payment amount rec9 ommended by the Comptroller General 

10 in the report described in clause (i) or 

11 (ii) of subparagraph (E), as applica12 ble; or 

13 ‘‘(II) the payment amount speci14 fied pursuant to clause (i). 

15 ‘‘(D) REPORT BY THE COMPTROLLER GEN16 ERAL.—Not later than January 1, 2025, the 

17 Comptroller General shall, in consultation with 

18 qualified providers that are representative of 

19 the types of qualified providers eligible for pay20 ment under this subsection, submit to the Sec21 retary of Health and Human Services a report 

22 that recommends a single payment amount for 

23 ALS-related services that takes into account the 

24 average amount of payment for each item or 

25 service included in ALS-related services that 


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1 the Comptroller General estimates would have 

2 been payable— 

3 ‘‘(i) under this title for such a service 

4 based on per patient utilization data from 

5 whichever single coverage year from 2021 

6 through 2023 has the highest per patient 

7 utilization of ALS-related services, even if 

8 such service is not payable for a particular 

9 ALS individual because of the application 

10 of section 1862(a)(1)(A) with respect to an 

11 item or service provided to such individual; 

12 ‘‘(ii) in the case that an estimate is 

13 unable to be determined pursuant to clause 

14 (i), by health insurance issuers and group 

15 health plans (as such terms are defined in 

16 section 2791 of the Public Health Service 

17 Act) and MA plans under part C for such 

18 a service, based on such data from which19 ever single coverage year from 2021 

20 through 2023 has the highest per patient 

21 utilization of ALS-related services; and 

22 ‘‘(iii) in the case that an estimate is 

23 unable to be determined pursuant to clause 

24 (ii), based on the recommendation of the 

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1 date Committee of the American Medical 

2 Association or the estimate of the Comp3 troller General for such a service. 

4 ‘‘(E) SUBSEQUENT REPORTS.—For the 

5 purpose of subparagraph (C)(ii)(I), the Comp6 troller General shall, not later than— 

7 ‘‘(i) January 1, 2028, submit a report 

8 to the Secretary in accordance with sub9 paragraph (D), except such subparagraph 

10 shall be applied by substituting ‘2024 

11 through 2026’ for ‘2021 through 2023’ 

12 each place it appears; and 

13 ‘‘(ii) January 1, 2031, and every 3 

14 years thereafter, submit a report to the 

15 Secretary in accordance with subparagraph 

16 (D), after application of clause (i), except 

17 clause (i) shall be applied by substituting 

18 coverage years that are 3 years later than 

19 the coverage years previously applicable for 

20 reports under clause (i) or this clause for 

21 ‘2024 through 2026’. 

22 ‘‘(3) PAYMENT ADJUSTMENTS.—The payment 

23 system under this subsection shall include a payment 

24 adjustment— 


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1 ‘‘(A) for a qualified provider that is par2 ticipating in at least 1 clinical trial identified on 

3 the clinicaltrials.gov database (or any successor 

4 database) of the National Institutes of Health 

5 to account for the increased costs borne by such 

6 a qualified provider during such a clinical trial; 

7 and 

8 ‘‘(B) to account for a medical service or 

9 technology that is furnished as a part of ALS10 related services for which, as determined by the 

11 Secretary— 

12 ‘‘(i) payment for the service or tech13 nology as part of ALS-related services 

14 under this section was not being made in 

15 the preceding coverage year; and 

16 ‘‘(ii) the cost of the service or tech17 nology is not insignificant in relation to the 

18 payment amount (as determined under this 

19 subsection) payable for ALS-related serv20 ices. 

21 ‘‘(4) MECHANISM FOR PAYMENTS.—For pur22 poses of making payments for ALS-related services, 

23 the Secretary shall establish a mechanism under the 

24 payment system under this subsection which makes 

25 payment when a qualified provider submits a claim 


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1 for reimbursement which includes, with respect to a 

2 covered ALS individual, an alphanumeric code 

3 issued under the International Classification of Dis4 eases, 10th Revision, Clinical Modification (com5 monly referred to as ‘ICD–10–CM’) and its subse6 quent revisions that is for the treatment of a diag7 nosis of amyotrophic lateral sclerosis. 

8 ‘‘(5) NO COST SHARING.—Payment under this 

9 subsection shall be made only on an assignment-re10 lated basis without any cost sharing. 

11 ‘‘(6) QUALIFIED PROVIDER DEFINED.—In this 

12 section, the term ‘qualified provider’ means a pro13 vider of services or a clinic which— 

14 ‘‘(A) is capable of furnishing care to a cov15 ered ALS individual, including by providing 

16 such services as providing specialized physician 

17 or nurse practitioner support, occupational 

18 therapy support, speech pathology support, 

19 physical therapy, dietary support, respiratory 

20 support, registered nurse support, and coordi21 nation of the furnishing of durable medical 

22 equipment; and 

23 ‘‘(B) meets such requirements as the Sec24 retary may prescribe by regulation to imple25 ment subparagraph (A), in consultation with— 


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1 ‘‘(i) covered ALS individuals and their 

2 representatives; 

3 ‘‘(ii) physicians who provide ALS-re4 lated services and their representatives; 

5 and 

6 ‘‘(iii) professional and non-profit orga7 nizations with expertise in amyotrophic lat8 eral sclerosis. 

9 ‘‘(e) CLARIFICATION.—Payment under subsection (d) 

10 shall be in addition to, and shall not supplant, any pay11 ment that would be otherwise made to a provider of serv12 ices, physician, practitioner, supplier, or laboratory under 

13 any other provision of this title for an item or service fur14 nished to a covered ALS individual. 

15 ‘‘(f) IMPLEMENTATION.— 

16 ‘‘(1) IN GENERAL.—Except as provided under 

17 paragraph (2), the Secretary may implement the 

18 provisions of this section by program instruction or 

19 otherwise. 

20 ‘‘(2) RULEMAKING.—The Secretary shall imple21 ment subsections (c) and (d)(6) through notice and 

22 comment rulemaking. 

23 ‘‘(g) FUNDING.—For purposes of carrying out this 

24 section and subject to subsection (e), payment under this 

25 section shall be made from the Federal Supplementary 


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1 Medical Insurance Trust Fund under section 1841 or 

2 from the Federal Hospital Insurance Trust Fund under 

3 section 1817.’’. 

4 (b) CONFORMING AMENDMENTS.— 

5 (1) ENSURING SUPPLEMENTAL PAYMENTS FOR

6 ALS-RELATED SERVICES.—Section 1833(t) of the 

7 Social Security Act (42 U.S.C. 1395(t) is amended 

8 by adding at the end the following new paragraph: 

9 ‘‘(23) ENSURING SUPPLEMENTAL PAYMENTS

10 FOR ALS-RELATED SERVICES.—Any covered OPD 

11 service furnished to a covered ALS individual (as de12 fined in section 1881B(b)) that is otherwise payable 

13 to a qualified provider (as defined in section 

14 1881B(d)(6)) pursuant to paragraph (4) shall be 

15 payable under such paragraph notwithstanding any 

16 payment made under section 1881B(d).’’. 

17 (2) DEFINITION OF ‘‘ARRANGEMENTS’’.—Sec18 tion 1861(w)(1) of the Social Security Act (42 

19 U.S.C. 1395x(w)(1)) is amended by inserting ‘‘quali20 fied provider (as defined in section 1881B(d)(6)) 

21 with respect to ALS-related services (as defined in 

22 section 1881B(c)),’’ before ‘‘or hospice program’’. 


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1 SEC. 4. REPORT ON CHALLENGES WITH RESPECT TO THE 

2 ADMINISTRATION AND STAFFING OF 

3 AMYOTROPHIC LATERAL SCLEROSIS CLIN4 ICAL TRIALS. 

5 Not later than 90 days after the date of the enact6 ment of this Act, the Secretary of Health and Human 

7 Services, acting through the Director of the National In8 stitute of Neurological Disorders and Stroke, shall submit 

9 to Congress and publish on the Internet website of the 

10 agency a report that identifies— 

11 (1) any challenges with respect to the adminis12 tration and staffing of clinical trials for the preven13 tion, diagnosis, mitigation, treatment, or cure of 

14 amyotrophic lateral sclerosis; 

15 (2) actions that the Director of the National In16 stitute of Neurological Disorders and Stroke will 

17 take to address such challenges; and 

18 (3) any legislative recommendations (including 

19 requests for appropriations) to further improve the 

20 administration of such clinical trials. 

Æ 


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