I 

118TH CONGRESS 

2D SESSION H. R. 8816 

To amend title XVIII of the Social Security Act to provide for a cognitive 

impairment detection benefit under the Medicare program, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 25, 2024 

Mr. BUCHANAN 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 

for a cognitive impairment detection benefit under the 

Medicare program, 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 ‘‘American Medical In5 novation and Investment Act of 2024’’. 


ssavage on LAPJG3WLY3PROD with BILLS
2 

•HR 8816 IH

1 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 

2 THE MEDICARE ANNUAL WELLNESS VISIT 

3 AND INITIAL PREVENTIVE PHYSICAL EXAM4 INATION. 

5 (a) ANNUAL WELLNESS VISIT.— 

6 (1) IN GENERAL.—Section 1861(hhh)(2) of the 

7 Social Security Act (42 U.S.C. 1395x(hhh)(2)) is 

8 amended by striking subparagraph (D) and inserting 

9 the following: 

10 ‘‘(D) Detection of any cognitive impair11 ment that shall— 

12 ‘‘(i) be performed using one of the 

13 cognitive impairment detection tools identi14 fied by the National Institute on Aging as 

15 meeting its criteria for selecting instru16 ments to detect cognitive impairment in 

17 the primary care setting; and 

18 ‘‘(ii) include documentation of the tool 

19 used for detecting cognitive impairment 

20 and results of the assessment in the pa21 tient’s medical record.’’. 

22 (2) EFFECTIVE DATE.—The amendment made 

23 by paragraph (1) shall apply to annual wellness vis24 its furnished on or after January 1, 2025. 

25 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA26 TION.— 


ssavage on LAPJG3WLY3PROD with BILLS
3 

•HR 8816 IH

1 (1) IN GENERAL.—Section 1861(ww)(1) of the 

2 Social Security Act (42 U.S.C. 1395x(ww)(1)) is 

3 amended by striking ‘‘agreement with the individual, 

4 and’’ and inserting ‘‘agreement with the individual, 

5 detection of any cognitive impairment as described 

6 in subsection (hhh)(2)(D), and’’. 

7 (2) EFFECTIVE DATE.—The amendment made 

8 by paragraph (1) shall apply to initial preventive 

9 physical examinations furnished on or after January 

10 1, 2025. 

11 SEC. 3. IMPROVING THE NATIONAL AND LOCAL COVERAGE 

12 DETERMINATION PROCESSES UNDER THE 

13 MEDICARE PROGRAM. 

14 (a) IN GENERAL.—Section 1862(l) of the Social Se15 curity Act (42 U.S.C. 1395y(l)) is amended by adding at 

16 the end the following new paragraph: 

17 ‘‘(7) LIMITATION ON DURATION OF COVERAGE

18 WITH EVIDENCE DEVELOPMENT DETERMINA19 TIONS.— 

20 ‘‘(A) IN GENERAL.—Subject to subpara21 graph (B), in the case of a final decision under 

22 paragraph (3)(C)(i) (including any such deci23 sion made on a class-wide basis) made on or 

24 after the date of the enactment of this para25 graph that results in coverage of an item or 


ssavage on LAPJG3WLY3PROD with BILLS
4 

•HR 8816 IH

1 service pursuant to subsection (a)(1)(E), the 

2 Secretary shall, not later than 10 years after 

3 the date on which such coverage becomes effec4 tive pursuant to such subsection, initiate a re5 determination with respect to such item or serv6 ice. 

7 ‘‘(B) EXCEPTION.—The Secretary may 

8 delay a redetermination described in subpara9 graph (A) with respect to an item or service for 

10 a period of time determined appropriate by the 

11 Secretary if— 

12 ‘‘(i) the Secretary finds that such 

13 item or service is reasonable and necessary 

14 to carry out the purposes described in sec15 tion 1142; or 

16 ‘‘(ii) the entity responsible for such 

17 item or service requests such extension. 

18 ‘‘(C) POSTING OF INFORMATION.—Not 

19 later than 1 year after the date of the enact20 ment of this paragraph, and annually there21 after, the Secretary post on the public website 

22 of the Centers for Medicare & Medicaid Serv23 ices the following information: 


ssavage on LAPJG3WLY3PROD with BILLS
5 

•HR 8816 IH

1 ‘‘(i) The number of items and services 

2 covered under this title pursuant to sub3 section (a)(1)(E). 

4 ‘‘(ii) A description of each such item 

5 or service. 

6 ‘‘(iii) The year in which coverage of 

7 each such item or service became effective 

8 pursuant to such subsection.’’. 

9 (b) PROVISION OF EXPLANATION IN CASE OF CER10 TAIN REJECTED REQUESTS.—Section 1862(l) of the So11 cial Security Act (42 U.S.C. 1395y(l)), as amended by 

12 subsection (a), is further amended by adding at the end 

13 the following new paragraph: 

14 ‘‘(8) REQUIREMENT TO PROVIDE EXPLANATION

15 IN CASE OF CERTAIN REJECTED REQUESTS.—With 

16 respect to each document received by the Secretary 

17 on or after the date that is 1 year after the date of 

18 the enactment of this paragraph that identifies itself 

19 as a complete, formal request for a national coverage 

20 determination (as described in the notice entitled 

21 ‘Medicare Program; Revised Process for Making Na22 tional Coverage Determinations’ (78 Fed. Reg. 

23 48164) or a successor regulation), the Secretary 

24 shall, not later than 90 days after receipt of such 

25 document— 


ssavage on LAPJG3WLY3PROD with BILLS
6 

•HR 8816 IH

1 ‘‘(A) determine whether such document is 

2 a complete, formal request for a national cov3 erage determination; and 

4 ‘‘(B) in the case that the Secretary finds 

5 that such document is not a complete, formal 

6 request for a national coverage determination, 

7 transmit to the entity submitting such docu8 ment information on such finding that includes 

9 a specification of additional information needed 

10 to make such document a complete, formal re11 quest for a national coverage determination.’’. 

12 (c) IMPROVING ACCESS TO ITEMS AND SERVICES

13 UNDER LOCAL COVERAGE DETERMINATIONS.—Section 

14 1862(l)(5) of the Social Security Act (42 U.S.C. 

15 1395y(l)(5)) is amended by adding at the end the fol16 lowing new subparagraph: 

17 ‘‘(E) ENSURING CONSISTENCY WITH AP18 PLICABLE RULES.—The Secretary shall require 

19 each Medicare administrative contractor that 

20 develops a local coverage determination to en21 sure that any such local coverage determination 

22 does not conflict with any law, ruling, regula23 tion, national coverage determination, payment 

24 policy, or coding policy.’’. 


ssavage on LAPJG3WLY3PROD with BILLS
7 

•HR 8816 IH

1 (d) FUNDING.—There are authorized to be appro2 priated $1,000,000 for fiscal year 2024 for purposes of 

3 carrying out the amendments made by this section. 

4 SEC. 4. MEDICARE COVERAGE OF EXTERNAL INFUSION 

5 PUMPS AND NON-SELF-ADMINISTRABLE 

6 HOME INFUSION DRUGS. 

7 Section 1861(n) of the Social Security Act (42 U.S.C. 

8 1395x(n)) is amended by adding at the end the following 

9 new sentence: ‘‘Beginning with the first calendar quarter 

10 beginning on or after the date that is 1 year after the 

11 date of the enactment of this sentence, an external infu12 sion pump and associated home infusion drug (as defined 

13 in subsection (iii)(3)(C)) or other associated supplies that 

14 do not meet the appropriate for use in the home require15 ment applied to the definition of durable medical equip16 ment under section 414.202 of title 42, Code of Federal 

17 Regulations (or any successor to such regulation) shall be 

18 treated as meeting such requirement if each of the fol19 lowing criteria is satisfied: 

20 ‘‘(1) The prescribing information approved by 

21 the Food and Drug Administration for the home in22 fusion drug associated with the pump instructs that 

23 the drug should be administered by or under the su24 pervision of a health care professional. 


ssavage on LAPJG3WLY3PROD with BILLS
8 

•HR 8816 IH

1 ‘‘(2) A qualified home infusion therapy supplier 

2 (as defined in subsection (iii)(3)(D)) administers or 

3 supervises the administration of the drug or biologi4 cal in a safe and effective manner in the patient’s 

5 home (as defined in subsection (iii)(3)(B)). 

6 ‘‘(3) The prescribing information described in 

7 paragraph (1) instructs that the drug should be in8 fused at least 12 times per year— 

9 ‘‘(A) intravenously or subcutaneously; or 

10 ‘‘(B) at infusion rates that the Secretary 

11 determines would require the use of an external 

12 infusion pump.’’. 

13 SEC. 5. GUIDANCE ON MEDICARE PAYMENT FOR CERTAIN 

14 ITEMS INVOLVING ARTIFICIAL INTEL15 LIGENCE. 

16 Not later than January 1, 2026, the Secretary of 

17 Health and Human Services shall use existing communica18 tions mechanisms to issue guidance on requirements for 

19 payment under part B of title XVIII of the Social Security 

20 Act (42 U.S.C. 1395j et seq.) for remote monitoring de21 vices, such as continuous glucose monitors, that— 

22 (1) use an artificial intelligence component 

23 (such as a continuous adjustment component); and 


ssavage on LAPJG3WLY3PROD with BILLS
9 

•HR 8816 IH

1 (2) transmit information to a health care pro2 vider for purposes of management and treatment of 

3 an individual. 

4 SEC. 6. CLARIFYING PAYMENT FOR PRESCRIPTION DIG5 ITAL THERAPEUTICS UNDER MEDICARE. 

6 (a) GUIDANCE TO PHYSICIANS.—Not later than Jan7 uary 1, 2026, the Secretary of Health and Human Serv8 ices (in this section referred to as the ‘‘Secretary’’) shall 

9 use existing communication mechanisms to issue guidance 

10 on requirements for payment under part B of title XVIII 

11 of the Social Security Act (42 U.S.C. 1395j et seq.) for 

12 a prescription digital therapeutic furnished by a physician 

13 or incident to a physician’s professional service. 

14 (b) GUIDANCE TO MA ORGANIZATIONS.—Not later 

15 than 1 year after the date of the enactment of this Act, 

16 the Secretary shall issue to MA organizations guidance to 

17 clarify the requirements relating to when such organiza18 tions may provide a prescription digital therapeutic as a 

19 supplemental benefit to an individual enrolled under a MA 

20 plan. 

21 (c) REPORT TO CONGRESS.—Not later than January 

22 1, 2026, the Secretary shall submit to the Committee on 

23 Ways and Means and the Committee on Energy and Com24 merce of the House of Representatives, and the Finance 

25 Committee of the Senate, a report that includes— 


ssavage on LAPJG3WLY3PROD with BILLS
10 

•HR 8816 IH

1 (1) an analysis of any existing statutory author2 ity for the Secretary to provide payment for pre3 scription digital therapeutics under the Medicare 

4 program; and 

5 (2) a description of any additional statutory au6 thority that is needed by the Secretary to expand 

7 such coverage. 

8 (d) DEFINITIONS.—In this section: 

9 (1) MA TERMS.—The terms ‘‘MA plan’’, ‘‘MA 

10 organization’’, and ‘‘supplemental benefit’’ have the 

11 meanings given each such term in part C of title 

12 XVIII of the Social Security Act (42 U.S.C. 1395w– 

13 21 et seq.). 

14 (2) MEDICARE PROGRAM.—The term ‘‘Medicare 

15 program’’ means the Medicare program under title 

16 XVIII of the Social Security Act (42 U.S.C. 1395 et 

17 seq.). 

18 (3) PHYSICIAN.—The term ‘‘physician’’ has the 

19 meaning given such term in section 1861(r) of the 

20 Social Security Act (42 U.S.C. 1395x(r)). 

21 (4) PRESCRIPTION DIGITAL THERAPEUTIC.— 

22 The term ‘‘prescription digital therapeutic’’ means 

23 an evidence-based software product, including any 

24 such product that is a combination product de25 scribed in section 503(g) of the Federal Food, Drug, 


ssavage on LAPJG3WLY3PROD with BILLS
11 

•HR 8816 IH

1 and Cosmetic Act (21 U.S.C. 353(g)), intended for 

2 use in the management, prevention, or treatment of 

3 a disease or condition, that acts directly as a medical 

4 intervention or guides the delivery of a medical 

5 intervention and that— 

6 (A) is regulated by the Food and Drug Ad7 ministration as a device (as defined in section 

8 201 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 321)), including any such device 

10 regulated as a combination product (as de11 scribed in section 503(g) of such Act (21 

12 U.S.C. 353(g)); 

13 (B) is cleared under section 510(k), classi14 fied under section 513(f)(2), or approved under 

15 section 515 of such Act (21 U.S.C. 360(k), 

16 360c(f)(2), 360e); and 

17 (C) may not be furnished to an individual 

18 without a prescription from a physician. 

Æ 


ssavage on LAPJG3WLY3PROD with BILLS