I 

118TH CONGRESS 

1ST SESSION H. R. 5396 

To amend title XVIII of the Social Security Act to prohibit Medicare local 

coverage determinations from restricting access to care, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2023 

Mr. BUCSHON introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy 

and Commerce, 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 prohibit 

Medicare local coverage determinations from restricting 

access to care, 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 ‘‘Coverage Determina5 tion Clarity Act of 2023’’. 


pbinns on DSKJLVW7X2PROD with $$_JOB
2 

•HR 5396 IH

1 SEC. 2. IMPROVING ACCESS TO ITEMS AND SERVICES 

2 UNDER MEDICARE LOCAL COVERAGE DETER3 MINATIONS. 

4 (a) IN GENERAL.—Section 1862(l)(5) of the Social 

5 Security Act (42 U.S.C. 1395y(l)(5)) is amended— 

6 (1) in subparagraph (A), by striking ‘‘The Sec7 retary’’ and inserting ‘‘Subject to subparagraph (E), 

8 the Secretary’’; and 

9 (2) by adding at the end the following new sub10 paragraph: 

11 ‘‘(E) PROHIBITION ON LIMITING ACCESS

12 ITEMS AND SERVICES.— 

13 ‘‘(i) REVIEW OF LOCAL COVERAGE

14 DETERMINATIONS.—Beginning in 2024, 

15 and annually thereafter, the Secretary 

16 shall review each local coverage determina17 tion in effect as of the date of such review 

18 to determine whether such local coverage 

19 determination denies, limits, or conditions 

20 the coverage or provision of items or serv21 ices beyond that provided by a national 

22 coverage determination that has deter23 mined that such items or services be cov24 ered nationally under this title. 

25 ‘‘(ii) CONFLICT BETWEEN A NA26 TIONAL COVERAGE DETERMINATION AND A


pbinns on DSKJLVW7X2PROD with $$_JOB
3 

•HR 5396 IH

1 LOCAL COVERAGE DETERMINATION.—A 

2 local coverage determination denies, limits, 

3 or conditions the coverage or provision of 

4 items or services for purposes of clause (i) 

5 to the extent that such local coverage de6 termination limits access to such items or 

7 services by imposing restrictions that do 

8 not directly interpret provisions of a na9 tional coverage determination that has de10 termined that such items or services be 

11 covered nationally under this title. 

12 ‘‘(iii) REVISION OF LOCAL COVERAGE

13 DETERMINATIONS.— 

14 ‘‘(I) IN GENERAL.—If the review 

15 conducted by the Secretary under 

16 clause (i) determines that a local cov17 erage determination denies, limits, or 

18 conditions the coverage or provision of 

19 items or services that are approved, 

20 cleared, authorized, or licensed under 

21 section 505, 510(k), 513, or 515 of 

22 the Federal Food, Drug, and Cos23 metic Act or section 351 of the Public 

24 Health Service Act, the Secretary 

25 shall direct the appropriate Medicare 


pbinns on DSKJLVW7X2PROD with $$_JOB
4 

•HR 5396 IH

1 administrative contractor to expedi2 tiously revise such local coverage de3 termination to eliminate the limita4 tion. 

5 ‘‘(II) TIMING.—A Medicare ad6 ministrative contractor shall publish a 

7 revised local determination no later 

8 than the date that is 180 days after 

9 the date on which the Secretary di10 rects such contractor to revise a local 

11 coverage determination under sub12 clause (I). 

13 ‘‘(iv) NEW LOCAL COVERAGE DETER14 MINATIONS.—The Secretary shall require 

15 each Medicare administrative contractor 

16 that develops a local coverage determina17 tion to ensure that any such local coverage 

18 determination does not deny, limit, or con19 dition the coverage or provision of items or 

20 services pursuant to clause (ii) beyond that 

21 provided by a national coverage determina22 tion that has determined that such items 

23 or services be covered nationally under this 

24 title. 


pbinns on DSKJLVW7X2PROD with $$_JOB
5 

•HR 5396 IH

1 ‘‘(v) ERROR VERIFICATION AND COR2 RECTIVE ACTIONS.—In verifying any po3 tential errors and taking corrective actions, 

4 Medicare administrative contractors, com5 prehensive error rate testing recovery audi6 tors, and unified program integrity con7 tractors and independent review agencies— 

8 ‘‘(I) shall not deviate from local 

9 coverage determination provisions ap10 plicable in the region in which such 

11 verification or corrective action occurs; 

12 and 

13 ‘‘(II) shall provide transparent 

14 review by publishing the names of the 

15 reviewers and their qualifications in a 

16 place and format available to pro17 viders. 

18 ‘‘(vi) REPORTS TO CONGRESS.—Be19 ginning in 2025 and each year thereafter, 

20 the Secretary shall submit a report to the 

21 appropriate committees of Congress on the 

22 findings of the review conducted under 

23 clause (i) and any local coverage deter24 minations revised pursuant to clause (iii) 

25 during the preceding year.’’. 


pbinns on DSKJLVW7X2PROD with $$_JOB
6 

•HR 5396 IH

1 (b) EFFECTIVE DATE.—The amendments made by 

2 subsection (a) shall apply with respect to proposed and 

3 final local coverage determinations posted on Medicare ad4 ministrative contractor websites on and after January 1, 

5 2023. 

Æ 


pbinns on DSKJLVW7X2PROD with $$_JOB