I 

118TH CONGRESS 

1ST SESSION H. R. 5395 

To amend title XVIII of the Social Security Act to establish a demonstration 

program relating to medical necessity determinations under the Medicare 

program. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2023 

Mrs. HARSHBARGER 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 establish 

a demonstration program relating to medical necessity 

determinations under the Medicare program. 

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 Parity for 

5 Medicare Patients Act of 2023’’. 


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1 SEC. 2. ESTABLISHING A DEMONSTRATION PROGRAM RE2 LATING TO MEDICAL NECESSITY DETER3 MINATIONS UNDER THE MEDICARE PRO4 GRAM. 

5 Section 1862 of the Social Security Act (42 U.S.C. 

6 1395y) is amended by adding at the end the following new 

7 subsection: 

8 ‘‘(p) DEMONSTRATION PROGRAM RELATING TO

9 MEDICAL NECESSITY DETERMINATIONS.— 

10 ‘‘(1) IN GENERAL.—Not later than January 1, 

11 2026, the Secretary shall establish a demonstration 

12 program (in this subsection referred to as the ‘pro13 gram’) under which an item or service furnished to 

14 an individual entitled to benefits under part A or en15 rolled under part B is deemed to be reasonable and 

16 necessary for purposes of subsection (a)(1) if such 

17 item or service meets the criteria specified in para18 graph (3). 

19 ‘‘(2) SELECTION OF PARTICIPATING AREAS.— 

20 The Secretary shall select no fewer than 5 States 

21 (or, at the option of the Secretary, no fewer than 3 

22 Medicare administrative contractor jurisdictions re23 lating to the administration of parts A and B (as 

24 specified by the Secretary)) in which to carry out the 

25 program. 

26 ‘‘(3) SPECIFIED CRITERIA.— 


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1 ‘‘(A) IN GENERAL.—For purposes of para2 graph (1), the criteria specified in this para3 graph are, with respect to an item or service 

4 furnished to an individual in a State or jurisdic5 tion (as applicable) selected by the Secretary 

6 under paragraph (2), the following: 

7 ‘‘(i) Such item or service so furnished 

8 would be covered under a significant num9 ber of group health plans and group or in10 dividual health insurance coverage offered 

11 in such State or jurisdiction if so furnished 

12 to a similarly situated individual enrolled 

13 under such plan or coverage (as applica14 ble). 

15 ‘‘(ii) The item or service is safe and 

16 effective. 

17 ‘‘(iii) The item or service— 

18 ‘‘(I) is not experimental or inves19 tigational; or 

20 ‘‘(II) is experimental or inves21 tigational, but is furnished as part of 

22 a clinical trial that meets the stand23 ards of coverage applicable under any 

24 national coverage determination relat25 ing to clinical trials. 


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1 ‘‘(B) SIGNIFICANT COVERAGE.—The Sec2 retary shall through notice-and-comment rule3 making establish requirements for what con4 stitutes coverage of an item or service under a 

5 significant number of group health plans and 

6 group or individual health insurance coverage in 

7 a State or jurisdiction. Such requirements may 

8 provide that such significant number is dem9 onstrated through a showing that a majority of 

10 similarly situated individuals covered under 

11 such a plan or group or individual health insur12 ance coverage in such State or jurisdiction 

13 would have benefits available under such plan 

14 or coverage for such item or service or through 

15 such other similar metrics determined appro16 priate by the Secretary. 

17 ‘‘(4) DURATION.— 

18 ‘‘(A) IN GENERAL.—The program shall be 

19 in effect for a period of not less than 4 years. 

20 ‘‘(B) EXPANSION.—The Secretary may, 

21 during the period in which the program is in ef22 fect and as determined appropriate by the Sec23 retary, expand the program to additional States 

24 or jurisdictions not originally selected under 

25 paragraph (2). 


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1 ‘‘(C) TERMINATION.—The Secretary may 

2 terminate the program— 

3 ‘‘(i) only on or after the date that is 

4 4 years after the effective date of the pro5 gram; and 

6 ‘‘(ii) only once the Secretary has con7 cluded a 60-day public comment period 

8 with respect to such termination.’’. 

Æ 


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