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 En-
ergy 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Coverage Parity for 
Medicare Patients Act of 2023’’. 
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SEC. 2. ESTABLISHING A DEMONSTRATION PROGRAM RE-
LATING TO MEDICAL NECESSITY DETER-
MINATIONS UNDER THE MEDICARE PRO-
GRAM. 
Section 1862 of the Social Security Act (42 U.S.C. 
1395y) is amended by adding at the end the following new 
subsection: 
‘‘(p) DEMONSTRATION
PROGRAM
RELATING
TO 
MEDICAL NECESSITY DETERMINATIONS.— 
‘‘(1) IN GENERAL.—Not later than January 1, 
2026, the Secretary shall establish a demonstration 
program (in this subsection referred to as the ‘pro-
gram’) under which an item or service furnished to 
an individual entitled to benefits under part A or en-
rolled under part B is deemed to be reasonable and 
necessary for purposes of subsection (a)(1) if such 
item or service meets the criteria specified in para-
graph (3). 
‘‘(2) SELECTION OF PARTICIPATING AREAS.— 
The Secretary shall select no fewer than 5 States 
(or, at the option of the Secretary, no fewer than 3 
Medicare administrative contractor jurisdictions re-
lating to the administration of parts A and B (as 
specified by the Secretary)) in which to carry out the 
program. 
‘‘(3) SPECIFIED CRITERIA.— 
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‘‘(A) IN GENERAL.—For purposes of para-
graph (1), the criteria specified in this para-
graph are, with respect to an item or service 
furnished to an individual in a State or jurisdic-
tion (as applicable) selected by the Secretary 
under paragraph (2), the following: 
‘‘(i) Such item or service so furnished 
would be covered under a significant num-
ber of group health plans and group or in-
dividual health insurance coverage offered 
in such State or jurisdiction if so furnished 
to a similarly situated individual enrolled 
under such plan or coverage (as applica-
ble). 
‘‘(ii) The item or service is safe and 
effective. 
‘‘(iii) The item or service— 
‘‘(I) is not experimental or inves-
tigational; or 
‘‘(II) is experimental or inves-
tigational, but is furnished as part of 
a clinical trial that meets the stand-
ards of coverage applicable under any 
national coverage determination relat-
ing to clinical trials. 
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‘‘(B) SIGNIFICANT COVERAGE.—The Sec-
retary shall through notice-and-comment rule-
making establish requirements for what con-
stitutes coverage of an item or service under a 
significant number of group health plans and 
group or individual health insurance coverage in 
a State or jurisdiction. Such requirements may 
provide that such significant number is dem-
onstrated through a showing that a majority of 
similarly situated individuals covered under 
such a plan or group or individual health insur-
ance coverage in such State or jurisdiction 
would have benefits available under such plan 
or coverage for such item or service or through 
such other similar metrics determined appro-
priate by the Secretary. 
‘‘(4) DURATION.— 
‘‘(A) IN GENERAL.—The program shall be 
in effect for a period of not less than 4 years. 
‘‘(B) EXPANSION.—The Secretary may, 
during the period in which the program is in ef-
fect and as determined appropriate by the Sec-
retary, expand the program to additional States 
or jurisdictions not originally selected under 
paragraph (2). 
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‘‘(C) TERMINATION.—The Secretary may 
terminate the program— 
‘‘(i) only on or after the date that is 
4 years after the effective date of the pro-
gram; and 
‘‘(ii) only once the Secretary has con-
cluded a 60-day public comment period 
with respect to such termination.’’. 
Æ 
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