I 
116TH CONGRESS 
1ST SESSION 
H. R. 448 
To amend title XVIII of the Social Security Act to provide for the negotiation 
of lower covered part D drug prices on behalf of Medicare beneficiaries 
and the establishment and application of a formulary by the Secretary 
of Health and Human Services under Medicare part D, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 10, 2019 
Mr. CUMMINGS (for himself, Mr. WELCH, Mr. DOGGETT, Mr. SEAN PATRICK 
MALONEY of New York, Mr. POCAN, Ms. DELAURO, Ms. GABBARD, Ms. 
BONAMICI, Ms. OMAR, Mr. KHANNA, Ms. NORTON, Ms. JAYAPAL, Ms. 
SCHAKOWSKY, Mr. HIGGINS of New York, Mr. NEGUSE, Mr. COHEN, Mr. 
KRISHNAMOORTHI, and Ms. TLAIB) 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 provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to provide 
for the negotiation of lower covered part D drug prices 
on behalf of Medicare beneficiaries and the establishment 
and application of a formulary by the Secretary of 
Health and Human Services under Medicare part D, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Drug Price 
Negotiation Act’’. 
SEC. 2. NEGOTIATION OF LOWER COVERED PART D DRUG 
PRICES ON BEHALF OF MEDICARE BENE-
FICIARIES; ESTABLISHMENT AND APPLICA-
TION OF FORMULARY BY THE SECRETARY OF 
HEALTH 
AND 
HUMAN 
SERVICES 
UNDER 
MEDICARE PART D. 
(a) IN GENERAL.—Section 1860D–11 of the Social 
Security Act (42 U.S.C. 1395w–111) is amended by strik-
ing subsection (i) (relating to noninterference) and insert-
ing the following: 
‘‘(i) NEGOTIATION OF LOWER DRUG PRICES; ESTAB-
LISHMENT AND APPLICATION OF FORMULARY.— 
‘‘(1) NEGOTIATION.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
other provision of law, subject to subparagraph 
(B), the Secretary shall, with respect to an ap-
plicable period (as defined in subparagraph 
(H))— 
‘‘(i) during the negotiation year (as 
defined in such subparagraph) for such pe-
riod, negotiate with pharmaceutical manu-
facturers the prices (including discounts, 
rebates, and all other price concessions) 
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that may be charged to PDP sponsors and 
MA organizations for applicable covered 
part D drugs (as defined in such subpara-
graph) furnished to enrollees during such 
period; and 
‘‘(ii) complete such negotiations not 
less than 30 days before the first day of 
the application review process for the first 
plan year during the applicable period for 
new contracts or expanding existing con-
tracts with PDP sponsors and MA organi-
zations to offer prescription drug plans or 
MA–PD plans, respectively. 
‘‘(B) USE OF FALLBACK IF NEGOTIATIONS 
FAIL.— 
‘‘(i) IN GENERAL.—If, after negotia-
tions under subparagraph (A) with respect 
to an applicable period, the Secretary is 
not successful in obtaining an appropriate 
price for applicable covered part D drugs 
in accordance with clause (ii), the price 
that may be charged to PDP sponsors and 
MA organizations for applicable covered 
part D drugs furnished to enrollees during 
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such period shall be the lowest of the fol-
lowing: 
‘‘(I) The contract price applied 
pursuant to section 8126 of title 38, 
United States Code, for such drug for 
the contract year (as defined in such 
section 8126). 
‘‘(II) The average of the prices 
available, during the most recent 12- 
month period for which data is avail-
able from the manufacturer to any 
wholesaler, retailer, provider, health 
maintenance organization, nonprofit 
entity, or governmental entity in Can-
ada, the United Kingdom, Germany, 
France, and Japan. 
‘‘(III) The best price determined 
under section 1927(c)(1)(C) for such 
drug for the most recent rebate period 
(as defined in section 1927(k)(8)) ap-
plicable to such first plan year of the 
applicable period. 
‘‘(ii) GUIDANCE.—Not later than 6 
months before the Secretary begins nego-
tiations under subparagraph (A) with re-
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spect to the first applicable period, the 
Secretary shall issue guidance on criteria 
to be considered for purposes of deter-
mining under clause (i) whether or not the 
Secretary is successful in obtaining an ap-
propriate price for an applicable covered 
part D drug. Such criteria shall include at 
least the following: 
‘‘(I) The comparative clinical ef-
fectiveness and cost effectiveness, if 
available, of such covered part D 
drug. 
‘‘(II) The budgetary impact of 
providing coverage under this part for 
such covered part D drug. 
‘‘(III) The number of similarly 
effective drug or alternative treatment 
regimens for each approved use of 
such covered part D drug. 
‘‘(IV) Associated unmet need or 
severity of illness. 
‘‘(C) IDENTIFICATION
OF
APPLICABLE 
COVERED PART D DRUGS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall, for each applicable period, in accord-
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