ered part D drug that is identified as an 
applicable covered part D drug for an ap-
plicable period, such covered part D drug 
shall be identified as an applicable covered 
part D drug for each subsequent third ne-
gotiation year. 
‘‘(iv) REASONABLE
NOTIFICATION.— 
The Secretary shall carry out this subpara-
graph in such manner as to provide for 
public notification of applicable covered 
part D drugs for the applicable period 
within a reasonable period before the be-
ginning of the negotiation year for such 
period. 
‘‘(D) PRIORITIZATION
OF
CERTAIN
COV-
ERED PART D DRUGS.—For purposes of sub-
paragraph (C)(ii), the Secretary shall prioritize 
covered part D drugs— 
‘‘(i) that are among— 
‘‘(I) the 40 covered part D drugs 
that are utilized by at least 1,000 
Medicare part D beneficiaries and 
with respect to which there were the 
highest total expenditures under this 
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part during the most recent 12-month 
period for which data is available; 
‘‘(II) the 40 covered part D 
drugs that are utilized by at least 
1,000 Medicare part D beneficiaries 
with respect to whom the total annual 
spending per such a beneficiary under 
this part for coverage of such a drug 
is at least $10,000; or 
‘‘(III) the 20 covered part D 
drugs that are utilized by at least 
1,000 Medicare part D beneficiaries 
and with respect to which there are 
unit cost increases at or above the 
95th percentile of overall covered part 
D drug unit cost increases during the 
most recent 12-month period prior to 
the beginning of such negotiation year 
for which data is available; 
‘‘(ii) with respect to which the cost of 
such a drug to the part D eligible indi-
vidual involved would exceed the annual 
out-of-pocket threshold applicable under 
section 1860D–2(b)(4)(B) for such nego-
tiation year, if the drug were prescribed to 
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pbinns on DSK79D2C42PROD with BILLS
the individual for the period of the year or 
with respect to which a single treatment 
regimen is priced above such annual out- 
of-pocket threshold applicable under such 
section 1860D–2(b)(4)(B) for the year; or 
‘‘(iii) that are single-source drugs or 
biologicals 
(as 
defined 
in 
section 
1847A(c)(6)(D)) and that satisfy at least 
one other criterion described in a previous 
clause of this subparagraph. 
‘‘(E) ANNUAL
REPORT
TO
CONGRESS.— 
Not later than 30 days after the date on which 
the Secretary completes negotiations under this 
paragraph for the first negotiation year and 
each year thereafter, the Secretary shall submit 
to Congress and make available to the public a 
report describing the negotiations during the 
preceding negotiation year, including— 
‘‘(i) the number of applicable covered 
part D drug prices negotiated; 
‘‘(ii) 
the 
magnitude 
of 
savings 
achieved as a result of such negotiations; 
‘‘(iii) the number of times price nego-
tiations failed (based on the criteria in-
cluded in the guidance issued pursuant to 
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pbinns on DSK79D2C42PROD with BILLS
clause (ii) of subparagraph (B)) and re-
sulted in the use of fallback prices under 
clause (i) of such subparagraph, and the 
rationale for any such decisions; 
‘‘(iv) the progress made toward nego-
tiating the prices of covered part D drugs 
that are prioritized under subparagraph 
(D); and 
‘‘(v) the barriers, if any, to achieving 
savings through negotiations. 
‘‘(F) GAO REPORT.—Not later than De-
cember 31, 2024, the Comptroller General of 
the United States shall submit to Congress a 
report on the negotiations conducted by the 
Secretary under this paragraph, including a de-
scription and analysis of— 
‘‘(i) the extent to which such price ne-
gotiations are achieving lower prices for 
covered part D drugs for enrollees; 
‘‘(ii) the parties benefitting from such 
lower prices, such as enrollees, the Federal 
government, 
States, 
prescription 
drug 
plans and MA–PD plans, or other entities; 
‘‘(iii) how such price negotiations are 
affecting— 
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pbinns on DSK79D2C42PROD with BILLS
‘‘(I) the list price of covered part 
D drugs; and 
‘‘(II) drug prices in the private 
market; and 
‘‘(iv) recommendations for improving 
price negotiations, if applicable. 
‘‘(G) DEFINITIONS.—For purposes of this 
paragraph: 
‘‘(i) APPLICABLE
COVERED
PART
D 
DRUGS.—The term ‘applicable covered part 
D drugs’ means, for an applicable period, 
covered part D drugs identified by the Sec-
retary under subparagraph (C) for such 
period. 
‘‘(ii) APPLICABLE PERIOD.—The term 
‘applicable period’ means, with respect to a 
negotiation year and applicable covered 
part D drugs, the 3-plan year period be-
ginning with the first plan year beginning 
after the negotiation year for such covered 
part D drugs. 
‘‘(iii) NEGOTIATION YEAR.—The term 
‘negotiation year’ means, with respect to 
an applicable period, a plan year, begin-
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