‘‘(i) preventing the sponsor of a pre-
scription drug plan, or an organization of-
fering an MA–PD plan, from obtaining a 
discount or reduction of the price for a 
covered part D drug described in subpara-
graph (A) below the price negotiated under 
such subparagraph or determined under 
subparagraph (B); or 
‘‘(ii) permitting the Secretary to make 
proprietary data available to the public. 
‘‘(E) DEFINITIONS.—In this paragraph: 
‘‘(i) 
DRUG
MANUFACTURER.—The 
term ‘drug manufacturer’ has the meaning 
given the term ‘manufacturer’ in section 
1860D–14A(g)(5). 
‘‘(ii) SINGLE SOURCE DRUG OR BIO-
LOGICAL.—The term ‘single source drug or 
biological’ has the meaning given such 
term in section 1847A(c)(6)(D).’’. 
(b) REQUIRING PARTICIPATION
IN NEGOTIATION 
PROCESS AS CONDITION OF PART D DRUG COVERAGE.— 
Section 1860D–14A(b) of the Social Security Act (42 
U.S.C. 1395w–114a(b)) is amended by adding at the end 
the following new paragraph: 
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‘‘(5) PARTICIPATION
IN
NEGOTIATION
PROC-
ESS.—Each agreement under this subsection shall 
include, with respect to plans years beginning with 
plan year 2019, an agreement by the manufacturer, 
with respect to each specified drug of such manufac-
turer under section 1860d–11(i)(2), to participate in 
the negotiation process under such section for such 
drug, including accepting the price resulting from 
the negotiation (or, in the case that such negotiation 
does not result in a price for such drug that is 
agreed to by the Secretary and the manufacturer, 
the price resulting from the application of subpara-
graph (B)(ii) of such section) as the maximum price 
for such drug for the period provided under such 
section.’’. 
SEC. 3. STUDY AND REPORT. 
(a) STUDY.—The Secretary of Health and Human 
Services shall conduct a study examining— 
(1) the impact of the amendments made by sec-
tion 2 on— 
(A) the cost of single source drugs and 
biologicals 
(as 
defined 
in 
section 
1847A(c)(6)(D) of the Social Security Act (42 
U.S.C. 1395w–3a(c)(6)(D))) for which payment 
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is made under part B of title XVIII of such 
Act; and 
(B) the accessibility of such drugs and 
biologicals for individuals entitled to benefits 
under part A of such title or enrolled under 
part B of such title; and 
(2) options that would permit or require the 
Secretary to create and implement, not later than 
one year after the date of the report described in 
subsection (b)— 
(A) a method to apply to such single 
source drugs and biologicals for which the Sec-
retary determines appropriate— 
(i) an authority similar to the author-
ity granted to the Secretary under sub-
paragraph (A) of section 1860D–11(i)(2) 
of such Act (relating to negotiating with 
drug manufacturers the part D prices for 
certain specified drugs); and 
(ii) a negotiation process similar to 
the process under subparagraph (B) of 
such section; and 
(B) a method, such as a rebate program, 
to incorporate the rate negotiated for such 
drugs and biologicals pursuant to the authority 
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described in subparagraph (A) into payments 
for such drugs and biologicals under part B of 
such Act. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit a report to Congress on the 
results of the study conducted under subsection (a). Such 
report shall include recommendations regarding the op-
tions examined pursuant to paragraph (2) of such sub-
section. 
Æ 
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