156 
physicians, pharmacists, and other clinicians, 
retail pharmacies, plan sponsors, entities dele-
gated by plan sponsors, and biopharmaceutical 
manufacturers for input regarding the topics 
described in subparagraph (B). 
(B) TOPICS DESCRIBED.—The topics de-
scribed in this subparagraph are the topics of— 
(i) the anticipated impact of drug 
management programs for at-risk bene-
ficiaries under paragraph (5) of section 
1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c)) on cost-sharing and 
ensuring accessibility to prescription drugs 
for enrollees in prescription drug plans of 
PDP sponsors, and enrollees in MA–PD 
plans, who are at-risk beneficiaries for pre-
scription drug abuse (as defined in sub-
paragraph (C) of such paragraph); 
(ii) the use of an expedited appeals 
process under which such an enrollee may 
appeal an identification of such enrollee as 
an at-risk beneficiary for prescription drug 
abuse under such paragraph (similar to the 
processes established under the Medicare 
Advantage program under part C of title 
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157 
XVIII of the Social Security Act that allow 
an automatic escalation to external review 
of claims submitted under such part); 
(iii) the types of enrollees that should 
be treated as exempted individuals, as de-
scribed in subparagraph (C)(ii) of such 
paragraph; 
(iv) the manner in which terms and 
definitions in such paragraph should be ap-
plied, such as the use of clinical appro-
priateness in determining whether an en-
rollee is an at-risk beneficiary for prescrip-
tion drug abuse as defined in subpara-
graph (C) of such paragraph; 
(v) the information to be included in 
the notices described in subparagraph (B) 
of such paragraph and the standardization 
of such notices; and 
(vi) with respect to a PDP sponsor 
(or Medicare Advantage organization) that 
establishes a drug management program 
for at-risk beneficiaries under such para-
graph, the responsibilities of such PDP 
sponsor (or organization) with respect to 
the implementation of such program. 
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(g) RULEMAKING.—The Secretary of Health and 
Human Services shall promulgate regulations based on the 
input gathered pursuant to subsection (f)(2)(A). 
SEC. 502. EXCLUSION OF AUTHORIZED GENERIC DRUGS 
FROM CALCULATION OF AVERAGE MANUFAC-
TURER PRICE FOR BRAND NAME DRUGS. 
(a) IN GENERAL.—Section 1927(k)(1)(C) of the So-
cial Security Act (42 U.S.C. 1396r–8(k)(1)(C)) is amend-
ed— 
(1) in the subparagraph heading, by striking 
‘‘INCLUSION’’ and inserting ‘‘EXCLUSION’’; 
(2) by striking ‘‘a new drug application’’ and 
inserting ‘‘the manufacturer’s new drug applica-
tion’’; and 
(3) by striking ‘‘inclusive’’ and inserting ‘‘exclu-
sive’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall take effect one year after the date of 
the enactment of this section. 
Æ 
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