SEC. 2. PROVIDING A REVIEW PROCESS FOR ADVERSE NA-
TIONAL COVERAGE DETERMINATIONS WITH 
RESPECT TO DRUG COVERAGE UNDER THE 
MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1862(l) of the Social Se-
curity Act (42 U.S.C. 1395y(l)) is amended— 
(1) by redesignating paragraphs (5) and (6) as 
paragraphs (7) and (8), respectively; and 
(2) by inserting after paragraph (4) the fol-
lowing new paragraphs: 
‘‘(5) REVIEW OF NATIONAL COVERAGE DETER-
MINATIONS FOR DRUGS AND BIOLOGICALS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (D), not later than 30 days after receiv-
ing a request for a review of a specified na-
tional coverage determination (as defined in 
subparagraph (E)), the Secretary shall initiate 
such a review in accordance with the provisions 
of this paragraph. 
‘‘(B) PUBLIC COMMENT PERIOD.—Begin-
ning on the date of the initiation of a review of 
a specified national coverage determination 
under subparagraph (A), the Secretary shall 
provide for a 30-day public comment period as 
to whether such determination should be af-
firmed, reversed, or otherwise modified. 
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‘‘(C) FINAL DECISION.—Not later than 30 
days after the conclusion of the 30-day period 
described in subparagraph (B) with respect to 
a specified national coverage determination, the 
Secretary shall— 
‘‘(i) make a final decision as to wheth-
er such determination should be affirmed, 
reversed, or otherwise modified; 
‘‘(ii) include in such final decision 
summaries of the public comments received 
and responses to such comments; 
‘‘(iii) make available to the public the 
clinical evidence and other data used in 
making such decision when such decision 
differs from the recommendations of the 
Medicare Coverage Advisory Committee; 
and 
‘‘(iv) in the case of a final decision 
under clause (i) to reverse or modify such 
determination, the Secretary shall assign a 
temporary or permanent code (whether ex-
isting or unclassified) and implement the 
coding change as applicable. 
‘‘(D) LIMITATION
ON
SUCCESSIVE
RE-
VIEWS.—Subparagraph (A) shall not apply with 
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respect to a request for a review of a specified 
national coverage determination if the Secretary 
has made a final decision with respect to a pre-
vious review of such determination under this 
paragraph during the 2-year period ending on 
the date of the receipt of such request. Nothing 
in the preceding sentence shall be construed to 
limit the authority of the Secretary to review or 
reconsider a national coverage determination if 
determined appropriate by the Secretary. 
‘‘(E) SPECIFIED NATIONAL COVERAGE DE-
TERMINATION
DEFINED.—In this paragraph, 
the term ‘specified national coverage determina-
tion’ means a national coverage determination 
made with respect to a drug or biological ap-
proved under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act or licensed 
under section 351 of the Public Health Service 
Act under which coverage of such drug or bio-
logical under this title was denied or otherwise 
limited in a manner inconsistent with such ap-
proval or licensure. 
‘‘(6) PROHIBITION ON APPLICATION OF CER-
TAIN EXISTING NATIONAL COVERAGE DETERMINA-
TIONS
TO
NEWLY-APPROVED
DRUGS
AND 
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BIOLOGICALS.—The Secretary may not, with respect 
to a drug approved under section 505(c) of the Fed-
eral Food, Drug, and Cosmetic Act or a biological 
licensed under section 351 of the Public Health 
Service Act, apply a national coverage determination 
that was made prior to the date of such approval or 
licensure (as applicable) to the extent that such ap-
plication would result in a denial or other limit of 
coverage under this title for such drug or biological 
in a manner inconsistent with such approval or li-
censure.’’. 
(b) NONRELIANCE ON CERTAIN NCDS UNDER PART 
D.—Section 1860D–2(e)(3) of the Social Security Act (42 
U.S.C. 1395w–102(e)(3)) is amended by adding at the end 
the following new sentence: ‘‘In determining whether pay-
ment would not be made with respect to a covered part 
D drug if section 1862(a) applied to this part, a prescrip-
tion drug plan or MA–PD plan may not base such deter-
mination on a national coverage determination made with 
respect to such drug if such determination is a specified 
national coverage determination (as defined in section 
1862(l)(5)).’’. 
Æ 
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