[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2408 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 2408
To amend title XVIII of the Social Security Act to provide a review
process for adverse national coverage determinations with respect to
drug coverage under the Medicare program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 30, 2023
Ms. Barragan (for herself and Mr. Joyce of Pennsylvania) introduced the
following bill; which was referred to the Committee on Ways and Means,
and in addition to the Committee on Energy and Commerce, for a period
to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to provide a review
process for adverse national coverage determinations with respect to
drug coverage under the Medicare program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Access to Innovative Treatments Act
of 2023''.
SEC. 2. PROVIDING A REVIEW PROCESS FOR ADVERSE NATIONAL COVERAGE
DETERMINATIONS WITH RESPECT TO DRUG COVERAGE UNDER THE
MEDICARE PROGRAM.
(a) In General.--Section 1862(l) of the Social Security 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 following new
paragraphs:
``(5) Review of national coverage determinations for drugs
and biologicals.--
``(A) In general.--Subject to subparagraph (D), not
later than 30 days after receiving a request for a
review of a specified national 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.--Beginning 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
affirmed, reversed, or otherwise modified.
``(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 whether
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 existing
or unclassified) and implement the coding
change as applicable.
``(D) Limitation on successive reviews.--
Subparagraph (A) shall not apply with 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 previous 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 determination
defined.--In this paragraph, the term `specified
national coverage determination' means a national
coverage determination made with respect to a drug or
biological approved 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 biological under this title
was denied or otherwise limited in a manner
inconsistent with such approval or licensure.
``(6) Prohibition on application of certain existing
national coverage determinations to newly approved drugs and
biologicals.--The Secretary may not, with respect to a drug
approved under section 505(c) of the Federal 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
application 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 licensure.''.
(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 payment would not be made with respect to a covered
part D drug if section 1862(a) applied to this part, a prescription
drug plan or MA-PD plan may not base such determination 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)).''.
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