Access to Innovative Treatments Act of 2022
Bill: H.R.9358 | Sponsor: Rep. Barragan, Nanette Diaz (D-CA)
Policy area: Health

Summary:
Access to Innovative Treatments Act of 2022
This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so. (Under the bill, adverse national coverage determinations are denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration.) The bill's requirements do not apply if the CMS already conducted such a review within a two-year period.
The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.

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 2022''.

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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