I 

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. BARRAGA ́N (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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Innovative 

5 Treatments Act of 2023’’. 


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1 SEC. 2. PROVIDING A REVIEW PROCESS FOR ADVERSE NA2 TIONAL COVERAGE DETERMINATIONS WITH 

3 RESPECT TO DRUG COVERAGE UNDER THE 

4 MEDICARE PROGRAM. 

5 (a) IN GENERAL.—Section 1862(l) of the Social Se6 curity Act (42 U.S.C. 1395y(l)) is amended— 

7 (1) by redesignating paragraphs (5) and (6) as 

8 paragraphs (7) and (8), respectively; and 

9 (2) by inserting after paragraph (4) the fol10 lowing new paragraphs: 

11 ‘‘(5) REVIEW OF NATIONAL COVERAGE DETER12 MINATIONS FOR DRUGS AND BIOLOGICALS.— 

13 ‘‘(A) IN GENERAL.—Subject to subpara14 graph (D), not later than 30 days after receiv15 ing a request for a review of a specified na16 tional coverage determination (as defined in 

17 subparagraph (E)), the Secretary shall initiate 

18 such a review in accordance with the provisions 

19 of this paragraph. 

20 ‘‘(B) PUBLIC COMMENT PERIOD.—Begin21 ning on the date of the initiation of a review of 

22 a specified national coverage determination 

23 under subparagraph (A), the Secretary shall 

24 provide for a 30-day public comment period as 

25 to whether such determination should be af26 firmed, reversed, or otherwise modified. 


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1 ‘‘(C) FINAL DECISION.—Not later than 30 

2 days after the conclusion of the 30-day period 

3 described in subparagraph (B) with respect to 

4 a specified national coverage determination, the 

5 Secretary shall— 

6 ‘‘(i) make a final decision as to wheth7 er such determination should be affirmed, 

8 reversed, or otherwise modified; 

9 ‘‘(ii) include in such final decision 

10 summaries of the public comments received 

11 and responses to such comments; 

12 ‘‘(iii) make available to the public the 

13 clinical evidence and other data used in 

14 making such decision when such decision 

15 differs from the recommendations of the 

16 Medicare Coverage Advisory Committee; 

17 and 

18 ‘‘(iv) in the case of a final decision 

19 under clause (i) to reverse or modify such 

20 determination, the Secretary shall assign a 

21 temporary or permanent code (whether ex22 isting or unclassified) and implement the 

23 coding change as applicable. 

24 ‘‘(D) LIMITATION ON SUCCESSIVE RE25 VIEWS.—Subparagraph (A) shall not apply with 


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•HR 2408 IH

1 respect to a request for a review of a specified 

2 national coverage determination if the Secretary 

3 has made a final decision with respect to a pre4 vious review of such determination under this 

5 paragraph during the 2-year period ending on 

6 the date of the receipt of such request. Nothing 

7 in the preceding sentence shall be construed to 

8 limit the authority of the Secretary to review or 

9 reconsider a national coverage determination if 

10 determined appropriate by the Secretary. 

11 ‘‘(E) SPECIFIED NATIONAL COVERAGE DE12 TERMINATION DEFINED.—In this paragraph, 

13 the term ‘specified national coverage determina14 tion’ means a national coverage determination 

15 made with respect to a drug or biological ap16 proved under section 505(c) of the Federal 

17 Food, Drug, and Cosmetic Act or licensed 

18 under section 351 of the Public Health Service 

19 Act under which coverage of such drug or bio20 logical under this title was denied or otherwise 

21 limited in a manner inconsistent with such ap22 proval or licensure. 

23 ‘‘(6) PROHIBITION ON APPLICATION OF CER24 TAIN EXISTING NATIONAL COVERAGE DETERMINA25 TIONS TO NEWLY APPROVED DRUGS AND


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•HR 2408 IH

1 BIOLOGICALS.—The Secretary may not, with respect 

2 to a drug approved under section 505(c) of the Fed3 eral Food, Drug, and Cosmetic Act or a biological 

4 licensed under section 351 of the Public Health 

5 Service Act, apply a national coverage determination 

6 that was made prior to the date of such approval or 

7 licensure (as applicable) to the extent that such ap8 plication would result in a denial or other limit of 

9 coverage under this title for such drug or biological 

10 in a manner inconsistent with such approval or li11 censure.’’. 

12 (b) NONRELIANCE ON CERTAIN NCDS UNDER PART

13 D.—Section 1860D–2(e)(3) of the Social Security Act (42 

14 U.S.C. 1395w–102(e)(3)) is amended by adding at the end 

15 the following new sentence: ‘‘In determining whether pay16 ment would not be made with respect to a covered part 

17 D drug if section 1862(a) applied to this part, a prescrip18 tion drug plan or MA–PD plan may not base such deter19 mination on a national coverage determination made with 

20 respect to such drug if such determination is a specified 

21 national coverage determination (as defined in section 

22 1862(l)(5)).’’. 

Æ 


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