Access to Innovative Treatments Act of 2023

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 cov- erage 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 consider- ation 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 determina- tions with respect to drug coverage under the Medicare program. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Access to Innovative 4 Treatments Act of 2023’’. 5 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2408.IH H2408 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 2408 IH SEC. 2. PROVIDING A REVIEW PROCESS FOR ADVERSE NA- 1 TIONAL COVERAGE DETERMINATIONS WITH 2 RESPECT TO DRUG COVERAGE UNDER THE 3 MEDICARE PROGRAM. 4 (a) IN GENERAL.—Section 1862(l) of the Social Se- 5 curity Act (42 U.S.C. 1395y(l)) is amended— 6 (1) by redesignating paragraphs (5) and (6) as 7 paragraphs (7) and (8), respectively; and 8 (2) by inserting after paragraph (4) the fol- 9 lowing new paragraphs: 10 ‘‘(5) REVIEW OF NATIONAL COVERAGE DETER- 11 MINATIONS FOR DRUGS AND BIOLOGICALS.— 12 ‘‘(A) IN GENERAL.—Subject to subpara- 13 graph (D), not later than 30 days after receiv- 14 ing a request for a review of a specified na- 15 tional coverage determination (as defined in 16 subparagraph (E)), the Secretary shall initiate 17 such a review in accordance with the provisions 18 of this paragraph. 19 ‘‘(B) PUBLIC COMMENT PERIOD.—Begin- 20 ning on the date of the initiation of a review of 21 a specified national coverage determination 22 under subparagraph (A), the Secretary shall 23 provide for a 30-day public comment period as 24 to whether such determination should be af- 25 firmed, reversed, or otherwise modified. 26 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2408.IH H2408 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 2408 IH ‘‘(C) FINAL DECISION.—Not later than 30 1 days after the conclusion of the 30-day period 2 described in subparagraph (B) with respect to 3 a specified national coverage determination, the 4 Secretary shall— 5 ‘‘(i) make a final decision as to wheth- 6 er such determination should be affirmed, 7 reversed, or otherwise modified; 8 ‘‘(ii) include in such final decision 9 summaries of the public comments received 10 and responses to such comments; 11 ‘‘(iii) make available to the public the 12 clinical evidence and other data used in 13 making such decision when such decision 14 differs from the recommendations of the 15 Medicare Coverage Advisory Committee; 16 and 17 ‘‘(iv) in the case of a final decision 18 under clause (i) to reverse or modify such 19 determination, the Secretary shall assign a 20 temporary or permanent code (whether ex- 21 isting or unclassified) and implement the 22 coding change as applicable. 23 ‘‘(D) LIMITATION ON SUCCESSIVE RE- 24 VIEWS.—Subparagraph (A) shall not apply with 25 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2408.IH H2408 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 2408 IH respect to a request for a review of a specified 1 national coverage determination if the Secretary 2 has made a final decision with respect to a pre- 3 vious review of such determination under this 4 paragraph during the 2-year period ending on 5 the date of the receipt of such request. Nothing 6 in the preceding sentence shall be construed to 7 limit the authority of the Secretary to review or 8 reconsider a national coverage determination if 9 determined appropriate by the Secretary. 10 ‘‘(E) SPECIFIED NATIONAL COVERAGE DE- 11 TERMINATION DEFINED.—In this paragraph, 12 the term ‘specified national coverage determina- 13 tion’ means a national coverage determination 14 made with respect to a drug or biological ap- 15 proved under section 505(c) of the Federal 16 Food, Drug, and Cosmetic Act or licensed 17 under section 351 of the Public Health Service 18 Act under which coverage of such drug or bio- 19 logical under this title was denied or otherwise 20 limited in a manner inconsistent with such ap- 21 proval or licensure. 22 ‘‘(6) PROHIBITION ON APPLICATION OF CER- 23 TAIN EXISTING NATIONAL COVERAGE DETERMINA- 24 TIONS TO NEWLY APPROVED DRUGS AND 25 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2408.IH H2408 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 2408 IH BIOLOGICALS.—The Secretary may not, with respect 1 to a drug approved under section 505(c) of the Fed- 2 eral Food, Drug, and Cosmetic Act or a biological 3 licensed under section 351 of the Public Health 4 Service Act, apply a national coverage determination 5 that was made prior to the date of such approval or 6 licensure (as applicable) to the extent that such ap- 7 plication would result in a denial or other limit of 8 coverage under this title for such drug or biological 9 in a manner inconsistent with such approval or li- 10 censure.’’. 11 (b) NONRELIANCE ON CERTAIN NCDS UNDER PART 12 D.—Section 1860D–2(e)(3) of the Social Security Act (42 13 U.S.C. 1395w–102(e)(3)) is amended by adding at the end 14 the following new sentence: ‘‘In determining whether pay- 15 ment would not be made with respect to a covered part 16 D drug if section 1862(a) applied to this part, a prescrip- 17 tion drug plan or MA–PD plan may not base such deter- 18 mination on a national coverage determination made with 19 respect to such drug if such determination is a specified 20 national coverage determination (as defined in section 21 1862(l)(5)).’’. 22 Æ VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H2408.IH H2408 pbinns on DSKJLVW7X2PROD with $$_JOB