Facilitating Innovative Nuclear Diagnostics Act of 2023

II 118TH CONGRESS 1ST SESSION S. 1544 To amend title XVIII of the Social Security Act to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharma- ceuticals under the Medicare hospital outpatient prospective payment system. IN THE SENATE OF THE UNITED STATES MAY 10, 2023 Mrs. BLACKBURN (for herself and Ms. BALDWIN) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system. 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 ‘‘Facilitating Innovative 4 Nuclear Diagnostics Act of 2023’’. 5 VerDate Sep 11 2014 02:01 May 20, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1544.IS S1544 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1544 IS SEC. 2. SEPARATE PAYMENT FOR CERTAIN DIAGNOSTIC 1 RADIOPHARMACEUTICALS. 2 (a) IN GENERAL.—Section 1833(t)(16) of the Social 3 Security Act (42 U.S.C. 1395l(t)(16)) is amended by add- 4 ing at the end the following new subparagraph: 5 ‘‘(H) SEPARATE PAYMENT FOR CERTAIN 6 DIAGNOSTIC RADIOPHARMACEUTICALS.— 7 ‘‘(i) IN GENERAL.—Notwithstanding 8 any other provision of this subsection, with 9 respect to services furnished on or after 10 January 1, 2024, the Secretary shall not 11 package, and shall make a separate pay- 12 ment as specified in clause (ii) for a diag- 13 nostic radiopharmaceutical (as defined in 14 clause (v)) with an estimated mean per day 15 product cost equal to or exceeding the 16 threshold specified in clause (iii). 17 ‘‘(ii) SEPARATE PAYMENT.—For pur- 18 poses of clause (i), the separate payment 19 specified in this subclause for a diagnostic 20 radiopharmaceutical described in clause (i) 21 shall be equal to— 22 ‘‘(I) the average sales price for 23 the drug established under section 24 1847A, to the extent the average sales 25 price is available, as calculated and 26 VerDate Sep 11 2014 02:01 May 20, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1544.IS S1544 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1544 IS adjusted by the Secretary to the ex- 1 tent such adjustment is adopted for 2 other specified covered outpatient 3 drugs under paragraph (14)(A); or 4 ‘‘(II) if the data necessary to cal- 5 culate the average sales price for the 6 drug in the year under the section 7 and paragraph specified in subclause 8 (I) is not available, the wholesale ac- 9 quisition cost (as defined in section 10 1847A(c)(6)(B)), as calculated and 11 adjusted by the Secretary to the ex- 12 tent such adjustment is adopted for 13 other specified covered outpatient 14 drugs under paragraph (14)(A), or, if 15 the wholesale acquisition cost is not 16 available, the mean unit cost data de- 17 rived from hospital claims data. 18 Nothing in this subparagraph shall be con- 19 strued as affecting the eligibility of diag- 20 nostic radiopharmaceuticals for pass- 21 through payments under paragraph (6). 22 ‘‘(iii) THRESHOLD.—For purposes of 23 this subparagraph, the threshold specified 24 in this clause— 25 VerDate Sep 11 2014 02:01 May 20, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1544.IS S1544 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1544 IS ‘‘(I) for 2024, is $500; and 1 ‘‘(II) for a subsequent year, is 2 the amount specified in this clause for 3 the preceding year increased by the 4 OPD fee schedule increase factor 5 under paragraph (3)(C)(iv) for the 6 year. 7 ‘‘(iv) BUDGET NEUTRALITY.—The 8 Secretary shall make such adjustments as 9 are necessary under paragraph (9)(B) to 10 ensure that the amount of expenditures 11 under this subsection for a year with appli- 12 cation of this subparagraph is equal to the 13 amount of expenditures that would be 14 made under this subsection for such year 15 without application of this subparagraph. 16 ‘‘(v) DEFINITION OF DIAGNOSTIC 17 RADIOPHARMACEUTICAL.—For purposes of 18 this subparagraph, the term ‘diagnostic 19 radiopharmaceutical’ means a drug or bio- 20 logical that is described in section 315.2(a) 21 of title 21, Code of Federal Regulations, or 22 any successor regulation, and is approved 23 by the Food and Drug Administration on 24 or after January 1, 2008.’’. 25 VerDate Sep 11 2014 02:01 May 20, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1544.IS S1544 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1544 IS (b) NO IMPACT ON COPAYMENT.—Section 1 1833(t)(8)(E) of the Social Security Act (42 U.S.C. 2 1395l(t)(8)(E)) is amended— 3 (1) in the heading, by inserting ‘‘AND SEPA- 4 RATE PAYMENTS FOR CERTAIN DIAGNOSTIC RADIO- 5 PHARMACEUTICALS’’ after ‘‘PASS-THROUGH ADJUST- 6 MENTS’’; and 7 (2) by inserting ‘‘and paragraph (16)(H)’’ after 8 ‘‘such adjustments)’’. 9 Æ VerDate Sep 11 2014 02:01 May 20, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S1544.IS S1544 kjohnson on DSK79L0C42PROD with BILLS