II 

117TH CONGRESS 

1ST SESSION S. 2609 

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. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 4, 2021 

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. 

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 ‘‘Facilitating Innovative 

5 Nuclear Diagnostics Act of 2021’’. 


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1 SEC. 2. SEPARATE PAYMENT FOR CERTAIN DIAGNOSTIC 

2 RADIOPHARMACEUTICALS. 

3 (a) IN GENERAL.—Section 1833(t)(16) of the Social 

4 Security Act (42 U.S.C. 1395(t)(16)) is amended by add5 ing at the end the following new subparagraph: 

6 ‘‘(G) SEPARATE PAYMENT FOR CERTAIN

7 DIAGNOSTIC RADIOPHARMACEUTICALS.— 

8 ‘‘(i) IN GENERAL.—Notwithstanding 

9 any other provision of this subsection, with 

10 respect to services furnished on or after 

11 January 1, 2022, the Secretary shall not 

12 package, and shall make a separate pay13 ment as specified in clause (ii) for a diag14 nostic radiopharmaceutical (as defined in 

15 clause (v)) with an estimated mean per day 

16 product cost equal to or exceeding the 

17 threshold specified in clause (iii). 

18 ‘‘(ii) SEPARATE PAYMENT.—For pur19 poses of clause (i), the separate payment 

20 specified in this subclause for a diagnostic 

21 radiopharmaceutical described in clause (i) 

22 shall be equal to— 

23 ‘‘(I) the average sales price for 

24 the drug established under section 

25 1847A, to the extent the average sales 

26 price is available, as calculated and 


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1 adjusted by the Secretary to the ex2 tent such adjustment is adopted for 

3 other specified covered outpatient 

4 drugs under paragraph (14)(A); or 

5 ‘‘(II) if the data necessary to cal6 culate the average sales price for the 

7 drug in the year under the section 

8 and paragraph specified in subclause 

9 (I) is not available, the wholesale ac10 quisition cost (as defined in subsection 

11 1847A(c)(6)(B)), as calculated and 

12 adjusted by the Secretary to the ex13 tent such adjustment is adopted for 

14 other specified covered outpatient 

15 drugs under paragraph (14)(A), or, if 

16 the wholesale acquisition cost is not 

17 available, the mean unit cost data de18 rived from hospital claims data. 

19 Nothing in this subparagraph shall be con20 strued as affecting eligibility of diagnostic 

21 radiopharmaceuticals for pass-through pay22 ments under paragraph (6). 

23 ‘‘(iii) THRESHOLD.—For purposes of 

24 this subparagraph, the threshold specified 

25 in this clause— 


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1 ‘‘(I) for 2022, is $500; and 

2 ‘‘(II) for a subsequent year, is 

3 the amount specified in this clause for 

4 the preceding year increased by the 

5 OPD fee schedule increase factor 

6 under paragraph (3)(C)(iv) for the 

7 year. 

8 ‘‘(iv) BUDGET NEUTRALITY.—The 

9 Secretary shall make such adjustments as 

10 are necessary under paragraph (9)(B) to 

11 ensure that the amount of expenditures 

12 under this subsection for a year with appli13 cation of this subparagraph is equal to the 

14 amount of expenditures that would be 

15 made under this subsection for such year 

16 without application of this subparagraph. 

17 ‘‘(v) DEFINITION OF DIAGNOSTIC

18 RADIOPHARMACEUTICAL.—For purposes of 

19 this subparagraph, the term ‘diagnostic 

20 radiopharmaceutical’ means a drug or bio21 logical that is described in section 315.2(a) 

22 of title 21, Code of Federal Regulations, or 

23 any successor regulation, and is approved 

24 by the Food and Drug Administration on 

25 or after January 1, 2008.’’. 


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1 (b) NO IMPACT ON COPAYMENT.—Section 

2 1833(t)(8)(E) of the Social Security Act (42 U.S.C. 

3 1395l(t)(8)(E)) is amended— 

4 (1) in the heading, by inserting ‘‘AND SEPA5 RATE PAYMENTS FOR CERTAIN DIAGNOSTIC RADIO6 PHARMACEUTICALS’’ after ‘‘PASS-THROUGH ADJUST7 MENTS’’; and 

8 (2) by inserting ‘‘and paragraph (16)(G)’’ after 

9 ‘‘such adjustments)’’. 

Æ 


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