I 

118TH CONGRESS 

1ST SESSION H. R. 1199 

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 HOUSE OF REPRESENTATIVES 

FEBRUARY 27, 2023 

Mr. DUNN of Florida (for himself, Mr. MURPHY, Mr. PETERS, Ms. SEWELL, 

Mrs. TRAHAN, Ms. BLUNT ROCHESTER, Mrs. MILLER-MEEKS, Mr. 

AUCHINCLOSS, Mr. TONKO, Mr. JOYCE of Pennsylvania, Mrs. WATSON

COLEMAN, Ms. KUSTER, Mr. PAPPAS, Mr. RESCHENTHALER, Mr. 

MCGOVERN, and Mr. BUCSHON) introduced the following bill; which was 

referred to the Committee on Energy and Commerce, and in addition to 

the Committee on Ways and Means, 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 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Facilitating Innovative 

3 Nuclear Diagnostics Act of 2023’’. 

4 SEC. 2. SEPARATE PAYMENT FOR CERTAIN DIAGNOSTIC 

5 RADIOPHARMACEUTICALS. 

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

7 Security Act (42 U.S.C. 1395(t)(16)) is amended by add8 ing at the end the following new subparagraph: 

9 ‘‘(H) SEPARATE PAYMENT FOR CERTAIN

10 DIAGNOSTIC RADIOPHARMACEUTICALS.— 

11 ‘‘(i) IN GENERAL.—Notwithstanding 

12 any other provision of this subsection, with 

13 respect to services furnished on or after 

14 January 1, 2024, the Secretary shall not 

15 package, and shall make a separate pay16 ment as specified in clause (ii) for a diag17 nostic radiopharmaceutical (as defined in 

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

19 product cost equal to or exceeding the 

20 threshold specified in clause (iii). 

21 ‘‘(ii) SEPARATE PAYMENT.—For pur22 poses of clause (i), the separate payment 

23 specified in this subclause for a diagnostic 

24 radiopharmaceutical described in clause (i) 

25 shall be equal to— 


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1 ‘‘(I) the average sales price for 

2 the drug established under section 

3 1847A, to the extent the average sales 

4 price is available, as calculated and 

5 adjusted by the Secretary to the ex6 tent such adjustment is adopted for 

7 other specified covered outpatient 

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

9 ‘‘(II) if the data necessary to cal10 culate the average sales price for the 

11 drug in the year under the section 

12 and paragraph specified in subclause 

13 (I) is not available, the wholesale ac14 quisition cost (as defined in subsection 

15 1847A(c)(6)(B)), as calculated and 

16 adjusted by the Secretary to the ex17 tent such adjustment is adopted for 

18 other specified covered outpatient 

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

20 the wholesale acquisition cost is not 

21 available, the mean unit cost data de22 rived from hospital claims data. 

23 Nothing in this subparagraph shall be con24 strued as affecting eligibility of diagnostic 


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1 radiopharmaceuticals for pass-through pay2 ments under paragraph (6). 

3 ‘‘(iii) THRESHOLD.—For purposes of 

4 this subparagraph, the threshold specified 

5 in this clause— 

6 ‘‘(I) for 2024, is $500; and 

7 ‘‘(II) for a subsequent year, is 

8 the amount specified in this clause for 

9 the preceding year increased by the 

10 OPD fee schedule increase factor 

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

12 year. 

13 ‘‘(iv) BUDGET NEUTRALITY.—The 

14 Secretary shall make such adjustments as 

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

16 ensure that the amount of expenditures 

17 under this subsection for a year with appli18 cation of this subparagraph is equal to the 

19 amount of expenditures that would be 

20 made under this subsection for such year 

21 without application of this subparagraph. 

22 ‘‘(v) DEFINITION OF DIAGNOSTIC

23 RADIOPHARMACEUTICAL.—For purposes of 

24 this subparagraph, the term ‘diagnostic 

25 radiopharmaceutical’ means a drug or bioVerDate Sep 11 2014 07:12 Mar 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1199.IH H1199

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1 logical that is described in section 315.2(a) 

2 of title 21, Code of Federal Regulations, or 

3 any successor regulation, and is approved 

4 by the Food and Drug Administration on 

5 or after January 1, 2008.’’. 

6 (b) NO IMPACT ON COPAYMENT.—Section 

7 1833(t)(8)(E) of the Social Security Act (42 U.S.C. 

8 1395l(t)(8)(E)) is amended— 

9 (1) in the heading, by inserting ‘‘AND SEPA10 RATE PAYMENTS FOR CERTAIN DIAGNOSTIC RADIO11 PHARMACEUTICALS’’ after ‘‘PASS-THROUGH ADJUST12 MENTS’’; and 

13 (2) by inserting ‘‘and paragraph (16)(H)’’ after 

14 ‘‘such adjustments)’’. 

Æ 


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