I 

116TH CONGRESS 

1ST SESSION H. R. 3772 

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 

JULY 16, 2019 

Mr. PETERS (for himself, Mr. RUSH, and Mr. HOLDING) 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Diagnostic 

5 Radiopharmaceutical Payment Equity Act of 2019’’. 


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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. 1395l(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, 2020, the Secretary shall not 

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

20 this clause for a diagnostic radiopharma21 ceutical described in clause (i) shall be 

22 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 sections 

8 specified in subclause (I) is not avail9 able, the wholesale acquisition cost as 

10 defined in subsection 1847A(c)(6)(B), 

11 or, if the wholesale acquisition cost is 

12 not available, the mean unit cost data 

13 derived from hospital claims data. 

14 ‘‘(III) Nothing in this subpara15 graph shall be construed as affecting 

16 eligibility of diagnostic radiopharma17 ceuticals for pass-through payments 

18 under paragraph (6). 

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

20 this subparagraph, the threshold specified 

21 in this clause— 

22 ‘‘(I) for 2020, is $500; and 

23 ‘‘(II) for subsequent years, is the 

24 amount specified in this clause for the 

25 preceding year increased by the perVerDate Sep 11 2014 02:59 Jul 26, 2019 Jkt 034408 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3772.IH H3772

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1 centage of the OPD fee schedule in2 crease factor under paragraph 

3 (3)(C)(iv) for the applicable year. 

4 ‘‘(iv) BUDGET NEUTRALITY.—The 

5 Secretary shall make such adjustments as 

6 are necessary under subparagraph 9(B) to 

7 ensure that the amount of expenditures 

8 under this subsection for such year with 

9 application of this subparagraph is equal 

10 to the amount of expenditures that would 

11 be made under this subsection for such 

12 year without application of this subpara13 graph. 

14 ‘‘(v) DEFINITION.—For purposes of 

15 this subparagraph, a diagnostic radio16 pharmaceutical is a drug or biological that 

17 is described in section 315.2(a) of title 21, 

18 Code of Federal Regulations, or any suc19 cessor regulation, and is approved by the 

20 Food and Drug Administration on or after 

21 January 1, 2008.’’. 

22 (b) NO IMPACT ON COPAYMENT.—Section 1833(t) of 

23 the Social Security Act (42 U.S.C. 1395l(t)(8)(E)) is 

24 amended by— 


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1 (1) inserting ‘‘AND SEPARATE PAYMENTS 

2 FOR CERTAIN DIAGNOSTIC RADIOPHARMA3 CEUTICALS’’ after ‘‘PASS–THROUGH ADJUST4 MENTS’’; and 

5 (2) inserting after ‘‘such adjustments)’’ the 

6 phrase ‘‘and subparagraph (16)(G)’’. 

Æ 


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