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 radiopharma- ceuticals 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 fol- lowing bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on Ways and Means, for a pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee 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. 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 ‘‘Medicare Diagnostic 4 Radiopharmaceutical Payment Equity Act of 2019’’. 5 VerDate Sep 11 2014 02:59 Jul 26, 2019 Jkt 034408 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3772.IH H3772 Pbinns on DSK79D2C42PROD with BILLS 2 •HR 3772 IH 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 ‘‘(G) 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, 2020, 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 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), payment specified in 19 this clause for a diagnostic radiopharma- 20 ceutical described in clause (i) shall be 21 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 02:59 Jul 26, 2019 Jkt 034408 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3772.IH H3772 Pbinns on DSK79D2C42PROD with BILLS 3 •HR 3772 IH 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 sections 7 specified in subclause (I) is not avail- 8 able, the wholesale acquisition cost as 9 defined in subsection 1847A(c)(6)(B), 10 or, if the wholesale acquisition cost is 11 not available, the mean unit cost data 12 derived from hospital claims data. 13 ‘‘(III) Nothing in this subpara- 14 graph shall be construed as affecting 15 eligibility of diagnostic radiopharma- 16 ceuticals for pass-through payments 17 under paragraph (6). 18 ‘‘(iii) THRESHOLD.—For purposes of 19 this subparagraph, the threshold specified 20 in this clause— 21 ‘‘(I) for 2020, is $500; and 22 ‘‘(II) for subsequent years, is the 23 amount specified in this clause for the 24 preceding year increased by the per- 25 VerDate Sep 11 2014 02:59 Jul 26, 2019 Jkt 034408 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3772.IH H3772 Pbinns on DSK79D2C42PROD with BILLS 4 •HR 3772 IH centage of the OPD fee schedule in- 1 crease factor under paragraph 2 (3)(C)(iv) for the applicable year. 3 ‘‘(iv) BUDGET NEUTRALITY.—The 4 Secretary shall make such adjustments as 5 are necessary under subparagraph 9(B) to 6 ensure that the amount of expenditures 7 under this subsection for such year with 8 application of this subparagraph is equal 9 to the amount of expenditures that would 10 be made under this subsection for such 11 year without application of this subpara- 12 graph. 13 ‘‘(v) DEFINITION.—For purposes of 14 this subparagraph, a diagnostic radio- 15 pharmaceutical is a drug or biological that 16 is described in section 315.2(a) of title 21, 17 Code of Federal Regulations, or any suc- 18 cessor regulation, and is approved by the 19 Food and Drug Administration on or after 20 January 1, 2008.’’. 21 (b) NO IMPACT ON COPAYMENT.—Section 1833(t) of 22 the Social Security Act (42 U.S.C. 1395l(t)(8)(E)) is 23 amended by— 24 VerDate Sep 11 2014 02:59 Jul 26, 2019 Jkt 034408 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3772.IH H3772 Pbinns on DSK79D2C42PROD with BILLS 5 •HR 3772 IH (1) inserting ‘‘AND SEPARATE PAYMENTS 1 FOR CERTAIN DIAGNOSTIC RADIOPHARMA- 2 CEUTICALS’’ after ‘‘PASS–THROUGH ADJUST- 3 MENTS’’; and 4 (2) inserting after ‘‘such adjustments)’’ the 5 phrase ‘‘and subparagraph (16)(G)’’. 6 Æ VerDate Sep 11 2014 02:59 Jul 26, 2019 Jkt 034408 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H3772.IH H3772 Pbinns on DSK79D2C42PROD with BILLS