I 116th CONGRESS 1st Session H. R. 3772 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. Short title This Act may be cited as the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 . 2. Separate payment for certain diagnostic radiopharmaceuticals (a) In general Section 1833(t)(16) of the Social Security Act ( 42 U.S.C. 1395l(t)(16) ) is amended by adding at the end the following new subparagraph: (G) Separate payment for certain diagnostic radiopharmaceuticals (i) In general Notwithstanding any other provision of this subsection, with respect to services furnished on or after January 1, 2020, the Secretary shall not package, and shall make a separate payment as specified in clause (ii) for, a diagnostic radiopharmaceutical defined in clause (v) with an estimated mean per day product cost equal to or exceeding the threshold specified in clause (iii). (ii) Separate payment For purposes of clause (i), payment specified in this clause for a diagnostic radiopharmaceutical described in clause (i) shall be equal to— (I) the average sales price for the drug established under section 1847A, to the extent the average sales price is available, as calculated and adjusted by the Secretary to the extent such adjustment is adopted for other specified covered outpatient drugs under paragraph (14)(A); or (II) if the data necessary to calculate the average sales price for the drug in the year under the sections specified in subclause (I) is not available, the wholesale acquisition cost as defined in subsection 1847A(c)(6)(B), or, if the wholesale acquisition cost is not available, the mean unit cost data derived from hospital claims data. (III) Nothing in this subparagraph shall be construed as affecting eligibility of diagnostic radiopharmaceuticals for pass-through payments under paragraph (6). (iii) Threshold For purposes of this subparagraph, the threshold specified in this clause— (I) for 2020, is $500; and (II) for subsequent years, is the amount specified in this clause for the preceding year increased by the percentage of the OPD fee schedule increase factor under paragraph (3)(C)(iv) for the applicable year. (iv) Budget neutrality The Secretary shall make such adjustments as are necessary under subparagraph 9(B) to ensure that the amount of expenditures under this subsection for such year with application of this subparagraph is equal to the amount of expenditures that would be made under this subsection for such year without application of this subparagraph. (v) Definition For purposes of this subparagraph, a diagnostic radiopharmaceutical is a drug or biological that is described in section 315.2(a) of title 21, Code of Federal Regulations, or any successor regulation, and is approved by the Food and Drug Administration on or after January 1, 2008. . (b) No impact on copayment Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t)(8)(E) ) is amended by— (1) inserting AND SEPARATE PAYMENTS FOR CERTAIN DIAGNOSTIC RADIOPHARMACEUTICALS after PASS–THROUGH ADJUSTMENTS ; and (2) inserting after such adjustments) the phrase and subparagraph (16)(G) .