Section 1 Short title
This Act may be cited as the “Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018”.
Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
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.
Sec. 2 Separate payment for certain diagnostic radiopharmaceuticals
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, 2019, the Secretary shall not package, and shall make a separate payment as specified in clause (ii) for, a diagnostic radiopharmaceutical 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 price for the drug in the year under the sections specified in subclause (I) is not available, the average acquisition cost for the drug for that year (which, at the option of the Secretary, may vary by hospital group (as defined by the Secretary based on volume of covered OPD services or other relevant characteristics)), as determined by the Secretary taking into account the hospital acquisition cost survey data under paragraph (14)(D).
“(iii) Threshold—For purposes of this subparagraph, the threshold specified in this clause—
“(I) for 2019, 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 this subsection, with respect to a year, 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.”