Title: Facilitating Innovative Nuclear Diagnostics Act of 2021
Policy area: Health

Summary:
Facilitating Innovative Nuclear Diagnostics Act of 2021
This bill establishes separate payment requirements for diagnostic radiopharmaceuticals under the Medicare prospective payment system for hospital outpatient department services. The bill's requirements apply to diagnostic radiopharmaceuticals that have an average daily cost of $500 or more in 2022 and as adjusted based on a specified fee schedule factor in each year thereafter.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2609 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 2609

  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 SENATE OF THE UNITED STATES

                             August 4, 2021

 Mrs. Blackburn (for herself and Ms. Baldwin) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Facilitating Innovative Nuclear 
Diagnostics Act of 2021''.

SEC. 2. SEPARATE PAYMENT FOR CERTAIN DIAGNOSTIC RADIOPHARMACEUTICALS.

    (a) In General.--Section 1833(t)(16) of the Social Security Act (42 
U.S.C. 1395(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, 2022, the Secretary shall not 
                        package, and shall make a separate payment as 
                        specified in clause (ii) for a diagnostic 
                        radiopharmaceutical (as 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), the separate payment specified in 
                        this subclause 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 section 
                                and paragraph specified in subclause 
                                (I) is not available, the wholesale 
                                acquisition cost (as defined in 
                                subsection 1847A(c)(6)(B)), 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, if the wholesale 
                                acquisition cost is not available, the 
                                mean unit cost data derived from 
                                hospital claims data.
                        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 2022, is $500; and
                                    ``(II) for a subsequent year, is 
                                the amount specified in this clause for 
                                the preceding year increased by the OPD 
                                fee schedule increase factor under 
                                paragraph (3)(C)(iv) for the year.
                            ``(iv) Budget neutrality.--The Secretary 
                        shall make such adjustments as are necessary 
                        under paragraph (9)(B) to ensure that the 
                        amount of expenditures under this subsection 
                        for a 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 of diagnostic 
                        radiopharmaceutical.--For purposes of this 
                        subparagraph, the term `diagnostic 
                        radiopharmaceutical' means 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)(8)(E) of the Social 
Security Act (42 U.S.C. 1395l(t)(8)(E)) is amended--
            (1) in the heading, by inserting ``and separate payments 
        for certain diagnostic radiopharmaceuticals'' after ``pass-
        through adjustments''; and
            (2) by inserting ``and paragraph (16)(G)'' after ``such 
        adjustments)''.
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