[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1544 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 1544
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.
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IN THE SENATE OF THE UNITED STATES
May 10, 2023
Mrs. Blackburn (for herself and Ms. Baldwin) introduced the following
bill; which was read twice and referred to the Committee on Finance
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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 2023''.
SEC. 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:
``(H) 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, 2024, 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 section
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 the 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 2024, 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)(H)'' after ``such
adjustments)''.
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