United States S 2609: Facilitating Innovative Nuclear Diagnostics Act of 2021

Bill Text

II
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 radiopharma-
ceuticals 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 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 ‘‘Facilitating Innovative 4
Nuclear Diagnostics Act of 2021’’. 5
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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. 1395(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, 2022, 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 (as 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), the separate payment 19
specified in this subclause for a diagnostic 20
radiopharmaceutical described in clause (i) 21
shall be 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
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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 section 7
and paragraph specified in subclause 8
(I) is not available, the wholesale ac-9
quisition cost (as defined in subsection 10
1847A(c)(6)(B)), as calculated and 11
adjusted by the Secretary to the ex-12
tent such adjustment is adopted for 13
other specified covered outpatient 14
drugs under paragraph (14)(A), or, if 15
the wholesale acquisition cost is not 16
available, the mean unit cost data de-17
rived from hospital claims data. 18
Nothing in this subparagraph shall be con-19
strued as affecting eligibility of diagnostic 20
radiopharmaceuticals for pass-through pay-21
ments under paragraph (6). 22
‘‘(iii) THRESHOLD.—For purposes of 23
this subparagraph, the threshold specified 24
in this clause— 25
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‘‘(I) for 2022, is $500; and 1
‘‘(II) for a subsequent year, is 2
the amount specified in this clause for 3
the preceding year increased by the 4
OPD fee schedule increase factor 5
under paragraph (3)(C)(iv) for the 6
year. 7
‘‘(iv) BUDGET NEUTRALITY.—The 8
Secretary shall make such adjustments as 9
are necessary under paragraph (9)(B) to 10
ensure that the amount of expenditures 11
under this subsection for a year with appli-12
cation of this subparagraph is equal to the 13
amount of expenditures that would be 14
made under this subsection for such year 15
without application of this subparagraph. 16
‘‘(v) DEFINITION OF DIAGNOSTIC 17
RADIOPHARMACEUTICAL.—For purposes of 18
this subparagraph, the term ‘diagnostic 19
radiopharmaceutical’ means a drug or bio-20
logical that is described in section 315.2(a) 21
of title 21, Code of Federal Regulations, or 22
any successor regulation, and is approved 23
by the Food and Drug Administration on 24
or after January 1, 2008.’’. 25
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(b) NO IMPACT ON COPAYMENT.—Section 1
1833(t)(8)(E) of the Social Security Act (42 U.S.C. 2
1395l(t)(8)(E)) is amended— 3
(1) in the heading, by inserting ‘‘AND SEPA-4
RATE PAYMENTS FOR CERTAIN DIAGNOSTIC RADIO-5
PHARMACEUTICALS’’ after ‘‘PASS-THROUGH ADJUST-6
MENTS’’; and 7
(2) by inserting ‘‘and paragraph (16)(G)’’ after 8
‘‘such adjustments)’’. 9
Æ
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