I 
117TH CONGRESS 
1ST SESSION H. R. 4479 
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 HOUSE OF REPRESENTATIVES 
JULY 16, 2021 
Mr. PETERS (for himself, Mr. RUSH, Mr. DUNN, and Mr. MURPHY of North 
Carolina) introduced the following bill; which was referred to the Com-
mittee 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. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
VerDate Sep 11 2014 
16:14 Jul 26, 2021
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4479.IH
H4479
pamtmann on DSKBC07HB2PROD with BILLS
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 add-
ing 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 pay-
ment as specified in clause (ii) for a diag-
nostic 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 pur-
poses 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 
VerDate Sep 11 2014 
16:14 Jul 26, 2021
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4479.IH
H4479
pamtmann on DSKBC07HB2PROD with BILLS
adjusted by the Secretary to the ex-
tent such adjustment is adopted for 
other specified covered outpatient 
drugs under paragraph (14)(A); or 
‘‘(II) if the data necessary to cal-
culate the average sales price for the 
drug in the year under the section 
and paragraph specified in subclause 
(I) is not available, the wholesale ac-
quisition cost (as defined in subsection 
1847A(c)(6)(B)), as calculated and 
adjusted by the Secretary to the ex-
tent 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 de-
rived from hospital claims data. 
Nothing in this subparagraph shall be con-
strued as affecting eligibility of diagnostic 
radiopharmaceuticals for pass-through pay-
ments under paragraph (6). 
‘‘(iii) THRESHOLD.—For purposes of 
this subparagraph, the threshold specified 
in this clause— 
VerDate Sep 11 2014 
16:14 Jul 26, 2021
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4479.IH
H4479
pamtmann on DSKBC07HB2PROD with BILLS