I 
116TH CONGRESS 
2D SESSION 
H. R. 7518 
To amend title XVIII of the Social Security Act to promote preparedness 
and Medicare beneficiary access to safer, more accurate sterile intra-
venous drug preparations through automated hospital infrastructure. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 9, 2020 
Mr. MICHAEL F. DOYLE of Pennsylvania (for himself and Mr. KELLY of 
Pennsylvania) introduced the following bill; which was referred to the 
Committee on Ways and Means 
A BILL 
To amend title XVIII of the Social Security Act to promote 
preparedness and Medicare beneficiary access to safer, 
more accurate sterile intravenous drug preparations 
through automated hospital infrastructure. 
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 ‘‘Safer Compounding 
in Hospitals Act of 2020’’. 
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SEC. 2. PROMOTING PREPAREDNESS AND MEDICARE BENE-
FICIARY ACCESS TO SAFER, MORE ACCURATE 
STERILE 
INTRAVENOUS 
DRUG 
PREPARA-
TIONS THROUGH AUTOMATED HOSPITAL IN-
FRASTRUCTURE. 
(a) IN GENERAL.—Section 1886(d)(5) is amended by 
adding at the end the following new subparagraph: 
‘‘(N)(i) Subject to clause (iv), in the case of a sub-
section (d) hospital and with respect to a discharge of an 
individual occurring on or after October 1, 2020, and be-
fore October 1, 2026, who was furnished a sterile intra-
venous treatment prepared with closed system automation 
device technology (as defined in clause (v)) by such hos-
pital in compliance with all applicable requirements and 
regulations of the Food and Drug Administration, the Sec-
retary shall provide an additional payment to such hospital 
of $25 for each such treatment so furnished. 
‘‘(ii) The Secretary shall establish a method to iden-
tify sterile intravenous treatments prepared with closed 
system automation device technology through the use of 
ICD 10 PCS codes, diagnosis codes, condition codes, or 
such other means as determined appropriate by the Sec-
retary. 
‘‘(iii) The Secretary shall make such adjustments to 
payments under this subsection as the Secretary deter-
mines necessary to ensure that aggregate expenditures 
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under this subsection with respect to a fiscal year with 
application of this subparagraph are estimated to be equal 
to such expenditures under this subsection with respect 
to such year without application of this subparagraph. 
‘‘(iv) Aggregate payments made under this subpara-
graph with respect to discharges occurring during a fiscal 
year may not exceed $40,000,000. 
‘‘(v) For purposes of this subparagraph, the term 
‘closed system automation device technology’ means equip-
ment that is cleared or approved by the Food and Drug 
Administration and that— 
‘‘(I) aseptically compounds ready-to-administer 
compounded sterile preparations without direct 
human manipulation; 
‘‘(II) 
creates, 
monitors, 
and 
assures 
an 
uncompromised ISO 5 environment, with continuous 
isolation of its interior from the external environ-
ment; 
‘‘(III) demonstrates unidirectional air within 
the compounding chamber and loading area or 
areas; 
‘‘(IV) incorporates barcode verification of all 
drug ingredients, which are comprised solely of fin-
ished sterile drug products approved by the Food 
and Drug Administration; 
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‘‘(V) assures drug dose accuracy and control 
using gravimetric (or comparable) analysis; 
‘‘(VI) provides photographic evidence of all sup-
ply containers; 
‘‘(VII) applies labels to compounded sterile 
preparations within ISO 5 environment; 
‘‘(VIII) maintains detailed compounding, clean-
ing, and other operational records; and 
‘‘(IX) is developed, manufactured, and serviced 
as a pharmacy compounding device or system per 
guidance promulgated by the Food and Drug Ad-
ministration.’’. 
Æ 
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