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 intravenous 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safer Compounding 

5 in Hospitals Act of 2020’’. 


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1 SEC. 2. PROMOTING PREPAREDNESS AND MEDICARE BENE2 FICIARY ACCESS TO SAFER, MORE ACCURATE 

3 STERILE INTRAVENOUS DRUG PREPARA4 TIONS THROUGH AUTOMATED HOSPITAL IN5 FRASTRUCTURE. 

6 (a) IN GENERAL.—Section 1886(d)(5) is amended by 

7 adding at the end the following new subparagraph: 

8 ‘‘(N)(i) Subject to clause (iv), in the case of a sub9 section (d) hospital and with respect to a discharge of an 

10 individual occurring on or after October 1, 2020, and be11 fore October 1, 2026, who was furnished a sterile intra12 venous treatment prepared with closed system automation 

13 device technology (as defined in clause (v)) by such hos14 pital in compliance with all applicable requirements and 

15 regulations of the Food and Drug Administration, the Sec16 retary shall provide an additional payment to such hospital 

17 of $25 for each such treatment so furnished. 

18 ‘‘(ii) The Secretary shall establish a method to iden19 tify sterile intravenous treatments prepared with closed 

20 system automation device technology through the use of 

21 ICD 10 PCS codes, diagnosis codes, condition codes, or 

22 such other means as determined appropriate by the Sec23 retary. 

24 ‘‘(iii) The Secretary shall make such adjustments to 

25 payments under this subsection as the Secretary deter26 mines necessary to ensure that aggregate expenditures 


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1 under this subsection with respect to a fiscal year with 

2 application of this subparagraph are estimated to be equal 

3 to such expenditures under this subsection with respect 

4 to such year without application of this subparagraph. 

5 ‘‘(iv) Aggregate payments made under this subpara6 graph with respect to discharges occurring during a fiscal 

7 year may not exceed $40,000,000. 

8 ‘‘(v) For purposes of this subparagraph, the term 

9 ‘closed system automation device technology’ means equip10 ment that is cleared or approved by the Food and Drug 

11 Administration and that— 

12 ‘‘(I) aseptically compounds ready-to-administer 

13 compounded sterile preparations without direct 

14 human manipulation; 

15 ‘‘(II) creates, monitors, and assures an 

16 uncompromised ISO 5 environment, with continuous 

17 isolation of its interior from the external environ18 ment; 

19 ‘‘(III) demonstrates unidirectional air within 

20 the compounding chamber and loading area or 

21 areas; 

22 ‘‘(IV) incorporates barcode verification of all 

23 drug ingredients, which are comprised solely of fin24 ished sterile drug products approved by the Food 

25 and Drug Administration; 


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1 ‘‘(V) assures drug dose accuracy and control 

2 using gravimetric (or comparable) analysis; 

3 ‘‘(VI) provides photographic evidence of all sup4 ply containers; 

5 ‘‘(VII) applies labels to compounded sterile 

6 preparations within ISO 5 environment; 

7 ‘‘(VIII) maintains detailed compounding, clean8 ing, and other operational records; and 

9 ‘‘(IX) is developed, manufactured, and serviced 

10 as a pharmacy compounding device or system per 

11 guidance promulgated by the Food and Drug Ad12 ministration.’’. 

Æ 


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