I 

118TH CONGRESS 

2D SESSION H. R. 8749 

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 

JUNE 14, 2024 

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 2024’’. 


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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 Section 1886(d)(5) of the Social Security Act (42 

7 U.S.C. 1395ww(d)(5)) is amended by adding at the end 

8 the following new subparagraph: 

9 ‘‘(N)(i) Subject to clause (iv), in the case of a sub10 section (d) hospital and with respect to a discharge of an 

11 individual occurring on or after October 1, 2025, and be12 fore October 1, 2031, who was furnished a sterile intra13 venous treatment prepared with closed system automation 

14 device technology (as defined in clause (v)) by such hos15 pital in compliance with all applicable requirements and 

16 regulations of the Food and Drug Administration, the Sec17 retary shall provide an additional payment to such hospital 

18 of $40 for each such treatment so furnished. 

19 ‘‘(ii) The Secretary shall establish a method to iden20 tify sterile intravenous treatments prepared with closed 

21 system automation device technology through the use of 

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

23 such other means as determined appropriate by the Sec24 retary. 

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

26 payments under this subsection as the Secretary deterVerDate Sep 11 2014 22:42 Aug 05, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8749.IH H8749

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1 mines necessary to ensure that aggregate expenditures 

2 under this subsection with respect to a fiscal year with 

3 application of this subparagraph are estimated to be equal 

4 to such expenditures under this subsection with respect 

5 to such year without application of this subparagraph. 

6 ‘‘(iv) Aggregate payments made under this subpara7 graph with respect to discharges occurring during a fiscal 

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

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

10 ‘closed system automation device technology’ means equip11 ment that is cleared or approved by the Food and Drug 

12 Administration and that— 

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

14 compounded sterile preparations without direct 

15 human manipulation; 

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

17 uncompromised ISO 5 environment, with continuous 

18 isolation of its interior from the external environ19 ment; 

20 ‘‘(III) demonstrates unidirectional air within 

21 the compounding chamber and loading area or 

22 areas; 

23 ‘‘(IV) incorporates barcode verification of all 

24 drug ingredients, which are comprised solely of finVerDate Sep 11 2014 22:42 Aug 05, 2024 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8749.IH H8749

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1 ished sterile drug products approved by the Food 

2 and Drug Administration; 

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

4 using gravimetric (or comparable) analysis; 

5 ‘‘(VI) provides photographic evidence of all sup6 ply containers; 

7 ‘‘(VII) applies labels to compounded sterile 

8 preparations within ISO 5 environment; 

9 ‘‘(VIII) maintains detailed compounding, clean10 ing, and other operational records; and 

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

12 as a pharmacy compounding device or system per 

13 guidance promulgated by the Food and Drug Ad14 ministration.’’. 

Æ 


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