Safer Compounding in Hospitals Act of 2020

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safer Compounding 4 in Hospitals Act of 2020’’. 5 VerDate Sep 11 2014 18:14 Jul 27, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7518.IH H7518 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 7518 IH SEC. 2. PROMOTING PREPAREDNESS AND MEDICARE BENE- 1 FICIARY ACCESS TO SAFER, MORE ACCURATE 2 STERILE INTRAVENOUS DRUG PREPARA- 3 TIONS THROUGH AUTOMATED HOSPITAL IN- 4 FRASTRUCTURE. 5 (a) IN GENERAL.—Section 1886(d)(5) is amended by 6 adding at the end the following new subparagraph: 7 ‘‘(N)(i) Subject to clause (iv), in the case of a sub- 8 section (d) hospital and with respect to a discharge of an 9 individual occurring on or after October 1, 2020, and be- 10 fore October 1, 2026, who was furnished a sterile intra- 11 venous treatment prepared with closed system automation 12 device technology (as defined in clause (v)) by such hos- 13 pital in compliance with all applicable requirements and 14 regulations of the Food and Drug Administration, the Sec- 15 retary shall provide an additional payment to such hospital 16 of $25 for each such treatment so furnished. 17 ‘‘(ii) The Secretary shall establish a method to iden- 18 tify sterile intravenous treatments prepared with closed 19 system automation device technology through the use of 20 ICD 10 PCS codes, diagnosis codes, condition codes, or 21 such other means as determined appropriate by the Sec- 22 retary. 23 ‘‘(iii) The Secretary shall make such adjustments to 24 payments under this subsection as the Secretary deter- 25 mines necessary to ensure that aggregate expenditures 26 VerDate Sep 11 2014 22:03 Jul 27, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7518.IH H7518 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 7518 IH under this subsection with respect to a fiscal year with 1 application of this subparagraph are estimated to be equal 2 to such expenditures under this subsection with respect 3 to such year without application of this subparagraph. 4 ‘‘(iv) Aggregate payments made under this subpara- 5 graph with respect to discharges occurring during a fiscal 6 year may not exceed $40,000,000. 7 ‘‘(v) For purposes of this subparagraph, the term 8 ‘closed system automation device technology’ means equip- 9 ment that is cleared or approved by the Food and Drug 10 Administration and that— 11 ‘‘(I) aseptically compounds ready-to-administer 12 compounded sterile preparations without direct 13 human manipulation; 14 ‘‘(II) creates, monitors, and assures an 15 uncompromised ISO 5 environment, with continuous 16 isolation of its interior from the external environ- 17 ment; 18 ‘‘(III) demonstrates unidirectional air within 19 the compounding chamber and loading area or 20 areas; 21 ‘‘(IV) incorporates barcode verification of all 22 drug ingredients, which are comprised solely of fin- 23 ished sterile drug products approved by the Food 24 and Drug Administration; 25 VerDate Sep 11 2014 18:14 Jul 27, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7518.IH H7518 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 7518 IH ‘‘(V) assures drug dose accuracy and control 1 using gravimetric (or comparable) analysis; 2 ‘‘(VI) provides photographic evidence of all sup- 3 ply containers; 4 ‘‘(VII) applies labels to compounded sterile 5 preparations within ISO 5 environment; 6 ‘‘(VIII) maintains detailed compounding, clean- 7 ing, and other operational records; and 8 ‘‘(IX) is developed, manufactured, and serviced 9 as a pharmacy compounding device or system per 10 guidance promulgated by the Food and Drug Ad- 11 ministration.’’. 12 Æ VerDate Sep 11 2014 18:14 Jul 27, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H7518.IH H7518 pamtmann on DSKBC07HB2PROD with BILLS