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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8749 Introduced in House (IH)]

<DOC>

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.

    Be it enacted by the Senate and House of Representatives 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 2024''.

SEC. 2. PROMOTING PREPAREDNESS AND MEDICARE BENEFICIARY ACCESS TO 
              SAFER, MORE ACCURATE STERILE INTRAVENOUS DRUG 
              PREPARATIONS THROUGH AUTOMATED HOSPITAL INFRASTRUCTURE.

    Section 1886(d)(5) of the Social Security Act (42 U.S.C. 
1395ww(d)(5)) is amended by adding at the end the following new 
subparagraph:
    ``(N)(i) Subject to clause (iv), in the case of a subsection (d) 
hospital and with respect to a discharge of an individual occurring on 
or after October 1, 2025, and before October 1, 2031, who was furnished 
a sterile intravenous treatment prepared with closed system automation 
device technology (as defined in clause (v)) by such hospital in 
compliance with all applicable requirements and regulations of the Food 
and Drug Administration, the Secretary shall provide an additional 
payment to such hospital of $40 for each such treatment so furnished.
    ``(ii) The Secretary shall establish a method to identify 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 
Secretary.
    ``(iii) The Secretary shall make such adjustments to payments under 
this subsection as the Secretary determines necessary to ensure that 
aggregate expenditures 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 subparagraph 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 equipment 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 environment;
            ``(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 finished sterile 
        drug products approved by the Food and Drug Administration;
            ``(V) assures drug dose accuracy and control using 
        gravimetric (or comparable) analysis;
            ``(VI) provides photographic evidence of all supply 
        containers;
            ``(VII) applies labels to compounded sterile preparations 
        within ISO 5 environment;
            ``(VIII) maintains detailed compounding, cleaning, 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 Administration.''.
                                 <all>
```