United States 118th Congress Status: In Committee 1 R cosponsors

HR 8749 — Safer Compounding in Hospitals Act of 2024

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

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.

Bill Text

How this bill changes current law

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Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds a new payment provision for hospitals providing sterile intravenous treatments using closed system automation device technology.

  • 42 U.S.C. 1395ww(d)(5)

    ``(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."

    This new provision allows hospitals to receive an additional payment for certain sterile intravenous treatments, incentivizing the use of advanced technology.

  • 42 U.S.C. 1395ww(d)(5)

    ``(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."

    This mandates the Secretary to create a system for identifying specific treatments associated with automation technology.

  • 42 U.S.C. 1395ww(d)(5)

    ``(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."

    This requires payment adjustments to maintain budget neutrality concerning the new payment provision.

  • 42 U.S.C. 1395ww(d)(5)

    ``(iv) Aggregate payments made under this subparagraph with respect to discharges occurring during a fiscal year may not exceed $40,000,000."

    This sets a cap on the total payments for the new provision within a fiscal year.

  • 42 U.S.C. 1395ww(d)(5)

    ``(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."

    This defines the criteria for what constitutes closed system automation device technology, ensuring quality and safety standards.

Action History

  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Ways and Means.

  3. Introduced in House

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 8749 do?
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.
Who sponsors HR 8749?
HR 8749 is sponsored by Kelly, Mike (Republican).
What is the current status of HR 8749?
This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 8749?
Track HR 8749 free on One Click Politics — get push/email alerts when it moves.

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