United States 119th Congress Status: In Committee Bipartisan · 10 R · 9 D cosponsors
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HR 946 — ORPHAN Cures Act

Last action — Sponsor introductory remarks on measure. (CR H535-536)

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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 is in committee in the House. Introduced February 04, 2025. It must pass committee before a floor vote.

Next likely step: a committee vote, then a floor vote in the House.

Prognosis

Advancing 44% · high confidence

Where this bill stands today.

Odds of enactment

Low

How often bills like it became law.

  • In Committee

    Current position in the legislative process.

  • 19 sponsors

    1 primary, 18 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (10 R · 9 D) — cross-party backing.

  • Spreading across states

    Near-identical bills in 1 other state — cross-state momentum.

Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.

Summary

Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures ActThis bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition.The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.

Bill Text

Sections of law this bill changes

1 section in 1 law

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-124).

Social security · 42 U.S.C. ch. 7 1 section
  • § 1320f-1 Selection of negotiation-eligible drugs as selected drugs Amends

    42 U.S.C. § 1320f-1 — at 1320f-1(e)

    The law today

    (a) In general Not later than the selected drug publication date with respect to an initial price applicability year, in accordance with subsection (b), the Secretary shall select and publish a list of— (1) with respect to the initial price applicability year 2026, 10 negotiation-eligible drugs described in subparagraph (A) of subsection (d)(1), but not subparagraph (B) of such subsection, with respect to such year (or, all (if such number is less than 10) such negotiation-eligible drugs with respect to such year); (2) with respect to the initial price applicability year 2027, 15 negotiation-eligible drugs described in subparagraph (A) of subsection (d)(1), but not subparagraph (B) of such subsection, with respect to such year (or, all (if such number is less than 15) such negotiation-eligible drugs with respect to such year); (3) with respect to the initial price applicability year 2028, 15 negotiation-eligible drugs described in subparagraph (A) or (B) of subsection (d)(1) with respect to such year (or, all (if such number is less than 15) such negotiation-eligible drugs with respect to such year); and (4) with respect to the initial price applicability year 2029 or a subsequent year, 20 negotiation-eligible drugs described in subparagraph (A) or (B) of subsection (d)(1), with respect to such year (or, all (if such number is less than 20) such negotiation-eligible drugs with respect to such year). Subject to subsection (c)(2) and section 1320f–3(f)(5) of this title, each drug published on the list pursuant to the previous sentence and subsection (b)(3) shall be subject to the negotiation process under section 1320f–3 of this title for the negotiation period with respect to such initial price applicability year (and the renegotiation process under such section as applicable for any subsequent year during the applicable price applicability period). (b) Selection of drugs (1) In general In carrying out subsection (a), subject to paragraph (2), the Secretary shall, with respect to an initial price applicability year, do the following: (A) Rank negotiation-eligible drugs described in subsection (d)(1) according to the total expenditures for such drugs under parts B and D of subchapter XVIII, as determined by the Secretary, during the most recent period of 12 months prior to the selected drug publication date (but ending not later than October 31 of the year prior to the year of such drug publication date), with respect to such year, for which data are available, with the negotiation-eligible drugs with the highest total expenditures being ranked the highest. (B) Select from such ranked drugs with respect to such year the negotiation-eligible drugs with the highest such rankings. (C) In the case of a biological product for which the inclusion of the biological product as a selected drug on a list published under subsection (a) has been delayed under subsection (f)(2), remove such biological product from the rankings under subparagraph (A) before making the selections under subparagraph (B). (2) High spend part D drugs for 2026 and 2027 With respect to the initial price applicability year 2026 and with respect to the initial price applicability year 2027, the Secretary shall apply paragraph (1) as if the reference to “negotiation-eligible drugs described in subsection (d)(1)” were a reference to “negotiation-eligible drugs described in subsection (d)(1)(A)” and as if the reference to “total expenditures for such drugs under parts B and D of subchapter XVIII” were a reference to “total expenditures for such drugs under part D of subchapter XVIII”. (3) Inclusion of delayed biological products Pursuant to subparagraphs (B)(ii)(I) and (C)(i) of subsection (f)(2), the Secretary shall select and include on the list published under subsection (a) the biological products described in such subparagraphs. Such biological products shall count towards the required number of drugs to be selected under subsection (a)(1). (c) Selected drug (1)...

    16 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

How this bill changes current law

3 changes Share ↗

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

The bill modifies the exclusion criteria for orphan drugs within the Drug Price Negotiation Program to include former orphan drugs and to expand the definition of qualifying diseases.

  • 42 U.S.C. 1320f-1(e)(1)

    ``(C) Treatment of former orphan drugs.--In calculating the amount of time that has elapsed with respect to the approval of a drug or licensure of a biological product under subparagraph (A)(ii) and subparagraph (B)(ii), respectively, the Secretary shall not take into account any period during which such drug or product was a drug described in paragraph (3)(A).''

    This addition clarifies that the approval time for drugs previously classified as orphan drugs won't count towards the time limit.

  • 42 U.S.C. 1320f-1(e)(3)(A)

    only one rare disease or condition → one or more rare diseases or conditions

    This change allows drugs for multiple rare diseases to be classified as orphan drugs.

  • 42 U.S.C. 1320f-1(e)(3)(A)

    such disease or condition → one or more rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act)

    This provides a clearer definition for what constitutes a rare disease or condition under this context.

Action History

  1. Sponsor introductory remarks on measure. (CR H535-536)

  2. Introduced in House

  3. Introduced in House

  4. Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

  5. Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Sponsors

Sponsorship breakdown

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1 sponsors · 18 co-sponsors · 528 not signed on

Sponsors (1)

Co-sponsors (18)

Not signed on (528)

528 members have not signed on to this bill.

Show all 528 →

"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.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare health-insurance

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Frequently asked questions

What does HR 946 do?
Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures ActThis bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition.The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.
Who sponsors HR 946?
HR 946 is sponsored by Joyce, John (Republican), Davis, Donald G. (Democratic), Hern, Kevin (Republican), Peters, Scott H. (Democratic), Miller-Meeks, Mariannette (Republican), Keating, William R. (Democratic), Hudson, Richard (Republican), Thanedar, Shri (Democratic), Bilirakis, Gus M. (Republican), Gottheimer, Josh (Democratic), Smucker, Lloyd (Republican), Bynum, Janelle S. (Democratic), Kean, Thomas H. (Republican), Titus, Dina (Democratic), Salinas, Andrea (Democratic), Dunn, Neal P. (Republican), Gray, Adam (Democratic), Crenshaw, Dan (Republican), and Bresnahan, Robert P. (Republican).
What is the current status of HR 946?
This bill is in committee in the House. Introduced February 04, 2025. It must pass committee before a floor vote.
Where can I track HR 946?
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