This bill amends the Social Security Act to allow prescription drug plan sponsors to make mid-year changes to their formularies for certain biosimilar biological products and their reference products starting in 2025. Sec. 2, Facilitating midyear formulary changes for biosimilars: For plan year 2025 and later, a Part D plan sponsor may change the preferred or tiered cost-sharing status of a reference biological product after the first 60 days of the plan year, if the sponsor adds the corresponding biosimilar biological product to the formulary at the same or a higher preferred status or same or lower cost-sharing tier. The sponsor must submit a request to the Secretary of Health and Human Services for approval; if the Secretary approves or does not decide within 30 days, the sponsor may make the change. The Secretary may implement this amendment by program instruction, and the Paperwork Reduction Act does not apply to its implementation.
Summary of the bill text as introduced in House (Sep 8, 2023), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
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HouseCommittee Consideration and Mark-up Session HeldDec 6, 2023
HouseOrdered to be Reported (Amended) by the Yeas and Nays: 48 - 0.Dec 6, 2023
HouseCommittee Consideration and Mark-up Session HeldDec 5, 2023
HouseSubcommittee Consideration and Mark-up Session HeldNov 15, 2023
HouseForwarded by Subcommittee to Full Committee by Voice Vote.Nov 15, 2023
HouseReferred to the Subcommittee on Health.Sep 15, 2023
HouseIntroduced in HouseSep 8, 2023
HouseReferred 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.Sep 8, 2023
House Energy and Commerce CommitteeMarkup By Dec 6, 2023Markup By, Dec 5, 2023Referred To, Sep 8, 2023
Subcommittee: Health SubcommitteeReported by
House Ways and Means CommitteeReferred To Sep 8, 2023
Sponsor and cosponsors1 cosponsor
Rep. John Joyce (R-PA-13)Sponsor, Sep 8, 2023
Scott Peters (D-CA-50)OriginalJoined Sep 8, 2023
Amendments0
No amendments offered
Cost estimates and reports1
CBO: H.R. 5372, Expanding Seniors’ Access to Lower Cost Medications Act of 2023Mar 13, 2024As ordered reported by the House Committee on Energy and Commerce on December 6, 2023
Titles2
Short titles
Expanding Seniors' Access to Lower Cost Medicines Act of 2023Short Title(s) as Introduced
Official titles
To amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars.Official Title as Introduced