News

Senate Finance Committee Introduces Draft Bill to Create Medicare Drug Shortage Prevention and Mitigation Program

• On Friday, the Senate Finance Committee published a draft bill that would create a new program in Medicare called the Medicare Drug Shortage Prevention and Mitigation Program. The draft bill would require the Secretary of the Department of Health and Human Services (HHS) to establish the program by January 1, 2027. This program is intended to incentivize hospitals, group purchasing organizations (GPOs), and other prescription drug supply chain stakeholders to create longer-term stable pricing for generic drug manufacturers. This program would structure payments to reward quality, stability, and extended contracts while reducing the continuing problem of drug shortages (Inside Health Policy, May 3; Modern Healthcare; May 6).

Federal Regulation and Guidance

CMS Releases Draft Guidance on Medicare Drug Pricing Negotiations

• CMS released a draft of new guidance on May 3 outlining how CMS intends to implement the next round of Medicare drug negotiations. The draft guidance includes additional policies, requirements, and procedures around the new maximum fair price (MFP) for drug makers and various Part D drug dispensing entities in 2026 and 2027. It also specifies the procedures that may be applicable to pharmacies, mail-order services, Part D plan sponsors, Medicare Advantage prescription drug plans, and other dispensing entities. The draft guidance details how drug makers must ensure that eligible Medicare beneficiaries have access to drugs at the negotiated MFP. Under the draft guidance, participating primary manufacturers of a selected drug will be required to provide access to the drug at the MFP for all dosage forms, strengths, and package sizes. The draft guidance also proposes two options for working with a Medicare Transaction Facilitator (MTF) to facilitate the exchange of data between drug supply chain entities to ensure that the drugs are accurately dispensed to eligible beneficiaries. CMS seeks additional feedback by July 2, 2024, on various program features from stakeholders outlined in the guidance document and intends to issue final guidance later this year (Inside Health Policy, May 3).

CMS Finalizes Rule to Increase Access to Healthcare Coverage for DACA Recipients

• On May 8, CMS published a final rule intended to increase healthcare coverage and access for Deferred Action for Childhood Arrivals (DACA) recipients beginning as early as December 1 of this year. The rule clarifies that DACA recipients (and certain other noncitizens) will be included in the definitions of ‘‘lawfully present’’ that are used in determining an individual’s eligibility to enroll in a Qualified Health Plan (QHP) through the ACA Health Insurance Marketplace, for coverage through a Basic Health Program (BHP) and for Advance Payments of the Premium Tax Credit (APTC) and Cost-Sharing Reductions (CSRs). CMS specified that the rule is not intended to define lawful presence for purposes of any law or program other than these specific Department of Health and Human Services (HHS) healthcare programs. Responding to concerns raised by states and other commentators, CMS chose not to finalize provisions included in the proposed rule that would have similarly altered the definition of “lawfully present” for purposes of Medicaid and Children’s Health Insurance Program (CHIP) in those states covering ‘‘lawfully residing’’ pregnant individuals and children under section 214 of the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) (GovInfo.gov, May 8).