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Governor’s 2025-26 May Revision Proposes Major Cuts to Healthcare and Undermines Medi-Cal Expansion Commitments

California Academy of Family Physicians (CAFP)

Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.

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MN Legislative Session 2025: Updates on Hearings and Bills

Minnesota Academy of Family Physicians

SENATE HEALTH AND HUMAN SERVICES COMMITTEE Patient-Centered Care Program ( SF 1059 ): Proposal: The bill proposes removing managed care from MA by having the Department of Human Services (DHS) make direct payments to providers. Supporters Say: This will improve care coordination.

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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog

The pandemic also deeply impacted how industry and the government conduct their operations. An estimated timeline for the return of in-person meetings has not been provided by CDRH. The pandemic had changed the way people live, work and communicate. Such changes are not limited to personal circumstances.

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An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

FDA Law Blog

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). The complaint characterizes this as political deception that conscripts companies to legitimize government extortion.

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027. Though the Orphan Drug Act (now) includes a clinical superiority clause, Jazz argues that it is not a third exception to ODE.

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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

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