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Schumer, Johnson Trade Barbs On Approps; Shutdown Prospects Increase

It’s yet another government shutdown watch week: The House and Senate are returning to work this week without an appropriations agreement, increasing the prospects of a partial government shutdown on Friday (March 1), and leaving funding for FDA and HHS, as well as the futures of many health programs, hanging in the balance.

MA Debate

CMS’ 2025 MA And Part D Final Rule At White House Budget Office

CMS’ annual technical update for MA and & Part D is at the White House Office of Management and Budget.

Paragon Echoes Community Plans’ Recs In New Suite Of MA Reforms

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An industry group representing companies developing cell and gene therapies is pushing the HHS Office of Inspector General (OIG) to adopt safe harbor provisions under the Federal Anti-Kickback Statute (AKS) that would allow companies to provide more assistance to patients, while a bill before the House Energy & Commerce Committee would legally establish a similar policy.

The House Energy & Commerce Committee will consider bipartisan legislation Thursday (Feb. 29) that would mandate FDA implement within 180 days a 2022 law that allows drug sponsors to use alternatives to animal testing, coming amid growing frustration by lawmakers that the agency hasn’t updated its guidance to reflect the 2022 law.

The Coalition For Health AI has been at the forefront of a push for the federal government to fund an ecosystem of assurance labs for testing AI models intended for use in health care -- but the coalition is still working to reach internal consensus on how the models should be tested by the labs.

Ahead of oral arguments in the Supreme Court case over the abortion pill mifepristone, the anti-abortion physician plaintiffs in the case are again arguing that FDA’s move in 2021 to allow the drug to be prescribed via telehealth violates the 1870 Comstock Act, providing a potential pathway for the justices to restrict access to the drug despite the plaintiffs’ weak case for standing.

CMS says it was following Congress’ instructions when it decided to finalize all its proposed changes to the Medicaid Disproportionate Share Hospital allocations despite the tens of millions of dollars the rule is expected to slash from some hospitals’ finances.

Ahead of FDA’s annual Rare Disease Day event March 1, the House Energy & Commerce Committee will hold a legislative hearing to consider 18 bills aimed at assisting patients with rare diseases, including legislation reauthorizing FDA’s pediatric rare disease priority review voucher and expanding the number of orphan drugs excluded from the Inflation Reduction Act’s (IRA) Medicare drug price negotiation program.