Health Law Advisor

[UPDATE: This post has been updated to reflect the Drug Enforcement Administration’s November 10, 2025, notice of the upcoming Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.]

The United States just made its latest move regarding Medicare telehealth flexibilities, which expired on September 30, 2025.

On November 9, the Senate voted 60-40 to end the then-nearly 40-day U.S. government shutdown, hammering out a continuing resolution (CR) that would extend the telehealth flexibilities extended in the Consolidated Appropriations Act of 2023 through January 30, 2026. The House vote on November 12, 222-209, clinched the deal.

It’s a welcome development. A research brief updated on November 10, 2025, by the Center for Advancing Health Policy Through Research (CAHPR) and the Brown University School of Public Health reports that telemedicine visits declined by 24 percent in the first 17 days of October for Medicare fee-for-service beneficiaries, and by 13 percent for Medicare Advantage beneficiaries. This is compared to visits from the start of July to the end of September, when the U.S. government’s failure to extend Medicare telehealth coverage sent practitioners and patients alike over what is now commonly termed a telehealth policy “cliff.”

The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information.  The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a "Withdrawn RLD").  The Draft Guidance explains how a generic manufacturer may submit an updated ...

For the last week or so, the health reform public policy debate has been keyed to the Senate HELP Committee’s draft and thus dominated by whether or not the “Exchange” to be employed in access reform should include a “public plan” and, if so, whether such a plan should have the power to access provider payment rates tied to Medicare and whether Medicare participating providers would be required to contract with it. With this week’s release of the Senate Finance Committee’s draft, it will be interesting to see whether payment reform can similarly capture the ...