CMS temporarily finalized on Friday (June 20) numerous pieces of its health exchange program integrity rule through 2026, extending an opening for the Senate to pick up and codify the policies, which include new verification requirements, changes to the auto re-enrollment process and more in its version of the reconciliation bill.
The Supreme Court ruled 7-2 Friday (June 20) that R. J. Reynolds Vapor (RJR) can challenge FDA’s denial of their application to market e-cigarettes in the conservative Fifth Circuit Court of Appeals, paving the way for “venue shopping.”
As FDA and other federal agencies faced a deadline this week to provide the White House a list of rules they want to scrap, an FDA official signaled guidance documents are largely absent from the agency’s regulatory hit list.
The Senate’s draft reconciliation text scrapped a Medicare pharmacy benefit manager (PBM) “delinking” reform included in the House-passed bill even though senators included several Medicaid PBM reforms, but sources expect the delinking policy to resurface in a future health package.
Digital health groups want HHS to enforce existing information blocking regulations they say are key to the growth of health apps and artificial intelligence, but health care stakeholders are divided on how current penalty and regulatory exception requirements should be updated.
The CEOs of Community Health Centers (CHCs) in Missouri, Texas and North Carolina told Inside Health Policy they traveled to Capitol Hill this week as part of an urgent lobbying push to warn lawmakers that proposed Medicaid cuts would backfire on these health centers, which are legally required to serve all patients regardless of their ability to pay and get roughly half their revenue from Medicaid -- and comes as CHCs also face losing federal funding unless Congress acts by Oct. 1.
Former FDA Commissioner Scott Gottlieb called FDA’s abrupt dismissal of its top cell and gene therapy official, Nicole Verdun, a significant setback for the therapeutics, after Verdun and her deputy Rachel Anatol reportedly were placed on administrative leave and escorted out of FDA headquarters this week.
