HHS told a federal court that it intends to release by Nov. 1 a proposal that would move the effective date for the 340B ceiling prices and penalties rule to Jan. 1, up from July 1, and for that reason the court should put a lawsuit over the date on hold.

Two weeks after the IRS collected an Obamacare tax from Medicaid managed care plans, a federal judge denied a request from six GOP-led states that sought to bar the collection of that tax.

FDA is planning to move on a range of deregulatory actions in the medical device space, including implementing the timeframes and procedures for how the agency handles internal review of device-related decisions; no longer publishing lists of certain device approvals and denials; and harmonizing domestic and international quality requirements for devices.

Senate Majority Leader Mitch McConnell (R-KY) is defending the administration's decision to ask a federal court to throw out the Affordable Care Act's protections for people with preexisting conditions if it finds the mandate is no longer valid, and suggested that a win would allow the GOP to “start over” on health care reforms.

HHS Secretary Alex Azar touted the agency's Regulatory Sprint to Coordinated Care on Wednesday (Oct. 17), including upcoming work on 42 CFR Part 2 privacy requirements, and the administration’s fall unified agenda indicates the Substance Abuse and Mental Health Services Administration intends to publish a proposed rule on the privacy requirements next year.

FDA wants to help health care providers better understand the different levels of potency across opioid medications, FDA Commissioner Scott Gottlieb said Thursday (Oct. 18).

Democrats have exhausted their immediate legislative options to block the expansion of short-term health plans, leaving the upcoming federal court case as the party's best chance to restrict so-called junk insurance policies prior to the midterms or the start of Obamacare open enrollment.

The Trump Administration is arguing that the stakeholders seeking to immediately suspend new federal regulations on short-term plans fail to show that they would be harmed by the rule and therefore their request for a preliminary injunction should be rejected.