The Infectious Diseases Society of America and Sen. Patty Murray (D-WA) are doubling down on calls to get Murray and Sen. Richard Burr’s (R-NC) pandemic preparedness legislation passed by the end of the year, with IDSA signaling that it’s willing to make some concessions to get the legislation passed with only high-priority provisions.
HHS Friday (Dec. 2) announced it is extending its enforcement discretion that was set to expire Dec. 31 for a provision in the No Surprises Act that requires convening providers crafting a good faith estimate (GFE) for people paying their own bills to get cost estimates from any co-providers or co-facilities.
The Texas Medical Association (TMA) has filed another suit over the rules implementing the surprise billing law, this time arguing that the methodology the Biden administration crafted for calculating the qualifying payment amount, or in-network median rate, conflicts with statute, allows insurers to artificially deflate the QPA and should be thrown out.
With the COVID-19 public health emergency expected to come to an end sometime in early 2023, FDA is preparing to help drug makers transition from emergency use authorization to full approval and will continue to focus on curbing ongoing drug shortages, including by updating its drug shortage guidance to include details about risk management plans that drug makers are now required to have in place, Valerie Jensen, director of FDA’s drug shortage staff, said Wednesday (Dec. 1).
The White House budget office is reviewing an FDA draft guidance on development of drugs and biological products for mpox, formerly known as monkeypox, coming as the Biden administration announces it won’t renew the mpox public health emergency that expires Jan. 31, 2023.
HHS Secretary Xavier Becerra on Tuesday (Nov. 29) delegated to the National Institutes of Health and FDA authority to establish and implement a public-private partnership to boost research on rare neurodegenerative diseases.
Acute hospital care at home telehealth flexibilities are likely to make it into the expected year-end bill, according to three telehealth lobbyists, as lawmakers reach the final stretch of negotiations over what health riders to tuck into the massive funding package.
The HHS Office for Civil Rights issued a bulletin stressing that HIPAA-covered entities -- including doctors, hospitals and insurers -- are responsible for ensuring their business associates’ use of patient user data complies with the federal privacy law.
