The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG hits Mississippi hospital for polysomnography claims; BD expands Chloraprep recall to all 50 states.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neovasc snares second patent term extension; CMS drops CT image quality proposal; TGA opens docket for nanomaterials regulation; ATA supports OIG statement on telehealth.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Noridian overpaid for facet-joint injections; Hill-Rom patient lift recalled; New legislation directed to heart valve disease.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA unveils policy concerns for 2021; NRC seeks nominees for medical isotopes adcomm; Senators: More protection needed for genomic data; Veterans’ genomic data put at risk; DNA sequencing claims struck down.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Telehealth bill resurfaces in 117th Congress; OIG includes telehealth in FY 2021 workplan.
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
