Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture. A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.
Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...
2016 is poised to be a major year in network adequacy developments across public and private insurance markets. Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges. The developing standards and enforcement will vary significantly across these markets.
Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act's insurance exchanges ("Exchanges"). Others reported on ...
A Nelson Hardiman and Epstein Becker Green Webinar Series
The post-acute spectrum of care is going through a period of profound legal changes, from newly emerging risks to integration with acute care and the transition to managed care. This series features leading attorneys sharing insights into compliance challenges and strategies. Join us for this series and stay ahead of the latest regulatory updates in long-term care.
* * * * * *
A Complimentary Two-Part Webinar on the Americans with Disabilities Act (ADA)
Health Care Entities and the ADA: Part I - Complex Issues in the Reasonable ...
Blog Editors
Recent Updates
- At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration . . .)
- Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and Circumstances of Independent Contractor Arrangements
- DOJ’s False Claims Act Recoveries Top $2.9 Billion in FY 2024, but Health Care Numbers Dip—What Could FY 2025 Hold for Health Care Enforcement?
- Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook
- Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill