Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
On March 30, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued a decision in Braidwood Management Inc. v. Becerra (“Braidwood”), invalidating the Affordable Care Act’s (“ACA’s”) mandate...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more
2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more
This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more
HIPAA and Emerging Technologies - Editor’s Note: According to a HIMSS Mobile Technology Survey of healthcare provider employees, about 90% say they are using mobile devices to engage patients in their healthcare—and 36%...more
This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more