In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.
In light of these recent actions, what challenges are dietary supplement manufacturers now facing?
On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...
It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.
Recent Updates
- Comment Period Closes on California OHCA’s Proposed Emergency Regulations Expanding Private Equity, Hedge Fund, and MSO Reporting in Health Care Transactions
- DOJ Revises Justice Manual on Non-Binding Guidance and Qui Tam Dismissals: Practical Considerations
- Additional SBA Crackdown on Pandemic-Era Fraud Leads to Program and Loan Suspensions, Possible FCA Enforcement
- Federal Regulatory Views on Cybersecurity and AI Amidst a Growing Threat Landscape
- Remote Monitoring Services Under the 2027 PFS Proposed Rule: Epstein Becker Green Submits Comments to CMS