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.
Blog Editors
Recent Updates
- Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future
- Indiana Senate Enrolled Act 9 Requires Written Notice of Health Care Entities’ Mergers or Acquisitions
- Connecticut Bill Calls for Office of Health Strategy to Develop a Plan Regarding Private Equity Firms in Health Care
- Revised OCR Guidance Provides New Examples, but Raises More Questions, Regarding Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines