For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
4/2/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
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Medical Devices ,
OIG ,
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Sunshine Act
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting.
Are you prepared for a Sunshine Act audit? Reporting...more
2/9/2024
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
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Sunshine Act
The U.S. Food and Drug Administration (FDA) is taking definitive steps to reinforce regulations surrounding laboratory-developed tests (LDTs). On September 29, 2023, the FDA announced its Proposed Rule seeking to clarify...more
Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more
9/29/2022
/ AdvaMed ,
Anti-Fraud Provisions ,
Anti-Kickback Statute ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
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Ethics ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
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Value-Based Care