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Manufacturers Centers for Medicare & Medicaid Services (CMS) Today's Popular Updates

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

Hogan Lovells on

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

Morgan Lewis

AI in Medical Devices and Healthcare: Opportunities, Challenges, and What Lies Ahead

Morgan Lewis on

In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more

Goodwin

Novel DOJ Settlement For Sunshine Act Violations

Goodwin on

On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

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