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Medicare › Medical Reimbursement › Food and Drug Administration (FDA)

Gardner Law

TCET—A Medicare Coverage Option for Breakthrough Devices

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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

Nelson Mullins Riley & Scarborough LLP

Federal Regulatory Update: CMS Medicare Payment Changes & Congressional Next Steps

Nelson Mullins Riley & Scarborough LLP on

The Centers for Medicare & Medicaid Services (CMS) have released significant updates affecting Medicare payments for 2025. The changes, outlined in two final rules, will impact both physicians and hospitals, eliciting strong...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

BakerHostetler

Never Fear Regulatory Violations – Focus on Conditions to Payment

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The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were...more

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