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Proposed CMS Regulation Pushes Alignment Between Medicare Coverage and FDA Breakthrough Device Approvals

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to align Medicare coverage decisions with breakthrough technologies approved by the Food and Drug Administration (FDA), thereby speeding...more

Beware Billing Medicare for Non-Approved Imported Drugs

Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more

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