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Centers for Medicare & Medicaid Services (CMS) › Final Rules › FDA Approval

Gardner Law

TCET—A Medicare Coverage Option for Breakthrough Devices

Gardner Law on

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

Foley Hoag LLP - Medicaid and the Law

CMS Weighs in on FDA Importation Rule

Foley Hoag LLP - Medicaid and the Law on

On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

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