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

September 10, 2020

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 access to new therapies. Aligning CMS coverage policy with FDA approval is a long-standing goal of device and drug manufacturers that have been frustrated by delays in Medicare coverage and reimbursement decisions following the FDA’s comprehensive review and approval.

The proposed rule would create a new coverage category, Medicare Coverage of Innovative Technology (MCIT), providing four years of Medicare payment for devices designated as a breakthrough device by the FDA. CMS requests public comment on whether diagnostics, drugs and/or biologics should be included in MCIT. During the four years, real-world evidence of the breakthrough device’s effectiveness would be gathered. That evidence would then inform permanent payment through traditional coverage options, such as a National Coverage Determination (NCD) or Local Coverage Determinations (LCDs).

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