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CMS Reverses Course on Medicare Coverage of “Breakthrough” Medical Devices

On September 15, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule that would repeal the Medicare Coverage of Innovative Technology final rule (“MCIT final rule”), which was published on January 14, 2021 and is scheduled to become effective on December 15, 2021. CMS established the MCIT final rule to provide Medicare beneficiaries with faster access to FDA-designated “Breakthrough Devices”―devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Specifically, the MCIT final rule provided national Medicare coverage of Breakthrough Devices for four years starting on the date of FDA marketing authorization or a select date up to two years after the market authorization date as requested by the device manufacturer. Additionally, the MCIT final rule would codify CMS’s longstanding interpretation of the “reasonable and necessary” standard used to determine which items and services are covered under Medicare.

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Chinese FDA Soliciting Public Comments on Rules for Re-Packaging of IVDs

Practices: Life Sciences, Health Care, Government Enforcement / White Collar Crime, China Life Sciences Industries: Biotechnology & Pharmaceuticals

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