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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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New California Law Requires Pharmaceutical Companies to Adopt Compliance Programs


Time to Read: 1 minutes Practices: Life Sciences, Health Care Industries: Biotechnology & Pharmaceuticals

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California recently enacted a law requiring pharmaceutical companies to adopt “Comprehensive Compliance Programs.”  The programs must be “in accordance with” the HHS Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers and the PhRMA Code on Interactions with Health Care Professionals.  The requirement becomes effective July 1, 2005.

The Comprehensive Compliance Programs must include annual dollar limits on gifts, incentives, and “promotional materials” furnished to healthcare professionals.  The law exempts the following items from the limits, provided that they comply with the guidance from OIG and PhRMA:

  • Drug samples intended for free distribution to patients
  • Financial support for continuing medical education forums and health education scholarships
  • Payments to health and medical professionals for their legitimate professional services, as long as the payments do not exceed fair market value.

A pharmaceutical company must certify annually that it is in compliance with its Comprehensive Compliance Program and with this new California law.  It must also make available on its website its Program and declaration of compliance, as well as a toll-free telephone number where copies of these documents can be requested.  There is no enforcement mechanism on the face of the statute.

The new law includes ambiguous provisions and raises a number of questions about its interpretation and enforcement.

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