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Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard

On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare reimbursement landscape for medical devices approved under the Food and Drug Administration’s (“FDA”) “Breakthrough Devices Program.” The rule, which represents the culmination of years of advocacy by the medical device industry and patient and provider interest groups, finalizes a September 1, 2020 proposed rule that aimed to address the substantial time lag between FDA authorization of medical devices and Medicare coverage of the same. Specifically, the rule establishes a Medicare Coverage of Innovative Technology (“MCIT”) pathway for Medicare coverage of Breakthrough Devices and related medical procedures during a four-year period that begins immediately upon FDA marketing authorization. The final rule also codifies the definition of the “reasonable and necessary” standard that is used to determine when other items and services (and MCIT devices after the four-year period) may be covered by the Medicare program. The new rule becomes effective March 15, 2021.

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CMS Finalizes Permanent Changes for Certain Telehealth Services Modified During COVID-19 Public Health Emergency


Time to Read: 1 minutes Practices: Health Care

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On December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the annual Physician Fee Schedule Final Rule (“Final Rule”). Among other things, the Final Rule:

  • Makes permanent certain changes that CMS had put in place since the declaration of the public health emergency for the COVID-19 global pandemic (“PHE”) that modified coverage of telehealth services in the Medicare program;
  • Adds certain services permanently to the list of telehealth services covered by Medicare (“Medicare Telehealth Services List”);
  • Reduces, on a permanent basis, frequency limitations on nursing facility services delivered through telehealth;
  • Removes an outdated and, due to the existence of smartphones, confusing reference to “telephones” in the definition of interactive telecommunications system;
  • Makes permanent certain flexibilities that CMS had granted during the PHE related to remote monitoring care management services and virtual Communication Technology-Based Services (“CTBS”) based on CMS’ determination that these are not considered telehealth services; and
  • Clarifies several payment policies related to remote physiologic monitoring (“RPM”) services.

The Final Rule’s regulations became effective on January 1, 2021, though select policies will be applicable retroactive to January 1, 2020, or from the start of the PHE on January 27, 2020. For a discussion of the proposed rule and prior modifications to telehealth services during the PHE, please see Ropes & Gray’s prior Alert.

This Alert summarizes key telehealth changes made by the Final Rule, and includes a table for quick reference.

Click here to read the full Alert.

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