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November 09, 2020

The Progress and Potential for Medicare Coverage of Innovative Technology

This Briefing is brought to you by AHLA’s Health Information and Technology and Regulation, Accreditation, and Payment Practice Groups.
  • November 09, 2020
  • Ty Kayam , Microsoft
  • Brady Mickelsen , Paul Hastings LLP

On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule establishing a pathway for faster access to innovative medical devices for Medicare beneficiaries. While groundbreaking in many respects, the biggest feature of this rule is the coordination between CMS and the U.S. Food and Drug Administration (FDA or Agency) to introduce a method of Medicare coverage for medical devices that is immediate upon FDA market authorization. The comment period for this proposed rule ended on November 2, 2020 with approximately 90 comments submitted for CMS review.

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