New Medicare Ruling Speeds Approval of Innovative Healthcare Technology

Mar 16, 2021 at 04:21 pm by pj

A new Medicare coverage pathway, Medicare Coverage of Innovative Technology (MCIT), will provide national Medicare coverage for breakthrough devices as soon as the Food and Drug Administration approves them.(1) “A breakthrough device, as defined by the MCIT ruling,” says Dave Rich, CEO of Ensurem, a Florida-based insurance technology and product distribution firm, “is something that provides for more effective treatment of a life-threatening or irreversibly debilitating disease. For some patients, this accelerated access could be a life-saver.”


Before MCIT, notes Rich, FDA approval of a new medical device was followed by an often lengthy and expensive second approval process for Medicare coverage. After that hurdle, the device then had to go through the local coverage determination process, which is governed by 16 Medicare Administrative Contractors (MACs). (2) (An MAC is a private health care insurer with the geographic jurisdiction to process Medicare Part A or Part B medical claims or durable medical equipment claims for Medicare fee-for-service beneficiaries.)(3)


In addition to further delay, Rich notes, the MAC approval process could result in Medicare covering technology in one part of the country but not in another. Under the new MCIT rule, however, Medicare can provide national coverage of a breakthrough technology device as soon as it receives FDA approval, for a period of up to four years. (2)


The new system, says Rich, is a win for all sides. For medical technology companies, it should encourage development and investment by offering a relatively short path to market, followed by a four-year window of opportunity to develop evidence of the new product’s applicability to Medicare populations, allowing Medicare coverage to continue. For Medicare beneficiaries, it provides safety; both Medicare and the FDA require that the product be safe, effective, and past the experimental stage. Perhaps even more importantly, it offers them more immediate access to innovative and potentially life-saving devices.


Insurers offering Medicare Advantage plans, notes Rich, will of course be determining their own cost and coverage approaches to MCIT products. His own company, Ensurem, will be a clearinghouse of information on both the products available and the various carriers’ approaches to covering them. “Our agents,” says Rich, “are advocates for seniors, and our job is to help them find the best product for their needs. We’ll stay informed of these developments as they come along, and if there’s an innovation that fits a particular senior’s needs, we will let them know about it.”

Ensurem, headquartered in Clearwater, FL, is a leading technology and product distribution company serving carriers and consumers within the massive U.S. senior market. The company provides end-to-end solutions for carriers, including product development, digital marketing, and consumer-centric front ends and back end. For more information, please visit

  1. “Fact Sheet Medicare Coverage of Innovative Technology (CMS-3372-F).” CMS,
  2. Lagasse, Jeff. “CMS Issues Final Rule on Healthcare Technology Access for Seniors.” Healthcare Finance News,
  3. “What Is a MAC.” CMS,