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FDA Designated Breakthrough Devices-Upcoming Proposal to Expedite Medicare Coverage
FDA Designated Breakthrough Devices-Upcoming Proposal to Expedite Medicare Coverageadmin2022-04-27T05:58:20-07:00
Why this Newsletter
Rowinski Group https://rowinskigroup.com continues to get questions from companies on the MCIT (Medicare Coverage for Innovative Technology) program.
It is important for companies to understand Medicare repleaded the MCIT in November 2021. The MCIT would have granted expedited Medicare coverage for up to four years for all US FDA-designated breakthrough devices once the device received or cleared market authorization.
It is equally important for companies to know Medicare will be proposing a replacement to the MCIT in late 2022. This newsletter includes information about the upcoming Medicare proposal.
Medicare proposed the MCIT in September 2020 and repealed it 14 months later. MCIT was developed in part due to concerns that delays and uncertainty in Medicare coverage impaired Medicare beneficiary access to FDA designated breakthrough devices.
The primary reason for the repeal is the MCIT guaranteed coverage of any device that received FDA breakthrough designation and market authorization without consideration as to whether the device is appropriate and provides clinical benefits for the Medicare population.
When Medicare repealed the MCIT, the agency did so with the intent to propose a revised coverage pathway for US FDA-designated breakthrough devices. This new coverage pathway is referred to as Transitional Coverage for Emerging Technologies (TCET). The TCET proposal is scheduled for release in the fall of 2022. Questions, please contact Daniel Zimmerman, firstname.lastname@example.org.
About Rowinski Group
Founded in 2004, Rowinski Group LLC is a reimbursement and healthcare payer data analytics consulting firm for medical device, digital health, diagnostics, and imaging companies. Rowinski Group main US office is in San Francisco with offices at selected client locations.
Rowinski Group has two core service offerings; 1) Secure codes, coverage and/or reimbursement on behalf of our company clients and, 2) Apply healthcare payer data analytics to help companies solve business matters like responding to questions from the FDA and US healthcare payers, the identification of FDA clinical sites etc.
Rowinski Group LLC is a US-based nationally certified Women’s Business Enterprise. This certification is relevant for companies (publicly traded, privately held and not-for-profit) and universities who use supplier diversity programs to award contracted services.
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