Reimbursement Consulting Services for Medical Device, Diagnostics & Digital Therapeutics Companies
FDA Designated Breakthrough Devices-Upcoming Proposal to Expedite Medicare Coverage
FDA Designated Breakthrough Devices-Upcoming Proposal to Expedite Medicare Coverageadmin2022-05-31T17:10:28-07:00
Why this Newsletter
We continue to receive questions from companies on the Medicare Coverage for Innovative Technology (MCIT) program. It is important for companies to understand in late 2022 Medicare will announce its overhaul to the MCIT program. The MCIT program provides expedited Medicare coverage for US FDA-designated breakthrough devices.
This newsletter includes information about the upcoming Medicare proposal.
Medicare proposed the MCIT in September 2020 and repealed it 14 months later, in November 2021. The 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 MCIT granted expedited Medicare coverage for up to four years for all FDA-designated breakthrough devices once the device received or cleared market authorization.
The primary reason the MCIT was repealed is the program guaranteed coverage of any device that received FDA breakthrough designation and market authorization without consideration as to whether the device was appropriate and provided 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When Medicare repealed the MCIT, the agency did so with the intent to propose a revised coverage pathway for US FDA-designated breakthrough devices.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 late 2022. Questions, 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, California 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 is a US-based nationally certified Women’s Business Enterprise (WBE). 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.