Covidien Seeks Participation In FDA-CMS Parallel Review Program
This article was originally published in The Gray Sheet
The firm’s corporate chief medical officer Michael Tarnoff says Covidien is developing a standard-of-care-disrupting device that would gain from early formal attention by CMS; he hopes to hear from the agencies on acceptance for parallel review by year’s end. Tarnoff said he thinks the program is underutilized.
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CMS granted the company a broad-based national coverage policy at breakneck speed and a positive preliminary payment decision to boot for the Cologuard DNA stool test. It is the first national coverage determination resulting from the FDA-CMS parallel review pilot.
The device center is in the very early stages of launching the “CDRH Reimbursement Program,” planning to go beyond its current parallel-review collaboration with CMS to work with device firms, CMS and private payers to streamline the pathway from market approval to reimbursement.
Amplified message at AdvaMed 2013: Device firms must remake businesses to adapt to constrained resources and new market incentives.