Industry Pushes CMS For Details On Centralized Coverage Review Of IDE Trials

Article preview from "The Gray Sheet" - September 16, 2013

 Whether they support centralized review or not, device manufacturers want CMS to provide more detail on how the process would work – including timelines, the extent of manufacturer interactions with agency staff, and how appeals would be handled.

Industry Pushes CMS For Details On Centralized Coverage Review Of IDE Trials

Article preview from "The Gray Sheet" - September 16, 2013

Some device companies say they generally support CMS’ proposal to centralize coverage review of investigational device exemption studies, while others want to retain the current Medicare Administrative Contractor-based coverage process. But virtually all industry stakeholders providing feedback to CMS say that if the agency does switch to centralized review, it must first offer a lot more detail about how the process would work.

For example, CMS should specify a timeline for its reviews, create a formal appeals process, and ensure that coverage determinations are communicated to MACs, Medtronic and Covidien wrote in separate comments to CMS on the proposal, which appeared in the agency’s 2014 proposed physician fee schedule. (See "CMS Proposes Centralized Review, New Standards For Reimbursement Of IDE Studies" — "The Gray Sheet," Jul. 9, 2013.) Both companies expressed overall support for centralized review.

The two firms, joined by Abbott, AdvaMed and others, suggested a 30-day timeline for the centralized reviews. That timeframe would roughly align with the current performance of MACs, according to Covidien, which wrote that IDE coverage reviews by Medicare contractors typically range from one week to 30 days. Abbott, which urged CMS to retain the current decentralized review process, said that in its latest experience with a large U.S. investigational device exemption trial, the average turnaround time from submission to MAC coverage approval was 20 calendar days.

Continued...

To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to "The Gray Sheet".

Plus:

To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact  Kristy Kennedy at (480) 985-9512