Major Private Payers Step Forward to Give Device Companies Early Input

Seven major private payers and health technology assessment groups have raised their hand to give interested medical device companies early feedback on clinical trial plans and potential evidence requirements.

In what is akin to an expansion of the Parallel Review program, CDRH has publicized the names of seven private payer and health technology assessment (HTA) organizations who have volunteered to help medical device companies gain more insight into clinical evidence needed for reimbursement coverage.

Those seven organizations are:

A common complaint from industry is that reimbursement, not regulatory approval, is the real challenge in bringing new medical devices to market. This effort is intended to give industry more resources to better understand what data and evidence they need to collect for payer scrutiny. The Parallel Review program already allows medical device companies to simultaneously consult FDA and CMS about a new device--this brings private payers to the table.

As MD+DI reported earlier this year, CDRH asked private payers for their interest in participating in this effort. The expansion of the Parallel Review program, managed by CMS and CDRH's Payer Communication Task Force, will allow device companies to request that a specific private payer or payers participate in its FDA pre-submission meeting discussion.

An email sent earlier this week notifying companies about the private payer/HTA participation emphasized that this effort doesn't change FDA's regulatory approval process. In addition, participation is voluntary for device companies and the organizations. The list is expected to be updated from time to time with new organizations.

[Image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]