FDA wants more device companies to consider inviting payers in the room during FDA pre-submission meetings. To accomplish this goal, the device center is taking steps to serve as a matchmaker of sorts between product developers and private health insurers to facilitate earlier conversations about what data will be needed to support positive coverage policies.

The agency put out a notice on Feb. 23 asking for buy-in from private payers. It is a "request for expressions of interest" by third-party commercial health insurance organizations, payer/provider organizations, health technology assessment groups, and other organizations involved in making coverage recommendations or decisions.

FDA hopes a critical mass of these entities will respond to the request and agree to make themselves available to participate in device pre-submission meetings. Pre-sub meetings are increasingly requested by sponsors to gain feedback from FDA in advance of submitting an investigational device exemption application for a new clinical trial or other application types. (See Also see "FDA MDUFA III Performance, By The Numbers" - Medtech Insight, 19 November, 2015..) The device center wants to take advantage of that trend to support the overall product development process, beyond regulatory approval.

Assuming the coverage organizations respond, the agency will list participating groups on its website and create a mechanism for device companies to contact the payer groups to participate in an upcoming pre-sub meeting.

"There are many, many highly innovative, small companies that don't really understand that the requirements that FDA has for approval and clearance are actually different from the requirements that many of these third-party coverage organizations have," CDRH's Murray Sheldon says.

FDA insists it is not getting involved in making coverage decisions, but device center officials say they want to help address what is recognized as a major barrier to bringing innovative devices to market – the gap between achieving FDA clearance or approval and securing reimbursement.

Teaming with the Center for Medicare and Medicaid Services, FDA's device center launched the parallel review pilot program in 2011, allowing companies to apply to engage FDA on approval issues and CMS on the national coverage determination (NCD) process at the same time. (See Also see "FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says" - Medtech Insight, 1 April, 2013..) But Parallel review is limited to Medicare, and specifically to companies seeking a national coverage policy for their device. This latest outreach to private payers is part of CDRH's efforts to streamline reimbursement outside of the Medicare NCD process. (See Also see "CDRH Preps New Program To Streamline Approval-To-Reimbursement Path" - Medtech Insight, 20 December, 2013..)

"One of the things that we have realized is there are many, many highly innovative, small companies that don't really understand that the requirements that FDA has for approval and clearance are actually different from the requirements that many of these third-party coverage organizations have, and they have not really taken that into consideration," Murray Sheldon, CDRH’s associate director for technology and innovation, told "The Gray Sheet" in an interview.

Focus On Small Start-Ups

The private-payer program the device center is rolling out is focused particularly on those small companies. CDRH wants to provide them the opportunity to hear about data requirements for coverage when firms are still developing a data collection plan for FDA, rather than hearing about unanticipated requirements from insurers after large trials are already complete and investor money is spent.

"We want to get them together earlier to learn about what requirements may be needed at a time when they can do something about it," Sheldon said.

Companies are already free to invite a payer along to a pre-submissions meeting with FDA. And there have been a handful of occasions when that has happened, Sheldon said. But it is typically a large, established company with more experience that takes that step on its own initiative, he noted. The center hopes the new program will make it easier for a more diverse set of firms, including start-ups, to make use of feedback from payers earlier.

"Most medical device innovation comes from the 70% of the medical device companies in the US that have 10 or fewer employees, and who might not have done this more than once or twice," the FDA official said.

The concept for the program described in the Feb. 23-posted notice was developed based on research performed several years ago by a team put together under CDRH's Entrepreneur-In-Residence program. (See Also see "CDRH Entrepreneurs Take Two: Streamlining Data Collection And The Path To Reimbursement" - Medtech Insight, 22 October, 2012..) The EIR team found that both private payers and small companies supported FDA developing a mechanism to facilitate earlier communication as a means to avoid post-approval surprises.

Sheldon would not speculate on how many private coverage organizations might sign up to participate or precisely when the device center would be ready to post a list of participating organizations.

"We found in our research that there is a considerable interest, so we would hope that we would get a fairly robust response in the near term," he said.

Bring CMS Along Too, CDRH Says

Sheldon also emphasizes that CDRH wants to facilitate early feedback from CMS on clinical trial design even to companies that do not qualify or are not interested in the formal parallel review program.

One industry critique of the parallel review program has been that its sole focus on PMA or de novo-route devices seeking national coverage determinations is overly restrictive. (See Also see "Device Firms Weigh Pros And Cons Of FDA-CMS Parallel Review" - Medtech Insight, 22 November, 2010..) The device center now emphasizes that companies can request CMS participation, as well as private-payer involvement, in a pre-submissions meeting regardless of the regulatory or reimbursement pathway that is planned.

"There may be a device that a sponsor is creating that can be used for Medicare beneficiaries and non-Medicare beneficiaries, and may not want parallel review and a national coverage determination," Sheldon said. "But they still would want to get the input from both organizations as to … what [do they] want to see in the early stages to inform [the company's] decisions on how they want to create their clinical trial design."

Bringing Private Payers To The Regulatory Table: FDA Reaches Out To Insurers

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