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Regulatory Focus™ > News Articles > FDA and CMS Parallel Reviews of Devices to Continue

FDA and CMS Parallel Reviews of Devices to Continue

Posted 21 October 2016 | By Michael Mezher 

FDA and CMS Parallel Reviews of Devices to Continue

A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday.

The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or the granting of a de novo and a national coverage determination (NCD) by CMS.

Currently, CMS takes six to nine months, depending on whether an external technology assessment is needed, to make a national coverage determination. However, by beginning their assessment while FDA is reviewing the device, that time can be cut to just a couple of months.

With the announcement, the agencies are calling on device makers to apply to the program, though the agencies note they are prioritizing innovative devices that are likely to be approved and are "expected to have the most impact on the Medicare population."

To date only a single device has successfully gone through the program—Cologuard, anon-invasive DNA screening test for colorectal cancer—since it launched in 2011. On the same day FDA approved Cologuard, CMS released a proposed national coverage determination for the device, which it went on to finalize just two months later.

"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, said at the time.

FDA spokesperson Angela Stark told Focus that while only one device has successfully cleared the program, the agency has seen more interest in the program from industry.

"We have received approximately 60 inquiries regarding the parallel review program [and] have received 26 applications," Stark said, declining to disclose how many of those had been accepted.

Another advantage of the program, the agencies say, is that manufacturers are able to receive feedback that could reduce the number of pivotal trials necessary to reach a decision from both agencies.

However, there have been a number of criticisms of the program so far. One of the main criticisms is that few device makers have gone through the program.

Focus was only able to identify two other devices that were accepted to the program—Foundation Medicines' FoundationOne comprehensive genomic profiling assay and Medtronics' Symplicity renal denervation system—neither of which has been approved yet by FDA.

A recent Health Affairs analysis pointed to another challenge: alignment between the two agencies in their determinations for devices.

"For the twenty-one devices in our sample that received premarket approval and thus would have been eligible for parallel review, the two agencies' decisions were equivalent on only five occasions, or 24 percent of the time," the authors of the analysis wrote. For the rest of the devices, CMS either did not cover the device, or covered the devices with more or less restrictions than per the FDA label.

"These disparities do not bode well for parallel review; they highlight the challenge of maintaining consistent processes and endpoints across two agencies with different statutory mandates," the authors concluded.

Federal Register


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