Funding cuts hamper initiatives to ease med device regulation bottlenecks

Two initiatives are in play to address bottlenecks created by the need for device makers to adhere to mandates by both the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services--however, funding cuts have kept the programs from reaching their full potential, according to a Health Affairs policy brief.

Implementation for the two initiatives--parallel review and coverage with evidence development (CED)--has been "slow and piecemeal," according to the brief.

Currently, medical devices are approved by the FDA if they are deemed "safe and effective." At the same time, CMS' decision is based on whether the product is "reasonable and necessary."

"In practice, this has created two separate evidentiary hurdles for some product sponsors, which can lead to substantial delays or limitations in patient access or can even block market entry," according to the brief.

To that end, under CED, CMS offers temporary reimbursement for a device if the beneficiary is part of a study that can be used to revise coverage for the tool.

However, the Agency for Healthcare Research and Quality is responsible for the "statutory basis" for requiring those studies. And if the AHRQ is eliminated, which a recent House Appropriations Committee draft budget put forth, it creates a question of whether CED can be invoked by CMS down the road.

Meanwhile, under parallel review, device makers have the ability to ask CMS to start coverage determination while a device is still under review by the FDA, according to the article. The pilot for the review was set for two years and then extended to this December. It will expire at the end of the year, but there are indications it will be extended again, the article adds.

Still, questions remain about the value of parallel review, according to the article. 

"Given that an early failure in obtaining coverage may derail a product's development, manufacturers may be reluctant to subject a new product to such a gamble," the brief notes. "Others may be reluctant to focus their data collection on Medicare's requirements, particularly if the device is intended for a broader patient population."

What's more, the brief notes that there is "limited potential" for parallel review to impact more than a few products a year, which has led to calls for eligibility standards reforms.

Cologuard, which can diagnose the presence of colorectal cancer markers in a patient's stool, was the first product reviewed through the latter program.

"Regardless of whether these budget cuts become a reality, CMS will be limited in its ability to implement or improve either program without additional resources, and the current political environment makes that unlikely," the article notes.

To learn more:
- read the brief