FDA Device Effort May Cut Development Costs

BNA’s Health Care Daily Report™ sets the standard for reliable, high-intensity coverage of breaking health care news, covering all major legal, policy, industry, and consumer developments in a...

By Michael D. Williamson

Feb. 23 — A new FDA effort to spur collaboration between the insurance and device industries may reduce development costs, a former White House science and technology official said Feb. 23.

Medical device companies, under a program outlined in a notice (FR Doc. 2016-03909; FDA-2012-D-0530) released Feb. 23, could contact insurance companies and other coverage organizations to seek input on gathering clinical evidence needed to support positive coverage decisions.

Early input from payers regarding their evidentiary needs can streamline the process from FDA approval or clearance of a device to payer coverage while also improving public health, the notice said.

Such a program “has a been a long time coming,” Ken Yale, the chief of staff for the White House Office of Science and Technology during the George H.W. Bush administration and an attorney experienced with FDA regulations, told Bloomberg BNA Feb. 23. Health insurers should welcome the Food and Drug Administration efforts on this and “I personally applaud” the agency for releasing the notice, Yale said.

Likewise, the Advanced Medical Technology Association (AdvaMed), a device industry group, “appreciates FDA’s efforts to connect medical technology premarket submission sponsors with coverage organizations during pre-submission meetings on a voluntary basis,” a spokesman for the group told Bloomberg BNA in a Feb. 23 e-mail. “The information provided by coverage organizations could help facilitate private payer coverage of a medical technology post-FDA clearance or approval and provide more timely patient access to new medical innovations,” the spokesman said.

Instructions for coverage organizations to express interest in participating in the program are included in the notice. The notice is effective Feb. 24. A comment due date isn't specified.

Gauging Interest

The FDA requested expressions of interest from insurance firms interested in participating in the unnamed program. If insurance companies express interest, the FDA “intends to provide a mechanism for such organizations to identify themselves so that medical device sponsors who would like to obtain coverage input can voluntarily contact them to participate in a FDA Pre-Submission meeting,” the notice said. The FDA notice is set for Feb. 24 publication in the Federal Register.

The FDA's Center for Devices and Radiological Health (CDRH) intends to list interested insurance companies on its website, according to the notice.

Clinical Trials

The agency also said the program may help device sponsors who voluntarily meet with insurance companies early in the development process to conduct clinical trials that simultaneously capture the data necessary for FDA approval or clearance and to acquire a positive coverage decision.

The effort may speed patient access to new devices, because many sponsors currently seek coverage decisions only after receiving the FDA's approval or clearance to sell a device, the notice said. Payers don't always require the same clinical evidence for a coverage decision as the FDA requires, which delays “broad patient access” and negatively affects public health, the FDA said.

The notice doesn't require sponsors to include a coverage organization in any pre-submission meeting. It also doesn't require insurance companies to express interest in covering a device to be included in a pre-submission meeting.

Communication Helpful

Lessons learned from the FDA's experience with the parallel device review program with the Centers for Medicare & Medicaid Service showed that early input from payers regarding their evidentiary needs can streamline the process from FDA approval or clearance to payer coverage, the notice said.

Parallel review was first launched in 2011 as a pilot program between the CDRH and the CMS. Under the pilot program, manufacturers can request that the CMS begin its coverage determination process while the investigational device is undergoing review by the FDA.

Efforts to increase communication between device sponsors and insurance companies are a natural extension of the parallel review program, Yale said.

To contact the reporter on this story: Michael D. Williamson in Washington at mwilliamson@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com