by Brendon Nafziger
, DOTmed News Associate Editor | October 07, 2011
Once medical device manufacturers pass the hurdles laid out by the Food and Drug Administration for new products, they aren't entirely in the clear. While the shiny new device can be sold in the U.S. market, it doesn't mean one of the most important potential buyers - Medicare - is on board.
The Centers for Medicare and Medicaid Services has its own clinical review process, and there's often a delay between a product's FDA approval and CMS' national coverage determination.
Now, the two agencies are working to reduce that lag, through the launch of a pilot "parallel review" program.
Starting Friday, the two agencies said they'll start accepting submissions from manufacturers for "innovative device technologies" for concurrent reviews for premarket approval from the FDA and national coverage decisions from CMS.
"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," Dr. Patrick Conway, CMS' chief medical officer, said in a statement.
The pilot program was first floated by the agencies
in September last year. FDA and CMS received about 37 comments on the process, and they said they've incorporated those ideas into the new pilot program.
The new initiative is completely voluntary, initiated by the sponsor (manufacturer), and doesn't affect review standards, the agencies said in their Federal Register posting about the program launch. Also, they only expect to accept between three and five candidates a year, because of limited resources.
For the pilot project, FDA and CMS said they want to focus on "truly innovative technologies that are most likely to benefit from the efficiencies of parallel review."
This means, the agencies said, they want products that have already received or are working toward an investigational device exemption, and would fall under FDA guidelines for devices that are completely novel.
The FDA and CMS said they expect the pilot project to accept applications over the next two years. They also said they'll use the experience they gain from this program to try something similar with drugs or biologic products.
When asked about the pilot program, the Advanced Medical Technology Association (AdvaMed), a device lobby, said it was still reviewing the specifics of the project.
“Overall, we support efforts to improve the timeliness, predictability and efficiency of FDA’s regulatory decision-making process and CMS’ coverage, coding, and payment determinations so that patients may benefit from earlier access to innovative medical devices and diagnostics that can save and improve lives and increase the quality of care," Ann-Marie Lynch, executive vice president of payment and health care delivery policy with AdvaMed, said in a statement e-mailed to DOTmed News. "However, we believe it is important to preserve the currently separate and distinct regulatory missions of FDA and CMS to ensure that each agency does not influence the functions and decisions of the other and to ensure the confidentiality of all proprietary information provided by manufacturers.”