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CMS, FDA to Launch Parallel Review of New Medical Devices

Cheryl Clark, October 10, 2011

Two federal agencies that usually conduct separate reviews of medical devices, drugs, and biologic tests to determine safety, effectiveness, and whether they merit federal coverage have announced a parallel review for innovative concepts.

"It has come to our attention that innovators have generally focused solely on obtaining FDA [U.S. Food and Drug Administration] approval, only to later realize that Medicare payment may not automatically be forthcoming," says the announcement, published Friday in the Federal Register.

Over the years, regional coverage decisions on certain types of medical equipment – from breast cancer drugs like Avastin to surgical devices like the CyberKnife – have received FDA approval, yet have gained spotty or partial approval from regional Centers for Medicare & Medicaid Services contracting agencies, in a process known as local coverage decision-making. Some FDA-approved products wait years before CMS accumulates enough information to determine whether the technology will or won't be covered.

The pilot program is intended to assure safety and effectiveness while reducing the time between FDA approval or clearance decisions and Medicare's decision to cover the innovation at a national level, the joint announcement says.

"Patients are expected to gain quicker access to innovative medical technologies if they are covered," the agencies say.

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