Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?

Article preview from IN VIVO - February 1, 2011

The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies.

Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting? 

Article preview from IN VIVO - February 1, 2011

The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies. Parallel review may represent an example of regulators being ahead of industry in streamlining the regulatory process, and the burden will be on FDA and CMS to demonstrate the true value of this approach.

While the device industry has been anything but shy with its criticism of the FDA's pre-market product clearance program of late, there remains an equally important additional hurdle after FDA approval that can stop even the most promising new technologies in their tracks but which has managed to avoid the spotlight: Medicare reimbursement coverage. Indeed, possibly the only thing more daunting for a device company with an innovative new product than staring down FDA's pre-market review staff is having to make one's case to the Centers for Medicare and Medicaid (CMS) for reimbursement decisions.

While it may not be discussed quite as much as fears regarding the 510(k) program, after product approval, reimbursement is next on the list of device makers' regulatory concerns. FDA's review in itself can be a lengthy, multi-million dollar process, requiring extensive clinical trials and data, but as one device industry executive puts it, "CMS is like FDA on steroids in terms of the types of studies they want to see." The Medicare process can add years – and significant cost – before a company can truly see uptake in the market for their new technology; without federal reimbursement coverage, which often leads to similar decisions from private payors, companies can be left in the no-man's-land of having an approved product that won't get paid for.

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