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The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?

Readers: After this story was published, FDA and CMS launched a Pilot Program for Parallel Review of Medical Products. Current information can be found on FDA's web site. −Editor


Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs of two Federal agencies with fundamentally different missions? Possibly.

Over the years, FDA and CMS (Medicare) have published numerous independent regulations, memorandums, guidance documents, policies, provisions and reviews of medical technologies independent from one another. Additionally, each has its own perspective on what defines an accepted proof source and what level of information is necessary to achieve their individual objectives.

The end result from these independent agency reviews and considerations? Time! Time to market, time to increased clinical adoption, time to patient accessibility of a new technology and time to revenue generation. In the end, who is the bearer of the burden of the independent review conundrum? The device manufacturer.

The impact of time on device approval and subsequent reimbursement is not new to either agency, nor is its consequence new to device manufacturers. Unfortunately, it has taken several years for this concern to be officially recognized, acted upon and a solution proposed.

On June 24, 2010, Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH), announced that a Memorandum of Understanding (MOU) had been initiated between FDA and the Centers for Medicare and Medicaid Services (CMS). The goal? To promote “data sharing” for new medical technologies. The intention of the MOU is to establish collaboration between the two agencies to create a new, parallel review process for medical technologies to achieve each agency’s respective mission: market clearance and Medicare coverage for a new technology. This initiative may also be the first step towards the decision of the agencies to consider defining certain circumstances when an FDA determination on safety and effectiveness is adequate for CMS to begin covering and paying for a new technology "without additional evidence."

However, is this concept really “new”? The idea of data sharing between agencies has been forthcoming for some time. In 2005, Tommy Thompson, the Health and Human Services Secretary, stated that a broad interagency information-sharing initiative was in place that included a parallel review of a technology at the request of an applicant and with the concurrence of both agencies. Unfortunately, the details of such a project and the underlying value of this type of program remained virtually unknown to those within the respective agencies, as well as the device sector. As a result, adoption of this government initiative did not occur. If the value proposition and details of such a program had been better communicated to the device industry, there might have been more examples of products that received simultaneous Medicare coverage and FDA clearance other than drug eluding stents and human recombinant erythropoietin for chronic dialysis patients.