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CMS, FDA to Launch Parallel Review of New Medical Devices

Cheryl Clark, October 10, 2011

Officials for the Blue Cross and Blue Shield Association also worried about unintended consequences. "We urge that any change to FDA or CMS review of new technologies maintains meticulous attention to the scientific evidence supporting a product as well as the item’s impact on patient outcomes and clinical safety," wrote Allan M. Korn, MD, senior vice president and Justine Handelman, vice president of legislative and regulatory policy for BCBSA.

"Failure to do so would not only put individual patients at unnecessary risk, but also put the entire healthcare system at risk of continued, unsustainable cost increases that result in part from ineffective treatments or inadequate consideration of the comparative clinical effectiveness of new technologies."

Korn and Handelman added that they are aware of "numerous instances where the science supporting new devices cleared by the FDA did not also demonstrate improved clinical benefit or safety relative to existing covered products. In light of this, the establishment of parallel review must not allow a foregone conclusion that products evaluated through parallel review will be covered by Medicare if cleared for market by the FDA. Whether operating sequentially or in parallel, the two agencies must be able to draw independent conclusions based on their independent statutory authorities and the strength of the scientific evidence before them."

Raj D. Rao, professor of orthopedic surgery and neurosurgery and director of spine surgery at Medical College Physicians in Milwaukee, wrote, "The FDA looks at device safety and effectiveness with no consideration as to its cost, whereas CMS must take the financial element into account with its decisions. While this is somewhat of an obvious statement, it is difficult to harmonize in combining the different perspectives of FDA and CMS.

"It appears to me that the current process is working well as is," Rao wrote. The FDA should initially review and approve products for their scientific merit. After the product has been in use by the community for a couple of years, it is likely that more efficacy studies will be available, from users other than the industry-sponsored physicians."

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