CMS, FDA to Launch Parallel Review of New Medical Devices

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.

Many companies and individuals have commented that they are opposed to the idea, out of concern for sufficient review and an expedient process. But CMS and FDA officials say they intend that the parallel review will "focus attention on health outcomes of importance to Medicare, and provide early awareness of any remaining evidence gaps." If there are gaps, the CMS may implement an evidence development policy, covering the device only within certain parameters of a post-approval study.

"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," Patrick Conway, MD, CMS' chief medical officer, says in a statement. Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, adds that the program will make the process work "efficiently for expedient patient access to safe and effective medical devices."

The pilot program will last up to two years and will accept no more than three to five submissions per year. The emphasis will initially be on medical devices but the agencies say they will use the experience to develop similar pilots for drugs and biologics. Eventually, the agencies hope the program will "inform guidance for a broader program applicable to all medical products."

The announcement comes one year after the FDA and CMS announced their intention to implement the review process. But several individuals and companies have posted comments on Regulations.gov that the parallel review was necessary, and that changing the process in fact may slow down reviews. 

For example, Genentech's vice president of government affairs, Evan L. Morris, wrote: "if CMS requires data for its review that are not required in the FDA clearance or approval process, the manufacturer might be required to submit additional data that could prolong the parallel review process as well as potentially requiring both the manufacturer and the Agencies to devote more resources to the review than was originally anticipated."

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."