On October 7 the FDA and the Centers for Medicare & Medicaid Services (CMS) on announced a “parallel review” pilot program for reviewing medical devices for FDA approval and Medicare coverage.
Both organizations have agreed on guiding principles that are designed to streamline the processes and reduce the time span between marketing approval or clearance decisions and national coverage/payment determinations.
“By reducing the interval between FDA marketing approval and Medical coverage, this process will facilitate the development of innovative products and shorten the time it takes to bring these important products to patients,” states the FDA.
Often, device sponsors focus strictly on obtaining FDA approval, only to find that Medicare coverage does not automatically follow. Both agencies rely on clinical data in reaching their decisions; although they have distinctly different regulatory responsibilities, parallel review will hopefully reduce the time between FDA approval and Medicare national coverage determinations.
“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,” writes Cheryl Clark at www.healthleadersmedia.com. “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 will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It is also only available for qualifying new medical device technologies and participation is voluntary; the program will accept no more than three-five submissions per year.
Appropriate candidates for the pilot are medical devices that meet one of the following criteria:
- New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation
- New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review
- New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision (NCD)
Pharma and biological manufacturers are not eligible at this time; however, the agencies plan to use their experience with the medical device pilot program to expand the program to include drugs and biological products in the future.
“Based on the criteria set out for eligible devices, molecular diagnostics in the personalized medicine field may be potential candidates for the pilot,” indicates Turna Ray, editor for PGx Reporter at www.genomeweb.com.
Ray indicates that molecular diagnostics firm Exact Sciences will utilize the FDA/CMS parallel review process for Cologuard, a stool-based DNA colon cancer screening test based on a biomarker and platform technology licensed from MDxHealth. “The company plans to file a premarket approval application for the test with the FDA in the fourth quarter of 2012, at which point CMS will conduct its national coverage assessment for the test,” she adds.
Clark indicates that some stakeholders have expressed concern on Regulations.gov that changing the process may actually slow down the process.
Genentech, for example, wrote that “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,” says Clark.
BCBSA’s senior vice president Allan M. Korn and vice president of legislative and regulatory policy Justine Handelman wrote that they were 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.”