CMS and FDA announce pilot program for parallel preview of medical devices

On 7 October 2011, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced plans to launch a voluntary pilot program for parallel review of medical devices. The announcement responds to comments received from a 17 September 2010 notice by CMS and FDA seeking comments on a potential parallel review process intended to reduce the time between FDA marketing approval or clearance and Medicare's national coverage determinations (NCDs). The pilot program will accept requests to participate from device sponsors/requesters for two years, and the agencies expect to review no more than five products each year under the program. The notice of the pilot program was published in the Federal Register on 11 October 2011.1

Guiding principles for the pilot program

The parallel review pilot program is "intended to reduce the time between FDA marketing approval and CMS NCDs, thereby improving the quality of patient healthcare by facilitating earlier access to innovative medical products for Medicare beneficiaries."2

CMS and FDA established five guiding principles for the pilot program. 

  1. Participation in parallel review will not affect the review standard for device approval by FDA or for a coverage determination by CMS.
  2. The agencies will adhere to all statutory and regulatory requirements as stipulated in the memorandum of understanding between FDA and CMS.3
  3. A sponsor/requester may withdraw from, and FDA and CMS may terminate, parallel review up until the time of CMS's public posting of an NCD tracking sheet.
  4. The agencies will not publicly disclose participation of a sponsor/requester in parallel review prior to CMS's posting of an NCD tracking sheet, unless the sponsor/requester consents or has already made this information public or disclosure is required by law. If a sponsor/requester does not wish the information that would be revealed by the posting of the NCD tracking sheet to become public, it must withdraw from parallel review prior to this point.
  5. Due to agency resource issues the pilot program expects to accept no more than three to five candidates per year.

The pilot program will not address coding or Medicare reimbursement for new technologies, including eligibility for special payment provisions under the hospital inpatient and outpatient prospective payment systems. These issues were identified in some of the comments to CMS and FDA as additional obstacles to access to innovative technologies.

Candidates for parallel review

The pilot program will focus on "truly innovative technologies," specifically medical devices that meet the following criteria:

  1. New technologies for which the sponsor/requester has had sufficient pre-investigational device exemption (IDE) interaction with FDA or approved IDE application.
  2. New technologies for which an original or supplemental application for premarket approval (PMA) or petition for de novo review would be required.
  3. New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to an NCD.

The third criterion significantly limits the reach of the pilot program. Innovative products that are subject to negative NCDs would not be eligible for the pilot program. Sponsors of these technologies will continue to need to pursue the nine to twelve month national coverage analysis process to overturn a restrictive NCD.

The pilot program will apply to devices only, but CMS and FDA plan to use their experience with the pilot program to develop a parallel review program for drugs and biological products.

Procedures for parallel review

The parallel review process will be voluntary and can be initiated only by the "sponsor/requester" of the device. The sponsor/requester will nominate its device for parallel review by providing information to the FDA on the device and an explanation of why it is an appropriate candidate for the pilot program. The FDA and CMS will meet to consider the nomination within 30 days of receiving the request, and will notify the sponsor/requester whether the product is an appropriate product upon completion of that meeting. If the product is an acceptable candidate, the sponsor/requester will meet with the agencies to accept participation in the pilot.

FDA will review the product using the normal FDA review process. CMS will begin its informal review process sometime after submission of the PMA or de novo petition, and will not publicly disclose its review prior to posting of the NCD tracking sheet on the CMS website. As noted above, the process will not change the CMS standard for coverage determinations or the FDA standard of approval. In addition, it will not affect user fees or review timeframes or procedures. 

The sponsor/requester may withdraw from the parallel review process by notifying both agencies in writing prior to CMS's formal opening of the NCD by posting of the NCD tracking sheet.

Questions

The CMS-FDA notice provides important details about the parallel review pilot program, but the amount of interest in the new program from device manufacturers remains to be seen. For those interested in participating in the pilot program, it will be important to position the nomination correctly given the few devices the agencies expect to accept into the program.