On September 17, 2010, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) issued a notice describing a new, voluntary parallel review process under consideration by these agencies for medical products.1 Although still in the early stages of its development, it represents a potential opportunity for new technologies, particularly those that would face coverage challenges after FDA approval, to pursue affirmative coverage on a more expedited timetable than currently available. The agencies have provided some details about the parallel review process, and seek comments on a number of aspects of the contemplated parallel review process, which must be submitted by December 16, 2010. The agencies also discuss a small pilot program for the parallel review process.
Currently, companies developing new technologies approach FDA and CMS sequentially. They must first demonstrate to the FDA that the product is safe and effective through clinical trials, the protocols for which are often developed in conjunction with the FDA. Once FDA grants approval, manufacturers seek coverage under the Medicare program and by other insurers. Because CMS typically does not consider a national coverage determination (NCD) request for a new product until it has FDA approval, there is a significant coverage gap since the NCD process can take 9-12 months.
Under the contemplated parallel review process, CMS would begin its NCD-related review while FDA is working on its premarket review of the product. The agencies propose a process that would be voluntary, where all three stakeholders (i.e., manufacturer, CMS, FDA) would need to consent to use of the process for a particular product, although the agencies request comments as to whether others should be allowed to initiate a review. A sponsor requesting parallel review would have to meet the various submission requirements of FDA and CMS, although the agencies would work on ways to streamline the requirements to increase efficiency and decrease duplication. The agencies also seek comment on whether the sponsor can meet with both agencies to develop clinical trial protocols that would meet the standards of both agencies, potentially lessening the number of studies a manufacturer would need to conduct. The description of the parallel review process is largely devoid of details, but the list of issues identified for public comment addresses topics that may be included in the more detailed "joint draft guidance" that the agencies will issue after reviewing the public comments on this notice.
While the agencies are moving forward on a joint draft guidance, they will consider a "small number of requests from sponsors of innovative medical devices for parallel review on a pilot basis," 75 Fed. Reg. at 57047. The procedures for participating in the pilot will be announced at a later time. This pilot seems to present an important opportunity for a medical product under development that might be subject to a national Medicare noncoverage determination to lessen the time after FDA approval to permit Medicare contractors to pay for the technology.
As a result of the dual strength of its FDA and Health practices, Hogan Lovells US LLP is uniquely positioned to advise clients on the potential important aspects of the parallel review process. Given the limited nature of the pilot program, we urge companies to carefully consider whether to approach the agencies for participation in the parallel review pilot program.
With respect to the full-scale parallel review process, the formative time for this process is now, and the comments that FDA and CMS receive will be important to ensure that the program fulfills the stated goals of expediting approval and coverage of new products while adhering to established standards that many companies have been working under for years.