Newsletter for Leaders in the Medical Device Industry – November 2010

Although both the FDA and the Centers for Medicare and Medicaid Services (CMS) are organizationally housed within the federal Department of Health and Human Services (HHS), historically there has been limited interaction between the two entities even when addressing the same product. Increased collaboration has been a recent goal, as evidenced, for example, by the CMS regulation that authorized sharing of CMS' Part D (prescription drug) data to support the FDA's Sentinel Initiative in its efforts to identify possible post-market adverse events.

Recently, the FDA and CMS jointly issued an official notice that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review (Notice, 75 Fed. Reg. 57045 (September 17, 2010)). Public comments were requested and will be accepted until December 16, 2010. The agencies also announced their intent to create a pilot program for parallel review of medical devices, to begin after both agencies have reviewed the public comments received in response to this notice.

The advantages of a parallel process are clear, and discussed at some length in the Notice. The FDA is responsible for assuring that drugs and medical devices intended for use in the treatment of humans are safe and effective for their intended uses and that product labeling reflects true and accurate information. CMS makes coverage and payment determinations for Medicare beneficiaries, as well as setting certain broad parameters for product coverage and payment by state Medicaid programs, which are funded in part by the federal government.

Manufacturers have faced a long process to finally secure payment for their products, having to first secure FDA approval and then navigate through the CMS coverage process and payment determinations, particularly if they are seeking a CMS national coverage determination (NCD). Many payers follow Medicare's lead for coverage determinations, so the adverse impact of payment delay can be multiplied. There also is no assurance of a good result (i.e., Medicare payment) from CMS even if the FDA has approved the product. Different types of information may be required by CMS than that which has already been compiled for the FDA. In appropriate circumstances, CMS may even consider coverage of products for FDA-unapproved or off-label use, clearly requiring significantly different information than that submitted for FDA approval.

According to the Notice, a parallel process where both FDA and CMS approval are processed more or less simultaneously (rather than sequentially as is now the case) will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and issuance of NCDs. Among the reasons expressed in the Notice supporting this parallel process are the following:

  • Both agencies believe they should address the growing need to improve public health by speeding consumer access to and spurring the development of new, affordable, reliable, safer, and more effective medical products and services
  • The limited predictability of market access may hinder investment in the development of innovative therapies and diagnostics
  • A parallel review process can furnish an opportunity to educate developers regarding clinical study designs that are more likely to simultaneously address both FDA and CMS questions

The Notice includes 17 specific issues for which public comments are requested. These include topics such as who should be able to initiate a request for parallel review (for example, the FDA, CMS, an interested third party); which classes of products would various stakeholders benefit most from parallel review; how to decide whether to grant a request for parallel review; how limits should be placed on the number and/or type of products concurrently under parallel review; and identifying potential disadvantages and barriers to parallel review.

Conclusion

Parallel FDA and CMS product review offers an opportunity to reduce the time it now takes to secure Medicare payment for new products. Innovators, manufacturers, and other stakeholders have an opportunity to influence the development of this process, and should consider submitting comments by the December 16, 2010 deadline.

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