CMS is Proposing Major Changes to its coverage of IDE Trials

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The proposed change was announced in the 2014 Proposed Physician Fee Schedule. While some of the changes are beguiling, the heart of the change makes it quite likely that FDA clinical trials of the type that you have done historically will no longer be covered.

The beguiling part is that CMS is proposing to centralize review of coverage requests. This could mean no more dealing with the individual MACs and (possibly) dealing directly with CMS instead of through sites and investigators.

However, the standards for coverage which CMS is proposing have rarely, if ever, been met in the IDE trials with which we are familiar. There are two standards of particular note.

The first is proposed section 405.212(a)(1), which says that to be eligible for coverage, “The principle purpose of the study is to test whether the item or service meaningfully improves health outcomes of patients who are represented by Medicare-enrolled subjects.” This standard is problematic for several reasons including that IDE trials as they have been conducted to date would not meet it.

The second is CMS preference for “superiority” clinical trial design. While its not clear that only “superiority” trials will be covered, the proposed regulation stats a clear preference for them. In the regulation it states that trials having superiority design (and meeting all other conditions) “are covered,” but states only that trials meeting all other conditions “may be covered.”

We believe these proposed new standards essentially change the game from one in which CMS covers most IDE trials to one in which CMS is attempting to change the nature of an IDE trial in order to qualify for coverage. The changed nature of the trial may not even satisfy the FDA purposes for doing the trial. We think these changes would disrupt the medical device innovation process indefinitely.

If you agree with us we urge you to make your opinion known to CMS via the formal comment process. Comments are due September 6, 2013. Comments should be made in response to the 2014 Proposed Physician Fee Schedule. You may submit comments is one of the following ways:

Electronically: you may submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions for “submitting a comment.”

By Regular Mail: You may submit written comments to the following address only:

Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
Attention: CMS-1600-P,
P.O. Box 8016,
Baltimore, MD 21244-8016

By Express or Overnight Mail: You may send written comments via express or overnight mail to the following address ONLY:

Centers for Medicare & Medicaid,
Department of Health and Human Services.
Attention: CMS-1600-P,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850

Please contact us for more information.