Medical Device Link.

Originally Published MX November/December 2002

GOVERNMENTAL & LEGAL AFFAIRS

Realistically, adoption of IMDMC's proposal to harmonize the FDA approval and Medicare coverage processes is a long-term objective that is unlikely to be completed any time soon. In the meantime, manufacturers of medical devices must have strategies for working appropriately with the two agencies. Those strategies should be built around the following five general principles.

In the Beginning, Stay Local. Manufacturers need not try to achieve a national coverage determination quickly on the heels of FDA approval. In many instances, the local coverage process provides a better, more flexible route to obtaining coverage than would a premature request for a national coverage determination. If the manufacturer decides that local coverage will be sufficient early in a product's life cycle, it may be less important for the company to pursue early coordination activities with FDA and CMS. However, such efforts can still be worthwhile in order to lay the groundwork for an eventual national coverage application.

Seek Efficiencies, Understand Constraints, Manage Communication. To ensure that the manufacturer satisfies both FDA and CMS criteria, some early dialogue with both agencies can help the company as it designs its clinical trials. However, there are limitations on what is possible. In many instances, a single trial or set of trials will not be able to address all the issues of interest to both agencies. It may well be that the data necessary to obtain a national coverage decision will not be available until after the device receives FDA approval.

To accomplish the objective of efficient data development, there is usually no need to have a three-way conversation among the two agencies and the manufacturer. Two independent, bilateral discussions between the manufacturer and each of the agencies is typically satisfactory. Such bilateral discussions should make it possible for the company to compare what it has heard from the two agencies and determine whether there are opportunities to achieve both agencies' objectives through a single study.

Generally speaking, manufacturers should not encourage direct communication between the two agencies, for example, by inviting CMS to attend the company's meetings with FDA. Brought together in this way, the two agencies might well try to compete with one another on some level, with each agency trying to identify more issues than the other. That kind of regulatory one-upmanship is unhealthy for the process. Although manufacturers cannot prevent the two agencies from communicating, in most instances the company should not encourage the two agencies to work together directly.

First FDA, Then CMS. FDA and CMS possess very different agency cultures, and it is important for manufacturers to understand the implications of such differences. FDA is accustomed to having discussions with manufacturers early on—before a clinical trial design and protocol have been finalized—especially when the device in question will be subject to the agency's premarket approval process. CMS is much more thinly staffed and, as a result, has not historically been involved in manufacturers' early efforts to design clinical trials.

Some manufacturers have experienced awkward meetings with CMS when they have met with the agency before adequately developing their clinical study design. Because CMS seems to expect a higher level of completion, when meetings occur too early, CMS can react as though the manufacturer is simply ill-prepared. Experience suggests that manufacturers should visit FDA first and conduct meetings with CMS at a later point in the process.

Early Education Is Important. Even though meetings to solicit CMS input may not be productive when held too early, it is important to begin the education process as early as possible. In this context, education refers to a broad set of communications that may not focus on clinical trial design but may gradually bring the agencies along in their understanding of the technology being developed. There are many forms of communication that can be used to keep both FDA and CMS apprised of a developing technology in advance of asking the agencies for their reactions to specific clinical trial designs.

Shoot Straight. Manufacturers need to be very careful, factual, and accurate when reporting discussions with one agency to another. There have been a number of instances in which an agency has gotten upset because it believed the manufacturer had misrepresented the nature of their discussions to the other agency.

To ensure that there is a record, manufacturers that report one agency's actions to the other should do so in writing, and oral discussions should be followed up with a written summary. When people are talking second-, third-, and fourthhand, it is too easy for the message to become garbled. It is important for the manufacturer to be able to defend its integrity by demonstrating exactly what it said.

Abiding by guidelines such as these can help manufacturers work with the two agencies to achieve FDA approval and Medicare coverage in the most direct and efficient manner possible under the current regulatory system. In the long term, however, the goal of the IMDMC proposal is to more clearly harmonize the roles and responsibilities of the two agencies so as to reduce some of the challenges outlined above.

Copyright ©2002 MX