CMS Promotes Trials via Coverage With Evidence

By Mark S. Lesney

WASHINGTON -- Officials from the Centers for Medicare and Medicaid Services stressed the growing need for cooperation and coordination between the agency and manufacturers throughout the entire development, testing, market-approval, and reimbursement process for new medical devices, in presentations at the annual meeting of the Medical Device Manufacturers Association.

CMS is transforming from a primarily accounting and reimbursement agency to an authentic public health agency seeking greater participation in the creation of new health opportunities for its clientele, according to Barry Straube, M.D., acting chief medical officer of CMS.

In the changing device- and drug-regulation scene, CMS has a new role as envisioned by its current director, Mark B. McClellan, M.D. The agency is "getting into the business of medical-evidence development" through promoting expansion of clinical trials of both drugs and devices to include the elderly. This is being done primarily through working early on with individual manufacturers to develop protocols that include the aged. Benefits to the manufacturer include a greater future likelihood of successfully negotiating the process of CMS reimbursement approval, he said.

In addition, the agency is looking into the feasibility of amassing clinically relevant data through the use of its vast patient base of Medicaid and Medicare recipients both as a source of potential volunteers for clinical trials and a ready-made population for cost-effective post-market approval studies and monitoring.

Such information could benefit both manufacturers and the public at large--with individual patient privacy being paramount in the collection of data, according to Dr. McClellan.

This new interest on the part of CMS in the clinical trials process is not meant to be an interference with the FDA's traditional role of mandating safety and efficacy, but rather, an attempt to expand the patient populations involved and improve the potential for post-market approval studies, according to panelists discussing the evolving challenge in federal evidence standards.

Rather than rejecting treatments without clear-cut evidence outright, CMS has, in a limited number of cases, established funding of medical treatments where the evidence for their patient population remains unclear, said Dr. McClellan. This has been done with the proviso that such coverage will include the establishment of registries and data collection on the treatment to answer the questions of effectiveness and value.

"One example of this is our coverage of ICDs earlier this year. This decision was based on some sound medical evidence in a clinical trial that showed that ICDs can save lives in a broad medical population that added to some existing studies. But it's also a decision where we're going to be generating more and better medical evidence. We linked our coverage to the generation of additional medical data through a registry. And this system is already in use nationwide. It started right with the coverage decision that came within days of that clinical trial being published," Dr. McClellan said.

"We are collecting this registry information by building off of electronic data reporting systems that hospitals are already using across the country for hospital quality reports and so the incremental cost is very low. By doing this, we were able to expand our coverage decision to some important indications where the evidence was more marginal such as patients with an ejection fraction greater than 35% and patients with narrow QRF complexes," he added.

CMS will continue to work with providers and developers to determine how their elderly patient population with all its comorbidities and real-world problems differs from the population treated in the idealized setting of a clinical trial, Dr. McClellan said.

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