Medical Device Daily Executive Editor

DANA POINT, California – The Friday morning link-up may have been by videoconference, but it's clear that Centers for Medicare & Medicaid Services (CMS; Baltimore) Administrator Mark McClellan, MD, connects with the medical technology industry.

Though McClellan addressed the annual meeting of the Advanced Medical Technology Association (AdvaMed; Washington) annual meeting at the St. Regis Monarch Beach Resort & Spa electronically, his message of greater cooperation with the industry in getting innovative technologies covered by CMS more quickly was received as if he had delivered it on a one-to-one basis.

The former FDA commissioner, who this month marks the one-year anniversary of his switch to head CMS, spoke of working in partnership with AdvaMed and its member companies to ensure that such technologies get into the hands of doctors who can use them to enhance the lives of their patients.

"We need to take a careful look together" at the best ways to gather the evidence needed to support coverage decisions on new medical technologies, McClellan said, responding to a question from his audience on the opposite coast.

The bottom line, he said, "is that we want to make sure the changes we make to our processes lead to doctors and patients getting the best medical treatments possible."

Central to his vision – and to his talk to the AdvaMed membership – is "Pay for Performance," slogan-speak for making sure the nation's largest healthcare payer gets the most bang for the almost unfathomably large bucks it spends.

"Pay for Performance is coming in all aspects of the Medicare program," McClellan said. "The Pay for Performance approach works," he asserted. "Under Pay for Performance, we'll see more investment in electronic health systems of all sorts."

He cited both the growth in the development of electronic medical records and electronic capture of clinical information and the need to accelerate that growth. "We're promoting the adoption of healthcare IT because that will improve the delivery of care."

McClellan said electronic health systems "can do a lot to help doctors and patients make better decisions" about their care.

His primary goal is simple: "I want to keep decision-making in the hands of doctors and their patients – we need to do more to make that system work." And, he said, "We need to support them by developing better decision-making tools."

A key, McClellan said, is looking at how evidence-based medicine can promote innovations such as those produced by the companies represented in his audience.

"We want to make sure we're using medical technology to improve [health] outcomes," he said. "Medical technology holds tremendous promise for getting better value from our Medicare dollars."

Central to the changes he is endeavoring to usher in at the agency, long known for its intransigence, is the effort to create what he termed "a much better business case" for new technologies.

McClellan noted, for instance, "we're going to have competition and innovation in the way the new Medicare drug benefit is delivered."

As for getting new technologies approved for coverage, he noted: "We are having to act faster on decisions ... we are meeting accelerated timeframes on coverage decisions."

Citing the need for "faster, more transparent, more predictable coverage decisions," McClellan said CMS would issue draft guidance later this month on such decision-making, with the goal of getting additional input, particularly by those in the industry.

As part of the "faster" element in making coverage decisions, he cited the agency's January decision to broaden its coverage of implantable cardioverter-defibrillators, noting that the decision was announced within a week of publication of the clinical trial results that supported the expanded coverage.

Through such means as electronic gathering of clinical trial data and patient registries for newly approved technologies, McClellan said CMS "can provide coverage while we're generating additional evidence."

Declaring that "we want to take further steps to improve our coverage process," he said, "This is the best path forward. [Patients'] health can be improved through innovative technologies."

Referring to the med-tech industry and CMS as "partners" in the process of getting new technologies into doctors' hands, McClellan told the AdvaMed members listening to his presentation: "We're going to continue talking as we move forward."

Responding to a question about the difference in requirements between the FDA for approval of a technology and CMS for reimbursement of that technology, he said, "We [CMS] need to be clear about the benefits outweighing the costs of providing that benefit."

Answering another query, he said local Medicare coverage decisions "are important to providing access to technologies and in helping collect evidence for national decisions," but that the focus of the initiatives he had been discussing was on improving the process of making national coverage decisions.

Agreeing with another questioner that smaller companies that may be developing technologies with a more narrow use or smaller revenue potential cannot afford to fund large trials, McClellan said: "We can work together to help reduce the costs of data-gathering. We want to make sure the benefits of gathering such evidence outweigh the costs of doing so."