Nobody who listened to Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health (CDRH) during his appearance at last month's annual meeting of the Advanced Medical Technology Association (AdvaMed; Washington) could say he wasn't responsive to the views of the med-tech industry. When a questioner followed up Schultz's presentation during the closing session of the meeting with a question about his view on the FDA and the Centers for Medicare & Medicaid Services (CMS; Baltimore) conducting parallel reviews of new devices for market approval and reimbursement, respectively, the CDRH head was both swift and decisive in his response.

"I'd be more than happy for us to do this," said Schultz. What's more, he added, "If anyone [from industry] tries to do it and gets pushback [from the agency], I would like to know about it."

Noting that the idea of parallel product reviews by the two agencies that ultimately hold the commercialization fate of new med-tech products in their hands is part of former Health and Human Services Secretary Tommy Thompson's concept of "one HHS," Schultz told his questioner: "I really think it is starting to take hold."

Still addressing the parallel review question, he said, "From our point of view, this is something we'd like to engage in. We'd need to decide the respective FDA and CMS areas of review [but] I think it's more of an issue for industry than for us."

Responding to another question relating to the FDA's Office of Combination Products, he said that the strengths of that fledgling office outweigh its weak- nesses. "The most important point is that it's there." Acknowledging that "there's a ways to go" in that area, Schultz reminded his audience that it's a very small operation thus far. "We're talking about five people," he said. "It's a very small group, but a good group, and," he said with only a slightly suppressed smile, "it's led by a device guy."

During his presentation, Schultz said that CDRH covers "an incredibly broad range of products that present us with scientific and regulatory challenges."

Among those challenges:

• Evaluating smaller and smaller devices.
• Combination drug/device products. "One of the most exciting things happening in this industry today . . . and one of the most challenging for us."
• Combined diagnostic and therapeutic products.
• Technology for children.
• Technology he described as being something "we hope we never need," such as anthrax detection kits.
• The proliferation of device companies, which he said numbered 10,000-plus in 1998, but now total more than 14,000.
• The growing complexity of applications addressed by products coming out of those companies.

While CDRH has numerous priorities, initiatives and goals, Schultz said the center's No. 1 goal is meeting the Medical Device User Fees and Modernization Act (MDUFMA) goals for fiscal 2005. As part of that, he cited the unit's Magnet for Excellence priority hiring program, with some 132 positions added since the advent of MDUFMA. "This has made an incredible difference to us and to you," he said.

He also cited the number of internal training programs being implemented to make sure existing staff keep up on technological developments, as well as the Medical Device Fellowship Program, which brings outside expertise into the agency as a supplement to permanent staff.

Schultz also said CDRH has "a lot of 'e' [for electronic] initiatives," including e-Consult to improve the flow of information back and forth between the agency and companies whose applications are under consideration. He cited in particular the Turbo 510(k) program, which is being piloted in the area of in vitro diagnostics.

Among center initiatives, he noted the reorganization of the "RH" part of its program, radiological health staff in a push carried out last fall.

"We need to follow through on these items," Schultz said. "We need to make sure we balance our short-term and long-term efforts [in order to assure] a successful device program."

McClellan sees CMS, industry 'partnering'

At the same meeting, Centers for Medicare & Medicaid Services Administrator Mark McClellan, MD, showed that he too connects with the medical technology industry. Though McClellan addressed the meeting attendees via videoconference, 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 just marked 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 in March on such decision-making, with the goal of getting additional input, particularly by those in the industry.

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."

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."

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."

Bipartisan focus seen on healthcare IT

Last month, two senators one Democrat and the other a Republican outlined their respective parties' healthcare agendas for the coming year. Though both lawmakers clearly differed in their prescriptions for healing the U.S. healthcare system, they shared a common theme: reforming healthcare information technology (IT).

"It is time to accelerate the IT revolution as it relates to healthcare," Sen. Ron Wyden (D-Oregon) told a gathering at the 2005 National Policy Forum for America's Health Insurance Plans (Washington). Wyden is active in the Senate on healthcare issues. Calling current efforts "fragmented and haphazard," he said revolutionizing healthcare IT and paving the way toward the widespread adoption of electronic health records (EHR) one of the three main democratic healthcare goals of 2005. "This is an opportunity for bipartisan cooperation," Wyden said.

"Almost daily, there is a new drug or device, but we are so far behind in the information technology for healthcare," said Senate Majority Leader Bill Frist (R-Tennessee), proving that interest in the topic does indeed cross party lines. "Other industries use IT to get rid of waste an ineffectiveness, but American healthcare has remained in the Stone Age. This sector must make information technology a priority."

As a cardiovascular surgeon before being elected to the Senate in 1994, Frist said he was used to rapidly changing medical technology, but was "constantly amazed" by how hard it was to do something as transfer patient information and diagnostic images to consulting physicians or healthcare facilities "just across the street." He said improved healthcare IT would reduce costs by making the system more efficient, and would save lives and money by reducing medical errors through better tracking of a patient's medical records, their allergies, and other conditions.

"You can access your banking information from anywhere in the world with an ATM card," he said. "Similar technology could be used, for example, by emergency personnel after a car accident to save critical time and lives."