Originally Published MDDI April 2004

NEWSTRENDS

Mark B. McClellan, MD, PhD, new head of the Centers for Medicare and Medicaid Services.

Erik Swain

In a move shaking up the leadership at the two federal agencies most important to the device industry, FDA Commissioner Mark B. McClellan, MD, PhD, left the agency to head the Centers for Medicare and Medicaid Services (CMS; Baltimore). The Senate confirmed him for the CMS post on March 12, 2004, about three weeks after President Bush nominated him.

McClellan will be charged with a huge task. He will lead the implementation of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the most significant Medicare legislation in more than 30 years. While it is most notable for adding prescription drugs to Medicare coverage, it contains a number of provisions affecting the device industry (see “Device Industry Praises Medicare Reform,” MD&DI, February 2004, p. 22). The previous CMS administrator, Thomas Scully, stepped down in December 2003.

Industry welcomed the move, noting that McClellan's background and tenure at FDA make him a good choice to lead CMS through a major overhaul. McClellan is both a physician and an economist, and has written extensively on medical technology.

Pamela G. Bailey, president of AdvaMed (Washington, DC), called McClellan “enormously qualified” for the CMS job. “He understands the challenges ahead and the importance of ensuring that the regulation meets the goals of the legislation,” she said. “Moreover, he understands the value advanced medical technology provides to the nation's 40 million Medicare patients and the overall healthcare system—value that will be better realized through the implementation of recently enacted reforms.”

She noted that his initiatives to make FDA reviews more efficient indicate that he may try to improve the long delays in CMS coverage, coding, and payment decisions. 

Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington), agreed. “I think he would be a great person to quarterback the implementation of the Medicare bill, given his understanding of the importance of medical technology innovation, the costs associated with it, and its overall benefits to the healthcare system,” he said.

Ted Mannen, managing director of Aventor (Washington, DC), said McClellan's appointment should be a positive for the device industry. “I've always viewed him as someone who is pro technology and cognizant of the productivity implications that technology can bring to healthcare,” he explained. 

But this is not to say a McClellan tenure at CMS will be entirely smooth sailing. Patrick Driscoll, president of MedMarket Diligence (Foothill Ranch, CA), noted that CMS suffers from even more bureaucratic stasis than FDA did when McClellan took over. “McClellan's perspective can help move CMS in the right direction, but there is so much inertia, and so much politics, that it's hard to say what will happen.”

The confirmation process was not a mere formality. Soon after the administration announced McClellan as its choice, Senator John McCain (R–AZ) threatened to hold up the nomination unless the Bush team provided more information on its drug reimportation policy, and lamented that McClellan had not testified before Congress on the topic. That issue was resolved, apparently, when McClellan said during his confirmation hearing that he would work with Congress to ensure the safety of any drugs reimported from Canada. 

Deputy Commissioner Lester M. Crawford, DVM, PhD, will serve as acting FDA commissioner until a replacement is confirmed. He also held this interim post from February through November 2002, when McClellan took office.

Liz Jacobson, Advamed's executive vice president for technological and regulatory affairs, said the association hopes McClellan's successor understands the device industry as well as he did. “His most significant accomplishment was the attention he paid to MDUFMA [the Medical Device User Fee and Modernization Act of 2002],” she said. “He understood the importance of the MDUFMA goals and of getting the appropriate level of funding so it could go forward. We have such rapidly evolving technology, and we need the agency to review more technologies.” 

Leahey praised McClellan's ability to reduce FDA administrative costs and said his successor needs to be a similarly strong leader. “We need someone who holds everyone to the same [level of] accountability, and someone who is willing to confront the increasing challenges relating to innovation that we find today,” he said.

No successor to the position had been nominated at press time. Industry insiders speculated that no names would come forth until after the presidential election, as filling the post is often a politically sensitive task. They said, however, that Crawford's previous experience as acting commissioner alleviates any concern that the agency will not be in good hands.

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