Originally Published MX March/April 2004
BUSINESS NEWS
FDA Commissioner McClellan Named to Head CMS |
| Mark B. McClellan |
In mid-February, President Bush nominated FDA commissioner Mark B. McClellan, MD, PhD, to become the next administrator of the Centers for Medicare and Medicaid Services (CMS; Baltimore). Responding in near-record time, the full Senate approved the nomination on March 12. The confirmation puts McClellan in charge of the agency responsible for the healthcare of 40 million Medicare recipients and an additional 44 million beneficiaries in the federal-state Medicaid program. CMS outlays over the next fiscal year will be $482 billion.
The medtech industry responded very favorably to the news, particularly in regard to the potential for addressing reimbursement issues, which are now typically of much greater concern than the FDA approval process.
Pamela Bailey, president of AdvaMed (Washington, DC) described McClellan as "tremendously qualified" and someone who "understands the value of advanced medical technology." In a prepared statement, Bailey said she hoped that he would bring the same modern, less-bureaucratic, more-efficient approach to CMS that he championed at FDA. She specifically cited the need to address the long delays in the CMS coverage, coding, and payment processes. "Commissioner McClellan is well suited for this new role because he recognizes the need to ensure patients access to high-quality, affordable healthcare, which includes timely access to new innovations."
Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington, DC) concurred, stating that McClellan was "uniquely suited" to head CMS based on his "leadership skills" and "keen understanding of the benefits of medical technology to the healthcare system."
McClellan had sailed through the Senate confirmation process twice before, and approval of his nomination was never seriously in doubt. He enjoys wide bipartisan support in Congress. Senate majority leader Bill Frist (R–TN) characterized him as "the best man for the job," while Senator Edward Kennedy (D–MA)—an outspoken critic of the administration's recently enacted Medicare reform legislation—called McClellan "a superb choice" and "someone who will bring to the job a powerful intellect, a deep knowledge of the programs, and a commitment to public service."
McClellan will take the helm of the Medicare program as it begins to implement the most sweeping changes in its 38-year history—namely, the prescription drug benefit program for senior citizens. The program was initially pegged to cost $400 billion over 10 years, but its estimated costs have since been revised upward to $530 billion.
The CMS position had been vacant since late December, when former administrator Tom Scully resigned to take a position with a private law firm.
Charles E. Grassley (R–IA), chairman of the Senate Finance Committee, moved quickly to take up the McClellan nomination. The committee voted 18-2-1 in favor of recommending the nomination to the full Senate. "CMS has more responsibility than ever before. We need a CMS leader who understands how to do the job not just adequately, but very well," Grassley said.
At FDA, Lester Crawford, DVM, the current FDA deputy commissioner, will become the agency's acting commissioner. Crawford has served as deputy commissioner since McClellan's appointment. He was also FDA's acting commissioner for nine months prior to McClellan's appointment.
Copyright ©2004 MX
