Medical Device Daily Washington Editor

WASHINGTON — In the midst of much more contentious debate concerning cabinet-level nominations, the Senate confirmed Michael Leavitt to serve as secretary of the Department of Health and Human Services (HHS), replacing Tommy Thompson.

Before receiving President George Bush's nomination in December, the 53-year-old Leavitt was a three-term governor of Utah and most recently occupied another cabinet post as the administrator of the Environmental Protection Agency, where he has been for the past 15 months.

Leavitt now will head the largest department in the federal government, with 300 programs, 66,000 employees and a budget of more than $550 billion.

The Senate's Finance Committee unanimously approved his nomination earlier in the week, which cleared the way for a full Senate vote on Wednesday. Leavitt enjoyed such broad bipartisan support that he was confirmed by voice vote only, which means the names or numbers of senators voting on each side are not recorded.

Some of the most important topics waiting for Leavitt at HHS will include increased scrutiny of the drug-approval process at the FDA in the wake of some bad press after several arthritis drugs were pulled from the market because of increased risk of heart problems and strokes.

During his nomination hearings on Capitol Hill, senators urged Leavitt to work toward naming a permanent head of the FDA. That agency has been without a commissioner since Mark McClellan left in March to serve as administrator of the Centers for Medicare & Medicaid Services (CMS; Baltimore). Acting Commissioner Lester Crawford has been in charge at the FDA since that time.

During his testimony before the Health, Education, Labor and Pensions Committee, Leavitt had harsh words for CMS's Medicaid program, calling it “flawed and inefficient“ and adding that “we can do better and expand access to medical insurance to more people by creating flexibility for our state partners and transforming the way we deliver it.“

Jay Nawrocki, an analyst on the Medicare and Medicaid programs for CCH (Riverwoods, Illinois), said that among Leavitt's first challenges would be the implementation of Medicare's prescription drug benefit and the reformation of the Medicare Plus Choice program into the Medicare Advantage program.

“The implementation of those two programs is happening as we speak,“ he said, adding that final rules came out a week ago. “The providers are scurrying about trying to understand what they need to do to provide the prescription drug benefit and to participate in the Medicare Advantage program. That will be over the entire year.“

Nawrocki added that Leavitt's talk of Medicaid reform, brought up during his confirmation hearings, could have some substance as it relates to block grants and reductions in open-ended federal spending. Nawrocki said that as Utah's governor, Leavitt received waiver approval to reshape that state's Medicaid program.

“There is some indication that that might be coming down the road, some type of Medicaid reform issue,“ Nawrocki said. “On the Medicare side, we're also hearing conversations about how spending in that program needs to be looked at and addressed, cutting back a little in some spending areas.“

He added the observation that such Medicare spending reform talk might not be sincere, but instead a political maneuver to shift Republican attention away from Social Security reform.

Also on Leavitt's watch, President Bush is expected to continue to push for the adoption of healthcare information technology.

“That initiative dates all the way back to the Clinton days to get savings in the healthcare system by bringing new communication technologies forward,“ Nawrocki said. “Bush seems to be picking up on that and carrying that agenda this year as well, so that could be another issue confronting Secretary Leavitt.“

During part of his testimony, Leavitt noted that the office of Dr. David Brailer, the national coordinator for health information technology, had been de-funded in the final budget accord signed into law by the president. “I have read about [Brailer's] work,“ Leavitt said. “We must have that kind of technology and vision in healthcare.“