Washington Editor

WASHINGTON - With relatively little fanfare, Michael Leavitt last week received Senate confirmation to become the new secretary of the Department of Health and Human Services.

His approval process sparked little in the way of controversy, unlike concurrent debate over Condoleezza Rice's nomination to be secretary of state. In fact, bickering over Rice on the Senate floor led to a delay in a vote on Leavitt, which was expected Tuesday after he received official backing that morning from the Senate Committee on Finance. Instead, he received approval on Wednesday.

At the preceding Senate Committee on Finance meeting, no senators in attendance voted against the nomination, nor did any opt to further discuss the appointment. Leavitt himself did not attend the brief meeting, which essentially served as a formality a week after he sat for a pair of hearings to consider his selection. The same Committee on Finance had grilled him for several hours, as did the Health, Education, Labor and Pensions Committee.

With the confirmation process now in his rearview mirror, Leavitt is charged with leading the federal government's largest department. HHS includes 300 programs, has 66,000 employees and a budget of more than $550 billion - almost one out of every four federal dollars. Among its major agencies and programs are the FDA, the National Institutes of Health, the Centers for Disease Control and Prevention, and Medicare and Medicaid.

CCH Inc.'s Jay Nawrocki, a Medicare and Medicaid analyst for the Chicago-area firm that provides tax and business law information and software, talked about initial challenges Leavitt would face. Among them, he said, 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 told BioWorld Today, 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. During his tenure as governor of Utah, Leavitt received waiver approval to reshape that state's Medicaid program, Nawrocki said.

"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."

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

Other issues sure to creep up early include problems at the FDA related to recent questions surrounding drug safety. Along with issues at the regulatory agency are leadership concerns; the FDA has been without an official commissioner since Mark McClellan left nearly a year ago to serve as administrator of the Centers for Medicare & Medicaid Services. Since then, Lester Crawford has served as the FDA's acting commissioner. He previously had held that post in an official capacity.

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

"That initiative dates all the way back to the Clinton days to get savings in the health care 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."

He was nominated last month by Bush to replace outgoing HHS Secretary Tommy Thompson, who two weeks before said he would leave after serving during the first four years of the current administration. (See BioWorld Today, Dec. 6, 2004, and Dec. 14, 2004.)

Leavitt, 53, is the 20th secretary of HHS. Before receiving Bush's nomination last month, he most recently was the administrator of the Environmental Protection Agency. Prior to that, he served three terms as Utah's governor.