New year heralds medical reform

Washington - How the new, more conservative, more Republican Congress and the Bush administration deal with several key issues will have a very direct and significant impact upon how dermatologists practice medicine in the coming years.

In some cases, the fact that the U.S. Senate is now decidedly more conservative than in years past could proveto be helpful to dermatologists andother physicians concerned aboutskyrocketing malpractice insurance costs. But continuing budget pressures and election-year pledges to reduce the deficit could hinder efforts to ease the impact of looming reductions in Medicare reimbursement rates.

Expect the American Academy of Dermatology (AAD) to focus on the following key legislative and regulatory priority issues in the year ahead:

IsotretinoinAccutane received unfavorable attention when it was listed during a Senate drug safety hearing late last year by a U.S. Food and Drug Administration (FDA) scientist as one of several potentially unsafe drugs currently on the market.

AAD President Boni E. Elewski, M.D. immediately declared that the drug is carefully regulated, and she says the FDA and the manufacturers of isotretinoin are developing a more rigorous regulatory program, with input from AAD.

"The new risk management program for isotretinoin will be one of the most stringent programs ever developed for a drug sold in the United States," she says.

Slated to be launched in July, the program will be modeled after an oversight system established for thalidomide, banned because of its potential for causing birth defects, but then approved by the FDA in 1998 because of its value for treating Hansen's Disease (leprosy).

The FDA invoked unprecedented regulatory authority to tightly control the marketing of thalidomide in the United States. A System for Thalidomide Education and Prescribing Safety (STEPS) oversight program was initiated, including limiting authorized prescribers and pharmacies, extensive patient education about the risks associated with thalidomide and a 100 percent patient registry.

"This oversight program is designed to help insure a zero tolerance policy for thalidomide exposure during pregnancy," the FDA says.

Medical malpracticePresident Bush, in mid-December, told an economic summit in Washington that "the class-action meat grinder" and malpractice suits are forcing many physicians to stop treating patients.

"I am here to...make it as clear as I possibly can that I intend to take a legislative package to Congress which says we expect the House and the Senate to pass meaningful liability reform on asbestos, on class action and medical liability," President Bush told the summit.

A series of bills limiting suits in civil cases, including malpractice cases, have been approved in recent years by the House but have been held up in the Senate by mainly Democrats and a handful of Republicans. The filibuster rule has enabled that to happen.

Representatives of dermatology, among many other medical specialties, have been frustrated by the roadblocks in the Senate after working so hard to get bills passed by the House. Some Senate leaders, including Majority Leader Bill Frist, M.D. (R-TN), a heart transplant surgeon, have promised to seek repeal of the filibuster provision, a move that Democrats ferociously oppose.

Whether that effort succeeds or not, lobbyists working the issue know that the best way to assure success is to convince enough Senators - Republicans and Democrats alike - to support reform.