News in brief - Jan. 23, 2006

Doctors still seeing Medicare patients - AstraZeneca to continue prescription drug assistance - Eli Lilly settles claims it wrongly marketed off-label uses for Evista - Bill aims to limit lawsuits against flu vaccine makers

Doctors still seeing Medicare patients

About 73% of physicians said their practices were open to all new Medicare patients in 2004 and 2005, according to a recent study.

About 3.4% of physicians reported that they were completely closed to new patients during that time period. The remainder accepted some or most new patients.

The Center for Studying Health System Change, which surveyed more than 6,600 physicians, said that beneficiary access remained steady despite a 5.4% cut in Medicare reimbursements to doctors in 2002.

The center's report challenges the assertion that Medicare rate cuts automatically will lead to declines in access, said Paul B. Ginsburg, PhD, HSC's president.

But the study's conclusions also mean that some harmful effects of Medicare payment rates lagging behind physician costs are lurking below the surface, said American Medical Association President J. Edward Hill, MD.

"Physicians often take other measures before stopping patient care, yet HSC reports that 35% of primary care physicians were not accepting new Medicare patients in 2004-2005," he said.

AstraZeneca to continue prescription drug assistance

AstraZeneca has decided to keep offering its drug assistance program to low-income seniors through the May 15 deadline to sign up for a Medicare drug plan.

Late last year, federal officials informed drugmakers that they could not continue to offer free or discounted prescriptions to beneficiaries who enrolled in a Medicare drug plan. The move prompted AstraZeneca to announce that it would discontinue its assistance program for all Medicare-eligible individuals once the new benefit launched Jan. 1, regardless of whether they signed up for the federal program.

But the firm decided to keep up its prescription support through the initial enrollment period to serve as a stopgap measure for poor seniors who hadn't signed up for Medicare drugs right away, said AstraZeneca spokesman Andy Izquierdo.

Eli Lilly settles claims it wrongly marketed off-label uses for Evista

Eli Lilly and Co. agreed to plead guilty to a federal misdemeanor charge in a $36 million settlement with the government for illegally promoting Evista.

The Dept. of Justice's Office of Consumer Litigation and the U.S. Attorney's Office for the Southern District of Indiana alleged that in 1998 the company marketed Evista for the prevention of breast cancer and cardiovascular risks. The Food and Drug Administration has approved Evista in the United States for the prevention and treatment of osteoporosis in post-menopausal women. A company cannot promote drugs for unapproved purposes, though doctors may prescribe them for "off-label" uses, according to FDA policy.

In a separate civil complaint, the government accused Eli Lilly of continuing the illegal conduct in 2000. The company did not admit to wrong-doing in this matter but agreed to settle the claims to close the investigation, which began in 2002.

Bill aims to limit lawsuits against flu vaccine makers

The Defense Dept. appropriations bill, passed by Congress and signed by President Bush, has a rider that gives liability protection to flu vaccine manufacturers. The provision limits suits against drug manufacturers by requiring proof of "willful misconduct" by drugmakers. Lawyers say this is a higher standard of proof than the negligence threshold needed in most product liability cases. "Administrators," which include doctors, also are protected.

The provision was spearheaded by Senate Majority Leader Bill Frist, MD (R, Tenn.), who said it was necessary to encourage drug development. Supporters also say it will prevent frivolous lawsuits. Consumer groups and attorneys who oppose the provision called it a "giveaway to the pharmaceutical industry."