Washington Report

Congress Delays 10% Medicare Fee Cut for 6 Months

Congress substituted a 0.5% increase in Medicare fees for the first 6 months of 2008 for the 10% reduction that would otherwise have been enacted. That reduction in what is called the Medicare fee "update" was predetermined by a formula Congress itself put in place. If physicians bill Medicare in any given year more than the formula says they should, the update is negative in the following year, the percentage being determined by how much physicians overshot that spending limit.

Both Republicans and Democrats said they were unhappy with the temporary 6-month fix, which will have to be revisited by the end of June to prevent the 10% reduction from going into effect for the second half of 2008.

Senator Questions Use of Antipsychotics in Nursing Homes

Sen Charles Grassley (R, Iowa), a frequent pharmaceutical industry antagonist, has added his voice to those already raised by a number of state attorneys general who are questioning the way antipsychotics are prescribed and used. A Wall Street Journal story detailing the use of atypical antipsychotics to treat dementia in nursing home patients caught Grassley's attention. Atypical antipsychotics have not been approved by the FDA for treatment of dementia. Grassley, in letters to Eli Lilly, AstraZeneca, and Janssen, asked for copies of marketing information sent to nursing home physicians and other staff, the companies' internal and external communications relating to off-label use, and information on payments to physicians related to the use of antipsychotics.

In his letters, Grassley noted that the newspaper story reported that nearly 21% of nursing home residents are receiving antipsychotic drugs off-label. In a separate letter to the Inspector General at the Department of Health and Human Services, whom Grassley asked to investigate, the Iowa Republican wrote: "This is disturbing and alarming on several levels."

Of course, prescribing any drug off-label is not illegal, and it is often good medicine. The Practice Guideline for the Treatment of Patients With Alzheimer's Disease and Other Dementias, published last October by the American Psychiatric Association (APA), discusses the use of antipsychotics for patients with dementia. It says: "On the basis of good evidence, antipsychotic medications are recommended for the treatment of psychosis in patients with dementia and for the treatment of agitation." Clinical trial data back that assertion, supporting use of the drugs for up to 12 weeks. Clinical experience validates the use beyond 12 weeks. The guideline does note the severe adverse events with which the drugs may be associated, and advises that they be used with caution and at the lowest effective dosage "after considering the risks of not treating the psychiatric symptoms." It also mentions the black-box warnings risperidone (Risperdal), quetiapine (Seroquel), and olanzapine (Zyprexa) carry because of increased risk of mortality in the elderly.

A January 2007 review of 84 published studies by the Agency for Healthcare Research and Quality Effective Health Care Program was a bit more skeptical. It concluded that much of the evidence for off-label use of antipsychotics was of insufficient quality because studies were too small or lacked scientific rigor.

Peter V. Rabins, MD, MPH, professor of psychiatry at Johns Hopkins School of Medicine, chaired the APA work group that wrote the guideline. In an interview, he stressed that non-pharmacological interventions should be tried first with psychotic or aggressive nursing home patients with Alzheimer disease or dementia, unless the patients pose a clear danger to themselves or others. If those interventions do not work, antipsychotics can be "modestly effective," Rabins said.

Rabins added that the question of whether antipsychotics are being overused in nursing homes is an important one. "I don't think there is enough scientific evidence to say they are overused," he explained. "There is good evidence that even when they are appropriately used, the dose can often be lowered or the drug can be discontinued after several months." He noted that while federal regulations dictate that attempts be made to wean nursing home patients off antipsychotics and other drugs, "enforcement of those regulations varies from state to state."

Grassley suggested that antipsychotics may be overused, at least in part, because of off-label promotion and/or illegal inducements to physicians and other health care professionals working in nursing homes. Jim Minnick, a spokesman for AstraZeneca, said, "It is AstraZeneca pol-icy not to promote Seroquel for uses other than its approved indications in schizophrenia and bipolar disorder. AstraZeneca will fully cooperate with Senator Grassley's office."

As for inducements, Rabins, who works in nursing homes, said it is hard to know whether they have played a role. He has received speaking fees (as did others on the panel) from AstraZeneca, Janssen, Eli Lilly, and other pharmaceutical companies, a fact he disclosed in the Practice Guideline.

Funds Authorized for Sharing Data on Mental Illness of Potential Gun Buyers

Congress passed a bill (HR 2640) that authorizes 2 new significant grant programs for states and their court systems so that they can improve reporting of mental health-related court actions to the federal database used by gun dealers to screen potential buyers. The bill was introduced in the wake of the Virginia Tech tragedy last April in which a mentally troubled college student bought guns, despite a Virginia court action against him on mental health grounds, then went on a shooting spree that left 32 persons dead.

Seung-Hui Cho, the student, was able to buy the guns even though he had been ruled a danger to himself during a state court commitment hearing in 2005. He had been ordered to have outpatient mental health treatment and should have been barred from buying the 2 guns he used. But Virginia never forwarded the information to the FBI's National Instant Criminal Background Check System.

Congressional passage of the bill had been held up because Sen Tom Coburn (R, Okla) had prevented a compromise of the slightly different House and Senate versions because he was concerned that veterans returning from Iraq and Afghanistan who had posttraumatic stress disorder would be unable to purchase guns. In the end, Coburn negotiated a compromise with Sen Charles Schumer (D, NY). The bill also deals with Department of Defense and Department of Veterans Affairs reporting to the FBI, as well as reporting by the states.

The bill authorizes $250 million over 5 years to the states and $150 million for state court systems to computerize information relating to criminal history, criminal dispositions, mental illness, restraining orders, and misdemeanor convictions for domestic violence.