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MEDICARE'S “DOUGHNUT HOLE” AFFECTS NEUROLOGY

The Medicare prescription drug program that went into effect this January includes a coverage gap that threatens financial hardship for nearly 7 million people, according to a September report from the Democratic members of the House Ways and Means Committee. Many neurology patients may be affected, according to one neurologist.

This so-called “doughnut hole” refers to a coverage gap in the standard benefit option that takes effect once beneficiaries have used $2,250 worth of medications; coverage does not resume again until they have used a total of $5,100 in covered drugs, at which point the plan pays 95 percent of the excess drug costs.

While this $2,850 coverage gap may seem like a nominal fee to some, Gregory L. Barkley, MD, Clinical Vice Chair of Neurology at Henry Ford Medical Group in Detroit, said it is forcing many of his patients to stop taking medications or cut back on doses. “Some start scrimping on other things they need. Sometimes it's a choice between food or rent, or medications.” Considering the high cost of many neurology drugs, it usually only takes a few months for patients to reach the coverage threshold, he added.

According to the report, nationally, 88 percent of beneficiaries who do not receive extra subsidies from the government are enrolled in plans with substantial coverage gaps. To make matters worse, premiums for plans that do offer full coverage are 250 percent higher than in the standard plan.

To read the report, visit www.house.gov/waysandmeans_democrats.

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IOM ENDORSES PAY-FOR-PERFORMANCE

Because Medicare's fee-for-service payment system provides few incentives to improve the quality of care, the system should be replaced with one that pays physicians according to their performance, so concludes a new report from the Institute of Medicine (IOM).

The IOM report recommends that over the next three to five years, Medicare should reduce its base payments and then use that money to reward physicians who meet predetermined standards for high quality care. While the report leaves it up to Congress to determine decreased payment amounts, it emphasizes that the reward pools would have to be large enough to spur motivation for improvements. It also suggests that the program should be voluntary for physicians over the next three years, after which the Department of Health and Human Services would decide whether to make it mandatory.

James Stevens, MD, Chair of the AAN Pay-for-Performance Work Group, said a slow, phased-in approach is necessary because there is little information about how linking physician's payments to performance improves outcomes. “We all want high quality, efficient, and compassionate care,” he said. “But what types of behavior do you want to reward and what constitutes quality care?”

The September 19 issue of Neurology Today (page 14) includes a discussion with Dr. Stevens on AAN pay-for-performance initiatives.

Figure. Dr. James St...
Figure. Dr. James St...
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The IOM report, “Rewarding Provider Performance: Aligning Incentives in Medicare,” is the third in a series of studies requested by Congress. The report can be found at www.iom.edu.

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STUDY: ANGIOGRAPHY SAFE FOR CHILDREN

Contrary to many neurologists' fears, children with stroke, brain tumors, and other cerebrovascular complications can safely have catheter-based angiography, according to a new study.

Researchers examined data from 241 cerebral angiograms performed on 205 children - whose ages ranged from 1 week to 18 years - at the Johns Hopkins Children's Center in Baltimore between 1999 and 2006. Not one patient suffered complications during the procedure. However, one child died from an intracranial hemorrhage caused by rupture of a posterior fossa varix three hours after an angiogram. The post-procedural complication rate, therefore, was 0.4 percent.

The study, published in the October issue of Stroke (37:2535–2539), is believed to be the first in 25 years to analyze the safety of cerebral angiographies in children. The authors contend that digital subtraction angiography is still the most accurate imaging technique for evaluating the cerebrovascular system, and physicians have an ethical responsibility to perform the technique when appropriate.

James C. Grotta, MD, Director of the Stroke Program at the University of Texas Medical School in Houston, said many neurologists are reluctant to perform arteriograms on children because of a perceived risk. “Since a higher proportion of childhood stroke is due to vascular malformations, this reluctance might result in the correct diagnosis being missed in a substantial number of cases.”

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EPILEPSY DRUG MAY CAUSE BIRTH DEFECT

The epilepsy drug lamotrigine (Lamictal) may cause cleft palate or lip in babies exposed to the drug during the first three months of pregnancy, the Food and Drug Administration (FDA) said in September.

The warning is based on data collected by the North American Antiepileptic Drug Pregnancy Registry, which found that five oral cleft cases occurred in 564 women treated with lamotrigine. The total prevalence for those cases was 8.9 per 1,000. In contrast, in other studies in the US, Australia, and Europe, prevalence was .50 to 2.16 per 1,000 in nonepileptic mothers not taking the drug.

In an earlier report of data from the Neurodevelopmental Effect of Antiepileptic Drugs Study, however, lamotrigine had fewer adverse outcomes than other antiepileptic drugs, including carbamazepine, phenytoin, and valproate. Lamotrigine was linked to no fetal deaths and one congenital malformation out of 97 pregnancies, compared with two deaths and 12 malformations in 69 pregnant women taking valproate, which had the highest incidence of adverse effects (Neurology 2006:67:407–412). (For more on that study, see Neurology Today's “Valproate Linked to Increased Risk of Birth Defects and Mortality,” August 1, page 1.)

Figure. Dr. Jacqueli...
Figure. Dr. Jacqueli...
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The FDA said the clinical significance of the current report is uncertain until further data are collected. For now, the agency advised that women who are pregnant or are thinking of becoming pregnant should not stop taking the medication without consulting a doctor.

Jacqueline A. French, MD, Division Director of the Epilepsy Center at the University of Pennsylvania, said that while the data are not strong enough to stop prescribing lamotrigine, neurologists should inform their patients of the finding. “This may be the case of ‘the devil you know versus the devil you don't’,” she said, “since there is insufficient information in the registries for most new AEDS [anti-epileptic drugs] to determine whether they are safe in pregnancy or not.”

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NIH PROMOTES NEUROIMAGING

The NIH initiated a five-year, $3.8 million project in October to build a Web-based system meant to help scientists use neuroimaging technology.

The project, the Neuroimaging Informatics Tools and Resources Clearinghouse, will provide a central portal of new research tools and data sets for imaging the brain and nervous system. While it will initially focus on pooling resources for fMRI, the project is meant to address problems with current neuroimaging tools and databases, which the agency claims are underutilized because they are neither user-friendly nor easily adoptable and often not well-documented. The system would also allow users to provide feedback on particular tools and resources and make suggestions for improvement.

Neuroimaging researcher Brad Dickerson, MD, Professor of Neurology at Harvard University, said many investigators have not adopted neuroimaging tools that require arcane skills, such as computer programming. This project, he said, could help researchers become better trained in using imaging modalities and analysis toolsets. “I would hope to see a dynamic component to this resource enabling open discussions between investigators, including sophisticated members of the field and those who are new to the field.”

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FDA TO REGULATE IN VITRO INDEX ASSAYS

In a move intended to improve government oversight of gene- and protein-based assays, the FDA issued new draft guidelines for clinics and laboratories that use complex tests for diagnosing and treating such diverse conditions as Alzheimer disease, cardiovascular disease, and breast cancer. The FDA is seeking comments on proposed rules, and their guidance should only be viewed as recommendations.

The proposed rules apply to In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), a class of tests that use clinical data from one or more in vitro assays - and an algorithm formula - to provide a diagnosis or assess risk for a disease. The guidelines state that such tests should be subject to review and approval by the FDA.

“IVDMIAs could be developed for any disease, including neurological disorders,” Courtney Harper, PhD, FDA Associate Director for Toxicology in the Division of Chemistry and Toxicology Devices, told Neurology Today.

Raju Kucherlapati, PhD, Paul C. Cabot Professor of Genetics at Harvard Medical School and Scientific Director of the Harvard-Partners Center for Genetics and Genomics, supports guidelines from the FDA. “Many laboratories perform genetic tests but there are no standards for testing or interpreting results,” he said. “The FDA regulations could result in a wider acceptance of such testing as a routine part of medical practice.”

He also noted the dearth of reliable tests for accurately predicting the risk of Alzheimer disease (AD), adding that it is not clear what interventions, if any, can be offered to the patients.

But the impact of the regulations might be downstream for neurology, according to one neuroscientist. “We don't have an IVDMIA for AD with enough sensitivity or specificity yet to be affected by this,” said Rudolph E. Tanzi, PhD, Professor of Neurology at Harvard Medical School and Director of the Genetics and Aging Research Unit at Massachusetts General Hospital in Charlestown, MA.

The draft guidelines are available at www.fda.gov/cdrh/oivd/guidance/1610.html.

©2006 American Academy of Neurology

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