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Benzodiazepine Exclusion May Keep Drug From Many Who Need It

Since 1990 the federal government has refused to cover benzodiazepines under Medicaid and extended that ban to Medicare when the Part D drug benefit took effect in 2006. A study of benzodiazepine use begins to shed light on the possible impact of excluding this drug class from coverage.

The exclusion of the benzodiazepine class of medications under Medicare's Part D drug program may have affected a large number of beneficiaries, according to the first study assessing the extent of use of these types of drugs before Part D took effect.

Congress decided to exclude benzodiazepines from prescription drug coverage when it created Medicare's Part D program in 2003. The impact of that decision, sharply criticized by APA, had been unclear due to the lack of solid empirical data.

But a study published in the April Psychiatric Services has provided crucial pieces of data aimed at showing the impact of the Medicare policy on the use of benzodiazepines and potential substitute drugs.

The study, by researchers from Pharmaceutical Health Services Research at the University of Maryland, is based on analysis of the 2002 Medicare Current Beneficiary Survey, an in-person national survey of Medicare beneficiaries by the Centers for Medicare and Medicaid Services (CMS) that matched responses to patient records. This continuing study of Medicare beneficiaries provided national estimates of benzodiazepine use and expenditures among Medicare beneficiaries.

The baseline patient information, which dated from before Medicare offered extensive drug coverage, tracked benzodiazepine use among the Medicare-eligible population, including those who had drug coverage under Medicaid or private insurers and those with no drug insurance coverage.

Study data showed that nearly 14 percent of Medicare beneficiaries received at least one benzodiazepine prescription. It also concluded that being a woman, having chronic mental illness, being under age 65, and having a low income were significantly associated with benzodiazepine use in the Medicare population.

The researchers also found that in 2002 benzodiazepine users spent an average of $189.58 on benzodiazepines. The annual mean benzodiazepine spending was highest among beneficiaries with Medicaid ($277.59) and lowest among beneficiaries with no drug coverage ($141.48). Beneficiaries with anxiety disorders spent $310 on benzodiazepines annually—more than those with any other chronic conditions for which the drug is commonly used.

Beneficiaries with supplemental drug coverage were more likely than those without such coverage to use potential benzodiazepine substitute classes rather than benzodiazepines.

The findings led the authors to conclude that not only were benzodiazepines widely used by Medicare beneficiaries but also that drug coverage influences access to benzodiazepines and potential substitute classes.

"These findings have important implications for identifying beneficiaries potentially affected by the exclusion of benzodiazepine coverage under Medicare Part D," the authors wrote.

The research also added data to previous estimates that benzodiazepines were prescribed for an estimated 1.7 million of the so-called dual-eligible patients under Medicaid. The start of the Part D program in 2006 moved their drug coverage to Medicare, although all Medicaid programs added coverage for benzodiazepines through stateonly funding. CMS notified states in 2007 that they could receive federal Medicaid matching funds if they elected to supplement the Medicare drug benefit and cover benzodiazepines. However, Medicare recipients who were not eligible for Medicaid were not so fortunate.

"When Part D went into effect, we got a lot of calls from people who couldn't get their benzos covered," said Paul Precht, policy director of the Medicare Rights Center, a consumer-rights group based in New york.

The decision to exclude benzodiazepines from Part D coverage stemmed from concerns about their safety and reports of inappropriate use. The legislative origins of the ban date back to the 1990 exclusion of these drugs from federal reimbursement under Medicaid, leaving states to pay the full cost of the drugs since that time.

"Although there are some concerns for [benzodiazepine] use in the elderly population, there is also appropriate usage—and a legal exclusion like this doesn't distinguish between people who need this medicine and people who don't," Precht said.

The researchers described their study as having definite "limitations" but emphasized that it is designed to provide a benchmark for benzodiazepine utilization and expenditures before implementation of Part D.

"Additional work is needed to analyze the impact of drug coverage changes on discontinuation of benzodiazepines as well as of switching to more potent or more expensive therapeutic substitutes, including sedative-hypnotics, antidepressants, and select antipsychotics with sedative properties," the authors wrote.

The negative impact of the exclusion for patients with mental illness has been an ongoing concern of APA, according to Nicholas Meyers, director of APA's Department of Government Relations. It has been trying to find a regulatory or legislative solution to the problem. Both the House and Senate have had bills (HR 3025 and S 137) introduced in the current Congress to expand Part D coverage to include benzodiazepines, but neither bill has advanced.

Stevan Gressitt, M.D., medical director of the Office of Adult Mental Health Services in the Maine Department of Health and Human Services, struck a cautionary note. The study would have been more informative and addressed lingering health concerns about overuse of benzodiazepines if it had chronicled the length of time patients were using the drugs. His office has found that in Maine the duration of prescriptions for what is supposed to be a short-term drug has been increasing.

"That's not good," he said.

"Benzodiazepine Use and Expenditures for Medicare Beneficiaries and the Implications of Medicare Part D Exclusions" is posted at <http://psychservices.psychiatryonline.org/cgi/content/full/59/4/384>.

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