CMS Wants To Cut Antipsychotics In Nursing Homes
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By Ed Silverman // May 31st, 2012 // 10:52 am
After numerous disclosures that antipsychotics have been aggressively promoted to nursing homes, the Centers for Medicare & Medicaid Services is trumpeting a plan to reduce usage in nursing home residents by 15 percent by the end of this year. Why? CMS data show that, in 2010, more than 17 percent of nursing home patients had daily doses exceeding recommended levels.
“A CMS nursing home resident report found that almost 40 percent of nursing home patients with signs of dementia were receiving antipsychotic drugs at some point in 2010, even though there was no diagnosis of psychosis,” CMS Chief Medical Officer and Director of Clinical Standards and Quality Patrick Conway says in a statement that announced a partnership with nursing homes, advocacy groups, caregivers and government agencies to find a way to reduce usage.
To cope with the problem, CMS plans to offer a training series for nursing homes that emphasizes “person-centered care,” prevention of abuse and high-quality care for residents. CMS is also providing training focused on behavioral health to state and federal surveyors. The agency is also making data on each nursing home’s antipsychotic drug use available on the Nursing Home Compare web site starting in July, and will emphasize “non-pharmacological alternatives” for nursing home residents, including consistent staff assignments, increased exercise or time outdoors, monitoring and managing acute and chronic pain, and planning individualized activities.
Toby Edelman, senior policy attorney at the Center for Medicare Advocacy, tells The Boston Globe that strong rules are in place to combat overmedication in nursing homes, but regulators too often fail to enforce them. She combed through databases nationwide to track how often nursing homes were penalized specifically for overusing antipsychotics during the past six years and could find just a handful of cases. “Even when instances are cited, nothing happens,’’ she says.
Nonetheless, the widespread use of antipsychotics in nursing homes has been a controversial issue for many years. In some cases, the medications have been relied upon to subdue agitated patients, administered without proper consent or involve dosages that exceed safety standards. Meanwhile, the side effects associated with these drugs include an increased risk of harmful falls and death in the elderly (see here and here).
Last year, a report from the US Department of Health & Human Services Office of Inspector General found that, in the six-month period from January through June 2007, 51 percent of Medicare claims for atypical antipsychotics were erroneous. This amounted to a $116 million series of mistakes that also cost taxpayers. The HHS OIG cited overly aggressive marketing by the pharmaceutical industry as contributing to the problem.
“Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there’s ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety,” HHS OIG Daniel Levinson wrote in a statement. “Government, taxpayers, nursing home residents, as well as their families and caregivers should be outraged – and seek solutions.”
Several states have sued several drugmakers for improper marketing that cost state Medicaid programs money (see here). Johnson & Johnson is fighting a whistleblower lawsuit, which was joined by the US government, that kickbacks – in the form of rebates and educational grants – were paid to the Omnicare nursing home pharmacy so its Risperdal antipsychotic would be prescribed more often. As part of the proceedings, the feds are trying to depose J&J ceo Alex Gorsky (read this).
Other large drugmakers have run afoul of the feds over antipsychotic marketing. Five years ago, Bristol-Myers Squibb agreed to settle charges of giving kickbacks to docs and overcharging the government. Among the alleged infractions was off-label promotion of its Abilify antipsychotic, and creating a specialized long=term care sales force that called almost exclusively on nursing homes. The drugmaker subsequently paid $515 million and signed a five-year corporate integrity agreement, although a fresh subpoena was recently issued over Abilify marketing (look here).
Last year, AstraZeneca agreed to pay $68.5 million to 36 states and the District of Columbia to resolve a lawsuit charging the drugmaker with illegal marketing of its Seroquel antipsychotic, failing to sufficiently disclose potential side effects to health care providers and withholding negative info in studies about safety and effectiveness. The drugmaker allegedly marketed Seroquel, which was approved only for schizophrenia and bipolar disorder, for several off-label uses to treat both children and the elderly, specifically in nursing homes. Among the unapproved uses: Alzheimer’s Disease, dementia, anxiety, depression, sleep disorders and post traumatic stress disorder (read here).
http://www.pharmalot.com/2012/05/cms-wants-to-cut-antipsychotics-in-nursing-homes/
Tuesday, June 5, 2012
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