December 6, 2011

In testimony before the U.S. Senate’s Special Committee on Aging on November 30, 2011, the Inspector General of the U.S. Department of Health & Human Services (HHS) provided chilling evidence that elderly nursing home patients with dementia  are being given antipsychotic drugs for reasons other than medically accepted indications. This raises the issue whether prescribing such medications under such circumstances is medical malpractice.

The Office of Inspector General of HHS (OIG) reported that 14% of nursing home residents (almost 305,000 patients) had Medicare claims for atypical antipsychotic drugs, half of which should not have been paid by Medicare because their use was not for medically accepted indications (a possible indication of medical malpractice). One in five of the Medicare drug claims were in violation of governmental standards for their use (another indication of potential medical malpractice). One reason for this problem is that sponsors of Medicare’s Part D prescription drug plan (PDP) lack access to necessary information to determine appropriate reimbursement for antipsychotic drugs.

Hence, Medicare is paying for drugs that it should not and Part D prescription drug plans are unable to prevent inappropriate payments for drugs that do not meet coverage requirements.

The OIG found that nursing homes were “frequently” prescribing antipsychotic drugs for uses that are not approved by the FDA (called “off-label” uses, which are not uncommon and are permitted when such uses are prescribed by physicians), with manufacturers of these drugs illegally marketing them for off-label use (as an example: in January, 2009, Eli Lilly, the manufacturer of the antipsychotic drug Zyprexa, agreed to plead guilty and to pay $1.4 billion for the illegal promotion of Zyprexa). The OIG reported that 83% of Medicare claims for antipsychotic drugs were for elderly nursing home residents that were prescribed for off-label uses and that 88% were for residents with dementia. This is particularly disturbing since the FDA has strongly warned of an increased risk of death in elderly patients with dementia who are prescribed antipsychotic drugs. (We see the spectre of medical malpractice in these statistics….)

The OIG reported that almost 723,000 of the 1.4 million Medicare antipsychotic drug claims for antipsychotic drugs used for elderly nursing home residents in the first half of 2007 were not used for medically accepted indications, and that the payments made by Medicare for these claims were largely due to the PDP sponsors’ lack of access to information regarding proper reimbursement for these drugs (such as diagnostic information from the nursing homes’ records).

In order for nursing homes to participate in Medicare, they must comply with federal nursing home quality and safety standards, which include the requirement that nursing home residents be free from unnecessary drugs, which includes excessive doses, excessive durations of use, inadequate monitoring, inadequate indications for use, or the presence of adverse consequences that indicate that the dosage should be reduced or discontinued. The OIG found that 22% of the antipsychotic drugs claimed were not administered in compliance with Medicare standards regarding unnecessary drug use in nursing homes (317,971 of the 1.4 Medicare claims during the first half of 2007) and that 42% of these claims did not comply with Medicare standards for more than one reason.

The Inspector General concluded his Senate testimony by pointing out that over the next 18 years, 10,000 Americans will become newly eligible for Medicare each day.  As such, the inappropriate use of antipsychotic drugs, especially in the elderly population, is of much concern.


The Inspector General’s testimony was geared toward Medicare’s payment for the inappropriate use of antipsychotic drugs in the elderly nursing home population. Our concern is their misuse that borders on medical malpractice. Would it not be medical malpractice for a physician or other medical provider to prescribe or use an antipsychotic drug for an elderly patient with dementia for the primary purpose of  having the patient sleep, thereby reducing the nursing home staffing requirement at night (or at other times during the day) because sleeping patients need less attention than awake patients?

Many elderly patients who have urinary tract infections become agitated as a result of their infections yet they are deemed “behavioral problems” that are sometimes controlled by using antipsychotic drugs. Why would this misdiagnosis not be considered medical malpractice?

Medical malpractice, wherever it occurs, is serious and often injurious, but medical malpractice involving the particularly vulnerable, such as elderly nursing home residents who may not be able to fend for themselves or may not have close family members who can act as their advocates, are even more susceptible to the serious and often fatal consequences of medical errors and medical mistakes.

When medical malpractice (or worse) in nursing homes cause unnecessary injuries, suffering, or death, these most vulnerable victims deserve to have their rights vindicated. Visit our website to be connected with local medical malpractice lawyers who may be able to assist you or a loved one with a medical malpractice claim against a nursing home or call us toll free at 800-295-3959.

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