If you have a loved one currently living in a nursing home, you may want to check to see whether he or she has been prescribed the drug Nuedexta. If so, your loved one may be receiving a drug that is unnecessary and even unsafe, and the prescription that recommended Nuedexta may have been part of medical fraud.
That’s our take-away from this just-published investigative report by CNN. “Government issues warning about pill pushed on the elderly,” says the title. Insurance companies are reportedly being warned by the U.S. government to be “on the lookout for suspicious prescriptions of a drug being used in nursing homes across the country.” The drug, manufactured by Avanir Pharmaceuticals, is called Nuedexta. Approved for treatment of one particular neurological disorder, the drug is allegedly being pushed aggressively (and illegally) by Avanir sales representatives as a way for nursing homes to control residents, many with dementia, who exhibit disruptive behavior. In several cases patients appear to have received a fraudulent diagnosis so that Medicare or Medicaid will pay the prescription cost.
According to the CNN report, Nuedexta is the only FDA-approved drug prescribed to treat a condition called PBA – pseudobulbar affect – a disorder which causes sufferers to exhibit uncontrollable laughing or crying. The Avanir website says that about 2 million Americans live with PBA, either resulting from neurologic disease or, in some cases, from injury. “Although PBA is not a life threatening condition,” says the company, “it can significantly impact the daily life for those who have or are caring for someone with this condition.” But a CNN investigation published last fall found that Avanir had been “aggressively targeting” nursing homes suggesting they give Nuedexta to frail and elderly nursing home residents in order to control what the staff considered “unruly” behavior. “CNN found multiple examples in which doctors had inappropriately prescribed Nuedexta to dementia patients,” says the report, “using a PBA diagnosis” when there was actually no evidence of pseudobulbar affect. The CNN expose reports, “One Ohio physician who was a top prescriber of the drug was accused of accepting kickbacks in exchange for prescribing Nuedexta and fraudulently diagnosing patients with PBA to secure Medicare coverage.”
Frail elderly patients are at particular risk of the side effects of Nuedexta which can include dizziness, nausea, vomiting and headache. The drug can also aggravate mental confusion and make the patient more prone to dangerous falls. Some patients experience vision problems, irregular heartbeat, fever and chills. Yet one CNN report cited a Los Angeles nursing home in which one-quarter of the residents were being given Nuedexta.
Allegations of Misrepresentation
According to CNN, Nuedexta came onto the drug market in 2011, and it almost immediately came under scrutiny because of the potential for misuse. “Avanir has generated millions of dollars in annual sales from prescriptions of the drug in nursing homes,” CNN reports, “and the federal government has been footing a large portion of the bill” through Medicare Part D. As far back as 2012, insurance companies began raising major concerns about how the drug was being marketed. One insurer, BlueCross BlueShield of Arizona, “expressed concern that the drug-maker was misrepresenting Nuedexta as safe and effective in populations where it had not been adequately studied. ‘We believe that the manufacturer appears to be marketing Nuedexta far beyond the scope of the clinical evidence,’ the company stated in the letter.”
CNN obtained internal emails from Avanir dating from 2013 in which company officials clearly encouraged their marketing staff to suggest Nuedexta for unapproved purposes. One Avanir sales manager told the marketing team the “great news” that a large insurer had removed one of the safeguards against over-prescribing the drug. This action, the email stated, would open the door to prescribing Nuedexta to “4 million additional seniors” and called the decision “a very important win for our company.” (Remember, the condition that Nuedexta is prescribed to treat is estimated to afflict 2 million people in the entire country.)
Company Under Investigation
We noted from the Avanir company website that the criticism and scrutiny appear to have made an impression. In late April, the company launched what they called “a national, multi-channel campaign aimed at raising awareness of Pseudobulbar Affect.” (You can read Avanir’s statement here.) Meanwhile, the Centers for Medicare and Medicaid Services (CMS) issued a cautionary memo to its network last March “[reminding] plan sponsors that Nuedexta is only approved to treat PBA and [stating] that Part D insurers are legally required to ensure the drug is only being covered when prescribed for medically-accepted uses,” CNN reports. Other insurers are taking precautions to prevent fraudulent prescriptions of Nuedexta, and the City of Los Angeles is reportedly investigating Avanir’s business practices.
As we said at the start of this article, if you have a loved one in a nursing home who is taking Nuedexta, it might be time for closer scrutiny. It may be that the drug is being used appropriately – but if your loved one has never exhibited symptoms of PBA, you need to ask some hard questions of the nursing home staff and of your loved one’s primary care physician. This is yet another case where good professional advice from someone trained in geriatric medicine will prove indispensable. As Rajiv Nagaich of AgingOptions recommends, “We tell our clients that having a case manager look in from time to time can definitely minimize these sorts of issues. With the right case manager, your family always has someone watching out for you even when you can’t be on hand.” Contact us at AgingOptions and let us explain how to secure the services of a trustworthy professional care management service that will help protect your vulnerable loved one.
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(originally reported at www.cnn.com)