The U.S. government has issued a warning to insurance companies to be wary of suspicious prescriptions of a drug being widely used in nursing homes all over the country.
The medication in contention is named Nuedexta, which also happens to be the only drug approved by the Food and Drug Administration to treat a rare condition known as pseudobulbar affect (PBA) which is marked by uncontrollable laughing and crying.
Drugmaker Avanir Pharmaceuticals is claiming that many dementia patients are suffering from PBA, but regulators are concerned that Medicare may be paying for the drug not just for approved purposes and cases but for unapproved and potentially fraudulent uses as well.
While it is not illegal to prescribe for unapproved uses, diagnosing a patient with a condition just to secure Medicare coverage is regarded as fraud.
An investigation published in October found that the drugmaker behind Nuedexta had been aggressively targeting frail and elderly nursing home residents even if they don’t need the said drug and that it may be unsafe for them. It was discovered that doctors had inappropriately prescribed Nuedexta to dementia patients, using a PBA diagnosis when it was actually prescribed for the purpose of controlling unruly behaviors.
There was even a case of an Ohio doctor who became a top prescriber of the drug and was accused of accepting kickbacks in exchange for prescribing Nuedexta and committing fraud by diagnosing patients with PBA to secure Medicare coverage.
Avanir has earned millions of dollars in annual sales from prescriptions of the drug in nursing homes since Nuedexta came to the market in 2011. The federal government has been spending for the large portion of the bill in the form of Medicare Part D prescription drug funding for people 65 and over and the disabled.
Public record documents show that red flags have been raised to federal authorities about Nuedexta for years. Complaints filed to the FDA, in fact, date back to 2012 over concerns that the drugmaker was misrepresenting Nuedexta as a safe and effective and that it is being marketed far beyond the scope of the clinical evidence.