Nuedexta, a drug marketed for Pseudobulbar Affect (PBA), a condition causing uncontrollable laughing or crying, finds itself under a cloud of controversy. According to the manufacturer[1]:

“PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury”.

What’s the scheme? 

Nuedexta is the subject of alleged illegal off-label marketing, and kickback schemes. Kickbacks can occur when prescribers of a drug are showered with gifts or financial endowments in return for speaking engagements and increases in prescribing. Avanir, the manufacturer, settled two False Claims Act (FCA) cases where employees filed whistleblower lawsuits alleging the company was engaged in promoting kickbacks and prescribing Nuedexta for illnesses other than PBA.[2]

It’s crucial to remember that Nuedexta is still an approved medication for PBA under specific conditions. However, the ethical lapses surrounding its marketing raise serious concerns that warrant continuous monitoring.

What to look for? 

  1. Prescribing patterns: Analyzing prescribing patterns by healthcare providers can reveal irregularities. High prescription rates, especially for off-label uses in elderly dementia patients, could suggest inappropriate prescribing behavior.
  2. Diagnosis codes: Scrutinizing the diagnosis codes associated with Nuedexta claims can flag potential instances of upcoding or misrepresenting diagnoses to justify prescriptions. Patients should have a history of ICD-10 diagnosis F48.2. Avanir offers templates with suggested language for prescribers to receive approval for this drug.[3]
  3. Physician relationships: Look for prescribers receiving incentives from Avanir, potentially indicating kickback schemes.
  4. Artificial Intelligence: Use AI algorithms to identify claims exhibiting high fraud risk based on various factors like patient demographics, prescribing patterns, and billing anomalies to uncover hidden patterns and anomalies.

If you are using the HCFSPlatform™, HCFS has you covered. Our 1700+ library of alerts used in combination with our artificial intelligence detects known and unknown schemes. We capture known schemes involving Nuedexta with alerts such as:

[5308-01] – OFF-LABEL USE OF NUEDEXTA: This Alert identifies NDC’s for Nuedexta when billed without a supporting diagnosis of pseudobulbar affect or PBA as it may be being used off-label to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease), depression, agitation in Alzheimer’s disease, and irritability in autism.