Nuedexta® National Audit: A Tale of Medically Accepted Indications

PAAS National® stresses the importance of medications being prescribed for a medically accepted indication (MAI), particularly for Medicare, Medicaid and Tricare, as this carries an audit risk that is difficult to overturn on appeal. Nuedexta®, a medication approved for the treatment of Pseudobulbar Affect, or PBA, underwent a national audit conducted by Centers for Medicare & Medicaid Services (CMS) and Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC). PBA disorder is a neurological condition that results in an individual experiencing “emotional lability”. However, the FDA chose to use a more specific definition of PBA when determining Nuedexta®’s MAI. According to Section 1 – “Indications and Usage” in the package insert, it states “PBA occurs secondary to a variety of otherwise unrelated neurologic conditions…” and is a “specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.”

CMS’ desire to conduct a national audit was substantiated by the fact that in September 2019, Avanir Pharmaceuticals, Inc., the manufacturer of Nuedexta®, paid over $95 million to the Department of Justice (DOJ) to resolve allegations of kickbacks and false or misleading marketing efforts that lead to long-term care patients being prescribed Nuedexta® outside of the MAI. Therefore, the goal of the Nuedexta® National Audit was to assess for fraud, waste, and abuse associated with the medication in addition to the risk the medication poses if not used in a clinically supported manner.

From January 1, 2019 through December 31, 2020, select plan sponsors were asked to submit prescription drug event (PDE) documentation that would substantiate their coverage of Nuedexta®. According to the results, CMS agreed with most of the prior authorization parameters put in place by plan sponsors. In the instances that documentation was improper, CMS had plan sponsors address their process that resulted in Nuedexta® being covered inappropriately, such as relying on patients’ historical medical claims or information from prior coverage requests instead of clarifying Nuedexta®’s intended use with prescribers or denying prior authorization requests on the basis of non-MAI uses. In conclusion, CMS is requesting all plan sponsors to evaluate their coverage and payment of Nuedexta® based on their formulary and utilization management edits in place, to prevent Nuedexta® from being used outside of its MAI.

PAAS Tips:

  • Be mindful of a medication’s indication for patients on government sponsored health plans to ensure you are lowering your risk for audit
  • Use pharmacist drug utilization reviews to your advantage to ensure medication is being used properly. Do not disregard or bypass system flags without due diligence.
Meredith Thiede, PharmD