The United States has filed a lawsuit against an Alabama psychiatrist for improper prescribing of Nuedexta to nursing home residents. Nuedexta is indicated only for the treatment of Pseudobulbar Affect (PBA), and has not been shown to be safe and effective in non-PBA types of emotional lability that commonly occur in Alzheimer’s disease and other dementias.
The complaint alleges that an Alabama psychiatrist caused the submission to Medicare and Medicaid of false and fraudulent claims for the prescription drug Nuedexta. From 2015 through 2019, the pharmaceutical company that manufactures Nuedexta paid the Alabama psychiatrist more than $400,000 to make speeches about Nuedexta. The speeches had few attendees, were of little value, and are alleged to have been designed to compensate the Alabama psychiatrist for prescribing Nuedexta. One example included in the complaint alleges that in November 2016, the pharmaceutical company paid the psychiatrist a $2,000 speaker’s fee for a presentation in Alabama, but the company’s records show there were no attendees.
In addition, the complaint further alleges that with the consent of the psychiatrist, the pharmaceutical company’s sales representative visited nursing homes where the psychiatrist worked and sought to convince the facility’s nurses to refer patients to the psychiatrist to help him “build [his] base of business.” In return, the psychiatrist prescribed Nuedexta to nursing home residents who did not have pseudobulbar affect. In 2015, the psychiatrist accounted for more than half of all Medicare claims for Nuedexta that were submitted in Alabama, and between 2015 and 2019 he caused more than $6 million in Medicare claims and $800,000 in Medicaid claims to be submitted for the drug.
US Attorney Prim Escalona stated, “The Department of Justice will fight to protect nursing home residents, including by ensuring that prescribing decisions affecting them are free from undue influence, and the medications they receive are medically appropriate for them.”
Compliance Perspective
Issue
False claims can be generated in a variety of ways. A resident’s medication regimen should only include those drugs that have adequate indications for use based on accurate diagnoses. Each resident’s entire drug/medication regimen must be managed and monitored to promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being. All members of the healthcare team must be aware of what may cause submission of a false claim, including the ordering of unnecessary drugs or treatments. Failure to promptly report a false claim can result in lawsuits, fines, and other sanctions. An effective compliance and ethics program can help raise staff awareness and ultimately reduce fraud, waste, and abuse of government funds by empowering the healthcare team to participate actively in preventing and detecting criminal, civil, and administrative violations and promoting quality of care. Routine audits should be conducted, and the results of the audits should be reported at the compliance and ethics committee meetings and in reports to the governing body.
Discussion Points
- Review your policies and procedures for operating an effective compliance and ethics program to ensure that identifying and reporting of false claims or kickbacks is part of your policy. Ensure that your policies are reviewed at least annually and updated when new information becomes available.
- Provide education to nursing and business office personnel on their responsibility to identify and report any concerns that unnecessary medications, treatments, supplies, or equipment are being ordered for residents. Awareness training is an important part of your facility’s efforts to prevent false claims from being submitted. Train all staff on your compliance and ethics policies and procedures upon hire and at least annually, including what can be considered a false claim or a kickback. Document that these trainings occurred, and file the signed document in each employee’s education file.
- Periodically perform audits to ensure all staff are aware of their responsibility to identify and report compliance and ethics concerns and understand that it is their responsibility to report violations to their supervisor, the compliance officer, or via the anonymous hotline.
