Fraudulent Billing for Compromised Medications
A pharmacist who worked at a major big-box retail chain brought a qui tam claim under the False Claims Act for allegedly improperly transporting a store-brand medication, which caused it to be compromised by uncontrolled temperature extremes during transport.
The pharmacist alleged that for years, the chain consistently and routinely failed to store and handle this medication in accordance with manufacturer and FDA regulations. As a consequence, allegations claimed that the chain had been dispensing a drug that the FDA and Centers for Medicare and Medicaid Services (CMS) considered to be "adulterated" potentially endangering the lives of the medication users. Still, the chain sought payment from government programs, including Medicare, Medicaid, and TRICARE.
The medication is supposed to be kept within a certain temperature range from the time of manufacture through final sale to customers. However, the pharmacist alleged that the medication was exposed to temperature extremes during transportation, despite knowing of the drug manufacturer's protocol for maintaining a safe temperature.
By failing to follow and maintain proper shipping and storage practices, allegations were that the chain was unable to certify to government payors that the medication had been stored and handled in accordance with manufacturer and FDA requirements, that it was fully potent and contained the dosage strength according to the labeling, and that it was safe to use.
As a result of the chain's alleged failure to maintain the recommended temperature control, the whistleblower claim alleged the pharmacies sold a drug that was considered to be adulterated and submitted claims for payment of this product.