By: Christopher A. Parrella, Esq., CPC, CPCO, CHC

In a recent development that underscores the intricate relationship between healthcare compliance, medical device regulation, and federal health care program integrity, Utah-based Dolor Technologies, LLC (“Dolor”) has agreed to a settlement with the United States government. This agreement aims to resolve allegations of civil liability connected to a migraine treatment device marketed by the company. The settlement mandates monetary payments from Dolor, calculated based on the company’s ability to pay, a resolution that highlights the financial repercussions of non-compliance in the healthcare sector.
From July 2013 through July 2017, Dolor allegedly breached the False Claims Act (FCA) by influencing medical providers to submit fraudulent claims to the Medicare Program for procedures involving the SphenoCath device. This device, designed for migraine treatment through nerve blocks in the sphenopalatine ganglion, was not FDA-approved for this specific use. The government’s allegations suggest a deliberate bypass of FDA regulations, a serious infraction in the medical device industry.
Furthermore, Dolor is accused of coaching healthcare providers in submitting improper billing codes to Medicare, an action that not only contravenes legal and ethical standards but also potentially compromises patient safety and trust. This aspect of the case emphasizes the importance of accurate and honest medical billing, a cornerstone of healthcare compliance.
In a related criminal proceeding, Dolor’s former CEO, Mark Wright, pleaded guilty to misdemeanor charges related to the misbranding and adulteration of medical devices. His admission that the company did not seek FDA approval or clearance for the SphenoCath for headache treatment and ignored FDA recommendations for investigational studies spotlights the critical role of FDA oversight in ensuring the safety and efficacy of medical devices.
Special Agent in Charge George A. Scavdis of the FDA Office of Criminal Investigations and Mario M. Pinto of the HHS-OIG stressed the importance of FDA oversight and the dangers of submitting false claims to Medicare.
The case against Dolor Technologies serves as a cautionary tale for healthcare companies. It underscores the necessity of adhering to FDA regulations, ensuring accurate medical billing, and maintaining rigorous compliance standards to avoid legal pitfalls and uphold the integrity of federal health care programs. The legal community, particularly those specializing in healthcare compliance and defense, will undoubtedly follow the ramifications of this case closely, as it sets a precedent in the intersection of healthcare law, medical device regulation, and federal program integrity.