New Jersey Board of Medical Examiners Permanently Revokes License of Middlesex Doctor for Indiscriminately Prescribing “Subsys,” A Highly-Restricted Spray Form of Painkiller Fentanyl to His Patients
Revocation Follows Doctor’s Criminal Conviction for Concealing More Than $3.6 Million in Income from
His Medical Practice to Evade Taxes and for Paying Kickbacks to Other Doctors for Referrals to His Pain Management Centers
NEWARK – A Middlesex doctor convicted last month for engaging in sophisticated fraud and money laundering schemes in connection with his practices, has been permanently stripped of his medical license after the Board found, among other things, that he engaged in the indiscriminate prescribing of Subsys, a powerful, oral spray painkiller approved only for use in certain cancer patients, the State Board of Medical Examiners announced today.
Dr. Manoj Patharkar, who owns Pain Management Associates of Central Jersey (PMACJ) in Edison and Prospect Pain Management (PPM) in Passaic, is forever barred from practicing medicine in New Jersey under a Consent Order with the Board that found, among other things, that Dr. Patharkar engaged in “gross malpractice” that endangered the health, safety, and welfare of his patients.
“Dr. Patharkar recklessly ignored the well-established risks associated with Subsys, and put his patients in grave danger of overdose or death by flouting the strict rules for prescribing it,” said Steve Lee, Director of the Division of Consumer Affairs. “His reckless prescription of this powerful drug, coupled with the crimes he committed in connection with his pain management centers, renders him unfit to practice medicine in the State of New Jersey. A permanent revocation of Dr. Patharkar’s license is the only way to ensure he will do no further harm to the public.”
The revocation of Patharkar’s license is the latest enforcement action in the State’s crackdown on doctors who fail to follow the strict prescribing restrictions on the painkiller Subsys, a powerful oral spray form of fentanyl.
Subsys is the brand name of one of six transmucosal immediate release fentanyl ("TIRF") medications that instantly deliver the powerful painkiller fentanyl through the oral membranes. The federal Food and Drug Administration (FDA) has approved TIRF substances, including Subsys, strictly for the management of breakthrough pain in adult cancer patients who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.
Because Subsys and other TIRF medicines carry a high risk for misuse, abuse, addiction, overdose, and serious complications due to medication error, the FDA has subjected them to significant restrictions. Doctors who wish to prescribe Subsys must enroll in the TIRF REMS (Risk Evaluation and Mitigation Strategy) Access Program. The Program requires prescribers to undergo educational training about the drug's risks and enroll their Subsys patients in the program.
By enrolling in the Program, doctors acknowledge they have read the risks associated with Subsys, and understand that it was approved only for narrow uses as a cancer pain medication and that any "off-label" use could result in a fatal overdose.
Patharkar is the second NJ doctor whose license was restricted amid allegations of off-label prescribing of Subsys. Last month the Board temporarily suspended the license of Dr. Vivienne Matalon, a Cherry Hill family physician accused of indiscriminately prescribing a powerful spray form of the painkiller fentanyl to three patients, one of whom died. Her license will remain suspended until the allegations against her are resolved.
In revoking Dr. Patharkar’s license, the Board cited his criminal conviction last month for engaging in sophisticated fraud and money laundering schemes by which he hid approximately $3.6 million in income from his medical practices to evade taxes. He was also convicted for using money from the schemes to pay illegal kickbacks to other professionals for patient referrals to his practices. The Board also cited the Superior Court’s finding in a related civil insurance fraud lawsuit that Dr. Patharkar violated the Insurance Fraud Act.
Patharkar, 45, pleaded guilty in Middlesex County Superior Court to charges of first-degree conspiracy, first-degree money laundering, seven counts of third-degree filing fraudulent tax returns, and three counts of third-degree failure to pay taxes. He also entered guilty pleas to all of those same counts on behalf of his corporation PMACJ. Those charges were contained in an August 24, 2015 indictment. In addition, he pleaded guilty to an accusation charging him with second-degree conspiracy and second-degree commercial bribery in connection with the illegal kickback scheme.
In pleading guilty, Patharkar admitted he used two separate schemes to launder $3.6 million through his practices, PMACJ in Edison and Prospect Pain Management Associates in Passaic. He admitted that he evaded roughly $327,000 in state taxes by fabricating employee payroll and wage expenses totaling over $2.1 million and by diverting over $1.4 million in checks written for medical services provided by his businesses into personal bank accounts. He further admitted that he used laundered funds to pay commercial bribes to doctors who unlawfully referred patients to his pain clinics. The investigation revealed that he paid kickbacks totaling up to $1.5 million to 13 doctors. The state will recommend that Patharkar be sentenced to up to 10 years in state prison, including five years of parole ineligibility. He will be required to pay an anti-money laundering penalty of $500,000, and PMACJ must be dissolved.
Under the terms of the Consent Order, Patharkar must divest himself from any current and future financial interest in or benefit derived from the practice of medicine, and is precluded from managing, supervising, or overseeing the practice of medicine or the provision of healthcare in New Jersey. Dr. Patharkar’s permanent revocation will be effective on November 25, 2016.
Investigators with the Enforcement Bureau within the Division of Consumer Affairs conducted the investigation.
Deputy Attorney General Christopher Salloum, of the Professional Boards Prosecution Section in the Division of Law, is representing the State in this matter.
Matt Mandel Esq. represented Dr. Patharkar in this matter.
Patients who believe they were prescribed Subsys in violation of the FDA restrictions should contact the Division of Consumer Affairs by calling
1-800-242-5846 (toll free within New Jersey) or 973-504-6200.
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