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Prescribing Subsys or Insys? Be Careful! Criminal Action Against Physicians Is on the Rise

By Ronald W. Chapman, II

With the recent NBC news press coverage related to Insys Therapeutics, those who prescribe Subsys, a powerful fentanyl medication for breakthrough pain, are facing increasing scrutiny. Indictments, lawsuits, and Federal investigations appear to be ramping up against physicians who prescribe Subsys off-label for non-cancer related pain. Subsys is marketed and developed by Insys Therapeutics whose employees are currently facing multiple Federal Indictments for pushing off-label use of the powerful painkiller. Initially, Federal investigations and criminal charges were limited to Insys employees and contractors; however, Chapman Law Group has seen an increase in criminal and administrative action against physicians who are approved to prescribe Subsys.

Subsys is only FDA approved for use by cancer patients who are opioid-tolerant. Subsys has been described as 100 times more powerful than morphine, although this characterization is often disputed. Insys is accused of pushing physicians to prescribe Subsys to patients with non-cancer pain and who are not opioid-tolerant. According to the FDA, a patient is opioid tolerant if they have been receiving “around the clock medicine consisting of at least 60 mg of oral morphine per day” or an equivalent dosage of another opioid medication. Prescribers who provide Subsys to patients with non-cancer pain or who are not opioid tolerant face a significant risk of licensing DEA, or even criminal action. The Department of Justice has adjusted its sights after prosecuting Insys employees to the prosecution of doctors who prescribe Subsys.

In one such case, a Michigan physician faced immediate suspension of his DEA registration for prescribing Subsys to patients off-label who, according to the DEA, were not opioid tolerant. The DEA claims that prescribing Subsys to patients off-label for non-cancer pain was a violation of 21 C.F.R. 1304.06, which is the DEA regulation requiring physicians to prescribe controlled substances “for a legitimate medical purpose” and “in the usual course of professional practice.” With public data readily available, the DEA is able to quickly determine which physicians have most frequently utilized Subsys and which physicians have accepted payments from Insys. Coincidentally, the prescribers who accepted the most in speaking fees from Insys were also some of the largest prescribers.

If you are a physician prescribing Subsys, it is important to obtain a review of your prescribing history, prior authorizations, and drug utilization to avoid scrutiny of your Subsys prescribing. Early detection and modification of your Subsys prescribing may help avoid DEA, licensing, or criminal action. If you have accepted speaking fees from Insys and are also a prescriber, it is important to contact a health care law attorney to review your prescribing history and determine if you are at risk for an adverse action. Providers may face DEA, OIG, or criminal action under the False Claims Act, Anti-Kickback Statute, or Controlled Substances Act for improperly prescribing Subsys.

To make matters worse, plaintiff malpractice attorneys have begun to market lawsuits against prescribers and Insys in order to obtain enough clients to file class action lawsuits. As a result, we are sure to see an increase in State and Federal malpractice and class action lawsuits against prescribers for overdose deaths or injuries related to Subsys use.

If you are facing a lawsuit, Indictment, DEA order to show cause, or licensing complaint related to Subsys prescribing, you need to obtain an attorney knowledgeable in defending physicians accused of prescribing errors. Chapman Law Group is a multi-state health care law firm devoted to assisting health professionals with compliance, DEA, and criminal issues nationwide. Ronald W. Chapman II has significant experience defending physicians accused of over-prescribing medications and has defended a significant number of physicians related to opioid prescribing nationwide.