On Monday, November 21, 2016, the U.S. Attorney’s Office in Boston reached a $750,000 civil settlement with CleanSlate Centers, Inc. and Total Wellness Centers, LLC d/b/a CleanSlate, to resolve allegations that the two companies, which together operate opioid addiction treatment centers in Massachusetts and other states, improperly prescribed buprenorphine (Suboxone®) for opioid addiction treatment and improperly billed Medicare.
CleanSlate operates 17 clinics, offering treatment to individuals addicted to opioids, including heroin and prescription painkillers, through medication and counseling. The medication, buprenorphine, is a Schedule III controlled substance that also can be used to treat pain.
Until recently, only a physician could prescribe buprenorphine for addiction treatment. Congress modified the law in July 2016, allowing nurse practitioners and physician assistants to prescribe buprenorphine for addiction treatment, provided they meet certain training and state-law licensing requirements. In Massachusetts, those requirements have not yet been established.
United States Attorney Carmen M. Ortiz said, “Buprenorphine is an important drug used in the treatment of substance abuse, and until recently, only physicians were allowed to prescribe it. We will continue to closely monitor clinics that use buprenorphine for addiction treatment to ensure that they comply with strict prescribing requirements.”
“The DEA is committed to enforcing the Controlled Substances Act (CSA) by ensuring that all registrants abide by DEA’s prescribing regulations,” said Special Agent in Charge of the Drug Enforcement Administration Michael J. Ferguson. “Ensuring safe prescribing and dispensing of opioid medications and addiction treatment medications is a critical part of our ongoing efforts to protect patient safety and prevent drug diversion. In response to the ongoing opioid epidemic, DEA is committed to working with our law enforcement and regulatory partners to ensure these rules and regulations are followed.”
The settlement resolves two sets of allegations. First, the government alleged that, from March 2012 to February 2014, CleanSlate clinics routinely contacted pharmacies representing that physicians had prescribed buprenorphine for patients when, in fact, only midlevel practitioners had seen the patients. Days later, after patients had already picked up their medication from the pharmacies, part-time physicians employed by CleanSlate for as little as six hours per month accessed the patients’ electronic medical records. After reviewing the patient visit information, the part-time physicians signed the prescriptions, backdating them to the visit dates. These actions violated the Controlled Substances Act and regulations issued by the DEA.
Second, the government alleged that, from June 2010 to April 2016, CleanSlate repeatedly billed Medicare for patient visits using physicians’ identification numbers when, in fact, the patients saw midlevel practitioners and no physicians were on clinic premises to supervise those practitioners. Had CleanSlate properly billed under the midlevel practitioners’ identification numbers, Medicare would have paid less. These actions violated HHS’s rules for billing Medicare and violated the False Claims Act.
Upon learning of the prescribing and billing violations, CleanSlate cooperated fully with the federal investigation. It has appointed a new management team and has begun the process of hiring at least one full-time physician at each of its clinics. In addition, CleanSlate has implemented a new system under which only doctors can prescribe buprenorphine, and they do so electronically, thereby ensuring that no prescription is issued until after a doctor has reviewed the patient visit information.