The addiction industry is facing a great deal of scrutiny at every level. The laws and regulations are changing and compliance is lagging behind. Noble efforts to get patients treated quickly for substance abuse due to the growing opioid abuse epidemic will cause problems if the federal and state laws are not followed carefully especially where Suboxone and other scheduled drugs are involved (due to potential for misuse and diversion). Further, where there is Medicare/Medicaid or insurance billing involved issues of medical necessity, proper billing and proper medical supervision is key.
Treatment centers need to be mindful that federal rules and regulations regarding prescribing and billing must be followed carefully. A recent qui tam case addresses the prescribing of Buprenorphine (Suboxone), a Schedule III controlled substance that also can be used to treat pain, by mid-level practitioners and what happens when federal law changes but state regulations are not adopted. Providers must follow state and federal laws and regulations.
How did this qui tam case come about? 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.
A recent case shows the legal issues. On November 22, 2016, the U.S. Attorney’s Office in Boston reached a $750,000 civil settlement yesterday with CleanSlate Centers, Inc. and Total Wellness Centers, LLC d/b/a CleanSlate. This civil settlement resolved 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 is a fairly large company in that it operates 17 clinics, offering treatment to individuals addicted to opioids, including heroin and prescription painkillers, through medication and counseling. Buprenorphine, is a Schedule III controlled substance that also can be used to treat pain.
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 allegedly signed the prescriptions, backdating them to the visit dates. The government alleged that 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.
Why is this a civil qui tam case and not a criminal case? Cooperation. According to the government, upon learning of the prescribing and billing violations, CleanSlate cooperated fully with the federal investigation. It appointed a new management team and began the process of hiring at least one full-time physician at each of its clinics. In addition, CleanSlate 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.
Posted by Tracy Green
Attorney, Green and Associates