In the face of the devastating opioid epidemic, treatment professionals are searching for ways to help patients control their addiction. Medically Assisted Treatment (MAT) with buprenorphine is one treatment which has greatly expanded. From 2012 to 2015, there was an 82 percent increase in buprenorphine dispensing. The Kentucky Department of Medicaid Services paid over $20 million just for prescriptions of MAT drugs alone in 2013.
Suboxone, which combines buprenorphine with the opioid antagonist naloxone, is the most commonly prescribed drug for opioid treatment. Still, many healthcare professionals are concerned addicts need greater access – particularly in rural areas.
On the other hand, many in the regulatory and law enforcement communities are concerned that Suboxone, which is itself a Schedule III opioid, is being abused and diverted at high rates. Overdose deaths involving buprenorphine raised to thirty-seven in 2014 from less than five in 2011. Nearly five percent of all submissions to the Kentucky State Police laboratory involve buprenorphine.
To attempt to balance these concerns, both the federal and state governments have taken actions aimed at both increasing access and combating diversion. To ensure compliance with these regulations and to stay on the right side of the law, responsible Suboxone prescribers must be aware of these various issues before treating patients.
Know Federal Law
First, know the federal laws and regulations. To begin prescribing Suboxone for opioid treatment, a provider must obtain a waiver from the Substance Abuse and Mental Health Services Administration (SAMSHA). For a waiver, a physician must meet the following requirements:
- Possess a license to practice medicine under state law.
- Register to dispense controlled substances by the Drug Enforcement Administration.
- Hold either a special certification or complete an approved training course. For the first year, a physician may only treat 30 patients. After that, the limit raises to 100.
Over the past year, the federal government has expanded access in two critical ways. First, the Secretary of Health and Human Services increased the patient limit to 275 annually for physicians holding additional credentialing or practicing in a qualified practice setting. As with the initial waiver, eligible practitioners must submit a request through SAMSHA.
Next, in July 2016, President Barack Obama signed the Comprehensive Addiction and Recovery Act (CARA) into law. After CARA, qualifying nurse practitioners and physician assistants can now seek a SAMSHA waiver to provide a full spectrum of treatment services, including MAT services. The same limits apply to these providers.
Other federal regulations – too numerous to list – include the strict federal record keeping requirements related with substance abuse treatment records and Medicare/Medicaid regulations.
Know State Law
Second, know the state laws and regulations. Last year, the Kentucky Board of Medical Licensure (KBML) issued minimum requirements and professional standards for practitioners prescribing buprenorphine.
The KBML requires additional medical education specific to addiction medicine. The regulation also provides a laundry list of prescribing standards including requirements before one begins treatment and for ongoing treatment. These range from dosage limits to frequency of KASPER checks and include evaluation requirements. Following these standards are critical for Kentucky physicians.
Third, prepare and guard against increased scrutiny. For years, federal, state and local agencies have joined forces to curb prescription drug abuse through a combination of regulatory actions and criminal investigations. From the regulatory side, the KBML can immediately suspend or restrict a provider license. Federal agencies can take similar action to suspend a prescribing license.
Criminal investigations are often conducted jointly by state and federal authorities. While these investigations are usually reserved for more serious cases, often a case’s seriousness cannot be judged until after records have been seized, reviewed and analyzed. Responding to these inquiries can be time consuming and expensive. The best way to limit the effects of any of these actions is to keep good records showing compliance with the regulations.
Time will tell if the federal and state regulations achieve the goals of increasing access while controlling diversion. One thing is certain – as Suboxone prescribing grows, providers will be under increased scrutiny. However, if providers follow the regulations and document their activities, they can limit their exposure to these actions.
-Mitchel Denham is a partner at the Louisville, Ky. law firm of Thompson Miller & Simpson.