Best practices in compliance with highly regulated Suboxone treatment

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As hospitals and health systems continue to combine, likewise, primary care physicians and groups continue to seek employment, and hospitals and health systems continue to acquire them for a variety of strategic reasons.

Each practice is unique and has a culture unto itself. Each comes with its own set of unique challenges. Some acquired practices provide addiction and pain management services. If your newly acquired practice is providing these services, it is now your responsibility to ensure compliance with all applicable laws and regulations.

One of the more common scenarios relates to primary care practices which provide Suboxone treatment to their patients. Suboxone was approved by the FDA in 2002 to treat opioid addiction. According to the CDC, the opioid epidemic is rampant with a four-fold increase in opioid related deaths since 2000. In 2013, more people died from opioid addiction than from motor vehicle accidents. In 2014, there were 47,000 opioid related deaths in America. Moreover, chronic pain (which is often the predecessor to addiction) affects more than 100 million adults in America. The problem is real and is sizeable. Often, those impacted were productive members of society who were injured at work, in a fall or in an automobile accident. Over time, they become addicted to prescription pain killers. Many eventually turn to heroin and the illicit pill trade because they are cheaper and easier to get than properly prescribed opioids.

By way of background, Suboxone is intended to prevent withdrawal and cravings as well as the "high" typically associated with opioids. It is less likely to be abused than Methodone and people rarely overdose on Suboxone. There is less stigma attached to it, it can be taken at home, rather than daily at a clinic, and a 30 day supply can be obtained by prescription through your local neighborhood pharmacy. Its appeal and efficacy are obvious.

Provision of Suboxone treatment is governed by the Drug Addiction Treatment Act of 2002 ("DATA 2000"). The Secretary of the Department of Health and Human Services delegated authority over Suboxone treatment to the Center for Substance Abuse Treatment ("CSAT") of the Substance Abuse and Mental Health Services Administration ("SAMHSA").

Obtaining Suboxone through a family doctor and a local pharmacy was intended to provide convenient, affordable and ready access to treatment, without the stigma of daily trips to a methodone clinic and to reduce the likelihood that those with addiction would turn to illicit drugs and activities. It was also intended to reduce the possibility of death due to overdose.

The process of treating patients with Suboxone is highly regulated and acquiring hospitals are obligated to ensure that their practices comply fully with these laws and regulations. Below is a list of suggestions and recommendations in order to ensure compliance and to adopt best practices. This listing is not exhaustive, but meant to provide a framework of issues hospitals should consider to ensure compliance.

- In order to ensure compliance, hospitals need to ensure that there is appropriate informed consent documented in the chart of each patient. There should be clear documentation that the patient understands the risks and benefits of Suboxone treatment.

- Hospitals should ensure that there is an executed treatment agreement in the chart of each patient receiving Suboxone treatment.

- The treatment agreement should clearly indicate what the treatment entails and that the patient understands what is expected of him/her in order to remain in the program.

- Goals of treatment should be clearly set forth.

- One pharmacy should be identified as the only pharmacy which will be used in order to fill prescriptions for Suboxone.

- The treatment agreement should clearly set forth that the patient has authorized the treating physician to communicate with other health care providers about his or her care. Likewise, the treatment agreement should set forth authorization for the provider to consult the state's prescription drug monitoring program.

- The patient should affirmatively agree, in writing, to avoid the use of illicit drugs, to submit to random drug screens and to submit to pill counts.

- The treatment agreement should also set forth expected intervals between visits and how prescription renewals are handled.

- The treatment agreement should set forth the expectation that use of all other opioids be discontinued and there should be a clear understanding of which factors could result in termination of treatment, such as non-compliance, non-payment of fees, disruptive conduct, violence, threats or incarceration.

- The physician is expected to continually monitor for compliance and ensure that those in treatment are not using alcohol, illicit drugs or other prescription opioids. Hospitals should ensure such activities are taking place and are appropriately documented in the chart.

- The medical records have to contain a treatment plan, informed consent documentation, diagnostic studies related to monitoring for compliance, history and physical exam notes, lab studies, documented treatment plan, authorization to release information to providers, medication lists, all prescriptions for Suboxone, and a copy of the signed instructions given to the patient. The records must be kept on the premises of the treatment facility. Records should include documentation of the induction, stabilization and maintenance phases of treatment.

- Practices should develop and maintain diversion control plans to prevent misuse of Suboxone.

- The provider also has to comply with the heightened privacy requirements set forth in 42 CFR, Part 2. The hospitals' legal, compliance and privacy officers should review the practice to ensure compliance.

- Hospitals need to ensure that the treating physician has not exceeded any applicable cap on the number of patients he or she is permitted to treat.

- The hospital should ensure that the provider maintains records and inventories of all controlled substances dispensed.

- The hospital should ensure that the practice maintains a DATA 2000 binder which contains patient logs with patient status, inventory of Suboxone in stock, DATA 200 Policy with acknowledgement log, as well as a log of all related non-patient communications, such as communication with the DEA.

- The hospital should ensure that the Suboxone is stored under locked conditions.

- The hospital should ensure that only staff licensed to administer or prescribe Suboxone physically handle it.

- The hospital should ensure that a DEA compliant dispensing log be maintained.

A suggested best practice would be spot checks by officials from the hospital or health system to ensure compliance.

As with any practice acquisition, time and energy must be expended to ensure adherence to policies and procedures and compliance with laws and regulations. Practices which actively prescribe Suboxone require some special attention in order to ensure compliance. The points above are intended to provide hospitals with a framework and general guidance to assist in their ongoing compliance efforts.

The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.

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