Is counseling necessary for patients on buprenorphine? For physicians prescribing buprenorphine for the treatment of opioid use disorders, the answer from the American Society of Addiction Medicine (ASAM), the Substance Abuse and Mental Health Services Administration (SAMHSA) and the research literature is gradually coming into focus, but it’s still far from clear. And while some say that’s the way it should be in the practice of medicine, the fact remains that for patients in opioid treatment programs (OTPs) — clinics licensed to dispense methadone as well as buprenorphine — there is no choice. Counseling is required for all OTP patients.

Asked why counseling would be required for OTP patients but not patients in office-based opioid treatment (OBOT), David A. Fiellin, M.D., the researcher whose clinical trials got buprenorphine approved to treat opioid use disorders, said, “I have not seen research to address this.” However, he did refer us to four studies that indicate from zero to modest benefits for counseling. “I don’t think anyone advocates for no counseling,” he told ADAW last week. “I think the issue is determining if outcomes are improved with counseling above and beyond physician management.” Fiellin, who is professor of medicine, emergency medicine and public health at the Yale School of Medicine, used “medication management” visits with patients in trials. We read the studies (not for the first time) and summarize them briefly below.

  • In 2011, a Cochrane review found no benefits conferred by psychosocial counseling in addition to agonist treatments for opioid dependence. (Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial combined with agonist maintenance treatments versus agonist maintenance treatments alone for treatment of opioid dependence. Cochrane Database Syst Rev 2011 Oct 5; (10):CD004147. doi: 10.1002/14651858.CD004147.pub4.)
  • In a study that was commissioned by ASAM and published in the Journal of Addiction Medicine (which is published by ASAM), Karen Dugosh, Ph.D., and colleagues summarize literature showing a modest benefit of psychosocial interventions, but conclude that the research is skimpy and more is needed. “As opioid use and overdose deaths in this country exceed epidemic proportions, the urgency for an expanded research agenda on best practices for comprehensive treatment could not be more critical,” they conclude. (Dugosh K, Abraham A, Seymour B, et al. A systematic review on the use of psychosocial interventions in conjunction with medications for the treatment of opioid addiction. J Addict Med 2016 Mar–Apr; 10(2):93–103. doi: 10.1097/ADM.0000000000000193.)
  • In a commentary on the Dugosh paper also in the Journal of Addiction Medicine, Robert P. Schwartz, M.D., of the Friends Research Institute writes that the review itself was flawed by using too many vague outcomes such as “retention” in treatment instead of the sole outcome of illicit opioid use. He concludes, “Physicians should be encouraged to use these medications to treat their opioid-addicted patients and not be discouraged by the fact that they cannot by themselves address all of the additional psychosocial problems a particular patient might have. If this was the way medicine was practiced, many patients would not receive medical care.” (Schwartz RP. When added to opioid agonist treatment, psychosocial interventions do not further reduce the use of illicit opioids: A comment on Dugosh et al. J Addict Med 2016 Jul–Aug; 10(4):283–285. doi: 10.1097/ADM.0000000000000236.)
  • And this summer, in AJP in Advance, the researchers Kathleen M. Carroll, Ph.D., and Roger D. Weiss, M.D., reviewed literature showing either no benefit or some benefit from counseling. They had some questions about research design, and concluded that there is a clear conflict between the need to expand access to buprenorphine and the need for quality care. “[W]hile efforts to expand buprenorphine access are essential and urgent, there remains considerable room for improvement, given 6-month retention rates of about 50 percent and the significantly higher risk of relapse, overdose, and death that is associated with dropout,” they write. “Given these risks, we must find means of improving retention in office-based buprenorphine maintenance.” (Carroll KM, Weiss RD. The role of behavioral interventions in buprenorphine maintenance treatment: A review. Am J Psychiatry 2017 Aug 1; 174(8):738–747. doi: 10.1176/appi.ajp.2016.16070792. Epub 2016 Dec 16.)

High-volume prescribers

While leaving physicians who treat 100 or fewer patients with buprenorphine off the hook for paperwork, those who prescribe for more than that — up to the cap of 275 — will have to at least fill out an annual form telling the government how many patients are getting some kind of counseling. Last year, when SAMHSA raised the cap — the number of patients one doctor can treat with buprenorphine — from 100 to 275, it was clear that the counseling and drug testing requirements that had been in the proposed rule were dropped (see ADAW, July 11, 2016). At that time, the proposal that physicians prescribing at the 275 cap would have to submit additional paperwork was temporarily put on hold.

Last September, however, SAMHSA issued a final rule calling for physicians prescribing at the cap to file paperwork indicating that they would need to “report on the number of patients provided behavioral health services and referred to behavioral health services,” according to the final rule (https://www.federalregister.gov/documents/2016/09/27/2016-23277/medication-assisted-treatment-for-opioid-use-disorders-reporting-requirements). While not the same as a requirement to provide services, the reporting requirement “will strike the appropriate balance between collecting valuable information needed to assess compliance with the rule and avoiding undue burden on practitioners,” according to the final rule.

“Based on law and regulation, health care professionals have varying levels of responsibility with regard to assuring patients receiving buprenorphine receive psychosocial services,” said Melinda Campopiano, M.D., medical officer for SAMHSA’s Center for Substance Abuse Treatment, in an email to ADAW last week. “Prescribers with the lower patient limits must be able to provide a referral for appropriate services,” she said. “Prescribers with the higher patient limit must coordinate these services or provide them directly. The training health professionals must complete to obtain a waiver to prescribe buprenorphine for opioid use disorder covers not only pharmacotherapy, but also the need and importance of psychosocial services to establishing and maintaining recovery.” Asked how SAMHSA knows if providers are complying, she responded, “This, like many other aspects of medical practice, can be enforced by state medical boards if standards are not being met.”

Interestingly, Indivior, which makes the Suboxone brand of buprenorphine, does insist on counseling, regardless of how many patients are being treated by one physician. “Suboxone Film, a prescription medicine indicated for treatment of opioid dependence, should be used as part of a complete treatment plan to include counseling and psychosocial support,” a company spokesman told ADAW last week. “Treatment should begin under the supervision of a doctor. The doctor must be qualified under the Drug Addiction Treatment Act of 2000. In appropriate patients, treatment may continue at home with follow-up visits to a doctor at reasonable intervals.”

ASAM view

ASAM, which has consistently opposed caps and other regulations that would limit access to buprenorphine, and which in review courses tells physicians counseling is not necessary, suggested we talk to Yngvild Olsen, M.D., M.P.H., for more information on the topic of counseling. Olsen, who is medical director for the Institutes for Behavior Resources/REACH Health Services in Baltimore City, has both OBOT and OTP patients, and uses both methadone and buprenorphine in treatment. “The DATA 2000 law essentially says that a DATA 2000 waivered physician needs to be able to refer a patient to counseling,” she said. “But by law, counseling is not required, unlike with the rules for OTPs, where counseling is part of the regulation, something that is required.”

“In office-based treatment, there are patients with different degrees of severity of opioid use disorder,” she said. Isn’t this also true in OTPs? “I don’t know that you can equate OTPs and office-based models, because the severity of the patients may be different,” she said. “Even in the OTP world, when you try to make it one-size-fits-all, it doesn’t always work. In the OTP world, if you don’t attend your mandated counseling sessions, you get kicked out of care, and that isn’t good either.”

ASAM, for its part, refers prescribers to its guideline, which states that “psychosocial treatment is recommended for patients being treated with buprenorphine,” said Susan Awad, ASAM director of advocacy and government relations. The guideline also notes, however, that “the evidence for benefits of such psychosocial treatment is mixed,” she said. “But it still recommends clinicians should consider providing or referring patients to services such as cognitive behavioral therapy, contingency management, relapse prevention and/or motivational interviewing.” Awad added that ASAM has “opposed payer policies that would require counseling as a condition for covering the prescription costs of buprenorphine,” she said. “While clinically recommended, it should not be made a barrier to pharmacologic treatment.”

For the ASAM National Practice Guideline, go to https://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf?sfvrsn=24.