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Q&A: Talking about office-based opioid treatment programs

CARF spoke with Flora Sadri, who participated in the International Standards Advisory Committee that crafted CARF’s new standards

By CARF International

Following the release of CARF’s new standards for Office-Based Opioid Treatment programs, CARF invited Flora Sadri, D.O., M.P.H., to share more about this emerging medication-assisted treatment (MAT) setting and the need for a centralized quality framework.

Flora Sadri works in addiction medicine as a board-certified addiction physician for Clean Slate Centers, a national addiction treatment provider. She also is board-certified in family medicine. She has participated in multiple opioid task forces, lectured on substance use disorder as a chronic disease, and worked with the Massachusetts Department of Public Health to obtain licensure of the facilities she is employed by.

Thank you, Flora, for offering your insights into the field.

Q: What is an office-based opioid treatment program?

A: Office-based opioid treatment (OBOT) refers to outpatient treatment services provided in settings other than licensed Opioid Treatment Programs (OTPs). OBOT is provided by DATA 2000-waivered clinicians for patients with opioid use disorder (OUD).

For a patient, an OBOT visit is a chronic disease visit and includes a meeting with a clinician, a prescription for buprenorphine or naltrexone, and other medical and psychosocial interventions and support with markers of recovery to achieve and sustain remission.

Q: How does the OBOT setting differ from OTPs?

A: OBOTs differ from OTPs (also known as a Methadone Clinic or Methadone Maintenance Treatment Program), which are the only settings in the U.S. that can prescribe methadone for OUD. Unlike OBOT settings, U.S. OTPs must be certified by the Center for Substance Abuse Treatment (CSAT), a division of HHS-SAMHSA. OTPs operate under the supervision of a physician and provide counseling and other recovery supports along with medical services related to dosing and treatments on site, which usually require daily visits to the clinic.

OBOT programs, however, are provided by clinicians within their regular medical practice. This setting can help expand access to treatment and provide a more private experience for the patient with opioid use disorder. In the U.S. today, OBOT uses the medications buprenorphine and/or naltrexone.

OBOT programs have fewer requirements and regulations placed on the patient, which can allow easier access to treatment. For example, OBOT may have daily dosing on site, if needed, but dosing usually occurs within the patient’s home and usually is not witnessed by a medical professional.

There also is a limit to the number of patients an OBOT clinician may treat. The first year the limit is 30 patients, but the clinician can apply to SAMHSA for authorization to treat 100 patients. Certain circumstances allow a physician to apply for an increase to 275 patients. Federal code title 42 describes the requirements to obtain approval for 275.

Q: Can you give a brief history of OBOT settings?

A: The creation of OBOTs stems from the Drug Addiction Treatment Act of 2000 (DATA 2000). DATA 2000 created a pathway for qualified physicians to apply for a waiver separate from the Drug Enforcement Administration (DEA) registration requirements of OTPs. DATA 2000 allows physicians to use certain Schedule III-V controlled substances approved by the Food and Drug Administration (FDA) for the treatment of patients with substance use disorder and addiction involving opioid use.

In 2002, the FDA approved the use of buprenorphine to treat opioid addiction. The Comprehensive Addiction and Recovery Act of 2016 expanded on DATA 2000 to allow nurse practitioners and physician assistants to become eligible for a waiver as well.

Q: How is quality regulated in OBOT settings in the U.S.? At the federal level? State level?

A: Several federal laws, regulations, and guidelines govern aspects of MAT for opioid addiction.

To regulate the medications used in MAT, SAMHSA’s Division of Pharmacologic Therapies (DPT), part of CSAT, works with the DEA and the states.

In addition, some medications used in MAT are controlled substances governed by the Controlled Substances Act. The Act contains federal drug policy for regulating the manufacture, importation, possession, use, and distribution of controlled substances.

To obtain a waiver to prescribe these medications to treat addiction, a physician must notify SAMHSA in writing of his or her intent. SAMHSA certifies the physician’s qualifications and documents his or her DEA registration number. SAMHSA then will notify the DEA whether a waiver has been granted. If SAMHSA grants a waiver, the DEA will issue an identification number.

To improve treatment outcomes and meet regulatory criteria, DPT also works directly with MAT professionals.

However, there is no federal oversight for DATA 2000 practices. OBOT regulations vary greatly at the state level, and state legislators may impose regulations that licensed organizations must follow. Generally, the process involves a licensing requirement, possibly state health department oversight, and inspections. It may include requirements related to staff training, types of services offered, and/or limits on buprenorphine dosages and formulations as well as a minimum number of patients served.

Because regulations vary widely, and without any one body providing “gold” standards, quality in treatment historically has varied from state to state.

Q: What is the state of the OBOT field currently?

A: The decision to not have any federal oversight for DATA 2000 practices was an attempt to normalize addiction treatment so clinical practitioners could treat this illness without the “regulatory burden” that OTPs experience. This has led to a variety of treatment settings, from primary care offices to detox facilities and clinics that provide only MAT. Some OTPs even have created divisions that act as an OBOT.

But each state has enacted its own rules and regulations for OBOTs. Often this happened without consulting the medical community, especially addiction specialists. Some of the oversight developed is not evidence based and requires treatment that may actually cause harm and still relates to the idea of substance use disorder as a moral failing.

For example, the practice of mandatory medication taper schedules, or limits on dosages, means that a patient cannot receive the benefit of medication, but instead must abstain from relapse via willpower. Tapering or limiting doses of medication for a chronic disease happens nowhere else in medicine. We don’t rely on mind over matter with diabetes to manage the disease.

Also, some states decided to regulate OBOTs as stringently as OTPs. This can prevent access to patient care as the requirements of daily visits may interfere with the patient leading a normal life. There also may be different regulations for physicians that treat 100 patients or fewer (SAMHSA in fact has different requirements to treat more than 100 patients). This also can lead to limited access.

Finally, lack of centralized oversight of treatment facilities may contribute to diversion of the medication in some cases, harming its reputation as an evidence-based medicine and discouraging clinicians from obtaining a DATA 2000 waiver.

Q: Are there misconceptions about OBOT programs or MAT that you would like to dispel?

A: Yes. Substance use disorder is not a moral failing. It is a chronic disease and needs to be treated as such, with the respect and dignity that any other patient is treated with.

MAT in an OBOT setting is not replacing one drug with another drug. Treatment works and people do return to living a normal, successful, and meaningful life. Studies verify that relapse rates are much higher with therapy alone and that we need an integrative approach that includes medication and psychosocial supports together to provide the best outcomes.

Q: Can you share any studies demonstrating the efficacy of OBOT programs, buprenorphine, and/or naltrexone when used as part of comprehensive therapy and counseling programming?

Kako et al., Lancet 2003
1-year retention in treatment was 75% and 0% in the buprenorphine and placebo groups, respectively (p=0.0001; risk ratio 58.7 [95% CI 7.4-467.4]). Urine screens were about 75% negative for illicit opiates, central stimulants, cannabinoids, and benzodiazepines in the patients remaining in treatment.

Interpretation: The combination of buprenorphine and intensive psychosocial treatment is safe and highly efficacious, and should be added to the treatment options available for individuals who are dependent on heroin.

R.E. Clark Journal of Substance Abuse Treatment 2015
Highlights identified 52,278 individuals with opioid dependence between 2004 and 2010.

It included 104,840 episodes of methadone, buprenorphine, or behavioral health treatment without an opioid agonist. Methadone and buprenorphine were associated with lower relapse rates and costs.

Q: What are your thoughts on the new OBOT standards that you helped develop?

A: I am very proud of the standards. In addiction medicine, it is extremely important to have this accreditation. There is a no more vulnerable population that needs set standards in its care. I feel a practice that is CARF accredited ensures the patients are being provided the best possible care. Patients and families should seek out care from CARF-accredited sites to ensure their treatment is of the highest standards.

(Behavioral Health,Opioid Treatment and Recovery)

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