Our program was the first to obtain regulatory exemptions for methadone medical maintenance in a nonexperimental setting. Critical features of this model include close affiliation with a cooperative OTP, training and clinical support for generalist physicians and pharmacists, and integrated primary care medical services. These features enabled regulatory approval and good clinical outcomes, although substantial effort was required to obtain exemptions and develop office procedures and protocols. Our program applied to a minority of methadone maintenance patients, but given the close to 200,000 patients receiving methadone treatment in the United States today, extending this model could enhance care for a significant number of stable patients.
Patients remained stable after transferring to methadone medical maintenance. Our addiction outcomes were comparable to those of earlier successful experimental programs,9,14,15
and in addition we found possible improvement in patients' medical status over time. Similar temporal improvements were not found in previous office-based methadone trials that used the same ASI medical status measure.18,23
These trials, however, provided no integrated primary care services. While our observational design is limited, these results suggest that when methadone medical maintenance delivers multiple interventions for previously unaddressed medical problems, important health gains result. The benefits of medical care in conjunction with addiction treatment have been documented in other settings24–27
and add to the rationale for integrating these systems of care.
Affiliation with an existing OTP was required for regulatory approval and guarantees continuity of care if patients relapse and need more frequent methadone dispensing. ETS fully supported providing these services to eligible patients. Other programs might be concerned that the transfer of stable patients could affect staff morale or put a significant strain on revenues, as many programs receive comparable reimbursement for the most stable patients and for new patients with multiple problems. This could impede widespread implementation of methadone medical maintenance. However, patients who can benefit from a lower intensity of care should not suffer from such adverse payment mechanisms.
Our program is unique in providing methadone maintenance treatment in the “real world” medical practices of generalist physicians with no previous addiction medicine experience. Our brief initial training program and ongoing clinical support and consultation parallels practice patterns in other medical specialties. Physicians expressed satisfaction with this approach, and although we studied a small number of physicians, there was evidence of increasingly positive attitudes toward methadone maintenance. Such attitudes have been associated with improved patient treatment retention.28
Physicians perceived co-occurring mental health issues as a challenging aspect of care for this population, making this a potential target for additional training.
No previous U.S. methadone medical maintenance program has incorporated clinical pharmacists into methadone dispensing and assessment of patients. Regular pharmacist contact with patients facilitated their major role in clinical care coordination. Pharmacists have been involved in the expansion of methadone treatment capacity in other countries,29
and could play a similar role in the United States.
Our small sample size did not allow for meaningful cost estimates, though costs will influence widespread implementation of this model. Reduced addiction services utilization has been documented in methadone medical maintenance due to additional take-home methadone doses.14
However, Washington State methadone maintenance reimbursement policy does not allow a commensurate reduction in charges for patients in methadone medical maintenance. Thus, the additional provision of primary medical care in conjunction with addiction treatment monitoring may have increased overall costs of care while adding the benefits of medical services. Initial grant funding was required to develop and evaluate this program but did not support clinical services, allowing the continuation of this program as a self-funding, collaborative project of HMC and ETS.
The relatively infrequent monitoring of patients in methadone medical maintenance may have missed some drug use, as more frequent testing and hair analysis has detected more use in a similar population.18
However, unremitting dependent use is likely to be detected by monthly tests and clinical observations, and the clinical significance of intermittent use in this setting is not clear. Random call backs discovered no additional drug use or major irregularities in methadone adherence, and these have been continued for patients remaining in our program. This diversion control measure was not overly burdensome and may encourage patient adherence while providing verification of appropriate methadone use.
Methadone medical maintenance cannot substantially address the urgent need to increase access to initial methadone treatment in the United States, particularly for those in need of public funding. Other countries have successfully increased access to methadone by allowing generalist physicians to initiate treatment, with outcomes comparable to clinic-based practice.29–32
In the United States, initial treatment may be provided by trained and certified physicians using buprenorphine, a new medication recently approved by the FDA for treatment of opioid dependence.33
The reduced regulatory burden that applies to buprenorphine compared with methadone medical maintenance may make it more attractive to physicians. However, access to buprenorphine or methadone will remain restricted unless funding levels for addiction treatment are increased or parity between medical and addiction treatment insurance is established.
Recent changes in federal regulations permit OTPs new clinical flexibility.34
Clinics may now give 1-month supplies of take-home methadone to successful patients after 2 years in treatment, addressing part of the rationale for methadone medical maintenance. However, integrated methadone medical maintenance can provide the additional benefits of enhancing patient satisfaction with methadone treatment, reducing patient contact with less stabilized patients, developing physician expertise in addictions, and improving the medical care of patients in methadone treatment. The new regulations explicitly request exemption applications to create methadone medical maintenance programs and thus expand access to this care model for other stabilized methadone maintenance patients.
While complex, it is feasible to obtain regulatory approval and train generalist physicians and pharmacists to provide methadone medical maintenance with good patient outcomes, high levels of patient and provider satisfaction, and potential improvement in physician attitudes toward methadone treatment. While the complexity of regulatory policy and program protocol development is substantial and may limit expansion of this model of care, the precedent set by our program should facilitate smoother regulatory approval for future programs.