In addition to the material already presented in Pelletier and Hoffman's article (2001) "New Federal Regulations for Improving Quality in Opioid Treatment Programs"¹, some additional background information is included below.

The road from regulation to accreditation also had its impetus in the publication of the 1995 Institute of Medicine (IOM) report², which recommended reduction, but not elimination, of regulations for opioid treatment programs (OTPs). In 1997 the National Institutes of Health Consensus report³ urged, "Unnecessary regulation of methadone maintenance treatment (MMT) and all long acting agonist treatment programs be reduced" (p. 1,941). The IOM recommended that an accreditation model be adopted to improve the quality of methadone maintenance treatment. At the same time, the Food and Drug Administration (FDA) acknowledged its main responsibility as approving new drugs, not regulating existing ones, and that the only drug it still regulated was methadone.

The expected benefits of the accreditation model are that OTPs will develop quality improvement-oriented systems of care based on best practices and the findings from performance management activities. The former Federal regulations (with direct inspection from the FDA) were replaced with practice guidelines developed by the treatment community under the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment's (CSAT) oversight. These guidelines emphasize clinical judgment, individual treatment approaches, and patient involvement in the course of treatment.

Development of Accreditation Standards

The accrediting body's standards for OTPs were developed from the CSAT guidelines and created specifically for the SAMHSA OTP Accreditation Project. In 1996 Joyce M. Johnson, D.O., M.A., Assistant Surgeon General, and Director of the Office of Pharmacological and Alternative Therapies at CSAT, convened a special panel of pharmocotherapy experts to provide input to CSAT as it developed guidelines for accrediting organizations. The panel used a modified consensus approach to develop the guidelines that were provided to CSAT in 1997. Another expert review panel was held in 1998 to refine the document further, and additional comments were solicited amongst treatment experts and Federal officials. The final report was produced April 2, 1999, and released to the field. These specific standards supplemented the accrediting organizations' existing behavioral health standards that are applicable to all behavioral health programs seeking accreditation.

The CSAT guidelines were developed to guide accreditation agencies in developing their standards. CSAT guidelines are applicable to various phases of treatment. CSAT Opioid Accreditation Guidelines fall into 19 categories (see Figure 1). The standards related specifically to performance measurement are included in the standards sections related to risk management and continuous quality improvement.

CARF Accreditation Guidelines

The original CARF OTP standards addressed philosophy and mission, organizational leadership, fiscal management, human resources, quality and appropriateness of services, outcomes management, structure and staffing, admission and assessment, medication management, and seclusion and restraint. The standards related specifically to performance measurement are given under Quality Improvement Systems as follows:

• Organizational planning. This standard addresses documentation of a formal, systematic quality program described in an annual organizational plan, with written goals and objectives, an annual management report, and needs assessment.
  
• Quality and appropriateness of services. This standard states that organizations must have a systematic monitoring and evaluation process related to the ongoing measurement of quality, appropriateness, and utilization of services.
  
• Outcomes management. This standard requires that formal outcomes management systems measure program effectiveness (quality of life, symptomatology, functional status, health status), efficiency (access, use appropriateness, cost), and customer satisfaction⁴.

The original standards developed by CARF in 1999, and those revised in January 2001 and promulgated to the field in January 2002, adhered to the customary CARF procedure of convening a National Advisory Council (NAC) composed of consumers, CARF surveyors, CSAT staff, members of trade organizations such as the American Association for the Treatment of Opioid Dependence (AATOD), physicians, and staff from CARF-accredited programs. The NAC utilized a consensus approach and again reviewed the CSAT accreditation guidelines, and proposed the standards manual that was ultimately approved by the CARF Board of Trustees. Changes from the 1999 manual to the 2002 manual were primarily structural in nature, aligning the opioid standards with CARF's existing behavioral health standards.

In the 2003-2004 accreditation cycle, CARF adopted the single set of business practice standards that will be utilized in all of its standards manuals and customer service units. There is also the addition of a fourth accreditation condition, which reflects the need to demonstrate ongoing conformance to CARF standards.

Opioid Treatment Program Accreditation Project

CSAT gathered support from several other Federal agencies to explore the path to accreditation, leading to the OTP Accreditation Project. This project was in effect in 14 states throughout the United States from 1998 through 2002, when the new Federal regulations were passed mandating accreditation for all OTPs in the United States. The project included an experimental research study conducted by Research Triangle Institute (RTI) in Raleigh-Durham, North Carolina, from 1997 through 2001. Approximately 180 control and experimental OTP sites were selected from the 14 states, and between CARF and Joint Commission on Accreditation of Healthcare Organization (JCAHO) selected programs to determine the processes and impacts associated with accreditation on OTPs. As of this date, no final report has been published. CSAT is currently conducting the OTP Accreditation Evaluation through a contract with Northrop Grumman Information Technologies (NGIT). The goal of the evaluation is to assess the intermediate and long-term impacts of the accreditation process by exploring OTPs' experiences with the process of preparing for accreditation and identifying changing patterns of treatment. In addition, it is anticipated that this evaluation may facilitate a move toward an outcome-based treatment model for OTPs. Other issues to be studied include the total cost to the Federal Government, states, and OTPs for the ongoing national implementation of the new regulations, as well as any identified changes in the regulations and accrediting body standards.

Benefits of Accreditation

The benefits of accreditation are many and include the reduction of the need for multiple levels of oversight, the establishment of a common level of program expectations and performance, improved quality of treatment, and the reinforcement of confidence and trust in the competence and capability of the organization. The standards call for the increased use of professional or clinical (not regulatory) judgment, which can help ensure patient rights and improve clinical outcomes. Benefits also include providing the organization itself with an operational blueprint that guides organizational development, and ultimately demonstrates accountability.