It is understood that there are other forms of office based practice using buprenorphine for the treatment of chronic opiate dependence. Qualified physicians who meet the requirements of the Drug Abuse Treatment Act (DATA) of 2000 will be able to use any Schedule III, IV, or V medication to treat chronic opiate dependence in their practice settings. As you know, such practitioners are limited to treating 30 patients under the requirements of DATA, to be officially monitored by CSAT and the DEA.

AATOD Perspective
The following points summarize some of the most salient aspects of implementing medical maintenance treatment in the United States.

	The Association published its medical maintenance criteria in its December 1999 News Report. These criteria were based on the success of the Beth Israel Medical Maintenance model in New York City in addition to published articles.
	The time-related focus of our criteria was based on having a patient maintain clinical stability for a three year period of time in methadone maintenance treatment prior to making an off-site medical practice referral. AATOD's Policy Committee interpreted the criteria as applying to any patient who had achieved a three year consecutive period of stability, meeting the published criteria. Exceptions were built into the criteria. The entire policy was based on the patient's voluntary interest in participating. This applied to the methadone treatment program as well.
	There are three articles in support of our Association's position. The first one is titled "Medical Maintenance: The Treatment of Chronic Opiate Dependence in General Medical Practice" as authored by Dr. Novick and Herman Joseph, published in 1991. This article sets forth the parameters of the medical maintenance treatment concept in addition to citing criteria for admission to the program. You should note that these criteria included maintaining "stable employment and/or productive activities such as homemaking and enrollment in school or college within the last three years." The point is, the three year criterion had been recommended based on years of clinical practice. The article also indicated that 7% of the existing patient population would be likely to be eligible for medical maintenance treatment. This is significant in view of the 205,000 patients who are currently enrolled in methadone treatment throughout the United States.
	The second article is titled "Outcomes of Treatment of Socially Rehabilitated Methadone Maintenance Patients in Physicians' Offices (Medical Maintenance)", as authored by Dr. Novick and associates, published in 1994. Once again, they arrived at the conclusion that "there are many patients in methadone programs throughout the United States who would benefit from a greater availability of medical maintenance." This became the thrust of our Association's recommendation to increase access to this treatment option to improve access to care since a number of methadone treatment programs seemed to have a waiting list. It was also believed that patients would do better by being given the option of leaving the hub treatment site and entering a physician office for their continued and "stepped-down" care (please refer to the narrative description of our Association's recommendations, taken from the December, 1999 AMTA News Report).
	Finally the article "Methadone Medical Maintenance: Treating Chronic Opiate Dependence in Private Medical Practice - A Summary Report (1983 - 1998)", as authored by Dr. Edwin Salsitz and his associates, published in 2000. Once again, the basic clinical stability, as referenced, stands at three years of stability prior to referral to the off-site physician setting.
	This is the study that documented that 16.5% of the patients left medical maintenance treatment, not adhering to the requirements of the program. It is assumed that these patients were referred back to the hub methadone treatment program.

CSAT Perspective
The only officially promulgated correspondence from the FDA and CSAT on the topic of Medical Maintenance has been enclosed (March 30, 2000 letter to the field), as authored by Drs. David Lepay of the FDA and Westley Clark of CSAT. It set the broad parameters for such a Medical Maintenance policy and provided an update of recent CSAT-supported efforts in Seattle and Connecticut. It certainly hinted that the stable period of treatment would be 12 months of stability in a hub methadone treatment program prior to off-site referral. The numbers of subjects in these particular studies were extremely small when compared to the Beth Israel experience, which has been in existence for more than fifteen years.

The only other time that there was any published information on Medical Maintenance treatment was in draft form during the National Methadone Conference of April, 2000. The April 3, 2000 draft did not "reflect the official position of CSAT" but reflected the opinions of a Medical Maintenance Consensus Panel, which had been created by CSAT/SAMHSA. The eligibility criteria cited in this reference manual (unpublished to date) was a stability period for at least one year prior to being referred off-site from the methadone treatment program to a physician office.

This comprehensive reference book has not been published and continues to be in draft form to the present date. My understanding is that CSAT's expectation is that this topic will be covered in the new encyclopedic TIP, which will be produced by CSAT in draft form during April, 2003.

Medical Maintenance vs. OBOT
As a point of clarity, Medical Maintenance is a form of OBOT. Another form of OBOT, as referenced above, is the use of buprenorphine in physician based practices, who qualify under the provisions of the Drug Abuse Treatment Act of 2000.

The Association's position concerning the use of methadone in private practitioners' offices has been also clear, based on a series of meetings with other provider associations, federal officials and Board meetings. The following bullets summarize these points.

	The Association has supported Medical Maintenance, as indicated above and published in our December, 1999 News Report.
	The Association has also supported patients gaining access to office based care "de novo" in a private practitioner's office (OBOT), using methadone, in rural and medically underserved areas. These areas were defined as geographic areas where methadone maintenance treatment programs were not available. In such circumstances, physicians in geographically remote areas of the United States would be able to prescribe methadone for patients "de novo" with approval from the appropriate federal agencies.
	The Association has not supported having physicians in private medical practice prescribe methadone maintenance treatment "de novo" for chronic opiate dependent individuals unless they follow the same parameters that are currently being required for all methadone treatment programs under CSAT's newly promulgated accreditation standards (May 18, 2001).
	The rationale for this opposition is clear. If physicians in private practice, located near a methadone treatment program, were to prescribe methadone maintenance for "de novo" patients, without having to follow any of the required guidelines for patients in treatment, we would have a massive destabilization of the nation's methadone treatment programs. If NIDA and all credible research at present has repeatedly demonstrated the value of having ancillary services provided in support of medication (methadone/LAAM/buprenorphine), it would follow that all practitioners using this medication to treat chronic opiate dependence would follow suit.
	We also know that patients in methadone treatment programs who do not meet the criteria for medical maintenance treatment would be likely to go to physicians' offices, similar to pain management clinics, if they did not have to provide urinalysis, seek counseling, or meet other comprehensive care standards. The point is, why would the government have methadone maintenance treatment programs if it wants physicians in private practice settings to treat chronic opiate dependence by having doctors prescribe a medication without providing access to any other care? One would argue, if the government is going to take this position, it should eliminate methadone treatment programs.

Summary
In defining what our Association supports and does not support, AATOD realizes that we become victim to a number of criticisms. AATOD realizes that our policies have been criticized as being too conservative and protecting the financial interests of methadone treatment programs. AATOD's criteria have never had the interest of protecting financial concerns. They were based on Beth Israel Medical Center's longstanding medical maintenance treatment experience, which is clearly in evidence when you compare their criteria to our Association's published criteria, which had been promulgated by the Policy Committee and approved by the Board of Directors. It is fair to say that Beth Israel also had no financial interest in promulgating their standards.

Another important point needs to be stated in this regard. Our Association's view, which has been supported by Dr. Herman Joseph and his associates, has been that we would increase organizational instability in Medical Maintenance programs by decreasing the period of patient stability prior to referral off-site. Even in the Beth Israel model, which utilizes a three year period of stability, 16% of the patients had to be referred back to the hub site. This is not a criticism of the patients who needed to be referred back to the methadone programs. It only states the point that this percentage is likely to increase as the period of pre-referral clinical stability decreases.

It is also important to include reference to other studies that have been published citing different perspectives.

The first item is the article "A Multicenter Randomized Evaluation of Methadone Medical Maintenance" as authored by Dr. King and his associates, published in 2002. This focuses on a clinical standard of care of 12 months in treatment. Once again, the number of subjects is very small, at 73.

Another useful reference is "Office-Based Methadone Prescribing: Acceptance by Inner-City Practitioners in New York", reflecting the work of Dr. Ernest Drucker and Jennifer McNeely. It does not focus on any clinical standard of care but promulgates the value of medical maintenance treatment interventions.