Notice for Proposed Rule Making – Change in Federal Oversight for Methadone Treatment

General Barry R. McCaffrey, Director of the Office for National Drug Control Policy (ONDCP), released the Notice of Proposed Rule Making (NPRM) on July 22, 1999, in conjunction with Dr. Westley Clark, Director, Center for Substance Abuse Treatment/SAMHSA. This document provides notice to providers and regulatory agencies throughout the United States of the federal government’s intent to transition authority from FDA oversight of methadone treatment to a CSAT/SAMHSA managed accreditation system. This system will operate under the aegis of CSAT and draft accreditation guidelines are being pilot tested in approximately 180 programs in 15 states by both JCAHO and CARF.

The Association forwarded two survey documents to methadone treatment providers (Board of Directors of the Association) and all of the State Methadone Authorities, soliciting information which was included in the Association’s testimony on November 1, 1999 when the federal interagency hearing convened to receive guidance from the field.

The survey to the Board solicited information about the direct and indirect costs, which are associated with accrediting methadone treatment programs. These programs have already been accredited in a number of states. The second survey was forwarded to the State Methadone Authorities, attempting to understand how the states view the needs of methadone treatment programs, including the number of programs that are deficient according to state’s monitoring practices in addition to programs that are in need of programmatic technical assistance and physical plant improvements.

The results of these surveys were included in the Association’s formal response to the NPRM, which were presented during the hearing of November 1, 1999.

Six states have indicated that 21 treatment programs are currently in violation of FDA regulations. Ten states have reported that 45 programs are in violation of current state regulations. Five states have indicated that 5 programs are in danger of closing. Twenty-nine states have indicated that 155 programs need programmatic technical assistance. Sixteen states have indicated that 25 programs need physical plant improvements. Twenty-one states rated 172 programs as excellent. Thirty states rated 209 programs as good. Twenty-five states rated 145 programs as fair and 11 states rated 36 programs as poor.

The Association’s support for the development of standardized outcome measures and evaluating the efficacy of methadone maintenance treatment can be traced back to the development of the State Methadone Treatment Guidelines. These Guidelines were published in 1993 by CSAT following the release of several critical reports concerning the effectiveness of methadone treatment programs in the United States.

The Association’s support for accreditation is also rooted in the fact that a major segment of the healthcare system in the United States is being reviewed through such accreditation standards. We believe that accrediting methadone treatment will offer the potential of embracing such treatment as part of mainstream medicine in the United States.

It appears that the direct cost of accrediting a methadone treatment program ranges from $7,500.00 – $11,000.00 including the cost of an application (CARF only) and the cost of the on-site survey. Our Association is urging the federal government to develop a multi-year, multipurpose fund to ensure that methadone treatment programs and patients will not be adversely affected by the implementation of accreditation standards, ultimately decreasing access to care through program closure.

Such a fund would be implemented on a needs based model, which would pay for the cost of the survey. The fund would also provide financial and technical support in implementing improvements as a result of the accreditation survey.

Such improvements could be the training of personnel, implementing new information management systems and executing physical plant improvements.

The Association is aware that individual states have promulgated regulations, governing the practices of methadone programs in their respective jurisdictions. In certain states, the specific interests of elected and appointed officials have driven the complexity of particular state regulations. Eight states still do not have any methadone maintenance treatment programs, however, we have been informed that New Hampshire has recently opened an outpatient methadone to abstinence program (180 days).

We have recommended that the federal agencies, which will take primary responsibility for implementing accreditation, work in conjunction with the State Methadone Authorities to maximize the use of one accreditation standard. The Association is hopeful that individual states will adopt accreditation body findings once it is determined that the accreditation surveys are responding to the needs of the States in ensuring that good quality care is being provided within the methadone treatment programs.

The NPRM also raises questions about office based methadone treatment in private practice settings. Our Association has recommended that methadone treatment be offered in office based medical practices through the vehicle of expanding access to “Medical Maintenance Treatment” as a first stage effort. These recommendations have been listed in the text of this News Report. The recommendations include criteria for the participating treatment program, physicians and patient referrals.

The Association believes that stable patients should be given treatment options, including a referral from a methadone treatment program to an office-based practice. It is recognized that some patients may not choose such an option, however, we believe that such alternatives should be made available. Medical Maintenance operations currently exist in New York State and Maryland.

Research indicates that approximately 7% or 12,530 of the existing methadone maintenance population (179,000) would be eligible for referral to medical maintenance treatment. Our Association does not support the policy of having physicians involved in treating newly admitted patients, which have not been referred through a hub referral site, especially where treatment is available at an established methadone treatment program.

We have also urged the federal agencies to develop a series of technical assistance documents to assist programs with different patient census sizes throughout the country. Such publications would serve as “how to” documents, including model policy procedure manuals, model diversion management plans, model quality assurance packages in addition to other elements of the accreditation system.

The NPRM also raises the issue of lifting the prohibition of LAAM take home dosages. We support removing such a prohibition since we now have more than five years of experience in administering LAAM to patients in methadone treatment programs.

We have also supported the NPRM’s intent to provide greater clinical flexibility in determining take home dosages for patients, who have met the criteria under current federal law, ensuring stability prior to giving any take home medication. The Association has opted to support the second variation, which was proposed in the NPRM, allowing individual methadone treatment programs to dispense take home medication for up to fourteen days following one year of treatment and up to a thirty-one day supply following two years of treatment, providing that the patient has met the criteria as stipulated in the Proposed Rule.

In summary, the Association supports the federal government’s intent to shift regulatory oversight away from process oriented regulations to outcome oriented accreditation standards of care. We have urged the federal government not to create a two tiered system of regulatory oversight holding methadone treatment programs accountable to accreditation standards and individual practitioners to a lesser standard of care. We believe that the development of such a two tiered system would create instability throughout the entire system of treatment and would be counter to the intent of the Proposed Rule.

We are also hopeful that individual states will either adopt accreditation standards or accept the results of accreditation surveys in lieu of their own state regulatory inspections as a means of avoiding duplication of effort and cost.

Finally, we view the Proposed Rule as only one piece of a federal strategy to increase access to care, to improve the quality of care currently offered, to expand new opportunities for patients and to educate the public about the value of methadone treatment. Accrediting methadone treatment programs will not significantly increase access to care. An infusion of funds at the federal and state levels of government is required to improve treatment access and quality.

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