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Other Agencies of Interest

[Federal Register: January 17, 2001 (Volume 66, Number 11)]
[Rules and Regulations]
[Page 4075-4102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]


Substance Abuse and Mental Health Service Administration

21 CFR Part 291
42 CFR Part 8
[Docket No. 98N-0617] 
RIN 0910-AA52

Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction;

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Final rule.

SUMMARY: The Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. This final rule repeals the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and creates a new regulatory system based on an accreditation model. In addition, this final rule shifts administrative responsibility and oversight from FDA to SAMHSA. This rulemaking initiative follows a study by the Institute of Medicine (IOM) and reflects recommendations by the IOM and several other entities to improve opioid addiction treatment by allowing for increased medical judgment in treatment.

DATES: This final rule will become effective on March 19, 2001.

FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance Abuse Treatment (CSAT), SAMHSA, Rockwall II, 5600 Fishers Lane, Rm 12- 05, Rockville, MD 20857, 301-443-0457, email: nreuter@samhsa.gov.


I. Background

In the Federal Register of July 22, 1999, (64 FR 39810, July 22, 1999, hereinafter referred to as the July 22, 1999, notice or July 22, 1999, proposal) SAMHSA, FDA, and the Secretary, Health and Human Services (HHS), jointly published a Notice of Proposed Rulemaking (NPRM) to revise the conditions for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. The agencies also proposed the repeal of the existing narcotic treatment regulations enforced by the FDA, the creation of a new regulatory system based on an accreditation model under new 42 CFR part 8, and a shift in administrative responsibility and oversight from FDA to SAMHSA.

The July 22, 1999, notice traced the history of Federal regulatory oversight of Opioid Treatment Programs ("OTPs," also known as narcotic treatment programs, or, methadone programs), focusing on Federal regulations enforced by FDA since 1972. The July 22, 1999, notice summarized the periodic reviews, studies, and reports on the Federal oversight system, culminating with the 1995 Institute of Medicine (IOM) Report entitled, Federal Regulation of Methadone Treatment (Ref. 1). As noted in the July 22, 1999, proposal, the IOM report recommended that the existing FDA process-oriented regulations should be reduced in scope to allow more clinical judgment in treatment and greater reliance on guidelines. The IOM report also recommended designing a single inspection format, having multiple elements, that would (1) provide for consolidated, comprehensive inspections conducted by one agency (under a delegation of Federal authority, if necessary), which serves all agencies (Federal, State, local) and (2) improve the efficiency of the provision of methadone services by reducing the number of inspections and consolidating their purposes.

To address these recommendations, SAMHSA proposed a "certification" system, with certification based on accreditation. Under the system, as set forth in the July 22, 1999, proposal, a practitioner who intends to dispense opioid agonist medications in the treatment of opiate addiction must first obtain from SAMHSA, a certification that the practitioner is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification will depend upon the practitioner obtaining accreditation from a private nonprofit entity, or from a State agency, that has been approved by SAMHSA to accredit OTPs. Accreditation bodies would base accreditation decisions on a review of an application for accreditation and on surveys (on site inspections) conducted every three years by addiction treatment experts. In addition, accreditation bodies will apply specific opioid treatment accreditation elements that reflect "state-of-the-art" opioid treatment guidelines. Moreover, accreditation standards will require that OTPs have quality assurance systems that consider patient outcomes.

As noted in the July 22, 1999, proposal, this new system would replace the existing FDA regulatory system. The existing system provides for FDA "approval" of programs, with direct government inspection in accordance with more detailed process-oriented regulations. These process-oriented regulations are less flexible and prescribe many aspects of treatment. The existing regulations do not require that programs have quality assurance systems. Finally, under the existing system, programs are not subject to periodic certification and there is no set schedule for inspections.

Proposed Subpart A addressed accreditation and included steps that accreditation bodies will follow to achieve approval to accredit OTPs under the new system. It also set forth the accreditation bodies' responsibilities, including the use of accreditation elements during accreditation surveys. Proposed Subpart B established the sequence and requirements for obtaining certification. This section addressed how and when programs must apply for initial certification and renewal of their certification. Finally, Subpart C of proposed part 8 established the procedures for review of the withdrawal of approval of the accreditation body or the suspension and proposed revocation of an OTP certification.

In addition to proposing an entirely new oversight system, the July 22, 1999, proposal included several other new provisions. For example, the Federal opioid treatment standards were significantly reduced in scope to allow more flexibility and greater medical judgment in treatment. Certain restrictions on dosage forms were eliminated so that OTPs may now use solid dosage forms. Under the previous rules, OTPs were limited to the use of liquid dosage forms. Several reporting requirements and reporting forms were eliminated, including the requirements for physician notifications (FDA Reporting Form 2633) and the requirement that programs obtain FDA approval prior to dosing a patient above 100 milligrams. The proposal included a more flexible schedule for medications dispensed to patients for unsupervised use, including provisions that permit up to a 31-day supply. Under the current regulations, patients are limited to a maximum 6-day supply of medication. Many of these regulatory requirements had been in place essentially unchanged for almost 30 years.

SAMHSA distributed the July 22, 1999, notice to each OTP listed in the current FDA inventory, each State Methadone Authority, and to other interested parties. Interested parties were given 120 days, until November 19, 1999, to comment on the July 22,

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1999, proposal. In addition, on November 1, 1999, SAMHSA, FDA, the Office of National Drug Control Policy (ONDCP), the Drug Enforcement Administration (DEA), and other Federal agencies convened a Public Hearing on the proposal. The Public Hearing was announced in the Federal Register published October 19, 1999, (64 FR 59624, October 19, 1999), and was held in Rockville, MD. On January 31 and May 10, 2000, the SAMHSA/CSAT National Advisory Council Subcommittee on Accreditation met to assist SAMHSA/CSAT in its review of data and information from SAMHSA/CSAT's ongoing accreditation project. The SAMHSA/CSAT National Advisory Council convened to discuss the opioid accreditation project on May 12, 2000. The May 12, 2000, Council meeting provided an opportunity for comments from the public (65 FR 25352, May 1, 2000).

II. Comments and Agency Response

In response to the July 22, 1999, proposal, SAMHSA received almost 200 submissions, each containing one or more comments. The comments were from government, industry, industry trade associations, academia, health professionals, professional organizations, patient advocacy organizations, and individual patients.

A. General Comments

1. Many comments agreed in principle that the shift to an accreditation-based system will encourage OTPs to use individualized, clinically determined treatment plans that are guided by current, best-practice medical and clinical guidelines and to evaluate clinical outcomes. Other comments noted that the accreditation proposal recognizes that opiate addiction is a medical condition. Several comments affirmed that a major segment of the healthcare system in the United States is being reviewed through accreditation systems. As such, these comments stated that applying accreditation requirements to OTPs provides the potential for mainstream medicine to embrace opioid treatment.

While not opposing the proposal, some comments stated there should be no Federal regulations in this area. Other comments expressed concerns about additional costs to OTPs and, ultimately patients, for accreditation and duplicative assessments, noting that some States will continue to enforce process-oriented regulations, supported by considerable licensing fees. Based upon these "uncertainties," these comments suggest that SAMHSA wait for the results of further study before implementing new regulations.

The Secretary agrees that the SAMHSA-administered accreditation-based regulatory system will encourage the use of best-practice clinical guidelines and require quality improvement standards with outcome assessments. As set forth below, the Secretary does not agree that comments on the uncertainty about accreditation costs or State regulatory activities warrant additional study before implementing these new rules.

2. Several comments addressed the costs associated with accreditation and challenged the estimates provided in the July 22, 1999, proposed rule. One comment included the results from a survey of  OTPs with accreditation experience to indicate the indirect costs of accreditation will be considerable. According to the comment, these OTPs have had to spend considerable sums to hire consultants and additional staff, upgrade computers, develop infection control manuals, and make physical plant improvements. In some cases these costs were reported to approach $50,000. Some of these comments suggested that SAMHSA await the completion of the "accreditation impact study" to obtain additional information on costs, before proceeding. Other comments stated that accreditation can lead to increased treatment capacity, but only if additional funds are provided. One comment suggested that SAMHSA create a capital improvement fund, while another suggested that SAMHSA allow block grant funds to be used to pay for accreditation.

The Secretary believes that the estimated costs as set forth in the July 22, 1999, notice remain reasonably accurate. As discussed in greater detail below, information on accreditation developed under the accreditation impact study, together with other ongoing SAMHSA technical assistance programs, indicates that the accreditation system will not produce an excessive burden to programs to warrant delaying the implementation of this final rule.

There are many components to SAMHSA's accreditation project that have been proceeding concurrently with this rulemaking. In April 1999, SAMSHA's Center for Substance Abuse Treatment (CSAT) issued "Guidelines for the Accreditation of Opioid Treatment Programs." These guidelines are up-to-date best-practice guidelines that are based upon the Federal opioid treatment standards set forth under proposed section 8.12 as well as SAMHSA/CSAT's Treatment Improvement Protocols (TIPs) that address opiate addiction treatment. Two accreditation bodies, the Commission for the Accreditation of Rehabilitation Facilities (CARF) and the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), under contract to SAMHSA/CSAT, used these guidelines to develop "state-of-the-art" accreditation elements. These two accreditation bodies have surveyed dozens of programs with these new accreditation standards.

The July 22, 1999, proposal described an ongoing accreditation impact study. Under the accreditation impact study, CARF and JCAHO trained over 170 participating OTPs. In addition, more than 50 OTPs have been accredited under this system with technical assistance provided through a contract funded by SAMHSA/CSAT. None of the accredited programs have had to incur the kind of "physical plant" and other costly expenses predicted by some of the comments previously discussed. This direct and up-to-date information indicates that the cost estimates in the July 22, 1999, notice are up-to-date and reasonable. On the other hand, the survey discussed above that was submitted with one comment reflected accreditation surveys performed over 10 years ago. And, in some cases, the accreditation experiences discussed in these comments reflect accreditation of psychiatric hospitals, not OTPs.

The accreditation-based system which is the subject of this rule includes safeguards to reduce the risk of unnecessary and overly burdensome accreditation activities relating to OTPs. For example, SAMHSA will approve each accreditation body after reviewing its accreditation elements, accreditation procedures, and other pertinent information. SAMHSA will convene periodically an accreditation subcommittee, as part of the SAMHSA/CSAT National Advisory Council. The subcommittee will review accreditation activities and accreditation outcomes and make recommendations to the full SAMHSA/CSAT Council, and ultimately to SAMHSA on accreditation activities and guidelines. Finally, SAMHSA/CSAT has been providing technical assistance to OTPs in the accreditation impact study that has helped programs in achieving accreditation. SAMHSA/CSAT intends to continue providing technical assistance on accreditation during the 3-5 year transition period and possibly longer.

The Secretary does not agree that it is necessary to establish a special fund to help programs pay for accreditation fees and indirect "physical plant" improvements in order for OTPs to be

[[Page 4078]]

able to achieve accreditation. As noted above, the Secretary believes that the estimates in the July 22, 1999, proposal for the cost of accreditation are reasonably accurate (approximately $4-5 million per year, $5400 per OTP per year, $39 per patient per year). Nonetheless, the Secretary has taken steps to minimize the potential effects of this burden to OTPs, especially to OTPs that are small businesses or that operate in under-served communities. First, the Secretary has determined that States could use funds provided by SAMHSA under their Substance Abuse Prevention and Treatment (SAPT) Block Grants to offset costs of accreditation for programs qualified to receive assistance under the State's SAPT block grant. Second, SAMSHA has included in its budget, a plan to continue funding accreditation. Finally, SAMHSA will continue to provide technical assistance which will aid those programs that need help in achieving accreditation.

3. One OTP that is participating in the accreditation impact study, while commending the accreditation experience and accreditation in general, commented that the proposed change is premature. Some comments suggested that SAMHSA postpone implementation for an indefinite period to allow for an unspecified number of CARF and JCAHO accreditation results. Another comment stated that the first series of surveys will determine the utility of the first generation of standards, noting that the process can be focused and modified in response to results from the impact study. A few comments questioned whether all providers can make the transition.

On the other hand, many comments stated that the field has been subject to regulatory neglect long enough, and that SAMHSA should minimize the delay in finalizing rules. One comment submitted the results of a survey that suggested that as many as 155 OTPs currently need technical assistance in order to provide treatment in accordance with standards and regulations.

The Secretary does not believe that these final regulations should be delayed until the completion of the accreditation impact study. As stated in the July 22, 1999, proposal, the Department of Health and Human Services (HHS) has determined that accreditation is a valid and reliable system for providing external monitoring of the quality of health care--including substance abuse and methadone treatment. The SAMHSA/CSAT study is designed to provide additional information on the processes, barriers, administrative outcomes, and costs associated with an accreditation-based system. In addition, the study is expected to provide important information to allow SAMHSA to keep its guidelines, and its accreditation program, as responsive and up-to-date as possible. Among other things, the study will allow HHS to continuously monitor the monetary costs of accreditation, to ensure that successful OTPs are not precluded from operating by the costs of accreditation, and that patients are not denied treatment based on costs. The full study, which compares a representative sample of OTPs 6 months following accreditation to their baseline status across several variables, will require a few years to complete. Regulations can be modified at any time. If SAMHSA believes that the results of the study merit changes in the regulations, then such changes will be the subject of a future rulemaking.

The Secretary has reviewed preliminary results from the accreditation study by two accreditation bodies, CARF and JCAHO, of almost 10 percent (approximately 80 OTPs) of the entire inventory of approved outpatient OTPs. Well over 90 percent of the OTPs surveyed achieved accreditation under the "methadone specific" accreditation standards. Only a very few programs required a follow-up survey to achieve accreditation. And, to date, only one OTP failed to achieve accreditation. These accreditation outcome results are comparable to the historical compliance rate under the previous FDA process-oriented regulatory system. In addition, these rates correspond to the assumed accreditation resurvey rate stated in the July 22, 1999, proposal for estimating the indirect costs of accreditation.

These accreditation outcome results have been analyzed and presented to SAMHSA/CSAT's National Advisory Council's Accreditation Subcommittee (NACAS). As discussed in the July 22, 1999, proposal, SAMHSA/CSAT augmented NACAS with consultants representing OTPs (both large and small programs), medical and other substance abuse professionals, patients, and State officials. The subcommittee has met twice, on January 31 and May 10, 2000, and the public was provided an opportunity to participate in this advisory process. On May 12, 2000, the SAMHSA/CSAT National Advisory Council urged SAMHSA/CSAT to move expeditiously to finalize the July 22, 1999, proposal.

The Secretary believes that the interim results from the accreditation impact study confirm that the accreditation guidelines, along with the accreditation process itself, are a valid and reliable method for monitoring the quality of care provided by OTPs. The results indicate that most OTPs can achieve accreditation and that treatment capacity has not declined as a result. While SAMHSA intends to continue the study to fulfill its objectives, the Secretary does not believe that it is appropriate or necessary to delay implementation of these new rules until the full study is complete.

4. Many comments, especially from current and past OTP patients, questioned the impact of revised Federal regulations in light of State regulations. These comments contend that State regulations are much more restrictive on medical and clinical practices than Federal regulations, and that State regulatory authorities have expressed little or no interest in changing their regulations or the way State regulations are enforced. Comments from OTP sponsors stated that accreditation costs would add to State licensing fees, which, in some States, exceed several thousand dollars annually.

The Secretary shares the concerns expressed in these comments about State regulations and licensing requirements. Indeed, the July 22, 1999, proposal discussed State licensure and regulatory issues. The proposal also noted that there was considerable variation in the nature and extent of oversight at the State level. Some States have regulations and enforcement programs that exceed Federal regulations. Others have relied exclusively upon FDA and DEA regulatory oversight. An increasing number of States rely on accreditation, by nationally recognized accreditation bodies, for all or part of their healthcare licensing functions.

The Secretary believes that SAMHSA's ongoing coordination activities with States will minimize the impact of Federal-State regulatory disparities upon OTPs. One objective of these activities is to increase State authorities' acceptance of the new accreditation-based system. First, SAMHSA/CSAT's OTP accreditation guidelines were developed by a consensus process that included representation from State Methadone Authorities. In addition, some State officials have accompanied CARF and JCAHO accreditation survey teams to observe site visits. Finally, SAMHSA/CSAT has distributed information on accreditation to each State. This information includes the SAMHSA/CSAT OTP accreditation guidelines, the CARF OTP accreditation standards and the JCAHO OTP accreditation standards. SAMHSA/CSAT convened three national meetings of State officials

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between 1997 and 2000 and intends to continue coordinating activities with State authorities and national organizations such as the National Association of State Alcohol and Drug Abuse Directors (NASADAD).

This final rule includes provisions that would permit any State to apply for approval as an accreditation body and, if approved, accredit OTPs under the new Federal opioid treatment standards. Based on the
above, the Secretary expects that many states will consider OTP accreditation and Federal certification requirements as sufficient to fulfill all or a substantial part of their licensing requirements. Taken together, the Secretary believes that these measures will minimize significantly the existing disparity between Federal and State regulation of OTPs.

5. Office-Based Treatment. The July 22, 1999, proposal discussed the concept of "office-based opioid treatment" and specifically solicited comments on how the Federal opioid treatment standards might be modified to accommodate office-based treatment and on whether a separate set of Federal opioid treatment standards should be included in this rule for office-based treatment.

The Secretary received many diverse comments on the office-based treatment issue. Several comments from patients and individual physicians believed that office-based treatment provided an excellent opportunity to expand opioid agonist treatment. These comments reference opioid treatment delivery systems in other countries and suggest that the U.S. should adopt similar systems. A few comments recommended that community pharmacies be encouraged to dispense methadone and LAAM as "medication units" as a way to make treatment more convenient for patients.

While many comments suggested separate standards for office-based treatment, others feared that different standards would result in a two-tiered system of treatment. Overall many comments stated that existing and proposed rules do not facilitate the development of the office-based practice model. As such, accreditation and certification would be prohibitively expensive for individual physicians.

On the other hand, many comments expressed concerns with the concept of "office-based" treatment and prescribing methadone and LAAM. Many of these comments reflected concern about the lack of trained and experienced practitioners. One comment referenced literature reports that described experiences in Australia and the United Kingdom with deaths from iatrogenic methadone toxicity associated with patients early in treatment. The experiences in these two countries were associated with an accelerated rate of patient admissions and the involvement of new, inexperienced practitioners. One comment cited research on methadone medical maintenance that indicated that approximately 15 percent of the patients treated in physicians offices were referred back to OTPs after "relapsing" to illicit opiate use.

Generally, most comments on this issue stated that there was not enough information on office-based practice. These comments suggest that based on the available information, office-based treatment warrants a gradual, step-wise approach, along with more use of medication units. This approach would serve to "diffuse opioid agonist maintenance treatment into traditional settings."

After carefully considering the diverse comments, as well as other legal and regulatory factors, the Secretary is not including in this rule specific standards that would permit physicians to prescribe methadone and LAAM in office-based settings without an affiliation with an OTP. Instead, until additional information is generated, the Secretary is announcing administrative measures to facilitate the treatment of patients under a "medical maintenance" model.

Current regulations enforced by DEA do not permit registrants to prescribe narcotic drugs, including opioid agonist medications such as methadone and LAAM for the treatment of narcotic addiction (see 21 CFR 1306.07(a)). In addition, the Secretary agrees that, at the present time, there should be some linkage between OTPs and physicians who treat stable patients with methadone and LAAM in their offices to address patients' psychosocial needs in the event of relapse. The Secretary agrees with the comments about the lack of trained and experienced practitioners to diagnose, admit, and treat opiate addicts who are not sufficiently stabilized, without the support of an OTP.

The Secretary has taken steps to facilitate "medical maintenance," that will result in more patients receiving treatment with methadone and LAAM in an office-based setting. Medical maintenance refers to the treatment of stabilized patients with increased amounts of take-home medication for unsupervised use and fewer clinic visits for counseling or other services. First, the "take home" provisions in these rules have been revised from the previous regulations under 21 CFR Sec. 291.505 to permit stabilized patients up to a one-month supply of treatment medication. In addition, SAMHSA/CSAT has developed treatment guidelines and training curricula for practitioners to increase the information and education for practitioners in this area. Finally, SAMHSA/CSAT has issued announcements to the field explaining how patients and treatment programs can obtain authorizations for medical maintenance. These authorizations were developed to address program-wide exemptions under 21 CFR 291.505; however, SAMHSA/CSAT envisions a similar approach will be used under the program-wide exemption provisions of 42 CFR 8.11(h).

Under the medical maintenance model, office-based physicians maintain formal arrangements with established OTPs. Typically, patients who have been determined by a physician to be stabilized in treatment may be referred to office-based physicians. It has been estimated that over 12,000 current patients would be eligible for medical maintenance treatment. The Secretary believes that this is a reasonable approach that will expand treatment capacity gradually while additional information and experience is developed to evaluate and refine office-based treatment models.

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