Daily Rules, Proposed Rules, and Notices of the Federal Government

• Home
• Departments
• Agencies
• Dates

Top Searches

Popular Sites

Common CFR Searches

Federal Register: January 17, 2001 (Volume 66, Number 11)

DOCID: FR Doc 01-723

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Veterans Affairs Department

CFR Citation: 21 CFR Part 291

Docket ID: [Docket No. 98N-0617]

RIN ID: RIN 0910-AA52

NOTICE: Part II

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY:

Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction;

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

DOCUMENT 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.

SUMMARY:

Department of Health and Human Services, Substance Abuse and Mental Health Services Administration,

SUPPLEMENTAL INFORMATION

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 processoriented 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 ``stateoftheart'' 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 processoriented regulations. These processoriented 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 31day supply. Under the current regulations, patients are limited to a maximum 6day 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,
[[Page 4077]]
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 accreditationbased 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 processoriented 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 SAMHSAadministered accreditation based regulatory system will encourage the use of bestpractice 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 uptodate bestpractice 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 ``stateoftheart'' 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 uptodate information indicates that the cost estimates in the July 22, 1999, notice are uptodate 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 accreditationbased 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 35 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 $45 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 underserved 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 careincluding 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 accreditationbased 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 uptodate 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 followup 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 processoriented 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 FederalState 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
[[Page 4079]]
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. OfficeBased Treatment. The July 22, 1999, proposal discussed the concept of ``officebased opioid treatment'' and specifically solicited comments on how the Federal opioid treatment standards might be modified to accommodate officebased treatment and on whether a separate set of Federal opioid treatment standards should be included in this rule for officebased treatment.

The Secretary received many diverse comments on the officebased treatment issue. Several comments from patients and individual physicians believed that officebased 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 officebased treatment, others feared that different standards would result in a twotiered system of treatment. Overall many comments stated that existing and proposed rules do not facilitate the development of the officebased 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 ``officebased'' 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 officebased practice. These comments suggest that based on the available information, officebased treatment warrants a gradual, stepwise 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 officebased 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 officebased setting. Medical maintenance refers to the treatment of stabilized patients with increased amounts of takehome 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 onemonth 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 programwide exemptions under 21 CFR 291.505; however, SAMHSA/CSAT envisions a similar approach will be used under the programwide exemption provisions of 42 CFR 8.11(h).

Under the medical maintenance model, officebased 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 officebased 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.

B. Comments on Subpart ADefinitions and Accreditation

Proposed subpart A sets forth definitions as well as procedures, criteria, responsibilities and requirements relating to accreditation.

1. A comment from a State authority suggested that the treatment plan definition under Sec. 8.2 should be modified to require a reference to the services determined necessary to meet the goals identified in the plan. The Secretary agrees with this suggestion and has revised the treatment plan definition accordingly.

2. One comment suggested that the proposed definition of detoxification treatment specifies agonist and therefore precludes the use of mixed agonist or agonists in combination with other drugs. The Secretary has announced plans to develop new rules specifically for partial agonist medications for the treatment of opiate addiction (See 65 FR 25894, May 4, 2000). Therefore, use of the term ``agonist'' is appropriate in this context.

The use of ``other drugs'' (interpreted to mean nonnarcotic substances) in combination with methadone and LAAM are not subject to the regulatory requirements of this rule.

[[Page 4080]]

3. Several comments were submitted on the proposed definition of opiate addiction. Some comments suggested that the definition should be revised to remove behaviororiented concepts and rely on medical constructs only. One comment suggested substituting the definition of opiate addiction contained in the recent NIH consensus panel report. The Secretary concurs, and has revised the definition of opiate addiction to be more consistent with the recent NIH Consensus panel's recommendations.

4. A few comments were concerned that there would be only two accreditation bodies, CARF and JCAHO. In addition, these comments reflect concern that accreditation would be an additional requirement on top of existing FDA regulations.

As proposed in the July 22, 1999, notice (section 8.3(a)) any private nonprofit organization, State governmental entity, or political subdivision thereof, capable of meeting the requirements of subpart A is eligible to apply to become an accreditation body under the new rules. As discussed elsewhere in this final rule, some State authorities have contacted SAMHSA and expressed interest in becoming an accreditation body under subpart A. In addition, a number of non governmental entities have expressed similar interest. Accordingly, the Secretary believes that there will be more than two accreditation bodies that seek and obtain approval to become an accreditation body under these rules.

The requirements for accreditation and SAMSHA certification under this final rule will replace the requirements for FDA approval of OTPs under previous regulations. The previous regulations in place under 21 CFR 291.505 will be rescinded on March 19, 2001.

5. The Secretary received a considerable number of diverse comments from State authorities, OTPs, and patients on the provision proposed under section 8.3(a) that would permit States to serve as accreditation bodies under the new rules. The preamble to the July 22, 1999, notice emphasized the need for States to consider serving as accreditation bodies. This emphasis was based upon the recommendation in the IOM Report that strongly suggested that the Federal Government design a consolidated inspection system that reduces the burden on OTPs from multiple (Federal, State, local) inspections.

State authorities provided a mixed response in their comments on this issue. As discussed below, several States expressed an interest in becoming accrediting bodies under the new rules but believed that they were ineligible because they could not accredit 50 OTPs a year under proposed section 8.3. On the other hand, many States indicated that they were not interested in becoming accreditation bodies, while several indicated that they were undecided and would await additional information.

Comments from OTPs, for the most part, reflect a longstanding cooperative relationship with State regulatory authorities. OTPs, in general, did not appear to oppose the concept of State authorities serving as accreditation bodies under the proposed new system. Indeed, some OTPs, located within States that assess extensive licensing fees, commented that it would be imperative that States take on the role of accreditation bodies under the new system in order to eliminate the financial impact of licensing and accreditation fees.

Comments from patients on this issue suggested caution. Many patients sensed that State regulators would retain strict, ``process oriented'' regulations or philosophies. These comments urged that if SAMHSA permitted States to serve as accreditation bodies then the agency should carefully monitor accreditation standards and practices to assure that they conform with the Federal opioid treatment standards.

After considering the comments on this issue, the Secretary is retaining the provision that allows States to serve as accreditation bodies under the new rules. The Secretary acknowledges that many States will choose not to participate as accreditation bodies. Some of these States already accept accreditation by recognized accreditation bodies for licensing purposes. It is expected that more States, especially States with relatively few OTPs, will also choose to accept accreditation as meeting State licensure requirements in time. Indeed, legislation enacted recently in New Hampshire to allow methadone maintenance treatment incorporated a requirement for CARF accreditation (Ref. 2). Finally, some States will apply accreditation reviews and findings to complement their licensing activities. The Secretary recognizes that the States' role in adapting to the new system will change over time as additional information on accreditation is developed.

The Secretary believes that there are adequate safeguards to address patient concerns about overly restrictive State regulations and oversight. Under section 8.3(b)(3), SAMHSA will review each applicant accreditation body's proposed accreditation standards. As part of this review, SAMHSA will determine the extent to which the accreditation standards are consistent with the Federal opioid treatment standards. In addition, under section 8.5, SAMHSA will evaluate periodically the performance of accreditation bodies by inspecting a selected sample of the OTPs accredited by the accreditation body. As part of this effort SAMHSA may also consider followup inspections in cases where accreditation activities identify public health, public safety, and patient care issues.

The Secretary continues to believe, as outlined in the July 22 proposal, that there are benefits to States serving as accreditation bodies under this rule. This feature provides the potential to reduce the overall number of OTP inspections. It also permits the use and application of the vast expertise available within many State oversight agencies.

6. A number of State authorities and an accreditation body questioned the restriction under proposed section 8.3(b)(3) that would require accreditation bodies to be able to survey no less than 50 OTPs annually. Some comments contend that this would unfairly and inappropriately exclude smaller States or States with fewer OTPs from participating. These comments suggested that other requirements should be considered and applied or a waiver provision added. One accreditation body commented that accreditation bodies recognized by the Health Care Financing Administration are not subject to such arbitrary limitations. Other comments suggested that the 50 survey per year minimum was not necessary to achieve its stated purposeto ensure the quality of accreditation services and minimize the variability of accreditation standards.

The Secretary concurs with these comments. The provisions of section 8.3(b)(3) (submission and review of proposed accreditation standards) and section 8.5 (periodic evaluation of accreditation bodies) are adequate to enable SAMHSA to ensure the quality of accreditation services and minimize the potential variability in accreditation standards. Accordingly, section 8.3(b) has been modified to remove this requirement.

7. A few comments suggested that State authorities and patient advocates should be permitted to participate in the approval of accreditation bodies under the new rules and in the accreditation process in general. These comments believe that they can make substantial contributions to the process.

The Secretary agrees that patients and State authorities can contribute
[[Page 4081]]
substantially to the successful operation of the new system. State authorities and patients have participated in the committees that have developed SAMHSA/CSAT's Accreditation Guidelines. In addition, representatives from both these groups have served on the Accreditation Subcommittee of the SAMHSA/CSAT National Advisory Council. Accreditation standards include several provisions designed to solicit and consider individual patient views regarding treatment planning and other areas. Some, though not all, accreditation bodies also have patient hotlines that allow patients to convey concerns directly to accreditation bodies. Finally, SAMHSA and State authorities will continue to consult and interact under the new rules. The Secretary believes that these measures are adequate to assure the appropriate level of State authority and patient input into the accreditation process.

8. Several comments addressed proposed section 8.3(b)(6), pertaining to the qualifications of accreditation body personnel and proposed section 8.4(h) on accreditation teams. One State authority objected that the requirement that there be a licensed physician on the accreditation body staff was an unnecessary expense to accreditation bodies. Another comment recommended that accreditation teams should include a physician certified for dispensing opioids. Some patients advocated that the accreditation team should include a current patient.

The Secretary believes the requirements for accreditation personnel and accreditation teams as set forth in the July 22, 1999, proposal are sufficient. It is not clear that every OTP would benefit from having a physician or opioid agonist patient on the accreditation team. The Secretary has reviewed the results of accreditation surveys under the SAMHSA/CSAT methadone accreditation project. Based on these reviews, the requirements set forth under section 8.4(h) are adequate to assure that accreditation bodies carefully consider the qualifications of accreditation surveyors and accreditation teams.

9. A considerable number of comments were submitted, mostly by State authorities, concerning the absence of a definition for State authority. These comments suggested that adding a definition for state authority could reduce confusion in States that serve as accreditation bodies. In addition, these comments reflect a belief that this change would help clarify the FederalState consultation process set forth in the proposed rule. The Secretary agrees with these comments and has added a definition of State Authority. This definition tracks closely with the definition contained in the previous regulations under section 21 CFR 291.505.

C. Subpart BCertification

Subpart B establishes the criteria and procedures for the certification of OTPs. This section also addresses the conditions for certification and the interaction between the Federal Government and State authorities under the new rules.

1. Many comments from State regulators noted that there was no reference to a requirement that OTPs obtain a license or permit from States before receiving certification from the Federal Government. These comments reflect a concern that SAMHSA may certify a program in a State where no methadone authority exists, or without the knowledge of the State authority. Other comments urged Federal certification to pre empt State licensing, noting that ``initial State approval will remain a de facto requirement.''

The Secretary believes that the conditions for certification as set forth in the July 22, 1999, proposal, including the provisions relating to State licensure, are adequate and appropriate to fulfill the objectives of this rule. The Secretary's role in the oversight of narcotic treatment is to set standards for the appropriate use of narcotic drugs in the treatment of addiction, and then to ensure compliance with those standards. The States, on the other hand, have a broader set of responsibilities, including regional and local considerations such as the number and distribution of treatment facilities, the structural safety of each facility, and issues relating to the types of treatment services that should be available. Nothing in this part is intended to restrict State governments from regulating the use of opioid drugs in the treatment of opioid addiction. The Secretary notes that many States exercise this authority by choosing not to authorize methadone treatment at all.

The Secretary does not believe that OTPs will open and begin treating patients without State notification, review, and approval. The Secretary has been careful to state throughout this rule that OTPs (including medication units) must comply with all pertinent State and local laws as a condition of Federal certification. As such, OTPs will also be responsible for assuring that they have the necessary approvals and licensure at the State. Moreover, OTPs must obtain DEA registration prior to accepting opioid addiction treatment drugs for the treatment of opiate addiction. DEA registration is explicitly contingent upon State authority approval. Importantly, as noted below, there will be extensive consultation, coordination, and cooperation between SAMHSA and relevant State authorities.

2. One State regulator requested that the regulation be modified at section 8.11(c)(1) to add a requirement that SAMSHA notify the State upon receipt of applications for certification as well as approval and withdrawal. This comment was based upon a concern that provisionally certified programs could operate without a State's knowledge.

The Secretary agrees that it is imperative for States to be notified of significant certification activities, including new program applications, program suspensions and withdrawals. SAMHSA intends to notify States of all such developments under the provisions of section 8.11(c)(1). The Secretary believes that the rules are sufficiently clear on this point.

3. Some State authorities suggested revising proposed section 8.11(h), which states that SAMHSA ``may'' consult with State authorities prior to granting exemptions from a requirement under sections 8.11 or 8.12.

Section 8.11(h) permits OTPs to request exemptions from the requirements set forth under the regulation. This represents a continuation of a longstanding provision from the previous regulation under 21 CFR 291.505. The Secretary anticipates that most exemption requests under the new rule will be to permit variations from the treatment standards, including programwide exemptions for medical maintenance. The Secretary agrees that it is appropriate and necessary to consult with State authorities on requests for variations from existing standards. Accordingly, section 8.11(h) is revised to require consultation with the State authority prior to granting an exemption.

4. Several comments from patients suggested that Federal regulations should prevent States from imposing additional regulatory requirements beyond the Federal regulations. Many of these comments contend that State regulations prevent treatment expansion, hinder accountability for quality treatment, limit patient access, and lead to patient abuses.

As noted above, the Secretary acknowledges the authority within State government to regulate the practice of medicine. This rule does not preempt States from enacting regulations necessary to carry out these important responsibilities.

[[Page 4082]]

Many State regulations closely resemble the previous Federal regulations under 21 CFR 291.505. In addition, many States are currently reevaluating their regulations to determine if modifications are necessary to reflect the changes in Federal rules. The Secretary encourages States to consider the new information on changes in the opioid addiction treatment field, including phases of treatment, measuring accountability for improving the quality of patient care, and modern medication dosing practices, as States proceed in revising their regulations.

The Secretary also invites States to continue to enhance their partnership with Federal authorities in this area. As noted above, the final rule includes a new featurethe opportunity for States to serve as accreditation bodies. This new activity adds to existing partnership opportunities, such as the participation in the SAPT Block Grant program and its related technical assistance program. The Secretary hopes that these actions collectively will continue the regulatory reform started with the July 22, 1999, proposal.

5. A few comments expressed concern about proposed section 8.11(e), which permits provisional certification for one year, while a program obtains accreditation. These comments believe that one year was ``too long for a program to go without accreditation.''

The Secretary believes that the maximum 1year term (not including the 90day extension allowed under section 8.11(e)(2)) for provisional certification is reasonable and customary with accreditation in other areas of healthcare. The purpose of this provision is to permit new OTPs to initiate operations and generate patient records to aid in the accreditation application, survey, and review process. It should be noted that OTPs will be subject to SAMHSA, DEA, and State oversight during the tenure of provisional accreditation. These OTPs must comply with Federal opioid treatment regulations and are subject to compliance actions at any time.

6. Section 8.11(i)(2) proposed that certification as an OTP would not be required for the maintenance or detoxification treatment of a patient who is admitted to a hospital or longterm care facility for the treatment of medical conditions other than addiction. One comment noted that, as written, patients admitted to hospitals for cocaine or alcohol addiction would not be eligible for treatment under this provision. The comment suggested that adding the word ``opioid'' before ``addiction'' would help to clarify this issue. The Secretary concurs and the section 8.11(i)(2) has been changed to reflect this change. D. Subpart BTreatment Standards

1. A number of comments were submitted on proposed section 8.12 in general. These comments stated that the Federal Opioid Treatment standards are vague and lack specificity. As such, these comments contend that the standards are unenforceable as regulations. One comment suggested that the SAMHSA/CSAT Accreditation Guidelines be incorporated as regulations.

The Secretary believes that the Federal Opioid Treatment Standards are enforceable, and do not need to be modified to accomplish their purpose under the new rules. The July 22, 1999, proposal noted that in the past, HHS has attempted to write all facets of treatment, including required services, into regulation. In addition, the proposal acknowledged that it is now accepted that (a) different patients, at different times, may need vastly different services, and (b) the state of the clinical art has changed, to reflect scientific developments and clinical experience, and is likely to continue to change and evolve as our understanding of more effective treatment methods increases. Accordingly, the Secretary proposed a more flexible approach with a greater emphasis on performance and outcome measurement. With guidance from SAMHSA, the accreditation bodies will develop the elements needed to determine whether a given OTP is meeting patient needs for required services. SAMHSA will review these elements as part of the accreditation body's initial and renewal applications to ensure that accreditation bodies have incorporated the Federal opioid treatment standards into their accreditation elements. SAMHSA will also review accreditation body elements to ensure that the elements do not exceed Federal expectations in terms of opioid agonist treatment. Incorporating accreditation guidelines into regulations would subvert this approach.

As noted in the July 22, 1999, proposal, the Secretary believes that the standards are ``enforceable regulatory requirements that treatment programs must follow as a condition of certification (64 FR 39810, July 22, 1999).'' While the new regulations increase the flexibility and clinical judgement in the way OTPs meet the regulatory requirements, they are set forth under section 8.12 as the services, assessments, procedures, etc., that OTPs ``must'' and ``shall'' provide. As such, the new standards are as enforceable as the previous regulations under 21 CFR 291.505. OTPs that do not substantially conform with the Federal Opioid Treatment standards set forth under section 8.12 will risk losing SAMHSA certification.

2. One comment recommended that proposed section 8.12(b) should be modified to require a standard that OTPs should have adequate facilities. The comment stated that this provision existed in the previous regulation. The Secretary agrees and has added a requirement that OTP's must maintain adequate facilities. The Secretary notes, however, that SAMHSA/CSAT accreditation guidelines and accreditation standards used in the SAMHSA accreditation impact study, address the adequacy of the OTP's facility. These accreditation standards, in conjunction with treatment outcomes, will help determine whether facilities are adequate under the new rules.

3. One comment addressed proposed section 8.12(b), stating that rules should expressly require compliance with civil rights laws, not just ``pertinent'' Federal laws. As such, the comment suggests that the standards should require detailed patient grievance procedures, including appeals to neutral parties. The Secretary believes that it is not necessary to modify the rule to reflect civil rights laws specifically. These laws are included under the requirement as written. In addition, SAMHSA/CSAT Accreditation Guidelines, as well as the accreditation standards developed from them include provisions for accepting and acting upon patient grievances.

4. A number of respondents commented on proposed section 8.12(d) which addresses OTP staff credentials. Under the July 22, 1999, proposal, the Secretary proposed that each person engaged in the treatment of opiate addiction must have sufficient education, training, or experience or any combination thereof, to enable that person to perform the assigned functions. Further, all licensed professional care providers must comply with the credentialing requirements of their professions. The proposal encouraged, but did not require, that treatment programs retain credentialed staff.

Some comments requested that this standard be clarified to require American Society of Addiction Medicine (ASAM)certified medical professionals. Another comment questioned whether personnel had to be licensed in the State where the treatment program is located. Another comment from a State Authority, recommended that the regulations [[Page 4083]]
specify the license, training, experience, as well as the number of licensed counselors in a program, including a minimum counselorto patient ratio. On the other hand, an OTP medical director commented that none of the cited credentials ``conferred competence in dealing with opioid dependent patients, per se.'' According to this comment, SAMHSA/CSAT should instead develop curricula for medical directors and other care givers.

Except for the requirements of section 8.12(h), which relate to the qualifications for practitioners who administer or order medications, the Secretary does not believe that it is appropriate to further prescribe the qualifications for health professionals in this regulation. Under sections 8.12(b), (d), (e), (f) services must be provided by professionals qualified by education and training. The Secretary does not believe that one credentialing organization should be specified as a requirement for qualifications. Instead, the Secretary intends to rely on guidelines and accreditation standards together with patient outcome assessments to determine the adequacy of training and education level of professionals in OTPs. SAMHSA/CSAT is actively developing model training curricula in this area.

5. A few comments suggested that the regulations specify the outcome measures for quality assessment plans under section 8.12(c)(1). Similarly, some comments suggested that diversion control plans, which OTPs are required to develop under section 8.12(c)(2), should also be spelled out in regulations.

The Secretary believes that the regulation as proposed provides sufficient detail on outcome measures and diversion control plans. In keeping with the intent of the regulation reform, these general requirements are elaborated in bestpractice guidelines and in ``state oftheart'' accreditation standards. Indeed, following a review of the accreditation standards that are based upon SAMHSA/CSAT's opioid treatment accreditation guidelines, the Secretary has determined that they are adequate to ensure that OTPs will be able to develop meaningful outcome assessment and diversion control plans. In addition, these SAMHSA/CSAT accreditation guidelines and accreditation standards reflect the latest research findings in this area. Unlike the Federal regulations, these guidelines and standards will be updated periodically to reflect new research and clinical experience.

6. The Secretary received a considerable number of comments on the proposed definition and the standards for shortand longterm detoxification treatment. Most of these comments suggested that the word ``detoxification'' is a pejorative nonmedical term and does not constitute treatment, because few, if any, patients can be stabilized in such a short period of time. These comments suggested that all references to detoxification should be deleted from the regulations, or at least renamed.

These comments fail to recognize the distinction between opiate dependence, for which detoxification treatment is appropriate, and opiate addiction, for which maintenance treatment is appropriate. The Narcotic Addiction Treatment Act of 1974 (NATA) and regulations have long recognized these distinctions. While a majority of the available treatment research, including recent studies, concludes that maintenance treatment is much more effective than detoxification regimens, the Secretary believes that it is still necessary to retain distinct standards for maintenance and detoxification treatment (Ref. 3).

7. Several comments were submitted in response to the Secretary's specific request for comments on proposed section 8.12(e)(4) which set forth minimum requirements for detoxification treatment. The July 22, 1999, proposal retained the requirement from the existing regulation that ``a patient is required to wait no less than 7 days between concluding one detoxification episode before beginning another.'' Essentially, while sympathetic to the need for limits on detoxification treatment, all the comments on this item opposed continuing any waiting period between detoxification episodes. These respondents believe that seven days is ``artificial * * * or more time than is needed.'' In addition, these comments indicate that OTPs often request and are granted exemptions from the waiting period requirement under the existing regulation, creating an unnecessary paperwork burden for OTPs, as well as State and Federal regulators. Instead, the comments suggested a limit on the number of unsuccessful detoxification episodes in one year before the patient is assessed for opioid agonist maintenance or other treatment. In addition, these comments recommended that an unsuccessful detoxification attempt be defined to include any relapse to abuse.

The Secretary agrees with the recommendations that the intent of the restrictions on detoxification can be accomplished without a mandated time interval between detoxification admissions. The standards for detoxification treatment set forth under section 8.12(e)(2) and (4) have been revised to state that patients with two or more unsuccessful detoxification episodes within a 12month period must be assessed by the OTP physician for other forms of treatment. This change is consistent with SAMHSA/CSAT accreditation guidelines which also elaborate on unsuccessful detoxification treatment attempts.

8. A considerable number of diverse comments addressed proposed section 8.12(f) relating to required services. This section of the July 22, 1999, proposal requires that ``adequate medical, counseling, vocational, educational and assessment services are fully and reasonably available to patients enrolled in an OTP.''

Two comments strongly recommended that the regulation require integrated, simultaneous treatment by specially crosstrained staff, for cooccurring opioid treatment and mental illness. These respondents believe that integrated services for persons with an addiction(s) and a psychiatric disorder are crucial. These duallydiagnosed patients represent 5080 percent of substance dependent populations.

The Secretary agrees with the importance of providing adequate integrated services for opiateaddicted patients who also suffer from psychiatric disorders. Indeed, the SAMHSA/CSAT Accreditation Guidelines, along with the accreditation standards developed by CARF and JCAHO all address the need to evaluate patients for cooccurring illnesses, including mental illness. CARF Opioid Treatment Program Accreditation Standards state that services for cooccurring illness should be provided on site or by referral. However, the same standards note that ``coexisting conditions, especially in persons from disenfranchised populations, are most effectively treated at a single site.'' The Secretary takes note that these provisions for cooccurring disorders under these new rules will be a vast improvement over the previous regulatory system, which did not address cooccurring opiate addiction and psychiatric disorders at all. As such, under the new rules, patients' access to effective treatment for cooccurring disorders will be enhanced substantially. However, the Secretary believes that it would be prohibitively expensive to require every OTP to hire and retain specialists in the treatment of cooccurring disorders.

Other comments on this section stated that the regulations should specify a schedule for services. Some comments
[[Page 4084]]
recommended that the regulations require OTPs to document that patients actually receive services when they are referred to offsite providers. Other comments suggested that accreditation bodies should monitor the extent to which services are provided as part of their periodic onsite surveys. Still other comments, mostly from patients, suggested the requirement for services be eliminated, maintaining that medication is all they needed.

The Secretary believes that the requirements for services as stated in the July 22, 1999, proposal, together with the accreditation process, provide adequate assurance that patients enrolled in OTPs receive the services that they have been assessed to need. The July 22, 1999, proposal emphasized the need for these services as an essential part of treatment. However, in shifting to an accreditation approach with an emphasis on performance outcomes, the Secretary was no longer attempting to ``write all facets of these required services into regulation.'' OTPs must initially and periodically assess each patient and ensure that adequate services are available to patients determined to need them. SAMHSA/CSAT Accreditation Guidelines and accreditation standards will elaborate on the standards for services. OTPs will be accountable through the accreditation process to assure that patients receive the appropriate services they need for successful treatment outcomes; for some patients, medication services may be sufficient to produce positive outcomes.

9. A number of respondents submitted comments on proposed section 8.12(f)(2), which requires a complete medical examination within the first 30 days following admission. Some of these comments noted that this provision, as proposed, permitted patients to enter treatment while tests, some of which required several days, are completed. Others commented that the 30 days was too long to wait for a medical exam to be completed, noting that information from the exam is crucial to the first few days of treatment. Finally, some comments suggested that regulations should specify the contents of the medical exam.

The intent of proposing 30 days for the completion of the physical exam was to allow patients into treatment while OTPs wait for the results of serology and other tests that require, in some cases, several days to complete. Section 8.12(f)(2) has been revised to clarify the requirement for a physical exam upon admission, with serology and other tests results completed w/in 14 days. The Secretary does not agree that regulations should specify the contents of the medical examination. Instead, the Secretary believes that accreditation guidelines should express the stateoftheart content for a medical exam appropriate for the treatment of opiate addiction.

10. The July 22, 1999, notice proposed that OTPs conduct at least eight random drug abuse tests per year for each patient. Many comments suggested that the Federal standards specify more frequent drug abuse tests, including weekly testing, to balance the more flexible proposed takehome schedule. Other comments suggested that Federal regulations should specify measures to prevent adulteration. On the other hand, some comments suggested that quarterly drug abuse testing is appropriate. Moreover, one comment recommended substituting an ``honor system'' because patients can corrupt the testing process and falsify results.

After considering the comments on this issue, the Secretary is retaining the requirement for a minimum of eight random drug abuse tests per year for maintenance treatment. The Secretary believes that this is an adequate and balanced standard for drug abuse testing. There is extensive discussion on drug abuse testing issues in the SAMHSA/CSAT Treatment Improvement Protocols and the SAMHSA/CSAT Accreditation Guidelines. In addition, these guidelines elaborate on measures to address the corruption and falsification of results. Finally, as the Federal standard is a minimum, OTPs can require more frequent tests if desired.

11. The Secretary received many comments on proposed section 8.12(g)(2) which requires OTPs to determine and document that patients are not enrolled in other programs. Most respondents question how such determinations could be made without a patient registry. One comment stated that multiple enrollments are attributable to inadequate medication dosing practices.

The July 22, 1999, proposal retained the provisions relating to multiple enrollments from the previous regulations under 21 CFR 291.505. In proposing to retain the requirement, the Secretary noted that there have been cases of patients enrolling in more than one treatment program; however, the extent of this practice is undetermined but not considered to be widespread. The intent of this provision is for OTPs to make a good faith effort, using available resources and mechanisms to ascertain whether or not a prospective patient was currently enrolled in another OTP. Some individual States with OTPs concentrated within a community have established a patient registry and require OTPs to report new patients and patients who have discontinued in treatment. In other jurisdictions, patient registries are developed and maintained voluntarily by OTPs. OTPs also often contact other OTPs in the vicinity to determine if the patient is currently enrolled in an OTP, or they ask the patient. If used, these mechanisms must be used in accordance with the provisions at 42 CFR 2.34, regarding disclosures to prevent multiple enrollments. The Secretary acknowledges that none of these mechanisms can determine with complete certainty whether or not a patient is enrolled in more than one OTP. Accordingly, the Secretary expects that OTPs will document in each patient's record that the OTP made a good faith effort to review whether or not the patient is enrolled in any other OTP. Section 8.12(g)(2) has been revised accordingly.

12. The Secretary received many comments on proposed section 8.12(j), relating to interim methadone maintenance. Most of these comments were from patients who suggested interim maintenance as a model for long standing patients who have been stabilized in treatment. As such, these comments suggested that the term for interim methadone maintenance be extended beyond 120 days.

These comments reflect a misunderstanding of interim methadone maintenance. Interim methadone maintenance was mandated by the ADAMHA Reorganization Act of 1992 as a measure to address shortages in treatment capacity and documented waiting lists (Pub. L. 102321, See also 58 FR 495, January 5, 1993). The legislation included several restrictions which were incorporated and retained into Federal regulations. Although very few programs have applied for authorization to provide interim methadone maintenance, the Secretary does not at this time believe it is necessary or appropriate to change the standards. Instead, as discussed elsewhere in this notice, the Secretary believes that medical maintenance provides a more reasonable approach for expanding treatment capacity.

13. The Secretary received comments on proposed sectio

FOR FURTHER INFORMATION CONTACT

Nicholas Reuter, Center for Substance Abuse Treatment (CSAT), SAMHSA, Rockwall II, 5600 Fishers Lane, Rm 12 05, Rockville, MD 20857, 3014430457, email: nreuter@samhsa.gov.