Diversion Control Division, US Department of Justice, Drug Enforcement Administration

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Other Agencies of Interest

B. Comments on Subpart A--Definitions 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 § 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 non-narcotic substances) in combination with methadone and LAAM are not subject to the regulatory requirements of this rule.

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3. Several comments were submitted on the proposed definition of opiate addiction. Some comments suggested that the definition should be revised to remove behavior-oriented 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 follow-up 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 purpose--to 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

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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 Federal-State 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 B--Certification

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 long-standing 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 program-wide 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 pre-empt States from enacting regulations necessary to carry out these important responsibilities.

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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 feature--the 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 1-year term (not including the 90-day 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 long-term 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 B--Treatment 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

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specify the license, training, experience, as well as the number of licensed counselors in a program, including a minimum counselor-to-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 best-practice guidelines and in "state-of-the-art" 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 short-and long-term detoxification treatment. Most of these comments suggested that the word "detoxification" is a pejorative non-medical 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 12-month 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 cross-trained staff, for co-occurring opioid treatment and mental illness. These respondents believe that integrated services for persons with an addiction(s) and a psychiatric disorder are crucial. These dually-diagnosed patients represent 50-80 percent of substance dependent populations.

The Secretary agrees with the importance of providing adequate integrated services for opiate-addicted 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 co-occurring illnesses, including mental illness. CARF Opioid Treatment Program Accreditation Standards state that services for co-occurring 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 co-occurring disorders under these new rules will be a vast improvement over the previous regulatory system, which did not address co-occurring opiate addiction and psychiatric disorders at all. As such, under the new rules, patients' access to effective treatment for co-occurring 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 co-occurring disorders.

Other comments on this section stated that the regulations should specify a schedule for services. Some comments

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recommended that the regulations require OTPs to document that patients actually receive services when they are referred to off-site 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 state-of-the-art 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 take-home 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. 102-321, 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 section 8.11(h), which provides for exemptions from treatment standards or certification requirements. One comment suggested that the examples in the previous regulation for exemptions, be retained in the final new regulations. The comment suggests that this would encourage individual physicians, pharmacists, or both to

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provide methadone treatment in rural areas where methadone treatment is scarce or unavailable. Another comment suggested that SAMHSA streamline the exemption process and do more to publicize the availability of such regulatory options. The Secretary accepts both of these suggestions, and section 8.11(h) has been revised accordingly. In addition, SAMHSA has already taken steps to streamline the exemption process and publicize the availability of certain exemptions (Ref. 4).

14. Most comments strongly supported the provisions in proposed section 8.12(h)(3)(i) which permits OTPs to use solid dosage forms. Some patients reported spoilage and decomposition problems with 14-day supplies of liquid dosage form. Other comments suggested that the use of solid medication will reduce treatment cost modestly by eliminating the need for dosage bottles for solutions. The Secretary agrees that permitting OTPs to use solid medication will reduce treatment costs and increase treatment convenience to patients.

15. The Secretary received many comments on proposed section 8.11(h)(3)(iii) that would have required the program physician to justify in the patient record all doses above 100 mg. Most comments viewed this requirement as an inappropriate "value judgement" that hampers clinical judgement. The Secretary agrees that the requirement to justify a dose above 100 mg, which is a modification of a requirement under the previous regulation, is not necessary to reduce the risk of medication diversion. Accordingly, this requirement has
been eliminated from the final rule.

16. The Secretary specifically requested and received comments on proposed changes to the requirements under section 8.12(i) pertaining to medications dispensed for unsupervised use (hereinafter "take-homes"). The July 22, 1999, proposal set forth four options for addressing take-homes. These options ranged from retaining the previous requirements to a scheme based on a maximum dose. Option number 2 was discussed as the option preferred by HHS and endorsed by DEA. This option resembles the requirement under the previous regulations and retains the 8-point take-home criteria. However, option number 2 permitted patients in stable treatment for one year to receive up to a 31-day supply of medication, while the previous regulation included a maximum take-home supply of 6 days.

Most comments supported proposed option 2, with modifications. In supporting option 2, current patients stated that less frequent clinic attendance will make treatment much more convenient. In addition, Option 2 will eliminate travel hardships and facilitate employment commitments, ultimately increasing retention in treatment and rehabilitation. Option 1, which encompassed the take-home schedule from the previous regulation, was viewed by many comments as too restrictive. Many comments opposed option 3, which proposed a set 2-week maximum milligram amount for take-homes, because it unfairly penalized patients receiving higher doses.

On the other hand, a form letter circulated and submitted by several treatment programs stated that no patients should be eligible for a 31-day take-home supply. According to these comments, all patients must report to clinics often so that their rehabilitation can be monitored appropriately. In addition, these comments stated that allowing any patient a 31-day take-home supply presents an unacceptable risk of diversion.

The Secretary does not agree with these comments. Indeed, there is considerable evidence that many patients can responsibly handle supplies of take-home medications beyond the 6-day maximum allowed under the previous regulations. In addition, FDA has permitted hundreds of patients to receive monthly take-home supplies of methadone through exemptions or Investigational New Drug Applications. These investigations have been analyzed and reported in scientific literature and indicate that patients successfully continue in rehabilitation (Ref. 5). Moreover, these cases indicate that rehabilitation is enhanced through these "medical maintenance" models. Accordingly, and in response to an increased interest in this issue, FDA and SAMHSA/CSAT issued a "Dear Colleague" letter on March 30, 2000, that advised the field on procedures for obtaining OTP exemptions for medical maintenance, which include a provision for up to a 31-day supply of take-home medication (Ref 4).

The Secretary notes that many comments provided suggestions on refining the basic schedule for take-home eligibility outlined in proposed option 2. For example, many comments suggested that one year of stable treatment was still too short a period of time to evaluate whether patients can responsibly handle a 31-day supply of take-home medication. These comments suggested an interim step that permits a 14-day take-home supply after one year of stable treatment before a patient is eligible for a 31-day supply.

The Secretary concurs with these comments. The 2-year time in treatment requirement is more consistent with the studies and exemptions for medical maintenance granted to date under the previous rules. In addition, this schedule is more consonant with the schedule set forth in the SAMHSA/CSAT Accreditation Guidelines and the accreditation body standards. Accordingly, section 8.12(i)(3) has been revised to reflect a 14-day take-home step after one year of stable treatment and to reflect that patients are eligible for a take-home supply up to 31 days after two years of stable treatment. The language in other parts of section 8.12(i)(3) has been modified slightly for clarity to lengthen the duration of the steps within the first year of treatment, and to remove some requirements for observed ingestion.

17. Comments overwhelmingly supported the proposal to permit take-home use of LAAM and suggest that the Secretary apply the same schedule as methadone, e.g. option 2. A comment from a practitioner who has treated over 500 patients, stated that patients dislike being switched from LAAM to methadone when necessary for travel purposes. Most comments suggested that diversion of LAAM is no more likely than the diversion of methadone which generally is not problematic. One comment submitted the results of a 149-patient study on LAAM take-home use. Patients were randomized into take-home and clinic only groups. As part of the study, 545 take-home doses of LAAM were distributed to patients, and patients were subject to random "callbacks." There was no evidence of tampering, diversion, or interest in obtaining LAAM take-home supplies illicitly. In addition, there were no differences between the two groups in the measured outcome variables. The investigator concluded that methadone and LAAM should be subject to the same take-home requirements. The Secretary concludes that LAAM should be available for take-home use under this rule.

18. A comment submitted by a physician discussed his successful experience using LAAM for detoxification treatment, finding LAAM to be superior to methadone for detoxification with some patients. The comment suggested that the regulations should be modified to permit the use of LAAM for detoxification.

Although previous Federal Register notices may have suggested that LAAM was not available for use in detoxification treatment (58 FR 38704, July 20, 1993), the July 22, 1999, proposal does not prohibit the use of

[[Page 4086]]

methadone or LAAM for detoxification treatment. Indeed, the current FDA approved labeling for LAAM discusses and provides guidance on withdrawing patients from LAAM therapy:

ORLAAM is indicated for the management of opiate dependence * * * There is a limited experience with detoxifying patients from ORLAAM in a systematic manner, and both gradual reduction (5 to 10% a week) and abrupt withdrawal schedules have been used successfully. The decision to discontinue ORLAAM therapy should be made as part of a comprehensive treatment plan.

The Secretary believes that the regulations are adequately clear on this point.

19. A few respondents commented upon the proposed implementation plan and whether OTPs could be expected to comply with the timetables for achieving accreditation. Under proposed section 8.11(d), treatment programs approved under the previous regulations are deemed certified under the new rules. This "transitional certification" would expire on June 18, 2001 unless the OTPs certify with a written statement signed by the program sponsor that they will apply for accreditation within 90 days of the date SAMHSA approves the first accreditation body. Transitional certification, in that case, will expire on March 19, 2003. SAMHSA may extend transitional certification on a case-by-case basis for up to one year under certain conditions. The comments questioned whether SAMHSA had empirical evidence that OTPs could meet this timetable.

The Secretary believes that the timetables proposed in the July 22, 1999, notice remain reasonable. A significant number of OTPs have already had experience with accreditation. This includes programs located in Department of Veterans Affairs Medical Centers, as well as OTPs located in the several States that require accreditation of OTPs (Maryland, Indiana, North Carolina, Georgia, South Carolina, and Michigan). Moreover, as discussed previously, as part of SAMHSA/CSAT's accreditation implementation plan, two accreditation bodies conducted accreditation surveys of OTPs and accredited over 50 OTPs in just a few months. SAMHSA/CSAT has planned additional training and technical assistance to enable OTPs to understand and comply with the new regulations. In addition, the regulations have been streamlined with fewer reporting and recordkeeping requirements. OTPs have had ample opportunity to prepare for this final rule, and the SAMHSA/CSAT Accreditation Guidelines as well as the CARF and JCAHO accreditation standards have been widely available for years. Taken together, these factors provide the Secretary with reasonable confidence that OTPs can apply for and achieve accreditation within two years from the effective date of this rule.

The Secretary is sensitive to concerns about OTPs contacting accreditation bodies and scheduling accreditation reviews in a convenient manner. Therefore, while not changing the timetables for achieving accreditation under the final rule, the Secretary has modified section 8.11(d) to state that programs will agree to apply for accreditation within 90 days from the date SAMSHA announces the approval of the second accreditation body. The Secretary believes that tying this certification for OTPs to apply from the date SAMHSA announces the approval of the first accreditation body to the date SAMHSA announces approval of the second accreditation body will facilitate OTPs contacting and achieving accreditation under the final rule.

20. A few comments requested that OTPs that have been previously accredited by JCAHO and CARF should be "grandfathered" somehow under the new final regulations.

There are no provisions in the final rule to accept accreditation by accreditation bodies that have not been approved by SAMHSA under section 8.3(d). These accreditation bodies did not develop and apply accreditation standards that were based upon the opioid agonist treatment standards set forth under section 8.12. SAMHSA, however, will consider on a case-by-case basis, whether OTPs that achieved accreditation under the SAMHSA/CSAT implementation initiative can be exempted from re-accreditation under this final rule, pursuant to section 8.11(h).

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