[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Proposed Rules]
[Pages 39810-39857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18562]



[[Page 39809]]

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Part VI





Department of Health and Human Services





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Food and Drug Administration



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Public Health Service



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21 CFR Part 291



42 CFR Part 8



Narcotic Drugs in Maintenance and Detoxification Treatment of Narcotic 
Dependence; Repeal of Current Regulations and Proposal to Adopt New 
Regulations; Proposed Rule

  Federal Register / Vol. 64, No. 140 / Thursday, July 22, 1999 / 
Proposed Rules  

[[Page 39810]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 291

Public Health Service

42 CFR Part 8

[Docket No. 98N-0617]
RIN 0910-AA52


Narcotic Drugs in Maintenance and Detoxification Treatment of 
Narcotic Dependence; Repeal of Current Regulations and Proposal to 
Adopt New Regulations

AGENCIES: Food and Drug Administration and Substance Abuse and Mental 
Health Services Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Secretary of the Department of Health and Human Services 
(the Secretary) (DHHS) is proposing to revise the conditions for the 
use of narcotic drugs in maintenance and detoxification treatment of 
opioid addiction. The proposal includes the repeal of the existing 
narcotic treatment regulations enforced by the Food and Drug 
Administration (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 the Substance 
Abuse and Mental Health Services Administration (SAMHSA). This proposal 
follows a study by the Institute of Medicine (IOM) and reflects 
recommendations by the IOM and several other entities to improve 
narcotic addict treatment by allowing for increased clinical judgment 
in treatment. The proposal is also part of DHHS's Reinvention of 
Government review (Ref. 1).
DATES: Submit written comments on this proposal by November 19, 1999. 
Submit written comments on the information collection provisions by 
August 23, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857. Submit comments on the information collection 
requirements to the Office of Information and Regulatory Affairs, OMB, 
New Executive Office Bldg., 725 17th St. NW., Washington, DC 20503, 
Attn: Desk Officer for SAMHSA.

FOR FURTHER INFORMATION CONTACT:
    Primary Contact: Nicholas Reuter, Center for Substance Abuse 
Treatment (CSAT), SAMHSA, Rockwall II, 5515 Security Lane, Rockville, 
MD 20857, 301-443-0457, or
    Ellsworth Dory, Center for Drug Evaluation and Research (HFD-342), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7264.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Background
III. Summary of Proposed Rule
IV. Federal Opioid Treatment Standards
V. Legal Authority
VI. Proposed Implementation Plan
VII. Environmental Impact
VIII. Analysis of Impacts
IX. Paperwork Reduction Act of 1995
X. Request for Comments
XI. References

I. Introduction

    The use of therapeutic narcotic drugs in the treatment of narcotic 
addiction has been the subject of a unique system of Federal regulation 
for nearly 30 years. As described as follows, one component of that 
system has been the enforcement by FDA of ``process oriented 
regulations'' governing the operation of ``narcotic treatment 
programs.'' These regulations reflect the fact that narcotic addiction 
is an illness with medical and societal origins, the treatment of which 
must include careful professional oversight and the availability of 
specialized support services. The regulatory system enforced by FDA 
also reflects the risks of abuse and diversion that are endemic to 
opioid agonist therapy (Ref. 2).
    The current regulations and the system for enforcing those 
regulations emerged at a time when narcotic maintenance treatment 
experience was limited and abuses among practitioners providing 
narcotic drug products, including methadone, to narcotic addicts were 
not uncommon. In addition, there was considerable diversion of 
methadone. Thus, the intent of the current system was to help ensure 
quality treatment and reduce the risks of diversion while permitting 
further study of the relatively unfamiliar methadone maintenance 
treatment modality.
     Additional study and experience has demonstrated the value of 
narcotic maintenance therapy in reducing drug abuse, criminal behavior, 
and infectious disease transmission. However, the narcotic addict 
patient population, and the health-care system in general, have changed 
dramatically since the inception of the current regulations. Despite 
several retrospective reviews and prospective evaluations, the system 
has remained essentially unchanged.
    For example, compliance with the current system still depends upon 
inspections conducted by either FDA or State inspectors, rather than by 
expert accrediting teams (as is typical in many other areas of health 
care). Second, the regulations themselves have been criticized for 
imposing detailed requirements on program physicians and support 
personnel in a manner that has been said to stifle clinical judgment, 
to the detriment of the patient population. Several aspects of the 
current regulations also appear to reflect scientific views on opioid 
addiction that may be considered outdated. For example, the current 
regulations do not address phases of treatment, with more intense and 
focused treatment provided to patients at earlier stages. In addition, 
the current regulations emphasize the suppression of abstinence 
symptoms in determining appropriate dosing but do not integrate newer 
concepts such as ``blockade'' in determining adequate dosing.
    Third, the current regulations have been criticized as being overly 
``process oriented'' in that they establish administrative requirements 
for programs but ignore the need for ``effectiveness standards'' (Ref. 
3). It has been said that under the current system, process takes 
precedence over performance and that a reemphasis on clinical outcomes 
and controls would greatly improve the effectiveness of treatment (Ref. 
4).
    This proposal would repeal the existing regulatory system and 
substitute in its place an accreditation-based system that allows for 
greater administrative flexibility, fewer constraints on clinical 
judgment, and even more focus on the needs of patients. Among other 
things, the new system would increase significantly the direct 
participation of the medical community in the oversight of addiction 
treatment. Moreover, individual programs will have increased 
flexibility to design treatments for specific patients and communities. 
This is expected to increase patient compliance and adherence to 
therapeutic regimens which, in turn, will increase the likelihood of 
successful outcomes.
    Part and parcel with the proposed new regulatory approach will be a 
shift in administrative and oversight responsibilities. FDA will 
refocus its efforts on assuring the safety and effectiveness of new 
treatment modalities and will relinquish day-to-

[[Page 39811]]

day oversight of the treatment programs. SAMHSA will take full 
responsibility for carrying out the new system on behalf of the 
Secretary. The transfer of authority to SAMHSA, whose mission includes 
the goal of improving access to high quality programs for the treatment 
of addictive and mental disorders, reflects in part the evolution of 
methadone treatment from an emerging new drug therapy to a widely 
accepted and well understood treatment modality.

II. Background

A. Statutory and Regulatory Developments

    The current system by which FDA regulates and monitors the use of 
narcotic drugs in the treatment of narcotic addiction began in 1970 
with passage of the Comprehensive Drug Abuse Prevention and Control Act 
of 1970 (the CDAPCA) (Pub. L. 91-513). Prior to the CDAPCA, FDA's 
control over therapeutic narcotic drugs such as methadone, in the 
treatment of addiction, was based on FDA's regulation of new drugs 
under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355).
    Section 4 of Title I of the CDAPCA directed the Secretary to 
determine, after consultation with the Attorney General and national 
organizations, the appropriate methods of professional practice in the 
medical treatment of narcotic addiction of various classes of narcotic 
addicts (see 42 U.S.C. 257a). The primary intent of the legislation was 
to reduce ``uncertainty as to the extent to which [physicians] may 
prescribe narcotic drugs for addiction patients'' (Ref. 5). The 
legislation also consolidated existing Federal drug control statutes 
into the Controlled Substances Act (CSA) and the Controlled Substances 
Import and Export Act.
    In 1972, FDA issued its narcotic treatment regulations based in 
part on the new drug provisions of the act and the CDAPCA. These 
regulations provided for a closed distribution system for the treatment 
of narcotic addiction, detailed procedures for approval of treatment 
programs, medical treatment standards, and procedures for revoking 
approval for failure to comply with the standards.
    In 1974, Congress enacted the Narcotic Addict Treatment Act (the 
NATA) (Pub. L. 93-281) to establish the basis for increased control of 
narcotic addict treatment programs by the Attorney General and the 
Secretary. The NATA ensured that only confirmed narcotic addicts would 
be admitted to maintenance or detoxification treatment, that they would 
receive quality care, and that illicit diversions would be limited. 
Under the NATA, which amended the CSA (21 U.S.C. 801 et seq.), 
practitioners who dispense narcotic drugs in the treatment of narcotic-
dependent persons must obtain an annual registration from the Attorney 
General. This authority has been delegated to the Drug Enforcement 
Administration (DEA). To be registered, practitioners must comply with 
the requirements established by DEA for secure drug storage, 
recordkeeping, and unsupervised use; practitioners must be qualified 
under the treatment standards established by the Secretary; and 
practitioners must comply with standards established by the Secretary 
regarding quantities of narcotic drugs for unsupervised ``take-home'' 
use by persons undergoing treatment (21 U.S.C. 823(g)).
    In 1980, FDA and the National Institute on Drug Abuse (NIDA) 
jointly issued a final rule (45 FR 62694, September 19, 1980) amending 
FDA's narcotic treatment regulations to make them consistent with the 
requirements of the CSA, as amended by the NATA, and with implementing 
regulations issued by DEA. The amended regulations, codified at 
Sec. 291.505 (21 CFR 291.505), have provided the Secretary's regulatory 
standards for the use of narcotic drugs in treating narcotic addiction.
    The requirements of Sec. 291.505 have represented the minimum 
standards for the appropriate methods of professional practice in the 
medical treatment of narcotic addiction with narcotic drugs such as 
methadone. Under the regulations, FDA approves new programs, 
periodically inspects existing programs, and may revoke approval of a 
program's application if the program fails to abide by all of the 
requirements set forth in Sec. 291.505, or fails to monitor the 
activities of those employed in the program.
    New legislation enacted in 1992 restructured much of DHHS's drug 
abuse services and research responsibilities. Under the Alcohol, Drug 
Abuse and Mental Health Administration (ADAMHA) Reorganization Act 
(Pub. L. 102-321), ADAMHA was restructured to transfer its substance 
abuse and mental health research institutes, including NIDA, to the 
National Institutes of Health (NIH), with SAMHSA established to support 
and administer programs relating to substance abuse and mental health 
prevention and treatment services. Part of SAMHSA's mission is to 
improve the provision of substance abuse treatment and ``coordinate 
Federal policy with respect to the provision of treatment services for 
substance abuse utilizing anti-addiction medications, including 
methadone'' (42 U.S.C. 290aa(d)(7)). Within SAMHSA, the Center for 
Substance Abuse Treatment (CSAT) has developed and issued comprehensive 
Treatment Improvement Protocols (TIPS) and Technical Assistance 
Publications (TAPS), including the publication entitled ``Approval and 
Monitoring of Narcotic Treatment Programs: A Guide on the Roles of 
Federal and State Agencies and State Methadone Treatment Guidelines.'' 
CSAT has also developed guidelines on phases of treatment and 
guidelines on the dosing of Levo-Alpha-Acetyl-Methadol (LAAM), another 
approved opioid agonist treatment medication.
    In 1993, FDA and SAMHSA revised the methadone regulations to set 
forth conditions for authorizing ``interim methadone maintenance.'' The 
change, which implemented provisions of the ADAMHA Reorganization Act, 
authorizes public and nonprofit private narcotic treatment programs to 
provide interim maintenance treatment to patients awaiting placement in 
comprehensive maintenance treatment. In addition, the 1993 rule 
required all narcotic treatment programs to provide counseling on 
preventing exposure to, and preventing the transmission of, human 
immunodeficiency virus (HIV) disease (58 FR 495, January 6, 1993). 
Finally, the regulations were revised again in 1993 to establish 
standards for the use of LAAM in the maintenance treatment of narcotic 
addicts (58 FR 38704, July 20, 1993).

B. Current Oversight

    FDA has enforced the existing narcotic treatment regulations (part 
291 (21 CFR part 291)) by approving programs, monitoring programs 
through periodic inspections, and pursuing various means of obtaining 
compliance, including enforcement actions and proposals to revoke 
program approval. Approximately 900 treatment programs are approved 
under the regulations. The number of approved programs has not changed 
significantly over the years.
    Periodic compliance inspections are carried out by FDA personnel, 
who generally have no specialized expertise in drug abuse treatment, or 
by State officials under contract with FDA. These inspections are 
primarily documentation audits, with an emphasis on appropriate 
recordkeeping and control of take-home doses. FDA inspectors typically 
focus their review on a sample of patient records to determine whether 
the program has

[[Page 39812]]

complied with the regulations. If an inspection results in observations 
of possible violations, FDA has several options for bringing the 
program into compliance, ranging from informal meetings with the 
program to warning letters to proposals to revoke the program's 
operating approval.
    The frequency with which FDA conducts routine inspections has been 
steadily decreasing as FDA continues to focus on its other core 
priorities.

C. Evaluations of the Current System

    While both the patient population and the health risks associated 
with illicit narcotic drug abuse have changed substantially over the 
last 30 years, the Federal regulatory framework governing the treatment 
of narcotic addiction has remained relatively unchanged. Coordination 
among several Federal agencies through the Interagency Narcotic 
Treatment Policy Review Board (Ref. 6) (INTPRB) has brought about 
modest changes to the existing regulations. The INTPRB helped 
coordinate the introduction of interim methadone maintenance and led 
several changes that allowed increased flexibility with regard to 
issues such as counselor-to-patient ratios and certain reporting 
requirements (Ref. 7). Nevertheless, the system that remains in place 
today largely remains unchanged from the original regulatory system.
    The existing system, for example, has been roundly criticized for 
its rigidity and for the constraints it imposes on clinical judgment. 
As an expert agency-based panel noted:
     Some regulations, although intended to foster quality care, are 
based on the premise that a patient's behavior can be adequately 
controlled through rules. This idea often conflicts with the 
clinician's need to establish a therapeutic alliance and conflicts 
with most treatment professionals' understanding that one person is 
fundamentally powerless to control the drug use of another (Ref. 8).
 Many in the field have also expressed concern about the future of 
methadone maintenance treatment under managed care (Ref. 9). Since the 
inception of the existing regulations, the health-care system has been 
evolving to a managed care environment that relies on quality assurance 
assessments and outcome measurements, with careful matching of patient 
needs to particular treatment. In such an environment, the enforcement 
of process oriented regulations has been criticized as having 
``inhibited the development of patient-matching strategies [and] 
diverted attention from more clinically focused approaches, such as 
matching strategies and treatment guidelines'' (Ref. 10).
    Others have criticized the current enforcement process to the 
extent that ``[m]onitoring compliance by a regulatory agency is by 
definition adversarial,'' and that inspectors are trained to find 
violations and not to ``provide technical assistance'' (Ref. 11). Even 
the very need for the current regulations has been questioned, with one 
commentator noting:
    The authorities provided to DEA by the NATA and the 1984 CSA 
amendments [which provided DEA with ``public interest'' revocation 
authority] themselves are sufficient to prevent the excesses, which 
occurred during the late 1960's, of an unregulated narcotic 
addiction treatment system. Thus, program registration by both the 
FDA and the DEA is duplicative, costly, and unnecessary (Ref. 12).
    These types of concerns prompted several noteworthy assessments of 
the existing system, including reports by the General Accounting Office 
(GAO) and the IOM, and a thorough assessment of these reports and other 
relevant data by an interagency-work group.
1. The 1990 GAO Report
    In 1990, the GAO issued a lengthy report, based on its review of 24 
narcotic treatment programs, analyzing the effectiveness of the 
existing narcotic treatment regulations. The report focused on: (1) The 
extent of drug use by patients in methadone maintenance treatment 
programs; (2) the goals, objectives, and approaches of the treatment 
programs; and (3) the types of services available to patients in 
treatment.
    The report noted a wide disparity in the quality of treatment 
provided among the 24 narcotic treatment programs reviewed. The GAO 
found that:
    * * * policies, goals, and practices varied greatly among the 24 
methadone maintenance treatment programs. None of the 24 programs 
evaluated the effectiveness of their treatment. There are no federal 
treatment effectiveness standards for treatment programs. Instead, 
federal regulations are process oriented in that they establish 
administrative requirements for programs. Even with regard to these 
requirements, federal oversight of methadone maintenance treatment 
programs has been very limited since 1982 (Ref. 13).
    Based on these findings, the GAO recommended that the Secretary 
direct FDA or NIDA, as appropriate, to: (1) Develop result-oriented 
performance standards for methadone maintenance treatment programs, (2) 
provide guidance to treatment programs regarding the type of data that 
must be collected to permit assessment of programs' performance, and 
(3) assure increased program oversight oriented toward performance 
standards.
    In response to the GAO report, NIDA initiated the methadone 
treatment quality assurance system (MTQAS). The goal of the MTQAS was 
to develop outcome measures to compare the performance of methadone 
maintenance treatment programs. In 1993, NIDA developed a survey form 
with outcome variables adjusted for variations in case mix. For 
example, NIDA used retention in treatment and patient drug abuse as 
outcome variables for comparing the performance of individual treatment 
programs. Initial results from pilot tests of this system showed that 
performance measures, such as retention in treatment and decreased drug 
abuse, could in fact differentiate the quality and effectiveness of 
treatment.
    The GAO report and the new information from MTQAS prompted the 
Public Health Service (PHS) to fund a comprehensive study on the 
Federal regulation of methadone treatment by the IOM.
2. The 1993 IOM Study
    In 1993, NIDA, SAMHSA, and the Office of the Assistant Secretary 
for Health funded a 2-year IOM study of the current regulations, 
including enforcement issues, quality of treatment, and diversion.
    In a report issued in 1995, the IOM concluded that the current 
regulations have little effect on the quality of treatment provided in 
clinics (Ref. 14). In particular, the report emphasized the need to 
balance process oriented regulations with clinical practice guidelines 
and quality assurance systems. The IOM found that ``enforceable federal 
standards'' are needed, not for medical reasons, but to prevent 
substandard or unethical practices, and to maintain community support. 
It recommended, therefore, that the regulations be reduced in scope to 
be less intrusive and to allow more clinical judgment in treatment. 
Clinical practice guidelines, according to the IOM, would ensure that 
clinical discretion is exercised in a ``sound manner.''
    The IOM report also addressed the current system of enforcing the 
regulations, noting costly overlap among multiple Federal, State, and 
sometimes local inspections. As a result, the IOM recommended 
``reducing the scope of administrative control by FDA and other DHHS 
agencies'' (Ref. 15). This reduction in scope of administrative control 
would follow the IOM's recommendation that:
    FDA, with SAMHSA and NIDA, conduct an extensive review of 
methadone enforcement policies, procedures, and practices by all 
health agencies of

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government - federal, state, and local - for the purpose of 
designing a single inspection format, having multiple elements, that 
would provide for (1) consolidated, comprehensive inspections 
conducted by one agency (under a delegation of federal authority, if 
necessary), which serves all agencies and (2) improve the efficiency 
of the provision of methadone services by reducing the number of 
inspections and consolidating their purposes (Ref. 16).
    Moreover, the IOM recommended that ``DHHS conduct a review of its 
priorities in substance abuse treatment, including methadone treatment, 
in a way that integrates changes in regulations and the development of 
practice guidelines with decisions about treatment financing.'' 
Finally, the IOM recommended that policy leadership on drug abuse 
treatment should be elevated to the Office of the Assistant Secretary 
for Health (Ref. 17).
3. The Interagency Narcotic Treatment Policy Review Board
    In response to these recommendations, the Assistant Secretary for 
Health requested that the Interagency Narcotic Treatment Policy Review 
Board (INTPRB), which had been formed in the early 1970's to coordinate 
Federal policy regarding the use of methadone, evaluate the IOM's 
findings and recommendations. Membership on the INTPRB included 
representatives from FDA, NIDA, SAMHSA (including CSAT), the Office of 
the Secretary, the DEA, the Department of Veterans Affairs (VA), and 
the Office of National Drug Control Policy (ONDCP). Representatives 
from two other DHHS agencies, the Agency for Health Care Policy and 
Research and the Health Care Financing Administration (HCFA), were also 
included at various times.
    After careful consideration of the IOM's work and all that 
preceded, the INTPRB concluded that a regulatory system centered around 
a core set of Federal treatment standards, in conjunction with 
monitoring of treatment programs through private accreditation, would 
be both feasible and preferable to the existing system.
    First, the INTPRB reasoned that an accreditation-based system would 
be more consistent with the oversight approach in most other health-
care fields. For example, HCFA relies on accreditation to certify 
approximately 7,000 hospitals that provide services to Medicare 
patients. In addition, under the Clinical Laboratory Improvement Act of 
1988 (CLIA), private accreditation is now used as the primary basis for 
certifying human clinical laboratories.
    Moreover, a number of narcotic treatment programs are already 
subject to accreditation standards and inspections. As noted in the IOM 
report, approximately 5 percent of the methadone maintenance patients 
in the United States are treated in facilities under the VA medical 
system (Ref. 18), all of which are subject to outside accreditation.
    In addition, the INTPRB found that interest in accreditation is 
increasing steadily, due at least in part to its emphasis on self 
assessment and improvement, and on the integration of quality assurance 
and performance elements developed by expert accreditation 
organizations. The expanded use of accreditation, particularly in the 
substance abuse field, is reflected in the number of national 
accreditation bodies with standards for substance abuse treatment. The 
Joint Commission on the Accreditation of Healthcare Organizations 
(JCAHO) and two other national accreditation bodies, the Commission on 
Accreditation of Rehabilitation Facilities (CARF) and the Council on 
Accreditation of Services for Families and Children, Inc. (COA), have 
significant experience in accrediting substance abuse treatment 
programs. CARF conducts approximately 1,000 surveys each year (Ref. 19) 
and more than 100 entities, including the Federal government, have 
accepted accreditation by CARF. COA accredits approximately 1,000 
behavioral health-care programs and 3,000 social service programs 
annually (Ref. 20). CARF, COA, and JCAHO all have developed or 
expressed an interest in developing methadone treatment accreditation 
standards.
    The INTPRB also concluded that an accreditation-based system would 
improve the quality of treatment by increasing the participation of the 
treatment community in establishing measures for determining the 
effectiveness and overall success of treatment programs. Some have 
attributed problems in the methadone treatment area to the absence of 
the medical profession's participation in determining the standards of 
care in this area (Ref. 21). Professional accreditation bodies are 
expected to be able to focus closely on those aspects of treatment 
that, if maintained at appropriate levels, will show a measurable 
improvement in treatment outcomes and a measurable improvement in the 
overall quality of the medical care. Also, because of its widespread 
use in health care, an accreditation-based regulatory system may also 
help to mainstream the medical treatment of narcotic dependence.
    The INTPRB also reasoned that accreditation could significantly 
improve program performance, especially at poorly functioning programs, 
by providing much-needed advisory services that generally have been 
lacking under the existing system.
    Importantly, the INTPRB noted that an accreditation-based system 
provides an opportunity to reduce the layers of inspections from 
Federal, State, and local regulatory entities. State authorities may 
choose to apply to act as accreditation bodies for programs in their 
jurisdiction and, if approved, would consolidate inspections and 
minimize burdens. Alternatively, State authorities could adopt 
accreditation body findings. At least one State, Ohio, accepts as 
documentation of a program's compliance with State standards a 
program's accreditation by any of the leading private accreditation 
bodies (Ref. 22).
    Overall, the INTPRB concluded that fewer resources would be 
expended at the Federal level. While there would be costs to the 
government in monitoring accreditation bodies, assuring that 
accreditation body elements are appropriate, and reviewing and 
approving guidelines, the overall cost should be less than that of the 
present system. Treatment programs would be expected to absorb modest 
accreditation fees, but treatment quality would be greatly improved by 
being more closely matched to patient needs.
    In addition, accreditation holds out the prospect for more 
efficient treatment which, in time, would allow for more treatment at a 
lower cost to payers. Indeed, with its similarity to HCFA's oversight 
of Medicare and Medicaid programs, the accreditation-based regulatory 
system provides the potential for a model system that unifies 
``financing, treatment, and the regulation of services'' as envisioned 
by the IOM and others:
    Service providers have demanded that accrediting and regulatory 
bodies conduct their reviews jointly and/or at least accept all or 
part of each other's standards, reviews and reports as equivalent. 
It is a hopeful sign that in at least 23 states, the surveys of the 
JCAHO and of state health departments are being conducted jointly, 
and 17 others are considering such arrangements. These 
collaborations have been commended by the General Accounting Office 
of the U.S. Congress, as cost-containing efforts that successfully 
reduce some of the duplication of preparation and the overuse of 
scarce resources, which could better be used toward the improvement 
of quality of care (Ref. 70).
    The INTPRB in April 1995 forwarded its recommendations to the 
Assistant Secretary for Health who, thereafter, solicited views from 
all Federal agencies with a substantial interest in therapeutic and 
controlled substances. After

[[Page 39814]]

receiving and evaluating endorsements from other agencies, the 
Assistant Secretary for Health concluded that DHHS should take all 
necessary steps to phase out the existing regulatory approach and adopt 
in its place an accreditation-based system centered around a limited 
set of core Federal treatment standards.
    In September 1995, the Assistant Secretary for Health assigned to 
SAMHSA responsibility for developing the new regulatory approach. 
Subsequently, an interagency workgroup of the INTPRB, with 
representatives from DHHS (including SAMHSA, FDA, and NIDA), DEA, VA, 
and ONDCP, was formed to develop the new system, including the 
development of this proposed rule.
4. NIH Consensus Development Conference
    On November 17 to 19, 1997, NIDA, the NIH Office of Medical 
Applications Research, and the NIH Office of Research on Women's Health 
sponsored a consensus development conference on the effective medical 
treatment of heroin addiction. NIH convened this conference to present 
the available data on opioid agonist treatment for heroin addiction in 
order to address the most important and controversial issues 
surrounding narcotic maintenance treatment. The independent panel 
concluded that opioid addiction is a medical disorder and that 
pharmacologic agents, such as methadone and LAAM, are effective in its 
treatment. The panel also addressed barriers to such treatment, 
including the existing regulations:
    However well-intentioned the FDA's treatment regulations when 
written in 1972, they are no longer necessary. We recommend that 
these regulations be eliminated. Alternative means, such as 
accreditation, for improving the quality of [opioid treatment] 
should be instituted (Ref. 23).
5. State Licensure and Accreditation Activities
    Many States have adopted requirements that are more rigorous than 
the FDA standards alone. These requirements most often are imposed 
through licensure or funding authorities. Licensure in these States 
often involves a costly annual inspection program. However, the degree 
of oversight varies enormously across and within States. For example, 
many States require at least annual State licensure reviews. Of these, 
only one State has regulations that do not include more stringent 
compliance requirements than the FDA standards alone. Other States, 
beyond initial opening requirements, rely almost exclusively on FDA and 
DEA oversight of methadone programs for assuring continued compliance 
with those standards and regulations.
    FDA's model allows for more intense oversight by States, but does 
not require it. Thus, many of the same problems that have been 
identified at the Federal level have not necessarily been corrected at 
the State level unless specifically addressed by a given State. To 
raise the standard of care consistently throughout the country, 
standards issued and/or required at the Federal level will have to 
rise. Standards on which accreditation is based are generally viewed as 
the highest standards of care.
    At least one State, Michigan, has both a licensing and an 
accreditation requirement. Michigan requires opioid treatment programs 
(OTP's) to be accredited as a condition of receiving Medicaid and block 
grant funds. DHHS understands that a number of private payers in 
Michigan also require methadone programs to be accredited in order to 
receive payment for services. Payers in Michigan appear to have decided 
that opioid treatment should be held to the standards to which health-
care providers are held, and payers in Michigan generally require 
hospitals and clinics to be accredited as a condition of participation. 
In fact, a large number of private payers throughout the nation as a 
whole require accreditation as a means to insure that the health care 
meets standards of quality and appropriateness. Based on discussion 
with officials in Michigan, the move to accreditation for substance 
abuse programs has raised standards of care. Almost all OTP's in 
Michigan have been accredited under this system, and it has been noted 
that almost all of these OTP's increased the number of patients in 
treatment after receiving accreditation.
6. Conclusion
    This notice of proposed rulemaking (NPRM) addresses the problems 
and potential of opioid agonist treatment which so far in the United 
States has been limited to methadone and LAAM treatment. The NPRM is 
consistent with national policy and direction regarding the role of 
methadone and LAAM and other opioid agonist treatments in reducing 
opiate addiction. Indeed, the Office of National Drug Control Policy 
(ONDCP), in its ``Policy Paper--Opioid Agonist Treatment,'' highlights 
this proposed accreditation-based regulatory system as a key element in 
improving the quality of methadone treatment and expanding treatment 
capacity (see appendix 1). The ONDCP Policy Paper notes that in 
addition to a shortfall in treatment capacity, problems in the opioid 
agonist treatment system have long existed at two levels: (1) OTP's 
have not functioned with uniform high quality; and (2) Federal 
oversight, grounded in process-focused regulations, has not served to 
improve or maintain the quality of OTP's. To reduce the use of heroin 
and illicit opioid drugs, both of these problems must be addressed.
    Methadone, the most effective treatment for chronic opioid 
addiction, has been used for the treatment of heroin addiction since 
the 1960's. It is an effective, long-acting, synthetic opioid agonist 
that is taken orally. Methadone blocks the craving and produces 
tolerance to its own analgesic effects and psychoactive effects. When 
used properly, at adequate doses, it also produces a physiological 
cross-tolerance to other opioids, rendering the patient unable to 
experience pharmacologic pleasure from the administration of practical 
doses of other opioids. Treatment with methadone requires daily dosing; 
LAAM blocks the effects of injected heroin for up to 3 days.
    This NPRM introduces a model accreditation system for OTP's, with 
transfer of regulatory oversight from FDA to SAMHSA. The current, 
process-oriented regulatory approach, with routine inspections by HHS 
(FDA) staff, will be replaced by a clinically-based accreditation 
system, with additional oversight from SAMHSA.

D. Long Term Goals and Interim Steps

    The long-term goals of this initiative are to make Federal 
oversight more effective, reduce the variability in the quality of 
opioid treatment services, and reform the treatment system to provide 
for expanded treatment capacity. This requires a comprehensive set of 
reforms including, but not limited to, the changes proposed in this 
document.
    By incorporating accreditation into the oversight model as 
proposed, DHHS will be better able to identify and assist poorly 
functioning programs. Accreditation reviews will be conducted every 3 
years by experts in the field of substance abuse treatment. Oversight 
will be more effective because medical experts, including addiction 
treatment specialists, will be conducting the onsite reviews. In 
addition, the onsite reviews will include a focus on treatment outcomes 
rather than simply measuring adherence to process-oriented standards. 
Importantly, the shift to an accreditation model will result in a 
treatment system more responsive and accountable to the

[[Page 39815]]

public's desire to see improvement in outcomes of addiction care.
    Elsewhere in this proposed rule, DHHS describes a transition plan 
that sets forth a timetable for moving from the existing purely 
regulatory system to the accreditation-based system. In addition, DHHS 
has taken several key steps to ensure that the eventual implementation 
of an accreditation-based system will be accomplished in the least 
disruptive manner possible. CSAT has awarded a contract to CARF in 1997 
and JCAHO in 1998 for development of accreditation guidelines and to 
conduct accreditation surveys of a cohort of treatment programs. 
Technical assistance will be provided to assist programs in preparing 
for and working with these accreditation guidelines.
    The impact of accreditation on these programs will be studied over 
time and the findings used to help improve the accreditation approach. 
SAMHSA's CSAT has developed a project to study the impacts of 
accreditation using both existing standards and newly developed, 
methadone/LAAM specific standards, in a cohort of OTP's. This 
assessment will also help familiarize existing treatment programs with 
the accreditation process as it becomes the new standard. Finally, the 
study will allow for the phasing in of accreditation by providing 
administrative feedback that can be used to adjust the implementation 
of accreditation in such a manner as to minimize any potential 
disruptive effects. The Secretary believes that this study will 
demonstrate that programs will be able to achieve accreditation with 
minimal disruption to treatment capacity.

III. Summary of Proposed Rule

    The Secretary is proposing to add new part 8 under title 42 of the 
Code of Federal Regulations to codify the new accreditation-based 
system. The proposal also includes the repeal of the existing FDA-
enforced narcotic treatment regulations at 21 CFR part 291, which would 
go into effect when the new regulations are finalized and effective. 
The Secretary will delegate to SAMHSA the authority to oversee the new 
program proposed under 42 CFR part 8.
    The proposed regulations establish the procedures by which the 
Secretary will determine whether a practitioner is qualified under 
section 303(g) of the CSA (21 U.S.C. 823(g)(1)) to dispense certain 
therapeutic narcotic drugs in the treatment of individuals suffering 
from narcotic addiction. These regulations also establish the 
Secretary's standards regarding the appropriate quantities of narcotic 
drugs that may be provided for unsupervised use by individuals 
undergoing such treatment (21 U.S.C. 823(g)(3)). (See also 42 U.S.C. 
257a.)
    Under the proposed regulations, a practitioner who intends to 
dispense narcotic drugs in the treatment of addiction must first obtain 
from the Secretary or her delegated authority, 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 narcotic treatment programs.
    The proposed new regulations are divided into three parts, subpart 
A, subpart B, and subpart C. Subpart A addresses accreditation that 
includes, at proposed Sec. 8.3, the sequence of events that 
accreditation bodies will follow to achieve approval to accredit OTP's 
under the new system. It also establishes in proposed Sec. 8.4 the 
accreditation bodies' responsibilities, including the use of 
accreditation elements during accreditation surveys. Subpart B of part 
8 sets forth the sequence and requirement for obtaining certification. 
This section addresses how and when programs must apply for initial 
certification and renewal of their certification. DHHS's opioid 
treatment standards are included in this section and are segregated for 
a separate detailed discussion because of their importance. Subpart C 
of part 8 establishes the procedures for review of either withdrawal of 
approval of the accreditation body or the suspension or proposed 
revocation of an OTP certification. This section addresses procedural 
and informational requirements in the event of a challenge to a SAMHSA 
determination.

A. Subpart A--Accreditation

    Subpart A of part 8 would establish the procedures whereby an 
entity can apply to SAMHSA to become an approved accreditation body. 
This part also establishes ``accreditation body responsibilities'' and 
general standards for accreditation bodies to ensure that practitioners 
are consistently evaluated for compliance with the Secretary's 
standards for opioid treatment.
1. Definitions and Related Requirements
    Section 8.2 in subpart A defines a number of key terms for purposes 
of applying 42 CFR part 8. Most of these proposed definitions are 
identical or similar to those set forth under the existing regulations 
at Sec. 291.505(a). Several, however, are unique to the new 
accreditation-based system and require brief mention.
    For example, the Secretary is proposing to define the term 
``accreditation body'' to mean a body that has been approved by SAMHSA 
under proposed Sec. 8.3 to accredit OTP's. Under proposed Sec. 8.3(a), 
private nonprofit organizations as well as State governmental entities, 
including a political subdivision of a State (such as a county) may 
apply to serve as an accreditation body. The Secretary believes that 
allowing States to serve as accreditation bodies may also help expedite 
the transition of previously approved programs to the new system.
    It should be noted, however, that the Secretary is proposing in 
Sec. 8.3 to limit eligibility to those applicants (including States and 
political subdivisions of a State) who demonstrate that they will be 
able to accredit at least 50 OTP's per year. The Secretary believes 
that this requirement is needed to ensure the quality of the 
accreditation services performed by accreditation bodies and to 
minimize the variability in the standards used by accrediting 
organizations. The Secretary is interested in comments on this 
restriction and may revisit this requirement after the first 3 years.
    Under the proposal, prospective accreditation bodies will be 
required to develop and submit as part of an application for approval, 
``accreditation elements''. These elements, which are defined in 
proposed Sec. 8.2, are the elements that the accreditation body will 
apply during ``accreditation surveys'' as the basis or benchmark for 
determining whether a treatment program should receive accreditation. 
The accreditation elements are expected at a minimum to incorporate the 
``Federal opioid treatment standards'' issued by the Secretary in 
proposed Sec. 8.12, albeit with much greater detail. One focus of 
SAMHSA's oversight of the accreditation system will be the development 
and publication of up-to-date treatment guidelines to assist 
accreditation bodies in developing accreditation elements. It is also 
expected that an essential part of the accreditation elements will be 
clinical outcome and performance measures. Again, SAMHSA expects to 
issue detailed guidance on the development of such measures.
    As mentioned previously, accreditation bodies will base their 
accreditation decisions on experience gained during onsite ``surveys,'' 
as defined in proposed Sec. 8.2. The accreditation body's policies and 
procedures for conducting surveys will

[[Page 39816]]

be a major focus of the application process under proposed Sec. 8.3. 
The Secretary expects these accreditation body surveys to, in large 
measure, take the place of onsite inspections by DHHS investigators as 
the primary means of monitoring the operations of OTP's. Nevertheless, 
it is important to note that the Secretary has retained the right to 
conduct inspections of programs, including ``for-cause inspections,'' 
as defined in proposed Sec. 8.2. A ``certified opioid treatment 
program,'' as defined in proposed Sec. 8.2(i), is an organization that 
administers or dispenses ``opioid agonist treatment medications'' (see 
proposed Sec. 8.2(t)) for maintenance or detoxification treatment of 
opioid addiction, and that is the subject of a current certification 
issued by SAMHSA under proposed Sec. 8.11. As discussed below, to 
obtain certification from SAMHSA, under proposed Sec. 8.11, a treatment 
program must, at a minimum, ``be the subject of a current, valid 
accreditation by an accreditation body approved by SAMHSA * * *.'' 
Certification will be granted for a period not to exceed 3 years and 
will serve as the final determination by the Secretary that the program 
is ``qualified,'' as that term is used under section 303(g) of the CSA 
(21 U.S.C. 823(g)).
    It is important to note that the proposed definition of a 
``certified opioid treatment program'' includes individual 
practitioners, such as private physicians. Although the term 
``practitioners'' was used in the NATA, historically there have been 
few individual practitioners who have applied to dispense methadone or 
LAAM under the existing regulations. The Secretary is aware, however, 
that there is considerable interest in the issue of physicians in 
private or group practices providing opioid treatment outside the 
traditional OTP setting.
    The intent of this proposal is to develop a process for certifying 
qualified providers to dispense opioid drugs in the treatment of opioid 
addiction. Ideally, the proposed process would be sufficiently flexible 
to allow individual practitioners themselves to provide such services. 
Admittedly, the proposed Federal opioid treatment standards in some 
instances may not be well suited to office-based treatment. The 
Secretary therefore is specifically seeking comment on how the Federal 
opioid treatment standards might be modified to accommodate office-
based treatment and on whether a separate set of Federal opioid 
treatment standards should be included in this rule for office-based 
treatment.
    The proposal also retains the concept of ``medication units,'' as 
defined in proposed Sec. 8.2(s). A ``medication unit'' is a facility 
established as part of, but geographically dispersed from, the central 
location of an OTP. Licensed private practitioners and community 
pharmacists are permitted to administer and dispense opioid drugs from 
medication units without seeking a separate accreditation or a separate 
certification from SAMHSA. (Medication units, however, may require 
separate registration from DEA under section 303(g) of the CSA and 21 
CFR part 1300.) These units are also authorized to collect samples for 
drug testing or analysis for narcotic drugs. Medication units can serve 
to decrease the burden of patients who must travel considerable 
distances to obtain medication. SAMHSA must be notified before a 
medication unit can begin to provide opioid treatment medications to 
patients.
    Finally, the Secretary has proposed as a definition of the term 
``opioid addiction,'' in proposed Sec. 8.2(u), a condition in which an 
individual exhibits a compulsive craving for, or compulsively uses, 
opioid drugs despite being harmed or causing harm as a result of such 
craving or use. This definition reflects the idea that an individual 
suffering from opioid addiction may not exhibit concurrent physical 
dependence on opioids, as evidenced by the onset of signs of withdrawal 
upon administration of an opioid antagonist or following the last dose 
of an opioid drug.
2. Accreditation Body Approval and Related Requirements
    Proposed Sec. 8.3 outlines the process for applying to SAMHSA to 
become an approved accreditation body. The initial accreditation 
application shall include the name, address, and telephone number of 
the applicant and a responsible official for the application signed by 
the responsible official. The application also requires evidence of the 
nonprofit status of the applicant if the applicant is not a State 
governmental entity or political subdivision. The application must also 
include evidence that the applicant will be able to survey no less than 
50 OTP's annually.
     This section also requires that the application include a set of 
accreditation elements and a detailed discussion showing how the 
elements will ensure that each OTP surveyed by the applicant is 
qualified to meet or is meeting each of the Federal opioid treatment 
standards set forth in proposed Sec. 8.12. An accreditation body must 
also include a detailed description of its decisionmaking process. The 
process shall include procedures for initiating and performing onsite 
accreditation surveys of OTP's and the procedures for assessing OTP 
personnel qualifications.
     The accreditation body must submit copies of the application used 
for accreditation, along with guidelines, instructions, and other 
materials to be sent to OTP's during the accreditation process. This 
includes a request for a complete history of prior accreditation 
activities and a statement that all information and data submitted in 
the application for accreditation are true and accurate, and that no 
material fact has been omitted. Applicant accreditation bodies must 
also submit the policies and procedures for notifying OTP's and SAMHSA 
of deficiencies and for monitoring corrections of deficiencies by OTP's 
and policies and procedures for suspending or revoking an OTP's 
accreditation. The application shall include the policies and 
procedures that ensure processing of applications for accreditation and 
applications for renewal of accreditation within a timeframe approved 
by SAMHSA. Accreditation bodies must submit a description of the 
applicant's appeals process to allow OTP's to contest adverse 
accreditation decisions.
     The application also must include a description of the policies 
and procedures established by the accreditation body to avoid conflicts 
of interest or the appearance of conflicts of interest by the 
applicant's board members, commissioners, professional personnel, 
consultants, administrative personnel, and other representatives. In 
addition, the applicant must submit a description of the education, 
experience, and training requirements of the applicant's professional 
staff, accreditation survey team membership and the identification of 
at least one licensed physician on the applicant's staff and a 
description of the applicant's training policies. The application must 
include fee schedules, with supporting cost data. Applicant 
accreditation bodies must provide satisfactory assurances that the body 
will comply with the requirements of proposed Sec. 8.4, including a 
contingency plan for investigating complaints under proposed 
Sec. 8.4(e). Finally the application must include policies and 
procedures established to protect confidential information the 
applicant will collect or receive in its role as an accreditation body 
and any other information SAMHSA may require.
    Proposed Sec. 8.4 sets forth accreditation body responsibilities. 
Accreditation bodies will be responsible for conducting accreditation 
surveys and to take actions based upon the results of

[[Page 39817]]

these surveys. In addition, the accreditation body will have to keep 
certain records and submit periodic reports. Under proposed Sec. 8.5, 
SAMHSA will periodically evaluate the performance of accreditation 
bodies by inspecting a sample of OTP's that have been surveyed by the 
accreditation body and determining whether there are deficiencies that 
would warrant the withdrawal of the approval of the accreditation body 
under proposed Sec. 8.6. Proposed Sec. 8.6 establishes the actions and 
procedures that SAMSHA will take if it determines that an accreditation 
body is not complying with the requirements in this rule. This section 
describes contingencies for major and minor accreditation body 
deficiencies, including probationary status and reinstatement. Finally, 
proposed Sec. 8.6, provides an opportunity for accreditation bodies to 
challenge an adverse finding by requesting a hearing. Proposed 
Secs. 8.7 through 8.10 are reserved.
    These provisions were developed after consulting other Federal 
agencies, including the VA and the HCFA, and after reviewing existing 
accreditation systems. DHHS has also carefully reviewed existing 
certification-accreditation oversight systems, including FDA's 
mammography regulatory system. As such, DHHS believes that these 
provisions are reasonable and reflect what has become a standard 
approach for ensuring the quality of health-care practices. Similarly, 
it is customary for oversight agencies to validate the performance of 
accreditation bodies through periodic direct inspections of 
establishments that have or have not received full accreditation. DHHS 
believes that validation inspections are a reasonable and efficient 
mechanism for ensuring that approved accreditation bodies are carrying 
out their responsibilities.
    a. Patient confidentiality. The patient records maintained by OTP's 
are subject to the confidentiality protections of State and Federal 
laws. With respect to patient confidentiality, section 543 of the PHS 
Act (42 U.S.C. 290dd-1) and its implementing regulations, 42 CFR part 
2, are fully applicable to OTP's. OTP's are ``programs'' as defined by 
42 CFR 2.11 and are ``federally-assisted'' as defined by 42 CFR 
2.12(b)(2). Under these regulations, the treatment programs are 
prohibited from disclosing patient identifying information except in 
certain prescribed circumstances such as under patient consent, for 
purposes of research, audit or evaluation, or under a court order 
consistent with subpart E of 42 CFR part 2.
    The regulations at 42 CFR part 2 would permit programs to disclose 
patient records to accreditation bodies under the audit and evaluation 
exception at 42 CFR 2.53. To the extent that the accreditation body 
needs to copy records containing patient identifying information, it 
must agree in writing to: (1) Maintain the patient identifying 
information in accordance with the security requirements provided in 42 
CFR 2.16 of the regulations, (2) destroy all patient identifying 
information upon completion of the audit or evaluation, and (3) comply 
with the limitations on redisclosure of 42 CFR 2.53(d).
    b. Prevention of conflicts of interest. With respect to conflicts 
of interest, the Secretary is proposing that accreditation bodies must 
submit to SAMHSA, as part of an application for approval under proposed 
Sec. 8.3(b)(6), the policies and procedures maintained by the 
accreditation body to ensure that the body remains impartial and free 
of commercial, financial, and other pressures that might present an 
actual or apparent conflict. Although it is not possible to state 
categorically all of the criteria for assessing whether an 
accreditation body will be free of conflicts, the most common condition 
that would indicate a potential conflict would be one in which any 
member of the accreditation team (or an immediate family relative) has 
a financial interest of any type, direct or indirect, in the treatment 
program to which the team is assigned. Likewise, it may be appropriate 
that anyone employed by the accreditation body who is involved in any 
respect in the accreditation decision for a particular program must be 
free of a financial interest in the program. DHHS seeks comments on the 
types of financial conflicts that should be prohibited, or on the 
amount of financial interest that may be considered de minimus such 
that it would not rise to a conflict of interest. Fees charged to 
programs must in no way be made contingent, in whole or in part, on a 
particular accreditation decision or outcome.

B. Subpart B--Certification and Treatment Standards

    Subpart B of part 8 proposes the process by which OTP's may obtain 
certification from SAMHSA, the conditions necessary for remaining 
certified, and the process by which SAMHSA may suspend or revoke 
certification. In addition, subpart B of part 8 proposes the 
Secretary's Federal opioid treatment standards.
1. OTP Certification
    Under proposed Sec. 8.11, treatment programs must obtain 
certification from SAMHSA for the program to be considered 
``qualified'' by the Secretary under 21 U.S.C. 823(g). Certification 
will be for a term not to exceed 3 years but may be extended as 
necessary, with permission from SAMHSA, to accommodate accreditation 
cycles.
    A program must obtain a current, valid accreditation from a SAMHSA 
approved accreditation body in order to be considered eligible for 
certification. Although SAMHSA expects that most programs that obtain 
accreditation will, as a matter of course, obtain certification, there 
are circumstances in which SAMHSA could deny certification to an 
accredited program. Under proposed Sec. 8.11(c)(2), SAMHSA may deny 
certification if a program's application for certification (see 
proposed Sec. 8.11(b)) is deficient in any respect; if SAMHSA 
independently determines that the program will not be operated in 
accordance with the Federal opioid treatment standards; if the program 
has improperly denied access to the facilities or to its records; or if 
it is determined that the program has in any respect made 
misrepresentations or omitted material facts in the course of obtaining 
accreditation or applying for certification. Although it is expected 
that a denial of certification for a program that has obtained 
accreditation would be a rare occurrence, the Secretary nevertheless 
has retained the authority to deny certification. Likewise, the 
Secretary has retained the authority to independently certify a program 
that has not obtained accreditation. Again, this authority would be 
used only in rare circumstances.
    Proposed Sec. 8.11(d) provides for ``transitional certification'' 
during the period when the former regulations at part 291 will have 
been repealed and the new accreditation based regulations, under 42 CFR 
part 8, are just beginning to be implemented. The intent of these 
provisions is to allow programs that were approved under the old 
regulations to remain in operation for a reasonable period of time so 
that there is sufficient time for: (1) SAMHSA to approve one or more 
accreditation bodies, (2) programs to apply for and obtain 
accreditation from one of the approved accreditation bodies, and (3) 
SAMHSA to make certification decisions based on the outcome of the 
accreditation process.
    First, OTP's that have not obtained certification from SAMHSA, but 
are the subject of a current approval by FDA

[[Page 39818]]

under part 291 as of the effective date of the regulation will be 
granted ``transitional certification'' for a period of 90 days after 
the effective date of the final rule. Under the proposal, programs that 
are granted transitional certification must apply to SAMHSA during this 
90-day period to extend their transitional certification for up to 2 
years from the effective date of the regulation. To extend transitional 
certification, an OTP must submit the information that would be 
required in a new application for certification (proposed 
Sec. 8.11(b)). In addition, the program must include a statement 
certifying that the OTP will apply for accreditation from a SAMHSA 
approved accrediting body within 90 days from the date SAMHSA approves 
the first accreditation body under proposed Sec. 8.3. SAMHSA intends to 
announce the approval of accreditation bodies in the Federal Register 
and through other media. In addition, if a program has applied for 
accreditation but the accreditation body is unable to complete its 
survey prior to 2 years from the effective date of this regulation, 
SAMHSA may extend a program's transitional certification for up to 1-
additional year.
    It should be noted that the Secretary is proposing that treatment 
programs will be subject to the requirements of these rules upon the 
effective date. SAMHSA will be overseeing the regulations and will be 
monitoring programs during the 90-day application period as well as 
subsequently in accordance with the regulations. It is expected that 3 
years will be sufficient time for all OTP's to become accredited, 
although the Secretary would expect that most programs will be 
accredited within 2 years.
    Proposed Sec. 8.11 also provides a mechanism to allow for 
``provisional certification'' when a program is diligently pursuing 
accreditation. Under Sec. 8.11(e), OTP's that have not previously 
obtained certification from SAMHSA, but have applied for accreditation 
with an accreditation body, are eligible to receive a provisional 
certification for up to 1 year. To receive a provisional certification 
for up to 1 year, an OTP must submit the information set out in 
Sec. 8.11(b) to SAMHSA along with a statement identifying the 
accreditation body to which the OTP has applied for accreditation, the 
date on which the OTP applied for accreditation, the dates of any 
accreditation surveys that have taken place or are expected to take 
place, and the expected schedule for completing the accreditation 
process. A provisional certification for up to 1 year will be granted, 
following receipt of the information described in this paragraph, 
unless SAMHSA determines that patient health would be adversely 
affected by the granting of provisional certification.
    An extension of provisional certification may be granted in 
extraordinary circumstances or otherwise to protect public health. To 
apply for a 90-day extension of provisional certification, an OTP must 
submit to SAMHSA a statement explaining the program's efforts to obtain 
accreditation and a schedule for obtaining accreditation as 
expeditiously as possible.
    Proposed Sec. 8.11 also addresses the use of opioid treatment 
medications in patients hospitalized or admitted to long-term care 
facilities for treatment of a medical condition other than opioid 
addiction. Under proposed Sec. 8.11(a)(4), the Secretary will not 
require such facilities to seek certification in order to provide 
maintenance or detoxification treatment to a patient who has been 
admitted for medical conditions other than addiction or if the patient 
is already enrolled in a certified OTP and such enrollment has been 
verified. The terms ``hospital'' and ``long-term care facility'' are 
determined according to the law of the State in which the facility is 
located. This provision is not intended to relieve hospitals and long-
term care facilities from their obligations for registration under 
section 303(g) of the CSA and under regulations issued by DEA (see 21 
CFR 1306.07(c)).
    Under DEA's regulations, DEA requires (and will continue to 
require) registration of such facilities if approved controlled 
substances are dispensed or administered from a location, such as a 
long-term care facility, even though the controlled substances are not 
stored overnight. Further, if an OTP patient is admitted to a hospital 
for anything other than addiction, the hospital can administer or 
dispense a narcotic drug to maintain or detoxify a person as an 
incidental adjunct to medical or surgical treatment during the term of 
the stay in the hospital. However, because long-term care facilities 
are not considered hospitals by DEA, patients in long-term care 
facilities cannot currently receive methadone as an adjunct to medical 
or surgical treatment of conditions other than addiction unless the 
facility is registered with the DEA. However, if the individual was 
formerly a patient in an OTP, the OTP may transfer the opioid 
medication (i.e., methadone or LAAM) to the long-term care facility 
under a delivery protocol which complies with State and Federal 
regulations.
    Section 8.11(f) proposes the general conditions of certification. 
First, under the proposal, OTP's must agree to comply with all 
applicable State laws and regulations. The Secretary, however, will not 
require State approval of a program as a condition precedent to 
obtaining certification under proposed Sec. 8.11(c). DEA regulations 
will continue to require State approval before issuing a DEA 
registration.
    As provided in the CSA, 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 that should be available. For example, under 
the ADAMHA Reorganization Act of 1992, the Chief Public Health Officer 
within a State must certify that interim methadone maintenance will not 
``reduce the capacity of comprehensive programs'' within the State. In 
addition, some States consider the proximity of other treatment 
programs in deciding whether to approve a treatment program, or the 
number of treatment programs currently operating in the State (Refs. 25 
and 26). And, at least one State limits methadone treatment to 
nonprofit programs (Ref. 27).
    Nothing in this part is intended to restrict State governments from 
regulating the use of opioid drugs in the treatment of opioid 
addiction. Importantly, there will still be extensive cooperation 
between SAMHSA and relevant State authorities. However, in determining 
whether an OTP that is applying for certification satisfies the 
requirements of section 303(g) of the CSA (21 U.S.C. 823(g)), the 
Secretary will not require that the program first obtain approval from 
a relevant State authority.
    Second, treatment programs must agree to allow SAMHSA, DEA 
officials, relevant State officials, and authorized accreditation 
bodies access to conduct surveys and inspections (including unannounced 
inspections), and full access to patient records. Failure to allow such 
access will be grounds for denial of certification or, in the case of a 
certified facility, suspension or revocation of certification under 
proposed Sec. 8.14(a)(4). Note also that SAMHSA will continue to 
conduct inspections of OTP's to validate the performance of 
accreditation bodies, in instances where accreditation is determined to 
be inadequate and otherwise as needed to ensure that all treatment 
programs are operating in a

[[Page 39819]]

manner consistent with the Federal opioid treatment standards.
    Third, the proposal retains under Sec. 8.11(g) the provisions and 
requirements for authorizing interim methadone maintenance program 
approval. These provisions were mandated by the ADAMHA Reorganization 
Act of 1992 and remain in effect. Under proposed Sec. 8.12(e), SAMHSA 
will process requests for interim maintenance approval.
    The proposal retains, under Sec. 8.11(h), a provision that allows 
an OTP to request from SAMHSA an exemption from the regulatory 
requirements set forth under proposed Secs. 8.11 and 8.12. An example 
of a case in which an exemption might be granted would be for a private 
practitioner seeking to treat a limited number of patients in an area 
with few physicians and no geographically accessible rehabilitative 
services. In such an instance, SAMHSA would consider a request for an 
exemption from certain of the staff credential or required services 
standards, as well as an exemption from the requirement to be 
accredited. Another example would be an exemption that might be granted 
to a State sponsored pilot program which uses innovative dose schedules 
or dispensing practices for an already approved opioid agonist 
treatment medication.
    Finally, the proposal requires as a condition of continued 
certification that programs must notify SAMHSA within 3 weeks regarding 
any change in the status of the program sponsor, such as a corporate 
reorganization, or a change in the status of the medical director, such 
as the retirement or termination of the individual in that role.
2. Federal Opioid Treatment Standards
    Proposed Sec. 8.12 proposes the Secretary's ``Federal opioid 
treatment standards'' as enforceable regulatory requirements that 
treatment programs must follow as a condition of certification. The 
requirements, which are discussed in greater detail as follows, address 
the opioid drug products approved for use in certified OTP's, dosage 
form limitations, the requirements necessary to assure that medications 
dispensed for unsupervised or ``take-home'' use do not present 
inappropriate risks for diversion, the minimum program staffing 
requirements and staff responsibilities, admission and enrollment 
requirements, and required services. These standards will form the 
outline for, and will inform the development of, each accreditation 
body's approved accreditation elements.
    Proposed Secs. 8.13 and 8.14 address the process that SAMHSA will 
follow in suspending or revoking certification under these regulations. 
The proposal includes timeframes for notifying DEA when a treatment 
program's registration should be suspended or revoked. In addition, 
these sections address the contingencies when an accreditation body 
itself revokes a program's accreditation, or when an accreditation 
body's approval to perform accreditations is revoked.
    Proposed Sec. 8.14(b) provides the circumstances under which SAMHSA 
will suspend a treatment program's certification. If SAMHSA finds 
substantial evidence of an imminent hazard to health, SAMHSA will 
suspend certification and notify DEA to suspend registration under 21 
U.S.C. 824(d). Substantial evidence of imminent hazard could include 
evidence that treatment program practices are leading to unacceptable 
levels of diversion or other practices that create an unacceptable 
level of risk to the safety of patients or the community.
    The procedures set forth in this proposal for revoking or 
suspending certification of treatment programs are similar to the 
existing procedures for withdrawing approval under Sec. 291.505(h). 
Notice and an opportunity for an informal review and hearing will be 
provided prior to revocation, in accordance with proposed subpart C 
(discussed as follows). An expedited process is also included for 
seeking review of decisions to immediately suspend certification.
    It should be noted that DEA also has a process for review when a 
registration is revoked or suspended consistent with the requirements 
of 21 U.S.C. 824(c). (See part 1301 (21 CFR part 1301).) Although the 
procedures for review of a suspension or revocation set forth in this 
notice are being proposed at this time, DHHS intends to work with DEA 
to ensure that only a single hearing occurs when a program's 
certification is suspended or revoked under the DHHS regulations, so as 
not to duplicate effort. Specifically, it may be decided, as part of 
the final rule, that DEA should have the lead in conducting the 
hearing, in which case the regulations at part 1301 would apply rather 
than the hearing process in subpart C of part 8 of the proposed rule. 
Alternatively, it may be decided that the hearing process in subpart C 
of part 8 will be retained in the final rule, but that SAMHSA would 
request the DEA hearing official to defer to the decision of the 
Secretary with respect to determinations made under 21 U.S.C. 823(g)(1) 
and (g)(3). At this time, however, the Secretary is proposing a 
separate hearing process and is seeking comment on the proposed 
process.
    The final provision in subpart B (proposed 42 CFR 8.15) proposes 
two new application forms: SMA-162, Application for Certification for 
Use of Opioid Drugs in a Treatment Program; and SMA-163, Application 
for Becoming an Accreditation Body under proposed 42 CFR 8.3. SAMHSA is 
in the process of obtaining OMB review for these new forms.
    SMA-162, Application for Certification to Use Opioid Drugs in a 
Treatment Program, will closely track the existing application form for 
FDA approved treatment programs. The applicant will have to provide the 
name of the program (or primary dispensing location), the address of 
the primary dispensing location, the name and address of the program 
sponsor, along with appropriate telephone numbers. In addition, the 
form requires the submitter to provide estimates of the number of 
patients to be treated and the program funding source, along with 
descriptions of the organizational structure of the program. The new 
form will retain the language on establishing a patient record system, 
and maintaining patient records for at least 3 years. The proposed 
SAMHSA form would require information on the program's accreditation 
status as required by proposed Sec. 8.11(a)(2).
    Under the existing regulation, a treatment program is required to 
complete and submit a new form when there is a change in location of 
the treatment program, or a change in program sponsor. SAMHSA is 
retaining this reporting requirement. In addition, a treatment program 
must submit a new form before establishing a medication unit.
    Under the proposal, Form FDA-2635, Consent to Treatment with an 
Approved Narcotic Drug, would be eliminated. Current regulations 
require that the person responsible for the program must ensure that 
the patient has voluntarily chosen to participate in treatment; that 
all relevant facts concerning the use of the opioid drug are clearly 
and adequately explained; and that the patient, with full knowledge and 
understanding of its contents, signs the consent form. A specific 
consent to treatment form was considered necessary when methadone 
maintenance treatment was a relatively unfamiliar treatment modality in 
the early 1970's. Indeed, Form FDA-2635 reflected the idea that 
methadone is a drug that FDA had identified under 21 CFR 310.303 as one 
for which

[[Page 39820]]

additional long-term studies were needed. FDA, however, has removed 
that designation for methadone (61 FR 29476, June 11, 1996). While 
patients should continue to be counseled on the risks of opioid agonist 
maintenance therapy and provide written consent to treatment, and 
accreditation bodies should include elements to assure such counseling, 
the Secretary has tentatively concluded that a Federally mandated 
consent-to-treatment form is no longer necessary.
    Form FDA-2633, Medical Responsibility Statement for Use of Narcotic 
Drugs in a Treatment Program, would also be discontinued. This form 
predates the NATA, and was first announced in the initial 1972 
regulation (Ref. 28). According to a Paperwork Reduction Act analysis 
published in 1998 (Ref. 29), FDA estimated that 275 of these forms are 
submitted annually, requiring a total of 70 hours to complete. The form 
must be signed by all program physicians who, in turn, agree to assume 
responsibility for dispensing and administering opioid substances and 
agree to abide by the standards set forth in the regulations. In 
addition, program physicians agree to adhere to the patient 
confidentiality requirements of 42 CFR part 2. Finally, the form 
requires that those program physicians who are also medical directors 
will assume responsibility for administering medical services and for 
ensuring compliance with all applicable Federal, State, and local laws. 
While the Secretary is proposing to retain these requirements for 
program physicians and medical directors, as part of the Federal opioid 
treatment standards and as a condition for continued certification, the 
requirement that a form be submitted is no longer considered necessary 
in order to ensure compliance.
    The Secretary is also proposing to eliminate the requirement for 
separate forms for maintenance treatment and detoxification treatment 
(see FDA-2636 Hospital Request for Methadone Detoxification Treatment). 
Under the proposed rule, entities providing either maintenance or 
detoxification treatment must conform to the same core Federal opioid 
treatment standards. One qualification, however, is that a hospital-
based detoxification program would not be required to obtain a separate 
accreditation if the hospital itself is accredited by a SAMHSA approved 
accreditation body and certified by SAMHSA.

C. Subpart C--Procedures for Review of Denial, Suspension, or 
Revocation of Certification

    Subpart C of proposed part 8 sets forth procedures for programs to 
seek review of denials, suspensions, or revocations of certification. 
The subpart C procedures are also available to accreditation bodies who 
are denied approval or whose approval has been revoked by SAMHSA.
    The proposed procedures will ensure that programs will be given 
adequate notice of adverse actions, ample opportunity to submit written 
information, and an opportunity to request an oral hearing. The 
procedural framework follows the procedures applied by SAMHSA's 
Division of Workplace Programs under the ``Mandatory Guidelines for 
Federal Workplace Drug Testing Programs'' (59 FR 29908, June 9, 1994).

IV. Federal Opioid Treatment Standards

A. General

    Proposed Sec. 8.12 sets forth the Secretary's Federal opioid 
treatment standards. These standards represent the Secretary's core 
requirements for the medical treatment of opioid addiction with opioid 
agonist treatment medications. Taken together, the Secretary's 
standards outline the essential framework of a state-of-the-art 
addiction treatment program, with additional details to be supplied 
through Federal guidelines under development by SAMHSA and by 
accreditation elements to be developed by expert accreditation bodies.
    The Secretary's proposed standards also reflect the minimal 
requirements necessary to reduce the risk of diversion of opioid 
treatment drugs. Among other things, the Secretary has set forth 
specific quantities of opioid drugs to be used for unsupervised ``take 
home'' use and certain other constraints on take-home use.
    On the whole, these standards carefully balance the need for 
enforceable requirements, including clear standards to minimize the 
risk of diversion, against the pressing need to increase the clinical 
discretion and judgment in opioid addiction treatment. In addition, 
these standards reflect many of the elements that the IOM identified as 
necessary to prevent ``substandard treatment.''

B. Administrative and Organizational Structure

    Section 8.12(b) proposes to require that an OTP's organizational 
structure must be adequate to ensure patient care. At a minimum, there 
must be a program sponsor who agrees to adhere to regulatory 
requirements. In addition, the Secretary believes it is essential, as 
with other medical treatments, that physicians oversee the medical 
aspects of treatment. Therefore, all OTP's must have a designated 
medical director.

C. Continuous Quality Improvement

    Proposed Sec. 8.12(c) requires that OTP's have a quality assurance 
plan and pursue continuous quality improvement activities. Importantly, 
treatment programs must continuously assess patient outcomes. 
Consistent with the findings from the GAO report, programs will be 
required to assess and improve the quality of the treatment they 
provide. In addition, as discussed elsewhere in this document, 
considerable advancements have been made in the field of methadone 
treatment outcome assessment. (See section II.C. of this document, 
discussion of MTQAS.) Examples of possible outcomes include: Reducing 
or eliminating illicit drug use, reducing or eliminating associated 
criminal activities, reducing behaviors contributing to the spread of 
infectious diseases, and improving quality of life by restoration of 
physical and mental health status.
    The Secretary also proposes, under Sec. 8.12(c)(2), that treatment 
programs include a ``Diversion Control Plan'' as part of the quality 
assurance plan. As noted elsewhere in this proposal, the IOM devoted an 
entire chapter to the issue of the diversion of treatment medications, 
an issue that remains a serious concern. While existing regulations 
require programs to monitor patients with drug abuse tests, and to 
include contingencies for positive results, the Secretary believes that 
program specific diversion control plans will help to reduce the scope 
and significance of diversion. Such plans would describe, among other 
things, a comprehensive diversion monitoring program that assigns 
specific responsibility to medical and administrative staff for 
carrying out diversion control measures and functions.

D. Staff Credentials

    Proposed Sec. 8.12(d) requires that physicians, nurses, addiction 
counselors, and other licensed professionals have sufficient education, 
training, and experience to enable them to perform assigned functions. 
While the standard does not require that treatment programs retain on 
staff individuals credentialed in the addiction treatment field, the 
Secretary

[[Page 39821]]

notes the existence of such specialties and encourages treatment 
programs to maintain or employ sufficient expertise in the field of 
addiction treatment to ensure quality treatment. In addition, licensed 
professional care providers, including addictions counselors, must 
comply with the credentialing requirements of their respective 
professions.

E. Patient Admission Criteria

    The proposal retains most of the criteria from the existing 
regulation for admitting patients to maintenance and detoxification 
treatment. Under these criteria, patients eligible for admission to 
detoxification treatment (the IOM used the term ``Medically Supervised 
Withdrawal'') must be physiologically dependent upon opioids. In 
addition, qualified personnel must use accepted medical criteria, 
including those listed in the Diagnostic and Statistical Manual for 
Mental Disorders (DSM-IV), to determine that patients eligible for 
maintenance treatment are currently addicted to an opioid drug and 
became addicted at least 1 year before admission to treatment. The 
regulation retains exceptions for pregnant patients, patients released 
from penal institutions, and previously treated patients.
    The current criteria require a 7 day waiting period between each 
detoxification treatment admission. The rationale for this requirement 
seems to have been a concern that overlapping detoxification admissions 
could lead to de facto maintenance treatment, albeit without the 
comprehensive treatment requirements associated with maintenance 
treatment. The Secretary has now tentatively concluded that 7 days is 
more time than is needed for this purpose, and may unnecessarily expose 
addicts to increased risks from HIV and other infectious diseases. The 
Secretary seeks comments on a shorter period, perhaps 2 days, as a 
waiting period between detoxification admissions.

F. Required Services

    Under proposed Sec. 8.12(f), OTP's must provide adequate medical, 
counseling, vocational, educational, and assessment services to 
patients enrolled in the OTP. These services were identified in the IOM 
report and elsewhere as essential standards of adequate treatment. The 
proposal retains the provision that these services must be available at 
the primary facility, unless the program sponsor has entered into a 
formal agreement with another entity to provide these services. 
Further, the proposal retains the requirement for the development and 
periodic evaluation of a treatment plan for each patient that reflects 
an assessment of the patient's current needs.
    While the medication (methadone or LAAM) itself is an essential 
element of this modality of treatment, most patients also require a 
variety of other services to obtain the best and most expeditious 
outcomes. Since their inception, the existing regulations have 
reflected the need to provide services to patients in addition to the 
treatment medications. Indeed, the IOM report recommended that certain 
services should be retained as an enforceable requirement. This 
proposal specifies such services in the opioid treatment standards. In 
the past, DHHS has attempted to write all facets of these required 
services into regulation. It is now accepted, however, that: (1) 
Different patients, at different times, may need vastly different 
services, and (2) 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 treatment methods improve.
    Through this rulemaking, DHHS is proposing a more flexible, 
performance-based approach. 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 
application 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.

G. Recordkeeping and Patient Confidentiality

    Under proposed Sec. 8.12(g), OTP's must maintain a patient record 
system that is adequate to document and monitor patient care and 
outcomes, and comply with relevant Federal and State requirements. In 
addition, OTP's are required to keep patient records confidential in 
accordance with applicable Federal and State requirements.
    Although difficult to quantify, there have been cases of patients 
enrolling in more than one treatment program. The Secretary, therefore, 
is retaining the requirement that treatment programs determine that 
patients upon admission are not enrolled in any other OTP.

H. Medication Administration, Dispensing, and Use

    The proposal retains requirements from the existing regulations 
that treatment medications are dispensed by practitioners licensed 
under all applicable Federal and State laws to dispense such 
medications. In addition, the proposal retains initial and first day 
dose requirements for methadone which are consistent with the IOM 
recommendations.
    Proposed Sec. 8.12(h)(2) includes the requirement that only 
medications approved by FDA for the treatment of opioid dependence or 
addiction shall be available for use by OTP's in treating these 
conditions. Currently, methadone and LAAM are listed in this section. 
If FDA approves a new opioid medication for the treatment of opioid 
dependence, the Secretary would amend this regulation to address the 
new medication. This section is not intended to preclude the use of 
other types of medications in treating the patient for medical 
conditions other than opioid addiction. Similarly, this section is not 
intended to preclude the use of ancillary, approved nonnarcotic 
medications for the treatment of the opioid addiction to improve the 
effectiveness of the addiction treatment.
    Moreover, approved medications must be used in accordance with 
current, FDA-approved labeling. Deviations from the approved labeling 
must be approved by the program physician and justified in the 
patient's medical records.
    The proposed regulations do not include the specific requirements 
set forth in the existing regulations at Sec. 291.505(k)(1) for the use 
of LAAM. These requirements include provisions on initial dosing with 
LAAM, LAAM dosage form, distinguishing LAAM and methadone dosage forms, 
and prohibiting the unsupervised (take-home) use of LAAM. In addition, 
the regulations prohibit the use of LAAM in patients under 18 years of 
age and require initial and periodic pregnancy testing for the drug to 
be administered to patients of childbearing potential.
    The Secretary is proposing to withdraw these LAAM specific 
requirements from the Federal opioid treatment standards, to allow more 
room for clinical judgment. Some of these changes reflect the 
experience gained from over 4-years experience with the use of LAAM in 
OTP's. Requirements relating to the unsupervised use of LAAM are 
discussed as follows.
    The Secretary notes that there are new medications under 
development for the treatment of opioid addiction. While still under 
investigation and review, it is conceivable that these new medications 
will present safety and effectiveness profiles that differ from the 
existing approved treatment

[[Page 39822]]

medications, methadone and LAAM. A new medication, for example, could 
rely on weak or partial agonist properties or on mixed agonist-
antagonist properties, with pharmacokinetic and pharmacodynamic 
properties that would minimize the risk of deliberate abuse through 
injection and, in turn, would minimize the overall risk of diversion. 
As such, it may be appropriate to tailor the Federal opioid treatment 
standards to the specific characteristics of these future medications.

I. Unsupervised Use

    The existing regulations establish a complex scheme to address the 
unsupervised use of methadone, including extensive ``time in treatment 
requirements.'' The program physician's rationale for prescribing take-
home doses must be documented in the patient's medical records and must 
reflect eight subjective criteria (``take-home criteria'') specified in 
the regulations (Sec. 291.505(d)(6)(iv)(B)(1) through 
(d)(6)(iv)(B)(8)), to ensure that the patient will be responsible in 
handling the opioid drugs.
    Many have criticized the emphasis and extent of these requirements, 
noting that methadone patients are already subject to extraordinary 
degrees of monitoring (Ref. 30). The regulations governing the use of 
take-home medications in OTP's are among the requirements that have 
been in existence since 1972.
    As noted in the 1995 IOM report, problems associated with diverted 
methadone have been reduced substantially from the 1970's. The IOM, for 
example, examined 1992 Drug Use Forecasting (DUF) data on arrests and 
found that the recent use of methadone among those arrested is low 
relative to other drugs included in the DUF database. The IOM noted 
that ``while some street methadone is abused, it constitutes a 
relatively small part of the drug abuse problem generally * * * [and] 
instances of primary addiction are few'' (Ref. 31). The IOM concluded 
that most of the diversion associated with methadone is from patients' 
take-home supplies, however, ``the amount of methadone diverted to the 
street, by whatever means, is relatively small.'' The IOM also found a 
dearth of information on the degree to which methadone is implicated in 
drug-related crimes and on the amount of police effort devoted to the 
prevention of its diversion and, therefore, concluded that ``diverted 
methadone plays a small part in the overall drug-crime problem and 
receives a low priority in law enforcement efforts.''
    The IOM also examined the extent to which diverted methadone 
contributes to death and morbidity, and the extent to which proceeds 
from the sale of diverted methadone are used to purchase other illicit 
drugs. No strong evidence surfaced to demonstrate that methadone plays 
a significant role in drug-related deaths or emergency hospital care, 
or that proceeds from the sale of diverted methadone are used to any 
notable extent in the purchase of illicit drugs.
    DEA, on the other hand, published a ``Methadone Diversion'' (Ref. 
32) report in April 1995 citing cases of armed robbery and clandestine 
methadone laboratories and found that, indeed, methadone is diverted 
and abused. In addressing some of the IOM recommendations, DEA stated 
that ``[t]o relax controls in clearly identified areas which contribute 
to the illicit trafficking would not enhance treatment, but instead 
would further erode public confidence in treatment and expand traffic 
and abuse of methadone.''
    Having considered both sides of the issue, the Secretary is 
proposing several options for determining whether OTP's comply with 
standards respecting the quantities of opioid drugs which may be 
provided to patients for unsupervised use. The Secretary is 
specifically requesting comment on these approaches, as well as the 
optimal combination of regulatory requirements, accreditation elements, 
and oversight procedures to reduce the risks of diversion.
    The options set forth as follows reflect two important factors. 
First, the Secretary has tentatively concluded that certain of the 
restrictions in the existing regulations are too restrictive, 
especially when they are applied to those patients who have been in 
treatment for extended periods and have demonstrated responsibility in 
handling opioid drugs. Such a patient, for example, could greatly 
benefit from having access to take-home supplies beyond 6 days, an 
amount which under the current regulations would require the granting 
of a special exemption by FDA. The options, then, reflect greater 
flexibility for providing take-home supplies to certain long-term 
patients.
    Second, as noted previously, the current regulations prohibit the 
dispensing of LAAM for unsupervised use. This prohibition reflected the 
lack of experience with LAAM at the time of its approval in 1993, 
coupled with concerns about LAAM's lengthy induction properties. LAAM 
has now been available to treatment programs for several years, and the 
number of programs authorized to use LAAM has grown considerably. In 
addition, FDA and SAMHSA have received numerous inquiries expressing 
concern about the prohibition on the unsupervised use of LAAM, 
particularly with respect to those who need to travel and must abruptly 
switch to methadone. Such switching can be disruptive to patients 
stabilized on LAAM. Accordingly, the Secretary has tentatively decided 
to remove the prohibition on the unsupervised use of LAAM.
    Options 2, 3, and 4, would allow unsupervised use of any approved 
opioid treatment medication. The Secretary, however, is specifically 
requesting comments, including data from the treatment field, that bear 
on the issue of whether to allow take-home use of LAAM.
1. Option 1--Retain Current System
    Under the first option, the Secretary would retain the current 
regulatory scheme prohibiting the unsupervised use of LAAM. For 
methadone, the time-in-treatment requirements, maximum 6-day supply, 
probation, exemptions, and criteria for determining responsibility all 
remain as opioid treatment regulatory requirements. As in the current 
regulations, the program physician would be required to consider the 
following ``take-home criteria'' in determining whether a patient is 
responsible in handling opioid drugs:
    1. Absence of recent abuse of drugs (opioid or nonnarcotic), 
including alcohol;
    2. Regularity of clinic attendance;
    3. Absence of serious behavioral problems at the clinic;
    4. Absence of known recent criminal activity, e.g., drug dealing;
    5. Stability of the patient's home environment and social 
relationships;
    6. Length of time in comprehensive maintenance treatment;
    7. Assurance that take-home medication can be safely stored within 
the patient's home; and
    8. Whether the rehabilitative benefit to the patient derived from 
decreasing the frequency of clinic attendance outweighs the potential 
risks of diversion (Sec. 291.505(d)(6)(iv)(B)).
    Accreditation bodies would have elements designed to ensure that 
treatment program quality assurance plans include sentinel events and 
followup actions to assure that patients are not misusing medications 
provided for unsupervised use. SAMHSA would determine program-wide and 
individual patient exemptions for take-home use beyond a 6-day supply.

[[Page 39823]]

2. Option 2--Follow the IOM's Recommendation
    The second option tracks the IOM's recommendation. This option 
would retain the regulatory requirement that the medical director shall 
be responsible for determining whether a patient can responsibly handle 
opioid treatment drugs for unsupervised use. In addition, all decisions 
on take-home medications would be documented in the patient's medical 
chart. The basis for the medical director's clinical judgment must be, 
at a minimum, the eight criteria listed currently in 
Sec. 291.505(d)(6)(iv)(B). These criteria would be a required part of 
the accreditation elements that will be assessed periodically by 
accreditation bodies and would be included in the determination of 
whether to accredit the treatment program.
    The Federal opioid treatment standards would include the following 
restrictions on the use of controlled opioid medications for 
unsupervised use:
    1. For the first month of treatment, the maximum take-home supply 
is limited to a single dose each week and the patient shall ingest all 
other doses under appropriate supervision.
    2. In the second month of treatment, the maximum take-home supply 
is two doses after each supervised ingestion.
    3. In the third month of treatment, the patient should have 
ingestion observed at least twice a week, with take-home permitted for 
other doses.
    4. In the remaining months of the first year, the maximum take-home 
supply of methadone is three doses after each supervised ingestion.
    5. After 1 year, a selected patient would become eligible for less 
intensive supervision of medical ingestion and may be given up to a 31-
day supply of take-home medication and monthly visits. Another 
variation on this option would have patients receiving up to a 14 day 
take-home supply after 1 year, and up to a 31-day supply after 2 years. 
In addition, patients could be subject to monthly drug abuse 
tests.Under this option, SAMHSA would still consider individual, but 
not program-wide, exemptions for travel, medical, or other 
``hardships.''
    The Secretary has tentatively concluded that Option 2 contains the 
optimal level of control and has therefore included this option in 
Sec. 8.12 of the proposed rule. Option 2 is the alternative which 
follows the IOM's recommendations and which involves the regulatory 
requirement that the medical director shall be responsible for 
determining whether a patient can responsibly handle unsupervised 
medication. Documentation of the decision regarding take-home 
medication would continue to be required in the patient record, and the 
decision would be based on the eight criteria currently listed in 
Sec. 291.505(d)(6)(iv)(B). Restrictions on controlled opioid 
medications for unsupervised use would be: 1 take-home dose per week 
for the first month of treatment; 2 doses per week after each 
supervised ingestion in the second month of treatment; ingestion 
observed at least twice weekly with take-homes permitted for other 
doses during the third month of treatment and maximum take-home supply 
of 3 doses per week after each supervised ingestion for the remainder 
of the first year. After 1 year, a selected patient may become eligible 
for less intensive supervision and may have take-home doses varying 
from 14 to 31 days at a time. DHHS believes this take-home schedule 
reflects patient responsibility timeframes and adequately balances the 
need for clinical judgment in this treatment parameter with the risk of 
medication diversion. The DEA supports proposed Option 2.
3. Option 3--Maximum Amount Approach
    Under the third option, the regulations would set a maximum amount, 
1.5 grams of methadone or 0.8 grams of LAAM, per 2-week period. In 
addition, treatment programs would be required to maintain adequate 
records on the dispensing of opioids for unsupervised use to 
demonstrate compliance with conditions of accreditation. The existing 
regulatory criteria would become accreditation elements.
4. Option 4--Retain Existing Requirements, Subject to Continuous Review 
by Accreditation Bodies
    The fourth and final option would retain the regulatory requirement 
that the medical director, or a designated program physician, is 
responsible for determining that a patient can responsibly handle 
medication for unsupervised use. All decisions on take-home medications 
would be documented in the patients' medical chart, using a 
standardized format. The basis for the medical director's clinical 
judgment must follow, at a minimum, the types of criteria listed in 
Sec. 291.505(b)(3)(i)(D). The criteria and the methodology by which 
they are applied must be included in the accreditation elements, must 
be assessed periodically by accrediting bodies, and must be part of the 
determination of whether to accredit the program. The methodology shall 
include the OTP's quality assurance plan for regular review of all 
take-home decisions (initial authorization, renewals, and revocations).
    At least one existing accreditation body has accreditation 
standards that address take-home privileges. COA's Methadone 
Maintenance Service Standard requires that take-home privileges are 
earned by the individual and are part of each individual's service 
plan. A team consisting of the patients's counselor, medical and other 
appropriate personnel, the patient, and whenever possible, his/her 
family are involved in deciding whether the patient is ready to receive 
take-home privileges. Factors that support initiation of take-home 
privileges include: Length of time in treatment, attainment of clinical 
stability, progress in rehabilitation, medical necessity, behavioral 
factors, and emergency circumstances. In addition, the standard 
includes protocols for deciding when take-home medication is 
contraindicated, including: Signs or symptoms of withdrawal, continued 
illicit drug use, the absence of laboratory evidence of methadone in 
toxicology samples, potential complications from concurrent disorders, 
ongoing criminal behavior, and an unstable home environment.
    Moreover, under COA's standards, toxicology tests are to be 
scheduled regularly to ensure that the patient is consuming the 
methadone provided and remains free of illicit substance use, and other 
such measures to help avoid diversion must be implemented. Importantly, 
each patient's case or record is reviewed by a physician at least every 
90 days, or more frequently if clinically indicated, and the team 
periodically reviews the benefits and drawbacks of continuing take-home 
privileges.

I. Interim Maintenance Treatment

    The proposal retains standards for interim maintenance treatment. 
Conceptually, interim maintenance treatment allows authorized programs 
with documented treatment waiting lists to provide methadone treatment 
to eligible patients without some of the services required under the 
regulations. Interim maintenance treatment was mandated by the ADAMHA 
Reorganization Act.
    With respect to the issue of unsupervised use of opioid treatment 
medications, the proposal retains the prohibition on unsupervised use 
for patients in short-term detoxification treatment and interim 
maintenance

[[Page 39824]]

treatment. Under the existing regulations, patients in long-term 
detoxification treatment are permitted one unsupervised dose of 
methadone per week. The Secretary is proposing to allow the 
unsupervised use of treatment medications with responsible patients in 
long-term detoxification treatment because long-term detoxification 
patients who meet the time in treatment requirements set forth for 
patients in maintenance treatment should be also eligible to be 
considered for unsupervised use of treatment medications. This proposed 
change is consistent with other changes in this notice (e.g., 
consolidated application forms) that will make the regulations less 
complicated.

 V. Legal Authority

    The Secretary's legal authority under section 303(g) of the CSA to 
issue treatment standards, including standards regarding the quantities 
of opioid drugs that may be dispensed for unsupervised use, is well 
established. (See generally section II.A of this document. See also 42 
U.S.C. 257a.) In addition, the Secretary has specific authority, 
through the Administrator of SAMHSA, to coordinate Federal policy with 
respect to the provision of treatment services for substance abuse 
using medications such as methadone (21 U.S.C. 290aa(d)(7)). The 
Secretary is also authorized to establish conditions for allowing 
interim treatment of opioid addiction. (See section 1976 of the PHS 
Act, 42 U.S.C. 300y-11.)
    Part and parcel with the Secretary's general authority to establish 
treatment standards, and to ensure that those standards will be met, is 
the authority to delegate to qualified third parties a role in helping 
to ensure compliance with the Secretary's standards. The Secretary has 
retained full responsibility for all final determinations, including 
all standard setting determinations, as well as the authority to reject 
the recommendations of an accreditation body, to independently inspect 
treatment programs, and to perform her own independent certifications. 
The proposal also includes ample measures to ensure the impartiality of 
the accreditation body decision makers. Under these circumstances, the 
Secretary believes that her reliance on accreditation bodies, as 
outlined in the proposal, is fully consistent with the law as it 
pertains to subdelegation of agency responsibilities to third parties. 
See, e.g., Fleming v. Mohawk Wrecking and Lumber Co., 331 U.S. 111 
(1947); Tabor v. Joint Board for Enrollment of Actuaries, 566 F.2d 705, 
708 n.5 (D.C. Cir. 1977); National Association of Psychiatric Treatment 
v. Mendez, 857 F. Supp. 85, 91 (D.D.C. 1994); Hall v. Marshall, 476 F. 
Supp. 262, 272 (E.D. Pa. 1979), aff'd 622 F.2d 578 (3d Cir. 1980).

VI. Proposed Implementation Plan

    There are approximately 900 OTP's (currently referred to as 
narcotic treatment programs or ``NTPs'') approved under the existing 
regulatory system. The Secretary intends to move entirely to the 
accreditation-based system as soon as practicable, albeit with certain 
accommodations to allow treatment programs sufficient time to obtain 
accreditation and, thereafter, certification under new 42 CFR part 8.
    The Secretary is proposing that the effective date of the rule, 
once finalized, will be 60 days after publication of the final rule in 
the Federal Register. However, as discussed in section III.B of this 
document, the rule will allow for transitional certification for 
programs that were approved under part 291 as of the effective date of 
this regulation. In addition, SAMHSA will apply the provisional 
certification provisions under proposed Sec. 8.11(e) to allow new 
programs to begin to operate while completing accreditation.
    These provisions will allow a sufficient amount of time for 
accreditation bodies to apply for and obtain SAMHSA approval and, in 
turn, to begin conducting accreditation surveys.
    As part of the transition from the current regulatory approach to 
the proposed accreditation/regulatory approach, SAMHSA's CSAT has 
developed a study of an initial cohort of 180 randomly selected, 
volunteer OTP's (Ref. 33). The study will be used by SAMHSA to develop 
and continually update the agency's accreditation guidelines. The 
study, which is not expected to be completed for several years, may 
also provide useful information for refining the accreditation model 
that is the subject of this proposed rulemaking.
    The shift to an accreditation model is expected to have both 
administrative and clinical consequences. The CSAT study is designed to 
provide additional information on the processes, barriers, 
administrative outcomes, and costs associated with an accreditation-
based system. The study will measure program accessibility, client 
population served, program structure, operation and costs, clinical 
practice, staff attitudes and behavior, methadone diversion, patient 
satisfaction, and treatment outcomes at a sample of treatment providers 
before and after they go through the accreditation process. No OTP 
participating in the study will be prohibited by the FDA or the DEA 
from operating because of failure to meet the standards for 
accreditation.
    The focus of the study is a pretest-posttest design with a 
comparison or control group. This design assumes that a series of 
variables will be influenced by the intervention, i.e., accreditation, 
and that measurable information on these variables is available both 
prior to and following the intervention. The effect of the intervention 
is then measured by comparing the post-intervention values of the 
outcomes with the pre-intervention values. The evaluation contractor 
will collect pre-intervention data from participating OTP's at 
approximately 6 months prior to accreditation to provide sufficient 
lead time to measure the baseline status of these programs. It is 
expected that the OTP's will make program changes to meet the 
accreditation standards, apply for accreditation, undergo the 
accreditation process, deliver services post-accreditation, and 
collaborate in the evaluation. The evaluation contractor will collect 
post-intervention data from each participating OTP at approximately 6 
months following the accreditation survey to provide sufficient time to 
measure the changes in OTP operations after the accreditation process. 
The evaluation contractor will collect data from the control group at 
approximately the same time that data will be collected from the study 
group.
    SAMHSA's CSAT Advisory Council will assist in the evaluation of the 
study data. SAMHSA expects that the advisory council will establish a 
subcommittee that will make recommendations to the full committee 
which, after deliberation, will make recommendations to SAMHSA as 
appropriate. SAMHSA expects to bring in consultants to the subcommittee 
who ideally will include representation from stakeholders such as OTP's 
(both large and small programs), medical and other substance abuse 
professionals, consumers, and State officials. SAMHSA expects the first 
meeting of the advisory committee and subcommittee on the issues will 
convene within 6 months of the first group of accreditation surveys.
    DHHS has determined that accreditation is a valid and reliable 
system for providing external monitoring of the quality of health 
care--including substance abuse treatment. This study, which will 
proceed alongside the rulemaking proceeding, is expected to provide 
important information to allow DHHS to keep its guidelines, and its 
accreditation

[[Page 39825]]

program, as responsive and up-to-date as possible. Among other things, 
the study will allow DHHS to continuously monitor the monetary costs of 
accreditation, to ensure that successful OTP's are not precluded from 
operating by the costs of accreditation, and that patients are not 
denied treatment based on costs.
    Finally, under the project, SAMHSA will fund the accreditation of a 
large cohort of OTP's. As a result, a substantial subset of the 
universe of approved programs will have experience with accreditation. 
During the course of the study, CSAT will make technical assistance 
available to OTP's to help them meet accreditation requirements.

VII. Environmental Impact

    The Secretary has determined under 21 CFR 25.30(h) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VIII. Analysis of Impacts

A. Introduction

    This section briefly describes the current estimates of 
accreditation costs likely to accrue to OTP's as a result of this 
proposed rule.
    The Secretary has examined the impact of this proposed rule under 
Executive Order 12866, under the Regulatory Flexibility Act (Pub. L. 
96-354), under the Small Business Regulatory Enforcement Fairness Act 
(Pub. L. 104-121), and under the Unfunded Mandates Reform Act (Pub. L. 
104-4). Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages, distributive impacts, and equity). The Regulatory 
Flexibility Act requires agencies to analyze regulatory options that 
would minimize any significant impact of a rule on a substantial number 
of small entities. The Small Business Regulatory Enforcement Fairness 
Act extends the Regulatory Flexibility Act by making such analyses 
subject to more detailed reviews. The Unfunded Mandates Reform Act 
requires that agencies prepare an assessment of anticipated costs and 
benefits before proposing any expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of $100 
million (adjusted annually for inflation). A summary of the appropriate 
analyses follows.

B. Purpose of the Proposed Regulation

    Federal, State, local, and private sponsors spend billions of 
dollars each year for substance abuse treatment programs (Ref. 34), of 
which opioid maintenance has been an important option since the early 
1970's. OTP's have been subjected to regulations administered by FDA 
for more than 25 years. These regulations reflect the view that because 
such treatment programs dispense treatment drugs with abuse potential 
to drug abusers, they pose risks to communities from potential abuse 
and/or diversion of the supplied therapeutic drug (Ref. 35). In 
addition, DEA requires annual registration of OTP's, and enforces 
regulations relating to security and control of the controlled drug 
products (Ref. 36).
    The motivation for providing opioid maintenance is rarely based on 
economic criteria. One study indicated that treatment expenditures may 
be offset by decreased direct costs of incarceration and legal 
supervision (Ref. 37). Another study suggested that continued methadone 
treatment for recovering opioid addiction resulted in significant 
reductions in criminal activity (Ref. 38). Reduced health care costs 
have also been identified as a benefit of continued treatment, 
particularly as treatment procedures have been revised to reduce the 
spread of HIV infection through needles (Ref. 39). Continued treatment 
has also been shown to lead to increased earnings by allowing patients 
to maintain regular employment (Ref. 40) and family and personal 
relationships and to decrease mortality (Ref. 41). A recent study has 
estimated that the value of avoiding morbidity associated with drug use 
could be as high as $160,000 per case (Ref. 42). But studies show that 
these benefits are obtainable only if patients continue to take active 
roles in their treatments.
    As discussed in section II.B of this document, compliance with 
current regulations is assured through process oriented inspections 
conducted by either FDA or State inspectors. As FDA has focused on 
other core priorities, the annual number of OTP inspections by FDA has 
declined. Meanwhile, as summarized in section II.C of this document, 
several groups have questioned the emphasis of the current regulations. 
This proposal is designed to improve the quality of care by shifting 
oversight of OTP's from a system based on process compliance to an 
accreditation-based system refocused on the needs of patients.
    There has long been controversy centered around the appropriate 
measures to use in assessing outcomes from drug abuse treatment 
programs (Ref. 43), although substantial progress has been made in 
outcome assessment over the last 20 years. One of the important areas 
of progress from this research has been to shift the focus of treatment 
outcome assessment from implicitly conceptualizing drug addiction as an 
acute illness from which the patient either recovers (i.e., remains 
abstinent) or does not (everything else) to one that is chronic and 
relapsing. This shift in recognition has resulted in a change in 
expectations for the outcomes of any one treatment episode where 
reduced consumption, longer abstention periods, reduced psychiatric 
symptoms, improved health, maintaining employment, fewer legal 
problems, and improved family relations demonstrate treatment efficacy. 
The strategy for measuring success is similar to that used with other 
chronic disorders such as asthma, arthritis, diabetes, heart disease, 
hypertension, and other psychiatric disorders. This strategy for 
assessing outcomes has been adopted by the FDA for measuring 
pharmaceutical efficacy (Ref. 44).
    This change in the way drug addiction and abuse is viewed has led 
to the development of improved outcome measures, such as those 
contained in the Addiction Severity Index (Ref. 45), the Individual 
Assessment Profile (Ref. 46), and the Client Assessment Profile (Ref. 
46). These instruments all measure changes in the severity of the 
problem areas that are commonly affected by addiction. These areas are: 
Drug use, alcohol use, medical, legal, employment, family/social, and 
psychiatric. Particularly notable have been studies demonstrating 
reductions in criminal behavior associated with participation in 
methadone treatment (Refs. 47, 48, and 49).
    Improvements in outcomes after methadone treatment are almost 
always equal to or greater than improvements seen in treatments for 
other chronic relapsing disorders (Ref. 50). For example, studies of 
methadone maintenance programs routinely show reductions of 80 percent 
or more in heroin use after several months with even greater reductions 
for patients who remain in treatment for more than 1 year (Refs. 51, 
52, and 53). More recently, studies have consistently shown that the 
risk for HIV infection is significantly reduced by opioid agonist 
therapy, even

[[Page 39826]]

in the absence of total cessation of drug use (Refs. 54, 55, and 56). 
These proposed regulations are designed to improve the therapeutic 
impact of treatment programs by assuring adequate quality of care, 
including adequate doses of medication to have optimal therapeutic 
effects.

C. Baseline Description of the Industry

    FDA has approved 869 methadone treatment programs as of early 1997, 
including 209 programs also approved for LAAM treatment (Ref. 57). This 
total encompasses only outpatient maintenance programs and does not 
include almost 300 inpatient hospital detoxification units. This total 
likely overstates the actual universe of OTP's because FDA considers 
individual dispensing sites as separate treatment programs for 
inspectional purposes, although sites may be affiliated with other 
organizations. Another estimate of active programs includes 668 reports 
of active methadone services from SAMHSA's 1996 Uniform Facility Data 
Set (UFDS) (Ref. 58), although the definition of ``treatment unit'' was 
left up to the discretion of the respective States (Ref. 59). This 
estimate may understate the universe of approved treatment programs 
because not all treatment programs responded to the annual survey. For 
this assessment, the Secretary has assumed 900 active OTP's as the 
universe of affected programs.
    Data from SAMHSA's UFDS Data Set (Ref. 60) can be used to estimate 
the number of patients in treatment. The 1996 Data Set includes a 1-day 
census of patients in treatment, by type of care and jurisdiction. 
According to the most recent report, there were 940,131 patients in 
substance abuse treatment facilities (private and public funded) on 
October 1, 1996. The 1996 report indicates that 13.2 percent or 124,098 
of these patients were receiving narcotic substances (assumed to be 
methadone or LAAM). For the purposes of this analysis, the Secretary 
estimates the total census of patients in opioid treatment to be 
approximately 125,000.
    Data from SAMHSA indicate that some OTP's may be providing 
treatment to over 2,085 patients, but most programs have very small 
patient bases (Ref. 61). Approximately 20 percent of all programs treat 
50 or fewer patients (Ref. 62), and 10 percent treat 10 or fewer 
patients. The median OTP had a patient census of 125 patients, but the 
mean program size was much larger. Two studies that included methadone 
program cost parameters indicate a weighted average of 250 patients per 
OTP (Refs. 63 and 64). For this assessment, the Secretary has assumed a 
typical OTP can treat 140 patients, for a total industry census of 
125,000 patients.
    Current cost estimates of providing annual treatment have ranged 
from approximately $2,500 (Ref. 65) to $4,000 (Ref. 66). The lower cost 
estimate did not account for all fixed and variable costs associated 
with operating a treatment facility (e.g., rent and equipment 
maintenance and operating costs were not adequately accounted). For 
this assessment, the Secretary has estimated that it costs 
approximately $4,000 per year to treat one patient.

D. Costs of the Current Regulations

    For purposes of this analysis, the Secretary estimates the costs of 
enforcing the current regulations to average approximately $3.3 million 
per year. These costs include inspections, support, review of 
applications, and all overhead. In addition, OTP's found to be 
violative must improve performance in order to continue operations. 
Typically, many inspections result in observable violations based on a 
failure to fully document or record activities. The Secretary has 
estimated that a typical facility must improve patient recordkeeping as 
a result of an inspection at a cost of $4.70 per patient per year (or 
almost $660 per OTP per year ($4.70 x 140)). This cost is estimated by 
assuming that 10 minutes of nurse/technician time will be required to 
enter and check records for each patient per year. The total average 
compensation for a nurse/technician in the health services sector 
totaled $28.07 per hour in 1996 (Ref. 67). The estimated annual cost 
for programs to meet requirements of current inspections and correct 
violations equals $0.59 million. The Secretary seeks comments and 
information to further assess or estimate the costs for programs to 
meet the requirements of the current regulations. The total annual cost 
of continuing the current regulations (in the absence of these proposed 
regulations) is estimated to equal $3.9 million, most of which is 
administrative costs of maintaining a regulatory system.

E. Costs of the Proposed Regulation

    The proposed rule will generate regulatory costs to OTP's in two 
general areas. These areas are: (1) The direct costs of becoming 
accredited through a survey of practices and procedures, and (2) the 
more indirect costs of improving procedures, if necessary, to meet the 
quality level required to achieve and maintain accreditation, including 
resurvey costs. The Secretary has developed preliminary estimates of 
these cost elements in terms of costs per annual client. Thus, if an 
OTP must initiate an activity to become accredited, the costs include 
maintaining that activity at an acceptable level of quality.
    In addition, SAMHSA will incur costs to provide oversight of 
accreditation bodies, review and approve applications from prospective 
programs, and conduct ``for-cause'' inspections. The Secretary has 
assumed that DEA will not incur any change in enforcement costs due to 
these proposed regulations.
    Costs are estimated as average annual costs. A 7-percent discount 
rate is used to estimate the present value of future expenditures and 
to amortize one-time costs. A 3-year evaluation period (the length of 
the expected accreditation cycle) is used to analyze any one-time costs 
associated with compliance.

F. Accreditation of Opioid Treatment Programs

    The process of professional accreditation includes external peer 
review of practices in order to assure an acceptable level of quality. 
Most accrediting organizations have criteria of what clinical 
procedures assure a minimum level of quality of care. Usually, a team 
consisting of various professional specialties will spend several days 
at a candidate facility during an accrediting survey. The team will 
examine records and observe practices that determine the facility's 
level of quality. After receiving accreditation, a facility must show 
that quality remains at an acceptable level by maintaining proper 
procedures. Recently, the JCAHO announced that it would develop 
specific performance outcome measures as accreditation criteria.
    The costs of operating an accreditation program are estimated from 
data provided by three national accreditation bodies: JCAHO, CARF, and 
COA. Currently, most OTP's are not required to be routinely accredited 
by any national accreditation body. However, all three bodies have some 
experience accrediting OTP's. Approximately 36 hospital-affiliated 
OTP's are currently accredited by the JCAHO, and CARF has accredited 
some OTP's and is currently developing a specific accreditation manual. 
COA has drafted standards for OTP services that incorporate many of the 
requirements of the proposed regulation.
    JCAHO would charge a mental health facility with size and operating 
characteristics similar to an average OTP a base of $5,655 plus $0.23 
per outpatient-visit (Ref. 68). JCAHO's definition of an outpatient 
visit may not strictly apply to opioid treatment

[[Page 39827]]

because patients are typically treated as many as six times a week. For 
the purposes of this analysis, the Secretary has applied the $0.23 per 
outpatient-visit charge on a weekly basis. The estimated accreditation 
survey charge for JCAHO accreditation is the base charge plus $1,674 
(140 patients times $0.23 times 52 weeks), or approximately $7,300.
    Discussions with CARF have indicated that a facility seeking 
accreditation would pay an application fee of $300, purchase a survey 
manual for $100, and pay $950 per surveyor per day to conduct an 
accreditation survey. CARF expected a facility survey to require 2 days 
onsite, and while they estimated two-person teams, three-person teams 
may be likely. Thus, a CARF accreditation survey for an OTP seeking 
accreditation is estimated to cost approximately $5,100, including 
travel costs.
    COA presented data that showed an average charge of about $5,500, 
but added an additional $1,500 for travel expenses of the accreditation 
survey team. In addition to the direct accreditation costs, the survey 
team for COA incurs opportunity costs based on the time necessary to 
complete a survey. Discussions with COA show that typically a survey 
team consists of three unpaid persons from previously accredited 
facilities. While JCAHO and CARF indicated that the labor costs for a 
survey team were included in the charges, COA did not. For the purpose 
of estimating the opportunity costs of these survey members, the 
Secretary has estimated that a typical survey team will consist of an 
administrator or program director, and a nurse or counselor or social 
worker. A typical survey is expected to take 2 days to complete. The 
Bureau of Labor Statistics collects average wage rates by occupation 
(Ref. 69). In 1996 (the latest year for which these data are 
published), the average hourly compensation of a nurse or technologist 
was $28.07, while an administrator or clinic director had total hourly 
compensation of approximately $33.29. Thus, the opportunity cost of the 
survey team for conducting an accreditation survey adds almost $1,000 
for a total estimated survey cost of $8,000.
    For the purposes of this analysis, the Secretary estimates the 
direct cost of conducting an accreditation survey as the average of 
these three programs, or $6,800 per treatment program. Assuming a 3-
year accreditation cycle, and a 7-percent discount rate, the average 
annual cost to a treatment facility of conducting accreditation surveys 
will equal approximately $2,600. Overall, the total average annual 
accreditation costs for all affected programs are likely to equal $2.3 
million.

G. Compliance and Quality Assurance for Opioid Treatment Programs

    According to COA, approximately 30 percent of the nonvoluntary 
accreditation inspections result in some remedial action. CARF has 
reported an approximately 25 percent less-than-full accreditation rate 
for facilities that have been required to seek accreditation. 
Regardless of what the less-than-full accreditation rate is for the 
first accreditation cycle, subsequent accreditation cycles should have 
significantly lower rates of less-than-full accreditation as programs 
adjust to the accreditation process. In addition, CSAT will make 
available technical assistance to help programs meet accreditation 
requirements.
    While it is possible that increased Federal inspection and 
enforcement activity (in the absence of this rule) could result in 
fewer violative programs, the Secretary believes the requirement of 
accreditation will provide a greater impetus for program-by-program 
improvements. Shorter accreditation cycles are believed to minimize the 
opportunity for programs to become noncompliant. In addition, managed 
health-care payers for psychiatric care often require program 
accreditation for reimbursement (Ref. 70) and this trend is expected to 
continue for opioid treatment.
    The costs of remediation were estimated from variable program cost 
data developed for SAMHSA from nine OTP's (Ref. 71). This study 
presented annual operating costs per patient to maintain what is 
presumed to be an acceptable level of quality. The consultants 
collected accounting costs for 14 specific parameters that contribute 
to overall program quality such as initial assessment, medical 
examination, case management, etc. While the Secretary does not have 
data to show that these 14 parameters are inclusive, a weighted average 
of the costs for the variable cost parameters (for both methadone and 
LAAM patients) resulted in an average cost per activity of 
approximately $150 per parameter per patient.
    Remedial action to achieve accreditation could require 
implementation of a service that is currently not available, or it 
could require only marginal improvements to the level of an ongoing 
activity. For example, an OTP that did not offer acquired immune 
deficiency syndrome (AIDS) counseling would be required to start doing 
so, while a different OTP may be required to improve the quality of 
such counseling.
    At this time, the Secretary does not have data to indicate the 
minimum level of compliance that would currently allow an OTP to remain 
in operation. The Secretary has assumed that the complete absence of 
any one quality enhancing activity would result in a loss of 
accreditation. Assuming that 25 percent of facilities are expected to 
require remediation from the initial cycle of accreditation surveys, 
these facilities are likely to be distributed between two extremes.
    The most costly compliance activities would be for OTP's that 
currently do not offer one of the identified services. In order to 
continue operations, these facilities would be required to offer these 
services, and incur costs of $150 per patient or $21,000.
    The other extreme would be OTP's that must increase resources to 
one activity (e.g., improve recordkeeping). This may require increased 
costs of only $0.67 per patient (based on dividing $150 by 25 percent 
of the affected programs).
    The average cost for a typical less-than-fully accredited OTP to 
come into compliance during this initial inspection is estimated as the 
average of these amounts, or approximately $75 per patient or $10,500 
per noncompliant program. Having assumed that 25 percent of all OTP's 
(or 225 programs) would require improvements in the first accreditation 
cycle, the total costs to the industry are estimated to be $2.4 
million.
    These costs are estimated based on costs per patient per year, and 
are thus annual operating costs of ongoing quality assurance activities 
as well as implementation costs. As such, they also incorporate the 
cost of maintaining acceptable quality levels between accreditation 
cycles. These cost estimates take into account typical quality 
assurance programs that include development of quality assurance 
manuals and periodic meetings by a quality assurance staff through the 
evaluation period. Each OTP is likely to invest in a quality assurance 
program that will contain elements of authority, purpose, organization, 
scope, responsibility, implementation, and evaluation (Ref. 72). Future 
accreditation surveys may identify OTP's that do not receive full 
accreditation, but the noncompliant rate is expected to be low. By 
maintaining current expenditures and quality assurance programs as 
estimated in this section, no additional costs are attributable to this 
regulation.

[[Page 39828]]

    A resurvey would be required for each OTP needing remedial action. 
Direct costs for resurveying are part of the original survey, but 
indirect costs must be accounted for, as measured by the opportunity 
costs of the survey team. This would likely be travel costs ($1,500) 
and opportunity costs for the survey team ($1,000) for a total of 
approximately $2,500 for a resurvey. With an estimated 225 resurveys, 
the total industry cost would equal $0.6 million. This one-time cost, 
when amortized for 3 years at 7-percent discount rate to account for an 
accreditation cycle, results in an average annual cost for the industry 
of $0.2 million.

H. Annual Costs to Opioid Treatment Programs of the Proposed Regulation

    Total costs of this proposed regulation include average annual 
direct accreditation survey costs of approximately $2.3 million. The 
average annual costs of both coming into compliance and ensuring an 
acceptable level of quality is estimated to be $2.6 million. The total 
average annual costs to OTP's for this proposed regulation is $4.9 
million, which includes maintaining an improved quality level. These 
annual costs equal approximately $5,400 per facility and $39 per 
patient, an overall average increase of approximately 1.0 percent per 
patient. Costs are expected to vary by facility and by patient 
population.

I. Costs to SAMHSA of the Proposed Regulation

    The average estimated annual cost of administering an accreditation 
based system of regulation, based on SAMHSA estimates, is $3.4 million.

J. Total Net Costs of the Proposed Regulations

    The total cost of these proposed regulations is the combination of 
the industry and the government costs. The best estimate of the total 
average annual cost is $8.3 million. The annual cost of FDA enforcement 
of the current regulation of OTP's has been estimated to equal $3.9 
million. The average annual net cost of this proposal equals the 
difference, or $4.4 million.

K. Benefits of the Proposed Regulations

    Methadone maintenance (and by extension LAAM maintenance) has been 
identified as the most successful known treatment in avoiding relapses 
in addiction. Depending on definitions, approximately 80 percent of 
individuals seeking treatment for substance abuse (including alcohol), 
from all such treatments (including all alternative treatments), have 
been reported to have returned to substance use following treatment 
(Ref. 73). While individual opioid maintenance programs vary in success 
rates, a study of six clinics showed that the continued use of drugs 
ranged from only 10 percent of patients in the most effective clinic to 
56 percent in the least effective (Ref. 74). Among other factors, the 
more effective clinics were characterized by treatment goals of ongoing 
maintenance, better staff-patient relationships, and higher average 
medication doses (Ref. 75).
    A study of relapse rates reported that overall methadone 
maintenance programs reported a 40-percent average relapse rate (Ref. 
76), compared to an 80-percent relapse rate for all substance abuse 
treatment. However, for patients still in treatment, the reported 
relapse rate was 31.7 percent, while patients out of treatment reported 
a 65-percent relapse rate. But, those patients who had completed a 
course of treatment of at least 24 months reported relapse rates one-
third lower than those in treatment for fewer than 6 months (50 percent 
to 71.8 percent) (Ref. 77). These findings imply that continuing 
treatment and length of treatment decrease the probability of relapse.
    The Secretary cannot with certainty predict the effect of these 
regulations on the expected rate of relapse. However, the following 
example illustrates the range of potential benefits that might be 
achieved if the average patient remains in treatment for 6 months 
longer than the current reported average duration of treatment (14.7 
months to 20.7 months). In this instance, the expected average rate of 
relapses would decrease from 40 percent to 32.3 percent. This implies 
that the number of annual relapses from therapy would be reduced by 
12,320 patients. In 1993, there were more than 13,000 drug related 
mortalities (Ref. 78), not all of which could be attributable to drugs 
treatable by opioid maintenance. However, it is likely that at least 
some of these mortalities would be avoided if greater numbers of 
patients avoided relapse by maintaining treatment.
    In addition, other benefits such as reduced health expenditures, 
better personal relationships, and reduced criminal activity would be 
expected. Based on plausible values for such gains, even very minor 
improvements in patient outcomes could easily offset the net annual 
compliance cost of this proposed regulation.

L. Impact on Small Opioid Treatment Programs

1. Description of Impact
    As discussed previously, the proposal is expected to provide more 
frequent quality surveys of OTP's and allow for greater flexibility in 
the delivery of opioid treatment.
    Under definitions provided by the Small Business Administration 
(SBA), virtually the entire industry would be composed of small 
entities (Ref. 79). The SBA uses an estimate of $5.0 million in gross 
revenues as a definition of small entity for industry SIC 8093 
(Specialty Outpatient Facilities, NEC). An OTP would need to provide 
treatment to 1,250 to reach that level. As stated earlier, 20 percent 
of the OTP's serve 50 or fewer patients. This segment of the industry 
may be assumed to be considered small relative to the typical OTP.
    All small programs would be required to be accredited by an 
accreditation body approved by SAMHSA. Each OTP, regardless of size 
would be expected to maintain this accreditation in order to continue 
to treat patients. There are several important changes in these 
proposed regulations from current requirements, but no major changes in 
current recordkeeping.
2. Analysis of Alternatives
    Alternative regulatory schemes were considered. The continuation of 
the current regulatory oversight was dismissed in light of the findings 
and criticisms discussed in section II of this document. The idea of 
providing greater levels of self-certification was deemed insufficient, 
primarily because of concerns over the potential diversion of the 
treatment medications.
    SAMHSA has issued evaluation contracts to determine whether this 
proposal will result in unforeseen impacts on small programs. In 
particular, the feasibility of exempting small facilities from some 
requirements will be examined. Some small OTP's may find it necessary 
or desirable to forge arrangements with more financially secure 
organizations so as to provide quality treatment services to 
individuals in the community. SAMHSA will make every effort possible to 
ensure that access to quality opioid addiction treatment services is 
not diminished, especially in rural areas, as a consequence of this 
regulatory reform.
3. Assuring Small Entity Participation
    It is likely that this proposed rule may have a significant 
economic effect on a substantial number of small entities.

[[Page 39829]]

 Based on the cost parameters reported for the three smallest programs 
included in a SAMHSA analysis (Ref. 80), the average cost to maintain 
and service a patient for 1 year in a small, 50-patient facility was 
estimated to be $3,200. An average accreditation survey for a program 
of only 50 patients is expected to take only 1 day and cost 
approximately $4,000, or approximately $1,500/year (at a 7-percent 
discount rate). The average cost per patient of achieving and 
maintaining a quality-enhancing activity at a small OTP at an 
acceptable compliance level is assumed to be equal to the industry 
average of $45. A 25 percent less-than-full accreditation rate (the 
same as for the overall industry) was assumed and resurveys are 
estimated to cost $500.
    Overall, the cost per patient for a program servicing 50 patients 
would increase by slightly more than the industry average ($50 compared 
to $39) under the proposed regulations. This represents a greater 
proportionate increase (1.6 percent as compared to 1.0 percent) than 
the increase expected for the average sized facility. The Secretary is 
in the process of collecting better data on this industry segment and 
solicits comments in this area.

M. Conclusions

    The average annual net cost of this regulation is estimated to be 
$4.4 million. The costs represent a shift of costs to individual OTP's 
to maintain accreditation and the accompanying assurance of quality. 
Research has indicated that increased compliance with drug abuse 
treatment is correlated with beneficial and therapeutic outcomes to 
patients, and the Secretary believes that the use of private 
accreditation would improve treatment outcomes. If patient 
participation in therapy could be extended by an average of 6 months, 
relapse rates could decrease by approximately 20 percent. Even modest 
improvements, therefore, would bring substantial reductions in 
mortality and significant improvements in physical health, decreased 
criminal activity (including diversions), increased earnings and 
employment, better family and personal relationships (Ref. 81). The 
Secretary, including SAMHSA, continues to research this area and is 
specifically soliciting comments on these issues.
    This proposal constitutes a significant impact on a substantial 
number of small entities. The Secretary solicits comments on how to 
address this impact.
    The estimated annual cost of $4.4 million is far below the 
threshold defined by the Unfunded Mandates Act.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collections which are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3507(d)). The 
title, description, and respondent description of the information 
collections are shown in the following paragraphs with an estimate of 
the annual reporting and recordkeeping burden. Included in the estimate 
is the time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing the collection of information.
    Title: Narcotic Drugs in Maintenance and Detoxification Treatment 
of Narcotic Dependence; Repeal of Current Regulations and Proposal to 
Adopt New Regulations.
    Description. The Secretary is proposing to issue regulations to 
establish an accreditation-based regulatory system to replace the 
current system that relies solely upon direct Federal inspection of 
treatment programs for compliance with process oriented regulations.
    These proposed changes are intended to enhance the quality of 
opioid treatment by allowing increased clinical judgment in treatment 
and by the accreditation process itself with its emphasis on continuous 
quality assessment. As set forth in this proposed rule, there will be 
fewer reporting requirements and fewer required forms under the new 
system. The total reporting requirements are estimated at 2,074 hours 
for treatment programs, and 341 hours for accrediting organizations.
    A recent FDA information collection analysis (Ref. 82) estimated 
the annual paperwork burden for the existing regulations to be 
approximately 1,500 hours. The proposed regulation requires a one-time 
reporting requirement for transitioning from the old system to the new 
system. The estimated reporting burden for ``transitional 
certification'' is approximately 475 hours. The proposal also requires 
ongoing certification on a 3-year cycle, with an estimated reporting 
burden of approximately 300 hours. Deducting these two requirements 
(total 775 hours) from the estimate for the proposed system (2,074 
hours) leaves a reporting burden of approximately 1,300 hours, which is 
less than the estimated burden under the existing system. This is 
consistent with the streamlining of requirements under the proposal, 
and the elimination of certain forms and reporting requirements 
altogether.
    Description of Respondents: Business or other for-profit; Not-for-
profit institutions; Federal government; State, local or tribal 
government.

        Table 1.--Annual Reporting Burden for Treatment Programs
------------------------------------------------------------------------
 42 CFR
Citation      No. of       Responses per    Minutes per
   and      Respondents     Respondent       Response       Total Hours
 Purpose
------------------------------------------------------------------------
 8.11(b)       75               1              90             112.5
 -New
 program
 approva
 l SMA-
 162
 8.11(b)      300               1              60             300
 -Renewa
 l of
 approva
 l1 SMA-
 162
 8.11(b)       35               1              70              40.83
 (3)--Re
 locatio
 n SMA-
 162
 8.11(d)      300               1              95             475
 -Applic
 ation
 for
 transit
 ional
 certifi
 cation2
 SMA-162
 8.11(e)       75               1              30              37.5
 (1)--Ap
 plicati
 on for
 provisi
 onal
 certifi
 cation
 8.11(e)       30               1              15               7.5
 (2)--Ap
 plicati
 on for
 extensi
 on of
 provisi
 onal
 certifi
 cation
 8.11(f)       60               1              20              20
 (5)--No
 tificat
 ion of
 sponsor
 or
 medical
 directo
 r
 change
 8.11(g)        1               1             120               2
 (2)--Do
 cumenta
 tion to
 SAMHSA
 for
 interim
 mainten
 ance
 8.11(h)      800               3              26.25         1050
 -Reques
 t to
 SAMHSA
 for
 exempti
 on from
 8.11
 and
 8.12
 8.11(i)        3               1              15                .75
 (1)--No
 tificat
 ion to
 SAMHSA
 before
 establi
 shing
 medicat
 ion
 units
 8.12(j)        1               1              20               3.33
 (2)--No
 tificat
 ion to
 State
 Health
 Officer
 when
 patient
 begins
 interim
 mainten
 ance
 8.24--C        2               1              15                .5
 ontents
 of
 appella
 nt
 request
 for
 review
 of
 suspens
 ion
 8.25(a)        2               1              60               2
 -Inform
 al
 review
 request
 8.26(a)        2               1             300              10
 -Appell
 ant's
 review
 file
 and
 written
 stateme
 nt
 8.28(a)        2               1              60               2
 -Appell
 ant's's
 request
 for
 expedit
 ed
 review

[[Page 39830]]

 
 8.28(c)        2               1             300              10
 -Appell
 ant
 review
 file
 and
 written
 stateme
 nt
 Totals                                                     2,073.91
------------------------------------------------------------------------
\1\ Applications for renewal of certification are required every 3
  years.
\2\ Transitional Certification is a one-time requirement and will be
  included in the total annualized burden but averaged over the 3-year
  period of the OMB collection activity approval.

    The proposal does not increase the estimated annualized burden. 
Certain reporting requirements have been proposed for elimination, such 
as submissions for authorizations to use LAAM, the requirement to 
submit a physician responsibility statement (FDA Form 2633), and 
elimination of the requirement to obtain Federal approval for take-home 
doses of methadone in excess of 100 mg that exceed a 6-day supply. The 
proposal adds a one time requirement for existing programs to apply for 
transitional certification, and a requirement to apply for 
certification renewal every third year. The annualized burdens 
associated with these new reporting requirements offset the burdens 
proposed for elimination, resulting in no estimated net change.
    Accreditation bodies will also require treatment programs to submit 
information as part of the standard operating procedures for 
accreditation. As mentioned earlier in this proposal, accreditation 
bodies, under contract to SAMSHA, will be accrediting existing OTP's as 
part of an initiative to gain more information on the accreditation of 
OTP's. SAMHSA has prepared a separate OMB Paperwork Reduction notice 
and analysis for that information collection activity (63 FR 10030, 
February 27, 1998, OMB approval number 0930-0194).

   Table 2.--Annual Reporting Burden for Accreditation Organizations1
------------------------------------------------------------------------
 42 CFR
Citation      No. of       Responses per     Hours per
   and      Respondents     Respondents      Response       Total Hours
 Purpose
------------------------------------------------------------------------
 8.3(b)-       10               1               3              30
 -Initia
 l
 approva
 l SMA-
 163
 8.3(c)-        3               1               1               3
 -Renewa
 l of
 approva
 l SMA-
 163
 8.3(e)-        1               1               0.5             0.5
 -Relinq
 uishmen
 t
 notific
 ation
 8.3(f)-        1              90               0.1             9
 -Nonren
 ewal
 notific
 ation
 to
 accredi
 ted
 OTP's
 8.4(b)(        2               2               1               4
 1)(ii)-
 -Notifi
 cation
 to
 SAMHSA
 for
 serious
 noncomp
 liant
 program
 s
8.4(b)(1        2               2               1               4
 )(iii)-
 -Notifi
 cation
 to
 noncomp
 liant
 program
 s
 8.4(d)(       10               2               0.5            10
 1)--Gen
 eral
 documen
 ts and
 informa
 tion to
 SAMHSA
 upon
 request
 8.4(d)(       10               6               0.2            12
 2)--Acc
 reditat
 ion
 survey
 to
 SAMHSA
 upon
 request
 8.4(d)(       10               6               0.2            12
 3)--Lis
 t of
 surveys
 ,
 surveyo
 rs to
 SAMHSA
 upon
 request
 8.4(d)(       10               7.5             0.5            37.5
 4)--Les
 s than
 full
 accredi
 tation
 report
 to
 SAMHSA
 8.4(d)(       10              30               0.5           150
 5)--Sum
 maries
 of
 inspect
 ions
 8.4(e)-       10               1               0.5             5
 -Notifi
 cation
 complai
 nts
 8.6(a)(        1              90               0.3            27
 2) and
 (b)(3)-
 -Revoca
 tion
 Notific
 ation
 to
 accredi
 ted
 OTP's
 8.6(b)-        1               1              10              10
 -Submis
 sion of
 90-day
 correct
 ive
 plan to
 SAMHSA
 8.6(b)(        1              90               0.3            27
 1)--Not
 ificati
 on to
 accredi
 ted
 OTP's
 of
 probati
 onary
 status
 Totals                                                       341
------------------------------------------------------------------------
\1\ Because some of the numbers underlying these estimates have been
  rounded, figures in this table are approximate. There are no
  maintenance and operation costs nor start up and capital costs.

    Recordkeeping--The recordkeeping requirements for OTP's set forth 
in proposed Sec. 8.12 include maintenance of the following: A patient's 
medical evaluation and other assessments when admitted to treatment, 
and periodically throughout treatment Sec. 8.12(f)(4)); the provision 
of needed services, including any prenatal support provided the patient 
(Sec. 8.12(g)(1)and (g)(2)); justification of exceptional initial 
doses; changes in a patient's dose and dosage schedule; justification 
of exceptional daily doses (Sec. 8.12(h)(3)(iii)); justification for 
variations from the approved product labeling for LAAM and future 
medications (Sec. 8.12(h)(4)); and the rationale for decreasing a 
patient's clinic attendance (Sec. 8.12(i)(3)).
    In addition, proposed Sec. 8.4(c)(1) will require accreditation 
bodies to keep and retain for 5 years certain records pertaining to 
their respective accreditation activities. These recordkeeping 
requirements for OTP's and accreditation bodies are customary and usual 
practices within the medical and rehabilitative communities, and thus 
impose no additional response burden hours or costs.
    Disclosure--This proposal retains requirements that OTP's and 
accreditation organizations disclose information. For example, proposed 
Sec. 8.12(e)(1) requires that a physician explain the facts concerning 
the use of opioid drug treatment to each patient. This type of 
disclosure is considered to be consistent with the common medical 
practice and is not considered an additional burden. Further, the 
proposal requires under Sec. 8.4(i)(1) that each accreditation 
organization shall make public its fee structure. The Secretary notes 
that the preceding section of this notice contains publicly available 
information on the fee structure for each of three accreditation 
bodies. This type of disclosure is standard business practice and is 
not considered a burden in this analysis.
    As required by section 3507(d) of the PRA, the Secretary has 
submitted a copy of this proposed rule to OMB for its review. Comments 
on the information collection requirements are specifically solicited 
in order to: (1) Evaluate

[[Page 39831]]

whether the proposed collection of information is necessary for the 
proper performance of DHHS's functions, including whether the 
information will have practical utility; (2) evaluate the accuracy of 
DHHS's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) enhance the quality, utility, and clarity of the information 
to be collected; and (4) minimize the burden of the collection of 
information on those who are to respond, including through the use of 
appropriate automated, electronic, mechanical, or other technological 
collection techniques or other forms of information technology, e.g., 
permitting electronic submission of responses.
    OMB is required to make a decision concerning the collection of 
information contained in these proposed regulations between 30 and 60 
days after publication of this document in the Federal Register. 
Therefore, a comment to OMB is best assured of having its full effect 
if OMB receives it within 30 days of publication. This does not affect 
the deadline for the public to comment to DHHS on the proposed 
regulations.
    Organizations and individuals desiring to submit comments on the 
information collection requirements should direct them to the Office of 
Information and Regulatory Affairs, OMB, (address above).

X. Request for Comments

    Interested persons may, on or before November 19, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

 XI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Unified Agenda of Federal Regulatory and Deregulatory 
Actions, 61 FR 62003 to 62502, November 29, 1996.
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Controversial Treatment, Journal of the American Medical 
Association, vol. 269, no. 15, p. 1995, 1993.
    3. U.S. General Accounting Office, Methadone Maintenance: Some 
Treatment Programs Are Not Effective, Greater Federal Oversight is 
Needed, GAO/HRD-90-104, 1990.
    4. U.S. Institutes of Medicine, Federal Regulation of Methadone 
Treatment, National Academy Press, 1995.
    5. U.S. Code Congressional and Administrative News, 91st Cong., 
2d sess., vol. 3, p. 4580, 1970.
    6. METHADONE HEW/FDA Proposes Conditions for Use, 41 FR 17922, 
April 29, 1976.
    7. Nightingale, S. L., Methadone Treatment Programs, Quarterly 
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States, vol. 38, no. 2, pp. 99-101, 1974.
    8. Center for Substance Abuse Treatment, ``State Methadone 
Treatment Guidelines: Treatment Improvement Protocol (TIP) Series 
1,'' 1993.
    9. Molinari, S. P., J. R. Cooper, D. J. Czechowicz, ``Federal 
Regulation of Clinical Practice in Narcotic Addiction Treatment: 
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and Ethics, vol. 22, no. 3, 1994.
    10. Center for Substance Abuse Treatment, ``Matching Treatment 
to Patient Needs in Opioid Substitution Therapy: Treatment 
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Regulation of Clinical Practice in Narcotic Addiction Treatment: 
Purpose, Status, and Alternatives,'' The Journal of Law, Medicine 
and Ethics, vol. 22, no. 3, 1994.
    12. Molinari, S. P., J. R. Cooper, D. J. Czechowicz, ``Federal 
Regulation of Clinical Practice in Narcotic Addiction Treatment: 
Purpose, Status, and Alternatives,'' The Journal of Law, Medicine 
and Ethics, vol. 22, no. 3, 1994.
    13. United States General Accounting Office, ``Methadone 
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    15. IOM Report, p. 213.
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    17. IOM Report, p. 236.
    18. IOM Report, p. 166.
    19. The 1996 CARF Accreditation Sourcebook, Commission on 
Accreditation of Rehabilitation Facilities, 1996.
    20. A Voice for Quality: The Newsletter of the Council on 
Accreditation of Services for Families and Children., COA, 1996.
    21. Dole, V. P., ``Hazards of Process Regulations,'' Journal of 
the American Medical Association, vol. 267, p. 2234, April 1992.
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2-1-01, 1996.
    23. ``Effective Medical Treatment of Heroin Addiction,'' NIH 
Consensus Statement 1997, vol. 15, no. 6, p. 10, November 17 to 19, 
1997.
    24. ``Narcotic Analgesics,'' in The Pharmaceutical Basis of 
Therapeutics, edited by Louis Goodman and Alfred Gilman, 14th ed., 
p. 237, 1971.
    25. ``THIRD METHADONE CLINIC PROPOSED,'' Tammie Smith, The 
Tennessean, January 18, 1997.
    26. ``Marrero to Get Methadone Clinic,'' Copyright 1997 The 
Times-Picayune Publishing Co., The Times-Picayune, February 28, 
1997.
    27. Annotated Code, State of Ohio, Ohio Annotated Code, p. 3793, 
2-1-01, 1996.
    28. METHADONE: Listing as New Drug With Special Requirements and 
Opportunity for Hearing, 37 FR 26791, December 15, 1972.
    29. Agency Information Collection Activities; Submission for OMB 
Review; Request for Comments, Docket No. 97N-0456, Food and Drug 
Administration, ``Conditions for the Use of Narcotic Drugs for 
Treatment of Narcotic Addiction Reporting and Recordkeeping 
Requirements,'' OMB Control Number 0910-0140--Reinstatement, 63 FR 
14468, March 25, 1998.
    30. New York Times, February 2, 1997, Sunday, Late Edition--
Final: Section 1; p. 12; Column 1; National Desk, ``Ex-Addicts Find 
Methadone More Elusive Than Heroin,'' Christopher S. Wren.
    31. IOM Report, pp. 92-118.
    32. Methadone Diversion, DEA, April 1995.
    33. Substance Abuse and Mental Health Services Administration, 
``Request for Proposal (RFP) No. 270-97-7003: `Development and 
Implementation of Opioid Treatment Program Accreditation','' April 
15, 1997.
    34. U.S. General Accounting Office, Billions Spent Annually for 
Treatment and Prevention Activities, GAO/HEHS-97-12; October 8, 
1996.
    35. Glass, R. M., ``Methadone Maintenance: New Research on 
Controversial Treatment,'' Journal of the American Medical 
Association, vol. 269, no. 15, 1995.
    36. U.S. Drug Enforcement Administration, Methadone Diversion: 
1995, Office of Diversion Control, April 1995.
    37. Rice, D., S. P. Kelman et al., The Economic Costs of Alcohol 
and Drug Abuse and Mental Illness, 1985, San Francisco, University 
of California, Institute for Health and Aging, 1990.
    38. Anglin, M. D., G. Speckart et al., ``Consequences and Costs 
of Shutting Off Methadone,'' Addictive Behaviors, vol. 14, pp. 307-
326, 1989.
    39. Dennis, M., J. Fairbanks et al., ``Enhanced Counselor's 
Manual,'' NIDA Grant No. 1-R18DA7262-01, Research Triangle 
Institute, 1991.
    40. Bradley, C. J., M. T. French et al., ``Financing and Cost of 
Standard and Enhanced Methadone Treatment,'' Journal of Substance 
Abuse Treatment, vol. 11, no. 5, pp. 433-442, 1994.
    41. Ralston, G. E., and P. Watson, ``Methadone Programmes: The 
Costs and Benefits to Society and the Individual,'' 
PharmacoEconomics, vol. 10, no. 4, pp. 321-326, 1996.
    42. French M. T., J. A. Mauskoph et al., ``Estimating the Dollar 
Value of Health Outcomes from Drug Abuse Interventions,'' Medical 
Care, vol. 34, pp. 890-910, 1996.
    43. Goldschmidt, P. G., ``A Cost-Effectiveness Model for 
Evaluating Health Care Programs: Application to Drug Abuse 
Treatment,'' Inquiry, vol. 13, no. 3, pp. 29-47, 1976.

[[Page 39832]]

    44. U.S. Food and Drug Administration, Guidelines for 
Medications Development for Substance Abuse Disorders, 1996.
    45. McLellan, A. T., H. Kushner et al., ``The Fifth Edition of 
the Addiction Severity Index,'' Journal of Substance Abuse 
Treatment, vol. 9, pp. 199-213, 1992.
    46. Horton, A. M., ``Future Directions in the Development of 
Addiction Assessment Instruments,'' in Diagnostic Source Book on 
Drug Abuse Research and Treatment (NIDA Research Monograph No. xx) 
Rounsaville, B. J., F. M. Tims, A. M. Horton, and B. J. Sowder, 
(Eds), U.S. Department of Health and Human Services, National 
Institutes of Health, National Institute on Drug Abuse, Washington, 
D.C.: U.S. Government Printing Office, 1993.
    47. Anglin, M. D., G. Speckart et al., ``Consequences and Costs 
of Shutting Off Methadone,'' Addictive Behaviors, vol. 14, pp. 307-
326, 1989.
    48. Ball, G. A., A. Ross, The Effectiveness of Methadone 
Treatment, Springer Verlag, New York, 1991.
    49. Gerstein, D. R., R. A. Johnson et al., Evaluating Recovery 
Services: The California Drug and Alcohol Treatment Assessment 
(CALDATA), Sacramento, CA, California Department of Alcohol and Drug 
Programs, 1994.
    50. McLellan, A. T., D. S. Metzger et al., ``Worth It? Public 
Health Expectations, Policy-Based Comparisons,'' Millbank Quarterly, 
1995.
    51. Ball, G. A., A. Ross, The Effectiveness of Methadone 
Treatment, Springer Verlag, New York, 1991.
    52. Gerstein, D. R., R. A. Johnson et al, Evaluating Recovery 
Services: The California Drug and Alcohol Treatment Assessment 
(CALDATA), Sacramento, CA, California Department of Alcohol and Drug 
Programs, 1994.
    53. Hubbard, R. L., M. E. Marsden et al., Drug Abuse Treatment: 
A National Study of Effectiveness, Chapel Hill, NC, University of 
North Carolina Press, 1989.
    54. Des Jarlais, D. C., S. R. Friedman et al., ``HIV 1 Infection 
among Intravenous Drug Users in Manhattan, New York City: 1977 to 
1987'' Journal of the American Medical Association, vol. 261, pp. 
1008-1012, 1989.
    55. Metzger, D. S., G. E. Woody et al., ``HIV Conversion Among 
In and Out-of-Treatment Intravenous Drug Users in Philadelphia,'' 
Journal of AIDS, vol. 6, pp. 1049-1056, 1993.
    56. U.S. National Institutes for Health, NIH Consensus Panel on 
Prevention and Treatment of Substance Use Disorders for HIV Risk 
Reduction, Bethesda, MD, 1997.
    57. U.S. Food and Drug Administration, Narcotic Treatment 
Programs Directory, February 20, 1997.
    58. U.S. Substance Abuse and Mental Health Services 
Administration, Uniform Facility Data Set (UFDS): Data for 1996 and 
1980-1996, Office of Applied Studies, December 1997.
    59. U.S. Substance Abuse and Mental Health Services 
Administration, National Drug and Alcohol Treatment Unit Survey, 
1993a.
    60. U.S. Substance Abuse and Mental Health Services 
Administration, Uniform Facility Data Set (UFDS): Data for 1996 and 
1980-1996, Office of Applied Studies, December 1997.
    61. U.S. Substance Abuse and Mental Health Services 
Administration, 1997.
    62. U.S. Substance Abuse and Mental Health Services 
Administration, Uniform Facility Data Set (UFDS): Data for 1996 and 
1980-1996, Office of Applied Studies, December 1997.
    63. Capital Consulting Corporation and the Lewin Group 
``Methadone and LAAM: An Analysis of the Cost of Treatment Using 
Alternative Medications for Opiate Addiction,'' Contract No. SAMHSA 
270-91-8327, October 31, 1996.
    64. Bradley, C. J., M. T. French et al., ``Financing and Cost of 
Standard and Enhanced Methadone Treatment,'' Journal of Substance 
Abuse Treatment, vol. 11, no. 5, pp. 433-442, 1994.
    65. Capital Consulting Corporation and the Lewin Group, 
``Methadone and LAAM: An Analysis of the Cost of Treatment Using 
Alternative Medications for Opiate Addiction,'' Contract No. SAMHSA 
270-91-8327, October 31, 1996.
    66. Bradley, C. J., M. T. French et al., ``Financing and Cost of 
Standard and Enhanced Methadone Treatment,'' Journal of Substance 
Abuse Treatment, vol. 11, no. 5, pp. 433-442, 1994.
    67. U.S. Bureau of Labor Statistics, Compensation and Working 
Conditions, vol. 2, no. 4, p. 88, 1997.
    68. Joint Commission on Accreditation of Healthcare 
Organizations, 1996 Survey Fees, 1996.
    69. U.S. Bureau of Labor Statistics, Employment and Earnings, 
1995.
    70. Bonn, E. M., ``Accreditation and Regulation of Psychiatric 
Facilities,'' in Psychiatric Administration, edited by J. A. Talbott 
and S. R. Kaplan, Grune and Stratton, pp. 299-310, 1983.
    71. Capital Consulting Corporation and the Lewin Group 
``Methadone and LAAM: An Analysis of the Cost of Treatment Using 
Alternative Medications for Opiate Addiction,'' Contract No. SAMHSA 
270-91-8327, October 31, 1996.
    72. Conklin, T. J., ``Quality Assurance,'' in Psychiatric 
Administration, edited by J. A. Talbott and S. R. Kaplan, Grune and 
Stratton, pp. 273-285, 1983.
    73. Marlatt, G. A., J. R. Gordon, Relapse Prevention, Guilford 
Press, New York, 1985.
    74. Ball, G. A., A. Ross, The Effectiveness of Methadone 
Treatment, Springer Verlag, New York, 1991.
    75. Ball, G. A., A. Ross, The Effectiveness of Methadone 
Treatment, Springer Verlag, New York, 1991.
    76. Goldschmidt, P. G., ``A Cost-Effectiveness Model for 
Evaluating Health Care Programs: Application to Drug Abuse 
Treatment,'' Inquiry, vol. 13, no. 3, pp. 29-47, 1976.
    77. Goldschmidt, P. G., ``A Cost-Effectiveness Model for 
Evaluating Health Care Programs: Application to Drug Abuse 
Treatment,'' Inquiry, vol. 13, no. 3, pp. 29-47, 1976.
    78. U.S. National Center for Health Statistics, Monthly Vital 
Statistics Reports, 1993.
    79. U.S. Small Business Administration, Table of Size Standards, 
March 1, 1996.
    80. Capital Consulting Corporation and the Lewin Group, 
``Methadone and LAAM: An Analysis of the Cost of Treatment Using 
Alternative Medications for Opiate Addiction,'' Contract No. SAMHSA 
270-91-8327, October 31, 1996.
    81. Ralston, G. E., and P. Watson, ``Methadone Programmes: The 
Costs and Benefits to Society and the Individual,'' 
PharmacoEconomics, vol. 10, no. 4, pp. 321-326, 1996.
    82. Agency Information Collection Activities; Submission for OMB 
Review; Request for Comments, Docket No. 97N-0456, Food and Drug 
Administration, ``Conditions for the Use of Narcotic Drugs for 
Treatment of Narcotic Addiction Reporting and Recordkeeping 
Requirements,'' OMB Control Number 0910-0140--Reinstatement, 63 FR 
14468, March 25, 1998.

List of Subjects

21 CFR Part 291

    Health professions, Methadone, Reporting and recordkeeping 
requirements.

 42 CFR Part 8

    Health professionals, Levo-Alpha-Acetyl-Methadol (LAAM), Methadone, 
Reporting and recordkeeping requirements.
    Therefore, under the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, the Controlled Substances Act as amended by the 
Narcotic Addict Treatment Act of 1974, the Public Health Service Act, 
the Federal Food, Drug, and Cosmetic Act, and applicable delegations of 
authority thereunder, it is proposed that titles 21 and 42 of the Code 
of Federal Regulations be amended as follows:

21 CFR Chapter I

PART 291 [REMOVED]

    1. Under authority of sections 301(d), 543, 1976 of the Public 
Health Service Act (42 U.S.C. 241(d), 290dd-2, 300y-11); 38 U.S.C. 
7332, 42 U.S.C. 257a; sections 505, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 371); and section 303(g) of the Controlled 
Substances Act (21 U.S.C. 823(g)), amend title 21 of the Code of 
Federal Regulations by removing part 291.

 42 CFR Chapter I

     2. Amend 42 CFR Chapter I by adding part 8 to subchapter A to read 
as follows:

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

Subpart A--Accreditation

Sec.
   8.1   Scope.
  8.2   Definitions.

[[Page 39833]]

  8.3   Application for approval as an accreditation body.
  8.4   Accreditation body responsibilities.
  8.5   Periodic evaluation of accreditation bodies.
  8.6   Withdrawal of approval of accreditation bodies.

Subpart B--Certification and Treatment Standards

   8.11   Opioid treatment program certification.
  8.12   Federal opioid treatment standards.
  8.13   Revocation of accreditation and accreditation body 
approval.
  8.14   Suspension or revocation of certification.
  8.15   Forms.

Subpart C--Procedures for Review of Suspension or Proposed Revocation 
of OTP Certification

  8.21   Applicability.
  8.22   Definitions.
  8.23   Limitation on issues subject to review.
  8.24   Specifying who represents the parties.
  8.25   Informal review and the reviewing official's response.
  8.26   Preparation of the review file and written argument.
  8.27   Opportunity for oral presentation.
  8.28   Expedited procedures for review of immediate suspension.
  8.29   Ex parte communications.
  8.30   Transmission of written communications by reviewing 
official and calculation of deadlines.
  8.31   Authority and responsibilities of reviewing official.
  8.32   Administrative record.
  8.33   Written decision.
  8.34   Court review of final administrative action; exhaustion of 
administrative remedies.
    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 
300x-23, 300x-27(a), 300y-11.

 Subpart A--Accreditation


Sec. 8.1   Scope.

    The regulations in this part establish the procedures by which the 
Secretary of Health and Human Services (the Secretary) will determine 
whether a practitioner is qualified under section 303(g) of the 
Controlled Substances Act (21 U.S.C. 823(g)) to dispense opioid drugs 
in the treatment of opioid addiction. These regulations also establish 
the Secretary's standards regarding the appropriate quantities of 
opioid drugs that may be provided for unsupervised use by individuals 
undergoing such treatment (21 U.S.C. 823(g)(3)). Under these 
regulations, a practitioner who intends to dispense opioid drugs in the 
treatment of opioid addiction must first obtain from the Secretary or 
by delegation, from the Substance Abuse and Mental Health Services 
Administration (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 an accreditation body that 
has been approved by SAMHSA. These regulations establish the procedures 
whereby an entity can apply to become an approved accreditation body. 
This part also establishes requirements and general standards for 
accreditation bodies to ensure that practitioners are consistently 
evaluated for compliance with the Secretary's standards for opioid 
treatment.


Sec. 8.2   Definitions.

    The following definitions apply to this part:
    Accreditation means the process of review and acceptance by an 
accreditation body.
    Accreditation body means a body that has been approved by SAMHSA 
under Sec. 8.3 to accredit opioid treatment programs.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body, as 
described in Sec. 8.3(b).
    Accreditation elements mean the elements that are developed and 
adopted by an accreditation body and approved by SAMHSA.
    Accreditation survey means an onsite review and evaluation of an 
opioid treatment program by an accreditation body for the purpose of 
determining compliance with the Federal opioid treatment standards 
described in Sec. 8.12.
    Accredited opioid treatment program means an opioid treatment 
program that is the subject of a current, valid accreditation from an 
approved accreditation body.
    Certification means the process by which SAMHSA determines that an 
opioid treatment program is qualified to provide opioid treatment under 
the Federal opioid treatment standards.
    Certification application means the application filed by an opioid 
treatment program for purposes of obtaining certification from SAMHSA, 
as described in Sec. 8.11(b).
    Certified opioid treatment program means an opioid treatment 
program that is the subject of a current, valid certification under 
Sec. 8.11.
    Comprehensive maintenance treatment is maintenance treatment 
provided in conjunction with a comprehensive range of appropriate 
medical and rehabilitative services.
    Detoxification treatment means the dispensing of an opioid agonist 
treatment medication in decreasing doses to an individual to alleviate 
adverse physical or psychological effects incident to withdrawal from 
the continuous or sustained use of an opioid drug and as a method of 
bringing the individual to a drug-free state within such period.
    Federal opioid treatment standards means the standards established 
by the Secretary in Sec. 8.12 that are used to determine whether an 
opioid treatment program is qualified to engage in opioid treatment. 
The Federal opioid treatment standards established in Sec. 8.12 also 
include the standards established by the Secretary regarding the 
quantities of opioid drugs which may be provided for unsupervised use.
    For-cause inspection means an inspection of an opioid treatment 
program by the Secretary, or by an accreditation body, that may be 
operating in violation of Federal opioid treatment standards, may be 
providing substandard treatment, or may be serving as a possible source 
of diverted medications.
    Interim maintenance treatment means maintenance treatment provided 
in conjunction with appropriate medical services while a patient is 
awaiting transfer to a program that provides comprehensive maintenance 
treatment.
    Long-term detoxification treatment means detoxification treatment 
for a period more than 30 days but not in excess of 180 days.
    Maintenance treatment means the dispensing of an opioid agonist 
treatment medication at stable dosage levels for a period in excess of 
21 days in the treatment of an individual for opioid addiction.
    Medical director means a physician, licensed to practice medicine 
in the jurisdiction in which the opioid treatment program is located, 
who assumes responsibility for administering all medical services 
performed by the program, either by performing them directly or by 
delegating specific responsibility to authorized program physicians and 
healthcare professionals functioning under the medical director's 
direct supervision.
    Medical and rehabilitative services means services such as medical 
evaluations, counseling, and rehabilitative and other social programs 
(e.g., vocational and educational guidance, employment placement), that 
are intended to help patients in opioid treatment programs become 
productive members of society.
    Medication unit means a facility established as part of, but

[[Page 39834]]

geographically separate from, an opioid treatment program from which 
licensed private practitioners or community pharmacists dispense or 
administer an opioid agonist treatment medication or collect samples 
for drug testing or analysis.
    Opioid addiction means a condition in which an individual exhibits 
a compulsive craving for or compulsively uses opioid drugs despite 
being harmed or causing harm as a result of such craving or use.
    Opioid agonist treatment medication means any opioid agonist drug 
that is approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opioid addiction.
    Opioid drug means any drug having an addiction-forming or 
addiction-sustaining liability similar to morphine or being capable of 
conversion into a drug having such addiction-forming or addiction-
sustaining liability.
    Opioid treatment means the dispensing of an opioid agonist 
treatment medication, along with a comprehensive range of medical and 
rehabilitative services, when clinically necessary, to an individual to 
alleviate the adverse medical, psychological, or physical effects 
incident to opioid addiction. This term encompasses detoxification 
treatment, short-term detoxification treatment, long-term 
detoxification treatment, maintenance treatment, comprehensive 
maintenance treatment, and interim maintenance treatment.
    Opioid treatment program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment medication.
    Patient means any individual who undergoes treatment in an opioid 
treatment program.
    Program sponsor means the person named in the application for 
certification described in Sec. 8.11(b) as responsible for the 
operation of the opioid treatment program and who assumes 
responsibility for all its employees, including any practitioners, 
agents, or other persons providing medical, rehabilitative, or 
counseling services at the program or any of its medication units. The 
program sponsor need not be a licensed physician but shall employ a 
licensed physician for the position of medical director.
    Registered opioid treatment program means an opioid treatment 
program that is registered under 21 U.S.C. 823(g).
     Short-term detoxification treatment means detoxification treatment 
for a period not in excess of 30 days.
    Treatment plan means a plan that outlines for each patient 
attainable short-term treatment goals that are mutually acceptable to 
the patient and the opioid treatment program.


Sec. 8.3   Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State 
governmental entities, or political subdivisions thereof, capable of 
meeting the requirements of this part may apply for approval as an 
accreditation body.
    (b) Application for initial approval. Three copies of an 
accreditation body application form [SMA-163] shall be submitted to 
SAMHSA at rm. 12-105, 5600 Fishers Lane, Rockville, MD 20857, and 
marked ATTENTION: OTP Certification Program. Accreditation body 
applications shall include the following information and supporting 
documentation:
    (1) Name, address, and telephone number of the applicant and a 
responsible official for the application. The application shall be 
signed by the responsible official;
    (2) Evidence of the nonprofit status of the applicant (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a State governmental entity or 
political subdivision;
    (3) Evidence demonstrating that the applicant will be able to 
survey no less than 50 OTP's annually;
     (4) A set of the accreditation elements and a detailed discussion 
showing how the proposed accreditation elements will ensure that each 
OTP surveyed by the applicant is qualified to meet or is meeting each 
of the Federal opioid treatment standards set forth in Sec. 8.12;
    (5) A detailed description of the applicant's decisionmaking 
process, including:
    (i) Procedures for initiating and performing onsite accreditation 
surveys of OTP's;
    (ii) Procedures for assessing OTP personnel qualifications;
    (iii) Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTP's 
during the accreditation process, including a request for a complete 
history of prior accreditation activities and a statement that all 
information and data submitted in the application for accreditation is 
true and accurate, and that no material fact has been omitted;
    (iv) Policies and procedures for notifying OTP's and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTP's;
    (v) Policies and procedures for suspending or revoking an OTP's 
accreditation;
    (vi) Policies and procedures that will ensure processing of 
applications for accreditation and applications for renewal of 
accreditation within a timeframe approved by SAMHSA; and
    (vii) A description of the applicant's appeals process to allow 
OTP's to contest adverse accreditation decisions.
    (6) Policies and procedures established by the accreditation body 
to avoid conflicts of interest, or the appearance of conflicts of 
interest, by the applicant's board members, commissioners, professional 
personnel, consultants, administrative personnel, and other 
representatives;
    (7) A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician on the applicant's staff;
    (8) A description of the applicant's training policies;
    (9) Fee schedules, with supporting cost data;
    (10) Satisfactory assurances that the body will comply with the 
requirements of Sec. 8.4, including a contingency plan for 
investigating complaints under Sec. 8.4(e);
    (11) Policies and procedures established to protect confidential 
information the applicant will collect or receive in its role as an 
accreditation body; and
    (12) Any other information SAMHSA may require.
    (c) Application for renewal of approval. An accreditation body that 
intends to continue to serve as an accreditation body beyond its 
current term shall apply to SAMHSA for renewal, or notify SAMHSA of its 
intention not to apply for renewal, in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of an 
accreditation body's term of approval, the body shall inform SAMHSA in 
writing of its intent to seek renewal.
    (2) SAMHSA will notify the applicant of the relevant information, 
materials, and supporting documentation required under paragraph (b) of 
this section that the applicant shall submit as part of the renewal 
procedure.
    (3) At least 3 months before the date of expiration of the 
accreditation body's term of approval, the applicant shall furnish to 
SAMHSA three copies of a renewal application containing the 
information, materials, and supporting

[[Page 39835]]

documentation requested by SAMHSA under paragraph (c)(2) of this 
section.
    (4) An accreditation body that does not intend to renew its 
approval shall so notify SAMHSA at least 9 months before the expiration 
of the body's term of approval.
    (d) Rulings on applications for initial approval or renewal of 
approval. (1) SAMHSA will grant an application for initial approval or 
an application for renewal of approval if it determines the applicant 
substantially meets the accreditation body requirements of this 
subpart.
    (2) If SAMHSA determines that the applicant does not substantially 
meet the requirements set forth in subpart A of this part, SAMHSA will 
notify the applicant of the deficiencies in the application and request 
that the applicant resolve such deficiencies within 90 days of receipt 
of the notice. If the deficiencies are resolved to the satisfaction of 
SAMHSA within the 90-day time period, the body will be approved as an 
accreditation body. If the deficiencies have not been resolved to the 
satisfaction of SAMHSA within the 90-day time period, the application 
for approval as an accreditation body will be denied.
    (3) If SAMHSA does not reach a final decision on a renewal 
application before the expiration of an accreditation body's term of 
approval, the approval will be deemed extended until SAMHSA reaches a 
final decision, unless an accreditation body does not rectify 
deficiencies in the application within the specified time period, as 
required in paragraph (d)(2) of this section.
    (e) Relinquishment of approval. An accreditation body that intends 
to relinquish its accreditation approval before expiration of the 
body's term of approval shall submit a letter of such intent to SAMHSA, 
at the address in paragraph (b) of this section, at least 9 months 
before relinquishing such approval.
    (f) Notification. An accreditation body that does not apply for 
renewal of approval, or is denied such approval by SAMHSA, relinquishes 
its accreditation approval before expiration of its term of approval, 
or has its approval withdrawn, shall:
    (1) Transfer copies of records and other related information as 
required by SAMHSA to a location, including another accreditation body, 
and according to a schedule approved by SAMHSA; and
    (2) Notify, in a manner and time period approved by SAMHSA, all 
OTP's accredited or seeking accreditation by the body that the body 
will no longer have approval to provide accreditation services.
    (g) Term of approval. An accreditation body's term of approval is 
for a period not to exceed 5 years.
    (h) State accreditation bodies. State governmental entities, 
including political subdivisions thereof, may establish organizational 
units that may act as accreditation bodies, provided such units meet 
the requirements of this section, are approved by SAMHSA under this 
section, and have taken appropriate measures to prevent actual or 
apparent conflicts of interest, including cases in which State or 
Federal funds are used to support opioid treatment services.


Sec. 8.4   Accreditation body responsibilities.

    (a) Accreditation surveys and inspections. (1) Accreditation bodies 
shall conduct routine accreditation surveys for initial, renewal, and 
continued accreditation of each OTP at least every 3 years.
    (2) Accreditation bodies must agree to conduct for-cause 
inspections upon the request of SAMHSA.
    (3) Accreditation decisions shall be fully consistent with the 
policies and procedures submitted as part of the approved accreditation 
body application.
    (b) Response to noncompliant programs. (1) If an accreditation body 
receives or discovers information that suggests that an OTP is not 
meeting Federal opioid treatment standards, or if review of the OTP by 
the accreditation body otherwise demonstrates one or more deficiencies 
in the OTP, the accreditation body shall as appropriate either require 
and monitor corrective action or shall suspend or revoke accreditation 
of the OTP, as appropriate based on the significance of the 
deficiencies.
    (i) Accreditation bodies shall either not accredit or shall revoke 
the accreditation of any OTP that substantially fails to meet the 
Federal opioid treatment standards.
    (ii) Accreditation bodies shall notify SAMHSA as soon as possible 
but in no case longer than 48 hours after becoming aware of any 
practice or condition that may pose a serious risk to public health or 
safety or patient care.
    (iii) If an accreditation body determines that an OTP is 
substantially meeting the Federal opioid treatment standards, but is 
not meeting one or more accreditation elements, the accreditation body 
shall determine the necessary corrective measures to be taken by the 
OTP, establish a schedule for implementation of such measures, and 
notify the OTP in writing that it must implement such measures within 
the specified schedule in order to ensure continued accreditation. The 
accreditation body shall verify that the necessary steps are taken by 
the OTP within the schedule specified and that all accreditation 
elements are being substantially met or will be substantially met.
    (2) Nothing in this part shall prevent accreditation bodies from 
granting accreditation, contingent on promised programmatic or 
performance changes, to programs with less substantial violations. Such 
accreditation shall not exceed 12 months. Programs that have been 
granted such accreditation must have their accreditation revoked if 
they fail to make changes to receive unconditional accreditation upon 
resurvey or reinspection.
    (c) Recordkeeping. (1) Accreditation bodies shall maintain records 
of their accreditation activities for at least 5 years from the 
creation of the record. Such records must contain sufficient detail to 
support each accreditation decision made by the accreditation body.
    (2) Accreditation bodies shall establish procedures to protect 
confidential information collected or received in their role as 
accreditation bodies that are consistent with, and that are designed to 
ensure compliance with, all Federal and State laws, including 42 CFR 
part 2.
    (i) Information collected or received for the purpose of carrying 
out accreditation body responsibilities shall not be used for any other 
purpose or disclosed, other than to SAMHSA or its duly designated 
representatives, unless otherwise required by law or with the consent 
of the OTP.
     (ii) Nonpublic information that SAMHSA shares with the 
accreditation body concerning an OTP shall not be further disclosed 
except with the written permission of SAMHSA.
    (d) Reporting. (1) Accreditation bodies shall provide to SAMHSA any 
documents and information requested by SAMHSA within 5 days of receipt 
of the request.
    (2) Accreditation bodies shall make a summary of the results of 
each accreditation survey available to SAMHSA upon request. Such 
summaries shall contain sufficient detail to justify the accreditation 
action taken.
    (3) Accreditation bodies shall provide SAMHSA upon request a list 
of each OTP surveyed and the identity of all individuals involved in 
the conduct and reporting of survey results.
    (4) Accreditation bodies shall submit to SAMHSA the name of each 
OTP for

[[Page 39836]]

which the accreditation body accredits conditionally, denies, suspends, 
or revokes accreditation, and the basis for the action, within 48 hours 
of the action.
    (5) Notwithstanding any reports made to SAMHSA under paragraphs 
(d)(1) through (d)(4) of this section, each accreditation body shall 
submit to SAMHSA semi-annually, on January 15 and July 15 of each 
calendar year, a report consisting of a summary of the results of each 
accreditation survey conducted in the past year. The summary shall 
contain sufficient detail to justify each accreditation action taken.
    (6) All reporting requirements listed in this section shall be 
provided to SAMHSA at the address specified in Sec. 8.3(b).
    (e) Complaint response. Accreditation bodies shall have policies 
and procedures to respond to complaints from SAMHSA, patients, and 
others within a reasonable period of time but not more than 5 days of 
the receipt of the complaint. Accreditation bodies shall also agree to 
notify SAMHSA within 48 hours of receipt of a complaint and keep SAMHSA 
informed of all aspects of the response to the complaint.
    (f) Modifications of accreditation elements. Accreditation bodies 
shall obtain SAMHSA's authorization prior to making any substantive 
(i.e., noneditorial) change in accreditation elements.
    (g) Conflicts of interest. The accreditation body shall maintain 
and apply policies and procedures that SAMHSA has approved in 
accordance with Sec. 8.3 to reduce the possibility of actual conflict 
of interest, or the appearance of a conflict of interest, on the part 
of individuals who act on behalf of the accreditation body. Individuals 
who participate in accreditation surveys or otherwise participate in 
the accreditation decision or an appeal of the accreditation decision, 
as well as their spouses and minor children, shall not have a financial 
interest in the OTP that is the subject of the accreditation survey or 
decision.
    (h) Accreditation teams. (1) An accreditation body survey team 
shall consist of healthcare professionals with expertise in drug abuse 
treatment and, in particular, opioid treatment. The accreditation body 
shall consider factors such as the size of the OTP, the anticipated 
number of problems, and the OTP's accreditation history, in determining 
the composition of the team. At a minimum, survey teams shall consist 
of at least 2 healthcare professionals whose combined expertise 
includes:
    (i) The dispensing and administration of drugs subject to control 
under the Controlled Substances Act (21 U.S.C. 801 et seq.);
    (ii) Medical issues relating to the dosing and administration of 
opioid agonist treatment medications for the treatment of opioid 
addiction;
    (iii) Psychosocial counseling of individuals undergoing opioid 
treatment; and
    (iv) Organizational and administrative issues associated with 
opioid treatment programs.
    (2) Members of the accreditation team must be able to recuse 
themselves at any time from any survey in which either they or the OTP 
believes there is an actual conflict of interest or the appearance of a 
conflict of interest.
    (i) Accreditation fees. Fees charged to OTP's for accreditation 
shall be reasonable. SAMHSA generally will find fees to be reasonable 
if the fees are limited to recovering costs to the accreditation body, 
including overhead incurred. Accreditation body activities that are not 
related to accreditation functions are not recoverable through fees 
established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different OTP's.
    (2) At SAMHSA's request, accreditation bodies shall provide to 
SAMHSA financial records or other materials, in a manner specified by 
SAMHSA, to assist in assessing the reasonableness of accreditation body 
fees.


Sec. 8.5   Periodic evaluation of accreditation bodies.

    SAMHSA will evaluate periodically the performance of accreditation 
bodies primarily by inspecting a selected sample of the OTP's 
accredited by the accrediting body and by evaluating the accreditation 
body's reports of surveys conducted, to determine whether the OTP's 
surveyed and accredited by the accreditation body are in compliance 
with the Federal opioid treatment standards. The evaluation will 
include a determination of whether there are major deficiencies in the 
accreditation body's performance that, if not corrected, would warrant 
withdrawal of the approval of the accreditation body under Sec. 8.6.


Sec. 8.6   Withdrawal of approval of accreditation bodies.

    If SAMHSA determines that an accreditation body is not in 
substantial compliance with this subpart, SAMHSA shall take appropriate 
action as follows:
    (a) Major deficiencies. If SAMHSA determines that the accreditation 
body has a major deficiency, such as commission of fraud, material 
false statement, failure to perform a major accreditation function 
satisfactorily, or significant noncompliance with the requirements of 
this subpart, SAMHSA shall withdraw approval of that accreditation 
body.
    (1) In the event of a major deficiency, SAMHSA shall notify the 
accreditation body of the agency's action and the grounds on which the 
approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
each OTP that has been accredited or is seeking accreditation that the 
accreditation body's approval has been withdrawn. Such notification 
shall be made within a time period and in a manner approved by SAMHSA.
    (b) Minor deficiencies. If SAMHSA determines that the accreditation 
body has minor deficiencies in the performance of an accreditation 
function, that are less serious or more limited than the types of 
deficiencies described in paragraph (a) of this section, SAMHSA will 
notify the body that it has 90 days to submit to SAMHSA a plan of 
corrective action. The plan must include a summary of corrective 
actions and a schedule for their implementation. SAMHSA may place the 
body on probationary status for a period of time determined by SAMHSA, 
or may withdraw approval of the body if corrective action is not taken.
    (1) If SAMHSA places an accreditation body on probationary status, 
the body shall notify all OTP's that have been accredited, or that are 
seeking accreditation, of the accreditation body's probationary status 
within a time period and in a manner approved by SAMHSA.
    (2) Probationary status will remain in effect until such time as 
the body can demonstrate to the satisfaction of SAMHSA that it has 
successfully implemented or is implementing the corrective action plan 
within the established schedule, and the corrective actions taken have 
substantially eliminated all identified problems.
    (3) If SAMHSA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, SAMHSA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all OTP's that have been accredited, or are seeking accreditation, of 
the accreditation body's loss of SAMHSA approval within

[[Page 39837]]

a time period and in a manner approved by SAMHSA.
    (c) Reapplication. (1) An accreditation body that has had its 
approval withdrawn may submit a new application for approval if the 
body can provide information to SAMHSA to establish that the problems 
that were grounds for withdrawal of approval have been resolved.
    (2) If SAMHSA determines that the new application demonstrates that 
the body satisfactorily has addressed the causes of its previous 
unacceptable performance, SAMHSA may reinstate approval of the 
accreditation body.
    (3) SAMHSA may request additional information or establish 
additional conditions that must be met before SAMHSA approves the 
reapplication.
    (4) SAMHSA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud, 
material false statement, or willful disregard of public health.
    (d) Hearings. An opportunity to challenge an adverse action taken 
regarding withdrawal of approval of an accreditation body shall be 
addressed through the relevant procedures set forth in subpart C of 
this part, except that the procedures in Sec. 8.28 for expedited review 
of an immediate suspension would not apply to an accreditation body 
that has been notified under paragraph (a) or (b) of this section of 
the withdrawal of its approval.

 Subpart B--Certification and Treatment Standards


Sec. 8.11   Opioid treatment program certification.

    (a) General. (1) An OTP must be the subject of a current, valid 
certification from SAMHSA to be considered qualified by the Secretary 
under section 303(g)(1) and (g)(3) of the Controlled Substances Act (21 
U.S.C. 823(g)(1) and (g)(3)) to dispense opioid drugs in the treatment 
of opioid addiction. An OTP must be determined to be qualified under 
section 303(g)(1) and (g)(3) of the Controlled Substances Act, and must 
be determined to be qualified by the Attorney General under section 
303(g)(2), to be registered by the Attorney General to dispense opioid 
agonist treatment medications to individuals for treatment of opioid 
addiction.
    (2) To obtain certification from SAMHSA, an OTP must meet the 
Federal opioid treatment standards in Sec. 8.12, must be the subject of 
a current, valid accreditation by an accreditation body or other entity 
designated by SAMHSA, and must comply with any other conditions for 
certification established by SAMHSA.
    (3) Certification shall be granted for a term not to exceed 3 
years, except that certification may be extended during the third year 
if an application for accreditation is pending.
    (b) Application for certification. Three copies of an application 
for certification must be submitted by the OTP to the address 
identified in Sec. 8.3(b). The application for certification shall 
include:
    (1) A description of the current accreditation status of the OTP;
    (2) A description of the organizational structure of the OTP;
    (3) The names of the persons responsible for the OTP;
    (4) The address of the OTP and of each medication unit or other 
facility under the control of the OTP;
    (5) The sources of funding for the OTP and the name and address of 
each governmental entity that provides such funding; and
    (6) A statement that the OTP will comply with the conditions of 
certification set forth in paragraph (f) of this section.
    (7) The application shall be signed by the program sponsor who 
shall certify that the information submitted in the application is 
truthful and accurate.
    (c) Action on application. (1) Following SAMHSA's receipt of an 
application for certification of an OTP, and after consultation with 
the appropriate State authority regarding the qualifications of the 
applicant, SAMHSA may grant the application for certification, or renew 
an existing certification, if SAMHSA determines that the OTP has 
satisfied the requirements for certification or renewal of 
certification.
    (2) SAMHSA may deny the application if SAMHSA determines that:
    (i) The application for certification is deficient in any respect;
    (ii) The OTP will not be operated in accordance with the Federal 
opioid treatment standards established under Sec. 8.12;
    (iii) The OTP will not permit an inspection or a survey to proceed, 
or will not permit in a timely manner access to relevant records or 
information; or
    (iv) The OTP has made misrepresentations in obtaining accreditation 
or in applying for certification.
    (3) Within 5 days after it reaches a final determination that an 
OTP meets the requirements for certification, SAMHSA will notify the 
Drug Enforcement Administration (DEA) that the OTP has been determined 
to be qualified to provide opioid treatment under section 303(g)(1) and 
(g)(3) of the Controlled Substances Act.
    (d) Transitional certification. OTP's that on (date 60 days after 
date of publication of final rule in the Federal Register) were the 
subject of a current, valid approval by FDA under 21 CFR part 291, are 
deemed to be the subject of a current valid certification for purposes 
of paragraph (a)(11) of this section. Such ``transitional'' 
certification shall expire on (date 150 days after date of publication 
of final rule in the Federal Register), except that such transitional 
certification of an OTP that submits the information required by 
paragraph (b) of this section to SAMHSA on or before (date 150 days 
after date of publication of the final rule in the Federal Register), 
along with a statement certifying that the OTP will apply for 
accreditation from a SAMHSA approved accreditation body within 90 days 
from the date SAMHSA announces the approval of the first accreditation 
body under Sec. 8.3, shall expire on (date 2 years and 60 days after 
date of publication of final rule in the Federal Register). SAMHSA may 
extend the transitional certification of an OTP for up to 1 additional 
year provided the OTP demonstrates that it has applied for 
accreditation, that an accreditation survey has taken place or is 
scheduled to take place, and that an accreditation decision is expected 
within a reasonable period of time (e.g., within 90 days from the date 
of survey). Transitional certification under this section may be 
suspended or revoked in accordance with Sec. 8.14.
    (e) Provisional certification. (1) OTP's that have no current 
certification from SAMHSA, but have applied for accreditation with an 
accreditation body, are eligible to receive a provisional certification 
for up to 1 year. To receive a provisional certification, an OTP shall 
submit the information required by paragraph (b) of this section to 
SAMHSA along with a statement identifying the accreditation body to 
which the OTP has applied for accreditation, the date on which the OTP 
applied for accreditation, the dates of any accreditation surveys that 
have taken place or are expected to take place, and the expected 
schedule for completing the accreditation process. A provisional 
certification for up to 1 year will be granted, following receipt of 
the information described in this paragraph, unless SAMHSA determines 
that patient health would be adversely affected by the granting of 
provisional certification.
    (2) An extension of provisional certification may be granted in

[[Page 39838]]

extraordinary circumstances or otherwise to protect public health. To 
apply for a 90-day extension of provisional certification, an OTP shall 
submit to SAMHSA a statement explaining the program's efforts to obtain 
accreditation and a schedule for obtaining accreditation as 
expeditiously as possible.
    (f) Conditions for certification. (1) OTP's shall comply with all 
pertinent State laws and regulations. Nothing in this part is intended 
to limit the authority of State and local governmental entities to 
regulate the use of opioid drugs in the treatment of opioid addiction. 
The provisions of this section requiring compliance with requirements 
imposed by State law, or the submission of applications or reports 
required by the State authority, do not apply to programs operated 
directly by the Veterans' Administration or any other department or 
agency of the United States. Federal agencies operating narcotic 
treatment programs have agreed to cooperate voluntarily with State 
agencies by granting permission on an informal basis for designated 
State representatives to visit Federal narcotic treatment programs and 
by furnishing a copy of Federal reports to the State authority, 
including the reports required under this section.
    (2) OTP's shall allow, in accordance with Federal controlled 
substances laws and Federal confidentiality laws, inspections and 
surveys by duly authorized employees of SAMHSA, by accreditation 
bodies, by the DEA, and by authorized employees of any relevant State 
or Federal governmental authority.
    (3) Disclosure of patient records maintained by an OTP is governed 
by the provisions of 42 CFR part 2, and every program must comply with 
that part. Records on the receipt, storage, and distribution of opioid 
agonist treatment medications are also subject to inspection under 
Federal controlled substances laws and under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321 et seq.). Federally-sponsored treatment 
programs are subject to applicable Federal confidentiality statutes.
    (4) A treatment program or medication unit or any part thereof, 
including any facility or any individual, shall permit a duly 
authorized employee of SAMHSA to have access to and to copy all records 
on the use of opioid drugs in accordance with the provisions of 42 CFR 
part 2.
    (5) OTP's shall notify SAMHSA within 3 weeks of any replacement or 
other change in the status of the program sponsor or medical director.
    (6) OTP's shall comply with all regulations enforced by the DEA 
under 21 CFR chapter II, and must be registered by the DEA before 
administering or dispensing opioid agonist treatment medications.
    (7) OTP's must operate in accordance with Federal opioid treatment 
standards and approved accreditation elements.
    (g) Conditions for interim maintenance treatment program approval. 
(1) Before a public or nonprofit private OTP may provide interim 
maintenance treatment, the program must receive the approval of both 
SAMHSA and the chief public health officer of the State in which the 
OTP operates.
    (2) Before SAMHSA may grant such approval, the OTP must provide 
SAMHSA with documentation from the chief public health officer of the 
State in which the OTP operates demonstrating that:
    (i) Such officer does not object to the providing of interim 
maintenance treatment in the State;
    (ii) The OTP seeking to provide such treatment is unable to place 
patients in a public or nonprofit private comprehensive treatment 
program within a reasonable geographic area within 14 days of the time 
patients seek admission to such programs;
    (iii) The authorization of the OTP to provide interim maintenance 
treatment will not otherwise reduce the capacity of comprehensive 
maintenance treatment programs in the State to admit individuals 
(relative to the date on which such officer so certifies); and
    (iv) The State certifies that each individual enrolled in interim 
maintenance treatment will be transferred to a comprehensive 
maintenance treatment program no later than 120 days from the date on 
which each individual first requested treatment, as provided in section 
1923 of the Public Health Service Act (21 U.S.C. 300x-23).
    (3) SAMHSA will provide notice to the OTP denying or approving the 
request to provide interim maintenance treatment. The OTP shall not 
provide such treatment until it has received such notice from SAMHSA.
    (h) Exemptions. An OTP may, at the time of application for 
certification or any time thereafter, request from SAMHSA exemption 
from the regulatory requirements set forth under Secs. 8.11 and 8.12. 
The OTP shall support the rationale for the exemption with thorough 
documentation, to be supplied in an appendix to the initial application 
for certification or in a separate submission. SAMHSA will approve or 
deny such exemptions at the time of application, or any time 
thereafter, if appropriate. SAMHSA may consult with the appropriate 
State authority prior to taking action on an exemption request.
    (i) Medication units, long-term care facilities and hospitals. (1) 
Certified OTP's may establish medication units that are authorized to 
dispense opioid agonist treatment medications for observed ingestion. 
Before establishing a medication unit, a certified OTP must notify 
SAMHSA by submitting SMA-162. The OTP must also comply with the 
provisions of 21 CFR part 1300 before establishing a medication unit.
    (2) Certification as an OTP under this part will 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 and who requires maintenance or 
detoxification treatment during the period of his or her stay in that 
hospital or long-term care facility. The terms ``hospital'' and ``long-
term care facility'' as used in this section are to have the meaning 
that is assigned under the law of the State in which the treatment is 
being provided. Nothing in this section is intended to relieve 
hospitals and long-term care facilities from the obligation to obtain 
registration from the Attorney General, as appropriate, under section 
303(g) of the Controlled Substances Act.


Sec. 8.12   Federal opioid treatment standards.

    (a) General. OTP's must provide treatment in accordance with these 
standards and must comply with these standards as a condition of 
certification.
    (b) Administrative and organizational structure. An OTP's 
organizational structure shall be adequate to ensure quality patient 
care and to meet the requirements of all pertinent Federal, State, and 
local laws and regulations. At a minimum, each program shall formally 
designate a program sponsor and medical director. The program sponsor 
shall agree on behalf of the program to adhere to all requirements set 
forth in this part and any regulations regarding the use of opioid 
agonist treatment medications in the treatment of opioid addiction 
which may be promulgated in the future. The medical director shall 
assume responsibility for administering all medical services performed 
by the program. In addition, the medical director shall be responsible 
for ensuring that the program is in compliance with all applicable 
Federal, State, and local laws and regulations.
    (c) Continuous quality improvement. (1) An OTP must maintain 
current quality assurance and quality control plans that include, among 
other things,

[[Page 39839]]

annual reviews of program policies and procedures and ongoing 
assessment of patient outcomes.
    (2) An OTP must maintain a current ``Diversion Control Plan'' or 
``DCP'' as part of its quality assurance program that contains specific 
measures to reduce the possibility of diversion of controlled 
substances from legitimate treatment use and that assigns specific 
responsibility to the medical and administrative staff of the OTP for 
carrying out the diversion control measures and functions described in 
the DCP.
    (d) Staff credentials. Each person engaged in the treatment of 
opioid addiction must have sufficient education, training, and 
experience, or any combination thereof, to enable that person to 
perform the assigned functions. All physicians, nurses, and other 
licensed professional care providers, including addiction counselors, 
must comply with the credentialing requirements of their respective 
professions.
    (e) Patient admission criteria--(1) Maintenance treatment. An OTP 
shall maintain current procedures designed to ensure that patients are 
admitted to maintenance treatment by qualified personnel who have 
determined, using accepted medical criteria such as those listed in the 
Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), that 
the person is currently addicted to an opioid drug, and that the person 
became addicted at least 1 year before admission for treatment. In 
addition, a program physician shall ensure that each patient 
voluntarily chooses maintenance treatment and that all relevant facts 
concerning the use of the opioid drug are clearly and adequately 
explained to the patient, and that each patient provides informed 
written consent to treatment.
    (2) Maintenance treatment for persons under age 18. A person under 
18 years of age is required to have had two documented attempts at 
short-term detoxification or drug-free treatment to be eligible for 
maintenance treatment. A waiting period of no less than 7 days is 
required between the first and the second short-term detoxification 
treatment. No person under 18 years of age may be admitted to 
maintenance treatment unless a parent, legal guardian, or responsible 
adult designated by the relevant State authority consents in writing to 
such treatment.
    (3) Maintenance treatment admission exceptions. If clinically 
appropriate, the program physician may waive the requirement of a 1 
year history of addiction under paragraph (e)(1) of this section, for 
patients released from penal institutions (within 6 months after 
release), for pregnant patients (program physician must certify 
pregnancy), and for previously treated patients (up to 2 years after 
discharge).
    (4) Detoxification treatment. An OTP shall maintain current 
procedures that are designed to ensure that patients are admitted to 
short- or long-term detoxification treatment by qualified personnel, 
such as a program physician, who determines that such treatment is 
appropriate for the specific patient by applying established diagnostic 
criteria. At a minimum, a program physician shall determine that each 
patient admitted is physically dependent on opioid drugs. In addition, 
a patient is required to wait no less than 7 days between concluding a 
short-term detoxification or long-term detoxification treatment episode 
and beginning another.
    (f) Required services--(1) General. OTP's shall provide adequate 
medical, counseling, vocational, educational, and assessment services. 
These services must be available at the primary facility, except where 
the program sponsor has entered into a formal, documented agreement 
with a private or public agency, organization, practitioner, or 
institution to provide these services to patients enrolled in the OTP. 
The program sponsor, in any event, must be able to document that these 
services are fully and reasonably available to patients.
    (2) Initial medical examination services. OTP's shall require each 
patient to undergo a complete, fully documented medical evaluation by a 
program physician or a primary care physician, or an authorized 
healthcare professional under the supervision of a program physician, 
within the first 30 days following admission to the OTP.
    (3) Special services for pregnant patients. OTP's must maintain 
current policies and procedures that reflect the special needs of 
patients who are pregnant. Prenatal care and other gender specific 
services for pregnant patients must be provided either by the OTP or by 
referral to appropriate healthcare providers.
    (4) Initial and periodic assessment services. Each patient accepted 
for treatment at an OTP shall be assessed initially and periodically by 
qualified personnel to determine the most appropriate combination of 
services and treatment. The initial assessment must include preparation 
of a treatment plan that includes the patient's short-term goals and 
the tasks the patient must perform to complete the short-term goals; 
the patient's requirements for education, vocational rehabilitation, 
and employment; and the medical, psychosocial, economic, legal, or 
other supportive services that a patient needs. The treatment plan also 
must identify the frequency with which these services are to be 
provided. The plan must be reviewed and updated to reflect that 
patients's personal history, his or her current needs for medical, 
social, and psychological services, and his or her current needs for 
education, vocational rehabilitation, and employment services.
    (5) Counseling services. (i) OTP's must provide adequate substance 
abuse counseling to each patient as clinically necessary. This 
counseling shall be provided by a program counselor, qualified by 
education, training, or experience to assess the psychological and 
sociological background of drug abusers, to contribute to the 
appropriate treatment plan for the patient and to monitor patient 
progress.
    (ii) OTP's must provide counseling on preventing exposure to, and 
the transmission of, human immunodeficiency virus (HIV) disease for 
each patient admitted or readmitted to maintenance or detoxification 
treatment.
    (iii) OTP's must provide directly, or through referral to adequate 
and reasonably accessible community resources, vocational 
rehabilitation, education, and employment services for patients who 
either request such services or who have been determined by the program 
staff to be in need of such services.
    (6) Drug abuse testing services. OTP's must provide adequate 
testing or analysis for drugs of abuse, including at least eight random 
drug abuse tests per year, per patient, in accordance with generally 
accepted clinical practice. For patients in short-term detoxification 
treatment, the OTP shall perform at least one initial drug abuse test. 
For patients receiving long-term detoxification treatment, the program 
shall perform initial and monthly random tests on each patient.
    (g) Recordkeeping and patient confidentiality. (1) OTP's shall 
establish and maintain a recordkeeping system that is adequate to 
document and monitor patient care. This system is required to comply 
with all Federal and State reporting requirements relevant to opioid 
drugs approved for use in treatment of opioid addiction. All records 
are required to be kept confidential in accordance with all applicable 
Federal and State requirements.
    (2) OTP's shall include, as an essential part of the recordkeeping

[[Page 39840]]

system, documentation in each patient's record showing that the OTP 
made the determination, upon the admission of each patient, that the 
patient is not enrolled in any other OTP. A patient enrolled in an OTP 
shall not be permitted to obtain treatment in any other OTP except in 
exceptional circumstances. If the medical director or program physician 
of the OTP in which the patient is enrolled determines that such 
exceptional circumstances exist, the patient may be granted permission 
to seek treatment at another OTP, provided the justification for 
finding exceptional circumstances is noted in the patient's record both 
at the OTP in which the patient is enrolled and at the OTP that will 
provide the treatment.
    (h) Medication administration, dispensing, and use. (1) OTP's must 
ensure that opioid agonist treatment medications are administered or 
dispensed only by a practitioner licensed under the appropriate State 
law and registered under the appropriate State and Federal laws to 
administer or dispense opioid drugs, or by an agent of such a 
practitioner, supervised by and under the order of the licensed 
practitioner. This agent is required to be a pharmacist, registered 
nurse, or licensed practical nurse, or any other healthcare 
professional authorized by Federal and State law to administer or 
dispense opioid drugs.
    (2) OTP's shall use only those opioid agonist treatment medications 
that are approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opioid addiction. In addition, OTP's may administer a 
drug that has been authorized by the Food and Drug Administration under 
an investigational new drug application under section 505(i) of the 
Federal Food, Drug, and Cosmetic Act for investigational use in the 
treatment of opioid addiction, provided the investigational use of the 
drug by the OTP is fully consistent with the protocol and other 
conditions set forth in that application. Only the following opioid 
agonist treatment medications will be considered to be approved by the 
Food and Drug Administration for use in the treatment of opioid 
addiction:
    (i) Methadone; and
    (ii) Levo-Alpha-Acetyl-Methadol (LAAM).
    (3) OTP's shall maintain current procedures that are adequate to 
ensure that the following dosage form and initial dosing requirements 
are met:
    (i) Methadone shall be administered or dispensed only in oral form 
and shall be formulated in such a way as to reduce its potential for 
parenteral abuse.
    (ii) For each new patient enrolled in a program, the initial dose 
of methadone shall not exceed 30 milligrams and the total dose for the 
first day shall not exceed 40 milligrams, unless the program physician 
documents in the patient's record that 40 milligrams did not suppress 
opiate abstinence symptoms.
    (iii) The administering physician shall ensure that any time a 
daily dose greater than 100 milligrams is provided to a patient, the 
justification for such a daily dose is stated in the patient's record.
    (4) OTP's shall maintain current procedures adequate to ensure that 
each opioid agonist treatment medication used by the program is 
administered and dispensed in accordance with its approved product 
labeling. Dosing and administration decisions shall be made by a 
program physician familiar with the most up-to-date product labeling. 
These procedures must ensure that any deviations from the approved 
labeling, including deviations with regard to dose, frequency, or the 
conditions of use described in the approved labeling, are justified in 
the patient's record.
    (i) Unsupervised or ``take-home'' use. To limit the potential for 
diversion of opioid agonist treatment medications to the illicit 
market, opioid agonist treatment medications dispensed to patients for 
unsupervised use shall be subject to the following requirements.
    (1) Any patient in comprehensive maintenance treatment may receive 
a single take-home dose for a day that the clinic is closed for 
business, including Sundays and State and Federal holidays.
    (2) Treatment program decisions on dispensing opioid treatment 
medications to patients for unsupervised use beyond that set forth in 
paragraph (h)(4)(i)(1) of this section, shall be determined by the 
medical director. In determining which patients may be permitted 
unsupervised use, the medical director shall consider the following 
take-home criteria in determining whether a patient is responsible in 
handling opioid drugs for unsupervised use.
    (i) Absence of recent abuse of drugs (opioid or nonnarcotic), 
including alcohol;
    (ii) Regularity of clinic attendance;
    (iii) Absence of serious behavioral problems at the clinic;
    (iv) Absence of known recent criminal activity, e.g., drug dealing;
    (v) Stability of the patient's home environment and social 
relationships;
    (vi) Length of time in comprehensive maintenance treatment;
    (vii) Assurance that take-home medication can be safely stored 
within the patient's home; and
    (viii) Whether the rehabilitative benefit the patient derived from 
decreasing the frequency of clinic attendance outweighs the potential 
risks of diversion.
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (h)(4)(i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
following restrictions apply:
    (i) During the first month of treatment, the maximum take-home 
supply is limited to a single dose each week and the patient shall 
ingest all other doses under appropriate supervision as provided for 
under these regulations.
    (ii) In the second month of treatment, the maximum take-home supply 
is two doses after each supervised ingestion.
    (iii) In the third month of treatment, the patient shall have 
observed ingestion at least twice a week, with take-home permitted for 
other doses.
    (iv) In the remaining months of the first year, the maximum take-
home supply of opioid medication is three doses after each supervised 
ingestion.
    (v) After 1 year, a patient may be given a maximum of 31 days take-
home medication, but must make monthly visits.
    (4) No medications shall be dispensed to patients in short-term 
detoxification treatment or interim maintenance treatment for 
unsupervised or take-home use.
    (5) OTP's must maintain current procedures adequate to identify the 
theft or diversion of take-home medications, including labeling 
containers with the OTP's name, address, and telephone number. Programs 
also must ensure that take-home supplies are packaged in a manner that 
is designed to reduce the risk of accidental ingestion (see Poison 
Prevention Packaging Act, Pub. L. 91-601 (15 U.S.C. 1471 et seq.)).
    (j) Interim maintenance treatment. (1) The program sponsor of a 
public or nonprofit private OTP may place an individual, who is 
eligible for admission to comprehensive maintenance treatment, in 
interim maintenance treatment if the individual cannot be placed in a 
public or nonprofit private comprehensive program within a reasonable 
geographic area and within 14 days of the individual's application for 
admission to comprehensive maintenance treatment. An initial and at 
least two other urine screens shall be taken from interim patients 
during the maximum of 120 days permitted for

[[Page 39841]]

such treatment. A program shall establish and follow reasonable 
criteria for establishing priorities for transferring patients from 
interim maintenance to comprehensive maintenance treatment. These 
transfer criteria shall be in writing and shall include, at a minimum, 
a preference for pregnant women in admitting patients to interim 
maintenance and in transferring patients from interim maintenance to 
comprehensive maintenance treatment. Interim maintenance shall be 
provided in a manner consistent with all applicable Federal and State 
laws, including sections 1923, 1927(a), and 1976 of the Public Health 
Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11).
    (2) The program shall notify the State health officer when a 
patient begins interim maintenance treatment, when a patient leaves 
interim maintenance treatment, and before the date of mandatory 
transfer to a comprehensive program, and shall document such 
notifications.
    (3) SAMHSA may revoke the interim maintenance authorization for 
programs that fail to comply with the provisions of Sec. 8.12(j). 
Likewise, SAMHSA will consider revoking the interim maintenance 
authorization of a program if the State in which the program operates 
is not in compliance with the provisions of Sec. 8.11(g).
    (4) All requirements for comprehensive maintenance treatment apply 
to interim maintenance treatment with the following exceptions:
    (i) The opioid agonist treatment medication is required to be 
administered daily under observation;
    (ii) Unsupervised or ``take-home'' use is not allowed;
    (iii) An initial treatment plan and periodic treatment plan 
evaluations are not required;
    (iv) A primary counselor is not required to be assigned to the 
patient;
    (v) Interim maintenance cannot be provided for longer than 120 days 
in any 12 month-period; and
    (vi) Rehabilitative, education, and other counseling services 
described in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this 
section are not required to be provided to the patient.


Sec. 8.13   Revocation of accreditation and accreditation body 
approval.

    (a) SAMHSA action following revocation of accreditation. If an 
accreditation body revokes an OTP's accreditation, SAMHSA may conduct 
an investigation into the reasons for the revocation. Following such 
investigation, SAMHSA may determine that the OTP's certification should 
no longer be in effect, at which time SAMHSA will initiate procedures 
to revoke the facility's certification in accordance with Sec. 8.14. 
Alternatively, SAMHSA may determine that another action or combination 
of actions would better serve the public health, including the 
establishment and implementation of a corrective plan of action that 
will permit the certification to continue in effect while the OTP seeks 
reaccreditation.
    (b) Accreditation body approval. (1) If SAMHSA withdraws the 
approval of an accreditation body under Sec. 8.6, the certifications of 
OTP's accredited by such body shall remain in effect for a period of 1 
year after the date of withdrawal of approval of the accreditation 
body, unless SAMHSA determines that to protect public health or safety, 
or because the accreditation body fraudulently accredited treatment 
programs, the certifications of some or all of the programs should be 
revoked or suspended or that a shorter time period should be 
established for the certifications to remain in effect. SAMHSA may 
extend the time in which a certification remains in effect under this 
paragraph on a case-by-case basis.
    (2) Within 1 year from the date of withdrawal of approval of an 
accreditation body, or within any shorter period of time established by 
SAMHSA, OTP's currently accredited by the accreditation body must 
obtain accreditation from another accreditation body. SAMHSA may extend 
the time period for obtaining reaccreditation on a case-by-case basis.


Sec. 8.14   Suspension or revocation of certification.

    (a) Revocation. Except as provided in paragraph (b) of this 
section, SAMHSA may revoke the certification of an OTP if SAMHSA finds, 
after providing the program sponsor with notice and an opportunity for 
a hearing in accordance with subpart C of this part, that the program 
sponsor, or any employee of the OTP:
    (1) Has been found guilty of misrepresentation in obtaining the 
certification;
    (2) Has failed to comply with the Federal opioid treatment 
standards in any respect;
    (3) Has failed to comply with reasonable requests from SAMHSA or 
from an accreditation body for records, information, reports, or 
materials that are necessary to determine the continued eligibility of 
the OTP for certification or continued compliance with the Federal 
opioid treatment standards; or
    (4) Has refused a reasonable request of a duly designated SAMHSA 
inspector, Drug Enforcement Administration (DEA) Inspector, State 
Inspector, or accreditation body representative for permission to 
inspect the program or the program's operations or its records.
    (b) Suspension. Whenever SAMHSA has reason to believe that 
revocation may be required and that immediate action is necessary to 
protect public health or safety, SAMHSA may immediately suspend the 
certification of an OTP before holding a hearing under subpart C of 
this part. SAMHSA may immediately suspend as well as propose revocation 
of the certification of an OTP before holding a hearing under subpart C 
of this part if SAMHSA makes a finding described in paragraph (a) of 
this section and also determines that:
    (1) The failure to comply with the Federal opioid treatment 
standards presents an imminent danger to the public health or safety;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the failure to comply with the 
Federal opioid treatment standards was intentional or was associated 
with fraud.
    (c) Written notification. In the event that SAMHSA suspends the 
certification of an OTP in accordance with paragraph (b) of this 
section or proposes to revoke the certification of an OTP in accordance 
with paragraph (a) of this section, SAMHSA shall promptly provide the 
sponsor of the OTP with written notice of the suspension or proposed 
revocation by facsimile transmission, personal service, commercial 
overnight delivery service, or certified mail, return receipt 
requested. Such notice shall state the reasons for the action and shall 
state that the OTP may seek review of the action in accordance with the 
procedures in subpart C of this part.
    (d)(1) If SAMHSA suspends certification in accordance with 
paragraph (b) of this section:
    (i) SAMHSA will immediately notify DEA that the OTP's registration 
should be suspended under 21 U.S.C. 824(d); and
    (ii) SAMHSA will provide an opportunity for a hearing under subpart 
C of this part.
    (2) Suspension of certification under paragraph (b) of this section 
shall remain in effect until the agency determines that:
    (i) The basis for the suspension cannot be substantiated;

[[Page 39842]]

    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The OTP's certification shall be revoked.


Sec. 8.15   Forms.

    (a) SMA-162--Application for Certification to Use Opioid Agonist 
Treatment Medications for Opioid Treatment.
    (b) SMA-163--Application for Becoming an Accreditation Body under 
42 CFR 8.3.

 Subpart C--Procedures for Review of Suspension or Proposed 
Revocation of OTP Certification


Sec. 8.21   Applicability.

    These procedures apply when:
    (a) SAMHSA has notified an OTP in writing that its certification 
under these regulations has been suspended or that SAMHSA proposes to 
revoke such certification; and
    (b) The OTP has, within 30 days of the date of such notification or 
within 3 days of the date of such notification when seeking an 
expedited review of a suspension, requested in writing an opportunity 
for a review of the suspension or proposed revocation.


Sec. 8.22   Definitions.

    (a) Appellant means the treatment program which has been notified 
of its suspension or proposed revocation of its certification under 
these regulations and has requested a review thereof.
    (b) Respondent means the person or persons designated by the 
Secretary in implementing these regulations.
    (c) Reviewing official means the person or persons designated by 
the Secretary who will review the suspension or proposed revocation. 
The reviewing official may be assisted by one or more of his or her 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.


Sec. 8.23   Limitation on issues subject to review.

    The scope of review shall be limited to the facts relevant to any 
suspension or proposed revocation, the necessary interpretations of 
those facts, these regulations, and other relevant law.


Sec. 8.24   Specifying who represents the parties.

    The appellant's request for review shall specify the name, address, 
and phone number of the appellant's representative. In its first 
written submission to the reviewing official, the respondent shall 
specify the name, address, and phone number of the respondent's 
representative.


Sec. 8.25   Informal review and the reviewing official's response.

    (a) Within 30 days of the date of the notice of the suspension or 
proposed revocation, the appellant must submit a written request to the 
reviewing official seeking review, unless some other time period is 
agreed to by the parties. A copy must also be sent to the respondent. 
The request for review must include a copy of the notice of suspension 
or proposed revocation, a brief statement of why the decision to 
suspend or propose revocation is incorrect, and the appellant's request 
for an oral presentation, if desired.
    (b) Within 5 days after receiving the request for review, the 
reviewing official will send an acknowledgment and advise the appellant 
of the next steps. The reviewing official will also send a copy of the 
acknowledgment to the respondent.


Sec. 8.26   Preparation of the review file and written argument.

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's documents and brief. Within 15 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification is incorrect (appellant's brief).
    (b) Respondent's documents and brief. Within 15 days after 
receiving a copy of the acknowledgment of the request for review, the 
respondent shall submit to the reviewing official the following (with a 
copy to the appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification, tabbed and 
organized chronologically, and accompanied by an index identifying each 
document. Only essential documents should be submitted to the reviewing 
official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension or proposed revocation 
(respondent's brief).
    (c) Reply briefs. Within 5 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive documentation. The reviewing official may take any 
appropriate step to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.


Sec. 8.27   Opportunity for oral presentation.

    (a) Electing oral presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decisionmaking process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral 
presentation.
    (c) Preliminary conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the 
hearing altogether; scheduling the hearing; and any other matter that 
will assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding 
official may, at his or her discretion, produce a written document 
summarizing the conference or transcribe the conference, either of 
which will be made a part of the record.
    (d) Time and place of oral presentation. The presiding official 
will attempt to schedule the oral presentation within 30 days of the 
date appellant's request for review is

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received or within 10 days of submission of the last reply brief, 
whichever is later. The oral presentation will be held at a time and 
place determined by the presiding official following consultation with 
the parties.
    (e) Conduct of the oral presentation--(1) General. The presiding 
official is responsible for conducting the oral presentation. The 
presiding official may be assisted by one or more of his or her 
employees or consultants in conducting the oral presentation and 
reviewing the evidence. While the oral presentation will be kept as 
informal as possible, the presiding official may take all necessary 
steps to ensure an orderly proceeding.
    (2) Burden of proof/standard of proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend or propose revocation is appropriate. The 
appellant, however, has a responsibility to respond to the respondent's 
allegations with evidence and argument to show that the respondent is 
incorrect.
    (3) Admission of evidence. The rules of evidence do not apply and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. 
Each party may make an opening and closing statement, may present 
witnesses as agreed upon in the prehearing conference or otherwise, and 
may question the opposing party's witnesses. Since the parties have 
ample opportunity to prepare the review file, a party may introduce 
additional documentation during the oral presentation only with the 
permission of the presiding official. The presiding official may 
question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of justice or making of false statements.  
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing procedures. At his or her discretion, the 
presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may 
submit comments on any major prejudicial errors in the transcript.


Sec. 8.28   Expedited procedures for review of immediate suspension.

    (a) Applicability. When the Secretary notifies a treatment program 
in writing that its certification has been immediately suspended, the 
appellant may request an expedited review of the suspension and any 
proposed revocation. The appellant must submit this request in writing 
to the reviewing official within 5 days of the date the OTP received 
notice of the suspension. The request for review must include a copy of 
the suspension and any proposed revocation, a brief statement of why 
the decision to suspend and propose revocation is incorrect, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing official's response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review file and briefs. Within 10 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official in accordance 
with Sec. 8.27(a), the presiding official will attempt to schedule the 
oral presentation within 10 to 14 days of the date of appellant's 
request for review at a time and place determined by the presiding 
official following consultation with the parties. The presiding 
official may hold a pre-hearing conference in accordance with 
Sec. 8.27(c) and will conduct the oral presentation in accordance with 
the procedures of Sec. 8.27(e), (f), and (g).
    (e) Written decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7 to 10 days of the date of 
the oral presentation or within 3 days of the date on which the 
transcript is received or the date of the last submission by either 
party, whichever is later. All other provisions set forth in Sec. 8.33 
will apply.
    (f) Transmission of written communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be by facsimile transmission, personal 
service, commercial overnight delivery service, or certified mail, 
return receipt requested.


Sec. 8.29   Ex parte communications.

    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notice to the other party.


Sec. 8.30   Transmission of written communications by reviewing 
official and calculation of deadlines.

    (a) Because of the importance of a timely review, the reviewing 
official should normally transmit written communications to either 
party by facsimile transmission, personal service, commercial overnight 
delivery service, or certified mail, return receipt requested, in which 
case the date of transmission or day following mailing will be 
considered the date of receipt. In the case of communications sent by 
regular mail, the date of receipt will be considered 3 days after the 
date of mailing.
    (b) In counting days, include Saturdays, Sundays, and holidays. 
However, if a due date falls on a Saturday, Sunday, or Federal holiday, 
then the due date is the next Federal working day.


Sec. 8.31   Authority and responsibilities of reviewing official.

    In addition to any other authority specified in these procedures, 
the reviewing official and the presiding official, with respect to 
those authorities involving the oral presentation, shall have the 
authority to issue orders; examine witnesses; take all steps necessary 
for the conduct of an orderly hearing; rule on requests and motions; 
grant extensions of time for good

[[Page 39844]]

reasons; dismiss for failure to meet deadlines or other requirements; 
order the parties to submit relevant information or witnesses; remand a 
case for further action by the respondent; waive or modify these 
procedures in a specific case, usually with notice to the parties; 
reconsider a decision of the reviewing official where a party promptly 
alleges a clear error of fact or law; and to take any other action 
necessary to resolve disputes in accordance with the objectives of 
these procedures.


Sec. 8.32   Administrative record.

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.


Sec. 8.33   Written decision.

    (a) Issuance of decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefor in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of decision. The reviewing official will attempt to issue 
his or her decision within 15 days of the date of the oral 
presentation, the date on which the transcript is received, or the date 
of the last submission by either party, whichever is later. If there is 
no oral presentation, the decision will normally be issued within 15 
days of the date of receipt of the last reply brief. Once issued, the 
reviewing official will immediately communicate the decision to each 
party.
    (c) Public notice and communications to the Drug Enforcement 
Administration (DEA). 
    (1) If the suspension and proposed revocation are upheld, the 
revocation of certification will become effective immediately and the 
public will be notified by publication of a notice in the Federal 
Register. SAMHSA will notify DEA within 5 days that the OTP's 
registration should be revoked.
    (2) If the suspension and proposed revocation are denied, the 
revocation will not take effect and the suspension will be lifted 
immediately. Public notice will be given by publication in the Federal 
Register. SAMHSA will notify DEA within 5 days that the OTP's 
registration should be restored, if applicable.


Sec. 8.34   Court review of final administrative action; exhaustion of 
administrative remedies.

    Before any legal action is filed in court challenging the 
suspension or proposed revocation, respondent shall exhaust 
administrative remedies provided under this subpart, unless otherwise 
provided by Federal law. The reviewing official's decision, under 
Sec. 8.28(e) or Sec. 8.33(a), constitutes final agency action as of the 
date of the decision.

    Dated: July 14, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services 
Administration.
Donna E. Shalala,
Secretary of Health and Human Services.

    Note: The following appendix will not appear in the Code of 
Federal Regulations:

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[FR Doc. 99-18562 Filed 7-21-99; 8:45 am]
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