[Federal Register: July 22, 1999 (Volume 64, Number 140)]
[Proposed Rules]
[Page 39809-39857]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy99-36]

[[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

[[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.

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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
 l<SUP>1</SUP> 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
 cation<SUP>2</SUP>
 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 Organizations<SUP>1</SUP>
------------------------------------------------------------------------
 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.
    2. Glass, R. M., Methadone Maintenance New Research on
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
Bulletin of the Association of Food and Drug Officials of the United
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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    11. 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.
    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
Maintenance: Some Treatment Programs Are Not Effective; Greater
Federal Oversight Needed,'' GAO HRD-90-104, 1990.
    14. Institute of Medicine, Federal Regulation of Methadone
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    15. IOM Report, p. 213.
    16. IOM Report, p. 221.
    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.
    22. Annotated Code, State of Ohio, Ohio Annotated Code, p. 3793,
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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