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Federal Regulations
[Federal Register: January 17, 2001 (Volume 66, Number 11)]
[Rules and Regulations]
[Page 4075-4102]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ja01-9]
[[Page 4075]]
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Part II
Department of Health and Human Services
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Substance Abuse and Mental Health Services Administration
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21 CFR Part 291
42 CFR Part 8
Opioid Drugs in Maintenance and Detoxification
Treatment of Opiate Addiction; Final Rule
[[Page 4076]]
-----------------DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Service Administration
21 CFR Part 291
42 CFR Part 8
[Docket No. 98N-0617]
RIN 0910-AA52
Opioid Drugs in Maintenance and Detoxification Treatment of
Opiate Addiction;
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
ACTION: Final rule.
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SUMMARY:
The Department of Health and Human Services and the Substance
Abuse and Mental Health Services Administration (SAMHSA) are issuing
final regulations for the use of narcotic drugs in maintenance and
detoxification treatment of opioid addiction. This final rule repeals
the existing narcotic treatment regulations enforced by the Food and
Drug Administration (FDA), and creates a new regulatory system based on
an accreditation model. In addition, this final rule shifts
administrative responsibility and oversight from FDA to SAMHSA. This
rulemaking initiative follows a study by the Institute of Medicine
(IOM) and reflects recommendations by the IOM and several other
entities to improve opioid addiction treatment by allowing for
increased medical judgment in treatment.
DATES:
This final rule will become effective on March 19, 2001.
FOR FURTHER INFORMATION CONTACT:
Nicholas Reuter, Center for Substance Abuse Treatment (CSAT), SAMHSA,
1 Choke Cherry Road, Rm 12-05
Rockville, MD 20857,
Telephone: 301-443-0457
email: nreuter@samhsa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 22, 1999, (64 FR 39810, July 22,
1999, hereinafter referred to as the July 22, 1999, notice or July 22,
1999, proposal) SAMHSA, FDA, and the Secretary, Health and Human
Services (HHS), jointly published a Notice of Proposed Rulemaking
(NPRM) to revise the conditions for the use of narcotic drugs in
maintenance and detoxification treatment of opioid addiction. The
agencies also proposed the repeal of the existing narcotic treatment
regulations enforced by the FDA, the creation of a new regulatory
system based on an accreditation model under new 42 CFR part 8, and a
shift in administrative responsibility and oversight from FDA to
SAMHSA.
The July 22, 1999, notice traced the history of Federal regulatory
oversight of Opioid Treatment Programs (``OTPs,'' also known as
narcotic treatment programs, or, methadone programs), focusing on
Federal regulations enforced by FDA since 1972. The July 22, 1999,
notice summarized the periodic reviews, studies, and reports on the
Federal oversight system, culminating with the 1995 Institute of
Medicine (IOM) Report entitled, Federal Regulation of Methadone
Treatment (Ref. 1). As noted in the July 22, 1999, proposal, the IOM
report recommended that the existing FDA process-oriented regulations
should be reduced in scope to allow more clinical judgment in treatment
and greater reliance on guidelines. The IOM report also recommended
designing a single inspection format, having multiple elements, that
would (1) provide for consolidated, comprehensive inspections conducted
by one agency (under a delegation of Federal authority, if necessary),
which serves all agencies (Federal, State, local) and (2) improve the
efficiency of the provision of methadone services by reducing the
number of inspections and consolidating their purposes.
To address these recommendations, SAMHSA proposed a
``certification'' system, with certification based on accreditation.
Under the system, as set forth in the July 22, 1999, proposal, a
practitioner who intends to dispense opioid agonist medications in the
treatment of opiate addiction must first obtain from SAMHSA, a
certification that the practitioner is qualified under the Secretary's
standards and will comply with such standards. Eligibility for
certification will depend upon the practitioner obtaining accreditation
from a private nonprofit entity, or from a State agency, that has been
approved by SAMHSA to accredit OTPs. Accreditation bodies would base
accreditation decisions on a review of an application for accreditation
and on surveys (on site inspections) conducted every three years by
addiction treatment experts. In addition, accreditation bodies will
apply specific opioid treatment accreditation elements that reflect
``state-of-the-art'' opioid treatment guidelines. Moreover,
accreditation standards will require that OTPs have quality assurance
systems that consider patient outcomes.
As noted in the July 22, 1999, proposal, this new system would
replace the existing FDA regulatory system. The existing system
provides for FDA ``approval'' of programs, with direct government
inspection in accordance with more detailed process-oriented
regulations. These process-oriented regulations are less flexible and
prescribe many aspects of treatment. The existing regulations do not
require that programs have quality assurance systems. Finally, under
the existing system, programs are not subject to periodic certification
and there is no set schedule for inspections.
Proposed Subpart A addressed accreditation and included steps that
accreditation bodies will follow to achieve approval to accredit OTPs
under the new system. It also set forth the accreditation bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. Proposed Subpart B established the sequence and
requirements for obtaining certification. This section addressed how
and when programs must apply for initial certification and renewal of
their certification. Finally, Subpart C of proposed part 8 established
the procedures for review of the withdrawal of approval of the
accreditation body or the suspension and proposed revocation of an OTP
certification.
In addition to proposing an entirely new oversight system, the July
22, 1999, proposal included several other new provisions. For example,
the Federal opioid treatment standards were significantly reduced in
scope to allow more flexibility and greater medical judgment in
treatment. Certain restrictions on dosage forms were eliminated so that
OTPs may now use solid dosage forms. Under the previous rules, OTPs
were limited to the use of liquid dosage forms. Several reporting
requirements and reporting forms were eliminated, including the
requirements for physician notifications (FDA Reporting Form 2633) and
the requirement that programs obtain FDA approval prior to dosing a
patient above 100 milligrams. The proposal included a more flexible
schedule for medications dispensed to patients for unsupervised use,
including provisions that permit up to a 31-day supply. Under the
current regulations, patients are limited to a maximum 6-day supply of
medication. Many of these regulatory requirements had been in place
essentially unchanged for almost 30 years.
SAMHSA distributed the July 22, 1999, notice to each OTP listed in
the current FDA inventory, each State Methadone Authority, and to other
interested parties. Interested parties were given 120 days, until
November 19, 1999, to comment on the July 22.
[[Page 4077]]
1999, proposal. In addition, on November 1, 1999, SAMHSA, FDA, the
Office of National Drug Control Policy (ONDCP), the Drug Enforcement
Administration (DEA), and other Federal agencies convened a Public
Hearing on the proposal. The Public Hearing was announced in the
Federal Register published October 19, 1999, (64 FR 59624, October 19,
1999), and was held in Rockville, MD. On January 31 and May 10, 2000,
the SAMHSA/CSAT National Advisory Council Subcommittee on Accreditation
met to assist SAMHSA/CSAT in its review of data and information from
SAMHSA/CSAT's ongoing accreditation project. The SAMHSA/CSAT National
Advisory Council convened to discuss the opioid accreditation project
on May 12, 2000. The May 12, 2000, Council meeting provided an
opportunity for comments from the public (65 FR 25352, May 1, 2000).
II. Comments and Agency Response
In response to the July 22, 1999, proposal, SAMHSA received almost
200 submissions, each containing one or more comments. The comments
were from government, industry, industry trade associations, academia,
health professionals, professional organizations, patient advocacy
organizations, and individual patients.
A. General Comments
Many comments agreed in principle that the shift to an
accreditation-based system will encourage OTPs to use individualized,
clinically determined treatment plans that are guided by current, best-
practice medical and clinical guidelines and to evaluate clinical
outcomes. Other comments noted that the accreditation proposal
recognizes that opiate addiction is a medical condition. Several
comments affirmed that a major segment of the healthcare system in the
United States is being reviewed through accreditation systems. As such,
these comments stated that applying accreditation requirements to OTPs
provides the potential for mainstream medicine to embrace opioid
treatment.
While not opposing the proposal, some comments stated there should
be no Federal regulations in this area. Other comments expressed
concerns about additional costs to OTPs and, ultimately patients, for
accreditation and duplicative assessments, noting that some States will
continue to enforce process-oriented regulations, supported by
considerable licensing fees. Based upon these ``uncertainties,'' these
comments suggest that SAMHSA wait for the results of further study
before implementing new regulations.
The Secretary agrees that the SAMHSA-administered accreditation-
based regulatory system will encourage the use of best-practice
clinical guidelines and require quality improvement standards with
outcome assessments. As set forth below, the Secretary does not agree
that comments on the uncertainty about accreditation costs or State
regulatory activities warrant additional study before implementing
these new rules.
Several comments addressed the costs associated with
accreditation and challenged the estimates provided in the July 22,
1999, proposed rule. One comment included the results from a survey of
OTPs with accreditation experience to indicate the indirect costs of
accreditation will be considerable. According to the comment, these
OTPs have had to spend considerable sums to hire consultants and
additional staff, upgrade computers, develop infection control manuals,
and make physical plant improvements. In some cases these costs were
reported to approach $50,000. Some of these comments suggested that
SAMHSA await the completion of the ``accreditation impact study'' to
obtain additional information on costs, before proceeding. Other
comments stated that accreditation can lead to increased treatment
capacity, but only if additional funds are provided. One comment
suggested that SAMHSA create a capital improvement fund, while another
suggested that SAMHSA allow block grant funds to be used to pay for
accreditation.
The Secretary believes that the estimated costs as set forth in the
July 22, 1999, notice remain reasonably accurate. As discussed in
greater detail below, information on accreditation developed under the
accreditation impact study, together with other ongoing SAMHSA
technical assistance programs, indicates that the accreditation system
will not produce an excessive burden to programs to warrant delaying
the implementation of this final rule.
There are many components to SAMHSA's accreditation project that
have been proceeding concurrently with this rulemaking. In April 1999,
SAMSHA's Center for Substance Abuse Treatment (CSAT) issued
``Guidelines for the Accreditation of Opioid Treatment Programs.''
These guidelines are up-to-date best-practice guidelines that are based
upon the Federal opioid treatment standards set forth under proposed
section 8.12 as well as SAMHSA/CSAT's Treatment Improvement Protocols
(TIPs) that address opiate addiction treatment. Two accreditation
bodies, the Commission for the Accreditation of Rehabilitation
Facilities (CARF) and the Joint Commission for the Accreditation of
Healthcare Organizations (JCAHO), under contract to SAMHSA/CSAT, used
these guidelines to develop ``state-of-the-art'' accreditation
elements. These two accreditation bodies have surveyed dozens of
programs with these new accreditation standards.
The July 22, 1999, proposal described an ongoing accreditation
impact study. Under the accreditation impact study, CARF and JCAHO
trained over 170 participating OTPs. In addition, more than 50 OTPs
have been accredited under this system with technical assistance
provided through a contract funded by SAMHSA/CSAT. None of the
accredited programs have had to incur the kind of ``physical plant''
and other costly expenses predicted by some of the comments previously
discussed. This direct and up-to-date information indicates that the
cost estimates in the July 22, 1999, notice are up-to-date and
reasonable. On the other hand, the survey discussed above that was
submitted with one comment reflected accreditation surveys performed
over 10 years ago. And, in some cases, the accreditation experiences
discussed in these comments reflect accreditation of psychiatric
hospitals, not OTPs.
The accreditation-based system which is the subject of this rule
includes safeguards to reduce the risk of unnecessary and overly
burdensome accreditation activities relating to OTPs. For example,
SAMHSA will approve each accreditation body after reviewing its
accreditation elements, accreditation procedures, and other pertinent
information. SAMHSA will convene periodically an accreditation
subcommittee, as part of the SAMHSA/CSAT National Advisory Council. The
subcommittee will review accreditation activities and accreditation
outcomes and make recommendations to the full SAMHSA/CSAT Council, and
ultimately to SAMHSA on accreditation activities and guidelines.
Finally, SAMHSA/CSAT has been providing technical assistance to OTPs in
the accreditation impact study that has helped programs in achieving
accreditation. SAMHSA/CSAT intends to continue providing technical
assistance on accreditation during the 3-5 year transition period and
possibly longer.
The Secretary does not agree that it is necessary to establish a
special fund to help programs pay for accreditation fees and indirect
``physical plant'' improvements in order for OTPs to be
[[Page 4078]]
able to achieve accreditation. As noted above, the Secretary believes
that the estimates in the July 22, 1999, proposal for the cost of
accreditation are reasonably accurate (approximately $4-5 million per
year, $5400 per OTP per year, $39 per patient per year). Nonetheless,
the Secretary has taken steps to minimize the potential effects of this
burden to OTPs, especially to OTPs that are small businesses or that
operate in under-served communities. First, the Secretary has
determined that States could use funds provided by SAMHSA under their
Substance Abuse Prevention and Treatment (SAPT) Block Grants to offset
costs of accreditation for programs qualified to receive assistance
under the State's SAPT block grant. Second, SAMSHA has included in its
budget, a plan to continue funding accreditation. Finally, SAMHSA will
continue to provide technical assistance which will aid those programs
that need help in achieving accreditation.
One OTP that is participating in the accreditation impact study,
while commending the accreditation experience and accreditation in
general, commented that the proposed change is premature. Some comments
suggested that SAMHSA postpone implementation for an indefinite period
to allow for an unspecified number of CARF and JCAHO accreditation
results. Another comment stated that the first series of surveys will
determine the utility of the first generation of standards, noting that
the process can be focused and modified in response to results from the
impact study. A few comments questioned whether all providers can make
the transition.
On the other hand, many comments stated that the field has been
subject to regulatory neglect long enough, and that SAMHSA should
minimize the delay in finalizing rules. One comment submitted the
results of a survey that suggested that as many as 155 OTPs currently
need technical assistance in order to provide treatment in accordance
with standards and regulations.
The Secretary does not believe that these final regulations should
be delayed until the completion of the accreditation impact study. As
stated in the July 22, 1999, proposal, the Department of Health and
Human Services (HHS) has determined that accreditation is a valid and
reliable system for providing external monitoring of the quality of
health care--including substance abuse and methadone treatment. The
SAMHSA/CSAT study is designed to provide additional information on the
processes, barriers, administrative outcomes, and costs associated with
an accreditation-based system. In addition, the study is expected to
provide important information to allow SAMHSA to keep its guidelines,
and its accreditation program, as responsive and up-to-date as
possible. Among other things, the study will allow HHS to continuously
monitor the monetary costs of accreditation, to ensure that successful
OTPs are not precluded from operating by the costs of accreditation,
and that patients are not denied treatment based on costs. The full
study, which compares a representative sample of OTPs 6 months
following accreditation to their baseline status across several
variables, will require a few years to complete. Regulations can be
modified at any time. If SAMHSA believes that the results of the study
merit changes in the regulations, then such changes will be the subject
of a future rulemaking.
The Secretary has reviewed preliminary results from the
accreditation study by two accreditation bodies, CARF and JCAHO, of
almost 10 percent (approximately 80 OTPs) of the entire inventory of
approved outpatient OTPs. Well over 90 percent of the OTPs surveyed
achieved accreditation under the ``methadone specific'' accreditation
standards. Only a very few programs required a follow-up survey to
achieve accreditation. And, to date, only one OTP failed to achieve
accreditation. These accreditation outcome results are comparable to
the historical compliance rate under the previous FDA process-oriented
regulatory system. In addition, these rates correspond to the assumed
accreditation resurvey rate stated in the July 22, 1999, proposal for
estimating the indirect costs of accreditation.
These accreditation outcome results have been analyzed and
presented to SAMHSA/CSAT's National Advisory Council's Accreditation
Subcommittee (NACAS). As discussed in the July 22, 1999, proposal,
SAMHSA/CSAT augmented NACAS with consultants representing OTPs (both
large and small programs), medical and other substance abuse
professionals, patients, and State officials. The subcommittee has met
twice, on January 31 and May 10, 2000, and the public was provided an
opportunity to participate in this advisory process. On May 12, 2000,
the SAMHSA/CSAT National Advisory Council urged SAMHSA/CSAT to move
expeditiously to finalize the July 22, 1999, proposal.
The Secretary believes that the interim results from the
accreditation impact study confirm that the accreditation guidelines,
along with the accreditation process itself, are a valid and reliable
method for monitoring the quality of care provided by OTPs. The results
indicate that most OTPs can achieve accreditation and that treatment
capacity has not declined as a result. While SAMHSA intends to continue
the study to fulfill its objectives, the Secretary does not believe
that it is appropriate or necessary to delay implementation of these
new rules until the full study is complete.
Many comments, especially from current and past OTP patients,
questioned the impact of revised Federal regulations in light of State
regulations. These comments contend that State regulations are much
more restrictive on medical and clinical practices than Federal
regulations, and that State regulatory authorities have expressed
little or no interest in changing their regulations or the way State
regulations are enforced. Comments from OTP sponsors stated that
accreditation costs would add to State licensing fees, which, in some
States, exceed several thousand dollars annually.
The Secretary shares the concerns expressed in these comments about
State regulations and licensing requirements. Indeed, the July 22,
1999, proposal discussed State licensure and regulatory issues. The
proposal also noted that there was considerable variation in the nature
and extent of oversight at the State level. Some States have
regulations and enforcement programs that exceed Federal regulations.
Others have relied exclusively upon FDA and DEA regulatory oversight.
An increasing number of States rely on accreditation, by nationally
recognized accreditation bodies, for all or part of their healthcare
licensing functions.
The Secretary believes that SAMHSA's ongoing coordination
activities with States will minimize the impact of Federal-State
regulatory disparities upon OTPs. One objective of these activities is
to increase State authorities' acceptance of the new accreditation-
based system. First, SAMHSA/CSAT's OTP accreditation guidelines were
developed by a consensus process that included representation from
State Methadone Authorities. In addition, some State officials have
accompanied CARF and JCAHO accreditation survey teams to observe site
visits. Finally, SAMHSA/CSAT has distributed information on
accreditation to each State. This information includes the SAMHSA/CSAT
OTP accreditation guidelines, the CARF OTP accreditation standards and
the JCAHO OTP accreditation standards. SAMHSA/CSAT convened three
national meetings of State officials
[[Page 4079]]
between 1997 and 2000 and intends to continue coordinating activities
with State authorities and national organizations such as the National
Association of State Alcohol and Drug Abuse Directors (NASADAD).
This final rule includes provisions that would permit any State to
apply for approval as an accreditation body and, if approved, accredit
OTPs under the new Federal opioid treatment standards. Based on the
above, the Secretary expects that many states will consider OTP
accreditation and Federal certification requirements as sufficient to
fulfill all or a substantial part of their licensing requirements.
Taken together, the Secretary believes that these measures will
minimize significantly the existing disparity between Federal and State
regulation of OTPs.
Office-Based Treatment. The July 22, 1999, proposal discussed
the concept of ``office-based opioid treatment'' and specifically
solicited comments on how the Federal opioid treatment standards might
be modified to accommodate office-based treatment and on whether a
separate set of Federal opioid treatment standards should be included
in this rule for office-based treatment.
The Secretary received many diverse comments on the office-based
treatment issue. Several comments from patients and individual
physicians believed that office-based treatment provided an excellent
opportunity to expand opioid agonist treatment. These comments
reference opioid treatment delivery systems in other countries and
suggest that the U.S. should adopt similar systems. A few comments
recommended that community pharmacies be encouraged to dispense
methadone and LAAM as ``medication units'' as a way to make treatment
more convenient for patients.
While many comments suggested separate standards for office-based
treatment, others feared that different standards would result in a
two-tiered system of treatment. Overall many comments stated that
existing and proposed rules do not facilitate the development of the
office-based practice model. As such, accreditation and certification
would be prohibitively expensive for individual physicians.
On the other hand, many comments expressed concerns with the
concept of ``office-based'' treatment and prescribing methadone and
LAAM. Many of these comments reflected concern about the lack of
trained and experienced practitioners. One comment referenced
literature reports that described experiences in Australia and the
United Kingdom with deaths from iatrogenic methadone toxicity
associated with patients early in treatment. The experiences in these
two countries were associated with an accelerated rate of patient
admissions and the involvement of new, inexperienced practitioners. One
comment cited research on methadone medical maintenance that indicated
that approximately 15 percent of the patients treated in physicians
offices were referred back to OTPs after ``relapsing'' to illicit
opiate use.
Generally, most comments on this issue stated that there was not
enough information on office-based practice. These comments suggest
that based on the available information, office-based treatment
warrants a gradual, step-wise approach, along with more use of
medication units. This approach would serve to ``diffuse opioid agonist
maintenance treatment into traditional settings.''
After carefully considering the diverse comments, as well as other
legal and regulatory factors, the Secretary is not including in this
rule specific standards that would permit physicians to prescribe
methadone and LAAM in office-based settings without an affiliation with
an OTP. Instead, until additional information is generated, the
Secretary is announcing administrative measures to facilitate the
treatment of patients under a ``medical maintenance'' model.
Current regulations enforced by DEA do not permit registrants to
prescribe narcotic drugs, including opioid agonist medications such as
methadone and LAAM for the treatment of narcotic addiction (see 21 CFR
1306.07(a)). In addition, the Secretary agrees that, at the present
time, there should be some linkage between OTPs and physicians who
treat stable patients with methadone and LAAM in their offices to
address patients' psychosocial needs in the event of relapse. The
Secretary agrees with the comments about the lack of trained and
experienced practitioners to diagnose, admit, and treat opiate addicts
who are not sufficiently stabilized, without the support of an OTP.
The Secretary has taken steps to facilitate ``medical
maintenance,'' that will result in more patients receiving treatment
with methadone and LAAM in an office-based setting. Medical maintenance
refers to the treatment of stabilized patients with increased amounts
of take-home medication for unsupervised use and fewer clinic visits
for counseling or other services. First, the ``take home'' provisions
in these rules have been revised from the previous regulations under 21
CFR Sec. 291.505 to permit stabilized patients up to a one-month supply
of treatment medication. In addition, SAMHSA/CSAT has developed
treatment guidelines and training curricula for practitioners to
increase the information and education for practitioners in this area.
Finally, SAMHSA/CSAT has issued announcements to the field explaining
how patients and treatment programs can obtain authorizations for
medical maintenance. These authorizations were developed to address
program-wide exemptions under 21 CFR 291.505; however, SAMHSA/CSAT
envisions a similar approach will be used under the program-wide
exemption provisions of 42 CFR 8.11(h).
Under the medical maintenance model, office-based physicians
maintain formal arrangements with established OTPs. Typically, patients
who have been determined by a physician to be stabilized in treatment
may be referred to office-based physicians. It has been estimated that
over 12,000 current patients would be eligible for medical maintenance
treatment. The Secretary believes that this is a reasonable approach
that will expand treatment capacity gradually while additional
information and experience is developed to evaluate and refine office-
based treatment models.
B. Comments on Subpart A--Definitions and Accreditation
Proposed subpart A sets forth definitions as well as procedures,
criteria, responsibilities and requirements relating to accreditation.
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A comment from a State authority suggested that the treatment
plan definition under Sec. 8.2 should be modified to require a
reference to the services determined necessary to meet the goals
identified in the plan. The Secretary agrees with this suggestion and
has revised the treatment plan definition accordingly.
One comment suggested that the proposed definition of
detoxification treatment specifies agonist and therefore precludes the
use of mixed agonist or agonists in combination with other drugs. The
Secretary has announced plans to develop new rules specifically for
partial agonist medications for the treatment of opiate addiction (See
65 FR 25894, May 4, 2000). Therefore, use of the term ``agonist'' is
appropriate in this context.
The use of ``other drugs'' (interpreted to mean non-narcotic
substances) in combination with methadone and LAAM are not subject to
the regulatory requirements of this rule.
[[Page 4080]]
Several comments were submitted on the proposed definition of
opiate addiction. Some comments suggested that the definition should be
revised to remove behavior-oriented concepts and rely on medical
constructs only. One comment suggested substituting the definition of
opiate addiction contained in the recent NIH consensus panel report.
The Secretary concurs, and has revised the definition of opiate
addiction to be more consistent with the recent NIH Consensus panel's
recommendations.
-
A few comments were concerned that there would be only two
accreditation bodies, CARF and JCAHO. In addition, these comments
reflect concern that accreditation would be an additional requirement
on top of existing FDA regulations.
As proposed in the July 22, 1999, notice (section 8.3(a)) any
private nonprofit organization, State governmental entity, or political
subdivision thereof, capable of meeting the requirements of subpart A
is eligible to apply to become an accreditation body under the new
rules. As discussed elsewhere in this final rule, some State
authorities have contacted SAMHSA and expressed interest in becoming an
accreditation body under subpart A. In addition, a number of non-
governmental entities have expressed similar interest. Accordingly, the
Secretary believes that there will be more than two accreditation
bodies that seek and obtain approval to become an accreditation body
under these rules.
The requirements for accreditation and SAMSHA certification under
this final rule will replace the requirements for FDA approval of OTPs
under previous regulations. The previous regulations in place under 21
CFR 291.505 will be rescinded on March 19, 2001.
The Secretary received a considerable number of diverse comments
from State authorities, OTPs, and patients on the provision proposed
under section 8.3(a) that would permit States to serve as accreditation
bodies under the new rules. The preamble to the July 22, 1999, notice
emphasized the need for States to consider serving as accreditation
bodies. This emphasis was based upon the recommendation in the IOM
Report that strongly suggested that the Federal Government design a
consolidated inspection system that reduces the burden on OTPs from
multiple (Federal, State, local) inspections.
State authorities provided a mixed response in their comments on
this issue. As discussed below, several States expressed an interest in
becoming accrediting bodies under the new rules but believed that they
were ineligible because they could not accredit 50 OTPs a year under
proposed section 8.3. On the other hand, many States indicated that
they were not interested in becoming accreditation bodies, while
several indicated that they were undecided and would await additional
information.
Comments from OTPs, for the most part, reflect a longstanding
cooperative relationship with State regulatory authorities. OTPs, in
general, did not appear to oppose the concept of State authorities
serving as accreditation bodies under the proposed new system. Indeed,
some OTPs, located within States that assess extensive licensing fees,
commented that it would be imperative that States take on the role of
accreditation bodies under the new system in order to eliminate the
financial impact of licensing and accreditation fees.
Comments from patients on this issue suggested caution. Many
patients sensed that State regulators would retain strict, ``process-
oriented'' regulations or philosophies. These comments urged that if
SAMHSA permitted States to serve as accreditation bodies then the
agency should carefully monitor accreditation standards and practices
to assure that they conform with the Federal opioid treatment
standards.
After considering the comments on this issue, the Secretary is
retaining the provision that allows States to serve as accreditation
bodies under the new rules. The Secretary acknowledges that many States
will choose not to participate as accreditation bodies. Some of these
States already accept accreditation by recognized accreditation bodies
for licensing purposes. It is expected that more States, especially
States with relatively few OTPs, will also choose to accept
accreditation as meeting State licensure requirements in time. Indeed,
legislation enacted recently in New Hampshire to allow methadone
maintenance treatment incorporated a requirement for CARF accreditation
(Ref. 2). Finally, some States will apply accreditation reviews and
findings to complement their licensing activities. The Secretary
recognizes that the States' role in adapting to the new system will
change over time as additional information on accreditation is
developed.
The Secretary believes that there are adequate safeguards to
address patient concerns about overly restrictive State regulations and
oversight. Under section 8.3(b)(3), SAMHSA will review each applicant
accreditation body's proposed accreditation standards. As part of this
review, SAMHSA will determine the extent to which the accreditation
standards are consistent with the Federal opioid treatment standards.
In addition, under section 8.5, SAMHSA will evaluate periodically the
performance of accreditation bodies by inspecting a selected sample of
the OTPs accredited by the accreditation body. As part of this effort
SAMHSA may also consider follow-up inspections in cases where
accreditation activities identify public health, public safety, and
patient care issues.
The Secretary continues to believe, as outlined in the July 22
proposal, that there are benefits to States serving as accreditation
bodies under this rule. This feature provides the potential to reduce
the overall number of OTP inspections. It also permits the use and
application of the vast expertise available within many State oversight
agencies.
A number of State authorities and an accreditation body
questioned the restriction under proposed section 8.3(b)(3) that would
require accreditation bodies to be able to survey no less than 50 OTPs
annually. Some comments contend that this would unfairly and
inappropriately exclude smaller States or States with fewer OTPs from
participating. These comments suggested that other requirements should
be considered and applied or a waiver provision added. One
accreditation body commented that accreditation bodies recognized by
the Health Care Financing Administration are not subject to such
arbitrary limitations. Other comments suggested that the 50 survey per
year minimum was not necessary to achieve its stated purpose--to ensure
the quality of accreditation services and minimize the variability of
accreditation standards.
The Secretary concurs with these comments. The provisions of
section 8.3(b)(3) (submission and review of proposed accreditation
standards) and section 8.5 (periodic evaluation of accreditation
bodies) are adequate to enable SAMHSA to ensure the quality of
accreditation services and minimize the potential variability in
accreditation standards. Accordingly, section 8.3(b) has been modified
to remove this requirement.
A few comments suggested that State authorities and patient
advocates should be permitted to participate in the approval of
accreditation bodies under the new rules and in the accreditation
process in general. These comments believe that they can make
substantial contributions to the process.
The Secretary agrees that patients and State authorities can
contribute
[[Page 4081]]
substantially to the successful operation of the new system. State
authorities and patients have participated in the committees that have
developed SAMHSA/CSAT's Accreditation Guidelines. In addition,
representatives from both these groups have served on the Accreditation
Subcommittee of the SAMHSA/CSAT National Advisory Council.
Accreditation standards include several provisions designed to solicit
and consider individual patient views regarding treatment planning and
other areas. Some, though not all, accreditation bodies also have
patient hotlines that allow patients to convey concerns directly to
accreditation bodies. Finally, SAMHSA and State authorities will
continue to consult and interact under the new rules. The Secretary
believes that these measures are adequate to assure the appropriate
level of State authority and patient input into the accreditation
process.
Several comments addressed proposed section 8.3(b)(6),
pertaining to the qualifications of accreditation body personnel and
proposed section 8.4(h) on accreditation teams. One State authority
objected that the requirement that there be a licensed physician on the
accreditation body staff was an unnecessary expense to accreditation
bodies. Another comment recommended that accreditation teams should
include a physician certified for dispensing opioids. Some patients
advocated that the accreditation team should include a current patient.
The Secretary believes the requirements for accreditation personnel
and accreditation teams as set forth in the July 22, 1999, proposal are
sufficient. It is not clear that every OTP would benefit from having a
physician or opioid agonist patient on the accreditation team. The
Secretary has reviewed the results of accreditation surveys under the
SAMHSA/CSAT methadone accreditation project. Based on these reviews,
the requirements set forth under section 8.4(h) are adequate to assure
that accreditation bodies carefully consider the qualifications of
accreditation surveyors and accreditation teams.
A considerable number of comments were submitted, mostly by
State authorities, concerning the absence of a definition for State
authority. These comments suggested that adding a definition for state
authority could reduce confusion in States that serve as accreditation
bodies. In addition, these comments reflect a belief that this change
would help clarify the Federal-State consultation process set forth in
the proposed rule. The Secretary agrees with these comments and has
added a definition of State Authority. This definition tracks closely
with the definition contained in the previous regulations under section
21 CFR 291.505.
C. Subpart B--Certification
Subpart B establishes the criteria and procedures for the
certification of OTPs. This section also addresses the conditions for
certification and the interaction between the Federal Government and
State authorities under the new rules.
Many comments from State regulators noted that there was no
reference to a requirement that OTPs obtain a license or permit from
States before receiving certification from the Federal Government.
These comments reflect a concern that SAMHSA may certify a program in a
State where no methadone authority exists, or without the knowledge of
the State authority. Other comments urged Federal certification to pre-
empt State licensing, noting that ``initial State approval will remain
a de facto requirement.''
The Secretary believes that the conditions for certification as set
forth in the July 22, 1999, proposal, including the provisions relating
to State licensure, are adequate and appropriate to fulfill the
objectives of this rule. The Secretary's role in the oversight of
narcotic treatment is to set standards for the appropriate use of
narcotic drugs in the treatment of addiction, and then to ensure
compliance with those standards. The States, on the other hand, have a
broader set of responsibilities, including regional and local
considerations such as the number and distribution of treatment
facilities, the structural safety of each facility, and issues relating
to the types of treatment services that should be available. Nothing in
this part is intended to restrict State governments from regulating the
use of opioid drugs in the treatment of opioid addiction. The Secretary
notes that many States exercise this authority by choosing not to
authorize methadone treatment at all.
The Secretary does not believe that OTPs will open and begin
treating patients without State notification, review, and approval. The
Secretary has been careful to state throughout this rule that OTPs
(including medication units) must comply with all pertinent State and
local laws as a condition of Federal certification. As such, OTPs will
also be responsible for assuring that they have the necessary approvals
and licensure at the State. Moreover, OTPs must obtain DEA registration
prior to accepting opioid addiction treatment drugs for the treatment
of opiate addiction. DEA registration is explicitly contingent upon
State authority approval. Importantly, as noted below, there will be
extensive consultation, coordination, and cooperation between SAMHSA
and relevant State authorities.
One State regulator requested that the regulation be modified at
section 8.11(c)(1) to add a requirement that SAMSHA notify the State
upon receipt of applications for certification as well as approval and
withdrawal. This comment was based upon a concern that provisionally
certified programs could operate without a State's knowledge.
The Secretary agrees that it is imperative for States to be
notified of significant certification activities, including new program
applications, program suspensions and withdrawals. SAMHSA intends to
notify States of all such developments under the provisions of section
8.11(c)(1). The Secretary believes that the rules are sufficiently
clear on this point.
Some State authorities suggested revising proposed section
8.11(h), which states that SAMHSA ``may'' consult with State
authorities prior to granting exemptions from a requirement under
sections 8.11 or 8.12.
Section 8.11(h) permits OTPs to request exemptions from the
requirements set forth under the regulation. This represents a
continuation of a long-standing provision from the previous regulation
under 21 CFR 291.505. The Secretary anticipates that most exemption
requests under the new rule will be to permit variations from the
treatment standards, including program-wide exemptions for medical
maintenance. The Secretary agrees that it is appropriate and necessary
to consult with State authorities on requests for variations from
existing standards. Accordingly, section 8.11(h) is revised to require
consultation with the State authority prior to granting an exemption.
Several comments from patients suggested that Federal
regulations should prevent States from imposing additional regulatory
requirements beyond the Federal regulations. Many of these comments
contend that State regulations prevent treatment expansion, hinder
accountability for quality treatment, limit patient access, and lead to
patient abuses.
As noted above, the Secretary acknowledges the authority within
State government to regulate the practice of medicine. This rule does
not pre-empt States from enacting regulations necessary to carry out
these important responsibilities.
[[Page 4082]]
Many State regulations closely resemble the previous Federal
regulations under 21 CFR 291.505. In addition, many States are
currently reevaluating their regulations to determine if modifications
are necessary to reflect the changes in Federal rules. The Secretary
encourages States to consider the new information on changes in the
opioid addiction treatment field, including phases of treatment,
measuring accountability for improving the quality of patient care, and
modern medication dosing practices, as States proceed in revising their
regulations.
The Secretary also invites States to continue to enhance their
partnership with Federal authorities in this area. As noted above, the
final rule includes a new feature--the opportunity for States to serve
as accreditation bodies. This new activity adds to existing partnership
opportunities, such as the participation in the SAPT Block Grant
program and its related technical assistance program. The Secretary
hopes that these actions collectively will continue the regulatory
reform started with the July 22, 1999, proposal.
5. A few comments expressed concern about proposed section 8.11(e),
which permits provisional certification for one year, while a program
obtains accreditation. These comments believe that one year was ``too
long for a program to go without accreditation.''
The Secretary believes that the maximum 1-year term (not
including
the 90-day extension allowed under section 8.11(e)(2)) for provisional
certification is reasonable and customary with accreditation in other
areas of healthcare. The purpose of this provision is to permit new
OTPs to initiate operations and generate patient records to aid in the
accreditation application, survey, and review process. It should be
noted that OTPs will be subject to SAMHSA, DEA, and State oversight
during the tenure of provisional accreditation. These OTPs must comply
with Federal opioid treatment regulations and are subject to
compliance
actions at any time.
6. Section 8.11(i)(2) proposed that certification as an
OTP would
not be required for the maintenance or detoxification treatment of a
patient who is admitted to a hospital or long-term care facility for
the treatment of medical conditions other than addiction. One comment
noted that, as written, patients admitted to hospitals for cocaine or
alcohol addiction would not be eligible for treatment under this
provision. The comment suggested that adding the word ``opioid''
before
``addiction'' would help to clarify this issue. The Secretary concurs
and the section 8.11(i)(2) has been changed to reflect this change.
D. Subpart B--Treatment Standards
1. A number of comments were submitted on proposed
section 8.12 in
general. These comments stated that the Federal Opioid Treatment
standards are vague and lack specificity. As such, these comments
contend that the standards are unenforceable as regulations. One
comment suggested that the SAMHSA/CSAT Accreditation Guidelines be
incorporated as regulations.
The Secretary believes that the Federal Opioid Treatment
Standards
are enforceable, and do not need to be modified to accomplish their
purpose under the new rules. The July 22, 1999, proposal noted that in
the past, HHS has attempted to write all facets of treatment,
including
required services, into regulation. In addition, the proposal
acknowledged that it is now accepted that (a) different patients, at
different times, may need vastly different services, and (b) the state
of the clinical art has changed, to reflect scientific developments
and
clinical experience, and is likely to continue to change and evolve as
our understanding of more effective treatment methods increases.
Accordingly, the Secretary proposed a more flexible approach with a
greater emphasis on performance and outcome measurement. With guidance
from SAMHSA, the accreditation bodies will develop the elements needed
to determine whether a given OTP is meeting patient needs for required
services. SAMHSA will review these elements as part of the
accreditation body's initial and renewal applications to ensure that
accreditation bodies have incorporated the Federal opioid treatment
standards into their accreditation elements. SAMHSA will also review
accreditation body elements to ensure that the elements do not exceed
Federal expectations in terms of opioid agonist treatment.
Incorporating accreditation guidelines into regulations would subvert
this approach.
As noted in the July 22, 1999, proposal, the Secretary
believes
that the standards are ``enforceable regulatory requirements that
treatment programs must follow as a condition of certification (64 FR
39810, July 22, 1999).'' While the new regulations increase the
flexibility and clinical judgement in the way OTPs meet the regulatory
requirements, they are set forth under section 8.12 as the services,
assessments, procedures, etc., that OTPs ``must'' and ``shall''
provide. As such, the new standards are as enforceable as the previous
regulations under 21 CFR 291.505. OTPs that do not substantially
conform with the Federal Opioid Treatment standards set forth under
section 8.12 will risk losing SAMHSA certification.
2. One comment recommended that proposed section 8.12(b)
should be
modified to require a standard that OTPs should have adequate
facilities. The comment stated that this provision existed in the
previous regulation. The Secretary agrees and has added a requirement
that OTP's must maintain adequate facilities. The Secretary notes,
however, that SAMHSA/CSAT accreditation guidelines and accreditation
standards used in the SAMHSA accreditation impact study, address the
adequacy of the OTP's facility. These accreditation standards, in
conjunction with treatment outcomes, will help determine whether
facilities are adequate under the new rules.
3. One comment addressed proposed section 8.12(b),
stating that
rules should expressly require compliance with civil rights laws, not
just ``pertinent'' Federal laws. As such, the comment suggests that
the
standards should require detailed patient grievance procedures,
including appeals to neutral parties. The Secretary believes that it
is
not necessary to modify the rule to reflect civil rights laws
specifically. These laws are included under the requirement as
written.
In addition, SAMHSA/CSAT Accreditation Guidelines, as well as the
accreditation standards developed from them include provisions for
accepting and acting upon patient grievances.
4. A number of respondents commented on proposed section
8.12(d)
which addresses OTP staff credentials. Under the July 22, 1999,
proposal, the Secretary proposed that each person engaged in the
treatment of opiate addiction must have sufficient education,
training,
or experience or any combination thereof, to enable that person to
perform the assigned functions. Further, all licensed professional
care
providers must comply with the credentialing requirements of their
professions. The proposal encouraged, but did not require, that
treatment programs retain credentialed staff.
Some comments requested that this standard be clarified
to require
American Society of Addiction Medicine (ASAM)-certified medical
professionals. Another comment questioned whether personnel had to be
licensed in the State where the treatment program is located. Another
comment from a State Authority, recommended that the regulations
[[Page 4083]]
specify the license, training, experience, as well as the number of
licensed counselors in a program, including a minimum counselor-to-
patient ratio. On the other hand, an OTP medical director commented
that none of the cited credentials ``conferred competence in dealing
with opioid dependent patients, per se.'' According to this comment,
SAMHSA/CSAT should instead develop curricula for medical directors and
other care givers.
Except for the requirements of section 8.12(h), which
relate to the
qualifications for practitioners who administer or order medications,
the Secretary does not believe that it is appropriate to further
prescribe the qualifications for health professionals in this
regulation. Under sections 8.12(b), (d), (e), (f) services must be
provided by professionals qualified by education and training. The
Secretary does not believe that one credentialing organization should
be specified as a requirement for qualifications. Instead, the
Secretary intends to rely on guidelines and accreditation standards
together with patient outcome assessments to determine the adequacy of
training and education level of professionals in OTPs. SAMHSA/CSAT is
actively developing model training curricula in this area.
5. A few comments suggested that the regulations specify
the
outcome measures for quality assessment plans under section
8.12(c)(1).
Similarly, some comments suggested that diversion control plans, which
OTPs are required to develop under section 8.12(c)(2), should also be
spelled out in regulations.
The Secretary believes that the regulation as proposed
provides
sufficient detail on outcome measures and diversion control plans. In
keeping with the intent of the regulation reform, these general
requirements are elaborated in best-practice guidelines and in ``state-
of-the-art'' accreditation standards. Indeed, following a review of
the
accreditation standards that are based upon SAMHSA/CSAT's opioid
treatment accreditation guidelines, the Secretary has determined that
they are adequate to ensure that OTPs will be able to develop
meaningful outcome assessment and diversion control plans. In
addition,
these SAMHSA/CSAT accreditation guidelines and accreditation standards
reflect the latest research findings in this area. Unlike the Federal
regulations, these guidelines and standards will be updated
periodically to reflect new research and clinical experience.
6. The Secretary received a considerable number of
comments on the
proposed definition and the standards for short-and long-term
detoxification treatment. Most of these comments suggested that the
word ``detoxification'' is a pejorative non-medical term and does not
constitute treatment, because few, if any, patients can be stabilized
in such a short period of time. These comments suggested that all
references to detoxification should be deleted from the regulations,
or
at least renamed.
These comments fail to recognize the distinction between
opiate
dependence, for which detoxification treatment is appropriate, and
opiate addiction, for which maintenance treatment is appropriate. The
Narcotic Addiction Treatment Act of 1974 (NATA) and regulations have
long recognized these distinctions. While a majority of the available
treatment research, including recent studies, concludes that
maintenance treatment is much more effective than detoxification
regimens, the Secretary believes that it is still necessary to retain
distinct standards for maintenance and detoxification treatment (Ref.
3).
7. Several comments were submitted in response to the
Secretary's
specific request for comments on proposed section 8.12(e)(4) which set
forth minimum requirements for detoxification treatment. The July 22,
1999, proposal retained the requirement from the existing regulation
that ``a patient is required to wait no less than 7 days between
concluding one detoxification episode before beginning another.''
Essentially, while sympathetic to the need for limits on
detoxification
treatment, all the comments on this item opposed continuing any
waiting
period between detoxification episodes. These respondents believe that
seven days is ``artificial * * * or more time than is needed.'' In
addition, these comments indicate that OTPs often request and are
granted exemptions from the waiting period requirement under the
existing regulation, creating an unnecessary paperwork burden for OTPs,
as well as State and Federal regulators. Instead, the comments
suggested a limit on the number of unsuccessful detoxification
episodes
in one year before the patient is assessed for opioid agonist
maintenance or other treatment. In addition, these comments
recommended
that an unsuccessful detoxification attempt be defined to include any
relapse to abuse.
The Secretary agrees with the recommendations that the
intent of
the restrictions on detoxification can be accomplished without a
mandated time interval between detoxification admissions. The
standards
for detoxification treatment set forth under section 8.12(e)(2) and
(4)
have been revised to state that patients with two or more unsuccessful
detoxification episodes within a 12-month period must be assessed by
the OTP physician for other forms of treatment. This change is
consistent with SAMHSA/CSAT accreditation guidelines which also
elaborate on unsuccessful detoxification treatment attempts.
8. A considerable number of diverse comments addressed
proposed
section 8.12(f) relating to required services. This section of the
July
22, 1999, proposal requires that ``adequate medical, counseling,
vocational, educational and assessment services are fully and
reasonably available to patients enrolled in an OTP.''
Two comments strongly recommended that the regulation
require
integrated, simultaneous treatment by specially cross-trained staff,
for co-occurring opioid treatment and mental illness. These
respondents
believe that integrated services for persons with an addiction(s) and
a
psychiatric disorder are crucial. These dually-diagnosed patients
represent 50-80 percent of substance dependent populations.
The Secretary agrees with the importance of providing
adequate
integrated services for opiate-addicted patients who also suffer from
psychiatric disorders. Indeed, the SAMHSA/CSAT Accreditation
Guidelines, along with the accreditation standards developed by CARF
and JCAHO all address the need to evaluate patients for co-occurring
illnesses, including mental illness. CARF Opioid Treatment Program
Accreditation Standards state that services for co-occurring illness
should be provided on site or by referral. However, the same standards
note that ``coexisting conditions, especially in persons from
disenfranchised populations, are most effectively treated at a single
site.'' The Secretary takes note that these provisions for
co-occurring
disorders under these new rules will be a vast improvement over the
previous regulatory system, which did not address co-occurring opiate
addiction and psychiatric disorders at all. As such, under the new
rules, patients' access to effective treatment for co-occurring
disorders will be enhanced substantially. However, the Secretary
believes that it would be prohibitively expensive to require every OTP
to hire and retain specialists in the treatment of co-occurring
disorders.
Other comments on this section stated that the
regulations should
specify a schedule for services. Some comments
[[Page 4084]]
recommended that the regulations require OTPs to document that
patients
actually receive services when they are referred to off-site
providers.
Other comments suggested that accreditation bodies should monitor the
extent to which services are provided as part of their periodic onsite
surveys. Still other comments, mostly from patients, suggested the
requirement for services be eliminated, maintaining that medication is
all they needed.
The Secretary believes that the requirements for services
as stated
in the July 22, 1999, proposal, together with the accreditation
process, provide adequate assurance that patients enrolled in OTPs
receive the services that they have been assessed to need. The July
22,
1999, proposal emphasized the need for these services as an essential
part of treatment. However, in shifting to an accreditation approach
with an emphasis on performance outcomes, the Secretary was no longer
attempting to ``write all facets of these required services into
regulation.'' OTPs must initially and periodically assess each patient
and ensure that adequate services are available to patients determined
to need them. SAMHSA/CSAT Accreditation Guidelines and accreditation
standards will elaborate on the standards for services. OTPs will be
accountable through the accreditation process to assure that patients
receive the appropriate services they need for successful treatment
outcomes; for some patients, medication services may be sufficient to
produce positive outcomes.
9. A number of respondents submitted comments on proposed
section
8.12(f)(2), which requires a complete medical examination within the
first 30 days following admission. Some of these comments noted that
this provision, as proposed, permitted patients to enter treatment
while tests, some of which required several days, are completed.
Others
commented that the 30 days was too long to wait for a medical exam to
be completed, noting that information from the exam is crucial to the
first few days of treatment. Finally, some comments suggested that
regulations should specify the contents of the medical exam.
The intent of proposing 30 days for the completion of the
physical
exam was to allow patients into treatment while OTPs wait for the
results of serology and other tests that require, in some cases,
several days to complete. Section 8.12(f)(2) has been revised to
clarify the requirement for a physical exam upon admission, with
serology and other tests results completed w/in 14 days. The Secretary
does not agree that regulations should specify the contents of the
medical examination. Instead, the Secretary believes that
accreditation
guidelines should express the state-of-the-art content for a medical
exam appropriate for the treatment of opiate addiction.
10. The July 22, 1999, notice proposed that OTPs conduct
at least
eight random drug abuse tests per year for each patient. Many comments
suggested that the Federal standards specify more frequent drug abuse
tests, including weekly testing, to balance the more flexible proposed
take-home schedule. Other comments suggested that Federal regulations
should specify measures to prevent adulteration. On the other hand,
some comments suggested that quarterly drug abuse testing is
appropriate. Moreover, one comment recommended substituting an ``honor
system'' because patients can corrupt the testing process and falsify
results.
After considering the comments on this issue, the
Secretary is
retaining the requirement for a minimum of eight random drug abuse
tests per year for maintenance treatment. The Secretary believes that
this is an adequate and balanced standard for drug abuse testing.
There
is extensive discussion on drug abuse testing issues in the SAMHSA/CSAT
Treatment Improvement Protocols and the SAMHSA/CSAT Accreditation
Guidelines. In addition, these guidelines elaborate on measures to
address the corruption and falsification of results. Finally, as the
Federal standard is a minimum, OTPs can require more frequent tests if
desired.
11. The Secretary received many comments on proposed
section
8.12(g)(2) which requires OTPs to determine and document that patients
are not enrolled in other programs. Most respondents question how such
determinations could be made without a patient registry. One comment
stated that multiple enrollments are attributable to inadequate
medication dosing practices.
The July 22, 1999, proposal retained the provisions
relating to
multiple enrollments from the previous regulations under 21 CFR
291.505. In proposing to retain the requirement, the Secretary noted
that there have been cases of patients enrolling in more than one
treatment program; however, the extent of this practice is
undetermined
but not considered to be widespread. The intent of this provision is
for OTPs to make a good faith effort, using available resources and
mechanisms to ascertain whether or not a prospective patient was
currently enrolled in another OTP. Some individual States with OTPs
concentrated within a community have established a patient registry
and
require OTPs to report new patients and patients who have discontinued
in treatment. In other jurisdictions, patient registries are developed
and maintained voluntarily by OTPs. OTPs also often contact other OTPs
in the vicinity to determine if the patient is currently enrolled in
an
OTP, or they ask the patient. If used, these mechanisms must be used
in
accordance with the provisions at 42 CFR 2.34, regarding disclosures
to
prevent multiple enrollments. The Secretary acknowledges that none of
these mechanisms can determine with complete certainty whether or not
a
patient is enrolled in more than one OTP. Accordingly, the Secretary
expects that OTPs will document in each patient's record that the OTP
made a good faith effort to review whether or not the patient is
enrolled in any other OTP. Section 8.12(g)(2) has been revised
accordingly.
12. The Secretary received many comments on proposed
section
8.12(j), relating to interim methadone maintenance. Most of these
comments were from patients who suggested interim maintenance as a
model for long standing patients who have been stabilized in
treatment.
As such, these comments suggested that the term for interim methadone
maintenance be extended beyond 120 days.
These comments reflect a misunderstanding of interim
methadone
maintenance. Interim methadone maintenance was mandated by the ADAMHA
Reorganization Act of 1992 as a measure to address shortages in
treatment capacity and documented waiting lists (Pub. L. 102-321, See
also 58 FR 495, January 5, 1993). The legislation included several
restrictions which were incorporated and retained into Federal
regulations. Although very few programs have applied for authorization
to provide interim methadone maintenance, the Secretary does not at
this time believe it is necessary or appropriate to change the
standards. Instead, as discussed elsewhere in this notice, the
Secretary believes that medical maintenance provides a more reasonable
approach for expanding treatment capacity.
13. The Secretary received comments on proposed section
8.11(h),
which provides for exemptions from treatment standards or
certification
requirements. One comment suggested that the examples in the previous
regulation for exemptions, be retained in the final new regulations.
The comment suggests that this would encourage individual physicians,
pharmacists, or both to
[[Page 4085]]
provide methadone treatment in rural areas where methadone treatment
is
scarce or unavailable. Another comment suggested that SAMHSA
streamline
the exemption process and do more to publicize the availability of
such
regulatory options. The Secretary accepts both of these suggestions,
and section 8.11(h) has been revised accordingly. In addition, SAMHSA
has already taken steps to streamline the exemption process and
publicize the availability of certain exemptions (Ref. 4).
14. Most comments strongly supported the provisions in
proposed
section 8.12(h)(3)(i) which permits OTPs to use solid dosage forms.
Some patients reported spoilage and decomposition problems with 14-day
supplies of liquid dosage form. Other comments suggested that the use
of solid medication will reduce treatment cost modestly by eliminating
the need for dosage bottles for solutions. The Secretary agrees that
permitting OTPs to use solid medication will reduce treatment costs
and
increase treatment convenience to patients.
15. The Secretary received many comments on proposed
section
8.11(h)(3)(iii) that would have required the program physician to
justify in the patient record all doses above 100 mg. Most comments
viewed this requirement as an inappropriate ``value judgement'' that
hampers clinical judgement. The Secretary agrees that the requirement
to justify a dose above 100 mg, which is a modification of a
requirement under the previous regulation, is not necessary to reduce
the risk of medication diversion. Accordingly, this requirement has
been eliminated from the final rule.
16. The Secretary specifically requested and received
comments on
proposed changes to the requirements under section 8.12(i) pertaining
to medications dispensed for unsupervised use (hereinafter ``take-
homes''). The July 22, 1999, proposal set forth four options for
addressing take-homes. These options ranged from retaining the
previous
requirements to a scheme based on a maximum dose. Option number 2 was
discussed as the option preferred by HHS and endorsed by DEA. This
option resembles the requirement under the previous regulations and
retains the 8-point take-home criteria. However, option number 2
permitted patients in stable treatment for one year to receive up to a
31-day supply of medication, while the previous regulation included a
maximum take-home supply of 6 days.
Most comments supported proposed option 2, with
modifications. In
supporting option 2, current patients stated that less frequent clinic
attendance will make treatment much more convenient. In addition,
Option 2 will eliminate travel hardships and facilitate employment
commitments, ultimately increasing retention in treatment and
rehabilitation. Option 1, which encompassed the take-home schedule
from
the previous regulation, was viewed by many comments as too
restrictive. Many comments opposed option 3, which proposed a set 2-
week maximum milligram amount for take-homes, because it unfairly
penalized patients receiving higher doses.
On the other hand, a form letter circulated and submitted
by
several treatment programs stated that no patients should be eligible
for a 31-day take-home supply. According to these comments, all
patients must report to clinics often so that their rehabilitation can
be monitored appropriately. In addition, these comments stated that
allowing any patient a 31-day take-home supply presents an
unacceptable
risk of diversion.
The Secretary does not agree with these comments. Indeed,
there is
considerable evidence that many patients can responsibly handle
supplies of take-home medications beyond the 6-day maximum allowed
under the previous regulations. In addition, FDA has permitted
hundreds
of patients to receive monthly take-home supplies of methadone through
exemptions or Investigational New Drug Applications. These
investigations have been analyzed and reported in scientific
literature
and indicate that patients successfully continue in rehabilitation
(Ref. 5). Moreover, these cases indicate that rehabilitation is
enhanced through these ``medical maintenance'' models. Accordingly,
and
in response to an increased interest in this issue, FDA and SAMHSA/CSAT
issued a ``Dear Colleague'' letter on March 30, 2000, that advised the
field on procedures for obtaining OTP exemptions for medical
maintenance, which include a provision for up to a 31-day supply of
take-home medication (Ref 4).
The Secretary notes that many comments provided
suggestions on
refining the basic schedule for take-home eligibility outlined in
proposed option 2. For example, many comments suggested that one year
of stable treatment was still too short a period of time to evaluate
whether patients can responsibly handle a 31-day supply of take-home
medication. These comments suggested an interim step that permits a 14-
day take-home supply after one year of stable treatment before a
patient is eligible for a 31-day supply.
The Secretary concurs with these comments. The 2-year
time in
treatment requirement is more consistent with the studies and
exemptions for medical maintenance granted to date under the previous
rules. In addition, this schedule is more consonant with the schedule
set forth in the SAMHSA/CSAT Accreditation Guidelines and the
accreditation body standards. Accordingly, section 8.12(i)(3) has been
revised to reflect a 14-day take-home step after one year of stable
treatment and to reflect that patients are eligible for a take-home
supply up to 31 days after two years of stable treatment. The language
in other parts of section 8.12(i)(3) has been modified slightly for
clarity to lengthen the duration of the steps within the first year of
treatment, and to remove some requirements for observed ingestion.
17. Comments overwhelmingly supported the proposal to
permit take-
home use of LAAM and suggest that the Secretary apply the same
schedule
as methadone, e.g. option 2. A comment from a practitioner who has
treated over 500 patients, stated that patients dislike being switched
from LAAM to methadone when necessary for travel purposes. Most
comments suggested that diversion of LAAM is no more likely than the
diversion of methadone which generally is not problematic. One comment
submitted the results of a 149-patient study on LAAM take-home use.
Patients were randomized into take-home and clinic only groups. As
part
of the study, 545 take-home doses of LAAM were distributed to
patients,
and patients were subject to random ``callbacks.'' There was no
evidence of tampering, diversion, or interest in obtaining LAAM take-
home supplies illicitly. In addition, there were no differences
between
the two groups in the measured outcome variables. The investigator
concluded that methadone and LAAM should be subject to the same take-
home requirements. The Secretary concludes that LAAM should be
available for take-home use under this rule.
18. A comment submitted by a physician discussed his
successful
experience using LAAM for detoxification treatment, finding LAAM to be
superior to methadone for detoxification with some patients. The
comment suggested that the regulations should be modified to permit
the
use of LAAM for detoxification.
Although previous Federal Register notices may have
suggested that
LAAM was not available for use in detoxification treatment (58 FR
38704, July 20, 1993), the July 22, 1999, proposal does not prohibit
the use of
[[Page 4086]]
methadone or LAAM for detoxification treatment. Indeed, the current
FDA
approved labeling for LAAM discusses and provides guidance on
withdrawing patients from LAAM therapy:
ORLAAM is indicated for the management of opiate
dependence * *
* There is a limited experience with detoxifying patients from
ORLAAM in a systematic manner, and both gradual reduction (5 to 10%
a week) and abrupt withdrawal schedules have been used successfully.
The decision to discontinue ORLAAM therapy should be made as part of
a comprehensive treatment plan.
The Secretary believes that the regulations are
adequately clear on
this point.
19. A few respondents commented upon the proposed
implementation
plan and whether OTPs could be expected to comply with the timetables
for achieving accreditation. Under proposed section 8.11(d), treatment
programs approved under the previous regulations are deemed certified
under the new rules. This ``transitional certification'' would expire
on June 18, 2001 unless the OTPs certify with a written statement
signed by the program sponsor that they will apply for accreditation
within 90 days of the date SAMHSA approves the first accreditation
body. Transitional certification, in that case, will expire on March
19, 2003. SAMHSA may extend transitional certification on a case-by-
case basis for up to one year under certain conditions. The comments
questioned whether SAMHSA had empirical evidence that OTPs could meet
this timetable.
The Secretary believes that the timetables proposed in
the July 22,
1999, notice remain reasonable. A significant number of OTPs have
already had experience with accreditation. This includes programs
located in Department of Veterans Affairs Medical Centers, as well as
OTPs located in the several States that require accreditation of OTPs
(Maryland, Indiana, North Carolina, Georgia, South Carolina, and
Michigan). Moreover, as discussed previously, as part of SAMHSA/CSAT's
accreditation implementation plan, two accreditation bodies conducted
accreditation surveys of OTPs and accredited over 50 OTPs in just a
few
months. SAMHSA/CSAT has planned additional training and technical
assistance to enable OTPs to understand and comply with the new
regulations. In addition, the regulations have been streamlined with
fewer reporting and recordkeeping requirements. OTPs have had ample
opportunity to prepare for this final rule, and the SAMHSA/CSAT
Accreditation Guidelines as well as the CARF and JCAHO accreditation
standards have been widely available for years. Taken together, these
factors provide the Secretary with reasonable confidence that OTPs can
apply for and achieve accreditation within two years from the
effective
date of this rule.
The Secretary is sensitive to concerns about OTPs
contacting
accreditation bodies and scheduling accreditation reviews in a
convenient manner. Therefore, while not changing the timetables for
achieving accreditation under the final rule, the Secretary has
modified section 8.11(d) to state that programs will agree to apply
for
accreditation within 90 days from the date SAMSHA announces the
approval of the second accreditation body. The Secretary believes that
tying this certification for OTPs to apply from the date SAMHSA
announces the approval of the first accreditation body to the date
SAMHSA announces approval of the second accreditation body will
facilitate OTPs contacting and achieving accreditation under the final
rule.
20. A few comments requested that OTPs that have been
previously
accredited by JCAHO and CARF should be ``grandfathered'' somehow under
the new final regulations.
There are no provisions in the final rule to accept
accreditation
by accreditation bodies that have not been approved by SAMHSA under
section 8.3(d). These accreditation bodies did not develop and apply
accreditation standards that were based upon the opioid agonist
treatment standards set forth under section 8.12. SAMHSA, however,
will
consider on a case-by-case basis, whether OTPs that achieved
accreditation under the SAMHSA/CSAT implementation initiative can be
exempted from re-accreditation under this final rule, pursuant to
section 8.11(h).
E. Subpart C--Procedures for Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body
1. One comment recommended that subpart C should be
revised to add
discovery provisions. This would enable OTPs to obtain crucial
information on how ``accreditation bodies conducted their
investigation.'' The Secretary believes that the provisions of subpart
A that require that accreditation bodies have appeals procedures in
their accreditation decision-making process is adequate to assure that
OTPs can obtain the information they need on accreditation activities.
2. One comment suggested that subpart C should be revised
to allow
applicant OTPs to appeal decisions to deny approval of an initial
application. The Secretary does not agree and points out that OTPs
will
be able to appeal denials of accreditation by accreditation bodies
under Sec. 8.3(b)(4)(vii).
3. Response times in Sec. 8.26(a), (b) and (c) have
been
lengthened, as have the oral presentation timeframes in Sec. 8.27(d),
and expedited procedures in Sec. 8.28(a) and (d).
F. Conclusion and Delegation of Authority
After considering the comments submitted in response to
the July
22, 1999, proposal, along with the information presented during the
November 1, 1999, Public Hearing, the Secretary has determined that
the
administrative record in this proceeding supports the finalization of
new rules under 42 CFR part 8.
In a notice to be published in a future issue of the
Federal
Register, the Secretary will announce the delegation of authority to
the Administrator of SAMHSA, with the authority to redelegate,
responsibility for the administration of 42 CFR part 8.
III. Analysis of Economic Impacts
The Secretary has examined the impact of this rule under
Executive
Order 12866. Executive Order 12866 directs Federal 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). According to Executive Order 12866, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million; adversely affecting in a material way a sector of the
economy,
competition, or jobs; or if it raises novel legal or policy issues.
While this rule is not a significant economic regulation, the
Secretary
finds that this rule is a significant regulatory action as defined by
Executive Order 12866. As such, this rule has been reviewed by the
Office of Management and Budget (OMB) under the provisions of that
Executive Order. In addition, it has been determined that this rule is
not a major rule for the purpose of congressional review. For the
purpose of congressional review, a major rule is one which is likely
to
cause an annual effect on the economy of $100 million; a major
increase
in costs or prices; significant effects on competition, employment,
productivity, or
[[Page 4087]]
innovation; or significant effects on the ability of U.S.-based
enterprises to compete with foreign-based enterprises in domestic or
export markets.
A. Introduction
As noted in the July 22, 1999, proposal, approximately
900 OTPs
provide opioid agonist treatment to approximately 140,000 patients in
the U.S. For almost 30 years, FDA has applied process-oriented
regulations with periodic inspections to approve and monitor these
OTPs. This final rule establishes an accreditation-based regulatory
system, administered by SAMHSA, to carry out these responsibilities.
In
addition, this final rule includes changes that will make the
regulations more flexible, and provide the opportunity to increase
treatment capacity. OTPs will incur additional costs under the new
accreditation-based system, but these additional costs are modest, and
the Secretary believes are offset by benefits set forth under the new
rules.
The additional costs under these new rules are
attributable to the
costs of accreditation. FDA did not assess fees for inspections under
the previous regulations. Under the new rules, private not-for-profit
accreditation bodies will assess accreditation survey fees, and if
necessary, reinspection fees. The July 22, 1999, proposal estimated
that the direct and indirect costs of accreditation at $4.9 million
per
year. These annual cost equal approximately $5,400 per facility and
$39
per patient. The cost estimates were based on discussions with three
accreditation bodies. Overall, the net costs of the new system over
the
existing FDA system, factoring in SAMHSA's estimated annual oversight
costs of $3.4 million, was $4.4 million. The July 22, 1999, proposal
noted that additional information on accreditation costs would be
derived from SAMHSA/CSAT ongoing accreditation implementation project
and requested specific comments on the estimates provided.
As discussed above, although a number of comments
submitted in
response to the July 22, 1999, proposal predicted that accreditation
costs could be higher, these predictions were based upon accreditation
experiences in the past, not associated with the specific
accreditation
standards set forth under the new system. The results from
approximately 50 accreditation surveys under the SAMHSA accreditation
impact study suggest that the costs, as estimated in the July 22,
1999,
proposal, are reasonably accurate.
The July 22, 1999, proposal discussed the benefits of the
proposed
rule in terms of the advantages of accreditation and in terms of
relapse rates as a function of retention in treatment. Although
difficult to quantify, the Secretary believes that the accreditation-
based system will provide more frequent quality surveys of OTPs and
allow greater flexibility in the delivery of opioid treatment. In
addition, patients have commented that the increased flexibility of
the
new regulations, particularly in the standards for medications
dispensed for unsupervised use, will increase patient convenience,
increase patient satisfaction, and increase patient retention in
treatment. Importantly, changes in the regulations will facilitate and
expand medical maintenance treatment freeing resources to expand
treatment capacity. As noted in the July 22, 1999, proposal,
increasing
retention in treatment and increasing the number of patients in
treatment will lead to decreases in mortality and morbidity associated
with opiate addiction, decrease health expenditures, and decrease
criminal activity. These benefits are likely to be significantly
greater than the costs of these new regulations.
B. Small Entity Analysis
The Regulatory Flexibility Act (RFA) requires agencies to
analyze
regulatory options that would minimize any significant impact of a
rule
on a substantial number of small entities. SAMHSA included such an
analysis in the July 22, 1999, proposal.
1. Description of Impact
The July 22, 1999, proposal provided an extensive
description of
the industry, and concluded that, although the regulations were
streamlined under the proposal with fewer forms and reporting
requirements, the proposed rule constituted a significant impact on a
substantial number of small entities. This impact is attributable to
the requirement that all OTPs, regardless of size, must be accredited
and maintain accreditation in order to continue to treat patients.
Overall, the July 22, 1999, proposal estimated that the cost per
patient for a ``small'' OTP (defined as an OTP treating 50 or fewer
patients) would increase slightly more than the industry average ($50
compared to $39).
2. Analysis of Alternatives
The July 22, 1999, notice included a brief discussion
of
alternatives to the proposed accreditation-based regulatory scheme. In
the analysis set forth initially in the July 22, 1999 notice, the
Department discussed but dismissed the alternative of continuing the
existing direct, FDA monitored, regulatory system because of the
findings and criticisms of that system identified in the Institute of
Medicine Report and elsewhere. In addition, the alternative of
allowing
self-certification was discussed, but rejected due to concerns about
diversion and insufficient enforceability.
The preamble to the proposed rule also included a brief
discussion
of alternatives that would minimize the economic impact of the new
regulations on small businesses and other small entities. For example,
the notice discussed the alternative of exempting small facilities
from
some requirements. It was also noted that small facilities could seek
arrangements with larger facilities that could lower costs with
economy-of-scale features.
The issues in this initial analysis were highlighted for
specific
comment, and the notice itself was sent to every OTP identified in the
FDA inventory of approved programs. Except to say that small programs
should not have to close under the new rules, or that small programs
should be exempt from accreditation, very few comments addressed the
issue specifically, or provided information on alternatives.
Therefore,
this initial analysis does not require changing and is adopted as the
final regulatory flexibility analysis.
3. Response to Comments From Small Entities
These issues were highlighted for specific comment, and
the notice
itself was sent to every OTP identified in the FDA inventory of
approved programs. Except to say that small programs should not have
to
close under the new rules, or that small programs should be exempt
from
accreditation, very few comments addressed the issue specifically, or
provided information on alternatives.
As discussed above, SAMHSA has evaluated the results
of
accreditation surveys of OTPs conducted pursuant to the proposed
Federal opioid treatment standards. As such, SAMHSA has a better
understanding of how accreditation will work in both large and small
OTPs. Moreover, SAMHSA has provided technical assistance to
participating programs to help them achieve accreditation. SAMHSA
expects to continue providing technical assistance to programs during
and after the transition to the new system.
The accreditation-based system, the subject of these new
rules,
includes flexibility measures for small OTPs. The Secretary
anticipates
that there will be a number of approved accreditation bodies to choose
from, including those
[[Page 4088]]
that will adjust accreditation fees on a sliding scale tied to the
patient census. In addition, SAMHSA will retain the authority to
certify programs without accreditation and could apply this provision,
if necessary, to address burdens to OTPs with low patient censuses.
SAMHSA prefers this case-by-case approach to a blanket exemption from
accreditation requirements for programs below an arbitrary size. Such
a
blanket exemption would not be consistent with the intent of this
regulatory initiative--to enhance the quality of opioid agonist
treatment. The Secretary believes that, taken together, these
considerations can mitigate the impact on small entities, while still
meeting the objectives of this rulemaking.
C. Unfunded Mandates Reform Act of 1995
The Secretary has examined the impact of this rule under
the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This
rule does not trigger the requirement for a written statement under
section 202(a) of the UMRA because it does not impose a mandate that
results in an expenditure of $100 million (adjusted annually for
inflation) or more by State, local, and tribal governments in the
aggregate, or by the private sector, in any one year.
IV. Environmental Impact
The Secretary has previously considered the environmental
effects
of this rule as announced in the proposed rule (64 FR 39810 at 39825).
No new information or comments have been received that would affect
the
agency's previous determination that there is no significant impact on
the human environment and that neither an environmental assessment nor
an environmental impact statement is required.
V. Executive Order 13132: Federalism
The Secretary has analyzed this final rule in accordance
with
Executive Order 13132: Federalism. Executive Order 13132 requires
Federal agencies to carefully examine actions to determine if they
contain policies that have federalism implications or that preempt
State law. As defined in the Order, ``policies that have federalism
implications'' refer to regulations, legislative comments or proposed
legislation, and other policy statements or actions that have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of
power
and responsibilities among the various levels of government.
The Secretary is publishing this final rule to set forth
treatment
regulations that provide for the use of approved opioid agonist
treatment medications in the treatment of opiate addiction. The
Narcotic Addict Treatment Act (the NATA, Pub. L. 93-281) modified the
Controlled Substances Act (CSA) to establish the basis for the Federal
control of narcotic addiction treatment by the Attorney General and
the
Secretary. Because enforcement of these sections of the CSA is a
Federal responsibility, there should be little, if any, impact from
this rule on the distribution of power and responsibilities among the
various levels of government. In addition, this regulation does not
preempt State law. Accordingly, the Secretary has determined that this
final rule does not contain policies that have federalism implications
or that preempt State law.
VI. Paperwork Reduction Act of 1995
This final rule contains information collection
provisions 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 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 Adoption of
New Regulations.
Description: The Secretary is issuing 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 new rules 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 final rule, there will be
fewer reporting requirements and fewer required forms under the new
system. The total reporting requirements are estimated at 2,071 hours
for treatment programs, and 341 hours for accrediting organizations as
outlined in Tables 1 and 2.
The 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.
Description of Respondents: Business or other for-profit;
Not-for-
profit institutions; Federal Government; State, local or tribal
government.
No comments were submitted in response to the
Secretary's
invitation in the July 22, 1999, proposal to comment on the
information
collection requirements.
Table 1.--Annual Reporting Burden for Treatment Programs
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
42 CFR
citation
Purpose
respondents respondent
response Total hours
----------------------------------------------------------------------------------------------------------------
8.11(b).............. New programs
approval
75
1
1.50 112.50
(SMA-162).
8.11(b)................ Renewal of
approval
300
1
1.00 300.00
(SMA-162) \1\.
8.11(b)................ Relocation of
program
35
1
1.17 40.83
(SMA-162).
8.11(d).................... Application
for
300
1
1.58 475.00
transitional
certification (SMA-
162) \2\.
8.11(e)(1)................ Application
for
75
1
.50 37.50
provisional
certification.
8.11(e)(2)................ Application
for
30
1
.25 7.50
extension of
provisional
certification.
8.11(f)(5).............. Notification of
sponsor
60
1
.33 20.00
or medical director
change.
8.11(g)(2)..... Documentation to
SAMHSA
1
1
2 2.00
for interim
maintenance.
8.11(h).......... Request to SAMHSA
for
800
3
.438 1050.00
Exemption from 8.11
and 8.12.
[[Page 4089]]
8.11(i)(1)........ Notification to
SAMHSA
3
1
.25 .75
Before Establishing
Medication Units.
8.12(j)(2)............ Notification to
State
1
1
.33 .33
Health Officer When
Patient Begins Interim
Maintenance.
8.24................ Contents of
Appellant
2
1
.25 .50
Request for Review of
Suspension.
8.25(a).......... Informal Review
Request
2
1
1.00 2.00
8.26(a)............ Appellant's Review
File
2
1
5.00 10.00
and Written Statement.
8.28(a)............ Appellant's Request
for
2
1
1.00 2.00
Expedited Review.
8.28(c)............. Appellant's Review
File
2
1
5.00 10.00
and Written Statement.
-------------
Total....................
....................... ............ ............
............ 2,070.91
----------------------------------------------------------------------------------------------------------------
\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 final rule does not increase the estimated annualized
burden.
Certain reporting requirements have been eliminated, 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 new rule
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
eliminated, 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 notice, accreditation
bodies, under contract to SAMHSA, have accredited existing OTPs as
part
of an initiative to gain more information on the accreditation of OTPs.
SAMHSA 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
----------------------------------------------------------------------------------------------------------------
No. of
Responses/ Hours/
42 CFR
citation
Purpose
respondents respondent
response Total hours
----------------------------------------------------------------------------------------------------------------
8.3 (b) (1-11)................. Initial approval (SMA-
10
1
3.0 30.0
163).
8.3 (c)......................... Renewal of
approval
3
1
1.0 3.0
(SMA-163).
8.3 (e).......................... Relinguishment
1
1
0.5 0.5
notification.
8.3 (f) (2).........................
Non-renewal
1
90
0.1 9.0
notification to
accredited OTP's.
8.4 (b) (1) (ii)............... Notification to
SAMHSA
2
2
1.0 4.0
for serious
noncompliant programs.
8.4 (b) (1) (iii)................... Notification to OTP
for
2
2
1.0 4.0
serious noncompliance.
8.4 (d) (1)..................... General document
and
10
2
0.5 10.0
information to SAMHSA
upon request.
8.4 (d) (2)....................... Accrediation survey
to
10
6
0.2 12.0
SAMHSA upon request.
8.4 (d) (3).......................... List of
surveys,
10
6
0.2 12.0
surveyors to SAMHSA
upon request.
8.4 (d) (4)............................. Less than
full
10
7.5
0.5 37.5
accrediation report to
SAMHSA.
8.4 (d) (5)........................... Summaries
of
10
30
0.5 150.0
Inspections.
8.4 (e).................................... Notifications
of
10
1
0.5 5.0
Compliants.
8.6 (a) (2) and (b) (3)............ Revocation
notification
1
90
0.3 27.0
to Accredited OTP's.
8.6 (b)............................... Submission of
90-day
1
1
10 10.0
Corrective plan to
SAMHSA.
8.6 (b) (1)................................... Notification
to
1
90
0.3 27.0
accredited OTP's of
Probationary Status.
--------------
-------------
Total....................
.......................
82 ............
............ 341
----------------------------------------------------------------------------------------------------------------
Note: 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 OTPs
set forth in
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(f)(3) and (f)(4)) justification of exceptional initial
doses; changes in a patient's dose and dosage schedule; 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, sec. 8.4(c)(1) will require accreditation
bodies to
keep and retain for 5 years certain records pertaining to their
respective accreditation activities.
[[Page 4090]]
These recordkeeping requirements for OTPs 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 final rule retains requirements that
OTPs and
accreditation organizations disclose information. For example, 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 new rules require
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.
Individuals and organizations may submit comments on
these burden
estimates or any other aspect of these information collection
provisions, including suggestions for reducing the burden, and should
direct them to: SAMHSA Reports Clearance Officer, Room 16-105, Parklawn
Building, 1 Choke Cherry Road, Rockville, MD 20857.
The information collection provisions in this final rule
have been
approved under OMB control number 0930-0206. This approval expires 09/
30/2002. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services,
Administration.
Dated: January 5, 2001.
Donna E. Shalala,
Secretary of Health and Human Services.
VII. References
The following references have been placed on display at
SAMHSA/CSAT
Reading Room (7-220), 5515 Security Lane, Rockville, MD 20852.
1. Institute of Medicine, Federal Regulation of
Methadone
Treatment, National Academy Press, 1995.
2. ``New Hampshire Legislature Allows Methadone
Treatment,''
Copyright 2000, Alcoholism & Drug Abuse Weekly, Manisses
Communications Group, Inc., Vol. 12, No. 23, Monday, June 5, 2000.
3. Sees, K.L., D.O., et al., ``Methadone Maintenance vs
180-Day
Psychosocially Enriched Detoxification for Treatment of Opioid
Dependence, A Randomized Controlled Trial,'' Journal of the American
Medical Association, Vol 283, No. 10 p1303-1310, March 8, 2000.
4. Clark, H. Westly, M.D., Lepay, David, M.D., ``Dear
Colleague
Letter on Medical Maintenance'', March 30, 2000.
5. Schwartz, M.D., et al., ``A 12-Year Follow-Up of a
Methadone
Medical Maintenance Program, Am J Addiction, Vol. 8, pp 293-299,
1999.
List of Subjects
21 CFR Part 291
Health professions, Methadone, Reporting and
recordkeeping
requirements.
42 CFR Part 8
Health professions, 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,
and applicable delegations of authority thereunder, titles 21 and 42
of
the Code of Federal Regulations are 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; 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.
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, and of Adverse Action Regarding Withdrawal of
Approval of an Accreditation Body
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 arguments.
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 the 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)(1)). 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 Administrator, 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
[[Page 4091]]
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 opiate
addiction treatment with an opioid agonist treatment medication.
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 using opioid
agonist treatment medications.
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 or standards
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
accreditation body approved by SAMHSA under Sec. 8.3(d).
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 and/
or remain productive members of society.
Medication unit means a facility established as part of,
but
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.
Opiate addiction is defined as a cluster of cognitive,
behavioral,
and physiological symptoms in which the individual continues use of
opiates despite significant opiate-induced problems. Opiate dependence
is characterized by repeated self-administration that usually results
in opiate tolerance, withdrawal symptoms, and compulsive drug-taking.
Dependence may occur with or without the physiological symptoms of
tolerance and withdrawal.
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 opiate 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 opiate 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.
State Authority is the agency designated by the Governor
or other
appropriate official designated by the
[[Page 4092]]
Governor to exercise the responsibility and authority within the State
or Territory for governing the treatment of opiate addiction with an
opioid drug.
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 and which specifies the
services to be provided and the frequency and schedule for their
provision.
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, 1 Choke Cherry Road, Rockville, MD 20857, and
marked ATTENTION: OTP Certification Program. SAMHSA will consider and
accept the electronic submission of these materials when electronic
submission systems are developed and available. 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 accreditation body. 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) A set of the accreditation elements or standards and
a detailed
discussion showing how the proposed accreditation elements or
standards
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;
(4) A detailed description of the applicant's
decisionmaking
process, including:
(i) Procedures for initiating and performing onsite
accreditation
surveys of OTPs;
(ii) Procedures for assessing OTP personnel
qualifications;
(iii) Copies of an application for accreditation,
guidelines,
instructions, and other materials the applicant will send to OTPs
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 OTPs and
SAMHSA of
deficiencies and for monitoring corrections of deficiencies by OTPs;
(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
OTPs to contest adverse accreditation decisions.
(5) 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;
(6) 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;
(7) A description of the applicant's training policies;
(8) Fee schedules, with supporting cost data;
(9) 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);
(10) Policies and procedures established to protect
confidential
information the applicant will collect or receive in its role as an
accreditation body; and
(11) 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 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 this subpart. 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
[[Page 4093]]
another accreditation body, and according to a schedule approved by
SAMHSA; and
(2) Notify, in a manner and time period approved by
SAMHSA, all
OTPs 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 for cause 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 survey 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 in an OTP 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 OTPs with less substantial violations. Such
accreditation shall not exceed 12 months. OTPs 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 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 semiannually, 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,
facility
staff, 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
[[Page 4094]]
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 two 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 OTPs 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 OTPs.
(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 OTPs
accredited
by the accrediting body and by evaluating the accreditation body's
reports of surveys conducted, to determine whether the OTPs 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 OTPs 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 OTPs that have been accredited, or are seeking accreditation, of
the accreditation body's loss of SAMHSA approval within 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) of the Controlled Substances Act (21 U.S.C.
823(g)(1)) to dispense opioid drugs in the treatment of opioid
addiction. An OTP must be determined to be qualified under section
303(g)(1) of the Controlled Substances Act, and must be determined to
be qualified by the Attorney General under section 303(g)(1), to be
registered by the
[[Page 4095]]
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). SAMHSA will consider and accept the
electronic submission of these materials when electronic submission
systems are developed and available. 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 addresses 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) of
the Controlled Substances Act.
(d) Transitional certification. OTPs that before March
19, 2001
were the subject of a current, valid approval by FDA under 21 CFR,
part
291 (contained in the 21 CFR Parts 200 to 299 edition, revised as of
July 1, 2000), are deemed to be the subject of a current valid
certification for purposes of paragraph (a)(11) of this section. Such
`transitional certification' will expire on June 18, 2001 unless the
OTP submits the information required by paragraph (b) of this section
to SAMHSA on or before June 18, 2001. In addition to this application,
OTPs must certify with a written statement signed by the program
sponsor, that they will apply for accreditation within 90 days of the
date SAMHSA approves the second accreditation body. Transitional
certification, in that case, will expire on March 19, 2003. SAMHSA may
extend the transitional certification of an OTP for up to one
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) OTPs 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
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 its efforts to obtain
accreditation and a schedule for obtaining accreditation as
expeditiously as possible.
(f) Conditions for certification. (1) OTPs shall comply
with all
pertinent State laws and regulations. Nothing in this part is intended
to limit the authority of State and, as appropriate, 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 OTPs operated
directly by the Department of Veterans Affairs, the Indian Health
Service, or any other department or agency of the United States.
Federal agencies operating OTPs have agreed to cooperate voluntarily
with State agencies by granting permission on an informal basis for
designated State representatives to visit Federal OTPs and by
furnishing a copy of Federal reports to the State authority, including
the reports required under this section.
(2) OTPs 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
[[Page 4096]]
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) OTPs shall notify SAMHSA within 3 weeks of any
replacement or
other change in the status of the program sponsor or medical director.
(6) OTPs 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) OTPs 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 this section and
Sec. 8.12. An example of a case in which an exemption might be granted
would be for a private practitioner who wishes to treat a limited
number of patients in a non-metropolitan area with few physicians and
no rehabilitative services geographically accessible and requests
exemption from some of the staffing and service standards. 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 shall 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 OTPs 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 form SMA-162. The OTP must also comply with the
provisions of 21 CFR part 1300 before establishing a medication unit.
Medication units shall comply with all pertinent state laws and
regulations.
(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 opiate 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. OTPs must provide treatment in accordance
with the
standards in this section and must comply with these standards as a
condition of certification.
(b) Administrative and organizational structure. An OTP's
organizational structure and facilities 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 OTP
shall formally designate a program sponsor and medical director. The
program sponsor shall agree on behalf of the OTP 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 OTP. In addition, the medical director shall be
responsible for ensuring that the OTP 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, 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.
[[Page 4097]]
(2) Maintenance treatment for persons under age 18. A
person under
18 years of age is required to have had two documented unsuccessful
attempts at short-term detoxification or drug-free treatment within a
12-month period to be eligible for maintenance 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. Patients with two or more unsuccessful detoxification
episodes within a 12-month period must be assessed by the OTP
physician
for other forms of treatment. A program shall not admit a patient for
more than two detoxification treatment episodes in one year.
(f) Required services.--(1) General. OTPs shall provide
adequate
medical, counseling, vocational, educational, and other assessment and
treatment 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. OTPs shall
require each
patient to undergo a complete, fully documented physical evaluation by
a program physician or a primary care physician, or an authorized
healthcare professional under the supervision of a program physician,
before admission to the OTP. The full medical examination, including
the results of serology and other tests, must be completed within 14
days following admission.
(3) Special services for pregnant patients. OTPs must
maintain
current policies and procedures that reflect the special needs of
patients who are pregnant. Prenatal care and other gender specific
services or 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
patient'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) OTPs 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 patients, to contribute to the appropriate
treatment plan for the patient and to monitor patient progress.
(ii) OTPs 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) OTPs 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. OTPs must provide
adequate testing
or analysis for drugs of abuse, including at least eight random drug
abuse tests per year, per patient in maintenance treatment, 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) OTPs
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) OTPs shall include, as an essential part of the
recordkeeping
system, documentation in each patient's record that the OTP made a
good
faith effort to review whether or not the patient is enrolled 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)
OTPs 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) OTPs 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, OTPs who are fully
compliant with the protocol of an investigational use of a drug and
other conditions set forth in the application may administer a drug
that has been authorized by the Food and Drug Administration under an
investigational new drug application
[[Page 4098]]
under section 505(i) of the Federal Food, Drug, and Cosmetic Act for
investigational use in the treatment of opioid addiction. Currently
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) Levomethadyl acetate (LAAM).
(3) OTPs 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.
(4) OTPs 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 significant deviations from the
approved labeling, including deviations with regard to dose,
frequency,
or the conditions of use described in the approved labeling, are
specifically documented 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 (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 (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 90 days of treatment, the take-home
supply
(beyond that of paragraph (i)(1) of this section) is limited to a
single dose each week and the patient shall ingest all other doses
under appropriate supervision as provided for under the regulations in
this subpart.
(ii) In the second 90 days of treatment, the take-home
supply
(beyond that of paragraph (i)(1) of this section) is two doses per
week.
(iii) In the third 90 days of treatment, the take-home
supply
(beyond that of paragraph (i)(1) of this section) is three doses per
week.
(iv) In the remaining months of the first year, a patient
may be
given a maximum 6-day supply of take-home medication.
(v) After 1 year of continuous treatment, a patient may
be given a
maximum 2-week supply of take-home medication.
(vi) After 2 years of continuous treatment, a patient may
be given
a maximum one-month supply of 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) OTPs 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, including
child-proof containers (see Poison Prevention Packaging Act, Public
Law
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 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 this paragraph
(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;
[[Page 4099]]
(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
OTPs 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, OTPs 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;
(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
Sec. 8.3.
Subpart C--Procedures for Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body
Sec. 8.21 Applicability.
The procedures in this subpart apply when:
(a) SAMHSA has notified an OTP in writing that its
certification
under the regulations in subpart B of this part has been suspended or
that SAMHSA proposes to revoke the certification; and
(b) The OTP has, within 30 days of the date of the
notification or
within 3 days of the date of the notification when seeking an
expedited
review of a suspension, requested in writing an opportunity for a
review of the suspension or proposed revocation.
(c) SAMHSA has notified an accreditation body of an
adverse action
taken regarding withdrawal of approval of the accreditation body under
the regulations in subpart A of this part; and
(d) The accreditation body has, within 30 days of the
date of the
notification, requested in writing an opportunity for a review of the
adverse action.
[[Page 4100]]
Sec. 8.22 Definitions.
The following definitions apply to this subpart C.
(a) Appellant means:
(1) The treatment program which has been notified of its
suspension
or proposed revocation of its certification under the regulations of
this part and has requested a review of the suspension or proposed
revocation, or
(2) The accreditation body which has been notified of
adverse
action regarding withdrawal of approval under the regulations of this
subpart and has requested a review of the adverse action.
(b) Respondent means SAMHSA.
(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 HHS officers or
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, or adverse action, the necessary
interpretations of the facts the regulations, in the subpart, 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) Request for review. 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, proposed revocation, or adverse action, a brief
statement of why the decision to suspend, propose revocation, or take
an adverse action is incorrect, and the appellant's request for an
oral
presentation, if desired.
(b) Acknowledgment. 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 arguments.
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 30 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 or to take adverse action regarding
withdrawal of approval of the accreditation body is incorrect
(appellant's brief).
(b) Respondent's documents and brief. Within 30 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, or approval
as
an accreditation body, 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, proposed revocation, or
adverse action (respondent's brief).
(c) Reply briefs. Within 10 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 steps to reduce excessive documentation, including the
return of or refusal to consider documentation found to be irrelevant,
redundant, or unnecessary.
(f) Discovery. The use of interrogatories, depositions,
and other
forms of discovery shall not be allowed.
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 the presiding official's 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 45 days of the
date appellant's request for review is received or within 15 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 HHS officers or
employees or consultants in conducting the oral presentation and
reviewing the evidence. While the oral
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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, propose revocation, or take adverse action 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 pre-hearing 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. 1001 or 1505.
(g) Post-hearing procedures. At the presiding
official's
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 10 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 20 to 30 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 Secs. 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
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 sent by facsimile transmission, personal
service, or commercial overnight delivery service.
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) Timely review. Because of the importance of a timely
review,
the reviewing official should normally transmit written communications
to either party by facsimile transmission, personal service, or
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) Due date. 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 the reviewing official.
In addition to any other authority specified in this
subpart C, 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 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 the procedures in this subpart.
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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, proposed
revocation, or adverse action. The decision will set forth the reasons
for the decision and describe the basis for that decision 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
the 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 of
OTP certification 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 of OTP
certification
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, proposed revocation, or adverse action, 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.
[FR Doc. 01-723 Filed
1-16-01; 8:45 am]
BILLING CODE 4160-01-P
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