Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction: Final Rule

28 Pages·2001·0.52 MB·English

by  Federal Register

Wednesday,
January 17, 2001
Part II
Department of
Health and Human
Services
Substance Abuse and Mental Health
Services Administration
21 CFR Part 291
42 CFR Part 8
Opioid Drugs in Maintenance and
Detoxification Treatment of Opiate
Addiction; Final Rule
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4076 Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations
DEPARTMENT OF HEALTH AND accreditation model under new 42 CFR system. The existing system provides for
HUMAN SERVICES part 8, and a shift in administrative FDA ‘‘approval’’ of programs, with
responsibility and oversight from FDA direct government inspection in
Substance Abuse and Mental Health to SAMHSA. accordance with more detailed process-
Service Administration The July 22, 1999, notice traced the oriented regulations. These process-
history of Federal regulatory oversight oriented regulations are less flexible and
21 CFR Part 291 of Opioid Treatment Programs (‘‘OTPs,’’ prescribe many aspects of treatment.
also known as narcotic treatment The existing regulations do not require
42 CFR Part 8 programs, or, methadone programs), that programs have quality assurance
focusing on Federal regulations systems. Finally, under the existing
[Docket No. 98N–0617]
enforced by FDA since 1972. The July system, programs are not subject to
RIN 0910–AA52 22, 1999, notice summarized the periodic certification and there is no set
periodic reviews, studies, and reports schedule for inspections.
Opioid Drugs in Maintenance and
on the Federal oversight system, Proposed Subpart A addressed
Detoxification Treatment of Opiate culminating with the 1995 Institute of accreditation and included steps that
Addiction; Medicine (IOM) Report entitled, Federal accreditation bodies will follow to
AGENCY: Substance Abuse and Mental Regulation of Methadone Treatment achieve approval to accredit OTPs
(Ref. 1). As noted in the July 22, 1999, under the new system. It also set forth
Health Services Administration, HHS.
proposal, the IOM report recommended the accreditation bodies’
ACTION: Final rule.
that the existing FDA process-oriented responsibilities, including the use of
SUMMARY: The Department of Health and regulations should be reduced in scope accreditation elements during
Human Services and the Substance to allow more clinical judgment in accreditation surveys. Proposed Subpart
Abuse and Mental Health Services treatment and greater reliance on B established the sequence and
Administration (SAMHSA) are issuing guidelines. The IOM report also requirements for obtaining certification.
final regulations for the use of narcotic recommended designing a single This section addressed how and when
drugs in maintenance and detoxification inspection format, having multiple programs must apply for initial
treatment of opioid addiction. This final elements, that would (1) provide for certification and renewal of their
rule repeals the existing narcotic consolidated, comprehensive certification. Finally, Subpart C of
treatment regulations enforced by the inspections conducted by one agency proposed part 8 established the
Food and Drug Administration (FDA), (under a delegation of Federal authority, procedures for review of the withdrawal
and creates a new regulatory system if necessary), which serves all agencies of approval of the accreditation body or
based on an accreditation model. In (Federal, State, local) and (2) improve the suspension and proposed revocation
addition, this final rule shifts the efficiency of the provision of of an OTP certification.
administrative responsibility and methadone services by reducing the In addition to proposing an entirely
oversight from FDA to SAMHSA. This number of inspections and new oversight system, the July 22, 1999,
rulemaking initiative follows a study by consolidating their purposes. proposal included several other new
To address these recommendations, provisions. For example, the Federal
the Institute of Medicine (IOM) and
SAMHSA proposed a ‘‘certification’’ opioid treatment standards were
reflects recommendations by the IOM
system, with certification based on significantly reduced in scope to allow
and several other entities to improve
accreditation. Under the system, as set more flexibility and greater medical
opioid addiction treatment by allowing
forth in the July 22, 1999, proposal, a judgment in treatment. Certain
for increased medical judgment in
practitioner who intends to dispense restrictions on dosage forms were
treatment.
opioid agonist medications in the eliminated so that OTPs may now use
DATES: This final rule will become treatment of opiate addiction must first solid dosage forms. Under the previous
effective on March 19, 2001. obtain from SAMHSA, a certification rules, OTPs were limited to the use of
FORFURTHERINFORMATIONCONTACT: that the practitioner is qualified under liquid dosage forms. Several reporting
Nicholas Reuter, Center for Substance the Secretary’s standards and will requirements and reporting forms were
Abuse Treatment (CSAT), SAMHSA, comply with such standards. Eligibility eliminated, including the requirements
Rockwall II, 5600 Fishers Lane, Rm 12– for certification will depend upon the for physician notifications (FDA
05, Rockville, MD 20857, 301–443– practitioner obtaining accreditation Reporting Form 2633) and the
0457, email: [email protected]. from a private nonprofit entity, or from requirement that programs obtain FDA
SUPPLEMENTARYINFORMATION: a State agency, that has been approved approval prior to dosing a patient above
by SAMHSA to accredit OTPs. 100 milligrams. The proposal included
I. Background
Accreditation bodies would base a more flexible schedule for medications
In the Federal Register of July 22, accreditation decisions on a review of dispensed to patients for unsupervised
1999, (64 FR 39810, July 22, 1999, an application for accreditation and on use, including provisions that permit up
hereinafter referred to as the July 22, surveys (on site inspections) conducted to a 31-day supply. Under the current
1999, notice or July 22, 1999, proposal) every three years by addiction treatment regulations, patients are limited to a
SAMHSA, FDA, and the Secretary, experts. In addition, accreditation maximum 6-day supply of medication.
Health and Human Services (HHS), bodies will apply specific opioid Many of these regulatory requirements
jointly published a Notice of Proposed treatment accreditation elements that had been in place essentially unchanged
Rulemaking (NPRM) to revise the reflect ‘‘state-of-the-art’’ opioid for almost 30 years.
conditions for the use of narcotic drugs treatment guidelines. Moreover, SAMHSA distributed the July 22,
in maintenance and detoxification accreditation standards will require that 1999, notice to each OTP listed in the
treatment of opioid addiction. The OTPs have quality assurance systems current FDA inventory, each State
agencies also proposed the repeal of the that consider patient outcomes. Methadone Authority, and to other
existing narcotic treatment regulations As noted in the July 22, 1999, interested parties. Interested parties
enforced by the FDA, the creation of a proposal, this new system would were given 120 days, until November
new regulatory system based on an replace the existing FDA regulatory 19, 1999, to comment on the July 22,
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Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations 4077
1999, proposal. In addition, on for the results of further study before address opiate addiction treatment. Two
November 1, 1999, SAMHSA, FDA, the implementing new regulations. accreditation bodies, the Commission
Office of National Drug Control Policy The Secretary agrees that the for the Accreditation of Rehabilitation
(ONDCP), the Drug Enforcement SAMHSA-administered accreditation- Facilities (CARF) and the Joint
Administration (DEA), and other based regulatory system will encourage Commission for the Accreditation of
Federal agencies convened a Public the use of best-practice clinical Healthcare Organizations (JCAHO),
Hearing on the proposal. The Public guidelines and require quality under contract to SAMHSA/CSAT, used
Hearing was announced in the Federal improvement standards with outcome these guidelines to develop ‘‘state-of-
Register published October 19, 1999, assessments. As set forth below, the the-art’’ accreditation elements. These
(64 FR 59624, October 19, 1999), and Secretary does not agree that comments two accreditation bodies have surveyed
was held in Rockville, MD. On January on the uncertainty about accreditation dozens of programs with these new
31 and May 10, 2000, the SAMHSA/ costs or State regulatory activities accreditation standards.
CSAT National Advisory Council warrant additional study before The July 22, 1999, proposal described
Subcommittee on Accreditation met to implementing these new rules. an ongoing accreditation impact study.
assist SAMHSA/CSAT in its review of 2. Several comments addressed the Under the accreditation impact study,
data and information from SAMHSA/ costs associated with accreditation and CARF and JCAHO trained over 170
CSAT’s ongoing accreditation project. challenged the estimates provided in the participating OTPs. In addition, more
The SAMHSA/CSAT National Advisory July 22, 1999, proposed rule. One than 50 OTPs have been accredited
Council convened to discuss the opioid comment included the results from a under this system with technical
accreditation project on May 12, 2000. survey of OTPs with accreditation assistance provided through a contract
The May 12, 2000, Council meeting experience to indicate the indirect costs funded by SAMHSA/CSAT. None of the
provided an opportunity for comments of accreditation will be considerable. accredited programs have had to incur
from the public (65 FR 25352, May 1, According to the comment, these OTPs the kind of ‘‘physical plant’’ and other
have had to spend considerable sums to costly expenses predicted by some of
2000).
hire consultants and additional staff, the comments previously discussed.
II. Comments and Agency Response upgrade computers, develop infection This direct and up-to-date information
control manuals, and make physical indicates that the cost estimates in the
In response to the July 22, 1999,
plant improvements. In some cases July 22, 1999, notice are up-to-date and
proposal, SAMHSA received almost 200
these costs were reported to approach reasonable. On the other hand, the
submissions, each containing one or
$50,000. Some of these comments survey discussed above that was
more comments. The comments were
suggested that SAMHSA await the submitted with one comment reflected
from government, industry, industry
completion of the ‘‘accreditation impact accreditation surveys performed over 10
trade associations, academia, health
study’’ to obtain additional information years ago. And, in some cases, the
professionals, professional
on costs, before proceeding. Other accreditation experiences discussed in
organizations, patient advocacy
comments stated that accreditation can these comments reflect accreditation of
organizations, and individual patients.
lead to increased treatment capacity, but psychiatric hospitals, not OTPs.
A. General Comments only if additional funds are provided. The accreditation-based system which
One comment suggested that SAMHSA is the subject of this rule includes
1. Many comments agreed in
create a capital improvement fund, safeguards to reduce the risk of
principle that the shift to an
while another suggested that SAMHSA unnecessary and overly burdensome
accreditation-based system will
allow block grant funds to be used to accreditation activities relating to OTPs.
encourage OTPs to use individualized,
pay for accreditation. For example, SAMHSA will approve
clinically determined treatment plans The Secretary believes that the each accreditation body after reviewing
that are guided by current, best-practice estimated costs as set forth in the July its accreditation elements, accreditation
medical and clinical guidelines and to 22, 1999, notice remain reasonably procedures, and other pertinent
evaluate clinical outcomes. Other accurate. As discussed in greater detail information. SAMHSA will convene
comments noted that the accreditation below, information on accreditation periodically an accreditation
proposal recognizes that opiate developed under the accreditation subcommittee, as part of the SAMHSA/
addiction is a medical condition. impact study, together with other CSAT National Advisory Council. The
Several comments affirmed that a major ongoing SAMHSA technical assistance subcommittee will review accreditation
segment of the healthcare system in the programs, indicates that the activities and accreditation outcomes
United States is being reviewed through accreditation system will not produce and make recommendations to the full
accreditation systems. As such, these an excessive burden to programs to SAMHSA/CSAT Council, and
comments stated that applying warrant delaying the implementation of ultimately to SAMHSA on accreditation
accreditation requirements to OTPs this final rule. activities and guidelines. Finally,
provides the potential for mainstream There are many components to SAMHSA/CSAT has been providing
medicine to embrace opioid treatment. SAMHSA’s accreditation project that technical assistance to OTPs in the
While not opposing the proposal, have been proceeding concurrently with accreditation impact study that has
some comments stated there should be this rulemaking. In April 1999, helped programs in achieving
no Federal regulations in this area. SAMSHA’s Center for Substance Abuse accreditation. SAMHSA/CSAT intends
Other comments expressed concerns Treatment (CSAT) issued ‘‘Guidelines to continue providing technical
about additional costs to OTPs and, for the Accreditation of Opioid assistance on accreditation during the
ultimately patients, for accreditation Treatment Programs.’’ These guidelines 3–5 year transition period and possibly
and duplicative assessments, noting that are up-to-date best-practice guidelines longer.
some States will continue to enforce that are based upon the Federal opioid The Secretary does not agree that it is
process-oriented regulations, supported treatment standards set forth under necessary to establish a special fund to
by considerable licensing fees. Based proposed section 8.12 as well as help programs pay for accreditation fees
upon these ‘‘uncertainties,’’ these SAMHSA/CSAT’s Treatment and indirect ‘‘physical plant’’
comments suggest that SAMHSA wait Improvement Protocols (TIPs) that improvements in order for OTPs to be
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4078 Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations
able to achieve accreditation. As noted costs associated with an accreditation- quality of care provided by OTPs. The
above, the Secretary believes that the based system. In addition, the study is results indicate that most OTPs can
estimates in the July 22, 1999, proposal expected to provide important achieve accreditation and that treatment
for the cost of accreditation are information to allow SAMHSA to keep capacity has not declined as a result.
reasonably accurate (approximately $4– its guidelines, and its accreditation While SAMHSA intends to continue the
5 million per year, $5400 per OTP per program, as responsive and up-to-date study to fulfill its objectives, the
year, $39 per patient per year). as possible. Among other things, the Secretary does not believe that it is
Nonetheless, the Secretary has taken study will allow HHS to continuously appropriate or necessary to delay
steps to minimize the potential effects of monitor the monetary costs of implementation of these new rules until
this burden to OTPs, especially to OTPs accreditation, to ensure that successful the full study is complete.
that are small businesses or that operate OTPs are not precluded from operating 4. Many comments, especially from
in under-served communities. First, the by the costs of accreditation, and that current and past OTP patients,
Secretary has determined that States patients are not denied treatment based questioned the impact of revised
could use funds provided by SAMHSA on costs. The full study, which Federal regulations in light of State
under their Substance Abuse Prevention compares a representative sample of regulations. These comments contend
and Treatment (SAPT) Block Grants to OTPs 6 months following accreditation that State regulations are much more
offset costs of accreditation for programs to their baseline status across several restrictive on medical and clinical
qualified to receive assistance under the variables, will require a few years to practices than Federal regulations, and
State’s SAPT block grant. Second, complete. Regulations can be modified that State regulatory authorities have
SAMSHA has included in its budget, a at any time. If SAMHSA believes that expressed little or no interest in
plan to continue funding accreditation. the results of the study merit changes in changing their regulations or the way
Finally, SAMHSA will continue to the regulations, then such changes will State regulations are enforced.
provide technical assistance which will be the subject of a future rulemaking. Comments from OTP sponsors stated
aid those programs that need help in The Secretary has reviewed that accreditation costs would add to
achieving accreditation. preliminary results from the State licensing fees, which, in some
3. One OTP that is participating in the accreditation study by two accreditation States, exceed several thousand dollars
accreditation impact study, while bodies, CARF and JCAHO, of almost 10 annually.
commending the accreditation percent (approximately 80 OTPs) of the The Secretary shares the concerns
experience and accreditation in general, entire inventory of approved outpatient expressed in these comments about
commented that the proposed change is OTPs. Well over 90 percent of the OTPs State regulations and licensing
premature. Some comments suggested surveyed achieved accreditation under requirements. Indeed, the July 22, 1999,
that SAMHSA postpone implementation the ‘‘methadone specific’’ accreditation proposal discussed State licensure and
for an indefinite period to allow for an standards. Only a very few programs regulatory issues. The proposal also
unspecified number of CARF and required a follow-up survey to achieve noted that there was considerable
JCAHO accreditation results. Another accreditation. And, to date, only one variation in the nature and extent of
comment stated that the first series of OTP failed to achieve accreditation. oversight at the State level. Some States
surveys will determine the utility of the These accreditation outcome results are have regulations and enforcement
first generation of standards, noting that comparable to the historical compliance programs that exceed Federal
the process can be focused and modified rate under the previous FDA process- regulations. Others have relied
in response to results from the impact oriented regulatory system. In addition, exclusively upon FDA and DEA
study. A few comments questioned these rates correspond to the assumed regulatory oversight. An increasing
whether all providers can make the accreditation resurvey rate stated in the number of States rely on accreditation,
transition. July 22, 1999, proposal for estimating by nationally recognized accreditation
On the other hand, many comments the indirect costs of accreditation. bodies, for all or part of their healthcare
stated that the field has been subject to These accreditation outcome results licensing functions.
regulatory neglect long enough, and that have been analyzed and presented to The Secretary believes that
SAMHSA should minimize the delay in SAMHSA/CSAT’s National Advisory SAMHSA’s ongoing coordination
finalizing rules. One comment Council’s Accreditation Subcommittee activities with States will minimize the
submitted the results of a survey that (NACAS). As discussed in the July 22, impact of Federal-State regulatory
suggested that as many as 155 OTPs 1999, proposal, SAMHSA/CSAT disparities upon OTPs. One objective of
currently need technical assistance in augmented NACAS with consultants these activities is to increase State
order to provide treatment in representing OTPs (both large and small authorities’ acceptance of the new
accordance with standards and programs), medical and other substance accreditation-based system. First,
regulations. abuse professionals, patients, and State SAMHSA/CSAT’s OTP accreditation
The Secretary does not believe that officials. The subcommittee has met guidelines were developed by a
these final regulations should be twice, on January 31 and May 10, 2000, consensus process that included
delayed until the completion of the and the public was provided an representation from State Methadone
accreditation impact study. As stated in opportunity to participate in this Authorities. In addition, some State
the July 22, 1999, proposal, the advisory process. On May 12, 2000, the officials have accompanied CARF and
Department of Health and Human SAMHSA/CSAT National Advisory JCAHO accreditation survey teams to
Services (HHS) has determined that Council urged SAMHSA/CSAT to move observe site visits. Finally, SAMHSA/
accreditation is a valid and reliable expeditiously to finalize the July 22, CSAT has distributed information on
system for providing external 1999, proposal. accreditation to each State. This
monitoring of the quality of health The Secretary believes that the information includes the SAMHSA/
care—including substance abuse and interim results from the accreditation CSAT OTP accreditation guidelines, the
methadone treatment. The SAMHSA/ impact study confirm that the CARF OTP accreditation standards and
CSAT study is designed to provide accreditation guidelines, along with the the JCAHO OTP accreditation standards.
additional information on the processes, accreditation process itself, are a valid SAMHSA/CSAT convened three
barriers, administrative outcomes, and and reliable method for monitoring the national meetings of State officials
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Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations 4079
between 1997 and 2000 and intends to from iatrogenic methadone toxicity §291.505 to permit stabilized patients
continue coordinating activities with associated with patients early in up to a one-month supply of treatment
State authorities and national treatment. The experiences in these two medication. In addition, SAMHSA/
organizations such as the National countries were associated with an CSAT has developed treatment
Association of State Alcohol and Drug accelerated rate of patient admissions guidelines and training curricula for
Abuse Directors (NASADAD). and the involvement of new, practitioners to increase the information
This final rule includes provisions inexperienced practitioners. One and education for practitioners in this
that would permit any State to apply for comment cited research on methadone area. Finally, SAMHSA/CSAT has
approval as an accreditation body and, medical maintenance that indicated that issued announcements to the field
if approved, accredit OTPs under the approximately 15 percent of the patients explaining how patients and treatment
new Federal opioid treatment standards. treated in physicians offices were programs can obtain authorizations for
Based on the above, the Secretary referred back to OTPs after ‘‘relapsing’’ medical maintenance. These
expects that many states will consider to illicit opiate use. authorizations were developed to
OTP accreditation and Federal Generally, most comments on this address program-wide exemptions
certification requirements as sufficient issue stated that there was not enough under 21 CFR 291.505; however,
to fulfill all or a substantial part of their information on office-based practice. SAMHSA/CSAT envisions a similar
licensing requirements. Taken together, These comments suggest that based on approach will be used under the
the Secretary believes that these the available information, office-based program-wide exemption provisions of
measures will minimize significantly treatment warrants a gradual, step-wise 42 CFR 8.11(h).
the existing disparity between Federal approach, along with more use of
Under the medical maintenance
and State regulation of OTPs. medication units. This approach would
model, office-based physicians maintain
5. Office-Based Treatment. The July serve to ‘‘diffuse opioid agonist
formal arrangements with established
22, 1999, proposal discussed the maintenance treatment into traditional
OTPs. Typically, patients who have
concept of ‘‘office-based opioid settings.’’
been determined by a physician to be
treatment’’ and specifically solicited After carefully considering the diverse
stabilized in treatment may be referred
comments on how the Federal opioid comments, as well as other legal and
to office-based physicians. It has been
treatment standards might be modified regulatory factors, the Secretary is not
estimated that over 12,000 current
to accommodate office-based treatment including in this rule specific standards
patients would be eligible for medical
and on whether a separate set of Federal that would permit physicians to
maintenance treatment. The Secretary
opioid treatment standards should be prescribe methadone and LAAM in
believes that this is a reasonable
included in this rule for office-based office-based settings without an
approach that will expand treatment
treatment. affiliation with an OTP. Instead, until
capacity gradually while additional
The Secretary received many diverse additional information is generated, the
information and experience is
comments on the office-based treatment Secretary is announcing administrative
developed to evaluate and refine office-
issue. Several comments from patients measures to facilitate the treatment of
based treatment models.
and individual physicians believed that patients under a ‘‘medical maintenance’’
office-based treatment provided an model. B. Comments on Subpart A—Definitions
excellent opportunity to expand opioid Current regulations enforced by DEA and Accreditation
agonist treatment. These comments do not permit registrants to prescribe
Proposed subpart A sets forth
reference opioid treatment delivery narcotic drugs, including opioid agonist
definitions as well as procedures,
systems in other countries and suggest medications such as methadone and
criteria, responsibilities and
that the U.S. should adopt similar LAAM for the treatment of narcotic
requirements relating to accreditation.
systems. A few comments addiction (see 21 CFR 1306.07(a)). In
recommended that community addition, the Secretary agrees that, at 1. A comment from a State authority
pharmacies be encouraged to dispense the present time, there should be some suggested that the treatment plan
methadone and LAAM as ‘‘medication linkage between OTPs and physicians definition under §8.2 should be
units’’ as a way to make treatment more who treat stable patients with modified to require a reference to the
convenient for patients. methadone and LAAM in their offices to services determined necessary to meet
While many comments suggested address patients’ psychosocial needs in the goals identified in the plan. The
separate standards for office-based the event of relapse. The Secretary Secretary agrees with this suggestion
treatment, others feared that different agrees with the comments about the lack and has revised the treatment plan
standards would result in a two-tiered of trained and experienced practitioners definition accordingly.
system of treatment. Overall many to diagnose, admit, and treat opiate 2. One comment suggested that the
comments stated that existing and addicts who are not sufficiently proposed definition of detoxification
proposed rules do not facilitate the stabilized, without the support of an treatment specifies agonist and therefore
development of the office-based practice OTP. precludes the use of mixed agonist or
model. As such, accreditation and The Secretary has taken steps to agonists in combination with other
certification would be prohibitively facilitate ‘‘medical maintenance,’’ that drugs. The Secretary has announced
expensive for individual physicians. will result in more patients receiving plans to develop new rules specifically
On the other hand, many comments treatment with methadone and LAAM for partial agonist medications for the
expressed concerns with the concept of in an office-based setting. Medical treatment of opiate addiction (See 65 FR
‘‘office-based’’ treatment and maintenance refers to the treatment of 25894, May 4, 2000). Therefore, use of
prescribing methadone and LAAM. stabilized patients with increased the term ‘‘agonist’’ is appropriate in this
Many of these comments reflected amounts of take-home medication for context.
concern about the lack of trained and unsupervised use and fewer clinic visits The use of ‘‘other drugs’’ (interpreted
experienced practitioners. One for counseling or other services. First, to mean non-narcotic substances) in
comment referenced literature reports the ‘‘take home’’ provisions in these combination with methadone and
that described experiences in Australia rules have been revised from the LAAM are not subject to the regulatory
and the United Kingdom with deaths previous regulations under 21 CFR requirements of this rule.
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4080 Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations
3. Several comments were submitted accrediting bodies under the new rules review, SAMHSA will determine the
on the proposed definition of opiate but believed that they were ineligible extent to which the accreditation
addiction. Some comments suggested because they could not accredit 50 OTPs standards are consistent with the
that the definition should be revised to a year under proposed section 8.3. On Federal opioid treatment standards. In
remove behavior-oriented concepts and the other hand, many States indicated addition, under section 8.5, SAMHSA
rely on medical constructs only. One that they were not interested in will evaluate periodically the
comment suggested substituting the becoming accreditation bodies, while performance of accreditation bodies by
definition of opiate addiction contained several indicated that they were inspecting a selected sample of the
in the recent NIH consensus panel undecided and would await additional OTPs accredited by the accreditation
report. The Secretary concurs, and has information. body. As part of this effort SAMHSA
revised the definition of opiate Comments from OTPs, for the most may also consider follow-up inspections
addiction to be more consistent with the part, reflect a longstanding cooperative in cases where accreditation activities
recent NIH Consensus panel’s relationship with State regulatory identify public health, public safety,
recommendations. authorities. OTPs, in general, did not and patient care issues.
4. A few comments were concerned appear to oppose the concept of State The Secretary continues to believe, as
that there would be only two authorities serving as accreditation outlined in the July 22 proposal, that
accreditation bodies, CARF and JCAHO. bodies under the proposed new system. there are benefits to States serving as
In addition, these comments reflect Indeed, some OTPs, located within accreditation bodies under this rule.
concern that accreditation would be an States that assess extensive licensing This feature provides the potential to
additional requirement on top of fees, commented that it would be reduce the overall number of OTP
existing FDA regulations. imperative that States take on the role inspections. It also permits the use and
As proposed in the July 22, 1999, of accreditation bodies under the new application of the vast expertise
notice (section 8.3(a)) any private system in order to eliminate the available within many State oversight
nonprofit organization, State financial impact of licensing and agencies.
governmental entity, or political accreditation fees. 6. A number of State authorities and
subdivision thereof, capable of meeting Comments from patients on this issue an accreditation body questioned the
the requirements of subpart A is eligible suggested caution. Many patients sensed restriction under proposed section
to apply to become an accreditation that State regulators would retain strict, 8.3(b)(3) that would require
body under the new rules. As discussed ‘‘process-oriented’’ regulations or accreditation bodies to be able to survey
elsewhere in this final rule, some State philosophies. These comments urged no less than 50 OTPs annually. Some
authorities have contacted SAMHSA that if SAMHSA permitted States to comments contend that this would
and expressed interest in becoming an serve as accreditation bodies then the unfairly and inappropriately exclude
accreditation body under subpart A. In agency should carefully monitor smaller States or States with fewer OTPs
addition, a number of non-governmental accreditation standards and practices to from participating. These comments
entities have expressed similar interest. assure that they conform with the suggested that other requirements
Accordingly, the Secretary believes that Federal opioid treatment standards. should be considered and applied or a
there will be more than two After considering the comments on waiver provision added. One
accreditation bodies that seek and this issue, the Secretary is retaining the accreditation body commented that
obtain approval to become an provision that allows States to serve as accreditation bodies recognized by the
accreditation body under these rules. accreditation bodies under the new Health Care Financing Administration
The requirements for accreditation rules. The Secretary acknowledges that are not subject to such arbitrary
and SAMSHA certification under this many States will choose not to limitations. Other comments suggested
final rule will replace the requirements participate as accreditation bodies. that the 50 survey per year minimum
for FDA approval of OTPs under Some of these States already accept was not necessary to achieve its stated
previous regulations. The previous accreditation by recognized purpose—to ensure the quality of
regulations in place under 21 CFR accreditation bodies for licensing accreditation services and minimize the
291.505 will be rescinded on March 19, purposes. It is expected that more variability of accreditation standards.
2001. States, especially States with relatively The Secretary concurs with these
5. The Secretary received a few OTPs, will also choose to accept comments. The provisions of section
considerable number of diverse accreditation as meeting State licensure 8.3(b)(3) (submission and review of
comments from State authorities, OTPs, requirements in time. Indeed, legislation proposed accreditation standards) and
and patients on the provision proposed enacted recently in New Hampshire to section 8.5 (periodic evaluation of
under section 8.3(a) that would permit allow methadone maintenance accreditation bodies) are adequate to
States to serve as accreditation bodies treatment incorporated a requirement enable SAMHSA to ensure the quality of
under the new rules. The preamble to for CARF accreditation (Ref. 2). Finally, accreditation services and minimize the
the July 22, 1999, notice emphasized the some States will apply accreditation potential variability in accreditation
need for States to consider serving as reviews and findings to complement standards. Accordingly, section 8.3(b)
accreditation bodies. This emphasis was their licensing activities. The Secretary has been modified to remove this
based upon the recommendation in the recognizes that the States’ role in requirement.
IOM Report that strongly suggested that adapting to the new system will change 7. A few comments suggested that
the Federal Government design a over time as additional information on State authorities and patient advocates
consolidated inspection system that accreditation is developed. should be permitted to participate in the
reduces the burden on OTPs from The Secretary believes that there are approval of accreditation bodies under
multiple (Federal, State, local) adequate safeguards to address patient the new rules and in the accreditation
inspections. concerns about overly restrictive State process in general. These comments
State authorities provided a mixed regulations and oversight. Under section believe that they can make substantial
response in their comments on this 8.3(b)(3), SAMHSA will review each contributions to the process.
issue. As discussed below, several applicant accreditation body’s proposed The Secretary agrees that patients and
States expressed an interest in becoming accreditation standards. As part of this State authorities can contribute
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Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations 4081
substantially to the successful operation comments and has added a definition of registration is explicitly contingent
of the new system. State authorities and State Authority. This definition tracks upon State authority approval.
patients have participated in the closely with the definition contained in Importantly, as noted below, there will
committees that have developed the previous regulations under section be extensive consultation, coordination,
SAMHSA/CSAT’s Accreditation 21 CFR 291.505. and cooperation between SAMHSA and
Guidelines. In addition, representatives relevant State authorities.
C. Subpart B—Certification
from both these groups have served on 2. One State regulator requested that
the Accreditation Subcommittee of the Subpart B establishes the criteria and the regulation be modified at section
SAMHSA/CSAT National Advisory procedures for the certification of OTPs. 8.11(c)(1) to add a requirement that
Council. Accreditation standards This section also addresses the SAMSHA notify the State upon receipt
include several provisions designed to conditions for certification and the of applications for certification as well
solicit and consider individual patient interaction between the Federal as approval and withdrawal. This
views regarding treatment planning and Government and State authorities under comment was based upon a concern that
other areas. Some, though not all, the new rules. provisionally certified programs could
accreditation bodies also have patient 1. Many comments from State operate without a State’s knowledge.
hotlines that allow patients to convey regulators noted that there was no The Secretary agrees that it is
concerns directly to accreditation reference to a requirement that OTPs imperative for States to be notified of
bodies. Finally, SAMHSA and State obtain a license or permit from States significant certification activities,
authorities will continue to consult and before receiving certification from the including new program applications,
interact under the new rules. The Federal Government. These comments program suspensions and withdrawals.
Secretary believes that these measures reflect a concern that SAMHSA may SAMHSA intends to notify States of all
are adequate to assure the appropriate certify a program in a State where no such developments under the
level of State authority and patient methadone authority exists, or without provisions of section 8.11(c)(1). The
input into the accreditation process. the knowledge of the State authority.
Secretary believes that the rules are
8. Several comments addressed Other comments urged Federal
sufficiently clear on this point.
proposed section 8.3(b)(6), pertaining to certification to pre-empt State licensing,
3. Some State authorities suggested
the qualifications of accreditation body noting that ‘‘initial State approval will
revising proposed section 8.11(h),
personnel and proposed section 8.4(h) remain a de facto requirement.’’
which states that SAMHSA ‘‘may’’
on accreditation teams. One State The Secretary believes that the
authority objected that the requirement conditions for certification as set forth consult with State authorities prior to
that there be a licensed physician on the in the July 22, 1999, proposal, including granting exemptions from a requirement
accreditation body staff was an the provisions relating to State under sections 8.11 or 8.12.
unnecessary expense to accreditation licensure, are adequate and appropriate Section 8.11(h) permits OTPs to
bodies. Another comment to fulfill the objectives of this rule. The request exemptions from the
recommended that accreditation teams Secretary’s role in the oversight of requirements set forth under the
should include a physician certified for narcotic treatment is to set standards for regulation. This represents a
dispensing opioids. Some patients the appropriate use of narcotic drugs in continuation of a long-standing
advocated that the accreditation team the treatment of addiction, and then to provision from the previous regulation
should include a current patient. ensure compliance with those under 21 CFR 291.505. The Secretary
The Secretary believes the standards. The States, on the other anticipates that most exemption
requirements for accreditation hand, have a broader set of requests under the new rule will be to
personnel and accreditation teams as set responsibilities, including regional and permit variations from the treatment
forth in the July 22, 1999, proposal are local considerations such as the number standards, including program-wide
sufficient. It is not clear that every OTP and distribution of treatment facilities, exemptions for medical maintenance.
would benefit from having a physician the structural safety of each facility, and The Secretary agrees that it is
or opioid agonist patient on the issues relating to the types of treatment appropriate and necessary to consult
accreditation team. The Secretary has services that should be available. with State authorities on requests for
reviewed the results of accreditation Nothing in this part is intended to variations from existing standards.
surveys under the SAMHSA/CSAT restrict State governments from Accordingly, section 8.11(h) is revised
methadone accreditation project. Based regulating the use of opioid drugs in the to require consultation with the State
on these reviews, the requirements set treatment of opioid addiction. The authority prior to granting an
forth under section 8.4(h) are adequate Secretary notes that many States exemption.
to assure that accreditation bodies exercise this authority by choosing not 4. Several comments from patients
carefully consider the qualifications of to authorize methadone treatment at all. suggested that Federal regulations
accreditation surveyors and The Secretary does not believe that should prevent States from imposing
accreditation teams. OTPs will open and begin treating additional regulatory requirements
9. A considerable number of patients without State notification, beyond the Federal regulations. Many of
comments were submitted, mostly by review, and approval. The Secretary has these comments contend that State
State authorities, concerning the been careful to state throughout this rule regulations prevent treatment
absence of a definition for State that OTPs (including medication units) expansion, hinder accountability for
authority. These comments suggested must comply with all pertinent State quality treatment, limit patient access,
that adding a definition for state and local laws as a condition of Federal and lead to patient abuses.
authority could reduce confusion in certification. As such, OTPs will also be As noted above, the Secretary
States that serve as accreditation bodies. responsible for assuring that they have acknowledges the authority within State
In addition, these comments reflect a the necessary approvals and licensure at government to regulate the practice of
belief that this change would help the State. Moreover, OTPs must obtain medicine. This rule does not pre-empt
clarify the Federal-State consultation DEA registration prior to accepting States from enacting regulations
process set forth in the proposed rule. opioid addiction treatment drugs for the necessary to carry out these important
The Secretary agrees with these treatment of opiate addiction. DEA responsibilities.
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4082 Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations
Many State regulations closely issue. The Secretary concurs and the the previous regulations under 21 CFR
resemble the previous Federal section 8.11(i)(2) has been changed to 291.505. OTPs that do not substantially
regulations under 21 CFR 291.505. In reflect this change. conform with the Federal Opioid
addition, many States are currently Treatment standards set forth under
D. Subpart B—Treatment Standards
reevaluating their regulations to section 8.12 will risk losing SAMHSA
determine if modifications are necessary 1. A number of comments were certification.
to reflect the changes in Federal rules. submitted on proposed section 8.12 in 2. One comment recommended that
The Secretary encourages States to general. These comments stated that the proposed section 8.12(b) should be
consider the new information on Federal Opioid Treatment standards are modified to require a standard that
changes in the opioid addiction vague and lack specificity. As such, OTPs should have adequate facilities.
treatment field, including phases of these comments contend that the The comment stated that this provision
treatment, measuring accountability for standards are unenforceable as existed in the previous regulation. The
improving the quality of patient care, regulations. One comment suggested Secretary agrees and has added a
and modern medication dosing that the SAMHSA/CSAT Accreditation requirement that OTP’s must maintain
practices, as States proceed in revising Guidelines be incorporated as adequate facilities. The Secretary notes,
their regulations. regulations. however, that SAMHSA/CSAT
The Secretary also invites States to The Secretary believes that the accreditation guidelines and
continue to enhance their partnership Federal Opioid Treatment Standards are accreditation standards used in the
with Federal authorities in this area. As enforceable, and do not need to be SAMHSA accreditation impact study,
noted above, the final rule includes a modified to accomplish their purpose address the adequacy of the OTP’s
new feature—the opportunity for States under the new rules. The July 22, 1999, facility. These accreditation standards,
to serve as accreditation bodies. This proposal noted that in the past, HHS has in conjunction with treatment
new activity adds to existing attempted to write all facets of outcomes, will help determine whether
partnership opportunities, such as the treatment, including required services, facilities are adequate under the new
participation in the SAPT Block Grant into regulation. In addition, the rules.
program and its related technical proposal acknowledged that it is now 3. One comment addressed proposed
assistance program. The Secretary hopes accepted that (a) different patients, at section 8.12(b), stating that rules should
that these actions collectively will different times, may need vastly expressly require compliance with civil
continue the regulatory reform started different services, and (b) the state of the rights laws, not just ‘‘pertinent’’ Federal
with the July 22, 1999, proposal. clinical art has changed, to reflect laws. As such, the comment suggests
5. A few comments expressed concern scientific developments and clinical that the standards should require
about proposed section 8.11(e), which experience, and is likely to continue to detailed patient grievance procedures,
permits provisional certification for one change and evolve as our understanding including appeals to neutral parties. The
year, while a program obtains of more effective treatment methods Secretary believes that it is not
accreditation. These comments believe increases. Accordingly, the Secretary necessary to modify the rule to reflect
that one year was ‘‘too long for a proposed a more flexible approach with civil rights laws specifically. These laws
program to go without accreditation.’’ a greater emphasis on performance and are included under the requirement as
The Secretary believes that the outcome measurement. With guidance written. In addition, SAMHSA/CSAT
maximum 1-year term (not including from SAMHSA, the accreditation bodies Accreditation Guidelines, as well as the
the 90-day extension allowed under will develop the elements needed to accreditation standards developed from
section 8.11(e)(2)) for provisional determine whether a given OTP is them include provisions for accepting
certification is reasonable and meeting patient needs for required and acting upon patient grievances.
customary with accreditation in other services. SAMHSA will review these 4. A number of respondents
areas of healthcare. The purpose of this elements as part of the accreditation commented on proposed section 8.12(d)
provision is to permit new OTPs to body’s initial and renewal applications which addresses OTP staff credentials.
initiate operations and generate patient to ensure that accreditation bodies have Under the July 22, 1999, proposal, the
records to aid in the accreditation incorporated the Federal opioid Secretary proposed that each person
application, survey, and review process. treatment standards into their engaged in the treatment of opiate
It should be noted that OTPs will be accreditation elements. SAMHSA will addiction must have sufficient
subject to SAMHSA, DEA, and State also review accreditation body elements education, training, or experience or any
oversight during the tenure of to ensure that the elements do not combination thereof, to enable that
provisional accreditation. These OTPs exceed Federal expectations in terms of person to perform the assigned
must comply with Federal opioid opioid agonist treatment. Incorporating functions. Further, all licensed
treatment regulations and are subject to accreditation guidelines into regulations professional care providers must
compliance actions at any time. would subvert this approach. comply with the credentialing
6. Section 8.11(i)(2) proposed that As noted in the July 22, 1999, requirements of their professions. The
certification as an OTP would not be proposal, the Secretary believes that the proposal encouraged, but did not
required for the maintenance or standards are ‘‘enforceable regulatory require, that treatment programs retain
detoxification treatment of a patient requirements that treatment programs credentialed staff.
who is admitted to a hospital or long- must follow as a condition of Some comments requested that this
term care facility for the treatment of certification (64 FR 39810, July 22, standard be clarified to require
medical conditions other than 1999).’’ While the new regulations American Society of Addiction
addiction. One comment noted that, as increase the flexibility and clinical Medicine (ASAM)-certified medical
written, patients admitted to hospitals judgement in the way OTPs meet the professionals. Another comment
for cocaine or alcohol addiction would regulatory requirements, they are set questioned whether personnel had to be
not be eligible for treatment under this forth under section 8.12 as the services, licensed in the State where the
provision. The comment suggested that assessments, procedures, etc., that OTPs treatment program is located. Another
adding the word ‘‘opioid’’ before ‘‘must’’ and ‘‘shall’’ provide. As such, comment from a State Authority,
‘‘addiction’’ would help to clarify this the new standards are as enforceable as recommended that the regulations
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Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations 4083
specify the license, training, experience, the proposed definition and the detoxification treatment set forth under
as well as the number of licensed standards for short-and long-term section 8.12(e)(2) and (4) have been
counselors in a program, including a detoxification treatment. Most of these revised to state that patients with two or
minimum counselor-to-patient ratio. On comments suggested that the word more unsuccessful detoxification
the other hand, an OTP medical director ‘‘detoxification’’ is a pejorative non- episodes within a 12-month period must
commented that none of the cited medical term and does not constitute be assessed by the OTP physician for
credentials ‘‘conferred competence in treatment, because few, if any, patients other forms of treatment. This change is
dealing with opioid dependent patients, can be stabilized in such a short period consistent with SAMHSA/CSAT
per se.’’ According to this comment, of time. These comments suggested that accreditation guidelines which also
SAMHSA/CSAT should instead develop all references to detoxification should elaborate on unsuccessful detoxification
curricula for medical directors and other be deleted from the regulations, or at treatment attempts.
care givers. least renamed. 8. A considerable number of diverse
Except for the requirements of section These comments fail to recognize the comments addressed proposed section
8.12(h), which relate to the distinction between opiate dependence, 8.12(f) relating to required services. This
qualifications for practitioners who for which detoxification treatment is section of the July 22, 1999, proposal
administer or order medications, the appropriate, and opiate addiction, for requires that ‘‘adequate medical,
Secretary does not believe that it is which maintenance treatment is counseling, vocational, educational and
appropriate to further prescribe the appropriate. The Narcotic Addiction assessment services are fully and
qualifications for health professionals in Treatment Act of 1974 (NATA) and reasonably available to patients enrolled
this regulation. Under sections 8.12(b), regulations have long recognized these in an OTP.’’
(d), (e), (f) services must be provided by distinctions. While a majority of the Two comments strongly
professionals qualified by education and available treatment research, including recommended that the regulation
training. The Secretary does not believe recent studies, concludes that require integrated, simultaneous
that one credentialing organization maintenance treatment is much more treatment by specially cross-trained
should be specified as a requirement for effective than detoxification regimens, staff, for co-occurring opioid treatment
qualifications. Instead, the Secretary the Secretary believes that it is still and mental illness. These respondents
intends to rely on guidelines and necessary to retain distinct standards for believe that integrated services for
accreditation standards together with maintenance and detoxification persons with an addiction(s) and a
patient outcome assessments to treatment (Ref. 3). psychiatric disorder are crucial. These
determine the adequacy of training and 7. Several comments were submitted dually-diagnosed patients represent 50–
education level of professionals in in response to the Secretary’s specific 80 percent of substance dependent
OTPs. SAMHSA/CSAT is actively request for comments on proposed populations.
developing model training curricula in section 8.12(e)(4) which set forth The Secretary agrees with the
this area. minimum requirements for importance of providing adequate
5. A few comments suggested that the detoxification treatment. The July 22, integrated services for opiate-addicted
regulations specify the outcome 1999, proposal retained the requirement patients who also suffer from
measures for quality assessment plans from the existing regulation that ‘‘a psychiatric disorders. Indeed, the
under section 8.12(c)(1). Similarly, some patient is required to wait no less than SAMHSA/CSAT Accreditation
comments suggested that diversion 7 days between concluding one Guidelines, along with the accreditation
control plans, which OTPs are required detoxification episode before beginning standards developed by CARF and
to develop under section 8.12(c)(2), another.’’ Essentially, while sympathetic JCAHO all address the need to evaluate
should also be spelled out in to the need for limits on detoxification patients for co-occurring illnesses,
regulations. treatment, all the comments on this item including mental illness. CARF Opioid
The Secretary believes that the opposed continuing any waiting period Treatment Program Accreditation
regulation as proposed provides between detoxification episodes. These Standards state that services for co-
sufficient detail on outcome measures respondents believe that seven days is occurring illness should be provided on
and diversion control plans. In keeping ‘‘artificial* * * or more time than is site or by referral. However, the same
with the intent of the regulation reform, needed.’’ In addition, these comments standards note that ‘‘coexisting
these general requirements are indicate that OTPs often request and are conditions, especially in persons from
elaborated in best-practice guidelines granted exemptions from the waiting disenfranchised populations, are most
and in ‘‘state-of-the-art’’ accreditation period requirement under the existing effectively treated at a single site.’’ The
standards. Indeed, following a review of regulation, creating an unnecessary Secretary takes note that these
the accreditation standards that are paperwork burden for OTPs, as well as provisions for co-occurring disorders
based upon SAMHSA/CSAT’s opioid State and Federal regulators. Instead, under these new rules will be a vast
treatment accreditation guidelines, the the comments suggested a limit on the improvement over the previous
Secretary has determined that they are number of unsuccessful detoxification regulatory system, which did not
adequate to ensure that OTPs will be episodes in one year before the patient address co-occurring opiate addiction
able to develop meaningful outcome is assessed for opioid agonist and psychiatric disorders at all. As
assessment and diversion control plans. maintenance or other treatment. In such, under the new rules, patients’
In addition, these SAMHSA/CSAT addition, these comments recommended access to effective treatment for co-
accreditation guidelines and that an unsuccessful detoxification occurring disorders will be enhanced
accreditation standards reflect the latest attempt be defined to include any substantially. However, the Secretary
research findings in this area. Unlike the relapse to abuse. believes that it would be prohibitively
Federal regulations, these guidelines The Secretary agrees with the expensive to require every OTP to hire
and standards will be updated recommendations that the intent of the and retain specialists in the treatment of
periodically to reflect new research and restrictions on detoxification can be co-occurring disorders.
clinical experience. accomplished without a mandated time Other comments on this section stated
6. The Secretary received a interval between detoxification that the regulations should specify a
considerable number of comments on admissions. The standards for schedule for services. Some comments
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4084 Federal Register/Vol. 66, No. 11/Wednesday, January 17, 2001/Rules and Regulations
recommended that the regulations that regulations should specify the with OTPs concentrated within a
require OTPs to document that patients contents of the medical examination. community have established a patient
actually receive services when they are Instead, the Secretary believes that registry and require OTPs to report new
referred to off-site providers. Other accreditation guidelines should express patients and patients who have
comments suggested that accreditation the state-of-the-art content for a medical discontinued in treatment. In other
bodies should monitor the extent to exam appropriate for the treatment of jurisdictions, patient registries are
which services are provided as part of opiate addiction. developed and maintained voluntarily
their periodic onsite surveys. Still other 10. The July 22, 1999, notice proposed by OTPs. OTPs also often contact other
comments, mostly from patients, that OTPs conduct at least eight random OTPs in the vicinity to determine if the
suggested the requirement for services drug abuse tests per year for each patient is currently enrolled in an OTP,
be eliminated, maintaining that patient. Many comments suggested that or they ask the patient. If used, these
medication is all they needed. the Federal standards specify more mechanisms must be used in
The Secretary believes that the frequent drug abuse tests, including accordance with the provisions at 42
requirements for services as stated in weekly testing, to balance the more CFR 2.34, regarding disclosures to
the July 22, 1999, proposal, together flexible proposed take-home schedule. prevent multiple enrollments. The
with the accreditation process, provide Other comments suggested that Federal Secretary acknowledges that none of
adequate assurance that patients regulations should specify measures to these mechanisms can determine with
enrolled in OTPs receive the services prevent adulteration. On the other hand, complete certainty whether or not a
that they have been assessed to need. some comments suggested that quarterly patient is enrolled in more than one
The July 22, 1999, proposal emphasized drug abuse testing is appropriate. OTP. Accordingly, the Secretary expects
the need for these services as an Moreover, one comment recommended that OTPs will document in each
essential part of treatment. However, in substituting an ‘‘honor system’’ because patient’s record that the OTP made a
shifting to an accreditation approach patients can corrupt the testing process good faith effort to review whether or
with an emphasis on performance and falsify results. not the patient is enrolled in any other
outcomes, the Secretary was no longer After considering the comments on OTP. Section 8.12(g)(2) has been revised
attempting to ‘‘write all facets of these this issue, the Secretary is retaining the accordingly.
required services into regulation.’’ OTPs requirement for a minimum of eight 12. The Secretary received many
must initially and periodically assess random drug abuse tests per year for comments on proposed section 8.12(j),
each patient and ensure that adequate maintenance treatment. The Secretary relating to interim methadone
services are available to patients believes that this is an adequate and maintenance. Most of these comments
determined to need them. SAMHSA/ balanced standard for drug abuse were from patients who suggested
CSAT Accreditation Guidelines and testing. There is extensive discussion on interim maintenance as a model for long
accreditation standards will elaborate drug abuse testing issues in the standing patients who have been
on the standards for services. OTPs will SAMHSA/CSAT Treatment stabilized in treatment. As such, these
be accountable through the Improvement Protocols and the comments suggested that the term for
accreditation process to assure that SAMHSA/CSAT Accreditation interim methadone maintenance be
patients receive the appropriate services Guidelines. In addition, these guidelines extended beyond 120 days.
they need for successful treatment elaborate on measures to address the These comments reflect a
outcomes; for some patients, medication corruption and falsification of results. misunderstanding of interim methadone
services may be sufficient to produce Finally, as the Federal standard is a maintenance. Interim methadone
positive outcomes. minimum, OTPs can require more maintenance was mandated by the
9. A number of respondents submitted frequent tests if desired. ADAMHA Reorganization Act of 1992
comments on proposed section 11. The Secretary received many as a measure to address shortages in
8.12(f)(2), which requires a complete comments on proposed section treatment capacity and documented
medical examination within the first 30 8.12(g)(2) which requires OTPs to waiting lists (Pub. L. 102–321, See also
days following admission. Some of determine and document that patients 58 FR 495, January 5, 1993). The
these comments noted that this are not enrolled in other programs. Most legislation included several restrictions
provision, as proposed, permitted respondents question how such which were incorporated and retained
patients to enter treatment while tests, determinations could be made without into Federal regulations. Although very
some of which required several days, a patient registry. One comment stated few programs have applied for
are completed. Others commented that that multiple enrollments are authorization to provide interim
the 30 days was too long to wait for a attributable to inadequate medication methadone maintenance, the Secretary
medical exam to be completed, noting dosing practices. does not at this time believe it is
that information from the exam is The July 22, 1999, proposal retained necessary or appropriate to change the
crucial to the first few days of treatment. the provisions relating to multiple standards. Instead, as discussed
Finally, some comments suggested that enrollments from the previous elsewhere in this notice, the Secretary
regulations should specify the contents regulations under 21 CFR 291.505. In believes that medical maintenance
of the medical exam. proposing to retain the requirement, the provides a more reasonable approach for
The intent of proposing 30 days for Secretary noted that there have been expanding treatment capacity.
the completion of the physical exam cases of patients enrolling in more than 13. The Secretary received comments
was to allow patients into treatment one treatment program; however, the on proposed section 8.11(h), which
while OTPs wait for the results of extent of this practice is undetermined provides for exemptions from treatment
serology and other tests that require, in but not considered to be widespread. standards or certification requirements.
some cases, several days to complete. The intent of this provision is for OTPs One comment suggested that the
Section 8.12(f)(2) has been revised to to make a good faith effort, using examples in the previous regulation for
clarify the requirement for a physical available resources and mechanisms to exemptions, be retained in the final new
exam upon admission, with serology ascertain whether or not a prospective regulations. The comment suggests that
and other tests results completed w/in patient was currently enrolled in this would encourage individual
14 days. The Secretary does not agree another OTP. Some individual States physicians, pharmacists, or both to
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