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American Society of Addiction Medicine

Public Policy Statement on


Office-based Opioid Agonist Treatment (OBOT)
BACKGROUND
to prescription opioid analgesics are
Methadone maintenance treatment of
growing problems in the US, and the need
opioid addiction was developed in 1965 and
for increased availability of effective
implemented in the United States as a form
treatment is clear.
of opioid agonist treatment. In the 1970s, a
system of federal regulation was imposed in Methadone maintenance treatment has
response to reports of diversion of been a significantly underutilized treatment
methadone into illicit channels. In 1993, the modality in the US. Opioid agonist
US government gave approval to LAAM as treatment programs reach only about 1/4th
a second maintenance medication, and, in of the estimated 800,000 regular heroin
2002, buprenorphine, a partial agonist with users. In 2003, there were no Opioid
an improved safety profile, was approved Treatment Programs at all in five US states,
for limited office use by specially qualified and, in several other states, individual
physicians. [See ASAM Public Policy counties bar this treatment modality.
Statements: Methadone Treatment, rev.
1991, and Buprenorphine for Opiate
Dependence and Withdrawal, rev. 2002.] Treatment is underutilized at a time
when the need for it is increasing: there is
When methadone maintenance, an increased availability of unusually pure
administered in licensed and accredited and cheap heroin that can be profoundly
Opioid Treatment Programs (OTPs), is addicting in intranasal and smokeable
integrated with a comprehensive treatment forms; heroin use is growing particularly
service including individual and group rapidly among the young; and, there is a
psychotherapies and ancillary services rising incidence of addiction to prescription
such as occupational counseling, it has an opioid analgesics.
efficacy and safety profile that has been
solidly and repeatedly established in the DEFINITIONS:
clinical outcomes literature since 1965.
Several distinguished bodies and 1. Opioid Treatment Programs (OTPs):
consensus panels (e.g., NIH Consensus Licensed and accredited opioid agonist
Statement 1997) have summarized this treatment programs, often called
evidence and called for more access to this methadone maintenance treatment (MMT)
modality. Additionally, there is a growing programs, are currently authorized to
European and North American literature dispense methadone, LAAM, and
supporting the efficacy and safety of office- buprenorphine in highly structured protocols
based treatment with buprenorphine and defined by Federal and State law and
methadone. Heroin addiction and addiction
ASAM Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) 2

regulation.1 By regulation, patients must those medications have been approved for
earn take-home medication privileges by this indication and if the physician has “the
demonstrating, via urinalysis or other drug capacity to refer the patients for appropriate
testing, that they are free of illicit drugs, and counseling and other appropriate ancillary
by demonstrating cooperation with other services.”
treatment requirements. Research has Several different models of OBOT have
shown that the best outcomes are found been tested in the US and in other
when medication (methadone) is combined countries. In a US model of OBOT usually
with psychosocial treatments. Over time, called Medical Maintenance, there is a
many patients graduate to less structured close affiliation between the office practice
services, with medications dispensed in and the OTP that refers stable patients and
weekly to (at most) monthly take-home continues to offer ancillary psychosocial
quantities. The frequency and intensity of treatment services as needed. In this
psychosocial services should vary model, exemptions must be requested by
according the phase of care, determined by OTPs, and OBOT physicians must be
patient progress and needs. affiliated with a sponsoring OTP.
2. Office-Based Opioid Agonist Treatment European and Canadian models of
(OBOT): agonist care are significantly less restrictive
OBOT refers to models of opioid agonist because they are not OTP clinic-based.
treatment that seek to integrate the Patients may be admitted and entirely
treatment of opioid addiction into the managed in the physician’s office with
general medical and psychiatric care of the periodic visits, drug testing, and medication
patient. The foundation of OBOT is the management. In the Canadian model, for
conceptualization of opioid addiction as a example, agonist medications are
chronic medical condition with similarity to dispensed as frequently as daily from a
many other chronic conditions. An collaborating pharmacy, and, in addition to
important feature of OBOT is that it allows physician visits, patients participate in
primary care physicians to provide addiction community-based psychosocial care. In
treatment services in their usual clinical such models physicians work relatively
settings, thus expanding the availability of independently of OTPs.
care.
OBOT can refer to treatment with
3. Treatment Components, Structure
methadone (a Schedule II medication) or
and Intensity:
with buprenorphine (a Schedule III
medication). At present, only two Examples of treatment components
medications (both formulations of include counseling (individual and group),
sublingual buprenorphine) meet the general medical care, psychiatric services,
requirements of the authorizing law, the programs for family members,
Drug Abuse Treatment Act of 2000 (DATA educational/vocational counseling, financial
2000). DATA 2000 provides for a model of counseling, and legal services.
OBOT by authorizing Schedule III-V Treatment structure refers to elements
medications to be used by qualified such as the requirements a patient must
physicians in their offices for the treatment meet in order to continue in treatment.
of opioid dependence or opioid addiction if Examples of such requirements are
attendance compliance, no use of illicit
1
In 2003, the manufacturer of ORLAAM©, Roxane drugs, and participation in psychosocial
Pharmaceuticals, announced that it was ceasing production and
distribution of the product and expected supplies to be depleted
services.
by February 2004. The remainder of this Public Policy
Statement, therefore, refers only to methadone and
buprenorphine.
ASAM Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) 3

Treatment intensity refers to the number opioid agonist medication to be used. The
of treatment components the patient utilizes selection of an opioid agonist treatment
(each of which can range from less to more program, like the selection of any modality
rigorous) and the frequency with which the of treatment, should be based upon a
patient participates. For example, the multidimensional assessment of the
frequency of counseling sessions can vary patient’s severity of illness, matching
from one per day to one per month; the intensity and structure of treatment (level of
length of counseling session can range care), using objective criteria such as those
from ten minutes to one hour; the type of found in ASAM’s Patient Placement
counseling can range from classroom Criteria, Second Edition Revised (ASAM
sessions to those where the patient PPC-2R).
engages in an active role with the Some opioid-addicted patients can be
counselor. treated effectively with buprenorphine;
Current US models of opioid agonist others will require methadone. Some,
treatment rely on providing access to particularly those new to treatment, may
psychosocial services such as group require highly structured treatment
therapy, patient education classes, relapse programs involving on-site, observed
prevention services, mental health care, administration and dispensing of medication
access to medical diagnostics and care, such as is utilized in OTPs, combined with
and randomized urine drug testing. intensive psychosocial and adjunctive
Generally speaking, unstable patients in therapies. Other patients do well in less
early treatment require both more structured settings and with a lower level of
structured treatment and greater intensity of psychosocial services. The needs of
such services than patients who are stable patients change as their time in treatment
and have embraced a recovery-oriented lengthens and as they accomplish
lifestyle. treatment goals and life changes
associated with recovery. One size does
However, in areas where such services not fit all, and ASAM strongly supports the
are not available, such as areas where need for a full continuum of service, linked
there are no OTPs, pharmacological to psychosocial stability, results of urine
treatment alone with support of the treating drug tests, and other patient-progress
clinician may still represent an important criteria.
option for some patients.
ASAM believes that the level of
structure and intensity of services in
Rationale for Expansion of Office-Based treatment programs in which patient are
Opioid Treatment Programs: initiated on opioid agonist treatment with
Two formulations of buprenorphine are methadone should be higher than in
authorized by the Drug Abuse Treatment programs treating stable patients. ASAM
Act of 2000 (DATA 2000) for OBOT in the believes that appropriate levels of structure
US. Methadone is approved for OBOT in and intensity of services can be maintained
Canada and several European countries, by OBOT programs as well as by OTPs.
but not in the US. This situation means that For example, OBOT programs can have
whether a patient can be routinely treated in observed administration of medication, and
an office setting in the US is determined by psychosocial recovery resources, and
the Schedule of the medication to be used trained and qualified OBOT physicians,
and the approved indication, not by the knowledgeable about treating opioid
clinical circumstances of the patient. addiction.
The decision to provide OBOT should ASAM’s policy recommendations seek
not have to be made on the choice of the to simplify current procedures for providing
ASAM Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) 4

Medical Maintenance for stable patients, required to have completed a one-


encourage increased use of federal time training, over a 2-year period,
regulatory exemptions to test other consisting of 16 hours of accredited
innovative strategies for expanding access Category 1 continuing medical
to methadone, permit OBOT physicians to education (CME) specific to opioid
change from Schedule III opioid agonists to pharmacotherapy with methadone.
Schedule II opioid agonists when The content should be specified in
buprenorphine is not able to “hold” the practice guidelines developed
patient, and support public and private through collaboration among
insurance coverage for Office Based Opioid addiction medicine and addiction
Treatments. psychiatry organizations.

No part of this requirement would be


ASAM Policy Recommendations:
met by the training described in Drug
1. Clinical Guidelines: Abuse Treatment Act of 2000 to
Physicians who provide office-based qualify physicians to use the
opioid agonist treatment (OBOT) should Schedule III-V medications approved
take into consideration clinical guidelines for treatment of opioid dependence
related to that treatment. Such guidelines (sublingual buprenorphine).
should reflect research findings, best
practices, and the consensus of experts in 3. Continuum of Care:
the field of opioid addiction treatment.
ASAM recognizes the place that Opioid
Treatment Programs (OTPs) hold in the
ASAM recommends development of
continuum of care by providing highly
OBOT practice guidelines through
structured treatment environments. The
collaboration among addiction
clinical, social, and public health benefits of
medicine and addiction psychiatry
methadone maintenance administered in
organizations.
federally licensed and accredited Opioid
Treatment Programs have been repeatedly
2. Physician Training: demonstrated in clinical research studies
Specific training should be required for and are irrefutable. In addition, recent
physicians to qualify for approval to provide studies of Medical Maintenance support
office-based opioid treatment using opioid feasibility and efficacy of transferring stable
agonists. Clinical use of buprenorphine patients to office-based physician care.
requires certification in addiction medicine ASAM recognizes that “graduating”
or addiction psychiatry, or 8 hours of stable patients who wish to transfer from
specialized training, and receipt of a unique OTPs to office-based maintenance may
DEA number. The different safety profile of increase the severity and complexity of the
methadone compared with buprenorphine remaining patient mix within OTPs.
calls for additional specific training for Nonetheless, it is consistent with usual
physicians to be authorized to provide standards of medical practice to provide the
office-based opioid treatment with this least restrictive environment appropriate to
medication. the nature and stage of a patient’s illness.
ASAM recognizes that patients who
ASAM recommends that physicians
prove unstable in office settings will require
in office-based settings who treat
the level of structure and intensity of
patients for opioid dependence or
integrated services available in an OTP if a
opioid addiction using Schedule II
higher level of structure cannot be obtained
medication (methadone) should be
in the OBOT setting. It is essential that
ASAM Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) 5

referrals occur in both directions, i.e., that buprenorphine does represent an


patients have the capacity to be “stepped- expansion of treatment availability.
up into OTP” as well as “stepped-down to Not all patients who begin opioid
OBOT” based on clinical criteria. agonist treatment on buprenorphine in
ASAM recognizes that patients who an OBOT setting under DATA 2000
require a higher level of service intensity provisions can be satisfactorily
consume more resources and that higher managed on buprenorphine, and some
levels of funding are needed to support will require a transfer to methadone.
appropriate treatment for such complex ASAM supports allowing trained and
patients.. Without a proportional increase in qualified physicians to change the
funding to match the intensity of service, agonist medication from buprenorphine
there might be a de facto disincentive for to methadone when indicated.
OTPs to refer stable patients to the next
lower level in the continuum of care. ASAM recommends that, as a
further expansion of office-based
ASAM recommends:
agonist maintenance treatment,
(a) That all OTPs have the capacity to federal law and regulation be
“graduate” a patient to Medical revised to authorize use of
Maintenance when that level of Schedule II medication
care is indicated. (methadone) by appropriately
(b) That OBOT physicians, affiliated trained and qualified physicians
or independent, and OTPs for patients who were started on
establish a collaborative buprenorphine under DATA 2000
relationship that permits patients when a change in medication is
to be referred back and forth clinically indicated.
between programs, providing
differing models and intensities of (b) Medical Maintenance
treatment, according to clinical Simplification:
needs.
Current federal regulations provide
(c) That reimbursement levels be for exemptions for Medical Maintenance
more closely linked to the level of to be available only through OTPs.
care provided: more intensive, ASAM believes that knowledgeable and
more complex and time- trained physicians can provide Medical
consuming services should be Maintenance treatment without having a
reimbursed at higher rates. contractual or agent relationship with an
OTP.
4. Expansions of Office-Based Agonist ASAM recommends that federal
Treatment: law and regulations be revised to
(a) Medication Changes from (1) Endorse Medical Maintenance as
Schedule III to Schedule II: an advanced, but routine,
component of OTPs.
Currently, buprenorphine is the only
agent approved for prescription by (2) Eliminate the need for OTPs to
qualified physicians in office-based apply for a regulatory exemption
management of opioid dependence or for Medical Maintenance.
opioid addiction. Although each qualified (3) Make waivers available to
physician (or group practice) is currently qualified physicians to provide
limited to 30 patients, OBOT with Medical Maintenance Treatment
independent of an OTP.
ASAM Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) 6

these sites reported feasibility, reasonable


retention rates, comparable outcomes to
5. Insurance Coverage:
OTPs, and a high level of physician and
Opioid addiction and opioid dependence patient satisfaction. ASAM believes that
are medical illnesses defined in DSM-IV Medical Maintenance has been adequately
and ICD-10. High proportions of patients tested and should now be endorsed as a
with heroin addiction have co-occurring routine service component of OTP
disorders such as HIV, hepatitis B and C, programs (and no longer require application
soft tissue infections, and psychiatric for exemption).
disorders. Early and combined treatments
It is also important to evaluate the
will provide cost offsets against later, more
feasibility and efficacy of direct admissions
expensive, medical services.
to OBOT methadone maintenance
programs as is done in France and
ASAM recommends public and Canada. There are data from such studies
private medical insurance coverage conducted in other countries; studies
for treatment of opioid addiction or should evaluate analogous treatment
opioid dependence in both office- models under conditions in the US.
based settings and in Opioid ASAM recommends that federal
Treatment Programs. regulations provide for exemptions to study
ASAM recommends that public and models other than Medical Maintenance,
private insurers provide adequate especially models that incorporate elements
reimbursement for both the of structure appropriate to support patients
pharmacotherapeutic and new to treatment. Future regulatory
psychosocial components of exemptions should focus on other methods
addiction treatment because each is of expanding access to methadone. There
an essential element in recovery that is a great need to test European and other
reduces long-term medical costs. models that expand access to opioid
agonist medications. For example, rural and
underserved areas may not have OTPs
6. Demonstration Projects & Regulatory within reasonable driving distances, and
Exemptions: models of OBOT opioid agonist treatment
need to be tested in such locales.
Innovative projects evaluating a variety
of treatment delivery strategies are needed ASAM recommends that
in order to allow meaningful and measured SAMHSA/CSAT develop rules and
expansions of access to treatment. Such procedures for granting regulatory
projects can be especially important in exemptions for demonstration
medically underserved areas, in rural areas projects designed to evaluate the
and other parts of the country that currently safety and efficacy of direct
do not have access to OTPs. admissions to OBOT using
methadone and innovative models of
Transfer of stabilized OTP patients to treatment delivery, especially in
Medical Maintenance in office-based currently underserved areas.
settings was initially available to physicians
via an Investigational New Drug (IND) ASAM recommends additional
application only. In 2000, this was made federal funding and technical support
available, via application to CSAT, through for demonstration projects in
the OTP program-wide exemption community settings.
provisions of 21 CFR §291.505(d)(11). As
of December 2002, five exemptions had
been authorized; three publications from
ASAM Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) 7

ASAM recommends federal funding


to implement and evaluate these
models.

Approved by the ASAM Board of


Directors July 2004

© Copyright 2010. American Society


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Statements normally may be
referenced in their entirety only,
without editing or paraphrasing, and
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Excerpting any statement for any
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_____________________________________________

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Addiction Medicine
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