Current through 2024-38, September 18, 2024
1.
Develop and
Maintain Competency
A. The diagnosis
and medical management of OUD should be based on current knowledge and
research, and should encompass the use of both pharmacologic and
nonpharmacologic treatment modalities. Thus, before beginning to treat patients
for opioid addiction, clinicians must be knowledgeable about OUD and its
treatment, including the use of approved pharmacologic therapies and
evidence-based nonpharmacologic therapies. Clinicians should consult the DEA
regulations and the resources available on the DEA's website. Clinicians are
encouraged to complete continuing education in OBOT and to access the following
published guidelines on the use of medications for OUD:
1. SAMHSA - TIP 63 - Medication for Opioid
Use Disorder; and
2. ASAM National
Practice Guidelines For the Use of Medications in the Treatment of Addiction
Involving Opioid Use.
2.
OBOT Administration and Operations
Requirements
OBOT clinicians shall ensure that all OBOT medical settings
have and maintain all of the following in order to initiate and continue
prescribing Approved Medications:
A.
Sufficient space and adequate equipment to provide appropriate patient care and
monitoring, including but not limited to ensuring:
1. Security and privacy for the collection of
toxicology samples if samples are to be collected on site;
2. Clean and well maintained
environment;
3. Areas where privacy
and confidentiality can be maintained; and
4. Protection of all confidential medical
information and records in hard copy or electronic formats.
B. Referral arrangements with
other clinicians and practitioners to evaluate and treat medical comorbidities
and co-occurring disorders to ensure that OBOT is provided in the context of
other health issues the patient may have.
3.
Clinician Absence and Closure
Preparedness
A.
Continuity of
OBOT Services for Clinician Absence
Each OBOT clinician shall develop and maintain a written plan
for the administration of Approved Medications to treat established OUD
patients in the event of an absence. The plan should include:
1. Informing patients of alternate care; and
2. Emergency procedures for
obtaining prescriptions/access to medications in case of temporary
program/office closure. This should include an agreement with another clinician
authorized to prescribe Approved Medications or with an OTP. It should also
include the ability to transfer or provide access to patient
records.
B.
Permanent OBOT Program Closure
Each OBOT clinician shall have a written plan for ensuring
continuity of care in the event that a future voluntary or involuntary program
closure occurs. Clinicians shall have an operational plan for managing a
program closure. The plan shall include:
1. Orderly and timely transfer of patients
and records to another OBOT clinician; and
2. Notifying patients of transition
plans.
4.
Clinical Care and Management Requirements
A.
Diagnosis of OUD and Acceptance for
OBOT
When commencing OBOT, and in addition to ensuring that any
patient has an appropriate medical evaluation as described below in this rule,
the OBOT clinician shall assess the patient and diagnose and document an OUD as
defined by the current edition of the Diagnostic and Statistical Manual of
Mental Disorders.
B.
Evaluation of the Patient's Health Status
1. Medical Evaluation
When commencing OBOT, the OBOT clinician shall conduct an
appropriate medical, social, and family history, physical examination and
necessary laboratory tests (including pregnancy testing when appropriate), or
refer the patient to a medical professional who can perform such an evaluation.
Identification of signs and symptoms of opioid use and/or withdrawal, comorbid
medical and co-occurring psychologic conditions, and how they will be
addressed, should be a goal of the medical evaluation. Long-term management is
effective for many chronic diseases, including OUD.
2.
Psychosocial Assessment and Referral
to Servicesa. OBOT clinicians shall
conduct a psychosocial assessment, or shall refer the patient for such an
assessment to another clinician qualified by education, training or experience,
or to a licensed mental health provider, before or as soon as possible after
the initiation of the OBOT.
b.
Based on the outcomes of the psychosocial assessment, the OBOT clinician may
recommend to the patient that the patient should participate in ongoing
counseling or other behavioral interventions such as recovery programs.
Patients should be advised to receive counseling from OBOT clinicians or other
qualified licensed providers.
c. An
OBOT clinician should employ appropriate clinical judgment in deciding whether
to deny or discontinue OBOT based solely on a patient's decision not to follow
a recommendation to seek counseling or other behavioral interventions.
C.
Developing an OBOT Plan
1.
Individuals who are identified by OBOT clinicians as having higher needs for
care (e.g. ASAM level 2 or higher), or needing more clinical oversight or
structure than available through an OBOT, shall be referred to an appropriate
OTP or other more intensive level of care (e.g. inpatient).
2. OBOT clinicians shall register with the
Maine Prescription Monitoring Program (MPMP) and comply with Maine's laws and
rules regarding reporting on dispensed controlled substances. OBOT clinicians
shall check the MPMP prior to initiating OBOT and at least every ninety days
thereafter or more frequently when clinically indicated.
3. OBOT clinicians shall adhere to all
applicable standards of medical practice for providing treatment.
D.
Informed
Consent, Patient Treatment Agreement, Releases
Unless unable to do so as a result of a genuine "medical
emergency" as defined in Section
1 of this rule, prior to providing
OBOT, an OBOT clinician shall:
1.
Obtain and document voluntary Informed Consent to treatment from each patient,
which shall include the known risks and benefits of the medication being
prescribed.
2. Establish a written
treatment agreement outlining the responsibilities and expectations of the OBOT
clinician and the patient, which shall include possible reasons for discharge
from the practice.
3. Provide OUD
patients with education regarding the prevention of opioid overdose. In
addition, OBOT clinicians should consider prescribing overdose rescue
medications (e.g. naloxone) for all OUD patients.
4. Make reasonable efforts to obtain releases
of information for any health care providers or others important for the
coordination of care to the extent allowed by Health Insurance Portability and
Accountability Act (HIPAA) and 42 CFR, Part 2.
E.
Ongoing Patient Treatment and
Monitoring
In addition to following standard clinical practices, OBOT
clinicians must adhere to the following provisions:
1.
Monitoring for Diversion
To ensure patient and public safety, each OBOT clinician
shall develop a written policy outlining their clinical practices to minimize
risk of diversion of medications to treat OUD. The frequency of monitoring
procedures is based on the unique clinical treatment plan for each patient and
the patient's level of stability. At a minimum, this plan shall include the
following practices:
a. Querying the
MPMP;
b. Informing OBOT patients
that diversion is a criminal offense;
c. Conducting toxicological tests;
d. Conducting medication counts;
e. For patients receiving services from
multiple providers, the coordination of care and sharing of toxicology test
results is encouraged;
f.
Collecting all toxicological specimens with a standardized protocol and in a
therapeutic context; and
g.
Addressing and documenting the unexpected results of toxicological tests
promptly with patients.
2.
Education and Rescue
Medications
OBOT clinicians shall provide OUD patients with education
regarding the prevention of opioid overdose. In addition, OBOT clinicians
should consider prescribing overdose rescue medications (e.g. naloxone) for all
OUD patients.
5.
Administrative Discharge from
OBOT
A. Appropriate administrative
discharge from OBOT does not constitute patient abandonment. OBOT clinicians
may opt to discontinue prescribing medications for OUD and involuntarily
discharge patients from their OBOT in the following situations:
1. Disruptive behavior that has an adverse
effect on the OBOT practice, staff or other patients. This includes, but is not
limited to:
a. Violence;
b. Aggression;
c. Threats of violence;
d. Drug diversion;
e. Trafficking of illicit or prescription
drugs;
f. Repeated loitering in or
near the OBOT facility; and
g.
Conduct resulting in an observable, negative impact on the patient, and/or
staff and/or other patients.
2. Incarceration or other relevant change of
circumstance. However, if the incarceration follows criminal conduct that
occurred prior to OBOT, then resumption of OBOT following incarceration is
encouraged if clinically indicated.
3. Violation of or noncompliance with the
treatment agreement.
4. Nonpayment
of fees.
B. When an OBOT
clinician or practice decides to administratively discharge an OBOT patient,
the clinician must manage the appropriate tapering of buprenorphine or other
medication, when it is clinically appropriate, and as long as it does not
compromise the safety of patients, clinicians or program staff.
C. A patient who is involuntarily discharged
from OBOT should be provided referral information for other OBOT clinicians,
OTPs, or other OUD treatment programs. OBOT clinicians shall document referral
efforts in the patient's medical record.
D. Factors contributing to the involuntary
discharge from the program shall be documented in the patient's medical record
6.Patient
Records
OBOT clinicians shall keep accurate and complete patient
records, with emphasis on documentation of and the patient's response to
treatment. Information that shall be maintained in the patient record
includes:
A. Copies of signed informed
consent and treatment agreement;
B.
The patient's medical history and any records from prior providers;
C. Documentation of MPMP queries and their
effect on treatment;
D. Results of
the physical examination, laboratory tests, and toxicological tests;
E. Treatment plan;
F. A description of the treatments provided,
including all medications prescribed or administered (including the date, type,
dose, frequency and quantity);
G.
Results of ongoing monitoring of patient progress (or lack of
progress);
H. Notes on evaluations
by and consultations with specialists; and
I. Other medical decision making to support
the initiation, continuation, revision, or termination of treatment, and the
steps taken in response to any abnormal toxicological test results or aberrant
medication use behaviors.
7.
Reportable Acts
Generally, information gained as part of the
clinician/patient relationship remains confidential. However, the clinician has
an obligation to deal with persons who use the clinician to perpetrate illegal
acts, such as illegal acquisition or selling of drugs; this may include
reporting to law enforcement. Information suggesting inappropriate or
drug-seeking behavior should be addressed appropriately and documented. Use of
the MPMP is mandatory in this situation.
8.
Additional Requirements for Special
Populations
A. Pregnant Patients:
The decision to treat a pregnant patient with buprenorphine
or to refer her to an OTP for methadone is one that should be made in
conjunction with the patient. Due to the risks of opioid addiction to pregnant
women and their fetuses, a pregnant woman seeking OBOT should be given priority
for treatment, and every effort should be made for evaluation and treatment as
soon as possible. Because of the high risk to the fetus, every effort should be
made to maintain pregnant women on medications for OUD during pregnancy. If
there is a compelling reason for involuntarily withdrawing a pregnant woman
from OUD medications for reasons specified in this rule, the clinician shall
refer the woman to the most appropriate obstetric care available and an
alternative provider for OUD treatment as soon as possible.
B. Adolescent Patients:
OBOT clinicians who do not specialize in the treatment of
adolescent OUD should strongly consider consulting with or referring adolescent
patients to a more qualified clinician, if available.
C. Patients with Co-occurring Disorders:
OBOT clinicians should be aware of potential interactions
between medications used to treat co-occurring psychiatric conditions and
OUD.
All patients with psychiatric disorders should be asked about
suicidal ideation and/or attempts behavior. Patients with a history of suicidal
ideation or attempts should have OUD and psychiatric medication use closely
monitored. OBOT clinicians should consider referral to a mental health
clinician, if available.
