Ohio Admin. Code 4731-33-03 - Office-based opioid treatment
(A)
A physician who provides office-based opioid treatment
("OBOT") shall comply with the following requirements:
(1)
Before initiating
OBOT, the physician shall comply with section
3719.064 of the Revised
Code;
(2)
Comply with all federal and state laws and regulations
governing the prescribing of the medication;
(3)
Complete at least
eight hours of "Category 1" continuing medical education relating to substance
use disorder and addiction every two years. Courses completed in compliance
with this requirement shall be accepted toward meeting the physician's
"Category 1" continuing medical education requirement for biennial renewal of
the physician's license;
(4)
The physician who provides OBOT shall perform an
assessment of the patient to gather sufficient information and data to justify
the use of this treatment intervention. The assessment shall include a thorough
medical history, examination and laboratory testing. If any part of the
assessment cannot be completed prior to the initiation of OBOT, the physician
shall complete as soon as possible following initiation of treatment;
and
(5)
The physician shall provide accurate, objective and
complete documentation of all patient encounters, including referrals, test
results, and significant changes to the treatment plan.
(B)
The
physician who provides OBOT shall establish a treatment plan that includes the
following:
(1)
The physician's rationale for selection of the specific drug
to be used in the treatment based upon discussion of all MOUDs and
non-medication options with the patient;
(2)
Patient
education;
(3)
Random urine-drug screens;
(4)
A signed
treatment agreement that outlines the responsibilities of the patient and the
physician, and documents the patient's consent for treatment;
(5)
Documentation
regarding psychosocial interventions, pursuant to paragraph (D) of this rule;
and
(6)
The treatment plan shall be revised if the patient does
not show improvement with the original plan.
(C)
The physician
shall provide OBOT in accordance with an acceptable treatment protocol for
assessment, induction, stabilization, maintenance, and tapering. Acceptable
protocols are any of the following:
(1)
TIP 63 "Medications for Opioid Use Disorder" (2021)
available from the
https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder-Full-Document/PEP21-02-01-002
.
(2)
"ASAM National Practice Guideline for the Treatment of
Opioid Use Disorder: 2020 Focused Update" available from the website of the
American society of addiction medicine at
https://www.asam.org/quality-care/clinical-guidelines/national-practice-guideline
.
(D)
The physician
shall do the following with respect to psychosocial treatment for patients
receiving OBOT:
(1)
Assess for psychosocial treatment needs in addition to
medication;
(2)
Offer psychosocial interventions or referrals for
psychosocial interventions to all patients, but OBOT should not be declined or
discontinued if the patient is unable or unwilling to engage in psychosocial
interventions;
(3)
Ensure that psychosocial interventions are
person-centered and tailored to the patient's insight, motivation, and stage of
recovery;
(4)
Focus the psychosocial interventions on retaining the
patient in treatment, stabilizing the patient and assisting with progress in
the patient's treatment and recovery;
(5)
If the
psychosocial interventions are not available or if the patient declines to
participate, the physician shall continue to treat the patient with OBOT
provided that the patient adheres to all other treatment
requirements;
(6)
Psychosocial treatment or intervention includes the
following:
(a)
Cognitive behavioral treatment;
(b)
Community
reinforcement approach;
(c)
Contingency management and motivational
incentives;
(d)
Motivational interviewing;
(e)
Behavioral
couples counseling;
(f)
Twelve-step facilitation; and
(g)
Other therapies
based on the patient's individual needs;
(7)
When necessary,
the physician may make referrals for psychosocial treatment to qualified
behavioral healthcare providers, community addiction services or community
mental health services providers as defined in rule
4731-33-01 of the Administrative
Code; and
(8)
The physician may also refer patients for treatment
with non-licensed paraprofessionals such as case managers and peer support
specialists if the physician determines such intervention would benefit the
patient.
(E)
The physician who provides OBOT shall offer the patient
a prescription for an overdose reversal drug, directly provide the patient with
the overdose reversal drug, or direct the patient to an easily accessible
source to obtain overdose reversal drugs, such as
http://www.naloxone.ohio.gov
, a local health department, or other agency or facility
that provides overdose reversal drugs.
(1)
The physician
shall ensure that the patient and, if possible, those residing with the
patient, receive instruction on the overdose reversal drug's use including, but
not limited to, recognizing the signs and symptoms of opioid overdose and
calling 911 in an overdose situation.
(2)
The physician
shall offer the patient a new prescription for an overdose reversal drug upon
expiration or use.
(3)
The physician shall be exempt from this requirement if
the patient refuses the prescription. If the patient refuses the prescription
the physician shall provide the patient with information on where to obtain
overdose reversal drugs without a prescription.
(F)
In addition to
paragraphs (A) to (E) of this rule, the physician who provides OBOT using
buprenorphine products shall comply with the following requirements:
(1)
Treatment with a
buprenorphine product must be in compliance with the United States food and
drug administration approved "Risk Evaluation and Mitigation Strategy" for
buprenorphine products, which can be found on the United States food and drug
administration website at the following address:
https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
. With the exception of those conditions listed in paragraph
(G)(2) of this rule, a physician who treats the opioid use disorder with a
buprenorphine product shall only prescribe buprenorphine/naloxone combination
products for use in OBOT.
(2)
The physician may prescribe buprenorphine without
naloxone (buprenorphine mono-product) only in the following situation:
(a)
When a patient is
pregnant or breast-feeding;
(b)
When converting a
patient from buprenorphine mono-product to buprenorphine/naloxone combination
product;
(c)
In formulations other than tablet or film form for
indications approved by the United States food and drug administration;
or
(d)
When the patient has a genuine allergy to or
intolerance of a buprenorphine/naloxone combination product.
(3)
Due to
a higher risk of fatal overdose when buprenorphine is prescribed with other
opioids, benzodiazepines, sedative hypnotics, carisoprodol, gabapentin, or
tramadol, the physician shall only co-prescribe these substances when it is
medically necessary.
(a)
The physician shall verify the diagnosis for which the
patient is receiving the other drug and coordinate care with the prescriber for
the other drug, including whether acceptable alternative treatments are
available and whether it is possible to lower the dose or discontinue the drug.
If the physician prescribing buprenorphine is the prescriber of the other drug,
the physician shall also consider these options and consider consultation with
another healthcare provider. The physician shall educate the patient about the
serious risks of the combined use.
(b)
The physician
shall document the rationale for discontinuing, lowering, or continuing the
medication given potential risks and benefits.
(4)
During the
induction phase the physician shall not prescribe a dosage that exceeds the
recommendation in the United States food and drug administration approved
labeling, except for medically indicated circumstances as documented in the
patient record. The physician shall see the patient at least once a week during
this phase.
(5)
During the maintenance phase, the physician shall
prescribe a dosage of buprenorphine that avoids intoxication or sedation,
prevents withdrawal, and suppresses significant drug craving. For the first
twelve months of treatment, the physician shall prescribe no more than a
one-month supply of the buprenorphine product unless utilizing a formulation
with duration of action exceeding one month, such as injections or
implants.
(6)
The physician shall reduce the risk of buprenorphine
diversion by using the lowest effective dose, and by using one or more of the
following: scheduling appropriate frequency of office visits, conducting random
pill counts, checking OARRS and utilizing drug testing, serum medication
levels, and oral fluid testing to assess for patient adherence to prescribed
buprenorphine treatment.
(7)
When using any sublingual formulation of buprenorphine,
the physician shall not prescribe a dosage exceeding twenty-four milligrams of
buprenorphine per day, unless the prescriber is an addiction specialist
physician, or a consultation has been obtained from such a specialist
recommending the higher dose. Dosage shall not exceed thirty-two milligrams of
buprenorphine per day.
(8)
The physician shall incorporate relapse prevention
strategies into counseling or assure that they are addressed by a qualified
behavioral healthcare provider, as defined in rule
4731-33-01 of the Administrative
Code, who has the education and experience to provide substance use disorder
counseling.
(9)
The physician may treat a patient using the
administration of an extended-release, injectable, or implanted buprenorphine
product.
(a)
The
physician shall strictly comply with any required risk evaluation and
mitigation strategy program for the drug.
(b)
The physician
shall prescribe an extended-release buprenorphine product strictly in
accordance with the United States food and drug administration's approved
labeling for the drug's use.
(c)
The physician
shall document in the patient record the rationale for the use of the
extended-release buprenorphine product.
(d)
The physician who
orders or prescribes an extended-release, injectable, or implanted
buprenorphine product shall require it to be administered by an Ohio licensed
health care professional acting in accordance within the scope of their
professional license.
Replaces: 4731-33-03
Notes
Promulgated Under: 119.03
Statutory Authority: 4731.05, 4731.056
Rule Amplifies: 4731.056, 4731.83
Prior Effective Dates: 01/31/2015, 04/30/2019
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.