Ohio Administrative Code
Title 4731 - State Medical Board
Chapter 4731-11 - Controlled Substances
Section 4731-11-12 - Office based opioid treatment
Universal Citation: OH Admin Code 4731-11-12
Current through all regulations passed and filed through September 16, 2024
(A) For the purposes of this rule:
(1)
"Office Based Opioid Treatment," or "OBOT," means
treatment of opioid addiction utilizing a "Schedule III, IV, or V" controlled
substance narcotic.
(2)
"Board certified addictionologist or addiction
psychiatrist" means a medical doctor or doctor of osteopathic medicine and
surgery who holds one of the following certifications:
(a)
Subspecialty
board certification in addiction psychiatry from the American board of
psychiatry and neurology;
(b)
Board certification in addiction medicine from the
American board of addiction medicine;
(c)
Certification
from the American society of addiction medicine; or
(d)
Board
certification with additional qualification in addiction medicine from the
American osteopathic association.
(B) A physician shall provide OBOT in compliance with all of the provisions of this rule.
(1)
The physician
shall comply with all federal and state laws applicable to
OBOT;
(2)
Prior to providing OBOT, the physician shall conduct
an assessment meeting the following requirements:
(a)
The assessment
shall include, at a minimum, an appropriate history and physical, mental status
exam, substance use history, appropriate lab tests, pregnancy test for women of
childbearing years, toxicology tests for drugs and alcohol, and "hepatitis B"
and "hepatitis C" screens.
(b)
For other than
the toxicology tests for drugs and alcohol, appropriate history, substance
abuse history, hepatitis "B" and "C" screens and the pregnancy test, the
physician may satisfy the assessment requirements by reviewing records from a
physical examination of the patient that was conducted by a physician within a
reasonable period of time prior to the visit. For purposes of this paragraph,
"physician" means an individual holding a certificate under Chapter 4731. of
the Revised Code to practice medicine and surgery, osteopathic medicine and
surgery, or podiatric medicine and surgery and practicing within his or her
scope of practice as defined by section
4731.51 of the Revised Code, or
an individual practicing in another state where the individual holds an active
and unrestricted license to practice medicine and surgery, osteopathic medicine
and surgery, or podiatric medicine and surgery and practicing within his or her
scope of practice.
(3)
The physician
shall practice in accordance with an acceptable treatment protocol for
assessment, induction, stabilization, maintenance and tapering. Acceptable
protocols are any of the following:
(a)
"Clinical Guidelines For the Use of Buprenorphine in
the Treatment of Opioid Addiction" protocol approved by the substance abuse and
mental health services administration in 2004, (available from the substance
abuse and mental health services administration website at http://samhsa.gov/ );
(b)
The low dose protocol approved by the Ohio department
of alcohol and drug addiction services in or about 2011 (available from the
Ohio department of mental health and addiction services website at http://mha.ohio.gov/
); or
(c)
Any protocol for OBOT approved by the Ohio department
of mental health and addiction services and available from the Ohio department
of mental health and addiction services website at http://mha.ohio.gov.
(4)
The physician
shall diagnose an opioid disorder utilizing the criteria contained in the
diagnostic and statistical manual of mental disorders, 4th or 5th
edition.
(5)
The physician shall develop an individualized
treatment plan for each patient
(6)
The physician
shall require each patient to actively participate in appropriate behavioral
counseling or treatment for their addiction and shall document at each visit
that the patient is attending sufficient behavioral health treatment.
(a)
The physician
shall maintain meaningful interactions with the qualified chemical dependency
professional, addiction treatment provider, or other behavioral health
professional who is treating the patient.
(b)
If the physician
is a psychiatrist, board certified addictionologist, or board certified
addiction psychiatrist, the physician may personally provide behavioral health
treatment for the addiction.
(c)
If the physician
determines that the patient cannot reasonably be required to obtain
professional treatment or if the patient has successfully completed
professional treatment, the physician shall require the patient to actively
participate in a recovery care program such as alcoholics anonymous, narcotics
anonymous, or other appropriate twelve step program, and to document attendance
at program meetings.
(i)
For at least the first year the physician shall
require the patient to attend the meetings at least three times
weekly.
(ii)
Following the first year, the physician shall
determine the frequency with which the patient shall be required to attend the
meetings.
(iii)
The physician shall document in the patient record the
reasons that the patient cannot reasonably be required to obtain professional
treatment.
(7)
The physician
shall provide OBOT utilizing a drug product that has been specifically approved
by the United States food and drug administration for use in maintenance and
detoxification treatment. A physician shall not provide OBOT utilizing a drug
product that has not been specifically approved by the United States food and
drug administration for use in maintenance and detoxification
treatment.
(8)
The physician shall comply with all of the
following:
(a)
During the first twelve months of treatment, the physician shall not prescribe,
personally furnish, or administer more than a thirty day supply of OBOT
medications at one time.
(b)
The physician shall personally meet with and evaluate
the patient at each visit during the first twelve months of OBOT, and shall
document an assessment and plan for continuing treatment.
(c)
After twelve
months of OBOT, the physician shall personally meet with and evaluate the
patient at least every three months, unless more frequent meetings are
indicated.
(9)
The physician shall not provide OBOT to a patient whom
the physician knows or should know is receiving other controlled substances for
more than twelve consecutive weeks on an outpatient basis from any provider,
without having consulted with a board certified addictionologist or addiction
psychiatrist, who has recommended the patient receive OBOT. If the physician is
a board certified addictionologist or addiction psychiatrist, the consultation
is not required.
(10)
The physician shall not prescribe, personally furnish,
or administer greater than 16 milligrams of buprenorphine per day to a patient,
except in one of the following situations:
(a)
The dosage
greater than 16 milligrams was established before the effective date of this
rule;
(b)
The physician is a board certified addictionologist or
addiction psychiatrist and has determined that a dosage greater than 16
milligrams is required for the patient, and has documented patientspecific
reasons for the need for a dosage greater than 16 milligrams in the patient's
record; or
(c)
The physician has consulted with a board certified
addictionologist or addiction psychiatrist who has recommended a dosage greater
than 16 milligrams and that fact is documented in the patient's medical
record.
(11)
The physician shall access OARRS for each patient no
less frequently than every ninety days, and shall document receipt and
assessment of the information received.
(12)
) The physician
shall provide ongoing toxicological testing in compliance with all of the
following:
(a)
The physician shall assure that any inoffice kit used is "Clinical Laboratory
Improvement Amendments" waived.
(b)
The physician
shall require toxicological testing be performed at least monthly for the first
six months, then randomly at least once every three months
thereafter.
(c)
The physician may accept the results of toxicological
testing performed by a treatment program or pursuant to a court order to
satisfy the requirements of paragraph (B)(12)(b) of this rule.
(d)
A screen is
failed if the result is inconsistent with the treatment plan. A physician shall
address failed screens in a clinically appropriate manner.
(13)
Each
physician who provides OBOT shall complete at least eight hours of "Category I"
continuing medical education relating to substance abuse and addiction every
two years. Courses completed in compliance with this rule shall be accepted
toward meeting the physician's "Category I" continuing medical education
requirement for biennial renewal of the physician's
certificate.
(C) Notwithstanding the provisions of this rule, a physician may provide OBOT to a pregnant patient during the term of her pregnancy and for two months thereafter, in compliance with the minimal standards of care.
(D) A violation of any provision of this rule, as determined by the board, shall constitute any or all of the following violations:
(1)
"Failure to maintain minimal standards applicable to the selection or
administration of drugs," and "failure to employ acceptable scientific methods
in the selection of drugs or other modalities for treatment of disease," as
those clauses are used in division (B)(2) of section
4731.22 of the Revised Code, and
" a departure from, or the failure to conform to, minimal standards of care of
similar physicians under the same or similar circumstances, whether or not
actual injury to a patient is established," as that clause is used in division
(B)(6) of section 4731.22 of the Revised
Code.
(2)
A violation of paragraph (B)(7) of this rule shall
further constitute "selling, prescribing, giving away, or administering drugs
for other than legal and legitimate therapeutic purposes," as that clause is
used in division (B)(3) of section
4731.22 of the Revised
Code.
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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