Ohio Administrative Code
Title 4730 - Physician Assistants
Chapter 4730-4 - Opioid Addiction Treatment
Section 4730-4-03 - Office-based treatment for opioid addiction
Universal Citation: OH Admin Code 4730-4-03
Current through all regulations passed and filed through September 16, 2024
(A) A physician assistant who provides OBOT shall comply with the following requirements:
(1)
Before initiating
OBOT, the physician assistant 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
abuse and addiction every two years. Courses completed in compliance with this
requirement shall be accepted toward meeting the continuing medical education
requirement for biennial renewal of the physician assistant's license;
and
(4)
Only provide OBOT if the provision of OBOT is within
the supervising physician's normal course of practice and
expertise.
(B) The physician assistant who provides OBOT shall perform and document an assessment of the patient.
(1)
The assessment
shall include all of the following:
(a)
A comprenhensive medical and psychiatric
history;
(b)
A brief mental status exam;
(c)
Substance abuse
history;
(d)
Family history and psychosocial
supports;
(e)
Appropriate physical examination;
(f)
Urine drug screen
or oral fluid drug testing;
(g)
Pregnancy test
for women of childbearing age and ability;
(h) Review of the
patient's prescription information in OARRS;
(i)
Testing for human
immunodeficiency virus;
(j)
Testing for hepatitis B;
(k)Testing for
hepatitis C; and
(l)
Consideration of screening for tuberculosis and
sexually-transmitted diseases in patients with known risk
factors.
(2)
For other than the toxicology tests for drugs and
alcohol, appropriate history, substance abuse history, and the pregnancy test,
the physician assistant may satisfy the assessment requirements by reviewing
records from a physical examination and laboratory testing of the patient that
was conducted within a reasonable period of time prior to the
visit.
(3)
If any part of the assessment cannot be completed prior
to the initiation of OBOT, the physician assistant shall document the reasons
in the medical record.
(C) The physician assistant who provides OBOT shall establish and document a treatment plan that includes all of the following:
(1)
The physician assistant's rationale for selection of
the specific drug to be used in the medication-assisted
treatment;
(2)
Patient education;
(3)
The patient's
written, informed consent;
(4)
Random urine-drug
screens;
(5)
A signed treatment agreement that outlines the
responsibilities of the patient and the physician assistant;
and
(6)
A plan for psychosocial treatment, pursuant to
paragraph (E) of this rule.
(D) The physician assistant 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)
SAMHSA treatment
improvement protocol publications for medication assisted treatment available
from the SAMHSA website at: https://store.samhsa.gov/.
(2)
"National Practice Guideline for the Use of Medications
in the Treatment of Addiction Involving Opioid Use," approved by the American
society of addiction medicine in 2015, available from the website of the
American society of addiction medicine at: https://www.asam.org/.
(E) The physician assistant shall refer and work jointly with a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider, as those terms are defined in rule 4730-4-01 of the Administrative Code, to determine the optimal type and intensity of psychosocial treatment for the patient and document the treatment plan in the patient record.
(1)
The treatment shall, at a minimum, include a
psychosocial needs assessment, supportive counseling, links to existing family
supports, and referral to community services.
(2)
The treatment
shall include at least one of the following interventions, unless reasons for
exception are documented in the patient record:
(a)
Cognitive
behavioral treatment;
(b)
Community reinforcement approach;
(c)
Contingency
management/motivational incentives;
(d)
Motivational
interviewing; or
(e)
Behavioral couples counseling.
(3)
The
treatment plan shall include a structure for revision of the treatment plan if
the patient does not adhere to the original plan.
(4)
When clinically
appropriate or if the patient refuses treatment from a qualified behavioral
healthcare provider, community mental health services provider, or community
addiction services provider, as defined in rule
4730-4-01 of the
Administrative Code, the physician assistant shall ensure that the OBOT
treatment plan requires the patient to participate in a twelve step program. If
the patient is required to participate in a twelve step program, the physician
assistant shall require the patient to provide documentation of on-going
participation in the program.
(5)
If the physician
assistant refers the patient to a qualified behavioral healthcare provider,
community addiction services provider, or community mental health servics
provider, the physician assistant shall document the referral and the physician
assistant's maintenance of meaningful interactions with the provider in the
patient record.
(F) The physician assistant who provides OBOT shall offer the patient a prescription for a naloxone kit.
(1)
The physician assistant shall ensure that the patient
receives instruction on the kit's use including, but not limited to,
recognizing the signs and symptoms of overdose and calling 911 in an overdose
situation.
(2)
The physician assistant shall offer the patient a new
prescription for naloxone upon expiration or use of the old
kit.
(3)
The physician assistant shall be exempt from this
requirement if the patient refuses the prescription. If the patient refuses the
prescription the physician assistant shall provide the patient with information
on where to obtain a kit without a prescription.
(G) In addition to paragraphs (A) to (F) of this rule, the physician assistant who provides OBOT using buprenorphine products shall comply with all of the following requirements:
(1)
The provision shall 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: 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 assistant who treats opioid use disorder with
a buprenorphine product shall only prescribe buprenorphine/naloxone combination
products for use in OBOT.
(2)
The physician assistant shall prescribe buprenorphine
without naloxone (buprenorphine mono-product) only in the following situations,
and shall fully document the evidence for the decision to use buprenorphine
mono-product in the medical record:
(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;
(d)
For withdrawal
management when a buprenorphine/naloxone combination product is
contraindicated, with the contraindication included in the patient record;
or
(e)
When the patient has an allergy to or intolerance of a
buprenorphine/naloxone combination product, after explaining to the patient the
difference between an allergic reaction and symptoms of opioid withdrawal
precipitated by buprenorphine or naloxone, and with documentation included in
the patient record.
(3)
Due to a higher
risk of fatal overdose when buprenorphine is prescribed with other opioids,
benzodiazepines, sedative hypnotics, carisoprodol, or tramadol, the physician
assistant shall only co-prescribe these substances when it is medically
necessary.
(a)
The physician assistant 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 it is possible to taper the drug to
discontinuation. If the physician assistant prescribing buprenorphine is the
prescriber of the other drug, the physician assistant shall taper the other
drug to discontinuation, if it is safe to do so. The physician assistant shall
educate the patient about the serious risks of the combined
use.
(b)
The physician assistant shall document progress with
achieving the tapering plan.
(4)
During the
induction phase the physician assistant 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 medical record. The physician assistant shall see the patient at least
once a week during this phase.
(5)
During the
stabilization phase, when using any oral formulation of buprenorphine, the
physician assistant shall increase the daily dosage of buprenorphine in safe
and effective increments to achieve the lowest dose that avoids intoxication,
withdrawal, or significant drug craving.
(a)
During the first
ninety days of treatment, the physician assistant shall prescribe no more than
a two-week supply of buprenorphine product containing naloxone.
(b)
Starting with the
ninety-first day of treatment and until the completion of twelve months of
treatment, the physician assistant shall prescribe no more than a thirty-day
supply of the buprenorphine product containing naloxone.
(6)
The
physician assistant shall take steps to reduce the chances of buprenorphine
diversion by using the lowest effective dose, appropriate frequency of office
visits, pill counts, and checks of OARRS. The physician assistant shall also
require urine drug screens, serum medication levels, or oral fluid drug testing
at least twice per quarter for the first year of treatment and at least once
per quarter thereafter.
(7)
When using any oral formulation of buprenorphine, the
physician assistant shall document in the medical record the rationale for
prescribed doses exceeding sixteen milligrams of buprenorphine per day. The
physician assistant shall not prescribe a dosage exceeding twenty-four
milligrams of buprenorphine per day.
(8)
The physician
assistant shall incorporate relapse prevention strategies into the counseling
or assure that they are addressed by a qualified behavioral healthcare
provider, as defined in rule
4730-4-01 of the
Administrative Code, who has the education and experience to provide substance
abuse counseling.
(9)
The physician assistant may treat a patient using the
administration of an extended-release, injectable, or implanted buprenorphine
product.
(a)
The physician assistant shall strictly comply with any
required risk evaluation and mitigation strategy for the drug.
(b)
The physician
assistant 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
assistant shall document in the patient record the rationale for the use of the
extended-release buprenorphine product.
(d)
The physician
assistant who orders or prescribes an extended release, injectable, or
implanted buprenorphine product shall require it to be administered by an Ohio
licensed health care provider acting in accordance with the scope of their
professional license.
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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