Ohio Admin. Code 5122-40-05 - Personnel
(A) Each licensed
opioid treatment program shall
will have a program sponsor, who is the person
that assumes responsibility for the operation of and the employees of the
opioid treatment component of a community addiction services provider. The
program sponsor shall
will agree on behalf of the opioid treatment
program to adhere to all requirements set forth in federal or state laws,
rules, or regulations regarding the use of medications in the treatment of
opioid use disorder.
(1) The program sponsor
is responsible for the general establishment, certification, licensure, and
operation of the opioid treatment program.
(2) The program sponsor need not be a
licensed physician. If the program sponsor is not a licensed physician, the
opioid treatment program shall
will employ a licensed physician for the position
of medical director.
(B)
Each opioid treatment program shall have a designated medical director.
(1) The medical director
shall
will be
a physician licensed to practice medicine or osteopathy in the state of Ohio
and shall
will have either:
(a)
Certification from the American board of addiction medicine;
(b) Certification from a member board of
medical subspecialties with an addiction subspecialty;
(c) Certification from the American academy
of health care providers in the addictive disorders as a certified addiction
specialist;
(d) Certification from
the American osteopathic academy with an addiction medicine subspecialty;
or,
(e) A written plan to attain
competence in opioid treatment resulting in one of the designated
certifications within a probationary time period.
(i) The medical director may submit a written
plan to attain competence in opioid treatment to the department for approval at
least two weeks prior to employment at an opioid treatment program.
(ii) The time for completion of the plan
may not
will
not exceed twenty-four months from the date of the appointment as medical
director. The physician may work as a medical director during this probationary
time period, subject to the supervision and reporting requirements of this
rule. Waivers may be granted by the department if there are problems scheduling
certification examinations.
(iii)
During the probationary time period, the medical director
shall
will be
directly supervised at least once a week by a physician who holds an
appropriate medical certification in the field of opioid treatment pursuant to
paragraph (B)(1) of this rule.
(iv)
Consultation with and supervision of a medical director during the probationary
time period may be provided by telephone or video conferencing and
shall
will be
documented, signed, and dated by both the supervising physician and the
supervised physician.
(v) The
department may request periodic documentation of progress towards completion of
the training plan.
(vi) The program
administrator of the opioid treatment program is responsible for maintaining
documentation regarding the medical director's training and experience in a
file which is current and readily available at all times. The program
administrator is also responsible for ensuring that the plan of development is
completed within the approved time lines.
(2) The medical director
shall
will
maintain authority over the medical aspects of treatment offered by the opioid
treatment program. The medical director is responsible for:
(a) All medication treatment
decisions;
(b) Operation of all
medical aspects of the treatment program;
(c) Administration and supervision of all
medical services;
(d) Medication
storage and review of safe handling of medications;
(e) Ensuring that the opioid treatment
program is in compliance with all applicable federal, state and local laws,
rules and regulations;
(f) Ensuring
that evidence of current physiologic dependence on an opioid, length of opioid
dependence, and exceptions to admission criteria are documented in the
patient's clinical record before the patient receives the initial dose of
medication used in medication assisted treatment;
(g) Ensuring that a medical history and a
physical examination have been done before a patient receives the initial dose
of medication used in medication assisted treatment;
(h) Ensuring that appropriate laboratory
studies have been performed and reviewed. The initial dose of medication may be
administered before the results of the laboratory tests are reviewed;
(i) Ensuring all medical orders are signed as
required by federal, state, or local laws and regulations;
(j) Developing or approving policy and
procedures for take-home doses of medication used for medication assisted
treatment;
(k) Ensuring that
justification for take-home doses is recorded in the patient's clinical
record;
(l) Ensuring individuals
are appropriately admitted to the opioid treatment program;
(m) Ensuring all medical services are
appropriately performed by the opioid treatment program;
(n) Obtaining and maintaining their own
continuing medical education in the field of addiction on a documented and
ongoing basis;
(o) Determining the
ability of the program physicians or physician extenders to work independently
within the applicable scope of practice; and,
(3) Each opioid treatment program
shall
will
have at least one medical director per program location. Medical directors will
provide one hour of onsite service per week for every forty patients, with a
minimum of six hours of service per week. If the onsite time is greater than
twenty-four hours, then other program physicians or certified nurse
practitioners with a SAMHSA exemption may contribute to the patient to medical
director ratio to fulfill the standard.
(a)
Opioid treatment programs may appoint one additional person who meets the
qualifications in paragraph (B)(1) of this rule to be a co-medical director.
The co-medical director may contribute to the patient to medical director ratio
in paragraph (B)(3) of this rule.
(b) Opioid treatment programs that employ
co-medical directors shall
will inform the department of such an arrangement
in writing.
(4) The
medical director must
will have a current U.S. drug enforcement
administration (DEA) registration for prescribing, administering, or dispensing
controlled substances, and the medical director must
will have a DEA
waiver if they or any other healthcare professional they supervise prescribes,
administers, or dispenses partial opioid agonists.
(5) If a program utilizes regional medical
directors, they are expected to supervise site-level medical directors. The
regional medical director may contribute to the patient to medical director
ratio in paragraph (B)(3) of this rule. The regional medical director
must
will
meet the requirements in paragraph (B)(1)(a) or (B)(1)(b) of this rule. A
regional medical director may take on some of the roles of the site level
medical director if an organization has multiple programs in different
locations. The program must
will inform the department of such an arrangement
in writing, including:
(a) The schedule,
including total hours per week the regional medical director will spend at each
methadone program location.
(b) The
division of responsibilities between the regional and site-level medical
director.
(c) If the regional
medical director serves in this or a similar capacity for any opioid treatment
programs located outside the state of Ohio
(C) Each licensed opioid treatment program
shall
will
have a program administrator, who shall
will have at minimum either a master's degree in
any field or a bachelor's degree and two years work experience in a related
healthcare field.
(1) The program
administrator is responsible for the day-to-day operation of the opioid
treatment program in a manner consistent with the laws and regulations of the
United States department of health and human services, United States drug
enforcement administration, and the laws and rules of the state of Ohio,
including, but not limited to assuring:
(a)
Development and enforcement of policies and procedures for operation of the
facility;
(b) Maintenance and
security of the facility;
(c)
Employment, credentialing, evaluation, scheduling, training and management of
staff;
(d) Protection of patient
rights;
(e) Conformity of the
program with federal confidentiality regulations, namely, 42 CFR Part 2;
and,
(f) Management of the facility
budget.
(2) A regional
program administrator may take on some of the roles of the site-level program
administrator if an organization has multiple programs in different locations.
The program must
will inform the department of such an arrangement in
writing, including:
(a) The portion of the
program administrator time spent with each program, and include mention of any
competing priorities that might take away time allocated to the treatment
programs.
(b) The division of
responsibilities between the regional and site-level program
administrator.
(c) If the regional
program administrator serves in this or a similar capacity for any opioid
treatment programs located outside the state of Ohio.
(D) The opioid treatment program
may employ and use program physicians, physician extenders and other health
care professionals working within their scope of practice who have received
sufficient education, training and experience, or any combination thereof, to
enable that person to perform the assigned functions. All physicians, nurses
and other licensed professional care providers must
will comply with
the credentialing requirements of their respective professions. The opioid
treatment program may only employ certified nurse practitioners or clinical
nurse specialists, physician 's assistants, certified addiction registered
nurses, or board certified addiction specialist registered nurses as physician
extenders. A pharmacist may be a physician extender if authorized to manage
drug therapy pursuant section
4729.39 of the Revised Code and
specifically authorized by a consult agreement and to the extent specified in
the agreement.
(1) All physicians and
physician extenders employed by the opioid treatment program
shall
will be
actively licensed in Ohio and shall
will have:
(a) A
minimum of one year's experience in an addiction treatment settings;
or
(b) Completion within six months
of a plan of education for obtaining competence in addiction treatment methods.
The plan of education must
will be developed in consultation with and
approved by the medical director. The medical director
shall
will
certify the individual's completion of the plan of education when, in the
discretion of the medical director, it is satisfactorily accomplished. If the
medical director is completing a plan of competency described in paragraph
(B)(1)(c) of this rule, the medical director may assist the physician or
physician extender develop a plan and the plan shall
will be
approved by the medical director's supervising physician.
(2) During all hours of operation, every
opioid treatment program shall
will have a licensed physician on call and
available for consultation with other staff members at any time.
(3) During all hours of operation when
medication is being administered, every opioid treatment program
shall
will
have present and on duty at the facility at least one of the following:
(a) Physician assistant;
(b) Registered nurse acting in accordance
with division (B) of section
4723.01 of the Revised
Code;
(c) Licensed practical nurse
acting in accordance with division (F) of section
4723.01 of the Revised
Code;
(d) A pharmacist who is
authorized to manage drug therapy pursuant section
4729.39 of the Revised Code but
only if specifically authorized by a consult agreement and to the extent
specified in the agreement;
(e)
Certified nurse practitioner with a SAMHSA exemption request; or,
(f) Physician.
(4) Each opioid treatment program will have
adequate medical staff, and they will ensure proper implementation of the
medical plan of care. A prescriber will be available for consultation either in
person or by telephone during all hours of operation. A medical director will
be present onsite at least two days a week. Alternatively, a program physician
or certified nurse practitioner with a SAMHSA exemption may account for one day
of the two-day standard.
(5) In the
event of medical director absence for a limited- time period (six weeks or
less) alternative coverage arrangements may be acceptable with departmental
notice. Such alternative coverage arrangements may satisfy the medical director
hours and on-site requirements set forth in paragraphs (B)(3) and (D)(4) of
this rule.
(6) An employee will not
be appointed medical director or co-medical director of more than a total of
three opioid treatment programs or two opioid treatment programs if the
combined patient census is greater than one thousand patients.
(7) The medical director or a program
physician at the opioid treatment program shall
will meet with
each patient in person within
seventy-two hours
two weeks of the admission. The medical director or
program physician shall
will see patients at least once every six months
thereafter during treatment. Telehealth meetings
will only be conducted for stable patients. Each meeting
shall
will be
documented in the patient's record. After the first year of treatment, then the
medical director or program physician may only meet with the patient once per
year if the program employs a certified nurse practitioner who has prescriptive
authority for the patient.
(8)
Certified nurse practitioners with a SAMHSA exemption who personally furnish
medication assisted treatment at opioid treatment programs will meet with their
patients at least once every three months during treatment, however the meeting
with a medical director or program physician in paragraph (D)(5
7 ) of this rule may
be used to fulfill this standard for one of the quarterly meetings.
Telehealth meetings will only be conducted for
stable patients. Each meeting shall
will be
documented in the patient's record.
(a)
Certified nurse practitioners, with a SAMHSA exemption, personally furnishing
medication assisted treatment shall
will have a standard care arrangement with the
opioid treatment programs medical director pursuant section
4723.431 of the Revised Code. If
the medical director has five existing certified nurse practitioners with a
standard of care arrangement, then the standard of care arrangement
shall
will be
between a certified nurse practitioner and a program physician employed by the
opioid treatment program.
(b) Use
of a certified nurse practitioner, with a SAMHSA exemption, to personally
furnish medication assisted treatment does not remove the obligation of a
medical director or program physician to meet with patients.
(E)
If an opioid treatment program employs mid-level
practitioners pursuant to an exemption granted by SAMSHA the following
requirements must be met. For the purposes of this Chapter a mid-level
practitioner in an opioid treatment program is defined as an advanced practice
registered nurse who is a certified nurse practitioner or a clinical nurse
specialist with a current SAMHSA exemption:
(1)
A written plan
for ongoing supervision and case discussion to include mid-level practitioners
participation in:
(a)
Regularly scheduled supervisory sessions with the
medical director or prescribing physician. Sessions will be at least one hour
of supervision every 2 weeks; and,
(b)
Team meetings
where cases are reviewed with the medical director or prescribing physician
present.
(2)
The opioid treatment program must maintain a ratio of
no more than five midlevel practitioners with exemption per medical director or
prescribing physician per paragraph (A)(1) of section
4723.431 of the Revised
Code.
(3)
The mid-level practitioner must complete all federal
training requirements.
(4)
At initial hire, the provider must submit a training
and supervision plan to the SOTA in accordance with SAMHSA
regulations.
(5)
A supervision and training log must be maintained for
each mid-level practitioner documenting compliance with paragraphs (E)(1) and
(E)(3) of this rule.
I) criminal records check and a federal
bureau of investigations records check.
(1)
The criminal records check shall
will be based on electronic fingerprint
impressions that are submitted directly to BCI&I from a "webcheck" provider
agency located in Ohio. The employer may accept the results of a criminal
records check based on ink impressions from a "webcheck" provider agency only
in the event that readable electronic fingerprint impressions cannot be
obtained.
(2) A program
shall
will
not employ in a position which allows access to any form of medication to any
person who has been convicted of a felony relating to controlled
substances.
Notes
Promulgated Under: 119.03
Statutory Authority: 5119.37
Rule Amplifies: 5119.37
Prior Effective Dates: 07/01/2001, 10/01/2003, 06/01/2017, 01/01/2019, 04/10/2020 (Emer.), 06/11/2021
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