Ohio Administrative Code
Title 4731 - State Medical Board
Chapter 4731-29 - Pain Management Clinics
Section 4731-29-01 - Standards and procedures for the operation of a pain management clinic
Universal Citation: OH Admin Code 4731-29-01
Current through all regulations passed and filed through September 16, 2024
(A) For the purposes of this rule:
(1) "Board" means
state medical board of Ohio.
(2)
"Chronic pain" means pain that has persisted after reasonable medical efforts
have been made to relieve the pain or cure its cause and that has continued,
either continuously, or episodically, for longer than three continuous months.
"Chronic pain" does not include pain associated with a terminal condition or
with a progressive disease that, in the normal course of progression, may
reasonably be expected to result in a terminal condition.
(3) "Hospital" means a hospital registered
with the department of health under section
3701.07 of the Revised
Code.
(4) "Informed consent" means
a process of communication between a patient and physician that results in the
patient's signed authorization or agreement to undergo a specific medical
intervention after all of the following subjects are discussed:
(a) The patient's diagnosis;
(b) The nature and purpose of the proposed
treatment or procedure;
(c) The
risks and benefits of a proposed treatment or procedure;
(d) Alternatives regardless of their costs or
the extent to which the treatment options are covered by health
insurance;
(e) The risks and
benefits of the alternative treatment or procedure; and
(f) The risks and benefits of not receiving
or undergoing a treatment or procedure.
(5) "Owner" means each person included on the
list maintained under division (B) (5) of section
4729.552 of the Revised Code.
(6)
"Pain management clinic" means a facility
in which
the majority of patients of the prescribers at the facility
are provided treatment for chronic pain that includes the use of controlled
substances. In determining whether the facility meets the requirements of this
paragraph:
(a)
Calculation of the majority of patients will be based upon
the number of patients treated in a calendar month;
(b)
Patients
receiving controlled substances for treatment of an injury or illness that
lasts or is expected to last thirty days or less shall not be considered in the
calculation of the majority.
(7) "Pain management
clinic" does not include the following:
(a) A
hospital;
(b) A facility operated
by a hospital for the treatment of pain or chronic pain;
(c) A physician practice owned or controlled,
in whole or in part, by a hospital or by an entity that owns or controls, in
whole or in part, one or more hospitals;
(d) A school, college, university, or other
educational institution or program to the extent that it provides instruction
to individuals preparing to practice as physicians, podiatrists, dentists,
nurses, physician assistants, optometrists, or veterinarians or any affiliated
facility to the extent that it participates in the provision of that
instruction;
(e) A hospice program
licensed under Chapter 3712. of the Revised Code;
(f) An ambulatory surgical facility licensed
under section 3702.30 of the
Revised Code;
(g) An interdisciplinary pain rehabilitation
program with three-year accreditation from the commission on accreditation of
rehabilitation facilities;
(h)
A nursing home licensed under section
3721.02 of the Revised Code or
by a political subdivision certified under section
3721.09 of the Revised Code;
or
(i)
A facility conducting only clinical research that may
use controlled substances in studies approved by a hospital-based institutional
review board or an institutional review board accredited by the association for
the accreditation of human research protection programs.
(8) "Physician" means an individual authorized under
chapter 4731. of the Revised Code to practice medicine and surgery or
osteopathic medicine and surgery.
(9) "Prescriber" has
the same meaning as in section
4729.01 of the Revised Code.
(B) In the operation of a pain management clinic, the following requirements shall be met:
(1) The pain management clinic shall be owned
and operated by one or more physicians. Each physician owner of a pain
management clinic shall complete at least twenty hours of category I continuing
medical education in pain medicine every two years, to include one or more
courses addressing the potential for addiction. The courses completed in
compliance with this rule shall be accepted toward meeting the category I
requirement for certificate of registration renewal for the
physician.
(2) Each physician owner
of a pain management clinic must meet one of the following requirements:
(a) Hold current subspecialty certification
in pain
medicine by the American board of medical specialties,
or hold a current certificate of added qualification in pain
medicine by the American osteopathic association
bureau of osteopathic specialists; or
(b) Hold current subspecialty certification
in hospice and palliative medicine by the American board of medical
specialties, or hold a current certificate of added qualification in hospice
and palliative medicine by the American osteopathic association bureau of
osteopathic specialists; or
(c)
Hold current board certification by the American board of pain medicine; or
(d) Hold current board
certification by the American board of interventional pain physicians;
or
(e) Meet both of the following:
(i) Hold current board certification in
anesthesiology, psychiatry, neurology, physical medicine and rehabilitation,
occupational medicine, or rheumatology by the American board of medical
specialties or hold current primary certification in anesthesiology,
psychiatry, neurology, physical medicine and rehabilitation, occupational
medicine, or rheumatology by the American osteopathic association bureau of
osteopathic specialists.
(ii)
Demonstrate conformance with the minimal standards of care.
(3) To demonstrate
conformance with the minimal standards of care pursuant to paragraph
(B)(2)(e)(ii) of this rule, the board shall conduct an
inspection of the facility pursuant to division (E) of section
4731.054 of the Revised
Code.
(4) The pain management clinic shall be
licensed as a category III terminal distributor of dangerous drugs with a pain
management clinic classification under section
4729.552 of the Revised
Code.
(5) The pain management
clinic shall be operated in compliance with the drug prevention and control
act,
21
U.S.C. 801 to
971,
in effect as of May 1, 2016, and Chapters 3719.,
4729., 4730., and 4731. of the Revised Code.
(6) The pain management clinic shall have
proper equipment, materials, and personnel on premises to provide appropriate
medical treatment, as required by the minimal standards of care.
(C) Each physician who provides care at a pain management clinic shall complete at least twenty hours of category I continuing medical education in pain medicine every two years, to include one or more courses addressing the potential for addiction. The courses completed in compliance with this rule shall be accepted toward meeting the category I requirement for certificate of registration renewal for the physician.
(D) No physician owner of a pain management clinic, employee of the clinic, or person with whom the clinic contracts for services shall:
(1) Have
ever been denied a license to prescribe, dispense, administer, supply, or sell
a controlled substance by the drug enforcement administration or appropriate
issuing body of any state or jurisdiction, based, in whole or in part, on the
prescriber's inappropriate prescribing, dispensing, administering, supplying or
selling a controlled substance or other dangerous drug.
(2) Have held a license issued by the drug
enforcement administration or a state licensing agency in any jurisdiction,
under which the person may prescribe, dispense, administer, supply or sell a
controlled substance, that has ever been restricted, based, in whole or in
part, on the prescriber's inappropriate prescribing, dispensing, administering,
supplying, or selling a controlled substance or other dangerous drug.
(3) Have been subject to disciplinary action
by any licensing entity that was based, in whole or in part, on the prescribers
inappropriate prescribing, dispensing, diverting, administering, supplying or
selling a controlled substance or other dangerous drug.
(E) In providing supervision, direction, and control of individuals at a pain management clinic the physician owner shall establish and ensure compliance with the following:
(1) A requirement that a log of patients be
maintained for each day the clinic is in operation.
(a) Each log sheet shall contain the month,
day, and year;
(b) Each log entry
shall include the legible first and last name of each patient;
(c) Each patient shall be required to sign
the log at each visit; and
(d)
Patient logs shall be maintained for seven years.
(2) A requirement that providers obtain
informed consent for each patient prior to the commencement of
treatment.
(3) An on-going quality
assurance program that objectively and systematically monitors and evaluates
the quality and appropriateness of patient care, evaluates methods to improve
patient care, identifies and corrects deficiencies within the clinic, and
provides the opportunities to improve the clinic's performance and quality of
care.
(4) A requirement that the
background, training, certification, and licensure of all clinical staff be
documented. Verification of certification and licensure shall be made on an
annual basis.
(5) A requirement
that adequate billing records are maintained for all patients and made
available to the board, immediately upon request.
(a) Billing records shall include the amount
paid, method of payment, description of services, sufficient information to
identify the patient, and the amounts charged to the patient for each date of
service,
(b) Billing records shall
be maintained for seven years from the last date of treatment of the
patient.
(6) A
requirement that adequate patient records are maintained for all patients and
made available to the board, immediately upon request.
(a) Patient records shall contain sufficient
information to identify the patient, support the diagnosis, justify the
treatment and document the course and results of treatment accurately, by
including, at a minimum:
(i) Patient history
and physical examination, including history of drug abuse or
dependence;
(ii) Diagnostic,
therapeutic, and laboratory results, including drug testing results;
(iii) Reports of evaluations, consultations,
and hospitalizations;
(iv)
Treatment objectives, including discussion of risks and benefits;
(v) Records of drugs prescribed, dispensed or
administered, including the date, type, and dosage;
(vi) Treatments;
(vii) Receipt and assessment of drug database
or prescription monitoring program reports;
(viii) Copies of records or reports or other
documentation obtained from other health care practitioners at the request of
the physician and relied upon by the physician in determining the appropriate
treatment of the patient. Records provided by the patient shall be designated
as such.
(b) Patient
records shall be maintained for seven years from the last date of treatment of
the patient.
(c) In the treatment
of chronic pain the patient records shall contain the information required in
rule
4731-21-02
of the Administrative Code in lieu of the requirements of paragraphs
(E)(6)(a)(i) to (E)(6)(a)(vi) of this rule.
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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