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HOUSE OF REPRESENTATIVES - FLOOR VERSION
STATE OF OKLAHOMA
1st Session of the 58th Legislature (2021)
COMMITTEE
SUBSTITUTE
FOR
HOUSE BILL NO. 888 By: Standridge of the Senate
and
Echols of the House
COMMITTEE SUBSTITUTE
An Act relating to co ntrolled dangerous substances;
defining terms; requiring pain management clinics to
register with State Board of Medical Licensure and
Supervision; providing exemptions; stipulating
registration procedures; requiring clinics to
designate physician; providi ng for the denial,
revocation or suspension of registration under
certain circumstances; defining term; requiring
facility operations to cease when registration is
revoked or suspended; requiring removal of signage;
prohibiting person from applying to oper ate pain
management clinic for certain period of time after
revocation; limiting period of suspension; requiring
new registration application if clinic changes
ownership; prohibiting physicians from practicing
medicine in unregistered pain management clini cs;
providing for disciplinary action for violations;
limiting who may prescribe controlled dangerous
substances at registered pain management clinics;
prohibiting the dispensation of controlled dangerous
substances at pain management clinics; specifying
physician responsibilities; providing facility and
physical operations requirements; stipulating certain
infection control requirements; providing safety
requirements for buildings, grounds and equipment of
clinics; providing certain quality assurance
requirements; stipulating certain data collection and
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reporting requirements; providing for the
accessibility of certain data and reports; providing
penalties; directing promulgation of rules; providing
for codification; and providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2 -1101 of Title 63, unless there
is created a duplication in numbering, reads as follows:
As used in this act:
1. "Board eligible" means successful completion of an
anesthesia, physical medicine and rehabilitation, rheumatology or
neurology residency program approved by the Accreditation Council
for Graduate Medical Education or the American O steopathic
Association for a period of six (6) years from successful completion
of such residency program;
2. "Chronic nonmalignant pain" means pain unrelated to cancer
which persists beyond the usual course of disease or the injury that
is the cause of the pain or more than ninety (90) calendar days
after surgery; and
3. "Pain management clinic" or "clinic" means any publicly or
privately owned facility:
a. that advertises in any medium for any type of pain
management services, and
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b. where in any month a majority of patients are
prescribed opioids, benzodiazepines, barbiturates or
carisoprodol for the treatment of chronic nonmalignant
pain.
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-1102 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. Each pain management clinic shall register with the State
Board of Medical Licensure and Supervision unless:
1. The majority of the physicians who provide servic es in the
clinic primarily provide surgical services;
2. The clinic is affiliated with an accredited medical school
at which training is provided for medical students, residents or
fellows;
3. The clinic does not prescribe controlled dangerous
substances for the treatment of pain;
4. The clinic is wholly owned and operated by one or more
board-eligible or board-certified anesthesiologists, physiatrists,
rheumatologists or neurologists; or
5. The clinic is wholly owned and operated by a physician
multispecialty practice where one or more board -eligible or board-
certified medical specialists, who have also completed fellowships
in pain medicine approved by the Accreditation Council for Graduate
Medical Education or who are also certified in pain medicine b y the
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American Board of Pain Medicine or a board approved by the American
Board of Physician Specialties, the American Association of
Physician Specialists or the American Osteopathic Association,
perform interventional pain procedures of the type routinel y billed
using surgical codes.
B. Each clinic location shall be registered separately
regardless of whether the clinic is operated under the same business
name or management as another clinic.
C. As a part of registration, a clinic shall designate a
physician who is responsible for complying with all requirements
related to registration and operation of the clinic in compliance
with this act. Within ten (10) calendar days after termination of a
designated physician, the clinic shall notify the State Boar d of
Medical Licensure and Supervision of the identity of another
designated physician for that clinic. The designated physician
shall have a full, active and unencumbered license pursuant to
Section 480 et seq. or Section 620 et seq. of Title 59 of the
Oklahoma Statutes and shall practice at the clinic location for
which the physician has assumed responsibility. Failing to have a
licensed designated physician practicing at the location of the
registered clinic may be the basis for a summary suspension of the
clinic registration certificate as described in this section.
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D. The State Board of Medical Licensure and Supervision shall
deny registration to any pain management clinic owned by or with any
contractual or employment relationship with a physician:
1. Whose Drug Enforcement Administration number has ever been
revoked;
2. Whose application for a license to prescribe, dispense or
administer a controlled substance has been denied for disciplinary
action by the appropriate medical regulatory board of t he physician;
or
3. Who has been convicted of or pleaded guilty or nolo
contendere to, regardless of adjudication, an offense that
constitutes a felony for receipt of illicit or diverted drugs,
including a controlled substance listed in Schedule I, II, II I, IV
or V of the Uniform Controlled Dangerous Substances Act, in this
state, any other state or the United States.
E. If the State Board of Medical Licensure and Supervision
finds that a pain management clinic is owned, directly or
indirectly, by a perso n meeting any criteria listed in subsection D
of this section, the State Board of Medical Licensure and
Supervision shall revoke the certificate of registration previously
issued by the State Board of Medical Licensure and Supervision. As
determined by rule, the State Board of Medical Licensure and
Supervision may grant an exemption to denying a registration or
revoking a previously issued registration if more than five (5)
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years have elapsed since adjudication. As used in this section, the
term "convicted" includes an adjudication of guilt following a plea
of guilty or nolo contendere or the forfeiture of a bond when
charged with a crime.
F. If the registration of a pain management clinic is revoked
or suspended, the designated physician of the pain mana gement
clinic, the owner or lessor of the pain management clinic property,
the manager and the proprietor shall cease to operate the facility
as a pain management clinic as of the effective date of the
suspension or revocation.
G. If a pain management cli nic registration is revoked or
suspended, the designated physician of the pain management clinic,
the owner or lessor of the clinic property, the manager or the
proprietor is responsible for removing all signs and symbols
identifying the premises as a pain management clinic.
H. If the clinic’s registration is revoked, any person named in
the registration documents of the pain management clinic, including
persons owning or operating the pain management clinic, shall not,
as an individual or as a part of a g roup, apply to operate a pain
management clinic for one (1) year after the date the registration
is revoked.
I. The period of suspension for the registration of a pain
management clinic shall be prescribed by the State Board of Medical
Licensure and Supervision but shall not exceed one (1) year.
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J. A change of ownership of a registered pain management clinic
requires submission of a new registration application.
SECTION 3. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2 -1103 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. A physician shall not practice medicine in a pain management
clinic if the clinic is not registered with the State Board of
Medical Licensure and Supervision as required by this act. Any
physician who qualifies to practice medicine in a pain management
clinic pursuant to rules adopted by the appropriate medical
regulatory board of the physician may continue to practice medicine
in a pain management clinic as long as the physician continues to
meet the qualifications prescribed in the rules. A physician who
violates this subsection is subject to disciplinary action by the
appropriate medical regulatory board of the physician.
B. Only a physician licensed pursuant to Section 480 et seq. or
Section 620 et seq. of Title 59 of the Oklahoma Statutes may
prescribe a controlled dangerous substance on the premises of a
registered pain management clinic. No person shall dispense any
controlled dangerous substance on the premises of a pain management
clinic.
C. A physician, a physician assistant or an Advanced Practice
Registered Nurse shall perform a physical examination of a patient
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on the same day that the physician prescribes a controlled substance
to a patient at a pain management clinic.
D. A physician authorized to prescribe controlled dangerous
substances who practices at a pain management clinic is responsible
for maintaining the control and security of his or her prescription
blanks and any other method used for prescribing controlled
dangerous substance pain medication. The physician shall notify, in
writing, the State Board of Medical Licensure and Supervision within
twenty-four (24) hours following any theft or loss of a prescription
blank or breach of any other method for prescribing pain medication.
E. The designated physician of a pain management clinic shall
notify the applicable board in writing of the date of termination of
employment within ten (10) calendar days after terminating his or
her employment with a pain management clinic that is required to be
registered pursuant to this act. Each physician practicing in a
pain management clinic shall advise the State Board of Medical
Licensure and Supervision, in writing, within ten (10 ) calendar days
after beginning or ending his or her practice at a pain management
clinic.
F. Each physician practicing in a pain management clinic is
responsible for ensuring compliance with the following facility and
physical operations requirements:
1. A pain management clinic shall be located and operated at a
publicly accessible fixed location and shall:
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a. display a sign that can be viewed by the public that
contains the clinic name, hours of operations and a
street address,
b. have a publicly liste d telephone number and a
dedicated phone number to send and receive facsimiles,
c. have a reception and waiting area,
d. provide a restroom,
e. have private patient examination rooms,
f. have treatment rooms, if treatment is being provided
to the patients, and
g. display a printed sign located in a conspicuous place
in the waiting room viewable by the public with the
name and contact information of the clinic’s
designated physician and the names of all physicians
practicing in the clinic; and
2. This section does not excuse a physician from providing any
treatment or performing any medical duty without the proper
equipment and materials as required by the standard of care. This
section does not supersede the level of care, skill or treatment
recognized in general law related to health care licensure.
G. Each physician practicing in a pain management clinic is
responsible for ensuring compliance with the following infection
control requirements:
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1. The clinic shall maintain equipment and supplies to suppor t
infection prevention and control activities;
2. The clinic shall identify infection risks based on the
following:
a. geographic location, community and population served,
b. the care, treatment and services it provides, and
c. an analysis of its infecti on surveillance and control
data; and
3. The clinic shall maintain written infection prevention
policies and procedures that address the following:
a. prioritized risks,
b. limiting unprotected exposure to pathogens,
c. limiting the transmission of infect ions associated
with procedures performed in the clinic, and
d. limiting the transmission of infections associated
with the clinic’s use of medical equipment, devices
and supplies.
H. Each physician practicing in a pain management clinic is
responsible for ensuring that the clinic, including its grounds,
buildings, furniture, appliances and equipment is structurally
sound, in good repair, clean and free from health and safety
hazards.
I. The designated physician is responsible for ensuring
compliance with the following quality assurance requirements:
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1. Each pain management clinic shall have an ongoing quality
assurance program that objectively and systematically:
a. monitors and evaluates the quality and appropriateness
of patient care,
b. evaluates methods to improve patient care,
c. identifies and corrects deficiencies within the
facility,
d. alerts the designated physician to identify and
resolve recurring problems, and
e. provides for opportunities to improve the facility’s
performance and to enhance and improve the quality of
care provided to the public; and
2. The designated physician shall establish a quality assurance
program that includes the following components:
a. the identification, investigation and analysis of the
frequency and causes of ad verse incidents to patients,
b. the identification of trends or patterns of incidents,
c. the development of measures to correct, reduce,
minimize or eliminate the risk of adverse incidents to
patients, and
d. the documentation of these functions and perio dic
review no less than quarterly of such information by
the designated physician.
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J. The designated physician is responsible for ensuring
compliance with the following data collection and reporting
requirements:
1. The designated physician for each pain management clinic
shall report all adverse incidents to the State Board of Medical
Licensure and Supervision; and
2. The designated physician shall also report to the State
Board of Medical Licensure and Supervision, in writing, on a
quarterly basis the following data:
a. the number of new and repeat patients seen and treated
at the clinic who are prescribed controlled dangerous
substance medications for the treatment of chronic,
nonmalignant pain,
b. the number of patients discharged due to drug abuse,
c. the number of patients discharged due to drug
diversion, and
d. the number of patients treated at the clinic whose
domicile is located somewhere other than in this
state. A patient’s domicile is the patient’s fixed or
permanent home to which he or she i ntends to return
even though he or she may temporarily reside
elsewhere.
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K. The data and reports specified in subsection J of this
section shall be accessible to the Oklahoma State Bureau of
Narcotics and Dangerous Drugs Control.
SECTION 4. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2 -1104 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. The State Board of Medical Licensure and Supervision may
impose an administrative fine on a clinic of up to Five Thousand
Dollars ($5,000.00) per violation for violating the requirements of
this act or the rules of the State Board of Medical Licensure and
Supervision. In determining whether a penalty is to be imposed, and
in fixing the amount of the fine, the State Board of Medical
Licensure and Supervision shall consider the following factors:
1. The gravity of the violation, including the probability that
death or serious physical or emotional harm to a patient has
resulted, or could have resulted, from the pain management clinic’s
actions or the actions of the physician, the severity of the action
or potential harm and the extent to which the provisions of the
applicable laws or rules were violated;
2. What actions, if any , the owner or designated physician took
to correct the violations;
3. Whether there were any previous violations at the pain
management clinic; and
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4. The financial benefits that the pain management clinic
derived from committing or continuing to commit the violation.
B. Each day a violation continues after the date fixed for
termination of the violation as ordered by the State Board of
Medical Licensure and Supervision constitutes an additional,
separate and distinct violation.
C. The State Board of M edical Licensure and Supervision may
impose a fine and, in the case of an owner -operated pain management
clinic, revoke or deny a pain management clinic’s registration if
the clinic’s designated physician knowingly and intentionally
misrepresents actions t aken to correct a violation.
D. An owner or designated physician of a pain management clinic
who concurrently operates an unregistered pain management clinic is
subject to an administrative fine of Five Thousand Dollars
($5,000.00) per day.
E. If the owner of a pain management clinic that requires
registration fails to apply to register the clinic upon a change of
ownership and operates the clinic under the new ownership, the owner
is subject to a fine of Five Thousand Dollars ($5,000.00).
SECTION 5. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2 -1105 of Title 63, unless there
is created a duplication in numbering, reads as follows:
All affected agencies and boards shall promulgate such rules as
are necessary to implement the provisions of this act.
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SECTION 6. This act shall become effective November 1, 2021.
COMMITTEE REPORT BY: COMMITTEE ON ALCOHOL, TOBACCO AND CONTROLLED
SUBSTANCES, dated 04/08/2021 - DO PASS, As Amended.