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SENATE FLOOR VERSION
February 22, 2021
COMMITTEE SUBSTITUTE
FOR
SENATE BILL NO. 888 By: Standridge of the Senate
and
Echols of the House
An Act relating to controlled 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; stipulating procedures for
revocation and suspension of registration; limiting
period of suspension; requiring new registration
application if clinic changes ownership; specifying
physician responsibilities; providing facility and
physical operations requiremen ts; stipulating certain
infection control requirements; providing health and
safety requirements; providing certain quality
assurance requirements; stipulating certain data
collection and reporting requirements; providing that
designated physician is respo nsible for ensuring
compliance with all requirements; providing
penalties; directing promulgation of rules; amending
59 O.S. 2011, Section 355.1, as amended by Section
21, Chapter 230, O.S.L. 2015 (59 O.S. Supp. 2020,
Section 355.1), which relates to dispe nsation of
dangerous drugs; provi ding certain limitations on
dispensation of controlled dangerous substances;
providing exception; providing for codification; and
providing an effective date .
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOM A:
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SECTION 1. NEW LAW A new section of law to be codi fied
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 Osteopathic
Association for a period of six (6) y ears 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, or
b. where in any month a majority of patients are
prescribed opioids, benzodiazepines, barbiturates or
carisoprodol for the treatment of chronic nonm alignant
pain.
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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 f ollows:
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 services in the
clinic primarily provide s urgical services;
2. The clinic is owned by a publicly held corporation whose
shares are traded on a national exchange or on the over -the-counter
market and whose total assets at the end of the corporation ’s most
recent fiscal quarter exceeded Fifty Milli on Dollars
($50,000,000.00);
3. The clinic is affiliated with an accredited medical schoo l
at which training is provided for medical students, residents or
fellows;
4. The clinic does not prescribe controlled dangerous
substances for the treatment of pai n;
5. The clinic is owned by a corporate enti ty exempt from
federal taxation under 26 U.S .C., Section 501(c)(3) (1954);
6. The clinic is wholly owned and operated by one or more
board-eligible or board-certified anesthesiologists, physiatrists,
rheumatologists or neurologists; or
7. The clinic is wholly owned and operated by a physician
multispecialty practice where one or more board -eligible or board-
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certified medical specialists, who have also completed fellowships
in pain medicine approved by the Accr editation Council for Graduate
Medical Education or who are also certified in pain medicin e by the
American Board of Pain Medicine or a board approved by the American
Board of Medical Specialties, the American Association of Physician
Specialists or the Am erican Osteopathic Association, perform
interventional pain procedures of the type routine ly 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) calend ar days after termination of a
designated physician, the clinic shall notify the State Board of
Medical Licensure and Supervision of the identity of another
designated physician for that clinic. The designated physician
shall have a full, active and unenc umbered 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 pract icing at the location of the
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registered clinic may be the basis for a summary suspension o f the
clinic registration certificate as described in this section.
D. The State Board of Medical Licensure and Supervision shall
deny registration to any clinic tha t is not fully owned by a
physician licensed p ursuant to Section 480 et seq. or Section 62 0 et
seq. of Title 59 of the Oklahoma Statutes or group of physicians,
each of whom is licensed pursuant to Section 480 et seq. or Section
620 et seq. of Title 59 of the Oklahoma Statutes.
E. 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 nu mber has ever been
revoked;
2. Whose application for a license to prescribe, dispense or
administer a controlled substance has been denied by any
jurisdiction;
3. Who has been convicted of or pleaded guilty or nolo
contendere to, regardless of adjudicati on, an offense that
constitutes a felony for r eceipt of illicit or diverted drugs,
including a controlled substance listed in Schedule I, II, III, IV
or V of the Uniform Controlled Dangerous Substances Act, in this
state, any other state or the United Stat es.
F. If the State Board of Medical Licensur e and Supervision
finds that a pain management clinic does not meet the requirement of
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subsection D of this section or is owned, directly or indirectly, by
a person meeting any criteria listed in subsection E o f this
section, the State Board of Medical Lic ensure 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 ten (10) 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 for feiture of a bond when charged with a crime.
G. If the registration of a pain management clinic is revoked
or suspended, the designated physician of the pain management
clinic, the owner or lessor of the pain management clinic property,
the manager and the proprietor shall cease to operate the faci lity
as a pain management clinic as of the effective date of the
suspension or revocation.
H. If a pain management clinic registration is revoked or
suspended, the designated physician of the pain management clinic,
the owner or lessor of the clinic prope rty, the manager or the
proprietor is responsible for removing all signs and symbols
identifying the premises as a pain management clinic.
I. If the clinic’s registration is revoked, any person named in
the registration documents of the pain management clinic, including
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persons owning or operating the pain management clinic, shall not,
as an individual or as a part of a group, apply to operate a pain
management clinic for five (5) years after the date the registr ation
is revoked.
J. The period of suspensi on 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.
K. 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, unl ess there
is created a duplication in numberin g, reads as follows:
A. A physician shall no t 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 medicin e in a pain management
clinic pursuant to rul es adopted by the State Board of Medical
Licensure and Supervision 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 subsectio n is subject to disciplinary action by his or
her appropriate medical regulatory board.
B. Only a physician licensed pur suant to Section 480 et seq. or
Section 620 et seq. of Title 59 of the Oklahoma Statutes m ay
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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
on the same day that the physician prescribes a controlled substance
to a patient at a pain management clinic. If the physician
prescribes more than a seventy -two-hour dose of controlled dangerous
substances for the treatment of chronic nonmalignant pain, the
physician shall document in the patient ’s record the reason for
prescribing that quantity.
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
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registered pursuant to this act. Each physicia n 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 i n 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:
a. display a sign that can be viewed by t he public that
contains the clinic name, hours of operation s and a
street address,
b. have a publicly listed telephone number and a
dedicated phone number to send and receive facsimiles
with a facsimile machine that shall be ope rational
twenty-four (24) hours per day,
c. have emergency lighting and communications,
d. have a reception and waiting area,
e. provide a restroom,
f. have an administrative area, including room for
storage of medical records, supplies and equipment,
g. have private patient examina tion rooms,
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h. have treatment rooms, if treatment is being provided
to the patients, and
i. 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 wi th the following infection
control requirements:
1. The clinic shall maintain equipment and supplies to support
infection prevention and control activities;
2. The clinic shall identify infection risks based on the
following:
a. geographic location, comm unity and population served ,
b. the care, treatment and services it provides, and
c. an analysis of its infection surveillance and control
data; and
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3. The clinic shall maintain written infection prevention
policies and procedures that address the followi ng:
a. prioritized risks,
b. limiting unprotected exposure to pathogens,
c. limiting the transmission of infections 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 compliance with the following health and
safety requirements:
1. The clinic, including its grounds, buildings, furniture,
appliances and equipment shall be str ucturally sound, in good
repair, clean and free from health and safety hazards;
2. The clinic shall have evacuation procedures in the event of
an emergency, which shall include provisions for the evacuation of
disabled patients and employees;
3. The clinic shall have a writ ten facility-specific disaster
plan specifying actions that will be taken in the event of clinic
closure due to unforeseen disasters and shall include provisions for
the protection of medical records; and
4. Each clinic shall have at l east one employee on the premises
during patient care hours who is certified in basic life support and
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is trained in reacting to accidents and medical emergencies until
emergency medical personnel arrive.
I. The designated physic ian is responsible for ens uring
compliance with the following quality assurance requirements:
1. Each pain management clinic shall have an ongoing quality
assurance program that objectively and systematically:
a. monitors and evaluates the quality and app ropriateness
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 imp rove 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 a dverse 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
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d. the documentation of thes e functions and peri odic
review no less than quarterly of such information by
the designated physician.
J. The designated physician is responsible for ensuring
compliance with the following data collection and reporting
requirements:
1. The designated ph ysician 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 intends to return
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even though he or she may temporarily reside
elsewhere.
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 number ing, 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 requireme nts of
this act or the rules of the State Board of Medical Licensure and
Supervision. In determining whether a p enalty is to be imposed, and
in fixing the amount of the fine, the State Board of Medical
Licensure and Supervision shall consider the followin g factors:
1. The gravity of the violation, i ncluding the probability that
death or serious physical or emotiona l harm to a patient has
resulted, or could have resulted, from the pain management clinic’s
actions or the actions of the physician, the severi ty of the action
or potential harm and the ext ent to which the provisions of the
applicable laws or rules were vi olated;
2. What actions, if any, the owner or designated physician took
to correct the violations;
3. Whether there were any previous violati ons at the pain
management clinic; and
4. The financial benefits that the pain management clinic
derived from committing or continuing to commit the violation.
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B. Each day a violation continues after the date fixed for
termination of the violation as ord ered by the State Board of
Medical Licensure and Supervision constitutes an additional,
separate and distinct vio lation.
C. The State Board of Medical 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 inte ntionally
misrepresents actions taken 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 Dol lars ($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. AMENDATORY 59 O.S. 2 011, Section 355.1, as
amended by Section 21, C hapter 230, O.S.L. 2015 (59 O.S. Supp. 2020,
Section 355.1), is amended to read as follows:
Section 355.1. A. Except as provided for in Section 353.1 et
seq. of this title, only a licensed practitioner may d ispense
dangerous drugs to such practitioner ’s patients, and only for the
expressed purpose of serving the best interests and promoting the
welfare of such patients. The dangerous drugs shall be dispensed in
an appropriate container to which a label has b een affixed. Such
label shall include the name and office address of the licensed
practitioner, date dispensed, name of patient, directions for
administration, prescription number, the trade or generic name and
the quantity and strength, not meaning ingre dients, of the drug
therein contained; provided , this requirement shall not apply to
compounded medicines. The licensed practitioner shall keep a
suitable book, file or record in which shall be preserved for a
period of not less than five (5) years a reco rd of every dangerous
drug compounded or dispen sed by the licensed practitioner.
B. A prescriber desiring to dispense dangerous drugs pursuant
to this section shall register annually with the appropriate
licensing board as a dispenser, through a regulator y procedure
adopted and prescribed by such lice nsing board.
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C. A prescriber who dispenses professional samples to patients
shall be exempt from the requirement of subsection B of this section
if:
1. The prescriber furnishes the professional samples to th e
patient in the package provided by the manufa cturer;
2. No charge is made to the patient; and
3. An appropriate record is entered in the patient ’s chart.
D. This section shall not apply to the services provided
through the State Department of Health, city/county health
departments, or the Department of Mental Health and Substance Abuse
Services.
E. This section shall not apply to organizations and services
incorporated as state or federal tax -exempt charitable nonprofit
entities and/or organizations a nd services receiving all or part of
their operating funds from a local, state or federal governmental
entity; provided, such organizations and services shall comply with
the labeling and recordkeeping requirements set out in subsection A
of this section.
F. A prescriber who issues a prescription for a controlled
dangerous substance shall not dispense the controlled dangerous
substance pursuant to such prescription. A prescriber shall not
dispense a controlled dangerous substance pursuant to a prescriptio n
issued by another prescriber if the dispensin g prescriber has a
financial interest in the practice of the prescribing prescriber .
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The restrictions on dispensing of controlled dangerous substances
provided by this subsection shall not apply to substance abuse
treatment programs or services.
SECTION 7. This act shall become effective November 1, 20 21.
COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
February 22, 2021 - DO PASS AS AMENDED