Req. No. 8754 Page 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 STATE OF OKLAHOMA 2nd Session of the 58th Legislature (2022) HOUSE BILL 3004 By: West (Rick) AS INTRODUCED 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; providing 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 fr om applying to operate pain management clinic for certain period of time after revocation; limiting pe riod of suspension; requiring new registration application if clinic changes ownership; prohibiting physicians from practicing medicine in unregistered pa in management clinics; providing for disciplinary action for violations; limiting who may prescribe co ntrolled dangerous substances at registered pain management clinics; prohibiting the dispensation of controlled dangerous substances at pain management cl inics; 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 qual ity assurance requirements; stipulating certain data collection and reporting requirements; providing for the accessibility of certain data and reports; providing penalties; directing promulgation of rules; providing for codification; and providing an effe ctive date. Req. No. 8754 Page 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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 2-1111 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) years from successful com pletion 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 b. where in any month a majority of patient s are prescribed opioids, benzodiazepines, barbitur ates, or carisoprodol for the treatment of chronic nonmalignant pain. Req. No. 8754 Page 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 SECTION 2. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 2-1112 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 services 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 c ontrolled 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 o perated 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 als o certified in pain medicine by the American Board of Pain Medicine or a board approved by the America n Board of Physician Specialties, the American Association of Physician Specialists , or the American Osteopathic Association, Req. No. 8754 Page 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 perform interventional pain p rocedures of the type routinely billed using surgical codes. B. Each clinic location shall be registe red 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 clin ic 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 unencumbered license pursuant to Section 480 et seq. or Section 62 0 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 bas is for a summary suspension of the clinic registration certificate as described in this section. 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 r elationship with a physician: 1. Whose Drug Enforcement Administration number has ever been revoked; Req. No. 8754 Page 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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 the 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 substanc e 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 States. E. If the State Board of Medical Licensure and Supervision finds that a pain management clinic is owned, dire ctly or indirectly, by a person 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 Sup ervision. As determined by rule, the State Board of Medical Licensure and Supervision may grant an ex emption to denying a registration or revoking a previously issued registration if more than five (5) years have elapsed since adjudication. As used in th is 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. Req. No. 8754 Page 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 F. If the registration of a pain management clinic is revoked or suspended, the designa ted physician of the pain management clinic, the owner or lessor of the pain management clinic propert y, 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 clinic registration is revoked or suspended, the designated physician of th e pain management clinic, the owner or lessor of the clinic property, the manager or the proprietor shall be responsible for removing all signs and symbols identifying the premises as a pain management clinic. H. If the clinic's registration is revoked, any per son 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 group, apply to operate a pain management clinic for one (1) year after t he 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. J. A change of ownership of a registered pain management clinic requires submission of a new registration application. Req. No. 8754 Page 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 SECTION 3. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 2-1113 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 t o 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 qualificatio ns 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 Ti tle 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 o f a patient on the same day that the physician prescribes a controlled dangerous substance to a patient at a pain management clinic. Req. No. 8754 Page 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 D. A physician author ized 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 a 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 re quired 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 ensurin g compliance with the facility and physical operations requirements . A pain management clinic shall : 1. Be located and operated at a publicly accessible fixed location; 2. Display a sign that can be viewed by the public that contains the clinic name, hours of operation , and a street address ; Req. No. 8754 Page 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 3. Have a publicly listed telephone number and a dedicated phone number to send and receive facs imiles; 4. Have a reception and waiting area ; 5. Provide a restroom; 6. Have private patient examination rooms ; 7. Have treatment rooms, if treatment is being provided to the patients; and 8. 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 . The provisions of this section do not excuse a physician from providing any treatment o r 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 i n 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: 1. The clinic shall maintain equipment and supplies to supp ort infection prevention and control activities; 2. The clinic shall identify infection risks based on the following: Req. No. 8754 Page 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 a. geographic location, community , and population served, b. the care, treatment, and services it provides, and c. an analysis of its infec tion 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 infe ctions associated with procedures performed in the clinic, a nd 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: 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, Req. No. 8754 Page 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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 opportunities to improve the facility 's performance and to enhanc e 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 adverse incidents to patients, b. the identification of tren ds or patterns of incidents, c. the development of measures to correct, reduce, minimize, or eliminate the risk of a dverse incidents to patients, and d. the documentation of these functions and periodic review no less than quarterly of such information by the designated physician. J. The designated physician is responsible for ensuring compliance with the following dat a collection and reporting requirements: Req. No. 8754 Page 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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 Stat e 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 ch ronic 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 even though he or she may temporarily res ide elsewhere. K. The data and reports specified in subsection J of this section shall be accessible to the Oklaho ma State Bureau of Narcotics and Dangerous Drugs Control. Req. No. 8754 Page 13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 SECTION 4. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 2-1114 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 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 t he date fixed for termination of the violation as ordered by the State Board of Req. No. 8754 Page 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Medical Licensure and Supervision constitutes an additional, separate, and distinct violation. C. The State Board of Medical Licensure and Supervision may impose a fine and, i n 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 taken to correct a violation. D. An owner or designated p hysician 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 co dified in the Oklahoma Statutes as Section 2-1115 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. SECTION 6. This act shall become effective November 1, 2022. 58-2-8754 GRS 12/30/21