Req. No. 1437 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 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 1st Session of the 59th Legislature (2023) SENATE BILL 573 By: Standridge AS INTRODUCED An Act relating to controlled dangerous s ubstances; defining terms; requiring pain management clinics to register with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control ; providing exemptions; stipulating registration procedures; requiring clinics to designate owner or administrat or responsible for certain compliance ; directing denial of registration for specified reason s; limiting period of suspension; requiri ng new registration application if clinic changes ownership; specifying responsibilities of licensed prescriber and designated administrator ; providing facility and physical operations requirements; stipulating certain infection control requirements; providing certain quality assurance requirements; stipulating certain data collection and reporting requirements; requiring establishment of certain written policy; dire cting certain investigation by Bureau; 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 -1111 of Title 63, unless there is created a duplication in numbering, reads as follows: As used in this act: Req. No. 1437 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 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. “Chronic nonmalignant pain” means pain unrelated to cancer which persists beyond the usual course of disease or t he injury that is the cause of the pain or more than ninety (90) calendar days after surgery; 2. “Licensed prescriber” means a prescriber as defined in Section 353.1 of Title 59 of the Oklahoma Statutes other than a veterinarian, who has the authority to prescribe any controlled dangerous substance under Section 2 -312 of Title 63 of the Oklahoma Statutes; and 3. “Pain management clinic” or “clinic” means any publicly or privately owned facility: a. that engages in significant paid advertising in any medium for any type of pain management services, and b. where in any month over sixty percent (60%) of patients who are not being seen for hospice or palliative care are prescribed opioids, benzodiazepines, bar biturates, or carisoprodol for the treatment of chronic nonmalignant pain. SECTION 2. NEW LAW A ne w 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 cl inic shall register with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control unless: Req. No. 1437 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 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 clinic is affiliated wi th an accredited medical school at which training is provided for medical students, residents, or fellows; 2. The clinic does not prescribe controlled dangerous substances for the treatment of pain; 3. The clinic primarily treats hospice or palliative ca re patients; or 4. A majority of the patients treated by the clinic are t reated for acute pain. B. Each clinic location shall be registered separately regardless of whether the clinic is operated under the same business name or management as another cl inic and each clinic location shall be a permanent, fixed, physical address of operation. C. As a part of registration, a clin ic shall designate an owner or administrator who is responsible for ensuring compliance with all requirements related to registrati on and operation of the clinic under this act. Within ten (10) calendar d ays after termination of a designated administrator, the clinic shall notify the Bureau of the identity of another designated administrator for that clinic. Failing to have a designated administrator 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. Req. No. 1437 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 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. The Bureau shall deny registration to any pain management clinic owned by or with any contractual or employment relationship with a licensed prescriber: 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 licensing board; 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 Sc hedule 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 Bureau finds that a pain management clinic is owned, directly or indirectly, by a person meeting any criteria listed in subsection D of this section, the Bureau shall revoke the certificate of registration previously issued by the Bureau. As determined by rule, the Bureau may grant an exemption to denying a registration or revoking a previously issued registration if more than five (5) 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. Req. No. 1437 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 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 man agement clinic is revoked or suspended, the designated administrator of the pain management clinic, the owner or lessor of the pain management clinic property, the manager, and the proprietor shall cea se 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 administrator 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 document s of the pain management clinic including persons owning or oper ating 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 the date the registration is revoked. I. The period of suspension for the registration of a pain management clinic shall be prescribed by the Bureau but shall not exceed one (1) year. J. A change of ownership of a registered pain management clinic shall require submission of a new registration application. Req. No. 1437 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 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 licensed prescriber shall not be employed or contracted by or otherwise practice i n a pain management clinic if the clinic is not licensed by the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control under this act and registered with the Bureau under Section 2-301 et seq. of Title 63 of the Oklahoma Statutes. A licensed prescriber who qualifies to practice in a pain management clinic pursuant to rul es adopted by the appropriate licensing board may continue to practice in a pain management clinic as long as the licensed prescriber continues to meet the qualifications prescribed in the rules. A licensed prescriber who violates this subsection is subject to disciplinary action by the appropriate licensing board. B. Only a licensed prescriber licensed in this state and authorized to prescribe controlled dangerous substances under Section 2-312 of Title 63 of the Oklahoma Statutes may prescribe a controlled dangerous substance on the premises of a reg istered pain management clinic and only to the extent allowed by Section 2-312 of Title 63 of the Oklahoma Statutes . No person shall dispense any controlled dangerous substance on the premises of a pain m anagement clinic. The provisions of this subsection shall not be construed to expand or otherwise modify the prescriptive authority of any licensed prescriber. Req. No. 1437 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 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 C. A licensed prescriber shall perform a phys ical examination of a patient on the same day that t he licensed prescriber prescribes a controlled substance to a patient at a pain management clin ic. D. A licensed prescriber 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 an y other method used for prescribing controlled dangerous substance pain medication. The licensed prescriber shall notify, in writing, the Bureau within twenty-four (24) hours following any theft or loss of a prescription bl ank or breach of any other method for prescribing pain medication. The provisions of this subsection shall not be construed to exempt a licensed prescriber from any electronic prescription requirements stipulated in Section 2-309 of Title 63 of the Oklahoma Statutes. E. The designated administrator of a pain management clinic shall notify the Bureau 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 . F. The owners of a pain management clinic are jointly responsible for ensuring compliance with the following faci lity and physical operations requirements: 1. A pain management clinic shall be located and operated at a publicly accessible fixed location and shall: Req. No. 1437 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 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. display a sign that can be viewed b y the public that contains the clinic name, hours of operation , and a street address, b. have a publicly listed 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, i f 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 administrator and the names of all licensed prescribers practicing in the clinic; and 2. This section does not excuse a licensed prescriber 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 owner or designated administrator of a pain management clinic is responsible for ensuring compliance with infection Req. No. 1437 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 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 prevention and control requirements stipulated by the Occupational Safety and Health Administration. H. The designated administrator shall establish a quality assurance program that includes the identification, investigation, and analysis of the frequency and causes of adverse incidents to patients. The designated administrator is responsible for ensuring compliance with the quality assurance requirements. I. The designated administrator is responsible for ensuring compliance with the following d ata collection and reporting requirements: 1. The designated administrator for each pain management clinic shall report all significant adverse incidents to the Bureau; and 2. The designated administrator shall also report to the Bureau, in writing, on a quarterly basis the following data: a. the number of new and repeat patients seen a nd treated at the clinic who are p rescribed controlled dangerous substance medications for the treatment of chro nic, nonmalignant pain, b. the number of patients diagnosed with substance use disorder, 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 Req. No. 1437 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 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. 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 reside elsewhere. J. The data and reports specified in subsection I of this section shall be accessible to each appropriate licensing board. K. Each pain management clin ic shall establish a written po licy and administrative process for transferring care of patients diagnosed with a substance use disorder where appropriate for their continued treatment. Each appropriate licensing board shall issue guidance on best practices to ensure appropriate referr al and treatment of patients with a substance use disorder. L. Upon referral by the ap propriate licensing board, the Bureau shall investigate suspected instances of drug diversion involving a pain management clinic. Nothing in this act shall be construed to restrict the appropriate licensing board from con ducting its own investigation into instances of suspected drug diversion. SECTION 4. NEW LAW A new sectio n of law to be codified in the Oklahoma Statutes as Section 2-1114 of Title 63, unless there is created a duplication in number ing, reads as follows: A. The Oklahoma State Bureau of Narcotics and Dangerous Drugs Control may impose an administrative fine on a clinic of up to One Thousand Dollars ($1,000.00) per violation for vio lating the Req. No. 1437 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 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 requirements of this act or the rules promulgated by the Bureau to enforce this act. B. Each day a violation continues after the date fixed for termination of the violati on as ordered by the Bureau constitutes an additional, separate, and distinct violation. C. The Bureau 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 owner or designated administrator knowingly and intentionally misrepresents actions taken to correct a violation. D. An owner or designated administrator of a pain management clinic who concurren tly operates an unregistered pain management clinic is subject to an administrative fine of One Thousand Dollars ($1,000.00) per day. E. If the owner of a pain management clinic that requires registration fails to apply t o register the clinic upon a chan ge of ownership and operates the clinic under the new ownershi p, the owner is subject to a fine of One Thousand Dollars ($1,000.00). SECTION 5. NEW LAW A n ew section of law to be codified in the Oklahoma Statutes as Section 2 -1115 of Title 63, unless there is created a duplication in numbering , reads as follows: The Oklahoma State Bureau of Narcotics and Dangerous Drugs Control and all appropriate licensing boards shall promulgate such rules as are necessary to implement the pr ovisions of this act. Req. No. 1437 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 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 SECTION 6. This act shall become effective November 1, 2023. 59-1-1437 DC 1/17/2023 6:12:47 PM