459.0137 Pain-management clinics.
459.0137 Pain-management clinics.
(1) REGISTRATION.
(a) All privately owned pain-management clinics, facilities, or offices, hereinafter referred to as “clinics,” which advertise in any medium for any type of pain-management services, or employ an osteopathic physician who is primarily engaged in the treatment of pain by prescribing or dispensing controlled substance medications, must register with the department unless:
1. That clinic is licensed as a facility pursuant to chapter 395;
2. The majority of the physicians who provide services in the clinic primarily provide surgical services;
3. 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 $50 million;
4. The clinic is affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows;
5. The clinic does not prescribe or dispense controlled substances for the treatment of pain; or
6. The clinic is owned by a corporate entity exempt from federal taxation under 26 U.S.C. s. 501(c)(3).
(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 must designate an osteopathic physician who is responsible for complying with all requirements related to registration and operation of the clinic in compliance with this section. Within 10 days after termination of a designated osteopathic physician, the clinic must notify the department of the identity of another designated physician for that clinic. The designated physician shall have a full, active, and unencumbered license under chapter 458 or this chapter and shall practice at the clinic location for which the physician has assumed responsibility. Failing to have a licensed designated osteopathic 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 s. 456.073(8) for a license or s. 120.60(6).
(d) The department shall deny registration to any clinic that is not fully owned by a physician licensed under chapter 458 or this chapter or a group of physicians, each of whom is licensed under chapter 458 or this chapter; or that is not a health care clinic licensed under part X of chapter 400.
(e) The department 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 by any jurisdiction.
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 and diverted drugs, including a controlled substance listed in Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in this state, any other state, or the United States.
(f) If the department finds that a pain-management clinic does not meet the requirement of paragraph (d) or is owned, directly or indirectly, by a person meeting any criteria listed in paragraph (e), the department shall revoke the certificate of registration previously issued by the department. As determined by rule, the department may grant an exemption to denying a registration or revoking a previously issued registration if more than 10 years have elapsed since adjudication. As used in this subsection, 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.
(g) The department may revoke the clinic’s certificate of registration and prohibit all physicians associated with that pain-management clinic from practicing at that clinic location based upon an annual inspection and evaluation of the factors described in subsection (3).
(h) 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 facility as a pain-management clinic as of the effective date of the suspension or revocation.
(i) 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 property, the manager, or the proprietor is responsible for removing all signs and symbols identifying the premises as a pain-management clinic.
(j) Upon the effective date of the suspension or revocation, the designated physician of the pain-management clinic shall advise the department of the disposition of the medicinal drugs located on the premises. The disposition is subject to the supervision and approval of the department. Medicinal drugs that are purchased or held by a pain-management clinic that is not registered may be deemed adulterated pursuant to s. 499.006.
(k) 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, may not, as an individual or as a part of a group, make application for a permit to operate a pain-management clinic for 5 years after the date the registration is revoked.
(l) The period of suspension for the registration of a pain-management clinic shall be prescribed by the department, but may not exceed 1 year.
(m) A change of ownership of a registered pain-management clinic requires submission of a new registration application.
(2) PHYSICIAN RESPONSIBILITIES. These responsibilities apply to any osteopathic physician who provides professional services in a pain-management clinic that is required to be registered in subsection (1).
(a) An osteopathic physician may not practice medicine in a pain-management clinic, as described in subsection (4), if:
1. The pain-management clinic is not registered with the department as required by this section; or
2. Effective July 1, 2012, the physician has not successfully completed a pain-medicine fellowship that is accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association or a pain-medicine residency that is accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association or, prior to July 1, 2012, does not comply with rules adopted by the board.
Any physician who qualifies to practice medicine in a pain-management clinic pursuant to rules adopted by the Board of Osteopathic Medicine as of July 1, 2012, may continue to practice medicine in a pain-management clinic as long as the physician continues to meet the qualifications set forth in the board rules. An osteopathic physician who violates this paragraph is subject to disciplinary action by his or her appropriate medical regulatory board.
(b) A person may not dispense any medication, including a controlled substance, on the premises of a registered pain-management clinic unless he or she is a physician licensed under this chapter or chapter 458.
(c) An osteopathic physician must perform a physical examination of a patient on the same day that he or she dispenses or prescribes a controlled substance to a patient at a pain-management clinic. If the osteopathic physician prescribes or dispenses more than a 72-hour dose of controlled substances for the treatment of chronic nonmalignant pain, the osteopathic physician must document in the patient’s record the reason for prescribing or dispensing that quantity.
(d) An osteopathic physician authorized to prescribe controlled 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 substance pain medication. The osteopathic physician shall comply with the requirements for counterfeit-resistant prescription blanks in s. 893.065 and the rules adopted pursuant to that section. The osteopathic physician shall notify, in writing, the department within 24 hours following any theft or loss of a prescription blank or breach of any other method for prescribing pain medication.
(e) The designated osteopathic physician of a pain-management clinic shall notify the applicable board in writing of the date of termination of employment within 10 days after terminating his or her employment with a pain-management clinic that is required to be registered under subsection (1).
(3) INSPECTION.
(a) The department shall inspect the pain-management clinic annually, including a review of the patient records, to ensure that it complies with this section and the rules of the Board of Osteopathic Medicine adopted pursuant to subsection (4) unless the clinic is accredited by a nationally recognized accrediting agency approved by the Board of Osteopathic Medicine.
(b) During an onsite inspection, the department shall make a reasonable attempt to discuss each violation with the owner or designated physician of the pain-management clinic before issuing a formal written notification.
(c) Any action taken to correct a violation shall be documented in writing by the owner or designated physician of the pain-management clinic and verified by followup visits by departmental personnel.
(4) RULEMAKING.
(a) The department shall adopt rules necessary to administer the registration and inspection of pain-management clinics which establish the specific requirements, procedures, forms, and fees.
(b) The department shall adopt a rule defining what constitutes practice by a designated osteopathic physician at the clinic location for which the physician has assumed responsibility, as set forth in subsection (1). When adopting the rule, the department shall consider the number of clinic employees, the location of the pain-management clinic, the clinic’s hours of operation, and the amount of controlled substances being prescribed, dispensed, or administered at the pain-management clinic.
(c) The Board of Osteopathic Medicine shall adopt a rule establishing the maximum number of prescriptions for Schedule II or Schedule III controlled substances or the controlled substance Alprazolam which may be written at any one registered pain-management clinic during any 24-hour period.
(d) The Board of Osteopathic Medicine shall adopt rules setting forth standards of practice for osteopathic physicians practicing in privately owned pain-management clinics that primarily engage in the treatment of pain by prescribing or dispensing controlled substance medications. Such rules shall address, but need not be limited to:
1. Facility operations;
2. Physical operations;
3. Infection control requirements;
4. Health and safety requirements;
5. Quality assurance requirements;
6. Patient records;
7. Training requirements for all facility health care practitioners who are not regulated by another board;
8. Inspections; and
9. Data collection and reporting requirements.
An osteopathic physician is primarily engaged in the treatment of pain by prescribing or dispensing controlled substance medications when the majority of the patients seen are prescribed or dispensed controlled substance medications for the treatment of chronic nonmalignant pain. Chronic nonmalignant pain is pain unrelated to cancer which persists beyond the usual course of the disease or the injury that is the cause of the pain or more than 90 days after surgery.
(5) PENALTIES; ENFORCEMENT.
(a) The department may impose an administrative fine on the clinic of up to $5,000 per violation for violating the requirements of this section; chapter 499, the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug Abuse Prevention and Control Act; chapter 893, the Florida Comprehensive Drug Abuse Prevention and Control Act; or the rules of the department. In determining whether a penalty is to be imposed, and in fixing the amount of the fine, the department 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 osteopathic 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 osteopathic physician took to correct the violations.
3. Whether there were any previous violations at the pain-management clinic.
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 department constitutes an additional, separate, and distinct violation.
(c) The department 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 osteopathic physician knowingly and intentionally misrepresents actions taken to correct a violation.
(d) An owner or designated osteopathic physician of a pain-management clinic who concurrently operates an unregistered pain-management clinic is subject to an administrative fine of $5,000 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 $5,000.
History. s. 8, ch. 2010-211.