SECTION 458.3265. Pain-management clinics.

• (1) REGISTRATION.-

  (a)1. As used in this section, the term:

  a. “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 6 years from successful completion of such residency program.

  b. “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 90 days after surgery.

  c. “Pain-management clinic” or “clinic” means any publicly or privately owned facility:

  (I) That advertises in any medium for any type of pain-management services; or

  (II) Where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain.

  2. Each pain-management clinic must register with the department or hold a valid certificate of exemption pursuant to subsection (2).

  3. The following clinics are exempt from the registration requirement of paragraphs (c)-(m) and must apply to the department for a certificate of exemption:

  a. A clinic licensed as a facility pursuant to chapter 395;

  b. A clinic in which the majority of the physicians who provide services in the clinic primarily provide surgical services;

  c. A clinic 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;

  d. A clinic affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows;

  e. A clinic that does not prescribe controlled substances for the treatment of pain;

  f. A clinic owned by a corporate entity exempt from federal taxation under 26 U.S.C. s. 501(c)(3);

  g. A clinic wholly owned and operated by one or more board-eligible or board-certified anesthesiologists, physiatrists, rheumatologists, or neurologists; or

  h. A clinic 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 board-certified in pain medicine 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 American Osteopathic Association, perform interventional pain procedures of the type routinely 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 must designate a 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 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 this chapter or chapter 459 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 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 this chapter or chapter 459 or a group of physicians, each of whom is licensed under this chapter or chapter 459; 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 (4).

  (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, apply 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) CERTIFICATE OF EXEMPTION.-

  (a) A pain management clinic claiming an exemption from the registration requirements of subsection (1) must apply for a certificate of exemption on a form adopted in rule by the department. The form must require the applicant to provide:

  1. The name or names under which the applicant does business.

  2. The address at which the pain management clinic is located.

  3. The specific exemption the applicant is claiming with supporting documentation.

  4. Any other information deemed necessary by the department.

  (b) The department must approve or deny the certificate within 30 days after the receipt of a complete application.

  (c) The certificate of exemption must be renewed biennially, except that the department may issue the initial certificates of exemption for up to 3 years in order to stagger renewal dates.

  (d) A certificateholder must prominently display the certificate of exemption and make it available to the department or the board upon request.

  (e) A new certificate of exemption is required for a change of address and is not transferable. A certificate of exemption is valid only for the applicant, qualifying owners, licenses, registrations, certifications, and services provided under a specific statutory exemption and is valid only to the specific exemption claimed and granted.

  (f) A certificateholder must notify the department at least 60 days before any anticipated relocation or name change of the pain management clinic or a change of ownership.

  (g) If a pain management clinic no longer qualifies for a certificate of exemption, the certificateholder must notify the department within 3 days after becoming aware that the clinic no longer qualifies for a certificate of exemption and register as a pain management clinic under subsection (1) or cease operations.
  (3) PHYSICIAN RESPONSIBILITIES.-These responsibilities apply to any physician who provides professional services in a pain-management clinic that is required to be registered in subsection (1).

  (a) A physician may not practice medicine in a pain-management clinic, as described in subsection (5), if the pain-management clinic is not registered with the department as required by this section. Any physician who qualifies to practice medicine in a pain-management clinic pursuant to rules adopted by the Board of 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. A physician who violates this paragraph is subject to disciplinary action by his or her appropriate medical regulatory board.

  (b) Only a physician licensed under this chapter or chapter 459 may dispense medication or prescribe a controlled substance regulated under chapter 893 on the premises of a registered pain-management clinic.

  (c) A physician, a physician assistant, or an advanced practice registered nurse must 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 72-hour dose of controlled substances for the treatment of chronic nonmalignant pain, the physician must document in the patient’s record the reason for prescribing that quantity.

  (d) A 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 or electronic prescribing software used for prescribing controlled substance pain medication. A physician who issues written prescriptions shall comply with the requirements for counterfeit-resistant prescription blanks in s. 893.065 and the rules adopted pursuant to that section. A physician shall notify, in writing, the department within 24 hours after any theft or loss of a prescription blank or breach of his or her electronic prescribing software used 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 10 days after terminating his or her employment with a pain-management clinic that is required to be registered under subsection (1). Each physician practicing in a pain-management clinic shall advise the Board of Medicine, in writing, within 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 must:

  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 listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational 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 examination rooms.

  h. Have treatment rooms, if treatment is being provided to the patients.

  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.

  j. If the clinic stores and dispenses prescription drugs, comply with ss. 499.0121 and 893.07.

  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, and 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.

  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, community, and population served.

  b. The care, treatment, and services it provides.

  c. An analysis of its infection surveillance and control data.

  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 infections associated with procedures performed in the clinic.

  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 structurally 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 written facility-specific disaster plan setting forth 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 any controlled substances.

  4. Each clinic shall have at least one employee on the premises during patient care hours who is certified in Basic Life Support and is trained in reacting to accidents and medical emergencies until emergency medical personnel arrive.

  (i) The designated physician is responsible for ensuring compliance with the following quality assurance requirements. Each pain-management clinic shall have an ongoing quality assurance program that objectively and systematically monitors and evaluates the quality and appropriateness of patient care, evaluates methods to improve patient care, identifies and corrects deficiencies within the facility, alerts the designated physician to identify and resolve recurring problems, and provides for opportunities to improve the facility’s performance and to enhance and improve the quality of care provided to the public. The designated physician shall establish a quality assurance program that includes the following components:

  1. The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients.

  2. The identification of trends or patterns of incidents.

  3. The development of measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients.

  4. 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 data collection and reporting requirements:

  1. The designated physician for each pain-management clinic shall report all adverse incidents to the department as set forth in s. 458.351.

  2. The designated physician shall also report to the Board of Medicine, 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 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.

  d. The number of patients treated at the pain 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 reside elsewhere.
  (4) 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 Medicine adopted pursuant to subsection (5) unless the clinic is accredited by a nationally recognized accrediting agency approved by the Board of 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.
  (5) RULEMAKING.-

  (a) The department shall adopt rules necessary to administer the registration, exemption, and inspection of pain-management clinics which establish the specific requirements, procedures, forms, and fees.

  (b) The Board of Medicine shall adopt rules setting forth training requirements for all facility health care practitioners who are not regulated by another board.
  (6) 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 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.

  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 physician knowingly and intentionally 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 $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. 4, ch. 2010-211; s. 4, ch. 2011-141; s. 32, ch. 2012-160; s. 7, ch. 2015-34; s. 1, ch. 2015-49; s. 55, ch. 2016-10; s. 18, ch. 2016-105; s. 7, ch. 2016-224; s. 5, ch. 2016-231; s. 4, ch. 2018-13; s. 49, ch. 2018-106; s. 5, ch. 2019-112.

History.-s. 4, ch. 2010-211; s. 4, ch. 2011-141; s. 32, ch. 2012-160; s. 7, ch. 2015-34; s. 1, ch. 2015-49; s. 55, ch. 2016-10; s. 18, ch. 2016-105; s. 7, ch. 2016-224; s. 5, ch. 2016-231; s. 4, ch. 2018-13; s. 49, ch. 2018-106; s. 5, ch. 2019-112.