FROM THE FLORIDA PDMP FOUNDATION NEWSLETTER: LEGAL CORNER WITH GENERAL COUNSEL JASON WINN, ESQ.
Florida has regulated pain management clinics since 2010 and defines a pain management clinic in Florida Statute §458.3265 and §459.0137 as any publicly or privately-owned facility that either: 1) advertises in any medium for any type of pain-management services; or, 2) where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain. “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.
So, if you are advertising for any type of pain-management service or during any month you treat a majority of your patients for chronic non-malignant pain by prescribing opioids, benzodiazepines, barbiturates, or carisoprodol, YOU ARE A PAIN-MANAGEMENT CLINIC! If you are a pain-management clinic, you must register with the department of health (DOH) or hold a valid certificate of exemption. First, let’s address those practitioners that must register with the DOH. 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 chapter 458 or 459, F.S., 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), F.S.
A pain-management clinic that claims an exemption from the registration requirements above, the practitioner must apply for a certificate of exemption on a form adopted in rule by the DOH. Clinics claiming an exemption from the registration requirement must apply for a certificate of exemption on Application for Exemption from Pain Management Clinic Registration, form DH-MQA 5031 (6/2020), incorporated by reference and available here.
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 clinic licensed as a facility pursuant to chapter 395;
A clinic in which the majority of the physicians who provide services in the clinic primarily provide surgical services;
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;
A clinic affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows;
A clinic that does not prescribe controlled substances for the treatment of pain;
A clinic owned by a corporate entity exempt from federal taxation under 26 U.S.C. s. 501(c)(3);
A clinic wholly owned and operated by one or more board-eligible or board-certified anesthesiologists, physiatrists, rheumatologists, or neurologists; or
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 the American Osteopathic Association 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.
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. A certificate holder must prominently display the certificate of exemption and make it available to the department or the board upon request. 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. A certificate holder 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. If a pain management clinic no longer qualifies for a certificate of exemption, the certificate holder 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.
So, you have registered your pain-management clinic, what’s next? 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 or 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. A physician who violates this paragraph is subject to disciplinary action by his or her appropriate medical regulatory board.
Only a physician licensed under chapter 458 or chapter 459 may dispense medication or prescribe a controlled substance regulated under chapter 893 on the premises of a registered pain-management clinic. 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.
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.
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.
Finally, the inspection by the DOH.
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 (5) unless the clinic is accredited by a nationally recognized accrediting agency approved by the Board of Medicine or Osteopathic Medicine. 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. 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 follow up visits by departmental personnel.
Failing to abide by the requirements of registration, exemption, physician responsibilities or inspections, may result in administrative action against the licensee. 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:
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.
What actions, if any, the owner or designated osteopathic physician took to correct the violations.
Whether there were any previous violations at the pain-management clinic.
The financial benefits that the pain-management clinic derived from committing or continuing to commit the violation.
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. 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. 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. 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.
[Jason Winn, Esq., Tallahassee, is a 1996 graduate of the University of Maryland and received his Juris Doctorate from Nova Southeastern University - Shepard Broad Law in Ft. Lauderdale, Florida in 2000. He was admitted to the Florida Bar in 2001. Before opening his private law practice, he worked for the Assistant Public Defender in the Fifth Judicial Circuit.Mr. Winn currently serves as general counsel for the Florida PDMP Foundation, the Florida Osteopathic Medical Association (FOMA), the Florida Podiatric Medical Association (FPMA) and the Florida Society of Hearing Healthcare Professionals (FSHHP).]
Florida Osteopathic Medical Association (FOMA) | Tallahassee, FL