Sections 458.3265 and 459.0137, F.S., now require that pain management clinics that are exempt from registration obtain a Certificate of Exemption. A separate Certificate of Exemption is required for each clinic location.
The Florida Department of Health recently released the long-awaited Application for Exemption from Pain Management Clinic Registration.
All pain management practices that will not register as pain management clinics must obtain a Certificate of Exemption by January 1, 2019. Because the Department of Health has up to 30 days to approve or deny these initial applications, it is advisable to submit these applications as soon as possible, but in no event later than December 1, 2018.
Under Florida law, a pain management clinic is any facility (public or private) that: (i) advertises 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, non-malignant pain.
Pain management clinics may qualify for an exemption from registration for the following reasons:
- The clinic is a licensed facility under Chapter 395, Florida Statutes (example: hospitals and ambulatory surgical centers);
- The majority of physicians providing services in the clinic provide primarily surgical services;
- The clinic is owned by a publicly held corporation whose shares are traded on a national exchange or over-the-counter market and whose total assets at the end of its most recent fiscal quarter exceeded $50 million;
- The clinic is affiliated with an accredited medical school at which training is provided for medical students, residents or fellows;
- The clinic does not prescribe controlled substances for the treatment of pain;
- The clinic is owned by a corporate entity exempt from federal taxation under 26 U.S.C. Section 501(c)(3);
- The clinic is wholly owned and operated by one or more board-eligible or board-certified anesthesiologists, psychiatrists, rheumatologists, or neurologists; or
- The clinic is wholly owned and operated by a physician multispecialty practice where one or more board-certified or eligible 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 and perform interventional pain procedures of the type routinely billed using surgical codes.
The certificate of exemption must be renewed every two (2) years, provided that the Department of Health may issue initial certificates for up to three (3) years to stagger renewal dates.
Once received, the clinic must prominently display the Certificate of Exemption and make it available to the Department of Health or applicable board upon request. If any key information submitted on the application changes such as the applicant, qualifying owners, licenses, registrations, certifications, exemption reason, or location, the clinic must obtain a new Certificate of Exemption by completing a new application.
A clinic must notify the Department of Health at least sixty (60) days before any anticipated relocation or name change of the pain management clinic or a change of ownership. If the clinic no longer qualifies for a Certificate of Exemption, it must notify the Department of Health within three (3) days of becoming aware that it no longer qualifies and must register as a pain management clinic or cease operations.
The Department of Health may impose of fine on the clinic of up to $5,000 per day for violations. Furthermore, an owner or designated physician of a pain-management clinic who concurrently operates an unregistered pain-management clinic is also subject to a fine of $5,000 per day, including upon a change of ownership.
If you have any questions, please contact Gunster health care law attorney Samantha Prokop.
