Looming Deadline Could be a Pain for Exempt Florida Pain Management Clinics
By Jan. 1, 2019, all healthcare facilities that meet the statutory definition of "pain-management clinic" under Fla Stat. §§ 458.3265 and/or 459.0137 must be registered with the Department of Health (DOH) or hold a certificate of exemption. Under these statutes, public or private facilities that (i) advertise in any medium any type of pain management services, or (ii) have in any month a majority of the patients who are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic malignant pain, are required to register with the DOH unless that facility meets one of the many enumerated exemptions.
Under a previous version of the law, pain-management clinics exempt from registration were not required to take affirmative action to benefit from exempt status. Rather, a facility could make its own determination as to whether an exemption applied, potentially facing penalties if that determination was erroneous. However, the passage of House Bill 21 – signed into law by Governor Scott on Mar. 19, 2018 – requires exempt clinics to apply to DOH and hold a certificate of exemption by Jan. 1, 2019.
Under DOH guidance and the applicable statutes, an applicant for certificate of exemption must provide: (i) the name or names under which the applicant does business; the address at which the pain management clinic is located; (iii) the specific exemption that the applicant is claiming, along with supporting documentation; and (iv) any other information DOH deems necessary. DOH has 30 days to process applications for certificates of exemption. While the requirements for an exemption are set forth in Fla Stat. §§ 458.3265 and/or 459.0137, whether or not an exemption applies can often be a fact intensive inquiry. Layer on top of that the added complexity of complying with one of the many local ordinances and requirements that have both overlapping and separate requirements.
Operation of an unregistered pain-management clinic can result in fines of $5,000 per day. These substantial financial penalties in mind, facilities that arguably fit the definition of a pain-management clinic should quickly analyze its business under the statute and take appropriate action.