In response to the increasing threat posed by the abuse of prescription drugs, specifically narcotic painkillers, the Florida Legislature passed legislation aimed at limiting the availability of such drugs by slowing the proliferation of pain-management clinics throughout the state. As a result, many privately-owned pain-management clinics, facilities, or offices will be required to, among other things, register with the Florida Department of Health or face stiff penalties for non-compliance.
Florida Statutes Sections 458.3265(1)(a) (allopathic physicians) and 459.0137(1)(a) (osteopathic physicians) each provide that, effective October 1, 2010, privately-owned facilities, clinics, or offices “which advertise in any medium for any type of pain-management services, or employ a physician who is primarily engaged in the treatment of pain by prescribing or dispensing controlled substance medications, must register with the department unless [an exception applies].” Each statute provides for some limited exceptions. For example, practices with physicians that primarily render surgical services or that do not prescribe or dispense controlled substances for the treatment of pain are not required to register. Practices that do not qualify for an exception and are required to register will face a host of new obligations, including, but not limited to, obligations related to clinic operations, restrictions on prescribing and dispensing, training, treatment, patient examinations and testing, and record keeping.
We recommend that each practice conduct a fact-specific analysis of the practice’s operations to determine whether it is subject to the registration requirement. In our experience, however, this is not always a straightforward exercise. The “advertising” prong of analysis, i.e., does the practice advertise in any medium for any type of pain-management services, has been the most problematic—the scope is so broad that many physician practices that were not the intended targets of the legislation may be forced to register. Fortunately, the Florida Medical Association recently filed a Petition for Declaratory Statement with the Florida Department of Health requesting that the Department of Health clarify the specific advertising activities and content that will subject a practice location to the registration requirement.
It should also be noted that a pain-management clinic, two physicians, and a patient filed a lawsuit in federal court challenging the constitutionality of the legislation. In addition to challenging the validity of the law, the lawsuit seeks to enjoin the law pending final adjudication of the case. To date, the court has not acted on the injunction request.
In light of the additional burdens that registration entails, and the potential penalties that can be imposed for failing to register, the decision to register a practice location is critically important to your practice. If you have questions regarding the applicability of the registration requirement to one or more of your practice’s locations, we suggest that you closely monitor the progress of the legislative and judicial proceedings discussed above and consult with a health law attorney.
