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While it would not make any sense to concurrently prescribe an emergency opioid antagonist with a non-opioid Schedule II controlled substance, the Legislature did not limit this requirement. Hopefully, the boards will interpret this requirement in a reasonable manner. The FMA will seek guidance from the boards and will provide an update as information becomes available. In addition to the 3-7 day limitation on the prescribing of Schedule II opioids, HB 21 requires each board to adopt rules establishing guidelines for prescribing controlled substances for acute pain. The guidelines are to include evaluation of the patient, creation and maintenance of a treatment plan, obtaining informed consent and agreement for treatment, periodic review of the treatment plan, consultation, medical record review, and compliance with controlled substance laws and regulations. It is hoped that the guidelines will provide answers to the inevitable questions that will be raised based on the 3-7 day prescribing limitation. For example, does a physician have to physically see the patient after the 3-7 day prescription expires before the physician can issue another prescription? Can the physician consult with the patient over the phone after the initial 3-7 day prescription period and e-prescribe a Schedule II opioid that the patient can pick up without having to go the physician’s office? Can the physician hand the patient three staggered 3-7-day prescriptions for a Schedule II opioid? The FMA expects the guidelines from the Board of Medicine and Board of Osteopathic Medicine to be adopted sometime after the July 1 effective date of the legislation. The FMA will work to ensure that the guidelines are reasonable, will make all drafts available to our members, and will issue a notification once the guidelines are adopted. Pain-management Clinic Registration: On Oct. 1, 2010, the Florida Statutes began to require “pain-management clinics” to register with the Florida Depart-ment of Health. In 2011, the Legislature amended the definition of a “pain-management clinic” to require registration for all publicly or privately owned facilities that (1) advertise 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. The Legislature exempted the following entities from the registration requirement:• A clinic licensed as a facility pursuant • A clinic in which the majority of the physicians who provide services in the clinic primarily provide surgical service • 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• The clinic is 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. Prior to the passage of HB 21, a facility that met the definition of a “pain-management clinic” but did not have to register as a pain-management clinic because it fit into one of the exemptions, did not have to take action to comply with the pain-clinic legislation. The facility could determine on its own whether it was required to register. If the facility erroneously chose not to register, any physician who practiced medicine therein would be in violation of section 458.3265 or section 459.0137, Florida Statutes, and would be subject to discipline by his or her medical board. HB 21 changes this arrangement by requiring that the clinics exempt from having to register must apply to the DOH for a certificate of exemption. Thus, if a facility advertises in any medium for any type of pain-management service or prescribes in any month the above mentioned medications to a majority of the facility’s patients for the treatment of chronic nonmalignant pain, but fits within one of the eight exceptions, that facility has to apply for a certificate of exemption. The DOH will have to adopt a form for the application, and will have to approve or deny the certificate within 30 days after receipt of the application. The FMA will notify members as soon as the application form is approved and available. HB 21 requires each person registered with the DEA and authorized to prescribe controlled substances to take a board-approved two-hour continuing education course on prescribing controlled substances. The course must be taken from a “statewide professional association of physicians in this state that is accredited to provide educational activities designated for the AMA PRA Category 1 credit™ or the American Osteopathic Category 1-A continuing medical education credit as part of biennial license renewal.”The course must be taken by allopathic physicians, osteopathic physicians, podiatrists, dentists and optometrists who are registered with the DEA. Advanced registered nurse practitioners and physician assistants already have to take a three-hour course on controlled substance prescribing.The Board of Medicine and the Board of Osteopathic Medicine have approved a joint FMA/FOMA course, which is available at www.FLmedical.inreache.com. EACH PHYSICIAN REQUIRED TO TAKE THE COURSE MUST DO SO INITIALLY BY JAN. 31, 2019, AND THEN PRIOR TO EACH SUBSEQUENT LICENSURE RENEWAL. It should be noted that the standards of practice regarding the treatment of chronic, nonmalignant pain are unchanged. The 3-7 day limit on prescribing Schedule II opioids only applies to acute pain – not chronic nonmalinant pain. The requirement for checking the PDMP database, however, applies for the prescription of almost any controlled substance, for any reason. It does not matter if the prescription is for acute pain or chronic nonmalignant pain. If you are an FMA member who has questions about how HB 21 affects your practice, please contact FMA General Counsel Jeff Scott, Esq., at jscott@flmedical.org Florida Risk Management/Patient Safety Act Medical Errors Medical errors are a common occurrence in the healthcare industry. According to the landmark Institute of Medicine (IOM) report in 1999, To Err is Human: Building a Safer Health System, there are 44,000 to 98,000 deaths each year in the United States, or at least 120 deaths per day, because of human error related to the delivery of healthcare.

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