For the last few years, the Florida Legislature and the Department of Health have strived to curb the troublesome influx of pain clinics that overprescribe controlled substances, a/k/a pill mills. The latest effort came this past legislative session when the Legislature passed House Bill 7095. Effective on July 1, 2011, it makes regulatory changes affecting not only pill mills, but also to the prescribing and dispensing standards for controlled substances for physicians, “legitimate” pain management clinics, pharmacies, and wholesale pharmaceutical distributors. All health care practitioners should understand these changes in order to comply with new regulatory demands in today’s highly regulated and scrutinized environment.Some of the new requirements include:
• Limitations on Physician Dispensing and Prescribing Controlled Substances
According to HB 7095, physicians dispensing controlled substances may no longer dispense Schedule II or III drugs. Previously, dispensing physicians could dispense Schedules II, III, IV and V drugs in their offices. Now physicians may only dispense Schedules IV and V drugs and non-controlled substances in their offices unless one of a few exceptions apply, such as in treating hospice patients. The law also no longer differentiates between cash-paying patients and those with insurance for dispensing purposes. Previously, physicians practicing in registered pain clinics could dispense only a 72-hour supply of controlled substance to patients who paid out of pocket. There was no limit on insured patients. The new law removes the 72-hour limitation on physicians practicing in pain clinics but requires that any physician prescribing more than a 72-hour dose document the reason for prescribing in the patient’s record. In addition, all physicians who prescribe controlled substances must use counterfeit-proof prescription pads produced by a vendor approved by the Department of Health (“DOH”).
• Physician Registration and Standard of Care Requirements
Effective January 1, 2012, any physician, including physicians, osteopathic physicians, podiatrists and dentists, who prescribes controlled substances (Schedules II through V)to treat chronic nonmalignant pain must register with DOH by designating himself or herself as a Controlled Substance Prescribing Practitioner on his or her DOH Practitioner Profile.
For those physicians who prescribe controlled substances for the treatment of chronic nonmalignant pain, whether in a pain clinic or not, HB 7095 imposes additional standards of practice and documentation requirements, including:
• Documentation of complete medical history and physical examination before beginning any treatment.
• Written individualized treatment plan for each patient.
• Written controlled substances agreement that outlines the patient’s responsibilities and clarifies the risk and benefits of the use of controlled substances and the risk of abuse and addiction.
• A schedule of regular follow up visits with the patient, who must be seen at a minimum every three months, in order to assess the efficacy of the treatment and drug therapy.
• Referrals to specialists when indicated.
• Maintenance of accurate and complete records on each patient.
The law exempts certain categories of physicians, including board-certified anesthesiologists, physiatrists, neurologists, physicians who have completed fellowships in pain medicine or board-certified physicians with surgical privileges at a hospital or ambulatory care center.
• Physicians in Registered Pain Management Clinics
In addition to the requirement that physicians practicing at pain clinics complete a pain management fellowship or residency by July 1, 2012, now each physician working in a pain clinic is responsible for ensuring that the clinic complies with certain facility and infection control requirements, health and safety requirements, quality assurance measures and data collection and reporting.
All physicians should be aware of these new requirements because changing circumstances may cause these requirements to apply to them. The legislation imposes significant penalties on physicians who do not comply with these new requirements and enforcement is expected to be aggressive. Controlled substance regulation will remain an evolving area for physicians because DOH will most likely supplement these statutory changes with additional rules and it is critical for physicians to remain informed about their legal obligations.
