Out of the heated debate between the Attorney General representing law enforcement and the Kentucky Medical Association representing physicians, Kentucky’s “Pill Mill Bill” is sweeping legislation designed to combat prescription drug abuse through increased regulation of pain clinics and greater scrutiny of prescribing practices by various agencies of state government. The Legislation becomes effective on July 20, 2012 and imposes requirements not just for doctors practicing pain medicine, but for all practitioners who prescribe controlled substances. In addition to placing significant limits on the ownership of pain clinics and imposing a host of requirements governing the operations of pain clinics, the legislation also strengthens licensing standards for physicians and other practitioners and requires practitioners to take specific steps prior to prescribing or dispensing a Schedule II or Schedule III controlled substance.
The Legislation was specifically designed to target “pill mills” and pain clinics. Imposing a host of new requirements, the Legislation defines the term “pain management facility” as “a facility where the majority of patients of the practitioners at the facility are provided treatment for pain that includes the use of controlled substances” and “the facility’s primary practice component is the treatment of pain or the facility advertises in any medium for any type of pain management services.” The legislation provides that only a physician having a full and active license to practice medicine in the Commonwealth of Kentucky shall have an ownership or investment interest in a pain management facility. However, the legislation “grandfathers” non-physician owned pain management facilities that were existing and operating before the legislation was signed by Governor Beshear “unless there is an administrative sanction or criminal conviction related to controlled substances imposed on the facility or any person employed by the facility for an act or omission done within the scope of the facility’s licensure or the person’s employment.”
Regardless of the ownership of the facility, beginning on July 20, 2012, all pain management facilities must meet strict staffing requirements. The legislation requires at least one of the owners of the facility, or an owner’s designee, who is a physician, such as a medical director who is employed by and under the supervision of the owner, to be physically present practicing medicine in the facility for at least fifty percent (50%) of the time that patients are present in the facility. More importantly, the physician owner or the designee must meet specific specialty or subspecialty certification requirements or have completed an accredited residency or fellowship in pain management. The aim of these requirements is to assure that a pain clinic has a physician trained and certified in pain management present when patients are treated. This means that a pain clinic may not be staffed with mid-level practitioners without the presence of a physician at least half the time the clinic is open.
New Requirements for Prescribing Controlled Substances
The legislation imposes specific clinical and documentation standards on all practitioners prescribing any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone, irrespective of whether the practitioner is practicing in a “pain management facility” as defined by the legislation. The legislation provides that “prior to the initial prescribing or dispensing of any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone…a practitioner shall obtain a complete medical history and conduct a physical examination of the patient and document the information in the patient’s medical record; query the Kentucky All Schedules Prescription Electronic Reporting (“KASPER”) system for all available data on the patient; make a written treatment plan stating the objectives of the treatment and further diagnostic examinations required; discuss the risks and benefits of the use of controlled substances with the patient, the patient’s parent if the patient is a child, or the patient’s legal guardian or health care surrogate, including the risk of tolerance and drug dependence; and obtain written consent for the treatment.” The legislation further requires the practitioner to review the course of treatment at reasonable intervals and provide any new information about the treatment to the patient. As part of the review of the course of treatment, the practitioner is required to query the KASPER system not less than once every three (3) months for all available data on the patient and review that data before issuing any new prescription or refills for the patient for any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone. KASPER reports are to be kept in a patient’s medical record.
The legislation even goes so far as to dictate the required content of a patient’s medical record when a practitioner prescribes controlled substances. The legislation provides that “for each patient for whom a practitioner prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone, the practitioner shall keep accurate, readily accessible, and complete medical records which include medical history and physical examination; diagnostic, therapeutic, and laboratory results; evaluations and consultations; treatment objectives; discussion of risks, benefits, and limitations of treatments; treatments; medications, including date, type, dosage, and quantity prescribed or dispensed; instructions and agreements; and periodic review of the patient’s file.”
To assure enforcement, the Legislation powers of state licensing boards to issue regulations governing prescribing standards and to take enforcement actions against practitioners who have improper prescribing practices. The legislation requires each state licensing board, which includes the Kentucky Board of Medical Licensure, the Kentucky Board of Nursing, the Kentucky Board of Dentistry, the Kentucky Board of Optometric Examiners and the State Board of Podiatry to establish administrative regulations by September 1, 2012, the following: mandatory prescribing and dispensing standards related to controlled substances; a prohibition on a practitioner dispensing greater than a forty-eight (48) hour supply of any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone unless the dispensing is done as part of a narcotic treatment program licensed by the Kentucky Cabinet for Health and Family Services; a procedure for temporarily suspending, limiting or restricting a license where a substantial likelihood exists to believe that the continued unrestricted practice by the licensee would constitute a danger to the health, welfare or safety of the licensee’s patients or of the general public; and a procedure for the expedited review of complaints filed against licensees pertaining to the improper, inappropriate, or illegal prescribing or dispensing of controlled substances that is designed to commence an investigation within seven (7) days of a complaint being filed and produce a charging decision by the state licensing board on the complaint within one-hundred twenty (120) days of the receipt of the complaint, unless an extension for a definite period of time is requested by a law enforcement agency due to an ongoing criminal investigation.
Kentucky’s Pill Mill Bill requires not only pain management facilities but all practitioners prescribing controlled substances to make changes to conform their practices, procedures and operations to the requirements of this law. Consequently, the enforcement climate in Kentucky is now stricter and practitioners will need to emphasize compliance with proper prescribing practices to adapt to the new enforcement climate.
About the Author
Lisa English Hinkle is a Partner of McBrayer, McGinnis, Leslie & Kirkland, PLLC. Ms. Hinkle concentrates her practice area in health care law and is located in the firm’s Lexington office. She can be reached at firstname.lastname@example.org or at (859) 231-8780.
This article is intended as a summary of newly enacted federal law and does not constitute legal advice.