Out of the heated debate between the Attorney General representing law enforcement and the Kentucky Medical Association representing physicians, the legislature enacted Kentucky’s “Pill Mill Bill,” which 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 Pill Mill Bill becomes effective on July 20 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 who can own a pain clinic and how a pain clinic is operated, the legislation requires Kentucky’s licensing boards, including the Kentucky Board of Medical Licensure and the Kentucky Board of Nursing, to enact new regulations that impose standards for physicians, nurses and other practitioners when a Schedule II or Schedule III controlled substance is prescribed.
Because the Pill Mill Bill imposes sweeping changes for pain clinics and prescribing practices, all health-care providers and their patients will face new challenges as procedures change. Regardless of whether the legislation stops the shifting pattern of drug abuse from illicit to prescription drugs, physicians are at the center of the Pill Mill Bill and are now required to reduce the risk of diversion and abuse of prescription drugs when treating a patient’s pain. Whether the collateral effect of the Pill Mill Bill is the serious under treatment of pain is yet to be seen.
Pain clinics
One of the most important public health trends of the last 10 years is the shifting pattern of drug abuse from heroin, cocaine and marijuana to prescription drugs that are opioid based. Kentucky’s Pill Mill Bill was specifically designed to target “pill mills” and pain clinics. By defining a pain clinic 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, or where the clinic’s primary practice component is the treatment of pain, or where the facility advertises in any medium for any type of pain management services, the legislation is meant to cover any practice that holds itself out as treating chronic pain.
For clinics that meet the definition, the legislation requires that a physician having a full and active license to practice medicine in Kentucky shall have an ownership or investment interest in a pain management facility. The legislation, however, “grandfathers” non-physician-owned pain management facilities that were operating before the legislation was signed by Gov. Steve 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, 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 and practicing medicine in the facility for at least 50 percent of the time that patients are present in the facility.
More importantly, the physician owner or owner’s 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 who is trained and certified in pain medicine 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
In addition to regulating pain clinics, the Pill Mill Bill 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.
Now, by statute, a practitioner who prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone is required to (1) obtain a complete medical history and conduct a physical examination of the patient and document the information in the patient’s medical record; (2) perform a Kentucky All Schedules Prescription Electronic Reporting (”KASPER”) system search for all available data on a patient; (3) make a written treatment plan stating the objectives of the treatment and diagnostic examinations required; (4) discuss the risks and benefits of the use of controlled substances with the patient, the patient’s parent or a legal guardian that include the risk of tolerance and drug dependence; and (5) 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, a practitioner is required to query the KASPER system not less than once every three 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.
The legislation even goes so far as to dictate the required content of the medical record of a patient who receives controlled substances. The legislation requires a practitioner who prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone to keep accurate, readily accessible, and complete medical records that include medical history and physical examination results; diagnostic, therapeutic, and laboratory results; evaluations and consultations; treatment objectives; discussion of risks, benefits, and limitations of treatments; treatments; a list of medications, including date, type, dosage and quantity prescribed or dispensed; instructions and agreements; and conduct of periodic review of the patient’s file.
Requirements for licensing boards
State licensing boards are now required to promulgate administrative regulations governing prescribing standards and to take enforcement actions involving improper prescribing practices. The legislation requires state licensing boards that include 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 issue regulations by no later than Sept. 1 that address the following: mandatory prescribing and dispensing standards for controlled substances; prohibiting practitioners from dispensing greater than a
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 licensed narcotic treatment program; a procedure for temporarily suspending, limiting or restricting a license where a substantial likelihood exists that the unrestricted practice by the licensee would constitute a danger to the health, welfare or safety of patients or the public; and a procedure for the expedited review of complaints filed against licensees for prescribing or dispensing of controlled substances that is designed to start an investigation within seven days of a complaint being filed and produce a charging decision on the complaint within 120 days, 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 has made clinical standards for prescribing controlled substances the law, which will require not only pain management facilities but all practitioners prescribing controlled substances to make changes to conform their policies, procedures and operations to the requirements of the law as well as the regulations that will follow.
With only a few exceptions, practitioners will have to gather KASPER reports before prescriptions for controlled substances will be issued to patients. Because of the potential liability with licensing boards, practitioners may decide that prescribing pain medications creates too much risk. Consequently, risk also exists that pain will be undertreated. With the strict enforcement climate in Kentucky, all practitioners will need to incorporate the new requirements for prescribing into the their practices. Now, more than ever, compliance efforts must include prescribing practices.
Lisa English Hinkle is a partner of McBrayer, McGinnis, Leslie & Kirkland, PLLC, and Christopher J. Shaughnessy is an attorney at McBrayer, McGinnis, Leslie & Kirkland, PLLC. Both concentrate their practice areas in health-care law and are located in the firm’s Lexington office. They can be reached by email at lhinkle@mmlk.com or cshaughnessy@mmlk.com or by phone at (859) 231-8780.
Please note: This article is intended as a summary of newly enacted state law and state law enforcement activities and does not constitute legal advice.