On April 24, Governor Beshear signed into law Kentucky House Bill 1, which introduces restrictions on pain management clinics, strict new limits on prescribing controlled substances, and increased reporting requirements for practitioners using Kentucky’s “KASPER” electronic controlled substances monitoring system. Proponents of the new law hailed it as an important step in battling the prescription drug abuse epidemic that has arisen in Kentucky. Critics of the bill (including the Kentucky Medical Association) argue that it overreaches by intruding into the physician patient relationship and creating burdensome requirements on physicians.
HB 1 defines a “Pain Management Facility” as a facility where the majority of the patients of practitioners at the facility are provided treatment for pain that includes the use of controlled substances and either (i) the facility’s primary practice component is the treatment of pain or (ii) the facility advertises in any medium for any type of pain management services. Specifically excluded from this definition are educational institutions, hospices, ambulatory surgical centers, long-term care facilities, hospitals, and offices of hospital-employed physicians. HB 1 requires each pain management facility to be owned only by licensed physicians and to be operated by a certified pain management specialist (whether the owner or his or her designee).
HB 1 also places tight restrictions on health care practitioners prescribing controlled substances, whether or not in the context of a pain management facility. Specifically, HB 1 requires that prior to the initial prescribing or dispensing of certain classes of controlled substance, the 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 KASPER 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, including the risk of tolerance and drug dependence; and
- Obtain written consent for the treatment.
In addition, a practitioner must periodically monitor the course of treatment and query KASPER no less than once every three months before issuing any new prescription refills for the controlled substances. The practitioner must also create and maintain detailed records regarding the patient and the controlled substances prescribed. The bill also mandates that each health care professional licensing board in the Commonwealth establish regulations regarding controlled substances, including establishing mandatory prescribing and dispensing standards, prohibiting a practitioner from dispensing greater than a forty-eight hour supply of certain controlled substances, and establishing procedures for suspending a practitioner’s license to protect patients and the public.
HB 1 transfers operation of KASPER from the Cabinet for Health and Family Services to the Attorney General, and it requires all licensed health care practitioners and pharmacists to register to use KASPER. Dispensers of certain controlled substances must report data to KASPER within twenty-four hours of dispensation. Practitioners must query KASPER prior to prescribing or dispensing certain controlled substances.
Finally, HB 1 authorizes an interstate compact to permit state prescription monitoring programs to share prescription data among themselves. The provisions of the bill regarding the compact are to become effective and binding upon the legislative enactment of the compact into law by no less than six states.
HB 1 becomes effective on July 12, 2012.