Yesterday Gov. Steve Beshear signed into law House Bill 217 (HB 217), which modifies the state's prescription drug law passed during the 2012 special legislative session.
The 2012 legislation, commonly referred to as the "pill mill bill" or House Bill 1, was passed to combat prescription drug abuse in Kentucky through the close regulation of pain management clinics and the implementation of new standards on those prescribing and dispensing controlled substances.
Gov. Beshear and many lawmakers have touted the success of the law in closing pills mills and curbing painkiller abuse, but they have also acknowledged the law's unintended consequences. HB 217 alters the 2012 legislation to address some of these unintended consequences while preserving its original intent.
HB 217 provides that the administrative regulations promulgated under the prescription drug law must be modified to reflect numerous changes to the law. Key changes to the 2012 legislation made by HB 217 and the accompanying regulations include the following modifications to the required prescribing and dispensing protocol and reporting requirements:
- Medical histories and physical examinations. When "appropriate to the patient's medical complaint," a recent medical history must be obtained and a physical or mental health examination must be conducted before the initial prescribing or dispensing of a Schedule II or Schedule III controlled substance containing hydrocodone. Before HB 217, the law required that a medical history be obtained or a physical examination be conducted in each instance certain controlled substances were prescribed or dispensed for the first time. Conducting a mental health examination was previously not an option to satisfy this requirement.
- KASPER queries. When a query of the state's prescription drug monitoring system, KASPER, is required, only available data from the 12 months preceding the patient encounter must be utilized in the evaluation and treatment of patients. There was previously no time limit on the KASPER data that needed to be considered, which many found to be an administrative burden and unnecessary for the development of an effective treatment plan.
- KASPER reporting requirements. HB 217 modifies the 2012 legislation to provide an exemption to hospitals, long-term care facilities, and approved researchers from the law's requirement to report controlled substances administered directly to patients to the Cabinet for Health and Family Services (CHFS). Beginning July 1, 2013, all other licensees that are not exempt from the reporting requirements must notify CHFS through KASPER within one day of dispensing a controlled substance.
Furthermore, HB 217 provides that the administrative regulations may provide special exemptions to certain licensed providers. The regulations offer exemptions to the additional standards for prescribing or dispensing a Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone to the following providers:
- Hospitals and long-term care facilities that query KASPER for available data from the previous 12 months within 12 hours of the patient or resident's admittance into the facility and keep this query in the individual's medical record for the duration of his or her stay at the facility
- Licensees prescribing controlled substances as part of patient hospice or end-of-life care, as treatment of cancer and associated pain, or as a single dose issued during a diagnostic test or procedure
- Licensees substituting a new prescription for an initial prescription within 7 days of the initial prescribing or dispensing where refills for the initial prescription are canceled and the patient disposes of any unconsumed medication
- Licensees treating a patient for the same medical condition that another practitioner in the same practice or coverage arrangement also treated the patient for within 90 days of the initial prescription
- Licensees issuing controlled substances prior to, during, and 14 days after surgery when the medication relates to the procedure performed
- Researcher licensees offering controlled substances to subjects during certain approved research projects
Hospitals, long-term care facilities, and physician practices should be aware of how changes to the prescription drug law affect their operations. The administrative regulations promulgated under the prescription drug law provide important additional insight into the requirements of healthcare entities involved in the issuance of controlled substances in Kentucky. Policies and procedures incorporating the new standards on those prescribing and dispensing controlled substances will need to be updated accordingly.