Kentucky’s troubled history with the abuse of prescription medication is no secret. Recent legislation hopes to reduce access to prescription pills while not interfering with legitimate medical care. Following the introduction of Kentucky’s first Pill Mill Laws in July 2012, physicians responded to the regulations with concerns about their ability to effectively treat patients under the guidelines. In light of those concerns, the General Assembly and the Kentucky Board of Medical Licensure amended the “Pill Mill Law.” Effective March 4, 2013, the amended statute and regulations balance the concerns of prescription drug abuse with the needs of physicians to prescribe controlled substances in their practice. See KRS 218A.172 and 201 KAR 9:260.
The new laws continue to explicitly regulate how controlled substances can be prescribed in Kentucky. Due to the lengthy nature of the laws, this article will present highlights of the amended “Pill Mill Law.” The Kentucky Board of Medical Licensure’s web page contains additional information and material regarding the requirements of the new laws. Be advised that failure to follow these requirements may subject the physician to licensure inquiries before the KBML.
The statute, KRS 218A.172, focuses only on the prescription of Schedule II controlled substances and Schedule III controlled substances with hydrocodone. The KBML regulations, as discussed below, are much broader and encompass Schedule III and Schedule IV substances as well.
Under KRS 218A.172, the General Assembly created minimum guidelines for the prescription of Schedule II substances and Schedule III substances with hydrocodone, but left to the regulating entity the task of implementing these minimum guidelines. These include (1) obtaining a medical history and conducting a physical or mental examination “appropriate” to the complaint; (2) querying KASPER for the preceding 12month period; (3) creating a written plan listing the objectives of the treatment and potential diagnostic examinations; (4) discussing the risks (addiction) and benefits of the controlled substance; and (5) obtaining written consent for the treatment. Additionally, the practitioner must keep accurate and accessible medical records that explain the rationale for the prescription of these medications.
With regard to the prescription of Schedule II controlled substances and Schedule III controlled substances with hydrocodone to a patient, the statute requires the KBML to enact regulations that require the physician to (1) review the plan of care and the patient’s needs at reasonable intervals; (2) modify the plan as appropriate; (3) query KASPER once every three months for the preceding 12month period; and (4) review the KASPER data before issuing new prescriptions.
Interestingly, the statute allows the regulating entity, like the KBML, to enact exemptions to the general prescribing rules for Schedule II controlled substances and Schedule III controlled substances with hydrocodone. Those potential exemptions include (1) prescribing the medicine prior to, during or 14 days after a surgery; (2) in an emergency situation; (3) by a pharmacist; (4) when the patient is in a hospital or long term care facility; (5) as part of hospice; (6) for cancer treatment; and (7) as a single dose to relieve anxiety when submitting to a diagnostic exam or other procedure. Finally, the regulating entity can create additional exemptions by providing notice to the Kentucky Office of Drug Control Policy, making a factual finding based upon expert testimony, and submitting a report to the Governor and Legislative Research Commission.
The KBML guidelines implementing the controlled substances laws are intricate and are divided into two broad areas: (1) prescriptions of Schedule III (without hydrocodone) and IV substances and (2) prescriptions of Schedule II and III (with hydrocodone) substances. See 201 KAR 9:260. However, the typical exemptions apply to both: end of life; hospital inpatient; cancer treatment; long term care facility patient; during a mass disaster; or a single dose to ease anxiety before a procedure. The requirements to prescribe Schedule III (without hydrocodone) and IV substances on a short-term basis for pain are the same as the older version of the law, except it does not require verifying identity with a government issued ID, and the KASPER report only has to be reviewed for the 12 months preceding the prescription.
For long-term prescriptions (greater than three months) of Schedule III (without hydrocodone) and IV substances for pain, the restrictions are relaxed to allow partners in a single group practice to prescribe these medications if all of the prescribing partners follow the mandates of the regulation. See 201 KAR 9:260, Section 4. Be advised that the regulations continue to require a very strict chaperoning by the physician of those patients that require Schedule III (without hydrocodone) and IV substances for treatment of pain for longer than three months. The KBML has a summary of its controlled substances regulations on its web page to help the physician navigate these requirements.
As to Schedule II controlled substances and Schedule III controlled substances with hydrocodone, the baseline rule is that these substances can only be dispensed by a physician for a 48 hour supply unless the patient is part of a narcotic treatment program licensed by the Cabinet for Health and Family Services. Physicians cannot avoid this requirement by dispensing the substances on a consecutive or continuous basis. See 201 KAR 9:220.
When prescribing Schedule II controlled substances and Schedule III controlled substances with hydrocodone, the general standards from 201 KAR 9:260 apply as well as additional standards that the General Assembly has mandated in KRS 218A.172. Physicians prescribing Schedule II or III with hydrocodone to patients near the end of life, suffering from cancer, in a hospital or long term care facility or receiving a single dose for procedure anxiety are exempt from the general and specific prescription requirements in the statute and the regulation. Finally, physicians can prescribe a 14-day supply of these medications without meeting the additional standards required in KRS 218A.172 prior to or following surgery. However, the general prescription requirements apply.
With these new laws and regulations, the Commonwealth of Kentucky has taken another step in preventing further escalation of prescription drug abuse.
Andrew D. DeSimone is a partner with Sturgill, Turner, Barker & Moloney, PLLC. Mr. DeSimone concentrates his practice in the areas of healthcare law and medical malpractice defense. He can be reached at adesimone@sturgillturner.com or (859) 255-8581.
This article is intended as a summary of newly enacted state law and does not constitute legal advice.