On July 20, 2012, new laws became effective that will impact every physician practicing in the Commonwealth of Kentucky. These new laws explicitly regulate how controlled substances can be prescribed in Kentucky, because of their devastating impact on families and communities. The new laws attempt to control the illegal substances at the dispensing source, although many of the requirements are something that physicians should be doing already, such as performing physical examinations and charting the patient’s past medical history. The new laws leave many questions unanswered. This article will attempt to address the highlights of the new “Pill Mill Law”; however, the new laws are so lengthy that it can only be a short overview. Be advised that failure to follow these requirements may subject the physician to licensure inquiries before the KBML.
So what do the new laws require? The new statute, KRS 218A.205, states that before a physician can prescribe a Schedule II or Schedule III with hydrocodone, the physician must (1) obtain a complete medical history and conduct a physical examination; (2) query KASPER; (3) create a written treatment plan listing the objectives of the treatment and potential diagnostic examinations; (4) discuss the risks (addiction) and benefits of the controlled substance; and (5) obtain written consent for the treatment. The physician must routinely monitor the patient during the prescribing period and review KASPER reports every three months. Additionally, the practitioner must keep accurate and accessible medical records that explain the rationale for the prescription. However, the General Assembly created exceptions, such as during surgery, in emergency situations, or with hospice care.
The KBML created further mandatory requirements (regulations), while keeping the mandates required by the General Assembly. However, there are some discrepancies between the two. For instance, the regulation, 201 KAR 9:260, applies to the prescription of any controlled substance. Moreover, the exceptions created by the KBML are broader than those in the statute (cancer patients and nursing home residents are exempt). However, the General Assembly’s mandates control, and a physician must follow KRS 218A.205, and not the KBML regulation, when prescribing a Schedule II or III (with hydrocodone) controlled substance to a cancer patient or a nursing home resident.
Under the KBML guidelines, to prescribe any controlled substance the physician must (1) verify the identity of the patient by government issued photo ID; (2) obtain a medical history and conduct a physical examination; (3) review KASPER (this does not apply to Schedule IV or V medications with the exception of certain drugs including Ambien, Ativan, Klonopin, Soma, Tramadol, Valium, Versed, Xanax and others); (4) decide the prescription is appropriate; (5) prescribe the medication in the lowest dose for the shortest amount of time; (6) not prescribe long-acting or controlledrelease opioids for acute pain; (7) advise the patient to discontinue the use once the pain has resolved; and (8) explain how to safely dispose of the medication.
If the physician prescribes a controlled substance “for a total period of longer than three (3) months,” the physician must (1) obtain a past medical history on the patient and first degree relatives (which history must include illegal or legal substance abuse by the patient); (2) conduct a comprehensive physical examination sufficient to support the prescription of long term controlled substances; (3) obtain the medical records from other practitioners; (4) establish a working diagnosis (listing symptoms is insufficient); (5) formulate a treatment plan; (6) use screening tools (including a baseline urine drug screen for legal and illegal substances) to ensure that the patient is not addicted to any substance, suffering from psychiatric or psychological condition, or presents a risk of diverting the prescribed medication; (7) obtain an informed consent; and (8) prescribe the medication for the shortest duration and lowest dosage.
When prescribing a controlled substance for longer than three months the physician must (1) evaluate the patient at least once a month; (2) determine if the patient is improving (this includes discussing the patient with family members and other independent sources. If the physician sees no improvement, the physician must order an independent consultation for potential undiagnosed conditions, including potential psychiatric/ psychological counseling.); (3) perform once a year preventive health screening (or ensure that it is performed); (4) review KASPER every three months (if the physician learns that the patient is obtaining controlled substances from other practitioners, without knowledge and approval, the physician must notify law enforcement); (5) perform random pill counts and random urine screens to guard against diversion.
In the ER setting, along with a history and physical exam, the physician must review KASPER. If unable to do so, the physician must document in the patient’s chart that the medical necessity outweighs the risk of unlawful use or diversion of controlled substances. Additionally, the ER physician is “strongly discouraged and shall not routinely” administer IV controlled substances for chronic pain; provide replacement prescriptions for lost, stolen, or destroyed prescriptions; prescribe long-acting or controlled-released substances; or provide more than a three day supply of the controlled substance. If any of these guidelines are departed from, the physician must document the exceptional circumstances at issue.
Despite the importance of preventing diversion of properly prescribed controlled substances, these new laws raise serious questions that will need to be answered. The new laws are so pervasive that physicians might be considered a “state actor” for civil liability purposes when conducting urine screens and informing police of potential illegal activity. Will physicians simply stop prescribing controlled substances because of these new laws, potentially abandoning patients? Will insurance pay for the additional visits required under these laws? Does HIPAA prevent the disclosure of KASPER information to police? Does the regulation really mean that a child cannot be prescribed a controlled substance, because the child does not have a photo ID?
These and other questions must be answered as the new laws take effect. However, one thing is certain: the new laws have changed the practice of medicine in Kentucky.
IN THE ER SETTING, ALONG WITH A HISTORY AND PHYSICAL EXAM, THE PHYSICIAN MUST REVIEW KASPER. IF UNABLE TO DO SO, THE PHYSICIAN MUST DOCUMENT IN THE PATIENT’S CHART THAT THE MEDICAL NECESSITY OUTWEIGHS THE RISK OF UNLAWFUL USE OR DIVERSION OF CONTROLLED SUBSTANCES.
Andrew D. DeSimone is a partner with Sturgill, Turner, Barker & Moloney, PLLC. DeSimone concentrates his practice in the areas of healthcare law and medical malpractice defense. He can be reached at firstname.lastname@example.org or (859) 255-8581.
This article is intended as a summary of newly enacted state law and does not constitute legal advice.