Friday, April 5, 2013

House Bill 1 Revisited: Kentucky
General Assembly Amends “Pill Mill” Bill


In a 2012 Special Session, the Kentucky General Assembly passed House Bill 1, also known as the “pill mill” bill, to rein in the over-prescribing of prescription drugs and the diversion of prescription drugs.

Following passage of House Bill 1, and its being signed into law by Governor Beshear, the Cabinet and various licensure boards issued regulations implementing House Bill 1’s requirements.  After emergency regulations were promulgated, Governor Beshear’s office held a series of stakeholder meetings.  Governor Beshear’s office, as well as various licensure boards, recognized that House Bill 1 and the implementing regulations would require amendment and refinement to address concerns raised by the provider community and other stakeholders.  During the 2013 Regular Session of the General Assembly, some of these concerns were addressed in House Bill 217, which amended portions of House Bill 1.

House Bill 217 requires state licensing boards to issue regulations requiring practitioners to query the KASPER system prior to the initial prescribing or dispensing of any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone.  However, House Bill 217 provides that the practitioner only is required to query all available data on the patient for the twelve-month period immediately preceding the patient encounter and then utilize that data in the evaluation and treatment of the patient.

House Bill 217 also authorizes state licensing boards by regulation to exempt, in whole or in part, compliance with mandatory diagnostic, treatment, review of treatment plans, and other protocols and standards governing the prescribing of controlled substances in certain situations.  For example, licensing boards may provide an exemption from these mandatory standards for a licensee prescribing or administering a controlled substance immediately prior to, during or within fourteen days following an operative or invasive procedure or a delivery if the prescribing or administering is medically related to the operative or invasive procedure or the delivery and the medication usage does not extend beyond the fourteen days.

Likewise, House Bill 217 allows licensing boards by regulation to exempt from compliance with the mandatory prescribing standards a licensee prescribing or dispensing a controlled substance as part of the patient’s hospice or end-of-life treatment, for the treatment of pain associated with cancer or with the treatment of cancer, or in a single dose to relieve the anxiety, pain, or discomfort experienced by a patient submitting to a diagnostic test or procedure.

In addition to authorizing licensing boards to provide exemptions to compliance with mandatory diagnostic, treatment and other protocols and standards governing the prescribing of controlled substances in the circumstances specified in the bill, House Bill 217 gives licensing boards broad authority to carve out additional exemptions if specific procedures are followed.  Prior to promulgating administrative regulations providing for additional exemptions beyond those set forth in House Bill 217, a state licensing board must:

1.         Notify the Kentucky Office of Drug Control Policy that it is considering a proposal to promulgate an administrative regulation authorizing supplemental or additional exemptions and invite the Kentucky Office of Drug Control Policy to participate in the board meeting at which the proposal will be considered;

2.         Make a factual finding based on expert testimony as well as evidence or research submitted to the board that the exemption demonstrates a low risk of diversion or abuse and is supported by the dictates of good medical practice; and

3.         Submit a report to the Governor and the Legislative Research Commission of its actions, including a detailed explanation of the factual and policy basis underlying the board’s action, a copy of which shall be provided to the regulations compiler.

House Bill 217 goes a long way toward providing the needed regulatory flexibility lacking in House Bill 1.  Undoubtedly, as the provider community continues to deal with the requirements of House Bill 1, licensing boards will be given the flexibility to address specific scenarios encountered by the provider community that may warrant less stringent regulatory requirements.

Christopher J. Shaughnessy
cshaughnessy@mmlk.com
McBrayer, McGinnis, Leslie & Kirkland, PLLC
Lexington, Kentucky

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