The Latest on Proposed Changes to Wisconsin Patient Counseling Rule That Will Impact Mail Order Pharmacies
Health & Life Sciences Alert 10/30/19 Christine Cassetta, Susan B. Trujillo, Richard B. Davis
Update as of 10/29/2019: The Wisconsin Pharmacy Examining Board (the "Board") met on 10/28/19 and once again discussed proposed changes to the pharmacy counseling regulations, which we outlined in a previous alert. The outcome of the meeting was unclear, though based on the discussion it seems the Board may be leaning toward requiring mandatory verbal counseling before dispensing—albeit with an exception when the pharmacist decides such counseling is not needed "in her professional judgment."
The confusion arose due to the fact that the language the Board was discussing during the meeting did not align with what was written on their working draft. While the Board's proposed written draft language allowed the counseling requirement for mail order pharmacies to be met via written materials, at the meeting the Board continued to discuss the idea of requiring mandatory oral counseling before dispensing for all classes of pharmacy with a "professional judgment" exception. However, the Board never updated the written draft of the rule during the meeting to indicate mandatory oral counseling also applied to mail order pharmacies.
The proposed "professional judgment" exception is especially problematic in light of the Board's position (stated most recently during its 10/23/19 meeting) that the Board cannot answer questions, issue any clarifying guidance or policy statements, or provide feedback outside of the official rulemaking process. Accordingly, if this rule is adopted there is unlikely to be any additional guidance as to what circumstances constitute the reasonable exercise of professional judgement in foregoing counseling, and especially if it is reasonable to rely on this exception solely because the patient is a mail order patient. Pharmacists will have to conduct a case-by-case analysis as to whether their counseling decisions fell within the reasonable exercise of their professional judgment without any insight from the Board. This lack of guidance will likely create a chilling effect on the willingness and ability of pharmacists to rely on written materials to satisfy the counseling requirement, thus impacting patient care.
The Board indicated they will publish an updated draft of this rule this week and stakeholders will have the opportunity to submit economic impact comments. If there are economic impact comments, the Board will schedule another meeting (likely within 2 weeks) to discuss these comments. Quarles & Brady will continue to monitor this situation and will provide updates as they arise.
For more information on how the proposed rule changes may affect your business, please contact your Quarles & Brady attorney or: