Board’s Economic Impact Analysis Disputes Industry Submissions, Board Advances Proposed Rule Without Changes
Health & Life Sciences Alert 11/25/19 Susan B. Trujillo, Richard B. Davis
The Latest on Proposed Changes to Wisconsin Patient Counseling Rule That Will Impact Mail Order Pharmacies
As anticipated in our previous update, the Wisconsin Pharmacy Examining Board (the "Board") has declined to make any changes to its proposed oral counseling requirement as a result of its economic impact analysis. Therefore, the language requiring mandatory oral counseling will be subject to public comment at the next Board meeting on December 17, 2019.
The analysis disregarded evidence from mail order pharmacies about the significant economic impact based on an assumption that the proposed rule is no different than current practices. The summary states: "the Pharmacy Examining Board recognizes that the current practice of calling a patient when the pharmacist utilizes professional judgment to determine a phone call is in the best interest of the patient is in compliance with the proposed rule…and deems no action is necessary to mitigate this economic concern."
The Board argues that because some mail order pharmacies already provide oral counseling when it is "in the best interest of the patient," the proposed rule would not impose any additional compliance costs. Many mail order pharmacies would no doubt contend that they currently act in the patient's best interest by providing written materials and by providing a phone number for the patient to call. However, under the rule as proposed and without additional guidance on what the Board considers the patient's "best interest," these pharmacies risk discipline under the proposed rule. For example, will the Board consider oral counseling in the patient's best interest in every circumstance unless a pharmacist has a very specific reason it is not, such as the patient not having a current phone number?
The Board indicated it has taken "similar approaches" to its neighboring states via the implementation of the new counseling requirement, referencing Illinois, Iowa, Michigan, and Minnesota. A careful reading of the neighboring state requirements, however, reveals substantive differences. For example, in Iowa, there is an exception to the otherwise mandatory counseling requirement when counseling is "not practicable." The meaning of "not practicable" specifically encompasses situations involving the "absence of the patient." A key distinction between the proposed Wisconsin approach and the Iowa approach is that the Iowa approach provides a clear carve-out for situations where there is no face-to-face interaction between the pharmacist and the patient (e.g., mail order operations). Under the proposed Wisconsin approach, information must be transmitted orally unless the pharmacist makes a determination that it is not in the best interest of the patient and there is no mail order exception. In other words, to send written counseling materials and forego the oral counseling requirement, the pharmacist will have to conclude based on a case-by-case clinical assessment that it is not in the patient's best interest to receive oral counseling. This case-by-case assessment and corresponding oral counseling requirement may have a significant impact on the patient's ability to receive mail order medications in a timely manner.
The upcoming December 17, 2019 meeting is the last chance for stakeholders to make their voices heard. Written comments may be submitted to:
Sharon Henes, Administrative Rules Coordinator
Division of Policy Development
Department of Safety and Professional Services
PO Box 8366
Madison, WI 53708-8935
Comments must be received at or before the public hearing to be held on December 17, 2019 to be included in the record of rule-making proceedings.
For more information on how the proposed rule changes may affect your business, please contact your Quarles & Brady attorney or: