The Latest on Proposed Changes to Wisconsin Patient Counseling Rule That Will Impact Mail Order Pharmacies: Potential Relief for Mail Order Pharmacies?

The Latest on Proposed Changes to Wisconsin Patient Counseling Rule That Will Impact Mail Order Pharmacies: Potential Relief for Mail Order Pharmacies?

On November 1, 2019, the Wisconsin Pharmacy Examining Board (the "Board") released the latest draft of their proposed rules. As explained below, the Board ultimately incorporated language requiring all pharmacies (including mail order pharmacies) to provide verbal patient consultation prior to dispensing any new prescription to a patient.

The proposed rule states that a pharmacist may not satisfy the consultation requirement by only offering to provide consultation, but provides two potential exceptions to the mandatory counseling requirement:

• First, the pharmacist may "vary or omit the content of the consultation" if the pharmacist determines such variation or omission would serve "the best interest of the patient." A pharmacist may also decide not to provide the counseling orally (e.g., via solely written materials instead) if "in the pharmacist’s professional judgment it is not in the best interest of the patient or patient’s agent to be communicated orally." As discussed in our prior articles on the topic, the Board considers itself unable to issue any policy or guidance documents. Therefore, the Board will not likely be able to provide any guidance as to what constitutes "the best interest of the patient." Pharmacists attempting to rely on this exception will want to keep diligent records of their clinical reasoning as to why they deviated from the regulatory consultation requirements.
• Second, and perhaps more significantly, "a consultation is not required…if a patient or patient's agent refuses consultation." This is a new exception for Wisconsin. While the Board made several vague references to the notion of patient refusals during its discussion, the Board did not discuss adding this patient refusal exception during its recent meetings. Because of this, it isn't clear how the Board would expect a mail order pharmacy to obtain a patient's refusal. Nonetheless, a reasonable interpretation of this language suggests that mail order pharmacies may institute processes for obtaining patient refusals to counseling prior to dispensing. Under this possible approach, a pharmacy could institute a work flow that provides the patient the choice of either refusing verbal counseling and receiving written counseling materials or scheduling a telephone call to receive verbal counseling prior to the mailing of the drug. As there is no "professional judgment" component here, a pharmacist could rely on a documented patient refusal for counseling in order to omit verbal counseling prior to dispensing. Again, because the Board did not affirmatively discuss this approach during its last meetings, affected parties will want to submit comments confirming that this approach is in fact feasible and that any alternative requiring verbal counseling before mailing the prescription would cause economic harm and delays in patient care.

The time period for public comments related to the economic impact of the proposed rule is now open. 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
DSPSAdminRules@wisconsin.gov

The deadline for submitting economic impact comments is 12:00 p.m. on November 15, 2019.

The Board has scheduled a meeting for 12:00 p.m. on November 15, 2019, presumably to discuss and review the submitted comments.

The main Board meeting to review comments related to the new rules generally remains scheduled for December 17, 2019.

We will continue to monitor new Board publications and attend the relevant meetings to provide updates on the status of this proposed rulemaking.

For more information on how the proposed rule changes may affect your business, please contact your Quarles & Brady attorney or:

• Susan B. Trujillo: (602) 229-5318 / susan.trujillo@quarles.com
• Richard B. Davis: (414) 277-5844 / richard.davis@quarles.com