Update on Status of Proposed Wisconsin Patient Counseling Rule that Will Impact Mail Order Pharmacies
Health & Life Sciences Alert 10/25/19 Susan B. Trujillo, Richard B. Davis
Update as of 10/25/2019: The Board has scheduled a meeting for 10/28/19 to continue discussing updates to the pharmacy regulations. The attachments to the current agenda contain the same mandatory counseling language as previously proposed. It is not clear whether the Board considers this issue closed or will discuss the counseling requirement further on the 10/28/19 meeting. Quarles & Brady will be in attendance at this meeting and will continue to monitor this situation.
On October 23, 2019, during its ongoing rulemaking process, the Wisconsin Pharmacy Examining Board (the "Board") continued to discuss a proposed rule (to be codified at Phar 7.08) that would require mail order pharmacies to contact patients to provide counseling prior to mailing the patient his or her filled prescription. Unlike Wisconsin’s longstanding existing rule, this proposed rule does not allow a mail order pharmacy to satisfy the counseling requirement by providing counseling information solely via written materials that include a toll-free telephone number for patients if they have additional questions.
If Wisconsin adopts the new rule, it will be an outlier among the states:
- No other state has this requirement
- In 16 states, for prescriptions shipped through the mail, counseling or an offer to counsel is properly achieved by providing written materials and/or access to a toll-free telephone number for counseling from a pharmacist
- In 13 states, the law addresses situations where in-person counseling is not practical, and permits counseling by alternative methods, such as electronic, written, or telephonic means
- In 18 states, written materials are adequate for counseling
- In three states, counseling regulation is limited to prescriptions under Medicaid
The Board discussed this proposed rule at length during its meeting. After a lengthy discussion, however, no clear consensus emerged on next steps. Nonetheless, the Board did manage to distill its path forward to three potential options:
- Adopt the proposed rule generally in its current form;
- Maintain the existing rule generally in its current form (possibly clawing back existing mandatory counseling requirements for refill prescriptions in retail pharmacies); or
- Remove the mandatory counseling requirement for all pharmacies, and replace it with an offer to counsel requirement in both retail and mail order practice settings.
Though the Board did not take a formal vote, many (but not all) Board members were leaning toward the second option listed above. The public hearing for proposed Phar 7.08 is currently scheduled for December 17, 2019 and affected stakeholders should take this opportunity to submit comments either via writing or in person. The process for submitting a comment to the Board is outlined here.
For more information about how the new Wisconsin rulemaking may affect your business, please contact your Quarles & Brady attorney or: