2019 WISCONSIN ACT 12
Wisconsin Act 12 creates Wisconsin Statute, Section 632.866 Step therapy protocols. The newly created statute requires insurers, pharmacy benefit managers, and utilization review organizations who use step therapy protocols in their prescription drug coverage to comply with several new requirements. Step therapy protocols must be established using specified clinical review criteria, there must be an exception process, and the process must allow exceptions under specified circumstances. Additionally, websites are required to provide a description and access to the process and criteria used to develop protocols and the exception process.
Exception Process
We may grant an exception to our step therapy protocol if the prescribing provider submits complete, clinically relevant written documentation supporting the request; and ONE of the following:
- The prescription drug (Rx) required under the step therapy protocol is contraindicated, or (due to a documented adverse event with a previous use or a documented medical condition, including a comorbid condition) is likely to do any of the following:
- Cause a serious adverse reaction in the patient.
- Decrease the ability to achieve or maintain reasonable functional ability in performing daily activities
- Cause physical or psychiatric harm to the patient
- The Rx required under the step therapy protocol is expected to be ineffective based on ALL of the following:
- Sound clinical evidence or medical and scientific evidence
- The known clinical characteristics of the patient
- The known characteristics of the prescription drug regimen as described in peer-reviewed literature or the manufacturer’s prescribing information for the Rx.
- The patient has tried the Rx required under the step therapy protocol or another Rx in the same pharmacologic class, or with the same mechanism of action, under the policy or plan or a previous policy or plan; the patient was adherent to the prescription drug regimen for a time that allows for a positive treatment outcome; and the patient’s use of the Rx was discontinued by the patient’s provider due to lack of efficacy or effectiveness, diminished effect, or adverse event.
- The patient is stable on an Rx selected by his/her health care provider for the medical condition under consideration while covered under the policy or plan or a previous policy or plan.
We are allowed to require a patient to try another drug in the same pharmacologic class or with the same mechanism of action if that therapy sequence is supported by the required clinical review criteria we developed.
The provision of pharmaceutical samples to a patient will not satisfy a criterion for an exception to a step therapy protocol.
Turnaround Time
We will approve or deny a step therapy protocol exception request or appeal of a previously denied step therapy protocol exception request within three business days of receipt of the complete clinically relevant written documentation stated above. Upon approval of an exception to our step therapy protocol, we will process the Rx as indicated in the customer’s health plan, certificate, or policy.
For more information on step therapy protocols, contact our pharmacy department at 800-332-0899.