Wisconsin Passes Step Therapy Reform

On July 9, 2019, Governor Tony Evers signed legislation that will put common sense patient protections in place for the practice of step therapy.  The legislation becomes effective January 1, 2020 and will protect Wisconsonites insured through state regulated, individual market plans.

Health care providers will have access to a clear, readily accessible and convenient process to request an exception to the step therapy protocol. An override request will be granted if the following conditions are satisfied:

1. The prescription drug 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.
2. The prescription drug 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 prescription drug.
3. The patient has tried the prescription drug required under the step therapy protocol, or another prescription drug 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 prescription drug was discontinued by the patient’s provider due to lack of efficacy or effectiveness, diminished effect, or adverse event. This subdivision does not prohibit an insurer, pharmacy benefit manager, or utilization review organization from requiring 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 clinical review criteria under sub. (2) (a).
4. The patient is stable on a prescription drug selected by his or her health care provider for the medical condition under consideration while covered under the policy or plan or a previous policy or plan.

An insurer, pharmacy benefit manager, or utilization review organization shall grant or deny a request for any exception to the step therapy protocol within 3 business days of receipt of the complete, clinically relevant written documentation required under par. (b) to support a step therapy exception request under par. (b) or the receipt of a request to appeal a previous decision that includes the complete, clinically relevant written documentation supporting a step therapy exception request. In exigent circumstances, an insurer, pharmacy benefit manager, or utilization review organization shall grant or deny a request for an exception to the step therapy protocol by the end of the next business day after receipt of the complete, clinically relevant written documentation supporting a step therapy exception request under par. (b). If the insurer, pharmacy benefit manager, or utilization review organization does not grant or deny a request or an appeal under the time specified under this paragraph, the exception is considered granted.