632.866(3)(a)
(a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, pharmacy benefit manager, or utilization review organization through the use of a step therapy protocol, the insurer, pharmacy benefit manager, or utilization review organization shall provide access to a clear, readily accessible, and convenient process to request an exception to the step therapy protocol. An insurer, pharmacy benefit manager, or utilization review organization may use any existing medical exceptions process to satisfy the requirement under this paragraph. The exception process shall be made easily accessible on the Internet site of the insurer, pharmacy benefit manager, or utilization review organization.
632.866(3)(b)
(b) An insurer, pharmacy benefit manager, or utilization review organization shall grant an exception to the step therapy protocol if the prescribing provider submits complete, clinically relevant written documentation supporting a step therapy protocol exception request and any of the following are satisfied:
632.866(3)(b)1.
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:
632.866(3)(b)1.b.
b. Decrease the ability to achieve or maintain reasonable functional ability in performing daily activities.
632.866(3)(b)2.
2. The prescription drug required under the step therapy protocol is expected to be ineffective based on all of the following:
632.866(3)(b)2.c.
c. The known characteristics of the prescription drug regimen as described in peer-reviewed literature or the manufacturer's prescribing information for the prescription drug.
632.866(3)(b)3.
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).
632.866(3)(b)4.
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.
632.866(3)(c)
(c) Nothing in this subsection shall be construed to allow the use of a pharmaceutical sample to satisfy a criterion for an exception to a step therapy protocol.
632.866(3)(d)
(d) Upon granting an exception to the step therapy protocol under par.
(b), the insurer, pharmacy benefit manager, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider to the extent the prescribed drug is covered under the patient's policy or plan.
632.866(3)(e)
(e) An insured may appeal any request for an exception to the step therapy protocol that is denied.
632.866(3)(f)
(f) 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 protocol 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 protocol 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 protocol 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.
632.866(3)(g)
(g) Nothing in this subsection shall be construed to prevent any of the following:
632.866(3)(g)1.
1. An insurer, pharmacy benefit manager, or utilization review organization from requiring a patient to try an A-rated generic equivalent prescription drug, as designated by the federal food and drug administration, or a biosimilar, as defined under
42 USC 262 (i) (2), before providing coverage for the equivalent brand name prescription drug.
632.866(3)(g)2.
2. A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
632.866(4)
(4)
Rules. The commissioner shall promulgate any rules necessary to implement or enforce this section.
632.866 History
History: 2019 a. 12;
2021 a. 239 ss.
65,
66,
74.
632.867
632.867
Oral and injected chemotherapy. 632.867(1)(a)
(a) “Chemotherapy" means drugs and biologics that kill cancer cells directly, including antineoplastics, biologic response modifiers, hormone therapy, and monoclonal antibodies, and that are used to do any of the following:
632.867(1)(a)4.
4. Destroy microscopic cancer cells that may be present after a tumor is removed by surgery to prevent a cancer recurrence.