Chapter 632

632.865(7)(a) (a) Beginning on June 1, 2021, and annually thereafter, every pharmacy benefit manager shall submit to the commissioner a report that contains, from the previous calendar year, the aggregate rebate amount that the pharmacy benefit manager received from all pharmaceutical manufacturers but retained and did not pass through to health benefit plan sponsors and the percentage of the aggregate rebate amount that is retained rebates. Information required under this paragraph is limited to contracts held with pharmacies located in this state.

632.865(7)(b) (b) Reports under this subsection shall be considered a trade secret under the uniform trade secret act under s. 134.90.

632.865(7)(c) (c) The commissioner may not expand upon the reporting requirement under this subsection, except that the commissioner may effectuate this subsection.

632.865 History History: 2015 a. 55; 2021 a. 9.

632.866 632.866 Step therapy protocols.

632.866(1) (1) Definitions. In this section:

632.866(1)(a) (a) “Clinical practice guideline” means a systematically developed statement to assist decision making by health care providers and patients about appropriate health care for specific clinical circumstances and conditions.

632.866(1)(b) (b) “Clinical review criteria” means written screening procedures, decision abstracts, clinical protocols, and clinical practice guidelines used by an insurer, pharmacy benefit manager, or utilization review organization to determine whether health care services are medically necessary and appropriate.

632.866(1)(c) (c) “Exigent circumstances” means when a patient is suffering from a health condition that may seriously jeopardize the patient’s life, health, or ability to regain maximum function.

632.866(1)(d) (d) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

632.866(1)(e) (e) “Step therapy protocol” means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition, whether self-administered or physician-administered, that are medically appropriate for a particular patient are covered under a policy or plan.

632.866(1)(f) (f) “Utilization review organization” means an entity that conducts utilization review, other than an insurer or pharmacy benefit manager performing utilization review for its own policy or plan.

632.866(2) (2) Clinical review criteria.

632.866(2)(a) (a) When establishing a step therapy protocol, an insurer, pharmacy benefit manager, or utilization review organization shall use clinical review criteria that are based on clinical practice guidelines that are derived from peer-review publications, evidence-based research, and widely accepted medical practice. If such clinical practice guidelines are unavailable, the insurer, pharmacy benefit manager, or utilization review organization shall derive clinical review criteria from peer-reviewed publications, evidence-based research, and widely accepted medical practice. The insurer, pharmacy benefit manager, or utilization review organization shall continually update the clinical review criteria based on an update to the clinical practice guidelines or a review of new evidence and research and newly developed treatments.

632.866(2)(b) (b) Any individual involved in establishing a step therapy protocol under this subsection shall disclose to the insurer, pharmacy benefit manager, or utilization review organization any potential conflict of interest due to a financial or other relationship or payment from a pharmaceutical manufacturer and shall recuse himself or herself from voting on a decision regarding the step therapy protocol if he or she has a conflict of interest.

632.866(2)(c) (c) An insurer, pharmacy benefit manager, or utilization review organization shall describe on its Internet site the process and criteria used for selecting and evaluating clinical practice guidelines used under par. (a) to develop step therapy protocols.

632.866(2)(d) (d) Nothing in this subsection shall be construed to require insurers, pharmacy benefit managers, or the state to create a new entity to develop clinical review criteria used for step therapy protocols.

632.866(3) (3) Transparency of exceptions process.

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.a. a. Cause a serious adverse reaction in the patient.

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)1.c. c. Cause physical or psychiatric harm to the patient.

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.a. a. Sound clinical evidence or medical and scientific evidence.

632.866(3)(b)2.b. b. The known clinical characteristics of the patient.

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) (1) Definitions. In this section:

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)1. 1. Cure a specific cancer.

632.867(1)(a)2. 2. Control tumor growth when cure is not possible.

632.867(1)(a)3. 3. Shrink tumors before surgery or radiation therapy.

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.

632.867(1)(b) (b) “Disability insurance policy” has the meaning given in s. 632.895 (1) (a).

632.867(1)(c) (c) “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

632.867(2) (2) Copayment, deductible, or coinsurance requirements; limitations.

632.867(2)(a) (a) Except as provided in par. (am), a disability insurance policy that covers injected or intravenous chemotherapy and oral chemotherapy, or a self-insured health plan that covers injected or intravenous chemotherapy and oral chemotherapy, may not require a higher copayment, deductible, or coinsurance amount for oral chemotherapy than it requires for injected or intravenous chemotherapy, regardless of the formulation or benefit category determination by the policy or plan.

632.867(2)(am) (am) A disability insurance policy or self-insured health plan that limits copayments paid by a covered individual to no more than $100 for a 30-day supply of oral chemotherapy medication is considered to comply with this section. On January 1, 2016, and on each January 1 annually thereafter, a disability insurance policy or self-insured health plan may adjust the $100 limit under this paragraph by an amount that does not exceed the percentage increase in the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor.

632.867(2)(b) (b) A disability insurance policy or a self-insured health plan may not comply with par. (a) by increasing the copayment, deductible, or coinsurance amount required for injected or intravenous chemotherapy that is covered under the policy or plan.

632.867(2)(c) (c) Notwithstanding par. (a), for a disability insurance policy, or self-insured health plan, that is a high deductible health plan, as defined in 26 USC 223 (c) (2), par. (a) applies only after the plan enrollee’s deductible has been satisfied for the year.

632.867 History History: 2013 a. 186.

632.87 632.87 Restrictions on health care services.

632.87(1) (1) No insurer may refuse to provide or pay for benefits for health care services provided by a licensed health care professional on the ground that the services were not rendered by a physician as defined in s. 990.01 (28), unless the contract clearly excludes services by such practitioners, but no contract or plan may exclude services in violation of sub. (2), (2m), (3), (4), (4m), (5), or (6).

632.87(2) (2) No insurer may, under a contract or plan covering vision care services or procedures, refuse to provide coverage for vision care services or procedures provided by an optometrist licensed under ch. 449 within the scope of the practice of optometry, as defined in s. 449.01 (1), if the contract or plan includes coverage for the same services or procedures when provided by another health care provider.

632.87(2m) (2m) No health maintenance organization or preferred provider plan that provides vision care services or procedures within the scope of the practice of optometry, as defined in s. 449.01 (1), may do any of the following:

632.87(2m)(am) (am) Fail to provide to persons covered by the health maintenance organization or preferred provider plan, at the time of enrollment and annually thereafter, a listing of then participating vision care providers, including participating optometrists, setting forth the names of the vision care providers in alphabetical order by last name and their respective business addresses and telephone numbers, with the listing of participating vision care providers to be incorporated in any listing of all participating health care providers that includes the same information regarding all providers, if such listing is provided at the time of enrollment and annually thereafter, or with the listing of participating vision care providers otherwise to be provided separately.

632.87(2m)(b) (b) Fail to provide to persons covered by the health maintenance organization or preferred provider plan, at the time vision care services or procedures are needed, the opportunity to choose optometrists from the listing under par. (am) from whom the persons may obtain covered vision care services and procedures within the scope of the practice of optometry, as defined in s. 449.01 (1).

632.87(2m)(c) (c) Fail to include as participating providers in the health maintenance organization or preferred provider plan optometrists licensed under ch. 449 in sufficient numbers to meet the demand of persons covered by the health maintenance organization or preferred provider plan for optometric services.

632.87(2m)(d) (d) When vision care services or procedures are deemed appropriate by the health maintenance organization or preferred provider plan, restrict or discourage a person covered by the health maintenance organization or preferred provider plan from obtaining covered vision care services or procedures, within the scope of the practice of optometry as defined in s. 449.01 (1), from participating optometrists solely on the basis that the providers are optometrists.

632.87(3) (3) 

632.87(3)(a) (a) No policy, plan or contract may exclude coverage for diagnosis and treatment of a condition or complaint by a licensed chiropractor within the scope of the chiropractor’s professional license, if the policy, plan or contract covers diagnosis and treatment of the condition or complaint by a licensed physician or osteopath, even if different nomenclature is used to describe the condition or complaint. Examination by or referral from a physician shall not be a condition precedent for receipt of chiropractic care under this paragraph. This paragraph does not:

632.87(3)(a)1. 1. Prohibit the application of deductibles or coinsurance provisions to chiropractic and physician charges on an equal basis.

632.87(3)(a)2. 2. Prohibit the application of cost containment or quality assurance measures to chiropractic services in a manner that is consistent with cost containment or quality assurance measures generally applicable to physician services and that is consistent with this section.

632.87(3)(b) (b) No insurer, under a policy, plan or contract covering diagnosis and treatment of a condition or complaint by a licensed chiropractor within the scope of the chiropractor’s professional license, may do any of the following:

632.87(3)(b)1. 1. Restrict or terminate coverage for the treatment of a condition or a complaint by a licensed chiropractor within the scope of the chiropractor’s professional license on the basis of other than an examination or evaluation by or a recommendation of a licensed chiropractor or a peer review committee that includes a licensed chiropractor.

632.87(3)(b)2. 2. Refuse to provide coverage to an individual because that individual has been treated by a chiropractor.

632.87(3)(b)3. 3. Establish underwriting standards that are more restrictive for chiropractic care than for care provided by other health care providers.

632.87(3)(b)4. 4. Exclude or restrict health care coverage of a health condition solely because the condition may be treated by a chiropractor.

632.87(3)(c) (c) An exclusion or a restriction that violates par. (b) is void in its entirety.

632.87(4) (4) No policy, plan or contract may exclude coverage for diagnosis and treatment of a condition or complaint by a licensed dentist or dental therapist within the scope of the dentist’s or dental therapist’s license, if the policy, plan or contract covers diagnosis and treatment of the condition or complaint by another health care provider, as defined in s. 146.81 (1) (a) to (p).

632.87(4m) (4m) No policy, plan, or contract may exclude coverage for mental health or behavioral health treatment or services provided by the charter school established under a contract under s. 118.40 (2x) (cm), if the policy, plan, or contract covers the mental health or behavioral health treatment or services when provided by another health care provider, as defined in s. 146.81 (1) (a) to (p). The operator of the charter school established under a contract under s. 118.40 (2x) (cm) shall, upon the enrollment of a pupil in the charter school, notify the policy, plan, or contract that covers the pupil’s mental health or behavioral health treatment or services of the services that the policy, plan, or contract may be required to cover under this subsection. If requested by a policy, plan, or contract, an operator of the charter school established under a contract under s. 118.40 (2x) (cm) shall enter into a memorandum of understanding with a policy, plan, or contract on matters other than the coverage required under this subsection, including reimbursement, payment terms, and compliance with state and federal patient health information privacy laws.

632.87(5) (5) No insurer or self-insured school district, city or village may, under a policy, plan or contract covering gynecological services or procedures, exclude or refuse to provide coverage for Papanicolaou tests, pelvic examinations or associated laboratory fees when the test or examination is performed by a licensed nurse practitioner, as defined in s. 632.895 (8) (a) 3., within the scope of the nurse practitioner’s professional license, if the policy, plan or contract includes coverage for Papanicolaou tests, pelvic examinations or associated laboratory fees when the test or examination is performed by a physician.

632.87(6) (6) 

632.87(6)(a) (a)

632.87(6)(a)1. 1. Except as provided in subd. 2., in this subsection, “routine patient care” means all of the following:

632.87(6)(a)1.a. a. All health care services, items, and drugs for the treatment of cancer.

632.87(6)(a)1.b. b. All health care services, items, and drugs that are typically provided in health care; including health care services, items, and drugs provided to a patient during the course of treatment in a cancer clinical trial for a condition or any of its complications; and that are consistent with the usual and customary standard of care, including the type and frequency of any diagnostic modality.

632.87(6)(a)2. 2. “Routine patient care” does not include the health care service, item, or investigational drug that is the subject of the cancer clinical trial; any health care service, item, or drug provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient; an investigational drug or device that has not been approved for market by the federal food and drug administration; transportation, lodging, food, or other expenses for the patient or a family member or companion of the patient that are associated with travel to or from a facility providing the cancer clinical trial; any services, items, or drugs provided by the cancer clinical trial sponsors free of charge for any patient; or any services, items, or drugs that are eligible for reimbursement by a person other than the insurer, including the sponsor of the cancer clinical trial.

632.87(6)(b) (b) No policy, plan, or contract may exclude coverage for the cost of any routine patient care that is administered to an insured in a cancer clinical trial satisfying the criteria under par. (c) and that would be covered under the policy, plan, or contract if the insured were not enrolled in a cancer clinical trial.

632.87(6)(c) (c) A cancer clinical trial under par. (b) must satisfy all of the following criteria:

632.87(6)(c)1. 1. A purpose of the trial is to test whether the intervention potentially improves the trial participant’s health outcomes.

632.87(6)(c)2. 2. The treatment provided as part of the trial is given with the intention of improving the trial participant’s health outcomes.

632.87(6)(c)3. 3. The trial has therapeutic intent and is not designed exclusively to test toxicity or disease pathophysiology.

632.87(6)(c)4. 4. The trial does one of the following:

632.87(6)(c)4.a. a. Tests how to administer a health care service, item, or drug for the treatment of cancer.

632.87(6)(c)4.b. b. Tests responses to a health care service, item, or drug for the treatment of cancer.