Chapter 632

632.865(2)(b)5. 5. A requirement that a pharmacy benefit manager make a pricing adjustment no later than one day after the date of the final determination of the appeal.

632.865(3) (3) License required. No person may perform any activities of a pharmacy benefit manager without being licensed by the commissioner as an administrator or pharmacy benefit manager under s. 633.14.

632.865(4) (4) Accreditation for network participation. A pharmacy benefit manager or a representative of a pharmacy benefit manager shall provide to a pharmacy, within 30 days of receipt of a written request from the pharmacy, a written notice of any certification or accreditation requirements used by the pharmacy benefit manager or its representative as a determinant of network participation. A pharmacy benefit manager or a representative of a pharmacy benefit manager may change its accreditation requirements no more frequently than once every 12 months.

632.865(5) (5) Retroactive claim reduction. Unless required otherwise by federal law, a pharmacy benefit manager may not retroactively deny or reduce a pharmacist’s or pharmacy’s claim after adjudication of the claim unless any of the following is true:

632.865(5)(a) (a) The original claim was submitted fraudulently.

632.865(5)(b) (b) The payment for the original claim was incorrect. Recovery for an incorrect payment under this paragraph is limited to the amount that exceeds the allowable claim.

632.865(5)(c) (c) The pharmacy services were not rendered by the pharmacist or pharmacy.

632.865(5)(d) (d) In making the claim or performing the service that is the basis for the claim, the pharmacist or pharmacy violated state or federal law.

632.865(5)(e) (e) The reduction is permitted in a contract between a pharmacy and a pharmacy benefit manager and is related to a quality program.

632.865(6) (6) Audits of pharmacies or pharmacists.

632.865(6)(a) (a) Definitions. In this subsection:

632.865(6)(a)1. 1. “Audit” means a review of the accounts and records of a pharmacy or pharmacist by or on behalf of an entity that finances or reimburses the cost of health care services or prescription drugs.

632.865(6)(a)2. 2. “Entity” means a defined network plan, as defined in s. 609.01 (1b), insurer, self-insured health plan, or pharmacy benefit manager or a person acting on behalf of a defined network plan, insurer, self-insured health plan, or pharmacy benefit manager.

632.865(6)(a)3. 3. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

632.865(6)(b) (b) Procedures. An entity conducting an on-site or desk audit of pharmacist or pharmacy records shall do all of the following:

632.865(6)(b)1. 1. If the audit is an audit on the premises of the pharmacist or pharmacy, notify the pharmacist or pharmacy in writing of the audit at least 2 weeks before conducting the audit.

632.865(6)(b)2. 2. Refrain from auditing a pharmacist or pharmacy within the first 5 business days of a month unless the pharmacist or pharmacy consents to an audit during that time.

632.865(6)(b)3. 3. If the audit involves clinical or professional judgment, conduct the audit by or in consultation with a pharmacist licensed in any state.

632.865(6)(b)4. 4. Limit the audit review to no more than 250 separate prescriptions. For purposes of this subdivision, a refill of a prescription is not a separate prescription.

632.865(6)(b)5. 5. Limit the audit review to claims submitted no more than 2 years before the date of the audit, unless required otherwise by state or federal law.

632.865(6)(b)6. 6. Allow the pharmacist or pharmacy to use authentic and verifiable records of a hospital, physician, or other health care provider to validate the pharmacist’s or pharmacy’s records relating to delivery of a prescription drug and use any valid prescription that complies with requirements of the pharmacy examining board to validate claims in connection with a prescription, refill of a prescription, or change in prescription.

632.865(6)(b)7. 7. Allow the pharmacy or pharmacist to document the delivery of a prescription drug or pharmacist services to an enrollee under a health benefit plan using either paper or electronic signature logs.

632.865(6)(b)8. 8. Before leaving the pharmacy after concluding the on-site portion of an audit, provide to the representative of the pharmacy or the pharmacist a complete list of the pharmacy records reviewed.

632.865(6)(c) (c) Results of audit. An entity that has conducted an audit of a pharmacist or pharmacy shall do all of the following:

632.865(6)(c)1. 1. Deliver to the pharmacist or pharmacy a preliminary report of the audit within 60 days after the date the auditor departs from an on-site audit or the pharmacy or pharmacist submits paperwork for a desk audit. A preliminary report under this subdivision shall include claim-level information for any discrepancy reported, the estimated total amount of claims subject to recovery, and contact information for the entity or person that completed the audit so the pharmacist or pharmacy subject to the audit may review audit results, procedures, and discrepancies.

632.865(6)(c)2. 2. Allow a pharmacist or pharmacy that is the subject of an audit to provide documentation to address any discrepancy found in the audit within 30 days after the date the pharmacist or pharmacy receives the preliminary report.

632.865(6)(c)3. 3. Deliver to the pharmacist or pharmacy a final audit report, which may be delivered electronically, within 90 days of the date the pharmacist or pharmacy receives the preliminary report or the date of the final appeal of the audit, whichever is later. The final audit report under this subdivision shall include any response provided to the auditor by the pharmacy or pharmacist and consider and address the pharmacy’s or pharmacist’s response.

632.865(6)(c)4. 4. Refrain from assessing a recoupment or other penalty on a pharmacist or pharmacy until the appeal process is exhausted and the final report under subd. 3. is delivered to the pharmacist or pharmacy.

632.865(6)(c)5. 5. Refrain from accruing or charging interest between the time the notice of the audit is given under par. (b) 1. and the final report under subd. 3. has been delivered.

632.865(6)(c)6. 6. Exclude dispensing fees from calculations of overpayments.

632.865(6)(c)7. 7. Establish and follow a written appeals process that allows a pharmacy or pharmacist to appeal the final report of an audit and allow the pharmacy or pharmacist as part of the appeal process to arrange for, at the cost of the pharmacy or pharmacist, an independent audit.

632.865(6)(c)8. 8. Refrain from subjecting the pharmacy or pharmacist to a recoupment or recovery for a clerical or record-keeping error in a required document or record, including a typographical or computer error, unless the error resulted in an overpayment to the pharmacy or pharmacist.

632.865(6)(d) (d) Confidentiality of audit. Information obtained in an audit under this subsection is confidential and may not be shared unless the information is required to be shared under state or federal law and except that the audit may be shared with the entity on whose behalf the audit is performed. An entity conducting an audit may have access to the previous audit reports on a particular pharmacy only if the audit is conducted by the same entity.

632.865(6)(e) (e) Cooperation with audit. If an entity is conducting an audit that is complying with this subsection in auditing a pharmacy or pharmacist, the pharmacy or pharmacist that is the subject of the audit may not interfere with or refuse to participate in the audit.

632.865(6)(f) (f) Payment of auditors. A pharmacy benefit manager or entity conducting an audit may not pay an auditor employed by or contracted with the pharmacy benefit manager or entity based on a percentage of the amount recovered in an audit.

632.865(6)(g) (g) Applicability.

632.865(6)(g)1. 1. This subsection does not apply to an investigative audit that is initiated as a result of a credible allegation of fraud or willful misrepresentation or criminal wrongdoing.

632.865(6)(g)2. 2. If an entity conducts an audit to which a federal law applies that is in conflict with all or part of this subsection, the entity shall comply with this subsection only to the extent that it does not conflict with federal law.

632.865(7) (7) Transparency reports.

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.