Amendment ASA1-AB114

AB114-ASA1,7,12 450.135 (9) Links to be maintained by board. The board shall maintain links on the department's Internet site to the federal food and drug administration's lists of all currently approved interchangeable biological products. Each pharmacy shall make available for the public information on how to access the federal food and drug administration's lists of all currently approved interchangeable biological products through the department's Internet site.

AB114-ASA1,10 Section 10. 601.31 (1) (w) of the statutes is amended to read:

AB114-ASA1,7,15 601.31 (1) (w) For initial issuance and for each annual renewal of a license as an administrator or pharmacy benefit manager under ch. 633, $100.

AB114-ASA1,11 Section 11 . 601.46 (3) (b) of the statutes is amended to read:

AB114-ASA1,7,19 601.46 (3) (b) A general review of the insurance business in this state, including a report on emerging regulatory problems, developments and trends , including trends related to prescription drugs;

AB114-ASA1,12 Section 12. 609.83 of the statutes is amended to read:

AB114-ASA1,7,23 609.83 Coverage of drugs and devices. Limited service health organizations, preferred provider plans, and defined network plans are subject to ss. 632.853, 632.861, and 632.895 (16t).

AB114-ASA1,13 Section 13 . 616.09 (1) (a) 2. of the statutes is amended to read:

AB114-ASA1,8,4 616.09 (1) (a) 2. Plans authorized under s. 616.06 are subject to s. 610.21, 1977 stats., s. 610.55, 1977 stats., s. 610.57, 1977 stats., and ss. 628.34 to 628.39, 1977 stats., to chs. 600, 601, 620, 625, 627 and 645, to ss. 632.72, 632.755, 632.86 632.861 and 632.87 and to this subchapter except s. 616.08.

AB114-ASA1,14 Section 14 . 632.86 of the statutes is repealed.

AB114-ASA1,15 Section 15 . 632.861 of the statutes is created to read:

AB114-ASA1,8,7 632.861 Prescription drug charges. (1) Definitions. In this section:

AB114-ASA1,8,8 (a) “Disability insurance policy” has the meaning given in s. 632.895 (1) (a).

AB114-ASA1,8,10 (b) “Enrollee” means an individual who is covered under a disability insurance policy or a self-insured health plan.

AB114-ASA1,8,11 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB114-ASA1,8,12 (d) “Prescription drug” has the meaning given in s. 450.01 (20).

AB114-ASA1,8,13 (e) “Prescription drug benefit” has the meaning given in s. 632.865 (1) (e).

AB114-ASA1,8,14 (f) “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

AB114-ASA1,8,22 (2) Allowing disclosures. (a) A disability insurance policy or self-insured health plan that provides a prescription drug benefit may not restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the policy or plan from informing, or penalize such pharmacy for informing, an enrollee of any differential between the out-of-pocket cost to the enrollee under the policy or plan with respect to acquisition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or health insurance coverage.

AB114-ASA1,9,6 (b) A disability insurance policy or self-insured health plan that provides a prescription drug benefit shall ensure that any pharmacy benefit manager that provides services under a contract with the policy or plan does not, with respect to such policy or plan, restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the policy or plan from informing, or penalize such pharmacy for informing, an enrollee of any differential between the out-of-pocket cost to the enrollee under the policy or plan with respect to acquisition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or health insurance coverage.

AB114-ASA1,9,11 (3) Cost-sharing limitation. (a) A disability insurance policy or self-insured health plan that provides a prescription drug benefit or a pharmacy benefit manager that provides services under a contract with a policy or plan may not require an enrollee to pay at the point of sale for a covered prescription drug an amount that is greater than the lowest of all of the following amounts:

AB114-ASA1,9,13 1. The cost-sharing amount for the prescription drug for the enrollee under the policy or plan.

AB114-ASA1,9,16 2. The amount a person would pay for the prescription drug if the enrollee purchased the prescription drug at the dispensing pharmacy without using any health plan or health insurance coverage.

AB114-ASA1,9,25 (4) Drug substitution. (a) Except as provided in par. (b), a disability insurance policy that offers a prescription drug benefit, a self-insured health plan that offers a prescription drug benefit, or a pharmacy benefit manager acting on behalf of a disability insurance policy or self-insured health plan shall provide to an enrollee advanced written notice of a formulary change that removes a prescription drug from the formulary of the policy or plan or that reassigns a prescription drug to a benefit tier for the policy or plan that has a higher deductible, copayment, or coinsurance. The advanced written notice of a formulary change under this paragraph shall be provided no fewer than 30 days before the expected date of the removal or reassignment and shall include information on the procedure for the enrollee to request an exception to the formulary change. The policy, plan, or pharmacy benefit manager is required to provide the advanced written notice under this paragraph only to those enrollees in the policy or plan who are using the drug at the time the notification must be sent according to available claims history.

AB114-ASA1,10,8 (b) 1. A disability insurance policy, self-insured health plan, or pharmacy benefit manager is not required to provide advanced written notice under par. (a) if the prescription drug that is to be removed or reassigned is any of the following:

AB114-ASA1,10,9 a. No longer approved by the federal food and drug administration.

AB114-ASA1,10,12 b. The subject of a notice, guidance, warning, announcement, or other statement from the federal food and drug administration relating to concerns about the safety of the prescription drug.

AB114-ASA1,10,14 c. Approved by the federal food and drug administration for use without a prescription.

AB114-ASA1,10,22 2. A disability insurance policy, self-insured health plan, or pharmacy benefit manager is not required to provide advanced written notice under par. (a) if, for the prescription drug that is being removed from the formulary or reassigned to a benefit tier that has a higher deductible, copayment, or coinsurance, the policy, plan, or pharmacy benefit manager adds to the formulary a generic prescription drug that is approved by the federal food and drug administration for use as an alternative to the prescription drug or a prescription drug in the same pharmacologic class or with the same mechanism of action at any of the following benefit tiers:

AB114-ASA1,10,24 a. The same benefit tier from which the prescription drug is being removed or reassigned.

AB114-ASA1,11,2 b. A benefit tier that has a lower deductible, copayment, or coinsurance than the benefit tier from which the prescription drug is being removed or reassigned.

AB114-ASA1,11,10 (c) A pharmacist or pharmacy shall notify an enrollee in a disability insurance policy or self-insured health plan if a prescription drug for which an enrollee is filling or refilling a prescription is removed from the formulary and the policy or plan or a pharmacy benefit manager acting on behalf of a policy or plan adds to the formulary a generic prescription drug that is approved by the federal food and drug administration for use as an alternative to the prescription drug or a prescription drug in the same pharmacologic class or with the same mechanism of action at any of the following benefit tiers:

AB114-ASA1,11,12 1. The same benefit tier from which the prescription drug is being removed or reassigned.

AB114-ASA1,11,14 2. A benefit tier that has a lower deductible, copayment, or coinsurance than the benefit tier from which the prescription drug is being removed or reassigned.

AB114-ASA1,11,21 (d) If an enrollee has had an adverse reaction to the generic prescription drug or the prescription drug in the same pharmacologic class or with the same mechanism of action that is being substituted for an originally prescribed drug, the pharmacist or pharmacy may extend the prescription order for the originally prescribed drug to fill one 30-day supply of the originally prescribed drug for the cost-sharing amount that applies to the prescription drug at the time of the substitution.

AB114-ASA1,16 Section 16. 632.865 (1) (a) of the statutes is renumbered 632.865 (1) (aw).

AB114-ASA1,17 Section 17. 632.865 (1) (ae) and (ak) of the statutes are created to read:

AB114-ASA1,11,24 632.865 (1) (ae) “Health benefit plan” has the meaning given in s. 632.745 (11).

AB114-ASA1,11,25 (ak) “Health care provider” has the meaning given in s. 146.81 (1).

AB114-ASA1,18 Section 18. 632.865 (1) (c) of the statutes is renumbered 632.865 (1) (c) (intro.) and amended to read:

AB114-ASA1,12,5 632.865 (1) (c) (intro.) “Pharmacy benefit manager" means an entity doing business in this state that contracts to administer or manage prescription drug benefits on behalf of any of the following:

AB114-ASA1,12,6 1. An insurer or other.

AB114-ASA1,12,8 3. Another entity that provides prescription drug benefits to residents of this state.

AB114-ASA1,19 Section 19 . 632.865 (1) (c) 2. of the statutes is created to read:

AB114-ASA1,12,10 632.865 (1) (c) 2. A cooperative, as defined in s. 185.01 (2).

AB114-ASA1,20 Section 20. 632.865 (1) (dm) of the statutes is created to read:

AB114-ASA1,12,12 632.865 (1) (dm) “Prescription drug" has the meaning given in s. 450.01 (20).

AB114-ASA1,21 Section 21. 632.865 (3) to (7) of the statutes are created to read:

AB114-ASA1,12,16 632.865 (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.

AB114-ASA1,12,23 (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 24 months.

AB114-ASA1,13,3 (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:

AB114-ASA1,13,4 (a) The original claim was submitted fraudulently.

AB114-ASA1,13,7 (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.

AB114-ASA1,13,8 (c) The pharmacy services were not rendered by the pharmacist or pharmacy.

AB114-ASA1,13,10 (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.

AB114-ASA1,13,12 (e) The reduction is permitted in a contract between a pharmacy and a pharmacy benefit manager and is related to a quality program.

AB114-ASA1,13,13 (6) Audits of pharmacies or pharmacists. (a) Definitions. In this subsection:

AB114-ASA1,13,16 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.

AB114-ASA1,13,20 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.

AB114-ASA1,13,21 3. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

AB114-ASA1,13,23 (b) Procedures. An entity conducting an on-site or desk audit of pharmacist or pharmacy records shall do all of the following:

AB114-ASA1,14,3 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.

AB114-ASA1,14,6 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.

AB114-ASA1,14,8 3. If the audit involves clinical or professional judgment, conduct the audit by or in consultation with a pharmacist licensed in any state.

AB114-ASA1,14,10 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.

AB114-ASA1,14,12 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.

AB114-ASA1,14,18 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.

AB114-ASA1,14,21 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.

AB114-ASA1,14,24 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.

AB114-ASA1,15,2 (c) Results of audit. An entity that has conducted an audit of a pharmacist or pharmacy shall do all of the following:

AB114-ASA1,15,10 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.

AB114-ASA1,15,13 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.

AB114-ASA1,15,19 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.

AB114-ASA1,15,22 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.

AB114-ASA1,15,24 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.

AB114-ASA1,15,25 6. Exclude dispensing fees from calculations of overpayments.

AB114-ASA1,16,4 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.

AB114-ASA1,16,8 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.

AB114-ASA1,16,14 (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.

AB114-ASA1,16,18 (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 or refuse to participate in the audit.

AB114-ASA1,16,21 (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.

AB114-ASA1,16,24 (g) Applicability. 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.

AB114-ASA1,17,3 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.

AB114-ASA1,17,11 (7) Transparency reports. (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.

AB114-ASA1,17,13 (b) Reports under this subsection shall be considered a trade secret under the uniform trade secret act under s. 134.90.

AB114-ASA1,17,15 (c) The commissioner may not expand upon the reporting requirement under this subsection, except that the commissioner may effectuate this subsection.

AB114-ASA1,22 Section 22 . Chapter 633 (title) of the statutes is amended to read:

AB114-ASA1,17,20 CHAPTER 633 EMPLOYEE BENEFIT PLAN ADMINISTRATORS AND, PRINCIPALS , and Pharmacy benefit managers

AB114-ASA1,23 Section 23. 633.01 (1) (intro.) and (c) of the statutes are amended to read: