AB68: Bill Text

AB68,1544,10 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.

AB68,1544,12 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.

AB68,1544,18 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.

AB68,1544,21 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.

AB68,1544,24 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.

AB68,1545,2 (c) Results of audit. An entity that has conducted an audit of a pharmacist or pharmacy shall do all of the following:

AB68,1545,10 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.

AB68,1545,13 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.

AB68,1545,19 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.

AB68,1545,22 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.

AB68,1545,24 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.

AB68,1545,25 6. Exclude dispensing fees from calculations of overpayments.

AB68,1546,4 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.

AB68,1546,8 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.

AB68,1546,14 (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.

AB68,1546,18 (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 with or refuse to participate in the audit.

AB68,1546,21 (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.

AB68,1546,24 (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.

AB68,1547,3 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.

AB68,1547,11 (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.

AB68,1547,13 (b) Reports under this subsection shall be considered a trade secret under the uniform trade secret act under s. 134.90.

AB68,1547,15 (c) The commissioner may not expand upon the reporting requirement under this subsection, except that the commissioner may effectuate this subsection.

AB68,2966 Section 2966. 632.8655 of the statutes is created to read:

AB68,1547,17 632.8655 Hospital drug cost reporting. (1) Definitions. In this section:

AB68,1547,19 (a) “Brand-name drug” means a prescription drug approved under 21 USC 355 (b) or 42 USC 262.

AB68,1547,21 (b) “Covered hospital” means an entity described in 42 USC 256b (a) (4) (L) to (N) that participates in the federal drug pricing program under 42 USC 256b.

AB68,1547,22 (c) “Generic drug” means a prescription drug approved under 21 USC 355 (j).

AB68,1548,2 (d) “Margin” means, for a covered hospital, the difference between the net cost of a brand-name drug or generic drug covered under the federal drug pricing program under 42 USC 256b and the net payment by the covered hospital for that brand-name drug or generic drug.

AB68,1548,4 (e) “Net payment” means the amount paid for a brand-name drug or generic drug after all discounts and rebates have been applied.

AB68,1548,9 (2) Hospital margin spending. By March 1 annually, each covered hospital operating in this state shall report to the commissioner the per unit margin for each drug covered under the federal drug pricing program under 42 USC 256b dispensed in the previous year multiplied by the number of units dispensed at that margin and how the margin revenue was used.

AB68,1548,15 (3) Public reporting. The commissioner shall publicly post covered hospital documentation of how each hospital spends the margin revenue. The commissioner shall analyze data collected under this section and publish annually a report including an analysis on hospital-specific margins and how that revenue is spent or allocated on a hospital-specific basis. The commissioner shall keep any trade secret or proprietary information confidential.

AB68,2967 Section 2967. 632.8665 of the statutes is created to read:

AB68,1548,18 632.8665 Prescription drug cost reporting. (1) Definitions. In this section:

AB68,1548,20 (a) “Brand-name drug” means a prescription drug approved under 21 USC 355 (b) or 42 USC 262.

AB68,1548,21 (b) “Generic drug” means a prescription drug approved under 21 USC 355 (j).

AB68,1548,24 (c) “Manufacturer” has the meaning given in s. 450.01 (12). “Manufacturer” does not include an entity that is engaged only in the dispensing, as defined in s. 450.01 (7), of a brand-name drug or generic drug.

AB68,1549,4 (d) “Manufacturer-sponsored assistance program” means a program offered by a manufacturer or an intermediary under contract with a manufacturer through which a brand-name drug or generic drug is provided to a patient at no charge or at a discount.

AB68,1549,5 (e) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68,1549,9 (f) “Pharmacy services administrative organization” means an entity that provides contracting and other administrative services to a pharmacy to assist the pharmacy in interactions with a 3rd-party payer, pharmacy benefit manager, wholesale drug distributor, or other entity.

AB68,1549,13 (g) “Wholesale acquisition cost” means the most recently reported manufacturer list or catalog price for a brand-name drug or generic drug available to wholesalers or direct purchasers in the United States, before application of discounts, rebates, or reductions in price.

AB68,1549,19 (2) Price increase or introduction notice; justification report. (a) A manufacturer shall notify the commissioner if it is increasing the wholesale acquisition cost of a brand-name drug on the market in this state by more than 10 percent or by more than $10,000 during any 12-month period or if it intends to introduce to market in this state a brand-name drug that has an annual wholesale acquisition cost of $30,000 or more.

AB68,1549,23 (b) A manufacturer shall notify the commissioner if it is increasing the wholesale acquisition cost of a generic drug by more than 25 percent or by more than $300 during any 12-month period or if it intends to introduce to market a generic drug that has an annual wholesale acquisition cost of $3,000 or more.

AB68,1550,4 (c) The manufacturer shall provide the notice under par. (a) or (b) in writing at least 30 days before the planned effective date of the cost increase or drug introduction with a justification that includes all documents and research related to the manufacturer's selection of the cost increase or introduction price and a description of life cycle management, market competition and context, and estimated value or cost-effectiveness of the product.

AB68,1550,8 (3) Net prices paid by pharmacy benefit managers. By March 1 annually, the manufacturer shall report to the commissioner the value of price concessions, expressed as a percentage of the wholesale acquisition cost, provided to each pharmacy benefit manager for each drug sold in this state.

AB68,1550,13 (4) Rebates and price concessions. By March 1 annually, each pharmacy benefit manager shall report to the commissioner the amount received from manufacturers as drug rebates and the value of price concessions, expressed as a percentage of the wholesale acquisition cost, provided by manufacturers for each drug.

AB68,1550,17 (5) Manufacturer-sponsored assistance programs. By March 1 annually, each manufacturer shall provide the commissioner with a description of each manufacturer-sponsored patient assistance program in effect during the previous year that includes all of the following:

AB68,1550,18 (a) The terms of the programs.

AB68,1550,19 (b) The number of prescriptions provided to state residents under the program.

AB68,1550,21 (c) The total market value of assistance provided to residents of this state under the program.

AB68,1550,24 (6) Pharmacy services administrative organizations. By March 1 annually, each pharmacy services administrative organization shall report to the commissioner all of the following information:

AB68,1551,2 (a) The negotiated reimbursement rate of the 25 prescription drugs with the highest reimbursement rates during the previous year.

AB68,1551,4 (b) The 25 prescription drugs with the highest year-to-year change in reimbursement rate for the previous year.

AB68,1551,5 (c) The schedule of fees charged by the organization to pharmacies.

AB68,1551,11 (7) Certification and penalties for noncompliance. Each manufacturer and pharmacy services administrative organization that is required to report under this section shall certify each report as accurate under the penalty of perjury. A manufacturer or pharmacy services administrative organization that fails to submit a report required under this section is subject to a forfeiture of no more than $10,000 each day the report is overdue.

AB68,1551,14 (8) Hearing and public reporting. (a) The commissioner shall publicly post manufacturer price justification documents. The commissioner shall keep any trade secret or proprietary information confidential.

AB68,1551,20 (b) The commissioner shall analyze data collected under this section and publish annually a report on emerging trends in prescription prices and price increases and shall annually conduct a public hearing based on the analysis under this paragraph. The report under this paragraph shall include analysis of manufacturer prices and price increases and analysis of how pharmacy benefit manager discounts and net costs compare to retail prices paid by patients.

AB68,2968 Section 2968. 632.868 of the statutes is created to read:

AB68,1551,22 632.868 Insulin safety net programs. (1) Definitions. In this section:

AB68,1551,24 (a) “Manufacturer" means a person engaged in the manufacturing of insulin that is self-administered on an outpatient basis.

AB68,1551,25 (b) “Navigator" has the meaning given in s. 628.90 (3).

AB68,1552,2 (c) “Patient assistance program” means a program established by a manufacturer under sub. (3) (a).

AB68,1552,3 (d) “Pharmacy" means an entity licensed under s. 450.06 or 450.065.

AB68,1552,6 (e) “Urgent need of insulin" means having less than a 7-day supply of insulin readily available for use and needing insulin in order to avoid the likelihood of suffering a significant health consequence.

AB68,1552,8 (f) “Urgent need safety net program” means a program established by a manufacturer under sub. (2) (a).

AB68,1552,12 (2) Urgent need safety net program. (a) Establishment of program. No later than July 1, 2022, each manufacturer shall establish an urgent need safety net program to make insulin available in accordance with this subsection to individuals who meet the eligibility requirements under par. (b).

AB68,1552,14 (b) Eligible individual. An individual shall be eligible to receive insulin under an urgent need safety net program if all of the following conditions are met:

AB68,1552,15 1. The individual is in urgent need of insulin.

AB68,1552,16 2. The individual is a resident of this state.

AB68,1552,17 3. The individual is not receiving public assistance under ch. 49.

AB68,1552,22 4. The individual is not enrolled in prescription drug coverage through an individual or group health plan that limits the total cost sharing amount, including copayments, deductibles, and coinsurance, that an enrollee is required to pay for a 30-day supply of insulin to no more than $75, regardless of the type or amount of insulin prescribed.

AB68,1552,24 5. The individual has not received insulin under an urgent need safety net program within the previous 12 months, except as allowed under par. (d).

AB68,1553,4 (c) Provision of insulin under an urgent need safety net program. 1. In order to receive insulin under an urgent need safety net program, an individual who meets the eligibility requirements under par. (b) shall provide a pharmacy with all of the following:

AB68,1553,8 a. A completed application, on a form prescribed by the commissioner that shall include an attestation by the individual, or the individual's parent or legal guardian if the individual is under the age of 18, that the individual meets all of the eligibility requirements under par. (b).

AB68,1553,9 b. A valid insulin prescription.

AB68,1553,12 c. A valid Wisconsin driver's license or state identification card. If the individual is under the age of 18, the individual's parent or legal guardian shall meet this requirement.

AB68,1553,20 2. Upon receipt of the information described in subd. 1. a. to c., the pharmacist shall dispense a 30-day supply of the prescribed insulin to the individual. The pharmacy shall also provide the individual with the information sheet described in sub. (8) (b) 2. and the list of navigators described in sub. (8) (c). The pharmacy may collect a copayment, not to exceed $35, from the individual to cover the pharmacy's costs of processing and dispensing the insulin. The pharmacy shall notify the health care practitioner who issued the prescription no later than 72 hours after the insulin is dispensed.

AB68,1554,3 3. A pharmacy that dispenses insulin under subd. 2. may submit to the manufacturer, or the manufacturer's vendor, a claim for payment that is in accordance with the national council for prescription drug programs' standards for electronic claims processing, except that no claim may be submitted if the manufacturer agrees to send the pharmacy a replacement of the same insulin in the amount dispensed. If the pharmacy submits an electronic claim, the manufacturer or vendor shall reimburse the pharmacy in an amount that covers the pharmacy's acquisition cost.

AB68,1554,5 4. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the application form described in subd. 1. a.

AB68,1554,12 (d) Eligibility of certain individuals. An individual who has applied for public assistance under ch. 49 but for whom a determination of eligibility has not been made or whose coverage has not become effective or an individual who has an appeal pending under sub. (3) c. 4. may access insulin under this subsection if the individual is in urgent need of insulin. To access a 30-day supply of insulin, the individual shall attest to the pharmacy that the individual is described in this paragraph and comply with par. (c) 1.

AB68,1554,17 (3) Patient assistance program. (a) Establishment of program. No later than July 1, 2022, each manufacturer shall establish a patient assistance program to make insulin available in accordance with this subsection to individuals who meet the eligibility requirements under par. (b). Under the program, the manufacturer shall do all of the following:

AB68,1554,20 1. Provide the commissioner with information regarding the program, including contact information for individuals to call for assistance in accessing the program.

AB68,1554,22 2. Provide a hotline for individuals to call or access between 8 a.m. and 10 p.m. on weekdays and between 10 a.m. and 6 p.m. on Saturdays.

AB68,1554,24 3. List the eligibility requirements under par. (b) on the manufacturer's Internet site.

AB68,1555,4 4. Maintain the privacy of all information received from an individual applying for or participating in the program and not sell, share, or disseminate the information unless required under this section or authorized, in writing, by the individual.

AB68,1555,6 (b) Eligible individual. An individual shall be eligible to receive insulin under a patient assistance program if all of the following conditions are met:

AB68,1555,7 1. The individual is a resident of this state.

AB68,1555,10 2. The individual, or the individual's parent or legal guardian if the individual is under the age of 18, has a valid Wisconsin driver's license or state identification card.

AB68,1555,11 3. The individual has a valid insulin prescription.

AB68,1555,14 4. The family income of the individual does not exceed 400 percent of the poverty line as defined and revised annually under 42 USC 9902 (2) for a family the size of the individual's family,