Amendment SSA1-AB68

AB68-SSA1,1359,16 (2) Licensure. (a) A person may not operate as a pharmacy services administrative organization in this state without a pharmacy services administrative organization license. In order to obtain a license, a person shall apply to the commissioner in the form and manner prescribed by the commissioner. The application shall include all of the following:

AB68-SSA1,1359,18 1. The name, address, telephone number, and federal employer identification number of the applicant.

AB68-SSA1,1359,20 2. The name, business address, and telephone number of a contact person for the applicant.

AB68-SSA1,1359,21 3. The fee under s. 601.31 (1) (nw).

AB68-SSA1,1359,22 4. Evidence of financial responsibility of at least $1,000,000.

AB68-SSA1,1359,23 5. Any other information required by the commissioner.

AB68-SSA1,1359,25 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

AB68-SSA1,1360,4 (3) Disclosure to the commissioner. (a) A pharmacy services administrative organization shall disclose to the commissioner the extent of any ownership or control of the pharmacy services administrative organization by an entity that does any of the following:

AB68-SSA1,1360,5 1. Provides pharmacy services.

AB68-SSA1,1360,6 2. Provides prescription drug or device services.

AB68-SSA1,1360,8 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

AB68-SSA1,1360,11 (b) A pharmacy services administrative organization shall notify the commissioner in writing within 5 days of any material change in its ownership or control relating to an entity described in par. (a).

AB68-SSA1,1360,12 (4) Rules. The commissioner may promulgate rules to implement this section.

AB68-SSA1,2998 Section 2998. 632.865 (2m) of the statutes is created to read:

AB68-SSA1,1360,17 632.865 (2m) Fiduciary duty and disclosures to health benefit plan sponsors. (a) A pharmacy benefit manager owes a fiduciary duty to the health benefit plan sponsor to act according to the health benefit plan sponsor's instructions and in the best interests of the health benefit plan sponsor.

AB68-SSA1,1360,20 (b) A pharmacy benefit manager shall annually provide, no later than the date and using the method prescribed by the commissioner by rule, the health benefit plan sponsor all of the following information from the previous calendar year:

AB68-SSA1,1360,22 1. The indirect profit received by the pharmacy benefit manager from owning any interest in a pharmacy or service provider.

AB68-SSA1,1360,24 2. Any payment made by the pharmacy benefit manager to a consultant or broker who works on behalf of the health benefit plan sponsor.

AB68-SSA1,1361,4 3. From the amounts received from all drug manufacturers, the amounts retained by the pharmacy benefit manager, and not passed through to the health benefit plan sponsor, that are related to the health benefit plan sponsor's claims or bona fide service fees.

AB68-SSA1,1361,9 4. The amounts, including pharmacy access and audit recovery fees, received from all pharmacies that are in the pharmacy benefit manager's network or have a contract to be in the network and, from these amounts, the amount retained by the pharmacy benefit manager and not passed through to the health benefit plan sponsor.

AB68-SSA1,2999 Section 2999. 632.8655 of the statutes is created to read:

AB68-SSA1,1361,11 632.8655 Hospital drug cost reporting. (1) Definitions. In this section:

AB68-SSA1,1361,13 (a) “Brand-name drug” means a prescription drug approved under 21 USC 355 (b) or 42 USC 262.

AB68-SSA1,1361,15 (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-SSA1,1361,16 (c) “Generic drug” means a prescription drug approved under 21 USC 355 (j).

AB68-SSA1,1361,20 (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-SSA1,1361,22 (e) “Net payment” means the amount paid for a brand-name drug or generic drug after all discounts and rebates have been applied.

AB68-SSA1,1362,2 (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-SSA1,1362,8 (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-SSA1,3000 Section 3000. 632.8665 of the statutes is created to read:

AB68-SSA1,1362,11 632.8665 Prescription drug cost reporting. (1) Definitions. In this section:

AB68-SSA1,1362,13 (a) “Brand-name drug” means a prescription drug approved under 21 USC 355 (b) or 42 USC 262.

AB68-SSA1,1362,14 (b) “Generic drug” means a prescription drug approved under 21 USC 355 (j).

AB68-SSA1,1362,17 (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-SSA1,1362,21 (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-SSA1,1362,22 (e) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68-SSA1,1363,2 (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-SSA1,1363,6 (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-SSA1,1363,12 (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-SSA1,1363,16 (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-SSA1,1363,22 (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-SSA1,1364,2 (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-SSA1,1364,7 (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-SSA1,1364,11 (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-SSA1,1364,12 (a) The terms of the programs.

AB68-SSA1,1364,13 (b) The number of prescriptions provided to state residents under the program.

AB68-SSA1,1364,15 (c) The total market value of assistance provided to residents of this state under the program.

AB68-SSA1,1364,18 (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-SSA1,1364,20 (a) The negotiated reimbursement rate of the 25 prescription drugs with the highest reimbursement rates during the previous year.

AB68-SSA1,1364,22 (b) The 25 prescription drugs with the highest year-to-year change in reimbursement rate for the previous year.

AB68-SSA1,1364,23 (c) The schedule of fees charged by the organization to pharmacies.

AB68-SSA1,1365,4 (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-SSA1,1365,7 (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-SSA1,1365,13 (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-SSA1,3001 Section 3001. 632.868 of the statutes is created to read:

AB68-SSA1,1365,15 632.868 Insulin safety net programs. (1) Definitions. In this section:

AB68-SSA1,1365,17 (a) “Manufacturer" means a person engaged in the manufacturing of insulin that is self-administered on an outpatient basis.

AB68-SSA1,1365,18 (b) “Navigator" has the meaning given in s. 628.90 (3).

AB68-SSA1,1365,20 (c) “Patient assistance program” means a program established by a manufacturer under sub. (3) (a).

AB68-SSA1,1365,21 (d) “Pharmacy" means an entity licensed under s. 450.06 or 450.065.

AB68-SSA1,1365,24 (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-SSA1,1366,2 (f) “Urgent need safety net program” means a program established by a manufacturer under sub. (2) (a).

AB68-SSA1,1366,6 (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-SSA1,1366,8 (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-SSA1,1366,9 1. The individual is in urgent need of insulin.

AB68-SSA1,1366,10 2. The individual is a resident of this state.

AB68-SSA1,1366,11 3. The individual is not receiving public assistance under ch. 49.

AB68-SSA1,1366,16 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-SSA1,1366,18 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-SSA1,1366,22 (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-SSA1,1367,2 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-SSA1,1367,3 b. A valid insulin prescription.

AB68-SSA1,1367,6 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-SSA1,1367,14 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-SSA1,1367,22 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-SSA1,1367,24 4. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the application form described in subd. 1. a.

AB68-SSA1,1368,7 (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-SSA1,1368,12 (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-SSA1,1368,15 1. Provide the commissioner with information regarding the program, including contact information for individuals to call for assistance in accessing the program.

AB68-SSA1,1368,17 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-SSA1,1368,19 3. List the eligibility requirements under par. (b) on the manufacturer's Internet site.

AB68-SSA1,1368,23 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-SSA1,1368,25 (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-SSA1,1369,1 1. The individual is a resident of this state.

AB68-SSA1,1369,4 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-SSA1,1369,5 3. The individual has a valid insulin prescription.

AB68-SSA1,1369,8 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,

AB68-SSA1,1369,9 5. The individual is not receiving public assistance under ch. 49.

AB68-SSA1,1369,15 6. The individual is not eligible to receive health care through a federally funded program or receive prescription drug benefits through the U.S. department of veterans affairs, except that this subdivision does not apply to an individual who is enrolled in a policy under Part D of Medicare under 42 USC 1395w-101 et seq. if the individual has spent at least $1,000 on prescription drugs in the current calendar year.