Amendment AA3-SB70

SB70-AA3,122,10 (c) “Disability insurance policy” has the meaning given in s. 632.895 (1) (a).

SB70-AA3,122,11 (d) “Prescription drug” has the meaning given in s. 450.01 (20).

SB70-AA3,122,13 (e) “Self-insured health plan” means a self-insured health plan of the state or a county, city, village, town, or school district.

SB70-AA3,122,19 (2) Application of discounts. A disability insurance policy that offers a prescription drug benefit or a self-insured health plan shall apply to any calculation of an out-of-pocket maximum amount and to any deductible of the disability insurance policy or self-insured health plan for an enrollee the amount that any discount provided by the manufacturer of a brand name drug reduces the cost sharing amount charged to the enrollee for that brand name drug.

SB70-AA3,145 Section 145. 632.863 of the statutes is created to read:

SB70-AA3,122,21 632.863 Pharmaceutical representatives. (1) Definitions. In this section:

SB70-AA3,122,24 (a) “Health care professional” means a physician or other health care practitioner who is licensed to provide health care services or to prescribe pharmaceutical or biologic products.

SB70-AA3,123,2 (b) “Pharmaceutical” means a medication that may legally be dispensed only with a valid prescription from a health care professional.

SB70-AA3,123,5 (c) “Pharmaceutical representative” means an individual who markets or promotes pharmaceuticals to health care professionals on behalf of a pharmaceutical manufacturer for compensation.

SB70-AA3,123,12 (2) Licensure. Beginning on the first day of the 12th month beginning after the effective date of this subsection .... [LRB inserts date], no individual may act as a pharmaceutical representative in this state without being licensed by the commissioner as a pharmaceutical representative under this section. In order to obtain a license, the individual shall apply to the commissioner in the form and manner prescribed by the commissioner. The term of a license issued under this subsection is one year and is renewable.

SB70-AA3,123,15 (3) Display of license. A pharmaceutical representative licensed under sub. (2) shall display the pharmaceutical representative's license during each visit with a health care professional.

SB70-AA3,123,18 (4) Enforcement. (a) Any individual who violates this section shall be fined not less than $1,000 nor more than $3,000 for each offense. Each day of continued violation constitutes a separate offense.

SB70-AA3,123,22 (b) The commissioner may suspend or revoke the license of a pharmaceutical representative who violates this section. A suspended or revoked license may not be reinstated until the pharmaceutical representative remedies all violations related to the suspension or revocation and pays all assessed penalties and fees.

SB70-AA3,123,25 (5) Rules. The commissioner shall promulgate rules to implement this section, including rules that require pharmaceutical representatives to complete continuing educational coursework as a condition of licensure.

SB70-AA3,146 Section 146. 632.864 of the statutes is created to read:

SB70-AA3,124,3 632.864 Pharmacy services administrative organizations. (1) Definitions. In this section:

SB70-AA3,124,4 (a) “Administrative service” means any of the following:

SB70-AA3,124,5 1. Assisting with claims.

SB70-AA3,124,6 2. Assisting with audits.

SB70-AA3,124,7 3. Providing centralized payment.

SB70-AA3,124,8 4. Performing certification in a specialized care program.

SB70-AA3,124,9 5. Providing compliance support.

SB70-AA3,124,10 6. Setting flat fees for generic drugs.

SB70-AA3,124,11 7. Assisting with store layout.

SB70-AA3,124,12 8. Managing inventory.

SB70-AA3,124,13 9. Providing marketing support.

SB70-AA3,124,14 10. Providing management and analysis of payment and drug dispensing data.

SB70-AA3,124,15 11. Providing resources for retail cash cards.

SB70-AA3,124,18 (b) “Independent pharmacy" means a pharmacy operating in this state that is licensed under s. 450.06 or 450.065 and is under common ownership with no more than 2 other pharmacies.

SB70-AA3,124,19 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

SB70-AA3,124,21 (d) “Pharmacy services administrative organization” means an entity operating in this state that does all of the following:

SB70-AA3,124,23 1. Contracts with an independent pharmacy to conduct business on the independent pharmacy's behalf with a 3rd-party payer.

SB70-AA3,125,3 2. Provides at least one administrative service to an independent pharmacy and negotiates and enters into a contract with a 3rd-party payer or pharmacy benefit manager on behalf of the independent pharmacy.

SB70-AA3,125,6 (e) “Third-party payer” means an entity, including a plan sponsor, health maintenance organization, or insurer, operating in this state that pays or insures health, medical, or prescription drug expenses on behalf of beneficiaries.

SB70-AA3,125,13 (2) Licensure. (a) Beginning on the first day of the 12th month beginning after the effective date of this paragraph .... [LRB inserts date], no person may operate as a pharmacy services administrative organization in this state without being licensed by the commissioner as a pharmacy services administrative organization under this section. In order to obtain a license, the person shall apply to the commissioner in the form and manner prescribed by the commissioner. The application shall include all of the following:

SB70-AA3,125,15 1. The name, address, telephone number, and federal employer identification number of the applicant.

SB70-AA3,125,17 2. The name, business address, and telephone number of a contact person for the applicant.

SB70-AA3,125,18 3. The fee under s. 601.31 (1) (nw).

SB70-AA3,125,19 4. Evidence of financial responsibility of at least $1,000,000.

SB70-AA3,125,20 5. Any other information required by the commissioner.

SB70-AA3,125,22 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

SB70-AA3,126,2 (3) Disclosure to the commissioner. (a) A pharmacy services administrative organization licensed under sub. (2) 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:

SB70-AA3,126,3 1. Provides pharmacy services.

SB70-AA3,126,4 2. Provides prescription drug or device services.

SB70-AA3,126,6 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

SB70-AA3,126,9 (b) A pharmacy services administrative organization licensed under sub. (2) 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).

SB70-AA3,126,10 (4) Rules. The commissioner may promulgate rules to implement this section.

SB70-AA3,147 Section 147. 632.868 of the statutes is created to read:

SB70-AA3,126,12 632.868 Insulin safety net programs. (1) Definitions. In this section:

SB70-AA3,126,14 (a) “Manufacturer" means a person engaged in the manufacturing of insulin that is self-administered on an outpatient basis.

SB70-AA3,126,15 (b) “Navigator" has the meaning given in s. 628.90 (3).

SB70-AA3,126,17 (c) “Patient assistance program” means a program established by a manufacturer under sub. (3) (a).

SB70-AA3,126,18 (d) “Pharmacy" means an entity licensed under s. 450.06 or 450.065.

SB70-AA3,126,21 (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.

SB70-AA3,126,23 (f) “Urgent need safety net program” means a program established by a manufacturer under sub. (2) (a).

SB70-AA3,127,2 (2) Urgent need safety net program. (a) Establishment of program. No later than July 1, 2024, 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).

SB70-AA3,127,4 (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:

SB70-AA3,127,5 1. The individual is in urgent need of insulin.

SB70-AA3,127,6 2. The individual is a resident of this state.

SB70-AA3,127,7 3. The individual is not receiving public assistance under ch. 49.

SB70-AA3,127,12 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.

SB70-AA3,127,14 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).

SB70-AA3,127,18 (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:

SB70-AA3,127,22 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).

SB70-AA3,127,23 b. A valid insulin prescription.

SB70-AA3,128,3 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.

SB70-AA3,128,11 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.

SB70-AA3,128,19 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.

SB70-AA3,128,21 4. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the application form described in subd. 1. a.

SB70-AA3,129,3 (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.

SB70-AA3,129,8 (3) Patient assistance program. (a) Establishment of program. No later than July 1, 2024, 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 patient assistance program, the manufacturer shall do all of the following:

SB70-AA3,129,11 1. Provide the commissioner with information regarding the patient assistance program, including contact information for individuals to call for assistance in accessing the patient assistance program.

SB70-AA3,129,13 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.

SB70-AA3,129,15 3. List the eligibility requirements under par. (b) on the manufacturer's website.

SB70-AA3,129,19 4. Maintain the privacy of all information received from an individual applying for or participating in the patient assistance program and not sell, share, or disseminate the information unless required under this section or authorized, in writing, by the individual.

SB70-AA3,129,21 (b) Eligible individual. An individual shall be eligible to receive insulin under a patient assistance program if all of the following conditions are met:

SB70-AA3,129,22 1. The individual is a resident of this state.

SB70-AA3,129,25 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.

SB70-AA3,130,1 3. The individual has a valid insulin prescription.

SB70-AA3,130,4 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.

SB70-AA3,130,5 5. The individual is not receiving public assistance under ch. 49.

SB70-AA3,130,11 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.

SB70-AA3,130,16 7. 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 needed.

SB70-AA3,130,25 (c) Application for patient assistance program. 1. An individual may apply to participate in a patient assistance program by filing an application with the manufacturer that established the patient assistance program, the individual's health care practitioner if the practitioner participates in the patient assistance program, or a navigator included on the list under sub. (8) (c). A health care practitioner or navigator shall immediately submit the application to the manufacturer. Upon receipt of an application, the manufacturer shall determine the individual's eligibility under par. (b) and, except as provided in subd. 2., notify the individual of the determination no later than 10 days after receipt of the application.

SB70-AA3,131,6 2. If necessary to determine the individual's eligibility under par. (b), the manufacturer may request additional information from an individual who has filed an application under subd. 1. no later than 5 days after receipt of the application. Upon receipt of the additional information, the manufacturer shall determine the individual's eligibility under par. (b) and notify the individual of the determination no later than 3 days after receipt of the requested information.

SB70-AA3,131,12 3. Except as provided in subd. 5., if the manufacturer determines under subd. 1. or 2. that the individual is eligible for the patient assistance program, the manufacturer shall provide the individual with a statement of eligibility. The statement of eligibility shall be valid for 12 months and may be renewed upon a determination by the manufacturer that the individual continues to meet the eligibility requirements under par. (b).

SB70-AA3,131,23 4. If the manufacturer determines under subd. 1. or 2. that the individual is not eligible for the patient assistance program, the manufacturer shall provide the reason for the determination in the notification under subd. 1. or 2. The individual may appeal the determination by filing an appeal with the commissioner that shall include all of the information provided to the manufacturer under subds. 1. and 2. The commissioner shall establish procedures for deciding appeals under this subdivision. The commissioner shall issue a decision no later than 10 days after the appeal is filed, and the commissioner's decision shall be final. If the commissioner determines that the individual meets the eligibility requirements under par. (b), the manufacturer shall provide the individual with the statement of eligibility described in subd. 3.

SB70-AA3,132,7 5. In the case of an individual who has prescription drug coverage through an individual or group health plan, if the manufacturer determines under subd. 1. or 2. that the individual is eligible for the patient assistance program but also determines that the individual's insulin needs are better addressed through the use of the manufacturer's copayment assistance program rather than the patient assistance program, the manufacturer shall inform the individual of the determination and provide the individual with the necessary coupons to submit to a pharmacy. The individual may not be required to pay more than the copayment amount specified in par. (d) 2.

SB70-AA3,132,14 (d) Provision of insulin under a patient assistance program. 1. Upon receipt from an individual of the eligibility statement described in par. (c) 3. and a valid insulin prescription, a pharmacy shall submit an order containing the name of the insulin and daily dosage amount to the manufacturer. The pharmacy shall include with the order the pharmacy's name, shipping address, office telephone number, fax number, email address, and contact name, as well as any days or times when deliveries are not accepted by the pharmacy.