SB719: Bill Text

The bill directs the commissioner to promulgate ethical standards for pharmaceutical representatives. Additionally, the bill prohibits a pharmaceutical representative from engaging in deceptive or misleading marketing of a pharmaceutical product; using a title or designation that could reasonably lead a licensed health care professional, or an employee or representative of such a professional, to believe that the pharmaceutical representative is licensed to practice in a health occupation unless the pharmaceutical representative holds a license to practice in that health occupation; or attending a patient examination without the patient’s consent.

An individual who violates any of the requirements under this bill is subject to a fine, and the individual’s license may be suspended or revoked. An individual whose license is revoked must wait at least two years before applying for a new license.

Insulin safety net programs

The bill requires insulin manufacturers to establish a program under which qualifying Wisconsin residents who are in urgent need of insulin and are uninsured or have limited insurance coverage can be dispensed insulin at a pharmacy. Under the program, if a qualifying individual in urgent need of insulin provides a pharmacy with a form attesting that the individual meets the program’s eligibility requirements, specified proof of residency, and a valid insulin prescription, the pharmacy must dispense a 30-day supply of insulin to the individual and may charge the individual a copayment of no more than $35. The pharmacy may submit an electronic payment claim for the insulin’s acquisition cost to the manufacturer or agree to receive a replacement of the same insulin in the amount dispensed.

The bill also requires that each insulin manufacturer establish a patient assistance program to make insulin available to any qualifying Wisconsin resident who, among other requirements, is uninsured or has limited insurance coverage and whose family income does not exceed 400 percent of the federal poverty line. Under the bill, an individual must apply to participate in a manufacturer’s program. If the manufacturer determines that the individual meets the program’s eligibility requirements, the manufacturer must issue the individual a statement of eligibility, which is valid for 12 months and may be renewed. Under the bill, if an individual with a statement of eligibility and valid insulin prescription requests insulin from a pharmacy, the pharmacy must submit an order to the manufacturer, who must then provide a 90-day supply of insulin at no charge to the individual or pharmacy. The pharmacy may charge the individual a copayment of no more than $50. Under the bill, a manufacturer is not required to issue a statement of eligibility if the individual has prescription drug coverage through an individual or group health plan and the manufacturer determines that the individual’s insulin needs are better addressed through the manufacturer’s copayment assistance program. In such case, the manufacturer must provide the individual with the necessary drug coupons, and the individual may not be required to pay more than a $50 copayment for a 90-day supply of insulin.

Under the bill, if the manufacturer determines that an individual is not eligible for the patient assistance program, the individual may file an appeal with OCI. The bill directs OCI to establish procedures for deciding appeals. Under the bill, OCI must issue a decision within 10 days, and that decision is final.

The bill requires that insulin manufacturers annually report to OCI certain information, including the number of individuals served and the cost of insulin dispensed under the programs and that OCI annually report to the governor and the legislature on the programs. The bill also directs OCI to conduct public outreach and develop an information sheet about the programs, conduct satisfaction surveys of individuals and pharmacies that participate in the programs, and report to the governor and the legislature on the surveys by July 1, 2026. Additionally, the bill requires that OCI develop a training program for health care navigators to assist individuals in accessing appropriate long-term insulin options and maintain a list of trained navigators.

The bill provides that a manufacturer that fails to comply with the bill’s provisions may be assessed a penalty of up to $200,000 per month of noncompliance, which increases to $400,000 per month if the manufacturer continues to be in noncompliance after six months and to $600,000 per month if the manufacturer continues to be in noncompliance after one year. The bill’s requirements do not apply to manufacturers with annual insulin sales revenue in Wisconsin of no more than $2,000,000 or to insulin that costs less than a specified dollar amount.

This proposal may contain a health insurance mandate requiring a social and financial impact report under s. 601.423, stats.

Because this bill creates a new crime or revises a penalty for an existing crime, the Joint Review Committee on Criminal Penalties may be requested to prepare a report.

For further information see the state fiscal estimate, which will be printed as an appendix to this bill.

SB719,,4 The people of the state of Wisconsin, represented in senate and assembly, do enact as follows:

SB719,1 Section 1. 20.005 (3) (schedule) of the statutes: at the appropriate place, insert the following amounts for the purposes indicated:

SB719,2 Section 2. 20.145 (1) (a) of the statutes is created to read:

SB719,,7 20.145 (1) (a) State operations. The amounts in the schedule for general program operations.

SB719,3 Section 3. 49.45 (18) (ac) of the statutes is amended to read:

SB719,,9 49.45 (18) (ac) Except as provided in pars. (am) to (d), and subject to par. (ag), any person eligible for medical assistance under s. 49.46, 49.468, or 49.47, or for the benefits under s. 49.46 (2) (a) and (b) under s. 49.471, shall pay up to the maximum amounts allowable under 42 CFR 447.53 to 447.58 for purchases of services provided under s. 49.46 (2). The service provider shall collect the specified or allowable copayment, coinsurance, or deductible, unless the service provider determines that the cost of collecting the copayment, coinsurance, or deductible exceeds the amount to be collected. The department shall reduce payments to each provider by the amount of the specified or allowable copayment, coinsurance, or deductible. No provider may deny care or services because the recipient is unable to share costs, but an inability to share costs specified in this subsection does not relieve the recipient of liability for these costs.

SB719,4 Section 4. 49.45 (18) (ag) of the statutes is repealed.

SB719,5 Section 5. 49.45 (18) (b) 8. of the statutes is created to read:

SB719,,12 49.45 (18) (b) 8. Prescription drugs.

SB719,6 Section 6. 255.056 (2g) of the statutes is created to read:

SB719,,14 255.056 (2g) The department may partner with out-of-state drug repository programs. The department may authorize a medical facility or pharmacy that elects to participate in the drug repository program to receive drugs or supplies from out of state, and the department may authorize an out-of-state entity that participates in a partner out-of-state drug repository program to receive drugs or supplies from Wisconsin.

SB719,7 Section 7. 450.085 (3) of the statutes is created to read:

SB719,,16 450.085 (3) An applicant for renewal of a license under s. 450.08 (2) (a) may count, for purposes of the continuing education requirement under sub. (1), up to 10 hours spent as a volunteer at a free and charitable clinic approved by the board.

SB719,8 Section 8. 601.31 (1) (nv) of the statutes is created to read:

SB719,,18 601.31 (1) (nv) For issuing or renewing a license as a pharmaceutical representative under s. 632.863, an amount to be set by the commissioner by rule.

SB719,9 Section 9. 601.31 (1) (nw) of the statutes is created to read:

SB719,,20 601.31 (1) (nw) For issuing or renewing a license as a pharmacy services administrative organization under s. 632.864, an amount to be set by the commissioner by rule.

SB719,10 Section 10. 601.41 (13) of the statutes is created to read:

SB719,,22 601.41 (13) Value-based diabetes medication pilot project. The commissioner shall develop a pilot project to direct a pharmacy benefit manager, as defined in s. 632.865 (1) (c), and a pharmaceutical manufacturer to create a value-based, sole-source arrangement to reduce the costs of prescription medication used to treat diabetes. The commissioner may promulgate rules to implement this subsection.

SB719,11 Section 11. 601.415 (14) of the statutes is created to read:

SB719,,24 601.415 (14) Patient pharmacy benefits tool. (a) From the appropriation under s. 20.145 (1) (a), beginning in the 2024-25 fiscal year, the office shall award grants in a total amount of up to $500,000 each fiscal year to health care providers to develop and implement a tool for prescribers to disclose the cost of prescription drugs for patients. The tool must be usable by physicians and other prescribers to determine the cost of prescription drugs for their patients.

SB719,,25 (b) Any health care provider that receives a grant under par. (a) shall contribute matching funds equal to at least 50 percent of the grant amount awarded.

SB719,12 Section 12. 601.575 of the statutes is created to read:

SB719,,27 601.575 Prescription drug importation program. (1) Importation program requirements. The commissioner, in consultation with persons interested in the sale and pricing of prescription drugs and appropriate officials and agencies of the federal government, shall design and implement a prescription drug importation program for the benefit of residents of this state, that generates savings for residents, and that satisfies all of the following:

SB719,,28 (a) The commissioner shall designate a state agency to become a licensed wholesale distributor or to contract with a licensed wholesale distributor and shall seek federal certification and approval to import prescription drugs.

SB719,,29 (b) The program shall comply with relevant requirements of 21 USC 384, including safety and cost savings requirements.

SB719,,30 (c) The program shall import prescription drugs from Canadian suppliers regulated under any appropriate Canadian or provincial laws.

SB719,,31 (d) The program shall have a process to sample the purity, chemical composition, and potency of imported prescription drugs.

SB719,,32 (e) The program shall import only those prescription drugs for which importation creates substantial savings for residents of this state and only those prescription drugs that are not brand-name drugs and that have fewer than 4 competitor prescription drugs in the United States.

SB719,,33 (f) The commissioner shall ensure that prescription drugs imported under the program are not distributed, dispensed, or sold outside of this state.

SB719,,34 (g) The program shall ensure all of the following:

SB719,,35 1. Participation by any pharmacy or health care provider in the program is voluntary.

SB719,,36 2. Any pharmacy or health care provider participating in the program has the appropriate license or other credential in this state.

SB719,,37 3. Any pharmacy or health care provider participating in the program charges a consumer or health plan the actual acquisition cost of the imported prescription drug that is dispensed.

SB719,,38 (h) The program shall ensure that a payment by a health plan or health insurance policy for a prescription drug imported under the program reimburses no more than the actual acquisition cost of the imported prescription drug that is dispensed.

SB719,,39 (i) The program shall ensure that any health plan or health insurance policy participating in the program does all of the following:

SB719,,40 1. Maintains a formulary and claims payment system with current information on prescription drugs imported under the program.

SB719,,41 2. Bases cost-sharing amounts for participants or insureds under the plan or policy on no more than the actual acquisition cost of the prescription drug imported under the program that is dispensed to the participant or insured.

SB719,,42 3. Demonstrates to the commissioner or a state agency designated by the commissioner how premiums under the plan or policy are affected by savings on prescription drugs imported under the program.

SB719,,43 (j) Any wholesale distributor importing prescription drugs under the program shall limit its profit margin to the amount established by the commissioner or a state agency designated by the commissioner.

SB719,,44 (k) The program may not import any generic prescription drug that would violate federal patent laws on branded products in the United States.

SB719,,45 (L) The program shall comply with tracking and tracing requirements of 21 USC 360eee and 360eee-1, to the extent practical and feasible, before the prescription drug to be imported comes into the possession of this state’s wholesale distributor and fully after the prescription drug to be imported is in the possession of this state’s wholesale distributor.

SB719,,46 (m) The program shall establish a fee or other mechanism to finance the program that does not jeopardize significant savings to residents of this state.

SB719,,47 (n) The program shall have an audit function that ensures all of the following:

SB719,,48 1. The commissioner has a sound methodology to determine the most cost-effective prescription drugs to include in the program.

SB719,,49 2. The commissioner has a process in place to select Canadian suppliers that are high quality, high performing, and in full compliance with Canadian laws.

SB719,,50 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

SB719,,51 4. The program is complying with the requirements of this subsection.

SB719,,52 5. The program is adequately financed to support administrative functions of the program while generating significant cost savings to residents of this state.

SB719,,53 6. The program does not put residents of this state at a higher risk than if the program did not exist.

SB719,,54 7. The program provides and is projected to continue to provide substantial cost savings to residents of this state.

SB719,,55 (2) Anticompetitive behavior. The commissioner, in consultation with the attorney general, shall identify the potential for and monitor anticompetitive behavior in industries affected by a prescription drug importation program.

SB719,,56 (3) Approval of program design; certification. No later than the first day of the 7th month beginning after the effective date of this subsection .... [LRB inserts date], the commissioner shall submit to the joint committee on finance a report that includes the design of the prescription drug importation program in accordance with this section. The commissioner may not submit the proposed program to the federal department of health and human services unless the joint committee on finance approves the proposed program. Within 14 days of the date of approval by the joint committee on finance of the proposed program, the commissioner shall submit to the federal department of health and human services a request for certification of the approved program.

SB719,,57 (4) Implementation of certified program. After the federal department of health and human services certifies the prescription drug importation program submitted under sub. (3), the commissioner shall begin implementation of the program, and the program shall be fully operational by 180 days after the date of certification by the federal department of health and human services. The commissioner shall do all of the following to implement the program to the extent the action is in accordance with other state laws and the certification by the federal department of health and human services:

SB719,,58 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.

SB719,,59 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c) and (n).

SB719,,60 (c) Create an outreach and marketing plan to communicate with and provide information to health plans and health insurance policies, employers, pharmacies, health care providers, and residents of this state on participating in the program.

SB719,,61 (d) Develop and implement a registration process for health plans and health insurance policies, pharmacies, and health care providers interested in participating in the program.

SB719,,62 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

SB719,,63 (f) Create, publicize, and implement a method of communication to promptly answer questions from and address the needs of persons affected by the implementation of the program before the program is fully operational.

SB719,,64 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

SB719,,65 (h) Conduct any other activities determined by the commissioner to be important to successful implementation of the program.

SB719,,66 (5) Report. By January 1 and July 1 of each year, the commissioner shall submit to the joint committee on finance a report including all of the following:

SB719,,67 (a) A list of prescription drugs included in the prescription drug importation program under this section.

SB719,,68 (b) The number of pharmacies, health care providers, and health plans and health insurance policies participating in the prescription drug importation program under this section.

SB719,,69 (c) The estimated amount of savings to residents of this state, health plans and health insurance policies, and employers resulting from the implementation of the prescription drug importation program under this section reported from the date of the previous report under this subsection and from the date the program was fully operational.

SB719,,70 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.

SB719,,71 (6) Rulemaking. The commissioner may promulgate any rules necessary to implement this section.

SB719,13 Section 13. 609.83 of the statutes is amended to read:

SB719,,73 609.83 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 (6) (b), (16t), and (16v).

SB719,14 Section 14. 632.863 of the statutes is created to read:

SB719,,75 632.863 Pharmaceutical representatives. (1) Definitions. In this section:

SB719,,76 (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.

SB719,,77 (b) “Pharmaceutical” means a medication that may legally be dispensed only with a valid prescription from a health care professional.

SB719,,78 (c) “Pharmaceutical representative” means an individual who markets or promotes pharmaceuticals to health care professionals on behalf of a pharmaceutical manufacturer for compensation.

SB719,,79 (d) “Wholesale acquisition cost” means the most recently reported manufacturer list or catalog price for a brand-name or generic drug available to wholesalers or direct purchasers in the United States, before application of discounts, rebates, or reductions in price.