Amendment AA2-ASA2-AB68

AB68-ASA2-AA2,61,21 (b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for public comment at each open meeting and shall provide the public with the opportunity to provide written comments on pending decisions of the board.

AB68-ASA2-AA2,61,24 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board concerning proprietary data and information shall be conducted in closed session and shall in all respects remain confidential.

AB68-ASA2-AA2,62,2 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

AB68-ASA2-AA2,62,6 (4) Conflicts of interest. (a) A member of the board shall recuse himself or herself from a decision by the board relating to a prescription drug product if the member or an immediate family member, as defined in s. 97.605 (4) (a) 2., has received or could receive any of the following:

AB68-ASA2-AA2,62,8 1. A direct financial benefit deriving from a determination, or a finding of a study or review, by the board relating to the prescription drug product.

AB68-ASA2-AA2,62,11 2. A financial benefit in excess of $5,000 in a calendar year from any person who owns, manufactures, or provides a prescription drug product to be studied or reviewed by the board.

AB68-ASA2-AA2,62,15 (b) A conflict of interest shall be disclosed by the board when hiring board staff, by the appointing authority when appointing members to the board, and by the board when a member of the board is recused from any final decision resulting from a review of a prescription drug product.

AB68-ASA2-AA2,62,18 (c) A conflict of interest shall be disclosed no later than 5 days after the conflict is identified, except that, if the conflict is identified within 5 days of an open meeting of the board, the conflict shall be disclosed prior to the meeting.

AB68-ASA2-AA2,62,23 (d) The board shall disclose a conflict of interest under this subsection on the board's Internet site unless the chair of the board recuses the member from a final decision resulting from a review of the prescription drug product. The disclosure shall include the type, nature, and magnitude of the interests of the member involved.

AB68-ASA2-AA2,63,3 (e) A member of the board or a 3rd-party contractor may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the board.

AB68-ASA2-AA2,63,5 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

AB68-ASA2-AA2,63,10 (a) A brand name drug or biologic that, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, has a launch wholesale acquisition cost of at least $30,000 per year or course of treatment or whose wholesale acquisition cost increased at least $3,000 during a 12–month period.

AB68-ASA2-AA2,63,13 (b) A biosimilar drug that has a launch wholesale acquisition cost that is not at least 15 percent lower than the referenced brand biologic at the time the biosimilar is launched.

AB68-ASA2-AA2,63,17 (c) A generic drug that has a wholesale acquisition cost, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, that meets all of the following conditions:

AB68-ASA2-AA2,63,23 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the U.S. food and drug administration, a supply lasting a patient for fewer than 30 days based on the recommended dosage approved for labeling by the federal food and drug administration, or one unit of the drug if the labeling approved by the federal food and drug administration does not recommend a finite dosage.

AB68-ASA2-AA2,64,3 2. Increased by at least 200 percent during the preceding 12–month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the preceding 12 months.

AB68-ASA2-AA2,64,6 (d) Other prescription drug products, including drugs to address public health emergencies, that may create affordability challenges for the health care system and patients in this state.

AB68-ASA2-AA2,64,11 (2) Affordability review. (a) After identifying prescription drug products under sub. (1), the board shall determine whether to conduct an affordability review for each identified prescription drug product by seeking stakeholder input about the prescription drug product and considering the average patient cost share of the prescription drug product.

AB68-ASA2-AA2,64,17 (b) The information to conduct an affordability review under par. (a) may include any document and research related to the manufacturer's selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in this state, market competition and context, projected revenue, and the estimated value or cost–effectiveness of the prescription drug product.

AB68-ASA2-AA2,64,19 (c) The failure of a manufacturer to provide the board with information for an affordability review does not affect the authority of the board to conduct the review.

AB68-ASA2-AA2,65,2 (3) Affordability challenge. When conducting an affordability review of a prescription drug product, the board shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the federal food and drug administration or standard medical practice has led or will lead to an affordability challenge for the health care system in this state, including high out–of–pocket costs for patients. To the extent practicable, in determining whether a prescription drug product has led or will lead to an affordability challenge, the board shall consider all of the following factors:

AB68-ASA2-AA2,65,4 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

AB68-ASA2-AA2,65,8 (b) The average monetary price concession, discount, or rebate the manufacturer provides, or is expected to provide, to health plans in this state as reported by manufacturers and health plans, expressed as a percent of the wholesale acquisition cost for the prescription drug product under review.

AB68-ASA2-AA2,65,12 (c) The total amount of the price concessions, discounts, and rebates the manufacturer provides to each pharmacy benefit manager for the prescription drug product under review, as reported by the manufacturer and pharmacy benefit manager and expressed as a percent of the wholesale acquisition costs.

AB68-ASA2-AA2,65,13 (d) The price at which therapeutic alternatives have been sold in this state.

AB68-ASA2-AA2,65,16 (e) The average monetary concession, discount, or rebate the manufacturer provides or is expected to provide to health plan payors and pharmacy benefit managers in this state for therapeutic alternatives.

AB68-ASA2-AA2,65,19 (f) The costs to health plans based on patient access consistent with labeled indications by the federal food and drug administration and recognized standard medical practice.

AB68-ASA2-AA2,65,21 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

AB68-ASA2-AA2,65,23 (h) The current or expected dollar value of drug–specific patient access programs that are supported by the manufacturer.

AB68-ASA2-AA2,66,3 (i) The relative financial impacts to health, medical, or social services costs that can be quantified and compared to baseline effects of existing therapeutic alternatives.

AB68-ASA2-AA2,66,5 (j) The average patient copay or other cost sharing for the prescription drug product in the state.

AB68-ASA2-AA2,66,6 (k) Any information a manufacturer chooses to provide.

AB68-ASA2-AA2,66,7 (L) Any other factors as determined by the board by rule.

AB68-ASA2-AA2,66,11 (4) Upper payment limit. (a) If the board determines under sub. (3) that use of a prescription drug product has led or will lead to an affordability challenge, the board shall establish an upper payment limit for the prescription drug product after considering all of the following:

AB68-ASA2-AA2,66,12 1. The cost of administering the drug.

AB68-ASA2-AA2,66,13 2. The cost of delivering the drug to consumers.

AB68-ASA2-AA2,66,14 3. Other relevant administrative costs related to the drug.

AB68-ASA2-AA2,66,20 (b) For a prescription drug product identified in sub. (1) (d), the board shall solicit information from the manufacturer regarding the price increase. To the extent that the price increase is not a result of the need for increased manufacturing capacity or other effort to improve patient access during a public health emergency, the board shall establish an upper payment limit under par. (a) that is equal to the cost to consumers prior to the price increase.

AB68-ASA2-AA2,66,24 (c) 1. The upper payment limit established under this subsection shall apply to all purchases and payor reimbursements of the prescription drug product dispensed or administered to individuals in this state in person, by mail, or by other means.

AB68-ASA2-AA2,67,11 2. Notwithstanding subd. 1., while state-sponsored and state-regulated health plans and health programs shall limit drug reimbursements and drug payment to no more than the upper payment limit established under this subsection, a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse more than the upper payment limit. A provider who dispenses and administers a prescription drug product in this state to an individual in this state may not bill a payor more than the upper payment limit to the patient regardless of whether a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above the upper payment limit.

AB68-ASA2-AA2,67,13 (5) Public inspection. Information submitted to the board under this section shall be open to public inspection only as provided under ss. 19.31 to 19.39.

AB68-ASA2-AA2,67,17 (6) No prohibition on marketing. Nothing in this section may be construed to prevent a manufacturer from marketing a prescription drug product approved by the federal food and drug administration while the prescription drug product is under review by the board.

AB68-ASA2-AA2,67,22 (7) Appeals. A person aggrieved by a decision of the board may request an appeal of the decision no later than 30 days after the board makes the determination. The board shall hear the appeal and make a final decision no later than 60 days after the appeal is requested. A person aggrieved by a final decision of the board may petition for judicial review in a court of competent jurisdiction.”.

AB68-ASA2-AA2,67,23 100. Page 355, line 3: after that line insert:

AB68-ASA2-AA2,67,24 “ Section 412b. 609.045 of the statutes is created to read:

AB68-ASA2-AA2,68,2 609.045 Balance billing; emergency medical services. (1) Definitions. In this section:

AB68-ASA2-AA2,68,6 (a) “Emergency medical services” means emergency medical services for which coverage is required under s. 632.85 (2) and includes emergency medical services described under s. 632.85 (2) as if section 1867 of the federal Social Security Act applied to an independent freestanding emergency department.

AB68-ASA2-AA2,68,10 (b) “Preferred provider plan,” notwithstanding s. 609.01 (4), includes only any preferred provider plan, as defined under s. 609.01 (4), that has a network of participating providers and imposes on enrollees different requirements for using providers that are not participating providers.

AB68-ASA2-AA2,68,14 (c) “Self-insured governmental plan” means a self-insured health plan of the state or a county, city, village, town, or school district that has a network of participating providers and imposes on enrollees in the self-insured health plan different requirements for using providers that are not participating providers.

AB68-ASA2-AA2,68,19 (2) Emergency medical services. A defined network plan, preferred provider plan, or self-insured governmental plan that covers any benefits or services provided in an emergency department of a hospital or emergency medical services provided in an independent freestanding emergency department shall cover emergency medical services in accordance with all of the following:

AB68-ASA2-AA2,68,20 (a) The plan may not require a prior authorization determination.

AB68-ASA2-AA2,68,23 (b) The plan may not deny coverage based on whether or not the health care provider providing the services is a participating provider or participating emergency facility.

AB68-ASA2-AA2,69,3 (c) If the emergency medical services are provided to an enrollee by a provider or in a facility that is not a participating provider or facility, the plan complies with all of the following:

AB68-ASA2-AA2,69,7 1. The emergency medical services are covered without imposing on an enrollee a requirement for prior authorization or any coverage limitation that is more restrictive than requirements or limitations that apply to emergency medical services provided by participating providers or in participating facilities.

AB68-ASA2-AA2,69,11 2. Any cost-sharing requirement imposed on an enrollee for the emergency medical service is no greater than the requirements that would apply if the emergency medical service were provided by a participating provider or in a participating facility.

AB68-ASA2-AA2,69,16 3. Any cost-sharing amount imposed on an enrollee for the emergency medical service is calculated as if the total amount that would have been charged for the emergency medical service if provided by a participating provider or in a participating facility is equal to the amount paid to the provider or facility that is not a participating provider or facility as determined by the commissioner.

AB68-ASA2-AA2,69,17 4. The plan does all of the following:

AB68-ASA2-AA2,69,20 a. No later than 30 days after the provider or facility transmits to the plan the bill for emergency medical services, sends to the provider or facility an initial payment or a notice of denial of payment.

AB68-ASA2-AA2,69,24 b. Pays to the provider or facility a total amount that, incorporating any initial payment under subd. 4. a., is equal to the amount by which the rate for a provider or facility that is not a participating provider or facility exceeds the cost-sharing amount.

AB68-ASA2-AA2,70,5 5. The plan counts any cost-sharing payment made by the enrollee for the emergency medical services toward any in-network deductible or out-of-pocket maximum applied by the plan in the same manner as if the cost-sharing payment was made for an emergency medical service provided by a participating provider or in a participating facility.

AB68-ASA2-AA2,70,16 (3) Provider billing limitation for emergency medical services; ambulance services. A provider of emergency medical services or a facility in which emergency medical services are provided that is entitled to payment under sub. (2) may not bill or hold liable an enrollee for any amount for the emergency medical service that is more than the cost-sharing amount determined under sub. (2) (c) 3. for the emergency service. A provider of ambulance services that is not a participating provider under an enrollee's defined network plan, preferred provider plan, or self-insured governmental plan may not bill or hold liable an enrollee for any amount of the ambulance service that is more than the cost-sharing amount that the enrollee would be charged if the provider of ambulance services was a participating provider under the enrollee's plan.

AB68-ASA2-AA2,70,22 (4) Nonparticipating provider in participating facility. For items or services other than emergency medical services that are provided to an enrollee of a defined network plan, preferred provider plan, or self-insured governmental plan by a provider who is not a participating provider but who is providing services at a participating facility, the plan shall provide coverage for the item or service in accordance with all of the following:

AB68-ASA2-AA2,70,25 (a) The plan may not impose on an enrollee a cost-sharing requirement for the item or service that is greater than the cost-sharing requirement that would have been imposed if the item or service was provided by a participating provider.

AB68-ASA2-AA2,71,4 (b) Any cost-sharing amount imposed on an enrollee for the item or service is calculated as if the total amount that would have been charged for the item or service if provided by a participating provider is equal to the amount paid to the provider that is not a participating provider as determined by the commissioner.

AB68-ASA2-AA2,71,6 (c) No later than 30 days after the provider transmits the bill for services, the plan shall send to the provider an initial payment or a notice of denial of payment.

AB68-ASA2-AA2,71,10 (d) The plan shall make a total payment directly to the provider that provided the item or service to the enrollee that, added to any initial payment described under par. (c), is equal to the amount by which the out-of-network rate for the item or service exceeds the cost-sharing amount.

AB68-ASA2-AA2,71,14 (e) The plan counts any cost-sharing payment made by the enrollee for the item or service toward any in-network deductible or out-of-pocket maximum applied by the plan in the same manner as if the cost-sharing payment was made for the item or service when provided by a participating provider.

AB68-ASA2-AA2,71,20 (5) Charging for services by nonparticipating provider; notice and consent. (a) Except as provided in par. (c), a provider of an item or service that is entitled to payment under sub. (4) may not bill or hold liable an enrollee for any amount for the item or service that is more than the cost-sharing amount determined under sub. (4) (b) for the item or service unless the nonparticipating provider provides notice and obtains consent in accordance with all of the following:

AB68-ASA2-AA2,71,23 1. The notice states that the provider is not a participating provider in the enrollee's defined network plan, preferred provider plan, or self-insured governmental plan.

AB68-ASA2-AA2,72,2 2. The notice provides a good faith estimate of the amount that the provider may charge the enrollee for the item or service involved, including notification that the estimate does not constitute a contract with respect to the charges estimated for the item or service.

AB68-ASA2-AA2,72,5 3. The notice includes a list of the participating providers at the facility that would be able to provide the item or service and notification that the enrollee may be referred to one of those participating providers.

AB68-ASA2-AA2,72,8 4. The notice includes information about whether or not prior authorization or other care management limitations may be required before receiving an item or service at the participating facility.

AB68-ASA2-AA2,72,13 5. The enrollee provides consent to the provider to be treated by the nonparticipating provider, and the consent acknowledges that the enrollee has been informed that the charge paid by the enrollee may not meet a limitation that the enrollee's defined network plan, preferred provider plan, or self-insured governmental plan places on cost sharing, such as an in-network deductible.

AB68-ASA2-AA2,72,15 6. A signed copy of the consent described under subd. 5. is provided to the enrollee.

AB68-ASA2-AA2,72,17 (b) To be considered adequate, the notice and consent under par. (a) shall meet one of the following requirements, as applicable:

AB68-ASA2-AA2,72,21 1. If the enrollee makes an appointment for the item or service at least 72 hours before the day on which the item or service is to be provided, any notice under par. (a) shall be provided to the enrollee at least 72 hours before the day of the appointment at which the item or service is to be provided.

AB68-ASA2-AA2,72,24 2. If the enrollee makes an appointment for the item or service less than 72 hours before the day on which the item or service is to be provided, any notice under par. (a) shall be provided to the enrollee on the day that the appointment is made.

AB68-ASA2-AA2,73,6 (c) A provider of an item or service that is entitled to payment under sub. (4) may not bill or hold liable an enrollee for any amount for the ancillary item or service that is more than the cost-sharing amount determined under sub. (4) (b) for the item or service, unless the commissioner specifies by rule that the provider may balance bill for the specified item or service, if the ancillary item or service is any of the following:

AB68-ASA2-AA2,73,7 1. Related to an emergency medical service.

AB68-ASA2-AA2,73,8 2. Anesthesiology.

AB68-ASA2-AA2,73,9 3. Pathology.

AB68-ASA2-AA2,73,10 4. Radiology.

AB68-ASA2-AA2,73,11 5. Neonatology.

AB68-ASA2-AA2,73,12 6. A item or service provided by an assistant surgeon, hospitalist, or intensivist.

AB68-ASA2-AA2,73,13 7. Diagnostic service, including a radiology or laboratory service.

AB68-ASA2-AA2,73,15 8. An item or service provided by a specialty practitioner that the commissioner specifies by rule.

AB68-ASA2-AA2,73,18 9. An item or service provided by a nonparticipating provider when there is no participating provider who can furnish the item or service at the participating facility.

AB68-ASA2-AA2,74,3 (6) Notice by provider or facility. Beginning no later than January 1, 2022, a health care provider or health care facility shall make available, including posting on an Internet site, to enrollees in defined network plans, preferred provider plans, and self-insured governmental plans notice of the requirements on a provider or facility under subs. (3) and (5), of any other applicable state law requirements on the provider or facility with respect to charging an enrollee for an item or service if the provider or facility does not have a contractual relationship with the plan, and of information on contacting appropriate state or federal agencies in the event the enrollee believes the provider or facility violates any of the requirements under this section or other applicable law.

AB68-ASA2-AA2,74,20 (7) Negotiation; dispute resolution. A provider or facility that is entitled to receive an initial payment or notice of denial under sub. (2) (c) 4. a. or (4) (c) may initiate, within 30 days of receiving the initial payment or notice of denial, open negotiations with the defined network plan, preferred provider plan, or self-insured governmental plan to determine a payment amount for the emergency medical service or other item or service for a period that terminates 30 days after initiating open negotiations. If the open negotiation period under this subsection terminates without determination of a payment amount, the provider, facility, defined network plan, preferred provider plan, or self-insured governmental plan may initiate, within the 4 days beginning on the day after the open negotiation period ends, the independent dispute resolution process as specified by the commissioner. If the independent dispute resolution decision maker determines the payment amount, the party to the independent dispute resolution process whose amount was not selected shall pay the fees for the independent dispute resolution. If the parties to the independent dispute resolution reach a settlement on the payment amount, the parties to the independent dispute resolution shall equally divide the payment for the fees for the independent dispute resolution.