AB43: Bill Text

AB43,,8466 (b) A conflict of interest under this subsection 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 decision relating to a review of a prescription drug product.

AB43,,8467 (c) A conflict of interest under this subsection 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.

AB43,,8468 (d) The board shall disclose a conflict of interest under this subsection on the board’s website unless the chair of the board recuses the member from a final decision relating to a review of the prescription drug product. The disclosure shall include the type, nature, and magnitude of the interests of the member involved.

AB43,,8469 (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.

AB43,3045 Section 3045. 601.79 of the statutes is created to read:

AB43,,8471 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

AB43,,8472 (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.

AB43,,8473 (b) 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 wholesale acquisition cost that has increased at least $3,000 during a 12-month period.

AB43,,8474 (c) A biosimilar 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.

AB43,,8475 (d) 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:

AB43,,8476 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 federal food and drug administration, a supply lasting a patient for a period of 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.

AB43,,8477 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.

AB43,,8478 (e) 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.

AB43,,8479 (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.

AB43,,8480 (b) The information used 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.

AB43,,8481 (c) The failure of a manufacturer to provide the board with information for an affordability review under par. (b) does not affect the authority of the board to conduct the review.

AB43,,8482 (3) Affordability challenge. When conducting an affordability review of a prescription drug product under sub. (2), 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:

AB43,,8483 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

AB43,,8484 (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.

AB43,,8485 (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 cost.

AB43,,8486 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

AB43,,8487 (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 to the prescription drug product.

AB43,,8488 (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.

AB43,,8489 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

AB43,,8490 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

AB43,,8491 (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 to the prescription drug product.

AB43,,8492 (j) The average patient copay or other cost sharing for the prescription drug product in this state.

AB43,,8493 (k) Any information a manufacturer chooses to provide.

AB43,,8494 (L) Any other factors as determined by the board by rule.

AB43,,8495 (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:

AB43,,8496 1. The cost of administering the drug.

AB43,,8497 2. The cost of delivering the drug to consumers.

AB43,,8498 3. Other relevant administrative costs related to the drug.

AB43,,8499 (b) For a prescription drug product identified in sub. (1) (b) or (d) 2., 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.

AB43,,8500 (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.

AB43,,8501 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.

AB43,,8502 (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.

AB43,,8503 (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.

AB43,,8504 (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.

AB43,3046 Section 3046. 601.83 (1) (a) of the statutes is amended to read:

AB43,,8506 601.83 (1) (a) The commissioner shall administer a state-based reinsurance program known as the healthcare stability plan in accordance with the specific terms and conditions approved by the federal department of health and human services dated July 29, 2018. Before December 31, 2023, the commissioner may not request from the federal department of health and human services a modification, suspension, withdrawal, or termination of the waiver under 42 USC 18052 under which the healthcare stability plan under this subchapter operates unless legislation has been enacted specifically directing the modification, suspension, withdrawal, or termination. Before December 31, 2023, the commissioner may request renewal, without substantive change, of the waiver under 42 USC 18052 under which the health care stability plan operates in accordance with s. 20.940 (4) unless legislation has been enacted that is contrary to such a renewal request. The commissioner shall comply with applicable timing in and requirements of s. 20.940.

****Note: This is reconciled 2017 Wisconsin Act 370, section 44 (2) and (3). The elimination from this draft has been affected by drafts with the following LRB numbers: -1103/P1 and -0696/P1.

AB43,3047 Section 3047. 601.83 (1) (h) of the statutes is renumbered 601.83 (1) (h) (intro.) and amended to read:

AB43,,8508 601.83 (1) (h) (intro.) In 2019 and in each subsequent year Unless the joint committee on finance under s. 13.10 increases the amount upon request by the commissioner, the commissioner may expend no more than $200,000,000 the following amounts from all revenue sources for the healthcare stability plan under this section, unless the joint committee on finance under s. 13.10 has increased this amount upon request by the commissioner.:

AB43,,8509 (he) The commissioner shall ensure that sufficient funds are available for the healthcare stability plan under this section to operate as described in the approval of the federal department of health and human services dated July 29, 2018, and in any waiver extension approvals.

AB43,3048 Section 3048. 601.83 (1) (h) 1. and 3. of the statutes are created to read:

AB43,,8511 601.83 (1) (h) 1. In 2019, 2020, and 2021, $200,000,000.

AB43,,8512 3. In 2025 and in each year thereafter, the maximum expenditure amount for the previous year, adjusted to reflect the percentage increase, if any, in the consumer price index for all urban consumers, U.S. city average, for the medical care group, as determined by the U.S. department of labor, for the 12-month period ending on December 31 of the year before the year in which the amount is determined. The commissioner shall determine the annual adjustment amount for a particular year in January of the previous year. The commissioner shall publish the new maximum expenditure amount under this subdivision each year in the Wisconsin Administrative Register.

AB43,3049 Section 3049. 601.83 (1) (hm) of the statutes is renumbered 601.83 (1) (h) 2. and amended to read:

AB43,,8514 601.83 (1) (h) 2. Notwithstanding par. (h), in In 2022 and in each year thereafter, the commissioner may expend from all revenue sources, 2023, and 2024, $230,000,000 or less for the healthcare stability plan under this section.

AB43,3050 Section 3050. 609.045 of the statutes is created to read:

AB43,,8516 609.045 Balance billing; emergency medical services. (1) Definitions. In this section:

AB43,,8517 (a) “Emergency medical condition” means all of the following:

AB43,,8518 1. A medical condition, including a mental health condition or substance use disorder condition, manifesting itself by acute symptoms of sufficient severity, including severe pain, such that the absence of immediate medical attention could reasonably be expected to result in any of the following:

AB43,,8519 a. Placing the health of the individual or, with respect to a pregnant woman, the health of the woman or her unborn child, in serious jeopardy.

AB43,,8520 b. Serious impairment of bodily function.

AB43,,8521 c. Serious dysfunction of any bodily organ or part.

AB43,,8522 2. With respect to a pregnant woman who is having contractions, a medical condition for which there is inadequate time to safely transfer the pregnant woman to another hospital before delivery or for which the transfer may pose a threat to the health or safety of the pregnant woman or the unborn child.

AB43,,8523 (b) “Emergency medical services,” with respect to an emergency medical condition, has the meaning given for “emergency services” in 42 USC 300gg-111 (a) (3) (C).

AB43,,8524 (c) “Independent freestanding emergency department” has the meaning given in 42 USC 300gg-111 (a) (3) (D).

AB43,,8525 (d) “Out-of-network rate” has the meaning given by the commissioner by rule or, in the absence of such rule, the meaning given in 42 USC 300gg-111 (a) (3) (K).

AB43,,8526 (e) “Preferred provider plan,” notwithstanding s. 609.01 (4), includes only any preferred provider plan, as defined in 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.

AB43,,8527 (f) “Recognized amount” has the meaning given by the commissioner by rule or, in the absence of such rule, the meaning given in 42 USC 300gg-111 (a) (3) (H).

AB43,,8528 (g) “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.

AB43,,8529 (h) “Terminated” means the expiration or nonrenewal of a contract. “Terminated” does not include a termination of a contract for failure to meet applicable quality standards or for fraud.

AB43,,8530 (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:

AB43,,8531 (a) The plan may not require a prior authorization determination.

AB43,,8532 (b) The plan may not deny coverage on the basis of whether or not the health care provider providing the services is a participating provider or participating emergency facility.

AB43,,8533 (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 participating facility, the plan complies with all of the following:

AB43,,8534 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.

AB43,,8535 2. Any cost-sharing requirement imposed on an enrollee for the emergency medical services is no greater than the requirements that would apply if the emergency medical services were provided by a participating provider or in a participating facility.

AB43,,8536 3. Any cost-sharing amount imposed on an enrollee for the emergency medical services is calculated as if the total amount that would have been charged for the emergency medical services if provided by a participating provider or in a participating facility is equal to the recognized amount for such services, plan or coverage, and year.

AB43,,8537 4. The plan does all of the following:

AB43,,8538 a. No later than 30 days after the participating provider or participating 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.

AB43,,8539 b. Pays to the participating provider or participating facility a total amount that, incorporating any initial payment under subd. 4. a., is equal to the amount by which the out-of-network rate exceeds the cost-sharing amount.

AB43,,8540 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 emergency medical services provided by a participating provider or in a participating facility.

AB43,,8541 (3) 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:

AB43,,8542 (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.

AB43,,8543 (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 recognized amount for such item or service, plan or coverage, and year.

AB43,,8544 (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.

AB43,,8545 (d) The plan shall make a total payment directly to the provider who 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.

AB43,,8546 (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.

AB43,,8547 (4) Charging for services by nonparticipating provider; notice and consent. (a) Except as provided in par. (c), a provider of an item or service who is entitled to payment under sub. (3) may not bill or hold liable an enrollee for any amount for the item or service that is more than the cost-sharing amount calculated under sub. (3) (b) for the item or service unless the nonparticipating provider provides notice and obtains consent in accordance with all of the following:

AB43,,8548 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.

AB43,,8549 2. The notice provides a good faith estimate of the amount that the nonparticipating 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.

AB43,,8550 3. The notice includes a list of the participating providers at the participating facility who would be able to provide the item or service and notification that the enrollee may be referred to one of those participating providers.

AB43,,8551 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.

AB43,,8552 5. The notice clearly states that consent is optional and that the patient may elect to seek care from an in-network provider.

AB43,,8553 6. The notice is worded in plain language.