Amendment AA3-SB70

SB70-AA3,88,7 (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.

SB70-AA3,88,11 (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:

SB70-AA3,88,17 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.

SB70-AA3,88,20 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.

SB70-AA3,88,23 (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.

SB70-AA3,89,3 (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.

SB70-AA3,89,9 (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.

SB70-AA3,89,12 (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.

SB70-AA3,89,20 (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:

SB70-AA3,89,22 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

SB70-AA3,90,2 (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.

SB70-AA3,90,6 (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.

SB70-AA3,90,8 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

SB70-AA3,90,11 (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.

SB70-AA3,90,14 (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.

SB70-AA3,90,16 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

SB70-AA3,90,18 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

SB70-AA3,90,21 (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.

SB70-AA3,90,23 (j) The average patient copay or other cost sharing for the prescription drug product in this state.

SB70-AA3,90,24 (k) Any information a manufacturer chooses to provide.

SB70-AA3,90,25 (L) Any other factors as determined by the board by rule.

SB70-AA3,91,4 (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:

SB70-AA3,91,5 1. The cost of administering the drug.

SB70-AA3,91,6 2. The cost of delivering the drug to consumers.

SB70-AA3,91,7 3. Other relevant administrative costs related to the drug.

SB70-AA3,91,13 (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.

SB70-AA3,91,17 (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.

SB70-AA3,92,3 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.

SB70-AA3,92,5 (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.

SB70-AA3,92,9 (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.

SB70-AA3,92,14 (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.

SB70-AA3,9123 Section 9123. Nonstatutory provisions; Insurance.

SB70-AA3,92,21 (1u) Staggered terms for board. Notwithstanding the length of terms specified for the members of the board under s. 15.735 (1) (b) to (e), 2 of the initial members shall be appointed for terms expiring on May 1, 2025; 2 of the initial members shall be appointed for terms expiring on May 1, 2026; 2 of the initial members shall be appointed for terms expiring on May 1, 2027; and 2 of the initial members shall be appointed for terms expiring on May 1, 2028.

SB70-AA3,9423 Section 9423. Effective dates; Insurance.

SB70-AA3,93,2 (1v) Prescription drug affordability review board. The treatment of ss. 15.07 (3) (bm) 7., 15.735, 601.78, 601.785, and 601.79 and subch. VI (title) of ch. 601 and Section 9123 (1u) of this act take effect on the first day of the 7th month beginning after publication.”.

SB70-AA3,93,3 206. Page 374, line 11: after that line insert:

SB70-AA3,93,5 “ Section 84. 20.005 (3) (schedule) of the statutes: at the appropriate place, insert the following amounts for the purposes indicated: - See PDF for table

SB70-AA3,85 Section 85. 20.435 (5) (ch) of the statutes is created to read:

SB70-AA3,93,8 20.435 (5) (ch) Suicide and crisis lifeline grants. The amounts in the schedule for grants under s. 46.533.

SB70-AA3,86 Section 86. 46.533 of the statutes is created to read:

SB70-AA3,93,12 46.533 Suicide and crisis lifeline; grants. (1) In this section, “national crisis hotline” means the telephone or text access number “988,” or its successor, that is maintained under the federally administered program under 42 USC 290bb-36c.

SB70-AA3,93,16 (2) From the appropriation under s. 20.435 (5) (ch), the department shall award grants to organizations that provide crisis intervention services and crisis care coordination to individuals who contact the national crisis hotline from anywhere within this state.”.

SB70-AA3,93,17 207. Page 374, line 11: after that line insert:

SB70-AA3,93,18 “ Section 87. 49.79 (9) (f) of the statutes is repealed.”.

SB70-AA3,93,19 208. Page 374, line 11: after that line insert:

SB70-AA3,93,20 “ Section 88. 46.48 (36) of the statutes is created to read:

SB70-AA3,94,7 46.48 (36) Amyotrophic lateral sclerosis. From the appropriation under s. 20.435 (1) (b), the department shall award $250,000 in each fiscal year as a grant to an organization that supports and provides services to individuals with amyotrophic lateral sclerosis for the purposes of assisting individuals diagnosed with amyotrophic lateral sclerosis and their families with the costs of respite care and costs associated with amyotrophic lateral sclerosis that are not covered by insurance.”.

SB70-AA3,94,8 209. Page 374, line 11: after that line insert:

SB70-AA3,94,9 “ Section 9119. Nonstatutory provisions; Health Services.

SB70-AA3,94,23 (1) Low-value care analysis grant. From the appropriation under s. 20.435 (1) (b), in the 2023-24 and 2024-25 fiscal years, the department of health services shall award a grant in an amount not to exceed $900,000 in each fiscal year to an organization for the purpose of conducting a data analysis of claims under the medical assistance program administered by the department of health services and claims under health care coverage plans offered by the state under s. 40.51 (6) to identify low-value care. The recipient of the grant under this subsection shall report the organization's findings, including any recommendations for providing effective and efficient care, to the department of health services and the department of employee trust funds. The department of health services and the department of employee trust funds shall distribute the findings reported under this subsection to health care providers that provide services covered by the medical assistance program or a health care coverage plan and to health maintenance organizations and insurance companies that provide health insurance to state employees.”.

SB70-AA3,94,24 210. Page 374, line 11: after that line insert:

SB70-AA3,95,2 “ Section 89. 20.005 (3) (schedule) of the statutes: at the appropriate place, insert the following amounts for the purposes indicated: - See PDF for table - See PDF for table

SB70-AA3,90 Section 90. 20.435 (1) (ex) of the statutes is created to read:

SB70-AA3,95,6 20.435 (1) (ex) Maternal and infant mortality prevention and response. The amounts in the schedule for the prevention of and response to maternal and infant mortality under s. 253.143.

SB70-AA3,91 Section 91. 253.143 of the statutes is created to read:

SB70-AA3,95,10 253.143 Maternal and infant mortality prevention and response. From the appropriation under s. 20.435 (1) (ex), the department shall do all of the following:

SB70-AA3,95,12 (1) Annually award grants to community organizations whose goal is the prevention of maternal and infant mortality.

SB70-AA3,95,16 (2) Annually award grants to support the expansion of fetal and infant mortality review and maternal mortality review teams statewide and expand technical assistance and support for existing fetal and infant mortality review and child death review teams.

SB70-AA3,95,18 (3) Provide funding and technical assistance to community-based organizations aimed at preventing infant morality.

SB70-AA3,96,2 (4) Provide funding for grief and bereavement programming for those impacted by infant loss.

SB70-AA3,9119 Section 9119. Nonstatutory provisions; Health Services.

SB70-AA3,96,8 (1) Maternal and infant mortality prevention and response. The authorized FTE positions for the department of health services are increased by 2.0 FTE positions, to be funded from the appropriation under s. 20.435 (1) (ex), for the purpose of administering the maternal and infant mortality prevention and response program.”.

SB70-AA3,96,9 211. Page 374, line 11: after that line insert:

SB70-AA3,96,10 “ Section 92. 49.45 (7m) of the statutes is created to read:

SB70-AA3,96,18 49.45 (7m) Pay-for-performance; health information exchange. The department shall develop and implement for non-hospital providers in the Medical Assistance program, including physicians, clinics, health departments, home health agencies, and post-acute care facilities, a payment system based on performance to incentivize participation in health information data sharing to facilitate better patient care, reduced costs, and easier access to patient information. The department shall establish performance metrics for the payment system under this subsection that satisfy all of the following:

SB70-AA3,96,20 (a) The metric shall include participation by providers in a health information exchange at a minimum level of patient record access.

SB70-AA3,96,22 (b) The payment under the payment system shall increase as the participation level in the health information exchange increases.

SB70-AA3,96,23 (c) The payment system shall begin in the 2024 rate year.

SB70-AA3,97,2 (d) For purposes of the payment system, the department shall seek any available federal moneys.”.

SB70-AA3,97,3 212. Page 374, line 11: after that line insert:

SB70-AA3,97,4 “ Section 93. 49.45 (30p) of the statutes is created to read:

SB70-AA3,97,5 49.45 (30p) Detoxification and stabilization services. (a) In this subsection:

SB70-AA3,97,18 1. “Adult residential integrated behavioral health stabilization service” means a residential behavioral health treatment service, delivered under the oversight of a medical director, that provides withdrawal management and intoxication monitoring, as well as integrated behavioral health stabilization services, and includes nursing care on site for medical monitoring available on a 24-hour basis. “Adult residential integrated behavioral health stabilization service” may include the provision of services including screening, assessment, intake, evaluation and diagnosis, medical care, observation and monitoring, physical examination, determination of medical stability, medication management, nursing services, case management, drug testing, counseling, individual therapy, group therapy, family therapy, psychoeducation, peer support services, recovery coaching, recovery support services, and crisis intervention services, to ameliorate acute behavioral health symptoms and stabilize functioning.

SB70-AA3,97,21 2. “Community-based withdrawal management” means a medically managed withdrawal management service delivered on an outpatient basis by a physician or other service personnel acting under the supervision of a physician.

SB70-AA3,97,24 3. “Detoxification and stabilization services” means adult residential integrated behavioral health stabilization service, residential withdrawal management service, or residential intoxication monitoring service.

SB70-AA3,98,9 4. “Residential intoxication monitoring service” means a residential service that provides 24-hour observation to monitor the safe resolution of alcohol or sedative intoxication and to monitor for the development of alcohol withdrawal for intoxicated patients who are not in need of emergency medical or behavioral healthcare. “Residential intoxication monitoring service” may include the provision of services including screening, assessment, intake, evaluation and diagnosis, observation and monitoring, case management, drug testing, counseling, individual therapy, group therapy, family therapy, psychoeducation, peer support services, recovery coaching, and recovery support services.

SB70-AA3,98,22 5. “Residential withdrawal management service” means a residential substance use treatment service that provides withdrawal management and intoxication monitoring, and includes medically managed 24-hour on-site nursing care, under the supervision of a physician. “Residential withdrawal management service” may include the provision of services, including screening, assessment, intake, evaluation and diagnosis, medical care, observation and monitoring, physical examination, medication management, nursing services, case management, drug testing, counseling, individual therapy, group therapy, family therapy, psychoeducation, peer support services, recovery coaching, and recovery support services, to ameliorate symptoms of acute intoxication and withdrawal and to stabilize functioning. “Residential withdrawal management service” may also include community-based withdrawal management and intoxication monitoring services.

SB70-AA3,99,2 (b) Subject to par. (c), the department shall provide reimbursement for detoxification and stabilization services under the Medical Assistance program under s. 49.46 (2) (b) 14r. The department shall certify providers under the Medical Assistance program to provide detoxification and stabilization services in accordance with this subsection.

SB70-AA3,99,10 (c) The department shall submit to the federal department of health and human services any request for a state plan amendment, waiver, or other federal approval necessary to provide reimbursement for detoxification and stabilization services as described in this subsection. If the federal department approves the request or if no federal approval is necessary, the department shall provide the reimbursement under par. 49.46 (2) (b) 14r. If the federal department disapproves the request, the department may not provide the reimbursement described in this subsection.

SB70-AA3,94 Section 94. 49.46 (2) (b) 14r. of the statutes is created to read:

SB70-AA3,99,13 49.46 (2) (b) 14r. Detoxification and stabilization services as specified under s. 49.45 (30p).”.

SB70-AA3,99,14 213. Page 374, line 11: after that line insert:

SB70-AA3,99,15 “ Section 95. 49.45 (6xm) of the statutes is created to read:

SB70-AA3,99,19 49.45 (6xm) Pediatric inpatient supplement. (a) From the appropriations under s. 20.435 (4) (b), (o), and (w), the department shall, using a method determined by the department, distribute a total sum of $2,000,000 in each state fiscal year to hospitals that meet all of the following criteria:

SB70-AA3,99,20 1. The hospital is an acute care hospital located in this state.

SB70-AA3,99,23 2. During the hospital's fiscal year, the inpatient days in the hospital's acute care pediatric units and intensive care pediatric units totaled more than 12,000 days, not including neonatal intensive care units. For purposes of this subdivision, the hospital's fiscal year is the hospital's fiscal year that ended in the 2nd calendar year preceding the beginning of the state fiscal year.

SB70-AA3,100,7 (b) Notwithstanding par. (a), from the appropriations under s. 20.435 (4) (b), (o), and (w), the department may, using a method determined by the department, distribute an additional total sum of $10,000,000 in each state fiscal year to hospitals that are freestanding pediatric teaching hospitals located in Wisconsin that have a percentage calculated under s. 49.45 (3m) (b) 1. a. greater than 45 percent.”.

SB70-AA3,100,8 214. Page 374, line 11: after that line insert:

SB70-AA3,100,9 “ Section 96. 49.45 (3) (e) 12. of the statutes is amended to read: