COMMITTEE ON LEGISLATIVE RESEARCH OVERSIGHT DIVISION FISCAL NOTE L.R. No.:0404H.03C Bill No.:HCS for HB 197 Subject:Drugs and Controlled Substances; Pharmacy; Insurance - Health Type:Original Date:February 15, 2023Bill Summary:This proposal creates provisions relating to payments for prescription drugs. FISCAL SUMMARY ESTIMATED NET EFFECT ON GENERAL REVENUE FUNDFUND AFFECTEDFY 2024FY 2025FY 2026General Revenue Fund* $0 to (Unknown)$0 to (Unknown)$0 to (Unknown) Total Estimated Net Effect on General Revenue $0 to (Unknown)$0 to (Unknown)$0 to (Unknown) *Officials from the Missouri Consolidated Health Care Plan (MCHCP) state to the extent the proposed language would not preclude MCHCP separately contracting with a specialty pharmacy for supply and payment of specialty drugs, the expected fiscal impact would be $0. However, should the language allow retail pharmacies to supply and bill for specialty drugs, then MCHCP would likely have an unknown increase in cost of over $250,000. Oversight has reflected a $0 or Unknown cost to various state and local funds that pay for health insurance. ESTIMATED NET EFFECT ON OTHER STATE FUNDSFUND AFFECTEDFY 2024FY 2025FY 2026Other State Funds$0 to (Unknown)$0 to (Unknown)$0 to (Unknown)Total Estimated Net Effect on Other State Funds $0 to (Unknown)$0 to (Unknown)$0 to (Unknown) Numbers within parentheses: () indicate costs or losses. L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 2 of February 15, 2023 HWC:LR:OD ESTIMATED NET EFFECT ON FEDERAL FUNDSFUND AFFECTEDFY 2024FY 2025FY 2026Federal Funds$0 to (Unknown)$0 to (Unknown)$0 to (Unknown)Total Estimated Net Effect on All Federal Funds $0 to (Unknown)$0 to (Unknown)$0 to (Unknown) ESTIMATED NET EFFECT ON FULL TIME EQUIVALENT (FTE)FUND AFFECTEDFY 2024FY 2025FY 2026Total Estimated Net Effect on FTE 000 ☒ Estimated Net Effect (expenditures or reduced revenues) expected to exceed $250,000 in any of the three fiscal years after implementation of the act or at full implementation of the act. ☐ Estimated Net Effect (savings or increased revenues) expected to exceed $250,000 in any of the three fiscal years after implementation of the act or at full implementation of the act. ESTIMATED NET EFFECT ON LOCAL FUNDSFUND AFFECTEDFY 2024FY 2025FY 2026Local Government$0 to (Unknown)$0 to (Unknown)$0 to (Unknown) L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 3 of February 15, 2023 HWC:LR:OD FISCAL ANALYSIS §§103.200, 338.015 and 376.387 - 376.689 – Payments for Prescription Drugs Officials from the Missouri Consolidated Health Care Plan (MCHCP) state to the extent the proposed language would not preclude MCHCP separately contracting with a specialty pharmacy for supply and payment of specialty drugs, the expected fiscal impact would be $0. However, should the language allow retail pharmacies to supply and bill for specialty drugs, then MCHCP would likely have an unknown increased cost of over $250,000. Oversight will range the fiscal impact to MCHCP as $0 (the language would not preclude MCHCP from separately contracting with a specialty pharmacy for supply and payment of specialty drugs) to a negative Unknown (retail pharmacies are allowed to supply and bill for specialty drugs) to the General Revenue Fund, Other State Funds, Federal Funds and Local Political Subdivisions. Oversight notes §103.200.6 provides that the plan (MCHCP) may impose a penalty of no more than $7,500 on its pharmacy benefits manager (PBM) for each violation of the provisions of the section. Since the provisions are permissible, Oversight assumes a $0 to minimal fiscal impact to MCHCP and will not present any penalty income for fiscal note purposes. In addition, Oversight notes the provisions of §376.414.3 state the Department of Commerce and Insurance shall impose a civil penalty on a health carrier, PBM or an agent/affiliate of such entity that violates the provisions of the section in an amount not to exceed $5,000 per day. Oversight assumes the amount of penalties collected will be minimal and will not present penalty income for fiscal note purposes. Officials from the Department of Commerce and Insurance, the Department of Social ServicesCity of Kansas City and the City of Springfield each assume the proposal will have no fiscal impact on their respective organizations. Oversight does not have any information to the contrary. Therefore, Oversight will reflect a zero impact in the fiscal note for these agencies. Officials from the Department of Public Safety, Missouri Highway Patrol defer to the MoDOT/MHP Health Care Board for response relating to the fiscal impact of this proposal on their organization. Officials from the Office of Administration defer to the MCHCP for any impact this legislation may have. L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 4 of February 15, 2023 HWC:LR:OD In response to the previous version of this proposal, officials from the Missouri Department of Conservation, the Missouri Department of Transportation, the Administrative Hearing Commission, the City of Claycomo and the City of O‘Fallon each assumed the proposal would have no fiscal impact on their organizations. Rule Promulgation Officials from the Joint Committee on Administrative Rules assume this proposal is not anticipated to cause a fiscal impact beyond its current appropriation. Oversight notes, in response to other legislation that contains similar rules language, officials from the state many bills considered by the General Assembly include provisions allowing or requiring agencies to submit rules and regulations to implement the act. The SOS is provided with core funding to handle a certain amount of normal activity resulting from each year's legislative session. The fiscal impact for this fiscal note to the SOS for Administrative Rules is less than $5,000. The SOS recognizes that this is a small amount and does not expect that additional funding would be required to meet these costs. However, the SOS also recognizes that many such bills may be passed by the General Assembly in a given year and that collectively the costs may be in excess of what the office can sustain with its core budget. Therefore, the SOS reserves the right to request funding for the cost of supporting administrative rules requirements should the need arise based on a review of the finally approved bills signed by the governor. Oversight only reflects the responses received from state agencies and political subdivisions; however, other cities were requested to respond to this proposed legislation but did not. A general listing of political subdivisions included in the Missouri Legislative Information System (MOLIS) database is available upon request. FISCAL IMPACT – State GovernmentFY 2024 (10 Mo.) FY 2025FY 2026GENERAL REVENUE FUNDCost – MCHCP (§§103.200-376.414) Specialty Pharmacy for Specialty Drugs $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) ESTIMATED NET EFFECT TO THE GENERAL REVENUE FUND $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 5 of February 15, 2023 HWC:LR:OD FISCAL IMPACT – State Government (continued) FY 2024 (10 Mo.) FY 2025FY 2026OTHER STATE FUNDSCost – MCHCP (§§103.200-376.414) Specialty Pharmacy for Specialty Drugs $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) ESTIMATED NET EFFECT ON OTHER STATE FUNDS $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) FEDERAL FUNDSCost – MCHCP (§§103.200-376.414) Specialty Pharmacy for Specialty Drugs $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) ESTIMATED NET EFFECT ON FEDERAL FUNDS $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) FISCAL IMPACT – Local GovernmentFY 2024 (10 Mo.) FY 2025FY 2026LOCAL POLITICAL SUBDIVISIONS Cost – MCHCP (§§103.200-376.414) Specialty Pharmacy for Specialty Drugs $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) ESTIMATED NET EFFECT TO LOCAL POLITICAL SUBDIVISIONS $0 to (Unknown) $0 to (Unknown) $0 to (Unknown) FISCAL IMPACT – Small Business No direct fiscal impact to small businesses would be expected as a result of this proposal. L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 6 of February 15, 2023 HWC:LR:OD FISCAL DESCRIPTION This bill is related to payments for prescription drugs. Beginning March 1, 2025, and annually thereafter, a pharmacy benefits manager (PBM) utilized by the Missouri Consolidated Health Care Plan shall file a report with the Plan for the immediately preceding calendar year regarding rebates, as defined in the bill. The report shall include: (1) The aggregate dollar amount of rebates collected from pharmaceutical manufacturers; (2) The aggregate dollar amount of the rebates that were not passed on to the Plan, and (3) The aggregate dollar amount of all fees and payments received from pharmaceutical manufacturers. The Plan shall establish a form for the reporting that minimizes administrative burden and cost. Documents, materials, and other information submitted to the Plan shall not be subject to disclosure or compromise the financial, competitive, or proprietary nature of the information, or allow a third party to identify rebate values for a particular outpatient prescription drug, except to the extent they are reported in the aggregate. The Plan shall annually report to the General Assembly the aggregate dollar amount of pharmaceutical rebates and provide information describing the rebate practices of health carriers utilizing pharmacy benefits managers. The Plan may impose a penalty of up to $7,500 on its PBM for each violation of these provisions (§103.200, RSMo). The bill specifies that certain provisions of law pertaining to pharmacists and pharmacies shall not be construed to prohibit patients' ability to obtain prescription services from any licensed pharmacist "or pharmacy", and repeals language specifying that the provisions do not remove patients' ability to waive their freedom of choice under a contract with regard to payment or coverage of prescription expenses and no PBM shall penalize or restrict a health carrier or enrollees from obtaining services from a contracted pharmacy (§338.015). Additionally, the bill repeals a provision of law specifying that certain PBM regulations shall not apply with regard to Medicare Part D, or other health plans regulated partly or wholly under federal law. Pharmacy benefits managers shall notify health carriers and pharmacies in writing of any potential conflict of interest, including but not limited to common ownership or any other relationship between the PBM and any other health carrier or pharmacy with which the PBM contracts. The bill provides standardized definitions for the terms "generic" and "rebate" applicable to PBMs and health carriers, and specifies that PBMs shall owe a fiduciary duty to the state or any health carrier, health benefit plan, or political subdivision with which it contracts (§376.387). The bill repeals a portion of a definition to specify that certain provisions relating to the maximum allowable cost of a prescription drug are applicable to all pharmacies, rather than only to contracted pharmacies. If the reimbursement for a drug to a contracted pharmacy is below the pharmacy's cost to purchase the drug, the PBM shall sustain an appeal and increase L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 7 of February 15, 2023 HWC:LR:OD reimbursement for the pharmacy and other contracted pharmacies to cover the cost of purchasing the drug (§376.388). The bill specifies that health carriers or pharmacy benefits managers cannot discriminate against a covered entity, as defined in the Public Health Service Act, or a pharmacy licensed under Chapter 338 with which a covered entity has contracted to dispense 340B drugs on behalf of the covered entity. The Director of the Department of Commerce and Insurance shall enforce these rules and impose a civil penalty that shall not exceed $5,000 per violation per day on any health carrier or pharmacy benefits manager that violates these provisions (§376.414). This bill provides a definition for “prescription insulin drug” and states the provisions in the section applies to any individual policy of accident and health insurance amended, delivered, issued or renewed on/after August 28, 2023. An insurer that provides coverage for prescription insulin drugs shall limit the total amount that an insured is required to pay for a thirty-day supply of covered insulin drugs at an amount not to exceed $75, regardless of the quantity or type of covered prescription insulin drug used. On January 1 of each year, the limit on the amount that an insured is required to pay for a 30-day supply shall increase by a percentage equal to the change in the Consumer Price Index of the preceding year. (§376.687) Before November 2, 2023, the department of commerce, in conjunction with the department of health and senior services and the department of social services, shall make available to the public a report that details each department’s findings for the following: a) Summary of insulin pricing practices and variable that contribute to the pricing of health plans; b) Public policy recommendations to control and prevent overpricing of prescription insulin drugs, and c) Any other information the department of commerce and insurance finds necessary. These provisions terminate on January 1, 2024. (§376.689) This legislation is not federally mandated, would not duplicate any other program and would not require additional capital improvements or rental space. L.R. No. 0404H.03C Bill No. HCS for HB 197 Page 8 of February 15, 2023 HWC:LR:OD SOURCES OF INFORMATION Office of Administration - Administrative Hearing Commission Department of Commerce and Insurance Department of Public Safety - Missouri Highway Patrol Department of Social Services Missouri Department of Conservation Missouri Department of Transportation Office of Administration Office of the Secretary of State Missouri Consolidated Health Care Plan City of Claycomo City of Kansas City City of O’Fallon City of Springfield Joint Committee on Administrative Rules Julie MorffRoss StropeDirectorAssistant DirectorFebruary 15, 2023February 15, 2023