HF3756

Purpose

Explain and expand Minnesota’s approach to help people access insulin when they are in urgent need. Create a formal system where manufacturers, pharmacies, and state agencies work together to provide affordable, temporary insulin while people pursue long-term coverage or assistance. The bill defines what counts as “covered insulin,” sets up an urgent-need safety net, requires manufacturers to participate, and establishes funding, oversight, and penalties to ensure access and accountability.

Key concepts and definitions

• Covered insulin: insulin drugs prescribed for diabetes that are eligible for this program.
• Urgent need: a situation where a person would have less than a 7-day supply and risks significant health problems if they don’t get insulin soon.
• Insulin safety net program: the state program to rapidly provide a 30-day (or longer) supply of insulin when urgent need exists.
• Manufacturer: a company licensed to manufacture prescription covered insulin.
• MNsure: Minnesota’s health insurance marketplace/portal.
• Navigator: trained staff who help people access medical assistance, MNsure plans, or manufacturer programs.
• Patient assistance programs (PAPs): manufacturer programs that help people pay for insulin.
• 340B program: a federal program referenced as a source of information for providers and patient support.
• Health care access fund and insulin repayment account: state funds used to reimburse manufacturers and support the program.
• Private data on individuals: protection of personal information collected through the program.

How urgent-need access works (eligibility and process)

• Eligibility for urgent-need insulin:
  • Must be a Minnesota resident.
  • Not enrolled in medical assistance (MA) or MinnesotaCare.
  • Not enrolled in prescription drug coverage with cost-sharing for a 30-day supply exceeding 75 (copays, deductibles, or coinsurance) regardless of insulin type.
  • Has not received an urgent-need insulin supply in the prior 12 months unless authorized for a later exception.
  • Is in urgent need of insulin.
• What “urgent need” means:
  • Readily available less than a 7-day supply and necessary to avoid significant health consequences.
• Application and dispensing:
  • MNsure will develop a standardized application form (accessible online and through pharmacies, prescribers, hospitals, clinics).
  • To get insulin, a person must have a valid prescription and Minnesota residency ID, except for guardians of minors.
  • A completed application is reviewed at the pharmacy; the pharmacist dispenses a 30-day supply once the form is signed and submitted.
  • The pharmacist must notify the prescriber within 72 hours after dispensing.
  • Pharmacies can submit a claim to the insulin’s manufacturer to be reimbursed for dispensing costs; manufacturers may replace the dispensed insulin if they choose.
  • Copayment for the 30-day supply cannot exceed 35.
  • The pharmacy provides an information sheet and a list of navigators to help with ongoing coverage options (medical assistance, MinnesotaCare, MNsure plans, and access to other programs).
  • Pharmacy keeps a copy of the application for reporting and auditing.

Roles and responsibilities (who does what)

• Manufacturers:
  • Must participate in the urgent-need program and maintain PAPs.
  • May be reimbursed by the state for urgent-need insulin dispensed under the program (see funding).
  • Offer eligibility determinations within defined timeframes; provide documentation when eligible; ensure access to copayment assistance if long-term coverage is pursued.
  • If a patient has other coverage, manufacturers can steer them toward copayment assistance to minimize out-of-pocket costs.
• Pharmacies:
  • Dispense a 30-day (urgent-need) or 90-day (continuing safety net) supply of insulin at no charge to the patient, with possible copayments for processing/dispensing.
  • May submit claims to manufacturers for reimbursement (or receive replacements if the manufacturer opts to replace).
  • For 90-day supplies, may collect up to 50 copay for processing/dispensing if the insulin is shipped to the pharmacy.
  • May place 90-day orders to manufacturers; may use mail-order pathways.
• MNsure and Board of Pharmacy:
  • Create and manage application forms, navigator training, and information materials.
  • Maintain lists of trained navigators and coordinate with providers and pharmacies.
  • Develop an information sheet describing programs and access routes; ensure information is accessible to patients and providers.
  • Manage reimbursement processes and oversee program administration.
• Navigators:
  • Help individuals understand eligibility and access to ongoing insulin coverage (medical assistance, MinnesotaCare, MNsure plans, PAPs, etc.).
  • May receive a one-time bonus for helping with applications, funded within available appropriations.

Financials and funding (how money moves)

• Manufacturer registration fee:
  • The Board of Pharmacy assesses an annual registration fee of $100,000 per manufacturer, with possible exemptions if a manufacturer’s Minnesota sales of prescription covered insulin are very small compared to national sales.
• Reimbursement and funding mechanisms:
  • A separate insulin repayment account is created in the state’s special revenue fund.
  • Money in that account is used to reimburse manufacturers for 30-day or 90-day insulin dispensed under the safety net program and to cover related administration costs.
  • The state transfers funds into the insulin repayment account from the health care access fund as directed (starting in 2025 and annually thereafter, based on certified expenditures).
  • Reimbursement amounts:
  • For 30-day supplies dispensed under the urgent-need process, the state may reimburse the manufacturer up to a set amount per 30-day supply (specific cap described in the text for different scenarios).
  • For 90-day supplies dispensed under the continuing safety net program, the state may reimburse up to 105 for each 90-day supply (if the supply qualifies under the program) or up to 35 per 30-day unit for shorter supplies if needed.
• Patient costs:
  • For urgent-need 30-day supplies, the patient’s out-of-pocket copayment cannot exceed 35.
  • For 90-day supplies, the patient may face a copayment up to 50 to cover processing and dispensing costs if the 90-day supply is sent to the pharmacy.
• Penalties for noncompliance:
  • Manufacturers failing to comply can face escalating administrative penalties (up to 200,000 per month, increasing to 400,000 after six months, 600,000 after one year, and staying at 600,000 thereafter).
  • Penalties also apply if a manufacturer does not provide a hotline or post eligibility information on their site.
  • Penalties are deposited into the new covered insulin assistance account.

Data privacy, reporting, and program review

• Data privacy:
  • Data collected about individuals seeking urgent-need insulin or participating in manufacturer PAPs are classified as private data on individuals and may not be retained longer than ten years.
  • Manufacturers must protect privacy and cannot sell or share data except as required by the program or with signed authorizations.
• Reporting:
  • By February 15 each year, manufacturers must report to the Board of Pharmacy the number of Minnesota residents who accessed insulin on an urgent-need basis and the number participating in PAPs, plus the total value of insulin provided (based on wholesale cost).
  • By March 15 each year, the Board must share these reports with state legislative committees and include any penalties assessed.
• Program review:
  • The Legislative Auditor is asked to conduct a review of program effectiveness, including:
  • Whether manufacturers reimburse pharmacies in a timely manner.
  • Whether eligibility determinations and notifications are timely.
  • Whether pharmacists receive and dispense insulin from PAPs efficiently.
  • Whether navigator training and availability are adequate.
• Repeal and appendices:
  • The statute repeals a prior subdivision related to program satisfaction surveys, with related expectations moved into an Appendix.

Oversight, enforcement, and accountability

• The Board of Pharmacy enforces compliance with penalties for noncompliance.
• The program requires a hotline and public-facing eligibility information.
• Data and reporting are designed to ensure transparency to legislators and the public.
• A legislative auditor review provides independent evaluation of program performance and vendor compliance.

Implementation timeline and expected effects

• Establishes a formal system by which urgent-need insulin can be accessed quickly, with ongoing access through manufacturer PAPs and copayment assistance where appropriate.
• Creates a dedicated funding stream (insulin repayment account) to reimburse manufacturers for urgent-need and 90-day supplies.
• Sets up oversight, reporting, and accountability mechanisms to monitor program performance and ensure data privacy.
• Aims to reduce gaps in insulin access for Minnesota residents who are uninsured or underinsured and who cannot immediately obtain affordable insulin through existing programs.

Potential changes to existing law

• Amends multiple Minnesota Statutes to create the insulin safety net program, define covered insulin, and establish roles, funding, and penalties.
• Adds new definitions and modifies how manufacturers register and interact with state agencies.
• Repeals a former satisfaction-survey provision and replaces it with a new framework and reporting requirements.
• Introduces a new insulin repayment account and funding flow from the Health Care Access Fund.

Relevant Terms - insulin safety net program - covered insulin - urgentneed - MNsure - Board of Pharmacy - manufacturer registration fee - manufacturer - patient assistance program (PAP) - copayment - wholesale acquisition cost (WAC) - 30-day supply - 90-day supply - navigator - 340B program - health care access fund - insulin repayment account - private data on individuals - administrative penalties - hotline - eligibility requirements - long-term coverage options - medical assistance (MA) - MinnesotaCare - Minnesota resident - private data retention limits - reporting and audits - legislative auditor review