SF4138

Purpose and goals

• Establish an insulin safety net program to help people in Minnesota get urgent, affordable access to insulin (the “urgent-need covered insulin”).
• Clarify what counts as “covered insulin” and how manufacturers, pharmacists, and state agencies work together to make insulin available when a person is in urgent need.
• Create financial support mechanisms to reimburse manufacturers and support access, while adding oversight, privacy protections, and reporting requirements.

Key concepts and terms used in the bill

• urgent-need covered insulin, covered insulin
• insulin safety net program
• manufacturer patient assistance program
• copayment, out-of-pocket costs
• MNsure (Minnesota’s health insurance marketplace)
• Board of Pharmacy
• navigator
• 30-day supply, 90-day supply
• wholesale acquisition cost (WAC)
• 340B program
• MinnesotaCare
• Health Care Access Fund, insulin repayment account
• private data on individuals (privacy protections)

What the bill changes or adds (main provisions)

• Defines and protects data related to people seeking urgent-need insulin (privacy safeguards).
• Establishes who must participate and how covered insulin is defined and priced, including exemptions for small manufacturers and price thresholds to keep insulin affordable.
• Sets eligibility rules for people to receive urgent-need insulin, including residency, lack of other coverage, and a threshold for cost-sharing.
• Creates a process to apply for urgent-need insulin via MNsure and by presenting a prescription at a pharmacy; outlines what information is needed and what the pharmacist must do.
• Requires pharmacists to dispense a 30-day supply (and, in some cases, a 90-day supply) of insulin at no charge to the patient, with possible copayments under certain limits.
• Allows pharmacists to request reimbursement from manufacturers for the cost of dispensed insulin; manufacturers may also provide a 90-day (or 30-day) supply directly to patients, with state reimbursement to the manufacturer.
• Requires manufacturers to run patient assistance programs and to help eligible Minnesota residents access insulin, with income and residency checks and timelines for eligibility decisions.
• Creates a framework for copayments, reimbursements, and possible mail-order insulin distribution.
• Establishes duties for the Board of Pharmacy and MNsure to train navigators, provide information sheets, and maintain a list of trained navigators to help people access long-term insulin options.
• Establishes penalties for manufacturers that fail to comply with the program, including large monthly penalties and hotline requirements.
• Sets up a system to report yearly on how many Minnesotans used the program, how much insulin was provided, and how many were helped by manufacturer programs; authorizes a program review by the Legislative Auditor.
• Creates an insulin repayment account in the state’s special revenue fund to reimburse manufacturers and to cover related administrative costs; transfers funds from the Health Care Access Fund as needed.
• Repeals a prior subsection related to a satisfaction survey component and updates related definitions.

How the urgent-need insulin safety net works (high-level flow)

• A Minnesota resident applies for urgent-need insulin, via MNsure or at a pharmacy, by attesting to eligibility rules (resident, lack of other coverage, low enough cost-sharing, urgent need).
• If eligible, the patient can receive a 30-day supply from a pharmacy; the pharmacist must notify the prescriber within 72 hours.
• The pharmacy may seek reimbursement from the insulin manufacturers for the cost of dispensing; manufacturers may replace dispensed insulin if needed.
• The patient may pay a small copayment (limits apply: up to a certain amount per 30-day supply, and higher limits may apply for 90-day supplies).
• If the patient has access to manufacturer or other assistance programs, those options may be used to reduce costs, with navigation support to help access long-term solutions.
• The state and Board of Pharmacy oversee information sheets, navigator training, and a directory of navigators to help people find ongoing affordable insulin options and other benefits (e.g., medical assistance, MinnesotaCare, or qualified health plans).

Roles of key players

• Manufacturers: run patient assistance programs, determine eligibility for their programs, reimburse pharmacies for urgent-need insulin dispensed, and provide wholesale-cost-based support. Must report eligible patients and program activity.
• Pharmacies: dispense urgent-need insulin, collect limited copayments, submit reimbursement claims, and supply information and navigator contacts to patients.
• Navigators: trained by MNsure with input from the Board of Pharmacy to help people access long-term coverage and insulin options; may receive a one-time application assistance payment for helping enrollments.
• MNsure and Board of Pharmacy: develop application forms, provide training, maintain navigator lists, and ensure information is available to pharmacies and health care providers.
• Commissioner of Administration: processes and pays approved manufacturer reimbursements; oversees a separate insulin repayment account funded from the Health Care Access Fund.
• Legislative Auditor: may review program implementation and effectiveness.

Eligibility and benefits (who can get urgent-need insulin and how it works)

• Eligible individuals must be Minnesota residents, not enrolled in Medical Assistance or MinnesotaCare, not enrolled in a prescription-drug plan that limits cost-sharing to a low level for a 30-day supply, and must have urgent need (less than a 7-day supply or risk of significant health consequences).
• A 30-day supply is dispensed at no charge to the patient; copays may apply up to defined limits.
• In certain cases, a 90-day supply can be dispensed, with separate copayment limits and reimbursement rules.
• For people already enrolled in manufacturer programs or who have other coverage, the bill allows use of manufacturer copayment assistance so long as the patient’s out-of-pocket costs stay within the program’s rules.

Funding, fees, and reimbursement

• Manufacturers must pay an annual registration fee (with an exemption for some small manufacturers based on revenue, to avoid significant cost barriers).
• An insulin repayment account is created in the state’s special revenue fund; money there is used to reimburse manufacturers for insulin dispensed under the safety net and to cover related administration costs.
• Transfers from the Health Care Access Fund support the insulin repayment account, with annual certification of expenditures and transfers to the insulin repayment account to match those expenditures.
• Reimbursements to manufacturers have defined caps for different supply types (e.g., up to $35 per 30-day supply; up to $105 per 90-day supply; other caps apply for different distribution arrangements).

Oversight, accountability, and data privacy

• Data about individuals seeking urgent-need insulin or participating in manufacturer programs is protected as private data and kept for a limited time.
• Penalties apply to manufacturers who fail to comply, including escalating monthly penalties and the need to maintain a hotline and clear eligibility information on their websites.
• Annual reporting requirements: manufacturers report usage and program activity; the Board of Pharmacy reports to legislative committees; penalties are disclosed.
• A program review by the Legislative Auditor is planned to assess how well manufacturers are meeting responsibilities, including reimbursement, eligibility processing, and navigator training.

Implementation timeline and changes to law

• The bill updates definitions and creates a new framework for the insulin safety net, including how covered insulin is defined and how the safety net interacts with existing programs like MNsure and MinnesotaCare.
• It repeals a former subsection related to program satisfaction surveys and replaces it with a broader set of reporting and oversight provisions.
• It creates new funding mechanisms (insulin repayment account) and adjusts how manufacturers pay registration fees and how reimbursements are calculated and paid.

Practical implications (what this means for people)

• It aims to make urgent, short-term insulin access more reliable and affordable for Minnesotans who lack other coverage and are in urgent need.
• It provides a structured process at the pharmacy and through manufacturers to obtain insulin quickly, with clear rules for reimbursement and cost-sharing limits.
• It emphasizes privacy protections for people’s data and establishes state oversight to monitor program effectiveness and ensure accountability.

Note on terminology and public relevance

• The bill uses terms like urgent-need insulin, covered insulin, insulin safety net program, and manufacturer patient assistance programs. It also involves familiar elements like copayments, the 30-day and 90-day supply concepts, and well-known programs and agencies like MNsure and the Board of Pharmacy.

Relevant Terms - urgent-need insulin, covered insulin, insulin safety net program - MNsure, Board of Pharmacy, navigator - manufacturer patient assistance program - copayment, cost-sharing, wholesale acquisition cost (WAC) - 30-day supply, 90-day supply - 340B program, MinnesotaCare - Health Care Access Fund, insulin repayment account - private data on individuals, data privacy, reporting, statutory penalties - Medical Assistance, Medicare Part D (in eligibility considerations)