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H.F. No. 3100 - Insulin Safety Net Program (Conference Committee Report) (Minnesota Laws 2020, Chapter 73)
 
Author: Senator Scott M. Jensen
 
Prepared By: Katie Cavanor, Senate Counsel (651/296-3801)
 
Date: April 15, 2020



 

Chapter 73 establishes an avenue for eligible individuals to obtain a 30-day supply of insulin if in urgent need, and access ongoing insulin supply options including assistance in applying to and obtaining insulin through an insulin manufacturer's patient assistance program.

Section 1 allows for this act to be cited as the "Alec Smith Insulin Affordability Act."

Section 2 (62Q.678) requires group health plans and health plan companies to provide written notice to enrollees with dependent child coverage that the dependent’s child’s coverage ends when the child reaches the age of 26.  The notice must be sent at least 60 days before the child reaches the age of 26 and must include the date on which coverage ends and information on accessing the MNsure website.

Section 3 (151.06, subdivision 6) requires information on the insulin safety net program to be added to the information provided on the Board of Pharmacy’s website.

Section 4 (151.74) creates the insulin safety net program which establishes access to insulin for individuals in urgent need and provides assistance for individuals in need of long term solutions for affordable insulin, including assistance in accessing manufacturers’ patient assistance programs.

Subdivision 1, paragraph (a) requires each manufacturer of insulin to establish by July 1, 2020, procedures make insulin available to eligible individuals who are in urgent need of insulin or who are in need of an affordable long term supply of insulin.

Paragraph (b) defines manufacturer; MNsure; navigator; and pharmacy.

Paragraph (c) exempts from this section any insulin manufacturer with an annual gross revenue of $2,000,000 or less from insulin sales in Minnesota.

Paragraph (d) exempts from this section an insulin product if the wholesale acquisition cost is $8 or less per milliliter or per applicable National Council for Prescription Drug Plan per unit.

Subdivision 2, paragraph (a) establishes eligibility for obtaining an urgent-need supply of insulin.  An individual is eligible if the individual attests to:

    1. being a resident of Minnesota;

    2. not being enrolled in medical assistance or MinnesotaCare;

    3. not being enrolled in prescription drug coverage that limits the total amount of cost sharing for insulin to $75 or less for a 30 day supply of insulin, regardless of the type or amount of insulin prescribed;

    4. not having received an urgent-need supply of insulin through this program within the 12 previous months, unless otherwise authorized; and

    5. being in urgent need of insulin.

Paragraph (b) defines “urgent need of insulin” as having readily available for use less than a 7-day supply of insulin and needing insulin in order to avoid suffering significant health consequences.

Subdivision 3, paragraph (a) requires MNsure to develop an application form to be used by an individual in urgent need of insulin. Requires the form to be available on MNsure's website and make available to pharmacies, providers, hospitals, and clinics.

Paragraph (b) requires an individual in need of insulin to present  to a pharmacy a completed, signed, and dated application form, and to have a valid insulin prescription and to provide the pharmacy with identification indicating Minnesota residency.

Paragraph (c) requires the pharmacy to dispense a 30 day supply of insulin and to notify the prescriber of the insulin prescription, no later than 72 hours after insulin is dispensed.

Paragraph (d) requires the pharmacy to submit to the manufacturer a claim for payment for the dispensed insulin in accordance with the National Council for Prescription Drug Program standards for electronic claims processing. Requires the manufacturer to reimburse the pharmacy in an amount that covers the pharmacy's acquisition cost.

Paragraph (e) authorizes the pharmacy to collect a co-payment from the individual in an amount not to exceed $35 for the 30-day supply.

Paragraph (f) requires the pharmacy to provide the individual with an information sheet developed by the Board of Pharmacy and a list of trained navigators to contact to assist in accessing ongoing insulin options, including assistance in applying to manufacturer patient assistance programs.

Paragraph (g) requires the pharmacy to retain a copy of the individual's application.

Subdivision 4, paragraph (a) requires each insulin manufacturer to make their patient assistance program available to any individual who meets the requirements in paragraph (b). Requires each manufacturer to provide the Board of Pharmacy with information regarding the manufacturer’s assistance programs.

Paragraph (b) To be eligible to participate in a manufacturer’s patient assistance program, the individual must:

  1. be a Minnesota resident with a valid Minnesota identification card of driver's license or permit;

  2. have a family income that is equal to or less than 400 percent of the federal poverty guidelines;

  3. not be enrolled in medical assistance or MinnesotaCare;

  4. not be eligible to receive health care through a federally funded program or receive drug benefits through the VA; and

  5. not be enrolled in prescription drug coverage through an individual or group health plan that limits the total amount of cost sharing for insulin to $75 or less for a 30 day supply of insulin, regardless of the type or amount of insulin prescribed.

Paragraph (c) states that an individual who is enrolled in Medicare and meets the requirements in paragraph (b), clauses (1) to (3) may be eligible for a manufacturer’s patient assistance program if the individual has spent $1,000 on prescription drugs in the current calendar year.

Paragraph (d) specifies that an individual may apply to a manufacturer’s patient assistance program directly, through their health care practitioner, or may contact a trained navigator to assist in applying to the manufacturer’s patient assistance program.

Subdivision 5, paragraph (a) Upon receipt of an application, requires the manufacturer to process the application to their patient assistance program and determine eligibility within 10 business days. If additional information is requested by the manufacturer, the manufacturer must notify the individual within five business days of receiving the application, and must determine eligibility within three business days upon receipt of the requested information. Specifies that if the manufacturer determines the individual is not eligible, the individual may appeal to a three person panel under subdivision 8.

Paragraph (b) requires the manufacturers to provide an individual with an eligibility statement, or other indication that the individual is eligible for the manufacturer’s patient assistance program. Specifies that eligibility is valid for 12 months, and is renewable upon a redetermination of eligibility.

Paragraph (c) specifies that if an eligible individual has prescription drug coverage through an individual or group health plan, the manufacturer may determine that the manufacturer’s co-payment assistance program would better address the individual’s needs, and requires the manufacturer to inform the individual and provide them with the necessary coupon to submit to a pharmacy. In no instance shall an eligible individual be required to pay more than $50 for a 90-day supply.

Subdivision 6, paragraph (a) requires the individual to submit to a pharmacy the eligibility statement provided by the manufacturer. The pharmacy shall submit an order to the manufacturer containing the name of the insulin product and the daily dosage amount contained on the prescription.

Paragraph (b) requires the pharmacy to submit with the order: the pharmacy's name and address; contact information; and any specific days or times when deliveries are not accepted by the pharmacy.

Paragraph (c) requires a manufacturer, upon receipt of an order from a pharmacy, to send to the pharmacy a 90-day supply of insulin as ordered at no charge to the pharmacy or patient.

Paragraph (d) Upon receipt of the insulin from the manufacturer, the pharmacy must provide the insulin to the patient at no cost to the patient, except as provided in paragraph (e), and must not provide the insulin to any other patient or seek third-party reimbursement for the insulin.

Paragraph (e) authorizes the pharmacy to charge a patient a copayment for administration services not to exceed $50 for each 90 day supply of insulin sent to the pharmacy.

Paragraph (f) requires a manufacturer to send to a pharmacy an additional 90 day supply upon receipt of a reorder at no charge to the pharmacy or patient.

Paragraph (g) authorizes the manufacturer to send the insulin directly to the patient if the manufacturer provides a mail order option.

Subdivision 7, paragraph (a) requires the Board of Pharmacy to develop an information sheet to post on its website describing the urgent need insulin supply program; each manufacturer’s patient assistance program and cost-sharing assistance program and how to access these programs; how to contact a trained navigator for assistance to applying to medical assistance, MinnesotaCare, or a manufacturer’s patient assistance program, if applicable; and notification that the individual in need of assistance may also contact their local county social service department.

Paragraph (b) requires the board to inform individuals who access urgent-need insulin or a manufacturer's patient assistance program that they can participate in a patient satisfaction survey conducted by the Department of Health.

Paragraph (c) requires MNsure, in consultation with the Board of Pharmacy and the commissioner of human services, to develop a training program for navigators to provide navigators with the necessary information and resources to assist individuals in accessing appropriate options.

Paragraph (d) requires MNsure to compile a list of navigators who have completed training, and have the list available through the Board of Pharmacy's website.

Paragraph (e) authorizes payment to a trained navigator of a onetime application assistance bonus of $25.

Subdivision 8 requires the Board of Pharmacy to compile a three-person panel to review an individual’s eligibility if the manufacturer determines an individual is not eligible for the manufacturer’s patient assistance program. Requires the panel to render a decision within 10 business days and specifies that the panel’s decision is final.

Subdivision 9 authorizes an additional urgent-need 30-day supply of insulin to be dispensed by a pharmacy if an individual has applied for medical assistance or MinnesotaCare but has not been determined eligible or has been determined eligible but coverage has not become effective or the individual has requested a review from the board of pharmacy of a manufacturer’s determination that the individual is not eligible and the review is still pending.

Subdivision 10 authorizes the Board of Pharmacy to assess an administrative penalty of $200,000 for noncompliance of this section, with the penalty increasing to $400,000 per month if noncompliance continues for six months, increasing to $600,000 per month after one year, and continues at $600,000 per month for as long as the manufacturer continues to be in noncompliance. Also specifies that the manufacturer is subject to the administrative penalty if the manufacturer does not (1) maintain a hotline for individuals to call; and (2) list on the manufacturer’s website the eligibility requirements for the manufacturer’s patient assistance programs for Minnesota residents.

Subdivision 11 classifies the data collected under this section related to the individual seeking access to insulin as private data on individuals and may not be retained longer than ten years. Manufacturers are also required to maintain the privacy of all data received from any individual and is prohibited from selling, sharing, or disseminating data received unless specifically authorized by the individual.

Subdivision 12 specifies that any entity participating in this program is not subject to liability under the state’s conflict of interest statute.  It also specifies that no entity’s participation or administration of this program seeks or requests the entity to seek reimbursement or other compensation for which the payment may be made in whole or in part under a federal health care program.

Subdivision 13, paragraph (a) requires each insulin manufacturer to annual report to the Board of Pharmacy the following:

  1. the number of Minnesota residents receiving insulin on an urgent-need basis in the preceding calendar year;
  2. the number of Minnesota residents receiving insulin from the manufacturer through the manufacturer's assistance program in the preceding calendar year, including the number of Minnesota residents that were determined ineligible for the manufacturer's assistance program; and
  3. the value of the insulin provided by the manufacturer under clauses (1) and (2).

Paragraph (b) requires the Board of Pharmacy to submit the information in paragraph (a) to the legislature, and any administrative penalties assessed.

Subdivision 14 requests the legislative auditor to conduct a program review to determine whether the manufacturers are complying with the program and whether the training program for navigators is adequate and easily accessable for interested navigators.

Subdivision 15 requires the commissioner of health to develop and conduct a survey of individuals who have accessed urgent need insulin through the program and who have accessed a manufacturer’s patient assistance program to determine overall satisfaction with the program and a survey of pharmacies to determine if the manufacturer are complying with the program.

Subdivision 16 requires the legislature to review the reports submitted by the Board of Pharmacy and the program review of the legislative auditor and the results of the survey conducted by the commissioner of health and make a determination on whether there is a need for continued implementation of the long term safety net program to ensure access to affordable insulin or whether the market has sufficiently changed to where the continuation of the program is no longer needed past December 31, 2024. Sunsets the long term program on December 31, 2024 unless the legislature affirmatively determines that there is a need for the continuation of the long term program.

Section 5 (214.122) requires the Boards of Medical Practice and Nursing to ensure that licensees are provided with information on the insulin safety net program.

Section 6 requires MNsure to conduct a public awareness campaign to create awareness on the availability of the insulin safety net program and the availability of the manufacturer’s patient assistance programs.

Section 7 adds a severability provision.

Section 8 appropriates money from the health care access fund to MNsure, the Board of Pharmacy, and the commissioner of health.

 
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