Section 12-280-139 - Insulin affordability program - record keeping - reimbursement - definitions(1) As used in this section and section 12-280-140, unless the context otherwise requires: (a) "Consumer price index" means the United States department of labor's bureau of labor statistics consumer price index for Denver-Aurora-Lakewood for all items paid by all urban consumers, or its applicable predecessor or successor index.(b) "Division of insurance" means the division of insurance in the department of regulatory agencies, created in section 10-1-103.(c) "Manufacturer" means a person: (I) Engaged in the manufacturing of insulin that is self-administered on an outpatient basis and is available for purchase by residents of this state; and(II) That has annual gross revenue of more than two million dollars from the sale of insulin in this state.(d) "Pharmacy" means a pharmacy outlet registered pursuant to this article 280 where prescriptions are compounded and dispensed.(e) "Program" means the insulin affordability program created in subsection (2) of this section.(f)(I) "Wholesale acquisition cost" means a manufacturer's list price for insulin to wholesalers or direct purchasers in the United States for the most recent month for which the information is reported in wholesale price guides or other publications of drug or biological pricing data.(II) "Wholesale acquisition cost" does not include prompt pay or other discounts, rebates, or reductions in price.(2) Effective January 1, 2022, the insulin affordability program is hereby created to provide low-cost insulin to eligible individuals. By January 1, 2022, each manufacturer shall establish procedures to make insulin available in accordance with this section to eligible individuals who need access to an affordable insulin supply.(3) To be eligible to receive insulin under the program, an individual must:(a) Be a resident of Colorado;(b) Not be eligible for or enrolled in assistance provided through the "Colorado Medical Assistance Act", articles 4 to 6 of title 25.5, or the federal "Health Insurance for the Aged Act", Title XVIII of the federal "Social Security Act", 42 U.S.C. sec. 1395 et seq., as amended;(c) Have a valid insulin prescription or be eligible for an emergency supply as provided in section 12-280-125.5; and(d) Not be enrolled in prescription drug coverage that limits the total amount of cost sharing that the enrollee is required to pay for a thirty-day supply of insulin to one hundred dollars as described in section 10-16-151.(4)(a) The division of insurance shall develop an application form to be used by an individual who is seeking insulin under the program. The application form must require the individual to show proof that the individual meets the requirements of subsection (3) of this section.(b) The division of insurance and the department of health care policy and financing shall make the application form available on each agency's website. The division of insurance shall also make the application form available to pharmacies, health-care providers, and health facilities that prescribe or dispense insulin.(5) To access insulin through the program, an individual must present, at a pharmacy, a completed, signed, and dated application form with proof of the individual's Colorado residency. If the individual is under eighteen years of age, the individual's parent or legal guardian may provide the pharmacist with proof of residency.(6)(a) Upon receipt of an individual's completed, signed, and dated application form demonstrating that the individual is eligible pursuant to subsection (3) of this section and the individual's proof of residency, a pharmacist shall dispense the prescribed insulin in an amount that will provide the individual with a thirty-day supply. An individual who is eligible to receive insulin pursuant to this section may receive the insulin for twelve months.(b) The pharmacist is encouraged to inform the individual that they may be eligible for the "Colorado Medical Assistance Act", articles 4 to 6 of title 25.5, or an affordable insurance product on the state-based marketplace.(c) The pharmacist is encouraged to notify the individual of any manufacturer-sponsored programs that assist individuals who cannot afford their prescription insulin.(d) The pharmacist shall retain a copy of the application form submitted by the individual for two years after the date the insulin was initially dispensed.(7) A pharmacy that dispenses insulin pursuant to subsection (6)(a) of this section may collect a copayment from the individual to cover the pharmacy's costs of processing and dispensing the insulin in an amount not to exceed fifty dollars for each thirty-day supply of insulin dispensed.(8)(a) Except as provided in subsection (8)(d) of this section, unless the manufacturer agrees to send to the pharmacy a replacement supply of the same insulin dispensed in the amount dispensed through the program, the pharmacy may submit to the manufacturer of the dispensed insulin, directly or through the manufacturer's delegated representative, subcontractor, or other vendor, an electronic claim for payment that is made in accordance with the National Council for Prescription Drug Programs' standards for electronic claims processing.(b) By January 1, 2022, each manufacturer shall develop a process for a pharmacy to submit an electronic claim for reimbursement as provided in subsection (8)(a) of this section.(c) If the pharmacy submits an electronic claim to the manufacturer pursuant to subsection (8)(a) of this section, the manufacturer or the manufacturer's delegated representative, subcontractor, or other vendor shall, within thirty days after receipt of the claim, either: (I) Reimburse the pharmacy in an amount that covers the difference between the pharmacy's wholesale acquisition cost for the insulin dispensed through the program and the amount the individual paid for the insulin pursuant to subsection (7) of this section; or(II) Send the pharmacy a replacement supply of the same insulin in an amount equal to or greater than the amount that covers the difference between the pharmacy's wholesale acquisition cost for the insulin dispensed through the program and the amount the individual paid for the insulin pursuant to subsection (7) of this section.(d) A pharmacy shall not submit a claim for payment for insulin with a wholesale acquisition cost of eight dollars or less per milliliter, adjusted annually based on the annual percentage change in the consumer price index.(9) The division of insurance and the department of health care policy and financing shall promote the availability of the program to Coloradans. The promotional material must include information about each manufacturer's consumer insulin programs. Each agency may seek and accept gifts, grants, and donations to fulfill the requirements of this subsection (9).(10) A manufacturer's reimbursement pursuant to subsection (8)(b) of this section is not a kickback.(11) A manufacturer that fails to comply with the requirements of this section is subject to a fine of ten thousand dollars for each month of noncompliance.Added by 2021 Ch. 437, § 3, eff. 9/7/2021. For the legislative declaration in HB 21-1307, see section 1 of chapter 437, Session Laws of Colorado 2021.