Colorado Code § 12-280-139

Insulin affordability program - record keeping - reimbursement - penalty - definitions
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(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(b) Repealed.
(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 board 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 board shall make the application form available on its website. The board 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 board shall promote the availability of the program to Coloradans. The
promotional material must include information about each manufacturer's consumer insulin
programs. The board 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) A manufacturer that fails to comply with the requirements of this section:
(I) Is subject to a fine in an amount and frequency that is equal to the amount and
frequency of the fine permitted under the "Colorado Consumer Protection Act", part 1 of article
1 of title 6; and
(II) Engages in a deceptive trade practice under section 6-1-105 (1)(ffff).
(b) The attorney general is authorized to enforce this section.

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