2023 Colorado Revised Statutes › Title 12 - PROFESSIONS AND OCCUPATIONS (§§ 12-1-101 — 12-315-310) › HEALTH CARE PROFESSIONS AND OCCUPATIONS (§§ 12-170-101 — 12-315-310) › Article 280 - PHARMACISTS, PHARMACY BUSINESSES, AND PHARMACEUTICALS (§§ 12-280-101 — 12-280-604) › Part 1 - GENERAL PROVISIONS (§§ 12-280-101 — 12-280-143) › Section 12-280-142 - Epinephrine auto-injector affordability program - record keeping - reimbursement - definitions

(1)
As used in this section:
(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[Repealed by 2024 Amendment.]
(c)
"Epinephrine auto-injector" means an automatic injection device for injecting a measured dose of epinephrine based on the weight of the person who is to receive the injection.
(d)
"Manufacturer" means a person engaged in manufacturing epinephrine auto-injectors that are available for purchase in this state.
(e)
"Pharmacy" means a pharmacy outlet registered pursuant to this article 280 where prescriptions are compounded and dispensed.
(f)
"Program" means the epinephrine auto-injector affordability program created in subsection (2) of this section.
(g)
"Proof of residency" means a current and valid document that is in English, or is translated into English and is unaltered, and that includes the individual's, or in the case of a minor, the minor's parent's or guardian's, printed name and Colorado residential address. Documents that may be used for proof of residency are:
(I)
A Colorado-issued driver's license or Colorado identification card;
(II)
A printed bill, including a utility, telephone, internet, cable, insurance, mortgage, rent, waste disposal, water or sewer, medical, or other bill;
(III)
A credit card or bank statement;
(IV)
A pay stub or earnings statement;
(V)
A piece of post-marked first-class mail or United States postal service change of address confirmation;
(VI)
A printed rent receipt or residential lease;
(VII)
A transcript or report card from an accredited school;
(VIII)
A vehicle title or registration;
(IX)
An insurance policy;
(X)
A government-issued letter or state or federal government-issued check; or
(XI)
A record of medical service from a shelter, treatment facility, or assisted living facility, including a homeless shelter, women's shelter, other nonprofit shelter, halfway house, nursing home, or rehabilitation facility.
(2)
Effective January 1, 2024, the epinephrine auto-injector affordability program is created to provide low-cost epinephrine auto-injectors to eligible individuals. By January 1, 2024, each manufacturer shall establish procedures to and shall make epinephrine auto-injectors available in accordance with this section to eligible individuals who hold a valid prescription for epinephrine auto-injectors.
(3)
To be eligible to receive epinephrine auto-injectors through the program, an individual must:
(a)
Demonstrate proof of residency in Colorado;
(b)
Not be eligible for 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 epinephrine auto-injector prescription; 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 covered prescription to not more than sixty dollars for a two-pack of epinephrine auto-injectors, regardless of the amount or type of epinephrine needed to fill the prescription.
(4)
(a)
The board shall develop an epinephrine auto-injector affordability program application form to be used by an individual who is seeking epinephrine auto-injectors through the program. All manufacturers subject to this section shall participate in the program. The application form must be available to individuals, pharmacies, health-care providers, and health facilities through the board's website and must be accessible through a quick response (QR) code or other machine-readable code. Within a reasonable period of time after the publication of the program website, all manufacturers required to participate in the program shall include a link to the program website on the manufacturer's consumer epinephrine auto-injector program website. At a minimum, the application form must:
(I)
Provide information related to program eligibility and coverage in English, Spanish, and in each language spoken by at least two and one-half percent of the population of any county in which such population speaks English less than very well, as defined by the United States bureau of the census American community survey or comparable census data, and speaks a shared minority language at home;
(II)
Require the individual to attest that the individual meets the requirements of subsection (3) of this section; and
(III)
Include the information required for a pharmacy to successfully submit, pursuant to subsection (8) of this section, an electronic claim for reimbursement that is made in accordance with the National Council for Prescription Drug Programs' standards for electronic claims processing for the cost to dispense the epinephrine auto-injectors, above any required cost sharing by the individual and adjudicated at the point of sale.
(b)
The board shall supply pharmacies with information about the program to provide to individuals who are seeking access to the program. The information must contain a quick response (QR) code or other machine-readable code that an individual may use to access the program application and include information on how to submit a program application.
(5)
To access epinephrine auto-injectors through the program, an individual must present, at a pharmacy, a completed, signed, and dated application form with proof of 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 proof of residency and completed, signed, and dated application form demonstrating that the individual is eligible pursuant to subsection (3) of this section, a pharmacist shall dispense the prescribed epinephrine auto-injectors. An individual who is eligible to receive epinephrine auto-injectors through the program may receive epinephrine auto-injectors as prescribed for twelve months.
(b)
The pharmacist is encouraged to inform the individual:
(I)
That the individual may be eligible for medical assistance programs pursuant to the "Colorado Medical Assistance Act", articles
4
to
6
of title
25.5
, or an affordable insurance product on the health benefit exchange created in section
10-22-104
; and
(II)
Of any manufacturer-sponsored programs that assist individuals who cannot afford their prescription epinephrine auto-injectors and provide the individual with the information described in subsection (4)(b) of this section about the program.
(c)
The pharmacist shall retain a copy of the application form submitted by the individual for two years after the date the epinephrine auto-injector was initially dispensed.
(7)
A pharmacy that dispenses epinephrine auto-injectors 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 epinephrine auto-injector, which copayment amount must not exceed sixty dollars for each two-pack of epinephrine auto-injectors that the pharmacy dispenses to the individual.
(8)
(a)
Except as provided in subsection (8)(c) of this section, unless the manufacturer agrees to send to the pharmacy a replacement supply of the same number of epinephrine auto-injectors dispensed through the program, the pharmacy may submit to the manufacturer of the dispensed epinephrine auto-injectors, 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, 2024, each manufacturer shall develop a process for a pharmacy to submit an electronic claim for reimbursement, including an accessible online application for reimbursement claims from pharmacies under the program, 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 the pharmacy paid for the number of epinephrine auto-injectors dispensed through the program; or
(II)
Send the pharmacy a replacement supply of epinephrine auto-injectors in an amount equal to the number of epinephrine auto-injectors dispensed through the program pursuant to subsection (6)(a) of this section.
(9)
The board shall promote the availability of the program to Coloradans. The promotional material must include information about each manufacturer's consumer epinephrine auto-injector program, as applicable. 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)(c) 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)(zzz)
.
(b)
The attorney general is authorized to enforce this section.
Amended by 2024 Ch. 351,§ 4, eff. 6/3/2024.
Added by 2023 Ch. 447,§ 3, eff. 8/7/2023.
2023 Ch. 447, was passed without a safety clause. See Colo. Const. art. V, § 1(3).