Colorado Revised Statutes Title 12. Professions and Occupations § 12-280-142. Epinephrine auto-injector affordability program--record keeping--reimbursement--penalty--definitions

(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(b) Repealed by Laws 2024, Ch. 351 (H.B. 24-1438), § 4, eff. June 3, 2024.

(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:

(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:

(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.

(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:

(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.

(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:

(11)(a) A manufacturer that fails to comply with the requirements of this section:

(b) The attorney general is authorized to enforce this section.