C.R.S. 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)

“Division of insurance” means the division of insurance in the department of regulatory agencies created in section 10-1-103.

(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)

Intentionally left blank —Ed.

(a)

The division of insurance shall develop an application form to be used by an individual who is seeking epinephrine auto-injectors through the program. 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; and

(II)

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 epinephrine auto-injectors.

(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)

Intentionally left blank —Ed.

(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.

(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)

Intentionally left blank —Ed.

(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 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 epinephrine auto-injector program, as applicable. 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)(c) of this section is not a kickback.

(11)

A manufacturer that fails to comply with the requirements of this section:

(a)

Is subject to a fine of ten thousand dollars for each month of noncompliance; and

(b)

Engages in a deceptive trade practice under section 6-1-105 (1)(zzz).

Source: Section 12-280-142 — Epinephrine auto-injector affordability program - record keeping - reimbursement - definitions, https://leg.­colorado.­gov/sites/default/files/images/olls/crs2023-title-12.­pdf (accessed Oct. 20, 2023).

12‑280‑101
Public interest - rules 12‑280‑102
Applicability of common provisions 12‑280‑103
Definitions - rules 12‑280‑104
State board of pharmacy - creation - subject to review - repeal of parts 12‑280‑105
Membership of board - removal - compensation - meetings 12‑280‑106
Veterinary pharmaceutical advisory committee - creation - appointments - rules - repeal 12‑280‑107
Rules 12‑280‑108
Powers and duties - rules 12‑280‑109
Drugs, devices, and other materials 12‑280‑110
Publications 12‑280‑111
Malpractice claims information - not public - exception 12‑280‑112
Fees 12‑280‑113
Approval of schools 12‑280‑114
Licensure, certification, or registration - applicability - applications - licensure and certification requirements - rules 12‑280‑115
Exemptions from licensure - hospital residency programs - home renal dialysis - research companies 12‑280‑115.5
Certification of pharmacy technicians - requirements - provisional certification - criminal history record check - rules 12‑280‑116
Expiration and renewal of licenses, certifications, or registrations 12‑280‑117
Continuing education - exceptions - inactive status 12‑280‑117.5
Continuing education for pharmacy technicians - exceptions - inactive status 12‑280‑118
Prescription drug outlet under charge of pharmacist - rules 12‑280‑119
Registration of facilities - rules 12‑280‑120
Compounding - dispensing - sale of drugs and devices - rules - definition 12‑280‑121
Compounding drugs for office use by a veterinarian - rules - definitions 12‑280‑122
Limited authority to delegate activities constituting practice of pharmacy to pharmacy interns or pharmacy technicians 12‑280‑123
Prescription required - exception - dispensing opiate antagonists - selling nonprescription syringes and needles 12‑280‑124
Labeling - rules 12‑280‑125
Substitution of prescribed drugs and biological products authorized - when - conditions 12‑280‑125.3
Pharmacists’ authority - minor prescription adaptions 12‑280‑125.5
Pharmacists’ authority to dispense chronic maintenance drugs - rules - liability 12‑280‑125.7
Pharmacists’ authority to prescribe and dispense HIV prevention drugs - definitions - rules 12‑280‑126
Unprofessional conduct - grounds for discipline 12‑280‑127
Disciplinary actions 12‑280‑128
Judicial review 12‑280‑129
Unlawful acts - civil fines 12‑280‑130
Unauthorized practice - penalties 12‑280‑131
New drugs - when sales permissible 12‑280‑132
Advertising of prescription drug prices 12‑280‑133
Nonresident prescription drug outlet - registration 12‑280‑133.5
Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - rules 12‑280‑133.7
Third-party logistics providers - registration - denial, revocation, or suspension - rules 12‑280‑134
Records 12‑280‑135
Unused medication - licensed facilities - correctional facilities - reuse - definitions - rules 12‑280‑136
Confidential agreement to limit practice 12‑280‑137
Investigations of suspicious drugs 12‑280‑138
Patient counseling - pharmacists required to perform - patient may decline - rules 12‑280‑139
Insulin affordability program - record keeping - reimbursement - definitions 12‑280‑140
Emergency prescription insulin supply - eligibility - record keeping 12‑280‑141
Prescription drugs - automated pharmacy dispensing system - rules - definition 12‑280‑142
Epinephrine auto-injector affordability program - record keeping - reimbursement - definitions 12‑280‑201
Legislative declaration 12‑280‑202
Definitions 12‑280‑203
Pharmacy peer health assistance fund - rules 12‑280‑204
Eligibility - participants 12‑280‑205
Liability 12‑280‑206
Immunity 12‑280‑301
Definitions 12‑280‑303
Wholesaler registration requirements - rules 12‑280‑304
Record check 12‑280‑305
Restrictions on transactions 12‑280‑306
Records - pedigree - compliance with DQSA 12‑280‑307
Penalty 12‑280‑308
Manufacturer, agent, representative, or employee - drug cost information - required - definitions 12‑280‑401
Legislative declaration 12‑280‑402
Definitions 12‑280‑403
Prescription drug use monitoring program - registration required - applications - rules - appropriation - repeal 12‑280‑404
Program operation - access - rules - definitions 12‑280‑405
Prescription drug monitoring fund - creation - fee 12‑280‑406
Violations - penalties 12‑280‑407
Prescription drug outlets - prescribers - responsibilities - liability 12‑280‑408
Exemption - waiver 12‑280‑409
Examination and analysis of prescription drug monitoring program - recommendations to executive director 12‑280‑501
Written guidelines and procedures for making therapeutic interchange and therapeutically equivalent selections 12‑280‑502
Therapeutic interchange and therapeutically equivalent selections for nursing care facility or long-term acute care hospital patients - rules 12‑280‑601
Definitions 12‑280‑602
Collaborative pharmacy practice agreements - pharmacist requirements 12‑280‑603
Rules
Green check means up to date. Up to date

Current through Fall 2024

§ 12-280-142’s source at colorado​.gov