First Regular Session
Seventy-fourth General Assembly
STATE OF COLORADO
ENGROSSED
This Version Includes All Amendments Adopted
on Second Reading in the House of Introduction
LLS NO. 23-0428.01 Kristen Forrestal x4217
HOUSE BILL 23-1002
House Committees Senate Committees
Health & Insurance
Appropriations
A BILL FOR AN ACT
C
ONCERNING THE AFFORDABILITY OF EPINEPHRINE
AUTO-INJECTORS,101
AND, IN CONNECTION THEREWITH, MAKING AN APPROPRIATION.102
Bill Summary
(Note: This summary applies to this bill as introduced and does
not reflect any amendments that may be subsequently adopted. If this bill
passes third reading in the house of introduction, a bill summary that
applies to the reengrossed version of this bill will be available at
http://leg.colorado.gov
.)
Effective January 1, 2024, the bill creates an epinephrine
auto-injector affordability program (program) to provide low-cost
epinephrine auto-injectors to individuals who:
! Are residents of this state;
! Are not enrolled in the state medicaid program or the
federal medicare program;
HOUSE
Amended 2nd Reading
March 7, 2023
HOUSE SPONSORSHIP
Mabrey and Jodeh,
SENATE SPONSORSHIP
Roberts,
Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
Capital letters or bold & italic numbers indicate new material to be added to existing law.
Dashes through the words or numbers indicate deletions from existing law. ! Have a prescription for an epinephrine auto-injector; and
! Are not enrolled in prescription drug coverage that limits
the total amount of cost sharing that the enrollee is required
to pay for an epinephrine auto-injector.
The bill requires the division of insurance in the department of
regulatory agencies (division) to create an application for the program and
requires the division and the department of health care policy and
financing to make the application available on their websites and to
promote the availability of the program.
The bill requires a carrier that provides coverage for prescription
epinephrine auto-injectors to cap the total amount that a covered person
is required to pay for all covered prescription epinephrine auto-injectors
at an amount not to exceed $60 for a 2-pack of epinephrine auto-injectors.
A pharmacy that dispenses epinephrine auto-injectors is authorized
to collect a copayment not to exceed $60 from the individual to cover the
pharmacy's costs of processing and dispensing a 2-pack of epinephrine
auto-injectors.
A manufacturer of epinephrine auto-injectors:
! Is required to make epinephrine auto-injectors available to
individuals through the program; and
! May be required to reimburse the dispensing pharmacy an
amount that covers the difference between the pharmacy's
wholesale acquisition cost for the number of epinephrine
auto-injectors dispensed through the program and the
amount the recipients of the epinephrine auto-injectors paid
for the same number of epinephrine auto-injectors or send
the pharmacy a replacement supply of the same number of
epinephrine auto-injectors.
If a manufacturer fails to comply with the requirements of the bill,
the manufacturer may be subject to a fine.
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. Legislative declaration. (1) The general assembly2
finds and declares that:3
(a) Individuals who have moderate to severe allergies, severe4
asthma, or genetic conditions such as angioedema are at risk of reactions5
that can occur within seconds or minutes and that can lead to anaphylaxis,6
a potentially fatal reaction;7
(b) Epinephrine works quickly to improve breathing, stimulate the8
1002-2- heart, raise dropping blood pressure, prevent airways from closing,1
prevent or decrease shock, reverse hives, and reduce swelling of the face,2
lips, and throat;3
(c) Delay in appropriate treatment for anaphylaxis almost certainly4
contributes to death in individuals, so it is critical that all anaphylaxis5
reactions are treated as a medical emergency;6
(d) In Colorado, there are approximately 565,824 individuals with7
life-threatening food allergies, which is more than the population of8
Colorado Springs; of these individuals, 101,848 are under 18 years of age,9
which means that the number of children with food allergies in Colorado10
is larger than the population of Longmont;11
(e) Epinephrine auto-injectors are essential because they are the12
easiest and most efficient way to potentially save the life of an individual13
exhibiting symptoms of or experiencing anaphylactic shock;14
(f) Many individuals are unable to afford an epinephrine15
auto-injector because they cannnot pay the copayment amount required16
under their insurance plan or, if they are uninsured, the cost of an17
epinephrine auto-injector; these individuals risk their lives every day by18
not having access to this life-saving medicine if faced with an allergic19
reaction; and20
(g) Rising costs of epinephrine auto-injectors make this21
life-saving medication difficult or impossible to obtain for many people,22
even those with private health insurance or who are enrolled in a public23
health benefit program.24
(2) Therefore, it is the intent of the general assembly to establish25
an epinephrine auto-injector affordability program to ensure Colorado26
residents have greater access to epinephrine.27
1002
-3- SECTION 2. In Colorado Revised Statutes, add 10-16-158 as1
follows:2
10-16-158. Cost sharing - prescription epinephrine - limits -3
rules - definition. (1) A
S USED IN THIS SECTION, UNLESS THE CONTEXT4
OTHERWISE REQUIRES, "EPINEPHRINE AUTO-INJECTOR" HAS THE SAME5
MEANING AS SET FORTH IN SECTION 12-280-141 (1)(c).6
(2) A
CARRIER THAT PROVIDES COVERAGE FOR PRESCRIPTION7
EPINEPHRINE AUTO-INJECTORS PURSUANT TO THE TERMS OF A HEALTH8
COVERAGE PLAN THE CARRIER OFFERS SHALL CAP THE TOTAL AMOUNT9
THAT A COVERED PERSON IS REQUIRED TO PAY FOR ALL COVERED10
PRESCRIPTION EPINEPHRINE AUTO -INJECTORS AT AN AMOUNT NOT TO11
EXCEED SIXTY DOLLARS FOR A TWO -PACK OF EPINEPHRINE12
AUTO-INJECTORS, REGARDLESS OF THE AMOUNT OR TYPE OF EPINEPHRINE13
NEEDED TO FILL THE COVERED PERSON 'S PRESCRIPTION.14
(3) N
OTHING IN THIS SECTION PREVENTS A CARRIER FROM15
REDUCING A COVERED PERSON 'S COST SHARING TO AN AMOUNT THAT IS16
LOWER THAN THE AMOUNT SPECIFIED IN SUBSECTION (2) OF THIS SECTION.17
(4) T
HE COMMISSIONER MAY USE ANY OF THE COMMISSIONER 'S18
ENFORCEMENT POWERS TO OBTAIN A CARRIER 'S COMPLIANCE WITH THIS19
SECTION.20
(5) T
HE COMMISSIONER MAY PROMULGATE RULES AS NECESSARY21
TO IMPLEMENT AND ADMINISTER THIS SECTION AND TO ALIGN WITH22
FEDERAL REQUIREMENTS.23
SECTION 3. In Colorado Revised Statutes, add 12-280-141 as24
follows:25
12-280-141. Epinephrine auto-injector affordability program26
- record keeping - reimbursement - definitions. (1) A
S USED IN THIS27
1002
-4- SECTION:1
(a) "C
ONSUMER PRICE INDEX " MEANS THE UNITED STATES2
DEPARTMENT OF LABOR'S BUREAU OF LABOR STATISTICS CONSUMER PRICE3
INDEX FOR DENVER-AURORA-LAKEWOOD FOR ALL ITEMS PAID BY ALL4
URBAN CONSUMERS , OR ITS APPLICABLE PREDECESSOR OR SUCCESSOR5
INDEX.6
(b) "D
IVISION OF INSURANCE" MEANS THE DIVISION OF INSURANCE7
IN THE DEPARTMENT OF REGULATORY AGENCIES , CREATED IN SECTION8
10-1-103.9
(c) "E
PINEPHRINE AUTO-INJECTOR" MEANS AN AUTOMATIC10
INJECTION DEVICE FOR INJECTING A MEASURED DOSE OF EPINEPHRINE11
BASED ON THE WEIGHT OF THE PERSON WHO IS TO RECEIVE THE INJECTION .12
(d) "M
ANUFACTURER" MEANS A PERSON ENGAGED IN13
MANUFACTURING EPINEPHRINE AUTO -INJECTORS THAT ARE AVAILABLE14
FOR PURCHASE IN THIS STATE.15
(e) "P
HARMACY" MEANS A PHARMACY OUTLET REGISTERED16
PURSUANT TO THIS ARTICLE 280 WHERE PRESCRIPTIONS ARE COMPOUNDED17
AND DISPENSED.18
(f) "P
ROGRAM" MEANS THE EPINEPHRINE AUTO -INJECTOR19
AFFORDABILITY PROGRAM CREATED IN SUBSECTION (2) OF THIS SECTION.20
(g) "P
ROOF OF RESIDENCY" MEANS A CURRENT AND VALID21
DOCUMENT THAT IS IN ENGLISH, OR IS TRANSLATED INTO ENGLISH AND IS22
UNALTERED, AND THAT INCLUDES THE INDIVIDUAL'S, OR IN THE CASE OF23
A MINOR, THE MINOR'S PARENT'S OR GUARDIAN'S, PRINTED NAME AND24
C
OLORADO RESIDENTIAL ADDRESS . DOCUMENTS THAT MAY BE USED FOR25
PROOF OF RESIDENCY ARE:26
(I) A
COLORADO-ISSUED DRIVER'S LICENSE OR COLORADO27
1002
-5- IDENTIFICATION CARD;1
(II) A
PRINTED BILL, INCLUDING A UTILITY, TELEPHONE, INTERNET,2
CABLE, INSURANCE, MORTGAGE, RENT, WASTE DISPOSAL, WATER OR3
SEWER, MEDICAL, OR OTHER BILL;4
(III) A
CREDIT CARD OR BANK STATEMENT ;5
(IV) A
PAY STUB OR EARNINGS STATEMENT ;6
(V) A
PIECE OF POST-MARKED FIRST-CLASS MAIL OR UNITED7
S
TATES POSTAL SERVICE CHANGE OF ADDRESS CONFIRMATION ;8
(VI) A
PRINTED RENT RECEIPT OR RESIDENTIAL LEASE;9
(VII) A
TRANSCRIPT OR REPORT CARD FROM AN ACCREDITED10
SCHOOL;11
(VIII) A
VEHICLE TITLE OR REGISTRATION;12
(IX) A
N INSURANCE POLICY;13
(X) A
GOVERNMENT-ISSUED LETTER OR STATE OR FEDERAL14
GOVERNMENT-ISSUED CHECK; OR15
(XI) A
RECORD OF MEDICAL SERVICE FROM A SHELTER ,16
TREATMENT FACILITY, OR ASSISTED LIVING FACILITY , INCLUDING A17
HOMELESS SHELTER, WOMEN'S SHELTER, OTHER NONPROFIT SHELTER ,18
HALFWAY HOUSE, NURSING HOME, OR REHABILITATION FACILITY.19
20
(2) E
FFECTIVE JANUARY 1, 2024, THE EPINEPHRINE21
AUTO-INJECTOR AFFORDABILITY PROGRAM IS CREATED TO PROVIDE22
LOW-COST EPINEPHRINE AUTO-INJECTORS TO ELIGIBLE INDIVIDUALS. BY23
J
ANUARY 1, 2024, EACH MANUFACTURER SHALL ESTABLISH PROCEDURES24
TO AND SHALL MAKE EPINEPHRINE AUTO -INJECTORS AVAILABLE IN25
ACCORDANCE WITH THIS SECTION TO ELIGIBLE INDIVIDUALS WHO HOLD A26
VALID PRESCRIPTION FOR EPINEPHRINE AUTO -INJECTORS.27
1002
-6- (3) TO BE ELIGIBLE TO RECEIVE EPINEPHRINE AUTO -INJECTORS1
THROUGH THE PROGRAM , AN INDIVIDUAL MUST:2
(a) D
EMONSTRATE PROOF OF RESIDENCY IN COLORADO;3
(b) N
OT BE ELIGIBLE FOR ASSISTANCE PROVIDED THROUGH THE4
"C
OLORADO MEDICAL ASSISTANCE ACT", ARTICLES 4 TO 6 OF TITLE 25.5,5
OR THE FEDERAL "HEALTH INSURANCE FOR THE AGED ACT", TITLE XVIII6
OF THE FEDERAL "SOCIAL SECURITY ACT", 42 U.S.C. SEC. 1395 ET SEQ.,7
AS AMENDED;8
(c) H
AVE A VALID EPINEPHRINE AUTO-INJECTOR PRESCRIPTION;9
AND10
(d) N
OT BE ENROLLED IN PRESCRIPTION DRUG COVERAGE THAT11
LIMITS THE TOTAL AMOUNT OF COST SHARING THAT THE ENROLLEE IS12
REQUIRED TO PAY FOR A COVERED PRESCRIPTION TO NOT MORE THAN13
SIXTY DOLLARS FOR A TWO -PACK OF EPINEPHRINE AUTO -INJECTORS,14
REGARDLESS OF THE AMOUNT OR TYPE OF EPINEPHRINE NEEDED TO FILL15
THE PRESCRIPTION.16
(4) (a) T
HE DIVISION OF INSURANCE SHALL DEVELOP AN17
APPLICATION FORM TO BE USED BY AN INDIVIDUAL WHO IS SEEKING18
EPINEPHRINE AUTO-INJECTORS THROUGH THE PROGRAM . AT A MINIMUM,19
THE APPLICATION FORM MUST:20
(I) P
ROVIDE INFORMATION RELATED TO PROGRAM ELIGIBILITY AND21
COVERAGE IN ENGLISH, SPANISH, AND IN EACH LANGUAGE SPOKEN BY AT22
LEAST TWO AND ONE-HALF PERCENT OF THE POPULATION OF ANY COUNTY23
IN WHICH SUCH POPULATION SPEAKS ENGLISH LESS THAN VERY WELL, AS24
DEFINED BY THE UNITED STATES BUREAU OF THE CENSUS AMERICAN25
COMMUNITY SURVEY OR COMPARABLE CENSUS DATA , AND SPEAKS A26
SHARED MINORITY LANGUAGE AT HOME ; AND27
1002
-7- (II) REQUIRE THE INDIVIDUAL TO SHOW PROOF THAT THE1
INDIVIDUAL MEETS THE REQUIREMENTS OF SUBSECTION (3) OF THIS2
SECTION.3
(b) T
HE DIVISION OF INSURANCE AND THE DEPARTMENT OF HEALTH4
CARE POLICY AND FINANCING SHALL MAKE THE APPLICATION FORM5
AVAILABLE ON EACH AGENCY 'S WEBSITE. THE DIVISION OF INSURANCE6
SHALL ALSO MAKE THE APPLICATION FORM AVAILABLE TO PHARMACIES ,7
HEALTH-CARE PROVIDERS, AND HEALTH FACILITIES THAT PRESCRIBE OR8
DISPENSE EPINEPHRINE AUTO-INJECTORS.9
(5) T
O ACCESS EPINEPHRINE AUTO -INJECTORS THROUGH THE10
PROGRAM, AN INDIVIDUAL MUST PRESENT , AT A PHARMACY , A11
COMPLETED, SIGNED, AND DATED APPLICATION FORM WITH PROOF OF12
RESIDENCY. IF THE INDIVIDUAL IS UNDER EIGHTEEN YEARS OF AGE , THE13
INDIVIDUAL'S PARENT OR LEGAL GUARDIAN MAY PROVIDE THE14
PHARMACIST WITH PROOF OF RESIDENCY .15
(6) (a) U
PON RECEIPT OF AN INDIVIDUAL'S PROOF OF RESIDENCY16
AND COMPLETED , SIGNED, AND DATED APPLICATION FORM17
DEMONSTRATING THAT THE INDIVIDUAL IS ELIGIBLE PURSUANT TO18
SUBSECTION (3) OF THIS SECTION, A PHARMACIST SHALL DISPENSE THE19
PRESCRIBED EPINEPHRINE AUTO -INJECTORS. AN INDIVIDUAL WHO IS20
ELIGIBLE TO RECEIVE EPINEPHRINE AUTO -INJECTORS THROUGH THE21
PROGRAM MAY RECEIVE EPINEPHRINE AUTO -INJECTORS AS PRESCRIBED22
FOR TWELVE MONTHS.23
(b) T
HE PHARMACIST IS ENCOURAGED TO INFORM THE INDIVIDUAL :24
(I) T
HAT THE INDIVIDUAL MAY BE ELIGIBLE FOR MEDICAL25
ASSISTANCE PROGRAMS PURSUANT TO THE "COLORADO MEDICAL26
A
SSISTANCE ACT", ARTICLES 4 TO 6 OF TITLE 25.5, OR AN AFFORDABLE27
1002
-8- INSURANCE PRODUCT ON THE HEALTH BENEFIT EXCHANGE CREATED IN1
SECTION 10-22-104; AND2
(II) O
F ANY MANUFACTURER-SPONSORED PROGRAMS THAT ASSIST3
INDIVIDUALS WHO CANNOT AFFORD THEIR PRESCRIPTION EPINEPHRINE4
AUTO-INJECTORS.5
(c) T
HE PHARMACIST SHALL RETAIN A COPY OF THE APPLICATION6
FORM SUBMITTED BY THE INDIVIDUAL FOR TWO YEARS AFTER THE DATE7
THE EPINEPHRINE AUTO-INJECTOR WAS INITIALLY DISPENSED.8
(7) A
PHARMACY THAT DISPENSES EPINEPHRINE AUTO -INJECTORS9
PURSUANT TO SUBSECTION (6)(a) OF THIS SECTION MAY COLLECT A10
COPAYMENT FROM THE INDIVIDUAL TO COVER THE PHARMACY 'S COSTS OF11
PROCESSING AND DISPENSING THE EPINEPHRINE AUTO -INJECTOR, WHICH12
COPAYMENT AMOUNT MUST NOT EXCEED SIXTY DOLLARS FOR EACH13
TWO-PACK OF EPINEPHRINE AUTO -INJECTORS THAT THE PHARMACY14
DISPENSES TO THE INDIVIDUAL.15
(8) (a) E
XCEPT AS PROVIDED IN SUBSECTION (8)(d) OF THIS16
SECTION, UNLESS THE MANUFACTURER AGREES TO SEND TO THE17
PHARMACY A REPLACEMENT SUPPLY OF THE SAME NUMBER OF18
EPINEPHRINE AUTO-INJECTORS DISPENSED THROUGH THE PROGRAM , THE19
PHARMACY MAY SUBMIT TO THE MANUFACTURER OF THE DISPENSED20
EPINEPHRINE AUTO -INJECTORS, DIRECTLY OR THROUGH THE21
MANUFACTURER'S DELEGATED REPRESENTATIVE , SUBCONTRACTOR, OR22
OTHER VENDOR, AN ELECTRONIC CLAIM FOR PAYMENT THAT IS MADE IN23
ACCORDANCE WITH THE NATIONAL COUNCIL FOR PRESCRIPTION DRUG24
P
ROGRAMS' STANDARDS FOR ELECTRONIC CLAIMS PROCESSING .25
(b) B
Y JANUARY 1, 2024, EACH MANUFACTURER SHALL DEVELOP26
A PROCESS FOR A PHARMACY TO SUBMIT AN ELECTRONIC CLAIM FOR27
1002
-9- REIMBURSEMENT, INCLUDING AN ACCESSIBLE ONLINE APPLICATION FOR1
REIMBURSEMENT CLAIMS FROM PHARMACIES UNDER THE PROGRAM , AS2
PROVIDED IN SUBSECTION (8)(a) OF THIS SECTION.3
(c) I
F THE PHARMACY SUBMITS AN ELECTRONIC CLAIM TO THE4
MANUFACTURER PURSUANT TO SUBSECTION (8)(a) OF THIS SECTION, THE5
MANUFACTURER OR THE MANUFACTURER 'S DELEGATED REPRESENTATIVE,6
SUBCONTRACTOR, OR OTHER VENDOR SHALL, WITHIN THIRTY DAYS AFTER7 RECEIPT OF THE CLAIM, REIMBURSE THE PHARMACY THE AMOUNT THAT8
THE PHARMACY PAID THE MANUFACTURER FOR THE NUMBER OF9
EPINEPHRINE AUTO-INJECTORS DISPENSED THROUGH THE PROGRAM .10
(9) T
HE DIVISION OF INSURANCE AND THE DEPARTMENT OF HEALTH11
CARE POLICY AND FINANCING SHALL PROMOTE THE AVAILABILITY OF THE12
PROGRAM TO COLORADANS. THE PROMOTIONAL MATERIAL MUST INCLUDE13
INFORMATION ABOUT EACH MANUFACTURER 'S CONSUMER EPINEPHRINE14
AUTO-INJECTOR PROGRAM, AS APPLICABLE. EACH AGENCY MAY SEEK AND15
ACCEPT GIFTS, GRANTS, AND DONATIONS TO FULFILL THE REQUIREMENTS16
OF THIS SUBSECTION (9).17
(10) A
MANUFACTURER 'S REIMBURSEMENT PURSUANT TO18
SUBSECTION (8)(c) OF THIS SECTION IS NOT A KICKBACK.19
(11) A
MANUFACTURER THAT FAILS TO COMPLY WITH THE20
REQUIREMENTS OF THIS SECTION:21
(a) IS SUBJECT TO A FINE OF TEN THOUSAND DOLLARS FOR EACH22
MONTH OF NONCOMPLIANCE ; AND23
(b) ENGAGES IN A DECEPTIVE TRADE PRACTICE UNDER SECTION24
6-1-105 (1)(uuu).25
SECTION 4. In Colorado Revised Statutes, 6-1-105, amend26
(1)(uuu) as follows:27
1002
-10- 6-1-105. Unfair or deceptive trade practices. (1) A person1
engages in a deceptive trade practice when, in the course of the person's2
business, vocation, or occupation, the person:3
(uuu) FAILS TO COMPLY WITH THE REQUIREMENTS OF SECTION4
12-280-141.5
SECTION 5. Appropriation. For the 2023-24 state fiscal year,6
$58,291 is appropriated to the department of regulatory agencies for use7
by the division of insurance. This appropriation is from the division of8
insurance cash fund created in section 10-1-103 (3), C.R.S. To implement9
this act, the division may use this appropriation as follows:10
(a) $49,176 for personal services, which amount is based on an11
assumption that the division will require an additional 0.7 FTE; and12
(b) $9,115 for operating expenses.13
SECTION 6. Act subject to petition - effective date. This act14
takes effect at 12:01 a.m. on the day following the expiration of the15
ninety-day period after final adjournment of the general assembly; except16
that, if a referendum petition is filed pursuant to section 1 (3) of article V17
of the state constitution against this act or an item, section, or part of this18
act within such period, then the act, item, section, or part will not take19
effect unless approved by the people at the general election to be held in20
November 2024 and, in such case, will take effect on the date of the21
official declaration of the vote thereon by the governor.22
1002
-11-