First Regular Session
Seventy-fourth General Assembly
STATE OF COLORADO
INTRODUCED
LLS NO. 23-0428.01 Kristen Forrestal x4217
HOUSE BILL 23-1002
House Committees Senate Committees
Health & Insurance
A BILL FOR AN ACT
C
ONCERNING THE AFFORDABILITY OF EPINEPHRINE AUTO -INJECTORS.101
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;
! Have a prescription for an epinephrine auto-injector; and
! Are not enrolled in prescription drug coverage that limits
HOUSE SPONSORSHIP
Mabrey, 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 statute.
Dashes through the words indicate deletions from existing statute. 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
heart, raise dropping blood pressure, prevent airways from closing,9
HB23-1002-2- prevent or decrease shock, reverse hives, and reduce swelling of the face,1
lips, and throat;2
(c) Delay in appropriate treatment for anaphylaxis almost certainly3
contributes to death in individuals, so it is critical that all anaphylaxis4
reactions are treated as a medical emergency;5
(d) In Colorado, there are approximately 565,824 individuals with6
life-threatening food allergies, which is more than the population of7
Colorado Springs; of these individuals, 101,848 are under 18 years of age,8
which means that the number of children with food allergies in Colorado9
is larger than the population of Longmont;10
(e) Epinephrine auto-injectors are essential because they are the11
easiest and most efficient way to potentially save the life of an individual12
exhibiting symptoms of or experiencing anaphylactic shock;13
(f) Many individuals are unable to afford an epinephrine14
auto-injector because they cannnot pay the copayment amount required15
under their insurance plan or, if they are uninsured, the cost of an16
epinephrine auto-injector; these individuals risk their lives every day by17
not having access to this life-saving medicine if faced with an allergic18
reaction; and19
(g) Rising costs of epinephrine auto-injectors make this20
life-saving medication difficult or impossible to obtain for many people,21
even those with private health insurance or who are enrolled in a public22
health benefit program.23
(2) Therefore, it is the intent of the general assembly to establish24
an epinephrine auto-injector affordability program to ensure Colorado25
residents have greater access to epinephrine.26
SECTION 2. In Colorado Revised Statutes, add 10-16-158 as27
HB23-1002
-3- follows:1
10-16-158. Cost sharing - prescription epinephrine - limits -2
rules - definition. (1) A
S USED IN THIS SECTION, UNLESS THE CONTEXT3
OTHERWISE REQUIRES, "EPINEPHRINE AUTO-INJECTOR" HAS THE SAME4
MEANING AS SET FORTH IN SECTION 12-280-141 (1)(c).5
(2) A
CARRIER THAT PROVIDES COVERAGE FOR PRESCRIPTION6
EPINEPHRINE AUTO-INJECTORS PURSUANT TO THE TERMS OF A HEALTH7
COVERAGE PLAN THE CARRIER OFFERS SHALL CAP THE TOTAL AMOUNT8
THAT A COVERED PERSON IS REQUIRED TO PAY FOR ALL COVERED9
PRESCRIPTION EPINEPHRINE AUTO -INJECTORS AT AN AMOUNT NOT TO10
EXCEED SIXTY DOLLARS FOR A TWO -PACK OF EPINEPHRINE11
AUTO-INJECTORS, REGARDLESS OF THE AMOUNT OR TYPE OF EPINEPHRINE12
NEEDED TO FILL THE COVERED PERSON 'S PRESCRIPTION.13
(3) N
OTHING IN THIS SECTION PREVENTS A CARRIER FROM14
REDUCING A COVERED PERSON 'S COST SHARING TO AN AMOUNT THAT IS15
LOWER THAN THE AMOUNT SPECIFIED IN SUBSECTION (2) OF THIS SECTION.16
(4) T
HE COMMISSIONER MAY USE ANY OF THE COMMISSIONER 'S17
ENFORCEMENT POWERS TO OBTAIN A CARRIER 'S COMPLIANCE WITH THIS18
SECTION.19
(5) T
HE COMMISSIONER MAY PROMULGATE RULES AS NECESSARY20
TO IMPLEMENT AND ADMINISTER THIS SECTION AND TO ALIGN WITH21
FEDERAL REQUIREMENTS.22
SECTION 3. In Colorado Revised Statutes, add 12-280-141 as23
follows:24
12-280-141. Epinephrine auto-injector affordability program25
- record keeping - reimbursement - definitions. (1) A
S USED IN THIS26
SECTION:27
HB23-1002
-4- (a) "CONSUMER PRICE INDEX " MEANS THE UNITED STATES1
DEPARTMENT OF LABOR'S BUREAU OF LABOR STATISTICS CONSUMER PRICE2
INDEX FOR DENVER-AURORA-LAKEWOOD FOR ALL ITEMS PAID BY ALL3
URBAN CONSUMERS , OR ITS APPLICABLE PREDECESSOR OR SUCCESSOR4
INDEX.5
(b) "D
IVISION OF INSURANCE" MEANS THE DIVISION OF INSURANCE6
IN THE DEPARTMENT OF REGULATORY AGENCIES , CREATED IN SECTION7
10-1-103.8
(c) "E
PINEPHRINE AUTO-INJECTOR" MEANS AN AUTOMATIC9
INJECTION DEVICE FOR INJECTING A MEASURED DOSE OF EPINEPHRINE10
BASED ON THE WEIGHT OF THE PERSON WHO IS TO RECEIVE THE INJECTION .11
(d) "M
ANUFACTURER" MEANS A PERSON ENGAGED IN12
MANUFACTURING EPINEPHRINE AUTO -INJECTORS THAT ARE AVAILABLE13
FOR PURCHASE IN THIS STATE.14
(e) "P
HARMACY" MEANS A PHARMACY OUTLET REGISTERED15
PURSUANT TO THIS ARTICLE 280 WHERE PRESCRIPTIONS ARE COMPOUNDED16
AND DISPENSED.17
(f) "P
ROGRAM" MEANS THE EPINEPHRINE AUTO -INJECTOR18
AFFORDABILITY PROGRAM CREATED IN SUBSECTION (2) OF THIS SECTION.19
(g) "P
ROOF OF RESIDENCY" MEANS A CURRENT AND VALID20
DOCUMENT THAT IS IN ENGLISH, OR IS TRANSLATED INTO ENGLISH AND IS21
UNALTERED, AND THAT INCLUDES THE INDIVIDUAL'S, OR IN THE CASE OF22
A MINOR, THE MINOR'S PARENT'S OR GUARDIAN'S, PRINTED NAME AND23
C
OLORADO RESIDENTIAL ADDRESS . DOCUMENTS THAT MAY BE USED FOR24
PROOF OF RESIDENCY ARE:25
(I) A
COLORADO-ISSUED DRIVER'S LICENSE OR COLORADO26
IDENTIFICATION CARD;27
HB23-1002
-5- (II) A PRINTED BILL, INCLUDING A UTILITY, TELEPHONE, INTERNET,1
CABLE, INSURANCE, MORTGAGE, RENT, WASTE DISPOSAL, WATER OR2
SEWER, MEDICAL, OR OTHER BILL;3
(III) A
CREDIT CARD OR BANK STATEMENT ;4
(IV) A
PAY STUB OR EARNINGS STATEMENT ;5
(V) A
PIECE OF POST-MARKED FIRST-CLASS MAIL OR UNITED6
S
TATES POSTAL SERVICE CHANGE OF ADDRESS CONFIRMATION ;7
(VI) A
PRINTED RENT RECEIPT OR RESIDENTIAL LEASE;8
(VII) A
TRANSCRIPT OR REPORT CARD FROM AN ACCREDITED9
SCHOOL;10
(VIII) A
VEHICLE TITLE OR REGISTRATION;11
(IX) A
N INSURANCE POLICY;12
(X) A
GOVERNMENT-ISSUED LETTER OR STATE OR FEDERAL13
GOVERNMENT-ISSUED CHECK; OR14
(XI) A
RECORD OF MEDICAL SERVICE FROM A SHELTER ,15
TREATMENT FACILITY, OR ASSISTED LIVING FACILITY , INCLUDING A16
HOMELESS SHELTER, WOMEN'S SHELTER, OTHER NONPROFIT SHELTER ,17
HALFWAY HOUSE, NURSING HOME, OR REHABILITATION FACILITY.18
(h) "W
HOLESALE ACQUISITION COST" MEANS A MANUFACTURER 'S19
LIST PRICE FOR AN EPINEPHRINE AUTO -INJECTOR TO WHOLESALERS OR20
DIRECT PURCHASERS IN THE UNITED STATES FOR THE MOST RECENT21
MONTH FOR WHICH THE INFORMATION IS REPORTED IN WHOLESALE PRICE22
GUIDES OR OTHER PUBLICATIONS OF DRUG OR BIOLOGICAL PRICING DATA .23
(2) E
FFECTIVE JANUARY 1, 2024, THE EPINEPHRINE24
AUTO-INJECTOR AFFORDABILITY PROGRAM IS CREATED TO PROVIDE25
LOW-COST EPINEPHRINE AUTO-INJECTORS TO ELIGIBLE INDIVIDUALS. BY26
J
ANUARY 1, 2024, EACH MANUFACTURER SHALL ESTABLISH PROCEDURES27
HB23-1002
-6- TO AND SHALL MAKE EPINEPHRINE AUTO -INJECTORS AVAILABLE IN1
ACCORDANCE WITH THIS SECTION TO ELIGIBLE INDIVIDUALS WHO HOLD A2
VALID PRESCRIPTION FOR EPINEPHRINE AUTO -INJECTORS.3
(3) T
O BE ELIGIBLE TO RECEIVE EPINEPHRINE AUTO -INJECTORS4
THROUGH THE PROGRAM , AN INDIVIDUAL MUST:5
(a) D
EMONSTRATE PROOF OF RESIDENCY IN COLORADO;6
(b) N
OT BE ELIGIBLE FOR ASSISTANCE PROVIDED THROUGH THE7
"C
OLORADO MEDICAL ASSISTANCE ACT", ARTICLES 4 TO 6 OF TITLE 25.5,8
OR THE FEDERAL "HEALTH INSURANCE FOR THE AGED ACT", TITLE XVIII9
OF THE FEDERAL "SOCIAL SECURITY ACT", 42 U.S.C. SEC. 1395 ET SEQ.,10
AS AMENDED;11
(c) H
AVE A VALID EPINEPHRINE AUTO-INJECTOR PRESCRIPTION;12
AND13
(d) N
OT BE ENROLLED IN PRESCRIPTION DRUG COVERAGE THAT14
LIMITS THE TOTAL AMOUNT OF COST SHARING THAT THE ENROLLEE IS15
REQUIRED TO PAY FOR A COVERED PRESCRIPTION TO NOT MORE THAN16
SIXTY DOLLARS FOR A TWO -PACK OF EPINEPHRINE AUTO -INJECTORS,17
REGARDLESS OF THE AMOUNT OR TYPE OF EPINEPHRINE NEEDED TO FILL18
THE PRESCRIPTION.19
(4) (a) T
HE DIVISION OF INSURANCE SHALL DEVELOP AN20
APPLICATION FORM TO BE USED BY AN INDIVIDUAL WHO IS SEEKING21
EPINEPHRINE AUTO-INJECTORS THROUGH THE PROGRAM . AT A MINIMUM,22
THE APPLICATION FORM MUST:23
(I) P
ROVIDE INFORMATION RELATED TO PROGRAM ELIGIBILITY AND24
COVERAGE IN ENGLISH, SPANISH, AND IN EACH LANGUAGE SPOKEN BY AT25
LEAST TWO AND ONE-HALF PERCENT OF THE POPULATION OF ANY COUNTY26
IN WHICH SUCH POPULATION SPEAKS ENGLISH LESS THAN VERY WELL, AS27
HB23-1002
-7- DEFINED BY THE UNITED STATES BUREAU OF THE CENSUS AMERICAN1
COMMUNITY SURVEY OR COMPARABLE CENSUS DATA , AND SPEAKS A2
SHARED MINORITY LANGUAGE AT HOME ; AND3
(II) R
EQUIRE THE INDIVIDUAL TO SHOW PROOF THAT THE4
INDIVIDUAL MEETS THE REQUIREMENTS OF SUBSECTION (3) OF THIS5
SECTION.6
(b) T
HE DIVISION OF INSURANCE AND THE DEPARTMENT OF HEALTH7
CARE POLICY AND FINANCING SHALL MAKE THE APPLICATION FORM8
AVAILABLE ON EACH AGENCY 'S WEBSITE. THE DIVISION OF INSURANCE9
SHALL ALSO MAKE THE APPLICATION FORM AVAILABLE TO PHARMACIES ,10
HEALTH-CARE PROVIDERS, AND HEALTH FACILITIES THAT PRESCRIBE OR11
DISPENSE EPINEPHRINE AUTO-INJECTORS.12
(5) T
O ACCESS EPINEPHRINE AUTO -INJECTORS THROUGH THE13
PROGRAM, AN INDIVIDUAL MUST PRESENT , AT A PHARMACY , A14
COMPLETED, SIGNED, AND DATED APPLICATION FORM WITH PROOF OF15
RESIDENCY. IF THE INDIVIDUAL IS UNDER EIGHTEEN YEARS OF AGE , THE16
INDIVIDUAL'S PARENT OR LEGAL GUARDIAN MAY PROVIDE THE17
PHARMACIST WITH PROOF OF RESIDENCY .18
(6) (a) U
PON RECEIPT OF AN INDIVIDUAL'S PROOF OF RESIDENCY19
AND COMPLETED , SIGNED, AND DATED APPLICATION FORM20
DEMONSTRATING THAT THE INDIVIDUAL IS ELIGIBLE PURSUANT TO21
SUBSECTION (3) OF THIS SECTION, A PHARMACIST SHALL DISPENSE THE22
PRESCRIBED EPINEPHRINE AUTO -INJECTORS. AN INDIVIDUAL WHO IS23
ELIGIBLE TO RECEIVE EPINEPHRINE AUTO -INJECTORS THROUGH THE24
PROGRAM MAY RECEIVE EPINEPHRINE AUTO -INJECTORS AS PRESCRIBED25
FOR TWELVE MONTHS.26
(b) T
HE PHARMACIST IS ENCOURAGED TO INFORM THE INDIVIDUAL :27
HB23-1002
-8- (I) THAT THE INDIVIDUAL MAY BE ELIGIBLE FOR MEDICAL1
ASSISTANCE PROGRAMS PURSUANT TO THE "COLORADO MEDICAL2
A
SSISTANCE ACT", ARTICLES 4 TO 6 OF TITLE 25.5, OR AN AFFORDABLE3
INSURANCE PRODUCT ON THE HEALTH BENEFIT EXCHANGE CREATED IN4
SECTION 10-22-104; AND5
(II) O
F ANY MANUFACTURER-SPONSORED PROGRAMS THAT ASSIST6
INDIVIDUALS WHO CANNOT AFFORD THEIR PRESCRIPTION EPINEPHRINE7
AUTO-INJECTORS.8
(c) T
HE PHARMACIST SHALL RETAIN A COPY OF THE APPLICATION9
FORM SUBMITTED BY THE INDIVIDUAL FOR TWO YEARS AFTER THE DATE10
THE EPINEPHRINE AUTO-INJECTOR WAS INITIALLY DISPENSED.11
(7) A
PHARMACY THAT DISPENSES EPINEPHRINE AUTO -INJECTORS12
PURSUANT TO SUBSECTION (6)(a) OF THIS SECTION MAY COLLECT A13
COPAYMENT FROM THE INDIVIDUAL TO COVER THE PHARMACY 'S COSTS OF14
PROCESSING AND DISPENSING THE EPINEPHRINE AUTO -INJECTOR, WHICH15
COPAYMENT AMOUNT MUST NOT EXCEED SIXTY DOLLARS FOR EACH16
TWO-PACK OF EPINEPHRINE AUTO -INJECTORS THAT THE PHARMACY17
DISPENSES TO THE INDIVIDUAL.18
(8) (a) E
XCEPT AS PROVIDED IN SUBSECTION (8)(d) OF THIS19
SECTION, UNLESS THE MANUFACTURER AGREES TO SEND TO THE20
PHARMACY A REPLACEMENT SUPPLY OF THE SAME NUMBER OF21
EPINEPHRINE AUTO-INJECTORS DISPENSED THROUGH THE PROGRAM , THE22
PHARMACY MAY SUBMIT TO THE MANUFACTURER OF THE DISPENSED23
EPINEPHRINE AUTO -INJECTORS, DIRECTLY OR THROUGH THE24
MANUFACTURER'S DELEGATED REPRESENTATIVE , SUBCONTRACTOR, OR25
OTHER VENDOR, AN ELECTRONIC CLAIM FOR PAYMENT THAT IS MADE IN26
ACCORDANCE WITH THE NATIONAL COUNCIL FOR PRESCRIPTION DRUG27
HB23-1002
-9- PROGRAMS' STANDARDS FOR ELECTRONIC CLAIMS PROCESSING .1
(b) B
Y JANUARY 1, 2024, EACH MANUFACTURER SHALL DEVELOP2
A PROCESS FOR A PHARMACY TO SUBMIT AN ELECTRONIC CLAIM FOR3
REIMBURSEMENT AS PROVIDED IN SUBSECTION (8)(a) OF THIS SECTION.4
(c) I
F THE PHARMACY SUBMITS AN ELECTRONIC CLAIM TO THE5
MANUFACTURER PURSUANT TO SUBSECTION (8)(a) OF THIS SECTION, THE6
MANUFACTURER OR THE M ANUFACTURER 'S DELEGATED REPRESENTATIVE,7
SUBCONTRACTOR, OR OTHER VENDOR SHALL, WITHIN THIRTY DAYS AFTER8
RECEIPT OF THE CLAIM, EITHER:9
(I) R
EIMBURSE THE PHARMACY IN AN AMOUNT THAT COVERS THE10
DIFFERENCE BETWEEN THE PHARMACY 'S WHOLESALE ACQUISITION COST11
FOR THE NUMBER OF EPINEPHRINE AUTO -INJECTORS DISPENSED THROUGH12
THE PROGRAM AND THE AMOUNT THE INDIVIDUAL PAID FOR THE SAME13
NUMBER OF EPINEPHRINE AUTO-INJECTORS PURSUANT TO SUBSECTION (7)14
OF THIS SECTION; OR15
(II) S
END THE PHARMACY A REPLACEMENT SUPPLY OF THE SAME16
NUMBER OF EPINEPHRINE AUTO -INJECTORS IN AN AMOUNT EQUAL TO OR17
GREATER THAN THE AMOUNT THAT COVERS THE DIFFERENCE BETWEEN18
THE PHARMACY'S WHOLESALE ACQUISITION COST FOR THE NUMBER OF19
EPINEPHRINE AUTO-INJECTORS DISPENSED THROUGH THE PROGRAM AND20
THE AMOUNT THE INDIVIDUAL PAID FOR THE SAME NUMBER OF21
EPINEPHRINE AUTO-INJECTORS PURSUANT TO SUBSECTION (7) OF THIS22
SECTION.23
(d) A
PHARMACY SHALL NOT SUBMIT A CLAIM FOR PAYMENT FOR24
EPINEPHRINE AUTO-INJECTORS WITH A WHOLESALE ACQUISITION COST OF25
TWENTY DOLLARS OR LESS PER TWO -PACK OF EPINEPHRINE26
AUTO-INJECTORS, ADJUSTED ANNUALLY BASED ON THE ANNUAL27
HB23-1002
-10- PERCENTAGE CHANGE IN THE CONSUMER PRICE INDEX .1
(9) T
HE DIVISION OF INSURANCE AND THE DEPARTMENT OF HEALTH2
CARE POLICY AND FINANCING SHALL PROMOTE THE AVAILABILITY OF THE3
PROGRAM TO COLORADANS. THE PROMOTIONAL MATERIAL MUST INCLUDE4
INFORMATION ABOUT EACH MANUFACTURER 'S CONSUMER EPINEPHRINE5
AUTO-INJECTOR PROGRAM, AS APPLICABLE. EACH AGENCY MAY SEEK AND6
ACCEPT GIFTS, GRANTS, AND DONATIONS TO FULFILL THE REQUIREMENTS7
OF THIS SUBSECTION (9).8
(10) A
MANUFACTURER 'S REIMBURSEMENT PURSUANT TO9
SUBSECTION (8)(c) OF THIS SECTION IS NOT A KICKBACK.10
(11) A
MANUFACTURER THAT FAILS TO COMPLY WITH THE11
REQUIREMENTS OF THIS SECTION IS SUBJECT TO A FINE OF TEN THOUSAND12
DOLLARS FOR EACH MONTH OF NONCOMPLIANCE .13
SECTION 4. 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
HB23-1002
-11-