HOUSE BILL 23-1002
BY REPRESENTATIVE(S) Mabrey and Jodeh, Amabile, Bacon, Bird,
Boesenecker, Brown, Daugherty, Dickson, Duran, Froelich, Garcia, Kipp,
Lieder, Lindsay, Lukens, Martinez, McCormick, McLachlan,
Michaelson Jenet, Parenti, Ricks, Sharbini, Sirota, Snyder, Story, Titone,
Valdez, Velasco, Vigil, Weissman, Willford, Woodrow, Young, McCluskie,
deGruy Kennedy, English, Hamrick, Joseph, Weinberg;
also SENATOR(S) Roberts, Buckner, Coleman, Cutter, Danielson, Exum,
Ginal, Gonzales, Hansen, Hinrichsen, Kolker, Marchman, Moreno, Priola,
Sullivan, Winter F., Fenberg.
C
ONCERNING THE AFFORDABILITY OF EPINEPHRINE AUTO -INJECTORS, AND,
IN CONNECTION THEREWITH, MAKING AN APPROPRIATION.
Be it enacted by the General Assembly of the State of Colorado:
SECTION 1. Legislative declaration. (1) The general assembly
finds and declares that:
(a) Individuals who have moderate to severe allergies, severe
asthma, or genetic conditions such as angioedema are at risk of reactions
that can occur within seconds or minutes and that can lead to anaphylaxis,
a potentially fatal reaction;
NOTE: This bill has been prepared for the signatures of the appropriate legislative
officers and the Governor. To determine whether the Governor has signed the bill
or taken other action on it, please consult the legislative status sheet, the legislative
history, or the Session Laws.
________
Capital letters or bold & italic numbers indicate new material added to existing law; dashes
through words or numbers indicate deletions from existing law and such material is not part of
the act. (b) Epinephrine works quickly to improve breathing, stimulate the
heart, raise dropping blood pressure, prevent airways from closing, prevent
or decrease shock, reverse hives, and reduce swelling of the face, lips, and
throat;
(c) Delay in appropriate treatment for anaphylaxis almost certainly
contributes to death in individuals, so it is critical that all anaphylaxis
reactions are treated as a medical emergency;
(d) In Colorado, there are approximately 565,824 individuals with
life-threatening food allergies, which is more than the population of
Colorado Springs; of these individuals, 101,848 are under 18 years of age,
which means that the number of children with food allergies in Colorado is
larger than the population of Longmont;
(e) Epinephrine auto-injectors are essential because they are the
easiest and most efficient way to potentially save the life of an individual
exhibiting symptoms of or experiencing anaphylactic shock;
(f) Many individuals are unable to afford an epinephrine
auto-injector because they cannot pay the copayment amount required under
their insurance plan or, if they are uninsured, the cost of an epinephrine
auto-injector; these individuals risk their lives every day by not having
access to this life-saving medicine if faced with an allergic reaction; and
(g) Rising costs of epinephrine auto-injectors make this life-saving
medication difficult or impossible to obtain for many people, even those
with private health insurance or who are enrolled in a public health benefit
program.
(2) Therefore, it is the intent of the general assembly to establish an
epinephrine auto-injector affordability program to ensure Colorado
residents have greater access to epinephrine.
SECTION 2. In Colorado Revised Statutes, add 10-16-160 as
follows:
10-16-160. Cost sharing - prescription epinephrine - limits -
rules - definition. (1) A
S USED IN THIS SECTION, UNLESS THE CONTEXT
PAGE 2-HOUSE BILL 23-1002 OTHERWISE REQUIRES, "EPINEPHRINE AUTO-INJECTOR" HAS THE SAME
MEANING AS SET FORTH IN SECTION
12-280-142 (1)(c).
(2) F
OR HEALTH COVERAGE PLANS ISSUED OR RENEWED ON OR AFTER
JANUARY 1, 2024, IF A CARRIER PROVIDES COVERAGE FOR PRESCRIPTION
EPINEPHRINE AUTO
-INJECTORS, THE CARRIER SHALL 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 SIXTY DOLLARS FOR A TWO
-PACK OF EPINEPHRINE AUTO-INJECTORS,
REGARDLESS OF THE AMOUNT OR TYPE OF EPINEPHRINE NEEDED TO FILL THE
COVERED PERSON
'S PRESCRIPTION.
(3) N
OTHING IN THIS SECTION PREVENTS A CARRIER FROM REDUCING
A COVERED PERSON
'S COST SHARING TO AN AMOUNT THAT IS LOWER THAN
THE AMOUNT SPECIFIED IN SUBSECTION
(2) OF THIS SECTION.
(4) T
HE COVERAGE REQUIRED BY THIS SECTION MAY BE OFFERED
THROUGH A HIGH DEDUCTIBLE PLAN THAT INCLUDES A HEALTH SAVINGS
ACCOUNT PURSUANT TO
26 U.S.C. SEC. 223 OF THE FEDERAL "INTERNAL
REVENUE CODE OF 1986"; EXCEPT THAT A CARRIER MAY APPLY DEDUCTIBLE
AMOUNTS FOR THE REQUIRED COVERAGE IF THE COVERAGE IS NOT
CONSIDERED BY THE
UNITED STATES DEPARTMENT OF THE TREASURY TO BE
PREVENTIVE OR TO HAVE AN ACCEPTABLE DEDUCTIBLE AMOUNT
.
(5) T
HE COMMISSIONER MAY USE ANY OF THE COMMISSIONER 'S
ENFORCEMENT POWERS TO OBTAIN A CARRIER
'S COMPLIANCE WITH THIS
SECTION
.
(6) T
HE COMMISSIONER MAY PROMULGATE RULES AS NECESSARY TO
IMPLEMENT AND ADMINISTER THIS SECTION AND TO ALIGN WITH FEDERAL
REQUIREMENTS
.
SECTION 3. In Colorado Revised Statutes, add 12-280-142 as
follows:
12-280-142. Epinephrine auto-injector affordability program -
record keeping - reimbursement - definitions. (1) A
S USED IN THIS
SECTION
:
(a) "C
ONSUMER PRICE INDEX " MEANS THE UNITED STATES
PAGE 3-HOUSE BILL 23-1002 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) "D
IVISION OF INSURANCE" MEANS THE DIVISION OF INSURANCE
IN THE DEPARTMENT OF REGULATORY AGENCIES
, CREATED IN SECTION
10-1-103.
(c) "E
PINEPHRINE 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) "M
ANUFACTURER" MEANS A PERSON ENGAGED IN
MANUFACTURING EPINEPHRINE AUTO
-INJECTORS THAT ARE AVAILABLE FOR
PURCHASE IN THIS STATE
.
(e) "P
HARMACY" MEANS A PHARMACY OUTLET REGISTERED
PURSUANT TO THIS ARTICLE
280 WHERE PRESCRIPTIONS ARE COMPOUNDED
AND DISPENSED
.
(f) "P
ROGRAM" MEANS THE EPINEPHRINE AUTO -INJECTOR
AFFORDABILITY PROGRAM CREATED IN SUBSECTION
(2) OF THIS SECTION.
(g) "P
ROOF 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 ;
PAGE 4-HOUSE BILL 23-1002 (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) A
N 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) E
FFECTIVE 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) T
O BE ELIGIBLE TO RECEIVE EPINEPHRINE AUTO -INJECTORS
THROUGH THE PROGRAM
, AN INDIVIDUAL MUST:
(a) D
EMONSTRATE PROOF OF RESIDENCY IN COLORADO;
(b) N
OT 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) H
AVE A VALID EPINEPHRINE AUTO-INJECTOR PRESCRIPTION; AND
PAGE 5-HOUSE BILL 23-1002 (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) T
HE 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) P
ROVIDE 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) T
HE 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) T
O 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) U
PON 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,
PAGE 6-HOUSE BILL 23-1002 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) T
HE PHARMACIST IS ENCOURAGED TO INFORM THE INDIVIDUAL :
(I) T
HAT 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) T
HE 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) E
XCEPT AS PROVIDED IN SUBSECTION (8)(d) 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
.
PAGE 7-HOUSE BILL 23-1002 (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) I
F 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) R
EIMBURSE 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) T
HE 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) I
S 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).
PAGE 8-HOUSE BILL 23-1002 SECTION 4. In Colorado Revised Statutes, 6-1-105, add (1)(zzz)
as follows:
6-1-105. Unfair or deceptive trade practices. (1) A person
engages in a deceptive trade practice when, in the course of the person's
business, vocation, or occupation, the person:
(zzz) F
AILS TO COMPLY WITH THE REQUIREMENTS OF SECTION
12-280-142.
SECTION 5. Appropriation. (1) For the 2023-24 state fiscal year,
$58,291 is appropriated to the department of regulatory agencies for use by
the division of insurance. This appropriation is from the division of
insurance cash fund created in section 10-1-103 (3), C.R.S. To implement
this act, the division may use this appropriation as follows:
(a) $49,176 for personal services, which amount is based on an
assumption that the division will require an additional 0.7 FTE; and
(b) $9,115 for operating expenses.
SECTION 6. Act subject to petition - effective date. This act
takes effect at 12:01 a.m. on the day following the expiration of the
ninety-day period after final adjournment of the general assembly; except
that, if a referendum petition is filed pursuant to section 1 (3) of article V
of the state constitution against this act or an item, section, or part of this act
within such period, then the act, item, section, or part will not take effect
PAGE 9-HOUSE BILL 23-1002 unless approved by the people at the general election to be held in
November 2024 and, in such case, will take effect on the date of the official
declaration of the vote thereon by the governor.
____________________________ ____________________________
Julie McCluskie Steve Fenberg
SPEAKER OF THE HOUSE PRESIDENT OF
OF REPRESENTATIVES THE SENATE
____________________________ ____________________________
Robin Jones Cindi L. Markwell
CHIEF CLERK OF THE HOUSE SECRETARY OF
OF REPRESENTATIVES THE SENATE
APPROVED________________________________________
(Date and Time)
_________________________________________
Jared S. Polis
GOVERNOR OF THE STATE OF COLORADO
PAGE 10-HOUSE BILL 23-1002