Second Regular Session Seventy-fourth General Assembly STATE OF COLORADO REVISED This Version Includes All Amendments Adopted on Second Reading in the Second House LLS NO. 24-1123.01 Brita Darling x2241 HOUSE BILL 24-1438 House Committees Senate Committees Health & Human Services Judiciary Appropriations Appropriations A BILL FOR AN ACT C ONCERNING THE IMPLEMENTATION OF CERTAIN AFFORDABLE101 PRESCRIPTION DRUG PROGRAMS, AND, IN CONNECTION102 THEREWITH, MAKING AN APPROPRIATION .103 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 .) The bill makes it a deceptive trade practice under the "Colorado Consumer Protection Act" for a manufacturer to fail to comply with: ! The insulin affordability program; and ! The requirements for the emergency supply of prescription insulin. SENATE Amended 2nd Reading May 1, 2024 HOUSE 3rd Reading Unamended April 24, 2024 HOUSE Amended 2nd Reading April 20, 2024 HOUSE SPONSORSHIP Mabrey and Jodeh, Amabile, Bacon, Boesenecker, Brown, Clifford, Duran, Epps, Froelich, Garcia, Hernandez, Kipp, Lieder, Lindsay, Lindstedt, Lukens, Martinez, Marvin, Mauro, McCluskie, McCormick, McLachlan, Ortiz, Parenti, Ricks, Rutinel, Sirota, Story, Valdez, Velasco, Woodrow, Young 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. The bill authorizes the attorney general to enforce: ! The insulin affordability program; ! The requirements for the emergency supply of prescription insulin; and ! The epinephrine auto-injector affordability program (epinephrine program). The bill also increases the amount of a fine for a manufacturer's failure to comply with the requirements of the insulin affordability program, the requirements for the emergency supply of prescription insulin, and the epinephrine program to the amount and frequency that is permitted under the "Colorado Consumer Protection Act". The bill requires the state board of pharmacy to provide flyers to be distributed to pharmacies about the epinephrine program that include a quick response (QR) code to allow individuals to access and complete the epinephrine program's application online. The completed, printed application will include a billing code or other method for the dispensing pharmacy to be reimbursed for the cost of the epinephrine auto-injector above any required cost sharing by the individual. Be it enacted by the General Assembly of the State of Colorado:1 SECTION 1. In Colorado Revised Statutes, 6-1-105, add2 (1)(eeee) as follows:3 6-1-105. Unfair or deceptive trade practices. (1) A person4 engages in a deceptive trade practice when, in the course of the person's5 business, vocation, or occupation, the person:6 (eeee) F AILS TO COMPLY WITH THE MANUFACTURER7 REQUIREMENTS UNDER THE INSULIN AFFORDABILITY PROGRAM PURS UANT8 TO SECTION 12-280-139 OR THE MANUFACTURER REQUIREMENTS FOR THE9 EMERGENCY SUPPLY OF PRESCRIPTION INSULIN PURSUANT TO SECTION10 12-280-140.11 SECTION 2. In Colorado Revised Statutes, 12-280-139, amend12 (4), (9), and (11); and repeal (1)(b) as follows:13 12-280-139. Insulin affordability program - record keeping -14 reimbursement - definitions. (1) As used in this section and section15 1438-2- 12-280-140, unless the context otherwise requires:1 (b) "Division of insurance" means the division of insurance in the2 department of regulatory agencies, created in section 10-1-103.3 (4) (a) The division of insurance BOARD shall develop an4 application form to be used by an individual who is seeking insulin under5 the program. The application form must require the individual to show6 proof that the individual meets the requirements of subsection (3) of this7 section.8 (b) The division of insurance and the department of health care9 policy and financing BOARD shall make the application form available on10 each agency's ITS website. The division of insurance BOARD shall also11 make the application form available to pharmacies, health-care providers,12 and health facilities that prescribe or dispense insulin.13 (9) The division of insurance and the department of health care14 policy and financing BOARD shall promote the availability of the program15 to Coloradans. The promotional material must include information about16 each manufacturer's consumer insulin programs. Each agency THE BOARD17 may seek and accept gifts, grants, and donations to fulfill the18 requirements of this subsection (9).19 (11) (a) A manufacturer that fails to comply with the requirements20 of this section:21 (I) Is subject to a fine of ten thousand dollars for each month of22 noncompliance. IN AN AMOUNT AND FREQUENCY THAT IS EQUAL TO THE23 AMOUNT AND FREQUENCY OF THE FINE PERMITTED UNDER THE24 "C OLORADO CONSUMER PROTECTION ACT", PART 1 OF ARTICLE 1 OF TITLE25 6; AND26 (II) E NGAGES IN A DECEPTIVE TRADE PRACTICE UNDER SECTION27 1438 -3- 6-1-105 (1)(eeee).1 (b) T HE ATTORNEY GENERAL IS AUTHORIZED TO ENFORCE THIS2 SECTION.3 SECTION 3. In Colorado Revised Statutes, 12-280-140, amend4 (3)(a), (7), and (9) as follows:5 12-280-140. Emergency prescription insulin supply - eligibility6 - record keeping. (3) (a) The division of insurance BOARD shall create7 and make available to the public an application form for individuals8 seeking an emergency prescription insulin supply pursuant to this section.9 (7) The division of insurance and the department of health care10 policy and financing BOARD shall promote the availability of the11 emergency prescription insulin supply to Coloradans. The promotional12 material must include information about each manufacturer's consumer13 insulin programs. Each agency THE BOARD may seek and accept gifts,14 grants, and donations to fulfill the requirements of this subsection (7).15 (9) (a) A manufacturer that fails to comply with the requirements16 of this section:17 (I) Is subject to a fine of ten thousand dollars for each month of18 noncompliance. IN AN AMOUNT AND FREQUENCY THAT IS EQUAL TO THE19 AMOUNT AND FREQUENCY OF THE FINE PERMITTED UNDER THE20 "C OLORADO CONSUMER PROTECTION ACT", PART 1 OF ARTICLE 1 OF TITLE21 6; AND22 (II) E NGAGES IN A DECEPTIVE TRADE PRACTICE UNDER SECTION23 6-1-105 (1)(eeee).24 (b) T HE ATTORNEY GENERAL IS AUTHORIZED TO ENFORCE THIS25 SECTION.26 SECTION 4. In Colorado Revised Statutes, 12-280-142, amend27 1438 -4- (4), (6)(b)(II), (9), and (11); and repeal (1)(b) as follows: 1 12-280-142. Epinephrine auto-injector affordability program2 - record keeping - reimbursement - definitions. (1) As used in this3 section:4 (b) "Division of insurance" means the division of insurance in the5 department of regulatory agencies created in section 10-1-103.6 (4) (a) The division of insurance BOARD shall develop an7 EPINEPHRINE AUTO-INJECTOR AFFORDABILITY PROGRAM application form 8 to be used by an individual who is seeking epinephrine auto-injectors9 through the program. ALL MANUFACTURERS SUBJECT TO THIS SECTION10 SHALL PARTICIPATE IN THE PROGRAM. THE APPLICATION FORM MUST BE11 AVAILABLE TO INDIVIDUALS, PHARMACIES, HEALTH-CARE PROVIDERS, AND12 HEALTH FACILITIES THROUGH THE BOARD 'S WEBSITE AND MUST BE13 ACCESSIBLE THROUGH A QUICK RESPONSE (QR) CODE OR OTHER14 MACHINE-READABLE CODE. WITHIN A REASONABLE PERIOD OF TIME AFTER15 THE PUBLICATION OF THE PROGRAM WEBSITE, ALL MANUFACTURERS16 REQUIRED TO PARTICIPATE IN THE PROGRAM SHALL INCLUDE A LINK TO17 THE PROGRAM WEBSITE ON THE MANUFACTURER 'S CONSUMER18 EPINEPHRINE AUTO-INJECTOR PROGRAM WEBSITE. At a minimum, the19 application form must:20 (I) Provide information related to program eligibility and coverage21 in English, Spanish, and in each language spoken by at least two and22 one-half percent of the population of any county in which such population23 speaks English less than very well, as defined by the United States bureau24 of the census American community survey or comparable census data,25 and speaks a shared minority language at home; and26 (II) Require the individual to show proof ATTEST that the27 1438 -5- individual meets the requirements of subsection (3) of this section; AND1 (III) INCLUDE THE INFORMATION REQUIRED FOR A PHARMACY TO2 SUCCESSFULLY SUBMIT, PURSUANT TO SUBSECTION (8) OF THIS SECTION,3 AN ELECTRONIC CLAIM FOR REIMBURSEMENT THAT IS MADE IN4 ACCORDANCE WITH THE NATIONAL COUNCIL FOR PRESCRIPTION DRUG5 PROGRAMS' STANDARDS FOR ELECTRONIC CLAIMS PROCESSING FOR THE6 COST TO DISPENSE THE EPINEPHRINE AUTO-INJECTORS, ABOVE ANY7 REQUIRED COST SHARING BY THE INDIVIDUAL AND ADJUDICATED AT THE8 POINT OF SALE.9 (b) The division of insurance and the department of health care10 policy and financing shall make the application form available on each11 agency's website. The division of insurance shall also make the12 application form available to pharmacies, health-care providers, and13 health facilities that prescribe or dispense epinephrine auto-injectors14 BOARD SHALL SUPPLY PHARMACIES WITH INFORMATION ABOUT THE15 PROGRAM TO PROVIDE TO INDIVIDUALS WHO ARE SEEKING ACCESS TO THE16 PROGRAM. THE INFORMATION MUST CONTAIN A QUICK RESPONSE (QR)17 CODE OR OTHER MACHINE-READABLE CODE THAT AN INDIVIDUAL MAY USE18 TO ACCESS THE PROGRAM APPLICATION AND INCLUDE INFORMATION ON19 HOW TO SUBMIT A PROGRAM APPLICATION .20 (6) (b) The pharmacist is encouraged to inform the individual:21 (II) Of any manufacturer-sponsored programs that assist22 individuals who cannot afford their prescription epinephrine23 auto-injectors AND PROVIDE THE INDIVIDUAL WITH THE INFORMATION24 DESCRIBED IN SUBSECTION (4)(b) OF THIS SECTION ABOUT THE25 PROGRAM.26 (9) The division of insurance and the department of health care27 1438 -6- policy and financing BOARD shall promote the availability of the program1 to Coloradans. The promotional material must include information about2 each manufacturer's consumer epinephrine auto-injector program, as3 applicable. Each agency THE BOARD may seek and accept gifts, grants,4 and donations to fulfill the requirements of this subsection (9).5 (11) (a) A manufacturer that fails to comply with the requirements6 of this section:7 (a) (I) Is subject to a fine of ten thousand dollars for each month8 of noncompliance. IN AN AMOUNT AND FREQUENCY THAT IS EQUAL TO THE9 AMOUNT AND FREQUENCY OF THE FINE PERMITTED UNDER THE10 "C OLORADO CONSUMER PROTECTION ACT", PART 1 OF ARTICLE 1 OF TITLE11 6; and12 (b) (II) Engages in a deceptive trade practice under section13 6-1-105 (1)(zzz).14 (b) T HE ATTORNEY GENERAL IS AUTHORIZED TO ENFORCE THIS15 SECTION.16 SECTION 5. Appropriation. For the 2024-25 state fiscal year,17 $8,874 is appropriated to the department of regulatory agencies for use by18 the division of professions and occupations. This appropriation is from19 the division of professions and occupations cash fund created in section20 12-20-105 (3), C.R.S., and is based on an assumption that the division21 will require an additional 0.2 FTE. To implement this act, the division22 may use this appropriation for personal services.23 SECTION 6. Safety clause. The general assembly finds,24 determines, and declares that this act is necessary for the immediate25 preservation of the public peace, health, or safety or for appropriations for26 1438 -7- the support and maintenance of the departments of the state and state1 institutions.2 1438 -8-