Second 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. 24-1123.01 Brita Darling x2241 HOUSE BILL 24-1438 House Committees Senate Committees Health & Human Services 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. HOUSE Amended 2nd Reading April 20, 2024 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. 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 (9) as follows:5 12-280-140. Emergency prescription insulin supply - eligibility6 - record keeping. (9) (a) A manufacturer that fails to comply with the7 requirements of this section:8 (I) Is subject to a fine of ten thousand dollars for each month of 9 noncompliance. IN AN AMOUNT AND FREQUENCY THAT IS EQUAL TO THE10 AMOUNT AND FREQUENCY OF THE FINE PERMITTED UNDER THE11 "C OLORADO CONSUMER PROTECTION ACT", PART 1 OF ARTICLE 1 OF TITLE12 6; AND13 (II) E NGAGES IN A DECEPTIVE TRADE PRACTICE UNDER SECTION14 6-1-105 (1)(eeee).15 (b) T HE ATTORNEY GENERAL IS AUTHORIZED TO ENFORCE THIS16 SECTION.17 SECTION 4. In Colorado Revised Statutes, 12-280-142, amend18 (4), (6)(b)(II), (9), and (11); and repeal (1)(b) as follows: 19 12-280-142. Epinephrine auto-injector affordability program20 - record keeping - reimbursement - definitions. (1) As used in this21 section:22 (b) "Division of insurance" means the division of insurance in the23 department of regulatory agencies created in section 10-1-103.24 (4) (a) The division of insurance BOARD shall develop an25 EPINEPHRINE AUTO-INJECTOR AFFORDABILITY PROGRAM application form 26 to be used by an individual who is seeking epinephrine auto-injectors27 1438 -4- through the program. ALL MANUFACTURERS SUBJECT TO THIS SECTION1 SHALL PARTICIPATE IN THE PROGRAM. THE APPLICATION FORM MUST BE2 AVAILABLE TO INDIVIDUALS, PHARMACIES, HEALTH-CARE PROVIDERS, AND3 HEALTH FACILITIES THROUGH THE DIVISION'S WEBSITE AND MUST BE4 ACCESSIBLE THROUGH A QUICK RESPONSE (QR) CODE OR OTHER5 MACHINE-READABLE CODE. WITHIN A REASONABLE PERIOD OF TIME AFTER6 THE PUBLICATION OF THE PROGRAM WEBSITE, ALL MANUFACTURERS7 REQUIRED TO PARTICIPATE IN THE PROGRAM SHALL INCLUDE A LINK TO8 THE PROGRAM WEBSITE ON THE MANUFACTURER 'S CONSUMER9 EPINEPHRINE AUTO-INJECTOR PROGRAM WEBSITE. At a minimum, the10 application form must:11 (I) Provide information related to program eligibility and coverage12 in English, Spanish, and in each language spoken by at least two and13 one-half percent of the population of any county in which such population14 speaks English less than very well, as defined by the United States bureau15 of the census American community survey or comparable census data,16 and speaks a shared minority language at home; and17 (II) Require the individual to show proof ATTEST that the18 individual meets the requirements of subsection (3) of this section; AND19 (III) INCLUDE THE INFORMATION REQUIRED FOR A PHARMACY TO20 SUCCESSFULLY SUBMIT, PURSUANT TO SUBSECTION (8) OF THIS SECTION,21 AN ELECTRONIC CLAIM FOR REIMBURSEMENT THAT IS MADE IN22 ACCORDANCE WITH THE NATIONAL COUNCIL FOR PRESCRIPTION DRUG23 PROGRAMS' STANDARDS FOR ELECTRONIC CLAIMS PROCESSING FOR THE24 COST TO DISPENSE THE EPINEPHRINE AUTO-INJECTORS, ABOVE ANY25 REQUIRED COST SHARING BY THE INDIVIDUAL AND ADJUDICATED AT THE26 POINT OF SALE.27 1438 -5- (b) The division of insurance and the department of health care1 policy and financing shall make the application form available on each2 agency's website. The division of insurance shall also make the3 application form available to pharmacies, health-care providers, and4 health facilities that prescribe or dispense epinephrine auto-injectors5 BOARD SHALL SUPPLY PHARMACIES WITH INFORMATION ABOUT THE6 PROGRAM TO PROVIDE TO INDIVIDUALS WHO ARE SEEKING ACCESS TO THE7 PROGRAM. THE INFORMATION MUST CONTAIN A QUICK RESPONSE (QR)8 CODE OR OTHER MACHINE-READABLE CODE THAT AN INDIVIDUAL MAY USE9 TO ACCESS THE PROGRAM APPLICATION AND INCLUDE INFORMATION ON10 HOW TO SUBMIT A PROGRAM APPLICATION .11 (6) (b) The pharmacist is encouraged to inform the individual:12 (II) Of any manufacturer-sponsored programs that assist13 individuals who cannot afford their prescription epinephrine14 auto-injectors AND PROVIDE THE INDIVIDUAL WITH THE INFORMATION15 DESCRIBED IN SUBSECTION (4)(b) OF THIS SECTION ABOUT THE16 PROGRAM.17 (9) The division of insurance and the department of health care18 policy and financing BOARD shall promote the availability of the program19 to Coloradans. The promotional material must include information about20 each manufacturer's consumer epinephrine auto-injector program, as21 applicable. Each agency THE BOARD may seek and accept gifts, grants,22 and donations to fulfill the requirements of this subsection (9).23 (11) (a) A manufacturer that fails to comply with the requirements24 of this section:25 (a) (I) Is subject to a fine of ten thousand dollars for each month26 of noncompliance. IN AN AMOUNT AND FREQUENCY THAT IS EQUAL TO THE27 1438 -6- AMOUNT AND FREQUENCY OF TH E FINE PERMITTED UNDER THE1 "C OLORADO CONSUMER PROTECTION ACT", PART 1 OF ARTICLE 1 OF TITLE2 6; and3 (b) (II) Engages in a deceptive trade practice under section4 6-1-105 (1)(zzz).5 (b) T HE ATTORNEY GENERAL IS AUTHORIZED TO ENFORCE THIS6 SECTION.7 SECTION 5. Appropriation. For the 2024-25 state fiscal year,8 $8,874 is appropriated to the department of regulatory agencies for use by9 the division of professions and occupations. This appropriation is from10 the division of professions and occupations cash fund created in section11 12-20-105 (3), C.R.S., and is based on an assumption that the division12 will require an additional 0.2 FTE. To implement this act, the division13 may use this appropriation for personal services.14 SECTION 6. Safety clause. The general assembly finds,15 determines, and declares that this act is necessary for the immediate16 preservation of the public peace, health, or safety or for appropriations for17 the support and maintenance of the departments of the state and state18 institutions.19 1438 -7-