Session of 2023 HOUSE BILL No. 2347 By Committee on Health and Human Services 2-8 AN ACT concerning health and healthcare; relating to prescription drugs; insulin drugs and devices for the management of diabetes; providing price limitations and requirements therefor under health insurance plans; establishing the insulin affordability program for the uninsured and procedures to acquire emergency insulin supplies. Be it enacted by the Legislature of the State of Kansas: Section 1. (a) Every individual or group health insurance policy, medical service plan, contract, hospital service corporation contract, hospital and medical service corporation contract, fraternal benefit society or health maintenance organization that provides coverage for accident and health services and that is delivered, issued for delivery, amended or renewed on or after January 1, 2024, shall provide coverage for prescription insulin drugs in accordance with this section. (b) All coverage for accident and health services described in subsection (a) shall limit the total amount that a covered person is required to pay for a 30-day supply for: (1) All covered prescription insulin drugs, including any amount or type of insulin needed to fill the covered person's prescription and any number of prescriptions filled, to an amount not to exceed $35; and (2) all devices, to an amount not to exceed $100. (c) All coverage for accident and health services described in subsection (a) shall cover: (1) At least one type of prescription insulin drug in each of the following categories: (A) Rapid acting; (B) ultra rapid acting; (C) short acting; (D) intermediate acting; (E) long acting; (F) pre-mixed insulin products; (G) pre-mixed insulin/GLP-1 RA products; and (H) concentrated human regular insulin; and (2) diabetes self-management education to ensure that persons with diabetes are educated on the proper self-management and treatment of diabetes, including, but not limited to, information on proper diets, 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 HB 2347 2 provided by a healthcare provider who has been appropriately trained as specified in rules and regulations adopted by the secretary of health and environment. (d) Any provider of coverage for accident and health services described in subsection (a) shall provide an appeals process for covered persons who are not able to take one or more of the prescription insulin drugs described in subsection (c)(1). Such appeals process shall be provided in writing and shall provide covered persons and the covered person's healthcare providers a meaningful opportunity to participate in the appeals process. (e) (1) The commissioner of insurance shall adopt rules and regulations as necessary to implement this section. (2) The secretary of health and environment shall adopt rules and regulations to establish training requirements for healthcare providers providing diabetes self-management education required to be covered under subsection (c)(2). (f) (1) No contract between a provider of coverage for accident and health services described in subsection (a) and a pharmacy benefits manager, as defined in K.S.A. 40-3822, and amendments thereto, shall contain any provision that allows any charge, collection or other required payment that exceeds the limitations provided in subsection (b). (2) A pharmacy benefits manager, provider of coverage for accident and health services described in subsection (a) or any other third party that reimburses a pharmacy for drugs or services shall not reimburse a pharmacy at a lower rate or assess any fee, charge-back or adjustment upon a pharmacy on the basis that a covered person's cost-sharing requirements are being affected. (g) As used in this section: (1) "Device" means a blood glucose test strip, glucometer, continuous glucose monitor and transmitter, lancet, lancing device or insulin syringe used to cure, diagnose, mitigate, prevent or treat diabetes or low blood sugar. "Device" does not include an insulin pump. (2) "Prescription insulin drug" means a prescription drug that contains insulin and is used to treat diabetes. Sec. 2. (a) On and after January 1, 2024, there is created the insulin affordability program for the uninsured. Prior to January 1, 2024, each manufacturer shall establish procedures to make insulin available to eligible individuals in accordance with this section. (b) To be eligible to receive insulin under the program, an individual shall: (1) Be a resident of Kansas; (2) not be eligible for or enrolled in medical assistance or the federal health insurance for the aged act, 42 U.S.C. § 1395 et seq.; 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 HB 2347 3 (3) have a valid prescription order for insulin; and (4) not be enrolled in coverage for accident and health services subject to the requirements of section 1, and amendments thereto. An individual enrolled in short-term coverage, a healthcare sharing ministry or self-insured coverage shall not be excluded from eligibility under this paragraph. (c) The commissioner of insurance shall develop an application form to be used by an individual who is seeking insulin under the program and make such form available on the insurance department's website and to pharmacies, healthcare providers and healthcare facilities that prescribe or dispense insulin. (d) (1) To acquire insulin through the program, an individual shall present to a pharmacy a completed, signed and dated application form with proof of the individual's Kansas residency. If the individual is younger than 18 years of age, the individual's parent or legal guardian may provide such proof of residency. (2) Upon receipt of an application form meeting the requirements of paragraph (1) and demonstrating eligibility pursuant to subsection (b), a pharmacist shall dispense the prescribed insulin in an amount that will provide the individual with a 30-day supply of insulin. (3) An individual may receive 30-day supplies of insulin for up to 12 months per valid application and may reapply for additional 12-month periods. (e) (1) A pharmacist dispensing insulin pursuant to subsection (d) may inform the individual that the individual may be eligible for medical assistance or an affordable insurance product on the state-based marketplace. (2) A pharmacist shall retain a copy of any application form provided by an individual pursuant to this section for two years after the date the insulin was initially dispensed. (3) A pharmacy dispensing insulin pursuant to this section may collect a one-time fee from the individual in an amount not to exceed $15. (f) (1) Except as provided in paragraph (4), unless the manufacturer agrees to send the pharmacy a replacement supply of insulin dispensed in the amount provided through the program, the pharmacy may submit to the manufacturer an electronic claim for payment that is made in accordance with the national council for prescription drug programs' standards for electronic claims processing, or other substantially equivalent standards determined by the commissioner of insurance. (2) Prior to January 1, 2024, each manufacturer shall develop a process for a pharmacy to submit an electronic claim for reimbursement as provided in paragraph (1). (3) If a pharmacy submits an electronic claim to a manufacturer 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 HB 2347 4 pursuant to this subsection, within 30 calendar days after receipt of the claim, the manufacturer shall reimburse the pharmacy in an amount, or send the pharmacy a replacement supply of the same insulin in an equal or greater amount, that covers the difference between the pharmacy's wholesale acquisition cost for the insulin dispensed through the program and the amount that the individual paid for the insulin pursuant to subsection (e)(3). (4) A pharmacy shall not submit a claim for payment for insulin with a wholesale acquisition cost of $8 or less per milliliter, adjusted annually based on the annual percentage change in the consumer price index as determined by the commissioner of insurance. (g) The commissioner of insurance may promote the availability of the program to Kansans. Promotional material provided by the commissioner may include information regarding each manufacturer's consumer insulin programs. The insurance department may accept gifts, grants and donations to meet the requirements of this subsection. (h) The commissioner of insurance may impose a fine of $10,000 upon a manufacturer that fails to comply with the requirements of this section for each month of noncompliance. (i) The commissioner of insurance shall adopt rules and regulations as necessary to implement this section. (j) As used in this section: (1) "Consumer price index" means the consumer price index for all urban consumers in the midwest region published by the United States department of labor, bureau of labor statistics. (2) "Manufacturer" means an entity: (A) Engaged in the manufacture of insulin that is self-administered on an outpatient basis and is available for purchase by residents of this state; and (B) that has an annual gross revenue of more than $2,000,000 from the sale of insulin in this state. (3) "Pharmacist" and "pharmacy" mean the same as defined in K.S.A. 65-1626, and amendments thereto. (4) "Wholesale acquisition cost" means a manufacturer's list price for insulin to wholesalers or direct purchasers in the United States for the most recent month for which the information is reported in wholesale price guides or other publications of drug or biological pricing data. "Wholesale acquisition cost" does not include prompt pay or other discounts, rebates or reductions in price. Sec. 3. (a) (1) On and after January 1, 2024, an individual may acquire from a pharmacy one emergency 30-day supply of prescription insulin drugs within a 12-month period. The pharmacy may charge the individual an amount not to exceed $35 for such 30-day supply. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 HB 2347 5 (2) Each manufacturer shall establish procedures to make insulin available in accordance with this section to eligible individuals who need access to an emergency prescription insulin drug supply. (b) To be eligible to receive an emergency prescription insulin drug supply, an individual shall: (1) Be a resident of Kansas; (2) have a valid prescription for insulin; (3) have less than a seven-day supply of insulin available; and (4) be required to pay more than $100 out of pocket each month for prescribed insulin drugs, whether insured or uninsured. (c) (1) The commissioner of insurance shall create and make available to the public an application form for individuals seeking to acquire an emergency prescription insulin drug supply pursuant to this section. Such application form shall require an individual to provide proof of eligibility under subsection (b). (2) Each pharmacy in this state shall make the application form available at the pharmacy. (d) (1) To acquire an emergency 30-day supply of insulin under this section, an individual shall present to a pharmacy a completed, signed and dated application form with proof of the individual's Kansas residency. If the individual is younger than 18 years of age, the individual's parent or legal guardian may provide such proof of residency. (2) Upon receipt of an application form meeting the requirements of paragraph (1) and demonstrating eligibility pursuant to subsection (b), a pharmacist shall dispense the prescribed insulin in an amount that will provide the individual with a 30-day supply. (e) (1) A pharmacist shall retain a copy of any application form provided by an individual pursuant to this section for two years after the date the insulin was initially dispensed. (2) A pharmacy dispensing insulin pursuant to this section may collect a copayment from the individual to cover the pharmacy's costs of processing and dispensing the insulin in an amount not to exceed $35 for the emergency 30-day supply of insulin. (f) (1) Except as provided in paragraph (4), unless the manufacturer agrees to send the pharmacy a replacement supply of insulin dispensed in the amount provided through the program, the pharmacy may submit to the manufacturer an electronic claim for payment that is made in accordance with the national council for prescription drug programs' standards for electronic claims processing, or other substantially equivalent standards determined by the commissioner of insurance. (2) Prior to January 1, 2024, each manufacturer shall develop a process for a pharmacy to submit an electronic claim for reimbursement as provided in paragraph (1). 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 HB 2347 6 (3) If a pharmacy submits an electronic claim to a manufacturer pursuant to this subsection, within 30 calendar days after receipt of the claim, the manufacturer shall reimburse the pharmacy in an amount, or send the pharmacy a replacement supply of the same insulin in an equal or greater amount, that covers the difference between the pharmacy's wholesale acquisition cost for the insulin dispensed through the program and the amount that the individual paid for the insulin pursuant to subsection (e)(3). (4) A pharmacy shall not submit a claim for payment for insulin with a wholesale acquisition cost of $8 or less per milliliter, adjusted annually based on the annual percentage change in the consumer price index as determined by the commissioner of insurance. (g) The commissioner of insurance shall promote the availability of emergency insulin under this section to Kansans. Promotional material provided by the commissioner shall include information regarding each manufacturer's consumer insulin programs. The insurance department may accept gifts, grants and donations to meet the requirements of this subsection. (h) The commissioner of insurance may impose a fine of $10,000 upon a manufacturer that fails to comply with the requirements of this section for each month of noncompliance. (i) The commissioner of insurance shall adopt rules and regulations as necessary to implement this section. (j) As used in this section, "consumer price index," "manufacturer," "pharmacist," "pharmacy" and "wholesale acquisition cost" mean the same as defined in section 2, and amendments thereto. Sec. 4. This act shall take effect and be in force from and after its publication in the statute book. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28