A. "Eligible individual" means an individual who has been determined to qualify for assistance under the program pursuant to subsection 3 or 4.   [PL 2021, c. 303, §1 (NEW).]

B. "Insulin" has the same meaning as in section 13786‑D, subsection 1, paragraph A, except for an insulin product that has a wholesale acquisition cost of $8 or less per milliliter or applicable National Council for Prescription Drug Plan billing unit, for the entire assessment time period, adjusted annually based on the Consumer Price Index Annual Average, for All Urban Consumers, CPI-U: U.S. City Averages, All Items reported by the United States Department of Labor, Bureau of Labor Statistics.   [PL 2021, c. 303, §1 (NEW).]

C. "Manufacturer" means a manufacturer engaged in the manufacturing of insulin that is self-administered on an outpatient basis, except for a manufacturer with an annual gross revenue of $2,000,000 or less from insulin sales in this State.   [PL 2021, c. 303, §1 (NEW).]

D. "Urgent need of insulin" means having readily available for use less than a 7-day supply of insulin and in need of insulin in order to avoid the likelihood of suffering significant health consequences.   [PL 2021, c. 303, §1 (NEW).]

A. To be eligible, an individual must demonstrate on an application form developed by the board that the individual:  

B. The board shall make the application form accessible through the board's publicly accessible website and make the form available to pharmacies and health care providers who prescribe or dispense insulin, hospital emergency departments, urgent care clinics and community health clinics.   [PL 2021, c. 303, §1 (NEW).]

C. In addition to a completed, signed and dated application, an individual shall also present to a pharmacy a valid insulin prescription and identification indicating residency in the form of a valid Maine identification card, driver's license or permit. If the individual in urgent need of insulin is under the age of 18, the individual's parent or legal guardian shall provide the pharmacy with proof of residency. Upon receipt of the information required by this paragraph, the pharmacist shall dispense the prescribed insulin in an amount that will provide the individual a 30-day supply. If an individual does not have a valid prescription, a pharmacist may dispense an emergency refill of insulin pursuant to section 13786‑D.   [PL 2021, c. 303, §1 (NEW).]

D. The pharmacy shall notify the health care practitioner who issued the prescription order presented under paragraph C no later than 72 hours after the insulin is dispensed.   [PL 2021, c. 303, §1 (NEW).]

E. The pharmacy may submit to the manufacturer of the dispensed insulin product or to the manufacturer's vendor a claim for payment for insulin dispensed under paragraph C that is in accordance with the standards developed by a national council for prescription drug programs for electronic claims processing, unless the manufacturer agrees to send to the pharmacy a replacement supply of the same insulin as dispensed in the amount dispensed. If the pharmacy submits an electronic claim to the manufacturer or the manufacturer's vendor, the manufacturer or vendor shall reimburse the pharmacy in an amount that covers the pharmacy's acquisition cost.   [PL 2021, c. 303, §1 (NEW).]

F. The pharmacy may collect an insulin copayment from the eligible individual to cover the pharmacy's costs of processing and dispensing in an amount not to exceed $35 for the 30-day supply of insulin dispensed under paragraph C.   [PL 2021, c. 303, §1 (NEW).]

G. The pharmacy shall provide each eligible individual an information sheet provided by the board with contact information for the Health Insurance Consumer Assistance Program established in Title 24‑A, chapter 56‑A, subchapter 2‑A, including the program's publicly accessible website, toll-free telephone number and e-mail address, so that the individual may access additional information and assistance related to ongoing insulin coverage options, including assistance in: applying for MaineCare; applying for a qualified health plan offered through the federally facilitated marketplace, subject to open and special enrollment periods; accessing information on providers who participate in prescription drug discount programs, including providers who are authorized to participate in the federal program under section 340b of the federal Public Health Service Act, United States Code, Title 42, section 256b; and accessing insulin manufacturers' patient assistance programs and other assistance programs through nonprofit organizations.   [PL 2021, c. 303, §1 (NEW).]

H. The pharmacy shall retain a copy of the application form submitted by the individual under paragraph A to the pharmacy for reporting and compliance purposes.   [PL 2021, c. 303, §1 (NEW).]

A. Each manufacturer shall provide the Health Insurance Consumer Assistance Program established in Title 24‑A, chapter 56‑A, subchapter 2‑A information regarding the manufacturer's patient assistance program, including contact information for individuals to call for assistance in accessing the patient assistance program.   [PL 2021, c. 303, §1 (NEW).]

B. To be eligible to participate in a manufacturer's patient assistance program, an individual must:  

C. An individual who is interested in participating in a manufacturer's patient assistance program may apply directly to the manufacturer or through the individual's health care practitioner, if the practitioner participates in the manufacturer's patient assistance program.   [PL 2021, c. 303, §1 (NEW).]

D. Upon receipt of an application for the manufacturer's patient assistance program, the manufacturer shall process the application and determine eligibility. The manufacturer shall notify the applicant of the determination within 10 business days of receipt of the application. If necessary, the manufacturer may request additional information from the applicant. If additional information is needed, the manufacturer shall notify the applicant within 5 business days of receipt of the application as to what information is being requested. Within 3 business days of receipt of the requested information, the manufacturer shall determine eligibility and notify the applicant of the determination. If the individual has been determined to be not eligible, the manufacturer shall include the reasons for denying eligibility in the notification. The individual may seek an appeal of the determination in accordance with this section. If the individual is determined to be eligible, the manufacturer shall provide the individual with an eligibility statement or other indication that the individual has been determined eligible for the manufacturer's patient assistance program. An individual's eligibility is valid for 12 months and is renewable upon a redetermination of eligibility.   [PL 2021, c. 303, §1 (NEW).]

E. If the eligible individual has prescription drug coverage through an individual or group health plan, the manufacturer may determine that the individual's insulin needs are better addressed by providing financial assistance for copayments and other cost-sharing requirements of the individual's individual or group health plan. The manufacturer shall establish a copayment assistance program to provide such financial assistance. The manufacturer shall inform the individual and provide the individual with the necessary coupons to submit to a pharmacy. Under the manufacturer's copayment assistance program, an eligible individual may not be required to pay more than a copayment of $35 for a 30‑day supply of insulin.   [PL 2021, c. 303, §1 (NEW).]

F. The eligible individual shall submit to a pharmacy the eligibility statement provided by the manufacturer under paragraph D. Upon receipt of an individual's eligibility status, the pharmacy shall dispense insulin in accordance with this paragraph.  

G. If an individual disagrees with a manufacturer's determination of eligibility under this subsection, the individual may contact the board to request a review of eligibility. The review of eligibility must be conducted by the board administrator, in consultation with a board member. The individual requesting the review shall submit to the board, with the request, all documents submitted by the individual to the manufacturer. The board shall provide the reviewer or reviewers with the documents submitted by the individual. The review of eligibility must be completed within 10 business days of receipt of all the necessary documents from the individual. The review decision is final. If the review determines that the individual is eligible for the manufacturer's patient assistance program, the manufacturer shall provide the individual with an eligibility statement in accordance with this subsection.   [PL 2021, c. 303, §1 (NEW).]