LC 52 0165 A BILL TO BE ENTITLED AN ACT To amend Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating to public1 assistance, so as to make insulin accessible to individuals who are in urgent need of a2 short-term affordable insulin supply; to provide for a short title; to provide for definitions;3 to require a pharmacy to dispense a 30 day supply of insulin to an eligible individual through4 the Urgent Insulin Safety Net Program; to allow a pharmacy to collect a copayment not to5 exceed $35.00 for insulin dispensed through such program; to provide for a pharmacy to6 submit a claim for payment or a replacement supply after dispensing insulin through such7 program; to require a manufacturer to reimburse or resupply a pharmacy dispensing insulin8 through such program; to provide for a pharmacy to dispense one additional short-term9 affordable urgent insulin supply under certain conditions; to require the Department of10 Community Health to develop an application form, an information sheet, and satisfaction11 surveys regarding such program; to require a manufacturer of insulin to establish procedures12 to make insulin available under such program; to provide for enforcement, penalties, and13 appellate procedures; to provide for reporting; to provide for related matters; to provide for14 an effective date; to repeal conflicting laws; and for other purposes.15 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:16 - 1 - LC 52 0165 SECTION 1.17 Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating to public assistance,18 is amended by adding a new article to read as follows:19 "Article 1020 49-4-200.21 This article shall be known and may be cited as the 'Urgent Insulin Safety Net Program22 Act.'23 49-4-201.24 As used in this article, the term:25 (1) 'Board' means the State Board of Pharmacy.26 (2) 'Department' means the Department of Community Health.27 (3) 'Eligible individual' means an individual qualified for assistance under the program28 as provided in Code Section 49-4-204.29 (4) 'Insulin' means various types of insulin analogs and insulin-like medications,30 regardless of activation period or whether the solution is mixed before or after31 dispensation. An insulin product is exempt from the provisions of this article if the32 wholesale acquisition cost of the insulin is $8.00 or less per milliliter or applicable33 National Council for Prescription Drug Plan billing unit for the entire assessment time34 period, adjusted annually based on the Consumer Price Index.35 (5) 'Manufacturer' means a manufacturer engaged in the production of insulin that is36 self-administered on an outpatient basis. Such term shall not include a manufacturer with37 an annual gross revenue of $2 million or less from insulin sales in this state.38 (6) 'Pharmacy' shall have the same meaning as provided in Code Section 26-4-5.39 (7) 'Program' means the Urgent Insulin Safety Net Program as provided for in this article.40 - 2 - LC 52 0165 (8) 'Proper identification' means any document issued by a governmental agency41 containing a description of the individual, such individual's photograph, or both, and42 giving such individual's date of birth and includes, without being limited to, a passport,43 military identification card, driver's license, or an identification card authorized under44 Code Sections 40-5-100 through 40-5-104. Proper identification shall not include a birth45 certificate.46 (9) 'Urgent need of insulin' means having readily available for use less than a seven-day47 supply of insulin and in need of insulin in order to avoid the likelihood of suffering48 significant health consequences.49 49-4-202.50 (a) Upon receipt of a completed, signed, and dated application form, as provided for in51 Code Section 49-4-204, proof of proper identification, and a copy of a current valid insulin52 prescription, a pharmacy shall dispense one 30 day supply of insulin to an eligible53 individual in urgent need of insulin; provided, however, that a pharmacy may dispense one54 additional 30 day supply of insulin within a 12 month period to an eligible individual as55 provided in Code Section 49-4-203.56 (b) The pharmacy may collect a copayment from the individual to whom insulin was57 dispensed through the program to cover such pharmacy's costs of processing and58 dispensing insulin as part of the program in an amount not to exceed $35.00 for the 30 day59 supply of insulin dispensed.60 (c) The pharmacy shall notify the healthcare provider who issued the insulin prescription61 for the eligible individual no later than 72 hours after the insulin is dispensed.62 (d) The pharmacy shall submit to the manufacturer of the dispensed insulin product or to63 the manufacturer's vendor a claim for payment that conforms with the National Council for64 Prescription Drug Program standards for electronic claims processing. The manufacturer65 shall timely reimburse the pharmacy in an amount that covers the pharmacy's acquisition66 - 3 - LC 52 0165 cost for the insulin and shall timely send the pharmacy a replacement supply of the same67 insulin dispensed under the program.68 (e) When the pharmacy dispenses the insulin to the eligible individual, the pharmacy shall69 also provide an information sheet and a survey, as provided for in Code Sections 49-4-20570 and 49-4-206, respectively.71 (f) The pharmacy shall retain a copy of submitted applications for reporting and auditing72 purposes.73 49-4-203.74 (a) A pharmacy shall dispense one additional 30 day supply of insulin to an eligible75 individual in urgent need of insulin within a 12 month period if such individual has applied76 for medical assistance, Georgia Medicaid, or PeachCare for Kids, and has not been77 determined eligible or has been determined eligible and coverage has not become effective.78 (b) To access one additional 30 day supply of insulin, such eligible individual shall attest79 to the pharmacy that the individual meets the requirements of subsection (a) of this Code80 section and shall be in compliance with the requirements provided in Code81 Section 49-4-204.82 49-4-204.83 (a) To be deemed eligible for services under this article, an individual shall attest on an84 application form as provided for in subsection (b) of this Code section that the individual:85 (1) Is a resident of this state;86 (2) Is not enrolled in any medical assistance or other health coverage or prescription drug87 coverage program that limits such enrollee's total amount of cost-sharing for a 30 day88 supply of insulin, including copayments, deductibles, or coinsurance, to $75.00 or less,89 regardless of the type or amount of insulin prescribed;90 - 4 - LC 52 0165 (3) Has not received insulin through the program within the previous 12 months, except91 as provided in Code Section 49-4-203; and92 (4) Has an urgent need of insulin.93 (b) The department shall develop and make available on its website an application form94 for the program.95 49-4-205.96 (a) The department, in coordination with the board, shall develop an information sheet that97 shall include, but shall not be limited to:98 (1) A description of the program, including how to access it;99 (2) Information on applying for medical assistance;100 (3) Information on applying for a qualified health benefit plan offered through the101 exchange as defined in Code Section 33-23-201; and102 (4) Information on accessing healthcare providers who participate in prescription drug103 discount programs, including providers who are authorized to participate in the 340B104 program under section 340B of the federal Public Health Service Act, 42 U.S.C.105 Section 256b, as amended.106 (b) The department shall post the information sheet provided for in subsection (a) of this107 Code section on its website.108 49-4-206.109 (a) The department, in coordination with the board, shall develop a survey to assess an110 eligible individual's satisfaction with the program, including:111 (1) Adequacy of information available and provided to individuals;112 (2) Accessibility to insulin; and113 (3) Individual's ability to access affordable insulin.114 - 5 - LC 52 0165 (b) The department, in coordination with the board, shall develop a survey to assess a115 pharmacy's satisfaction with the program, including:116 (1) Timeliness of reimbursement from the manufacturers for insulin dispensed through117 the program;118 (2) Ease in submitting claims and insulin product orders to the manufacturers; and119 (3) Timeliness of receiving insulin replacement orders from the manufacturers.120 (c) The department shall post the surveys provided for in subsections (a) and (b) of this121 Code section on its website.122 49-4-207.123 Each manufacturer shall:124 (1) Establish procedures to make insulin available in accordance with this article through125 pharmacies to eligible individuals who are in urgent need of insulin;126 (2) Establish a hotline to provide information on the program and shall list on its website127 information about the program; and128 (3) Provide for dedicated personnel to promptly respond to individuals, pharmacies, and129 healthcare providers and the department.130 49-4-208.131 (a) Any person who by means of a false statement, failure to disclose information, or132 impersonation, or by other fraudulent device, obtains or attempts to obtain any assistance,133 benefit, or payment under this article to which such person is not entitled shall be guilty of134 a misdemeanor; provided, however, that if the value of the assistance so obtained exceeds135 $1,500.00, such person shall be guilty of a felony.136 (b)(1) If a manufacturer fails to comply with the provisions of this article, the department137 may assess an administrative penalty of $200,000.00 per month of such noncompliance.138 - 6 - LC 52 0165 (2) Such penalty shall increase to $400,000.00 per month if the manufacturer continues139 to be in noncompliance after six months and shall increase to $600,000.00 per month if140 the manufacturer continues to be in noncompliance after one year.141 (3) The penalty shall remain at $600,000.00 per month for as long as the manufacturer142 continues in noncompliance.143 (c) An individual or entity that is aggrieved by the action of the department pursuant to144 subsection (a) or (b) of this Code section shall be entitled to a hearing conducted in145 accordance with Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.'146 49-4-209.147 (a) By February 15, 2024, and every February 15 thereafter, each manufacturer shall report148 to the department the following information for the preceding calendar year:149 (1) The number of Georgia residents who accessed and received insulin through the150 program;151 (2) The total value of the insulin, determined by the wholesale acquisition cost of the152 insulin, provided by the manufacturer for the program;153 (3) The adequacy and timeliness of the manufacturer in responding to a pharmacy154 requesting reimbursement or resupply of insulin dispensed through the program;155 (4) Any administrative penalties assessed under Code Section 49-4-208; and156 (5) Any additional information deemed necessary by the department.157 (b) By February 15, 2024, and every February 15 thereafter, a pharmacy that received any158 applications for the program shall report to the department the following information for159 the preceding calendar year:160 (1) The number of applications for an urgent insulin supply received and the number of161 applications for additional urgent insulin supply received;162 (2) The reasons for determinations of ineligibility;163 (3) The amount of insulin dispensed through the program;164 - 7 - LC 52 0165 (4) The average and total amount of copayment collected from individuals;165 (5) The timeliness of manufacturers' responses to requests for payment and re-supply of166 insulin; and167 (6) Any additional information deemed necessary by the department.168 (c) By March 15, 2025, and every March 15 thereafter, the department shall submit to the169 General Assembly a report regarding the implementation of the program under this article. 170 Such report shall include the following information for the preceding year:171 (1) The data collected under subsections (a) and (b) of this Code section;172 (2) The results of the satisfaction surveys provided for in Code Section 49-4-206; and173 (3) Any additional information deemed necessary by the department to assess the174 effectiveness of the implementation of the program."175 SECTION 2.176 This Act shall become effective upon its approval by the Governor or upon its becoming law177 without such approval.178 SECTION 3.179 All laws and parts of laws in conflict with this Act are repealed.180 - 8 -