| 1 | 1 | | LC 52 0165 |
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| 2 | 2 | | A BILL TO BE ENTITLED |
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| 3 | 3 | | AN ACT |
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| 4 | 4 | | To amend Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating to public1 |
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| 5 | 5 | | assistance, so as to make insulin accessible to individuals who are in urgent need of a2 |
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| 6 | 6 | | short-term affordable insulin supply; to provide for a short title; to provide for definitions;3 |
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| 7 | 7 | | to require a pharmacy to dispense a 30 day supply of insulin to an eligible individual through4 |
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| 8 | 8 | | the Urgent Insulin Safety Net Program; to allow a pharmacy to collect a copayment not to5 |
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| 9 | 9 | | exceed $35.00 for insulin dispensed through such program; to provide for a pharmacy to6 |
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| 10 | 10 | | submit a claim for payment or a replacement supply after dispensing insulin through such7 |
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| 11 | 11 | | program; to require a manufacturer to reimburse or resupply a pharmacy dispensing insulin8 |
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| 12 | 12 | | through such program; to provide for a pharmacy to dispense one additional short-term9 |
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| 13 | 13 | | affordable urgent insulin supply under certain conditions; to require the Department of10 |
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| 14 | 14 | | Community Health to develop an application form, an information sheet, and satisfaction11 |
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| 15 | 15 | | surveys regarding such program; to require a manufacturer of insulin to establish procedures12 |
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| 16 | 16 | | to make insulin available under such program; to provide for enforcement, penalties, and13 |
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| 17 | 17 | | appellate procedures; to provide for reporting; to provide for related matters; to provide for14 |
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| 18 | 18 | | an effective date; to repeal conflicting laws; and for other purposes.15 |
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| 19 | 19 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:16 |
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| 20 | 20 | | - 1 - LC 52 0165 |
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| 21 | 21 | | SECTION 1.17 |
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| 22 | 22 | | Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating to public assistance,18 |
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| 23 | 23 | | is amended by adding a new article to read as follows:19 |
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| 24 | 24 | | "Article 1020 |
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| 25 | 25 | | 49-4-200.21 |
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| 26 | 26 | | This article shall be known and may be cited as the 'Urgent Insulin Safety Net Program22 |
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| 27 | 27 | | Act.'23 |
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| 28 | 28 | | 49-4-201.24 |
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| 29 | 29 | | As used in this article, the term:25 |
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| 30 | 30 | | (1) 'Board' means the State Board of Pharmacy.26 |
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| 31 | 31 | | (2) 'Department' means the Department of Community Health.27 |
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| 32 | 32 | | (3) 'Eligible individual' means an individual qualified for assistance under the program28 |
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| 33 | 33 | | as provided in Code Section 49-4-204.29 |
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| 34 | 34 | | (4) 'Insulin' means various types of insulin analogs and insulin-like medications,30 |
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| 35 | 35 | | regardless of activation period or whether the solution is mixed before or after31 |
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| 36 | 36 | | dispensation. An insulin product is exempt from the provisions of this article if the32 |
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| 37 | 37 | | wholesale acquisition cost of the insulin is $8.00 or less per milliliter or applicable33 |
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| 38 | 38 | | National Council for Prescription Drug Plan billing unit for the entire assessment time34 |
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| 39 | 39 | | period, adjusted annually based on the Consumer Price Index.35 |
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| 40 | 40 | | (5) 'Manufacturer' means a manufacturer engaged in the production of insulin that is36 |
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| 41 | 41 | | self-administered on an outpatient basis. Such term shall not include a manufacturer with37 |
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| 42 | 42 | | an annual gross revenue of $2 million or less from insulin sales in this state.38 |
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| 43 | 43 | | (6) 'Pharmacy' shall have the same meaning as provided in Code Section 26-4-5.39 |
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| 44 | 44 | | (7) 'Program' means the Urgent Insulin Safety Net Program as provided for in this article.40 |
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| 45 | 45 | | - 2 - LC 52 0165 |
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| 46 | 46 | | (8) 'Proper identification' means any document issued by a governmental agency41 |
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| 47 | 47 | | containing a description of the individual, such individual's photograph, or both, and42 |
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| 48 | 48 | | giving such individual's date of birth and includes, without being limited to, a passport,43 |
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| 49 | 49 | | military identification card, driver's license, or an identification card authorized under44 |
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| 50 | 50 | | Code Sections 40-5-100 through 40-5-104. Proper identification shall not include a birth45 |
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| 51 | 51 | | certificate.46 |
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| 52 | 52 | | (9) 'Urgent need of insulin' means having readily available for use less than a seven-day47 |
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| 53 | 53 | | supply of insulin and in need of insulin in order to avoid the likelihood of suffering48 |
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| 54 | 54 | | significant health consequences.49 |
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| 55 | 55 | | 49-4-202.50 |
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| 56 | 56 | | (a) Upon receipt of a completed, signed, and dated application form, as provided for in51 |
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| 57 | 57 | | Code Section 49-4-204, proof of proper identification, and a copy of a current valid insulin52 |
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| 58 | 58 | | prescription, a pharmacy shall dispense one 30 day supply of insulin to an eligible53 |
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| 59 | 59 | | individual in urgent need of insulin; provided, however, that a pharmacy may dispense one54 |
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| 60 | 60 | | additional 30 day supply of insulin within a 12 month period to an eligible individual as55 |
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| 61 | 61 | | provided in Code Section 49-4-203.56 |
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| 62 | 62 | | (b) The pharmacy may collect a copayment from the individual to whom insulin was57 |
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| 63 | 63 | | dispensed through the program to cover such pharmacy's costs of processing and58 |
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| 64 | 64 | | dispensing insulin as part of the program in an amount not to exceed $35.00 for the 30 day59 |
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| 65 | 65 | | supply of insulin dispensed.60 |
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| 66 | 66 | | (c) The pharmacy shall notify the healthcare provider who issued the insulin prescription61 |
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| 67 | 67 | | for the eligible individual no later than 72 hours after the insulin is dispensed.62 |
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| 68 | 68 | | (d) The pharmacy shall submit to the manufacturer of the dispensed insulin product or to63 |
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| 69 | 69 | | the manufacturer's vendor a claim for payment that conforms with the National Council for64 |
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| 70 | 70 | | Prescription Drug Program standards for electronic claims processing. The manufacturer65 |
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| 71 | 71 | | shall timely reimburse the pharmacy in an amount that covers the pharmacy's acquisition66 |
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| 72 | 72 | | - 3 - LC 52 0165 |
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| 73 | 73 | | cost for the insulin and shall timely send the pharmacy a replacement supply of the same67 |
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| 74 | 74 | | insulin dispensed under the program.68 |
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| 75 | 75 | | (e) When the pharmacy dispenses the insulin to the eligible individual, the pharmacy shall69 |
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| 76 | 76 | | also provide an information sheet and a survey, as provided for in Code Sections 49-4-20570 |
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| 77 | 77 | | and 49-4-206, respectively.71 |
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| 78 | 78 | | (f) The pharmacy shall retain a copy of submitted applications for reporting and auditing72 |
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| 79 | 79 | | purposes.73 |
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| 80 | 80 | | 49-4-203.74 |
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| 81 | 81 | | (a) A pharmacy shall dispense one additional 30 day supply of insulin to an eligible75 |
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| 82 | 82 | | individual in urgent need of insulin within a 12 month period if such individual has applied76 |
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| 83 | 83 | | for medical assistance, Georgia Medicaid, or PeachCare for Kids, and has not been77 |
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| 84 | 84 | | determined eligible or has been determined eligible and coverage has not become effective.78 |
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| 85 | 85 | | (b) To access one additional 30 day supply of insulin, such eligible individual shall attest79 |
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| 86 | 86 | | to the pharmacy that the individual meets the requirements of subsection (a) of this Code80 |
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| 87 | 87 | | section and shall be in compliance with the requirements provided in Code81 |
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| 88 | 88 | | Section 49-4-204.82 |
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| 89 | 89 | | 49-4-204.83 |
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| 90 | 90 | | (a) To be deemed eligible for services under this article, an individual shall attest on an84 |
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| 91 | 91 | | application form as provided for in subsection (b) of this Code section that the individual:85 |
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| 92 | 92 | | (1) Is a resident of this state;86 |
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| 93 | 93 | | (2) Is not enrolled in any medical assistance or other health coverage or prescription drug87 |
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| 94 | 94 | | coverage program that limits such enrollee's total amount of cost-sharing for a 30 day88 |
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| 95 | 95 | | supply of insulin, including copayments, deductibles, or coinsurance, to $75.00 or less,89 |
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| 96 | 96 | | regardless of the type or amount of insulin prescribed;90 |
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| 97 | 97 | | - 4 - LC 52 0165 |
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| 98 | 98 | | (3) Has not received insulin through the program within the previous 12 months, except91 |
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| 99 | 99 | | as provided in Code Section 49-4-203; and92 |
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| 100 | 100 | | (4) Has an urgent need of insulin.93 |
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| 101 | 101 | | (b) The department shall develop and make available on its website an application form94 |
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| 102 | 102 | | for the program.95 |
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| 103 | 103 | | 49-4-205.96 |
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| 104 | 104 | | (a) The department, in coordination with the board, shall develop an information sheet that97 |
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| 105 | 105 | | shall include, but shall not be limited to:98 |
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| 106 | 106 | | (1) A description of the program, including how to access it;99 |
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| 107 | 107 | | (2) Information on applying for medical assistance;100 |
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| 108 | 108 | | (3) Information on applying for a qualified health benefit plan offered through the101 |
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| 109 | 109 | | exchange as defined in Code Section 33-23-201; and102 |
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| 110 | 110 | | (4) Information on accessing healthcare providers who participate in prescription drug103 |
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| 111 | 111 | | discount programs, including providers who are authorized to participate in the 340B104 |
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| 112 | 112 | | program under section 340B of the federal Public Health Service Act, 42 U.S.C.105 |
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| 113 | 113 | | Section 256b, as amended.106 |
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| 114 | 114 | | (b) The department shall post the information sheet provided for in subsection (a) of this107 |
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| 115 | 115 | | Code section on its website.108 |
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| 116 | 116 | | 49-4-206.109 |
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| 117 | 117 | | (a) The department, in coordination with the board, shall develop a survey to assess an110 |
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| 118 | 118 | | eligible individual's satisfaction with the program, including:111 |
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| 119 | 119 | | (1) Adequacy of information available and provided to individuals;112 |
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| 120 | 120 | | (2) Accessibility to insulin; and113 |
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| 121 | 121 | | (3) Individual's ability to access affordable insulin.114 |
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| 122 | 122 | | - 5 - LC 52 0165 |
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| 123 | 123 | | (b) The department, in coordination with the board, shall develop a survey to assess a115 |
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| 124 | 124 | | pharmacy's satisfaction with the program, including:116 |
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| 125 | 125 | | (1) Timeliness of reimbursement from the manufacturers for insulin dispensed through117 |
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| 126 | 126 | | the program;118 |
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| 127 | 127 | | (2) Ease in submitting claims and insulin product orders to the manufacturers; and119 |
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| 128 | 128 | | (3) Timeliness of receiving insulin replacement orders from the manufacturers.120 |
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| 129 | 129 | | (c) The department shall post the surveys provided for in subsections (a) and (b) of this121 |
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| 130 | 130 | | Code section on its website.122 |
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| 131 | 131 | | 49-4-207.123 |
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| 132 | 132 | | Each manufacturer shall:124 |
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| 133 | 133 | | (1) Establish procedures to make insulin available in accordance with this article through125 |
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| 134 | 134 | | pharmacies to eligible individuals who are in urgent need of insulin;126 |
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| 135 | 135 | | (2) Establish a hotline to provide information on the program and shall list on its website127 |
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| 136 | 136 | | information about the program; and128 |
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| 137 | 137 | | (3) Provide for dedicated personnel to promptly respond to individuals, pharmacies, and129 |
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| 138 | 138 | | healthcare providers and the department.130 |
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| 139 | 139 | | 49-4-208.131 |
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| 140 | 140 | | (a) Any person who by means of a false statement, failure to disclose information, or132 |
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| 141 | 141 | | impersonation, or by other fraudulent device, obtains or attempts to obtain any assistance,133 |
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| 142 | 142 | | benefit, or payment under this article to which such person is not entitled shall be guilty of134 |
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| 143 | 143 | | a misdemeanor; provided, however, that if the value of the assistance so obtained exceeds135 |
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| 144 | 144 | | $1,500.00, such person shall be guilty of a felony.136 |
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| 145 | 145 | | (b)(1) If a manufacturer fails to comply with the provisions of this article, the department137 |
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| 146 | 146 | | may assess an administrative penalty of $200,000.00 per month of such noncompliance.138 |
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| 147 | 147 | | - 6 - LC 52 0165 |
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| 148 | 148 | | (2) Such penalty shall increase to $400,000.00 per month if the manufacturer continues139 |
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| 149 | 149 | | to be in noncompliance after six months and shall increase to $600,000.00 per month if140 |
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| 150 | 150 | | the manufacturer continues to be in noncompliance after one year.141 |
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| 151 | 151 | | (3) The penalty shall remain at $600,000.00 per month for as long as the manufacturer142 |
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| 152 | 152 | | continues in noncompliance.143 |
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| 153 | 153 | | (c) An individual or entity that is aggrieved by the action of the department pursuant to144 |
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| 154 | 154 | | subsection (a) or (b) of this Code section shall be entitled to a hearing conducted in145 |
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| 155 | 155 | | accordance with Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.'146 |
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| 156 | 156 | | 49-4-209.147 |
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| 157 | 157 | | (a) By February 15, 2024, and every February 15 thereafter, each manufacturer shall report148 |
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| 158 | 158 | | to the department the following information for the preceding calendar year:149 |
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| 159 | 159 | | (1) The number of Georgia residents who accessed and received insulin through the150 |
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| 160 | 160 | | program;151 |
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| 161 | 161 | | (2) The total value of the insulin, determined by the wholesale acquisition cost of the152 |
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| 162 | 162 | | insulin, provided by the manufacturer for the program;153 |
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| 163 | 163 | | (3) The adequacy and timeliness of the manufacturer in responding to a pharmacy154 |
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| 164 | 164 | | requesting reimbursement or resupply of insulin dispensed through the program;155 |
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| 165 | 165 | | (4) Any administrative penalties assessed under Code Section 49-4-208; and156 |
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| 166 | 166 | | (5) Any additional information deemed necessary by the department.157 |
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| 167 | 167 | | (b) By February 15, 2024, and every February 15 thereafter, a pharmacy that received any158 |
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| 168 | 168 | | applications for the program shall report to the department the following information for159 |
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| 169 | 169 | | the preceding calendar year:160 |
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| 170 | 170 | | (1) The number of applications for an urgent insulin supply received and the number of161 |
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| 171 | 171 | | applications for additional urgent insulin supply received;162 |
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| 172 | 172 | | (2) The reasons for determinations of ineligibility;163 |
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| 173 | 173 | | (3) The amount of insulin dispensed through the program;164 |
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| 174 | 174 | | - 7 - LC 52 0165 |
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| 175 | 175 | | (4) The average and total amount of copayment collected from individuals;165 |
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| 176 | 176 | | (5) The timeliness of manufacturers' responses to requests for payment and re-supply of166 |
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| 177 | 177 | | insulin; and167 |
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| 178 | 178 | | (6) Any additional information deemed necessary by the department.168 |
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| 179 | 179 | | (c) By March 15, 2025, and every March 15 thereafter, the department shall submit to the169 |
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| 180 | 180 | | General Assembly a report regarding the implementation of the program under this article. 170 |
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| 181 | 181 | | Such report shall include the following information for the preceding year:171 |
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| 182 | 182 | | (1) The data collected under subsections (a) and (b) of this Code section;172 |
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| 183 | 183 | | (2) The results of the satisfaction surveys provided for in Code Section 49-4-206; and173 |
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| 184 | 184 | | (3) Any additional information deemed necessary by the department to assess the174 |
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| 185 | 185 | | effectiveness of the implementation of the program."175 |
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| 186 | 186 | | SECTION 2.176 |
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| 187 | 187 | | This Act shall become effective upon its approval by the Governor or upon its becoming law177 |
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| 188 | 188 | | without such approval.178 |
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| 189 | 189 | | SECTION 3.179 |
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| 190 | 190 | | All laws and parts of laws in conflict with this Act are repealed.180 |
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| 191 | 191 | | - 8 - |
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