| 1 | 1 | | LC 52 0164 |
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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, under certain conditions, to an eligible individual2 |
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| 6 | 6 | | who needs an affordable supply of insulin for up to one year, with the option to renew3 |
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| 7 | 7 | | annually; to provide for a short title; to provide for definitions; to require a manufacturer of4 |
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| 8 | 8 | | insulin to establish a patient assistance program and alternative plans for making insulin5 |
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| 9 | 9 | | more affordable and accessible to qualifying Georgia residents; to provide for an individual6 |
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| 10 | 10 | | to apply directly to the manufacturer; to require a manufacturer to promptly determine7 |
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| 11 | 11 | | eligibility and to provide an individual with an eligibility statement; to require a pharmacy8 |
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| 12 | 12 | | to dispense a 90 day supply of insulin to an eligible individual through such program; to9 |
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| 13 | 13 | | allow the pharmacy to collect a co-payment not to exceed $75.00 for insulin dispensed10 |
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| 14 | 14 | | through such program; to provide for re-orders and renewals; to provide for the development11 |
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| 15 | 15 | | of an application form, an information sheet, and satisfaction surveys; to provide for12 |
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| 16 | 16 | | enforcement, penalties, and appellate procedures; to provide for reporting; to provide for13 |
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| 17 | 17 | | related matters; to provide for an effective date; to repeal conflicting laws; and for other14 |
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| 18 | 18 | | 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 0164 |
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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 'Continuing Insulin Safety Net Act.'22 |
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| 27 | 27 | | 49-4-201.23 |
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| 28 | 28 | | As used in this article, the term:24 |
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| 29 | 29 | | (1) 'Alternative plan' means an alternative plan established by the manufacturer as25 |
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| 30 | 30 | | provided for in Code Section 49-4-202.26 |
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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 for in Code Section 49-4-203.29 |
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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 | | - 2 - LC 52 0164 |
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| 45 | 45 | | (7) 'Program' means the patient assistance program established by each manufacturer as40 |
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| 46 | 46 | | provided for in Code Section 49-4-202.41 |
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| 47 | 47 | | (8) 'Proper identification' means any document issued by a governmental agency42 |
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| 48 | 48 | | containing a description of the individual, such individual's photograph, or both, and43 |
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| 49 | 49 | | giving such individual's date of birth, and includes, without being limited to, a passport,44 |
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| 50 | 50 | | military identification card, driver's license, or identification card authorized under Code45 |
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| 51 | 51 | | Sections 40-5-100 through 40-5-104. Proper identification shall not include a birth46 |
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| 52 | 52 | | certificate.47 |
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| 53 | 53 | | 49-4-202.48 |
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| 54 | 54 | | (a) Each manufacturer shall make a patient assistance program that:49 |
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| 55 | 55 | | (1) Is made available to eligible individuals;50 |
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| 56 | 56 | | (2) Provides a 90 day supply of insulin at no charge to an eligible individual or pharmacy51 |
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| 57 | 57 | | and can be re-ordered for up to one year; and52 |
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| 58 | 58 | | (3) Is renewable annually if an individual still meets eligibility requirements.53 |
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| 59 | 59 | | (b) To ensure that insulin is affordable and accessible to Georgia residents in need of54 |
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| 60 | 60 | | insulin each manufacturer shall, in addition to the program, establish at least one alternative55 |
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| 61 | 61 | | plan, such as a cost-sharing assistance plan or a mechanism for providing an emergency56 |
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| 62 | 62 | | or urgent supply of insulin.57 |
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| 63 | 63 | | (c) Each manufacturer shall:58 |
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| 64 | 64 | | (1) Provide information about its program and any alternative plans to the department;59 |
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| 65 | 65 | | (2) Post information and a hotline for the program and any alternative plans on its60 |
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| 66 | 66 | | website; and61 |
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| 67 | 67 | | (3) Provide for dedicated personnel to promptly respond to individuals, pharmacies,62 |
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| 68 | 68 | | healthcare providers, and the department regarding the program and any alternative plans.63 |
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| 69 | 69 | | - 3 - LC 52 0164 |
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| 70 | 70 | | 49-4-203.64 |
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| 71 | 71 | | (a) To be deemed eligible to participate in a manufacturer's program, an individual shall:65 |
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| 72 | 72 | | (1) Provide proper identification that indicates the individual is a resident of this state. 66 |
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| 73 | 73 | | If the individual is under the age of 18, such individual's parent or legal guardian shall67 |
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| 74 | 74 | | provide proper identification that indicates residency of this state;68 |
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| 75 | 75 | | (2) Have a family income that is equal to or less than 400 percent of the federal poverty69 |
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| 76 | 76 | | guidelines;70 |
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| 77 | 77 | | (3) Not be enrolled in medical assistance;71 |
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| 78 | 78 | | (4) Not be eligible to receive healthcare through a federally funded program or receive72 |
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| 79 | 79 | | prescription drug benefits through the Department of Veteran Affairs; provided, however,73 |
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| 80 | 80 | | that an individual who is enrolled in Medicare Part D is eligible for a manufacturer's74 |
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| 81 | 81 | | patient assistance program if such individual has spent $1,000.00 or more on prescription75 |
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| 82 | 82 | | drugs in the current calendar year; and76 |
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| 83 | 83 | | (5) Not be enrolled in prescription drug coverage through an individual or group health77 |
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| 84 | 84 | | plan that limits the total amount of cost-sharing for a 90 day supply of insulin, including78 |
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| 85 | 85 | | co-payments, deductibles, or coinsurance to $75.00 or less, regardless of the type or79 |
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| 86 | 86 | | amount of insulin needed.80 |
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| 87 | 87 | | (b) An individual shall apply directly to the manufacturer to participate in the program. 81 |
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| 88 | 88 | | Upon receipt of an application for the program, the manufacturer shall process the82 |
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| 89 | 89 | | application and determine eligibility of the individual. The manufacturer shall notify the83 |
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| 90 | 90 | | applicant within ten business days of receipt of the application. When additional84 |
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| 91 | 91 | | information is required, the manufacturer shall notify the applicant within five business85 |
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| 92 | 92 | | days of receipt of the application as to what additional information is required. Within86 |
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| 93 | 93 | | three business days of receipt of the requested additional information, the manufacturer87 |
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| 94 | 94 | | shall determine eligibility of the individual and shall notify the applicant of such88 |
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| 95 | 95 | | determination.89 |
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| 96 | 96 | | - 4 - LC 52 0164 |
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| 97 | 97 | | (c) When the individual is determined to be eligible, the manufacturer shall provide such90 |
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| 98 | 98 | | individual with an eligibility statement. An individual's eligibility is valid for twelve91 |
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| 99 | 99 | | months and is renewable upon a redetermination of eligibility.92 |
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| 100 | 100 | | (d) When the individual is determined to be ineligible, the manufacturer shall include in93 |
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| 101 | 101 | | its notification the reasons for such determination. The individual may appeal the94 |
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| 102 | 102 | | determination as provided for in Code Section 49-4-205.95 |
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| 103 | 103 | | (e) The manufacturer shall provide to any applicant deemed ineligible information about96 |
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| 104 | 104 | | any alternative plans available to such individual.97 |
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| 105 | 105 | | 49-4-204.98 |
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| 106 | 106 | | (a) An eligible individual shall submit to a pharmacy the eligibility statement provided by99 |
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| 107 | 107 | | the manufacturer.100 |
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| 108 | 108 | | (b) Upon receipt of an individual's eligibility statement, the pharmacy shall submit an101 |
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| 109 | 109 | | order containing the name of the insulin product and the daily dosage amount as contained102 |
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| 110 | 110 | | in a valid prescription to the product's manufacturer. The pharmacy shall include with the103 |
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| 111 | 111 | | order to the manufacturer the pharmacy's name and shipping address, necessary contact104 |
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| 112 | 112 | | information, and any specific days or times when deliveries are not accepted by such105 |
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| 113 | 113 | | pharmacy.106 |
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| 114 | 114 | | (c) Upon receipt of an order and necessary information as provided for in subsection (b)107 |
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| 115 | 115 | | of this Code section, the manufacturer shall send to the pharmacy a 90 day supply of108 |
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| 116 | 116 | | insulin as ordered, unless a lesser amount is requested in the order, at no charge to the109 |
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| 117 | 117 | | individual or pharmacy.110 |
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| 118 | 118 | | (d) Except as authorized under subsection (e) of this Code section, the pharmacy shall111 |
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| 119 | 119 | | provide the insulin to the individual at no charge to such individual. The pharmacy shall112 |
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| 120 | 120 | | not provide insulin received from the manufacturer to any individual other than the113 |
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| 121 | 121 | | individual associated with the specific order. The pharmacy shall not seek reimbursement114 |
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| 122 | 122 | | for the insulin received from the manufacturer or from any third-party payer.115 |
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| 123 | 123 | | - 5 - LC 52 0164 |
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| 124 | 124 | | (e) The pharmacy may collect a co-payment from the individual to cover the pharmacy's116 |
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| 125 | 125 | | costs for processing and dispensing the insulin in an amount not to exceed $50.00 for each117 |
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| 126 | 126 | | 90 day supply of insulin sent to and dispensed from the pharmacy for an order or for a118 |
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| 127 | 127 | | re-order.119 |
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| 128 | 128 | | (f) The pharmacy may submit to a manufacturer a reorder for an individual if such120 |
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| 129 | 129 | | individual's eligibility has not expired. Upon receipt of a reorder from a pharmacy, the121 |
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| 130 | 130 | | manufacturer shall send to the pharmacy an additional 90 day supply of insulin, unless a122 |
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| 131 | 131 | | lesser amount is requested, at no charge to the individual or the pharmacy.123 |
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| 132 | 132 | | (g) Notwithstanding subsection (c) of this Code section, a manufacturer may send the124 |
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| 133 | 133 | | insulin as ordered directly to the individual if the manufacturer provides a mail order125 |
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| 134 | 134 | | service option.126 |
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| 135 | 135 | | 49-4-205.127 |
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| 136 | 136 | | (a) When an individual disagrees with a manufacturer's determination of ineligibility, such128 |
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| 137 | 137 | | individual may contact the department to request a review of such determination. Such129 |
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| 138 | 138 | | review shall be completed by a panel composed of three members of the department. The130 |
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| 139 | 139 | | individual requesting the review shall submit to the department with the request for review131 |
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| 140 | 140 | | all documents submitted by the individual to the manufacturer, which the department shall132 |
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| 141 | 141 | | provide to the panel. The panel shall render a decision within ten business days of receipt133 |
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| 142 | 142 | | of all the necessary documents from the individual. The decision of the panel shall be134 |
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| 143 | 143 | | final.135 |
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| 144 | 144 | | (b) If the panel determines that the individual is eligible, the manufacturer shall provide136 |
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| 145 | 145 | | the individual with an eligibility statement.137 |
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| 146 | 146 | | 49-4-206.138 |
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| 147 | 147 | | (a) The department, in coordination with the manufacturer, shall develop an information139 |
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| 148 | 148 | | sheet that shall include, but shall not be limited to:140 |
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| 149 | 149 | | - 6 - LC 52 0164 |
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| 150 | 150 | | (1) A description of the program, including how to access it and information about any141 |
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| 151 | 151 | | alternative plans;142 |
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| 152 | 152 | | (2) Information on applying for medical assistance;143 |
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| 153 | 153 | | (3) Information on applying for a qualified health plan offered through the exchange as144 |
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| 154 | 154 | | defined in Code Section 33-23-201; and145 |
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| 155 | 155 | | (4) Information on accessing healthcare providers who participate in prescription drug146 |
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| 156 | 156 | | discount programs, including providers who are authorized to participate in the 340B147 |
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| 157 | 157 | | program under section 340B of the federal Public Health Service Act, 42 U.S.C.148 |
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| 158 | 158 | | Section 256b, as amended.149 |
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| 159 | 159 | | (b) The department shall post the information sheet provided for in subsection (a) of this150 |
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| 160 | 160 | | Code section on its website.151 |
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| 161 | 161 | | 49-4-207.152 |
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| 162 | 162 | | (a) The department, in coordination with the manufacturer, shall develop a survey to assess153 |
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| 163 | 163 | | an eligible individual's satisfaction with the program and any alternative plans, including:154 |
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| 164 | 164 | | (1) Adequacy of information available and provided to individuals;155 |
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| 165 | 165 | | (2) Accessibility to insulin; and156 |
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| 166 | 166 | | (3) Individual's ability to access affordable insulin.157 |
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| 167 | 167 | | (b) The department, in coordination with the manufacturer, shall develop a survey to158 |
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| 168 | 168 | | assess a pharmacy's satisfaction with the program and alternative plans, including:159 |
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| 169 | 169 | | (1) Ease in submitting claims and insulin product orders to the manufacturers; and160 |
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| 170 | 170 | | (2) Timeliness of receiving insulin re-orders or renewal orders from the manufacturers.161 |
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| 171 | 171 | | (c) The department shall post the surveys provided for in subsections (a) and (b) of this162 |
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| 172 | 172 | | Code section on its website.163 |
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| 173 | 173 | | - 7 - LC 52 0164 |
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| 174 | 174 | | 49-4-208.164 |
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| 175 | 175 | | (a) Any data collected, created, received, maintained, or disseminated by the department165 |
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| 176 | 176 | | pursuant to this article related to an individual seeking access to the program or any166 |
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| 177 | 177 | | alternative plans shall be kept confidential and shall be retained for no longer than ten167 |
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| 178 | 178 | | years.168 |
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| 179 | 179 | | (b) Each pharmacy and manufacturer shall maintain the privacy of all data received from169 |
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| 180 | 180 | | any individual applying for the manufacturer's program or any alternative plans and shall170 |
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| 181 | 181 | | be prohibited from selling, sharing, or disseminating such data received unless required to171 |
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| 182 | 182 | | do so under this article or when an individual has provided the manufacturer with signed172 |
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| 183 | 183 | | authorization.173 |
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| 184 | 184 | | 49-4-209.174 |
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| 185 | 185 | | (a) Any person who by means of a false statement, failure to disclose information, or175 |
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| 186 | 186 | | impersonation, or by other fraudulent device, obtains, attempts to obtain, or retains for176 |
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| 187 | 187 | | himself, herself, or any other person any medical assistance or other benefit or payment177 |
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| 188 | 188 | | under this article to which such person is not entitled or in an amount greater than that to178 |
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| 189 | 189 | | which such person is entitled shall be guilty of a misdemeanor. If the total amount of the179 |
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| 190 | 190 | | value of the assistance so obtained exceeds $1,500.00, such person shall be guilty of a180 |
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| 191 | 191 | | felony.181 |
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| 192 | 192 | | (b)(1) If a manufacturer fails to comply with the provisions of this article, the department182 |
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| 193 | 193 | | may assess an administrative penalty of $200,000.00 per month of such noncompliance.183 |
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| 194 | 194 | | (2) Such penalty shall increase to $400,000.00 per month if the manufacturer continues184 |
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| 195 | 195 | | to be in noncompliance after six months and shall increase to $600,000.00 per month if185 |
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| 196 | 196 | | the manufacturer continues to be in noncompliance after one year.186 |
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| 197 | 197 | | (3) The penalty shall remain at $600,000.00 per month for as long as the manufacturer187 |
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| 198 | 198 | | continues in noncompliance.188 |
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| 199 | 199 | | - 8 - LC 52 0164 |
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| 200 | 200 | | (c) An individual or entity that is aggrieved by the action of the department pursuant to189 |
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| 201 | 201 | | subsections (a) or (b) of this Code section shall be entitled to a hearing conducted in190 |
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| 202 | 202 | | accordance with Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.'191 |
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| 203 | 203 | | 49-4-210.192 |
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| 204 | 204 | | (a) By February 15, 2024, and every February 15 thereafter, each manufacturer shall report193 |
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| 205 | 205 | | to the department the following information for the preceding calendar year:194 |
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| 206 | 206 | | (1) A description of the program and any changes made to the program;195 |
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| 207 | 207 | | (2) The number of Georgia residents who accessed and received insulin through the196 |
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| 208 | 208 | | program;197 |
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| 209 | 209 | | (3) The total value of the insulin, determined by the wholesale acquisition cost of the198 |
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| 210 | 210 | | insulin, provided by the manufacturer through the program;199 |
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| 211 | 211 | | (4) A description of the alternative plans and any changes made to them;200 |
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| 212 | 212 | | (5) The number of Georgia residents who accessed and received insulin through the201 |
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| 213 | 213 | | alternative plans;202 |
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| 214 | 214 | | (6) The total value of the insulin, determined by the wholesale acquisition cost of the203 |
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| 215 | 215 | | insulin, provided by the manufacturer through the alternative plans;204 |
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| 216 | 216 | | (7) The number of individuals deemed ineligible for the program or the alternative plans205 |
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| 217 | 217 | | and the reasons for their ineligibility;206 |
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| 218 | 218 | | (8) The number of appeals and the number of eligibility statuses that were sustained or207 |
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| 219 | 219 | | reversed;208 |
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| 220 | 220 | | (9) The timeliness and adequacy of the manufacturers in responding to individuals209 |
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| 221 | 221 | | applying for the program or the alternative plans and pharmacies requesting insulin210 |
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| 222 | 222 | | through the program or the alternative plans;211 |
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| 223 | 223 | | (10) Any administrative penalties assessed under Code Section 49-4-209; and212 |
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| 224 | 224 | | (11) Any additional information deemed necessary by the department.213 |
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| 225 | 225 | | - 9 - LC 52 0164 |
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| 226 | 226 | | (b) By February 15, 2024, and every February 15 thereafter, a pharmacy that received any214 |
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| 227 | 227 | | eligibility statements from individuals for the program or the alternative plans shall report215 |
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| 228 | 228 | | to the department the following information for the preceding calendar year:216 |
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| 229 | 229 | | (1) The number of eligibility statements received;217 |
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| 230 | 230 | | (2) The amount of insulin dispensed through the program;218 |
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| 231 | 231 | | (3) The average and total amount of copayment collected from individuals;219 |
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| 232 | 232 | | (4) The timeliness and adequacy of manufacturers' responses; and220 |
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| 233 | 233 | | (5) Any additional information deemed necessary by the department.221 |
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| 234 | 234 | | (b) By March 15, 2025, and every March 15 thereafter, the department shall submit to the222 |
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| 235 | 235 | | General Assembly a report regarding the implementation of the program under this article. 223 |
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| 236 | 236 | | Such report shall include the following information for the preceding year:224 |
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| 237 | 237 | | (1) The data collected under subsections (a) and (b) of this Code section;225 |
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| 238 | 238 | | (2) The results of the satisfaction surveys provided for in Code Section 49-4-207; and226 |
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| 239 | 239 | | (3) Any additional information deemed necessary by the department to assess the227 |
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| 240 | 240 | | implementation and effectiveness of the program."228 |
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| 241 | 241 | | SECTION 2.229 |
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| 242 | 242 | | This Act shall become effective upon its approval by the Governor or upon its becoming law230 |
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| 243 | 243 | | without such approval.231 |
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| 244 | 244 | | SECTION 3.232 |
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| 245 | 245 | | All laws and parts of laws in conflict with this Act are repealed.233 |
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| 246 | 246 | | - 10 - |
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