| 1 | 1 | | 25 LC 57 9001 |
|---|
| 2 | 2 | | House Bill 898 |
|---|
| 3 | 3 | | By: Representatives Au of the 50 |
|---|
| 4 | 4 | | th |
|---|
| 5 | 5 | | , Hugley of the 141 |
|---|
| 6 | 6 | | st |
|---|
| 7 | 7 | | , Park of the 107 |
|---|
| 8 | 8 | | th |
|---|
| 9 | 9 | | , Miller of the 62 |
|---|
| 10 | 10 | | nd |
|---|
| 11 | 11 | | , |
|---|
| 12 | 12 | | Frye of the 122 |
|---|
| 13 | 13 | | nd |
|---|
| 14 | 14 | | , and others |
|---|
| 15 | 15 | | A BILL TO BE ENTITLED |
|---|
| 16 | 16 | | AN ACT |
|---|
| 17 | 17 | | To amend Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating to public |
|---|
| 18 | 18 | | 1 |
|---|
| 19 | 19 | | assistance, so as to make insulin accessible, under certain conditions, to an eligible individual2 |
|---|
| 20 | 20 | | who needs an affordable supply of insulin for up to one year, with the option to renew3 |
|---|
| 21 | 21 | | annually; to provide for a short title; to provide for definitions; to require a manufacturer of4 |
|---|
| 22 | 22 | | insulin to establish a patient assistance program and alternative plans for making insulin5 |
|---|
| 23 | 23 | | more affordable and accessible to qualifying Georgia residents; to provide for an individual6 |
|---|
| 24 | 24 | | to apply directly to the manufacturer; to require a manufacturer to promptly determine7 |
|---|
| 25 | 25 | | eligibility and to provide an individual with an eligibility statement; to require a pharmacy8 |
|---|
| 26 | 26 | | to dispense a 90 day supply of insulin to an eligible individual through such program; to9 |
|---|
| 27 | 27 | | allow the pharmacy to collect a co-payment for insulin dispensed through such program; to10 |
|---|
| 28 | 28 | | provide for reorders and renewals; to provide for the development of an application form, an11 |
|---|
| 29 | 29 | | information sheet, and satisfaction surveys; to provide for enforcement, penalties, and12 |
|---|
| 30 | 30 | | appellate procedures; to provide for reporting; to provide for related matters; to provide for13 |
|---|
| 31 | 31 | | an effective date; to repeal conflicting laws; and for other purposes.14 |
|---|
| 32 | 32 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:15 |
|---|
| 33 | 33 | | H. B. 898 |
|---|
| 34 | 34 | | - 1 - 25 LC 57 9001 |
|---|
| 35 | 35 | | SECTION 1. |
|---|
| 36 | 36 | | 16 |
|---|
| 37 | 37 | | Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating to public assistance,17 |
|---|
| 38 | 38 | | is amended by adding a new article to read as follows:18 |
|---|
| 39 | 39 | | "ARTICLE 10 |
|---|
| 40 | 40 | | 19 |
|---|
| 41 | 41 | | 49-4-200.20 |
|---|
| 42 | 42 | | This article shall be known and may be cited as the 'Continuing Insulin Safety Net Act.'21 |
|---|
| 43 | 43 | | 49-4-201.22 |
|---|
| 44 | 44 | | As used in this article, the term:23 |
|---|
| 45 | 45 | | (1) 'Alternative plan' means an alternative plan established by the manufacturer as24 |
|---|
| 46 | 46 | | provided for in Code Section 49-4-202.25 |
|---|
| 47 | 47 | | (2) 'Department' means the Department of Community Health.26 |
|---|
| 48 | 48 | | (3) 'Eligible individual' means an individual qualified for assistance under the program27 |
|---|
| 49 | 49 | | as provided for in Code Section 49-4-203.28 |
|---|
| 50 | 50 | | (4) 'Insulin' means various types of insulin analogs and insulin-like medications,29 |
|---|
| 51 | 51 | | regardless of activation period or whether the solution is mixed before or after30 |
|---|
| 52 | 52 | | dispensation. An insulin product is exempt from the provisions of this article if the31 |
|---|
| 53 | 53 | | wholesale acquisition cost of the insulin is $8.00 or less per milliliter or applicable32 |
|---|
| 54 | 54 | | National Council for Prescription Drug Plan billing unit, for the entire assessment time33 |
|---|
| 55 | 55 | | period, adjusted annually based on the Consumer Price Index.34 |
|---|
| 56 | 56 | | (5) 'Manufacturer' means a manufacturer engaged in the production of insulin that is35 |
|---|
| 57 | 57 | | self-administered on an outpatient basis. Such term shall not include a manufacturer with36 |
|---|
| 58 | 58 | | an annual gross revenue of $2 million or less from insulin sales in this state.37 |
|---|
| 59 | 59 | | (6) 'Pharmacy' shall have the same meaning as provided in Code Section 26-4-5.38 |
|---|
| 60 | 60 | | H. B. 898 |
|---|
| 61 | 61 | | - 2 - 25 LC 57 9001 |
|---|
| 62 | 62 | | (7) 'Program' means the patient assistance program established by each manufacturer as39 |
|---|
| 63 | 63 | | provided for in Code Section 49-4-202.40 |
|---|
| 64 | 64 | | (8) 'Proper identification' means any document issued by a governmental agency41 |
|---|
| 65 | 65 | | containing a description of the individual, such individual's photograph, or both, and42 |
|---|
| 66 | 66 | | giving such individual's date of birth, and includes, without being limited to, a passport,43 |
|---|
| 67 | 67 | | military identification card, driver's license, or identification card authorized under Code44 |
|---|
| 68 | 68 | | Sections 40-5-100 through 40-5-104. Proper identification shall not include a birth45 |
|---|
| 69 | 69 | | certificate.46 |
|---|
| 70 | 70 | | 49-4-202.47 |
|---|
| 71 | 71 | | (a) Each manufacturer shall make a patient assistance program that:48 |
|---|
| 72 | 72 | | (1) Is made available to eligible individuals;49 |
|---|
| 73 | 73 | | (2) Provides a 90 day supply of insulin at no charge to an eligible individual or pharmacy50 |
|---|
| 74 | 74 | | and can be reordered for up to one year; and51 |
|---|
| 75 | 75 | | (3) Is renewable annually if an individual still meets eligibility requirements.52 |
|---|
| 76 | 76 | | (b) To ensure that insulin is affordable and accessible to Georgia residents in need of53 |
|---|
| 77 | 77 | | insulin each manufacturer shall, in addition to the program, establish at least one alternative54 |
|---|
| 78 | 78 | | plan, such as a cost-sharing assistance plan or a mechanism for providing an emergency55 |
|---|
| 79 | 79 | | or urgent supply of insulin.56 |
|---|
| 80 | 80 | | (c) Each manufacturer shall:57 |
|---|
| 81 | 81 | | (1) Provide information about its program and any alternative plans to the department;58 |
|---|
| 82 | 82 | | (2) Post information and a hotline for the program and any alternative plans on its59 |
|---|
| 83 | 83 | | website; and60 |
|---|
| 84 | 84 | | (3) Provide for dedicated personnel to promptly respond to individuals, pharmacies,61 |
|---|
| 85 | 85 | | healthcare providers, and the department regarding the program and any alternative plans.62 |
|---|
| 86 | 86 | | H. B. 898 |
|---|
| 87 | 87 | | - 3 - 25 LC 57 9001 |
|---|
| 88 | 88 | | 49-4-203.63 |
|---|
| 89 | 89 | | (a) To be deemed eligible to participate in a manufacturer's program, an individual shall:64 |
|---|
| 90 | 90 | | (1) Provide proper identification that indicates the individual is a resident of this state. 65 |
|---|
| 91 | 91 | | If the individual is under the age of 18, such individual's parent or legal guardian shall66 |
|---|
| 92 | 92 | | provide proper identification that indicates residency of this state;67 |
|---|
| 93 | 93 | | (2) Have a family income that is equal to or less than 400 percent of the federal poverty68 |
|---|
| 94 | 94 | | guidelines;69 |
|---|
| 95 | 95 | | (3) Not be enrolled in medical assistance;70 |
|---|
| 96 | 96 | | (4) Not be eligible to receive healthcare through a federally funded program or receive71 |
|---|
| 97 | 97 | | prescription drug benefits through the Department of Veteran Affairs; provided, however,72 |
|---|
| 98 | 98 | | that an individual who is enrolled in Medicare Part D is eligible for a manufacturer's73 |
|---|
| 99 | 99 | | patient assistance program if such individual has spent $1,000.00 or more on prescription74 |
|---|
| 100 | 100 | | drugs in the current calendar year; and75 |
|---|
| 101 | 101 | | (5) Not be enrolled in prescription drug coverage through an individual or group health76 |
|---|
| 102 | 102 | | plan that limits the total amount of cost-sharing for a 90 day supply of insulin, including77 |
|---|
| 103 | 103 | | co-payments, deductibles, or coinsurance to $75.00 or less, regardless of the type or78 |
|---|
| 104 | 104 | | amount of insulin needed.79 |
|---|
| 105 | 105 | | (b) An individual shall apply directly to the manufacturer to participate in the program. 80 |
|---|
| 106 | 106 | | Upon receipt of an application for the program, the manufacturer shall process the81 |
|---|
| 107 | 107 | | application and determine eligibility of the individual. The manufacturer shall notify the82 |
|---|
| 108 | 108 | | applicant within ten business days of receipt of the application. When additional83 |
|---|
| 109 | 109 | | information is required, the manufacturer shall notify the applicant within five business84 |
|---|
| 110 | 110 | | days of receipt of the application as to what additional information is required. Within85 |
|---|
| 111 | 111 | | three business days of receipt of the requested additional information, the manufacturer86 |
|---|
| 112 | 112 | | shall determine eligibility of the individual and shall notify the applicant of such87 |
|---|
| 113 | 113 | | determination.88 |
|---|
| 114 | 114 | | H. B. 898 |
|---|
| 115 | 115 | | - 4 - 25 LC 57 9001 |
|---|
| 116 | 116 | | (c) When the individual is determined to be eligible, the manufacturer shall provide such89 |
|---|
| 117 | 117 | | individual with an eligibility statement. An individual's eligibility is valid for twelve90 |
|---|
| 118 | 118 | | months and is renewable upon a redetermination of eligibility.91 |
|---|
| 119 | 119 | | (d) When the individual is determined to be ineligible, the manufacturer shall include in92 |
|---|
| 120 | 120 | | its notification the reasons for such determination. The individual may appeal the93 |
|---|
| 121 | 121 | | determination as provided for in Code Section 49-4-205.94 |
|---|
| 122 | 122 | | (e) The manufacturer shall provide to any applicant deemed ineligible information about95 |
|---|
| 123 | 123 | | any alternative plans available to such individual.96 |
|---|
| 124 | 124 | | 49-4-204.97 |
|---|
| 125 | 125 | | (a) An eligible individual shall submit to a pharmacy the eligibility statement provided by98 |
|---|
| 126 | 126 | | the manufacturer.99 |
|---|
| 127 | 127 | | (b) Upon receipt of an individual's eligibility statement, the pharmacy shall submit an100 |
|---|
| 128 | 128 | | order containing the name of the insulin product and the daily dosage amount as contained101 |
|---|
| 129 | 129 | | in a valid prescription to the product's manufacturer. The pharmacy shall include with the102 |
|---|
| 130 | 130 | | order to the manufacturer the pharmacy's name and shipping address, necessary contact103 |
|---|
| 131 | 131 | | information, and any specific days or times when deliveries are not accepted by such104 |
|---|
| 132 | 132 | | pharmacy.105 |
|---|
| 133 | 133 | | (c) Upon receipt of an order and necessary information as provided for in subsection (b)106 |
|---|
| 134 | 134 | | of this Code section, the manufacturer shall send to the pharmacy a 90 day supply of107 |
|---|
| 135 | 135 | | insulin as ordered, unless a lesser amount is requested in the order, at no charge to the108 |
|---|
| 136 | 136 | | individual or pharmacy.109 |
|---|
| 137 | 137 | | (d) Except as authorized under subsection (e) of this Code section, the pharmacy shall110 |
|---|
| 138 | 138 | | provide the insulin to the individual at no charge to such individual. The pharmacy shall111 |
|---|
| 139 | 139 | | not provide insulin received from the manufacturer to any individual other than the112 |
|---|
| 140 | 140 | | individual associated with the specific order. The pharmacy shall not seek reimbursement113 |
|---|
| 141 | 141 | | for the insulin received from the manufacturer or from any third-party payer.114 |
|---|
| 142 | 142 | | H. B. 898 |
|---|
| 143 | 143 | | - 5 - 25 LC 57 9001 |
|---|
| 144 | 144 | | (e) The pharmacy may collect a co-payment from the individual to cover the pharmacy's115 |
|---|
| 145 | 145 | | costs for processing and dispensing the insulin in an amount not to exceed $50.00 for each116 |
|---|
| 146 | 146 | | 90 day supply of insulin sent to and dispensed from the pharmacy for an order or for a117 |
|---|
| 147 | 147 | | reorder.118 |
|---|
| 148 | 148 | | (f) The pharmacy may submit to a manufacturer a reorder for an individual if such119 |
|---|
| 149 | 149 | | individual's eligibility has not expired. Upon receipt of a reorder from a pharmacy, the120 |
|---|
| 150 | 150 | | manufacturer shall send to the pharmacy an additional 90 day supply of insulin, unless a121 |
|---|
| 151 | 151 | | lesser amount is requested, at no charge to the individual or the pharmacy.122 |
|---|
| 152 | 152 | | (g) Notwithstanding subsection (c) of this Code section, a manufacturer may send the123 |
|---|
| 153 | 153 | | insulin as ordered directly to the individual if the manufacturer provides a mail order124 |
|---|
| 154 | 154 | | service option.125 |
|---|
| 155 | 155 | | 49-4-205.126 |
|---|
| 156 | 156 | | (a) When an individual disagrees with a manufacturer's determination of ineligibility, such127 |
|---|
| 157 | 157 | | individual may contact the department to request a review of such determination. Such128 |
|---|
| 158 | 158 | | review shall be completed by a panel composed of three members of the department. The129 |
|---|
| 159 | 159 | | individual requesting the review shall submit to the department with the request for review130 |
|---|
| 160 | 160 | | all documents submitted by the individual to the manufacturer, which the department shall131 |
|---|
| 161 | 161 | | provide to the panel. The panel shall render a decision within ten business days of receipt132 |
|---|
| 162 | 162 | | of all the necessary documents from the individual. The decision of the panel shall be133 |
|---|
| 163 | 163 | | final.134 |
|---|
| 164 | 164 | | (b) If the panel determines that the individual is eligible, the manufacturer shall provide135 |
|---|
| 165 | 165 | | the individual with an eligibility statement.136 |
|---|
| 166 | 166 | | 49-4-206.137 |
|---|
| 167 | 167 | | (a) The department, in coordination with the manufacturer, shall develop an information138 |
|---|
| 168 | 168 | | sheet that shall include, but shall not be limited to:139 |
|---|
| 169 | 169 | | H. B. 898 |
|---|
| 170 | 170 | | - 6 - 25 LC 57 9001 |
|---|
| 171 | 171 | | (1) A description of the program, including how to access it and information about any140 |
|---|
| 172 | 172 | | alternative plans;141 |
|---|
| 173 | 173 | | (2) Information on applying for medical assistance;142 |
|---|
| 174 | 174 | | (3) Information on applying for a qualified health plan offered through the exchange as143 |
|---|
| 175 | 175 | | defined in Code Section 33-23-201; and144 |
|---|
| 176 | 176 | | (4) Information on accessing healthcare providers who participate in prescription drug145 |
|---|
| 177 | 177 | | discount programs, including providers who are authorized to participate in the 340B146 |
|---|
| 178 | 178 | | program under section 340B of the federal Public Health Service Act, 42 U.S.C.147 |
|---|
| 179 | 179 | | Section 256b, as amended.148 |
|---|
| 180 | 180 | | (b) The department shall post the information sheet provided for in subsection (a) of this149 |
|---|
| 181 | 181 | | Code section on its website.150 |
|---|
| 182 | 182 | | 49-4-207.151 |
|---|
| 183 | 183 | | (a) The department, in coordination with the manufacturer, shall develop a survey to assess152 |
|---|
| 184 | 184 | | an eligible individual's satisfaction with the program and any alternative plans, including:153 |
|---|
| 185 | 185 | | (1) Adequacy of information available and provided to individuals;154 |
|---|
| 186 | 186 | | (2) Accessibility to insulin; and155 |
|---|
| 187 | 187 | | (3) Individual's ability to access affordable insulin.156 |
|---|
| 188 | 188 | | (b) The department, in coordination with the manufacturer, shall develop a survey to157 |
|---|
| 189 | 189 | | assess a pharmacy's satisfaction with the program and alternative plans, including:158 |
|---|
| 190 | 190 | | (1) Ease in submitting claims and insulin product orders to the manufacturers; and159 |
|---|
| 191 | 191 | | (2) Timeliness of receiving insulin reorders or renewal orders from the manufacturers.160 |
|---|
| 192 | 192 | | (c) The department shall post the surveys provided for in subsections (a) and (b) of this161 |
|---|
| 193 | 193 | | Code section on its website.162 |
|---|
| 194 | 194 | | H. B. 898 |
|---|
| 195 | 195 | | - 7 - 25 LC 57 9001 |
|---|
| 196 | 196 | | 49-4-208.163 |
|---|
| 197 | 197 | | (a) Any data collected, created, received, maintained, or disseminated by the department164 |
|---|
| 198 | 198 | | pursuant to this article related to an individual seeking access to the program or any165 |
|---|
| 199 | 199 | | alternative plans shall be kept confidential and shall be retained for no longer than ten166 |
|---|
| 200 | 200 | | years.167 |
|---|
| 201 | 201 | | (b) Each pharmacy and manufacturer shall maintain the privacy of all data received from168 |
|---|
| 202 | 202 | | any individual applying for the manufacturer's program or any alternative plans and shall169 |
|---|
| 203 | 203 | | be prohibited from selling, sharing, or disseminating such data received unless required to170 |
|---|
| 204 | 204 | | do so under this article or when an individual has provided the manufacturer with signed171 |
|---|
| 205 | 205 | | authorization.172 |
|---|
| 206 | 206 | | 49-4-209.173 |
|---|
| 207 | 207 | | (a) Any person who by means of a false statement, failure to disclose information, or174 |
|---|
| 208 | 208 | | impersonation, or by other fraudulent device, obtains, attempts to obtain, or retains for175 |
|---|
| 209 | 209 | | himself, herself, or any other person any medical assistance or other benefit or payment176 |
|---|
| 210 | 210 | | under this article to which such person is not entitled or in an amount greater than that to177 |
|---|
| 211 | 211 | | which such person is entitled shall be guilty of a misdemeanor. If the total amount of the178 |
|---|
| 212 | 212 | | value of the assistance so obtained exceeds $1,500.00, such person shall be guilty of a179 |
|---|
| 213 | 213 | | felony.180 |
|---|
| 214 | 214 | | (b)(1) If a manufacturer fails to comply with the provisions of this article, the department181 |
|---|
| 215 | 215 | | may assess an administrative penalty of $200,000.00 per month of such noncompliance.182 |
|---|
| 216 | 216 | | (2) Such penalty shall increase to $400,000.00 per month if the manufacturer continues183 |
|---|
| 217 | 217 | | to be in noncompliance after six months and shall increase to $600,000.00 per month if184 |
|---|
| 218 | 218 | | the manufacturer continues to be in noncompliance after one year.185 |
|---|
| 219 | 219 | | (3) The penalty shall remain at $600,000.00 per month for as long as the manufacturer186 |
|---|
| 220 | 220 | | continues in noncompliance.187 |
|---|
| 221 | 221 | | H. B. 898 |
|---|
| 222 | 222 | | - 8 - 25 LC 57 9001 |
|---|
| 223 | 223 | | (c) An individual or entity that is aggrieved by the action of the department pursuant to188 |
|---|
| 224 | 224 | | subsections (a) or (b) of this Code section shall be entitled to a hearing conducted in189 |
|---|
| 225 | 225 | | accordance with Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.'190 |
|---|
| 226 | 226 | | 49-4-210.191 |
|---|
| 227 | 227 | | (a) By July 1, 2026, and every July 1 thereafter, each manufacturer shall report to the192 |
|---|
| 228 | 228 | | department the following information for the preceding calendar year:193 |
|---|
| 229 | 229 | | (1) A description of the program and any changes made to the program;194 |
|---|
| 230 | 230 | | (2) The number of Georgia residents who accessed and received insulin through the195 |
|---|
| 231 | 231 | | program;196 |
|---|
| 232 | 232 | | (3) The total value of the insulin, determined by the wholesale acquisition cost of the197 |
|---|
| 233 | 233 | | insulin, provided by the manufacturer through the program;198 |
|---|
| 234 | 234 | | (4) A description of the alternative plans and any changes made to them;199 |
|---|
| 235 | 235 | | (5) The number of Georgia residents who accessed and received insulin through the200 |
|---|
| 236 | 236 | | alternative plans;201 |
|---|
| 237 | 237 | | (6) The total value of the insulin, determined by the wholesale acquisition cost of the202 |
|---|
| 238 | 238 | | insulin, provided by the manufacturer through the alternative plans;203 |
|---|
| 239 | 239 | | (7) The number of individuals deemed ineligible for the program or the alternative plans204 |
|---|
| 240 | 240 | | and the reasons for their ineligibility;205 |
|---|
| 241 | 241 | | (8) The number of appeals and the number of eligibility statuses that were sustained or206 |
|---|
| 242 | 242 | | reversed;207 |
|---|
| 243 | 243 | | (9) The timeliness and adequacy of the manufacturers in responding to individuals208 |
|---|
| 244 | 244 | | applying for the program or the alternative plans and pharmacies requesting insulin209 |
|---|
| 245 | 245 | | through the program or the alternative plans;210 |
|---|
| 246 | 246 | | (10) Any administrative penalties assessed under Code Section 49-4-209; and211 |
|---|
| 247 | 247 | | (11) Any additional information deemed necessary by the department.212 |
|---|
| 248 | 248 | | H. B. 898 |
|---|
| 249 | 249 | | - 9 - 25 LC 57 9001 |
|---|
| 250 | 250 | | (b) By July 1, 2026, and every July 1 thereafter, a pharmacy that received any eligibility213 |
|---|
| 251 | 251 | | statements from individuals for the program or the alternative plans shall report to the214 |
|---|
| 252 | 252 | | department the following information for the preceding calendar year:215 |
|---|
| 253 | 253 | | (1) The number of eligibility statements received;216 |
|---|
| 254 | 254 | | (2) The amount of insulin dispensed through the program;217 |
|---|
| 255 | 255 | | (3) The average and total amount of copayment collected from individuals;218 |
|---|
| 256 | 256 | | (4) The timeliness and adequacy of manufacturers' responses; and219 |
|---|
| 257 | 257 | | (5) Any additional information deemed necessary by the department.220 |
|---|
| 258 | 258 | | (b) By August 15, 2027, and every August 15 thereafter, the department shall submit to221 |
|---|
| 259 | 259 | | the General Assembly a report regarding the implementation of the program under this222 |
|---|
| 260 | 260 | | article. Such report shall include the following information for the preceding year:223 |
|---|
| 261 | 261 | | (1) The data collected under subsections (a) and (b) of this Code section;224 |
|---|
| 262 | 262 | | (2) The results of the satisfaction surveys provided for in Code Section 49-4-207; and225 |
|---|
| 263 | 263 | | (3) Any additional information deemed necessary by the department to assess the226 |
|---|
| 264 | 264 | | implementation and effectiveness of the program."227 |
|---|
| 265 | 265 | | SECTION 2.228 |
|---|
| 266 | 266 | | This Act shall become effective July 1, 2025.229 |
|---|
| 267 | 267 | | SECTION 3.230 |
|---|
| 268 | 268 | | All laws and parts of laws in conflict with this Act are repealed.231 |
|---|
| 269 | 269 | | H. B. 898 |
|---|
| 270 | 270 | | - 10 - |
|---|