| 1 | 1 | | 25 LC 52 0858 |
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| 2 | 2 | | House Bill 931 |
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| 3 | 3 | | By: Representatives Lupton of the 83 |
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| 4 | 4 | | rd |
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| 5 | 5 | | and Lim of the 98 |
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| 6 | 6 | | th |
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| 7 | 7 | | |
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| 8 | 8 | | A BILL TO BE ENTITLED |
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| 9 | 9 | | AN ACT |
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| 10 | 10 | | To amend Title 31 of the Official Code of Georgia Annotated, relating to health, so as to |
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| 11 | 11 | | 1 |
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| 12 | 12 | | establish a framework to control the high costs of prescription drugs in this state; to provide2 |
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| 13 | 13 | | for definitions; to establish the Prescription Drug Affordability Board; to provide for such3 |
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| 14 | 14 | | board's membership, powers, duties, and meetings; to provide for assessments; to authorize4 |
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| 15 | 15 | | the board to identify certain prescription drugs for affordability review; to provide for certain5 |
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| 16 | 16 | | health benefit plans to submit information to the board; to authorize the board to conduct an6 |
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| 17 | 17 | | affordability review of certain prescription drugs; to authorize the board to establish an upper7 |
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| 18 | 18 | | payment limit on certain prescription drugs; to provide for rights of aggrieved persons; to8 |
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| 19 | 19 | | provide for the use of savings; to provide for notice requirements for a manufacturer to9 |
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| 20 | 20 | | withdraw a drug from this state; to provide for penalties; to provide for annual reports; to10 |
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| 21 | 21 | | provide for rules and regulations; to provide for programs receiving certain funds to negotiate11 |
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| 22 | 22 | | specialist rates; to provide for related matters; to provide for legislative findings; to provide12 |
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| 23 | 23 | | for an effective date; to repeal conflicting laws; and for other purposes.13 |
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| 24 | 24 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:14 |
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| 25 | 25 | | SECTION 1.15 |
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| 26 | 26 | | (a) The purpose of this Act is to protect the safety, health, and economic well-being of16 |
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| 27 | 27 | | H. B. 931 |
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| 28 | 28 | | - 1 - 25 LC 52 0858 |
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| 29 | 29 | | Georgians by taking steps to increase access to affordable prescription drugs. In enacting |
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| 30 | 30 | | 17 |
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| 31 | 31 | | this Act, the legislature finds that:18 |
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| 32 | 32 | | (1) Access to prescription drugs is necessary for Georgians to maintain or acquire good19 |
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| 33 | 33 | | health;20 |
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| 34 | 34 | | (2) Excessive costs negatively impact the ability of Georgians to obtain prescription21 |
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| 35 | 35 | | drugs, and costs that exceed reasonable levels endanger the health and safety of22 |
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| 36 | 36 | | Georgians and their ability to maintain or achieve good health;23 |
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| 37 | 37 | | (3) Lack of affordability of prescription drugs threatens the economic well-being of24 |
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| 38 | 38 | | Georgians and endangers their ability to afford other necessary and essential goods and25 |
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| 39 | 39 | | services, including housing, food, and utilities;26 |
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| 40 | 40 | | (4) Excessive costs for prescription drugs contribute significantly to healthcare and27 |
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| 41 | 41 | | health insurance costs and threaten the overall ability of Georgians to obtain healthcare28 |
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| 42 | 42 | | coverage and maintain or achieve good health;29 |
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| 43 | 43 | | (5) The high cost of prescription drugs contributes significantly to rising costs to the state30 |
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| 44 | 44 | | for healthcare provided and paid for through health insurance programs for public31 |
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| 45 | 45 | | employees, including employees of the state, municipalities and counties, school districts,32 |
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| 46 | 46 | | institutions of higher education, and retirees whose healthcare costs are funded by public33 |
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| 47 | 47 | | programs, thereby threatening the ability of the state to fund those programs adequately34 |
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| 48 | 48 | | and further threatening the ability of the state to fund other programs necessary for the35 |
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| 49 | 49 | | public good, such as public education and public safety; and36 |
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| 50 | 50 | | (6) The costs to consumers, health benefit plans, and the state for prescription drug37 |
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| 51 | 51 | | coverage is higher than the costs in other countries because the prices charged by38 |
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| 52 | 52 | | manufacturers and distributors of drugs in Georgia are higher.39 |
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| 53 | 53 | | (b) Based on these findings, the legislature finds that high costs of prescription drugs40 |
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| 54 | 54 | | threaten the safety and well-being of Georgians and finds it is necessary to act in order to41 |
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| 55 | 55 | | protect Georgians from the negative impact of excessive costs for prescription drugs.42 |
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| 56 | 56 | | H. B. 931 |
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| 57 | 57 | | - 2 - 25 LC 52 0858 |
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| 58 | 58 | | SECTION 2. |
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| 59 | 59 | | 43 |
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| 60 | 60 | | Title 31 of the Official Code of Georgia Annotated, relating to health, is amended in Chapter44 |
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| 61 | 61 | | 2, relating to Department of Community Health, by designating Code Sections 31-2-145 |
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| 62 | 62 | | through 31-2-19 as Article 1.46 |
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| 63 | 63 | | SECTION 3.47 |
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| 64 | 64 | | Said title is further amended in said chapter by adding a new article to read as follows:48 |
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| 65 | 65 | | "ARTICLE 2 |
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| 66 | 66 | | 49 |
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| 67 | 67 | | 31-2-30.50 |
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| 68 | 68 | | As used in this article, the term:51 |
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| 69 | 69 | | (1) 'Affordability challenge' means a determination by the board that the costs of52 |
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| 70 | 70 | | appropriate utilization of a prescription drug:53 |
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| 71 | 71 | | (A) Exceed the therapeutic benefit of such drug; or54 |
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| 72 | 72 | | (B) Are not sustainable to consumers or to public or private healthcare systems.55 |
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| 73 | 73 | | (2) 'Biological product' means a virus, therapeutic serum, toxin, antitoxin, vaccine,56 |
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| 74 | 74 | | blood, blood component or derivative, allergenic product, protein, or analogous product,57 |
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| 75 | 75 | | or arsphenamine or derivative of arsphenamine or any other trivalent organic arsenic58 |
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| 76 | 76 | | compound, applicable to the prevention, treatment, or cure of a disease or condition of59 |
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| 77 | 77 | | human beings.60 |
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| 78 | 78 | | (3) 'Biosimilar product' means a biological product highly similar to a reference61 |
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| 79 | 79 | | biological product with no clinically meaningful differences in terms of the safety, purity,62 |
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| 80 | 80 | | and potency of the product and with minor differences in clinically inactive components.63 |
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| 81 | 81 | | (4) 'Board' means the Prescription Drug Affordability Board established under Code64 |
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| 82 | 82 | | Section 31-2-31.65 |
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| 83 | 83 | | H. B. 931 |
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| 84 | 84 | | - 3 - 25 LC 52 0858 |
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| 85 | 85 | | (5) 'ERISA plan' means a plan qualified under the federal Employee Retirement Income66 |
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| 86 | 86 | | Security Act of 1974, 29 U.S.C. Section 1001, et seq.67 |
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| 87 | 87 | | (6) 'Health benefit plan' means any hospital, health, or medical insurance policy; hospital68 |
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| 88 | 88 | | or medical service contract; employee welfare benefit plan; contract or agreement with69 |
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| 89 | 89 | | a health maintenance organization; subscriber contract or agreement; contract or70 |
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| 90 | 90 | | agreement with a preferred provider organization; accident and sickness insurance benefit71 |
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| 91 | 91 | | plan; or other insurance contract under any other name. Such term shall include any72 |
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| 92 | 92 | | health insurance or benefit plan established pursuant to Part 6 of Article 17 of Chapter73 |
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| 93 | 93 | | 2 of Title 20, Code Section 31-2-4, Article 1 of Chapter 18 of Title 45, and Article 7 of74 |
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| 94 | 94 | | Chapter 4 of Title 49, the 'Georgia Medical Assistance Act of 1977.'75 |
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| 95 | 95 | | (7) 'Manufacturer' means an entity that engages in the manufacture, marketing, or76 |
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| 96 | 96 | | distribution of a prescription drug or enters into an agreement with another manufacturer77 |
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| 97 | 97 | | to manufacture, market, or distribute a prescription drug under such entity's name and sets78 |
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| 98 | 98 | | or changes the wholesale acquisition cost of the prescription drug it manufactures,79 |
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| 99 | 99 | | markets, or distributes.80 |
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| 100 | 100 | | (8) 'Participating ERISA plan' means an ERISA plan that has elected to participate in the81 |
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| 101 | 101 | | requirements and restrictions as provided in Code Section 31-2-35.82 |
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| 102 | 102 | | (9) 'Pharmacy benefits manager' shall have the same meaning as set forth in Code83 |
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| 103 | 103 | | Section 33-64-1.84 |
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| 104 | 104 | | (10) 'Pharmacy wholesale distributor' means any person engaged in the wholesale85 |
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| 105 | 105 | | distribution of prescription drugs, including, but not limited to, manufacturers; repackers;86 |
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| 106 | 106 | | own label distributors; private-label distributors; jobbers; brokers; warehouses, including87 |
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| 107 | 107 | | manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug88 |
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| 108 | 108 | | warehouses; independent wholesale drug traders; and retail pharmacies that conduct89 |
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| 109 | 109 | | wholesale distributions.90 |
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| 110 | 110 | | (11) 'Prescription drug' shall have the same meaning as set forth in Code Section91 |
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| 111 | 111 | | 26-4-201. Such term shall include any biological product or biosimilar product.92 |
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| 112 | 112 | | H. B. 931 |
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| 113 | 113 | | - 4 - 25 LC 52 0858 |
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| 114 | 114 | | (12) 'State entity' means any agency of state government that purchases prescription93 |
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| 115 | 115 | | drugs on behalf of the state for a person whose healthcare is paid for by the state,94 |
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| 116 | 116 | | including any agent, vendor, fiscal agent, contractor, or other party acting on behalf of95 |
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| 117 | 117 | | the state.96 |
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| 118 | 118 | | (13) 'Wholesale acquisition cost' has the same meaning as set forth in 42 U.S.C. Section97 |
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| 119 | 119 | | 1395w-3a(c)(6)(B).98 |
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| 120 | 120 | | 31-2-31.99 |
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| 121 | 121 | | (a) There is hereby established the Prescription Drug Affordability Board for the purpose100 |
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| 122 | 122 | | of protecting residents of this state, state and local governments, health benefit plans,101 |
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| 123 | 123 | | healthcare providers, pharmacies, and other stakeholders within the healthcare system in102 |
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| 124 | 124 | | this state from the high costs of prescription drugs.103 |
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| 125 | 125 | | (b)(1) The board shall consist of five members appointed by the Governor and confirmed104 |
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| 126 | 126 | | by the Senate. The Governor shall designate the initial terms of the members of the board105 |
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| 127 | 127 | | as follows: one member shall be appointed for one year, two members shall be appointed106 |
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| 128 | 128 | | for two years, and two members shall be appointed for three years. Thereafter, all107 |
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| 129 | 129 | | members shall serve for terms of four years and until their successors are appointed and108 |
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| 130 | 130 | | qualified.109 |
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| 131 | 131 | | (2) When a vacancy occurs for any reason other than expiration of term, the Governor110 |
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| 132 | 132 | | shall make an appointment to become immediately effective for the remainder of the111 |
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| 133 | 133 | | unexpired term. Any appointment made by the Governor when the Senate is not in112 |
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| 134 | 134 | | session shall be effective until the appointment is acted upon by the Senate.113 |
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| 135 | 135 | | (c) A board member shall:114 |
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| 136 | 136 | | (1) Be a resident of this state;115 |
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| 137 | 137 | | (2) Have an advanced degree, experience, or expertise in healthcare policy, healthcare116 |
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| 138 | 138 | | economics, or clinical medicine; and117 |
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| 139 | 139 | | H. B. 931 |
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| 140 | 140 | | - 5 - 25 LC 52 0858 |
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| 141 | 141 | | (3) Not be an employee or board member of or consultant to a manufacturer, pharmacy118 |
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| 142 | 142 | | benefits manager, health benefit plan, pharmacy wholesale distributor, or related trade119 |
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| 143 | 143 | | association.120 |
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| 144 | 144 | | (d)(1) The board shall elect a chairperson and a vice chairperson from among its121 |
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| 145 | 145 | | members, each to serve for a term of one year commencing on the first day of July each122 |
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| 146 | 146 | | year.123 |
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| 147 | 147 | | (2) The board shall have the authority to hire an executive director and staff necessary124 |
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| 148 | 148 | | to conduct the board's activity as provided in this article.125 |
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| 149 | 149 | | (e) The commissioner or his or her designee shall serve as an ex officio member of the126 |
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| 150 | 150 | | board, and the department shall provide staff support and may employ consultants,127 |
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| 151 | 151 | | investigators, or other staff as necessary for the board to carry out its duties.128 |
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| 152 | 152 | | (f) The board shall assess and collect an annual assessment on manufacturers, health129 |
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| 153 | 153 | | benefit plans, pharmacy benefits managers, and pharmacy wholesale distributors that sell130 |
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| 154 | 154 | | or offer for sale any prescription drugs to persons in this state. The board shall specify the131 |
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| 155 | 155 | | methodology for determining the amount of such assessment and the methodology and132 |
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| 156 | 156 | | timeline for collecting such assessment pursuant to rules and regulations promulgated and133 |
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| 157 | 157 | | adopted by the board.134 |
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| 158 | 158 | | (g) The board shall have the authority to enter into a contract with a third party for any135 |
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| 159 | 159 | | service necessary to carry out the powers and duties of the board.136 |
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| 160 | 160 | | (h) The board may seek, accept, and expend gifts, grants, and donations from private or137 |
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| 161 | 161 | | pubic sources for the purposes of this article; provided, however, that the board shall not138 |
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| 162 | 162 | | accept any gift, grant, or donation that creates a conflict of interest or the appearance of any139 |
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| 163 | 163 | | conflict of interest for any board member.140 |
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| 164 | 164 | | (i) Board members, department employees, and contractors providing services to or on141 |
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| 165 | 165 | | behalf of the board shall recuse themselves from any board activity in which they have a142 |
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| 166 | 166 | | conflict of interest. As used in this subsection, the term 'conflict of interest' means an143 |
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| 167 | 167 | | association, including a financial or personal association, that has the potential to bias or144 |
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| 168 | 168 | | H. B. 931 |
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| 169 | 169 | | - 6 - 25 LC 52 0858 |
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| 170 | 170 | | appear to bias an individual's decisions in matters related to the board or the activities of145 |
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| 171 | 171 | | the board.146 |
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| 172 | 172 | | (j) The board may establish advisory groups consisting of relevant stakeholders.147 |
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| 173 | 173 | | (k) The board has the authority to promulgate and adopt rules and regulations to allow it148 |
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| 174 | 174 | | to carry out its duties and powers under this article.149 |
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| 175 | 175 | | (l) A simple majority of the board's membership shall constitute a quorum for the purpose150 |
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| 176 | 176 | | of conducting business. Decisions of the board shall be determined by majority vote of151 |
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| 177 | 177 | | board members present.152 |
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| 178 | 178 | | (m) All meetings of the board shall be open to the public in accordance with Chapter 14153 |
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| 179 | 179 | | of Title 50, relating to open and public meetings, and all public records shall be subject to154 |
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| 180 | 180 | | disclosure in accordance with Article 4 of Chapter 18 of Title 50, relating to open records;155 |
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| 181 | 181 | | provided, however, that the board may hold executive sessions to discuss trade secrets or156 |
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| 182 | 182 | | proprietary information, and such information shall be confidential by law and privileged;157 |
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| 183 | 183 | | shall not be subject to disclosure under the provisions of Article 4 of Chapter 18 of Title158 |
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| 184 | 184 | | 50, relating to open records; shall not be subject to subpoena; and shall not be subject to159 |
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| 185 | 185 | | discovery or admissible in evidence in any private civil action.160 |
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| 186 | 186 | | (n) The board shall meet at least quarterly at a time and place determined by the161 |
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| 187 | 187 | | chairperson. The board may also meet at other times and places specified by the call of the162 |
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| 188 | 188 | | chairperson or a majority of the board members.163 |
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| 189 | 189 | | (o) Each board member shall receive the daily expense allowance and travel164 |
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| 190 | 190 | | reimbursement as provided in Code Section 45-7-21 for actual attendance at board165 |
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| 191 | 191 | | meetings in this state.166 |
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| 192 | 192 | | 31-2-32.167 |
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| 193 | 193 | | (a) The board shall select prescription drugs for affordability review from the categories168 |
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| 194 | 194 | | of prescription drugs identified pursuant to subsection (b) of this Code section.169 |
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| 195 | 195 | | (b) Beginning January 1, 2026, and annually thereafter, the board shall identify:170 |
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| 196 | 196 | | H. B. 931 |
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| 197 | 197 | | - 7 - 25 LC 52 0858 |
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| 198 | 198 | | (1) Prescription drugs that, as adjusted annually by the increase or decrease in the cost171 |
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| 199 | 199 | | of living for the previous calendar year, have:172 |
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| 200 | 200 | | (A) A wholesale acquisition cost of $3,000.00 or more per year; or173 |
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| 201 | 201 | | (B) A wholesale acquisition cost increase of $300.00 or more in the preceding 12174 |
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| 202 | 202 | | month period; or175 |
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| 203 | 203 | | (B) A wholesale acquisition cost increase of 200 percent or more in the preceding 12176 |
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| 204 | 204 | | months;177 |
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| 205 | 205 | | (2) Biosimilar products with an initial wholesale acquisition cost that is not at least 15178 |
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| 206 | 206 | | percent below the wholesale acquisition cost of the reference biological product at the179 |
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| 207 | 207 | | time the biosimilar product is launched;180 |
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| 208 | 208 | | (3) Prescription drugs referred to the board as possessing potential affordability181 |
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| 209 | 209 | | challenges;182 |
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| 210 | 210 | | (4) Prescription drugs referred to the board by any advisory group created by the board;183 |
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| 211 | 211 | | and184 |
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| 212 | 212 | | (5) The following information on categories of prescription drugs and premiums, based185 |
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| 213 | 213 | | on reports submitted annually from each health benefit plan:186 |
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| 214 | 214 | | (A) The 50 prescription drugs that are most frequently dispensed by pharmacies for187 |
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| 215 | 215 | | claims covered under such plan and the total number of paid claims for each such drug;188 |
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| 216 | 216 | | (B) The 50 prescription drugs that are most costly with respect to such plan based on189 |
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| 217 | 217 | | total annual spending and the annual amount paid for each such drug after any rebates190 |
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| 218 | 218 | | or other price concessions;191 |
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| 219 | 219 | | (C) The 50 prescription drugs with the greatest increase in expenditures under such192 |
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| 220 | 220 | | plan during the year preceding the year of the report, and, for each such drug, the193 |
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| 221 | 221 | | change in the amount expended under such plan in each year after any rebates or other194 |
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| 222 | 222 | | price concessions;195 |
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| 223 | 223 | | (D) The 50 prescription drugs that are most costly based on average out-of-pocket cost196 |
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| 224 | 224 | | per insured, member, or covered person under such plan;197 |
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| 225 | 225 | | H. B. 931 |
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| 226 | 226 | | - 8 - 25 LC 52 0858 |
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| 227 | 227 | | (E) Any impact on premiums of such plan from rebates, fees, and other remuneration198 |
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| 228 | 228 | | paid by manufacturers to such plan or its administrators or service providers with199 |
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| 229 | 229 | | respect to prescription drugs prescribed to insureds, members, or covered persons under200 |
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| 230 | 230 | | such plan, including, but not limited to:201 |
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| 231 | 231 | | (i) The amounts paid by manufacturers for each therapeutic class of drugs; and202 |
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| 232 | 232 | | (ii) The amounts by paid manufacturers for each of the 25 drugs that yielded the203 |
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| 233 | 233 | | highest amount of rebates and other remuneration under such plan during the prior204 |
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| 234 | 234 | | year; and205 |
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| 235 | 235 | | (F) Any reduction in premiums and out-of-pocket costs to insureds, members, or206 |
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| 236 | 236 | | covered persons under the plan.207 |
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| 237 | 237 | | (c) The reports submitted to the board by each health benefit plan as provided for in208 |
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| 238 | 238 | | paragraph (5) of subsection (b) of this Code section shall include the following information209 |
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| 239 | 239 | | for each prescription drug:210 |
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| 240 | 240 | | (1) Total annual spending by the plan after any rebates and other price concessions;211 |
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| 241 | 241 | | (2) Total annual spending by insureds, members, or covered persons under the plan;212 |
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| 242 | 242 | | (3) The number of insureds, members, or covered persons with a paid prescription drug213 |
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| 243 | 243 | | claim;214 |
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| 244 | 244 | | (4) Total dosage units dispensed; and215 |
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| 245 | 245 | | (5) The number of paid claims.216 |
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| 246 | 246 | | 31-2-33.217 |
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| 247 | 247 | | (a) In performing an affordability review of a prescription drug, the board shall be218 |
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| 248 | 248 | | authorized to consider any documents and information relating to the manufacturer's219 |
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| 249 | 249 | | selection of the introductory price or any price increase of such drug, including documents220 |
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| 250 | 250 | | and information relating to:221 |
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| 251 | 251 | | (1) Life cycle management;222 |
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| 252 | 252 | | (2) The average cost of such drug;223 |
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| 253 | 253 | | H. B. 931 |
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| 254 | 254 | | - 9 - 25 LC 52 0858 |
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| 255 | 255 | | (3) Market competition and context;224 |
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| 256 | 256 | | (4) Projected revenue;225 |
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| 257 | 257 | | (5) The estimated cost-effectiveness of the drug;226 |
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| 258 | 258 | | (6) Off-label usage of the drug;227 |
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| 259 | 259 | | (7) Development and manufacturing costs; and228 |
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| 260 | 260 | | (8) Any consumer assistance programs funded by the manufacturer.229 |
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| 261 | 261 | | (b) To the extent practicable, the board shall access pricing information for prescription230 |
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| 262 | 262 | | drugs by:231 |
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| 263 | 263 | | (1) Accessing available information from the all-payer claims database in this state and232 |
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| 264 | 264 | | other states;233 |
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| 265 | 265 | | (2) Entering into an interagency agreement with any state entity to share information234 |
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| 266 | 266 | | collected by such entity;235 |
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| 267 | 267 | | (3) Entering into a memorandum of understanding with another state to which236 |
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| 268 | 268 | | manufacturers already report pricing information; and237 |
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| 269 | 269 | | (4) Accessing other publicly available pricing information.238 |
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| 270 | 270 | | 31-2-34.239 |
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| 271 | 271 | | (a) The board shall be authorized to conduct an affordability review of any prescription240 |
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| 272 | 272 | | drug identified pursuant to Code Section 31-2-32 to determine whether the cost of such241 |
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| 273 | 273 | | drug poses an affordability challenge.242 |
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| 274 | 274 | | (b) When conducting an affordability review for a prescription drug, the board shall be243 |
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| 275 | 275 | | authorized to consider any of the following criteria:244 |
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| 276 | 276 | | (1) The relevant factors contributing to the price paid for the drug, including the245 |
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| 277 | 277 | | wholesale acquisition cost, discounts, rebates, or other price concessions;246 |
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| 278 | 278 | | (2) The average patient co-pay or other cost-sharing for the drug;247 |
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| 279 | 279 | | (3) The effect of the price on consumers' access to the drug in this state;248 |
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| 280 | 280 | | H. B. 931 |
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| 281 | 281 | | - 10 - 25 LC 52 0858 |
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| 282 | 282 | | (4) Whether the cost of the drug contributes to inequities in the availability of healthcare249 |
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| 283 | 283 | | to underserved communities in this state;250 |
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| 284 | 284 | | (5) The dollar value and accessibility of patient assistance programs offered by the251 |
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| 285 | 285 | | manufacturer for the drug;252 |
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| 286 | 286 | | (6) The price and availability of therapeutic alternatives;253 |
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| 287 | 287 | | (7) Input from any advisory groups established by the board;254 |
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| 288 | 288 | | (8) Input from patients affected by the condition or disease treated by the drug and255 |
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| 289 | 289 | | individuals with medical or scientific expertise related to the condition or disease treated256 |
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| 290 | 290 | | by the drug;257 |
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| 291 | 291 | | (9) Life cycle management;258 |
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| 292 | 292 | | (10) The average cost of the drug in this state;259 |
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| 293 | 293 | | (11) Market competition and context;260 |
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| 294 | 294 | | (12) Projected manufacturer revenue, if available;261 |
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| 295 | 295 | | (13) Off-label usage of the drug; and262 |
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| 296 | 296 | | (14) Any other relevant factors as determined by the board.263 |
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| 297 | 297 | | (c) Prior to conducting an affordability review under this Code section, the board shall264 |
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| 298 | 298 | | publish which prescription drugs are subject to such review and shall notify the265 |
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| 299 | 299 | | manufacturer of any prescription drug subject to review.266 |
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| 300 | 300 | | (d) At the conclusion of an affordability review under this Code section, the board shall267 |
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| 301 | 301 | | determine whether the cost of a reviewed prescription drug presents an affordability268 |
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| 302 | 302 | | challenge necessitating the establishment of an upper payment limit as provided for in269 |
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| 303 | 303 | | Code Section 33-2-35.270 |
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| 304 | 304 | | 31-2-35.271 |
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| 305 | 305 | | (a) Prior to setting any upper payment limits, the board shall establish by rule a272 |
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| 306 | 306 | | methodology for setting upper payment limits.273 |
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| 307 | 307 | | H. B. 931 |
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| 308 | 308 | | - 11 - 25 LC 52 0858 |
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| 309 | 309 | | (b) The board may set an upper payment limit for each prescription drug for which it274 |
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| 310 | 310 | | determines there is an affordability challenge.275 |
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| 311 | 311 | | (c) The methodology used by the board to set an upper payment limit may take into276 |
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| 312 | 312 | | consideration:277 |
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| 313 | 313 | | (1) The cost of administering the prescription drug;278 |
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| 314 | 314 | | (2) The cost of delivering the prescription drug to patients;279 |
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| 315 | 315 | | (3) The status of the prescription drug on the drug shortage list published by the United280 |
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| 316 | 316 | | States Food and Drug Administration;281 |
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| 317 | 317 | | (4) The difference between the price of the drug in this state and other states and between282 |
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| 318 | 318 | | the price in the United States and in other countries;283 |
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| 319 | 319 | | (5) Other relevant administrative costs related to the production and delivery of the284 |
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| 320 | 320 | | prescription drug; and285 |
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| 321 | 321 | | (6) Other relevant criteria the board, accounting for any stakeholder input, determines286 |
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| 322 | 322 | | is necessary.287 |
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| 323 | 323 | | (d) The methodology determined by the board shall consider whether an upper payment288 |
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| 324 | 324 | | limit may help alleviate health disparities and inequitable outcomes for underserved289 |
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| 325 | 325 | | communities, people with disabilities, older adults, or any other socially, economically, or290 |
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| 326 | 326 | | environmentally disadvantaged group.291 |
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| 327 | 327 | | (e) The board shall not employ a measure or metric which assigns a reduced value to the292 |
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| 328 | 328 | | life extension provided by a prescription drug based on a pre-existing disability or chronic293 |
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| 329 | 329 | | health condition of the individuals whom the prescription drug would benefit.294 |
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| 330 | 330 | | (f) The board shall be authorized to suspend an upper payment limit if it determines that295 |
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| 331 | 331 | | there is a shortage of the drug in this state, unless the board determines that such shortage296 |
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| 332 | 332 | | was caused by a manufacturer or its agent.297 |
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| 333 | 333 | | (g) An upper payment limit for a prescription drug established by the board applies to all298 |
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| 334 | 334 | | purchases of the prescription drug and reimbursements for a claim for the drug when such299 |
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| 335 | 335 | | drug is dispensed or administered to an individual in this state in person, by mail, or by300 |
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| 336 | 336 | | H. B. 931 |
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| 337 | 337 | | - 12 - 25 LC 52 0858 |
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| 338 | 338 | | other means. An upper payment limit does not include a pharmacy dispensing fee, and301 |
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| 339 | 339 | | nothing in this article shall be interpreted to prevent a retail pharmacy from receiving a302 |
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| 340 | 340 | | payment that includes a dispensing fee above the upper payment limit.303 |
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| 341 | 341 | | (h) An ERISA plan may elect to be subject to the upper payment limits established by the304 |
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| 342 | 342 | | board.305 |
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| 343 | 343 | | (i) The board shall publish a list of prescription drugs for which it has set an upper306 |
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| 344 | 344 | | payment limit.307 |
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| 345 | 345 | | (j) Unless the board prescribes a specific effective date, upper payment limits established308 |
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| 346 | 346 | | by the board shall become effective six months after the adoption of the upper payment309 |
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| 347 | 347 | | limit and apply only to purchases, contracts, and plans that are issued on or renewed after310 |
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| 348 | 348 | | the effective date.311 |
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| 349 | 349 | | (k) The establishment of an upper payment limit shall constitute final agency action. Any312 |
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| 350 | 350 | | person or entity may request a contested case hearing, in accordance with the procedures313 |
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| 351 | 351 | | established for such hearings by Chapter 13 of Title 50, the 'Georgia Administrative314 |
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| 352 | 352 | | Procedure Act,' no later than 30 days after the decision is issued. The board shall consider315 |
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| 353 | 353 | | the appeal and issue a final decision concerning the appeal within 60 days after the board316 |
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| 354 | 354 | | receives the appeal. Final decisions as a result of such appeals are subject to judicial317 |
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| 355 | 355 | | review.318 |
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| 356 | 356 | | 31-2-36.319 |
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| 357 | 357 | | Any savings generated by a health benefit plan, state entity, or participating ERISA plan320 |
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| 358 | 358 | | that are attributable to the implementation of an upper payment limit established by the321 |
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| 359 | 359 | | board shall be used to reduce costs to consumers, prioritizing the reduction of out-of-pocket322 |
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| 360 | 360 | | costs for prescription drugs. No later than April 1 of each calendar year, each health323 |
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| 361 | 361 | | benefit plan, state entity, and participating ERISA plan shall submit to the board, the324 |
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| 362 | 362 | | commissioner, and the Commissioner of Insurance a report describing the savings achieved325 |
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| 363 | 363 | | H. B. 931 |
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| 364 | 364 | | - 13 - 25 LC 52 0858 |
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| 365 | 365 | | as a result of implementing upper payment limits and how those savings were used to326 |
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| 366 | 366 | | reduce costs to consumers.327 |
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| 367 | 367 | | 31-2-37.328 |
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| 368 | 368 | | (a) Any manufacturer that intends to withdraw from sale or distribution within this state329 |
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| 369 | 369 | | a prescription drug for which the board has established an upper payment limit shall330 |
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| 370 | 370 | | provide a notice of withdrawal in writing at least six months before the withdrawal to the331 |
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| 371 | 371 | | board, the commissioner, the Commissioner of Insurance, the Attorney General, and any332 |
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| 372 | 372 | | state entity with which the manufacturer has a contract for the sale or distribution of the333 |
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| 373 | 373 | | drug.334 |
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| 374 | 374 | | (b) The board shall assess a penalty not to exceed $500,000.00 if the board determines that335 |
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| 375 | 375 | | a manufacturer failed to provide the notice required by subsection (a) of this Code section336 |
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| 376 | 376 | | before withdrawing from sale or distribution within this state any prescription drug for337 |
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| 377 | 377 | | which the board has established an upper payment limit.338 |
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| 378 | 378 | | 31-2-38.339 |
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| 379 | 379 | | All assessments, penalties, and donations and grants received by the board and any interest340 |
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| 380 | 380 | | earned on such shall be paid over into the general fund of the state treasury in accordance341 |
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| 381 | 381 | | with Code Section 45-12-92.342 |
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| 382 | 382 | | 31-2-39.343 |
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| 383 | 383 | | No later than December 1, 2026, and annually thereafter, the board shall submit a report344 |
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| 384 | 384 | | to the commissioner, the Commissioner of Insurance, the Office of Health Strategy and345 |
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| 385 | 385 | | Coordination, and the chairpersons of the House Committee on Health, the House346 |
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| 386 | 386 | | Committee on Insurance, the House Committee on Public and Community Health, the347 |
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| 387 | 387 | | Senate Health and Human Services Committee, and the Senate Insurance and Labor348 |
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| 388 | 388 | | Committee. Such report shall include the following information:349 |
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| 389 | 389 | | H. B. 931 |
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| 390 | 390 | | - 14 - 25 LC 52 0858 |
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| 391 | 391 | | (1) Publicly available data concerning price trends for prescription drugs;350 |
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| 392 | 392 | | (2) A list of the prescription drugs that were subjected to an affordability review by the351 |
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| 393 | 393 | | board, including the results of such affordability review;352 |
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| 394 | 394 | | (3) A list of each prescription drug for which the board established an upper payment353 |
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| 395 | 395 | | limit, including the amount of the upper payment limit;354 |
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| 396 | 396 | | (4) With respect to each prescription drug for which the board conducted an affordability355 |
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| 397 | 397 | | review, how the board determined whether the cost of such drug contributes to health356 |
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| 398 | 398 | | disparities and inequitable outcomes for underserved communities, people with357 |
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| 399 | 399 | | disabilities, older adults, or any other socially, economically, or environmentally358 |
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| 400 | 400 | | disadvantaged group;359 |
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| 401 | 401 | | (5) With respect to each drug for which the board set an upper payment limit, how the360 |
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| 402 | 402 | | board assessed health disparities and inequitable outcomes for underserved communities,361 |
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| 403 | 403 | | people with disabilities, older adults, or any other socially, economically, or362 |
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| 404 | 404 | | environmentally disadvantaged group;363 |
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| 405 | 405 | | (6) The known impact of any upper payment limits established by the board on364 |
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| 406 | 406 | | healthcare providers and pharmacies and the ability of Georgians to access such drugs;365 |
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| 407 | 407 | | (7) A summary of any appeals of decisions by the board and the outcome of any such366 |
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| 408 | 408 | | appeal;367 |
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| 409 | 409 | | (8) A description of each conflict of interest that was disclosed to the board during the368 |
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| 410 | 410 | | preceding year;369 |
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| 411 | 411 | | (9) A description of any violations of any of the provisions of this article, including an370 |
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| 412 | 412 | | indication of any enforcement action taken in response to any such violation; and371 |
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| 413 | 413 | | (10) Any recommendations the board may have for legislative and regulatory changes372 |
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| 414 | 414 | | to increase the affordability of prescription drugs and reduce the effects of costs on373 |
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| 415 | 415 | | consumers and the healthcare systems in this state.374 |
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| 416 | 416 | | H. B. 931 |
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| 417 | 417 | | - 15 - 25 LC 52 0858 |
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| 418 | 418 | | 31-2-40.375 |
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| 419 | 419 | | The board shall promulgate rules and regulations necessary to implement the provisions376 |
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| 420 | 420 | | of this article."377 |
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| 421 | 421 | | SECTION 4.378 |
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| 422 | 422 | | Said title is further amended in Chapter 8, relating to care and protection of indigent and379 |
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| 423 | 423 | | elderly patients, by revising Code Section 31-8-154, relating to authorized expenditure of380 |
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| 424 | 424 | | contributed funds, as follows:381 |
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| 425 | 425 | | "31-8-154.382 |
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| 426 | 426 | | All moneys contributed and revenues deposited and transferred to the trust fund pursuant383 |
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| 427 | 427 | | to this article and any interest earned on such moneys shall be appropriated to the384 |
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| 428 | 428 | | department for only the following purposes:385 |
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| 429 | 429 | | (1) To expand Medicaid eligibility and services;386 |
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| 430 | 430 | | (2) For programs to support rural and other health care healthcare providers, primarily387 |
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| 431 | 431 | | hospitals, who serve the medically indigent, provided that such programs shall negotiate388 |
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| 432 | 432 | | specialist care rates with primary healthcare programs described in paragraph (3) of this389 |
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| 433 | 433 | | Code section;390 |
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| 434 | 434 | | (3) For primary health care healthcare programs for medically indigent citizens and391 |
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| 435 | 435 | | children of this state; or392 |
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| 436 | 436 | | (4) Any combination of purposes specified in paragraphs (1) through (3) of this Code393 |
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| 437 | 437 | | section."394 |
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| 438 | 438 | | SECTION 5.395 |
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| 439 | 439 | | This Act shall become effective upon its approval by the Governor or upon its becoming law396 |
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| 440 | 440 | | without such approval.397 |
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| 441 | 441 | | H. B. 931 |
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| 442 | 442 | | - 16 - 25 LC 52 0858 |
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| 443 | 443 | | SECTION 6. |
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| 444 | 444 | | 398 |
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| 445 | 445 | | All laws and parts of laws in conflict with this Act are repealed.399 |
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| 446 | 446 | | H. B. 931 |
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| 447 | 447 | | - 17 - |
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