| 7 | | - | provide for preeclampsia biomarker testing for pregnant women during their course of3 |
|---|
| 8 | | - | prenatal care when deemed necessary and ordered by her attending physician; to provide for4 |
|---|
| 9 | | - | a short title; to provide for definitions; to provide for how preeclampsia biomarker testing5 |
|---|
| 10 | | - | shall be conducted; to authorize the Department of Public Health to promulgate rules and6 |
|---|
| 11 | | - | regulations; to amend Chapter 24 of Title 33 of the Official Code of Georgia Annotated,7 |
|---|
| 12 | | - | relating to insurance generally, so as to require health benefit policy coverage for8 |
|---|
| 13 | | - | preeclampsia biomarker testing for pregnant women during their course of prenatal care; to9 |
|---|
| 14 | | - | provide for conforming changes; to amend Code Section 49-4-159.3 of the Official Code of10 |
|---|
| 15 | | - | Georgia Annotated, relating to biomarker testing for Medicaid recipients, so as to require11 |
|---|
| 16 | | - | preeclampsia biomarker testing coverage for pregnant women during their course of prenatal12 |
|---|
| 17 | | - | care; to provide for related matters; to repeal conflicting laws; and for other purposes.13 |
|---|
| 18 | | - | BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:14 |
|---|
| 19 | | - | H. B. 1081 (SUB) |
|---|
| 20 | | - | - 1 - 24 LC 33 9652S |
|---|
| 21 | | - | SECTION 1.15 |
|---|
| 22 | | - | Chapter 12 of Title 31 of the Official Code of Georgia Annotated, relating to control of16 |
|---|
| 23 | | - | hazardous conditions, preventable diseases, and metabolic disorders, is amended by adding17 |
|---|
| 24 | | - | a new Code section to read as follows:18 |
|---|
| 25 | | - | "31-12-15.19 |
|---|
| 26 | | - | (a) This Code section shall be known and may be cited as the 'Georgia Preeclampsia20 |
|---|
| 27 | | - | Biomarker Testing Act of 2024.'21 |
|---|
| 28 | | - | (b) As used in this Code section, the term:22 |
|---|
| 29 | | - | (1) 'Biomarker' means a characteristic that is objectively measured and evaluated as an23 |
|---|
| 30 | | - | indicator of normal biological processes, pathogenic processes, or pharmacologic24 |
|---|
| 31 | | - | responses to a specific therapeutic intervention. Such term includes, but is not limited to,25 |
|---|
| 32 | | - | gene mutations, protein expression, known gene-drug interactions for medications, and26 |
|---|
| 33 | | - | characteristics of genes.27 |
|---|
| 34 | | - | (2) 'Biomarker testing' means the analysis of a patient's tissue, blood, or other28 |
|---|
| 35 | | - | biospecimen for the presence of a biomarker using an FDA approved method of analysis. 29 |
|---|
| 36 | | - | Such term includes, but is not limited to, single-analyte tests, multiplex panel tests, whole30 |
|---|
| 37 | | - | genome sequencing, protein expression, whole exome, and whole transcriptome.31 |
|---|
| 38 | | - | (3) 'Consensus statements' means statements developed by an independent,32 |
|---|
| 39 | | - | multidisciplinary panel of experts utilizing a transparent methodology and reporting33 |
|---|
| 40 | | - | structure and with a conflict-of-interest policy. Such statements are aimed at specific34 |
|---|
| 41 | | - | clinical circumstances and base the statements on the best available evidence for the35 |
|---|
| 42 | | - | purpose of optimizing the outcomes of clinical care.36 |
|---|
| 43 | | - | (4) 'Nationally recognized clinical practice guidelines' means evidence based clinical37 |
|---|
| 44 | | - | practice guidelines developed by independent organizations or medical professional38 |
|---|
| 45 | | - | societies utilizing a transparent methodology and reporting structure and with a39 |
|---|
| 46 | | - | conflict-of-interest policy. Such guidelines establish standards of care informed by a40 |
|---|
| 47 | | - | H. B. 1081 (SUB) |
|---|
| 48 | | - | - 2 - 24 LC 33 9652S |
|---|
| 49 | | - | systematic review of evidence and an assessment of the benefits and risks of alternative41 |
|---|
| 50 | | - | care options and include recommendations intended to optimize patient care.42 |
|---|
| 51 | | - | (c)(1) A pregnant woman may be screened for preeclampsia using biomarker testing43 |
|---|
| 52 | | - | when ordered by the attending physician in accordance with this Code section.44 |
|---|
| 53 | | - | (2) Each preeclampsia biomarker test shall be conducted by the physician or other45 |
|---|
| 54 | | - | healthcare provider who is providing prenatal care for such pregnant woman according46 |
|---|
| 55 | | - | to nationally recognized clinical practice guidelines and consensus statements.47 |
|---|
| 56 | | - | (d) The department shall be authorized to promulgate rules and regulations for the purpose48 |
|---|
| 57 | | - | of administering the requirements under this Code section."49 |
|---|
| 58 | | - | SECTION 2.50 |
|---|
| 59 | | - | Chapter 24 of Title 33 of the Official Code of Georgia Annotated, relating to insurance51 |
|---|
| 60 | | - | generally, is amended in Code Section 33-24-24, relating to provision in group or blanket52 |
|---|
| 61 | | - | accident and sickness policies of coverage for complications of pregnancy, by revising53 |
|---|
| 62 | | - | subparagraph (a)(1)(A) as follows:54 |
|---|
| 63 | | - | "(A) Conditions requiring hospital confinement when the pregnancy is not terminated55 |
|---|
| 64 | | - | and whose diagnoses are distinct from pregnancy but are adversely affected by56 |
|---|
| 65 | | - | pregnancy or are caused by pregnancy, such as acute nephritis, nephrosis, cardiac57 |
|---|
| 66 | | - | decompensation, missed abortion, pre-eclampsia preeclampsia, intrauterine fetal growth58 |
|---|
| 67 | | - | retardation restriction, and similar medical and surgical conditions of comparable59 |
|---|
| 68 | | - | severity; but the term shall not include false labor, occasional spotting, physician60 |
|---|
| 69 | | - | prescribed rest during the period of pregnancy, morning sickness, hyperemesis61 |
|---|
| 70 | | - | gravidarum, and similar conditions associated with the management of a difficult62 |
|---|
| 71 | | - | pregnancy not constituting a nosologically distinct complication of pregnancy; and"63 |
|---|
| 72 | | - | H. B. 1081 (SUB) |
|---|
| 73 | | - | - 3 - 24 LC 33 9652S |
|---|
| 74 | | - | SECTION 3.64 |
|---|
| 75 | | - | Said chapter is further amended by revising subsection (b) of Code Section 33-24-59.33,65 |
|---|
| 76 | | - | relating to required coverage for biomarker testing, as follows:66 |
|---|
| 77 | | - | "(b)(1) All health benefit policies renewed or issued on or after July 1, 2023, shall67 |
|---|
| 78 | | - | include coverage for biomarker testing as provided in this Code section.68 |
|---|
| 79 | | - | (2) All health benefit policies renewed or issued on or after July 1, 2024, shall include69 |
|---|
| 80 | | - | coverage for biomarker testing for preeclampsia as provided for in Code Section70 |
|---|
| 81 | | - | 31-12-15."71 |
|---|
| 82 | | - | SECTION 4.72 |
|---|
| 83 | | - | Code Section 49-4-159.3 of the Official Code of Georgia Annotated, relating to biomarker73 |
|---|
| 84 | | - | testing for Medicaid recipients, is amended by revising subsection (b) as follows:74 |
|---|
| 85 | | - | "(b) The department shall provide biomarker testing for Medicaid recipients in accordance75 |
|---|
| 86 | | - | with the requirements of Code Section 31-12-15 and this Code section."76 |
|---|
| 87 | | - | SECTION 5.77 |
|---|
| 88 | | - | All laws and parts of laws in conflict with this Act are repealed.78 |
|---|
| 89 | | - | H. B. 1081 (SUB) |
|---|
| 20 | + | provide for mandatory preeclampsia biomarker testing for pregnant women during their first3 |
|---|
| 21 | + | prenatal visit; to provide for a short title; to provide for definitions; to provide for additional4 |
|---|
| 22 | + | testing when deemed necessary and ordered by an attending physician; to provide for how5 |
|---|
| 23 | + | preeclampsia biomarker testing shall be conducted; to authorize the Department of Public6 |
|---|
| 24 | + | Health to promulgate rules and regulations; to amend Chapter 24 of Title 33 of the Official7 |
|---|
| 25 | + | Code of Georgia Annotated, relating to insurance generally, so as to require health benefit8 |
|---|
| 26 | + | policy coverage for preeclampsia biomarker testing for pregnant women during their first9 |
|---|
| 27 | + | prenatal visit and as deemed necessary and ordered by an attending physician thereafter; to10 |
|---|
| 28 | + | provide for conforming changes; to provide for an effective date; to amend Code Section11 |
|---|
| 29 | + | 49-4-159.3 of the Official Code of Georgia Annotated, relating to biomarker testing for12 |
|---|
| 30 | + | Medicaid recipients, so as to require preeclampsia biomarker testing coverage for pregnant13 |
|---|
| 31 | + | women during their first prenatal visit and as deemed necessary and ordered by an attending14 |
|---|
| 32 | + | physician thereafter; to provide for related matters; to repeal conflicting laws; and for other15 |
|---|
| 33 | + | purposes.16 |
|---|
| 34 | + | BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:17 |
|---|
| 35 | + | H. B. 1081 |
|---|
| 36 | + | - 1 - 24 LC 54 0322 |
|---|
| 37 | + | SECTION 1. |
|---|
| 38 | + | 18 |
|---|
| 39 | + | Chapter 12 of Title 31 of the Official Code of Georgia Annotated, relating to control of19 |
|---|
| 40 | + | hazardous conditions, preventable diseases, and metabolic disorders, is amended by adding20 |
|---|
| 41 | + | a new Code section to read as follows:21 |
|---|
| 42 | + | "31-12-15. |
|---|
| 43 | + | 22 |
|---|
| 44 | + | (a) This Code section shall be known and may be cited as the 'Georgia Preeclampsia23 |
|---|
| 45 | + | Biomarker Testing Act of 2024.'24 |
|---|
| 46 | + | (b) As used in this Code section, the term:25 |
|---|
| 47 | + | (1) 'Biomarker' means a characteristic that is objectively measured and evaluated as an26 |
|---|
| 48 | + | indicator of normal biological processes, pathogenic processes, or pharmacologic27 |
|---|
| 49 | + | responses to a specific therapeutic intervention. Such term includes, but is not limited to,28 |
|---|
| 50 | + | gene mutations, protein expression, known gene-drug interactions for medications, and29 |
|---|
| 51 | + | characteristics of genes.30 |
|---|
| 52 | + | (2) 'Biomarker testing' means the analysis of a patient's tissue, blood, or other31 |
|---|
| 53 | + | biospecimen for the presence of a biomarker. Such term includes, but is not limited to,32 |
|---|
| 54 | + | single-analyte tests, multiplex panel tests, whole genome sequencing, protein expression,33 |
|---|
| 55 | + | whole exome, and whole transcriptome.34 |
|---|
| 56 | + | (3) 'Consensus statements' means statements developed by an independent,35 |
|---|
| 57 | + | multidisciplinary panel of experts utilizing a transparent methodology and reporting36 |
|---|
| 58 | + | structure and with a conflict-of-interest policy. Such statements are aimed at specific37 |
|---|
| 59 | + | clinical circumstances and base the statements on the best available evidence for the38 |
|---|
| 60 | + | purpose of optimizing the outcomes of clinical care.39 |
|---|
| 61 | + | (4) 'Nationally recognized clinical practice guidelines' means evidence based clinical40 |
|---|
| 62 | + | practice guidelines developed by independent organizations or medical professional41 |
|---|
| 63 | + | societies utilizing a transparent methodology and reporting structure and with a42 |
|---|
| 64 | + | conflict-of-interest policy. Such guidelines establish standards of care informed by a43 |
|---|
| 65 | + | H. B. 1081 |
|---|
| 66 | + | - 2 - 24 LC 54 0322 |
|---|
| 67 | + | systematic review of evidence and an assessment of the benefits and risks of alternative44 |
|---|
| 68 | + | care options and include recommendations intended to optimize patient care.45 |
|---|
| 69 | + | (c)(1) A pregnant woman shall be screened for preeclampsia using biomarker testing at46 |
|---|
| 70 | + | the pregnant woman's first prenatal visit.47 |
|---|
| 71 | + | (2) A pregnant woman may be screened for preeclampsia using biomarker testing at any48 |
|---|
| 72 | + | other point during her pregnancy as deemed necessary and ordered by the attending49 |
|---|
| 73 | + | physician in accordance with this Code section and the rules, regulations, and standards50 |
|---|
| 74 | + | adopted and promulgated pursuant to this Code section.51 |
|---|
| 75 | + | (3) Each preeclampsia biomarker test shall be conducted by the physician or other52 |
|---|
| 76 | + | healthcare provider who is providing prenatal care for such pregnant woman according53 |
|---|
| 77 | + | to nationally recognized clinical practice guidelines and consensus statements.54 |
|---|
| 78 | + | (d) The department shall be authorized to promulgate rules and regulations for the purpose55 |
|---|
| 79 | + | of administering the requirements under this Code section."56 |
|---|
| 80 | + | SECTION 2.57 |
|---|
| 81 | + | Chapter 24 of Title 33 of the Official Code of Georgia Annotated, relating to insurance58 |
|---|
| 82 | + | generally, is amended in Code Section 33-24-24, relating to provision in group or blanket59 |
|---|
| 83 | + | accident and sickness policies of coverage for complications of pregnancy, by revising60 |
|---|
| 84 | + | subparagraph (a)(1)(A) as follows:61 |
|---|
| 85 | + | "(A) Conditions requiring hospital confinement when the pregnancy is not terminated62 |
|---|
| 86 | + | and whose diagnoses are distinct from pregnancy but are adversely affected by63 |
|---|
| 87 | + | pregnancy or are caused by pregnancy, such as acute nephritis, nephrosis, cardiac64 |
|---|
| 88 | + | decompensation, missed abortion, pre-eclampsia preeclampsia, intrauterine fetal growth65 |
|---|
| 89 | + | retardation, and similar medical and surgical conditions of comparable severity; but the66 |
|---|
| 90 | + | term shall not include false labor, occasional spotting, physician prescribed rest during67 |
|---|
| 91 | + | the period of pregnancy, morning sickness, hyperemesis gravidarum, and similar68 |
|---|
| 92 | + | H. B. 1081 |
|---|
| 93 | + | - 3 - 24 LC 54 0322 |
|---|
| 94 | + | conditions associated with the management of a difficult pregnancy not constituting a |
|---|
| 95 | + | 69 |
|---|
| 96 | + | nosologically distinct complication of pregnancy; and"70 |
|---|
| 97 | + | SECTION 3.71 |
|---|
| 98 | + | Said chapter is further amended by revising subsection (b) of Code Section 33-24-59.33,72 |
|---|
| 99 | + | relating to required coverage for biomarker testing, as follows:73 |
|---|
| 100 | + | "(b)(1) |
|---|
| 101 | + | All health benefit policies renewed or issued on or after July 1, 2023, shall74 |
|---|
| 102 | + | include coverage for biomarker testing as provided in this Code section.75 |
|---|
| 103 | + | (2) All health benefit policies renewed or issued on or after July 1, 2024, shall include76 |
|---|
| 104 | + | coverage for biomarker testing for preeclampsia as provided for in Code Section77 |
|---|
| 105 | + | 31-12-15 and this Code section."78 |
|---|
| 106 | + | SECTION 4.79 |
|---|
| 107 | + | Code Section 49-4-159.3 of the Official Code of Georgia Annotated, relating to biomarker80 |
|---|
| 108 | + | testing for Medicaid recipients, is amended by revising subsection (b) as follows:81 |
|---|
| 109 | + | "(b) The department shall provide biomarker testing for Medicaid recipients in accordance82 |
|---|
| 110 | + | with the requirements of Code Section 31-12-15 and this Code section."83 |
|---|
| 111 | + | SECTION 5.84 |
|---|
| 112 | + | All laws and parts of laws in conflict with this Act are repealed.85 |
|---|
| 113 | + | H. B. 1081 |
|---|