| Old | New | Differences | |
|---|---|---|---|
| 1 | 1 | ||
| 2 | 2 | ||
| 3 | - | LCO 3675 \\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06628-R01- | |
| 4 | - | HB.docx | |
| 5 | - | 1 of 2 | |
| 3 | + | LCO No. 3675 1 of 3 | |
| 6 | 4 | ||
| 7 | 5 | General Assembly Raised Bill No. 6628 | |
| 8 | 6 | January Session, 2023 | |
| 9 | 7 | LCO No. 3675 | |
| 10 | 8 | ||
| 11 | 9 | ||
| 12 | 10 | Referred to Committee on HUMAN SERVICES | |
| 13 | 11 | ||
| 14 | 12 | ||
| 15 | 13 | Introduced by: | |
| 16 | 14 | (HS) | |
| 17 | 15 | ||
| 18 | 16 | ||
| 17 | + | ||
| 18 | + | ||
| 19 | 19 | AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER | |
| 20 | 20 | TESTING. | |
| 21 | 21 | Be it enacted by the Senate and House of Representatives in General | |
| 22 | 22 | Assembly convened: | |
| 23 | 23 | ||
| 24 | 24 | Section 1. (NEW) (Effective July 1, 2023) (a) As used in this section: 1 | |
| 25 | 25 | (1) "Biomarker" means a characteristic, including, but not limited to, 2 | |
| 26 | 26 | a gene mutation or protein expression that can be objectively measured 3 | |
| 27 | - | and evaluated as an indicator of normal biological processes, 4 | |
| 28 | - | ||
| 29 | - | ||
| 30 | - | (2) "Biomarker testing" means the analysis of a patient's tissue, 7 | |
| 31 | - | ||
| 32 | - | ||
| 33 | - | ||
| 27 | + | and evaluated as an indicator of normal biological processes, pathogenic 4 | |
| 28 | + | processes or pharmacologic responses to a specific therapeutic 5 | |
| 29 | + | intervention for a disease or condition. 6 | |
| 30 | + | (2) "Biomarker testing" means the analysis of a patient's tissue, blood 7 | |
| 31 | + | or other biospecimen for the presence of a biomarker, including, but not 8 | |
| 32 | + | limited to, tests for a single substance, tests for multiple substances, 9 | |
| 33 | + | diseases or conditions, and whole genome sequencing. 10 | |
| 34 | 34 | (3) "Consensus statements" means statements developed by an 11 | |
| 35 | 35 | independent, multidisciplinary panel of experts utilizing a transparent 12 | |
| 36 | 36 | methodology and reporting structure and with a conflict-of-interest 13 | |
| 37 | - | policy that are aimed at (A) specific clinical circumstances, and (B) 14 | |
| 38 | - | based on the best available evidence for the purpose of optimizing 15 Bill No. 6628 | |
| 37 | + | policy that are aimed at (A) specific clinical circumstances, and (B) based 14 Raised Bill No. 6628 | |
| 39 | 38 | ||
| 40 | 39 | ||
| 41 | - | LCO 3675 {\\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06628- | |
| 42 | - | R01-HB.docx } | |
| 43 | - | 2 of 3 | |
| 44 | 40 | ||
| 45 | - | clinical care outcomes. 16 | |
| 41 | + | LCO No. 3675 2 of 3 | |
| 42 | + | ||
| 43 | + | on the best available evidence for the purpose of optimizing clinical care 15 | |
| 44 | + | outcomes. 16 | |
| 46 | 45 | (4) "Nationally recognized clinical practice guidelines" means 17 | |
| 47 | 46 | evidence-based guidelines developed by independent organizations or 18 | |
| 48 | 47 | medical professional societies utilizing transparent methodologies and 19 | |
| 49 | 48 | reporting structures and conflict-of-interest policies that (A) establish 20 | |
| 50 | 49 | standards of care informed by a systematic review of evidence and 21 | |
| 51 | - | assessments of the benefits and costs of alternative care options, and 22 | |
| 52 | - | ||
| 50 | + | assessments of the benefits and costs of alternative care options, and (B) 22 | |
| 51 | + | include recommendations intended to optimize patient care. 23 | |
| 53 | 52 | (b) The Commissioner of Social Services, to the extent permissible 24 | |
| 54 | 53 | under federal law, shall provide coverage for biomarker testing for the 25 | |
| 55 | 54 | purpose of diagnosis, treatment, appropriate management or ongoing 26 | |
| 56 | 55 | monitoring of a Medicaid enrollee's disease or condition. The 27 | |
| 57 | 56 | commissioner shall condition such coverage on medical and scientific 28 | |
| 58 | - | evidence supporting such test, including, but not limited to (1) 29 | |
| 59 | - | ||
| 57 | + | evidence supporting such test, including, but not limited to (1) approval 29 | |
| 58 | + | of such test by the federal Food and Drug Administration or 30 | |
| 60 | 59 | recommendations on labels of drugs approved by the federal Food and 31 | |
| 61 | 60 | Drug Administration to conduct such test, (2) national coverage 32 | |
| 62 | 61 | determinations or local coverage determinations for Medicare 33 | |
| 63 | 62 | Administrative Contractors by the Centers for Medicare and Medicaid 34 | |
| 64 | 63 | Services, or (3) nationally recognized clinical practice guidelines and 35 | |
| 65 | 64 | consensus statements. 36 | |
| 66 | 65 | (c) The Commissioner of Social Services shall provide online access 37 | |
| 67 | 66 | to a Medicaid enrollee and a Medicaid provider to a clear, readily 38 | |
| 68 | 67 | accessible and convenient process to request an exception to a prior 39 | |
| 69 | 68 | authorization requirement or other coverage policy provision for 40 | |
| 70 | 69 | biomarker testing. 41 | |
| 71 | 70 | This act shall take effect as follows and shall amend the following | |
| 72 | 71 | sections: | |
| 73 | 72 | ||
| 74 | 73 | Section 1 July 1, 2023 New section | |
| 75 | - | ||
| 76 | - | HS Joint Favorable C/R APP Bill No. 6628 | |
| 74 | + | Raised Bill No. 6628 | |
| 77 | 75 | ||
| 78 | 76 | ||
| 79 | - | LCO 3675 {\\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06628- | |
| 80 | - | R01-HB.docx } | |
| 81 | - | 3 of 3 | |
| 82 | 77 | ||
| 78 | + | LCO No. 3675 3 of 3 | |
| 79 | + | ||
| 80 | + | Statement of Purpose: | |
| 81 | + | To improve treatments for cancer and other conditions and diseases by | |
| 82 | + | approving Medicaid coverage for biomarker testing. | |
| 83 | + | [Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except | |
| 84 | + | that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not | |
| 85 | + | underlined.] | |
| 83 | 86 |