| 47 | 48 | | |
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| 48 | 49 | | |
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| 49 | 50 | | |
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| 50 | 51 | | An Act |
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| 51 | 52 | | |
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| 52 | 53 | | |
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| 53 | 54 | | |
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| 54 | 55 | | amending sections 20-1376.10 and 20-1406.10, Arizona Revised Statutes; relating to biomarker testing. |
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| 56 | 57 | | |
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| 59 | 60 | | |
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| 60 | 61 | | (TEXT OF BILL BEGINS ON NEXT PAGE) |
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| 62 | 63 | | |
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| 63 | 64 | | |
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| 64 | 65 | | Be it enacted by the Legislature of the State of Arizona: Section 1. Section 20-1376.10, Arizona Revised Statutes, is amended to read: START_STATUTE20-1376.10. Biomarker testing; coverage; definitions A. A disability insurer that issues, amends, delivers or renews a policy on or after January 1, 2023 shall provide coverage for biomarker testing. B. A policy shall cover biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of an insured's disease or condition to guide treatment decisions when the test provides clinical utility as demonstrated by medical and scientific evidence, including any of the following: 1. Labeled indications for tests that are approved or cleared by the United States food and drug administration or indicated tests for a drug that is approved by the United States food and drug administration. 2. Centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations. 3. Nationally recognized clinical practice guidelines and consensus statements. C. A disability insurer must ensure that coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. D. The insured and prescribing practitioner must have access to a clear, readily accessible and convenient process to request an exception to a coverage policy of a disability insurer. The process shall be readily accessible on the disability insurer's website. This subsection does not require a separate process if the disability insurer's existing process complies with this subsection. E. A policy that is issued or renewed by a disability insurer does not include a policy that provides limited benefit coverage as defined in section 20-1137. E. F. For the purposes of this section: 1. "Biomarker": (a) Means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a specific therapeutic intervention. (b) Includes gene mutations or protein expression. 2. "Biomarker testing": (a) Means the analysis of a patient's tissue, blood or other biospecimen for the presence of a biomarker. (b) Includes single-analyte tests, multiplex panel tests and whole genome sequencing. 3. "Clinical utility" means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patients outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision. 4. "Consensus statements" means statements that are all of the following: (a) Are Developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure that includes a conflict of interest policy. (b) Are Based on the best available evidence for the purpose of optimizing clinical care outcomes. (c) Are Aimed at specific clinical circumstances. 5. "Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that both: (a) Are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and a conflict of interest policy. (b) Establish standards of care that are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options that includes recommendations intended to optimize patient care. END_STATUTE Sec. 2. Section 20-1406.10, Arizona Revised Statutes, is amended to read: START_STATUTE20-1406.10. Biomarker testing; coverage; definitions A. A group or blanket disability insurer that issues, amends, delivers or renews a policy on or after January 1, 2023 shall provide coverage for biomarker testing. B. A policy shall cover biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of an insured's disease or condition to guide treatment decisions when the test provides clinical utility as demonstrated by medical and scientific evidence, including any of the following: 1. Labeled indications for tests that are approved or cleared by the United States food and drug administration or indicated tests for a drug that is approved by the United States food and drug administration. 2. Centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations. 3. Nationally recognized clinical practice guidelines and consensus statements. C. A group or blanket disability insurer must ensure coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. D. The insured and prescribing practitioner must have access to a clear, readily accessible and convenient process to request an exception to a coverage policy of a group or blanket disability insurer. The process shall be readily accessible on a the group or blanket disability insurer's website. This subsection does not require a separate process if the group or blanket disability insurer's existing process complies with this subsection. E. A policy that is issued or renewed by a GROUP or blanket disability insurer does not include a policy that provides a limited benefit coverage as defined in section 20-1137. E. F. For the purposes of this section: 1. "Biomarker": (a) Means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a specific therapeutic intervention. (b) Includes gene mutations or protein expression. 2. "Biomarker testing": (a) Means the analysis of a patient's tissue, blood or other biospecimen for the presence of a biomarker. (b) Includes single-analyte tests, multiplex panel tests and whole genome sequencing. 3. "Clinical utility" means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patients outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision. 4. "Consensus statements" means statements that are all of the following: (a) Are Developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure that includes a conflict of interest policy. (b) Are Based on the best available evidence for the purpose of optimizing clinical care outcomes. (c) Are Aimed at specific clinical circumstances. 5. "Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that both: (a) Are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and a conflict of interest policy. (b) Establish standards of care that are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options that includes recommendations intended to optimize patient care. END_STATUTE |
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| 65 | 66 | | |
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| 66 | 67 | | Be it enacted by the Legislature of the State of Arizona: |
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| 67 | 68 | | |
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| 68 | 69 | | Section 1. Section 20-1376.10, Arizona Revised Statutes, is amended to read: |
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| 69 | 70 | | |
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| 70 | 71 | | START_STATUTE20-1376.10. Biomarker testing; coverage; definitions |
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| 71 | 72 | | |
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| 72 | 73 | | A. A disability insurer that issues, amends, delivers or renews a policy on or after January 1, 2023 shall provide coverage for biomarker testing. |
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| 73 | 74 | | |
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| 74 | 75 | | B. A policy shall cover biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of an insured's disease or condition to guide treatment decisions when the test provides clinical utility as demonstrated by medical and scientific evidence, including any of the following: |
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| 75 | 76 | | |
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| 76 | 77 | | 1. Labeled indications for tests that are approved or cleared by the United States food and drug administration or indicated tests for a drug that is approved by the United States food and drug administration. |
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| 77 | 78 | | |
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| 78 | 79 | | 2. Centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations. |
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| 79 | 80 | | |
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| 80 | 81 | | 3. Nationally recognized clinical practice guidelines and consensus statements. |
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| 81 | 82 | | |
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| 82 | 83 | | C. A disability insurer must ensure that coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. |
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| 83 | 84 | | |
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| 84 | 85 | | D. The insured and prescribing practitioner must have access to a clear, readily accessible and convenient process to request an exception to a coverage policy of a disability insurer. The process shall be readily accessible on the disability insurer's website. This subsection does not require a separate process if the disability insurer's existing process complies with this subsection. |
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| 85 | 86 | | |
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| 86 | 87 | | E. A policy that is issued or renewed by a disability insurer does not include a policy that provides limited benefit coverage as defined in section 20-1137. |
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| 87 | 88 | | |
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| 88 | 89 | | E. F. For the purposes of this section: |
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| 89 | 90 | | |
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| 90 | 91 | | 1. "Biomarker": |
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| 91 | 92 | | |
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| 92 | 93 | | (a) Means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a specific therapeutic intervention. |
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| 93 | 94 | | |
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| 94 | 95 | | (b) Includes gene mutations or protein expression. |
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| 95 | 96 | | |
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| 96 | 97 | | 2. "Biomarker testing": |
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| 97 | 98 | | |
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| 98 | 99 | | (a) Means the analysis of a patient's tissue, blood or other biospecimen for the presence of a biomarker. |
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| 99 | 100 | | |
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| 100 | 101 | | (b) Includes single-analyte tests, multiplex panel tests and whole genome sequencing. |
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| 101 | 102 | | |
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| 102 | 103 | | 3. "Clinical utility" means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patients outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision. |
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| 103 | 104 | | |
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| 104 | 105 | | 4. "Consensus statements" means statements that are all of the following: |
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| 105 | 106 | | |
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| 106 | 107 | | (a) Are Developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure that includes a conflict of interest policy. |
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| 107 | 108 | | |
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| 108 | 109 | | (b) Are Based on the best available evidence for the purpose of optimizing clinical care outcomes. |
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| 109 | 110 | | |
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| 110 | 111 | | (c) Are Aimed at specific clinical circumstances. |
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| 111 | 112 | | |
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| 112 | 113 | | 5. "Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that both: |
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| 113 | 114 | | |
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| 114 | 115 | | (a) Are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and a conflict of interest policy. |
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| 115 | 116 | | |
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| 116 | 117 | | (b) Establish standards of care that are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options that includes recommendations intended to optimize patient care. END_STATUTE |
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| 117 | 118 | | |
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| 118 | 119 | | Sec. 2. Section 20-1406.10, Arizona Revised Statutes, is amended to read: |
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| 119 | 120 | | |
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| 120 | 121 | | START_STATUTE20-1406.10. Biomarker testing; coverage; definitions |
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| 121 | 122 | | |
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| 122 | 123 | | A. A group or blanket disability insurer that issues, amends, delivers or renews a policy on or after January 1, 2023 shall provide coverage for biomarker testing. |
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| 123 | 124 | | |
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| 124 | 125 | | B. A policy shall cover biomarker testing for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of an insured's disease or condition to guide treatment decisions when the test provides clinical utility as demonstrated by medical and scientific evidence, including any of the following: |
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| 125 | 126 | | |
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| 126 | 127 | | 1. Labeled indications for tests that are approved or cleared by the United States food and drug administration or indicated tests for a drug that is approved by the United States food and drug administration. |
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| 127 | 128 | | |
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| 128 | 129 | | 2. Centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations. |
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| 129 | 130 | | |
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| 130 | 131 | | 3. Nationally recognized clinical practice guidelines and consensus statements. |
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| 131 | 132 | | |
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| 132 | 133 | | C. A group or blanket disability insurer must ensure coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. |
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| 133 | 134 | | |
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| 134 | 135 | | D. The insured and prescribing practitioner must have access to a clear, readily accessible and convenient process to request an exception to a coverage policy of a group or blanket disability insurer. The process shall be readily accessible on a the group or blanket disability insurer's website. This subsection does not require a separate process if the group or blanket disability insurer's existing process complies with this subsection. |
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| 135 | 136 | | |
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| 136 | 137 | | E. A policy that is issued or renewed by a GROUP or blanket disability insurer does not include a policy that provides a limited benefit coverage as defined in section 20-1137. |
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| 137 | 138 | | |
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| 138 | 139 | | E. F. For the purposes of this section: |
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| 139 | 140 | | |
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| 140 | 141 | | 1. "Biomarker": |
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| 141 | 142 | | |
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| 142 | 143 | | (a) Means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a specific therapeutic intervention. |
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| 143 | 144 | | |
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| 144 | 145 | | (b) Includes gene mutations or protein expression. |
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| 145 | 146 | | |
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| 146 | 147 | | 2. "Biomarker testing": |
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| 147 | 148 | | |
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| 148 | 149 | | (a) Means the analysis of a patient's tissue, blood or other biospecimen for the presence of a biomarker. |
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| 149 | 150 | | |
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| 150 | 151 | | (b) Includes single-analyte tests, multiplex panel tests and whole genome sequencing. |
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| 151 | 152 | | |
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| 152 | 153 | | 3. "Clinical utility" means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patients outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision. |
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| 153 | 154 | | |
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| 154 | 155 | | 4. "Consensus statements" means statements that are all of the following: |
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| 155 | 156 | | |
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| 156 | 157 | | (a) Are Developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure that includes a conflict of interest policy. |
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| 157 | 158 | | |
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| 158 | 159 | | (b) Are Based on the best available evidence for the purpose of optimizing clinical care outcomes. |
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| 159 | 160 | | |
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| 160 | 161 | | (c) Are Aimed at specific clinical circumstances. |
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| 161 | 162 | | |
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| 162 | 163 | | 5. "Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that both: |
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| 163 | 164 | | |
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| 164 | 165 | | (a) Are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and a conflict of interest policy. |
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| 165 | 166 | | |
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| 166 | 167 | | (b) Establish standards of care that are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options that includes recommendations intended to optimize patient care. END_STATUTE |
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