AB382 - Revises provisions relating to health insurance coverage for biomarker testing. (BDR 57-913)

A.B. 382 - *AB382* ASSEMBLY BILL NO. 382–ASSEMBLYMEMBERS FLANAGAN; DALIA, DICKMAN, EDGEWORTH, GONZÁLEZ, GOULDING, GRAY, JACKSON, KARRIS, KASAMA, LA RUE HATCH, NGUYEN AND ORENTLICHER MARCH 10, 2025 ____________ JOINT SPONSORS: SENATORS NGUYEN, OHRENSCHALL AND PAZINA ____________ Referred to Committee on Commerce and Labor SUMMARY—Revises provisions relating to health insurance coverage for biomarker testing. (BDR 57-913) FISCAL NOTE: Effect on Local Government: May have Fiscal Impact. Effect on the State: Yes. CONTAINS UNFUNDED MANDATE (§ 2 & NRS 287.010) (NOT REQUESTED BY AFFECTED LOCAL GOVERNMENT) ~ EXPLANATION – Matter in bolded italics is new; matter between brackets [omitted material] is material to be omitted. AN ACT relating to insurance; expanding the scope of required insurance coverage for biomarker testing; and providing other matters properly relating thereto. Legislative Counsel’s Digest: Existing law requires certain public and private health plans, including 1 Medicaid and health plans for state and local employees to provide coverage, in 2 certain circumstances, for medically necessary biomarker testing for the diagnosis, 3 treatment, appropriate management and ongoing monitoring of cancer when such 4 biomarker testing is supported by medical evidence. (NRS 287.010, 287.04335, 5 422.272364, 689A.0446, 689B.0361, 695C.050, 689C.1688, 695A.1859, 6 695B.19087, 695C.16932, 695G.1703) This bill removes the limitations that such 7 coverage is only required if the biomarker testing is: (1) medically necessary; and 8 (2) for the diagnosis, treatment, appropriate management and ongoing monitoring 9 of cancer. This bill thus requires public and private health plans to cover any 10 biomarker testing for the diagnosis, treatment, appropriate management and 11 ongoing management of a medical condition or disease when such biomarker 12 testing is supported by medical evidence, regardless of whether the biomarker 13 testing is determined to be medically necessary. 14 – 2 – - *AB382* THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS: Section 1. NRS 689A.0446 is hereby amended to read as 1 follows: 2 689A.0446 1. Subject to the limitations prescribed by 3 subsection 4, an insurer that issues a policy of health insurance shall 4 include in the policy coverage for [medically necessary] biomarker 5 testing for the diagnosis, treatment, appropriate management and 6 ongoing monitoring of [cancer] a medical condition or disease 7 when such biomarker testing is supported by medical and scientific 8 evidence. Such evidence includes, without limitation: 9 (a) The labeled indications for a biomarker test or medication 10 that has been approved or cleared by the United States Food and 11 Drug Administration; 12 (b) The indicated tests for a drug that has been approved by the 13 United States Food and Drug Administration or the warnings and 14 precautions included on the label of such a drug; 15 (c) A national coverage determination or local coverage 16 determination, as those terms are defined in 42 C.F.R. § 400.202; or 17 (d) Nationally recognized clinical practice guidelines or 18 consensus statements. 19 2. An insurer shall: 20 (a) Provide the coverage required by subsection 1 in a manner 21 that limits disruptions in care and the need for multiple specimens; 22 (b) Establish a clear and readily accessible process for an 23 insured or provider of health care to: 24 (1) Request an exception to a policy excluding coverage for 25 biomarker testing for the diagnosis, treatment, management or 26 ongoing monitoring of [cancer;] a medical condition or disease; or 27 (2) Appeal a denial of coverage for such biomarker testing; 28 and 29 (c) Make the process described in paragraph (b) available on an 30 Internet website maintained by the insurer. 31 3. If an insurer requires an insured to obtain prior authorization 32 for a biomarker test described in subsection 1, the insurer shall 33 respond to a request for such prior authorization: 34 (a) Within 24 hours after receiving an urgent request; or 35 (b) Within 72 hours after receiving any other request. 36 4. The provisions of this section do not require an insurer to 37 provide coverage of biomarker testing: 38 (a) For screening purposes; 39 (b) Conducted by a provider of health care for whom the 40 biomarker testing is not within his or her scope of practice, training 41 and experience; or 42 – 3 – - *AB382* (c) Conducted by a provider of health care or a facility that does 1 not participate in the network plan of the insurer . [; or 2 (d) That has not been determined to be medically necessary by a 3 provider of health care for whom such a determination is within his 4 or her scope of practice, training and experience.] 5 5. A policy of health insurance subject to the provisions of this 6 chapter that is delivered, issued for delivery or renewed on or after 7 [October] January 1, [2023,] 2026, has the legal effect of including 8 the coverage required by this section, and any provision of the 9 policy or renewal which is in conflict with the provisions of this 10 section is void. 11 6. As used in this section: 12 (a) “Biomarker” means a characteristic that is objectively 13 measured and evaluated as an indicator of a normal biological 14 process, a pathogenic process or a pharmacological response to a 15 specific therapeutic intervention and includes, without limitation: 16 (1) An interaction between a gene and a drug that is being 17 used by or considered for use by the patient; 18 (2) A mutation or characteristic of a gene; and 19 (3) The expression of a protein. 20 (b) “Biomarker testing” means the analysis of the tissue, blood 21 or other biospecimen of a patient for the presentation of a biomarker 22 and includes, without limitation, single-analyte tests, multiplex 23 panel tests and whole genome, whole exome and whole 24 transcriptome sequencing. 25 (c) “Consensus statement” means a statement aimed at a specific 26 clinical circumstance that is: 27 (1) Made for the purpose of optimizing the outcomes of 28 clinical care; 29 (2) Made by an independent, multidisciplinary panel of 30 experts that has established a policy to avoid conflicts of interest; 31 (3) Based on scientific evidence; and 32 (4) Made using a transparent methodology and reporting 33 procedure. 34 (d) [“Medically necessary” means health care services or 35 products that a prudent provider of health care would provide to a 36 patient to prevent, diagnose or treat an illness, injury or disease, or 37 any symptoms thereof, that are necessary and: 38 (1) Provided in accordance with generally accepted standards 39 of medical practice; 40 (2) Not primarily provided for the convenience of the patient 41 or provider of health care; and 42 (3) Significant in guiding and informing the provider of 43 health care in providing the most appropriate course of treatment for 44 – 4 – - *AB382* the patient in order to prevent, delay or lessen the magnitude of an 1 adverse health outcome. 2 (e)] “Nationally recognized clinical practice guidelines” means 3 evidence-based guidelines establishing standards of care that 4 include, without limitation, recommendations intended to optimize 5 care of patients and are: 6 (1) Informed by a systemic review of evidence and an 7 assessment of the risks and benefits of alternative options for care; 8 and 9 (2) Developed using a transparent methodology and 10 reporting procedure by an independent organization or society of 11 medical professionals that has established a policy to avoid conflicts 12 of interest. 13 [(f)] (e) “Network plan” means a policy of health insurance 14 offered by an insurer under which the financing and delivery of 15 medical care, including items and services paid for as medical care, 16 are provided, in whole or in part, through a defined set of providers 17 under contract with the insurer. The term does not include an 18 arrangement for the financing of premiums. 19 [(g)] (f) “Provider of health care” has the meaning ascribed to it 20 in NRS 629.031. 21 Sec. 2. NRS 689B.0361 is hereby amended to read as follows: 22 689B.0361 1. Subject to the limitations prescribed by 23 subsection 4, an insurer that issues a policy of group health 24 insurance shall include in the policy coverage for [medically 25 necessary] biomarker testing for the diagnosis, treatment, 26 appropriate management and ongoing monitoring of [cancer] a 27 medical condition or disease when such biomarker testing is 28 supported by medical and scientific evidence. Such evidence 29 includes, without limitation: 30 (a) The labeled indications for a biomarker test or medication 31 that has been approved or cleared by the United States Food and 32 Drug Administration; 33 (b) The indicated tests for a drug that has been approved by the 34 United States Food and Drug Administration or the warnings and 35 precautions included on the label of such a drug; 36 (c) A national coverage determination or local coverage 37 determination, as those terms are defined in 42 C.F.R. § 400.202; or 38 (d) Nationally recognized clinical practice guidelines or 39 consensus statements. 40 2. An insurer shall: 41 (a) Provide the coverage required by subsection 1 in a manner 42 that limits disruptions in care and the need for multiple specimens; 43 (b) Establish a clear and readily accessible process for an 44 insured or provider of health care to: 45 – 5 – - *AB382* (1) Request an exception to a policy excluding coverage for 1 biomarker testing for the diagnosis, treatment, management or 2 ongoing monitoring of [cancer;] a medical condition or disease; or 3 (2) Appeal a denial of coverage for such biomarker testing; 4 and 5 (c) Make the process described in paragraph (b) available on an 6 Internet website maintained by the insurer. 7 3. If an insurer requires an insured to obtain prior authorization 8 for a biomarker test described in subsection 1, the insurer shall 9 respond to a request for such prior authorization: 10 (a) Within 24 hours after receiving an urgent request; or 11 (b) Within 72 hours after receiving any other request. 12 4. The provisions of this section do not require an insurer to 13 provide coverage of biomarker testing: 14 (a) For screening purposes; 15 (b) Conducted by a provider of health care for whom the 16 biomarker testing is not within his or her scope of practice, training 17 and experience; or 18 (c) Conducted by a provider of health care or a facility that does 19 not participate in the network plan of the insurer . [; or 20 (d) That has not been determined to be medically necessary by a 21 provider of health care for whom such a determination is within his 22 or her scope of practice, training and experience.] 23 5. A policy of group health insurance subject to the provisions 24 of this chapter that is delivered, issued for delivery or renewed on or 25 after [October] January 1, [2023,] 2026, has the legal effect of 26 including the coverage required by this section, and any provision of 27 the policy or renewal which is in conflict with the provisions of this 28 section is void. 29 6. As used in this section: 30 (a) “Biomarker” means a characteristic that is objectively 31 measured and evaluated as an indicator of a normal biological 32 process, a pathogenic process or a pharmacological response to a 33 specific therapeutic intervention and includes, without limitation: 34 (1) An interaction between a gene and a drug that is being 35 used by or considered for use by the patient; 36 (2) A mutation or characteristic of a gene; and 37 (3) The expression of a protein. 38 (b) “Biomarker testing” means the analysis of the tissue, blood 39 or other biospecimen of a patient for the presentation of a biomarker 40 and includes, without limitation, single-analyte tests, multiplex 41 panel tests and whole genome, whole exome and whole 42 transcriptome sequencing. 43 (c) “Consensus statement” means a statement aimed at a specific 44 clinical circumstance that is: 45 – 6 – - *AB382* (1) Made for the purpose of optimizing the outcomes of 1 clinical care; 2 (2) Made by an independent, multidisciplinary panel of 3 experts that has established a policy to avoid conflicts of interest; 4 (3) Based on scientific evidence; and 5 (4) Made using a transparent methodology and reporting 6 procedure. 7 (d) [“Medically necessary” means health care services or 8 products that a prudent provider of health care would provide to a 9 patient to prevent, diagnose or treat an illness, injury or disease, or 10 any symptoms thereof, that are necessary and: 11 (1) Provided in accordance with generally accepted standards 12 of medical practice; 13 (2) Not primarily provided for the convenience of the patient 14 or provider of health care; and 15 (3) Significant in guiding and informing the provider of 16 health care in providing the most appropriate course of treatment for 17 the patient in order to prevent, delay or lessen the magnitude of an 18 adverse health outcome. 19 (e)] “Nationally recognized clinical practice guidelines” means 20 evidence-based guidelines establishing standards of care that 21 include, without limitation, recommendations intended to optimize 22 care of patients and are: 23 (1) Informed by a systemic review of evidence and an 24 assessment of the risks and benefits of alternative options for care; 25 and 26 (2) Developed using a transparent methodology and 27 reporting procedure by an independent organization or society of 28 medical professionals that has established a policy to avoid conflicts 29 of interest. 30 [(f)] (e) “Network plan” means a policy of group health 31 insurance offered by an insurer under which the financing and 32 delivery of medical care, including items and services paid for as 33 medical care, are provided, in whole or in part, through a defined set 34 of providers under contract with the insurer. The term does not 35 include an arrangement for the financing of premiums. 36 [(g)] (f) “Provider of health care” has the meaning ascribed to it 37 in NRS 629.031. 38 Sec. 3. NRS 689C.1688 is hereby amended to read as follows: 39 689C.1688 1. [Text truncated for display. Full text available on LegiScan.]