HOUSE OF REPRESENTATIVES H.C.R. NO. 35 THIRTY-THIRD LEGISLATURE, 2025 STATE OF HAWAII HOUSE CONCURRENT RESOLUTION requesting the auditor to assess the social and financial effects of mandatory health insurance coverage for biomarker testing. HOUSE OF REPRESENTATIVES H.C.R. NO. 35 THIRTY-THIRD LEGISLATURE, 2025 STATE OF HAWAII HOUSE OF REPRESENTATIVES H.C.R. NO. 35 THIRTY-THIRD LEGISLATURE, 2025 STATE OF HAWAII HOUSE CONCURRENT RESOLUTION requesting the auditor to assess the social and financial effects of mandatory health insurance coverage for biomarker testing. WHEREAS, biomarker testing is an invaluable tool in the diagnosis, treatment, appropriate management, and ongoing monitoring of diseases or conditions; and WHEREAS, biomarker testing is the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker; and WHEREAS, biomarkers are characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to specific therapeutic interventions, including known gene-drug interactions for medications being considered for use or already being administered, and includes gene mutations, gene characteristics, and protein expression; and WHEREAS, biomarker tests have many different uses in clinical practice, including: (1) Disease screening tests, such as prostate-specific antigen; (2) Diagnostic tests, such as pathologic or histologic assessment of a tissue biopsy; (3) Predictive tests, which are used to predict patient response to specific treatments; (4) Treatment and posttreatment monitoring tests, which detect treatment complications or subsequent disease advancement; and (5) Prognostic tests for estimating risk or time to clinical outcomes: for example, aggressive cancers have a poorer prognosis than more indolent cancers; and WHEREAS, the predictive biomarker tests are used by health care providers to tailor treatment to a patient's clinical condition and treatment goals, leading to more effective and targeted interventions; and WHEREAS, biomarker tests are used to diagnose and tailor treatments for a number of diseases and conditions, including Alzheimer's disease, amyotrophic lateral sclerosis (also known as Lou Gehrig's disease), cancers (specifically, breast cancer, melanoma, ovarian cancer, pancreatic cancer, and prostate cancer), hyperlipidemia, hypertension, lupus, Parkinson's disease, preeclampsia, rheumatoid arthritis, and sickle cell disease; and WHEREAS, despite the fact that biomarker testing is essential to high-quality, personalized care to treat serious illness and enhance patients' quality of life, patients cannot easily access it; and WHEREAS, to address this restrictive access, House Bill No. 2223, H.D. 1, Regular Session of 2024 (HB2223 H.D. 1), required insurers, mutual benefit societies, and health maintenance organizations to provide coverage for medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition to guide treatment decisions when supported by medical and scientific evidence; and WHEREAS, the Legislature adopted House Concurrent Resolution No. 53, Regular Session of 2024 (HCR53), to fulfill the requirements of sections 23-51 and 23-52, Hawaii Revised Statutes, that require a concurrent resolution be passed for the Auditor to review and prepare a report assessing the social and financial effects of a proposed mandated health insurance coverage as proposed in HB2223 H.D. 1; and WHEREAS, in accordance with HCR53, the Auditor issued Report No. 25-01, "Assessment of Proposed Mandatory Health Insurance Coverage for Medically Necessary Biomarker Testing," in which the Auditor determined that there would be "no social or financial impacts caused by the mandate requiring that health insurance policies provide coverage for medically necessary biomarker testing" as proposed in HB2223 H.D. 1; and WHEREAS, the Auditor's determination was based on the responses by insurers stating that "their policies are already required to include coverage for medically necessary biomarker testing"; and WHEREAS, barriers to access still persist as insurers may delay determinations of a biomarker test's medical necessity or deny coverage of the test, further requiring the patient to either pay for the costs out-of-pocket or appeal the denial; and WHEREAS, accordingly, the coverage for biomarker tests should not be limited to when such tests are deemed to be medically necessary by the insurer's medical director, when the patient's health care provider, after assessing the patient and reviewing medical and scientific evidence, has already concluded that a test would be appropriate in the patient's circumstances; and WHEREAS, section 23-51, Hawaii Revised Statutes, requires that "[b]efore any legislative measure that mandates health insurance coverage for specific health services, specific diseases, or certain providers of health care services as part of individual or group health insurance policies, can be considered, there shall be concurrent resolutions passed requesting the auditor to prepare and submit to the legislature a report that assesses both the social and financial effects of the proposed mandated coverage"; and WHEREAS, section 23-51, Hawaii Revised Statutes, further provides that "[t]he concurrent resolutions shall designate a specific legislative bill that: (1) Has been introduced in the legislature; and (2) Includes, at a minimum, information identifying the: (A) Specific health service, disease, or provider that would be covered; (B) Extent of the coverage; (C) Target groups that would be covered; (D) Limitations on utilization, if any; and (E) Standards of care. For purposes of this part, mandated health insurance coverage shall not include mandated optionals."; and WHEREAS, section 23-52, Hawaii Revised Statutes, further specifies the minimum information required for assessing the social and financial impact of the proposed health coverage mandate in the Auditor's report; and WHEREAS, House Bill No. 553, H.D. 1, Regular Session of 2025, requires insurers, mutual benefit societies, and health maintenance organizations to provide coverage, beginning January 1, 2026, for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition to guide treatment decisions when supported by medical and scientific evidence; now, therefore, BE IT RESOLVED by the House of Representatives of the Thirty-third Legislature of the State of Hawaii, Regular Session of 2025, the Senate concurring, that the Auditor is requested to assess the social and financial effects of mandating health insurance coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition to guide treatment decisions when supported by medical and scientific evidence, as provided in House Bill No. 553, H.D. 1, Regular Session of 2025; and BE IT FURTHER RESOLVED that the Auditor is requested to submit a report of its findings and recommendations, including any proposed legislation, to the Legislature no later than twenty days prior to the convening of the Regular Session of 2026; and BE IT FURTHER RESOLVED that certified copies of this Concurrent Resolution be transmitted to the Auditor, Director of Commerce and Consumer Affairs, and Insurance Commissioner. OFFERED BY: _____________________________ WHEREAS, biomarker testing is an invaluable tool in the diagnosis, treatment, appropriate management, and ongoing monitoring of diseases or conditions; and WHEREAS, biomarker testing is the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker; and WHEREAS, biomarkers are characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to specific therapeutic interventions, including known gene-drug interactions for medications being considered for use or already being administered, and includes gene mutations, gene characteristics, and protein expression; and WHEREAS, biomarker tests have many different uses in clinical practice, including: (1) Disease screening tests, such as prostate-specific antigen; (2) Diagnostic tests, such as pathologic or histologic assessment of a tissue biopsy; (3) Predictive tests, which are used to predict patient response to specific treatments; (4) Treatment and posttreatment monitoring tests, which detect treatment complications or subsequent disease advancement; and (5) Prognostic tests for estimating risk or time to clinical outcomes: for example, aggressive cancers have a poorer prognosis than more indolent cancers; and WHEREAS, the predictive biomarker tests are used by health care providers to tailor treatment to a patient's clinical condition and treatment goals, leading to more effective and targeted interventions; and WHEREAS, biomarker tests are used to diagnose and tailor treatments for a number of diseases and conditions, including Alzheimer's disease, amyotrophic lateral sclerosis (also known as Lou Gehrig's disease), cancers (specifically, breast cancer, melanoma, ovarian cancer, pancreatic cancer, and prostate cancer), hyperlipidemia, hypertension, lupus, Parkinson's disease, preeclampsia, rheumatoid arthritis, and sickle cell disease; and WHEREAS, despite the fact that biomarker testing is essential to high-quality, personalized care to treat serious illness and enhance patients' quality of life, patients cannot easily access it; and WHEREAS, to address this restrictive access, House Bill No. 2223, H.D. 1, Regular Session of 2024 (HB2223 H.D. 1), required insurers, mutual benefit societies, and health maintenance organizations to provide coverage for medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition to guide treatment decisions when supported by medical and scientific evidence; and WHEREAS, the Legislature adopted House Concurrent Resolution No. 53, Regular Session of 2024 (HCR53), to fulfill the requirements of sections 23-51 and 23-52, Hawaii Revised Statutes, that require a concurrent resolution be passed for the Auditor to review and prepare a report assessing the social and financial effects of a proposed mandated health insurance coverage as proposed in HB2223 H.D. 1; and WHEREAS, in accordance with HCR53, the Auditor issued Report No. 25-01, "Assessment of Proposed Mandatory Health Insurance Coverage for Medically Necessary Biomarker Testing," in which the Auditor determined that there would be "no social or financial impacts caused by the mandate requiring that health insurance policies provide coverage for medically necessary biomarker testing" as proposed in HB2223 H.D. 1; and WHEREAS, the Auditor's determination was based on the responses by insurers stating that "their policies are already required to include coverage for medically necessary biomarker testing"; and WHEREAS, barriers to access still persist as insurers may delay determinations of a biomarker test's medical necessity or deny coverage of the test, further requiring the patient to either pay for the costs out-of-pocket or appeal the denial; and WHEREAS, accordingly, the coverage for biomarker tests should not be limited to when such tests are deemed to be medically necessary by the insurer's medical director, when the patient's health care provider, after assessing the patient and reviewing medical and scientific evidence, has already concluded that a test would be appropriate in the patient's circumstances; and WHEREAS, section 23-51, Hawaii Revised Statutes, requires that "[b]efore any legislative measure that mandates health insurance coverage for specific health services, specific diseases, or certain providers of health care services as part of individual or group health insurance policies, can be considered, there shall be concurrent resolutions passed requesting the auditor to prepare and submit to the legislature a report that assesses both the social and financial effects of the proposed mandated coverage"; and WHEREAS, section 23-51, Hawaii Revised Statutes, further provides that "[t]he concurrent resolutions shall designate a specific legislative bill that: (1) Has been introduced in the legislature; and (2) Includes, at a minimum, information identifying the: (A) Specific health service, disease, or provider that would be covered; (B) Extent of the coverage; (C) Target groups that would be covered; (D) Limitations on utilization, if any; and (E) Standards of care. For purposes of this part, mandated health insurance coverage shall not include mandated optionals."; and WHEREAS, section 23-52, Hawaii Revised Statutes, further specifies the minimum information required for assessing the social and financial impact of the proposed health coverage mandate in the Auditor's report; and WHEREAS, House Bill No. 553, H.D. 1, Regular Session of 2025, requires insurers, mutual benefit societies, and health maintenance organizations to provide coverage, beginning January 1, 2026, for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition to guide treatment decisions when supported by medical and scientific evidence; now, therefore, BE IT RESOLVED by the House of Representatives of the Thirty-third Legislature of the State of Hawaii, Regular Session of 2025, the Senate concurring, that the Auditor is requested to assess the social and financial effects of mandating health insurance coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition to guide treatment decisions when supported by medical and scientific evidence, as provided in House Bill No. 553, H.D. 1, Regular Session of 2025; and BE IT FURTHER RESOLVED that the Auditor is requested to submit a report of its findings and recommendations, including any proposed legislation, to the Legislature no later than twenty days prior to the convening of the Regular Session of 2026; and BE IT FURTHER RESOLVED that certified copies of this Concurrent Resolution be transmitted to the Auditor, Director of Commerce and Consumer Affairs, and Insurance Commissioner. OFFERED BY: _____________________________ OFFERED BY: _____________________________ Report Title: Auditor; Social and Financial Impact Assessment Report; Mandatory Health Insurance Coverage; Biomarker Testing Report Title: Auditor; Social and Financial Impact Assessment Report; Mandatory Health Insurance Coverage; Biomarker Testing