(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act) provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted or denied use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include biomarker testing, as prescribed, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions, as prescribed. The bill would authorize the department to implement these provisions by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act) provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted or denied use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include biomarker testing, as prescribed, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions, as prescribed. The bill would authorize the department to implement these provisions by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act) provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted or denied use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. This bill would not preclude any obligation imposed on a managed care plan by the Knox-Keene Act, as specified. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include biomarker testing, as prescribed, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions, as prescribed. The bill would authorize the department to implement these provisions by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975, 1975 (Knox-Keene Act) provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted or denied use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. This bill would apply these provisions relating to biomarker testing to the Medi-Cal program, including Medi-Cal managed care plans, as specified. not preclude any obligation imposed on a managed care plan by the Knox-Keene Act, as specified. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include medically necessary biomarker testing, as prescribed, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions, as prescribed. The bill would authorize the department to implement this provision these provisions by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. decisions, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted or denied use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. This bill would apply these provisions relating to biomarker testing to the Medi-Cal program, including Medi-Cal managed care plans, as specified. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include medically necessary biomarker testing, as prescribed, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. decisions, as prescribed. The bill would authorize the department to implement this provision by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. This bill would apply these provisions relating to biomarker testing to the Medi-Cal program, including Medi-Cal managed care plans, as specified. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include medically necessary biomarker testing testing, as prescribed, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. The bill would authorize the department to implement this provision by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after July 1, 2000, to provide coverage for all generally medically accepted cancer screening tests, and prohibits that contract or policy issued, amended, delivered, or renewed on or after July 1, 2022, from requiring prior authorization for biomarker testing for certain enrollees or insureds. Existing law applies the provisions relating to biomarker testing to Medi-Cal managed care plans, as prescribed.

This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollees or insureds disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. The bill would specify that it does not require a health care service plan or health insurer to cover biomarker testing for screening purposes unless otherwise required by law. The bill would subject restricted use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes. This bill would apply these provisions relating to biomarker testing to the Medi-Cal program, including Medi-Cal managed care plans, as specified. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(2)Existing law provides for the Medi-Cal program, administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law includes Rapid Whole Genome Sequencing as a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit.

Subject to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, this bill, by July 1, 2024, would expand the Medi-Cal schedule of benefits to include biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiarys disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. The bill would authorize the department to implement this provision by various means without taking regulatory action.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

 UNFINISHED BUSINESS  

Bill No: SB 496

Author: Limón (D), et al.

Amended: 9/7/23

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/19/23

AYES: Eggman, Nguyen, Dahle, Glazer, Gonzalez, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

NO VOTE RECORDED: Hurtado

SENATE APPROPRIATIONS COMMITTEE: 6-0, 5/18/23

AYES: Portantino, Jones, Ashby, Bradford, Wahab, Wiener

NO VOTE RECORDED: Seyarto

SENATE FLOOR: 40-0, 5/24/23

AYES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASSEMBLY FLOOR: 79-0, 9/13/23 - See last page for vote

SUBJECT: Biomarker testing

SOURCE: American Cancer Society Cancer Action Network

University of California

DIGEST:

This bill requires Medi-Cal, and, a health plan contract or a health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, and Medi-Cal, to cover medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence, as specified.

Assembly Amendments:

1. Require coverage for medically necessary biomarker testing to be subject to utilization controls.
2. Delete the requirement that the decision to test must be supported by medical and scientific evidence, as defined in this bill; and, instead requires coverage to include biomarker tests that meet one of the criteria in this bill.
3. Revise the criteria to ensure Medicare Administrative Contractor determinations must be those for California, and evidence-based clinical practice guidelines must be supported by peer-reviewed literature and peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff. Add a criterion that includes standards set by the National Academy of Medicine.
4. AllAllow denied use of biomarker testing to be subject to grievance and appeal processes under state and federal law.
5. Require DHCS to direct, by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, that biomarker testing is to be provided in a manner that limits disruptions in care.
6. Require the all-county letter, plan letter, plan or provider bulletin, or similar instructions issued by the Department of Health Care Services (DHCS) to be based at a minimum on evidence-based, nationally recognized clinical practice guidelines, and may be based on consensus statements.

ANALYSIS:

Existing law:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans under the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act); California Department of Insurance (CDI) to regulate health and other insurance; and, DHCS to administer the Medi-Cal program. [HSC §1340, et seq., INS §106, et seq., and WIC §14000, et seq.]
2. Requires a health plan contract and health insurance policy, except for a specialized health plan contract and policy, to be deemed to provide coverage for all generally medically accepted cancer screening tests, subject to all terms and conditions that would otherwise apply. [HSC §1367.665 and INS §10123.20]
3. Prohibits a health plan contract and health insurance policy, except for a specialized health plan contract and policy from requiring prior authorization for either of the following:
   1. Biomarker testing for an enrollee with advanced or metastatic stage 3 or 4 cancer; or,
   2. Biomarker testing for cancer progression or recurrence in the enrollee with advanced or metastatic stage 3 or 4 cancer. [HSC §1367.665 and INS §10123.20]
4. Applies 3) above to health plan contracts and Medi-Cal managed care plan contracts with DHCS. [HSC §1367.665 and INS §10123.20]

This bill:

1. Requires a health plan contract, except for a specialized health plan contract, or a health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, to cover medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions that meets any of the following:
   1. A labeled indication for a test that has been approved or cleared by the FDA or is an indicated test for an FDA-approved drug;
   2. A national coverage determination made by the federal Centers for Medicare and Medicaid Services;
   3. A local coverage determination made by a Medicare Administrative Contractor for California;
   4. Evidence-based clinical practice guidelines, supported by peer-reviewed literature and peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff; or,
   5. Standards set by the National Academy of Medicine.
2. Requires a health plan or health insurer to use a specified process to determine whether biomarker testing is medically necessary.
3. Requires the health plan or health insurance policy to ensure that biomarker testing is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples, but this bill does not require coverage of biomarker testing for screening purposes unless otherwise required by law.
4. Applies substantially similar provisions described above to the Medi-Cal program subject to utilization controls, and only to the extent federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained. Permits DHCS to implement this bill by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking any further regulatory action.

Comments

Author’s statement. According to the author, this bill requires a health plan and health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing. Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. This bill improves access to biomarker testing, ensuring patients receive the right treatment at the right time.

California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requested the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and conducted an abbreviated review of SB 912 (Limón, 2022), which is similar to this bill.

Background. According to CHBRP, biomarker is a characteristic that can be measured to specify normal or abnormal health processes or to indicate a condition or disease. These measurements can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Nonphysiologic tests are often done in a laboratory using samples of blood, tissue, or other clinical samples to quantify and evaluate the biomarker. In recent years, biomarker testing has been used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients’ genetic, environmental, and lifestyle factors rather than a single approach to a disease or condition for all patients. Biomarkers can be tested a variety of ways, including through common blood biomarker tests, individually (single-analyte tests), within a multiplex panel test, or as part of whole genome or exome sequencing. Biomarker testing can be performed for cancer including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis; type 2 diabetes; and other conditions. Additionally, many biomarkers may be associated with several diseases and conditions. Performing biomarker testing for cancer, for example, enables a provider to accurately match the therapy to an individual patient by focusing on treatments most likely to be effective, and decreases treatment harms by avoiding treatments that are unlikely to result in improvement (e.g., chemotherapy), or may result in an adverse reaction. Biomarker tests can be used across the continuum of care for many diseases and conditions for the purposes of screening asymptomatic individuals, determining the presence of disease (diagnosis), estimating the risk or time to clinical outcomes (prognosis), identifying the likelihood of a patient to benefit from certain therapies (predictive) and to experience therapy-related risks (pharmacogenomics), or for treatment monitoring purposes.

Related/Prior Legislation

SB 912 (Limon, 2022) would have required health plan contracts, disability insurance policies, and Medi-Cal to cover biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring if the test is supported by medical and scientific evidence, as specified. SB 912 was vetoed by the Governor, who stated:

This bill would require health care service plans, including the Medi-Cal program, to provide coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition, as long as the test is supported by medical and scientific evidence, as defined in the bill.

While I appreciate the author's efforts to provide biomarker testing coverage, these services are already covered by Medi-Cal. Furthermore, biomarker testing is valuable when it can inform a condition's diagnosis and treatment, but this bill would require Medi-Cal to cover unnecessary testing that may not inform the best treatment to care for the beneficiary.

For example, this bill would require the Department of Health Care Services (Department) to cover biomarker testing supported by local coverage determinations, which can contradict each other, and tests supported by "nationally recognized clinical practice guidelines and consensus statements," which may not be evidenced-based. In contrast, Medi-Cal policy is based upon the gold standard of guidelines with standards set by the National Academy of Medicine.

This bill would establish broad and contradictory coverage requirements that go beyond the Department's evidence-based policies, which would unnecessarily increase costs without increasing the quality of coverage. I believe the Department should retain its current flexibility to establish evidence-based policies in light of the dynamic and changing nature of medicine.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Appropriations Committee,

• CDI estimates this bill will cost $22,000 in fiscal year (FY) 2024-25 to review forms submitted by insurers (Insurance Fund).
• DMHC estimates additional workload to address an increase in consumer complaints; revise survey methodology and compliance monitoring tools, including reviewing health plans’ utilization management processes and providing guidance to plans; and increases in consulting and technology costs of approximately $431,000 in FY 2023-24; $791,000 in FY 2024-25; $1.2 million in FY 2025-26; and $1.5 million in FY 2026-27; and annually thereafter (Managed Care Fund).
• Costs of an unknown amount to DHCS for Medi-Cal (General Fund, federal funds). CHBRP analyzed a similar bill in 2022, and estimated no additional costs to DHCS, as full-scope Medi-Cal currently provides coverage for biomarker testing as required by this bill.
• The CHBRP analysis noted health plans and insurers currently provide coverage for biomarker testing as required by this bill. However, as new therapies develop, health care expenditures may increase due to increased utilization of high-cost medications. Costs could also be avoided, to the extent that biomarker testing enables safer, more effective interventions. If this bill significantly expands access to biomarker testing, it might increase costs of health coverage, but could also decrease costs if it results in more effective, targeted care.

SUPPORT: (Verified 9/7/23)

American Cancer Society Cancer Action Network (co-source)

University of California (co-source)

Advanced Medical Technology Association

Alliance for Patient Access

American Kidney Fund

Association of Regional Center Agencies

Biocom California

Biogen

Biotechnology Innovation Organization

California Academy of Family Physicians

California Chronic Care Coalition

California Clinical Laboratories Association

California Life Sciences

California Manufacturers & Technology Association

California Medical Association

Children’s Specialty Care Coalition

City of Hope National Medical Center

Crohn’s and Colitis Foundation

GSK

International Foundation for Autoimmune and Inflammatory Arthritis

MiOra

Natera

The Latino Cancer Institute

The Michael J. Fox Foundation for Parkinson’s Research

OPPOSITION: (Verified 9/7/23)

None received

ARGUMENTS IN SUPPORT: According to the American Cancer Society Cancer Action Network and University of California, co-sponsors of this bill, cancer biomarkers can include molecules like proteins or genetic alterations such as mutations, rearrangements, or fusions. Testing patients for specific biomarkers is integral to precision medicine in cancer care but, despite evidence pointing to the clinical benefits associated with biomarker testing, routine clinical use does not always follow, and testing rates lag behind clinical guideline recommendations. In a 2021 survey, 66% of oncology providers reported that insurance coverage for biomarker testing is a significant or moderate barrier to appropriate biomarker testing. Insurance coverage for biomarker testing is failing to keep pace with innovations and advancements in treatment. This bill will require state-regulated insurance plans, including Medi-Cal, to cover comprehensive biomarker testing when supported by medical and scientific evidence, including nationally recognized clinical practice guidelines. Timely access to appropriate biomarker testing can help achieve better health outcomes, improve quality of life and reduce costs by connecting patients to the most effective treatment for their cancer. The Crohn’s and Colitis Foundation write procedures, like colonoscopy, help diagnose and evaluate irritable bowel syndrome, which is very helpful, but also invasive, expensive, and carries some risk; and fail to answer all questions. As irritable bowel syndrome biomarkers become available, coverage should not be a barrier for patients to receive biomarker testing when being treated.

SUPPORT IF AMENDED: The Protection of the Education Rights of Kids has a support if amended position requesting amendments to include protections for information collected, including but not limited to sharing information with third parties or for any other type of use, sharing, of genetic sequencing or medical information detected from the test results.

ASSEMBLY FLOOR: 79-0, 9/13/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORD: Essayli

Prepared by: Teri Boughton / HEALTH / (916) 651-4111

9/14/23 12:44:47

**** END ****

SENATE THIRD READING

STR Bill Id:SB 496

Author:(Limón)

As Amended Ver:September 7, 2023

Majority vote

SUMMARY

Requires a health plan contract or health insurance policy, as specified, to provide coverage for medically necessary biomarker testing, subject to utilization review management. Requires biomarker testing coverage for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee or insured's disease or condition to guide treatment decisions. Requires biomarker test coverage to meet any of the following: 1) A labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA) or is an indicated test for an FDA-approved drug; 2) A national coverage determination made by the federal Centers for Medicare and Medicaid Services; 3) A local coverage determination by a Medicare Administrative Contractor that applies to California; 4) Evidence-based clinical practice guidelines, as specified; and 5) Standards set by the National Academy of Medicine. Includes as a Medi-Cal benefit, biomarker testing subject to utilization controls and medical necessary requirements, as specified. Applies Medi-Cal provisions to Medi-Cal managed care plans and clarifies that nothing in this bill be construed to remove an obligation that is otherwise applicable to Medi-Cal managed care plans.

Major Provisions

COMMENTS

According to the California Health Benefits Review Program (CHBRP), a biomarker is a characteristic that can be measured to specify normal or abnormal health processes or to indicate a condition or disease. These measurements can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Nonphysiologic tests are often done in a laboratory using samples of blood, tissue, or other clinical samples to quantify and evaluate the biomarker. In recent years, biomarker testing has been used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients' genetic, environmental, and lifestyle factors rather than a single approach to a disease or condition for all patients. Biomarkers can be tested a variety of ways, including through common blood biomarker tests, individually (single-analyte tests), within a multiplex panel test, or as part of whole genome or exome sequencing. Biomarker testing can be performed for cancer including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer's disease; rheumatoid arthritis; type 2 diabetes; and, other conditions. Additionally, many biomarkers may be associated with several diseases and conditions. Performing biomarker testing for cancer, for example, enables a provider to accurately match the therapy to an individual patient by focusing on treatments most likely to be effective, and decreases treatment harms by avoiding treatments that are unlikely to result in improvement (e.g., chemotherapy), or may result in an adverse reaction. Biomarker tests can be used across the continuum of care for many diseases and conditions for the purposes of screening asymptomatic individuals, determining the presence of disease (diagnosis), estimating the risk or time to clinical outcomes (prognosis), identifying the likelihood of a patient to benefit from certain therapies (predictive) and to experience therapy-related risks (pharmacogenomics), or for treatment monitoring purposes. Several studies have found biomarker-driven treatment improves treatment outcomes, including survival rate, and may also be cost effective, leading to elimination of costs for other less-targeted therapies or offsets in the form of reduced emergency department and in-patient hospital admission. However, the clinical effectiveness of biomarker tests and related treatments varies based on the disease or condition and patient characteristics.

CHBRP analysis. CHBRP states the following in its analysis of AB 912 (Limon) of 2022, which was substantially similar to this bill:

1. Enrollees covered. According to CHBRP, all enrollees with health insurance subject to this bill have coverage for biomarker testing that is supported by medical and scientific evidence and is determined medically necessary. There may be some biomarker tests that are newly covered based on the implementation of this bill, but CHBRP is unable to determine to which biomarker tests this applies.
2. Impact on expenditures. Since this bill would not result in changes in benefit coverage, there would be no changes in utilization of biomarker tests or changes in health care expenditures as a result of this bill.
3. EHBs. Under existing law, plans and policies are required to cover medically necessary diagnostic lab services and ongoing disease management services. Additionally, biomarker testing is broadly covered by California's EHB-benchmark plan. Since this bill would not require coverage for a new state benefit mandate, it does not appear to exceed the definition of EHBs in California.
4. Medical effectiveness. According to CHBRP, the definitions of biomarker and biomarker testing encompass a vast array of biomarkers and tests, ranging from more traditional biomarkers tests (e.g., white blood cell count) to biomarkers testing for genetic variation (sometimes identified using whole genome and exome sequencing). Due to the number of biomarker tests, CHBRP is unable to conduct a medical effectiveness review of biomarker testing within its 60-day timeline.
5. Public health. Since enrollees with health insurance subject to this bill currently have coverage for biomarker testing generally, there is no measurable public health impact. However, despite reported benefit coverage of biomarker testing, utilization of biomarker testing differs between commercial and CalPERS enrollees and for Medi-Cal beneficiaries. Literature indicates that the disparities in testing by race or ethnicity, age, and socio-economic status could widen inequities in utilization of biomarker testing if not specifically addressed. Additionally, studies have suggested that clinician barriers, including familiarity with guidelines and knowledge of best practices for use of biomarker testing, expertise in genomic testing, or access to a multidisciplinary specialty team impact whether patients receive testing.
6. Long-term impacts. CHBRP assumes it is likely that plans and policies will continue to incorporate new clinical guidelines as they become available in future years. While not directly related to this bill, there are implications for health plans and policies, including Medi-Cal, as new biomarker tests become available and new therapies indicated by biomarker testing become available. Some medications with biomarker-indications cost more than $100,000 annually. Although utilization of these high-cost medications is relatively low, should utilization increase, related health care expenditures would increase as well. As noted previously, evidence supports clinical utility and cost-effectiveness of several biomarker tests and related treatments, which could contribute to offsets in health care expenditures or improved quality of life for enrollees.

According to the Author

This bill requires a health plan and health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing. Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer's disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. The author concludes this bill will improve access to biomarker testing, ensuring patients receive the right treatment at the right time.

Arguments in Support

The American Cancer Society Cancer Action Network (ACS CAN), cosponsor of this bill, writes that precision medicine uses information about a person's own genes or proteins to prevent, diagnose, or treat disease. When used in the treatment of cancer, precision medicine incorporates specific information (e.g., genetic alterations, molecular signatures) about a person's cancer to inform diagnosis, prognosis, therapy selection, and to monitor how well therapy is working. The knowledge and practice of precision medicine in cancer have been progressing rapidly and advances have led to targeted cancer therapies, which work by interfering with specific cellular processes involved in the growth, spread, and progression of cancer. Treatment with targeted therapy often requires diagnostic testing to analyze biological samples taken from patients, to identify and evaluate specific biomarkers. Research shows that targeted therapy can improve patient survival and quality of life. When doctors connect patients to the most effective treatment for their cancer, patients can avoid treatments that will be ineffective or have more adverse effects. Biomarkers provide insight into physiological processes, medical conditions, or diseases. Cancer biomarkers can include molecules like proteins or genetic alterations such as mutations, rearrangements, or fusions. Testing patients for specific biomarkers is integral to precision medicine in cancer care but, despite evidence pointing to the clinical benefits associated with biomarker testing, routine clinical use does not always follow, and testing rates lag behind clinical guideline recommendations. In a 2021 survey, 66% of oncology providers reported that insurance coverage for biomarker testing is a significant or moderate barrier to appropriate biomarker testing. Insurance coverage for biomarker testing is failing to keep pace with innovations and advancements in treatment. This bill will require state-regulated insurance plans, including Medi-Cal, to cover comprehensive biomarker testing when supported by medical and scientific evidence, including nationally recognized clinical practice guidelines. ACS CAN concludes that timely access to appropriate biomarker testing can help achieve better health outcomes, improve quality of life and reduce costs by connecting patients to the most effective treatment for their cancer.

The University of California (UC), cosponsor of this bill, states that the UC is a leader in cancer care through our five National Cancer Institute-designated Comprehensive Cancer Centers, comprising the UC Cancer Consortium (UCCC). UCCC is focused on addressing health disparities and promoting health equity in cancer diagnosis and care as we work to improve patient outcomes across California. The UC concludes that this bill will bring the hope and promise of precision medicine to all Californians.

Arguments in Support if Amended

The Protection of the Education Rights of Kids has a support if amended position and request amendments to include protections for information collected, including but not limited to sharing information with third parties or for any other type of use, sharing, of genetic sequencing or medical information detected from the test results.

Arguments in Opposition

There is no known opposition to this bill. The California Association of Health Plans, America's Health Plans, and the Association of California Life and Health Insurance Companies were formerly opposed and are now neutral on this bill.

FISCAL COMMENTS

According to the Assembly Appropriations Committee,

1. The Department of Insurance estimates this bill will cost $22,000 in fiscal year (FY) 2024-25 to review forms submitted by insurers (Insurance Fund).
2. The Department of Managed Health Care estimates additional workload to address an increase in consumer complaints; revise survey methodology and compliance monitoring tools, including reviewing health plans’ utilization management processes and providing guidance to plans; and increases in consulting and technology costs of approximately $431,000 in FY 2023-24; $791,000 in FY 2024-25; $1.2 million in FY 2025-26; and $1.5 million in FY 2026-27; and annually thereafter (Managed Care Fund).
3. Costs of an unknown amount to the Department of Health Care Services (DHCS) for Medi-Cal (General Fund, federal funds). The California Health Benefits Review Program (CHBRP) analyzed a similar bill in 2022, and estimated no additional costs to DHCS, as full-scope Medi-Cal currently provides coverage for biomarker testing as required by this bill.
4. The CHBRP analysis noted health plans and insurers currently provide coverage for biomarker testing as required by this bill. However, as new therapies develop, health care expenditures may increase due to increased utilization of high-cost medications. Costs could also be avoided, to the extent that biomarker testing enables safer, more effective interventions. If this bill significantly expands access to biomarker testing, it might increase costs of health coverage, but could also decrease costs if it results in more effective, targeted care.

VOTES

SENATE FLOOR: 40-0-0

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASM HEALTH: 15-0-0

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner, Wendy Carrillo, Flora, Vince Fong, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ASM APPROPRIATIONS: 11-0-5

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Wilson

ABS, ABST OR NV: Megan Dahle, Dixon, Mathis, Sanchez, Soria

UPDATED

VERSION: September 7, 2023

CONSULTANT: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0001983

SENATE THIRD READING

STR Bill Id:SB 496

Author:(Limón)

As Amended Ver:September 1, 2023

Majority vote

SUMMARY

Requires a health plan contract or health insurance policy, as specified, to provide coverage for medically necessary biomarker testing, subject to utilization review management. Requires biomarker testing coverage for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee or insured's disease or condition to guide treatment decisions. Requires biomarker test coverage to meet any of the following: 1) A labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA) or is an indicated test for an FDA-approved drug; 2) A national coverage determination made by the federal Centers for Medicare and Medicaid Services, to the extent allowed under the Medicaid program; 3) A local coverage determination by a Medicare Administrative Contractor that applies to California; 4) Evidence-based clinical practice guidelines, as specified; and 5) Standards set by the National Academy of Medicine. Specifies that this bill does not preclude any obligation imposed on a managed care plan. Includes as a Medi-Cal benefit, biomarker testing subject to utilization controls and medical necessary requirements, as specified.

Major Provisions

COMMENTS

1. According to the California Health Benefits Review Program (CHBRP), a biomarker is a characteristic that can be measured to specify normal or abnormal health processes or to indicate a condition or disease. These measurements can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Nonphysiologic tests are often done in a laboratory using samples of blood, tissue, or other clinical samples to quantify and evaluate the biomarker. In recent years, biomarker testing has been used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients' genetic, environmental, and lifestyle factors rather than a single approach to a disease or condition for all patients. Biomarkers can be tested a variety of ways, including through common blood biomarker tests, individually (single-analyte tests), within a multiplex panel test, or as part of whole genome or exome sequencing. Biomarker testing can be performed for cancer including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer's disease; rheumatoid arthritis; type 2 diabetes; and, other conditions. Additionally, many biomarkers may be associated with several diseases and conditions. Performing biomarker testing for cancer, for example, enables a provider to accurately match the therapy to an individual patient by focusing on treatments most likely to be effective, and decreases treatment harms by avoiding treatments that are unlikely to result in improvement (e.g., chemotherapy), or may result in an adverse reaction. Biomarker tests can be used across the continuum of care for many diseases and conditions for the purposes of screening asymptomatic individuals, determining the presence of disease (diagnosis), estimating the risk or time to clinical outcomes (prognosis), identifying the likelihood of a patient to benefit from certain therapies (predictive) and to experience therapy-related risks (pharmacogenomics), or for treatment monitoring purposes. Several studies have found biomarker-driven treatment improves treatment outcomes, including survival rate, and may also be cost effective, leading to elimination of costs for other less-targeted therapies or offsets in the form of reduced emergency department and in-patient hospital admission. However, the clinical effectiveness of biomarker tests and related treatments varies based on the disease or condition and patient characteristics.

CHBRP analysis. CHBRP states the following in its analysis of AB 912 (Limon) of 2022, which was substantially similar to this bill:

1. Enrollees covered. According to CHBRP, all enrollees with health insurance subject to this bill have coverage for biomarker testing that is supported by medical and scientific evidence and is determined medically necessary. There may be some biomarker tests that are newly covered based on the implementation of this bill, but CHBRP is unable to determine to which biomarker tests this applies.
2. Impact on expenditures. Since this bill would not result in changes in benefit coverage, there would be no changes in utilization of biomarker tests or changes in health care expenditures as a result of this bill.
3. EHBs. Under existing law, plans and policies are required to cover medically necessary diagnostic lab services and ongoing disease management services. Additionally, biomarker testing is broadly covered by California's EHB-benchmark plan. Since this bill would not require coverage for a new state benefit mandate, it does not appear to exceed the definition of EHBs in California.
4. Medical effectiveness. According to CHBRP, the definitions of biomarker and biomarker testing encompass a vast array of biomarkers and tests, ranging from more traditional biomarkers tests (e.g., white blood cell count) to biomarkers testing for genetic variation (sometimes identified using whole genome and exome sequencing). Due to the number of biomarker tests, CHBRP is unable to conduct a medical effectiveness review of biomarker testing within its 60-day timeline.
5. Public health. Since enrollees with health insurance subject to this bill currently have coverage for biomarker testing generally, there is no measurable public health impact. However, despite reported benefit coverage of biomarker testing, utilization of biomarker testing differs between commercial and CalPERS enrollees and for Medi-Cal beneficiaries. Literature indicates that the disparities in testing by race or ethnicity, age, and socio-economic status could widen inequities in utilization of biomarker testing if not specifically addressed. Additionally, studies have suggested that clinician barriers, including familiarity with guidelines and knowledge of best practices for use of biomarker testing, expertise in genomic testing, or access to a multidisciplinary specialty team impact whether patients receive testing.
6. Long-term impacts. CHBRP assumes it is likely that plans and policies will continue to incorporate new clinical guidelines as they become available in future years. While not directly related to this bill, there are implications for health plans and policies, including Medi-Cal, as new biomarker tests become available and new therapies indicated by biomarker testing become available. Some medications with biomarker-indications cost more than $100,000 annually. Although utilization of these high-cost medications is relatively low, should utilization increase, related health care expenditures would increase as well. As noted previously, evidence supports clinical utility and cost-effectiveness of several biomarker tests and related treatments, which could contribute to offsets in health care expenditures or improved quality of life for enrollees.

According to the Author

This bill requires a health plan and health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing. Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer's disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. The author concludes this bill will improve access to biomarker testing, ensuring patients receive the right treatment at the right time.

Arguments in Support

The American Cancer Society Cancer Action Network (ACS CAN), cosponsor of this bill, writes that precision medicine uses information about a person's own genes or proteins to prevent, diagnose, or treat disease. When used in the treatment of cancer, precision medicine incorporates specific information (e.g., genetic alterations, molecular signatures) about a person's cancer to inform diagnosis, prognosis, therapy selection, and to monitor how well therapy is working. The knowledge and practice of precision medicine in cancer have been progressing rapidly and advances have led to targeted cancer therapies, which work by interfering with specific cellular processes involved in the growth, spread, and progression of cancer. Treatment with targeted therapy often requires diagnostic testing to analyze biological samples taken from patients, to identify and evaluate specific biomarkers. Research shows that targeted therapy can improve patient survival and quality of life. When doctors connect patients to the most effective treatment for their cancer, patients can avoid treatments that will be ineffective or have more adverse effects. Biomarkers provide insight into physiological processes, medical conditions, or diseases. Cancer biomarkers can include molecules like proteins or genetic alterations such as mutations, rearrangements, or fusions. Testing patients for specific biomarkers is integral to precision medicine in cancer care but, despite evidence pointing to the clinical benefits associated with biomarker testing, routine clinical use does not always follow, and testing rates lag behind clinical guideline recommendations. In a 2021 survey, 66% of oncology providers reported that insurance coverage for biomarker testing is a significant or moderate barrier to appropriate biomarker testing. Insurance coverage for biomarker testing is failing to keep pace with innovations and advancements in treatment. This bill will require state-regulated insurance plans, including Medi-Cal, to cover comprehensive biomarker testing when supported by medical and scientific evidence, including nationally recognized clinical practice guidelines. ACS CAN concludes that timely access to appropriate biomarker testing can help achieve better health outcomes, improve quality of life and reduce costs by connecting patients to the most effective treatment for their cancer.

The University of California (UC), cosponsor of this bill, states that the UC is a leader in cancer care through our five National Cancer Institute-designated Comprehensive Cancer Centers, comprising the UC Cancer Consortium (UCCC). UCCC is focused on addressing health disparities and promoting health equity in cancer diagnosis and care as we work to improve patient outcomes across California. The UC concludes that this bill will bring the hope and promise of precision medicine to all Californians.

Arguments in Support if Amended

The Protection of the Education Rights of Kids has a support if amended position and request amendments to include protections for information collected, including but not limited to sharing information with third parties or for any other type of use, sharing, of genetic sequencing or medical information detected from the test results.

Arguments in Opposition

There is no known opposition to this bill. The California Association of Health Plans, America's Health Plans, and the Association of California Life and Health Insurance Companies were formerly opposed and are now neutral on this bill.

FISCAL COMMENTS

According to the Assembly Appropriations Committee,

1. The Department of Insurance estimates this bill will cost $22,000 in fiscal year (FY) 2024-25 to review forms submitted by insurers (Insurance Fund).
2. The Department of Managed Health Care estimates additional workload to address an increase in consumer complaints; revise survey methodology and compliance monitoring tools, including reviewing health plans' utilization management processes and providing guidance to plans; and increases in consulting and technology costs of approximately $431,000 in FY 2023-24; $791,000 in FY 2024-25; $1.2 million in FY 2025-26; and $1.5 million in FY 2026-27; and annually thereafter (Managed Care Fund).
3. Costs of an unknown amount to the Department of Health Care Services (DHCS) for Medi-Cal (General Fund, federal funds). CHBRP analyzed a similar bill in 2022, and estimated no additional costs to DHCS, as full-scope Medi-Cal currently provides coverage for biomarker testing as required by this bill.
4. The CHBRP analysis noted health plans and insurers currently provide coverage for biomarker testing as required by this bill. However, as new therapies develop, health care expenditures may increase due to increased utilization of high-cost medications. Costs could also be avoided, to the extent that biomarker testing enables safer, more effective interventions. If this bill significantly expands access to biomarker testing, it might increase costs of health coverage, but could also decrease costs if it results in more effective, targeted care.

VOTES

SENATE FLOOR: 40-0-0

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASM HEALTH: 15-0-0

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner, Wendy Carrillo, Flora, Vince Fong, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ASM APPROPRIATIONS: 11-0-5

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Wilson

ABS, ABST OR NV: Megan Dahle, Dixon, Mathis, Sanchez, Soria

UPDATED

VERSION: September 1, 2023

CONSULTANT: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0001677

Date of Hearing: August 16, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

SBPCA Bill Id:SB 496

Author:(Limón) – As Amended Ver:July 13, 2023

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires a health insurance policy or health plan contract to provide coverage for medically necessary biomarker testing, including whole genome sequencing, to guide treatment decisions, if the test is supported by medical and scientific evidence, as prescribed. This bill applies biomarker testing provisions to the Medi-Cal program.

FISCAL EFFECT:

1. The Department of Insurance estimates this bill will cost $22,000 in fiscal year (FY) 2024-25 to review forms submitted by insurers (Insurance Fund).
2. The Department of Managed Health Care estimates additional workload to address an increase in consumer complaints; revise survey methodology and compliance monitoring tools, including reviewing health plans’ utilization management processes and providing guidance to plans; and increases in consulting and technology costs of approximately $431,000 in FY 2023-24; $791,000 in FY 2024-25; $1.2 million in FY 2025-26; and $1.5 million in FY 2026-27; and annually thereafter (Managed Care Fund).
3. Costs of an unknown amount to the Department of Health Care Services (DHCS) for Medi-Cal (General Fund, federal funds). The California Health Benefits Review Program (CHBRP) analyzed a similar bill in 2022, and estimated no additional costs to DHCS, as full-scope Medi-Cal currently provides coverage for biomarker testing as required by this bill.
4. The CHBRP analysis noted health plans and insurers currently provide coverage for biomarker testing as required by this bill. However, as new therapies develop, health care expenditures may increase due to increased utilization of high-cost medications. Costs could also be avoided, to the extent that biomarker testing enables safer, more effective interventions. If this bill significantly expands access to biomarker testing, it might increase costs of health coverage, but could also decrease costs if it results in more effective, targeted care.

COMMENTS:

1. Purpose. This bill is sponsored by the American Cancer Society Cancer Action Network and the University of California. According to the author:

Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. SB 496 will improve access to biomarker testing, ensuring patients receive the right treatment at the right time.

1. Background. According CHBRP, a biomarker is a characteristic that can be measured to identify normal or abnormal health processes or to indicate a condition or disease. Biomarkers can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Biomarker testing is increasingly used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients’ genetic, environmental, and lifestyle factors, rather than a single approach to a disease or condition for all patients. Biomarker testing can be performed for prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis; type 2 diabetes; and other conditions. Performing biomarker testing for cancer, as an example, enables a provider to focus on treatments most likely to be effective, and can decrease treatment harms by helping to avoid treatments that are unlikely to result in improvement or may result in an adverse reaction. Several studies have found biomarker-driven treatment improves treatment outcomes, and may also be cost effective, reducing costs for less-targeted therapies and emergency department and in-patient hospital admissions.
2. Prior Legislation.
   1. SB 535 (Limón), Chapter 605, Statutes of 2021, prohibited health plans and insurers from requiring prior authorization for biomarker testing for advanced or metastatic stage 3 or 4 cancer, and cancer progression or recurrence.
      
   2. SB 912 (Limón), of the 2021-22 Legislative Session, was substantially similar to this bill, but included a different approach to defining when biomarker testing is appropriate. Governor Newsom vetoed SB 912, stating, in part:

While I appreciate the author's efforts to provide biomarker testing coverage, these services are already covered by Medi-Cal. Furthermore, biomarker testing is valuable when it can inform a condition's diagnosis and treatment, but this bill would require Medi-Cal to cover unnecessary testing that may not inform the best treatment to care for the beneficiary. For example, this bill would require [DHCS] to cover biomarker testing supported by local coverage determinations, which can contradict each other, and tests supported by "nationally recognized clinical practice guidelines and consensus statements," which may not be evidenced-based. In contrast, Medi-Cal policy is based upon the gold standard of guidelines with standards set by the National Academy of Medicine. This bill would establish broad and contradictory coverage requirements that go beyond [DHCS’] evidence-based policies, which would unnecessarily increase costs without increasing the quality of coverage. I believe [DHCS] should retain its current flexibility to establish evidence-based policies in light of the dynamic and changing nature of medicine. For these reasons, I cannot sign this bill.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: July 11, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 496

Author:(Limón) – As Amended Ver:April 25, 2023

SENATE VOTE: 40-0

SUBJECT: Biomarker testing.

SUMMARY: Requires a health plan contract or health insurance policy, as specified, to provide coverage for medically necessary biomarker testing, as prescribed, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions if the test is supported by medical and scientific evidence, as prescribed. Applies biomarker testing provisions to the Medi-Cal program, including Medi-Cal managed care plans, as specified. Specifically, this bill:

1. Requires a health plan contract or insurance policy, except as specified, that is issued, amended, delivered, or renewed on or after July 1, 2024, to cover medically necessary biomarker testing.
2. Requires biomarker testing to be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee or insured’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence.
3. Defines medical and scientific evidence to mean one or more of the following:
   1. A labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA) or is an indicated test for an FDA-approved drug;
   2. A national coverage determination made by the federal Centers for Medicare and Medicaid Services;
   3. A local coverage determination made by a Medicare Administrative Contractor; or,
   4. Evidence-based, nationally recognized clinical practice guidelines and consensus statements.
4. Requires a health plan or insurer to use existing utilization review process to determine whether biomarker testing is medically necessary, and at a minimum, requires the process to be supported by medical and scientific evidence, as defined in 3) above.
5. Requires a health plan or insurer to ensure that biomarker testing is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. Specifies that this bill does not require coverage of biomarker testing for screening purposes unless otherwise required and that restricted use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of any medical condition is subject to grievance and appeal processes under state and federal law.
6. Applies this bill to any health plan contract and Medi-Cal managed care plan contract with the State Department of Health Care Services (DHCS) and by July 1, 2024, adds medically necessary biomarker testing to Medi-Cal’s schedule of benefits. Specifies that this bill is to be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained. Authorizes DHCS to implement this bill by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking any further regulatory action.
7. Defines the following:
   1. Biomarker to mean a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a specific therapeutic intervention. Includes, but is not limited to, gene mutations or protein expression;
   2. Biomarker testing to mean the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Includes, but is not limited to, single-analyte tests, multiplex panel tests, and whole genome sequencing;
   3. Consensus statements to mean statements developed by an independent, multidisciplinary panel of experts who utilize a transparent methodology and reporting structure, and are subject to a conflict of interest policy. Provides that these statements are aimed at specific clinical circumstances and are based on the best available evidence to optimize the outcomes of clinical care; and,
   4. Nationally recognized clinical practice guidelines to mean evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure, and are subject to a conflict-of-interest policy. Specifies that clinical practice guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options, and those guidelines include recommendations intended to optimize clinical care.

EXISTING LAW:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans, and the California Department of Insurance (CDI) to regulate health insurance. [Health and Safety Code (HSC) §1340, et seq.Insurance Code (INS) §106, et seq.]
2. Establishes as California's essential health benefits (EHBs), the Kaiser Small Group Health Maintenance Organization benchmark plan, existing California mandates, and 10 Patient Protection and Affordable Care Act mandated benefits. [HSC §1367.005 and INS §10112.27]
3. Prohibits an individual or group health plan contract or health insurance policy, that provides coverage for prescribed, orally administered anticancer medications used to kill or slow the growth of cancerous cells from requiring an enrollee or insured to pay, notwithstanding any deductible, a total amount of copayments and coinsurance that exceeds $250 for an individual prescription of up to a 30-day supply of a prescribed orally administered anticancer medication, as specified. Sunsets on January 1, 2024. [HSC §1367.656 and INS §10123.206]
4. Requires the criteria or guidelines used by plans or insurers, or any entities with which plans contract for services that include utilization review or utilization management functions, to determine whether to authorize, modify, or deny health care services to:
   
   1. Be developed with involvement from actively practicing health care providers;
   2. Be consistent with sound clinical principles and processes;
   3. Be evaluated, and updated if necessary, at least annually;
   4. If used as the basis of a decision to modify, delay, or deny services in a specified case under review, be disclosed to the provider and the enrollee in that specified case;
   5. Be available to the public upon request. Specifies a plan or insurer to only be required to disclose the criteria or guidelines for the specific procedures or conditions requested. [HSC 1365.5 and INS 10123.135]
      
5. Requires a health plan contract and health insurance policy, except for a specialized health plan contract and policy, to be deemed to provide coverage for all generally medically accepted cancer screening tests, subject to all terms and conditions that would otherwise apply. [HSC §1367.665 and INS §10123.20]
6. Prohibits a health plan contract and health insurance policy, except for a specialized health plan contract and policy from requiring prior authorization for either of the following:
   
   1. Biomarker testing for an enrollee with advanced or metastatic stage 3 or 4 cancer; or,
   2. Biomarker testing for cancer progression or recurrence in the enrollee with advanced or metastatic stage 3 or 4 cancer. [HSC §1367.665 and INS §10123.20]
7. Applies 6) above to health plan contracts and Medi-Cal managed care plan contracts with DHCS. [HSC §1367.665 and INS §10123.20]
8. Defines “biomarker test” for purposes of 6) above as a diagnostic test, such as single or multigene, of the cancer patient’s biospecimen, such as tissue, blood, or other bodily fluids, for DNA (deoxyribonucleic acid) or RNA (ribonucleic acid) alterations, including phenotypic characteristics of a malignancy, to identify an individual with a subtype of cancer, in order to guide patient treatment. [HSC §1367.665 and INS §10123.20]
9. States that 6) above does not prohibit a health plan or insurer from requiring prior authorization on biomarker testing that is not for an FDA -approved therapy for advanced or metastatic stage 3 or 4 cancer, and does not limit, prohibit, or modify an enrollee’s or insured’s rights to biomarker testing as part of an approved clinical trial under existing law. [HSC §1367.665 and INS §10123.20]
   
10. Requires every health plan to establish and maintain a grievance system approved by DMHC under which enrollees may submit grievances to the plan. Requires a plan’s response to also comply with federal requirements. [HSC §1368]
    
11. Requires reviews, for purposes of Independent Medical Review (IMR), to determine whether the disputed health care service was medically necessary based on the specific medical needs of the enrollee or insured and any of the following:
    
12. Peer-reviewed scientific and medical evidence regarding the effectiveness of the disputed service;
13. Nationally recognized professional standards;
14. Expert opinion;
15. Generally accepted standards of medical practice; or,
16. Treatments that are likely to provide a benefit to a patient for conditions for which other treatments are not clinically efficacious. [HSC §1374.33 and INS §10169.3]
17. Establishes the Medi-Cal program, administered by DHCS, under which low-income individuals are eligible for medical coverage. [Welfare and Institutions Code (WIC) § 14000, et seq.]
18. Establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at state option but for which federal financial participation is available. [WIC § 14132]
    

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. DMHC estimates costs to be approximately $431,000 in 2023-24, $791,000 in 2024-25, $1,201,000 in 2025-26, $1,504,000 in 2026-27, and $1,495,000 in 2027-28 and annually thereafter (Managed Care Fund) to administer the provisions;
2. CDI estimates costs of $22,000 in 2024-25 (Insurance Fund); and,
3. Unknown potential costs for DHCS to administer the provisions.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill requires a health plan and health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing. Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. The author concludes this bill will improve access to biomarker testing, ensuring patients receive the right treatment at the right time.
2. BACKGROUND. According to the California Health Benefits Review Program (CHBRP), a biomarker is a characteristic that can be measured to specify normal or abnormal health processes or to indicate a condition or disease. These measurements can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Nonphysiologic tests are often done in a laboratory using samples of blood, tissue, or other clinical samples to quantify and evaluate the biomarker. In recent years, biomarker testing has been used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients’ genetic, environmental, and lifestyle factors rather than a single approach to a disease or condition for all patients. Biomarkers can be tested a variety of ways, including through common blood biomarker tests, individually (single-analyte tests), within a multiplex panel test, or as part of whole genome or exome sequencing. Biomarker testing can be performed for cancer including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis; type 2 diabetes; and, other conditions. Additionally, many biomarkers may be associated with several diseases and conditions. Performing biomarker testing for cancer, for example, enables a provider to accurately match the therapy to an individual patient by focusing on treatments most likely to be effective, and decreases treatment harms by avoiding treatments that are unlikely to result in improvement (e.g., chemotherapy), or may result in an adverse reaction. Biomarker tests can be used across the continuum of care for many diseases and conditions for the purposes of screening asymptomatic individuals, determining the presence of disease (diagnosis), estimating the risk or time to clinical outcomes (prognosis), identifying the likelihood of a patient to benefit from certain therapies (predictive) and to experience therapy-related risks (pharmacogenomics), or for treatment monitoring purposes. Several studies have found biomarker-driven treatment improves treatment outcomes, including survival rate, and may also be cost effective, leading to elimination of costs for other less-targeted therapies or offsets in the form of reduced emergency department and in-patient hospital admission. However, the clinical effectiveness of biomarker tests and related treatments varies based on the disease or condition and patient characteristics.
   1. CHBRP analysis. AB 1996 (Thomson), Chapter 795, Statutes of 2002, requests the University of California (UC) to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996. SB 125 (Hernandez), Chapter 9, Statutes of 2015, added an impact assessment on EHBs, and legislation that impacts health insurance benefit designs, cost sharing, premiums, and other health insurance topics. CHBRP states the following in its analysis of AB 912 (Limon) of 2022, which was substantially similar to this bill:
      1. Enrollees covered. According to CHBRP, all enrollees with health insurance subject to this bill have coverage for biomarker testing that is supported by medical and scientific evidence and is determined medically necessary. There may be some biomarker tests that are newly covered based on the implementation of this bill, but CHBRP is unable to determine to which biomarker tests this applies.
      2. Impact on expenditures. Since this bill would not result in changes in benefit coverage, there would be no changes in utilization of biomarker tests or changes in health care expenditures as a result of this bill.
      3. EHBs. Under existing law, plans and policies are required to cover medically necessary diagnostic lab services and ongoing disease management services. Additionally, biomarker testing is broadly covered by California’s EHB-benchmark plan. Since this bill would not require coverage for a new state benefit mandate, it does not appear to exceed the definition of EHBs in California.
      4. Medical effectiveness. According to CHBRP, the definitions of biomarker and biomarker testing encompass a vast array of biomarkers and tests, ranging from more traditional biomarkers tests (e.g., white blood cell count) to biomarkers testing for genetic variation (sometimes identified using whole genome and exome sequencing). Due to the number of biomarker tests, CHBRP is unable to conduct a medical effectiveness review of biomarker testing within its 60-day timeline.
      5. Public health. Since enrollees with health insurance subject to this bill currently have coverage for biomarker testing generally, there is no measurable public health impact. However, despite reported benefit coverage of biomarker testing, utilization of biomarker testing differs between commercial and CalPERS enrollees and for Medi-Cal beneficiaries. Literature indicates that the disparities in testing by race or ethnicity, age, and socio-economic status could widen inequities in utilization of biomarker testing if not specifically addressed. Additionally, studies have suggested that clinician barriers, including familiarity with guidelines and knowledge of best practices for use of biomarker testing, expertise in genomic testing, or access to a multidisciplinary specialty team impact whether patients receive testing.
      6. Long-term impacts. CHBRP assumes it is likely that plans and policies will continue to incorporate new clinical guidelines as they become available in future years. While not directly related to this bill, there are implications for health plans and policies, including Medi-Cal, as new biomarker tests become available and new therapies indicated by biomarker testing become available. Some medications with biomarker-indications cost more than $100,000 annually. Although utilization of these high-cost medications is relatively low, should utilization increase, related health care expenditures would increase as well. As noted previously, evidence supports clinical utility and cost-effectiveness of several biomarker tests and related treatments, which could contribute to offsets in health care expenditures or improved quality of life for enrollees.
3. SUPPORT. The American Cancer Society Cancer Action Network (ACS CAN), cosponsor of this bill, writes that precision medicine uses information about a person’s own genes or proteins to prevent, diagnose, or treat disease. When used in the treatment of cancer, precision medicine incorporates specific information (e.g., genetic alterations, molecular signatures) about a person’s cancer to inform diagnosis, prognosis, therapy selection, and to monitor how well therapy is working. The knowledge and practice of precision medicine in cancer have been progressing rapidly and advances have led to targeted cancer therapies, which work by interfering with specific cellular processes involved in the growth, spread, and progression of cancer. Treatment with targeted therapy often requires diagnostic testing to analyze biological samples taken from patients, to identify and evaluate specific biomarkers. Research shows that targeted therapy can improve patient survival and quality of life. When doctors connect patients to the most effective treatment for their cancer, patients can avoid treatments that will be ineffective or have more adverse effects. Biomarkers provide insight into physiological processes, medical conditions, or diseases. Cancer biomarkers can include molecules like proteins or genetic alterations such as mutations, rearrangements, or fusions. Testing patients for specific biomarkers is integral to precision medicine in cancer care but, despite evidence pointing to the clinical benefits associated with biomarker testing, routine clinical use does not always follow, and testing rates lag behind clinical guideline recommendations. In a 2021 survey, 66% of oncology providers reported that insurance coverage for biomarker testing is a significant or moderate barrier to appropriate biomarker testing. Insurance coverage for biomarker testing is failing to keep pace with innovations and advancements in treatment. This bill will require state-regulated insurance plans, including Medi-Cal, to cover comprehensive biomarker testing when supported by medical and scientific evidence, including nationally recognized clinical practice guidelines. ACS CAN concludes that timely access to appropriate biomarker testing can help achieve better health outcomes, improve quality of life and reduce costs by connecting patients to the most effective treatment for their cancer.

The UC, cosponsor of this bill, states that the UC is a leader in cancer care through our five National Cancer Institute-designated Comprehensive Cancer Centers, comprising the UC Cancer Consortium (UCCC). UCCC is focused on addressing health disparities and promoting health equity in cancer diagnosis and care as we work to improve patient outcomes across California. The UC concludes that this bill will bring the hope and promise of precision medicine to all Californians.

1. SUPPORT IF AMENDED. The Protection of the Education Rights of Kids has a support if amended position and request amendments to include protections for information collected, including but not limited to sharing information with third parties or for any other type of use, sharing, of genetic sequencing or medical information detected from the test results.
2. RELATED LEGISLATION.
   1. SB 421 (Limon) makes permanent existing law provisions that prohibit an individual or group health plan contract or health insurance policy, that provides coverage for prescribed, orally administered anticancer medications used to kill or slow the growth of cancerous cells from requiring an enrollee or insured to pay, notwithstanding any deductible, a total amount of copayments and coinsurance that exceeds $250 for an individual prescription of up to a 30-day supply of a prescribed orally administered anticancer medication, as specified. SB 421 is pending on the Assembly Floor.
   2. AB 948 (Berman) makes permanent existing law provisions that prohibit the copayment, coinsurance, or any other form of cost sharing for a covered outpatient prescription drug for an individual prescription from exceeding $250 for a supply of up to 30 days or $500 for bronze products, except as specified; and, requires a non-grandfathered individual or small group plan contract or insurance policy to use specified definitions for each tier of a drug formulary. SB 948 is pending in Senate Health Committee.
3. PREVIOUS LEGISLATION.
   1. SB 912 (Limon) of 2022 would have required a health plan contract or health insurance policy issued, amended, or renewed on or after July 1, 2023, to provide coverage for biomarker testing, including whole genome sequencing, for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition if the test is supported by medical and scientific evidence, as prescribed. Would have applied these provisions relating to biomarker testing to the Medi-Cal program, including Medi-Cal managed care plans, as specified. Governor Newsom vetoed this bill with the following message:

I am returning Senate Bill 912 without my signature.

This bill would require health care service plans, including the Medi-Cal program, to provide coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition, as long as the test is supported by medical and scientific evidence, as defined in the bill.

While I appreciate the author's efforts to provide biomarker testing coverage, these services are already covered by Medi-Cal. Furthermore, biomarker testing is valuable when it can inform a condition's diagnosis and treatment, but this bill would require Medi-Cal to cover unnecessary testing that may not inform the best treatment to care for the beneficiary.

For example, this bill would require the Department of Health Care Services (Department) to cover biomarker testing supported by local coverage determinations, which can contradict each other, and tests supported by "nationally recognized clinical practice guidelines and consensus statements," which may not be evidenced-based. In contrast, Medi-Cal policy is based upon the gold standard of guidelines with standards set by the National Academy of Medicine.

This bill would establish broad and contradictory coverage requirements that go beyond the Department's evidence-based policies, which would unnecessarily increase costs without increasing the quality of coverage. I believe the Department should retain its current flexibility to establish evidence-based policies in light of the dynamic and changing nature of medicine.

For these reasons, I cannot sign this bill.

• 1. SB 535 (Limon), Chapter 605, Statutes of 2021, prohibits health plans and insurers from requiring prior authorization for biomarker testing for advanced or metastatic stage 3 or 4 cancer, and cancer progression or recurrence.
  2. SB 583 (Jackson), Chapter 482, Statutes of 2019, expands coverage for clinical trials under a plan contract or insurance policy to include a clinical trial relating to the prevention, detection, or treatment of a life-threatening disease or condition, as defined, and include a clinical trial funded by, among others, a qualified nongovernmental research entity. Prohibits a plan contract or insurance policy from, among other things, discriminating against an enrollee or insured for participating in an approved clinical trial. Authorizes a plan or insurer to require a qualified enrollee or insured to participate in a clinical trial, as specified, and to restrict coverage to an approved clinical trial in this state, unless the clinical trial is not offered or available through a participating provider in this state.
  3. AB 1860 (Limon), Chapter 457, Statutes of 2018, increases the $200 copayment and coinsurance limit to $250 for prescribed, orally administered anticancer medications used to kill or slow the growth of cancerous cells, and deletes the sunset on the law that establishes this limit on the coinsurance and copayment amount for prescribed, orally administered anticancer medications and extends the sunset to January 1, 2024.

1. AMENDMENTS. To address concerns raised by the Committee and remaining issues the author has raised, the Committee and author have agreed to the following amendments:
   1. To ensure this bill focuses on defining what is covered and to avoid the precedent of establishing a definition of “medical and scientific evidence” that is specific to a single benefit, remove the definition of “medical and scientific evidence” and instead specify that tests are covered that meet any of the identified criteria;
   2. Clarify coverage for biomarker tests examined by FDA to specify coverage of:
      1. Any biomarker test that has been approved or cleared by the FDA; and,
      2. Any biomarker test for a biomarker listed as an indication on a medication label of an FDA-approved drug;
   3. To address the author’s concern that parameters of coverage may be defined in an unnecessarily restrictive manner, require coverage guidance promulgated by DHCS be based at a minimum on evidence-based, nationally recognized clinical practice guidelines, and allow such guidance to be based on consensus statements;
   4. Clarify the application of statutes enacted by SB 535 only apply to coverage through Medi-Cal managed care plans;
   5. To address the author’s concern the current language does not address denials of coverage, clarify denials of biomarker testing are also subject to grievance and appeal processes under state and federal law; and,
   6. Other conforming changes.
      

REGISTERED SUPPORT / OPPOSITION:

Support

American Cancer Society Cancer Action Network, Inc. (cosponsor)

University of California (cosponsor)

Advanced Medical Technology Association

Albie Aware Breast Cancer Foundation

Alliance for Patient Access

American College of Obstetricians and Gynecologists, District IX

American Kidney Fund

Association of Northern California Oncologists

Association of Regional Center Agencies

Biocom California

Biogen

Biotechnology Innovation Organization

California Academy of Family Physicians

California Chronic Care Coalition

California Clinical Laboratory Association

California Life Sciences

California Manufacturers and Technology Association

California Medical Association

Children's Specialty Care Coalition

City of Hope National Medical Center

Crohns and Colitis Foundation

Glaxosmithkline

GSK

International Foundation for Autoimmune and Inflammatory Arthritis

Medical Oncology Association of Southern California

Miora

Natera, Inc.

Quest Diagnostics, Inc.

The ALS Association

The Latino Cancer Institute

The Michael J. Fox Foundation for Parkinson's Research

Opposition

None on file.

Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 496

Author: Limón (D), et al.

Amended: 4/25/23

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/19/23

AYES: Eggman, Nguyen, Dahle, Glazer, Gonzalez, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

NO VOTE RECORDED: Hurtado

SENATE APPROPRIATIONS COMMITTEE: 6-0, 5/18/23

AYES: Portantino, Jones, Ashby, Bradford, Wahab, Wiener

NO VOTE RECORDED: Seyarto

SUBJECT: Biomarker testing

SOURCE: American Cancer Society Cancer Action Network

University of California

DIGEST:

This bill requires a health plan contract or a health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, and Medi-Cal, to cover medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence, as specified.

ANALYSIS:

Existing law:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans under the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act); California Department of Insurance (CDI) to regulate health and other insurance; and, the Department of Health Care Services (DHCS) to administer the Medi-Cal program. [HSC §1340, et seq., INS §106, et seq., and WIC §14000, et seq.]
2. Requires a health plan contract and health insurance policy, except for a specialized health plan contract and policy, to be deemed to provide coverage for all generally medically accepted cancer screening tests, subject to all terms and conditions that would otherwise apply. [HSC §1367.665 and INS §10123.20]
3. Prohibits a health plan contract and health insurance policy, except for a specialized health plan contract and policy from requiring prior authorization for either of the following:
   1. Biomarker testing for an enrollee with advanced or metastatic stage 3 or 4 cancer; or,
   2. Biomarker testing for cancer progression or recurrence in the enrollee with advanced or metastatic stage 3 or 4 cancer. [HSC §1367.665 and INS §10123.20]
4. Applies 3) above to health plan contracts and Medi-Cal managed care plan contracts with DHCS. [HSC §1367.665 and INS §10123.20]

This bill:

1. Requires a health plan contract, except for a specialized health plan contract, or a health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, to cover medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence. Defines, “medical and scientific evidence” as one or more of the following:
   1. A labeled indication for a test that has been approved or cleared by the FDA or is an indicated test for an FDA-approved drug;
   2. A national coverage determination made by the federal Centers for Medicare and Medicaid Services;
   3. A local coverage determination made by a Medicare Administrative Contractor; or,
   4. Evidence-based, nationally recognized clinical practice guidelines and consensus statements.
2. Requires a health plan or health insurer to use a specified process to determine whether biomarker testing is medically necessary, and at a minimum, requires the plan’s or insurer’s process to be supported by medical and scientific evidence, as defined in 1) directly above.
3. Requires the health plan or health insurance policy to ensure that biomarker testing is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples, but this bill does not require coverage of biomarker testing for screening purposes unless otherwise required by law.
4. Applies this bill to Medi-Cal and to any health plan contract and Medi-Cal managed care plan contract, or insurance policy with DHCS.
5. Applies the provisions described above to the Medi-Cal program subject to utilization controls, and only to the extent federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained. Permits DHCS to implement this bill by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking any further regulatory action.

Comments

According to the author, this bill requires a health plan and health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing. Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. This bill will improve access to biomarker testing, ensuring patients receive the right treatment at the right time.

California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requested the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and conducted an abbreviated review of SB 912 (Limón, 2022), which is similar to this bill. Key findings include:

Background. According to CHBRP, biomarker is a characteristic that can be measured to specify normal or abnormal health processes or to indicate a condition or disease. These measurements can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Nonphysiologic tests are often done in a laboratory using samples of blood, tissue, or other clinical samples to quantify and evaluate the biomarker. In recent years, biomarker testing has been used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients’ genetic, environmental, and lifestyle factors rather than a single approach to a disease or condition for all patients. Biomarkers can be tested a variety of ways, including through common blood biomarker tests, individually (single-analyte tests), within a multiplex panel test, or as part of whole genome or exome sequencing. Biomarker testing can be performed for cancer including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis; type 2 diabetes; and other conditions. Additionally, many biomarkers may be associated with several diseases and conditions. Performing biomarker testing for cancer, for example, enables a provider to accurately match the therapy to an individual patient by focusing on treatments most likely to be effective, and decreases treatment harms by avoiding treatments that are unlikely to result in improvement (e.g., chemotherapy), or may result in an adverse reaction. Biomarker tests can be used across the continuum of care for many diseases and conditions for the purposes of screening asymptomatic individuals, determining the presence of disease (diagnosis), estimating the risk or time to clinical outcomes (prognosis), identifying the likelihood of a patient to benefit from certain therapies (predictive) and to experience therapy-related risks (pharmacogenomics), or for treatment monitoring purposes.

Coverage impacts and enrollees covered. If enacted, the bill would apply to the health insurance of approximately 24.5 million enrollees (62.3% of all Californians). This represents enrollees in plans regulated by DMHC and policies regulated by the CDI, as well as Medi-Cal beneficiaries enrolled in County Organized Health Systems (COHS) or whose benefits are administered by DHCS. According to CHBRP there may be some variation in coverage of biomarker testing at baseline, but CHBRP is unable to identify which biomarker tests may not be currently covered.

Benefit Coverage. CHBRP indicates that broadly speaking, all enrollees with health insurance subject to this bill have coverage for biomarker testing that is supported by medical and scientific evidence and is determined medically necessary. There may be some biomarker tests that are newly covered based on the implementation of this bill, but CHBRP is unable to determine to which biomarker tests this applies.

Utilization and expenditures. Because this bill would not result in changes in benefit coverage, there would be no changes in utilization of biomarker tests or changes in health care expenditures as a result of this bill. More than 200,000 commercial and CalPERS enrollees and 100,000 Medi-Cal beneficiaries use biomarker testing each year. Some enrollees may use multiple forms of biomarker testing. Utilization of biomarker testing per 1,000 commercial and CalPERS enrollees is 14 for single-analyte tests, 3.2 for multiplex panel tests, and 0.4 for whole exome or genome sequencing. Utilization of biomarker testing per 1,000 Medi-Cal beneficiaries is 10.3 for single-analyte tests, 2.3 for multiplex panel tests, and 0.4 for whole exome or genome sequencing. Because biomarker testing is already broadly covered, utilization is not expected to change as a result of the passage of this bill. The average annual cost per user of biomarker testing for enrollees with commercial or CalPERS coverage was $677 for single-analyte tests, $948 for multiplex panel tests, and $984 for whole exome or genome testing. The average annual cost per user of biomarker testing for Medi-Cal beneficiaries was $426 for a single-analyte test, $460 for a multiplex panel test, and $488 for whole exome or genome testing. The average annual cost-sharing for commercial and CalPERS enrollees using biomarker testing ranges between $64 and $90. CHBRP indicates this bill would not result in changes to benefit coverage and therefore no resulting changes in utilization of biomarker tests and related treatments, it is important to understand how use of biomarker tests may lead to other health care utilization and expenditure impacts.

Medical effectiveness. Several studies have found biomarker-driven treatment improves treatment outcomes, including survival rate, and may also be cost-effective, leading to elimination of costs for other less-targeted therapies or offsets in the form of reduced emergency department and in-patient hospital admission. However, the clinical effectiveness of biomarker tests and related treatments varies based on the disease or condition and patient characteristics. Due to the number of biomarker tests, CHBRP is unable to conduct a medical effectiveness review of biomarker testing within its 60-day timeline.

Health disparities and social determinants of health. Literature indicates that the disparities in testing by race or ethnicity, age, and socio-economic status could widen inequities in utilization of biomarker testing if not specifically addressed. Additionally, studies have suggested that clinician barriers, including familiarity with guidelines and knowledge of best practices for use of biomarker testing, expertise in genomic testing, or access to a multidisciplinary specialty team, impact whether patients receive testing.

Related/Prior Legislation

SB 912 (Limon, 2022) would have required health plan contracts, disability insurance policies, and Medi-Cal to cover biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring if the test is supported by medical and scientific evidence, as specified. SB 912 was vetoed by the Governor, who stated:

This bill would require health care service plans, including the Medi-Cal program, to provide coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition, as long as the test is supported by medical and scientific evidence, as defined in the bill.

While I appreciate the author's efforts to provide biomarker testing coverage, these services are already covered by Medi-Cal. Furthermore, biomarker testing is valuable when it can inform a condition's diagnosis and treatment, but this bill would require Medi-Cal to cover unnecessary testing that may not inform the best treatment to care for the beneficiary.

For example, this bill would require the Department of Health Care Services (Department) to cover biomarker testing supported by local coverage determinations, which can contradict each other, and tests supported by "nationally recognized clinical practice guidelines and consensus statements," which may not be evidenced-based. In contrast, Medi-Cal policy is based upon the gold standard of guidelines with standards set by the National Academy of Medicine.

This bill would establish broad and contradictory coverage requirements that go beyond the Department's evidence-based policies, which would unnecessarily increase costs without increasing the quality of coverage. I believe the Department should retain its current flexibility to establish evidence-based policies in light of the dynamic and changing nature of medicine.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee:

• The DMHC estimates costs to be approximately $431,000 in 2023-24, $791,000 in 2024-25, $1,201,000 in 2025-26, $1,504,000 in 2026-27, and $1,495,000 in 2027-28 and annually thereafter (Managed Care Fund) to administer the provisions.
• The CDI estimates costs of $22,000 in 2024-25 (Insurance Fund).
• Unknown potential costs for the DHCS to administer the provisions.

SUPPORT: (Verified 5/18/23)

American Cancer Society Cancer Action Network (co-source)

University of California (co-source)

Advanced Medical Technology Association

Alliance for Patient Access

American Kidney Fund

Association of Regional Center Agencies

Biocom California

Biogen

Biotechnology Innovation Organization

California Academy of Family Physicians

California Chronic Care Coalition

California Clinical Laboratories Association

California Life Sciences

California Manufacturers & Technology Association

California Medical Association

Children’s Specialty Care Coalition

City of Hope National Medical Center

Crohn’s and Colitis Foundation

GSK

International Foundation for Autoimmune and Inflammatory Arthritis

MiOra

Natera

The Michael J. Fox Foundation for Parkinson’s Research

OPPOSITION: (Verified 5/22/23)

None received

ARGUMENTS IN SUPPORT: According to the American Cancer Society Cancer Action Network and University of California, cosponsors of this bill, cancer biomarkers can include molecules like proteins or genetic alterations such as mutations, rearrangements, or fusions. Testing patients for specific biomarkers is integral to precision medicine in cancer care but, despite evidence pointing to the clinical benefits associated with biomarker testing, routine clinical use does not always follow, and testing rates lag behind clinical guideline recommendations. In a 2021 survey, 66% of oncology providers reported that insurance coverage for biomarker testing is a significant or moderate barrier to appropriate biomarker testing. Insurance coverage for biomarker testing is failing to keep pace with innovations and advancements in treatment. This bill will require state-regulated insurance plans, including Medi-Cal, to cover comprehensive biomarker testing when supported by medical and scientific evidence, including nationally recognized clinical practice guidelines. Timely access to appropriate biomarker testing can help achieve better health outcomes, improve quality of life and reduce costs by connecting patients to the most effective treatment for their cancer. The Crohn’s and Colitis Foundation write procedures, like colonoscopy, help diagnose and evaluate irritable bowel syndrome, which is very helpful, but also invasive, expensive, and carries some risk; and fail to answer all questions. As irritable bowel syndrome biomarkers become available, coverage should not be a barrier for patients to receive biomarker testing when being treated.

Prepared by: Teri Boughton / HEALTH / (916) 651-4111

5/22/23 15:14:41

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SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

SB 496 (Limón) - Biomarker testing

Bill Summary:

SB 496 would require health plan contracts or health insurance policies that are issued, amended, delivered, or renewed on or after July 1, 2024, to cover medically necessary biomarker testing, as specified. The bill would make medically necessary biomarker testing, a covered Medi-Cal benefit, as specified.

Fiscal Impact:

• The Department of Managed Health Care (DMHC) estimates costs to be approximately $431,000 in 2023-24, $791,000 in 2024-25, $1,201,000 in 2025-26, $1,504,000 in 2026-27, and $1,495,000 in 2027-28 and annually thereafter (Managed Care Fund) to administer the provisions.
• The Department of Insurance estimates costs of $22,000 in 2024-25 (Insurance Fund).
• Unknown potential costs for the Department of Health Care Services to administer the provisions.

Background:

The Department of Managed Health Care (DMHC) regulates health plans under the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act), the California Department of Insurance (CDI) regulates health and other insurance, and the Department of Health Care Services (DHCS) administers the Medi-Cal program.

Current law prohibits a health plan contract and health insurance policy, including Medi-Cal managed care plans, from requiring prior authorization for either of the following:

a) Biomarker testing for an enrollee with advanced or metastatic stage 3 or 4 cancer; or,

b) Biomarker testing for cancer progression or recurrence in the enrollee with advanced or metastatic stage 3 or 4 cancer.

“Biomarker test” is defined as a diagnostic test, such as single or multigene, of the cancer patient’s biospecimen, such as tissue, blood, or other bodily fluids, for DNA or RNA alterations, including phenotypic characteristics of a malignancy, to identify an individual with a subtype of cancer, in order to guide patient treatment. The law does not limit, prohibit, or modify an enrollee’s rights to biomarker testing as part of an approved clinical trial, as specified.

Current law covers as a Medi-Cal benefit, for one-year olds and younger who are receiving inpatient hospital services in an intensive care unit, Rapid Whole Genome Sequencing, including individual sequencing, trio sequencing for a parent or parents and their baby, and ultra-rapid sequencing.

Proposed Law:

Specific provisions of the bill would:

• Require health plan contracts or health insurance policies that are issued, amended, delivered, or renewed on or after July 1, 2024, to cover medically necessary biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence, as specified.
• Make medically necessary biomarker testing, a covered Medi-Cal benefit, subject to utilization controls, and only to the extent federal financial participation is available and any necessary federal approvals have been obtained. Require that biomarker testing be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a Medi-Cal beneficiary’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence. Permit DHCS to implement the provisions by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking any further regulatory action.
• Define “biomarker testing” for purposes of the bill’s provisions.

Related Legislation:

SB 912 (Limon, 2022) would have required health plans and insurers to cover biomarker testing, as specified. The bill was vetoed by the Governor.

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SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: SB 496

SUBJECT: Biomarker testing

SUMMARY:

Requires a health plan contract or a health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, to cover biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence, as specified.

Existing law:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans under the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act); California Department of Insurance (CDI) to regulate health and other insurance; and, the Department of Health Care Services (DHCS) to administer the Medi-Cal program. [HSC §1340, et seq., INS §106, et seq., and WIC §14000, et seq.]
   
2. Covers as a Medi-Cal benefit for one year olds and younger who are receiving inpatient hospital services in an intensive care unit Rapid Whole Genome Sequencing, including individual sequencing, trio sequencing for a parent or parents and their baby, and ultra-rapid sequencing. [WIC §14132]
   
3. Requires the criteria or guidelines used by health plans and insurers, or any entities with which plans or insurers contract for utilization review or utilization management functions, to determine whether to authorize, modify, or deny health care services to:
   1. Be developed with involvement from actively practicing health care providers;
   2. Be consistent with sound clinical principles and processes;
   3. Be evaluated, and updated if necessary, at least annually;
   4. If used as the basis of a decision to modify, delay, or deny services in a specified case under review, be disclosed to the provider and the enrollee or insured in that specified case; and,
   5. Be available to the public upon request. [HSC §1363.5 and INS §10123.135]
      
4. Requires a health plan contract and health insurance policy, except for a specialized health plan contract and policy, to be deemed to provide coverage for all generally medically accepted cancer screening tests, subject to all terms and conditions that would otherwise apply. [HSC §1367.665 and INS §10123.20]
5. Prohibits a health plan contract and health insurance policy, except for a specialized health plan contract and policy from requiring prior authorization for either of the following:
   1. Biomarker testing for an enrollee with advanced or metastatic stage 3 or 4 cancer; or,
   2. Biomarker testing for cancer progression or recurrence in the enrollee with advanced or metastatic stage 3 or 4 cancer. [HSC §1367.665 and INS §10123.20]
6. Applies 3) above to health plan contracts and Medi-Cal managed care plan contracts with DHCS. [HSC §1367.665 and INS §10123.20]
7. Defines “biomarker test” for purposes of 4) above as a diagnostic test, such as single or multigene, of the cancer patient’s biospecimen, such as tissue, blood, or other bodily fluids, for DNA or RNA alterations, including phenotypic characteristics of a malignancy, to identify an individual with a subtype of cancer, in order to guide patient treatment. [HSC §1367.665 and INS §10123.20]
8. States that 4) above does not prohibit a health plan or insurer from requiring prior authorization on biomarker testing that is not for an United States Food and Drug Administration (FDA) FDA-approved therapy for advanced or metastatic stage 3 or 4 cancer, and does not limit, prohibit, or modify an enrollee’s or insured’s rights to biomarker testing as part of an approved clinical trial under existing law. [HSC §1367.665 and INS §10123.20]
   
9. Requires every health plan to establish and maintain a grievance system approved by DMHC under which enrollees may submit grievances to the plan. Requires a plan’s response to also comply with federal requirements. [HSC §1368]
   
10. Establishes an independent medical review (IMR) process, under which enrollee and insured grievances involving a disputed health care service are eligible for review. Defines “disputed health care service” as any health care service eligible for coverage and payment under the contract that has been denied, modified, or delayed by a decision of the plan, or contracting provider, in whole or in part due to a finding that the service is not medically necessary. [HSC §1374.30 and INS §10169]
    
11. Establishes a process for expeditiously reviewing IMR requests related to imminent and serious threat to the enrollee. [HSC §1374.31 and INS §10169.1]
    
12. Requires under federal law a group health plan and a health insurance issuer offering group or individual health insurance coverage to implement an effective appeals process for appeals of coverage determinations and claims, including an internal claims appeal process with notices in a culturally and linguistically appropriate manner, of available internal and external appeals process. Establishes processes for internal and external reviews. [42 USC §300gg-19]

This bill:

1. Requires a health plan contract, except for a specialized health plan contract, or a health insurance policy that is issued, amended, delivered, or renewed on or after July 1, 2024, to cover biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s or insured’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence. Defines, “medical and scientific evidence” as one or more of the following:
   1. A labeled indication for a test that has been approved or cleared by the FDA or is an indicated test for an FDA-approved drug;
   2. A national coverage determination made by the federal Centers for Medicare and Medicaid Services;
   3. A local coverage determination made by a Medicare Administrative Contractor; or,
   4. Evidence-based, nationally recognized clinical practice guidelines and consensus statements.
      
2. Requires the health plan or health insurance policy to ensure that biomarker testing is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples, but this bill does not require coverage of biomarker testing for screening purposes unless otherwise required by law.
   
3. Subjects restricted use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of any medical condition to grievance and appeal processes under state and federal law.
   
4. Applies this bill to any health plan contract and Medi-Cal managed care plan contract, or insurance policy with DHCS.
   
5. Exempts vision-only, dental-only, accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, or disability income insurance, except that for accident-only, specified disease, or hospital indemnity insurance, coverage for benefits under this bill to apply to the extent that the benefits are covered under the general terms and conditions that apply to all other benefits under the policy or contract. States that this bill does not impose a new benefit mandate on accident-only, specified disease, or hospital indemnity insurance.
   
6. Establishes the following definitions:
   1. “Biomarker” is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a specific therapeutic intervention. A biomarker includes, but is not limited to, gene mutations or protein expression;
   2. “Biomarker testing” is the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes, but is not limited to, single-analyte tests, multiplex panel tests, and whole genome sequencing;
   3. “Consensus statements” are statements developed by an independent, multidisciplinary panel of experts who utilize a transparent methodology and reporting structure, and are subject to a conflict of interest policy. These statements are aimed at specific clinical circumstances and are based on the best available evidence to optimize the outcomes of clinical care; and,
   4. “Nationally recognized clinical practice guidelines” are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure, and are subject to a conflict-of-interest policy. Clinical practice guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options, and those guidelines include recommendations intended to optimize clinical care.
      
7. Applies the provisions described above to the Medi-Cal program subject to utilization controls, and only to the extent federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained. Permits DHCS to implement this bill by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking any further regulatory action.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, this bill requires a health plan and health insurance policy issued, amended, or renewed on or after July 1, 2024, to provide coverage for biomarker testing. Precision medicine improves patient outcomes by using their own genes or proteins (biomarkers) to prevent, diagnose, or treat diseases. Biomarker testing can be performed for cancer, including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis, type 2 diabetes; and other conditions. Timely care is vital for patients to treat their disease, slow disease recurrence or progression, and improve their quality of life. Targeted treatments will improve survival rates and reduce costs by connecting patients to the most effective treatments. This bill will improve access to biomarker testing, ensuring patients receive the right treatment at the right time.
   
2. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and conducted an abbreviated review of SB 912 (Limón of 2022), which is similar to this bill. Key findings include:
   
   1. Background. According to CHBRP, biomarker is a characteristic that can be measured to specify normal or abnormal health processes or to indicate a condition or disease. These measurements can also be used to determine the effects a treatment is having on a patient. Biomarker tests are a way to measure and quantify biomarkers. Nonphysiologic tests are often done in a laboratory using samples of blood, tissue, or other clinical samples to
      quantify and evaluate the biomarker. In recent years, biomarker testing has been used in the expansion of precision medicine, an approach in which treatment and prevention are based on patients’ genetic, environmental, and lifestyle factors rather than a single approach to a disease or condition for all patients. Biomarkers can be tested a variety of ways, including through common blood biomarker tests, individually (single-analyte tests), within a multiplex panel test, or as part of whole genome or exome sequencing.
      Biomarker testing can be performed for cancer including prostate, ovarian, colorectal, breast, and lung cancers; Alzheimer’s disease; rheumatoid arthritis; type 2 diabetes; and other conditions. Additionally, many biomarkers may be associated with several diseases and conditions. Performing biomarker testing for cancer, for example, enables a provider to accurately match the therapy to an individual patient by focusing on treatments most likely to be effective, and decreases treatment harms by avoiding treatments that are unlikely to result in improvement (e.g., chemotherapy), or may result in an adverse reaction. Biomarker tests can be used across the continuum of care for many diseases and conditions for the purposes of screening asymptomatic individuals, determining the presence of disease (diagnosis), estimating the risk or time to clinical outcomes (prognosis), identifying the likelihood of a patient to benefit from certain therapies (predictive) and to experience therapy-related risks (pharmacogenomics), or for treatment monitoring purposes.
   2. Coverage impacts and enrollees covered. If enacted, the bill would apply to the health insurance of approximately 24.5 million enrollees (62.3% of all Californians). This represents enrollees in plans regulated by DMHC and policies regulated by the CDI, as well as Medi-Cal beneficiaries enrolled in County Organized Health Systems (COHS) or whose benefits are administered by DHCS. According to CHBRP there may be some variation in coverage of biomarker testing at baseline, but CHBRP is unable to identify which biomarker tests may not be currently covered.
   3. Benefit Coverage. CHBRP indicates that broadly speaking, all enrollees with health insurance subject to this bill have coverage for biomarker testing that is supported by medical and scientific evidence and is determined medically necessary. There may be some biomarker tests that are newly covered based on the implementation of this bill, but CHBRP is unable to determine to which biomarker tests this applies.
   4. Utilization and expenditures. Because this bill would not result in changes in benefit coverage, there would be no changes in utilization of biomarker tests or changes in health care expenditures as a result of this bill. More than 200,000 commercial and CalPERS enrollees and 100,000 Medi-Cal beneficiaries use biomarker testing each year. Some enrollees may use multiple forms of biomarker testing. Utilization of biomarker testing per 1,000 commercial and CalPERS enrollees is 14 for single-analyte tests, 3.2 for multiplex panel tests, and 0.4 for whole exome or genome sequencing. Utilization of biomarker testing per 1,000 Medi-Cal beneficiaries is 10.3 for single-analyte tests, 2.3 for multiplex panel tests, and 0.4 for whole exome or genome sequencing. Because biomarker testing is already broadly covered, utilization is not expected to change as a result of the passage of this bill. The average annual cost per user of biomarker testing for enrollees with commercial or CalPERS coverage was $677 for single-analyte tests, $948 for multiplex panel tests, and $984 for whole exome or genome testing. The average annual cost per user of biomarker testing for Medi-Cal beneficiaries was $426 for a single-analyte test, $460 for a multiplex panel test, and $488 for whole exome or genome testing. The average annual cost-sharing for commercial and CalPERS enrollees using biomarker testing ranges between $64 and $90. CHBRP indicates this bill would not result in changes to benefit coverage and therefore no resulting changes in utilization of biomarker tests and related treatments, it is important to understand how use of biomarker tests may lead to other health care utilization and expenditure impacts.
   5. Medical effectiveness. Several studies have found biomarker-driven treatment improves treatment outcomes, including survival rate, and may also be cost-effective, leading to elimination of costs for other less-targeted therapies or offsets in the form of reduced emergency department and in-patient hospital admission. However, the clinical effectiveness of biomarker tests and related treatments varies based on the disease or condition and patient characteristics. Clinical guidelines are one source of information about the effectiveness of biomarker testing and related treatments. Due to the number of biomarker tests, CHBRP is unable to conduct a medical effectiveness review of biomarker testing within its 60-day timeline.
   6. Health disparities and social determinants of health. Literature indicates that the disparities in testing by race or ethnicity, age, and socio-economic status could widen inequities in utilization of biomarker testing if not specifically addressed. Additionally, studies have suggested that clinician barriers — including familiarity with guidelines and knowledge of best practices for use of biomarker testing, expertise in genomic testing, or access to a multidisciplinary specialty team — impact whether patients receive testing.
   7. Essential Health Benefits (EHBs). Under existing law, plans and policies are required to cover medically necessary diagnostic lab services and ongoing disease management services. Additionally, biomarker testing is broadly covered by California’s EHB benchmark plan. Because this bill would not require coverage for a new state benefit mandate, it therefore appears not to exceed the definition of EHBs in California.
   8. Long-term implications. CHBRP assumes it is likely that plans and policies will continue to incorporate new clinical guidelines as they become available in future years. While not directly related to this bill, there are implications for health plans and policies, including Medi-Cal, as new biomarker tests become available and new therapies indicated by biomarker testing become available. Some medications with biomarker-indications cost more than $100,000 annually. Although utilization of these high-cost medications is relatively low, should utilization increase, related health care expenditures would increase as well. As noted previously, evidence supports clinical utility and cost-effectiveness of several biomarker tests and related treatments, which could contribute to offsets in health care expenditures or improved quality of life for enrollees.
      
3. Related legislation. AB 700 (Grayson) requires the Department of Public Health to award grants to eligible educational institutions to conduct research using a fire service community-based participatory research model that includes the understanding of biomarkers of exposure and studying biomarkers of effect that quantify cancer-promoting cellular changes that ultimately lead to a cancer diagnosis. AB 700 passed out of the Assembly Health Committee on March 29, 2023 on 14-0 vote.
   
4. Prior legislation. SB 912 (Limon of 2022) would have required health plan contracts, disability insurance policies, and Medi-Cal to cover biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring if the test is supported by medical and scientific evidence, as specified. SB 912 was vetoed by the Governor, who stated:

This bill would require health care service plans, including the Medi-Cal program, to provide coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a person's disease or condition, as long as the test is supported by medical and scientific evidence, as defined in the bill.

While I appreciate the author's efforts to provide biomarker testing coverage, these services are already covered by Medi-Cal. Furthermore, biomarker testing is valuable when it can inform a condition's diagnosis and treatment, but this bill would require Medi-Cal to cover unnecessary testing that may not inform the best treatment to care for the beneficiary.

For example, this bill would require the Department of Health Care Services (Department) to cover biomarker testing supported by local coverage determinations, which can contradict each other, and tests supported by "nationally recognized clinical practice guidelines and consensus statements," which may not be evidenced-based. In contrast, Medi-Cal policy is based upon the gold standard of guidelines with standards set by the National Academy of Medicine.

This bill would establish broad and contradictory coverage requirements that go beyond the Department's evidence-based policies, which would unnecessarily increase costs without increasing the quality of coverage. I believe the Department should retain its current flexibility to establish evidence-based policies in light of the dynamic and changing nature of medicine.

SB 535 (Limón, Chapter 605, Statutes of 2021) prohibits health plans and insurers from requiring prior authorization for biomarker testing for advanced or metastatic stage 3 or 4 cancer, and cancer progression or recurrence.

1. Support. According to the American Cancer Society Cancer Action Network and University of California, cosponsors of this bill, cancer biomarkers can include molecules like proteins or genetic alterations such as mutations, rearrangements, or fusions. Testing patients for specific biomarkers is integral to precision medicine in cancer care but, despite evidence pointing to the clinical benefits associated with biomarker testing, routine clinical use does not always follow, and testing rates lag behind clinical guideline recommendations. In a 2021 survey, 66% of oncology providers reported that insurance coverage for biomarker testing is a significant or moderate barrier to appropriate biomarker testing. Insurance coverage for biomarker testing is failing to keep pace with innovations and advancements in treatment. This bill will require state-regulated insurance plans, including Medi-Cal, to cover comprehensive biomarker testing when supported by medical and scientific evidence, including nationally recognized clinical practice guidelines. Timely access to appropriate biomarker testing can help achieve better health outcomes, improve quality of life and reduce costs by connecting patients to the most effective treatment for their cancer. The Crohn’s and Colitis Foundation write procedures, like colonoscopy, help diagnose and evaluate irritable bowel syndrome, which is very helpful, but also invasive, expensive, and carries some risk; and fail to answer all questions. As irritable bowel syndrome biomarkers become available, coverage should not be a barrier for patients to receive biomarker testing when being treated. This bill removes this impediment by ensuring health plans provide coverage for this important testing.
   
2. Opposition unless amended. The California Association of Health Plans (CAHP) and Association of California Life and Health Insurance Companies (ACLHIC) write that this bill inadvertently requires health plans and insurers to cover biomarker testing in a way that will increase healthcare costs while potentially subjecting patients to lower levels of care. Biomarker testing is a broad category. While this category includes some tests that are the current standard of care, it includes others that are still classified as experimental. This is also a field that is rapidly expanding as new tests are frequently developed. Health plans and insurers work to ensure the patient meets the criteria for the test and the appropriate test is being ordered. Many testing companies have created large panels of tests that are often denied because a single test is really all that is medically necessary. This bill would require coverage of unnecessary testing which creates waste and potential harm to the patient. Prematurely opening the door to more testing mandates, with little proven benefit, will raise the cost of healthcare while providing very little benefit to patients. Further, reducing a plan or insurer from having oversight with respect to these types of services may incentivize testing companies to market large expensive panels of tests that far exceed what is needed in a particular case. CAHP and ACLHIC request an amendment to ensure that only those tests which are deemed to be both evidence based and medically necessary be covered.
3. Amendments. CDI has requested amendments to the Insurance Code to do the following:
   1. Subdivision (b) replace “chapter” with “part”
   2. Subdivision (c) add including Section 2719 of the federal Public Health Service Act (Sec. 300gg-19 of Title 45 of the United States Code) and any regulations subsequently adopted thereunder, and the Independent Medical Review System under Article 3.5 of Chapter 1 of Part 2 of Division 2 (commencing with section 10169).
   3. Subdivision (d) delete the entire subdivision.
   4. Subdivision (e) amend the subdivision to limit the exemption from the bill to vision-only, dental-only, or Medicare supplement insurance. According to CDI these are the only exemptions needed.
   5. CAHP and ACLHIC have requested an amendment to add that covered biomarker testing is medically necessary.
   6. In response to these requests the author asks the committee adopt amendments reflected in a)-d) above, and, the following (for health plans and insurers) to address the CAHP and ACLHIC request:

(a) A health care service plan contract, except for a specialized health care service plan contract, that is issued, amended, delivered, or renewed on or after July 1, 2024, shall cover medically necessary biomarker testing pursuant to this section. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition to guide treatment decisions only if the test is supported by medical and scientific evidence. For purposes of this subdivision, “medical and scientific evidence” means one or more of the following:

(1) A labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA) or is an indicated test for an FDA-approved drug.

(2) A national coverage determination made by the federal Centers for Medicare and Medicaid Services.

(3) A local coverage determination made by a Medicare Administrative Contractor.

(4) Evidence-based, nationally recognized clinical practice guidelines and consensus statements.

(b) For purposes of this section, “medically necessary” shall be developed using the process described in 1363.5 and at a minimum, shall include the criteria in subdivision (a).

SUPPORT AND OPPOSITION:

Support: American Cancer Society Cancer Action Network (cosponsor)

University of California (cosponsor)

Advanced Medical Technology Association

Alliance for Patient Access

Association of Regional Center Agencies

Biocom California

Biogen

Biotechnology Innovation Organization

California Chronic Care Coalition

California Clinical Laboratories Association

California Life Sciences

California Manufacturers & Technology Association

California Medical Association

Children’s Specialty Care Coalition

City of Hope
Crohn’s and Colitis Foundation

GSK
MiOra

Natera

The Michael J. Fox Foundation for Parkinson’s Research

Oppose: America’s Health Insurance Plans

Association of California Life and Health Insurance Companies (unless amended)

California Association of Health Plans (unless amended)

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