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 its provisions a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires every health care service plan contract and health insurance policy to provide coverage for screening for, diagnosis of, and treatment for, breast cancer, consistent with generally accepted medical practice and scientific evidence, upon the referral of the enrollees or insureds participating physician.

Existing law requires the State Department of Health Care Services to perform various health functions, including providing breast and cervical cancer screening and treatment for low-income individuals.

This bill would require health care service plans, health insurers, and the State Department of Health Care Services to cover breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force. By creating a new crime with respect to health care service plans, the bill would impose a state-mandated local program.

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.

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 its provisions a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires every health care service plan contract and health insurance policy to provide coverage for screening for, diagnosis of, and treatment for, breast cancer, consistent with generally accepted medical practice and scientific evidence, upon the referral of the enrollees or insureds participating physician.

Existing law requires the State Department of Health Care Services to perform various health functions, including providing breast and cervical cancer screening and treatment for low-income individuals.

This bill would require health care service plans, health insurers, and the State Department of Health Care Services to cover breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force. By creating a new crime with respect to health care service plans, the bill would impose a state-mandated local program.

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.

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 its provisions a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires every health care service plan contract and health insurance policy to provide coverage for screening for, diagnosis of, and treatment for, breast cancer, consistent with generally accepted medical practice and scientific evidence, upon the referral of the enrollees or insureds participating physician.

Existing law requires the State Department of Health Care Services to perform various health functions, including providing breast and cervical cancer screening and treatment for low-income individuals.

This bill would require health care service plans, health insurers, and the State Department of Health Care Services to cover breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force. By creating a new crime with respect to health care service plans, the bill would impose a state-mandated local program.

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.

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 its provisions a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires every health care service plan contract and health insurance policy to provide coverage for screening for, diagnosis of, and treatment for, breast cancer, consistent with generally accepted medical practice and scientific evidence, upon the referral of the enrollees or insureds participating physician.

Existing law requires the State Department of Health Care Services to perform various health functions, including providing breast and cervical cancer screening and treatment for low-income individuals.

This bill would require health care service plans, health insurers, and the State Department of Health Care Services to cover screening, genetic counseling, and testing for BRCA gene mutations in women who have not been diagnosed with BRCA-related cancer and do not have signs or symptoms of the disease, but who may have an increased risk based on one or more of specified family history risk factors. breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force. By creating a new crime with respect to health care service plans, the bill would impose a state-mandated local program.

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.

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 its provisions a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law requires every health care service plan contract and health insurance policy to provide coverage for screening for, diagnosis of, and treatment for, breast cancer, consistent with generally accepted medical practice and scientific evidence, upon the referral of the enrollees or insureds participating physician.

Existing law requires the State Department of Health Care Services to perform various health functions, including providing breast and cervical cancer screening and treatment for low-income individuals.

This bill would require health care service plans, health insurers, and the State Department of Health Care Services to cover screening, genetic counseling, and testing for BRCA gene mutations in women who have not been diagnosed with BRCA-related cancer and do not have signs or symptoms of the disease, but who may have an increased risk based on one or more of specified family history risk factors. By creating a new crime with respect to health care service plans, the bill would impose a state-mandated local program.

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.

GOVERNOR'S VETO

GV Bill Id:AB 2342

Author:(Burke and Waldron)

As Enrolled Ver:September 12, 2018

2/3 vote

Original Committee Reference: HEALTH

SUMMARY: Requires health care service plans (health plans), health insurers, and the Department of Health Care Services (DHCS) to provide coverage for breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force (USPSTF).

The Senate amendments make technical changes and add a co-author.

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. $2.0 million (General Fund (GF)) and 1.0 position in DHCS to provide breast and ovarian cancer susceptibility gene screenings as part of the Every Woman Counts (EWC) program, assuming that the intent of this bill is to provide services with federal Centers for Disease Control and Prevention (CDC) funds and within the EWC program. The staff workload is estimated to be $256,000 (GF) in the first year, and $247,000 ongoing annually thereafter for 1.0 permanent Medical Consultant, who would review, adjudicate, and track treatment authorization requests.
2. No immediate impact to capitation rates, as benefits in this bill are already covered under the Medi-Cal managed care plan. However, indeterminate cost pressures, to the extent that increased awareness of screenings could result in increased utilization of genetic counseling and breast cancer susceptibility gene (BRCA) testing, which could result in costs to Medi-Cal managed care plans.
3. One-time $7,000 (Insurance Fund) to the Department of Insurance for grandfathered health insurers to submit new policy forms to comply with this bill. The number of grandfathered plans still in force in California is very small, approximately 10 insurers that would need to file one to three amendments each to encompass this change.
4. No fiscal impact to the Department of Managed Health Care.

COMMENTS: According to the author, it is imperative that all high risk women, even those without symptoms of breast or ovarian cancer, be identified and given the opportunity to receive screening, counseling and testing, especially given that women of color are disproportionately dying due to lack of early detection and proper treatment. We need to ensure that all high-risk women, regardless of socio-economic status or color are provided with every resource possible to protect themselves and their family.

1. Other California programs. The EWC program provides free breast and cervical cancer screenings and diagnostic services to underserved populations. It is the state equivalent of a national program, the National Breast and Cervical Cancer Early Detection Program of the CDC. The Breast and Cervical Cancer Treatment Program provides cancer treatment to women with household incomes at or below 200% of the federal poverty level, who are under 65 years of age and with no other source of insurance, who have been diagnosed with breast or cervical cancer and require treatment.
2. Medicaid Coverage of BRCA Screening, Counseling, and/or Testing. States with expanded Medicaid programs are required to cover preventive services for adults who became newly eligible under the Patient Protection and Affordable Care Act's (ACA's) Medicaid expansion. This includes services outlined in the USPSTF recommendations with a grade A or grade B, such as screening, genetic counseling, and genetic testing for BRCA1 and BRCA2 gene mutations in women with a family history of BRCA-related cancer. However, states are not required to cover the same set of preventive services for adults enrolled in a traditional Medicaid program prior to Medicaid expansion. Still, 37 states, including California, cover genetic testing for BRCA1 and BRCA2 in their traditional Medicaid program.
3. The ACA. Under the ACA's Preventive Services requirement (Section 2713 of the Public Health Service Act), nongrandfathered group (small and large) and individual health insurance plans and policies are required to cover certain preventive services without cost sharing when delivered by in-network providers and as soon as 12 months after a recommendation appears in any of the following:
   1. The USPSTF's A and B recommendations;
   2. The Health Resources and Services Administration supported health plan coverage guidelines for women's preventive services;
   3. The HRSA-supported comprehensive guidelines for infants, children, and adolescents, which include:
      1. The Bright Futures Recommendations for Pediatric Preventive Health Care;
      2. The recommendations of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and,
      3. The Advisory Committee on Immunization Practices recommendations that have been adopted by the Director of the Centers for Disease Control and Prevention.

The City of Los Angeles, sponsor of this bill, states that codifying this bill in state law will ensure that there are no undue denials of coverage and that these vital services will continue to be covered regardless of the status of the ACA.

America's Health Insurance Plans, Association of California Life and Health Insurance Companies, and California Association of Health Plans, contend that a prior version of this bill will increase costs, reduce choice and competition, and further incentivize some employers and individuals to avoid state regulation by seeking alternative coverage options.

GOVERNOR'S VETO MESSAGE:

I am returning the following six bills without my signature:

AB 2043

AB 2342

AB 2593

SB 320

SB 1125

SB 1148

Each of these bills require significant, ongoing general fund commitments. As such, I commend these policies to the budget process where they may be prioritized along with other spending proposals and which begins again on January 3rd.

Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0005364

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2342

Author:(Burke and Waldron)

As Amended Ver:August 17, 2018

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Requires health care service plans (health plans), health insurers, and the Department of Health Care Services (DHCS) to provide coverage for breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force (USPSTF).

The Senate amendments make technical changes and add a co-author.

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. $2.0 million (General Fund (GF)) and 1.0 position in DHCS to provide breast and ovarian cancer susceptibility gene screenings as part of the Every Woman Counts (EWC) program, assuming that the intent of this bill is to provide services with federal Centers for Disease Control and Prevention (CDC) funds and within the EWC program. The staff workload is estimated to be $256,000 (GF) in the first year, and $247,000 ongoing annually thereafter for 1.0 permanent Medical Consultant, who would review, adjudicate, and track treatment authorization requests.
2. No immediate impact to capitation rates, as benefits in this bill are already covered under the Medi-Cal managed care plan. However, indeterminate cost pressures, to the extent that increased awareness of screenings could result in increased utilization of genetic counseling and breast cancer susceptibility gene (BRCA) testing, which could result in costs to Medi-Cal managed care plans.
3. One-time $7,000 (Insurance Fund) to the Department of Insurance for grandfathered health insurers to submit new policy forms to comply with this bill. The number of grandfathered plans still in force in California is very small, approximately 10 insurers that would need to file one to three amendments each to encompass this change.
4. No fiscal impact to the Department of Managed Health Care.

COMMENTS: According to the author, it is imperative that all high risk women, even those without symptoms of breast or ovarian cancer, be identified and given the opportunity to receive screening, counseling and testing, especially given that women of color are disproportionately dying due to lack of early detection and proper treatment. We need to ensure that all high-risk women, regardless of socio-economic status or color are provided with every resource possible to protect themselves and their family.

1. Other California programs. The EWC program provides free breast and cervical cancer screenings and diagnostic services to underserved populations. It is the state equivalent of a national program, the National Breast and Cervical Cancer Early Detection Program of the CDC. The Breast and Cervical Cancer Treatment Program provides cancer treatment to women with household incomes at or below 200% of the federal poverty level, who are under 65 years of age and with no other source of insurance, who have been diagnosed with breast or cervical cancer and require treatment.
2. Medicaid Coverage of BRCA Screening, Counseling, and/or Testing. States with expanded Medicaid programs are required to cover preventive services for adults who became newly eligible under the Patient Protection and Affordable Care Act's (ACA's) Medicaid expansion. This includes services outlined in the USPSTF recommendations with a grade A or grade B, such as screening, genetic counseling, and genetic testing for BRCA1 and BRCA2 gene mutations in women with a family history of BRCA-related cancer. However, states are not required to cover the same set of preventive services for adults enrolled in a traditional Medicaid program prior to Medicaid expansion. Still, 37 states, including California, cover genetic testing for BRCA1 and BRCA2 in their traditional Medicaid program.
3. The ACA. Under the ACA's Preventive Services requirement (Section 2713 of the Public Health Service Act), nongrandfathered group (small and large) and individual health insurance plans and policies are required to cover certain preventive services without cost sharing when delivered by in-network providers and as soon as 12 months after a recommendation appears in any of the following:
   1. The USPSTF's A and B recommendations;
   2. The Health Resources and Services Administration supported health plan coverage guidelines for women's preventive services;
   3. The HRSA-supported comprehensive guidelines for infants, children, and adolescents, which include:
      1. The Bright Futures Recommendations for Pediatric Preventive Health Care;
      2. The recommendations of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and,
      3. The Advisory Committee on Immunization Practices recommendations that have been adopted by the Director of the Centers for Disease Control and Prevention.

The City of Los Angeles, sponsor of this bill, states that codifying this bill in state law will ensure that there are no undue denials of coverage and that these vital services will continue to be covered regardless of the status of the ACA.

America's Health Insurance Plans, Association of California Life and Health Insurance Companies, and California Association of Health Plans, contend that a prior version of this bill will increase costs, reduce choice and competition, and further incentivize some employers and individuals to avoid state regulation by seeking alternative coverage options.

Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 FN: 00043900004390

 THIRD READING  

Bill No: AB 2342

Author:

Amended: 8/17/18 in Senate

Vote:

SENATE HEALTH COMMITTEE: 9-0, 6/27/18

AYES: Pan, Nguyen, Beall, Hernandez, Leyva, Mitchell, Monning, Nielsen, Roth

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/16/18

AYES: Portantino, Bates, Beall, Bradford, Hill, Nielsen, Wiener

ASSEMBLY FLOOR: 78-0, 5/31/18 - See last page for vote

SUBJECT:

SOURCE: City of Los Angeles

DIGEST:

This bill deems that breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force are covered in health plan contracts, and policies of disability insurance that provide coverage for hospital, medical or surgical expenses issued, amended, delivered, or renewed on or after January 1, 2019, and requires this coverage to be provided in the breast cancer screening and diagnostic services program.

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) and the California Department of Insurance (CDI) to regulate health insurance. [HSC §1340, et seq. and INS §106, et seq.]
   
2. Requires every plan contract, except a specialized health plan contract, and every policy of disability insurance that provides coverage for hospital, medical or surgical expenses that is issued, amended, delivered, or renewed on or after January 1, 2000, to provide coverage for screening for, diagnosis of, and treatment for, breast cancer. [HSC §1367.6 and INS §10123.8]
   
3. Deems every individual or group health plan contract, except for a specialized health care service plan contract, and every individual or group disability insurance policy that covers hospital, medical or surgical expenses that is issued, amended, delivered, or renewed on or after July 1, 2000, 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]
4. Establishes as California's essential health benefits (EHBs) benchmark the Kaiser Small Group Health Maintenance Organization, existing California mandates, and ten federal Affordable Care Act (ACA) mandated benefits including preventive and wellness services. Requires nongrandfathered individual and small group health plan contracts and health insurance policies to cover these EHBs and comply with Knox-Keene Act requirements.[HSC §1367.005 and INS §10112.27]
   
5. Requires, to the extent required by federal law, a group or individual health plan contract or health insurance policy issued, amended, renewed, or delivered on or after September 23, 2010, to comply with the preventive services requirement of the ACA and any rules or regulations issued under that section. [HSC §1367.002 and INS §10112.2]
   
6. Establishes the breast and cervical cancer early detection program under which the Department of Health Care Services (DHCS) provides for breast cancer and cervical cancer screening services under a federal grant at the level of funding budgeted from state and other resources to an individual with family income that does not exceed 200% of the federal poverty level. [HSC §104150]
   
7. Requires the following individuals to be eligible for breast cancer screening and diagnostic services pursuant to 6) above if they meet all other eligibility requirements:
   1. An individual of any age who is symptomatic;
   2. An individual whose age is within the age range for routine breast cancer screening, as recommended by the United States Preventive Services Task Force (USPSTF), subject to any federal action relating to breast cancer screening that overrides those recommendations; and,
8. Defines, “symptomatic” to mean an individual presenting with an abnormality or change in the look or feel of the breast, including, but not limited to, a lump, a hard knot, thickening or swelling of the breast tissue, a change in the color, size, or shape of the breast, or any discharge from the nipple. [HSC §104150]
   
9. Requires, under the ACA, a group health plan and a health insurance issuer offering group or individual insurance coverage to, at a minimum to provide coverage and not impose any cost sharing for the following preventive services, as soon as 12 months after the recommendation appears:
   1. Evidence-based items or services that have in effect a rating of “A” or “B” in the current recommendations of USPSTF;
   2. Immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved;
   3. With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration; and,
   4. With respect to women, such additional preventive care and screenings not otherwise described above as provided for in comprehensive guidelines supported by the Health Resources and Services Administration. [42 U.S.C. §300gg-13]

This bill:

1. Requires, in addition to the existing mandated coverage for screening for, diagnosis of, and treatment for, breast cancer, every health plan contract, except a specialized health plan contract, and every policy of disability insurance that provides coverage for hospital, medical or surgical expenses, that is issued, amended, delivered, or renewed on or after January 1, 2019, to be deemed to cover breast and ovarian cancer susceptibility screening as recommended by USPSTF.
2. Requires, in addition to the services described in the breast cancer screening and diagnostic services program, DHCS to provide breast and ovarian cancer susceptibility screening as recommended by USPSTF.

Comments

According to the author, it is imperative that all high risk women, even those without symptoms of breast or ovarian cancer, be identified and given the opportunity to receive the most up-to-date screenings as recommended by USPSTF, especially considering that women of color are disproportionately dying due to lack of early detection and proper treatment. We need to ensure that all high-risk women, regardless of socio-economic status or color are provided with every resource possible to protect themselves and their family. This bill would ensure that as medical science evolves and advances when it comes to screening for patients considered high-risk for breast and ovarian cancer, health coverage evolves and advances as well.

Breast cancer susceptibility gene (BRCA). According to the California Health Benefits Review Program (CHBRP), there are two (BRCA1 and BRCA2) cancer susceptibility genes that create tumor suppressor proteins. Individuals with inherited mutations in these genes experience an increased risk of developing some types of cancer, including breast and ovarian cancer. BRCA gene mutations can impact both men and women’s risk of developing certain kinds of cancer. Estimates of BRCA gene mutation prevalence in the general population (otherwise known as the carrier rate) range from 1:300 to 1:500 women and the prevalence of BRCA gene mutations among persons of Ashkenazi Jewish ancestry has been estimated to be 1:40. The American Cancer Society estimates that in 2018, there will be approximately 29,360 new cases of female breast cancer and 2,540 new cases of ovarian cancer in California; therefore, CHBRP estimates that 3,523 cases of breast cancer and 356 cases of ovarian cancer diagnosed in California in 2018 will be attributable to BRCA gene mutations.

USPSTF. CHBRP indicates that at the time of their report’s publication, the USPSTF recommends with a grade “B” that primary care providers screen women who have a family history of BRCA-related cancer (i.e., family members with breast, ovarian, tubal, or peritoneal cancer) with a screening tool designed to identify family history that may be associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes. Women who receive a positive screening result should then be offered genetic counseling, and if indicated, BRCA genetic testing. The population relevant to this USPSTF recommendation includes asymptomatic women who have not been diagnosed with a BRCA-related cancer but who have family member(s) with breast, ovarian, tubal (fallopian tube), or peritoneal cancer. The recommendation states that women with one or more family members with a known potentially harmful mutation in the BRCA1 or BRCA2 genes should be offered genetic counseling and testing. This recommendation does not apply to men. Based on the grade “B” rating, nongrandfathered group and individual health insurance plans and policies are currently required to cover, without cost sharing, screening, genetic counseling, and genetic testing, if indicated, for women whose family history is associated with an increased risk for BRCA1 or BRCA2 gene mutations.

Breast cancer screening. In 1990, the Centers for Disease Control and Prevention (CDC) created the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) through Public Law 101-354. This law authorized CDC to grant funds to states to screen a reasonable number of low income, uninsured women for breast and cervical cancers, provide referrals for follow-up and medical treatment for women with abnormal test results, develop and disseminate information for preventing breast and cervical cancers, improve the training of health professionals in preventing these cancers, and monitor the quality of screening procedures. In California, this is the Every Woman Counts (EWC) program. EWC provides free clinical breast exams, mammograms, pelvic exams, and Pap tests to California's low income uninsured and underserved women. These screening services facilitate early detection that may prevent untimely cancer deaths. Each year, EWC provides care for approximately 300,000 individuals. According to information available on DHCS’s Web site, EWC is funded, in part, by $.01 of the $.02 tax on each pack of cigarettes sold in California that is allocated to the Breast Cancer Fund. It could not be confirmed if EWC currently follows the USPSTF screening recommendations.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Senate Appropriations Committee:

• $2.0 million (General Fund) and 1.0 position in DHCS to provide breast and ovarian cancer susceptibility gene screenings as part of the Every Woman Counts (EWC) program, assuming that the intent of the bill is to provide services with federal CDC funds and within the EWC program. The staff workload is estimated to be $256,000 (General Fund) in the first year and $247,000 ongoing annually thereafter for 1.0 permanent Medical Consultant, who would review, adjudicate, and track treatment authorization requests (TARs). Please see Staff Comments for additional assumptions related to the potential impact on DHCS.
• No immediate impact to capitation rates, as benefits in the bill are already covered under the Medi-Cal managed care plan. However, indeterminate cost pressures, to the extent that increased awareness of screenings could result in increased utilization of genetic counseling and BRCA testing, which could result in costs to Medi-Cal managed care plans.
• One-time $7,000 (Insurance Fund) to CDI for grandfathered health insurers to submit new policy forms to comply with this bill. The number of grandfathered plans still in force in California is very small, approximately ten insurers that would need to file one to three amendments each to encompass this change. 
• No fiscal impact to DMHC.

SUPPORT: (Verified 8/15/18)

City of Los Angeles (source)

Association of Northern California Oncologists

Bay Area Women’s Health Advocacy Council

Breast Cancer Prevention Partners

California Legislative Women’s Caucus

California Life Sciences Association

Carrie’s Touch

Medical Oncology Association of Southern California

The Ovarian Cancer Circle/Inspired By Robin Babbini

Ovarian Cancer Coalition of California

Quest Diagnostics

OPPOSITION: (Verified 8/15/18)

Department of Health Care Services

Department of Managed Health Care

ARGUMENTS IN SUPPORT: The City of Los Angeles writes that this bill will guarantee that California women who could be considered high-risk for breast or ovarian cancer are appropriately assessed and, if necessary, receive genetic counseling and testing. While this testing is required as an EHB under the ACA, codifying this protection in state law will help ensure that there are no undue denials of coverage and these vital services will continue to be covered regardless of the status of the ACA. The California Life Sciences Association writes this bill is a step in the right direction towards increasing screening rates for genes currently held to be among the best indicators on likelihood to develop certain cancers. The Legislative Women’s Caucus writes decades of research have shown women of color are dying at disproportionate rates due to lack of early detection and proper treatment. Moving forward, we need to ensure all women, regardless of color or socioeconomic status are provided with resources that ensure a healthier future. Quest Diagnostics writes this bill is consistent with USPSTF recommendations for screening at-risk women for BRCA 1/2 mutations and meets the requirements of the ACA. Further, BRCA screening and testing is a preventive approach to cancer that allows women to make evidence-based, informed, decisions on their own healthcare to prevent cancer.

ARGUMENTS IN OPPOSITION: DMHC is opposed to this bill because it is duplicative of existing law and unnecessary. DHCS is opposed to this bill because it expands EWC.

ASSEMBLY FLOOR: 78-0, 5/31/18

AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bonta, Brough, Burke, Caballero, Calderon, Carrillo, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dahle, Daly, Eggman, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon

Prepared by:

8/19/18 13:37:35

**** END ****

SENATE COMMITTEE ON

Senator Anthony Portantino, Chair

2017 - 2018 Regular Session

AB 2342 (Burke) - Breast and ovarian cancer susceptibility screening

Bill Summary:

Requires breast and ovarian cancer susceptibility screening, as recommended by the United States Preventive Services Task Force, in the breast cancer screening and diagnostic services program, health plan contracts, and policies of disability insurance that provide coverage for hospital, medical or surgical expenses issued, amended, delivered, or renewed on or after January 1, 2019.

*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********

The following information is revised to reflect amendments

adopted by the committee on August 16, 2018

Fiscal Impact:

• $2.0 million (General Fund) and 1.0 position in the Department of Health Care Services to provide breast and ovarian cancer susceptibility gene screenings as part of the Every Woman Counts (EWC) program, assuming that the intent of the bill is to provide services with federal CDC funds and within the EWC program. The staff workload is estimated to be $256,000 (General Fund) in the first year, and $247,000 ongoing annually thereafter for 1.0 permanent Medical Consultant, who would review, adjudicate, and track treatment authorization requests (TARs). Please see Staff Comments for additional assumptions related to the potential impact on DHCS.
• No immediate impact to capitation rates, as benefits in the bill are already covered under the Medi-Cal managed care plan. However, indeterminate cost pressures, to the extent that increased awareness of screenings could result in increased utilization of genetic counseling and BRCA testing, which could result in costs to Medi-Cal managed care plans.
• One-time $7,000 (Insurance Fund) to the Department of Insurance for grandfathered health insurers to submit new policy forms to comply with this bill. The number of grandfathered plans still in force in California is very small, approximately 10 insurers that would need to file 1-3 amendments each to encompass this change. 
• No fiscal impact to the Department of Managed Healthcare.

Committee Amendments:

The committee amendments add a co-author.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2017 - 2018 Regular Session

AB 2342 (Burke) - Breast and ovarian cancer susceptibility screening

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

Requires breast and ovarian cancer susceptibility screening, as recommended by the United States Preventive Services Task Force, in the breast cancer screening and diagnostic services program, health plan contracts, and policies of disability insurance that provide coverage for hospital, medical or surgical expenses issued, amended, delivered, or renewed on or after January 1, 2019.

Fiscal Impact:

• $2.0 million (General Fund) and 1.0 position in the Department of Health Care Services to provide breast and ovarian cancer susceptibility gene screenings as part of the Every Woman Counts (EWC) program, assuming that the intent of the bill is to provide services with federal CDC funds and within the EWC program. The staff workload is estimated to be $256,000 (General Fund) in the first year, and $247,000 ongoing annually thereafter for 1.0 permanent Medical Consultant, who would review, adjudicate, and track treatment authorization requests (TARs). Please see Staff Comments for additional assumptions related to the potential impact on DHCS.
• No immediate impact to capitation rates, as benefits in the bill are already covered under the Medi-Cal managed care plan. However, indeterminate cost pressures, to the extent that increased awareness of screenings could result in increased utilization of genetic counseling and BRCA testing, which could result in costs to Medi-Cal managed care plans.
• One-time $7,000 (Insurance Fund) to the Department of Insurance for grandfathered health insurers to submit new policy forms to comply with this bill. The number of grandfathered plans still in force in California is very small, approximately 10 insurers that would need to file 1-3 amendments each to encompass this change. 
• No fiscal impact to the Department of Managed Healthcare.

Background:

State law requires every plan contract, except a specialized health plan contract, and every policy of disability insurance that provides coverage for hospital, medical or surgical expenses that is issued, amended, delivered, or renewed on or after January 1, 2000, to provide coverage for screening for, diagnosis of, and treatment for, breast cancer. The Department of Health Care Services (DHCS) also provides for breast cancer and cervical cancer screening services for eligible individuals (an individual with family income that does not exceed 200% of the federal poverty level). In addition, under the federal Patient Protection and Affordable Care Act, a group health plan and health insurer (individual or group coverage) to provide coverage and not impose cost-sharing for women’s preventative care and screenings.

There are two (BRCA1 and BRCA2) cancer susceptibility genes that create tumor suppressor proteins. Individuals with inherited mutations in these genes experience an increased risk of developing some types of cancer, including breast and ovarian cancer. BRCA gene mutations can impact both men and women’s risk of developing certain kinds of cancer. Estimates of BRCA gene mutation prevalence in the general population (otherwise known as the carrier rate) range from 1:300 to 1:500 women and the prevalence of BRCA gene mutations among persons of Ashkenazi Jewish ancestry has been estimated to be 1:40. The American Cancer Society estimates that in 2018, there will be approximately 29,360 new cases of female breast cancer and 2,540 new cases of ovarian cancer in California; therefore, CHBRP estimates that 3,523 cases of breast cancer and 356 cases of ovarian cancer diagnosed in California in 2018 will be attributable to BRCA gene mutations.

Proposed Law:

The bill includes the following provisions:

• Requires every (a) health care service plan contract, except a specialized health care service plan contract, that is issued, amended, delivered, or renewed on or after January 1, 2019, and (b) policy of disability insurance that provides coverage for hospital, medical, or surgical expenses, that is issued, amended, delivered, or renewed on or after January 1, 2019, to provide coverage for breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force.
• Requires DHCS to provide breast and cancer susceptibility screening as recommended by the U.S. Preventive Services Task Force.

Related Legislation:

The Legislature has considered similar proposals related to breast cancer or cancer screening, including:

• AB 1860 (Limon) raises 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 used to kill or slow growth of cancerous cells. AB 1860 set for hearing on June 27, 2018 in the Senate Health Committee.
• AB 1386 (Waldron, Chapter 693, Statutes of 2017) requires DHCS to include information relating to breast cancer susceptibility gene mutations in the next revision of a brochure that is provided to cancer patients.
  
• AB 1795 (Atkins, Chapter 608, Statutes of 2016) changes provisions of the EWC and the BCCTP within DHCS regarding eligibility for screenings, period of treatment, and eligibility of coverage after reoccurrence of cancer.

Staff Comments:

Staff notes DHCS assumes the following with its fiscal estimate:

• Based on current Every Women Counts caseload (of 160,000), about 10 percent (16,000 beneficiaries) would be screened for BRCA mutations annually. Half of those screened (about 8,000 beneficiaries) would be new patients with a higher per beneficiary basic rate ($68.90), double the existing patient rate ($37.50). Of those screened, about 576 would receive BRCA testing and genetic counseling ($1,988.69 per beneficiary), seeing a provider for about an hour per visit ($60 per beneficiary).
• The funding source is projected to be General Fund because EWC funding is authorized through the National Breast and Cervical Cancer Early Detection Program cooperative agreement, Breast Cancer Fund - Breast Cancer Control Account, and Proposition 99. Program funding from these accounts are specific to breast and cervical cancer screening, diagnostics, and referral to treatment services only, and cannot be utilized for the purpose of BRCA gene mutation screening, counseling, or testing services. Therefore, if enacted, DHCS anticipates needing General Fund (GF) to provide the services required by AB 2342 to the EWC population.

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SENATE COMMITTEE ON HEALTH

Senator Dr. Richard Pan, Chair

BILL NO: AB 2342

SUBJECT: Breast and ovarian cancer susceptibility screening.

SUMMARY:

1. Mandates breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force in the breast cancer screening and diagnostic services program, health plan contracts, and policies of disability insurance that provide coverage for hospital, medical or surgical expenses issued, amended, delivered, or renewed on or after January 1, 2019.

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) and the California Department of Insurance (CDI) to regulate health insurance. [HSC §1340, et seq. and INS §106, et seq.]
   
2. Requires every plan contract, except a specialized health plan contract, and every policy of disability insurance that provides coverage for hospital, medical or surgical expenses that is issued, amended, delivered, or renewed on or after January 1, 2000, to provide coverage for screening for, diagnosis of, and treatment for, breast cancer. [HSC §1367.6 and INS §10123.8]
   
3. Deems every individual or group health plan contract, except for a specialized health care service plan contract, and every individual or group disability insurance policy that covers hospital, medical or surgical expenses that is issued, amended, delivered, or renewed on or after July 1, 2000, 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]
4. Establishes as California's essential health benefits (EHBs) benchmark the Kaiser Small Group Health Maintenance Organization, existing California mandates, and ten federal Affordable Care Act (ACA) mandated benefits including preventive and wellness services. Requires nongrandfathered individual and small group health plan contracts and health insurance policies to cover these EHBs and comply with Knox-Keene Act requirements.[HSC §1367.005 and INS §10112.27]
   
5. Requires, to the extent required by federal law, a group or individual health plan contract or health insurance policy issued, amended, renewed, or delivered on or after September 23, 2010, to comply with the preventive services requirement of the ACA and any rules or regulations issued under that section. [HSC §1367.002 and INS §10112.2]
   
6. Establishes the breast and cervical cancer early detection program under which the Department of Health Care Services (DHCS) provides for breast cancer and cervical cancer screening services under a federal grant at the level of funding budgeted from state and other resources to an individual with family income that does not exceed 200% of the federal poverty level. [HSC §104150]
   
7. Requires the following individuals to be eligible for breast cancer screening and diagnostic services pursuant to 6) above if they meet all other eligibility requirements:
8. An individual of any age who is symptomatic;
9. An individual whose age is within the age range for routine breast cancer screening, as recommended by the United States Preventive Services Task Force (USPSTF), subject to any federal action relating to breast cancer screening that overrides those recommendations; and,
10. Defines, “symptomatic” to mean an individual presenting with an abnormality or change in the look or feel of the breast, including, but not limited to, a lump, a hard knot, thickening or swelling of the breast tissue, a change in the color, size, or shape of the breast, or any discharge from the nipple. [HSC §104150]
    
11. Requires, under the ACA, a group health plan and a health insurance issuer offering group or individual insurance coverage to, at a minimum to provide coverage and not impose any cost sharing for the following preventive services, as soon as 12 months after the recommendation appears:
12. Evidence-based items or services that have in effect a rating of “A” or “B” in the current recommendations of USPSTF;
13. Immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved;
14. With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration; and,
15. With respect to women, such additional preventive care and screenings not otherwise described above as provided for in comprehensive guidelines supported by the Health Resources and Services Administration. [42 U.S.C. §300gg-13]

This bill:

1. Requires, in addition to the existing mandated coverage for screening for, diagnosis of, and treatment for, breast cancer, every health plan contract, except a specialized health plan contract, and every policy of disability insurance that provides coverage for hospital, medical or surgical expenses, that is issued, amended, delivered, or renewed on or after January 1, 2019, to provide breast and ovarian cancer susceptibility screening as recommended by USPSTF.
2. Requires, in addition to the services described in the breast cancer screening and diagnostic services program, breast and ovarian cancer susceptibility screening to be provided as recommended by USPSTF.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, minor costs to CDI if grandfathered plans must submit new policy forms to comply with this bill (Insurance Fund). It is unclear whether any plans in the state do not cover this test and related services.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, it is imperative that all high risk women, even those without symptoms of breast or ovarian cancer, be identified and given the opportunity to receive the most up-to-date screenings as recommended by USPSTF, especially considering that women of color are disproportionately dying due to lack of early detection and proper treatment. We need to ensure that all high-risk women, regardless of socio-economic status or color are provided with every resource possible to protect themselves and their family. This bill would ensure that as medical science evolves and advances when it comes to screening for patients considered high-risk for breast and ovarian cancer, health coverage evolves and advances as well.
   
2. Breast cancer susceptibility gene (BRCA). According to the California Health Benefits Review Program (CHBRP), there are two (BRCA1 and BRCA2) cancer susceptibility genes that create tumor suppressor proteins. Individuals with inherited mutations in these genes experience an increased risk of developing some types of cancer, including breast and ovarian cancer. BRCA gene mutations can impact both men and women’s risk of developing certain kinds of cancer. Estimates of BRCA gene mutation prevalence in the general population (otherwise known as the carrier rate) range from 1:300 to 1:500 women and the prevalence of BRCA gene mutations among persons of Ashkenazi Jewish ancestry has been estimated to be 1:40. The American Cancer Society estimates that in 2018, there will be approximately 29,360 new cases of female breast cancer and 2,540 new cases of ovarian cancer in California; therefore, CHBRP estimates that 3,523 cases of breast cancer and 356 cases of ovarian cancer diagnosed in California in 2018 will be attributable to BRCA gene mutations.
   
3. USPSTF. CHBRP indicates that at the time of their report’s publication, the USPSTF recommends with a grade “B” that primary care providers screen women who have a family history of BRCA-related cancer (i.e., family members with breast, ovarian, tubal, or peritoneal cancer) with a screening tool designed to identify family history that may be associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes. Women who receive a positive screening result should then be offered genetic counseling, and if indicated, BRCA genetic testing. The population relevant to this USPSTF recommendation includes asymptomatic women who have not been diagnosed with a BRCA-related cancer but who have family member(s) with breast, ovarian, tubal (fallopian tube), or peritoneal cancer. The recommendation states that women with one or more family members with a known potentially harmful mutation in the BRCA1 or BRCA2 genes should be offered genetic counseling and testing. This recommendation does not apply to men. Based on the grade “B” rating, nongrandfathered group and individual health insurance plans and policies are currently required to cover, without cost sharing, screening, genetic counseling, and genetic testing, if indicated, for women whose family history is associated with an increased risk for BRCA1 or BRCA2 gene mutations.
4. Breast cancer screening. In 1990, the Centers for Disease Control and Prevention (CDC) created the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) through Public Law 101-354. This law authorized CDC to grant funds to states to screen a reasonable number of low income, uninsured women for breast and cervical cancers, provide referrals for follow-up and medical treatment for women with abnormal test results, develop and disseminate information for preventing breast and cervical cancers, improve the training of health professionals in preventing these cancers, and monitor the quality of screening procedures. In California, this is the Every Woman Counts (EWC) program. EWC provides free clinical breast exams, mammograms, pelvic exams, and Pap tests to California's low income uninsured and underserved women. These screening services facilitate early detection that may prevent untimely cancer deaths. Each year, EWC provides care for approximately 300,000 individuals. According to information available on DHCS’s Web site, EWC is funded, in part, by $.01 of the $.02 tax on each pack of cigarettes sold in California that is allocated to the Breast Cancer Fund. It could not be confirmed if EWC currently follows the USPSTF screening recommendations.
5. 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 reviewed this bill. According to CHBRP:
6. Coverage impacts and enrollees covered. An estimated 100% of enrollees have coverage for the benefits outlined in this bill;
7. Essential health benefits. Nongrandfathered individual and small group plans are required to cover EHBs, including preventive services with a grade “A” or “B” from the USPSTF. The bill requirements appear not to exceed the definition of EHBs in California;
8. Medical effectiveness. CHBRP finds evidence that: Familial risk screening tools can accurately identify women at risk for BRCA mutations. Genetic counseling before genetic testing improves risk perception accuracy and decreases intention to pursue testing among women unlikely to be BRCA carriers. Positive BRCA mutation test results accurately predict the risk of developing BRCA-related cancer. Risk-reducing interventions (intensive screening, medications, and surgery) can mitigate some BRCA-related cancer risk, particularly for BRCA related breast cancer, leading to reduced incidence of breast cancer and mortality;
9. Utilization. Because an estimated 100% of enrollees have coverage for the benefits outlined in this bill, CHBRP estimates no measurable change in utilization following enactment of this bill. Because this bill will not lead to a change in benefits for health plans, CHRBP assumes health plans will not invest in new marketing or documentation changes that may raise provider awareness or education. CHBRP indicates that while grandfathered plans are not required to comply with the preventive services requirement, the grandfathered plans surveyed indicate that they do cover BRCA screening;
10. Impact on expenditures. This bill would result in no measurable change in total net annual expenditures, premiums, or enrollee expenses for covered and/or noncovered benefits. Among publicly funded DMHC-regulated health plans, CHBRP estimates no impact on Medi-Cal Managed Care. Because this bill does not apply to Medi-Cal Fee-for Service or Medi-Cal County Organized Health Systems, CHBRP estimates no impact on these market segments; and,
11. Public health. Although the continuum of screening services for BRCA gene mutations — family-history based risk screening, genetic counseling, and genetic testing — is medically effective, CHBRP concludes that passage of this bill would have no short-term public health impact on breast cancer outcomes or disparities in screening among women in California due to no population level changes in coverage or utilization for BRCA screening services. It appears unlikely that this bill will have long term cost or public health impacts due to existing coverage for BRCA screening, counseling and testing as a grade “B” USPSTF recommended service. If the ACA is repealed or altered, it is possible that this bill would preserve coverage for BRCA screening, counseling and testing.
    
12. Market considerations. According to CHBRP, recent literature has documented an increase in BRCA testing from 2013 to 2014, thought to be associated with the clarification of ACA preventive services requirements that BRCA testing and genetic counseling qualified as a preventive service with elimination of cost sharing (based on the USPSTF recommendation) and celebrity publicity regarding BRCA risks. Another consideration is the presence of BRCA tests marketed to consumers, particularly following the Supreme Court decision eliminating a market monopoly on such tests. In March of 2018, the Food and Drug Administration approved direct-to-consumer marketing of a BRCA test that detects three specific BRCA1/BRCA2 gene mutations (out of thousands of possible BRCA gene mutations) that are common in people of Ashkenazi Jewish ancestry, but not the general population. CHBRP assumes the direct-to-consumer test would not be covered under this bill as the USPSTF recommends that primary care providers screen women with certain risk factors. Incomplete provider knowledge, lack of provider referrals, and lack of familiarity with family history patterns as appropriate indications for BRCA evaluation have been cited as the primary sources of underutilization of genetic counseling and BRCA testing.
    
13. Related legislation. AB 1860 (Limon) raises 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 used to kill or slow growth of cancerous cells. AB 1860 set for hearing on June 27, 2018 in the Senate Health Committee.
14. Prior legislation. AB 1386 (Waldron, Chapter 693, Statutes of 2017) requires DHCS to include information relating to breast cancer susceptibility gene mutations in the next revision of a brochure that is provided to cancer patients.
    

AB 1795 (Atkins, Chapter 608, Statutes of 2016) changes provisions of the EWC and the BCCTP within DHCS regarding eligibility for screenings, period of treatment, and eligibility of coverage after reoccurrence of cancer.

AB 2345 (De La Torre, Chapter 657, Statutes of 2010) requires health plan contracts and health insurance policies issued, amended, renewed, or delivered on or after September 23, 2010, to comply with the provisions of the ACA regarding coverage of, and cost sharing for, preventive services, and any rules or regulations issued pursuant to the ACA.

1. Support. The City of Los Angeles writes that this bill will guarantee that California women who could be considered high-risk for breast or ovarian cancer are appropriately assessed and, if necessary, receive genetic counseling and testing. While this testing is required as an EHB under the ACA, codifying this protection in state law will help ensure that there are no undue denials of coverage and these vital services will continue to be covered regardless of the status of the ACA. The California Life Sciences Association writes this bill is a step in the right direction towards increasing screening rates for genes currently held to be among the best indicators on likelihood to develop certain cancers. The Legislative Women’s Caucus writes decades of research have shown women of color are dying at disproportionate rates due to lack of early detection and proper treatment. Moving forward, we need to ensure all women, regardless of color or socioeconomic status are provided with resources that ensure a healthier future. Quest Diagnostics writes this bill is consistent with USPSTF recommendations for screening at-risk women for BRCA 1/2 mutations and meets the requirements of the ACA. Further, BRCA screening and testing is a preventive approach to cancer that allows women to make evidence-based, informed, decisions on their own healthcare to prevent cancer.
   
2. Policy comment. The health plan and insurance provisions in this bill are duplicative of existing law. Proponents suggest that the health plan and health insurance provisions are necessary to codify ACA requirements to ensure services regardless of the status of the ACA. An alternative approach would be to delink either California’s EHB provisions and/or the ACA preventive services provisions from federal law and regulations so that those provisions could stand alone and benefit all Californians in the event of a repeal of, or change to these provisions in federal law. Should the EWC not cover breast and ovarian cancer susceptibility screening as recommended by USPSTF this bill would create a new requirement on that program.
3. Amendment. The following technical amendment is needed in all three sections of this bill:
   1. HSC 1367.615 In addition to the services described in subdivision (c) of Section 1367.6, every health care service plan contract, except a specialized health care service plan contract, that is issued, amended, delivered, or renewed on or after January 1, 2019, shall provide cover breast and ovarian cancer screening as recommended by the United States Preventive Services Task Force.

SUPPORT AND OPPOSITION:

Support: The City of Los Angeles (sponsor)

Association of Northern California Oncologists

Bay Area Women’s Health Advocacy Council

Breast Cancer Prevention Partners

California Legislative Women’s Caucus

California Life Sciences Association

Carrie’s Touch

Medical Oncology Association of Southern California

The Ovarian Cancer Circle/Inspired By Robin Babbini

Ovarian Cancer Coalition of California

Quest Diagnostics

Oppose: None Received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2342

Author:(Burke and Waldron)

As Amended Ver:

Majority vote

SUMMARY: Requires health care service plans (health plans), health insurers, and the Department of Health Care Services (DHCS) to cover breast and ovarian cancer susceptibility screening as recommended by the United States Preventive Services Task Force (USPSTF).

FISCAL EFFECT: According to the Assembly Appropriations Committee, minor costs to the California Department of Insurance if grandfathered plans must submit new policy forms to comply with this bill (Insurance Fund). It is unclear whether any plans in the state do not cover this test and related services.

COMMENTS: According to the author, it is imperative that all high risk women, even those without symptoms of breast or ovarian cancer, be identified and given the opportunity to receive screening, counseling and testing, especially given that women of color are disproportionately dying due to lack of early detection and proper treatment. We need to ensure that all high-risk women, regardless of socio-economic status or color are provided with every resource possible to protect themselves and their family.

1. Other California programs. The Every Woman Counts program provides free breast and cervical cancer screenings and diagnostic services to underserved populations. It is the state equivalent of a national program, the National Breast and Cervical Cancer Early Detection Program of the Centers for Disease Control and Prevention. The Breast and Cervical Cancer Treatment Program provides cancer treatment to women with household incomes at or below 200% of the federal poverty level, who are under 65 years of age and with no other source of insurance, who have been diagnosed with breast or cervical cancer and require treatment.
2. Medicaid Coverage of Breast Cancer gene (BRCA) Screening, Counseling, and/or Testing. States with expanded Medicaid programs are required to cover preventive services for adults who became newly eligible under the ACA's Medicaid expansion. This includes services outlined in the USPSTF recommendations with a grade A or grade B, such as screening, genetic counseling, and genetic testing for BRCA1 and BRCA2 gene mutations in women with a family history of BRCA-related cancer. However, states are not required to cover the same set of preventive services for adults enrolled in a traditional Medicaid program prior to Medicaid expansion. Still, 37 states, including California, cover genetic testing for BRCA1 and BRCA2 in their traditional Medicaid program.
3. Patient Protection and Affordable Care Act (ACA). Under the ACA's Preventive Services requirement (Section 2713 of the Public Health Service Act), nongrandfathered group (small and large) and individual health insurance plans and policies are required to cover certain preventive services without cost sharing when delivered by in-network providers and as soon as 12 months after a recommendation appears in any of the following:
   1. The USPSTF's A and B recommendations;
   2. The Health Resources and Services Administration (HRSA)-supported health plan coverage guidelines for women's preventive services;
   3. The HRSA-supported comprehensive guidelines for infants, children, and adolescents, which include:
      1. The Bright Futures Recommendations for Pediatric Preventive Health Care;
      2. The recommendations of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and,
      3. The Advisory Committee on Immunization Practices recommendations that have been adopted by the Director of the Centers for Disease Control and Prevention.

The City of Los Angeles, sponsor of this bill, states that codifying this bill in state law will ensure that there are no undue denials of coverage and that these vital services will continue to be covered regardless of the status of the ACA.

America's Health Insurance Plans, Association of California Life and Health Insurance Companies, and California Association of Health Plans, contend that a prior version of this bill will increase costs, reduce choice and competition, and further incentivize some employers and individuals to avoid state regulation by seeking alternative coverage options.

Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0003417

Date of Hearing: May 9, 2018

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 2342

Author:(Burke) – As Introduced Ver:February 13, 2018

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

SUMMARY:

This bill requires health plans and insurers to provide coverage for breast cancer susceptibility gene (BRCA) screening, genetic counseling, and testing services, as specified.

FISCAL EFFECT:

Minor costs to the California Department of Insurance if grandfathered plans must submit new policy forms to comply with this bill (Insurance Fund). It is unclear whether any plans in the state do not cover this test and related services.

COMMENTS:

1. Purpose. This bill is intended to ensure all women have access to high-quality cancer screening care.
2. Background. Mutations in BRCA1 or BRCA2, two specific genes, can substantially increase a person’s lifetime risk for breast or ovarian cancer relative to the general population. In the first screening step for a BRCA test, patients are assessed for their general cancer risk as part of a family history. If it is determined a patient has risk factors, they may be referred to genetic counseling. Testing is conducted if counseling indicates it is appropriate.

Existing federal and state law requires health plans and insurers to cover specific services. The federal Affordable Care Act requires most plans and insurers cover services given a certain evidence "grade level" by the U.S. Preventive Services Task Force (USPSTF) —specifically, all services given an "A" or "B" grade must be covered. Currently, the USPSTF recommends with a grade "B" BRCA screening, counseling, and testing, which means the services must be covered without cost-sharing. Thus, a review of this bill by the California Health Benefits Review Program (CHBRP) estimated 100% of persons with coverage or insurance subject to this bill already have coverage or insurance consistent with this bill's mandate. However, if federal law or recommendations change, this bill would keep the BRCA coverage mandate in state law. In addition, so-called "grandfathered plans," not subject to the federal minimum requirements described above, currently are not required to provide BRCA-related coverage, though they may. This bill would require coverage.

1. Support and Opposition. The City of Los Angeles is this bill's sponsor and oncologists, laboratories, and the life sciences industry support it. Health plans and insurers oppose this bill, contending state mandates increase costs, reduce competition, and encourage individuals to seek alternative coverage options not subject to state regulation.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 24, 2018

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2342

Author:(Burke) – As Introduced Ver:February 13, 2018

SUBJECT: BRCA gene mutations: screening, counseling, and testing.

SUMMARY: Requires health care service plans (health plans), health insurers, and the Department of Health Care Services (DHCS) to cover screening, genetic counseling, and testing for breast cancer susceptibility gene (BRCA) mutations in women who have not been diagnosed with the BRCA related cancer and do not have signs or symptoms of the disease, but who may have an increased risk based on one or more of specified family history risk factors. Specifically, this bill:

1. Requires every health plan contract or disability insurer, except, issued, amended, delivered, or renewed on or after January 1, 2019, to provide coverage for BCRA screening, genetic counseling, and testing services, as specified, in addition to breast cancer coverage in existing law. Excludes specialized plans from the provisions of this bill.
2. Requires screening to be provided for women who have not been diagnosed with BRCA-related cancer and do not have signs or symptoms, but who may have an increased risk, as specified, based on one or more of the following family history risk factors:
   1. Breast cancer diagnosis before 50 years of age;
   2. Bilateral breast cancer;
   3. Breast and ovarian cancer;
   4. Presence of breast cancer in at least one male family member;
   5. Multiple cases of breast cancer in the family;
   6. At least one family member with two types of BCRA-related cancer; and,
   7. Ashkenazi Jewish ancestry.
3. Requires screening to be provided using a generally accepted screening tool designed to identify a family history, as specified.
4. Requires genetic counseling to be provided for women with positive screening results. Requires BRCA testing if indicated after counseling.
5. Requires, in addition to the breast cancer and cervical cancer screening services under the Breast and Cervical Cancer Early Detection Program Grant, screening, genetic counseling, and testing for BRCA gene mutations in women pursuant to the requirements set forth in 2) to 4) above.

EXISTING LAW:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans and the California Department of Insurance to regulate health insurers.
   
2. Establishes the federal Patient Protection and Affordable Care Act (ACA), which enacts various health care coverage market reforms including the availability of health insurance exchanges (exchanges) and new individual and small group products offered on and off the exchanges beginning 2014.
3. Requires health plans and health insurers providing health coverage in the individual and small group markets to cover, at a minimum, essential health benefits (EHBs), including the ten EHB benefit categories in the ACA, and consistent with California’s EHB benchmark plan, the Kaiser Foundation Health Plan Small Group HMO 30 plan, as specified in state law.
   
4. Specifies the EHBs in the following 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and, pediatric services, including oral and vision care.
5. Requires, under the federal ACA, all non-grandfathered group health plans and health insurance coverage offered in the individual or group market to cover without cost sharing all evidenced-based items or services that have in effect a rating of “A” or “B” in the current recommendations of the US Preventive Services Task Force (USPSTF).
6. Requires health plans to provide basic health care services, including: physician services; hospital inpatient and ambulatory care services; diagnostic laboratory and diagnostic and therapeutic radiologic services; home health services; preventive health services; emergency health care services; and, hospice care.
7. Requires health plans to make all services readily available at reasonable times to each enrollee consistent with good professional practice and in a manner providing continuity of care and ready referral of patients to other providers at times as may be appropriate consistent with good professional practice.
8. Requires health plans, except specialized health plans, to provide coverage for screening for, diagnosis of, and treatment for, breast cancer.
9. Establishes the Medi-Cal program, administered by DHCS, under which qualified low-income individuals receive health care services.
10. Establishes the Breast and Cervical Cancer Early Detection Program, administered by DHCS through the Every Woman Counts (EWC) program, to provide breast and cervical cancer screening services under the Centers for Disease Control and Prevention (CDC) grant at the level of funding budgeted from state and other resources during the fiscal year in which the Legislature has appropriated funds for this purpose.
11. Requires a provider or entity that participates in the federal National Breast and Cervical Cancer Early Detection Program (NBCCEDP) to provide screening services to an individual only if the individual's family income has been determined not to exceed 200% of the federal poverty level (FPL).

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, it is imperative that all high risk women, even those without symptoms of breast or ovarian cancer, be identified and given the opportunity to receive screening, counseling and testing, especially given that women of color are disproportionately dying due to lack of early detection and proper treatment. We need to ensure that all high-risk women, regardless of socio-economic status or color are provided with every resource possible to protect themselves and their family.
2. BACKGROUND.
3. BRCA1and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cell’s genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer. Hereditary Breast and Ovarian Cancer Syndrome (HBOC) is characterized by an inherited risk for breast and ovarian cancers that occurs at younger ages or with greater frequency than in the average population. HBOC is most commonly caused by harmful mutations in the BRCA1 and BRCA2 genes (or BRCA, generally) that can be passed down by both men and women. It is not uncommon for persons with HBOC to have several generations of family members affected by these cancers because BRCA gene mutations exhibit an autosomal dominant pattern of transmission. This means that offspring and siblings have a 50% chance of inheriting the gene mutation from a parent who carries the gene mutation(s), thereby becoming gene mutation carriers themselves. In the US, 10% to 20% of persons with breast and ovarian cancer have a close relative who has also had one of these cancers. Specific high-risk BRCA mutations that are clustered among certain ethnic groups, known as founder mutations, have also been implicated in hereditary breast and ovarian cancer susceptibility. There are known founder mutations for persons of Ashkenazi Jewish ancestry, African Americans, U.S. Hispanics, and among persons from the Netherlands, Iceland, and Sweden.
4. 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. SB 125 (Hernandez), Chapter 9, Statutes of 2015, added an impact assessment on essential health benefits, and legislation that impacts health insurance benefit designs, cost sharing, premiums, and other health insurance topics. CHBRP states in its analysis of AB 2342 the following:
   • 1. Enrollees covered. CHBRP estimates that 100% of enrollees with health insurance that would be subject to this bill have coverage for screening of family history risk for BRCA, genetic counseling, and BRCA mutation testing.
     2. Impact on expenditures. This bill would result in no measurable change in total net annual expenditures, premiums, or enrollee expenses for covered and/or non-covered benefits:
        1. Among publicly funded DMHC-regulated health plans, CHBRP estimates no impact on Medi-Cal Managed Care. Since this bill does not apply to Medi-Cal fee-for-service (FFS) or Medi-Cal county organized health systems, CHBRP estimates no impact on these market segments;
        2. CHBRP estimates no measureable impact projected on California Public Employees' Retirement System plans; and,
        3. CHBRP estimates no measurable impact on the number of people who are uninsured in California.
     3. EHBs. Nongrandfathered individual and small group plans are required to cover EHBs, including preventive services with a grade “A” or “B” from the USPSTF. At the time of CHBRP’s publication, the USPSTF recommends (with a grade “B”) that primary care providers screen women who have a family history of BRCA-related cancer (i.e., family members with breast, ovarian, tubal, or peritoneal cancer). The risk requirements described in this bill include several similar family history risk requirements, but also include Ashkenazi Jewish ancestry independent of family history. The USPSTF also recommends with a grade “B” that women who screen positive should then receive genetic counseling and, if indicated, genetic testing for BRCA gene mutations. The USPSTF recommendation does not apply to men. This bill would not require coverage for a new state benefit mandate, but would rather define the risk requirements for screening for BRCA1 and BRCA2 gene mutations. CHBRP concludes this bill’s requirements appear not to exceed the definition of EHBs in California.
     4. Medical effectiveness. Although there is no direct evidence that the clinical pathway outlined in this bill, familial risk screening, genetic counseling, and then genetic testing, leads to reductions in the incidence of BRCA-related cancer, cancer-related mortality, or all-cause mortality, there is indirect evidence supporting that each of these activities, as well as risk-reducing interventions for women identified as BRCA1 or BRCA2 mutation carriers, are effective. Through CHBRP’s review of the 2013 systematic review to inform the USPSTF, as well as studies published since 2012, CHBRP finds evidence that:
        1. Familial risk screening tools can accurately identify women at risk for BRCA mutations;
        2. Genetic counseling before genetic testing improves risk perception accuracy and decreases intention to pursue testing among women unlikely to be BRCA carriers;
        3. Positive BRCA mutation test results accurately predicts the risk of developing BRCA-related cancer; and,
        4. Risk-reducing interventions (intensive screening, medications, and surgery) can mitigate some BRCA-related cancer risk, particularly for BRCA-related breast cancer, leading to reduced incidence of breast cancer and mortality.
     5. Benefit coverage. CHBRP estimates that that this bill would not change benefit coverage because coverage at baseline (existing coverage projected to 2019) is 100%.
     6. Utilization. Because an estimated 100% of enrollees have coverage for the benefits outlined in this bill, CHBRP estimates no measurable change in utilization following enactment of this bill. Since this bill will not lead to a change in benefits for health plans, CHRBP assumes health plans will not invest in new marketing or documentation changes that may raise provider awareness or education.
     7. Public health. According to CHBRP, although the continuum of screening services for BRCA gene mutations — family-history based risk screening, genetic counseling, and genetic testing — is medically effective, CHBRP concludes that passage of this bill would have no short-term public health impact on breast cancer outcomes or disparities in screening among women in California due to no population level changes in coverage or utilization for BRCA screening services.
     8. Long-term impacts. According to CHBRP, it appears unlikely that this bill will have long term cost or public health impacts due to existing coverage for BRCA screening, counseling and testing as a grade “B” USPSTF recommended service. If the ACA is repealed or altered, it is possible that this bill would preserve coverage for BRCA screening, counseling and testing.
   1. Other California programs. The EWC program provides free breast and cervical cancer screenings and diagnostic services to underserved populations. It is the state equivalent of a national program, the NBCCEDP of the CDC. The Breast and Cervical Cancer Treatment Program (BCCTP) provides cancer treatment to women with household incomes at or below 200% of the FPL, who are under 65 years of age and with no other source of insurance, who have been diagnosed with breast or cervical cancer and require treatment. Since these programs are administered under the Medi-Cal FFS program, which is not impacted by this bill, and because they focus largely on patient populations that are uninsured, CHBRP considered these programs to be outside the scope of this bill as it relates to insurance coverage requirements.
   2. Similar requirements in other states. Several states have considered or are considering bills related to coverage of BRCA screening, genetic counseling, and/or genetic testing, including Hawaii, Kentucky, Maine, New Mexico, and Oregon.
   3. Medicaid Coverage of BRCA Screening, Counseling, and/or Testing. States with expanded Medicaid programs are required to cover preventive services for adults who became newly eligible under the ACA’s Medicaid expansion. This includes services outlined in the USPSTF recommendations with a grade A or grade B, such as screening, genetic counseling, and genetic testing for BRCA1 and BRCA2 gene mutations in women with a family history of BRCA-related cancer. However, states are not required to cover the same set of preventive services for adults enrolled in a traditional Medicaid program prior to Medicaid expansion. Still, 37 states, including California, cover genetic testing for BRCA1 and BRCA2 in their traditional Medicaid program.
5. SUPPORT. The City of Los Angeles, sponsor of this bill, states that codifying this bill in state law will ensure that there are no undue denials of coverage and that these vital services will continue to be covered regardless of the status of the ACA.
6. OPPOSITION. America’s Health Insurance Plans, Association of California Life and Health Insurance Companies, and California Association of Health Plans contend that this bill will increase costs, reduce choice and competition, and further incentivize some employers and individuals to avoid state regulation by seeking alternative coverage options
7. RELATED LEGISLATION.
   1. AB 1860 (Limon) removes the January 1, 2019 sunset in existing law that requires health plans and health insurers that provide 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 $200 for an individual prescription of up to a 30-day supply of a prescribed orally administered anticancer medication, as specified. AB 1860 is currently pending in Assembly Health Committee.
   2. SB 945 (Atkins) deletes the definition of period of coverage for the diagnosis of breast or cervical cancer, and, instead, provides that treatment services be provided for the duration of the period of treatment for an individual made eligible for treatment due to a diagnosis of breast cancer or cervical cancer, as long as the individual continues to meet all other eligibility requirements for Medi-Cal. SB 945 is currently pending in Senate Health Committee.
   3. SB 1034 (Mitchell) removes the January 1, 2019 sunset in existing law that requires a health facility at which a mammography examination is performed to include a prescribed notice on breast density in the summary of the written report that is sent to a patient, if specified circumstances apply. SB 1034 is currently pending in Senate Health Committee.
8. PREVIOUS LEGISLATION.
   1. AB 1386 (Waldron), Chapter 693, Statutes of 2017, requires DHCS to include information relating to breast cancer susceptibility gene mutations in the next revision of a brochure that is provided to cancer patients.
   2. AB 1795 (Atkins), Chapter 608, Statutes of 2016, changes provisions of the EWC and the BCCTP within DHCS regarding eligibility for screenings, period of treatment, and eligibility of coverage after reoccurrence of cancer.

REGISTERED SUPPORT / OPPOSITION:

Support

City of Los Angeles (sponsor)

Association of Northern California Oncologists

California Life Sciences Assocation

Medical Oncology Association of Southern California

Quest Diagnostics

Opposition

America’s Health Insurance Plans

Association of California Life and Health Insurance Companies

California Association of Health Plans

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