Existing law requires a physician and surgeon, as defined, to give a patient diagnosed with breast cancer a standardized written summary, made available to physicians and surgeons by the Medical Board of California, containing recommendations of the Cancer Advisory Council, to inform the patient of the advantages, disadvantages, risks, and descriptions of the procedures with regard to medically viable and efficacious alternative methods of breast cancer treatment. The summary is required to be revised every 3 years and include any new or revised information, as specified.

This bill would require the State Department of Health Care Services, in the first revision of the summary made following the effective date of the bill, to include information relating to breast cancer susceptibility gene (BRCA) mutations, in order to achieve increased genetic counseling and screening rates of individuals for whom BRCA test results can inform treatment decisions, as specified. The bill would also make related findings and declarations.

Existing law requires a physician and surgeon, as defined, to give a patient diagnosed with breast cancer a standardized written summary, made available to physicians and surgeons by the Medical Board of California, containing recommendations of the Cancer Advisory Council, to inform the patient of the advantages, disadvantages, risks, and descriptions of the procedures with regard to medically viable and efficacious alternative methods of breast cancer treatment. The summary is required to be revised every 3 years and include any new or revised information, as specified.

This bill would require the State Department of Health Care Services, in the first revision of the summary made following the effective date of the bill, to include information relating to breast cancer susceptibility gene (BRCA) mutations, in order to achieve increased genetic counseling and screening rates of individuals for whom BRCA test results can inform treatment decisions, as specified. The bill would also make related findings and declarations.

Existing law requires the State Department of Public Health to place priority on providing information to consumers, patients, and health care providers regarding womens gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.

This bill, until January 1, 2022, would require the department to establish a short-term program to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations among individuals newly diagnosed with breast and ovarian cancer, through a provider education campaign. The bill would require the department to apply for grants, and would authorize the department to accept donations from public or private entities or institutions, to fund the program.

Existing law requires the State Department of Public Health to place priority on providing information to consumers, patients, and health care providers regarding womens gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.

This bill, until January 1, 2024, 2022, would require the department to establish a pilot short-term program to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations that may lead to various forms of cancer, including breast and ovarian, through a public awareness among individuals newly diagnosed with breast and ovarian cancer, through a provider education campaign. The bill would require the department to apply for grants, and would authorize the department to accept donations from public or private entities or institutions, to fund the pilot program.

Existing law requires the State Department of Public Health to place priority on providing information to consumers, patients, and health care providers regarding womens gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.

This bill, until January 1, 2024, would require the department to establish a pilot program to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations that may lead to various forms of cancer, including breast and ovarian, through a public awareness campaign. The bill would require the department to apply for grants, and would authorize the department to accept donations from public or private entities or institutions, to fund the pilot program.

Existing law requires the State Department of Public Health to place priority on providing information to consumers, patients, and health care providers regarding womens gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.

This bill bill, until January 1, 2024, would make technical, nonsubstantive changes to that provision. require the department to establish a pilot program to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations that may lead to various forms of cancer, including breast and ovarian, through a public awareness campaign. The bill would require the department to apply for grants, and would authorize the department to accept donations from public or private entities or institutions, to fund the pilot program.

Existing law requires the State Department of Public Health to place priority on providing information to consumers, patients, and health care providers regarding womens gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.

This bill would make technical, nonsubstantive changes to that provision.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1386

Author:(Waldron)

As Amended Ver:September 1, 2017

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Requires the Department of Health Care Services (DHCS) to include information relating to breast cancer susceptibility gene mutations in the next revision of a brochure that is provided to cancer patients.

The Senate amendments delete and recast the provisions of this bill to require DHCS to include in its first revision of the standardized written summary of treatment options provided to breast cancer patients under existing law, made following the effective date of this bill, information relating to breast cancer susceptibility gene (BRCA) mutations, in order to increase genetic counseling and screening rates for individuals for whom BRCA test results can inform treatment decisions.

FISCAL EFFECT: According to the Senate Appropriations Committee, minor costs to DHCS to include information relating to breast cancer susceptibility gene mutations in the next revision of an existing brochure for patients (General Fund).

COMMENTS: According to the author, women with newly diagnosed breast or ovarian cancer are at high risk for having a BRCA mutation, which increases the odds of cancer. The author states that these women often do not get genetic testing or even a chance to speak with a genetic counselor that would help them weigh the necessity of such a test. The author concludes that test results could help guide treatment, as well as future efforts to prevent cancer by increasing patient knowledge of and access to breast and ovarian genetic testing in specified populations.

According to the American Cancer Society (ACS), breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an X-ray or felt as a lump. Breast cancer occurs almost entirely in women, but men can get breast cancer too. Certain inherited DNA mutations (changes) can dramatically increase the risk for developing certain cancers and are linked to many of the cancers that run in some families; including BRCA genes (BRCA1 and BRCA 2) which are tumor suppressor genes. When one of these genes changes, it no longer suppresses abnormal cell growth, and cancer is more likely to develop. A change in one of these genes can be passed on from a parent. ACS estimates that in 2017 about 252,710 new cases of invasive breast cancer will be diagnosed in women and about 40,610 women will die from breast cancer. Breast cancer is the second leading cause of cancer death in women, after lung cancer.

There is no opposition to this bill.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001854

 THIRD READING  

Bill No: AB 1386

Author:

Amended: 9/1/17 in Senate

Vote:

SENATE HEALTH COMMITTEE: 8-0, 7/12/17

AYES: Hernandez, Nguyen, Atkins, Leyva, Mitchell, Monning, Newman, Roth

NO VOTE RECORDED: Nielsen

SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/17

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

ASSEMBLY FLOOR: 76-0, 5/31/17 - See last page for vote

SUBJECT: Genomic cancer testing information

SOURCE: Author

DIGEST: This bill requires the California Department of Public Health (CDPH), with recommendations from the Cancer Advisory Council, to include in its first revision of the standardized written summary made following the effective date of this bill, information relating to breast cancer susceptibility gene (BRCA) mutations, in order to increase genetic counseling and screening rates for individuals for whom BRCA test results can inform treatment decisions.

ANALYSIS:

Existing law:

1. Establishes CDPH to, among other functions, serve the public by collecting statewide data about cancer and cancer risk factors, conducting surveillance and research into the causes, cures, and controls of cancer, and communicating the results to the public, through its Chronic Disease Surveillance and Research Branch.
2. Requires CDPH to provide information to consumers, patients, and health care providers regarding women’s gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.
3. Requires CDPH to publish and review a standardized written summary for the purpose of informing the patient of the advantages, disadvantages, risks, and descriptions of the procedures with regard to medically viable and efficacious alternative methods of treatment for breast cancer.
4. Requires CDPH to review and revise every three years the written summary if it determines that new ore revised information should be included.

This bill requires the CDPH, with recommendations from the Cancer Advisory Council, to include in its first revision of the standardized written summary made following the effective date of this bill, information relating to BRCA mutations, in order to increase genetic counseling and screening rates for individuals for whom BRCA test results can inform treatment decisions.

Comments

1. Author’s statement. According to the author, women with newly diagnosed breast or ovarian cancer are at high risk for having a BRCA mutation, which increases the odds of cancer. These women often do not get genetic testing or even a chance to speak with a genetic counselor that would help them weigh the necessity of such a test. Genetic testing could help guide treatment, as well as future efforts to prevent cancer by increasing patient knowledge of and access to breast and ovarian genetic testing in specified populations.
2. Breast and ovarian cancer. According to the National Cancer Institute (NCI), approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. In 2014, NCI estimated that over three million women in the U.S. were living with female breast cancer. Similarly, approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their life time, while over 200,000 women are living with it in the U.S. Two genes, BRCA1 and BRCA2, when mutated or damaged, have shown to increase a women’s risk of developing breast and/or ovarian cancer. They are human genes that when operating normally produce tumor suppressor proteins, which prevent cancer cells from forming.
3. Genetic cancer screening and recommendations. A positive BRCA1 or BRCA2 test result indicates that a person has inherited a known harmful mutation of BRCA1 or BRCA2, and therefore has an increased risk of developing certain cancers. However, a positive test result cannot tell whether or not an individual will actually develop cancer. Some women who inherit a harmful BRCA1 or BRCA2 mutation will never develop breast or ovarian cancer. A negative BRCA1 or BRCA2 test result may indicates that the individual does not have one of the mutated genes or that the individual does not carry one of the harmful mutations that was tested for. Scientists continue to discover new BRCA1 and BRCA2 mutations and have not yet identified all potential harmful ones. According to NCI, there are no direct medical harms of genetic testing, but the knowledge of the test results may have harmful effects on a person’s emotions, social relationships, finances, and medical choices. There is a small chance that the test result may not be accurate, leading people to make decisions about their career, marriage, childbearing, or health, based on incorrect information. However, it is important for people with certain types of cancer to learn if their cancer was caused by an inherited mutation because this information may affect treatment choices.

According to the NCI, breast cancer screening strategies, including breast magnetic resonance imaging (MRI) and mammography, are commonly performed in individuals who carry the mutated BRCA genes and in individuals at increased risk of breast cancer. Initiation of screening is generally recommended at earlier ages and at more frequent intervals in individuals with an increased risk due to genetics and family history than in the general population. NCI states that the timing of genetic testing and knowledge of carrying a mutated BRCA gene may influence decisions surround surgeries, such as subcutaneous mastectomy and simple (total) mastectomy, and could prevent subsequent surgeries.

According to data collected by NCI’s Surveillance, Epidemiology, and End Results Program (SEER), 55% to 65% of women who inherit a harmful BRCA1 mutation and around 45% of women who inherit a harmful BRCA2 mutation will develop breast cancer by age 70. Similarly, about 11% to 17% of women who inherit a harmful BRCA2 mutation will develop ovarian cancer by age 70. However, NCI notes that these are simply estimates and they continues to change as more studies are completed.

Several organizations, including the U.S. Preventive Services Task Force (USPSTF), the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American College of Radiology recommend that women who have family members with breast, ovarian, fallopian tube, or peritoneal cancer be evaluated via MRI, mammogram, and/or genetic testing to see if they have a family history of harmful mutation in one of the BRCA genes. However, USPSTF recommends against routine genetic counseling or BRCA testing for women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Senate Appropriations Committee, minor costs to the Department of Health Care Services to include information relating to breast cancer susceptibility gene mutations in the next revision of an existing brochure for patients (General Fund).

SUPPORT: (Verified 8/31/17)

Association of Northern California Oncologists

Breast Cancer Prevention Partners

California Life Sciences Association

Medical Oncology Association of Southern California

OPPOSITION: (Verified 8/31/17)

None received

ARGUMENTS IN SUPPORT: The Association of Northern California Oncologists supports this bill because the program will be a systems-approach to increase overall population-based awareness and screening to reach and screen populations at risk for breast and ovarian genetic mutation cancer, especially those women in underserved communities, and those on Medi-Cal or who do not have medical insurance. The California Life Sciences Association supports this bill because it is a step in the right direction to increase the screening rates to reach and provide access to populations at high risk for breast and ovarian cancer.

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

NO VOTE RECORDED: Chen, Choi, Eggman, Melendez

Prepared by:

9/5/17 9:41:44

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

AB 1386 (Waldron) - Genomic cancer testing program

Bill Summary:

AB 1386 would require the Department of Public Health to establish a program to promote screening amongst individuals newly diagnosed with breast or cervical cancer, for genetic mutations that increase the risk of breast or cervical cancer.

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

The following information is revised to reflect amendments

adopted by the committee on September 1, 2017

Fiscal Impact:

• Minor costs to the Department of Health Care Services to include information relating to breast cancer susceptibility gene mutations in the next revision of an existing brochure for patients (General Fund).

Author Amendments:

Delete the contents of the bill and require the Department of Health Care Services to include information relating to breast cancer susceptibility gene mutations in the next revision of a brochure that is provided to cancer patients.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

AB 1386 (Waldron) - Genomic cancer testing program

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

Bill Summary:

AB 1386 would require the Department of Public Health to establish a program to promote screening amongst individuals newly diagnosed with breast or cervical cancer, for genetic mutations that increase the risk of breast or cervical cancer.

Fiscal Impact:

• Annual staff costs of $270,000 per year for four years, for the Department of Public Health to solicit program funding, develop educational materials for health care providers, and engage in outreach and education for providers (General Fund).
• Unknown costs to conduct education of health care providers (General Fund or other unknown fund source). The size and scope of the provider education campaign required in the bill would depend on the availability of funding for the program, either grants, donations, or General Fund appropriations by the Legislature.
• Uncertain impact on health care spending by state programs such as Medi-Cal and CalPERS (various funds). Screening and testing for the genetic mutations addressed by this bill is covered by the Medi-Cal program and is generally covered by health plans and insurers (provided it is medically appropriate). By increasing provider knowledge about the benefits of genetic screening, the bill may result in increased levels of genetic counselling and testing. The size of that impact is unknown, in part because it is not known the extent to which patients are currently being given information on genetic counselling and testing when they have a cancer diagnosis. To the extent that utilization of genetic counselling and testing services increases under the bill, public programs would face some increase in costs. On the other hand, information gained by patients and providers through genetic screening and testing may inform treatment decisions and may reduce future health care spending by improving initial treatment plans.

Background:

About 12% of women will be diagnosed with breast cancer during their lifetimes (men also experience breast cancer, but at lower rates). About 1% of women will be diagnosed with ovarian cancer during the course of their lifetime.

There are two genes that have been identified, BRCA1 and BRCA2, that when a mutation occurs in those genes, women are at significantly increased risk of developing breast cancer or ovarian cancer. A woman with a mutation in either of those genes is at greater risk of developing cancer, but will not necessarily develop cancer.

The Unites States Preventative Services Task Force recommends a multi-stage screening process for BRCA1 or BRCA2 mutations. The Task Force recommends that women with a family history of certain cancers be screened (through a series of questions) to determine whether the family history of cancer is likely to be associated with one of those mutations. If the screening process yields a positive result, the Task Force recommends that the patient receive genetic counselling. Through genetic counselling, additional questions to the patient will determine whether it is recommended that the patient undergo actual genetic testing to attempt to identify whether the patient has an identified mutation of one of those two genes that is associated with increased cancer risk.

At this time, there are no specific cancer treatments that are recommended specifically to treat cancers associated with identified mutations of those genes. Rather, knowing that a patient has one or more identified mutations assists patients and health care providers in assessing the risks of the current cancer diagnosis and potential future cancer diagnoses. For example, a patient with a cancer diagnosis and a positive genetic testing result may opt for a more aggressive treatment plan.

Proposed Law:

AB 1386 would require the Department of Public Health to establish a program to promote screening amongst individuals newly diagnosed with breast or cervical cancer, for genetic mutations that increase the risk of breast or cervical cancer.

Specific provisions of the bill would:

• Require the Department of Public Health to establish a short-term program to promote and encourage screening for breast cancer susceptibility mutations amongst individuals newly diagnosed with breast or ovarian cancer;
• Require the Department to apply for grants and accept donations from public or private institutions for purposes of the program;
• Require the Department to use existing and low-cost communication channels to conduct provider education and outreach;
• Sunset the provisions of the bill on January 1, 2022.

Staff Comments:

Under current law, the Department is required to provide information to patients and health care providers regarding women’s’ gynecological cancers. That program is currently unfunded.

While the bill requires the Department to solicit grant funds and allows it to accept donations, operation of the bill is not contingent of the receipt of any outside funds. The Department would likely incur General Fund costs to establish the program, regardless of whether any outside funding were to materialize.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 1386

SUBJECT: Genomic cancer testing program

SUMMARY:

Requires the California Department of Public Health to establish a short-term program to remain in effect until January 1, 2022, to promote screening for breast cancer susceptibility gene mutations among persons newly diagnosed with breast and ovarian cancer.

Existing law:

1. Establishes the California Department of Public Health (CDPH) to, among other functions, serve the public by collecting statewide data about cancer and cancer risk factors, conducting surveillance and research into the causes, cures, and controls of cancer, and communicating the results to the public, through its Chronic Disease Surveillance and Research Branch.
   
2. Requires CDPH develop a coordinated state strategy for addressing the health-related needs of women, including implementation of goals and objectives for women’s health.
   
3. Requires CDPH to provide information to consumers, patients, and health care providers regarding women’s gynecological cancers, including signs and symptoms, risk factors, the benefits of early detection through appropriate diagnostic testing, and treatment options.
   
4. Establishes the Department of Health Care Services (DHCS) to provide Californians with access to affordable, integrated, high-quality health care, including medical, dental, mental health, substance use treatment services and long-term care. Establishes Every Woman Counts within DHCS' Cancer Detection and Treatment Branch, which provides free clinical breast exams, mammograms, pelvic exams, and Pap tests to California’s underserved women.

This bill:

1. Requires CDPH to establish a short-term program to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations among individuals newly diagnosed with breast and ovarian cancer through provider education campaigns.
   
2. Requires the program to employ a system approach to increase genetic counseling and screening of individuals newly diagnosed with breast and ovarian cancer, focusing on populations with disproportionately low rates of genetic counseling and screening.
   
3. Requires CDPH to apply for grants, and permits CDPH to accept donations from public or private institutions and entities, to be used for the program.
   
4. Requires CDPH to maximize the use of existing and low cost communication channels to conduct provider education and outreach.
   
5. Sunsets the program on January 1, 2022.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, General Fund costs to CDPH will be in the hundreds of thousands of dollars annually on a time-limited basis for the provider education and outreach campaign.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, women with newly diagnosed breast or ovarian cancer are at high risk for having a BRCA mutation, which increases the odds of cancer. These women often do not get genetic testing or even a chance to speak with a genetic counselor that would help them weigh the necessity of such a test. Genetic testing could help guide treatment, as well as future efforts to prevent cancer by increasing patient knowledge of and access to breast and ovarian genetic testing in specified populations.
2. Breast and ovarian cancer. According to the National Cancer Institute (NCI), approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. In 2014, NCI estimated that over three million women in the U.S. were living with female breast cancer. Similarly, approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their life time, while over 200,000 women are living with it in the U.S. Two genes, BRCA1 and BRCA2, when mutated or damaged, have shown to increase a women’s risk of developing breast and/or ovarian cancer. They are human genes that when operating normally produce tumor suppressor proteins, which prevent cancer cells from forming.
   
3. Genetic cancer screening and recommendations. A positive BRCA1 or BRCA2 test result indicates that a person has inherited a known harmful mutation of BRCA1 or BRCA2, and therefore has an increased risk of developing certain cancers. However, a positive test result cannot tell whether or not an individual will actually develop cancer. Some women who inherit a harmful BRCA1 or BRCA2 mutation will never develop breast or ovarian cancer. A negative BRCA1 or BRCA2 test result may indicates that the individual does not have one of the mutated genes or that the individual does not carry one of the harmful mutations that was tested for. Scientists continue to discover new BRCA1 and BRCA2 mutations and have not yet identified all potential harmful ones. According to NCI, there are no direct medical harms of genetic testing, but the knowledge of the test results may have harmful effects on a person’s emotions, social relationships, finances, and medical choices. There is a small chance that the test result may not be accurate, leading people to make decisions about their career, marriage, childbearing, or health, based on incorrect information.

According to the NCI, breast cancer screening strategies, including breast magnetic resonance imaging (MRI) and mammography, are commonly performed in individuals who carry the mutated BRCA genes and in individuals at increased risk of breast cancer. Initiation of screening is generally recommended at earlier ages and at more frequent intervals in individuals with an increased risk due to genetics and family history than in the general population. NCI states that the timing of genetic testing and knowledge of carrying a mutated BRCA gene may influence decisions surround surgeries, such as subcutaneous mastectomy and simple (total) mastectomy, and could prevent subsequent surgeries.

According to data collected by NCI’s Surveillance, Epidemiology, and End Results Program (SEER), 55% to 65% of women who inherit a harmful BRCA1 mutation and around 45% of women who inherit a harmful BRCA2 mutation will develop breast cancer by age 70. Similarly, about 11% to 17% of women who inherit a harmful BRCA2 mutation will develop ovarian cancer by age 70. However, NCI notes that these are simply estimates and they continues to change as more studies are completed.

Several organizations, including the U.S. Preventive Services Task Force (USPSTF), the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American College of Radiology recommend that women who have family members with breast, ovarian, fallopian tube, or peritoneal cancer be evaluated via MRI, mammogram, and/or genetic testing to see if they have a family history of harmful mutation in one of the BRCA genes. However, USPSTF recommends against routine genetic counseling or BRCA testing for women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes.

1. Support. The Association of Northern California Oncologists supports this bill because the program will be a systems-approach to increase overall population-based awareness and screening to reach and screen populations at risk for breast and ovarian genetic mutation cancer, especially those women in underserved communities, and those on Medi-Cal or who do not have medical insurance. The California Life Sciences Association supports this bill because it is a step in the right direction to increase the screening rates to reach and provide access to populations at high risk for breast and ovarian cancer. The California Legislative Women’s Caucus supports this bill because promotes and encourages genetic testing screening when indicated by the USPSTF and Centers for Disease Control and Prevention.
   
2. Amendments. The following proposed amendments change the recommended guidelines to be used:

“of individuals for whom BRCA test results can inform treatment decisions, consistent with National Comprehensive Cancer Network recommendations evidence-based national recommendations.”

SUPPORT AND OPPOSITION:

Support: Association of Northern California Oncologists

California Life Sciences Association
California Legislative Women’s Caucus

Oppose: None received.

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 1386

Author:(Waldron)

As Amended Ver:May 26, 2017

Majority vote

SUMMARY: Requires the Department of Public Health (DPH) to establish a program, to remain in effect until January 1, 2022, to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations among persons newly diagnosed with breast and ovarian cancer, through a provider education campaign with the goal of achieving increased genetic counseling and screening rates of individuals for whom BRCA test results can inform treatment decisions. Requires DPH to maximize the use of existing and low-cost communication channels to conduct provider education and outreach.

FISCAL EFFECT: According to the Assembly Appropriations Committee, General Fund costs to DPH in the hundreds of thousands of dollars annually on a time-limited basis for the provider education and outreach campaign.

COMMENTS: According to the author, women with newly diagnosed breast or ovarian cancer are at high risk for having a BRCA mutation, which increases the odds of cancer. The author states that these women often do not get genetic testing or even a chance to speak with a genetic counselor that would help them weigh the necessity of such a test. The author concludes that test results could help guide treatment, as well as future efforts to prevent cancer by increasing patient knowledge of and access to breast and ovarian genetic testing in specified populations.

According to the American Cancer Society (ACS), breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an X-ray or felt as a lump. Breast cancer occurs almost entirely in women, but men can get breast cancer too. Certain inherited DNA mutations (changes) can dramatically increase the risk for developing certain cancers and are linked to many of the cancers that run in some families; including BRCA genes (BRCA1 and BRCA 2) which are tumor suppressor genes. When one of these genes changes, it no longer suppresses abnormal cell growth, and cancer is more likely to develop. A change in one of these genes can be passed on from a parent. ACS estimates that in 2017 about 252,710 new cases of invasive breast cancer will be diagnosed in women and about 40,610 women will die from breast cancer. Breast cancer is the second leading cause of cancer death in women, after lung cancer.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0000706

Date of Hearing: May 10, 2017

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 1386

Author:(Waldron) – As Amended Ver:April 19, 2017

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

SUMMARY:

This bill requires the California Department of Public Health (CDPH), until January 1, 2024, to establish a public awareness campaign to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations that may lead to breast and ovarian cancer.

FISCAL EFFECT:

1. GF costs to CDPH of $270,000 to solicit funds and manage the program.
2. Cost pressure on the GF in the millions of dollars for a public awareness campaign. The bill authorizes CDPH to solicit grant funding and donations, but does not make implementation contingent on the receipt of non-state funds.

COMMENTS:

1. Purpose. This bill intends to improve screening for BRCA gene mutations that can place women at higher risk for breast and ovarian cancer.
2. Background. Breast cancer screening, most commonly through mammography, is generally recommended for women based on risk factors such as age and family history. In women who have family members with specific cancers, experts recommend screening with one of several screening tools designed to identify a family history that may be associated with an increased risk for potentially harmful mutations in breast cancer susceptibility genes (BRCA1 or BRCA2). If an individual screens positive using one of these tools, they should receive genetic counseling and, if indicated after counseling, a BRCA test. Individuals with BRCA gene mutations are at a much higher risk of developing cancer than the general public, and may chose prophylactic measures, enhanced monitoring, or chemoprevention (taking drugs or other agents to reduce risk), as a result of a positive test. Although they increase cancer risk significantly for individuals who have them, harmful BRCA1 and BRCA2 gene mutations are relatively rare in the general population
3. Staff Comments. Given BRCA screening is only recommended for individuals who have specific risk factors, and after genetic counseling to discuss an individual's risk factors and the pros and cons of the test, would a broad public awareness campaign to specifically promote screening for BRCA gene mutations be an effective and cost-effective public health intervention?

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

Date of Hearing: April 25, 2017

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 1386

Author:(Waldron) – As Amended Ver:April 19, 2017

SUBJECT: Genomic cancer testing pilot program.

SUMMARY: Requires the Department of Public Health (DPH), until January 1, 2024, to establish a pilot program to promote and encourage screening for breast cancer susceptibility gene (BRCA) mutations that may lead to breast and ovarian cancer, through a public awareness campaign. Specifically, this bill:

1. Requires DPH to establish a pilot program to promote breast cancer screening through a public awareness campaign to help achieve increased genetic screening rates for individuals with recommended indications, including, but not limited to:
   1. Multiple incidents of breast cancer;
   2. Breast cancer diagnosed before 50 years of age;
   3. Two or more primary types of BRCA-related cancers in a single family member; and,
   4. Ashkenazi Jewish, African American, and Hispanic ethnicity.
2. Requires the pilot program to have a systems approach to increase overall population-based screening to reach and screen populations at a high risk for breast and ovarian genetic mutation cancer, especially those who do not have medical insurance.
3. Requires DPH to apply for grants, and allows DPH to accept donations from public or private institutions and entities for the pilot program.
4. Makes findings and declarations stating that the awareness of, and the ability to obtain, recommended breast cancer genetic testing will increase the quality of life for hundreds of people in the state by detecting and preventing death from late-stage breast or ovarian cancer.

EXISTING LAW:

1. Establishes DPH to, among other functions, serve the public by collecting statewide data about cancer and cancer risk factors, conducting surveillance and research into the causes, cures, and controls of cancer, and communicating the results to the public, through its Chronic Disease Surveillance and Research Branch.
   
2. Establishes the Department of Health Care Services to provide Californians with access to affordable, integrated, high-quality health care, including medical, dental, mental health, substance use treatment services and long-term care. Establishes Every Woman Counts within DHCS' Cancer Detection and Treatment Branch, which provides free clinical breast exams, mammograms, pelvic exams, and Pap tests to California’s underserved women.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, women with newly diagnosed breast or ovarian cancer are at high risk for having a BRCA mutation, which increases the odds of cancer. The author states that these women often do not get genetic testing or even a chance to speak with a genetic counselor that would help them weigh the necessity of such a test. The author concludes that test results could help guide treatment, as well as future efforts to prevent cancer by increasing patient knowledge of and access to breast and ovarian genetic testing in specified populations.
2. BACKGROUND.
   1. Breast cancer. According to the American Cancer Society (ACS), breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an X-ray or felt as a lump. Breast cancer occurs almost entirely in women, but men can get breast cancer too. Certain inherited DNA mutations (changes) can dramatically increase the risk for developing certain cancers and are linked to many of the cancers that run in some families; including BRCA genes (BRCA1 and BRCA 2) which are tumor suppressor genes. When one of these genes changes, it no longer suppresses abnormal cell growth, and cancer is more likely to develop. A change in one of these genes can be passed on from a parent.
      
      ACS estimates that in 2017 about 252,710 new cases of invasive breast cancer will be diagnosed in women and about 40,610 women will die from breast cancer. Breast cancer is the second leading cause of cancer death in women, after lung cancer.
   2. US Preventive Services Task Force (USPSTF). In December 2013, the USPSTF issued a recommendations statement of Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-related Cancer in Women stating that the USPSTF recommends that primary care providers screen women who have family members with breast, ovarian, tubal, or peritoneal cancer with one of several screening tools designed to identify a family history that may be associated with an increased risk for potentially harmful mutations in breast cancer susceptibility genes (BRCA1 or BRCA2). The USPSTF concludes that women with positive screening results should receive genetic counseling and, if indicated after counseling, BRCA testing.

According to the USPSTF, specific BRCA mutations, known as founder mutations, occur among certain ethnic groups, including Ashkenazi Jewish, and African American and Hispanic persons.

• 1. Genetic testing. According to the National Human Genome Research Institute, genetic tests may be used to identify increased risks of health problems, to choose treatments, or to assess responses to treatments. There are many different types of genetic tests; such as:
     
     1. Diagnostic testing is used to precisely identify the disease that is making a person ill. The results of a diagnostic test may help an individual make choices about how to treat or manage their health;
        
     2. Predictive and pre-symptomatic genetic tests are used to find gene changes that increase a person's likelihood of developing diseases. The results of these tests provide individuals with information about the risks of developing a specific disease. Such information may be useful in decisions about lifestyle and healthcare; and,
        
     3. Carrier testing is used to find people who "carry" a change in a gene that is linked to disease. Carriers may show no signs of the disease; however, they have the ability to pass on the gene change to their children, who may develop the disease or become carriers themselves. Some diseases require a gene change to be inherited from both parents for the disease to occur. This type of testing usually is offered to people who have a family history of a specific inherited disease or who belong to certain ethnic groups that have a higher risk of specific inherited diseases.
        
  2. Population based screening. Population screening refers to a test that is offered to all individuals in a target group, usually defined by age, as part of an organized program. Screening involves simple tests to look for particular changes, or early signs of a disease, before a disease has developed or in its early stages before any symptoms develop.
     

1. SUPPORT. The California Life Sciences Association (CLSA) supports this bill, stating that while the testing for breast cancer associated genes, BRCA 1 and BRCA 2, have been available for 20 years, new technologies and less restrictive patent laws have reduced their costs. CLSA concludes these tests could help guide treatment and future efforts to prevent cancer by increasing patient awareness and access about genetic testing and counseling, especially among minorities and those in underserved communities.

REGISTERED SUPPORT / OPPOSITION:

Support

California Life Sciences Association

Opposition

None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097