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. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law generally requires a health care service plan contract or a health insurance policy issued, amended, or renewed on or after January 1, 2022, to provide coverage without cost sharing for a colorectal cancer screening test assigned either a grade of A or a grade of B by the United States Preventive Services Task Force and for a required colonoscopy for a positive result on a test with those grades.

This bill would additionally require that coverage if the screening test is assigned either a grade of A or a grade of B, or equivalent, in accordance with the most current recommendations established by another accredited or certified guideline agency approved by the California Health and Human Services Agency.

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. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law generally requires a health care service plan contract or a health insurance policy issued, amended, or renewed on or after January 1, 2022, to provide coverage without cost sharing for a colorectal cancer screening test, and for a colorectal cancer screening examination in specified circumstances, assigned either a grade of A or a grade of B by the United States Preventive Services Task Force.

This bill would additionally require that coverage if the test or screening examination is assigned either a grade of A or a grade of B, or equivalent, in accordance with the most current recommendations established by another accredited or certified guideline agency. agency approved by the California Health and Human Services Agency.

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. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law generally requires a health care service plan contract or a health insurance policy issued, amended, or renewed on or after January 1, 2022, to provide coverage without cost sharing for a colorectal cancer screening test, and for a colorectal cancer screening examination in specified circumstances, assigned either a grade of A or a grade of B by the United States Preventive Services Task Force.

This bill would additionally require that coverage if the test or screening examination is assigned either a grade of A or a grade of B B, or equivalent, in accordance with the most current recommendations established by another accredited or certified guideline agency.

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. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law generally requires a health care service plan contract or a health insurance policy issued, amended, or renewed on or after January 1, 2022, to provide coverage without cost sharing for a colorectal cancer screening test, and for a colorectal cancer screening examination in specified circumstances, assigned either a grade of A or a grade of B by the United States Preventive Services Task Force.

This bill would additionally require that coverage if the test or screening examination is assigned either a grade of A or a grade of B by another accredited or certified guideline agency.

GOVERNOR'S VETO

GV Bill Id:AB 3245

Author:(Joe Patterson)

As Enrolled Ver:September 3, 2024

2/3 vote

SUMMARY

Expands existing law to require a health plan contract and insurance policy to provide coverage without cost sharing for a colorectal cancer (CRC) screening test assigned either a grade of "A" or a grade of "B", or equivalent, in accordance with the most current recommendations established by another accredited or certified guideline agency approved by the California Health and Human Services Agency. Requires the colonoscopy for a positive result on a test or procedure that is a CRC screening examination or laboratory test assigned either a grade of A or a grade of B, or equivalent in accordance with the most current recommendations established by another accredited or certified guideline agencies to also be provided without any cost sharing.

Senate Amendments

Delete reference to the American Cancer Society and its guidelines to instead identify any agency approved by the California Health and Human Services Agency.

Governor’s Veto Message

This bill would expand existing law, which requires health plans to provide coverage for CRC screenings and subsequent colonoscopies assigned a grade A or B by the United States Preventive Services Task Force (USPSTF) without any cost sharing, to also require coverage for equivalent standards and recommendations established by another accredited or certified guideline agency approved by the California Health and Human Services Agency.

I strongly support access to preventive health care, including CRC screenings and colonoscopies. However, existing law that requires coverage for these services without cost sharing is sufficient. Going beyond the USPSTF standard to include guidelines from other organizations and "equivalent" ratings is vague and would be difficult to implement.

COMMENTS

According to the California Health Benefits Review Program (CHBRP), CRC is cancer that occurs in either the colon or rectum. Most CRCs arise from abnormal growth in the linings of the large bowel that take 10 to 15 years on average to progress to cancerous tissues. In California, CRC is the third leading cause of cancer death for women and men. For women, the first and second leading causes are lung and breast cancers, respectively; for men, the top two are lung and prostate cancer. CRC is known as a "silent killer" since individuals with the disease tend to remain asymptomatic during early stages, resulting in a larger proportion of late-stage diagnoses; survival declines to 71% and 14% for patients diagnosed with regional and distant metastases, respectively. Although CRC is sometimes observed in younger adults, an individual's risk for large bowel cancers increases rapidly after age 50 years. The USPSTF found little evidence for increased benefit of screenings above the age of 75 years. Accordingly, USPSTF recommends routine screening for all asymptomatic adults between the ages of 50 and 75 years who have an average risk of CRC based on their genetic and medical history. There are only two CRC screening strategies (Fecal Occult Blood Test and flexible sigmoidoscopy) that have been shown in randomized controlled trials to reduce CRC mortality. The USPSTF does not explicitly recommend any specific screening strategy for CRC, and instead provides information regarding efficacy, suggested screening intervals, and other considerations.

1. Patient Protection and Affordable Care Act (ACA) Preventive Care litigation. On March 30, 2023, a federal court in Texas struck down protections for preventive care benefits under the ACA in Braidwood Management Inc. v. Becerra. If Braidwood is upheld by the Supreme Court, elimination of the coverage requirements for USPSTF recommendations would invalidate the requirement to cover all of these services without cost sharing. California law, however, will still require coverage of recommended preventive care benefits (pursuant to AB 406 (Pan), Chapter 302, Statutes of 2020). One of the reasons preventive care was included in the ACA was because research showed that cost-sharing, even in small amounts, reduces the likelihood that people use preventive services. Millions of people each year report delaying or forgoing needed health care due to costs. The USPSTF is a group of independent experts that use a rigorous evidence-based process to review research, weighing both the benefits and risks of services. In the ACA, the preventive care coverage mandate was tied to recommendations by the USPSTF and other groups as a way of having a standard definition of what preventive care means, including changes over time as new evidence becomes available.
2. USPSTF Draft Recommendations. In 2020, the USPSTF proposed draft recommendations that replace the 2016 USPSTF recommendation on screening for CRC. In 2016, the USPSTF recommended screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A grade recommendation). In addition, the USPSTF concluded that the decision to screen for CRC in adults ages 76 to 85 years should be an individual one, taking into account the patient's overall health and prior screening history (C grade recommendation), and that screening should be discontinued after age 85 years. The current recommendation, while continuing to recommend CRC screening in adults ages 50 to 75 years, now recommends offering screening at age 45 years (B grade recommendation). As it did in 2016, the USPSTF continues to conclude that screening in adults ages 76 to 85 years should be an individual one (C grade recommendation) and screening should be discontinued after age 85 years. As of 2021, the USPSTF issued its final recommendation statement.
3. CHBRP analysis. CHBRP's analysis of this bill includes the following:
   1. No change in benefit. CHBRP determined that this bill would not result in a change of benefit coverage based on currently established recommendations for CRC screening tests, and there would be no impact in the first year postmandate of this bill as introduced. However, should there be new evidence-based guidelines or newly recommended screening test(s) that are different from those currently recommended by the USPSTF, health plans in California would be required to cover these newly specified tests without cost sharing. In such circumstances, these would potentially result in changes to the utilization of these screening tests and potential changes in health care expenditures. CHBRP assumes relevant evidence-based guidelines would not need to use an A/B rating as the USPSTF does, although it is possible to interpret the language of this bill as requiring such. This bill adds the requirement to cover without cost sharing CRC screening tests identified by accredited or certified guideline agencies, including the American Cancer Society and its guidelines.
   2. Ambiguities and Assumptions Regarding Bill Language. CHBRP makes the following assumptions regarding the bill language of this bill as introduced:
      1. "Accredited or certified guidelines" would equate to evidence-based guidelines, which are statements that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options; and,
      2. Screening tests or frequency of testing required to be covered would not include those that have very low-quality evidence. It is possible to interpret this bill language as requiring other guidelines to also use an A/B rating scale when evaluating evidence, but an A/B rating is not a universal measure for determining the strength of evidence-based recommendations.

CHBRP examined guidelines from US-based entities including the American College of Physicians, American College of Radiology, American Cancer Society, American College of Gastroenterology (and summarized by the American Academy of Family Physicians), American Gastroenterological Association, American Society of Clinical Oncology, National Comprehensive Cancer Network, and the US Multi-Society Task Force. Recommendations from these guidelines are in line with the grade A/B USPSTF recommendations. There are no recommendations supported by high-quality evidence that are beyond what USPSTF currently recommends with an A or B grade.

1. Recent innovations. A recent NY Times article (article), noted early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73%. Just 50 to 75% of middle-aged and older adults who should be screened regularly are being tested. There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test. A blood test is on the horizon. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. About 53,000 Americans are expected to die from CRC this year. It is the second-most common cause of cancer-related deaths in the United States, and while the death rate in older adults has fallen, it has increased in people under age 55. The article notes that the problem is convincing more people to be screened. The blood test takes advantage of the discovery that colon cancers and large polyps — clumps of cells on the lining of the colon that occasionally turn into cancers — shed fragments of DNA into the blood. A study this year in the New England Journal of Medicine found that a blood test searching for such DNA called Shield and made by the company Guardant Health detected 87% of cancers that were at an early and curable stage. The false positive rate was 10%. While the blood test detects cancers, it misses most large polyps, finding just 13% of them. In contrast, the fecal test detects 43% and a colonoscopy finds 94%. While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming. In particular, doctors need to understand that while this test helps detect cancer early, it does not prevent it because it is not good at finding precancerous polyps. Doctors will also need to explain to patients that if the blood test result is abnormal, they will have to schedule a colonoscopy to look for polyps or early-stage cancers and remove them if they are present. The article states that it is also not clear how often people should do the blood test. Guardant suggested every three years but that recommendation is not well established. The big unknown is cost. Guardant has applied to the U.S. Food and Drug Administration (FDA) for approval to market the test. The company sells it now as a "lab-based test," which does not require FDA approval but is also not covered by health insurance. For those who want to pay out of pocket, the price is $895. The Cologuard fecal test costs $581 to $681. Colonoscopies, usually needed half as often, typically cost $1,250 to $4,800, although some hospitals charge more. The average cost of a colonoscopy in the United States is $2,750. These tests are typically covered by insurance.

According to the Author

CRC awareness is not just a campaign; it is a call to action for early detection, proactive screenings, and empowering education. In 2023, there were more than 52,000 deaths from CRC. This bill will ensure that coverage for CRC screenings continue irrespective of litigation occurring in other states that jeopardizes this critical preventative care option. At 40 years young, a friend of the author was diagnosed with stage 3 CRC after many months fighting for his own health. Fortunately, he survived, but would not have without a screening. The author concludes this is why continuing to cover CRC screening is so important.

Arguments in Support

The California Life Sciences (CLS) writes CRC is the third most common cancer diagnosed in both men and women each year in the United States, excluding skin cancer. In 2023, over 153 thousand adults in the United States were diagnosed with CRC. These numbers included over 106 thousand new cases of colon cancer and over 46 thousand new cases of rectal cancer. Over 50,000 deaths from this disease occurred in the United States last year. However, when CRC is found early, it can often be cured. The death rate from this type of cancer in 2020 in the United States was 57% less than what it was in 1970. CLS states this is due to improvements in treatment and increased screening, which detects colorectal changes before they turn cancerous.

Arguments in Opposition

The California Association of Health Plans (CAHP), the Association of California Life and Health Insurance Companies (ACLHIC), and America's Health Insurance Plans (AHIP) oppose mandates for health plans and insurers to cover specific services, as well as bills that eliminate cost sharing and limit utilization management, which have similar cost impacts as coverage mandates. Moreover, they will increase costs, reduce choice and competition, and further incent some employers and individuals to avoid state regulation by seeking alternative coverage options. These bills will lead to higher premiums, harming affordability and access for small businesses and individual market consumers. CAHP, ACLHIC, and AHIP write that state mandates increase costs of coverage, especially for families who buy coverage without subsidies, small business owners who cannot or do not wish to self-insure, and California taxpayers who foot the bill for the state's share of those mandates.

FISCAL COMMENTS

According to the Senate Appropriations Committee, unknown, ongoing General Fund cost pressures for the California Health and Human Services Agency for activities related to approving accredited or certified guideline agencies. Unknown potential General Fund cost pressures to CalPERS health plan premiums, to the extent health plans would be required to cover tests that that are not assigned either a grade of "A" or "B" by the USPSTF. The Department of Managed Health Care anticipates minor and absorbable costs for state administration. The California Department of Insurance anticipates no fiscal impact for state administration.

VOTES

ASM HEALTH: 16-0-0

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Sanchez, Santiago, Schiavo, Weber

ASSEMBLY FLOOR: 72-0-8

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

ABS, ABST OR NV: Berman, Calderon, Megan Dahle, Flora, Low, Mathis, Weber, Robert Rivas

SENATE FLOOR: 39-0-1

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

ABS, ABST OR NV: Alvarado-Gil

ASSEMBLY FLOOR: 76-0-3

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

ABS, ABST OR NV: Cervantes, Ortega, Zbur

UPDATED

VERSION: September 3, 2024

CONSULTANT: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0005147

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 3245

Author:(Joe Patterson)

As Amended Ver:June 10, 2024

Majority vote

SUMMARY

Expands existing law to require a health plan contract and insurance policy to provide coverage without cost sharing for a colorectal cancer (CRC) screening test assigned either a grade of "A" or a grade of "B", or equivalent, in accordance with the most current recommendations established by another accredited or certified guideline agency approved by the California Health and Human Services Agency. Requires the colonoscopy for a positive result on a test or procedure that is a CRC screening examination or laboratory test assigned either a grade of A or a grade of B, or equivalent in accordance with the most current recommendations established by another accredited or certified guideline agencies to also be provided without any cost sharing.

Senate Amendments

Delete reference to the American Cancer Society and its guidelines to instead identify any agency approved by the California Health and Human Services Agency.

COMMENTS

According to the California Health Benefits Review Program (CHBRP), CRC is cancer that occurs in either the colon or rectum. Most CRCs arise from abnormal growth in the linings of the large bowel that take 10 to 15 years on average to progress to cancerous tissues. In California, CRC is the third leading cause of cancer death for women and men. For women, the first and second leading causes are lung and breast cancers, respectively; for men, the top two are lung and prostate cancer. CRC is known as a "silent killer" since individuals with the disease tend to remain asymptomatic during early stages, resulting in a larger proportion of late-stage diagnoses; survival declines to 71% and 14% for patients diagnosed with regional and distant metastases, respectively. Although CRC is sometimes observed in younger adults, an individual's risk for large bowel cancers increases rapidly after age 50 years. The U.S. Preventive Services Task Force (USPSTF) found little evidence for increased benefit of screenings above the age of 75 years. Accordingly, USPSTF recommends routine screening for all asymptomatic adults between the ages of 50 and 75 years who have an average risk of colorectal cancer based on their genetic and medical history. There are only two CRC screening strategies (Fecal Occult Blood Test and flexible sigmoidoscopy) that have been shown in randomized controlled trials to reduce CRC mortality. The USPSTF does not explicitly recommend any specific screening strategy for CRC, and instead provides information regarding efficacy, suggested screening intervals, and other considerations.

1. Patient Protection and Affordable Care Act (ACA) Preventive Care litigation. On March 30, 2023, a federal court in Texas struck down protections for preventive care benefits under the ACA in Braidwood Management Inc. v. Becerra. If Braidwood is upheld by the Supreme Court, elimination of the coverage requirements for USPSTF recommendations would invalidate the requirement to cover all of these services without cost sharing. California law, however, will still require coverage of recommended preventive care benefits (pursuant to AB 406 (Pan), Chapter 302, Statutes of 2020). One of the reasons preventive care was included in the ACA was because research showed that cost-sharing, even in small amounts, reduces the likelihood that people use preventive services. Millions of people each year report delaying or forgoing needed health care due to costs. The USPSTF is a group of independent experts that use a rigorous evidence-based process to review research, weighing both the benefits and risks of services. In the ACA, the preventive care coverage mandate was tied to recommendations by the USPSTF and other groups as a way of having a standard definition of what preventive care means, including changes over time as new evidence becomes available.
2. USPSTF Draft Recommendations. In 2020, the USPSTF proposed draft recommendations that replace the 2016 USPSTF recommendation on screening for CRC. In 2016, the USPSTF recommended screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A grade recommendation). In addition, the USPSTF concluded that the decision to screen for CRC in adults ages 76 to 85 years should be an individual one, taking into account the patient's overall health and prior screening history (C grade recommendation), and that screening should be discontinued after age 85 years. The current recommendation, while continuing to recommend CRC screening in adults ages 50 to 75 years, now recommends offering screening at age 45 years (B grade recommendation). As it did in 2016, the USPSTF continues to conclude that screening in adults ages 76 to 85 years should be an individual one (C grade recommendation) and screening should be discontinued after age 85 years. As of 2021, the USPSTF issued its final recommendation statement.
3. CHBRP analysis. CHBRP's analysis of this bill includes the following:
   1. No change in benefit. CHBRP determined that this bill would not result in a change of benefit coverage based on currently established recommendations for CRC screening tests, and there would be no impact in the first year postmandate of this bill as introduced. However, should there be new evidence-based guidelines or newly recommended screening test(s) that are different from those currently recommended by the USPSTF, health plans in California would be required to cover these newly specified tests without cost sharing. In such circumstances, these would potentially result in changes to the utilization of these screening tests and potential changes in health care expenditures. CHBRP assumes relevant evidence-based guidelines would not need to use an A/B rating as the USPSTF does, although it is possible to interpret the language of this bill as requiring such. This bill adds the requirement to cover without cost sharing CRC screening tests identified by accredited or certified guideline agencies, including the American Cancer Society and its guidelines.
   2. Ambiguities and Assumptions Regarding Bill Language. CHBRP makes the following assumptions regarding the bill language of this bill as introduced:
      1. "Accredited or certified guidelines" would equate to evidence-based guidelines, which are statements that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options; and,
      2. Screening tests or frequency of testing required to be covered would not include those that have very low-quality evidence. It is possible to interpret this bill language as requiring other guidelines to also use an A/B rating scale when evaluating evidence, but an A/B rating is not a universal measure for determining the strength of evidence-based recommendations.

CHBRP examined guidelines from US-based entities including the American College of Physicians, American College of Radiology, American Cancer Society, American College of Gastroenterology (and summarized by the American Academy of Family Physicians), American Gastroenterological Association, American Society of Clinical Oncology, National Comprehensive Cancer Network, and the US Multi-Society Task Force. Recommendations from these guidelines are in line with the grade A/B USPSTF recommendations. There are no recommendations supported by high-quality evidence that are beyond what USPSTF currently recommends with an A or B grade.

1. Recent innovations. A recent NY Times article (article), noted early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73%. Just 50 to 75% of middle-aged and older adults who should be screened regularly are being tested. There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test. A blood test is on the horizon. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. About 53,000 Americans are expected to die from CRC this year. It is the second-most common cause of cancer-related deaths in the United States, and while the death rate in older adults has fallen, it has increased in people under age 55. The article notes that the problem is convincing more people to be screened. The blood test takes advantage of the discovery that colon cancers and large polyps — clumps of cells on the lining of the colon that occasionally turn into cancers — shed fragments of DNA into the blood. A study this year in the New England Journal of Medicine found that a blood test searching for such DNA called Shield and made by the company Guardant Health detected 87% of cancers that were at an early and curable stage. The false positive rate was 10%. While the blood test detects cancers, it misses most large polyps, finding just 13% of them. In contrast, the fecal test detects 43% and a colonoscopy finds 94%. While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming. In particular, doctors need to understand that while this test helps detect cancer early, it does not prevent it because it is not good at finding precancerous polyps. Doctors will also need to explain to patients that if the blood test result is abnormal, they will have to schedule a colonoscopy to look for polyps or early-stage cancers and remove them if they are present. The article states that it is also not clear how often people should do the blood test. Guardant suggested every three years but that recommendation is not well established. The big unknown is cost. Guardant has applied to the U.S. Food and Drug Administration (FDA) for approval to market the test. The company sells it now as a "lab-based test," which does not require FDA approval but is also not covered by health insurance. For those who want to pay out of pocket, the price is $895. The Cologuard fecal test costs $581 to $681. Colonoscopies, usually needed half as often, typically cost $1,250 to $4,800, although some hospitals charge more. The average cost of a colonoscopy in the United States is $2,750. These tests are typically covered by insurance.

According to the Author

CRC awareness is not just a campaign; it is a call to action for early detection, proactive screenings, and empowering education. In 2023, there were more than 52,000 deaths from CRC. This bill will ensure that coverage for CRC screenings continue irrespective of litigation occurring in other states that jeopardizes this critical preventative care option. At 40 years young, a friend of the author was diagnosed with stage 3 CRC after many months fighting for his own health. Fortunately, he survived, but would not have without a screening. The author concludes this is why continuing to cover CRC screening is so important.

Arguments in Support

The California Life Sciences (CLS) writes CRC is the third most common cancer diagnosed in both men and women each year in the United States, excluding skin cancer. In 2023, over 153 thousand adults in the United States were diagnosed with CRC. These numbers included over 106 thousand new cases of colon cancer and over 46 thousand new cases of rectal cancer. Over 50,000 deaths from this disease occurred in the United States last year. However, when CRC is found early, it can often be cured. The death rate from this type of cancer in 2020 in the United States was 57% less than what it was in 1970. CLS states this is due to improvements in treatment and increased screening, which detects colorectal changes before they turn cancerous.

Arguments in Opposition

The California Association of Health Plans (CAHP), the Association of California Life and Health Insurance Companies (ACLHIC), and America's Health Insurance Plans (AHIP) oppose mandates for health plans and insurers to cover specific services, as well as bills that eliminate cost sharing and limit utilization management, which have similar cost impacts as coverage mandates. Moreover, they will increase costs, reduce choice and competition, and further incent some employers and individuals to avoid state regulation by seeking alternative coverage options. These bills will lead to higher premiums, harming affordability and access for small businesses and individual market consumers. CAHP, ACLHIC, and AHIP write that state mandates increase costs of coverage, especially for families who buy coverage without subsidies, small business owners who cannot or do not wish to self-insure, and California taxpayers who foot the bill for the state's share of those mandates.

FISCAL COMMENTS

According to the Senate Appropriations Committee, unknown, ongoing General Fund cost pressures for the California Health and Human Services Agency for activities related to approving accredited or certified guideline agencies. Unknown potential General Fund cost pressures to CalPERS health plan premiums, to the extent health plans would be required to cover tests that that are not assigned either a grade of "A" or "B" by the USPSTF. The Department of Managed Health Care anticipates minor and absorbable costs for state administration. The California Department of Insurance anticipates no fiscal impact for state administration.

VOTES:

ASM HEALTH: 16-0-0

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Sanchez, Santiago, Schiavo, Weber

ASSEMBLY FLOOR: 72-0-8

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

ABS, ABST OR NV: Berman, Calderon, Megan Dahle, Flora, Low, Mathis, Weber, Robert Rivas

SENATE FLOOR: 39-0-1

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

ABS, ABST OR NV: Alvarado-Gil

UPDATED

VERSION: June 10, 2024

CONSULTANT: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0004525

 THIRD READING  

Bill No: AB 3245

Author: Joe Patterson (R)

Amended: 6/10/24 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 10-0, 6/5/24

AYES: Roth, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Rubio, Smallwood-Cuevas, Wiener

NO VOTE RECORDED: Menjivar

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/15/24

AYES: Caballero, Jones, Ashby, Becker, Bradford, Seyarto, Wahab

ASSEMBLY FLOOR: 72-0, 5/2/24 - See last page for vote

SUBJECT: Coverage for colorectal cancer screening

SOURCE: Author

DIGEST:

This bill requires health plan contracts and health insurance policies to provide coverage, without cost-sharing, for colorectal cancer screening tests that are equivalent to those with a grade “A” or “B” assigned by the United States Preventive Services Task Force (USPSTF), or, in accordance with the most current recommendations established by another accredited or certified guideline agency (that is not USPSTF), approved by the California Health and Human Services Agency.

ANALYSIS:

Existing law:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans under the Knox-Keene Health Care Services Plan Act of 1975; the California Department of Insurance (CDI) to regulate health and other insurers; the Department of Health Care Services (DHCS) to administer the Medi-Cal program. [Health & Safety Code (HSC) §1340, et seq., Insurance Code (INS) §106, et seq., and, Welfare & Intuitions Code (WIC) §14000, et seq.]
   
2. Requires every health plan contract and insurance policy, except a specialized health plan contract or insurance policy, to provide coverage, without any cost-sharing, for a colorectal cancer screening test assigned either a grade of “A” or “B” by USPSTF. Includes a colonoscopy required for a positive result on a test or procedure that is a colorectal cancer screening examination or laboratory test (that is not a colonoscopy) assigned a grade of “A” or “B” by USPSTF. [HSC §1367.668 and INS §10123.207]
   
3. Requires a group or individual health plan contract or health insurance policy to, at a minimum, provide coverage for and not impose any cost-sharing requirements, for all of the following (codifies federal Affordable Care Act (ACA) requirements):
   1. Evidence-based items or services that have in effect a rating of “A” or “B” in USPSTF recommendations, as periodically updated;
   2. Immunizations that have in effect a recommendation, as periodically updated, from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) with respect to the individual involved;
   3. Evidence-informed preventive care and screening with respect to infants, children, and adolescents provided in the comprehensive guidelines, as periodically updated, supported by the Health Resources and Services Administration (HRSA);
   4. Additional preventive care and screenings for women not described in a) above as provided for in comprehensive guidelines supported by HRSA, as specified; and,
   5. Current USPSTF recommendations regarding breast cancer screening, mammography, and prevention. [HSC §1367.002 and INS §10112.2]
      
4. States that 3) above, does not prohibit a health plan contract or insurance policy from providing coverage for services in addition to those recommended by USPSTF or denying coverage for services that are not recommended by USPSTF. [HSC §1367.002 and INS §10112.2]

This bill expands the requirement for colorectal cancer screening coverage without cost-sharing to include tests that are equivalent to those with a grade “A” or “B” assigned by USPSTF, or, in accordance with the most current recommendations established by another accredited or certified guideline agency approved by the California Health and Human Services Agency.

Comments

1. Author’s statement. According to the author, colorectal cancer awareness isn't just a campaign; it's a call to action for early detection, proactive screenings, and empowering education. In 2023 there were more than 52,000 deaths from colorectal cancer. This bill will ensure that coverage for colorectal cancer screenings continue irrespective of litigation occurring in other states that jeopardizes this critical preventative care option. At 40 years young, a friend of mine was diagnosed with stage three colorectal cancer after losing many months fighting for his own health. Fortunately, he survived, but would not have without a screening. This is why continuing to cover colorectal cancer screening is so important.
   
2. USPSTF. The USPSTF was created in 1984, and is an independent, volunteer panel of national experts in prevention and evidence-based medicine. The USPSTF makes evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications. The USPSTF posts the final recommendation statement, final evidence review, and an evidence summary on its website. The recommendation statement and the evidence summary are also published in a peer-reviewed scientific journal.
3. Colorectal cancer background. According to the USPSTF recommendation statement published in the Journal of the American Medical Association on May 18, 2021, colorectal cancer is the third leading cause of cancer death for both men and women, with an estimated 52,980 persons in the U.S. projected to die of colorectal cancer in 2021. Colorectal cancer is most frequently diagnosed among persons aged 65 to 74 years. It is estimated that 10.5% of new colorectal cancer cases occur in persons younger than 50 years. Incidence of colorectal cancer (specifically adenocarcinoma) in adults aged 40 to 49 years has increased by almost 15% from 2000-2002 to 2014-2016. In 2016, 26% of eligible adults in the U.S. had never been screened for colorectal cancer, and in 2018, 31% were not up to date with screening. To update its 2016 recommendation, USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for colorectal cancer in adults 40 years or older. The review also examined whether these findings varied by age, sex, or race/ethnicity. In addition, as in 2016, USPSTF commissioned a report from the Cancer Intervention and Surveillance Modeling Network Colorectal Cancer Working Group to provide information from comparative modeling on how estimated life-years gained, colorectal cancer cases averted, and colorectal cancer deaths averted vary by different starting and stopping ages for various screening strategies. The USPSTF assessment of net benefit applies to stool-based tests with high sensitivity, colonoscopy, computed tomography (CT) colonography, and flexible sigmoidoscopy. The recommendation for screening for colorectal cancer does not include serum tests, urine tests, or capsule endoscopy for colorectal cancer screening because of the limited available evidence on these tests and because other effective tests (i.e., the recommended screening strategies) are available.
   
4. USPSTF updated recommendation. USPSTF assigns one of five letter grades (A, B, C, D, or I) which describe the strength of a recommendation. Grades A and B are recommended for practitioners, C should be selectively offered, D is not recommended, and I means there is insufficient evidence. USPSTF recommends: screening for colorectal cancer in all adults aged 50 to 75 years (“A” recommendation); screening for colorectal cancer in adults aged 45 to 49 years (“B” recommendation); and, that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years because evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient’s overall health, prior screening history, and preferences. (“C” recommendation)
   
5. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed AB 1986 (Gibson, 2020) and this bill. Key findings include:
   1. Assumptions. CHBRP assumes “accredited or certified guidelines” would equate to evidence-based guidelines, which are statements that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options. Screening tests or frequency of testing required to be covered would not include those that have very low-quality evidence.
   2. Tests and frequency.

• • 1. High-sensitivity guaiac fecal occult blood test (gFOBT) or fecal immunochemical test (FIT) every year.
    2. Stool DNA-FIT (sDNA-FIT) every one to three years.
    3. CT colonography every five years.
    4. Flexible sigmoidoscopy every five years.
    5. Flexible sigmoidoscopy every ten years + FIT every year.
    6. Colonoscopy screening every ten years.
  1. Other guidelines. CHBRP examined guidelines in February and March of 2024 from U.S.-based entities including the American College of Physicians, American College of Radiology, American Cancer Society, American College of Gastroenterology (and summarized by the American Academy of Family Physicians), American Gastroenterological Association, American Society of Clinical Oncology, National Comprehensive Cancer Network, and the U.S. Multi-Society Task Force. Recommendations from these guidelines are in line with the grade A/B USPSTF recommendations. There are no recommendations supported by high-quality evidence that are beyond what USPSTF currently recommends with an A or B grade. Should new guidelines from other organizations recommend screening that is more expansive than existing USPSTF guidelines, this bill would require plans and policies to newly cover, without cost-sharing, the specified colorectal cancer screening tests, including changes in frequency and age of recommended screening tests. For example, a March 2024 study describes a newly developed blood-based colorectal cancer screening. Should an organization such as the American Cancer Society determine there is enough evidence to recommend this new modality of colorectal cancer screening before the USPSTF reviews the evidence and makes a recommendation, this bill would require coverage without cost-sharing of this blood test.
  2. Litigation. Braidwood Management Inc. v. Becerra was brought forth by plaintiffs who assert, among other points, that the requirements in the ACA for specific expert committees and a federal government agency to recommend covered preventive services are unconstitutional. “In September 2022, Texas U.S. District Court Judge Reed O’Connor ruled that the preventive service requirement for USPSTF recommendations was unconstitutional because the task force members are neither appointed by the President nor confirmed by the Senate, thereby violating the Appointments Clause.” The 5th Circuit Court of Appeals issued an administrative stay of the Texas U.S. District Court Judge’s 2022 ruling while the decision is being appealed. Oral arguments were heard by the 5th Circuit Court of Appeals in March 2024. Existing California law that requires coverage without cost-sharing of colorectal cancer screening tests is part of California’s larger preventive services mandate, which is largely modeled after the ACA preventive services mandate. Should future court decisions uphold a portion or all of the lower court’s ruling, federal and state governments may be prohibited from requiring health insurers to cover some or all preventive services as recommended by USPSTF.

1. New blood test. A new blood test to detect colorectal cancer has been developed and is under review by the federal Food and Drug Administration. This new test has shown promise in detecting cancer cells and may provide an option for early detection when a colonoscopy isn’t feasible. However, experts indicate that colonoscopies are still the gold standard which is the only way to identify and remove precancerous lesions that are not detectible in blood tests.

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

According to the Senate Appropriations Committee:

• Unknown, ongoing General Fund cost pressures for the California Health and Human Services Agency for activities related to approving accredited or certified guideline agencies.
• Unknown potential General Fund cost pressures to CalPERS health plan premiums, to the extent health plans would be required to cover tests that that are not assigned either a grade of “A” or “B” by the United States Preventive Services Task Force.
• DMHC anticipates minor and absorbable costs for state administration.
• CDI anticipates no fiscal impact for state administration.

SUPPORT: (Verified 8/13/24)

California Life Sciences

California Medical Association

National Health Law Program

North East Medical Services

Oncology Nursing Society

OPPOSITION: (Verified 8/13/24)

America’s Health Insurance Plans

Association of California Life and Health Insurance Companies

California Association of Health Plans

ARGUMENTS IN SUPPORT: California Life Sciences writes that with this bill Californians will have increased access to colorectal cancer screenings that can potentially save their lives – or at least catch the cancer early enough to save the cost of the most expensive and arduous late-stage treatments. National Health Law Program (NHeLP) writes that this is a preventive measure aimed at ensuring that all people have access to affordable preventive colorectal cancer screening without cost as a barrier. Death from colorectal cancer has dropped significantly over the last decade, especially for individuals over age 50, which is largely attributed to increased access to screening. Nevertheless, colorectal cancer rates are on the rise among younger people and Black people in particular are being diagnosed with colorectal cancer at younger ages, and with more advanced disease. Thus, access to screening is particularly important for these populations to reducing the morbidity associated with the disease: colorectal polyps found by screening can be removed before they can develop into cancers and screening can find cancers earlier, when they are likely to be easier to treat. Ensuring that Californians have access to medically, indicated screening at no cost is important to making screening accessible, especially to those with an increased risk of colorectal cancers. NHeLP also raises concerns about the potential of the state having to defray Essential Health Benefit costs under the ACA based on the outcome of Braidwood.

ARGUMENTS IN OPPOSITION: The California Association of Health Plans, Association of California Life and Health Insurance Companies, and America’s Health Insurance Plans write to oppose this bill because it is one of 14 health insurance mandate bills that will increase costs, reduce choice and competition, and further incent some employers and individuals to avoid state regulation by seeking alternative coverage options. Benefit mandates impose a one-size-fits-all approach to medical care and benefit design driven by the legislature rather than consumer choice. These bills will lead to higher premiums, harming affordability and access for small businesses and individual market consumers. These opponents urge legislators to also consider the cumulative impacts of these mandates on premiums and access to coverage. All of these bills will increase costs and limit employer flexibility. The Legislature created the Office of Health Care Affordability to contain cost drivers. With this office in place and the state budget deficit, the Legislature should take a wait-and-see approach when considering costly mandates.

ASSEMBLY FLOOR: 72-0, 5/2/24

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

NO VOTE RECORDED: Berman, Calderon, Megan Dahle, Flora, Low, Mathis, Weber, Robert Rivas

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

8/18/24 17:50:30

**** END ****

SENATE COMMITTEE ON

Senator Anna Caballero, Chair

2023 - 2024 Regular Session

AB 3245 (Joe Patterson) - Coverage for colorectal cancer screening

Bill Summary:

AB 3245 would expand existing requirements for health plans and insurers to provide coverage, without cost-sharing, for colorectal cancer screening tests.

Fiscal Impact:

• Unknown, ongoing General Fund cost pressures for the California Health and Human Services Agency for activities related to approving accredited or certified guideline agencies.
• Unknown potential General Fund cost pressures to CalPERS health plan premiums, to the extent health plans would be required to cover tests that that are not assigned either a grade of “A” or “B” by the United States Preventive Services Task Force.
• The Department of Managed Health Care (DMHC) anticipates minor and absorbable costs for state administration.
• The California Department of Insurance (CDI) anticipates no fiscal impact for state administration.

Background:

The United States Preventive Services Task Force (USPSTF) is an independent, volunteer panel of national experts in prevention and evidence-based medicine. The USPSTF makes evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications. The USPSTF assigns one of five letter grades (A, B, C, D, or I) which describe the strength of a recommendation. Grades A and B are recommended for practitioners, C should be selectively offered, D is not recommended, and I means there is insufficient evidence. The USPSTF recommends: screening for colorectal cancer in all adults aged 50 to 75 years (“A” recommendation); screening for colorectal cancer in adults aged 45 to 49 years (“B” recommendation); and, that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years because evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient’s overall health, prior screening history, and preferences. (“C” recommendation)

The DMHC regulates health plans under the Knox-Keene Act and the CDI regulates health insurers. Current law requires every health plan contract and insurance policy, except a specialized health plan contract or insurance policy, to provide coverage, without any cost-sharing, for a colorectal cancer screening test assigned either a grade of “A” or “B” by the USPSTF. Current law provides that a colonoscopy required for a positive result on a test or procedure (not a colonoscopy) that is a colorectal cancer screening examination or laboratory test assigned a grade of “A” or “B” by USPSTF must also be provided without any cost-sharing.

Proposed Law:

AB 3245 would additionally require health plan contracts and health insurance policies to provide coverage, without cost-sharing, for colorectal cancer screening tests that are “equivalent” to those with a grade “A” or “B” assigned by the USPSTF, or, in accordance with the most current recommendations established by another accredited or certified guideline agency approved by the California Health and Human Services Agency.

Staff Comments:

The California Health Benefits Review Program (CHBRP) analysis of AB 3245 (introduced version) indicated that the bill would not result in a change in benefit coverage for enrollees in DMHC-regulated plans and CDI-regulated policies because the guidelines for colorectal cancer screening as recommended with an A or B grade by the USPSTF are the broadest, as of March 2024. Plans and policies are already required to cover colorectal cancer screening without cost sharing with these guidelines. However, CHBRP indicates that should another organization release colorectal cancer screening guidelines that are more expansive than those of the USPSTF, AB 3245 would result in a change in benefit coverage and therefore a change in utilization of screening tests and health care expenditures.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Richard Roth, Chair

BILL NO: AB 3245

SUBJECT: Coverage for colorectal cancer screening

SUMMARY:

Requires health plan contracts and health insurance policies to provide coverage, without cost-sharing, for colorectal cancer screening tests that are equivalent to those with a grade “A” or “B” assigned by the United States Preventive Services Task Force (USPSTF), or, in accordance with the most current recommendations established by another accredited or certified guideline agency (that is not USPSTF), such as the American Cancer Society.

Existing law:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans under the Knox-Keene Health Care Services Plan Act of 1975; the California Department of Insurance (CDI) to regulate health and other insurers; the Department of Health Care Services (DHCS) to administer the Medi-Cal program. [HSC §1340, et seq., INS §106, et seq., and, WIC §14000, et seq.]
   
2. Requires every health plan contract and insurance policy, except a specialized health plan contract or insurance policy, to provide coverage, without any cost-sharing, for a colorectal cancer screening test assigned either a grade of “A” or “B” by USPSTF. Includes a colonoscopy required for a positive result on a test or procedure that is a colorectal cancer screening examination or laboratory test (that is not a colonoscopy) assigned a grade of “A” or “B” by USPSTF. [HSC §1367.668 and INS §10123.207]
   
3. Requires a group or individual health plan contract or health insurance policy to, at a minimum, provide coverage for and not impose any cost-sharing requirements, for all of the following (codifies federal Affordable Care Act (ACA) requirements):
   1. Evidence-based items or services that have in effect a rating of “A” or “B” in USPSTF recommendations, as periodically updated;
   2. Immunizations that have in effect a recommendation, as periodically updated, from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) with respect to the individual involved;
   3. Evidence-informed preventive care and screening with respect to infants, children, and adolescents provided in the comprehensive guidelines, as periodically updated, supported by the Health Resources and Services Administration (HRSA);
   4. Additional preventive care and screenings for women not described in a) above as provided for in comprehensive guidelines supported by HRSA, as specified; and,
   5. Current USPSTF recommendations regarding breast cancer screening, mammography, and prevention. [HSC §1367.002 and INS §10112.2]
      
4. States that 3) above does not prohibit a health plan contract or insurance policy from providing coverage for services in addition to those recommended by USPSTF or denying coverage for services that are not recommended by USPSTF. [HSC §1367.002 and INS §10112.2]

This bill: Expands the requirement for colorectal cancer screening coverage without cost-sharing to include tests that are equivalent to those with a grade “A” or “B” assigned by USPSTF, or, in accordance with the most current recommendations established by another accredited or certified guideline agency, including the American Cancer Society and its guidelines.

FISCAL EFFECT:

This bill is keyed non-fiscal. However, this bill has been referred to the Senate Appropriations Committee should it pass out of this committee.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, colorectal cancer awareness isn't just a campaign; it's a call to action for early detection, proactive screenings, and empowering education. In 2023 there were more than 52,000 deaths from colorectal cancer. This bill will ensure that coverage for colorectal cancer screenings continue irrespective of litigation occurring in other states that jeopardizes this critical preventative care option. At 40 years young, a friend of mine was diagnosed with stage three colorectal cancer after losing many months fighting for his own health. Fortunately, he survived, but would not have without a screening. This is why continuing to cover colorectal cancer screening is so important.
   
2. USPSTF. The USPSTF was created in 1984, and is an independent, volunteer panel of national experts in prevention and evidence-based medicine. The USPSTF makes evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications. The USPSTF posts the final recommendation statement, final evidence review, and an evidence summary on its website. The recommendation statement and the evidence summary are also published in a peer-reviewed scientific journal.
3. Colorectal cancer background. According to the USPSTF recommendation statement published in the Journal of the American Medical Association on May 18, 2021, colorectal cancer is the third leading cause of cancer death for both men and women, with an estimated 52,980 persons in the U.S. projected to die of colorectal cancer in 2021. Colorectal cancer is most frequently diagnosed among persons aged 65 to 74 years. It is estimated that 10.5% of new colorectal cancer cases occur in persons younger than 50 years. Incidence of colorectal cancer (specifically adenocarcinoma) in adults aged 40 to 49 years has increased by almost 15% from 2000-2002 to 2014-2016. In 2016, 26% of eligible adults in the U.S. had never been screened for colorectal cancer, and in 2018, 31% were not up to date with screening. To update its 2016 recommendation, USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for colorectal cancer in adults 40 years or older. The review also examined whether these findings varied by age, sex, or race/ethnicity. In addition, as in 2016, USPSTF commissioned a report from the Cancer Intervention and Surveillance Modeling Network Colorectal Cancer Working Group to provide information from comparative modeling on how estimated life-years gained, colorectal cancer cases averted, and colorectal cancer deaths averted vary by different starting and stopping ages for various screening strategies. The USPSTF assessment of net benefit applies to stool-based tests with high sensitivity, colonoscopy, computed tomography (CT) colonography, and flexible sigmoidoscopy. The recommendation for screening for colorectal cancer does not include serum tests, urine tests, or capsule endoscopy for colorectal cancer screening because of the limited available evidence on these tests and because other effective tests (i.e., the recommended screening strategies) are available.
   
4. USPSTF updated recommendation. USPSTF assigns one of five letter grades (A, B, C, D, or I) which describe the strength of a recommendation. Grades A and B are recommended for practitioners, C should be selectively offered, D is not recommended, and I means there is insufficient evidence. USPSTF recommends: screening for colorectal cancer in all adults aged 50 to 75 years (“A” recommendation); screening for colorectal cancer in adults aged 45 to 49 years (“B” recommendation); and, that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years because evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient’s overall health, prior screening history, and preferences. (“C” recommendation)
   
5. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed AB 1986 (Gibson of 2020) and this bill. Key findings include:
   1. Assumptions. CHBRP assumes “accredited or certified guidelines” would equate to evidence-based guidelines, which are statements that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options. Screening tests or frequency of testing required to be covered would not include those that have very low-quality evidence.
   2. Tests and frequency.
      1. High-sensitivity guaiac fecal occult blood test (gFOBT) or fecal immunochemical test (FIT) every year.
      2. Stool DNA-FIT (sDNA-FIT) every one to three years.
      3. CT colonography every five years.
      4. Flexible sigmoidoscopy every five years.
      5. Flexible sigmoidoscopy every ten years + FIT every year.
      6. Colonoscopy screening every ten years.
   3. Other guidelines. CHBRP examined guidelines in February and March of 2024 from U.S.-based entities including the American College of Physicians, American College of Radiology, American Cancer Society, American College of Gastroenterology (and summarized by the American Academy of Family Physicians), American Gastroenterological Association, American Society of Clinical Oncology, National Comprehensive Cancer Network, and the U.S. Multi-Society Task Force. Recommendations from these guidelines are in line with the grade A/B USPSTF recommendations. There are no recommendations supported by high-quality evidence that are beyond what USPSTF currently recommends with an A or B grade. Should new guidelines from other organizations recommend screening that is more expansive than existing USPSTF guidelines, this bill would require plans and policies to newly cover, without cost-sharing, the specified colorectal cancer screening tests, including changes in frequency and age of recommended screening tests. For example, a March 2024 study describes a newly developed blood-based colorectal cancer screening. Should an organization such as the American Cancer Society determine there is enough evidence to recommend this new modality of colorectal cancer screening before the USPSTF reviews the evidence and makes a recommendation, this bill would require coverage without cost-sharing of this blood test.
   4. Litigation. Braidwood Management Inc. v. Becerra was brought forth by plaintiffs who

assert, among other points, that the requirements in the ACA for specific expert committees and a federal government agency to recommend covered preventive services are unconstitutional. “In September 2022, Texas U.S. District Court Judge Reed O’Connor ruled that the preventive service requirement for USPSTF recommendations was unconstitutional because the task force members are neither appointed by the President nor confirmed by the Senate, thereby violating the Appointments Clause.” The 5th Circuit Court of Appeals issued an administrative stay of the Texas U.S. District Court Judge’s 2022 ruling while the decision is being appealed. Oral arguments were heard by the 5th Circuit Court of Appeals in March 2024. Existing California law that requires coverage without cost-sharing of colorectal cancer screening tests is part of California’s larger preventive services mandate, which is largely modeled after the ACA preventive services mandate. Should future court decisions uphold a portion or all of the lower court’s ruling, federal and state governments may be prohibited from requiring health insurers to cover some or all preventive services as recommended by USPSTF.

1. New blood test. A new blood test to detect colorectal cancer has been developed and is under review by the federal Food and Drug Administration. This new test has shown promise in detecting cancer cells and may provide an option for early detection when a colonoscopy isn’t feasible. However, experts indicate that colonoscopies are still the gold standard which is the only way to identify and remove precancerous lesions that are not detectible in blood tests.
   
2. Related legislation. AB 2258 (Zbur) prohibits a group or individual, nongrandfathered health plan contract or insurance policy, from imposing a cost-sharing requirement for items or services integral to the provision of specified preventative care services and screenings. AB 2258 is pending in the Senate Rules Committee.
   
3. Prior legislation. AB 632 (Gibson of 2023) would have prohibited a health plan contract, except a specialized health plan contract, and a health insurance policy that is issued, amended, or renewed on or after January 1, 2024, from applying a deductible, copayment, or coinsurance to coverage for screening services for prostate cancer for certain high risk individuals, as specified. AB 632 was vetoed by the Governor who stated:

This bill would prohibit a health plan contract or insurance policy that is amended, renewed, or delivered on or after January 1, 2024, from applying a deductible, copayment, or coinsurance for prostate cancer screening services for an enrollee who is at a heightened risk of prostate cancer.

According to the California Health Benefits Review Program, approximately 97% of enrollees currently have coverage for prostate cancer screening without cost sharing and the remaining 3% pay an estimated $10 per screening. While the author's intent to increase prostate cancer screenings is commendable, this bill exceeds the cost sharing provisions under the Affordable Care Act (ACA). As such, this bill would result in increased costs to consumers through higher premiums. The State must weigh the potential benefits of all new mandates with the comprehensive costs to the entire delivery system.

AB 342 (Gipson, Chapter 436, Statutes of 2021) requires health plan contracts and health insurance policies to provide coverage without any cost sharing for a colorectal cancer screening test assigned either a grade of A or B by USPSTF, including when a colonoscopy is required after a positive result on a test or procedure that is a colorectal cancer screening or laboratory test assigned either a grade of A or B by USPSTF.

SB 406 (Pan, Chapter 302, Statutes of 2020), among other provisions, codifies the specific provisions of the ACA prevention services mandate in California law.

AB 1986 (Gibson of 2020) is substantially similar to AB 342. AB 1986 was not heard because of the COVID-19 pandemic.

AB 1763 (Gibson of 2016) would have required health plan and health insurance coverage, without cost sharing, for specified colorectal cancer screening examinations and laboratory tests for individuals at average risk, and would have required coverage for additional colorectal cancer screening examinations, without cost-sharing, for individuals at high risk, and prohibited the imposition of cost sharing on colonoscopies, including the removal of polyps, for an enrollee who is between 50 and 75 years of age and has received a positive test. AB 1763 was vetoed by the Governor, who stated:

This bill imposes a no cost-sharing mandate on health plans and insurance policies for colorectal cancer screening services that exceeds the requirements of the federal Affordable Care Act.

I understand the importance of preventative health care services, and in particular, screening for various types of cancer. I believe, however, the cost-sharing rules for these services as set in the Affordable Care Act are sufficient. Moreover, creating a no cost-sharing rule for colorectal cancer sets it apart from all other cancers and contributes to increasing everyone's health care costs.

1. Support. California Life Sciences writes that with this bill Californians will have increased access to colorectal cancer screenings that can potentially save their lives – or at least catch the cancer early enough to save the cost of the most expensive and arduous late-stage treatments. National Health Law Program (NHeLP) writes that this is a preventive measure aimed at ensuring that all people have access to affordable preventive colorectal cancer screening without cost as a barrier. Death from colorectal cancer has dropped significantly over the last decade, especially for individuals over age 50, which is largely attributed to increased access to screening. Nevertheless, colorectal cancer rates are on the rise among younger people and Black people in particular are being diagnosed with colorectal cancer at younger ages, and with more advanced disease. Thus, access to screening is particularly important for these populations to reducing the morbidity associated with the disease: colorectal polyps found by screening can be removed before they can develop into cancers and screening can find cancers earlier, when they are likely to be easier to treat. Ensuring that Californians have access to medically, indicated screening at no cost is important to making screening accessible, especially to those with an increased risk of colorectal cancers. NHeLP also raises concerns about the potential of the state having to defray Essential Health Benefit costs under the ACA based on the outcome of Braidwood.
   
2. Opposition. The California Association of Health Plans, Association of California Life and Health Insurance Companies, and America’s Health Insurance Plans write to oppose this bill because it is one of 14 health insurance mandate bills that will increase costs, reduce choice and competition, and further incent some employers and individuals to avoid state regulation by seeking alternative coverage options. Benefit mandates impose a one-size-fits-all approach to medical care and benefit design driven by the legislature rather than consumer choice. These bills will lead to higher premiums, harming affordability and access for small businesses and individual market consumers. These opponents urge legislators to also consider the cumulative impacts of these mandates on premiums and access to coverage. All of these bills will increase costs and limit employer flexibility. The Legislature created the Office of Health Care Affordability to contain cost drivers. With this office in place and the state budget deficit, the Legislature should take a wait-and-see approach when considering costly mandates.
3. Policy comments and questions.
   1. USPSTF is an independent, volunteer panel of national experts tasked with making evidence-based recommendations about clinical preventive services. It’s not clear why the recommendations from USPSTF are not sufficient to guide commercial health insurance coverage and cost-sharing for colorectal cancer screening as is the case for other preventive screening under the ACA. This bill would allow any accredited or certified guideline agency to dictate colorectal cancer screening without cost-sharing, making the USPSTF recommendations irrelevant.
   2. What is meant by “accredited or certified guideline agency?” This bill includes the American Cancer Society as an example of “an accredited or certified guideline agency” but it is not clear if the American Cancer Society is accredited or certified as a guideline agency. It appears that the American Cancer Society instead develops consensus guidelines. According to CHBRP, when the evidence is very limited or of very low quality, some guideline panels rely primarily on clinical experience and process is consensus-based. It may be possible that other “accredited or certified” organizations could develop recommendations that are not consistent with nationally recognized standards of care but would result in coverage and cost-sharing requirements on health plans and insurers. This could result in significant premium impacts for employers and families who purchase health coverage.
   3. California law already codifies the ACA preventive services mandate as well as includes a consistent mandate specific to colorectal screening so there is no need to reinforce California law further pending Braidwood. It is highly unlikely that a court decision to strike a federal law would result in “preemption” of a state law that is not linked to the federal law.
      

SUPPORT AND OPPOSITION:

Support: California Life Sciences

California Medical Association

National Health Law Program

Oncology Nursing Society

Oppose: America’s Health Insurance Plans

Association of California Life and Health Insurance Companies

California Association of Health Plans

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 3245

Author:(Joe Patterson)

As Introduced Ver:February 16, 2024

Majority vote

SUMMARY

Expands existing law to require a health plan contract and insurance policy to provide coverage without cost sharing for a colorectal cancer (CRC) screening test assigned either a grade of "A" or a grade of "B", or equivalent, in accordance with the most current recommendations established by another accredited or certified guideline agency, including the American Cancer Society and its guidelines. Requires the colonoscopy for a positive result on a test or procedure that is a CRC screening examination or laboratory test assigned either a grade of A or a grade of B, or equivalent in accordance with the most current recommendations established by another accredited or certified guideline agencies to also be provided without any cost sharing.

Major Provisions

COMMENTS

According to the California Health Benefits Review Program (CHBRP), CRC is cancer that occurs in either the colon or rectum. Most CRCs arise from abnormal growth in the linings of the large bowel that take 10 to 15 years on average to progress to cancerous tissues. In California, CRC is the third leading cause of cancer death for women and men. For women, the first and second leading causes are lung and breast cancers, respectively; for men, the top two are lung and prostate cancer. CRC is known as a "silent killer" since individuals with the disease tend to remain asymptomatic during early stages, resulting in a larger proportion of late-stage diagnoses; survival declines to 71% and 14% for patients diagnosed with regional and distant metastases, respectively. Although CRC is sometimes observed in younger adults, an individual's risk for large bowel cancers increases rapidly after age 50 years. The U.S. Preventive Services Task Force (USPSTF) found little evidence for increased benefit of screenings above the age of 75 years. Accordingly, USPSTF recommends routine screening for all asymptomatic adults between the ages of 50 and 75 years who have an average risk of colorectal cancer based on their genetic and medical history. There are only two CRC screening strategies (Fecal Occult Blood Test and flexible sigmoidoscopy) that have been shown in randomized controlled trials to reduce CRC mortality. The USPSTF does not explicitly recommend any specific screening strategy for CRC, and instead provides information regarding efficacy, suggested screening intervals, and other considerations.

1. Patient Protection and Affordable Care Act (ACA) Preventive Care litigation. On March 30, 2023, a federal court in Texas struck down protections for preventive care benefits under the ACA in Braidwood Management Inc. v. Becerra. If Braidwood is upheld by the Supreme Court, elimination of the coverage requirements for USPSTF recommendations would invalidate the requirement to cover all of these services without cost sharing. California law, however, will still require coverage of recommended preventive care benefits (pursuant to AB 406 (Pan), Chapter 302, Statutes of 2020). One of the reasons preventive care was included in the ACA was because research showed that cost-sharing, even in small amounts, reduces the likelihood that people use preventive services. Millions of people each year report delaying or forgoing needed health care due to costs. The USPSTF is a group of independent experts that use a rigorous evidence-based process to review research, weighing both the benefits and risks of services. In the ACA, the preventive care coverage mandate was tied to recommendations by the USPSTF and other groups as a way of having a standard definition of what preventive care means, including changes over time as new evidence becomes available.
2. USPSTF Draft Recommendations. In 2020, the USPSTF proposed draft recommendations that replace the 2016 USPSTF recommendation on screening for CRC. In 2016, the USPSTF recommended screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A grade recommendation). In addition, the USPSTF concluded that the decision to screen for CRC in adults ages 76 to 85 years should be an individual one, taking into account the patient's overall health and prior screening history (C grade recommendation), and that screening should be discontinued after age 85 years. The current recommendation, while continuing to recommend CRC screening in adults ages 50 to 75 years, now recommends offering screening at age 45 years (B grade recommendation). As it did in 2016, the USPSTF continues to conclude that screening in adults ages 76 to 85 years should be an individual one (C grade recommendation) and screening should be discontinued after age 85 years. As of 2021, the USPSTF issued its final recommendation statement.
3. 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's analysis of this bill includes the following:
   1. No change in benefit. CHBRP determined that this bill would not result in a change of benefit coverage based on currently established recommendations for CRC screening tests, and there would be no impact in the first year postmandate of this bill as introduced. However, should there be new evidence-based guidelines or newly recommended screening test(s) that are different from those currently recommended by the USPSTF, health plans in California would be required to cover these newly specified tests without cost sharing. In such circumstances, these would potentially result in changes to the utilization of these screening tests and potential changes in health care expenditures. CHBRP assumes relevant evidence-based guidelines would not need to use an A/B rating as the USPSTF does, although it is possible to interpret the language of this bill as requiring such. This bill adds the requirement to cover without cost sharing CRC screening tests identified by accredited or certified guideline agencies, including the American Cancer Society and its guidelines.
   2. Ambiguities and Assumptions Regarding Bill Language. CHBRP makes the following assumptions regarding the bill language of this bill as introduced:
      1. "Accredited or certified guidelines" would equate to evidence-based guidelines, which are statements that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options; and,
      2. Screening tests or frequency of testing required to be covered would not include those that have very low-quality evidence. It is possible to interpret this bill language as requiring other guidelines to also use an A/B rating scale when evaluating evidence, but an A/B rating is not a universal measure for determining the strength of evidence-based recommendations.

CHBRP examined guidelines from US-based entities including the American College of Physicians, American College of Radiology, American Cancer Society, American College of Gastroenterology (and summarized by the American Academy of Family Physicians), American Gastroenterological Association, American Society of Clinical Oncology, National Comprehensive Cancer Network, and the US Multi-Society Task Force. Recommendations from these guidelines are in line with the grade A/B USPSTF recommendations. There are no recommendations supported by high-quality evidence that are beyond what USPSTF currently recommends with an A or B grade.

1. Recent innovations. A recent NY Times article (article), noted early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73%. Just 50 to 75% of middle-aged and older adults who should be screened regularly are being tested. There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test. A blood test is on the horizon. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. About 53,000 Americans are expected to die from CRC this year. It is the second-most common cause of cancer-related deaths in the United States, and while the death rate in older adults has fallen, it has increased in people under age 55. The article notes that the problem is convincing more people to be screened. The blood test takes advantage of the discovery that colon cancers and large polyps — clumps of cells on the lining of the colon that occasionally turn into cancers — shed fragments of DNA into the blood. A study this year in the New England Journal of Medicine found that a blood test searching for such DNA called Shield and made by the company Guardant Health detected 87% of cancers that were at an early and curable stage. The false positive rate was 10%. While the blood test detects cancers, it misses most large polyps, finding just 13% of them. In contrast, the fecal test detects 43% and a colonoscopy finds 94%. While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming. In particular, doctors need to understand that while this test helps detect cancer early, it does not prevent it because it is not good at finding precancerous polyps. Doctors will also need to explain to patients that if the blood test result is abnormal, they will have to schedule a colonoscopy to look for polyps or early-stage cancers and remove them if they are present. The article states that it is also not clear how often people should do the blood test. Guardant suggested every three years but that recommendation is not well established. The big unknown is cost. Guardant has applied to the U.S. Food and Drug Administration (FDA) for approval to market the test. The company sells it now as a "lab-based test," which does not require FDA approval but is also not covered by health insurance. For those who want to pay out of pocket, the price is $895. The Cologuard fecal test costs $581 to $681. Colonoscopies, usually needed half as often, typically cost $1,250 to $4,800, although some hospitals charge more. The average cost of a colonoscopy in the United States is $2,750. These tests are typically covered by insurance.

According to the Author

CRC awareness is not just a campaign; it is a call to action for early detection, proactive screenings, and empowering education. In 2023, there were more than 52,000 deaths from CRC. This bill will ensure that coverage for CRC screenings continue irrespective of litigation occurring in other states that jeopardizes this critical preventative care option. At 40 years young, a friend of the author was diagnosed with stage 3 CRC after many months fighting for his own health. Fortunately, he survived, but would not have without a screening. The author concludes this is why continuing to cover CRC screening is so important.

Arguments in Support

The California Life Sciences (CLS) writes CRC is the third most common cancer diagnosed in both men and women each year in the United States, excluding skin cancer. In 2023, over 153 thousand adults in the United States were diagnosed with CRC. These numbers included over 106 thousand new cases of colon cancer and over 46 thousand new cases of rectal cancer. Over 50,000 deaths from this disease occurred in the United States last year. However, when CRC is found early, it can often be cured. The death rate from this type of cancer in 2020 in the United States was 57% less than what it was in 1970. CLS states this is due to improvements in treatment and increased screening, which detects colorectal changes before they turn cancerous.

Arguments in Opposition

The California Association of Health Plans (CAHP), the Association of California Life and Health Insurance Companies (ACLHIC), and America's Health Insurance Plans (AHIP) oppose mandates for health plans and insurers to cover specific services, as well as bills that eliminate cost sharing and limit utilization management, which have similar cost impacts as coverage mandates. Moreover, they will increase costs, reduce choice and competition, and further incent some employers and individuals to avoid state regulation by seeking alternative coverage options. These bills will lead to higher premiums, harming affordability and access for small businesses and individual market consumers. CAHP, ACLHIC, and AHIP write that state mandates increase costs of coverage, especially for families who buy coverage without subsidies, small business owners who cannot or do not wish to self-insure, and California taxpayers who foot the bill for the state's share of those mandates.

FISCAL COMMENTS

None.

VOTES

ASM HEALTH: 16-0-0

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Sanchez, Santiago, Schiavo, Weber

UPDATED

VERSION: February 16, 2024

CONSULTANT: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0002784

Date of Hearing: April 23, 2024

ASSEMBLY COMMITTEE ON HEALTH

Mia Bonta, Chair

ABPCA Bill Id:AB 3245 (

Author:(Joe Patterson) – As Introduced Ver:February 16, 2024

SUBJECT: Coverage for colorectal cancer screening.

SUMMARY: Expands existing law to require a health plan contract and insurance policy to provide coverage without cost sharing for a colorectal cancer (CRC) screening test assigned either a grade of “A” or a grade of “B” by other accredited or certified guideline agencies, including the American Cancer Society and its guidelines. Requires the required colonoscopy for a positive result on a test or procedure that is a CRC screening examination or laboratory test identified assigned either a grade of A or a grade of B by other accredited or certified guideline agencies to also be provided without any cost sharing.

EXISTING LAW:

1. Establishes the Department of Managed Health Care to regulate health plans under the Knox-Keene Health Care Service Plan Act of 1975 and the California Department of Insurance to regulate health insurers. [Health and Safety Code (HSC) § 1340, et seq., and (Insurance Code (INS) § 106, et seq.]
2. Establishes as California's essential health benefits (EHBs) benchmark under the federal Patient Protection and Affordable Care Act (ACA), the Kaiser Small Group Health Maintenance Organization contract, existing California health insurance mandates, and the 10 ACA mandated benefits. [HSC § 1367.005 and INS § 10112.27]
3. Defines “basic health care services” as all of the following:
   1. Physician services, including consultation and referral;
   2. Hospital inpatient services and ambulatory care services;
   3. Diagnostic laboratory and therapeutic radiologic services;
   4. Home health services;
   5. Preventive health services;
   6. Emergency health care services; and,
   7. Hospice care, as specified. [HSC § 1345]
4. Codifies the federal ACA provisions, in state law, to require a group or individual non-grandfathered health insurance policy to, at a minimum, provide coverage for and not impose any cost-sharing requirements for all of the following:
   1. Evidence-based items or services that have in effect a rating of “A” or “B” in the recommendations of the U.S. Preventive Services Task Force (USPSTF), as periodically updated;
   2. Immunizations that have in effect a recommendation, as periodically updated, from the Advisory Committee on Immunization Practices of the federal 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 in the comprehensive guidelines, as periodically updated, supported by the United States Health Resources and Services Administration (HRSA);
   4. With respect to women, those additional preventive care and screenings as provided for in comprehensive guidelines supported by HRSA; and,
   5. Requires the current recommendations of the USPSTF regarding breast cancer screening, mammography, and prevention to be considered the most current other than those issued in or around November 2009. [HSC §1367.002 and INS §10112.2]
5. Requires a health plan contract or a health insurance policy, except as specified, that is issued, amended, or renewed on or after January 1, 2022, to provide coverage for a CRC screening test assigned either a grade of A or a grade of B by the USPSTF, and requires the colonoscopy for a positive result on a test or procedure identified assigned either a grade of A or a grade of B by the USPSTF to be provided without cost sharing, unless the underlying test or procedure was a colonoscopy. [HSC §1367.668 and INS §10123.207]

FISCAL EFFECT: None.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, CRC awareness is not just a campaign; it is a call to action for early detection, proactive screenings, and empowering education. In 2023, there were more than 52,000 deaths from CRC. This bill will ensure that coverage for CRC screenings continue irrespective of litigation occurring in other states that jeopardizes this critical preventative care option. At 40 years young, a friend of the author was diagnosed with stage 3 CRC after many months fighting for his own health. Fortunately, he survived, but would not have without a screening. The author concludes this is why continuing to cover CRC screening is so important.
2. BACKGROUND. According to the California Health Benefits Review Program (CHBRP), CRC is cancer that occurs in either the colon or rectum. Most CRCs arise from abnormal growth in the linings of the large bowel that take 10 to 15 years on average progress to cancerous tissues. In California, CRC is the third leading cause of cancer death for women and men. For women, the first and second leading causes are lung and breast cancers, respectively; for men, the top two are lung and prostate cancer. CRC is known as a "silent killer" since individuals with the disease tend to remain asymptomatic during early stages, resulting in a larger proportion of late-stage diagnoses; survival declines to 71% and 14% for patients diagnosed with regional and distant metastases, respectively. Although CRC is sometimes observed in younger adults, an individual's risk for large bowel cancers increases rapidly after age 50 years. The USPSTF found little evidence for increased benefit of screenings above the age of 75 years. Accordingly, USPSTF recommends routine screening for all asymptomatic adults between the ages of 50 and 75 years who have an average risk of colorectal cancer based on their genetic and medical history. There are only two CRC screening strategies (Fecal Occult Blood Test (FOBT) and flexible sigmoidoscopy) that have been shown in randomized controlled trials to reduce CRC mortality. The USPSTF does not explicitly recommend any specific screening strategy for CRC, and instead provides information regarding efficacy, suggested screening intervals, and other considerations.
   
   1. ACA Preventive Care litigation. On March 30, 2023, a federal court in Texas struck down protections for preventive care benefits under the ACA in Braidwood Management Inc. v. Becerra. If Braidwood is upheld by the Supreme Court, elimination of the coverage requirements for USPSTF recommendations would invalidate the requirement to cover all of these services without cost sharing. California law, however, will still require coverage of recommended preventive care benefits (pursuant to AB 406 (Pan), Chapter 302, Statutes of 2020). One of the reasons preventive care was included in the ACA was because research showed that cost-sharing, even in small amounts, reduces the likelihood that people use preventive services. Millions of people each year report delaying or forgoing needed health care due to costs. The USPSTF is a group of independent experts that use a rigorous evidence-based process to review research, weighing both the benefits and risks of services. In the ACA, the preventive care coverage mandate was tied to recommendations by the USPSTF and other groups as a way of having a standard definition of what preventive care means, including changes over time as new evidence becomes available.
   2. USPSTF Draft Recommendations. In 2020, the USPSTF proposed draft recommendations that replace the 2016 USPSTF recommendation on screening for CRC. In 2016, the USPSTF recommended screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A grade recommendation). In addition, the USPSTF concluded that the decision to screen for CRC in adults ages 76 to 85 years should be an individual one, taking into account the patient’s overall health and prior screening history (C grade recommendation), and that screening should be discontinued after age 85 years. The current recommendation, while continuing to recommend CRC screening in adults ages 50 to 75 years, now recommends offering screening at age 45 years (B grade recommendation). As it did in 2016, the USPSTF continues to conclude that screening in adults ages 76 to 85 years should be an individual one (C grade recommendation) and screening should be discontinued after age 85 years. As of 2021, the USPSTF issued its final recommendation statement.
   3. 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 EHBs, and legislation that impacts health insurance benefit designs, cost sharing, premiums, and other health insurance topics. CHBRP’s analysis of this bill includes the following:
      1. No change in benefit. CHBRP determined that this bill would not result in a change of benefit coverage based on currently established recommendations for CRC screening tests, and there would be no impact in the first year postmandate of this bill as introduced. However, should there be new evidence-based guidelines or newly recommended screening test(s) that are different from those currently recommended by the USPSTF, health plans in California would be required to cover these newly specified tests without cost sharing. In such circumstances, these would potentially result in changes to the utilization of these screening tests and potential changes in health care expenditures. CHBRP assumes relevant evidence-based guidelines would not need to use an A/B rating as the USPSTF does, although it is possible to interpret the language of this bill as requiring such. This bill adds the requirement to cover without cost sharing CRC screening tests identified by accredited or certified guideline agencies, including the American Cancer Society and its guidelines.
      2. Ambiguities and Assumptions Regarding Bill Language. CHBRP makes the following assumptions regarding the bill language of this bill as introduced:
         1. “Accredited or certified guidelines” would equate to evidence-based guidelines, which are statements that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options; and,
         2. Screening tests or frequency of testing required to be covered would not include those that have very low-quality evidence. It is possible to interpret this bill language as requiring other guidelines to also use an A/B rating scale when evaluating evidence, but an A/B rating is not a universal measure for determining the strength of evidence-based recommendations.

CHBRP examined guidelines from US-based entities including the American College of Physicians, American College of Radiology, American Cancer Society, American College of Gastroenterology (and summarized by the American Academy of Family Physicians), American Gastroenterological Association, American Society of Clinical Oncology, National Comprehensive Cancer Network, and the US Multi-Society Task Force. Recommendations from these guidelines are in line with the grade A/B USPSTF recommendations. There are no recommendations supported by high-quality evidence that are beyond what USPSTF currently recommends with an A or B grade.

• 1. Recent innovations. A recent NY Times article (article), noted early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73%. Just 50 to 75% of middle-aged and older adults who should be screened regularly are being tested. There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test. A blood test is on the horizon. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. About 53,000 Americans are expected to die from CRC this year. It is the second-most common cause of cancer-related deaths in the United States, and while the death rate in older adults has fallen, it has increased in people under age 55. The article notes that the problem is convincing more people to be screened. The blood test takes advantage of the discovery that colon cancers and large polyps — clumps of cells on the lining of the colon that occasionally turn into cancers — shed fragments of DNA into the blood. A study this year in the New England Journal of Medicine found that a blood test searching for such DNA called Shield and made by the company Guardant Health detected 87% of cancers that were at an early and curable stage. The false positive rate was 10%. While the blood test detects cancers, it misses most large polyps, finding just 13% of them. In contrast, the fecal test detects 43% and a colonoscopy finds 94%. While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming. In particular, doctors need to understand that while this test helps detect cancer early, it does not prevent it because it is not good at finding precancerous polyps. Doctors will also need to explain to patients that if the blood test result is abnormal, they will have to schedule a colonoscopy to look for polyps or early-stage cancers and remove them if they are present. The article states that it is also not clear how often people should do the blood test. Guardant suggested every three years but that recommendation is not well established. The big unknown is cost. Guardant has applied to the U.S. Food and Drug Administration (FDA) for approval to market the test. The company sells it now as a “lab-based test,” which does not require FDA approval but is also not covered by health insurance. For those who want to pay out of pocket, the price is $895. The Cologuard fecal test costs $581 to $681. Colonoscopies, usually needed half as often, typically cost $1,250 to $4,800, although some hospitals charge more. The average cost of a colonoscopy in the United States is $2,750. These tests are typically covered by insurance.

1. SUPPORT. The California Life Sciences (CLS) writes CRC is the third most common cancer diagnosed in both men and women each year in the United States, excluding skin cancer. In 2023, over 153 thousand adults in the United States were diagnosed with CRC. These numbers included over 106 thousand new cases of colon cancer and over 46 thousand new cases of rectal cancer. Over 50,000 deaths from this disease occurred in the United States last year. However, when CRC is found early, it can often be cured. The death rate from this type of cancer in 2020 in the United States was 57% less than what it was in 1970. CLS states this is due to improvements in treatment and increased screening, which detects colorectal changes before they turn cancerous.
2. OPPOSITION. The California Association of Health Plans (CAHP), the Association of California Life and Health Insurance Companies (ACLHIC), and America’s Health Insurance Plans (AHIP) oppose mandates for health plans and insurers to cover specific services, as well as bills that eliminate cost sharing and limit utilization management, which have similar cost impacts as coverage mandates. Moreover, they will increase costs, reduce choice and competition, and further incent some employers and individuals to avoid state regulation by seeking alternative coverage options. These bills will lead to higher premiums, harming affordability and access for small businesses and individual market consumers. CAHP, ACLHIC, and AHIP write that state mandates increase costs of coverage, especially for families who buy coverage without subsidies, small business owners who cannot or do not wish to self-insure, and California taxpayers who foot the bill for the state’s share of those mandates.
3. RELATED LEGISLATION. AB 2258 (Zbur) prohibits a group or individual nongrandfathered health plan contract or insurance policy from imposing a cost-sharing requirement for items or services integral to the provision of specified preventative care services and screenings. AB 2258 passed this Committee on a vote of 13-0 on April 9, 2024 and is now pending hearing in the Assembly Appropriations Committee.
4. PREVIOUS LEGISLATION.
   1. AB 342 (Gipson), Chapter 436, Statutes of 2021, requires a health plan contract or a health insurance policy, except as specified, that is issued, amended, or renewed on or after January 1, 2022, to provide coverage for a colorectal cancer screening test, and would require the required colonoscopy for a positive result on a test or procedure to be provided without cost sharing, unless the underlying test or procedure was a colonoscopy.
   2. SB 406 (Pan), Chapter 302, Statutes of 2020, codifies existing ACA law into state law that prohibits lifetime or annual limits in health plan and health insurance policies and requires coverage of preventative health services without cost sharing.
      
5. PROPOSED AMENDMENTS. To address assumptions raised by CHBRP regarding current bill drafting, the Committee recommends the following amendment:

…out any cost sharing for a colorectal cancer screening test assigned either a grade of A or a grade of B by the United States Preventive Services Task Force. Force or in accordance with recommendations established by other accredited or certified guideline agency, including the American Cancer Society and its guidelines

REGISTERED SUPPORT / OPPOSITION:

Support

California Life Sciences

National Health Law Program
Oncology Nursing Society

Opposition

America's Health Insurance Plans (AHIP)

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