Existing law, the Real Estate Appraisers Licensing and Certification Law, provides for the licensure and regulation of real estate appraisers and vests the duty of enforcing and administering that law in the Bureau of Real Estate Appraisers within the Department of Consumer Affairs. Existing law requires an appraisal management company, as defined, to register with the bureau. Existing law requires the Chief of the Bureau of Real Estate Appraisers to adopt regulations governing the process and procedure of registration that require, at minimum, among other things, the business address and telephone number of the person or entity seeking registration.

This bill would additionally require that those regulations include the email address of the person or entity seeking registration.

Date of Hearing: May 11, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 2764

Author:(Bonilla) – As Amended Ver:March 18, 2016

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

SUMMARY:

This bill requires coverage of mammography by health plans and insurers to include digital mammography and digital breast tomosynthesis (DBT).

FISCAL EFFECT:

1. According to the California Health Benefits Review Program (CHBRP):
   1. Costs to Medi-Cal of $12.8 million (GF/federal), and costs to CalPERS of $1.4 million (GF/federal/special/local).
   2. Increased employer-funded premium costs in the private insurance market of approximately $17.8 million.
   3. Increased premium expenditures by employees and individuals purchasing insurance of $18.3 million, and reduced total out-of-pocket expenses of $10.8 million (based on $11.7 million in newly covered benefits, offset by cost-sharing of $0.9 million).
2. CHBRP also notes utilization of DBT and related costs may grow further in future years. CHBRP only estimates costs for a 12-month period post-mandate. With an estimated two-thirds of machines DBT-ready in 2017, CHBRP projections assume an increase of the portion of digital mammograms accompanied by DBTs - from near 30% to near 50%.  In future years, as more DBT-ready machines become available, DBTs could accompany as many as 90% of digital mammograms. 

This increased utilization appears to suggest costs could be higher than noted here within one to two years after the projection horizon, but CHBRP costs beyond the first year are difficult to estimate due to changing breast cancer screening and treatment technology. CHBRP also assumes DBT is provided without cost-sharing, as it is a preventive screening test.

1. Ongoing costs of $480,000 to the Department of Managed Care (DMHC) for an expected increase in complaints and independent medical reviews based on denial of coverage due to questions of medical necessity. (Managed Care Fund).
2. Minor costs to the California Department of Insurance (Insurance Fund) and DMHC, (Managed Care Fund) to verify health plans and insurers comply with this requirement.

COMMENTS:

1. Purpose. According to the author, patients are being billed for DBT since health plans are not providing coverage on the basis that DBT is investigational. The sponsor of this bill, the California Radiological Society, states the use of DBT in addition to two-dimensional (2D) mammography will detect more cancers early on, reduce false positives, and help reduce health care costs associated with high recall rates as well as false positives.
2. Background. Mammography provides an x-ray picture of the breast, and can be conducted as a screening or diagnostic test. As a screening test, its purpose is to identify potentially cancerous abnormalities in asymptomatic women. As a diagnostic test, it further investigates identified abnormalities or checks for abnormalities among women previously treated for breast cancer. DBT takes multiple cross-sectional images of the breast and then uses a computer algorithm to reconstruct a three-dimensional image. Digital mammography is frequently used as a breast cancer screening test. Less frequently, DBT is added to digital mammography when screening for breast cancer.
3. Current coverage guidelines and Essential Health Benefits (EHBs). The federal Affordable Care Act (ACA) requires health plans in the individual and small-group markets to cover ten types of health benefits, called EHBs. EHBs include preventive services without cost-sharing, for all preventive services given a high grade of evidence by the United States Preventive Services Task Force (USPSTF), an independent, volunteer panel of national experts in prevention and evidence-based medicine. Mammography is recommended by USPSTF for certain women and is covered with no cost-sharing.

For any new state mandate that exceeds EHBs as defined in the ACA, the state must make payments to defray the cost of those additionally mandated benefits, either by paying the covered individual or employer directly, or by paying the plan. Although this mandate requires coverage of DBT, which is currently not covered by some plans, DBT is a form of mammography. Since mammography is already required to be covered, CHBRP indicates this bill does not appear to exceed EHBs and therefore poses no additional fiscal risk to the state associated with exceeding EHBs.

1. Screening results in benefits and harms. It is important to understand that while screening is beneficial for women whose cancer is detected early, it can also cause harm. USPSTF recommendations, for example, are based on an assessment of net benefit—identified benefits minus identified harms. Routine screening is intended to catch the development of disease early enough for treatment to be beneficial. However, screening can lead to harms such as incorrect diagnosis; unnecessary diagnostic tests and treatment; anxiety, psychological harm, and lost productivity; and unnecessary radiation exposure from the X-rays used in mammography. On balance, routine screening is usually recommended for a population if the benefits (like early detection of dangerous and treatable cancers) outweigh the harms.
2. Breast cancer screening recommendations. There is consensus on the benefit of screening mammography from many nationally recognized groups. CHBRP states clinical guidelines from the American Academy of Family Physicians (AAFP), American Congress of Obstetrics and Gynecology (ACOG), American College of Radiology (ACR), American Cancer Society (ACS), National Comprehensive Cancer Network (NCCN), and USPSTF all recommend mammography for breast cancer screening. Mammography is also used in diagnosis, to follow up on a clinical finding or a screening mammogram.

Currently, there are no clinical guidelines recommending the use of DBT for breast cancer screening or diagnosis. The ACR has found that DBT is no longer an investigational modality and “improves key screening parameters compared to digital mammography,” but October 2015 ACS guidelines, as well as recommendations from AAFP, ACOG, NCCN, and USPSTF have cited insufficient evidence to recommend the use of DBT as a screening tool for breast cancer. The recent USPSTF and ACS recommendations on breast cancer screening were based on systematic evidence reviews by experts.

In sum, CHBRP finds this bill appears to increase costs and utilization of screening tests with little evidence of meaningful clinical benefits, such as improvements in morbidity, disease-free survival, or mortality.

1. Support. The California Radiological Society, the sponsor of this bill, contends this mandate ensures coverage of the state of the art in breast cancer screening and diagnosis, DBT offers higher accuracy and lower call-backs, and higher accuracy will lower costs overall. They state DBT allow radiologists to identify small cancers at an earlier stage while they are more treatable. They note a number of independent medical reviews have overturned plan decisions to deny coverage for DBT.
2. Opposition. Health plans and insurers, as well as the California Chamber of Commerce, oppose this bill. Plans state the USPSTF has specifically stated it does not support the blanket use of DBT because studies have not demonstrated an improvement in patient outcomes, a decrease in the occurrence of disease, or a decrease in the amount of treatment. They also state more generally that mandates raise premiums at a time when health care affordability is a significant issue for families.

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

Date of Hearing: April 19, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2764

Author:(Bonilla) – As Amended Ver:March 18, 2016

SUBJECT: Health care coverage: mammography.

SUMMARY: Requires health care service plans (health plans) and disability insurance or self-insured employee welfare benefit plans to provide coverage for digital mammography and breast tomosynthesis under mammography services.

EXISTING LAW:

1. Establishes the Department of Managed Health Care (DMHC) to regulate health plans and the California Department of Insurance (CDI) to regulate health insurers.
   
2. Requires health plans and insurers providing health coverage in the individual and small group markets to cover, at a minimum, essential health benefits (EHBs), including the ten EHB benefit categories in the Patient Protection and Affordable Care Act (ACA), and consistent with California’s EHB benchmark plan, the Kaiser Foundation Health Plan Small Group HMO 30 plan (Kaiser benchmark), as specified in state law.
3. Identifies EHBs in the following 10 categories: ambulatory patient services, emergency services, hospitalization, maternity and newborn care, mental health and substance use disorder services, including behavioral health treatment, prescription drugs, rehabilitative and habilitative services and devices, laboratory services, preventive and wellness services and chronic disease management, and pediatric services, including oral and vision care.
4. Identifies mammography as an EHB under laboratory services and preventive and wellness services and chronic disease management provides for mammography for screening and diagnostic purposes upon referral by a participating nurse practitioner, certified nurse-midwife, physician assistant, or physician providing care to the patient.
5. Provides for Independent Medical Review when a health plan denies coverage on the basis that a service is experimental or investigational.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, currently, patients are being billed for Digital Breast Tomosynthesis (DBT) since health plans are not providing coverage on the basis that DBT is investigational. The author states that the use of DBT in addition to two-dimensional (2D) mammography which will detect more cancers early on, reduce false positives, and help reduce health care costs associated with false positives. This bill ensures that all women have access to the best possible breast cancer detection technologies. Breast cancer is the second leading cause of cancer death in American women. While mammography has increased, the early detection of breast cancer, there is still a high rate of false positives. On average, a false-positive result costs the patient or the health plan an additional $1,025. Radiologists are choosing to use DBT in addition to 2D mammography because it reduces false-positives and also detects smaller tumors earlier.
   
   Additionally, the author notes that mammograms are the best method of detecting breast cancer. Most women over 40 years old receive 2D mammograms annually. Women at high risk for breast cancer often get mammograms beginning at 30 years of age. For a 2D mammogram, images are taken from the front and the side of the breasts. However, dense breast tissue (places where normal breast tissue overlaps), decreases the visibility of tumors and increases the likelihood of false-positive results. Between 15-30% of cancers are not detected with a standard 2D mammogram. The percentage is even higher in women younger than 50 years old who have dense breast tissue. When DBT is used in addition to 2D mammography, the rate of cancer detection increases by 10-54% and the rate of false-positives decreases between 15-37% compared to when 2D mammography is used alone. The author notes that DBT is always used in addition to 2D mammography and does increase the amount of radiation; however, the sponsor of this bill states it is still a very minimal amount. According to the California Radiological Society, newer technology will be available in a few months that will allow the 2D mammogram images to be created from the DBT data. This would cut the radiation exposure in half and the amount would be equal to the radiation exposure from a traditional 2D mammogram. Additionally, women are exposed to further radiation when they are called back for another screening. If it was a false-positive, that is completely unnecessary additional exposure to radiation. Since increasing the use of DBT reduces false-positives and callbacks, it also protects women from that additional radiation exposure.
   
   Based on the Centers for Medicare and Medicaid Services (CMS) payment rates, DBT costs only an additional $56 per visit. If a patient must return for an additional screening after a 2D mammogram results in a false-positive, doctors often perform a biopsy or ultrasound to determine if there is a tumor present. Among recalled women, the average cost for additional testing was $1,205. Overall, the cost savings worked out to $28 per woman screened, or $0.20 savings per member per month across the plan population, and an overall cost savings of $550 million per year for the plan. Using DBT at the women's annual preventative screening will save both patients and health plans money, undue worry, and time.
   
2. BACKGROUND. According to California Department of Public Health’s 2015 Cancer Fact sheet, breast cancer is the number one cancer among women of all racial/ethnic groups. Early detection is the best defense against breast cancer. For women at average risk of breast cancer, recently updated guidance from the American Cancer Society screening guidelines recommend that those 40 to 44 of age have the choice for annual mammography; those 45 to 54 have annual mammography; and those 55 years of age and older have biennial, or can choose annual mammography.

DBT (frequently called 3D mammography) uses existing digital mammography equipment to obtain additional radiographic data that are used to reconstruct cross-sectional "slices" of breast tissue. DBT hopes to improve the accuracy of digital mammography by reducing problems caused by overlapping tissue. DBT involves some additional imaging time and radiation exposure. Current radiographic approaches to mammography produce 2D images. DBT may be utilized along with full-field digital mammography (FFDM) in screening for breast cancer and may also be used as a technique for the diagnosis of breast cancer in helping to clarify equivocal mammographic findings.

The Federal Drug Administration approved the use of DBT in 2011 and Medi-Cal and Medicare began covering DBT in 2015. As of April 13, 2016, of the 123 applications submitted by DMHC enrollees for IMR review between 2015 and 2016, only 15 of the DBT requests were upheld and majority of the denials were overturned in favor of coverage.

• 1. Preventative Care. As part of the ACA, new health insurance plan or insurance policy beginning on or after September 23, 2010 must cover preventive services without a copayment or co-insurance or having to meet a deductible. This includes screenings every one to two years for women over 40. Preventive services, such as screening tests, counseling services, and preventive medicines, are tests or treatments that your doctor or others provide to prevent illnesses before they cause you symptoms or problems. To help doctors and patients decide together whether a preventive service is right for a person’s needs, the U.S. Preventive Services Task Force (USPSTF) develops recommendations based on a review of high-quality scientific evidence, and publishes its recommendations on its Website and/or in a peer-reviewed journal. The USPSTF has identified preventive services as an A or B grade that are relevant for implementing the Affordable Care Act. The USPSTF concluded that current evidence is insufficient to assess the additional benefits and harms of using either digital mammography or MRI instead of film mammography as a screening modality for breast cancer. The National Comprehensive Cancer Network noted that early studies show promise for DBT and that definitive studies are still pending.
     
  2. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson), Chapter 795, Statutes of 2002, requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996. 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.  Due to the late request for a CHBRP analysis on this bill, CHBRP only issued a preliminary letter and will issue a full report on May 6, 2016.
     1. Background. According to CHBRP, film and digital mammography are frequently used as breast cancer screening tools for asymptomatic persons. Both produce two dimensional images. In recent years, digital mammography has become the much more commonly used form. DBT takes multiple cross-sectional images of the breast and then uses a computer algorithm to reconstruct a 3-dimensional image. DBT images for screening are obtained in combination with digital mammography. Therefore, breast cancer screening generally consists of either digital mammography alone or digital mammography with DBT. In either case, when results indicate the possibility of breast cancer, a number of additional tests, additional mammographic views and/or tests other than a mammogram (possibly including breast ultrasound, breast magnetic resonance imaging, and or biopsies) may also be performed to verify the presence of cancer.
     2. Medical Effectiveness. While CHBRP’s medical effectiveness analysis is still underway, it is already possible to note that numerous studies have found that film and digital mammography are comparable as breast cancer screening tests for “average-risk women.” In addition, numerous clinical guidelines recommend film or digital mammography as breast cancer screening tests. Examples include current guidelines and recommendations issued by the following national sources:
        1. American Academy of Family Physicians (AAFP);
        2. American Congress of Obstetrics and Gynecology (ACOG);
        3. American College of Radiology (ACR);
        4. American Cancer Society (ACS);
        5. National Comprehensive Cancer Network (NCCN); and,
        6. USPSTF.

The recent USPSTF recommendations noted evidence that screening mammography (film or digital) impacts clinically significant health outcomes, reducing breast-cancer specific mortality among women ages 40 to 74 years and also reducing cancer stage at diagnosis among women aged 50 years and older. Although the ACR guidelines found that DBT is no longer an investigational modality and “improves key screening parameters compared to digital mammography,” citing insufficient evidence, the ACS guidelines, as well as the recommendations from AAFP, ACOG, NCCN, and USPSTF, have not recommended DBT as a screening tool for breast cancer.

• • 1. Benefit Coverage, Utilization, and Cost, Baselines and Impacts. Currently, coverage for digital mammography appears universal among persons enrolled in DMHC-regulated health plans or CDI-regulated policies. However, not all of these enrollees have coverage for DBT. Among these enrollees, CHBRP estimates that current utilization of digital mammography is significantly higher than is utilization of DBT. The average unit cost for a digital mammogram alone (the price paid by a plan or insurer for the test) is nearly $200 and CHBRP estimates that the average unit cost for a digital mammogram with DBT is approximately $270. Increased numbers of enrollees with benefit coverage generally result in increased use of the covered test. This would be the trend CHBRP would expect to use of DBT, should AB 2764 become law. As noted above, CHBRP is still reviewing the relevant data.

1. SUPPORT. The California Radiological Society (CRS), sponsor of the bill, states that when DBT is used in addition to 2D mammography, the rate of cancer detection increased by 27% and the rate of false-positives decreased by 15% compared to when 2D is used alone. CRS states that this bill would require coverage and not put the women at risk for out of pocket costs. CRS contends that DBT should be part of the preventative services that health plans and health insurers are obligated to provide to patients without cost sharing.
2. OPPOSITION. California Association of Health Plans (CAHP), the Association of California Life and Health Insurance Companies, and America’s Health Insurance Plans contend that health insurance mandates threaten efforts of all health care stakeholders to provide consumers with meaningful health care choices and affordable coverage options. They state that the ACA requires the state to pay for the increased cost associated with the mandate for those enrollees who purchase health insurance on the Exchange. They also state that benefit mandates eliminate the ability of health insurers and HMOs to provide unique benefit packages aimed at the needs of consumers by requiring individuals and employers to purchase benefits prescribed by the Legislature, not driven by consumer choice. Finally, they note that health benefit mandates stifle the use of innovative, evidence based medicine. Additionally, CAHP, states that the blanket mandated use of DBT for all women is unnecessary as the use of DBT for all women is not recommended by the USPDTF. In fact, the USPSTF has clarified that they do not support the blanket use of DBT because the studies have not demonstrated an improvement of patient outcomes, a decrease in the occurrence of the disease, or a decrease in the amount of treatment. The California Chamber of Commerce (CCC) states that without data, it is impossible to know if the use of DBT with traditional mammography would improve long term outcomes for women or eliminate the need for follow-up biopsies or ultrasounds to confirm the presence of tumors. CCC also notes that this bill would increase premiums for all enrollees by mandating coverage of an additional screening technique for breast cancer that is still unproven. CCC contends that this bill would, contrary to USPSTF, declare concurrent screening to be the standard for preventative care and require it in all cases, expanding its use regardless of the lack of evidence that this will improve outcomes, and regardless of the much larger dose of radiation.
3. POLICY COMMENTS. This bill would provide coverage for DBT under existing mammography coverage. Although the USPSTF has not recommended the use of DBT as a screening tool for cancer, it is important to note that Medicare reimburses DBT and Medi-Cal currently includes DBT as a Medi-Cal benefit for fee-for-service and Medi-Cal Managed Care Plans.

REGISTERED SUPPORT / OPPOSITION:

Support

California Radiological Society

Opposition

California Association of Health Plans

Association of California Life and Health Insurance Companies

America’s Health Insurance Plans

California Chamber of Commerce

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