ACOG STATE LEGISLATIVE TOOLKIT: Breast Density and Screening Mandates Guidance for States considering legislation These legislative mandates are problematic: No reliable, standardized method for assessing breast density. No clinical guidelines recommend additional screening solely on the basis of high breast density. Breast density is not a major cancer risk factor. Notice provision Which patients should receive the notice? If notice is mandated, ALL women regardless of their specific condition or density level should receive information about breast density in general not just women with dense breast tissue or only women with highly dense tissue. This is preferable to legislation that mandates sending the notice only to women with the highest density levels, for example. Why ALL women? This is a new area of focus and all women should be educated and informed about highly dense breasts. A patient could be on the edge of a high density classification. Currently, there is no reliable method for assessing breast density. The radiologist should feel confident in calling the grade as they see it, without pressure to assess all women at higher density levels. Breast density changes with various factors. For the patient, it could be confusing to get the notice one year and not the next. SUGGESTED LEGISLATIVE LANGUAGE: From Maryland HB 312 (2013 session), A center where mammography testing is performed shall include in a screening results letter that is sent to a patient, as required by federal law, the following notice: This notice contains the results of your recent mammogram, including information about breast density. What should be included in the notice? Consider all the below: High breast density is a common condition. 1
Density can change due to various factors including age, weight, hormones, childbearing, and breastfeeding. At the present time, the science on breast density and cancer risk is not clear. Research is being done to better understand highly dense breasts and how to better tailor screening. Regardless of mammogram results, if any lumps or symptoms, contact your physician immediately. Highly dense breasts can make it more difficult to see cancers. A check-box for digital mammography, so that women will know what type of screening they had. As of 2012, current science shows that digital mammography is the gold standard for a woman with highly dense breasts and NO other risk factors. Patients with dense breasts should be given a comprehensive description of their density level, not just the numerical density levels 1 thru 4. Currently, these are: 1 (almost entirely fatty), 2 (scattered fibroglandular densities), 3 (heterogeneously dense) and 4 (extremely dense). HOWEVER, current numerical levels and descriptors will evolve to keep up with the science. This is another reason why a legislative mandate is problematic. Mammography practices are already urged to VOLUNTARILY provide this descriptive information to patients. You and your physician can work together to determine the best screening for you. SUGGESTED LEGISLATIVE LANGUAGE: See the California, New York and Texas laws for suggested wording of some of the above items. These are excerpted in the ACOG 2012 TALLY. Who should provide the notice: If a legislative mandate is unavoidable, it should apply to mammography/radiology facilities and require facilities to send out as part of the patient lay summary a single, uniform notice, with density level specified and described (not just numerical level 1,2,3 or 4 but also an explanation). Expiration and/or required review of notice requirement (sunset provision) This is an important provision as it s difficult to craft notice language that is educational, nonprescriptive and won t be scientifically outdated shortly after the law is passed. Option one: Give your state Health Department authority to change the notice text if the science becomes out of date. This language could also require DOH to review the notice text within a specified number of years after enactment. SUGGESTED LEGISLATIVE LANGUAGE: From Maryland HB 312 (2013 session), If the Department finds significant difference between the content of the notice that is required to be provided under paragraph (2) of this subsection 2
and current medical evidence on breast density, the Department may adopt regulations that change the content of the notice. Option two: Include a provision whereby the law will automatically sunset (expire) if Congress amends the federal MQSA to address breast density cancer risk and screening. The federal rules would trump state law. SUGGESTED LEGISLATIVE LANGUAGE: From Maryland HB 312 (2013 session), This section does not apply if the federal Mammography Quality Standards Act of 1992, or regulations adopted under the act, requires a notice regarding breast density to be included in the screening results letter that is sent to a patient. Option three: If you are unsuccessful with options 1 and 2 above, consider the following SUGGESTED LEGISLATIVE LANGUAGE from the California law, nothing in this section shall be deemed to require a notice that is inconsistent with the provisions of the federal Mammography Quality Standards Act (42 U.S.C. Sec. 263b) or any regulations promulgated pursuant to that act. (See further in the section, No conflict with federal MQSA ) Supplemental screening & insurance coverage As more and more states pass these laws and as women become more aware of breast density, we should anticipate increased patient demand for additional, non-mammographic screening. This raises several concerns: 1. Additional screening for only highly dense breasts and no other risk factors is not recommended under any current guidelines. That s why, in some states (eg, Connecticut), proponents have sought specific coverage for ultrasound and/or MRI. Digital mammography is currently the gold standard in breast cancer screening for women with average risk. At the present time, there is no peer-reviewed data to suggest screening by any modality other than digital mammography. A number of organizations publish screening guidelines including ACOG, U.S. Preventive Services Task Force, American Cancer Society, and Susan G. Komen Foundation. None of these organizations recommend additional screening, other than digital mammography, for highly dense breasts and no other risk factors. Unless mandated, insurers would not cover an ultrasound or MRI as they are not medically necessary. (See standard definition of medically necessary below.) Although some ultrasounds might be paid for as they are relatively low-cost and therefore not always challenged. WATCH OUT FOR THIS LEGISLATIVE LANGUAGE: See #3 below. In some states, including an insurance coverage requirement in the bill could trigger sufficient opposition to prevent the bill from passing. Tactically, this is a decision for each individual state to make. 3
2. The impact of supplemental screening on patient morbidity and mortality is unknown at the present time. Recent study results for screening breast ultrasonography (US) and breast magnetic resonance (MRI) imaging pertain only to women of intermediate or high risk with known risk factors beyond their dense breasts. Other trials did not include control groups, so that the impact of additional screening cannot be determined. 3. These laws are likely to lead to an increase in unnecessary screening and procedures, putting women through unnecessary trauma at substantial cost for no additional benefit. We want to avoid leading women to unnecessary additional screening and related follow-up procedures, and divert scarce health dollars to better use. BUT WATCH OUT FOR THIS LEGISLATIVE LANGUAGE: From amendments to New Jersey AB 2022 (2012-13), The coverage required under this paragraph may be subject to utilization review, including periodic review, by the insurer of the medical necessity of the comprehensive ultrasound screenings if the provider has been determined by the insurer to have overutilized the coverage required under this paragraph. 4. Some women may not be able to afford an additional screening exam unless it is covered by insurance, which is unlikely unless there is a specific mandate to do so. Insurance coverage would reduce discrimination in access to cancer screening for lower income women. 5. Physicians may feel compelled to refer for additional screening on patient request because of concern for liability protection. Failure to diagnose is a frequent allegation in gynecologyrelated lawsuits. WATCH OUT FOR THIS LEGISLATIVE LANGUAGE: See #3 above. 6. The supply of radiologists available to provide additional screening is limited. Currently, there is a shortage of qualified breast imagers and breast ultrasonography (US) technologists who can perform competent screening US examinations. Patients seeking additional screening may crowd-out patients truly in need of additional testing. 7. There is no data or cost-analyses demonstrating that supplemental screening is a costeffective measure for women with dense breasts. The definition of medically necessary in the National Managed Care Contract is as follows: Medically Necessary or Medical Necessity means care based upon generally accepted medical practices in light of conditions at the time of treatment which is: (i) appropriate and consistent with the diagnosis and the omission of which could adversely affect or fail to improve the eligible enrollee s condition; (ii) ) compatible with the standards of acceptable medical practice; (iii) provided in a safe and appropriate setting given the nature of the diagnosis and the severity of the symptoms; (iv) not provided solely for the convenience of the Subscriber or the convenience of the MP; and (v) not primarily custodial care, unless custodial care is a Covered Service under the Subscriber s benefit plan. 4
Legal liability SUGGESTED LEGISLATIVE LANGUAGE: From the Texas law, Notwithstanding any other law, this section does not create a cause of action or create a standard of care, obligation, or duty that provides a cause of action. Also, consider language protecting the facility and/or primary or referring physician from failing to comply with the law s requirements before the effective date. SUGGESTED LEGISLATIVE LANGUAGE: From the California law: Nothing in this section shall be construed to create or impose liability on a health care facility to comply with the requirements of this section prior to [effective date]. No conflict with federal MQSA SUGGESTED LEGISLATIVE LANGUAGE: From the California law, Nothing in this section shall be deemed to require a notice which is inconsistent with the provisions of the Mammography Quality Standards Act or regulations promulgated pursuant to this act. Data collection and evaluation The optimal bill would include a provision authorizing and appropriating funds to review costs and outcomes. For example: false-positive rate; biopsy rate; cost for cancer pick-up rate; and improvement in mortality. Funding will be critical here. SUGGESTED LEGISLATIVE LANGUAGE: No current example. FDA role Consider including a provision (or a separate Resolution) urging the CDC and/or FDA to study and/or consider the following: Review the data on the relationship between breast density and cancer risk. Review national breast cancer screening practices including the role of comparative effectiveness research (CER) and patient-centered outcomes research in determining the effects of additional screening on individual outcomes for women with dense breasts. Review the benefits, possible harms and unintended consequences of reporting mammographic breast density to women. Review the data and experience from Connecticut s 2009 mandate. 5