ACOG ♦ GOVERNMENT AFFAIRS ♦ STATELEG@ACOG.ORG 1

Overview: Since Connecticut passed the first dense breast patient notice mandate in 2009, similar bills have been considered in over a dozen states and Congress. Laws have passed in seven states. These bills are problematic because they would legislate medical practice. There is no consensus within the scientific community on the relationship between breast density and cancer risk, no reliable method for assessing breast density, and no clinical guidelines that recommend additional screening solely on the basis of high breast density. Are You Dense Advocacy and the Density Education National Survivor’s Effort (D.E.N.S.E. ™) is a national grassroots campaign supporting state and federal patient notification mandates. In 2011, California’s governor vetoed a bill saying, “The notice contained in this bill goes beyond information about breast density. It advises that additional screening may be beneficial. If the state must mandate a notice about breast density – and I’m not sure that it should – such a notice must be more carefully crafted, with words that educate more than they prescribe.” California’s Governor signed a revised bill in 2012.

State Legislative Activity

• To date, 7 states have passed mandates (California, Connecticut, Illinois, New York, Texas, Utah, Virginia) See chart on page 2

• In 2011, at least 3 states considered bills (California, Florida, Texas) • In 2012, 14 states considered bills (California, Connecticut, Kansas, Maine, Missouri, Nebraska, New Hampshire, New

Jersey, New York, Pennsylvania, South Carolina, Tennessee, Utah and Virginia )

These state laws: • Require mammogram reports to include special notice to patients with dense breast tissue & prescribe the

content of the notice • Require notice about additional screening options • Some laws also require insurance coverage for a breast ultrasound, MRI, or both • Mandates apply to facilities and/or the patient’s primary care or referring physician

ACOG Clinical Guidance: ACOG Practice Bulletin 122 reviews breast cancer screening guidelines, the supporting evidence, new screening modalities and controversies surrounding screening. It cites the American Cancer Society’s (ACS) factors that increase a woman’s relative risk of breast cancer including high breast tissue density and reviews the evidence for ultrasonography, digital versus film mammography, and MRI screening.

American College of Radiology Position: ACR does not support the Are You Dense legislative initiative; ACR’s state chapters have taken varying positions on these bills. ACR acknowledges there is limited science to provide direction for patients, their primary care providers and breast imagers. While ACR supports the FDA mandate that information on breast parenchymal density be included in the mammography report, it has reservations about the patient lay summary. ACR’s Breast Imaging Reporting and Data System (BI-RADS ™)recommends that all mammography reports to referring providers include a description of breast density which physicians should use to discuss appropriate options given a patient’s history and other circumstances.

State Legislative Mandates: Mammography & Breast Density (2012)

ACOG ♦ GOVERNMENT AFFAIRS ♦ STATELEG@ACOG.ORG 2

In its October 2011 testimony to the FDA, ACR said Connecticut’s experience should be evaluated. ACR urged the FDA to proceed cautiously and consider the benefits, possible harms and unintended consequences of mandating the reporting of mammographic breast density in patient lay summaries. To view ACR’s statement and talking points on breast density mandates, visit www.acr.org/advocacy.

Density Education National Survivor’s Effort (D.E.N.S.E. ™): For more information about this grassroots advocacy campaign which started in Connecticut, visit Areyoudenseadvocacy.org.

STATE LAWS

PATIENT NOTIFICATION MANDATES LAW EXPIRES AND/OR NOTICE

RQRMNT WILL BE

REVIEWED AGAIN IN X YEARS

NO CONFLICT WITH MQSA

State notice requirement

is in force only until the

federal act is amended to

address breast density screening/risk

INSURANCE COVERAGE FOR SUPPLEMENTAL

SCREENING

LEGAL LIABILITY

Notice does not create a standard of

care for screenings or

cause of action

DATA COLLECTION

ON COSTS AND

OUTCOMES

NOTICE OF BREAST DENSITY

Applies only to patients w/ dense

breast tissue unless noted

NOTICE OF ADDITIONAL SCREENING OPTIONS

MANDATE ON

FACILITY (F) OR

PHYSICIAN(P)

CALIFORNIA (2012)

X* F X X X

CONNECTICUT (2009 & 2012)

X X F Ultrasound, MRI*

ILLINOIS (2009)

Ultrasound*

MAINE* (2012)

NEW YORK (2012)

X* X F

TEXAS (2011)

X* X* F X

UTAH (2012)

X* not

mandatory X*

F* not

mandatory

VIRGINIA (2012)

X F,P

State Mandates on Mammography & Breast Density

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EXPLANATION: * CALIFORNIA, NEW YORK, TEXAS: Law includes language about breast density being a common condition (see below). *CONNECTICUT: Enacted a second law in 2012 broadening the insurance coverage mandate to include MRI of entire breast or breasts. * ILLINOIS: Law mandates insurance coverage of additional screening as determined by the physician. * MAINE: Not a mandate; law sets up a stakeholder working group, including Are You Dense, to review and report on strategies to improve the dialogue between patients and physicians regarding breast density and breast imaging options. * UTAH: Not a mandate; law encourages facilities to provide notice of breast density. Also, Utah’s notice includes a statement that mammography is the only breast cancer screening examination which has been shown to reduce the death rate from breast cancer (see below).

Patient Notification Language Specified in State Laws CALIFORNIA

CONNECTICUT NEW YORK TEXAS

“If your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast MRI examination, or both, depending on your individual risk factors. A report of your mammography results, which contains information about your breast density, has been sent to your physician’s office and you should contact your physician if you have any questions or concerns about this report.”

“If your mammogram demonstrates that you have dense breast tissue, which could hide abnormalities, and you have other risk factors for breast cancer that have been identified, you might benefit from supplemental screening tests that may be suggested by your ordering physician. Dense breast tissue, in and of itself, is a relatively common condition. Therefore, this information is not provided to cause undue concern, but rather to raise your awareness and to promote discussion with your physician regarding the presence of other risk factors, in addition to dense breast tissue. A report of your mammography results will be sent to you and your physician. You should contact your physician if you have any questions or concerns regarding this report.”

“Your mammogram shows that your breast tissue is dense. Dense breast tissue is very common and is not abnormal. However, dense breast tissue can make it harder to find cancer on a mammogram and may also be associated with an increased risk of breast cancer. This information about the result of your mammogram is given to you to raise your awareness. Use this information to talk to your doctor about your own risks for breast cancer. At that time, ask your doctor if more screening tests might be useful, based on your risk. A report of your results was sent to your physician.”

“Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician.”

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UTAH VIRGINIA

The following information may be included in the mammography results sent to a patient with dense breast tissue: “Mammography is the only breast cancer screening examination which has been shown in multiple randomized clinical trials to reduce death rate from breast cancer. However, it is not a perfect test, specifically in women with dense breast tissue. Because your mammogram demonstrates that you have dense breast tissue, you may benefit from supplementary screening tests, depending on your personal risk factors and family history. Although other screening tests may find additional cancers, they may not necessarily increase survival. Nevertheless, you should discuss your mammography results with your health care provider. A copy of your mammography report has been sent to your health care provider’s office. Please contact your health care provider if you have any questions or concerns about this notice.”

“Your mammogram demonstrates that you may have dense breast tissue, which can hide cancer or other abnormalities. A report of your mammography results, which contains information about your breast density, has been sent to your referring physician’s office, and you should contact your physician if you have any questions or concerns about this report.”

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