New California Law on Breast Density - Notification and Recommendations

New California Law on Breast Density - Notification and Recommendations

New California Law – Breast Density Notification, Plus Risk Management Recommendations  

The Requirement

If a facility that performs mammograms categorizes a patient as having “heterogeneously dense breasts or extremely dense breasts” (per the American College of Radiology’s Breast Imaging Reporting and Data System – BI-RADS®), then that facility must include the following notice in its summary of the written report to the patient (1)

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.

This new law, Senate Bill 1538 (Simitian), went into effect April 1, 2013, and remains in effect until January 1, 2019. The new law adds Section 123222.3 to the California Health & Safety Code (1).

Four other states (Connecticut, New York, Virginia, and Texas) have breast density notification laws (2,3).

 

Issues for Physicians

Although the new law states that the requirement does not “create a duty of care or other legal obligation beyond the duty to provide notice...,” (1) physicians will likely find themselves in conversations with patients about how to address the dense breast finding.

Healthcare providers and professional organizations, such as the American College of Radiology (ACR), have identified issues that could complicate physician-patient discussions:

  • Concern about the accuracy and consistency of breast density assessment (i.e., variations can occur when more than one physician reads the same mammogram) (4)
  • Lack of data regarding the efficacy of additional, non-mammographic imaging (e.g., MRI, ultrasound) (4,5) According to the ACR’s “Statement on Reporting Breast Density in Mammography Reports and Patient Summaries”: “… it needs to be remembered that there is no randomized trial data that shows that adding either ultrasound or MRI to mammography screening saves lives” (4).
  • Increase in false-positives. A 2009 study published in the journal Radiology reported an increase of 3.2 additional cancers per 1,000 women screened since Connecticut passed its law. The study also cited an increase in the false-positive rate and a low positive-predictive value (2).

Risk Management Recommendations

NORCAL does not establish the standard of care and it does not have a position on the extent to which physicians should act following the notification to patients. NORCAL strongly encourages clear communication and appropriate follow up to support safe patient care. The following recommendations are not mandated by law; they represent prudent risk management practice:               

  • Radiologists and primary care (i.e., ordering) physicians should have systems in place to coordinate communication of the notice to patients (3).

o   Radiologists should copy the patient’s ordering physician on patient notification.

o   The breast density notification to the patient states, “A report of your results has been sent to your physician.” Radiologists could add the following to the notification:

-  Suggest that the patient use the report when she speaks to her PCP about her own risks for breast cancer.

-  Encourage the patient to discuss with her PCP whether further testing might be useful, based on her risk.

  • Recommendations for PCPs who are contacted by patients concerned about their breast density:

o   Review the degree of the patient’s breast density in the mammogram report.

o   Evaluate the patient’s family and health history and other risk factors in conjunction with the mammogram report, in order to have a patient-specific discussion about the appropriateness of further testing for the particular patient.

o   Outline the options for additional imaging (ultrasound and MRI)

o   Explain what each of these studies can/can’t detect, as well as risks, benefits and alternatives

o   Document all of the above in the medical record, including:

-  Your recommendation for the particular patient

-  What the patient decides (e.g., whether or not to undergo additional imaging, and what method of imaging) (3)

For more information about this new law, or any other risk management questions, please contact the Risk Management Department at: (800) 652-1051, ext. 2244.

References

1. California Health & Safety Code. Section 123222.3 was enacted by Senate Bill 1538, chapter 458. September 22, 2012. Available at: http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120SB1538. Accessed 4/25/13

2. Nelson R. California Soon to Have Breast Density Notification Law. Medscape. January 17, 2013. Available at: http://www.medscape.com/viewarticle/777826. Accessed: 4/25/13.

3. Hoffman, J. Breast Density and Patient Safety. CRICO Clinician Resources. January 28, 2013. Harvard Risk Management Foundation. Available at: http://www.rmf.harvard.edu/Clinician-Resources/Article/2013/SPS-Breast-Density-and-Patient-Safety. Accessed: 4/25/13.

4. ACR Statement on reporting breast density in mammography reports and patient summaries. April 24, 2012. American College of Radiology. Position Statements. Available at: http://www.acr.org/About-Us/Media-Center/Position-Statements/Position-Statements-Folder/Statement-on-Reporting-Breast-Density-in-Mammography-Reports-and-Patient-Summaries. Accessed: 4/30/13.

5. Aliferis, L. California’s Breast Density Law Goes into Effect. State of Health. March 29, 2013. KQED Radio. [Transcript.] Available at: http://www.californiahealthline.org/articles/2013/4/1/californias-breast-density-notification-law-goes-into-effect.aspx. Accessed: 4/25/13.

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