I 111th CONGRESS 2d Session H. R. 6404 IN THE HOUSE OF REPRESENTATIVES November 15, 2010 Mr. Meek of Florida (for himself, Ms. DeLauro, Mr. Israel, and Ms. Wasserman Schultz) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require that every mammography report delivered to a patient after a mammography examination, as required by section 354 of the Public Health Service Act (commonly referred to as the Mammography Quality Standards Act of 1992), contain a summary of the patient’s breast density and a statement concerning the benefit of supplementary screening tests for patients with dense breast tissue, where such additional evaluations are recommended by a patient’s interpreting physician.

1.

Short title

This Act may be cited as the Breast Density and Mammography Reporting Act of 2010.

2.

Findings

The Congress finds as follows: (1)Individuals receiving mammograms are not currently required to receive medical summaries or reports from their mammogram providers which address breast density or its correlation to breast cancer. (2)The American Cancer Society reports that an individual with dense breast tissue faces a risk of developing breast cancer 4 or more times higher than an individual without dense breast tissue. (3)The National Cancer Institute estimates that 1 in 8 women in the United States will develop a cancer of the breast in their lifetime. (4)The Centers for Disease Control and Prevention reports that breast cancer is the number one cause of cancer death among Hispanic women, and the number two cause of cancer death among White, Black, Asian/Pacific Islander, and American Indian/Alaska Native women. (5)The Breast Imaging Reporting and Data System (BI–RADS) is a standardized interpretation tool for mammogram evaluation developed by the American College of Radiology. BI–RADS is widely used in the industry to indicate the absence or likelihood of breast cancer. The BI–RADS scoring system evaluates likelihood based in part on measure of breast density.

3.

Breast density reporting by facilities that perform mammograms to physicians and patients

(a)

In general

Clause (ii) of section 354(f)(1)(G) of the Public Health Service Act (42 U.S.C. 263b(f)(1)(G)) is amended— (1)in each of subclauses (III) and (IV), by striking and at the end; and (2)by adding at the end the following: (V)the summary under subclause (IV) shall include information regarding the patient’s individual measure of breast density— (aa)based on the Breast Imaging Reporting and Data System (BI–RADS) established by the American College of Radiology and used by the National Cancer Institute; or (bb)as specified by the Secretary based upon new scientific knowledge, technological advances, or other updated medical procedures where the use of such screening developments is consistent with the practice of medical experts in the field; (VI)the summary under subclause (IV) shall convey to the patient his or her increased risk of developing breast cancer based on his or her individual measure of breast density as measured under subclause (V) and analyzed by the patient’s interpreting physician; and (VII)a written report under this clause shall include the following notice: If your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests for expanded detection, depending upon your individual risk factors and the recommendation of your interpreting physician. A report of your mammography results, which contains information about your breast density, has been sent to your treating physician’s office, and you should contact your treating physician if you have any questions or concerns about your report.; and . (b)

Rule of construction

This section and the amendments made by this section shall not be construed to alter in any way Federal requirements relating to financial obligations of any person in connection with health insurance.