I 
111TH CONGRESS 
2D SESSION 
H. R. 6404 
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 screen-
ing tests for patients with dense breast tissue, where such additional 
evaluations are recommended by a patient’s interpreting physician. 
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 (com-
monly referred to as the ‘‘Mammography Quality Stand-
ards 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 rec-
ommended by a patient’s interpreting physician. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
VerDate Mar 15 2010 
06:19 Nov 16, 2010
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H6404.IH
H6404
pwalker on DSKD5P82C1PROD with BILLS
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Breast Density and 
Mammography Reporting Act of 2010’’. 
SEC. 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 ad-
dress breast density or its correlation to breast can-
cer. 
(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 Pre-
vention 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 
VerDate Mar 15 2010 
06:19 Nov 16, 2010
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H6404.IH
H6404
pwalker on DSKD5P82C1PROD with BILLS
American College of Radiology. BI–RADS is widely 
used in the industry to indicate the absence or likeli-
hood of breast cancer. The BI–RADS scoring sys-
tem evaluates likelihood based in part on measure of 
breast density. 
SEC. 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 Imag-
ing 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 Sec-
retary based upon new scientific 
VerDate Mar 15 2010 
06:19 Nov 16, 2010
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H6404.IH
H6404
pwalker on DSKD5P82C1PROD with BILLS
knowledge, technological advances, or 
other updated medical procedures 
where the use of such screening devel-
opments is consistent with the prac-
tice 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 sub-
clause (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 ex-
panded detection, depending upon your in-
dividual risk factors and the recommenda-
tion of your interpreting physician. A re-
port of your mammography results, which 
contains information about your breast 
density, has been sent to your treating 
physician’s office, and you should contact 
VerDate Mar 15 2010 
06:19 Nov 16, 2010
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H6404.IH
H6404
pwalker on DSKD5P82C1PROD with BILLS
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 finan-
cial obligations of any person in connection with health 
insurance. 
Æ 
VerDate Mar 15 2010 
06:19 Nov 16, 2010
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6301
E:\BILLS\H6404.IH
H6404
pwalker on DSKD5P82C1PROD with BILLS