§1211.3. Notice concerning supplemental screening
A. Upon completion of any screening mammogram, regardless of whether the
mammogram was directed by prescription of a licensed practitioner, each mammography
facility certified by the United States Food and Drug Administration or by a certification
agency approved by the United States Food and Drug Administration shall mail to the
patient, in addition to any letter or report required by 21 CFR Part 900, the following notice
in conspicuous and legible type which is not smaller than twelve-point font:
"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 summary of your mammography results will be sent to you, and a full
mammography report will be sent to your physician and also to you. You should contact
your physician if you have any questions or concerns regarding your summary or report of
results."
B. The notice provided for in this Section may be transmitted to the patient by either
regular mail or certified mail via the United States Postal Service, or by any other
commercial mail delivery service.
C. Notwithstanding any other law, compliance with this Section does not create a
cause of action or create a standard of care, obligation, or duty that provides a basis for a
cause of action.
D. The information required by this Section or evidence that a person violated this
Section shall not be admissible in a civil, judicial, or administrative proceeding.
Acts 2015, No. 378, §§1, 3, eff. Jan. 1, 2016.