§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.