To: Radiologists in NY State
From:
Andrew Rosenkrantz, M.D.
President, NYS Radiological Society
Donna D’Alessio, M.D.
Chair, Breast Imaging Committee, NYS Radiological Society
Re: Required notification in patient lay summary regarding mammographic breast tissue density
Date: June 10, 2024
New federal regulations, which take effect September 24, 2024, require providers of mammography services to send a specific notification to patients regarding breast tissue density, as part of a patient lay summary. [1] The U.S. Food and Drug Administration (the “FDA”) has opined that providers must send the federally required notification “verbatim.”
New York State law requires providers to send a similar, but not identical, notification to patients with mammographically dense breast tissue. [2] However, in a letter to the New York State Radiological Society (“NYSRS”), the New York State Department of Health (“NYSDOH”) opined that the federally required notification will satisfy the notification requirements under New York law if a single sentence is added: “A report of your results was sent to your physician.”
Accordingly, to satisfy both federal and state notice requirements, providers of mammography services should send the following notification to patients whose mammograms demonstrates dense breast tissue (BI-RADS categories C and D):
Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to you healthcare provider about breast density, risks for breast cancer, and your individual situation.
A report of your results was sent to your physician.
Although New York State law does not require notification to patients with non-dense breast tissue (BI-RADS categories A and B), the new federal regulations require a specific notification for this group, effective September 10, 2024:
Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation. [3]
[1] See 88 FR 1512621; CFR 900.12(c)(2)(iv).
[2] See New York State Public Health Law § 2404-c.mammogram may help find cancers. Talk to your healthcare provider about breast density.
[3] See 88 FR 1512621; 21 CFR 900.12(c)(2)(iii). 10