Regulatory Update, March 28, 2019
From the FDA: For the first time in more than 20 years of regulating mammography facilities, the FDA has announced important new steps to modernize breast cancer screening and help empower patients with information when they are considering important decisions regarding their breast health care. The proposed updates include the requirement of breast density reporting to both patients and referring health providers. DB-I has analyzed the proposed language and submitted comments to the FDA during the designated “open for public comment” period. DB-I comments are available HERE.
When effective, will the new federal reporting minimum replace existing State laws?
Under the Mammography Quality Standards Act (MQSA), overseen by the FDA, all facilities would have to follow that federal reporting requirement and any specific language associated with it. However, the MQSA explicitly states that nothing in it limits the authority of any State to enact State laws relating to mammography that are at least as stringent as the MQSA or regulations under the MQSA. States might also choose to have any MQSA density reporting requirement supersede their State reporting requirements. Once the new standard is introduced, individual State law review will be necessary.
Dr. Wendie Berg, DB-I Chief Scientific Advisor, interviewed about the FDA’s proposed density inform language, how it could be strengthened, and potential impact on existing State inform laws, view HERE.
Legislative Update, February 15, 2019
It is now federal law in the United States that the Food and Drug Administration (FDA) develop breast density reporting language that must be included in patient letters and health provider reports. Exact language and effective date are not yet available; once the requirement details are in effect, it would set a minimum standard for all U.S. states.
The law directs the FDA, through the regulatory process, to develop reporting language and ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density. The information must include, at a minimum:
- The effect of breast density in masking the presence of breast cancer on a mammogram
- The qualitative assessment of the provider who interprets the mammogram, and
- A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.