As detailed at bottom, in 2019 there was progress on both the federal legislative and the FDA regulatory fronts for a national breast density reporting standard. In summary:
- February 2019: The federal law directs the Food and Drug Administration (FDA), through the regulatory process, to develop breast density reporting language for patients and health providers. No timeline for the development of reporting language was included in the law.
- March 2019: The FDA proposes reporting language updates; next steps would be the publication of the FDA/ Mammography Quality Standards Act (MQSA) Final Rule. The FDA reports that the Final Rule will be published late in 2022 or early in 2023. In the meantime, individual state “inform” laws remain in effect and guide reporting requirements.
Federal Legislation, February 15, 2019
A federal law directs the FDA, through the regulatory process, to develop breast density reporting language and ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density. This would create a minimum national reporting standard. No timeline was included in the law.
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.
Proposed Updates to Mammography Regulations, March 28, 2019
The FDA proposed important new steps to modernize breast cancer screening. 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, those 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.