In March 2023 the Food and Drug Administration (FDA) issued a Final Rule to amend the Mammography Quality Standards Act (MQSA). This Final Rule established new assessment and documentation requirements related to mammography examinations. Specifically, it requires that all mammography reports include specific breast density information and notification. Enforcement of this rule began on September 10, 2024.
Goals
The goals of the new rule include the following:
- Ensuring that patients are aware of the risks of breast density;
- informing patients of the limitations of mammography screening; and
- enabling patients to make an informed decision about additional testing.
Assessment and Documentation Requirements
Mammography reports must now include 1)an overall final assessment of findings, an overall assessment of breast density, and 3) specific patient notification statements.
The overall assessment of findings must be classified into one of the following categories:
- Probably Benign.
- Highly Suggestive of Malignancy.
- Known-Biopsy-Proven Malignancy; or
- Post-Procedure Mammogram for Marker Placement.
- In cases where no final assessment category can be assigned due to incomplete work-up, the report should state:
- Incomplete: Need additional imaging evaluation; or
- Incomplete: Need prior mammograms for comparison.
The overall assessment of breast density must be classified into one of the following categories:
- “The breasts are almost entirely fatty.”
- “There are scattered areas of fibroglandular density.”
- “The breasts are heterogeneously dense, which may obscure small masses;” or
- “The breasts are extremely dense, which lowers the sensitivity of mammography.”
Depending on the patient's breast density as indicated by the mammography report, the patient lay summary must include one of the following notification statements:
- Not dense: "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."
- Dense: "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 your healthcare provider about breast density, risks for breast cancer, and your individual situation."
Communication/Notification Timing Requirements
- When the overall assessment of findings is categorized as suspicious or highly suggestive of malignancy, the mammography report should be relayed to the patient’s healthcare provider within seven calendar days of the date of interpretation.
- The patient lay summary, including the breast density notification statements, should also be provided to the patient within seven calendar days of interpretation.
- When the overall assessment of findings is incomplete: need prior mammograms for comparison, the follow-up report should be issued within 30 calendar days of the initial report. It should contain a final overall assessment, whether or not prior views were received for comparison.
The mammography report must include the following contact information: facility name, full address, and telephone number.
The updated rules also strengthen the FDA’s oversight of facilities and include additional requirements related to accreditation, inspections, and the enforcement of standards to ensure mammography facilities are providing patients with high quality care.
Sources:
Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA) | FDA
