FDA Approves New Alternative Standard for MQSA Reporting

On October 29, 2024, the FDA approved new Alternative Standard #25 for MQSA reporting. This allows the provider to document an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison”.

The recent Alternative Standard #25 update revises how follow-up reports are managed for cases assessed as “Incomplete: Need prior mammograms for comparison”.

The recent alternative standard update to the Mammography Quality Standards Act (MQSA) revises how follow-up reports are managed for cases assessed as “Incomplete: Need prior mammograms for comparison.” The following is an explanation of the change:

Original Standard (21 CFR 900.12(c)(1)(v)(B)):

Under the original regulation, mammography exams deemed “Incomplete: Need prior mammograms for comparison” required a follow-up report within 30 calendar days. This follow-up report had to assign a final assessment category from a predefined list (A through E) of diagnostic outcomes, regardless of whether the prior mammograms were obtained in time for comparison.

Approved Alternative Standard:

The alternative standard broadens the follow-up report options by allowing the interpreting physician to assign an additional “Incomplete: Need additional imaging evaluation” designation (from section (c)(1)(v)(A)) if the prior mammograms were not obtained in time. This provides more flexibility for facilities and physicians to manage cases where the necessary comparisons cannot be made within the 30-day timeframe.

Key Changes:

1. Added Flexibility: Physicians can now issue another “Incomplete” assessment specifically for cases requiring additional imaging when prior comparisons remain unavailable.
2. Scope of Follow-Up Assessments: Follow-up reports can include:
   • Diagnostic categories from the original list (A through E).
   • A renewed “Incomplete: Need additional imaging evaluation” if required for further work-up.
3. Immediate Effectiveness: The change applies immediately and is available to all facilities governed by MQSA.

Implications:

• For Facilities: Simplifies compliance in cases where prior mammograms are delayed or unavailable, reducing the need to force a final diagnostic conclusion prematurely.
• For Patients: Ensures accurate and comprehensive assessment, even if prior imaging comparisons are delayed.
• No Time Limit: This alternative standard is permanent and universally applicable across MQSA-regulated facilities.

This update is for both screening and diagnostic mammography and reflects the FDA’s commitment to maintaining flexibility in diagnostic workflows while ensuring high standards of care for patients.

Update report templates to include this standard as applicable.

For complete details, visit the link below.

https://www.fda.gov/radiation-emitting-products/regulations-mqsa/25-issuing-report-assessment-incomplete-need-additional-imaging-evaluation-follow-initial-report?utm_medium=email&utm_source=govdelivery

Questions regarding the MQSA Alternative Standards can be sent to the following FDA website.

https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-mqsa-and-mqsa-program/contact-mqsa-program?utm_medium=email&utm_source=govdelivery

For information regarding MQSA reporting of breast density requirements, please see our prior blog here: https://streamlinemd.com/mammography-quality-standards-act-mqsa-fda-changes-effective-9-10-2024/

Reference:

FDA