On March 10, 2023, the FDA announced the final rule amending the MQSA regulations. Physicians and hospitals have had 18 months to adopt the FDA’s changes going into effect on September 10, 2024. These requirements are outlined below.
Breast Density Notification: Mammography reports must now include a classification of breast density using one of four categories. Depending on the density, patient lay summaries must consist of specific notification statements explaining breast density’s implications for cancer detection and risk.
Mammography Reports: Breast density refers to the proportion of fibrous and glandular tissue compared to fatty tissue in the breast. The four breast density classifications defined by the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS) have changed from numerical to alpha categories. One of these categories must be documented in the report.
1. Category A – Almost entirely fatty.
2. Category B – Scattered areas of fibroglandular density.
3. Category C – Heterogeneously dense.
4. Category D – Extremely dense.
Post-Biopsy Mammography:
Billable: If different modalities are used for biopsy guidance and post-biopsy mammography, the mammography is billable.
Non Billable: If the same modalities are used for biopsy guidance and post-mammography, the post-procedure mammography is not billable.
Examples:
- MRI-guided breast biopsy with post-biopsy mammography = Yes
- Stereotactic-guided breast biopsy with post-biopsy mammography = No
When post-biopsy mammography is performed and dictated in the same report as biopsy, a separate paragraph describing the post-biopsy mammogram technique and findings should be clearly stated.
Based on carrier policy, some plans may require a separate report.
Post-biopsy mammography is not required to have BI-RADS categories documented.
FDA Inspections for MQSA will now include the following requirements
Patient Lay Summaries: At a minimum, the reports must include the facility’s name, city, zip code, and telephone number. If there is more than one facility within a healthcare organization, the facility where the imaging took place must be listed on the report.
Depending on whether the patient’s breast density is dense or not dense, as indicated by the mammography report, the patient lay summary must include one of the following notification statements. The FDA strongly recommended adhering to this specific wording.
- “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.”
- “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 of Results: If a mammogram is assessed as “Suspicious” or “Highly Suggestive of Malignancy,” the healthcare provider and patient must be notified within 7 days.
If the exam has an assessment of “Incomplete: Need prior mammograms for comparison,” the facility issues a follow-up report with a final overall assessment within 30 calendar days of the initial report, regardless of whether comparison views are obtained.
Medical Outcomes Audit: Facilities must conduct an annual audit, tracking predictive values, cancer detection rates, and recall rates for each interpreting physician and the facility as a whole.
Accreditation and Equipment: Facilities failing three consecutive accreditation attempts will face a one-year ban from reapplying. All mammography devices must possess the applicable FDA premarket authorization standards.
Personnel Records: Facilities must maintain training and qualification records for current and former personnel, making these records available for review during MQSA inspections.
Records of personnel no longer employed by the facility must be maintained for no less than 24 months from the date of the departure of the employee, and these records must be available for review at the time of any annual inspection occurring during those 24 months.
The facility shall provide copies of these personnel records to current interpreting physicians, radiologic technologists, and medical physicists, upon request. Facilities must provide personnel records to former employees if the former employees communicate their request within 24 months of their departure date.
Recordkeeping and Transfer: Transfers of mammogram imaging and reports, or release of copies, must take place within 15 calendar days of the facility receiving the request. For digital mammograms or digital breast tomosynthesis, if the examination is being transferred or released for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically.
Before a facility closes or terminates mammography services, it must make arrangements for patients and healthcare providers to access those mammographic records. The facility must notify its accreditation body and certification agency in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients.
Self-Referred Patients: Facilities must have a system for referring patients without healthcare providers, especially when findings are potentially malignant.
Failure to comply with these regulations could result in enforcement actions by the FDA. Also important, the FDA may take action regardless of whether noncompliance is found by means other than an inspection.
Failure to meet the MQSA standards can cause the following actions.
- Warning Letters: The FDA may issue warning letters to facilities not complying with MQSA standards, detailing the specific violations and requiring corrective actions within a specified timeframe.
- Suspension or Revocation of Certification: The FDA can suspend or revoke the certification of a facility, which would prevent them from performing mammography services until compliance is achieved.
- Fines and Penalties: Non-compliant facilities may face monetary penalties or fines for failing to meet MQSA requirements.
- Legal Action: In severe cases, the FDA may pursue legal action, including seeking injunctions or other judicial remedies to enforce compliance.
- Patient Notification: Facilities may be required to inform patients and their physicians if the quality of mammograms is substandard due to non-compliance.
- Onsite Inspections: The FDA might conduct more frequent and rigorous inspections to ensure corrective actions are implemented and maintained.
- Mandatory Corrective Action Plans: Facilities could be required to submit and follow a detailed corrective action plan to address the deficiencies identified during inspections
Additional Information Excerpts
For the entire Federal Register :: Mammography Quality Standards Act
To read the entire FDA article; Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA) | FDA
Questions for MQSA: Hotline [email protected] or 1-800-838-7715
Resources: FDA, Federal Register
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