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

 

StreamlineMD provides Revenue Cycle Solutions to Radiology & Interventional Specialists. Our Mission is to Improve Healthcare for All Americans.  Our Core Values that guide us on our mission are Service Quality, Teamwork, Accountability, Efficiency, Adaptability, Communication, and Integrity. Proud winner of the Great Place To Work award. Learn more about us at streamlineMD.com,
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Cyber Incident Update – 9/28/25 at 6:00 pm EST:

StreamlineMD applications are up and live!

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We are pleased to inform you that, following clearance from our cybersecurity experts, client access to our system has been restored. You may begin accessing the system starting at 6:00 PM EST today, Sunday, September 28, 2025.

Please note that while core functionality is fully restored, the following features are currently unavailable as we continue working to bring all components back online:

1. SMD Mobile App (viewing PDF chart)
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We are working to restore these remaining services as quickly and securely as possible.

We will continue to monitor system performance closely and will provide updates as additional components become available.

If you experience any issues or require support, please contact our support team directly at 330-564-2641.

Thank you once again for your continued patience, understanding, and trust.

Cyber Incident Update – 9/28/25 at 2:00 pm EST:

Following our scheduled call with the cybersecurity team earlier today, we have been advised that additional security measures must be implemented before client access can be restored. Specifically, changes to our VPN configuration are required to ensure a more secure connection environment.

Our internal teams are actively working on these adjustments and will move as quickly and carefully as possible to complete the necessary changes.

Our next update will be at 4:00 PM EST.

Cyber Incident Update – 9/28/25 at 12:00 pm EST:

We are pleased to share that our internal teams currently have access to the system environment. In the interim, if needed, we are able to assist by running your patient appointment schedules for the week. Please contact our support team or email at smdhelpdesk@prcmedicalllc.zohosupport.com if you require this service.

We are scheduled to meet with our cybersecurity team at 1:00 PM EST today to review final clearance for restoring client access. We will provide another update following that discussion.

We appreciate your continued patience and partnership as we work to bring services back online safely and securely.

Cyber Incident Update – 9/27/25 at 10:00 pm EST:

We are pleased to report that our routine nightly processes have completed successfully, and the system environment remains stable and fully operational.

At this stage, we are awaiting final clearance from our cybersecurity partner before restoring client access.

However, our partner informed us that they need more time and so this clearance will not be available until after 1:00 PM EST tomorrow, Sunday, September 28, 2025.

Thank you for your patience while we maintain the highest standards of security and system integrity. 

Cyber Incident Update – 9/27/25 at 7:00 pm EST:

We are continuing to move forward with final preparations for restoring system access. Our internal teams have completed their validation processes, and the environment remains fully operational.

At this time, we are running our routine nightly processes to further confirm system stability and readiness. We continue to await final clearance from our cybersecurity experts to bring services fully back online.

We remain optimistic that systems will be accessible to clients by tomorrow morning, Sunday, September 29, 2025, at 7:00 AM EST.

As always, we are taking every measure to ensure a secure and controlled restoration.

Thank you again for your continued patience and support. Our next update will be provided by 10:00 PM EST.

Cyber Incident Update – 9/27/25 at 11:00 am EST:

We are pleased to share that our team has gained access to the system environment and is actively conducting testing—an important step toward the full restoration of services.

As part of this process, we have completed testing of the Practice Management (PM) and Coding software and are pleased to report that no issues have been identified with the software. Testing will continue across all system components to ensure overall stability and reliability.

Our teams will continue working throughout the day to validate all aspects of the system before bringing it back online.

We are deeply grateful for your continued patience, support, and trust as we proceed with restoration in a safe and controlled manner.

We will provide another update at 2:00 pm EST.

Cyber Incident Update – 9/26/25 at 7:00 pm EST:

We are pleased to share that our team is now gaining access to the system environment and actively conducting testing. This is an important step toward full restoration of services.

We again want to reassure you that there is no evidence of any compromise of Protected Health Information (PHI) or damage to our systems.

Our teams will continue to work throughout the evening and into the weekend to validate all aspects of the system before bringing it back online.

Thank you for your continued patience, support, and trust as we move forward with restoration in a safe and controlled manner.

We will provide another update at 10:00 am EST on Saturday, September 27, 2025.

Cyber Incident Update – 9/26/25 at 3:00 pm EST:

We continue to make steady progress in our restoration efforts. At this time, 95% of servers have been cleared; however, they remain behind protective firewalls as we work closely with our team of experts toward full restoration.

The StreamlineMD systems will remain unavailable for the rest of today, Friday, September 26, 2025. Our teams will begin comprehensive testing of all aspects of the system as soon as possible, likely this evening and over the weekend.

Importantly, there is no evidence of any compromise of Protected Health Information (PHI) or damage to our systems.

We truly appreciate your support and understanding during this process. You are important to us, and we remain committed to restoring services safely and securely.

We will provide another update at 6:00 pm EST.

Cyber Incident Update – 9/26/25 at 2:00 pm EST:

We continue to work diligently this afternoon with our cybersecurity team and are making steady progress.   

We anticipate the StreamlineMD systems will remain inaccessible for the remainder of today, Friday, September 26, 2025.  

We will provide another update at 6:00 pm EST.

We appreciate your continued patience and understanding as we work to restore services in a secure and controlled manner.

Cyber Incident Update – 9/26/25 at 11:00 am EST:

We continue to work throughout the day with our cybersecurity team and continue to make progress.  

We anticipate the StreamlineMD systems will not be accessible before 3:00 pm EST on Friday, September 26, 2025

We will provide another update at 2:00 pm EST.

We appreciate your continued patience and understanding as we work to restore services in a secure and controlled manner.

Cyber Incident Update – 9/26/25 at 09:00 am EST:

We continue to work this morning with our cybersecurity team and continue to make progress.   

We still don’t anticipate StreamlineMD systems to be fully operational before 12:00 pm EST on Friday, September 26, 2025.  

We will provide another update at 12:00 pm EST.

We appreciate your continued patience and understanding as we work to restore services in a secure and controlled manner.

Cyber Incident Update – 9/26/25 at 07:00 am EST:

We have continued to work through the night with our cybersecurity team and continue to make progress.  

We will continue restoring servers to service and testing internally. 

We still don’t anticipate StreamlineMD systems to be fully operational before 12:00 pm EST on Friday, September 26, 2025. 

We will provide another update at 9:00 am EST.

We appreciate your continued patience and understanding as we work to restore services in a secure and controlled manner.

Cyber Incident Update – 9/25/25 at 11:00 pm EST:

So far, we are making great progress, and our systems are internally coming back online. At this time, there is no evidence of system damage or PHI compromise.

Throughout the night, we will continue restoring servers to service and testing internally.

We don’t anticipate StreamlineMD systems to be fully operational before 12:00 pm EST on Friday, September 26, 2025.

We will provide another update on Friday, September 26, at 6:00 am EST


Cyber Incident Update –9/25/25 at 7:00 pm EST:

We are currently in the process of restoring our servers and anticipate determining a timeline for resuming full operations by 10:00 PM EST this evening, September 25, 2025.

Our team continues to work diligently and in close coordination with our security partners in response to the cybersecurity incident that occurred during the overnight hours of September 24, 2025. As a precaution, our systems remain offline to prevent any potential data compromise. We continue to follow our established cybersecurity protocols to ensure the protection and integrity of your data.

We will provide our next update by 10:00 PM EST today.

We appreciate your continued patience and understanding as we work to bring our systems back online safely.

Incident Update – 9/25/25 at 12:00 pm EST:

StreamlineMD is currently working closely with our security team to address a cybersecurity incident that occurred during the overnight hours of September 24, 2025. As a precautionary measure, we proactively shut down our systems to prevent any potential data compromise.

Our team is actively following established cybersecurity protocols to ensure the continued protection of your data. At this time, the software will remain inaccessible for the remainder of the day, September 25, 2025.

We understand the impact this may have on your operations and sincerely appreciate your patience and understanding. We are committed to providing updates as frequently as possible and will keep you informed of our progress.

StreamlineMD is experiencing a cyber incident

Our security software detected malicious behavior and our team of internal and external experts are working to resolve the issue. The security team has made it clear that we need to shut down our services altogether, pending a more detailed analysis.