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Frequently Asked Questions

  1. What is required to be in compliance of the Breast Density Rules in Iowa for mammography reports and patient lay letters?
  2. What has changed now that The State of Iowa is no longer an Accrediting Body (AB)?
  3. Why is Medicare denying claims for my newly installed Digital Breast Tomosynthesis (DBT) or Full Field Digital Mammography (FFDM) unit?
  4. What are appropriate assessment categories for the mammography report?
  5. When do I need to have my medical physicist check my facility and/or equipment?
  6. What do I need to do to install a new mammography unit at my facility?
  7. Are the Mammography Quality Standards Act regulations and the State of Iowa Bureau of Radiological Health Mammography rules (641 Chapter 41.6) the same?
  8. Does my facility have to accept self-referred patients?  If we choose to accept self-referred patients, what are the rules that apply?
  9. What are the IDPH fees I can expect to incur for my facility's mammography program?

 

1. What is required to be in compliance of the Breast Density Rules in Iowa for mammography reports and patient lay letters?

Iowa Administrative Code - Chapter 41.6(4)b.(10) contains the final regulations regarding information on a patient's breast density (p.99). 

For additional information:

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2. What has changed now that the State of Iowa is no longer an Accrediting Body (AB)?

As of January 1, 2020, the State of Iowa is no longer an AB.  All Iowa mammography facilities must be accredited by the American College of Radiology (ACR). 

For additional information:

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3. Why is Medicare denying claims for my newly installed Digital Breast Tomosynthesis (DBT) or Full Field Digital Mammography (FFDM) unit?

At times, a facility that installs new mammography equipment may experience payment problems with the Centers for Medicare & Medicaid Services (CMS) for DBT or FFDM services. The FDA does not provide MQSA certificates that specifically state that a facility is certified to perform DBT or FFDM. Instead, they send CMS a weekly file containing the most recent approval information. Your payer must look at the current MQSA file to see whether your facility is certified to perform FFDM and/or DBT mammography exams.

CMS Transmittal 828 explains the handling of these files. You may wish to provide a copy to your local payer.

You may contact the appropriate CMS headquarter representatives:

  • Medicare Carrier for non-payment of the professional component
  • Medicare Fiscal Intermediary (FI) for non-payment of the technical component

Please provide them with your facility’s 6-digit FDA ID number from your MQSA certificate and your MQSA expiration date.

 For additional information:

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4. What are appropriate assessment categories for the mammography report?

Final MQSA regulations require that each mammography report include an overall final assessment of the mammography examination. The acceptable wording for the assessment categories are as follows:

  • Negative
  • Benign
  • Probably Benign
  • Suspicious
  • Highly Suspicious of Malignancy
  • Incomplete: Need Additional Imaging Evaluation
  • Known Biopsy Proven Malignancy
  • Post Procedure Mammograms for Marker Placement

Accepted variations to these assessment terms can be found on the Acceptable Variations for Assessment Terms document link. 

Iowa Administrative Code - Chapter 41.6(4)b.(8) requires a separate and distinct section entitled “Assessment” be included in each mammography report.  The appropriate assessment term or equivalent must be included in the assessment, and this will be reviewed at the time of inspection.

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5. When do I need to have my medical physicist check my facility and/or equipment?

A medical physicist survey is required whenever a mammography facility installs new mammography equipment onsite or begins to use equipment located at an off-site location. Mammography equipment is considered to be but not limited to the mammography unit and review workstation (RWS).

Additionally, existing equipment must also be evaluated after major repairs, component replacements or some software updates. Note that FFDM equipment requires reference to the appropriate quality control manual to determine medical physicist requirements in these situations.  If you are relocating mammography equipment, contact IDPH Mammography Program staff for specific guidance. 

For additional information:

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6. What do I need to do to install a new mammography unit at my facility?

Additional information about new units can be found on our Authorization and Accreditation page.  Contact the IDPH Mammography Program staff for more information.

 
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7. Are the Mammography Quality Standards Act regulations and the State of Iowa Bureau of Radiological Health Mammography rules (641 Chapter 41.6) the same?

  For a list of the differences, click here: 

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8. Does my facility have to accept self-referred patients? If we choose to accept self-referred patients, what are the rules that apply?

For more information:

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9. What are the IDPH fees I can expect to incur for my facility's mammography program?

See the IDPH Mammography Fee Schedule PDF for more information.

You will receive a separate invoice for $548 from the FDA for the FDA Inspection Fee [waived if the facility meets government entity (GE) status].  

 

Example of IDPH fees for a facility inspection with an FFDM plus DBT unit:

$1575 - First Unit Inspection Fee

$375 - Additional Units Inspection Fee

$150 - Authorization Certification Fee

$120 - Registration Tube Fee 

$2220 - Total IDPH inspection fees

 

Example of IDPH fees for a stereotactic breast biopsy inspection with a prone FFDM unit:

$1575 - First Unit Inspection Fee

$120 - Registration Tube Fee

$1695 - Total IDPH stereotactic inspection fees

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