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Frequently Asked Questions

Why is Medicare denying claims for my newly installed Full Field Digital Mammography unit?

A number of practices are experiencing payment problems with the CMS for FFDM services. The FDA does not provide MQSA certificates that specifically state that a facility is certified to perform 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 digital mammography.

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.

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.


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. As an example, mammography equipment is considered to be:

  • Mammography Unit
  • Review Workstation
  • Printer
  • Film Screen Processor

Additionally, existing equipment must also be evaluated after major repairs or component replacement. See the attached document titled Medical Physicist Involvement in Equipment Adjustments, Changes or Repairs.

Note that digital mammography equipment requires reference to the appropriate quality control manual.


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

You will need to contact the Iowa Department of Public Health Mammography Program in order to receive an application for your new unit. Personnel information is available on the Contacts page.

In order to begin using the new unit on patients, you will need to submit:

  • a completed application,
  • a Mammography Equipment Evaluation performed by your Medical Physicist, and
  • a radiation shielding plan for the room where the unit will be located.

Your application must be approved by the IDPH Mammography Program before you begin to use the new unit.

Once the new unit is approved, you will have six months to complete the remainder of the accreditation/authorization process. If your facility accredits with IDPH, you must submit for review:

  • Clinical Images

One primarily fat-replaced tissue

One primarily glandular (dense) tissue

  • Phantom Image

These images should be submitted within four months of initial approval to use the unit.


What is the Personnel Attestation?

As a part of accreditation and certification requirements, your facility must demonstrate that all personnel participating in performance, interpretation, or survey evaluation for your mammography program meet all of the personnel requirements.

You can demonstrate this by:

Submitting documentation of the initial and continuing qualifications for each technologist, radiologist, and medical physicist.

OR

Reviewing the documentation with your lead interpreting physician to ensure that all personnel meet the requirements. Your lead interpreting physician can then sign the application indicating this and the actual documentation will be reviewed by IDPH at your next annual mammography inspection.

For more information on personnel qualifications, go to the Qualification Forms page.


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

Please see PDF file.

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

Please see the PDF file for guidance.

What are the costs I can expect to incur for my facility's mammography program?

Initial Unit Accreditation and Reaccreditation - Initial and every 3 yrs

$200/facility - Accreditation fee

$200/submission - Clinical Image Review fee

Examples:

One unit and the clinical image review passes on 1st submission:

  • The cost for accreditation will be $400.

Two units and each clinical image review passes 1st submission:

  • The cost for accreditation will be $600.

One unit and the clinical image review passes on 3rd submission:

  • The cost for accreditation will be $800.

Annual Inspection/Certification/Registration - Annual

$900/1st unit + $325 each additional unit - IDPH Inspection Fee

$548/inspection - FDA Inspection Fee [waived if the facility meets government entity (GE) status]

$50/inspection - Certification Fee

$51/X-ray tube - Tube Registration Fee

Example:

One Unit - IDPH - $1001 FDA- $548 Total - $1549

Two Units - IDPH - $1377 FDA- $548 Total - $1874