User Guide — Mammography FDA Certification FAQ

athenaCollector

This page lists questions and answers about mammography certification.

 

A mammography certification number is a number issued by the Food and Drug Administration (FDA). All facilities providing mammography services must be FDA-certified.

 

 

 

In order for Medicare to know whether the mammography facility is certified to perform digital mammography (and is therefore due a higher payment rate), the Centers for Medicare and Medicaid Services (CMS) and the FDA have instructed carriers to use the FDA mammography certification number submitted on the claim to determine whether the facility is certified to perform film or digital mammography.

 

 

 

All facilities providing mammography services must be FDA-certified. Providers must submit the 6-digit FDA mammography certification number on claims for screening and diagnostic mammography services. This requirement is for billing of global procedures and technical components only.

 

 

 

Information about certification requirements can be found at https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/facility-certification-and-inspection-mqsa or by calling MQSA Facility Hotline at 1-800-838-7715. Accreditation responsibilities have been delegated to participating states. Those responsibilities include:

  • Issuance, renewal, suspension, and revocation of certificates to mammography facilities within the State
  • Annual facility inspections
  • All compliance actions for any findings upon inspection

 

 

Providers must bill the correct FDA certification number based on the type of mammography performed.

  • If a film mammography HCPCS code is billed and the FDA certification number is certified for film mammography, the service will be paid. If the FDA certification number is missing or is not certified for a film mammography, the service will be denied or returned as "unprocessable."
  • If a digital mammography HCPCS code is billed and the FDA certification number is certified for digital mammography, the service will be paid. If the FDA certification number is missing or is not certified for a digital mammography, the service will be denied or returned as "unprocessable."

 

 

Mammography certification numbers should be entered using the Department Numbers page. Select the "Mammography Cert Number" provider number category. Please enter expiration dates when applicable.