US · guidance
CMS Pub. 100-04, ch. 18, § 20.1.2
FDA Certification Data
The FDA furnishes data to CMS on a weekly basis, which specify the certification of facilities
under the MQSA. This data are contained in a “MQSA file.”
Prior to April 1, 2003, the MQSA file showed all facilities that are certified to perform film
screening and diagnostic mammograms. After April 1, 2003, the file shows a new Record Type
with two indicators, “1” for film and “2” for digital to determine which mammograms the facility is
certified to perform.
Section 104 of the Benefits Improvement and Protection Act (BIPA) of 2000, entitled
“Modernization of Screening Mammography Benefit,” provided new payment methodologies for
both diagnostic and screening mammograms that utilize digital technology. The new digital
mammography codes have a higher payment rate. In order for Medicare to know whether the
mammography facility is certified to perform digital mammography and, therefore, due a higher
payment rate, CMS relies upon the FDA certification data contained in the MQSA file. The FDA
sends an updated file via the CMS Mainframe Telecommunications System (CMSTS), formerly
Network Data Mover, on a weekly basis.
Effective July 1, 2006, the MQSA file shows:
• Name of Facility,
• Certification number of the facility,
• Film certification obtained (Record-type =1) or digital certification obtained (Record-type = 2),
• Effective and Expiration dates of each certification,
• Letter “T” to designate the facility as terminated,
Some mammography facilities are certified to perform both film and digital mammography. In this
case, the facility’s name and FDA certification number shows up on this file twice. One line will
indicate film certification with effective date/expiration date while the other line will indicate
digital certification with effective date/expiration date.
NOTE: The FDA does not issue printed certification which indicates film or/and digital. Refer
to the MQSA file for proof of types of mammography the facility is certified to
perform.
If the MQSA file appears to be in error, contact your regional office mammography coordinator.
The coordinators will contact the FDA to research the apparent error.
History
(Rev. 1387, Issued: 12-07-07, Effective: 04-01-08, Implementation: 04-07-08)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
ec1cfbb0200970192ded3f26e1583846d11c9759e6fc25cc4a94f4395e800f66
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