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US · guidance

CMS Pub. 100-04, ch. 18, § 20.1.2

FDA Certification Data

activein force · 2026-08-25 – presentas-observed

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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