CMS Pub. 100-04, ch. 18, § 20.1

The Mammography Quality Standards Act (MQSA) provides specific standards regarding those

qualified to perform screening and diagnostic mammograms and how they should be certified. The

MQSA requires the Secretary to ensure that all facilities that provide mammography services meet

national quality standards. Effective October 1, 1994, all facilities providing screening and

diagnostic mammography services (except VA facilities) must have a certificate issued by the Food

and Drug Administration (FDA) to continue to operate. The FDA, Center for Devices and

Radiological Health, is responsible for collecting certificate fees and surveying mammography

facilities (screening and diagnostic).

The FDA provides CMS with a listing of all providers that have been issued certificates to perform

mammography services and CMS notifies A/B MACs (A) and (B) accordingly. A/B MACs (A)

and (B) are also notified of situations where a provider’s certificate has expired, or has been

suspended or revoked. The information provided includes the provider’s name, address, 6-position

certification number, effective/expiration dates and the letter “T” to designate the facility as

terminated.

Medicare will reimburse only FDA-certified mammography centers for mammography services.

A/B MACs (B) must inform physicians and suppliers at least annually, through their

provider/supplier publications, of those facilities centers, that are certified. A/B MACs (B)

encourage physicians to inform their patients about centers that are certified.

Mammography facilities that perform screening mammographies are not to release screening

mammography x-rays for interpretation to physicians who are not approved under the facility’s

certification number unless the patient has requested a transfer of the mammography from one

facility to another for a second opinion, or unless the patient has moved to another part of the

country where the next screening mammography will be performed. Interpretations are to be

performed only by physicians who are associated with the certified mammography facility. A/B

MACs (B) are not required to maintain a list of these associations unless there is a specific reason

for doing so and only on a case-by-case basis.

When adjudicating a screening mammography claim, MACs refer to the table of certified facilities

provided by the FDA through CMS and confirm that the facility listed on the claim is in fact

certified to perform the service. When the MAC determines that the facility that performed the

mammography service has not been issued a certificate by the FDA or the certificate is suspended

or revoked, the claim will be denied utilizing the denial language in §20.8.1 of this chapter, related

to certified facilities.