Certification of Mammography Facilities

20.1 - Certification of Mammography Facilities (Rev. 1387, Issued: 12-07-07, Effective: 04-01-08, Implementation: 04-07-08) 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.