Any facility that performs mammography without MQSA certification may be subject to civil money penalties of up to $10,000 per violation per day.
MQSA (42 U.S.C. 263b(h)(3))
1) Failure to obtain an MQSA certificate as required;
2) Each failure by a facility to substantially comply with, or each day on which a facility fails to substantially comply with, the standards established;
3) Each failure to notify a patient of risk as required by the Secretary; and
4) Each violation, or for each aiding and abetting in a violation of any provision of, or regulation promulgated under MQSA, by an owner, operator, or any employee of a facility required to have an MQSA certificate.
Facilities that are not MQSA certified cannot be reimbursed by the federal government for mammography services. The Centers for Medicare and Medicaid Services (CMS) will not reimburse facilities for Medicare screening and diagnostic mammography examinations if they do not have an MQSA certificate, or if their MQSA certificate has expired, been suspended, or been revoked. The amount and frequency of reimbursement is governed by CMS regulations. FDA provides CMS with an efficient system to confirm the certification status of all mammography facilities. CMS shares this information with insurance carriers, who are committed to reimburse only for lawfully performed mammography procedures.