Radiation-Emitting Products

Governmental Entity

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Discussion:

Facilities determined by FDA to be governmental entities are exempt from paying FDA-imposed MQSA inspection fees. Facilities in SAC States may still be responsible for paying any SAC-imposed fees. A governmental entity is a mammography facility that meets either of the following criteria:

1. The facility is operated by any federal department, state, district, territory, possession, federally-recognized Indian tribe, city, county, town, village, municipal corporation or similar political organization or subpart thereof. In addition, (1) the entire salary of all on-site personnel of the mammography facility is directly paid by a particular form of government as listed above; (2) all of the facility’s mammography equipment is owned, rented by, or leased by a particular form of government as listed above; and (3) the facility’s ultimate authority to make day-to-day decisions concerning the management and operation of the mammography facility comes from a particular form of government as listed above. If the facility meets these criteria, FDA will consider the facility to be a governmental entity. The facility should also list the particular form of government on the Governmental Entity Declaration form (Form 3422) in the space provided.

or

2. The facility provides services under the Centers for Disease Control and Prevention (CDC) grant supporting the Breast and Cervical Cancer Mortality Prevention Act of 1990, and at least 50% of the mammography screening examinations provided during the preceding 12 months were funded under this statute. Other breast cancer or mammography programs/grants are not recognized under the governmental entity exemption. For example, a facility that provides mammography services under the Medicare/Medicaid program does not qualify as a governmental entity, unless it meets the governmental entity criteria described above.

A Governmental Entity Declaration, FDA Form 3422, is included with each invoice for MQSA inspection services. A facility that believes that it qualifies as a governmental entity must complete this Declaration, have it signed by the facility’s Chief Financial Officer or Chief Operating Officer (or equivalent responsible person), and return it to FDA.

Any questions or concerns about billing and collection procedures may be addressed to Billing Inquiries c/o MQSA Hotline, P.O. Box 6057 Columbia, MD 21045-6057, 1-800-838-7715 or e-mail at MQSAhotline@hcmsllc.com.

Page Last Updated: 07/17/2014
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