The FDA Mammography Quality Standards Act (MQSA) inspection fee for a mammography facility with one unit is $2,150 effective October 1, 2007. The charge for each additional unit is $250. The fee for a follow-up inspection is $1,144. Facilities in certifying states (Illinois, Iowa, South Carolina and Texas) should contact their state certifying agency to determine the fees that apply to them. The FDA portion of the fee for facilities within approved certifying states is $548.
The Mammography Quality Standards Act (MQSA) of 1992 and the subsequent reauthorization Acts require the FDA to assess and collect fees from mammography facilities to cover the costs of inspections.
Federal Register Notice
FDA revised the following inspection fee structure under MQSA as explained in the July 6, 2007 Federal Register (FR) Notice (72 FR 37027)
|Number of Units||Fee|
|Follow-up Inspection Fee||$1,144 (if subject to fees)|
|Facilities Operating Within Approved Certifying States||$548|
Inspection Fee Payment: Government Entity (GE) Status Facilities
(1) A governmental entity is a mammography facility subject to inspection under section 354 (g)(1) of the Public Health Service Act, 42 U.S.C. 263b(g)(1) 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. The entire salary of all on-site personnel of the mammography facility must be directly paid by a particular form of government as listed above. All the facility's mammography equipment must be owned, rented by, or leased by a particular from of government as listed above. The facility's ultimate authority to make day-to-day decisions concerning the management and operation of the mammography facility must come from a particular form of government as listed above. All these requirements must be met in order for a facility to be considered a governmental entity. The particular form of government also must be listed on the Governmental Entity Declaration form (Form 3422) [PDF] in the space provided. FDA does not recognize a facility providing Medicare/Medicaid services without meeting the governmental entity criteria described above.
(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 that statute. The FDA does not recognize other breast cancer or mammography programs/grants under the governmental entity exemption.
Following the closure of the FDA MQSA inspection, the FDA issues an invoice and includes the Government Entity (GE) Declaration form mentioned above. If your facility fulfills the Government Entity (GE) criteria, please complete the form and return within 30 days of receipt of your MQSA inspectional invoice to the following address:
FDA FORM 3422 (GE): If your facility is claiming GE status, please complete the GE Declaration form (Form 3422) Government Entity Declaration (PDF) and submit it electronically to MQSAUserFeeSupport@fda.hhs.gov.
If the FDA accepts your facility as a governmental entity, you will not receive additional fee statements concerning the inspection. If you continue to receive fee statements, however, please contact the MQSA Hotline by one of the options outlined below to discuss the status of your claim.
NOTE: Facilities claiming governmental entity status must submit a governmental entity form each year. The FDA conducts a Governmental Entity Audit periodically. Your facility may be selected as part of an audit sample. If your facility is selected to participate in the audit, your facility may be notified to provide additional information substantiating your GE claim.
MQSA 2020 Governmental Entity (GE) Audit Results
On August 24, 2020 the Food and Drug Administration began it biennial Governmental Entity (GE) audit of certified mammography facilities who claim this exemption under the Mammography Quality Standards Act (MQSA). The Act requires that mammography facilities submit an annual self-certification form (Form FDA 3422) to have the annual mammography inspection fee waived.
To verify these claims, the FDA randomly selected a sample of 90 of the approximately 600 mammography facilities currently claiming GE status, between the dates of October 1, 2018 through December 31, 2019, to participate in this audit. Of the 90 facilities that were audited, the FDA was able to verify that 100% were eligible for exemption.
Inspection Fees: Non-Governmental Entity (GE) Status Facilities
If your facility is not eligible to apply for GE status under MQSA, you must pay your inspection fee within 30 days from the date of the invoice, issued following the closure of your MQSA inspection.
You can pay online at https://userfees.fda.gov/pay. (Note: Only full payments are accepted. No partial payments can be made online.) You may also pay your inspection fees through the U.S. Postal Service. Payment in the form of United States (U.S.) dollars by check, bank draft, or U.S. Postal Order drawn on or payable through a U.S. financial institution is accepted. Please make your payment to the order of the FDA MQSA Program and mail it through the U.S. Postal Service within the above-specified time frame to the following address:
Food and Drug Administration
P.O. Box 979109
St. Louis, MO 63197-9000
For Overnight Courier Address:
U.S. Bank ATTN: Government Lockbox 979109
1005 Convention Plaza
St. Louis, MO 63101
Non-Payment of Inspection Fee
If the FDA does not receive FULL payment within 30 days from the date of the invoice, your facility will be subject to the provisions of the Department of Health and Human Services (DHHS) Claims Collection Regulations at Section 30.13 of Title 45 of the Code of Federal Regulations (45 CFR 30.13). The Regulations give the FDA the authority to assess an interest penalty at the prevailing rate set by the Department of Treasury, subject to change on a quarterly basis (currently 9.75% APR); assess a $20 administrative fee for delinquent invoices over $100 for each full 30-day period the account remains outstanding; and assess a late penalty payment (6% per year).
Also, the FDA will take one or more of the following actions if you do not pay your inspection fee in FULL within 30 days of the invoice date:
- Report this debt to credit reporting agencies.
- Forward your account to a collection agency and/or the U.S. Department of Treasury (DOT) for enforced collection and credit bureau reporting, in accordance with the Debt Collection Act of 1982 and the Debt Collection Improvement Act of 1996 if you continue to be delinquent in paying this fee.
- Forward your account to the DOT, Treasury Offset Program (TOP), which offsets your Federal payments, including any tax refund due you from the Internal Revenue Service (IRS), to collect your delinquent debt.
- Refer your account to the Department of Justice (DOJ) for appropriate action, or to the IRS for reporting of additional income.
Note: All additional fees charged by these entities will be the responsibility of the facility (ranging from 3% to 28% of the total amount due).
Inspection Fee Consolidation
Providers with multiple mobile mammography units and some stationary sites operating under two or more MQSA certificates may have the option (for inspection purposes only) of combining their facilities to reduce their total inspection fee (Total Inspection Fee = $2,150 + n-1 x $250 where n = total number of units inspected). Discuss your eligibility for inspection fee consolidation with your MQSA inspector prior to the inspection. More information regarding inspection fee consolidation is available in the MQSA Inspection Procedures.
Changes to Facility Information
Billing Specific Changes:
- If the billing email address we used to email your fee statement is incorrect, please contact the MQSAUserFeeSupport@fda.hhs.gov.
Other Facility Changes (for example, official contact or address, EIN# and unit information):
- Please confirm your accreditation body has updated and correct information from your facility. The FDA provides facility information from accreditation body’s to the Centers for Medicare and Medicaid Services. Incorrect information may result in reimbursement delays or denials.
Inspection Fee Questions
If you have any questions about MQSA Inspection Fees or GE declaration you may contact MQSAUserFeeSupport@fda.hhs.gov.
If you have questions regarding MQSA certification, you may contact the MQSA Hotline at 1-800-838-7715 or by email MQSAhotline@versatechinc.com.