The FDA MQSA inspection fee for a mammography facility with one unit will be raised from $1,749 to $2,150 for inspections performed on or after October 1, 2007. The charge for each additional unit will increase to $250. The fee for a follow-up inspection will change from $991 to $1,144. Facilities in Certifying States should contact their State Certifying Agency to determine the fees that apply to them. The fee FDA assesses on facilities operating within approved Certifying States will increase to $548. The option of grouping inspections for a fee discount will continue for eligible mammography providers. For additional information, see the Federal Register notice (72 FR 37027) published on July 6, 2007.
The Mammography Quality Standards Act (MQSA) of 1992 and the subsequent reauthorization Acts require the Food and Drug Administration (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).
Table 1 - Annual Inspection Fee by Number of Units ($250 each for additional unit)
|Number of Units||Fee|
|Follow-up Inspection Fee||$1,144 (if subject to fees)|
|Facilities Operating Within Approved Certifying States||$548|
Non-Governmental Entity (GE) Status Facilities
If your facility is not eligible to apply for GE status under MQSA (described on the next page), you must pay your inspection fee within 30 days from the date of the invoice, issued following your MQSA inspection. You may pay in United States (U.S.) dollars by check, bank draft, or U.S. Postal Order drawn on or payable through a U.S. financial institution. Please make your payment to the order of the FDA MQSA Program and mail it via 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:
ATTN: Government Lockbox 979109
1005 Convention Plaza
St. Louis, MO 63101
*NOTE: Facilities that do not believe they are governmental entities do not need to return the GE Form.
Non-Payment of Inspection Fee
If 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 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 10.375% 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, FDA will take one or more of the following actions if you do not pay your inspection fee:
- 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).
Governmental Entity (GE) Status Facilities
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 of 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 of 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.
(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, (www.cdc.gov/cancer/nbccedp) and at least 50% of the mammography screening examinations provided during the preceding 12 months were funded under that statute. FDA does not recognize a facility providing Medicare/Medicaid services without meeting the governmental entity criteria described above. Additionally, other breast cancer or mammography programs/grants are not recognized under the governmental entity exemption.
Following the FDA MQSA inspection, FDA issues an invoice and includes the GE Declaration form mentioned above. . If you believe your facility meets the criteria, please complete it and return within 30 days of receipt to the following address:
MQSA Governmental Entity Declaration
FDA Mammography Quality Assurance Program
P.O. Box 6057
Columbia, MD 21046
Or Via Fax - 410-290-6351
If 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 via 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. FDA conducts a Governmental Entity Audit biennially. Your facility may be selected as part of an audit sample. If so, your facility may be notified to provide additional information substantiating your GE claim.
On May 14, 2012, the Food and Drug Administration began its 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 this information, FDA randomly selected 94 of the approximately 700 mammography facilities who claimed GE status to participate in this audit. Of the 94 facilities that were audited, FDA was able to verify the GE status of 95% . The remaining 5% were either no longer eligible for or denied GE status.
Inspection Fee Consolidation
Providers with multiple mobile mammography units and some stationary sites that are presently operating under two or more MQSA certificates may have the option (for inspection purposes only) of combining their facilities in order 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. Information regarding inspection fee consolidation can be found on the MQSA Policy Guidance Help System.
Facility Information Changes
Billing Specific Changes - If the billing address we used to mail your fee statement is incorrect, please contact the MQSA Hotline via one of the options provided below.
Other Facility Changes (e.g., official contact or address, EIN# and unit information) - Make sure that your Accreditation Body (AB) has updated and correct information from your facility. FDA provides facility information from AB’s to the Centers for Medicare and Medicaid Services. Incorrect information may result in reimbursement delays or denials.
If you have any questions about MQSA Inspection Fees, GE declaration, or MQSA certification, you may contact the MQSA Hotline via one of the following options:
|MQSA Website:||Mammography Quality Standards Act and Program (Search on the topic)|
|MQSA Hotline Phone Number:||1-800-838-7715|
|MQSA Fax:||Food and Drug Administration
|MQSA Hotline Email Address:||MQSAhotline@hcmsllc.com|
|MQSA Hotline Mail Address:||Mammography Quality Assurance Program
Food and Drug Administration
P.O. Box 6057
Columbia, MD 21045