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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Inspection Fee Consolidation

Policy Guidance Help System logo

Due to the various ways mammographic machines were originally accredited and later certified, some inequitable billing situations have occurred. To address this, FDA has instituted an inspection fee consolidation policy (inspectors and facilities in Certifying States should contact their State Certifying Agency to determine the policies that apply to them). While this was originally designed for mobile facilities, it also applies to some stationary facilities. We believe that this policy will affect only a small percentage of mammographic facilities but will go a long way in correcting these billing problems. While everyone has his/her own idea of what a mammographic facility is or should be, it is important to remember that for MQSA purposes, a mammographic facility is defined by its MQSA certificate: one certificate equals one facility. When you walk into a radiology department, you may intuitively think of it as an independent mammographic facility; however, it may actually be a small portion of a much larger operation with several mammographic machines at widely separated locations, covered by a single MQSA certificate. Remember, the consolidation policy refers to inspection fee billing issues only. Any changes to accreditation status must be handled between the facility and its Accreditation Body.

The three main factors determining the fee are:

  1. Ownership of the mammographic x-ray units by a single entity,

  2. The number of certificates, and

  3. The number of mammographic x-ray units.

When two or more facilities (remember, one certificate equals one facility) are being considered for inspection fee consolidation, the number of "sites" must also be evaluated. "Site" refers to the relative location of the mammographic machines at the time of inspection. Multiple facilities located at one "site" may have their inspection fees consolidated, while those at multiple "sites" may not. Determining when two or more facilities qualify for the inspection fee consolidation will require the judgment of the inspector and should be based on the following guidance.

1. The two main factors to consider are the proximity of the mammographic x-ray units at the time of the inspection and that all the mammographic machines are owned by a single entity. Paper records for all the facilities (QA, QC, medical audit, and personnel records) must be available at the time and location of the inspection.

2. X-ray units that are close enough (usually in the same building or separated by no more than a block or two) to allow an inspector to examine the machines in a reasonable amount of time should be considered one "site."

3. Mobile units that can be brought together (possibly at the site of one or more stationary units), thereby allowing an inspector to examine the machines in a reasonable amount of time, should be considered one "site-" for billing purposes. All processing must be done either centrally at the inspection site or on-board.

This policy is best illustrated by reviewing several representative examples. In all the cases below, it is assumed that the mammographic machines are owned by one entity.

  Example 1 — You are inspecting a facility and find out that they have a second mammographic unit under a different MQSA certificate number. The second unit is just down the hallway. In this case you can combine the inspections for billing purposes. The total charge will be $2150 (1 full fee) + $250 (1 additional unit fee).

 Example 2 — You are inspecting an entity that owns 5 mobile mammography units and 2 stationary mammography units. Each of the 7 mammographic units has its own MQSA certificate number. All mobile units have on-board processing. The 2 stationary units are located several miles apart. The owner is able to bring 2 of his mobile units to the same location as one of his stationary units. In this case you can combine these three inspections for billing purposes. The total charge will be $2150 + $250 + $250. The remaining units (3 mobile and 1 stationary) will be inspected at a later date or dates.

 Example 3 — You are inspecting a large university with a total of 4 units, all under one certificate. Three of the mammographic units are in the same building and the other is located 5 miles away in a satellite location. The total charge will be $2150 + $250 + $250 + $250. While this would seem to be a contradiction of the definition of a single "site" (units separated by 5 miles), the overriding factor in this case is that all the units are covered by a single MQSA certificate. While this may seem "unfair" to other facilities, by law, this facility cannot be charged as if it were two separate facilities.

 Example 4 — You are inspecting a mobile operator that has 2 mammographic units, each with its own MQSA certificate. Each of the units goes to 10 remote locations. The remote locations have their own processors. The mobile operator brings both mammographic units to one of the remote locations for the inspection. This example does not qualify for fee consolidation because all film processing is not done centrally or on-board the mobile units. Total charge will be $2150 + $2150.

The preceding guidance and examples should answer many of your questions but cannot take into account all the possible situations you may encounter. If inspectors have further questions or run into an unusual situation, they should contact the Facility Hotline at 1-800-838-7715 or MQSAhotline@hcmsllc.org.

The inspection software feature called Grouping Inspections for Billing should be used for this purpose. This software feature deals ONLY with fee consolidations. The inspection data should be entered in the usual manner. Each certificate-holding facility is to have its own data entered into its own inspection report. This will require you to input data common to the facilities into each of the inspection reports. For example, you will have to input the common data on the personnel, audits, QC, QA, and so on into all the inspection reports.