In the event that a test is determined by ARL’s Medicare fiscal intermediary to be medically unnecessary, the laboratory may only bill the patient if an Advance Beneficiary Notice (ABN) has been completed and signed by the patient prior to the time that the specimen is collected. The ABN is a three-part form available from ARL. Please see page 13 for information on completion of a valid ABN. Clients who have access to the Aspirus information system network are encouraged to use the ABN Compliance Checker to determine medical necessity and generate ABNs. The original ABN is submitted to ARL with the specimen for testing.
Medicare’s medical necessity requirements may not always be consistent with the reasons you believe a test is appropriate for a patient. Nevertheless, when you have reason to believe that Medicare may consider a test medically unnecessary, the patient should be asked to sign a completed ABN after receiving a clear explanation of the reason(s) the ABN is necessary. A new original ABN must be signed each time such conditions exist. An ABN signature may not be requested solely on the basis that a test being ordered is subject to coverage limitations under an LCD or NCD.
The ABN and your explanation ensure that the patient understands that he/she will be responsible to pay for any service marked on the form that Medicare does not cover for one of the following reasons:
- The test is subject to coverage limitations and the diagnosis for which the test is ordered is not considered to be indicative of medical necessity by Medicare.
- No diagnosis was provided.
- The test is ordered more frequently than Medicare considers medically necessary.
- The test is for research or investigational use only and is not approved by the Food and Drug Administration.
An Advance Beneficiary Notice may only be obtained when the laboratory or physician believes a test may not be covered. ABNs must not be obtained from every Medicare beneficiary (blanket ABN).
An ABN is not required for screening services or services that Medicare does not cover. However, the ABN is highly recommended because the patient must be informed that Medicare does not provide coverage for screening diagnoses or for a particular service.
If Medicare denies reimbursement for a test and a valid ABN has not been obtained, the client will be billed for the test at the client’s fee schedule rate.
All of the information on the Advance Beneficiary Notice form must be completed. The test(s) that you believe will be considered by Medicare to be medically unnecessary must be clearly marked. The reason for possible denial of payment must also be indicated. Please write the test name and CPT code as they appear in ARL’s test request form, reference manual or Misys function MIQ. Do not use synonyms or abbreviations.
Please be sure that the patient reads, understands and signs the ABN prior to the specimen being collected. If the patient is unable to sign, the form should be marked with an “X” and the patient’s guardian, guarantor or other responsible party should sign the form.