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When and how should I use an Advance Beneficiary Notice (ABN) when running iSTAT tests?

When a Medicare carrier is likely to deny payment because of medical necessity policy (for example, when the diagnosis is not covered by national or local policy, a frequency limit applies) the patient must be informed and consent to pay for the service before it is performed, or they have no obligation to pay for the test.

An Advance Beneficiary Notice or ABN is used to document that the patient is aware that Medicare may not pay for a test and has agreed to pay the provider in the event payment is denied. Each ABN must be specific to the service provided and the reason that Medicare may not pay for the service. Blanket waivers for all Medicare patients are not allowed.

An ABN must:

(1) be in writing;

(2) be obtained prior to the beneficiary receiving the service;

(3) clearly identify the particular service;

(4) state that the provider believes Medicare is likely to deny payment for the specific service;

(5) give the reason(s) that the provider believes that Medicare is likely to deny payment for the specific service; and

(6) include the beneficiary's signature and date.

Routine notices to beneficiaries that do nothing more than state that Medicare denial of payment is possible, or that the provider does not know whether Medicare will pay for a service, will not be considered acceptable evidence of advance notice. Unacceptable practices include:

(1) giving notice for all claims or services;

(2) failing to list the specific reason or rationale for likely denial;

(3) failing to state the particular test or service that Medicare is likely to deny.

However, providers may routinely provide ABNs is when the frequency of the test is restricted by either a national coverage decision or a local medical review policy. In this situation, a provider may provider an ABN almost every time the test is performed because the provider has no idea how often the procedure has been performed for the beneficiary in the past.

The CPT code modifier, -GA (Waiver of Liability Statement on File), must be used to indicate that the provider has notified the Medicare patient that the test performed may not be reimbursed by Medicare and may be billed to the patient.

A standard CMS ABN form must be used. CMS form No. CMS-R-131-L is specific for laboratory use. CMS form No. CMS-R-131-G is for general use. These forms are available on the CMS website at https://www.cms.gov/medicare/medicare-general-information/bni/abn.html. The forms may be printed on the back of laboratory requisitions, but must be single sided and may not be otherwise modified except for the customizable boxes.

Completing an effective ABN:

Both ABNs have customizable boxes that may be preprinted with check-off items. The laboratory version contains three boxes:

The first box is used to select or list a specific test that is not covered because of local or national coverage policy.

The second box is used to select or list a test that may be denied based on frequency limits.

The third box is used to identify research only or experimental tests that probably will not be covered. A list of tests can be preprinted in each box and selected as appropriate.

The Estimated Cost item is optional, lack of an entry or a value different from the actual cost billed to the patient does not invalidate the ABN.

At least two copies of the ABN are required; the provider retains the original and gives a copy to the patient.

A signature is not required so long as proof exists that the beneficiary was notified that Medicare might not pay for a service or otherwise knew that payment might be denied.

If a beneficiary refuses to sign an ABN, but demands that the service be provided, a witness can make a note to this effect and sign the ABN. The beneficiary will then be responsible for the service if it is subsequently denied.

A patient must be notified far enough in advance to make a rational decision, without undue pressure, as to whether they want a test or service and are willing to pay for it. Patients should be given an ABN before they are prepped for a procedure or otherwise put in a position where they feel they cannot reasonably refuse treatment. ABNs should never be given to trauma patients or in any EMTALA situation. ABNs given to patients under great duress are not valid.

When Medicare denies a service for which an ABN is on file, Medicare does not limit the amount the provider can collect from the patient. However, billing a very low amount (for example, significantly below what Medicare would pay) might be considered an inducement and implicate violation of the anti-kickback law.


1Reimbursement information source: Centers for Medicare and Medicaid Clinical Diagnostic Laboratory Fee Schedule (CLFS) 2025, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html

CLFS does not reflect 2% Payment Adjustment (Sequestration). Click here for more information.

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