Pathology/Lab Coding Alert

Beware LCD restrictions or lose pay.

Sometimes the only card you hold to get paid for an uncovered procedure is an advanced beneficiary notification (ABN). Look at the following prostate-testing case as a model for when and how an ABN can save the day for your lab.

Case: A 63-year-old male patient had a prior negative prostate biopsy, but continued to have repeated elevated prostate specific antigen (PSA) tests for two and a half years following the biopsy. To inform a decision for possible repeat prostate biopsy, the clinician orders the ConfirmMDx^® test, which your lab performs using the submitted representative portions of formalin-fixed paraffin-embedded (FFPE) prostate core biopsy tissue from the prior negative biopsy.

Procedure: Following removal of paraffin from the specimen, the lab analyst isolates DNA and treats it with ammonium bisulfite. Using methylation-specific primers for the APC, GSTP1, and RASSF1 genes, the analyst amplifies and quantifies the target DNA to determine methylation status. If the specimen demonstrates positive methylation, the test algorithm provides a risk score for likelihood of detecting prostate cancer on repeat biopsy, and a probability for high-grade versus low-grade disease. The report also includes prostate mapping.

Coding: Report 81551 (Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy) for the test.

Value: Code 81551 is one of several new non-invasive prognostic assays developed to help clinicians minimize unnecessary biopsies and the associated risks. Specifically, this test can confirm the absence of cancer in the prior biopsy, or identify cancer cells that earlier testing missed and provide direction about the value of a repeat biopsy.

Show Medical Necessity

Although Medicare doesn’t provide a national policy for the ConfirmMDx^® test, some payers have a local coverage determination (LCD) for clinical conditions that warrant payment for the test. To get paid for the test, your claim must demonstrate medical necessity that matches the payer’s policy.

For instance, CGS Administrators covers the test for 40-85-year-old males with a cancer-negative prostate biopsy within the past 24 months who have persistent cancer-risk factors (such as elevated PSA). The policy defines myriad other details, such as the type of biopsy specimen, and management by physician who is part of the ConfirmMDx® Certification and Training Registry (CTR). The policy also lists payable diagnoses, such as the following:

• N40.0 or N40.1 (Benign prostatic hyperplasia …)
• N40.2 or N40.3 (Nodular prostate …)
• N41.0 (Acute prostatitis)
• N41.1 (Chronic prostatitis)
• N41.9 (Inflammatory disease of prostate, unspecified)
• R97.20 (Elevated prostate specific antigen (PSA)).

Deploy ABN, When Necessary

Although the patient in this case may demonstrate “payable diagnoses” for the ConfirmMDx^® test, the timing of the test (two and one half years following biopsy) appears to fall outside the covered range of 24 months based on the payer LCD.

For that reason, your lab would need to obtain a signed advance beneficiary notice of noncoverage (ABN) before performing the test, and report 81551 with an appropriate ABN modifier.

Basics: An ABN is a form that you should get a patient to sign when your practice performs a service that Medicare might not cover completely, or at all. You can bill the patient for the service if you have a signed ABN, but you must also append the correct modifier to the service when you submit the claim, according to Lynn Radecky, office manager in Franklin Lakes, New Jersey.

Specifics: You must issue the ABN when you meet conditions such as the following:

• You believe Medicare may not pay for the service
• Medicare usually covers the item or service, but it might not in this case
• Medicare may not consider the item or service medically reasonable and necessary for this patient in this particular instance.

This case: When you bill 81551 to CGS for this patient who has signed an ABN, you should append modifier GA (Waiver of liability statement issued as required by payer policy, individual case). In this situation, the modifier indicates that while the service is covered by Medicare, it may not be covered at the time of service due to timing limitations, even if the patient has a payable diagnosis. When Medicare sees modifier GA, it will send an explanation of benefits (EOB) to the patient confirming that he is responsible for payment, because by signing the ABN, the patient has agreed to pay if Medicare denies. If you don’t append the modifier, Medicare will not inform the patient of his responsibility.

Bad: If you do not have a signed ABN on file in this case, you would need to bill 81551 with modifier GZ ((Item or service expected to be denied as not reasonable and necessary). You don’t want to be in the position to use modifier GZ, because it means that you probably won’t get paid for the service. However, by notifying Medicare using modifier GZ, you reduce the risk of allegations of fraud or abuse when filing claims that are not medically necessary.

Spotlight Other ABN Modifiers

Modifiers GA and GZ describe ABN status for a covered service, such as the 81551 case, but you also have modifiers to report ABN status for a non-covered service. You’re not required to issue an ABN in those cases, but filing one is considered a “courtesy” ABN.

For a non-covered service, “Many practices do provide ABN or related information to the patient to advise the patient of their options for having the service and understanding any related financial obligations,” explains Cynthia A. Swanson, RN, CPC, CEMC, CHC, CPMA, senior manager of healthcare consulting for Seim Johnson in Omaha, Nebraska.

If the patient has signed a courtesy ABN for a non-covered service, you should append modifier GX (Notice of liability issued, voluntary under payer policy). Medicare will then generate a denial notice for the claim, which the patient may use to seek payment from secondary insurance.

If you’re billing a non-covered service and you don’t have a signed ABN, you should append modifier GY (Item or service statutorily excluded, does not meet the definition of any Medicare benefit or, for non-Medicare insurers, is not a contract benefit).

Bottom line: You can bill the patient for a non-covered service whether you’re billing with modifier GX or GY, but obtaining the ABN and using modifier GX is a better choice for patient consideration.