Summary Of Evidence

N/A

Analysis of Evidence

N/A

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Evaluating tissue samples pathologically is crucial to the diagnosis and treatment of patients with malignancy. At times, standard pathologic analyses provide inconclusive information. Combining pathologic study with molecular analyses of microdissected tissue, is claimed to enhance the ability to provide more specific diagnostic information, to help guide treatment decisions. These testing combinations are generally known as "topographic genotyping."

Covered Indications

1. PathfinderTG^® will be considered medically reasonable and necessary when selectively used as an occasional second-line diagnostic supplement:
   
   
   • only where there remains clinical uncertainty as to either the current malignancy or the possible malignant potential of the pancreatic cyst based upon a comprehensive first-line evaluation; AND
   • a decision regarding treatment (e.g. surgery) has NOT already been made based on existing information.

Criteria for Coverage

The specific requirements for medical necessity involve:

1. Highly-concise affirmation, documented in the medical record, that a decision regarding treatment has not already been made and that the results of the molecular evaluation will assist in determining if more aggressive treatment than what is being considered is necessary.
   
   
2. Previous first-line diagnostics, such as, but not restricted to, the following have demonstrated:
   • A pancreatic cyst fluid carcinoembryonic antigen (CEA), which is greater than or equal to 200 ng/ml, suggesting a mucinous cyst, but is not diagnostic.
   • Cyst cytopathologic or radiographic findings, which raise the index of malignancy suspicion, but where second-line molecular diagnostics is expected to be more compelling in the context of a surgical vs. non-surgical care plan.

Limitations

All PathfinderTG^® indications other than pancreatic cyst fluid evaluation are considered investigational and are therefore not considered medically reasonable and necessary due to insufficient data on both analytical and clinical validity.

Specific criteria of Non-coverage to include either:

1. Image guided needle aspiration of the pancreatic cyst or cystic component of a mass lesion or dilated duct demonstrate definitive diagnosis of malignancy by cytology; OR
   
   
2. Cytology not showing malignancy but meets AGA guidelines to reach a definitive diagnosis of benign disease. Lesions must be:
   • Under 1 cm;
   • Lack a solid component;
   • Lack concerning cytology features;
   • Lack main pancreatic duct dilatation of > 1cm in diameter with absence of abrupt change in duct diameter;
   • Have fluid CEA level not exceeding 5 ng/ml

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG^®, (A56897), for applicable CPT codes and diagnosis codes.