Document and bill genetic tests correctly

First Coast regularly performs data analysis to identify services that are frequently not billed and coded correctly per Medicare guidelines. Recently, we found common documentation errors for providers billing genetic tests to Medicare, such as seen with large pharmacogenomic panels. 

When a large pharmacogenomic panel has no proprietary laboratory analyses code, it is often billed using CPT code stacks. However, in most cases, only one or a few of the genes billed have relevance to the beneficiary with the rest of the genes tested having no direct relevance to the beneficiary (e.g., the patient is not taking gene-associated medications, or the provider is not planning on starting the patient on gene-associated medications). If the test is billed as a code stack, any code not relevant to the beneficiary should have a GY modifier added to indicate the CPT code is not payable under Medicare policy. Only CPT codes that are reasonable and necessary, as well as meet LCD policy, should be billed to Medicare.

Documentation guidance

The following documentation should be found in the physician’s clinical note when they order a pharmacogenomic panel (note: the date of the order should match the date of the clinical note):

• What is/are the drug(s) with concern for genetic issues?
• Is the patient currently taking medications or anticipated to be started on medications with known issues potentially related to genetic factors?
• How will patient management change when the provider has test results?

Provider documentation should include both the named drugs of concern paired with genes potentially relevant to these drugs. Merely stating genetic testing will be performed without explaining why it is needed and how it will help is insufficient for demonstrating medical necessity.

Additional resources 

Please refer to First Coast’s LCD Pharmacogenomics Testing L39073 for coverage guidance and billing article A58812 for procedure and diagnosis codes. 

Make sure to review the medical policies to ensure you properly document the medical reasonableness and necessity of the services billed.