The following information will be effective 10/21/2019 for dates of service on or after 10/15/2019.

A panel of genes is a distinct procedural service from a series of individual genes. All services billed to Medicare must be reasonable and necessary. As such, if a provider or supplier submits a claim for a panel, then the patient’s medical record must reflect that the panel was reasonable and necessary. Alternatively, if a provider or supplier bills for a number of individual genes, then the patient’s medical record must reflect that each individual gene is reasonable and necessary.

For ease of reading the term “gene” when used in this document will be used to indicate a gene, region of a gene, and / or variant(s) of a gene.

Genes can be assayed serially or in parallel. Genes assayed on the same date of service are considered to be assayed in parallel if the result of one assay does not affect the decision to complete the assay on another gene, and the two genes are being tested for the same indication. Genes assayed on the same date of service are considered to be assayed serially when there is a reflexive decision component where the results of the analysis of one or more genes determines whether the results of additional analyses are reasonable and necessary.

If a laboratory assays two or more genes in a patient in parallel, then those two or more genes will be considered part of the same panel. A panel constitutes a single procedural service, so one HCPCS codes must be submitted for the panel. If the laboratory assays genes in serial, then the laboratory must submit claims for genes individually. The order by the treating clinician must reflect whether the treating clinician is ordering a panel or single genes, and additionally, the patient’s medical record must reflect that the service billed was reasonable and necessary.

Two examples:

Single Service Example: A clinician orders 5 specific genes associated with breast cancer. The laboratory analyzes the 5 genes for common mutations using polymerase chain reaction. All 5 PCR procedures are started prior to the results of any one PCR procedure being known. The results are signed off on simultaneously, and all 5 results are sent to a clinician.

This would be considered a single procedural service, a single 5 gene panel, and it must be billed as such. This single panel must be reasonable and necessary to be billed to Medicare.

Multiple Distinct Procedural Services Example: A clinician requests that genes associated with early onset colorectal cancer be analyzed in a patient. The clinician orders stepwise reflex testing where a negative or positive result in one gene determines whether additional analysis on other genes will be performed or what that will be.

Each gene assayed represents one procedural service, so if more than one gene is analyzed, then multiple procedural services may be billed in some patients for whom reflex testing goes beyond the first gene. Each gene billed to Medicare must be individually reasonable and necessary. A clinician’s order is not by itself sufficient to indicate that a test was reasonable and necessary. The record must reflect that the test is used in the management of the beneficiary's specific medical problem in accordance with CFR §410.32.

Labs must register a test with the Diagnostics Exchange as it reflected on the order form and is run in the laboratory. If a gene / variant is tested as part of a panel, then the lab must register the panel and must submit the correct z-code and CPT code for the panel. If a lab has a panel but sometimes also analyzes individual genes from the panel, the lab must register both the panel and the individual genes that are analyzed.

In general two or more codes describing a genetic test billed on the same beneficiary on the same date may constitute a panel, and if so the service must be billed as a single procedural service. We would generally expect that a provider or supplier would not bill for more than two distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service. If providers or suppliers do bill for more than two distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service, the provider or supplier must attest that each additional service billed is a distinct procedural service using the 59 modifier.

The use of the 59 modifier will be considered an attestation that distinct procedural services are being performed rather than a panel. Providers and suppliers must use the 59 modifier in conjunction with other modifiers where appropriate. When providers and suppliers bill for multiple distinct procedural services, each service must be reasonable and necessary.

Laboratories that are billing for many individual genes using the 59 modifier rather than panels may be subject to medical review as outliers.