Medicare Panel Coding Guidance #1
The oldest is the MolDx Molecular Test Panel Alert, currently in V5 updated October 2019, but dating back at least five or six years. Find it here. I also include at the bottom of this blog as "Exhibit A."
Presumably, this article applies to MolDx regions up until the publication of A57503 on 10/21/2019 and revised 1/1/2020, since the currently online article now states it applies up until the publication of such a title.
Medicare Panel Coding Guidance #2
The-next oldest, and longest, is the MolDx CMS Article Database article, MolDX: Testing of Multiple Genes (A57503). Find it here. I also include at the bottom of this blog as "Exhibit B." Published 10/21/2019 and revised 1/1/2020.
See also coverage of this when it was new, October 18, 2019 here.
Medicare Panel Coding Guidance #3
The newest, and shortest, is the Noridian online article published May 11, 2020, effective June 7, 2020. It shares some text with A57503, but appears on the Noridian website rather than the CMS article database. The text of this Noridian article (#3) is truncated quite quickly, related to A57503 at Palmetto (#2), and may not, entirely, mean the same thing. Find it here. And see it at bottom of blog as "Exhibit C."
And...Medicare Panel Coding Guidance #4
Finally, there is a nationally binding rulebook of correct coding guidance called National Correct Coding Inititative Policy Manual (NCCI-PM). Find it here. Download "Policy Manual for Medicare Services." This is national guidance for all 50 states, not just MolDx. It's confusing in context of guidances #1,#2, #3 above. The national NCCI guidance is also distinctive in being directly self-contradictory within the space of just four sentences. See at bottom of blog as "Exhibit D."
Note that CMS publishes separate, but identical, NCCI policy manuals for Medicare and Medicaid. The Medicaid one is here.
One of the problems with web-based contractor articles (see #1, #3) is that they are added, revised, and deleted at irregular intervals with no archival record of when which version was effective, making law enforcement and medical review very difficult.
In addition, here, there seems to be a lack of consistency between the national ruling (#4), which should be "enough guidance" and "national guidance" and the differing articles #1 and #2 and #3.
National guidance #4 clearly seems to allow different billing schemes at different prices for the same thing. It states that a party "may" bill one way or "may" bill another. This is the opposite of correct coding guidance. To borrow a phrase I've heard and try to apply in other contexts, if a correct coding guidance doesn't lead to one clear coding solution, the correct coding guidance isn't done yet.
In case CMS links change - I've put all four documents in a cloud file here.
For an article by attorney David Glaser on the problems when Medicare definitions accumulate and collide, here.
Exhibit A. MolDx Molecular Test Panel Alert
(Abridged; see full text on website.)
Molecular Test Panel Edit Alert (M00101, V5)
The guidance below only applies to MolDX jurisdictions for which the article "Billing and Coding: MolDX: Testing of Multiple Genes" has not been published by the local MAC to whom a provider or supplier submits claims.
Palmetto GBA has published the article "Billing and Coding: MolDX: Testing of Multiple Genes external link " for Jurisdictions J and M on the Medicare Coverage Database.
MolDX CPT code range affected: 81161-81408
Test Panel Definition: A predetermined set of medical tests composed of individual laboratory tests, related by medical condition, specimen type, frequency ordered, methodology or types of components to aid in the diagnosis/treatment of disease.
Palmetto considers the performance of multiple molecular biomarkers, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample to be a "panel" of tests. Therefore, each panel should be registered and billed with a single CPT code and a unique MolDX identifier. Based on data analysis of MolDX claims, labs are submitting multiple biomarker 'panels' as individual tests similar to the submission of the previous stacking codes.
Example: A lab receives a patient specimen and performs the following tests:
CPT code 81225-CYP2C19, cv
CPT code 81240-F2, 20210G>A
CPT code 81241-F5, Leiden
The panel of three tests listed above should be registered and claims submitted with CPT code 81479 and a single MolDX ID.
Exhibit B. MolDx Testing of Multiple Genes Article A57503 (CMS Database)
Billing and Coding: MolDX: Testing of Multiple Genes (A57503)
The following information will be effective 10/21/2019 for dates of service on or after 10/15/2019 [sic??].
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.
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.
Exhibit C. Noridian (Local Website) "Testing of Multiple Genes."
Billing and Coding: MolDx: Testing of Multiple Genes.
This coverage article has been published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV).
Effective Date: June 07, 2020
Summary of Article: 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 was 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.
Exhibit D. CMS National Correct Code Edits: Paragraph 8, Gene Panels
Note: CMS publishes separate, but usually identical, correct coding manuals for Medicare and Medicaid.
Correct Coding Edits, Medicare, Final 103119.docx, Laboratory Services, Chapter X.
8. If one laboratory procedure evaluates multiple genes
using a next generation sequencing procedure, the laboratory
shall report only one unit of service of one genomic sequencing
procedure, molecular multianalyte assay, multianalyte assay with
algorithmic analysis, or proprietary laboratory analysis CPT
If no CPT code accurately describes the procedure
performed, the laboratory may report CPT code 81479 (Unlisted
molecular pathology procedure) with one unit of service or may
report multiple individual CPT codes describing the component
test results when medically reasonable and necessary.
Procedures reported together must be both medically reasonable and
necessary (e.g., sequencing of procedures) and ordered by the
physician who is treating the beneficiary and using the results
in the management of the beneficiary's specific medical
If a single procedure is performed, only one HCPCS/CPT
code with one unit of service may be reported for the procedure.