Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)

CMS National Coverage PolicyInternet-Only Manuals (IOMs):CMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 16, Section 10 Background, Section 40.8 Date of Service (DOS) for Clinical Laboratory and Pathology Specimens and Section 120.1 Negotiated Rulemaking ImplementationChapter 18 Preventive and Screening ServicesCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 3 Verifying Potential Errors and Taking Corrective ActionsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Code of Federal Regulations (CFR) References:CFR, Title 42, Subchapter B, Part 410 Supplementary Medical Insurance (SMI) Benefits, Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCFR, Title 42, Section 414.502 DefinitionsCFR, Title 42, Subpart G, Section 414.507 Payment for clinical diagnostic laboratory tests and Section 414.510 Laboratory date of service for clinical laboratory and pathology specimensCFR, Title 42, Part 493 Laboratory RequirementsCFR, Title 42, Section 493.1253 Standard: Establishment and verification of performance specificationsCFR, Title 42, Section 1395y(b)(1)(F) Limitation on beneficiary liabilityMedicare National Correct Coding Initiative (NCCI) Policy Manual:Chapter 10, Section F Molecular PathologyChapter 10, Section M Medically Unlikely Edits (MUEs)Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L39365 Genetic Testing for Oncology. Please refer to the LCD for reasonable and necessary requirements.All instructions provided within the American Medical Association (AMA) Current Procedural Terminology (CPT) Codebook with rules and guidelines from the AMAs CPT Editorial Panel and the Medicare NCCI Policy Manual should be followed when utilizing CPT codes for billing. Proper coding involves interpreting code descriptions provided by these sources as well as any associated parentheticals. The instructions below do not represent the full breadth or depth of instructions found in the CPT Codebook and the Medicare NCCI Policy Manual. Providers that bill Medicare are expected to follow all instructions found in these sources.Molecular code descriptions in the CPT Codebook generally have some or all of the following components:Medical condition under investigationGenetic content to be testedTechnology/methodology used for testingSpecimen type evaluatedProviders must ensure that their use of molecular CPT codes represent the highest level of specificity in what testing was performed. The following reviews each of these components with general tips for each:1. Medical ConditionWhen a code designates coverage of a specific medical condition (e.g., CPT code 81432 - Hereditary breast cancer- related disorders), all genes billed under this code must fall under the description of the medical condition. Even if all the genes described by a CPT code are tested in a claim, the CPT code can only be used if the described medical condition matches the documented disease.2. Genetic ContentCommonly, molecular CPT codes have a gene(s) listed within their coding description. Special attention must be paid to what elements of a gene are analyzed since not all codes describe the analysis of an entire gene. A gene could be tested for a single well-known variant (e.g., CPT code 81210 - V600 variants in theBRAFgene) or the gene could be fully sequenced (e.g., CPT code 81406  full sequence of theBRAFgene). In fact, several codes in the Tier 1 molecular section cover the same gene but differ in what element of that gene they cover.For instance, the CPT codes 81201, 81202, and 81203 all describe tests for the same gene,APC, but cover different elements of the gene such as full gene sequence, known familial variants or duplication/deletion variants.As stated in the Medicare NCCI Policy Manual Chapter 10, these codes in general should not be billed together. An exception could be inuncommonscenariossuch as billing a code for full gene sequence with another code for duplication/deletion variants when the disease variants cannot be identified by performing full gene sequencing. 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 problem.Less commonly, molecular CPT codes are defined by only a test methodology, as is seen in codes for FluorescenceIn SituHybridization (FISH) found in the Surgical Pathology section of the CPT Codebook. In brief, FISH is a technique where a probe (a short, single-stranded nucleic acid sequence) targets a specific genetic sequence and is labeled/tagged with a fluorescent dye. If the target is found, the fluorescent dye becomes attached to that target and can be seen under microscopy or other related imaging. In oncology, FISH probes are used to evaluate many different genes for many different cancers; however, many FISH CPT codes do not specify which genes or which cancers are being evaluated. As a result, special attention must be paid to what unit of service (UOS) is found in the code description.A UOS for FISH testing could be defined in numerous ways, including number of slides evaluated, number of single source specimens evaluated, number of FISH probes used, number of FISH procedures performed, or number of cells counted. For Medicare, both the CPT Codebook and the Medicare NCCI Policy Manual specify which of these UOS applies, and billing for more UOS than were actually performed is not permitted.The NCCI manual states that regardless of how many blocks or slides are created from a surgical, cytologic, or hematologic specimen, testing multiple blocks or slides from the same specimen source (e.g., tube of blood) still is considered as 1 UOS per source specimen.For example:The UOS described for CPT code 88373 is both per specimen and each additional single probe stain procedure. Depending on the testing scenario, the code may or may not be used, and should only be used in relation to additional probes NOT additional specimens.If one single probe procedure is used for a specimen from one source (e.g., right iliac crest bone marrow aspiration), only 1 UOS may be claimed, even if multipleslidesfrom the specimen are tested with the same probe:1 UOS with the parent CPT code 88367,0 UOS should be reported with CPT code 88373 since only one single probe procedure was used, regardless of how many slides are made with the single source specimen.If two different single probe procedures are used to evaluate several slides from one source specimen, only 2 UOS may be claimed:1 UOS with the parent CPT code 88367, AND1 UOS with the additional CPT code 88373If one single probe procedure is used on two source specimens (e.g., one bone marrow aspiration specimen from the right iliac crest and another specimen from the left iliac crest), only 2 UOS may be claimed:2 UOS with the parent CPT code 88367,0 UOS should be reported with CPT code 88373 since only one single probe procedure was used.The same logic for single probe stain procedures is also true of using multiplex probe stain procedures (CPT code 88374); the UOS is based on the overall multiplex probe stainprocedureNOT the number ofprobeswithin the multiplex stain.CPT codes that describe a genomic sequencing panel (GSP) often include instructions that define the number of genes covered, for instance using a range (5-50 genes) or using a minimum number required (e.g., at least 10 genes).For instance:CPT code 81436 covers at least five genes and must include the genes MLH1, MSH2, EPCAM, SMAD4, and STK11.This means any test matching the CPT code description for 81436, regardless of whether the test analyzed five genes or 20 genes, would be billed under the CPT code 81436 code with only 1 UOS.Additionally, this means that any test without all five mandatory genes (MLH1, MSH2, EPCAM, SMAD4, and STK11) would NOT be billed with this code.When a CPT code for a panel is used in this context,no other CPT codes may be used to describe the panel, regardless of presence or absence of modifiers.3. Technology/MethodologyWhen a CPT code description specifies a particular technology and/or testing methodology, only that technology and/or methodology may be used when billing that code. Therefore, special attention must be paid to the full code description, especially if the type of content tested has technology that typically varies from CPT code to CPT code. For example, CPT codes describing a gene expression profiling (GEP) test often include the specific methodology used for that test, such as RT-PCR (e.g., 81518), microarray (e.g., 81521), and next-generation sequencing (e.g., 81523).Conversely, if a technology and/or methodology is NOT specified in a code description, there is no need to match the technology and/or methodology to that code (e.g., a full sequence analysis of three different genes can be performed by Sanger Sequencing or NGS). For example, CPT code 81279 describes targeted sequence analysis for the gene JAK2 without specifying a sequencing technology. JAK2 is often part of a sequence of reflexive tests evaluating for a myeloproliferative neoplasm, and commonly each step is performed using real time/quantitative (RT/q) PCR. However, each step of that testing sequence could also be performed with Sanger sequencing technology. Additionally, JAK2 could be part of a small NGS panel test with other genes, which, if less than five genes, could be billed as CPT code 81279 and three additional CPT codes representing three other genes. Finally, as technology advances, whole exome/genome sequencing is being utilized more and more as a backbone to customized testing, wherein all unanalyzed data is masked (only certain genetic content is made visible while the rest of the data is hidden from the interpreter) and only a smaller set of genes is analyzed and billed. The benefit to this newer method is the collected data can be reanalyzed as additional customized panels by unmasking additional genetic content without having to rerun the whole exome/genome sequencing. Again, if the custom panel is small, CPT code 81279 would be billed in tandem with up to three other gene codes.Per the Medicare NCCI Policy Manual Chapter 10, A Tier 1 or Tier 2 molecular pathology procedure CPT codeshould not, in general, be reported with a genomic sequencing procedure, molecular multianalyte assay, multianalyte assay with algorithmic analysis, or proprietary laboratory analysis CPT code where the CPT code descriptor includes testing for the analyte described by the Tier 1 or Tier 2 molecular pathology code. 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 problem.4. Specimen TypeSome CPT codes (particularly PLA codes) define what type of specimens or specimen sources are covered by the code description. For instance, some multianalyte assays with algorithmic analyses evaluate gene expression in tumor tissue. Sometimes these tests are restricted to fresh tissue whereas other tests have been optimized to use formalin-fixed, paraffin-embedded tissue. These definitions are often clearly stated within the CPT code description and must be followed when present.DefinitionsProviders should be familiar with all terminology found within the CPT code descriptions before billing Medicare for these codes. Many of the molecular terms utilized in the CPT Codebook describe specific parameters that limit a codes scope of coverage. Definitions are frequently provided at the beginning of sections and subsections within the CPT Codebook. The following are selected definitions of terminology and phrases commonly seen in the code descriptions:always including/must include: Targets that are required in testing described by a CPT code.at least/or greater: Minimum number of genes required to bill for a specific CPT code.For instance, if a CPT code description for a panel requires at least 10 genes, this means the panel size must, at minimum, analyze 10 genes. However, if the panel analyzes 11, 20, 50, or 100 genes and this code is used,no other codes may be used to describe the panel, regardless of presence or absence of modifiers.Common variants/Common deletions/etc.: Genetic variants most predominantly associated with a disease, as defined by professional society guidelines. Billing CPT codes with common variants in the code description should not include testing for uncommon and/or rare variants. If a variant is felt to be common,this designation must be supported by a professional societys guidelines.Deletion/duplication analysis: Testing that evaluates for loss (deletion) or gain (duplication) of stretches of genetic sequence (dosage of a particular genomic region).