Article - Billing and Coding: Biomarkers for Oncology (A52986)

CMS National Coverage PolicySocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L35396, Biomarkers for Oncology. Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.Test Panel DefinitionA 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 diseases. The performance of multiple molecular tests regardless of whether the requisition lists the tests as a panel or individually and completed on a single sample is considered to be a Panel of tests and should be billed under a single CPT code to prevent stacking of codes.Consistent with the Limitations outlined in LCD, Biomarkers for Oncology, the following tests will all be covered once per lifetime per beneficiary:CPT code 81345 - Brain Molecular BiomarkersCPT code 81437  Hereditary neuroendocrine tumor disordersCPT code 81438  Hereditary neuroendocrine tumor disorders; duplication/deletion analysisThyraMIR (CPT 0018U), Afirma (CPT 81546), ThyGeNEXT (CPT 0245U), RosettaGX Reveal (CPT 81479) and ThyroSeq tests (CPT 0026U) (CPT 0287U)Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with supporting documentationCPT code 81540 TUO CTID (Cancer TYPE ID)Review of General Molecular Pathology Coding ChangesIn 2012, CPT created new Tier 1 (gene specific) and Tier 2 molecular pathology codes.The Tier 1 molecular pathology codes are applicable to specific biomarkers. However, Tier 2 molecular pathology codes are used to identify groups of biomarkers that require the similar levels of technical and interpretive resources required to complete the testing. Tier 2 codes represent rare disease and molecular pathology procedures that are performed in lower volumes than Tier 1 procedures. These codes should rarely, if ever, be used unless instructed by other coding and billing articles.Because there are multiple biomarkers represented by each of the Tier 2 codes, when billing for these codes, the specific biomarker must be reported in the claim narrative/remarks.Reporting of the specific biomarker, WITHOUT providing the full descriptor will suffice. However, in some cases, such as the example provided below, it may be necessary to provide abbreviated information to identify the specific service provided.CPT code 81479 - Unlisted molecular pathology should be used to report a specific biomarker that is not represented by a Tier 1 code and is not accurately described by one of the Tier 2 codes.A description of the testing performed must be included in the narrative/remarks when using this code.Billing Claims with Multiple BiomarkersPlease refer to the Local Coverage Article A58917, Billing and Coding: Molecular Pathology and Genetic Testing for information.Selected Oncology Tests1. UroVysion Bladder Kit servicesThe following information should be reported on the claim:CPT code 88120 or 88121 as appropriate.'UroVysion should be placed in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'UroVysion' on an attachment to the claim form when submitting a paper claim.Laboratories reporting only the technical component for a UroVysion service should append the appropriate CPT code 88120 or 88121 with the TC HCPCS modifier.Note:Physicians may not submit claims for a CPT code 88120 and 88121 professional component when the interpretive information is provided by a lab technician or scientist. Please refer to CMS IOM 100-04, Chapter 23, Section 20.9 for National Correct Coding Initiative (NCCI) information.2. Rosetta Cancer Origin Test when a conventional surgical pathology/imaging work-up is unable to identify a primary neoplastic site.The following information should be reported on the claim:CPT code 81479 Unlisted molecular pathology procedureEnter 'Initial Work-Up  in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'Initial Work-Up  on an attachment to the claim form when submitting a paper claim.Note:The full, continued version of this Initial Work-Up comment DOES NOT have to be a standardized response, but simply a brief summary (totaling less than 80 characters) to ensure that a preliminary surgical pathology evaluation has been performed prior to the ordering of the biomarker. An example might read as follows: Initial Work-Up shows medium probability of breast CA via IHC.3. VeriStrat assay (CPT code 81538)Enter 'Initial Work-Up  in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'Initial Work-Up  on an attachment to the claim form when submitting a paper claim.Note:The full, continued version of this Initial Work-Up comment DOES NOT have to be a standardized response, but simply a brief summary (totaling less than 80 characters) to ensure that a preliminary predictive testing evaluation has been performed prior to the ordering of the VeriStrat assay. Two examples might read as follows:Initial Work-Up shows EGFR wild-typeInitial Work-Up without ability to test EGFR4. OVA1 and ROMA proteomic assaysOVA1 has been cleared by the FDA for women who meet all of the following criteria:Are over 18 years of ageHave an ovarian massHave surgery plannedEnter The patient meets all 3 FDA OVA1 criteria in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit The patient meets all 3 FDA OVA1 criteria on an attachment to the claim form when submitting a paper claim.For OVA1, use CPT code 81503.5. PROGENSA PCA3 test (regarding prostate cancer):Should be billed with CPT code 81313Claim must include PCA3 and contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 9 below.6. MyPRS Genetic Expression Profile TestingShould be billed with CPT code 81479MyPRS should be entered in box 19, or electronic equivalent, on the claimClaim must include one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 24 below.7. ThyraMIR, ThyGeNEXT, Afirma, RosettaGX Reveal or ThyroSeq ThyroidIntended use of ThyraMIRThyraMIR may be used for cytologically indeterminate thyroid nodules categorized as either AUS/FLUS or FN/SFN within the Bethesda classification scheme for FNA cytology. It is performed following a negative ThyGeNEXT result for all mutations or when mutations detected are not fully indicative of malignancy (i.e., ThyGeNEXT results which favor a benign nodule, but cancer could still be present). ThyGeNEXT, and ThyraMIR combination testing, along with other clinical information, may be used by physicians to help determine the need for surgery or clinical follow up when patients are diagnosed with indeterminate thyroid nodules.The original FNA sample collected for molecular testing with ThyGeNEXT is also used to perform the ThyraMIR test; a separate sample is not required.To report a ThyraMIR service, please submit the following claim information:CPT code0018UEnter ThyraMIR in the comment/narrative field for the following claim field/types:Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report ThyGeNEXT tests, please submit the following claim information:CPT code 0245UEnter ThyGeNEXT in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report Afirma tests, please submit the following claim information:CPT code 81546Enter Afirma in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report RosettaGX Reveal Thyroid tests, please submit the following claim information:CPT code 81479Enter Rosetta GX Reveal Thyroid in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report ThyroSeq Thyroid tests, please submit the following claim information:CPT code 0026U or 0287UEnter ThyroSeq test in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimPlease refer to LCD L35396-Biomarkers for Oncology for coverage detailsfor ThyraMIR, Afirma, ThyGeNEXT, RosettaGX Reveal and ThyroSeq Thyroid tests.8. Oncomine DX TestTo report Oncomine DX Test service, please submit the following claim information:CPT code 0022U - Tgt gen seq dna&rna 1-23 geneThe identifier of Oncomine DX must be in the comment/narrative field as follows:Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claim9. ColonSeq testShould be billed with CPT code 81445Enter ColonSeq in the comment/narrative field for the following claim field/types.Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.10. LungSeq testShould be billed with CPT code 81445Enter LungSeq in the comment/narrative field for the following claim field/types.Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 2 below.11. Colvera test (BCAT1/IKZF1 promoter hypermethylation)Intended use of ColveraColvera is a diagnostic laboratory test used to detect the presence of colorectal cancer circulating tumor DNA. Colvera is intended to be used to detect residual disease following surgery or treatment for primary or recurrent colorectal cancer, and to surveil for recurrence of a previously treated colorectal cancer. Testing is covered when all the following are met:The patient has been previously diagnosed with an AJCC stage I, II, III or IV colorectal cancer, or a recurrence of colorectal cancer, within the previous five years.The patient has no evidence of neoplastic disease at the time the test is ordered. (If the patient is known to be with cancer or presumed to have cancer, this testing is not indicated).The patient is able to tolerate surgery or adjuvant chemotherapy for residual or recurrent colorectal cancer.Testing may be ordered no more than four times per 12-month period.To report a Colvera service, please submit the following claim information: