Knowledge Base Article

Do you ever wonder what your ancestors would think of the modern day advances in technology and medicine? Even in my lifetime, the flip communicator of Star Trek science fiction fame has become a reality. In fact, flip-phones are already out of style and current cell-phones do much more than simply allow communication. Laboratory medicine is no exception to technology advances and scientists are now able to study gene sequences, gene mutations, and other biological markers. This opens a whole new world of laboratory testing and brings about a new subject for Medicare coverage policies.

There are numerous local coverage determinations (LCDs) related to this type of advanced laboratory testing. These policies may reference molecular pathology or molecular diagnostic studies, biomarkers, phenotyping, genomic assays or genetic testing. Palmetto GBA has developed the Molecular Diagnostic Program (MoIDX®) to identify and establish coverage and reimbursement for molecular diagnostic tests. The following Medicare Administrative Contractor (MAC) jurisdictions participate in this program, so these MACs may have more LCDs for biomarkers than non-participating MACs.

• Noridian JE and JF
• Palmetto GBA JM
• WPS J5 and J8
• CGS J15

The Novitas Local Coverage Determination for Biomarkers for Oncology discusses the consideration of medical necessity for biomarkers. “The emergence of personalized laboratory medicine has been characterized by a multitude of testing options which can more precisely pinpoint management needs of individual patients. As a result, the growing compendium of products described as biomarkers requires careful evaluation by both clinicians and laboratorians as to what testing configurations are reasonable and necessary under the Medicare Act. There are a plethora of burgeoning tools, including both gene-based (genomic) and protein-based (proteomic) assay formats, in tandem with more conventional (longstanding) flow cytometric, cytogenetic, etc. biomarkers.” In order to be medically necessary, these tests must have proven clinical validity/utility, be clinically actionable, and be used to assist in the management and/or treatment of the patient. Biomarkers may be used for diagnosis, classification, monitoring, surveillance, prognosis, or prediction of response to a particular therapy.

Below are some of the indications for which biomarkers are utilized. These tests may be performed by specialty laboratories but providers need to be familiar with the LCDs relevant to their MAC jurisdiction if they are performing or billing for this type of testing.

Oncologic Indications

• Molecular Pathology, Molecular Diagnostic Testing, and Biomarkers policies that list numerous genetic/biomarker tests and/or conditions that are covered. (J5, J8, JH, JL, J15, JN, J6, JK, and JN)
• Breast and Ovarian Cancer
• BRCA1 and BRCA2 genetic testing for susceptibility to breast or ovarian cancer is covered when there is a personal history of breast cancer or certain other types of cancer (JN, JE, JF, J15, JM, and JJ)
• OVA-1 is an ovarian cancer blood test that is reported to detect ovarian cancer in a pelvic mass (J6 and JK)
• Several LCDs address tests used to decide breast cancer treatment options, such as Oncotype DX TM, Prosigna test, and Breast Cancer Index℠ (JN, J15, JE, JF, and JM)
• Colorectal Cancer
• Testing for KRAS mutations before using Epidermal Growth Factor Receptor (EGFR) antibodies in the treatment of colorectal cancer (JJ)
• A stepped approach genetic testing for Lynch Syndrome, the most common hereditary cause of colorectal cancer (JN, J15, JE, JF, and JJ)
• NRAS testing for metastatic colorectal cancer (J15, JE, and JF)
• Prostate Cancer
• ConfirmMDx epigenetic assay for prostate cancer (MDxHealth, Irvine, CA) to reduce unnecessary repeat prostate biopsies under certain conditions (J15, JE, and JF)
• To assist in determining treatment options for prostate cancer such as Decipher®, Genomic HealthTMOncotype DX®, or PolarisTM PC Genomic Assay (JE, JF, J15 and JM)
• Non-Small Cell Lung Cancer
• Tests for genomic alterations in tumor specimens for NSCLC to determine if a patient is a candidate for targeted therapy (J6, JK, JE, JF, J15, JM, and JJ)
• Gliomas
• The presence of chromosome 1p/19q deletions in gliomas can assist in tumor differentiation, prognosis and treatment plan. (J15, JM, JE, and JF)
• MGMT promoter methylation status is a strong and independent prognostic factor in patients with newly diagnosed glioblastoma multiforme and can aid in treatment decisions for older patients. (J15, JE, JF, and JM)
• Myeloproliferative Disease
• Provides coverage of a sequential genetic testing approach for the diagnostic workup for myeloproliferative disease (MPD) including polycythemia vera (PV), essential thrombocytopenia (ET), and primary myelofibrosis (PMF). (J15, JE, JF, and JM)

Non-Oncologic Indications

• Pharmcogenomics
• Genetic testing (CYP2C19, CYP2D6, CYP2C9 and VKORC1) for drug response limited to certain drugs such as Plavix, amitriptyline or nortriptyline for treatment of depressive disorders and tetrabenazine doses greater than 50 mg/day, and warfarin. (J15, JN, J5, J8, JE, JF, and JJ)
• Lipid Biomarkers for Cardiovascular Risk Assessment
• The policies indicate the medical indication(s) for individual lipid biomarkers that may be covered to characterize a given lipid abnormality or disease, to determine a treatment plan or to assist with intensification of therapy. Each individual lipid biomarkers must be specifically ordered and the reason for the test order documented in the patient’s medical record. (J15, JM, JE, JF, J5, and J8)
• Hypercoagulability/Thrombophilia
• Testing for Factor V Leiden (FVL) variants in the F5 gene and F2 G20210A mutations is indicated for pregnant patients who have a history of personal VTE associated with a non-recurrent (transient) risk factor who are not otherwise receiving anticoagulant prophylaxis. (J5, J8, J15, JM, JE, and JF)
• RBC Phenotyping
• Medicare will cover pretransfusion molecular testing using the HEA BeadChip™ assay to prevent the development of alloantibodies or when identification of antibodies is difficult for specific reasons. (J15, JE, JF, JM and JJ)
• HLA-B*15:02 Genotype Testing
• Patients of Asian and Oceanian ancestry with the HLA-B*1502 had an increased risk to develop severe, sometimes lethal diseases of the skin and mucous membrane when exposed to carbamazepine, phenytoin or fosphenytoin. (J15, JE, JF, and JM)
• Refractory Depression
• Limited coverage for the GeneSight® Psychotropic gene panel ordered by licensed psychiatrists and neuropsychiatrists contemplating an alteration in neuropsychiatric medication for patients diagnosed with major depressive disorder (MDD) who are suffering with refractory moderate to severe depression after at least one prior neuropsychiatric medication failure.

(J15, JE, and JF)

As you can see, the uses of genetic testing are many and varied and will only expand over time as clinical studies demonstrate the efficacy of new tests. This means you will see more and more LCDs related to these types of tests – watch for these in our monthly updates of coverage policies.