Excluded Tests

Medicare is a defined benefit program. In order to be considered for Medicare coverage, an item or service must fall within a statutory benefit category. Although IOM 100-2, Ch. 15, Sec 10 identifies “Diagnostic X-Ray tests, laboratory tests, and other diagnostic tests;” as a benefit category; Sec. 1862 (1)(A) Statutory Exclusion “except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” must also be applied. In order to be paid under this benefit category, a diagnostic test must be ordered by a physician who is treating the beneficiary and the results used in the management of a beneficiary’s specific medical problem. Although many molecular diagnostic tests may provide valid and useful information, they do not meet this definition.

Does the test fall within a Medicare benefit category?
Although many molecular diagnostic tests may provide valid and useful information, they do not meet this definition. Based on the Medicare Benefit requirements, the following test types are examples of services that may not be considered a benefit (statutory excluded) and therefore would be denied as Medicare Excluded tests:

  • Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law
  • Tests that confirm a diagnosis or known information
  • Tests to determine risk for developing a disease or condition
  • Tests performed to measure the quality of a process
  • Tests without diagnosis specific indications 
  • Tests identified as investigational by available literature and/or the literature supplied by the developer, and are not a part of a clinical trial
  • Tests typically performed on patients less than 65 years of age and outside of the Medicare population
    • Tests performed on patients receiving Medicare benefits less than 65 years will be reviewed on a case-by-case basis

MolDX Excluded Tests

Article Title
Article ID#
4q25-AF Risk Genotype Coding and Billing Guidelines (M00004)
9p21 Genotype Test Coding and Billing Guidelines (M00082)
ApoE Genotype Coding and Billing Guidelines (M00083)
Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C) Testing Coding and Billing Guidelines (M00067)
Aspartoacyclase 2 Deficiency(ASPA) Testing Coding and Billing Guidelines (M00068)
ATP7B Gene Tests Coding and Billing Guidelines (M00052)
BCKDHB Gene Test Coding and Billing Guidelines (M00069)
BLM Gene Analysis Coding and Billing Guidelines (M00049)
BluePrint Coding and Billing Guidelines (M00010)
CDH1 Genetic Testing Coding and Billing Guidelines (M00087)
CFTR Gene Analysis Coding and Billing Guidelines (M00076)
CHD7 Gene Analysis Coding and Billing Guidelines (M00058)
Coenzyme Q10 (Q10) Coding and Billing Guideline (M00146)
CYP2B6 Test Coding and Billing Guidelines (M00054)
CYP2C9 and VKORC1 Coding and Billing Guidelines (M00137)
ENG and ACVRL1 Gene Tests Coding and Billing Guidelines (M00046)
FANCC Genetic Testing Coding and Billing Guidelines (M00073)
Flow Cytometry Coverage Clarification (M00147)
Fragile X Coding and Billing Guidelines (M00077)
GBA Genetic Testing Coding and Billing Guidelines (M00050)
HAX1 Gene Sequencing Coding and Billing Guidelines (M00074)
HBB Full Gene Sequencing Coding and Billing Guidelines (M00020)
HEXA Gene Analysis Coding and Billing Guidelines (M00070)
HTTLPR Gene Testing Coding and Billing Guidelines (M00008)
IKBKAP Genetic Testing Coding and Billing Guidelines (M00071)
KIF6 Genotype Coding and Billing Guidelines (M00017)
know error Coding and Billing Guidelines (M00053)
L1CAM Gene Sequencing Coding and Billing Guidelines (M00078)
LPA-Aspirin Genotype Coding and Billing Guidelines (M00006)
LPA-Intron 25 Genotype Coding and Billing Guidelines (M00007)
MCOLN1 Genetic Testing Coding and Billing Guidelines (M00075)
MECP2 Genetic Testing Coding and Billing Guidelines (M00066)
Mitochondrial Nuclear Gene Tests Coding and Billing Guidelines (M00079)
MMACHC Test Coding and Billing Guidelines (M00089)
myPap Billing and Coding Guidelines (M00051)
NSD1 Gene Tests Coding and Billing Guidelines (M00061)
OncoCee Coding and Billing Guidelines (M00036)
PAX6 Gene Sequencing Coding and Billing Guidelines (M00080)
PIK3CA Gene Tests Coding and Billing Guidelines (M00056)
PreDx Coding and Billing Guidelines (M00011)
PTCH1 Gene Testing Coding and Billing Guidelines (M00059)
Quidel Solana Strep Complete Assay and Quidel Lyra Direct Strep Assay Coding and Billing Guidelines (M00141)
RPS19 Gene Tests Coding and Billing Guidelines (M00062)
SEPT9 Gene Test Coding and Billing Guidelines (M00093)
SLCO1B1 Genotype Coding and Billing Guidelines (M00091)
SMPD1 Genetic Testing Coding and Billing Guidelines (M00072)
Special Stains and Immunohistochemistry (IHC) Indications for Gastric Pathology (M00097)
STAT3 Gene Testing Coding and Billing Guidelines (M00057)
SULT4A1 Genetic Testing Coding and Billing Guidelines (M00048)
TERC Gene Tests Coding and Billing Guidelines (M00063)
TP53 Gene Test Coding and Billing Guidelines (M00064)
UGT1A1 Gene Analysis Coding and Billing Guidelines (M00065)
VEGFR2 Tests Coding and Billing Guidelines (M00055)