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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that molecular pathology procedures (Tier1 and Tier 2) may be eligible for coverage when ALL 
of the following criteria are met: 
 
    Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are 
unavailable or results are clearly equivocal; AND 
    Availability of a clinically valid test, based on published peer reviewed medical literature; AND 
    Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) 
or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) of analytical 
validity and clinical utility; AND 
    Results of the testing must directly impact treatment or management of the Medicare beneficiary; AND 
    For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a 
tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test 
that are reasonable and necessary to obtain necessary information for therapeutic decision making; AND 
    Individual has not previously received genetic testing for the disease/condition. (In general, diagnostic 
genetic testing for a disease should be performed once in a lifetime.) Exceptions include clinical scenarios 
whereby repeat testing of somatically acquired mutations (for example, pre- and post- therapy) may be required 
to inform appropriate therapeutic decision-making. 
 
 Limitations: 
 
    Any procedures required prior to cell lysis should be reported separately and utilization must be clearly 
supported based on the application and clinical utility. Such claims may be subject to prepayment medical 
review. 
    The medically necessary interpretation and report of a molecular pathology test, written by a pathologist, 
which is above and beyond the report of standard laboratory results may not be reported by Non- physician 
practitioners (e.g., PhD, scientists etc.); only physicians are eligible to report this service. 
    Testing for quality assurance component of the service is not separately billable. 
 
Tier 2 Non-covered Codes/Gene Combinations  
The following individual Tier 2 genetic tests are unlikely to impact therapeutic decision-making, directly 
impact treatment, outcome and/or clinical management in the care of the beneficiary and will be denied as not 
medically necessary (Please note that this list of non-covered genes is not exhaustive, and the fact that a 
specific gene is not mentioned does not mean it is covered. In addition, many genes have several names that are 
used. The most common names have been used in this policy): 
ABCC8 
ACADM 
ACADS (acyl-CoA dehydrogenase) 
ACADVL (acyl-CoA dehydrogenase, very long chain) 
ADRB2 
AGTR1 
AIRE (APSI) 
AKT1 
ANG (angiogenin, ribonuclease, RNase A family, 5) 
APOE 
AQP2 (aquaporin 2 [collecting duct]) 
AR (androgen receptor) 
ARX (aristaless related homeobox) 
ATN1 
BTD (biotinidase) 
C9orf72 
CASR (CAR, EIG8, extracellular calcium-sensing receptor, FHH, FIH, GPRC2A, HHC, HHC1, NSHPT, 
PCAR1) 
CAV3 (caveolin 3) (eg, CAV3-related distal myopathy, limb-girdle muscular dystrophy type 1C), full gene 
sequence 
CBS (cystathionine-beta-synthase) 
CCR5 
CDKL5 (cyclin-dependent kinase-like 5) 
CFH/ARMS2 
Chromosome 18q- 
CLRN1 
CLRN1 (clarin 1) 
CYP1B1 (cytochrome P450, family 1, subfamily B, polypeptide 1) 
CYP21A2 (cytochrome P450, family 21, subfamily A, polypeptide2) 
CYP21A2 
DEK/NUP214 
DLAT (dihydrolipoamide S-acetyltransferase) 
DLD (dihydrolipoamide dehydrogenase) 
DMPK (dystrophia myotonica-protein kinase (DM gene and DM1) 
DMPK (dystrophia myotonica-protein kinase) 
DYT1 (TOR1A) 
EGR2 (early growth response 2) (eg, Charcot-Marie-Tooth) 
F8 (coagulation factor VIII) 
F8 (coagulation factor VIII) 
FGFR2 (fibroblast growth factor receptor 2) (2 EXONS) 
FGFR3 
FGFR3 
FGFR3 (fibroblast growth factor receptor 3) (4 EXONS) 
FGFR3 (fibroblast growth factor receptor 3) one exon 
FKRP (Fukutin related protein) 
FOXG1 (forkhead box G1) FSHMD1A (facioscapulohumeral muscular dystrophy 1A) 
FSHMD1A (facioscapulohumeral muscular dystrophy 1A) 
FXN (frataxin) 
GALT (galactose-1-phosphate uridylyltransferase) 
GALT (galactose-1-phosphate uridylyltransferase) 
GJB1 (gap junction protein, beta 1) (eg, Charcot-Marie-Tooth X-linked), full gene sequence 
H19 
HADHA (hydroxyacyl-CoA dehydrogenase/3-ketoacyl-CoA thiolase/enoyl-CoA hydratase [trifunctional 
protein] alpha subunit) 
HAX1 (HAX1_HUMAN, HCLS1- associated protein X-1, HCLSBP1, HS1-associating protein X-1, HS1 
binding protein, HS1-binding protein 1, HS1BP1, HSP1BP-1) 
HEXA (hexosaminidase A, alpha polypeptide) 
HNF1B (HNF1 homeobox B) 
HRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog Costello syndrome) 
HRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog) 
HTT (huntingtin) 
IL28B 
IVD 
KCNJ10 (potassium inwardly-rectifying channel, subfamily J, member 10) 
KCNQ10T1 (KCNQ1 overlapping transcript 1) 
KIF6 
Level 8 Molecular Pathology Procedures 
Level 9 Molecular Pathology Procedures 
LMNA (lamin A/C) 
LPA intron 25 genotype 
MEFV (Mediterranean fever) (eg, familial Mediterranean fever) 
MEG3/DLK1 
MEK1 
MLH1 
MLL/AFF 
MPZ (myelin protein zero) 
MT-ATP6 
MT-ND4, MT-ND6 
MT-ND5 mitochondrially encoded tRNA leucine 1 [UUA/G] mitochondrially encoded NADH dehydrogenase 
5) 
MT-RNR1 (mitochondrially encoded 12S RNA) 
MT-RNR1 (mitochondrially encoded 12S RNA) 
MT-TK (mitochondrially encoded tRNA lysine) 
MT-TL1 
MT-TS1 
MT-TS1 (mitochondrially encoded tRNA serine 1) 
MUTYH (mutY homolog [E. coli]) 
NF2 (neurofibromin 2 [merlin]) 
NSD1 (nuclear receptor binding SET domain protein 1) 
PAH (phenylalanine hydroxylase) 
PAX2 (paired box 2) 
PDHA1 (pyruvate dehydrogenase [lipoamide] alpha1) 
PIK3C, PI3Ks, PI(3)Ks, PI-3Ks 
POLG (polymerase [DNA directed], gamma) 
PRKAG2 (protein kinase, AMP-activated, gamma 2 non-catalytic subunit) 
PRSS1 (protease, serine, 1 [trypsin 1]) 
PTPN11 (protein tyrosine phosphatase, non-receptor type 11) RET (ret-proto-oncogene) (eg, Hirschsprung disease), full gene sequence 
SCA1 
SDA2 
SLC25A4 (solute carrier family 25 [mitochondrial carrier; adenine nucleotide translocation] 
SLC9A6 (solute carrier family 9 [sodium/hydrogen exchanger] member 6) 
SMN1 
SMN1 (survival of motor neuron 1, telomeric) 
SMN1/SMN2 (survival of motor neuron 1, telomeric/survival of motor neuron 2, centromeric) 
SOS1 (son of sevenless homolog 1) 
SPG4 
TAZ (tafazzin) 
TOR1A 
TRD 
TSC1 (tuberous sclerosis 1) 
TSC2 (tuberous sclerosis 2) 
UBE3A (ubiquitin protein ligase) 
UPD (Uniparental disomy) 
VEGFR2 (CD309, FLK1, VEGFR) 
VWF (von Willebrand factor) 
 
You can find this rule in the Local Coverage Determination (LCD) Molecular Pathology Procedures L35000. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.