Notification



Notification Issue Date:



Policy Attachment

Attachment to Policy # MA06.017r


Attachment:C

Policy #:MA06.017r

Description:Services that are Considered Experimental/Investigational

Title:Molecular Diagnostics


Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.


TABLE 1: MOLECULAR DIAGNOSTIC TESTS THAT ARE REPRESENTED BY SPECIFIC PROCEDURE CODES

The following procedure codes and services are considered experimental/investigational and, therefore, not covered.
Code
81227
81228
81229
81350
81355
81506
G9143
S3721
S3800
S3852
S3861
S3870
0004M
0006M
0007M
0010M


TABLE 2: MOLECULAR DIAGNOSTIC TESTS REPRESENTED BY PROCEDURE CODES THAT CAN BE REPORTED FOR OTHER SERVICES

The following services that are considered experimental/investigational and, therefore, not covered. These services are represented by procedure codes that can be reported for other services.
Name(s) or Type(s) of Test(s)Procedure Codes and Narratives
OncoCee 88346, 88313, 88361
ERG molecular marker for prostate cancer88368
PTEN molecular marker for prostate cancer88342



TABLE 3: MOLECULAR DIAGNOSTIC TESTS WITHOUT SPECIFIC PROCEDURE CODES

The following services are considered experimental/investigational and, therefore, not covered. These services lack a specific CPT or HCPCS code. Because unlisted procedure codes can be reported with many services, the intent of this section is to provide direction only for the specific genetic testing services listed below.

Name(s) or Type(s) of Test(s)Unlisted Procedure Codes
Whole Exome Sequencing
    81479
    84999
    89240
Genome-Wide (or Whole-Genome) Scanning/Sequencing
    81479
    84999
    89240
Mitochondrial DNA (mtDNA) Whole-Genome Scanning/Sequencing
    81479
MitoMet® Mitochondrial/Metabolic Microarray Analysis
    81599
    81479
    84999
    89240
NuclearMitoDx™ (formerly MitoNucleomeDx)
    81599
    81479
    84999
    89240
Comprehensive Mitochondial Nuclear Gene Panel
    81479
Mitochondrial Disorders Panel
    81599
    81479
    84999
    89240
BreastNext™ Next-Gen Cancer Panel
    81599
    81479
    84999
    89240
OvaNext™ Next-Gen Cancer Panel
    81599
    81479
    84999
    89240
ColoNext™
    81599
    81479
    84999
    89240
CancerNext™ Next-Gen Cancer Panel
    81599
    81479
    84999
    89240
Counsyl Universal Genetic Test
    81599
    81479
    84999
    89240
Macula Risk NXG test
    81479
    81599
Septin 9 (SEPT9), Methylated DNA Detection by Real-Time PCR
    81479
    81599
    84999
    89240
COLOVANTAGE™
    81479
    81599
    84999
    89240
HOXD3 for prostate cancer
    81479
    81599
    84999
    89240
PreDx® Diabetes Risk Score (DRS) by Tethys Bioscience
    84999
Pervenio Lung RS (an assay formerly known as Pinpoint Dx Lung)
    84999
PAX6 Gene Sequencing and Deletion/Duplication
    81479
L1CAM Gene Sequencing and Deletion/Duplication
    81479
HAX1 Gene Sequencing
    81479
ELA2 GENE ANALYSIS
    81479
4q25-AF Risk Genotype Test
    81479
    81599
    84999
    89240
Specimen Validity Testing
    81479
    81599
    84999
    89240
TERC Gene Tests, IPF Telomerase (TERT, TERC), TERC Gene Sequencing, Reflex Option to TERC
    81479
RPS19 Gene Tests, Diamond-Black FAN DNA ZBS62 81479,
DBA Reflex Option All Genes
    81479 (Note: Use to report testing for other than full gene sequencing or known familial variant)
Combinations of NSD1 analysis
    81479
PTCH1 Gene Sequencing and Dup/Del
    81479
PTCH1 Dup/Del
    81479
CHD7 testing (other than full gene sequencing)
    81479
Stat3 Gene Sequencing
    81479
PIK3CA Gene Tests, PIK3CA Mutation Detection, Precision PIK3CA
    81479
Colorectal Cancer Mutation Panel (KRAS, PIK3CA, BRAF, NRAS), PIK3CA Mutation Status by RT-PCR, PIK3CA MUTATION ANALYSIS, PIK3CA Mutation Analysis (Bi-Directional Sequencing) OnkoMatch Tumor Genotyping
    81479
VEGFR2 mRNA expression analysis
    81479
CYP2B6 Test
    81479
know error® DNA Specimen Provenance Assay
    84999
myPAP™ DNA
    84999
SULT4A1 Genetic Testing, single gene testing, panels of tests that include the SULT4A1
    81479
ACVRL1
    81479
Tests that include ENG and ACVRL1 gene testing
    81479
LPA-Intron 25 genotype test
    81479
LPA-Aspirin genotype test
    81479
KIF6 genotype test
    81479
BluePrint®
    84999
9p21 Genotype Test
    81479
Genetic Testing for Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C)
    81479
SF3B1, ex 14‐17
    81479
MicroRNA testing
    89240
miRview kidney assay

miRview lung assay

    89240
In Vitro Chemosensitivity and Chemoresistance Assays
    89240
    See the current version of the policy entitled In Vitro Chemosensitivity and Chemoresistance Assays, MA06.02.

TABLE 4: TIER 02 CPT CODES
    Tier 02 CPT codes, (81400 - 81408), for genetic testing services are nonspecific in nature. Individual tests, which do not have a Tier 01 CPT genetic testing code may be represented with Tier 02 genetic testing CPT codes. In this table 4, there is a list of specific genetic tests, (not an all-inclusive list), for each of the Tier 02 CPT genetic testing codes, which are considered experimental/investigational and, therefore, not covered.
    Tier 02 CPT Code
    • Specific Tests
    81400
    • LCT (lactase-phlorizin hydrolase) (eg, lactose intolerance) 13910 C>T variant
    • N48K variant DPYD (dihydropyrimidine dehydrogenase) (eg, 5-fluorouracil/5-FU and capecitabine drug metabolism)
    • ABCC8, F1388del
    • ACADM, K304E
    • AGTR1, 1166A>C
    • BCKDHA, cv
    • CCR5, del
    • CLRN1, N48K
    • DPYD, IVS14+1G>A
    • DYT1(TOR1A), IVS14+1G>A
    • FGFR1, P252R
    • FGFR3, P250R
    • FKTN, retrotransposon insertion variant
    • GNE, M712T
    • IL28B, rs12979860
    • IVD, A282V
    • NEB, exon 55
    • PCDH15, R245X
    • SHOC2, S2G
    • SLCO1B1, V174A
    • SMN1, exon 7 del
    • SRY
    81401
    • ABCC8, cv
    • ACADM, cv
    • ADRB2, cv
    • AFF2,
    • APOB, cv
    • APOE, cv
    • AR, alleles
    • ATN1
    • ATXN1
    • ATXN2
    • ATXN3
    • ATXN7
    • ATXN8OS
    • ATXN10
    • CACNA1A
    • CNBP
    • CBFB_MYH11, quan qual
    • CBS, cv
    • CFH_ARMS2, cv
    • CSTB
    • CYP3A4, cv
    • CYP3A5, cv
    • DMPK
    • ETV6/NTRK3
    • EWSR1/ATF1
    • FGFR3, cv
    • FLG, cv
    • FUS/DDIT3
    • FXN, alleles
    • GALC
    • GALT, cv
    • H19, ma
    • HBB, cv
    • HTT, alleles
    • KCNQ10T1 , ma
    • LRRK2, cv
    • MED12, cv
    • MEG3_DLK1, ma
    • MLL_AFF1, ta qual quan
    • MLL_MLLT3, ta, qual quan
    • MT–ATP6, cv
    • MT–ND4, MT–ND6, cv
    • MT–ND5, cv
    • MT–RNR1, cv
    • MT–TK, cv
    • MT–TL1, cv
    • MT–TS1, cv
    • NOD2
    • PABPN1
    • PPP2R2B
    • PRSS1, cv
    • PYGM, cv
    • SEPT9, ma
    • SMN1_SMN2, dosage
    • SS18/SSX1
    • SS18/SSX2
    • TBP
    81402
    • C18q
    • COL1A1/PDGFB, mbp qual quan
    • CYP21A2 , cv
    • ESR1_PGR, ratio
    • MEFV, cv
    • MPL, cv
    • TRD, gr
    • UPD, str
    81403
    • ANG, fgs
    • ARX
    • CEL, exon 11
    • CTNNB1
    • DAZ_SRY, cdel
    • DNMT3A, tsa
    • EPCAM
    • ENG, Known Familial Variants (Unlisted)
    • F12, ts
    • FGFR3, exon 7
    • GJB1, fgs
    • GNAQ, cv
    • HBB, dup_del
    • HRAS, exon 2
    • KCNC3, tsa
    • KCNJ11, fgs
    • KCNJ2, fgs
    • Killer cell immunoglobulin–like receptor
    • KRAS, exon 3
    • MC4R, fgs
    • MICA, cv
    • MPL , exon 10
    • MT–RNR1, fgs
    • MT–TS1 , fgs
    • NDP, d_d
    • NHLRC1, fgs
    • PHOX2B, dup_del
    • PLN, fgs
    • RPS19, if known familial variant
    • SH2D1A, dup_del
    • SMN1, kfv
    • TWIST1, dup_del
    • UBA1, tsa
    81404
    • ACADS, tsa
    • AFF2
    • AVPR2, fgs
    • AQP2, fgs
    • ARX, fgs
    • BBS10, fgs
    • BTD, fgs
    • C10orf2, fgs
    • CAV3, fgs
    • CD40LG, fgs
    • CLRN1, fgs
    • COX6B1, fgs
    • CPT2, fgs
    • CRX, fgs
    • CSTB, fgs
    • CYP1B1 , fgs
    • DMPK
    • EGR2, fgs
    • EMD, Dup_del
    • EPM2A, fgs
    • FGF23, fgs
    • FGFR2, exons 8,10
    • FGFR3, tsa
    • FHL1, fgs
    • FKRP, fgs
    • FOXG1 , fgs
    • FSHMD1A
    • FXN, fgs
    • GH1, fgs
    • GP1BB, fgs
    • HBA1_HBA2, dup_del
    • HBB, fgs
    • HNF1B, dup_del
    • HRAS, fgs
    • HSD3B2, fgs
    • HSD11B2, fgs
    • HSPB1, fgs
    • INS, fgs
    • KCNJ1, fgs
    • KCNJ10, fgs
    • LITAF, fgs
    • MEFV, fgs
    • MEN1, dup_del
    • MMACHC, fgs
    • NDP, fgs
    • NDUFA1, fgs
    • NDUFAF2, fgs
    • NDUFS4, fgs
    • NIPA1, fgs
    • NLGN4X, dup_del
    • NPC2, fgs
    • NR0B1, fgs
    • PDX1, fgs
    • PHOX2B, fgs
    • PLP1, Dup_del
    • PQBP1, Dup_del
    • PRNP, fgs
    • PROP1, fgs
    • PRPH2, fgs
    • RAF1, exons 7, 12,14,17
    • RET, cv
    • RHO, fgs
    • SCN1B, fgs
    • SCO2, fgs
    • SDHC, dup_del
    • SDHD, fgs
    • SGCG, dup_del
    • SH2D1A, fgs
    • SLC16A2, dup_del
    • SLC25A20, dup_del
    • SLC25A4, fgs
    • SOD1, fgs
    • SPINK1, fgs
    • STK11, dup_del
    • TACO1, fgs
    • THAP1, fgs
    • TOR1A, fgs
    • TP53, 2–5 exons
    • TTPA , fgs
    • TTR, fgs
    • TWIST1, fgs
    • TYR, fgs
    • USH1G, fgs
    • VWF, tsa (1C, exons 36, 27, 37)
    • ZEB2, dup_del
    • ZNF41, fgs
    • ACTA2, fgs
    • ANKRD1, fgs
    • ACTA2, fgs
    • ANKRD1, fgs
    81405
    • ABCD1, fgs
    • ACADS, fgs
    • ACTC1, fgs
    • Mopath procedure level 6
    • ABCD1, fgs
    • ACADS, fgs
    • ACTC1, fgs
    • APTX, fgs
    • AR, fgs
    • ARSA, fgs
    • BCKDHA, fgs
    • BCS1L, fgs
    • BMPR2 , dup_del
    • CASQ2, fgs
    • CASR, fgs
    • CDKL5, dup_del
    • CHRNA4 , fgs
    • CHRNB2, fgs
    • COX10, fgs
    • COX15, fgs
    • CYP11B1, fgs
    • CYP17A1, fgs
    • CYP21A2, fgs
    • Cytogenomic constitutional targeted microarray analysis of chromosome 22q13
    • Cytogenomic constitutional targeted microarray analysis of the X chromosome
    • DBT, dup_del
    • DCX, fgs
    • DES, fgs
    • DFNB59, fgs
    • DGUOK, fgs
    • DHCR7, fgs
    • EIF2B2, fgs
    • EMD, fgs
    • ENG, dup_del
    • EYA1, dup_del
    • F9, fgs
    • FH, fgs
    • FGFR1 , fgs
    • FKTN, fgs
    • FTSJ1, dup_del
    • GABRG2, fgs
    • GCH1 , fgs
    • GDAP1, fgs
    • GFAP, fgs
    • GHR, fgs
    • GHRHR, fgs
    • GLA, fgs
    • HBA1_HBA2, fgs
    • HNF1A, fgs
    • HNF1B, fgs
    • HTRA1, fgs
    • IDS, fgs
    • IL2RG , fgs
    • ISPD, fgs
    • KRAS, fgs
    • LAMP2, fgs
    • LDLR, dup_del
    • Mitochondrial genome deletions, dup_del
    • MMAA, fgs
    • MMAB. Fgs
    • MPI, fgs
    • MPV17, fgs
    • MPZ, fgs
    • MTM1, dup_del
    • MYL2, fgs
    • MYL3, fgs
    • MYOT, fgs
    • NDUFS7, fgs
    • NDUFS8, fgs
    • NDUFV1, fgs
    • NEFL, fgs
    • NF2, dup_del
    • NLGN3, fgs
    • NLGN4X, fgs
    • NPHP1, dup_del
    • NPHS2, fgs
    • NSD1, dup_del
    • OTC, fgs
    • PAFAH1B1, dup_del
    • PARK2, dup_del
    • PCCA, dup_del
    • PCDH19, fgs
    • PDHA1, dup_del
    • PDHB, fgs
    • PINK1, fgs
    • PLP1, fgs
    • POU1F1, fgs
    • PQBP1, fgs
    • PRX, fgs
    • PSEN1, fgs
    • RAB7A, fgs
    • RAI1, fgs
    • REEP1, fgs
    • RET, tsa
    • RPS19, fgs
    • RRM2B, fgs
    • SCO1, fgs
    • SDHB, fgs
    • SDHC, fgs
    • SGCA, fgs
    • SGCB, fgs
    • SGCD, fgs
    • SGCE, dup_del
    • SGCG, fgs
    • SHOC2, fgs
    • SHOX, fgs
    • SIL1, fgs
    • SLC16A2, fgs
    • SLC22A5, fgs
    • SLC25A20, fgs
    • SLC2A1, fgs
    • SMAD4, dup_del
    • SMN1, fgs
    • SPAST, dup_del
    • SPG7, dup_del
    • SPRED1, fgs
    • STAT3, tsa
    • STK11, fgs
    • SURF1, fgs
    • TARDBP, fgs
    • TBX5, fgs
    • TCF4, dup_del
    • TGFBR1, fgs
    • TGFBR2, fgs
    • THRB, fgs >5 exons
    • TK2, fgs
    • TNNI3, fgs
    • TNNC1, fgs
    • TP53, fgs or tsa >5 exons
    • TPM1, fgs
    • TSC1, dup_del
    • TYMP, fgs
    • WT1, fgs
    • ZEB2, fgs
    • AFG3L2, fgs
    • AIRE, fgs
    • ALDH7A1, fgs
    81406
    • full gene sequence PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer)
    • ACADVL, fgs
    • ACTN4, fgs
    • ANO5, fgs
    • APP, fgs
    • ASS1, fgs
    • ATL1, fgs
    • ATP1A2, fgs
    • ATP7B, fgs
    • BBS1, fgs
    • BBS2, fgs
    • BCKDHB, fgs
    • BEST1, fgs
    • BMPR2, fgs
    • BRAF, fgs
    • BSCL2, fgs
    • BTK, fgs
    • CACNB2, fgs
    • CBS, fgs
    • CDH1, fgs
    • CDKL5, fgs
    • CLCN1, fgs
    • CLCNKB, fgs
    • CNTNAP2, fgs
    • COL6A2, dup_del
    • CPT1A, fgs
    • CRB1, fgs
    • CREBBP, dup_del
    • Cytogenomic microarray analysis
    • DBT, fgs
    • DLAT, fgs
    • DLD, fgs
    • DSC2, fgs
    • DSG2, fgs
    • DSP, fgs
    • EFHC1, fgs
    • EIF2B3, fgs
    • EIF2B4, fgs
    • EIF2B5, fgs
    • ENG, fgs
    • EYA1, fgs
    • F8, dup_del
    • FAH, fgs
    • FASTKD2, fgs
    • FIG4, fgs
    • FTSJ1, fgs
    • FUS, fgs
    • GAA, fgs
    • GALC, fgs
    • GALT, fgs
    • GARS, fgs
    • GCDH, fgs
    • GCK, fgs
    • GLUD1, fgs
    • GNE, fgs
    • GRN, fgs
    • HADHA, fgs
    • HADHB,fgs
    • HEXA, fgs
    • HLCS, fgs
    • HNF4A, fgs
    • IDUA, fgs
    • INF2, fgs
    • IVD, fgs
    • JAG1, dup_del
    • JUP, fgs
    • KAL1, fgs
    • KCNH2, fgs
    • KCNQ1, fgs
    • KCNQ2, fgs
    • LDB3, fgs
    • LDLR, fgs
    • LEPR, fgs
    • LHCGR, fgs
    • LMNA, fgs
    • LRP5, fgs
    • MAP2K1, fgs
    • MAP2K2, fgs
    • MAPT, fgs
    • MCCC1, fgs
    • MCCC2, fgs
    • MFN2, fgs
    • MTM1, fgs
    • MUT, fgs
    • MUTYH, fgs
    • NDUFS1, fgs
    • NF2, fgs
    • NOTCH3, tsa
    • NPC1, fgs
    • NPHP1, fgs
    • NSD1, fgs
    • OPA1, dup_del
    • OPTN, fgs
    • PAFAH1B1, fgs
    • PAH, fgs
    • PARK2, fgs
    • PAX2, fgs
    • PC, fgs
    • PCCA, fgs
    • PCCB, fgs
    • PDHA1, fgs
    • PCDH15, dup_del
    • PDHX, fgs
    • PHEX, fgs
    • PKD2, fgs
    • PKP2, fgs
    • PNKD, fgs
    • POLG, fgs
    • POMGNT1, fgs
    • POMT1, fgs
    • POMT2, fgs
    • PRKAG2, fgs
    • PRKCG, fgs
    • PSEN2, fgs
    • PTPN11, fgs
    • PYGM, fgs
    • RAF1, fgs
    • RPE65, fgs
    • RYR1, tsa
    • SCNN1A, fgs
    • SCNN1B, fgs
    • SCNN1G, fgs
    • SDHA, fgs
    • SETX, fgs
    • SGCE, fgs
    • SH3TC2, fgs
    • SLC26A4, fgs
    • SLC37A4, fgs
    • SMAD4, fgs
    • SPAST, fgs
    • SPG7, fgs
    • STXBP1, fgs
    • SOS1, fgs
    • TAZ, fgs
    • TCF4, fgs
    • TH , fgs
    • TMEM43, fgs
    • TNNT2, fgs
    • TRPC6, fgs
    • TSC1, fgs
    • TSC2, dup_del
    • UBE3A, fgs
    • UMOD, fgs
    • VWF, etsa
    • WAS, fgs
    81407
    • ABCC8, fgs
    • AGL, fgs
    • AHI1, fgs
    • ASPM , fgs
    • CACNA1A, fgs
    • CHD7, fgs
    • COL4A4, fgs
    • COL4A5, dup_del
    • COL6A1, fgs
    • COL6A2, fgs
    • COL6A3, fgs
    • CREBBP, fgs
    • F8, fgs
    • JAG1, fgs
    • KDM5C, fgs
    • KIAA0196, fgs
    • L1CAM, fgs
    • LAMB2 , fgs
    • MYBPC3, fgs
    • MYH6, fgs
    • MYH7, fgs
    • MYO7A , fgs
    • NOTCH1, fgs
    • NPHS1, fgs
    • OPA1, fgs
    • PCDH15, fgs
    • PKD1, fgs
    • PLCE1, fgs
    • SCN1A, fgs
    • SLC12A1, fgs
    • SLC12A3, fgs
    • SPG11, fgs
    • SPTBN2, fgs
    • TMEM67, fgs
    • SCN5A, fgs
    • TSC2, fgs
    • USH1C, fgs
    • VPS13B, dup_del
    • WDR62 , fgs
    81408
    • ABCA4, fgs
    • ATM , fgs
    • CDH23 , fgs
    • CEP290, fgs
    • COL1A1, fgs
    • COL1A2 , fgs
    • COL4A1 , fgs
    • COL4A3 , fgs
    • COL4A5, fgs
    • DMD, fgs
    • DYSF, fgs
    • FBN1, fgs
    • ITPR1, fgs
    • LAMA2, fgs
    • NEB, fgs
    • NF1, fgs
    • LRRK2, fgs
    • MYH11, fgs
    • PKHD1 , fgs
    • RYR1, fgs
    • RYR2, fgs or tsa > 50
    • USH2A, fgs
    • VPS13B, fgs
    • VWF, fgs

    Miscellaneous
    Code
    0002U
    0003U
    0008U
    0009U
    0010U
    0011M
    0012M
    0013M
    0013U
    0014U
    0019U
    0021U
    0026U
    0029U
    0030U
    0031U
    0032U
    0033U
    0034U
    0036U
    0045U
    0050U
    0053U
    0055U
    0056U
    0060U
    0067U
    0068U
    0069U
    0078U
    0079U
    0080U
    0086U
    0087U
    0088U
    0089U
    0094U
    0097U
    0099U
    0100U
    0101U
    0102U
    0103U
    0109U
    0111U
    0112U
    0113U
    0114U
    0115U
    0118U
    0120U
    0124U
    0125U
    0126U
    0129U
    0130U
    0131U
    0132U
    0133U
    0134U
    0135U
    0136U
    0137U
    0138U
    0140U
    0141U
    0142U
    0151U
    0152U
    0153U
    0156U
    0157U
    0158U
    0159U
    0160U
    0161U
    0162U
    81283
    81313
    81328
    81346
    81410
    81411
    81415
    81416
    81417
    81422
    81425
    81426
    81427
    81430
    81431
    81435
    81436
    81440
    81445
    81448
    81450
    81455
    81460
    81465
    81470
    81471
    83006
    87505
    87506
    87507
    87623
    81432
    81433
    81434
    81437
    81438
    81442
    S3854




    Version Effective Date: 01/01/2020
    Version Issued Date: 01/03/2020
    Version Reissued Date: N/A

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    Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.