Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)

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General Information

Article ID
A57526
Article Title
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)
Article Type
Billing and Coding
Original Effective Date
11/01/2019
Revision Effective Date
04/17/2022
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2021 American Dental Association. All rights reserved.

Copyright © 2013 - 2021, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA) §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1 Clinical Laboratory Services

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.2 Independent Laboratory Specimen Drawing, §60.2. Travel Allowance

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Diagnostic Tests (MDT) L35160.

To report a Molecular Diagnostic Test service, please submit the following claim information:

  • Select appropriate CPT® code
  • Enter 1 unit of service (UOS)
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Item 19 for paper claim
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form

Coding Information

CPT/HCPCS Codes

Group 1

(445 Codes)
Group 1 Paragraph

The codes listed below fall within scope of the associated policy but do not automatically imply coverage.

Group 1 Codes
CodeDescription
81105 Hpa-1 genotyping
81106 Hpa-2 genotyping
81107 Hpa-3 genotyping
81108 Hpa-4 genotyping
81109 Hpa-5 genotyping
81110 Hpa-6 genotyping
81111 Hpa-9 genotyping
81112 Hpa-15 genotyping
81120 Idh1 common variants
81121 Idh2 common variants
81161 Dmd dup/delet analysis
81162 Brca1&2 gen full seq dup/del
81163 Brca1&2 gene full seq alys
81164 Brca1&2 gen ful dup/del alys
81165 Brca1 gene full seq alys
81166 Brca1 gene full dup/del alys
81167 Brca2 gene full dup/del alys
81168 Ccnd1/igh translocation alys
81170 Abl1 gene
81171 Aff2 gene detc abnor alleles
81172 Aff2 gene charac alleles
81173 Ar gene full gene sequence
81174 Ar gene known famil variant
81175 Asxl1 full gene sequence
81176 Asxl1 gene target seq alys
81177 Atn1 gene detc abnor alleles
81178 Atxn1 gene detc abnor allele
81179 Atxn2 gene detc abnor allele
81180 Atxn3 gene detc abnor allele
81181 Atxn7 gene detc abnor allele
81182 Atxn8os gen detc abnor allel
81183 Atxn10 gene detc abnor allel
81184 Cacna1a gen detc abnor allel
81185 Cacna1a gene full gene seq
81186 Cacna1a gen known famil vrnt
81187 Cnbp gene detc abnor allele
81188 Cstb gene detc abnor allele
81189 Cstb gene full gene sequence
81190 Cstb gene known famil vrnt
81191 Ntrk1 translocation analysis
81192 Ntrk2 translocation analysis
81193 Ntrk3 translocation analysis
81194 Ntrk translocation analysis
81200 Aspa gene
81201 Apc gene full sequence
81202 Apc gene known fam variants
81203 Apc gene dup/delet variants
81204 Ar gene charac alleles
81205 Bckdhb gene
81206 Bcr/abl1 gene major bp
81207 Bcr/abl1 gene minor bp
81208 Bcr/abl1 gene other bp
81209 Blm gene
81210 Braf gene
81212 Brca1&2 185&5385&6174 vrnt
81215 Brca1 gene known famil vrnt
81216 Brca2 gene full seq alys
81217 Brca2 gene known famil vrnt
81218 Cebpa gene full sequence
81219 Calr gene com variants
81220 Cftr gene com variants
81221 Cftr gene known fam variants
81222 Cftr gene dup/delet variants
81223 Cftr gene full sequence
81224 Cftr gene intron poly t
81225 Cyp2c19 gene com variants
81226 Cyp2d6 gene com variants
81227 Cyp2c9 gene com variants
81228 Cytog alys chrml abnr cgh
81229 Cytog alys chrml abnr snpcgh
81230 Cyp3a4 gene common variants
81231 Cyp3a5 gene common variants
81232 Dpyd gene common variants
81233 Btk gene common variants
81234 Dmpk gene detc abnor allele
81235 Egfr gene com variants
81236 Ezh2 gene full gene sequence
81237 Ezh2 gene common variants
81238 F9 full gene sequence
81239 Dmpk gene charac alleles
81240 F2 gene
81241 F5 gene
81242 Fancc gene
81243 Fmr1 gene detection
81244 Fmr1 gene charac alleles
81245 Flt3 gene
81246 Flt3 gene analysis
81247 G6pd gene alys cmn variant
81248 G6pd known familial variant
81249 G6pd full gene sequence
81250 G6pc gene
81251 Gba gene
81252 Gjb2 gene full sequence
81253 Gjb2 gene known fam variants
81254 Gjb6 gene com variants
81255 Hexa gene
81256 Hfe gene
81257 Hba1/hba2 gene
81258 Hba1/hba2 gene fam vrnt
81259 Hba1/hba2 full gene sequence
81260 Ikbkap gene
81261 Igh gene rearrange amp meth
81262 Igh gene rearrang dir probe
81263 Igh vari regional mutation
81264 Igk rearrangeabn clonal pop
81265 Str markers specimen anal
81266 Str markers spec anal addl
81267 Chimerism anal no cell selec
81268 Chimerism anal w/cell select
81269 Hba1/hba2 gene dup/del vrnts
81270 Jak2 gene
81271 Htt gene detc abnor alleles
81272 Kit gene targeted seq analys
81273 Kit gene analys d816 variant
81274 Htt gene charac alleles
81275 Kras gene variants exon 2
81276 Kras gene addl variants
81277 Cytogenomic neo microra alys
81278 Igh@/bcl2 translocation alys
81279 Jak2 gene trgt sequence alys
81283 Ifnl3 gene
81284 Fxn gene detc abnor alleles
81285 Fxn gene charac alleles
81286 Fxn gene full gene sequence
81287 Mgmt gene prmtr mthyltn alys
81288 Mlh1 gene
81289 Fxn gene known famil variant
81290 Mcoln1 gene
81291 Mthfr gene
81292 Mlh1 gene full seq
81293 Mlh1 gene known variants
81294 Mlh1 gene dup/delete variant
81295 Msh2 gene full seq
81296 Msh2 gene known variants
81297 Msh2 gene dup/delete variant
81298 Msh6 gene full seq
81299 Msh6 gene known variants
81300 Msh6 gene dup/delete variant
81301 Microsatellite instability
81302 Mecp2 gene full seq
81303 Mecp2 gene known variant
81304 Mecp2 gene dup/delet variant
81305 Myd88 gene p.leu265pro vrnt
81306 Nudt15 gene common variants
81307 Palb2 gene full gene seq
81308 Palb2 gene known famil vrnt
81309 Pik3ca gene trgt seq alys
81310 Npm1 gene
81311 Nras gene variants exon 2&3
81312 Pabpn1 gene detc abnor allel
81313 Pca3/klk3 antigen
81314 Pdgfra gene
81315 Pml/raralpha com breakpoints
81316 Pml/raralpha 1 breakpoint
81317 Pms2 gene full seq analysis
81318 Pms2 known familial variants
81319 Pms2 gene dup/delet variants
81320 Plcg2 gene common variants
81321 Pten gene full sequence
81322 Pten gene known fam variant
81323 Pten gene dup/delet variant
81324 Pmp22 gene dup/delet
81325 Pmp22 gene full sequence
81326 Pmp22 gene known fam variant
81327 Sept9 gen prmtr mthyltn alys
81328 Slco1b1 gene com variants
81329 Smn1 gene dos/deletion alys
81330 Smpd1 gene common variants
81331 Snrpn/ube3a gene
81332 Serpina1 gene
81333 Tgfbi gene common variants
81334 Runx1 gene targeted seq alys
81335 Tpmt gene com variants
81336 Smn1 gene full gene sequence
81337 Smn1 gen nown famil seq vrnt
81338 Mpl gene common variants
81339 Mpl gene seq alys exon 10
81340 Trb@ gene rearrange amplify
81341 Trb@ gene rearrange dirprobe
81342 Trg gene rearrangement anal
81343 Ppp2r2b gen detc abnor allel
81344 Tbp gene detc abnor alleles
81345 Tert gene targeted seq alys
81346 Tyms gene com variants
81347 Sf3b1 gene common variants
81348 Srsf2 gene common variants
81349 Cytog alys chrml abnr lw-ps
81350 Ugt1a1 gene common variants
81351 Tp53 gene full gene sequence
81352 Tp53 gene trgt sequence alys
81353 Tp53 gene known famil vrnt
81355 Vkorc1 gene
81357 U2af1 gene common variants
81360 Zrsr2 gene common variants
81361 Hbb gene com variants
81362 Hbb gene known fam variant
81363 Hbb gene dup/del variants
81364 Hbb full gene sequence
81374 Hla i typing 1 antigen lr
81377 Hla ii type 1 ag equiv lr
81381 Hla i typing 1 allele hr
81383 Hla ii typing 1 allele hr
81400 Mopath procedure level 1
81401 Mopath procedure level 2
81402 Mopath procedure level 3
81403 Mopath procedure level 4
81404 Mopath procedure level 5
81405 Mopath procedure level 6
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81408 Mopath procedure level 9
81410 Aortic dysfunction/dilation
81411 Aortic dysfunction/dilation
81412 Ashkenazi jewish assoc dis
81413 Car ion chnnlpath inc 10 gns
81414 Car ion chnnlpath inc 2 gns
81415 Exome sequence analysis
81416 Exome sequence analysis
81417 Exome re-evaluation
81419 Epilepsy gen seq alys panel
81420 Fetal chrmoml aneuploidy
81422 Fetal chrmoml microdeltj
81425 Genome sequence analysis
81426 Genome sequence analysis
81427 Genome re-evaluation
81430 Hearing loss sequence analys
81431 Hearing loss dup/del analys
81432 Hrdtry brst ca-rlatd dsordrs
81433 Hrdtry brst ca-rlatd dsordrs
81434 Hereditary retinal disorders
81435 Hereditary colon ca dsordrs
81436 Hereditary colon ca dsordrs
81437 Heredtry nurondcrn tum dsrdr
81438 Heredtry nurondcrn tum dsrdr
81439 Hrdtry cardmypy gene panel
81440 Mitochondrial gene
81442 Noonan spectrum disorders
81443 Genetic tstg severe inh cond
81445 Targeted genomic seq analys
81448 Hrdtry perph neurphy panel
81450 Targeted genomic seq analys
81455 Targeted genomic seq analys
81460 Whole mitochondrial genome
81465 Whole mitochondrial genome
81470 X-linked intellectual dblt
81471 X-linked intellectual dblt
81479 Unlisted molecular pathology
81493 Cor artery disease mrna
81504 Oncology tissue of origin
81507 Fetal aneuploidy trisom risk
81518 Onc brst mrna 11 genes
81519 Oncology breast mrna
81520 Onc breast mrna 58 genes
81521 Onc breast mrna 70 genes
81522 Onc breast mrna 12 genes
81523 Onc brst mrna 70 cnt 31 gene
81525 Oncology colon mrna
81528 Oncology colorectal scr
81529 Onc cutan mlnma mrna 31 gene
81540 Oncology tum unknown origin
81541 Onc prostate mrna 46 genes
81542 Onc prostate mrna 22 cnt gen
81546 Onc thyr mrna 10,196 gen alg
81551 Onc prostate 3 genes
81552 Onc uveal mlnma mrna 15 gene
81554 Pulm ds ipf mrna 190 gen alg
81595 Cardiology hrt trnspl mrna
0004M Scoliosis dna alys
0006M Onc hep gene risk classifier
0007M Onc gastro 51 gene nomogram
0011M Onc prst8 ca mrna 12 gen alg
0012M Onc mrna 5 gen rsk urthl ca
0013M Onc mrna 5 gen recr urthl ca
0016M Onc bladder mrna 209 gen alg
0017M Onc dlbcl mrna 20 genes alg
0001U Rbc dna hea 35 ag 11 bld grp
0005U Onco prst8 3 gene ur alg
0012U Germln do gene reargmt detcj
0013U Onc sld org neo gene reargmt
0014U Hem hmtlmf neo gene reargmt
0016U Onc hmtlmf neo rna bcr/abl1
0017U Onc hmtlmf neo jak2 mut dna
0018U Onc thyr 10 microrna seq alg
0019U Onc rna tiss predict alg
0022U Trgt gen seq dna&rna 1-23 gn
0023U Onc aml dna detcj/nondetcj
0026U Onc thyr dna&mrna 112 genes
0027U Jak2 gene trgt seq alys
0029U Rx metab advrs trgt seq alys
0030U Rx metab warf trgt seq alys
0031U Cyp1a2 gene
0032U Comt gene
0033U Htr2a htr2c genes
0034U Tpmt nudt15 genes
0036U Xome tum & nml spec seq alys
0037U Trgt gen seq dna 324 genes
0040U Bcr/abl1 gene major bp quan
0045U Onc brst dux carc is 12 gene
0046U Flt3 gene itd variants quan
0047U Onc prst8 mrna 17 gene alg
0048U Onc sld org neo dna 468 gene
0049U Npm1 gene analysis quan
0050U Trgt gen seq dna 194 genes
0055U Card hrt trnspl 96 dna seq
0056U Hem aml dna gene reargmt
0060U Twn zyg gen seq alys chrms2
0069U Onc clrct microrna mir-31-3p
0070U Cyp2d6 gen com&slct rar vrnt
0071U Cyp2d6 full gene sequence
0072U Cyp2d6 gen cyp2d6-2d7 hybrid
0073U Cyp2d6 gen cyp2d7-2d6 hybrid
0074U Cyp2d6 nonduplicated gene
0075U Cyp2d6 5' gene dup/mlt
0076U Cyp2d6 3' gene dup/mlt
0078U Pain mgt opi use gnotyp pnl
0079U Cmprtv dna alys mlt snps
0084U Rbc dna gnotyp 10 bld groups
0087U Crd hrt trnspl mrna 1283 gen
0088U Trnsplj kdn algrft rej 1494
0089U Onc mlnma prame & linc00518
0090U Onc cutan mlnma mrna 23 gene
0091U Onc clrct scr whl bld alg
0094U Genome rapid sequence alys
0101U Hered colon ca do 15 genes
0102U Hered brst ca rltd do 17 gen
0103U Hered ova ca pnl 24 genes
0111U Onc colon ca kras&nras alys
0113U Onc prst8 pca3&tmprss2-erg
0114U Gi barretts esoph vim&ccna1
0118U Trnsplj don-drv cll-fr dna
0120U Onc b cll lymphm mrna 58 gen
0129U Hered brst ca rltd do panel
0130U Hered colon ca do mrna pnl
0131U Hered brst ca rltd do pnl 13
0132U Hered ova ca rltd do pnl 17
0133U Hered prst8 ca rltd do 11
0134U Hered pan ca mrna pnl 18 gen
0135U Hered gyn ca mrna pnl 12 gen
0136U Atm mrna seq alys
0137U Palb2 mrna seq alys
0138U Brca1 brca2 mrna seq alys
0153U Onc breast mrna 101 genes
0154U Onc urthl ca rna fgfr3 gene
0155U Onc brst ca dna pik3ca gene
0156U Copy number sequence alys
0157U Apc mrna seq alys
0158U Mlh1 mrna seq alys
0159U Msh2 mrna seq alys
0160U Msh6 mrna seq alys
0161U Pms2 mrna seq alys
0162U Hered colon ca trgt mrna pnl
0169U Nudt15&tpmt gene com vrnt
0170U Neuro asd rna next gen seq
0171U Trgt gen seq alys pnl dna 23
0172U Onc sld tum alys brca1 brca2
0173U Psyc gen alys panel 14 genes
0175U Psyc gen alys panel 15 genes
0177U Onc brst ca dna pik3ca 11
0179U Onc nonsm cll lng ca alys 23
0180U Abo gnotyp abo 7 exons
0181U Co gnotyp aqp1 exon 1
0182U Crom gnotyp cd55 exons 1-10
0183U Di gnotyp slc4a1 exon 19
0184U Do gnotyp art4 exon 2
0185U Fut1 gnotyp fut1 exon 4
0186U Fut2 gnotyp fut2 exon 2
0187U Fy gnotyp ackr1 exons 1-2
0188U Ge gnotyp gypc exons 1-4
0189U Gypa gnotyp ntrns 1 5 exon 2
0190U Gypb gnotyp ntrns 1 5 seux 3
0191U In gnotyp cd44 exons 2 3 6
0192U Jk gnotyp slc14a1 exon 9
0193U Jr gnotyp abcg2 exons 2-26
0194U Kel gnotyp kel exon 8
0195U Klf1 targeted sequencing
0196U Lu gnotyp bcam exon 3
0197U Lw gnotyp icam4 exon 1
0198U Rhd&rhce gntyp rhd1-10&rhce5
0199U Sc gnotyp ermap exons 4 12
0200U Xk gnotyp xk exons 1-3
0201U Yt gnotyp ache exon 2
0203U Ai ibd mrna xprsn prfl 17
0204U Onc thyr mrna xprsn alys 593
0205U Oph amd alys 3 gene variants
0209U Cytog const alys interrog
0211U Onc pan-tum dna&rna gnrj seq
0212U Rare ds gen dna alys proband
0213U Rare ds gen dna alys ea comp
0214U Rare ds xom dna alys proband
0215U Rare ds xom dna alys ea comp
0216U Neuro inh ataxia dna 12 com
0217U Neuro inh ataxia dna 51 gene
0218U Neuro musc dys dmd seq alys
0221U Abo gnotyp next gnrj seq abo
0222U Rhd&rhce gntyp next gnrj seq
0228U Onc prst8 ma molec prfl alg
0229U Bcat1 promoter mthyltn alys
0230U Ar full sequence analysis
0231U Cacna1a full gene analysis
0232U Cstb full gene analysis
0233U Fxn gene analysis
0234U Mecp2 full gene analysis
0235U Pten full gene analysis
0236U Smn1&smn2 full gene analysis
0237U Car ion chnlpthy gen seq pnl
0238U Onc lnch syn gen dna seq aly
0239U Trgt gen seq alys pnl 311+
0242U Trgt gen seq alys pnl 55-74
0244U Onc solid orgn dna 257 genes
0245U Onc thyr mut alys 10 gen&37
0246U Rbc dna gnotyp 16 bld groups
0250U Onc sld org neo dna 505 gene
0258U Ai psor mrna 50-100 gen alg
0260U Rare ds id opt genome mapg
0262U Onc sld tum rtpcr 7 gen
0264U Rare ds id opt genome mapg
0265U Rar do whl gn&mtcdrl dna als
0266U Unxpl cnst hrtbl do gn xprsn
0267U Rare do id opt gen mapg&seq
0268U Hem ahus gen seq alys 15 gen
0269U Hem aut dm cgen trmbctpna 14
0270U Hem cgen coagj do 20 genes
0271U Hem cgen neutropenia 23 gen
0272U Hem genetic bld do 51 genes
0273U Hem gen hyprfibrnlysis 8 gen
0274U Hem gen pltlt do 43 genes
0276U Hem inh thrombocytopenia 23
0277U Hem gen pltlt funcj do 31
0278U Hem gen thrombosis 12 genes
0282U Rbc dna gntyp 12 bld grp gen
0285U Onc rsps radj cll fr dna tox
0286U Cep72 nudt15&tpmt gene alys
0287U Onc thyr dna&mrna 112 genes
0288U Onc lung mrna quan pcr 11&3
0289U Neuro alzheimer mrna 24 gen
0290U Pain mgmt mrna gen xprsn 36
0291U Psyc mood do mrna 144 genes
0292U Psyc strs do mrna 72 genes
0293U Psyc suicidal idea mrna 54
0294U Lngvty&mrtlty rsk mrna 18gen
0296U Onc orl&/orop ca 20 mlc feat
0297U Onc pan tum whl gen seq dna
0298U Onc pan tum whl trns seq rna
0299U Onc pan tum whl gen opt mapg
0300U Onc pan tum whl gen seq&opt

Group 2

(2 Codes)
Group 2 Paragraph

The following CPT codes require a Z-code if the testing is molecular (DNA/RNA) based.

Group 2 Codes
CodeDescription
81599 Unlisted maaa
87999 Microbiology procedure

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
XX000 Not Applicable

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

N/A


N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
04/17/2022 R6

Under CPT/HCPCS Codes Group1: Codes deleted 81599.

Under CPT/HCPCS Codes Group 2: Paragraph added the verbiage, “The following CPT codes require a Z-code if the testing is molecular (DNA/RNA) based.”

Under CPT/HCPCS Codes Group 2: added codes 81599 AND 87999.

This revision is effective on 04/17/2022. 

01/01/2022 R5

Under CPT/HCPCS Codes Group 1: Paragraph added the verbiage “The codes listed below fall within scope of the associated policy but do not automatically imply coverage. This revision is effective January 1, 2022.

Under CPT/HCPCS Codes Group 1: Codes added 0285U, 0286U, 0287U, 0288U, 0289U, 0290U, 0291U, 0292U, 0293U, 0294U, 0296U, 0297U, 0298U, 0299U, 0300U, 81349, and 81523. Deleted 0208U. The description was revised for 0016M, 0017M, 0090U,0154U, 0155U, 0177U, 0180U, 0193U, 0200U, 0205U, 0216U, 0221U, 0244U, 0258U, 0262U, 0265U, 0266U, 0276U, 81194, 81228, and 81229. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on January 1, 2022.

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history. However, these revisions do not change coverage or guidance.

10/01/2021Under CPT/HCPCS Codes Group 1: Codes added 0258U, 0260U, 0262U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U, 0282U and deleted 0168U. This revision is due to the Q4 2021 CPT®/HCPCS Code Update and is effective for dates of service on or after 10/1/2021.

07.01.2021: Under CPT/HCPCS Codes Group 1: Codes added 0016M. This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021. Under CPT/HCPCS Codes Group 1: Codes added 0250U. This revision is due to the Q3 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 7/1/2021.

12/09/2021 - The following CPT/HCPCS codes were deleted: 0208U was deleted from Group 1

04/01/2021 R4

Under CPT/HCPCS Group 1: Codes added 0017M and deleted 0105U. This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021.

Under CPT/HCPCS Group 1: Codes added 0242U, 0244U, 0245U, and 0246U. This revision is due to the Q2 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2021.

01/01/2021 R3

Under CPT/HCPCS Codes Group 1: Codes added 81374, 81377, 81381, 81383, 0069U, 0133U, 0168U, 0169U, 0170U, 0171U, 0172U, 0173U, 0175U, 0177U, 0179U, 0180U, 0181U, 0182U, 0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 0198U, 0199U, 0200U 0201U, 0203U, 0204U, 0205U, 0208U, 0209U, 0211U, 0212U, 0213U, 0214U, 0215U, 0216U, 0217U, 0218U, 0221U, and 0222U and deleted 81490, 81500, 81503, 81506, 81508, 81509, 81510, 81511, 81512, 81535, 81536, 81538, 81539, 81545, 84999, 85999, 86152, 86153, 86849, 87999, 0003U, 0009U, 0021U, 0024U, 0039U, 0053U, 0054U, 0058U, 0059U, 0062U, 0067U, 0068U, 0080U, 0083U, 0092U, 0107U, and 0108U. 

Under CPT/HCPCS Codes Group 1: Codes added 81168, 81191, 81192, 81193, 81194, 81278, 81279, 81338, 81339, 81347, 81348, 81351, 81352, 81353, 81357, 81360, 81419, 81529, 81546, 81554, 0228U, 0229U, 0230U, 0231U, 0232U, 0233U, 0234U, 0235U, 0236U, 0237U, 0238U, 0239U. 

Under CPT/HCPCS Codes Group 2: Codes moved 81401, 81403, 81406, 81407, 81412 to CPT/HCPCS Codes Group 1: Codes.  

This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021.

This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021.

01/01/2020 R2

Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 87999, 0045U-0050U, 0053U-0060U, 0062U, 0067U, 0068U, 0070U-0076U, 0078U-0080U, 0083U, 0105U, 0107U, 0108U, 0111U, 0113U, 0114U, 0118U, 0120U, 0129U-0132U, and 0134U-0138U. CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U, 0041U-0044U, 0086U, 0093U, 0095U-0100U were deleted. CPT code range 0084U-0103U was revised to add/delete applicable codes above. This addition and deletion is due to coding that is applicable to the MolDX program.

Under CPT/HCPCS Codes Group 1: Codes CPT® code range 81161-81400 was revised to 81161-81364 including the addition of 81277, 81307, 81308, 81309, 81522, 81542, 81552, and added code range 0153U-0162U. CPT® codes 0009M and 0085U were deleted. The code descriptions were revised for CPT® codes 81350, 0101U, 0102U, and 0103U. This revision is due to the Annual CPT®/HCPCS Code Update and becomes effective on 1/1/2020.

Typographical errors were corrected in CMS National Coverage Policy.

11/01/2019 R1

11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of the related MolDX: Molecular Diagnostic Tests (MDT) L35160 LCD and placed in this article.

Under CPT/HCPCS Codes Group 1: Codes deleted CPT® codes 81401, 81403, 81406, 81407, and 81412. Under CPT/HCPCS Codes Group 2: Paragraph added verbiage CPT® codes that are also referenced in other articles. Under CPT/HCPCS Codes Group 2: Codes added CPT® codes 81401, 81403, 81406, 81407, and 81412.

The above revisions will become effective on 11/01/19.

Under CPT/HCPCS Codes Group 1: Codes: CPT code 0104U was deleted. Under CPT/HCPCS Codes Group 1: Codes: CPT codes 0008U and 81404 descriptions were changed. Under CPT/HCPCS Codes Group 2: Codes: CPT code 81407 description was changed. These revisions are due to the Q4 CPT®/HCPCS Code Updates and are retroactive effective for dates of service on or after 11/1/19.

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