Local Coverage Article Billing and Coding

Billing and Coding: Molecular Pathology and Genetic Testing

A58917

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Article ID
A58917
Article Title
Billing and Coding: Molecular Pathology and Genetic Testing
Article Type
Billing and Coding
Original Effective Date
11/08/2021
Revision Effective Date
04/01/2022
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

Internet-Only Manuals (IOMs):

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, and Section 280 Preventive and Screening Services
  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 16, Section 10 Background, Section 40.8 Date of Service (DOS) for Clinical Laboratory and Pathology Specimens and Section 120.1 Negotiated Rulemaking Implementation
    • Chapter 18 Preventive and Screening Services
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 3 Verifying Potential Errors and Taking Corrective Actions

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.
  • Title XVIII of the Social Security Act, Section 1862 [42 U.S.C. 1395Y] (a) states notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services—

(1)(A) which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Code of Federal Regulations (CFR) References:

  • CFR, Title 42, Subchapter B, Part 410 Supplementary Medical Insurance (SMI) Benefits, Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
  • CFR, Title 42, Section 414.502 Definitions
  • CFR, Title 42, Subpart G, Section 414.507 Payment for clinical diagnostic laboratory tests and Section 414.510 Laboratory date of service for clinical laboratory and pathology specimens
  • CFR, Title 42, Part 493 Laboratory Requirements
  • CFR, Title 42, Section 493.1253 Standard: Establishment and verification of performance specifications
  • CFR, Title 42, Section 1395y (b)(1)(F) Limitation on beneficiary liability

National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services:

  • Chapter 10, Section F Molecular Pathology

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for molecular pathology services, genomic sequencing procedures and other multianalyte assays, multianalyte assays with algorithmic analyses, and applicable proprietary laboratory analyses codes and Tier 1 and Tier 2 molecular pathology procedures. Consistent with CFR, Title 42, Section 414.502 Advanced diagnostic laboratory tests must provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.

This instruction focuses on coding and billing for molecular pathology diagnostics and genetic testing. Nothing stated in this instruction implies or infers coverage.

Molecular diagnostic testing and laboratory developed testing are rapidly evolving areas and thus present billing and coding challenges. Due to the rapid changes in this field, the CMS Clinical Laboratory Fee Schedule pricing methodology does not account for the unique characteristics of these tests. These challenges have led to services being incorrectly coded and improperly billed. It is the MAC’s responsibility to pay for services that are medically reasonable and necessary and coded correctly. The intent of this billing and coding article is to provide guidance for accurate coding and proper submission of claims.

Prior to January 1, 2013, each step of the process of a molecular diagnostic test was billed utilizing a separate CPT code to describe that process. Such billing was termed “stacking” with each step of a molecular diagnostic test utilizing a different CPT code to create a “Stack”. The updates to CPT after January 1, 2013, were to create a more granular, analyte and/or gene specific coding system for these services and to eliminate, or greatly reduce, the “stacking” of codes in billing for molecular pathology services. The current CPT and HCPCS codes include all analytic services and processes performed with the test. This approach has resulted in the following subgroups of CPT codes:

  • Genomic Sequencing Procedures
  • Multi-Analyte with Algorithmic Analyses (MAAA)
  • Proprietary Laboratory Analyses (PLA codes)
  • Tier 1 - Analyte Specific codes; a single test or procedure corresponds to a single CPT code
  • Tier 2 – Rare disease and low volume molecular pathology services

However, the updates to CPT since 2013 have NOT resulted in the elimination or reduction of stacking of codes in billing. Rather the billing of multiple CPT codes for a unique molecular pathology or genetic test has significantly increased over the last two (2) years. Coding issues have been identified throughout all the molecular pathology coding subgroups, but these issues of billing multiple CPT codes for a specific test have been significant in the Tier 2 (81403 - 81408) and Not Otherwise Classified (81479) codes. Per Title 42 of the United States Code (USC) Section 1320c-5(a)(3), providers are required by law to “provide economical medical services and then, only where medically necessary.” In keeping with Title 42 of the USC Section 1320c-5(a)(3), claims inappropriately billed utilizing stacking or unbundling of services will be rejected or denied.

Many applications of the molecular pathology procedures are not covered services given a lack of benefit category (e.g., preventive service or screening for a genetic abnormality in the absence of a suspicion of disease) and/or failure to meet the medically reasonable and necessary threshold for coverage (e.g., based on quality of clinical evidence and strength of recommendation or when the results would not reasonably be used in the management of a beneficiary). Furthermore, payment of claims in the past (based on “stacking” codes) or in the future (based on the new code series) is not a statement of coverage since the service may not have been audited for compliance with program requirements and documentation supporting the medically reasonable and necessary testing for the beneficiary. Certain molecular pathology procedures may be subject to medical review (medical records requested). The medical records must support the service billed.

Molecular pathology tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or that result in early death (e.g., Canavan disease) are subject to automatic denials since these tests are generally not relevant to a Medicare beneficiary.

The following types of tests are examples of services that are not relevant to a Medicare beneficiary, are not considered a Medicare benefit (statutorily excluded), and therefore will 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 performed to determine carrier screening
  • Tests performed for screening hereditary cancer syndromes
  • Prenatal diagnostic testing
  • Tests performed on patients without signs or symptoms 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

Screening services such as pre-symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a Medicare benefit and are not covered.

In accordance with the Code of Federal Regulations, Title 42, Subchapter B, Part 410, Section 410.32, the referring/ordering practitioner must have an established relationship with the patient, and the test results must be used by the ordering/referring practitioner in the management of the patient’s specific medical problem.

For ease of reading, the term “gene” in this document will be used to indicate a gene, region of a gene, and/or variant(s) of a gene.

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.

Code selection is based on the specific gene(s) that is being analyzed. Codes that describe tests to assess for the presence of gene variants use common gene variant names. All of the listed variants would usually be tested; however, these lists are not exclusive. If additional variants, for the same gene, are also tested in the analysis they are included in the procedure and are not reported separately.

Full gene sequencing is not reported using codes that assess for the presence of gene variants unless the CPT code specifically states full gene sequence in the descriptor.

Tier 1 codes generally describe testing for a specific gene or Human Leukocyte Antigen (HLA) locus. Tier 2 molecular pathology procedure codes (81400-81408) are used to report procedures not listed in the Tier 1 molecular pathology codes (81161, 81200-81383). These codes represent rare diseases and molecular pathology procedures that are performed in lower volumes than Tier 1 procedures. These codes should rarely, if ever, be used unless instructed by other coding and billing articles.

If billing utilizing the following Tier 2 codes, additional information will be required to identify the specific analyte/gene(s) tested in the narrative of the claim or the claim will be rejected:

  • 81403
  • 81404
  • 81405
  • 81406
  • 81407
  • 81408

Unlisted Molecular Pathology - CPT Code 81479

Providers are required to use a procedure code that most accurately describes the service being rendered. If the analyte being tested is not represented by a Tier 1 code or is not accurately described by a Tier 2 code, the unlisted molecular pathology procedure code 81479 should be reported.

However, when reporting CPT code 81479, the specific gene being tested must be entered in block 80 (Part A for the UBO4 claim), box 19 (Part B for a paper claim) or electronic equivalent of the claim. Failure to include this information on the claim will result in Part A claims being returned to the provider and Part B claims being rejected. In addition, medical records may be requested when 81479 is billed. The medical record must clearly identify the unique molecular pathology procedure performed, its analytic validity and clinical utility, and why CPT code 81479 was billed.

When multiple procedure codes are submitted on a claim (unique and/or unlisted), the documentation supporting each code must be easily identifiable. If on review the contractor cannot link a billed code to the documentation, these services will be denied based on Title XVIII of the Social Security Act, Section 1833(e).

Testing for Multiple Genes and Next Generation Sequencing (NGS) testing

A panel of genes is a distinct procedural service from a series of individual genes. All services billed to Medicare must be medically reasonable and necessary. As such, if a provider or supplier submits a claim for a panel, then the patient’s medical record must reflect that the panel was medically reasonable and necessary. Alternatively, if a provider or supplier bills for individual genes, then the patient’s medical record must reflect that each individual gene is medically reasonable and necessary.

Genes can be assayed serially or in parallel. Genes assayed on the same date of service are considered to be assayed in parallel if the result of one (1) assay does not affect the decision to complete the assay on another gene, and the two (2) genes are being tested for the same indication.

Genes assayed on the same date of service are considered to be assayed serially when there is a reflexive decision component where the results of the analysis of one (1) or more genes determines whether the results of additional analyses are medically reasonable and necessary.

If the laboratory method is NGS testing, and the laboratory assays two (2) or more genes in a patient in parallel, then those two (2) or more genes will be considered part of the same panel, consistent with the NCCI manual Chapter 10, Section F, number 8.

If the laboratory assays genes in serial, then the laboratory must submit claims for genes individually. The order by the treating clinician must reflect whether the treating clinician is ordering a panel or single genes, and additionally, the patient’s medical record must reflect that the service billed was medically reasonable and necessary.

CMS payment policy does not allow separate payment for multiple methods to test for the same analyte.

We would not expect that a provider or supplier would routinely bill for more than one (1) distinct laboratory genetic testing procedural service on a single beneficiary on a single date of service. In the rare circumstance that more than one (1) distinct genetic test is medically reasonable and necessary for the same beneficiary on the same date of service, the provider or supplier must attest that each additional service billed is a distinct procedural service using the 59 modifier.

-59 Modifier; Distinct Procedural Service

This modifier is allowable for radiology services and it may also be used with surgical or medical codes in appropriate circumstances.

When billing, report the first code without a modifier. On subsequent lines, report the code with the modifier. Under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-Evaluation and Management (E/M) services performed on the same day. Modifier 59 is used to identify procedures/services, other than E/M services, that are not normally reported together, but are appropriate under the circumstances. Documentation must support a different session, different procedure or surgery, different site or organ system, separate incision/excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. However, when another already established modifier is appropriate it should be used rather than modifier 59. Only if a more descriptive modifier is unavailable, and the use of modifier 59 best explains the circumstances, should modifier 59 be used.

The use of the 59 modifier will be considered an attestation that distinct procedural services are being performed rather than a panel and may result in the request for medical records.

Frequent use of the 59 modifier may be subject to medical review.

Genomic Sequencing Profiles (GSP)

When a GSP assay includes a gene or genes that are listed in more than one code descriptor, the code for the most specific test for the primary disorder sought must be reported, rather than reporting multiple codes for the same gene(s). Reporting multiple codes for the same gene will result in claim rejection or denial.

Multianalyte Assays with Algorithmic Analyses (MAAAs) and Proprietary Laboratory Analyses (PLA)

A valid PLA code takes precedence over Tier 1 and Tier 2 codes and must be reported if available. Reporting of a Tier 1 or Tier 2 code in this circumstance or in addition to a PLA code is incorrect coding and will result in claim rejection or denial.

Per CPT, the results of individual component procedure(s) that are inputs to the MAAAs may be provided on the associated reporting, however these assays are not reported separately using additional codes. Claims reporting such, will be rejected or denied.

Date of Service (DOS)

As a general rule, the DOS for either a clinical laboratory test or the technical component of a physician pathology service is the date the specimen was collected. In situations where a specimen is collected over a period of two calendar days, the DOS is the date the collection ended. There are some exceptions to the DOS policy. Please refer to the CMS IOM Publication 100-04, Chapter 16, Section 40.8 for complete information related to the DOS policy.

Documentation Requirements

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. In accordance with CFR Section 410.32, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed and will be used in the management of the beneficiary's specific medical problem.
  5. The medical record must support that the referring/ordering practitioner who ordered the test for a specific medical problem is treating the beneficiary for this specific medical problem. An example of documentation that could support the practitioner’s management of the beneficiary’s specific medical problem would be at least two E/M visits performed by the ordering/referring practitioner over the previous six months.
  6. The medical record must include documentation of how the ordering/referring practitioner used the test results in the management of the beneficiary’s specific medical problem.
  7. The ordering physician/nonphysician practitioner (NPP) documentation in the medical record must include, but is not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results).
  8. The medical record from the ordering physician/NPP must clearly indicate all tests that are to be performed.
  9. Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.

Coding Information

CPT/HCPCS Codes

Group 1

(495 Codes)
Group 1 Paragraph

Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book.

Providers should refer to the current CPT book for applicable CPT codes.

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
81370 Hla i & ii typing lr
81371 Hla i & ii type verify lr
81372 Hla i typing complete lr
81373 Hla i typing 1 locus lr
81374 Hla i typing 1 antigen lr
81375 Hla ii typing ag equiv lr
81376 Hla ii typing 1 locus lr
81377 Hla ii type 1 ag equiv lr
81378 Hla i & ii typing hr
81379 Hla i typing complete hr
81380 Hla i typing 1 locus hr
81381 Hla i typing 1 allele hr
81382 Hla ii typing 1 loc 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
81490 Autoimmune rheumatoid arthr
81493 Cor artery disease mrna
81500 Onco (ovar) two proteins
81503 Onco (ovar) five proteins
81504 Oncology tissue of origin
81506 Endo assay seven anal
81507 Fetal aneuploidy trisom risk
81508 Ftl cgen abnor two proteins
81509 Ftl cgen abnor 3 proteins
81510 Ftl cgen abnor three anal
81511 Ftl cgen abnor four anal
81512 Ftl cgen abnor five anal
81513 Nfct ds bv rna vag flu alg
81514 Nfct ds bv&vaginitis dna alg
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
81535 Oncology gynecologic
81536 Oncology gynecologic
81538 Oncology lung
81539 Oncology prostate prob score
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
81596 Nfct ds chrnc hcv 6 assays
81599 Unlisted maaa
G0452 Molecular pathology interpr
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
0001U Rbc dna hea 35 ag 11 bld grp
0005U Onco prst8 3 gene ur alg
0007U Rx test prsmv ur w/def conf
0008U Hpylori detcj abx rstnc dna
0009U Onc brst ca erbb2 amp/nonamp
0010U Nfct ds strn typ whl gen seq
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
0053U Onc prst8 ca fish alys 4 gen
0055U Card hrt trnspl 96 dna seq
0056U Hem aml dna gene reargmt
0060U Twn zyg gen seq alys chrms2
0068U Candida species pnl amp prb
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
0086U Nfct ds bact&fng org id 6+
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
0094U Genome rapid sequence alys
0096U Hpv hi risk types male urine
0101U Hered colon ca do 15 genes
0102U Hered brst ca rltd do 17 gen
0103U Hered ova ca pnl 24 genes
0105U Neph ckd mult eclia tum nec
0109U Id aspergillus dna 4 species
0111U Onc colon ca kras&nras alys
0112U Iadi 16s&18s rrna genes
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
0140U Nfct ds fungi dna 15 trgt
0141U Nfct ds bact&fng gram pos
0142U Nfct ds bact&fng gram neg
0152U Nfct ds dna untrgt ngnrj seq
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
0219U Nfct agt hiv gnrj seq alys
0221U Abo gnotyp next gnrj seq abo
0222U Rhd&rhce gntyp next gnrj seq
0227U Rx asy prsmv 30+rx/metablt
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
0252U Ftl aneuploidy str alys dna
0253U Rprdtve med rna gen prfl 238
0254U Reprdtve med alys 24 chrmsm
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
0301U Iadna bartonella ddpcr
0302U Iadna brtnla ddpcr flwg liq
0313U Onc pncrs dna&mrna seq 74
0314U Onc cutan mlnma mrna 35 gene
0315U Onc cutan sq cll ca mrna 40

CPT/HCPCS Modifiers

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
59 DISTINCT PROCEDURAL SERVICE: UNDER CERTAIN CIRCUMSTANCES, THE PHYSICIAN MAY NEED TO INDICATE THAT A PROCEDURE OR SERVICE WAS DISTINCT OR INDEPENDENT FROM OTHER SERVICES PERFORMED ON THE SAME DAY. MODIFIER -59 IS USED TO IDENTIFY PROCEDURES/SERVICES THAT ARE NOT NORMALLY REPORTED TOGETHER, BUT ARE APPROPRIATE UNDER THE CIRCUMSTANCES. THIS MAY REPRESENT A DIFFERENT SESSION OR PATIENT ENCOUNTER, DIFFERENT PROCEDURE OR SURGERY, DIFFERNET SITE OR ORGAN SYSTEM, SEPARATE INCISION/EXCISION, SEPARATE LESION, OR SEPARATE INJURY (OR AREA OF INJURY IN EXTENSIVE INJURIES) NOT ORDINARILY ENCOUNTERED OR PERFORMED ON THE SAME DAY BY THE SAME PHYSICIAN. HOWEVER, WHAN ANOTHER ALREADY ESTABLISHED MODIFIER IS APPROPRIATE IT SHOULD BE USED RATHER THAN MODIFIER -59. ONLY IF NO MORE DESCRIPTIVE MODIFIER IS AVAILABLE, AND THE USE OF MODIFIER -59 BEST EXPLAINS THE CIRCUMSTANCES, SHOULD MODIFIER -59 BE USED. MODIFIER CODE 09959 MAY BE USED AS AN ALTERNATE TO MODIFIER -59.

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

Group 1 Codes

N/A

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

N/A

ICD-10-PCS 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

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
04/01/2022 R4

Article revised and published on 05/05/2022 effective for dates of service on and after 04/01/2022 to reflect the April Quarterly CPT/HCPCS Update. The following CPT codes have been added to the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’: 0313U, 0314U and 0315U. The following CPT code has been deleted from the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’: 0097U. For the following CPT code either the short description and/or the long description was changed. Depending on which description is used in this article, there may not be any change in how the code displays: 0022U in the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’.

01/01/2022 R3

Article revised and published on 01/20/2022 effective for dates of service on and after 01/01/2022 to reflect the Annual HCPCS/CPT Code Updates. The following CPT codes have been added to the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’: 81349, 81523, 0285U, 0286U, 0287U, 0288U, 0289U, 0290U, 0291U, 0292U, 0293U, 0294U, 0296U, 0297U, 0298U, 0299U, 0300U, 0301U, and 0302U. The following CPT code has been deleted from the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’ and therefore has been removed from the article: 0208U. For the following CPT codes either the short description and/or the long description was changed. Depending on which description is used in this article, there may not be any change in how the code displays: 0016M, 0090U, 0154U, 0155U, 0177U, 0180U, 0193U, 0200U, 0205U, 0216U, 0221U, 0244U, 0258U, 0262U, 0265U, 0266U, 0276U, 81194, 81228, 81229, and 81405 in the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’.

12/30/2021 R2

Article revised and published on 12/30/2021. Documentation requirement #5 has been revised. Information regarding the requirement for a relationship between the ordering/referring practitioner and the patient has been added to the text of the article and a separate documentation requirement, #6, was created to address using the test results in the management of the patient. The following CPT codes have been removed from the Group 1 CPT Codes: 0115U, 0151U, 0202U, 0223U, 0225U, 0240U, and 0241U.

11/08/2021 R1

Article revised and published on November 4, 2021 effective for dates of service on and after November 8, 2021. The instructions for reporting CPT code 81479 have been clarified, multiple CPT codes that did not represent molecular pathology services have been deleted and the following CPT codes have been added in response to the October 2021 Quarterly HCPCS Update: 0258U, 0260U, 0262U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U, and 0282U.

Associated Documents

Related National Coverage Documents
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
04/29/2022 04/01/2022 - N/A Currently in Effect You are here
01/14/2022 01/01/2022 - 03/31/2022 Superseded View
12/23/2021 12/30/2021 - 12/31/2021 Superseded View
10/29/2021 11/08/2021 - 12/29/2021 Superseded View
10/01/2021 11/08/2021 - N/A Superseded View

Keywords

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