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eviCore Lab Management (AmeriHealth)
06.02.52ai

Policy

​
This policy does not apply to Members for whom eviCore Lab Management Program is not applicable. This policy only applies to members for whom the Program is applicable. Individual benefits must be verified before/prior to providing services. 

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.​

This policy does not apply to self-funded groups for whom eviCore's Lab Management Program is not applicable; individual benefits must be verified.

The intent of this policy is to communicate that the Company has delegated the responsibility for utilization management activities of genetic/genomic tests and certain molecular analyses and cytogenetic tests to CareCore National, LLC d/b/a eviCore healthcare (eviCore), with the exception of services performed in the emergency room or during an inpatient or observation unit stay.

PRE-SERVICE REVIEWS

The Company requires pre-service reviews for certain genetic/genomic tests through CareCore National, LLC d/b/a eviCore healthcare (eviCore), including but not limited to:
  • BRCA gene testing (breast and ovarian cancer syndrome)
  • Lynch syndrome gene testing
  • Cystic fibrosis full gene sequencing and deletion/duplication analyses
  • Select pharmacogenomic testing
  • Genetic panels (e.g., cancer type panels for colon, breast, or neuroendocrine cancers)
  • Cancer gene expression tests (e.g., OncotypeDX®, MammaPrint®, Afirma® Thyroid Fine-Needle Aspiration [FNA] Analysis)
  • Tumor molecular profiling (e.g., FoundationOne®, neoTYPE™, OncoPlexDX®)
  • Expanded carrier screening panels (e.g., Carrier Status DNA Insight®, Counsyl Family Prep Screen, Pan-Ethnic Carrier Screening)
  • Genome-wide tests (e.g., microarray studies, whole exome testing, whole genome testing, mitochondrial genome or nuclear testing)
Refer to Attachment A of this policy for a complete list of procedure codes that represent genetic/genomic tests requiring pre-service reviews. In addition to the requirement for pre-service reviews, the procedure codes listed in Attachment A will undergo prepayment reviews.

Genetic/genomic tests, which are listed in Attachment A of this policy, that do not meet coverage criteria may be considered experimental/investigational or not medically necessary, and, therefore, not covered.

PREPAYMENT REVIEWS

All genetic/genomic tests, along with certain molecular analyses (e.g., immunohistochemistry [IHC], morphometric analyses, flow cytometry) and molecular cytogenetic tests (e.g., fluorescent in situ hybridization [FISH], karyotyping), will be reviewed prior to claim payment.

In addition to the procedure codes in Attachment A, refer to Attachment B of this policy for a list of additional procedure codes that represent laboratory tests that will undergo prepayment reviews. The procedure codes listed in Attachment B do not require pre-service reviews.

Genetic/genomic tests, molecular analyses, and cytogenetic tests, which are listed in Attachment B of this policy, that do not meet coverage criteria may be considered experimental/investigational or not medically necessary, and, therefore, not covered.

EVICORE LAB MANAGEMENT PROGRAM CLINICAL GUIDELINES

eviCore utilizes its Lab Management Program Clinical Guidelines for medical necessity determination related to the delegated genetic/genomic tests and certain molecular analyses and cytogenetic tests.

eviCore's Lab Management Program Clinical Guidelines are available at: 
AmeriHealth New Jersey: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=AmeriHealth New Jersey
AmeriHealth Pennsylvania: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=AmeriHealth PA
AmeriHealth Administrators: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=AmeriHealth Administrators​
REQUIRED DOCUMENTATION

The individual’s medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, genetic/genomic tests, molecular analyses, and cytogenetic tests are covered under the medical benefits of the Company’s products when the medical necessity criteria for the services are met. However, services that are identified as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the company.

Procedure codes listed in this policy also continue to be subject to Company claims adjudication logic, eligibility, benefits, limitations, exclusions, referral requirements, provider contracts, and Company policies.

Description

The Company has delegated utilization management of genetic/genomic testing and certain molecular analyses and cytogenetic tests to CareCore National, LLC d/b/a eviCore healthcare (eviCore). This utilization management program through eviCore will encompass pre-service reviews and/or prepayment reviews as follows:
  • Pre-service reviews will be required for certain genetic/genomic tests.
  • All genetic/genomic tests, along with certain molecular analyses and cytogenetic tests, will be reviewed prior to claim payment.
eviCore utilizes its Lab Management Program Clinical Guidelines for medical necessity determinations related to the delegated genetic/genomic tests and certain molecular analyses and cytogenetic tests.

eviCore's Lab Management Program Clinical Guidelines are based on peer-reviewed literature, evidence-based guidelines and recommendations from national and international medical societies, and evidence-based medical research centers, including, but not limited to, the National Comprehensive Cancer Network (NCCN), the American College of Obstetricians and Gynecologists (ACOG), the American College of Medical Genetics (ACMG), the American Society of Human Genetics (ASHG), the European Federation of Neurological Societies (EFNS), the American Academy of Neurology (AAN), the National Society of Genetic Counselors (NSGC), the Society for Assisted Reproductive Technology (SART), the American Society for Reproductive Medicine (ASRM), the American Thoracic Society (ATS), the European Respiratory Society (ERS), and the American Society of Clinical Oncology (ASCO).

References

CareCore National, LLC d/b/a eviCore healthcare. Clinical Guidelines: Lab Management Program. Available at:

AmeriHealth New Jersey: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=AmeriHealth New Jersey.​

AmeriHealth Pennsylvania: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=AmeriHealth PA.

AmeriHealth Administrators: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=AmeriHealth Administrators.

Coding

CPT Procedure Code Number(s)
See Attachments A and B.
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)
See Attachments A and B.
Revenue Code Number(s)
N/A



Coding and Billing Requirements

Policy History

Revisions From 06.02.52ai:
01/01/2025This version of the policy will become effective on 01​/01/2025.

Effective 01/01/2025, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0523U, 0529U, 0530U, 81195, & 81558 


Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

0527U, 0528U, 81515, 87513, 87564, 87594, & 87626 ​​
 

REVISED

  • Non-substantive revisions ​were made to multiple codes.

DELETED 

  • 0352U, ​​0380U, 0428U, 0448U, ​0456U

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On January 01st, 2025, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2025. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

01/01/2025 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52ai)

Executive Summary of Changes

There are 03 new guideline. 86 existing guidelines have been revised (including 20 with substantive criteria changes). Nine guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Laboratory Billing and Reimbursement
  2. ColoSense for Colorectal Cancer
  3. Inflammatory Bowel Disease Biomarker Testing​
​Criteria Updates (Substantive):

  1. Flow Cytometry
  2. Immunohistochemistry (IHC)
  3. Sexually Transmitted and Other Reproductive Tract Infection Testing
  4. Experimental, Investigational,  or Unproven Laboratory Testing
  5. Dentatorubral-Pallidoluysian Atrophy Genetic Testing
  6. Expanded Carrier Screening Panels
  7. Somatic Mutation Testing
  8. Von Hippel-Lindau Disease Genetic Testing
  9. BRCA Analysis
  10. Epilepsy Genetic Testing
  11. Gastrointestinal Pathogen Panel (GIPP) Molecular Testing
  12. Myotonic Dystrophy Type 1 Genetic Testing
  13. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  14. Human Platelet and Red Blood Cell Antigen Genotyping
  15. Pathology Testing with Mohs Micrographic Surgery
  16. Special Circumstances Influencing Coverage Determinations
  17. Urinary Tract Infection Molecular Testing
  18. Genetic Testing to Predict Disease Risk
  19. Whole Genome Sequencing
  20. Exome Sequencing​

Criteria Updates (Non-Substantive):

  1. Medicare: Hierarchy for Applying Coverage Decision for Laboratory Testing
  2. Unique Test Identifiers for Non-Specific Procedure Codes
  3. Genetic Testing for Carrier Status
  4. Genetic Testing for Non-Medical Purposes
  5. Genetic Testing for Prenatal Screening and Diagnostic Testing
  6. Afirma Thyroid Cancer Classifier Tests
  7. Alpha-1 Antitrypsin Deficiency Testing
  8. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  9. APOE Variant Analysis for Alzheimer Disease Testing
  10. Ashkenazi Jewish Carrier Screening
  11. Ataxia-Telangiectasia Genetic Testing
  12. Charcot-Marie-Tooth Neuropathy Genetic Testing
  13. Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)
  14. Cystic Fibrosis Genetic Testing
  15. Duchenne and Becker Muscular Dystrophy Testing
  16. Early Onset Familial Alzheimer Disease Genetic Testing
  17. Familial Adenomatous Polyposis Genetic Testing
  18. Familial Malignant Melanoma Genetic Testing
  19. FMR1-Related Disorders (Fragile X) Genetic Testing
  20. Hereditary Cancer Syndrome Multigene Panels
  21. HFE Hemochromatosis Genetic Testing
  22. Li-Fraumeni Syndrome Genetic Testing
  23. Lynch Syndrome Tumor Screening - Second-Tier
  24. Mammaprint 70-Gene Breast Cancer Recurrence Assay
  25. MUTYH Associated Polyposis Genetic Testing
  26. Non-Invasive Prenatal Screening
  27. Oncotype DX for Breast Cancer Prognosis
  28. Peutz-Jeghers Syndrome Genetic Testing
  29. Prosigna Breast Cancer Prognostic Gene Signature Assay
  30. PTEN Hamartoma Tumor Syndromes  Genetic Testing
  31. Spinal Muscular Atrophy Genetic Testing
  32. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing
  33. EndoPredict for Breast Cancer Prognosis
  34. Breast Cancer Index for Breast Cancer Prognosis
  35. PALB2 Genetic Testing for Breast Cancer Risk
  36. Oncotype DX Breast DCIS
  37. Confirmatory Genetic Testing
  38. Maturity-Onset Diabetes of the Young (MODY) Genetic Testing
  39. Mitochondrial Disorders Genetic Testing
  40. Ehlers-Danlos Syndrome Genetic Testing
  41. Hereditary Connective Tissue Disorder Genetic Testing
  42. ThyroSeq
  43. PancraGEN
  44. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  45. Multiple Endocrine Neoplasia Type 2 Genetic Testing
  46. Limb-Girdle Muscular Dystrophy Genetic Testing
  47. Genetic Testing for Variants of Uncertain Clinical Significance
  48. Legius Syndrome Genetic Testing
  49. Medical Necessity Review Information Requirements
  50. Hemoglobinopathies Genetic Testing
  51. Friedreich Ataxia Genetic Testing
  52. Hereditary Ataxia Multigene Panel Testing
  53. Spinocerebellar Ataxia Genetic Testing
  54. Medically Necessary Laboratory Testing
  55. Chromosomal Microarray for Solid Tumors
  56. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  57. Human Papillomavirus (HPV) Molecular Testing
  58. Inherited Thrombophilia Genetic Testing
  59. Infectious Disease Laboratory Testing
  60. Nail Disorder Infectious Disease Testing, Including Onychomycosis
  61. Cardiomyopathy and Arrhythmia Genetic Testing
  62. Pharmacogenomic Testing for Drug Toxicity and Response
  63. Lynch Syndrome Genetic Testing
  64. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  65. Noonan Spectrum Disorder Genetic Testing
  66. Genetic Testing by Multigene Panels​
 
Retired Guideline:

  1. Bloom Syndrome Genetic Testing
  2. Canavan Disease Genetic Testing
  3. Gaucher Disease Genetic Testing
  4. Niemann-Pick Disease Types A and B Genetic Testing
  5. Niemann-Pick Disease Type C Genetic Testing
  6. Tay-Sachs Disease Genetic Testing
  7. Laboratory Claim Reimbursement
  8. Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors
  9. Laboratory Procedure Code Requirements​


Other Note:(E/I/U = Experimental, Investigational, or Unproven​) -- 

See the tables below that follow (which provide more details for the guideline changes):



New Guidelines:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) 
Laboratory Billing and ReimbursementMOL.AD.412.BOallNew guideline replacing Laboratory Claim Reimbursement (MOL.CS.105) and Laboratory Procedure Code Requirements (MOL.AD.391)
ColoSense for Colorectal CancerMOL.TS.413.A81599New guideline managing ColoSense colorectal cancer screening test (standard non-coverage version)
Inflammatory Bowel Disease Biomarker TestingMOL.TS.359.A81401, 83520, 86021, 86255, 81479, 82397, 86140, 88346, 88350, 0203UNew guideline to manage molecular Inflammatory Bowel Disease testing

​​Criteria Updates (Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Rationale / supporting guideline for clinically significant updates 
Flow CytometryMOL.CS.103.A88182, 88184, 88185, 88187, 88188, 88189Criteria: Added criterion that flow cytometry is not medically necessary when performed in peripheral blood in cases of isolated anemia or thrombocytopenia (per ASCP Choosing Wisely), changed criterion regarding IHC and flow cytometry performed on same DOS - previously was considered always not medically necessary and now will be considered on a case by case basis such as for lymphoma (per NCCN guideline for B-cell lymphoma which supports doing both IHC and flow), admin updates and clarification of intent edits throughout, addition of approvable ICD codes in Billing & Reimbursement (addressed by existing coverage criteria; no change in decision making); Background: Added benefit/harm statement per CMS final rule, other updates; References: updated.ASCP Choosing Wisely recommendation (American Society for Clinical Pathology. Thirty Five Things Physicians and Patients Should Question. Updated September 1, 2020. Available at: https://www.ascp.org/content/docs/default-source/get-involved-pdfs/istp_choosingwisely/ascp-35-things-list_2020_final.pdf

 Zelenetz AD, Gordon LI, Abramson JS, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2024 - April 30, 2024. B-Cell Lymphomas, available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf
Immunohistochemistry (IHC)MOL.CS.104.A88341, 88342, 8844Criteria: removed unit limit rules, clarified language when IHC is performed on histological lesions, clarified coverage for H. pylori infections with chronic gastritis, clarified language around performance of IHC and Flow together (per NCCN); Billing and Reimbursement: Removed corresponding B&R rules to align with criteria changes. Guideline and Evidence: Admin editsKavus H, Ding Y, Dhesi M. Updates in Immunohistochemistry for Hematopoietic and Lymphoid Neoplasms. Arch Pathol Lab Med. 2024 Mar 1;148(3):292-298. doi: 10.5858/arpa.2022-0465-RA. PMID: 37270801

Batts KP KS, Kakar S, et al. Appropriate use of special stains for identifying Helicobacter pylori.  Recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society. Am J Surg Pathol. 2013;37:e13-e22

NCCN - https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.A81513, 81514, 0352U, 87510, 87511, 0068U, 87490, 87590, 87529, 87660, 87661; Added 0505UCriteria: added coverage criteria for 3 select BV assays previously considered E/I/U (CPT codes: 81513, 81514, & 0352U) per IDSA/ASM 2024 guide, changed Gardnerella vaginalis detection testing (87510, 87511) from covered with criteria to not medically necessary (per IDSA/ASM 2024 guide), added new PLA code to BV section (E/I/U) - 0505U (Vaginal Infection Testing from NxGen MDx), changed Candida subtyping test 0068U from E/I/U to NMN to align with new eviCore standard definitions since exceptions can be considered (no change in decision making), clarified symptoms associated with Candida in Criteria section, specified that repeat testing for test-of-cure is not medically necessary for Candida and BV (per IDSA/ASM 2024 and ACOG 2020 guideline for Vaginitis, added additional symptoms to existing list in criteria for Chlamydia and N. Gonorrhoeae per CDC and WHO, reduced frequency limits for direct probe studies from 3 units to1 unit per DOS for Chlamydia (87490) and N. gonorrhoeae (87590) (supported by CDC 2021 guideline, which only mentions amplified techniques for extragenital specimens), clarification of intent edit - specifying that T. vaginalis testing is medically necessary in individuals with an affected partner even if individual is asymptomatic (already included in Billing & Reimbursement section), increased frequency limit for amplified probe for HSV (87529) from 1 per DOS to 2 per DOS (per CDC STI guidelines, extragenital sites may also need to be tested), reduced frequency limit for T. vaginalis (CPT 87660 & 87661) from 3 units per DOS to 1 unit per DOS (CDC STI guideline does not mention the need to test multiple specimens or extragenital sites), removed ICD code table for NOS Testing for Genitourinary Conditions (currently not in use), admin and clarification of intent edits throughout; CPT code table: added 0505U; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; Background: added to guideline; Test Information: updated, added RCL for NAT/NAAT; References: updatedIDSA/ASM 2024 - Miller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease Society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024). doi:10.1093/cid/ciae104)

ACOG Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin,  Clinical management guidelines for obstetrician-gynecologists, Number 215: Vaginitis in nonpregnant patients. Obstet Gynecol. 2020;135(1):e1-e17

Centers for Disease Control and Prevention (CDC). Preexposure Prophylaxis for the Prevention of HIV Infection in the United States- 2021 Update: A Clinical Practice Guideline. Available at:  https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf  

WHO 2021 STI guidelines - World Health Organization. Guidelines for the management of symptomatic sexually transmitted infections. Updated 2021. Available at: https://www.who.int/publications/i/item/9789240024168
Experimental, Investigational,  or Unproven Laboratory TestingMOL.CU.117.IADDED new PLA Codes: 0507U, 0496U, 0506U, 0486U, 0497U, 0498U, 0493U, 0510U, 0501U, 0495U, 0508U, 0509U; DELETED: 0396U, 83520, 86021, 86255, 81479, 82397, 86140, 88346, 88350, 0203UCriteria: Added Guardant Reveal and BarreGEN, removed the following tests that are now addressed in Inflammatory Bowel Disease Biomarker Testing guideline (still E/I/U) Crohn's Prognostic, IBD sgi Diagnostic, PredictSURE IBD; CPT Code Table: Added Guardant Reveal and BarreGEN, removed Crohn's Prognostic, IBD sgi Diagnostic, PredictSURE IBD; Corrected PLA code for EarlyTect to 0452U; ADDED new PLA Codes: Avantect Ovarian Cancer Test (0507U), ColoScape PLUS (0496U), EndoSign Barrett's Esophagus Test (0506U), Northstar Response (0486U), OncoAssure Prostate (0497U), OptiSeq Colorectal Cancer NGS Panel (0498U), Prospera (0493U, new code and updated description), PurISTSM (0510U), QuantiDNA Colorectal Cancer Triage Test (0501U), Stockholm3 (0495U),  VitaGraft Kidney Baseline + 1st Plasma Test (0508U), VitaGraft Kidney Subsequent (0509U); DELETED: 0396U (Spectrum PGT-M); EDITED name or description for 0118U (Eurofins TRAC dd-cfDNA), 0465U (UriFind Urothelial Carcinoma Assay), 0403U (MyProstateScore 2.0); Background: Added benefit/harm statement per CMS final ruleN/A
Dentatorubral-Pallidoluysian Atrophy Genetic TestingMOL.TS.159.A81177Criteria: added white matter lesion as a feature for diagnostic testing, admin edit, clarified ethnicity language; Background: updated and added reference; Test Information: added information on ATN1 testing; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, deleted introduction, deleted redundant information present in other parts of the guideline, admin edit; References: deleted introduction, added reference, updated reference.Sugiyama A, Sato N, Kimura Y, et al. The cerebellar white matter lesions in dentatorubral-pallidoluysian atrophy. J Neurol Sci. 2020 Sep 15;416:117040;

Prades S, Melo de Gusmao C, Grimaldi S, et al. DRPLA. 1999 Aug 6 [Updated 2023 Sep 21]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024
Expanded Carrier Screening PanelsMOL.TS.165.A81479, 0400U, 81443, 0449UCriteria: Removed criteria for individual genes since this guideline now focuses on panels, opened up coverage for carrier screening panels per ACMG recommendation - previously had stricter coverage criteria; Billing and Reimbursement: Updated to align with broader coverage of carrier screening panels; CPT Code Table: removed individual genes; Background: admin edits; Guidelines and Evidence: Added ACOG Hemoglobinopathies and deleted section on concerns for large panels, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introduction; TITLE CHANGE: Carrier Screening Panels, Including Targeted, Pan-Ethnic, Universal, and ExpandedGregg AR, Aarabi M, Klugman S, et al.  Screening for autosomal recessive and X-linked conditions during pregnancy and preconception: a practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(10):1793-1806
Somatic Mutation TestingMOL.TS.230.AVarious panel codes - see CPT code table in guidelineCriteria: New indications for NGS panel testing in patients with metastatic prostate cancer and unresectable or metastatic biliary tract cancer- based on NCCN guidelines, admin update; Billing and Reimbursement: updated name of referenced guideline on coding;  CPT code table: added new PLA codes 0481U (IDH1, IDH2, and TERT Mutation Analysis, Next-Generation Sequencing, Tumor (IDTRT)), 0478U (Lung HDPCR), 0499U (OptiSeq Dual Cancer Panel Kit); Guidelines and Evidence: Added benefit/harm statement per CMS final rule; CPT code table: admin update; Guidelines and Evidence: updated, added Prostate cancer and Biliary Tract cancers NCCN guidelines; References: updated.Schaeffer EM, Srinivas S, Adra N, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 4.2024 – May 17, 2024 Prostate Cancer, available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

Benson AB, D'Angelica MI, Abrams T, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – July 2, 2024 Biliary Tract Cancers, available at: https://www.nccn.org/professionals/physician_gls/pdf/btc.pdf
Von Hippel-Lindau Disease Genetic TestingMOL.TS.233.A81401, 81403, S3842Criteria: expanded indications for testing of symptomatic individuals to include paraganglioma, endolymphatic sac tumor, pancreatic neuroendocrine tumor, admin edits, removed information on prenatal testing as this is addressed by a clinical use guideline; Intro and CPT code table: admin edits; Background: updated; Guidelines and Evidence: removed intro, added benefit/harm statement per CMS final rule, added a paragraph on clinical diagnostic criteria to support criteria changes; References: removed intro, added references, updated.van Leeuwaarde RS, Ahmad S, van Nesselrooij B, et al. Von Hippel-Lindau Syndrome. 2000 May 17 [Updated 2024 Feb 29]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024.

Binderup M, Smerdel M, Borgwadt L et al. von Hippel-Lindau disease: Updated guideline for diagnosis and surveillance. Eur J Med Genet. 2022 Aug;65(8):104538
BRCA AnalysisMOL.TS.238.AVarious codes - see CPT code table in guidelineCriteria: Based on NCCN HBOC recommendations - added indications 1) full gene sequencing for individuals with cancer and Ashkenazi Jewish ancestry, 2) dx of prostate cancer with close fam member w/ triple neg breast cancer or high risk prostate, admin updates; CPT code table: admin updates; Background: updated; Test information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, Added ASCO/SSO, AUA/ASTRO & AUA/SUO guidelines, updated; References: updatedDaly MB, Pal T, AlHilli Z, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – February 12, 2024. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, available at: https://www.nccn.org/professionals/physician_gls/pdf/genetics_bop.pdf
Epilepsy Genetic TestingMOL.TS.257.A81419Criteria: added indications for panel testing in drug resistant focal epilepsy and focal epilepsy with a positive family history suggesting of a monogenic cause (per peer reviewed literature and NSGC practice guideline), Billing and Reimbursement: updated name of referenced guideline on coding; CPT code table: admin edits; Background: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule; References: updatedKarge R, Knopp C, Weber Y, Wolking S. Genetics of nonlesional focal epilepsy in adults and surgical implications. Clinical Epileptology. 2023;36:91-97 

NSGC: Smith L, Malinowski J, Ceulemans S, et al. Genetic testing and counseling for the unexplained epilepsies: An evidence-based practice guideline of the National Society of Genetic Counselors. J Genet Couns. 2023 Apr;32(2):266-280. doi: 10.1002/jgc4.1646
Gastrointestinal Pathogen Panel (GIPP) Molecular TestingMOL.CS.277.A87505, 87506, 87507, 0369UCriteria - Billing and Reimbursement section - opened coverage for GIPP panels of any size in immunocompromised individuals per ACG guidelines on IBD that recommend ruling out infectious conditions that might mimic IBD inflammation; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updatedLichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018;113(4):481-517. doi: 10.1038/ajg.2018.27

Rubin D, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019 Mar;114(3):384-413. doi: 10.14309/ajg.0000000000000152
Myotonic Dystrophy Type 1 Genetic TestingMOL.TS.312.A81234, 81239, S3853Criteria: added "Posterior subcapsular cataracts with detectable red and green iridescent opacities on slit lamp examination" into criteria for symptomatic individuals, admin edit, Procedures addressed: admin edits; Background: updated with info on cataracts with associated reference and admin edits; Test Information: edited intro, admin edits; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, admin edits; References: admin edit, updatedBird TD. Myotonic Dystrophy Type 1. 1999 Sep 17 [Updated 2024 Mar 21]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024

Moshirfar M, Webster CR, Seitz TS, et al. Ocular Features and Clinical Approach to Cataract and Corneal Refractive Surgery in Patients with Myotonic Dystrophy. Clin Ophthalmol. 2022 Aug 25;16:2837-2842
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A88341, 88342, 81301Criteria: updated name of referenced guideline, added esophageal and esophagogastric junction cancer as approvable cancer types based on NCCN guideline, updated; CPT code table: admin updates; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, added NCCN esophageal guideline, updated; References: updatedAjani JA, D'Amico TA, Barzi A, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – April 26, 2024. Esophageal and Esophagogastric Junction Cancers, available at: https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf)
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A81403, Added 0494U, 0488UCriteria: opened coverage for fetal RhD by NIPS in alloimmunized women with at-risk pregnancies per 2024 ACOG Clinical Practice Update; Guidelines and Evidence: updated, incorporated current EviCore HTA, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, admin edits, deleted introduction; Added new PLA codes: Rh Test - Natera (0494U), UNITY Fetal Antigen NIPT (0488U)American College of Obstetricians and Gynecologists. Clinical Practice Update. Paternal and Fetal Genotyping in the Management of Alloimmunization in Pregnancy. Obstet Gynecol ():10.1097/AOG.0000000000005630, June 4, 2024. | DOI: 10.1097/AOG.000000000000563
Pathology Testing with Mohs Micrographic SurgeryMOL.CS.363.A88342, 88341, 88344Criteria: updated to change IHC to medically necessary when performed in conjunction with Mohs procedures (per NCCN cutaneous melanoma guideline), admin edit; Billing and Reimbursement: admin edit; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introductionNCCN Guidelines Version 2.2024 Melanoma: Cutaneous, available at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.AvariousCriteria: Added Jurisdiction column to both tables along with description in table notes. Added the following bills to the Broad Biomarker Bills table: Colorado (SB 124), Connecticut (SB 307), Florida (HB 885), Indiana (S 273), Iowa (HF 2668), Minnesota (SF 2995), New York (A 8502). Added information for the following state bills under the “Other Applicable Bills": Illinois (HB 3202), Illinois (HB 2350), Minnesota (HF 5247), New Jersey (A5235), also added covered lines of business for existing state bills; Background: Added benefit/harm statement per CMS final rule, admin edits throughout; References: UpdatedDependent upon legislative requirements in various state bills
Urinary Tract Infection Molecular TestingMOL.CS.403.Avarious (see guideline);  Added 0504UCriteria: added new PLA code 0504U (Urinary Tract Infection Testing from NexGen MDx) to list of E/I/U UTI panels; added coverage criteria for single-organism tests and multiple-organism panels for select organisms for which nucleic-acid based testing is appropriate for diagnosis and management in UTIs (per 2024 IDSA/ASM and American Society of Transplantation guidelines), admin and clarification of intent edits throughout; CPT code table: added new PLA code 0504U (Urinary Tract Infection Testing from NexGen MDx); Background: updated; Test Information: updated, added Reused content language for NAT/NAAT; Guidelines & Evidence: updated;  References: updatedIDSA/ASM: Miller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease
society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024). doi: 10.1093/cid/ciae104

American Society of Transplantation guidelines:   Goldman JD, Julian K. Urinary tract infections in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13507. doi: 10.1111/ctr.13507
Genetic Testing to Predict Disease RiskMOL.CU.115.AN/ACriteria: incorporated criteria from the Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors guideline and restructured to accommodate; Clarification of intent edit - added phrase 'Member is at risk based on the inheritance pattern of the disorder in question.' to the Known Familial mutation section; created a single Limitations and Exclusions section to apply to all criteria sections, admin edit in general criteria section; Background: Added benefit/harm statement per CMS final rule, updated with info on testing in minors; References: updatedN/A
Whole Genome SequencingMOL.TS.306.IN/ACriteria: clarification of intent edits - amended provider requirements to make clear that non-genetics providers can order testing, added epilepsy as an example in the list of complex neurodevelopmental disorders, admin update; CPT code table: added introduction, admin update; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updatedN/A
Exome SequencingMOL.TS.235.IN/ACriteria: clarification of intent edits - amended provider requirements to make clear that non-genetics providers can order testing, added epilepsy as an example in the list of complex neurodevelopmental disorders; CPT code table: admin edits; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updatedN/A


Criteria Updates (Non-Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) 
Medicare: Hierarchy for Applying Coverage Decision for Laboratory TestingMOL.AD.101.BN/ACriteria: updated reference to Laboratory Procedure Code Requirements with the new name "Laboratory Billing and Reimbursement".
Unique Test Identifiers for Non-Specific Procedure CodesMOL.AD.107.AN/ACriteria: admin edits. Background: Added intro statement, added benefit/harm statement per CMS final rule
Genetic Testing for Carrier StatusMOL.CU.110.AN/ACriteria: updated language throughout from 'indicated' and 'considered' to 'is medically necessary', deleted Routine Carrier Screening section as this information is addressed in greater detail by multiple test-specific guidelines; References: deleted as references are no longer included; Background: Added benefit/harm statement per CMS final rule
Genetic Testing for Non-Medical PurposesMOL.CU.111.AN/ACriteria: expanded to specifically name beauty care/skin care testing, as this seems to be a growing market segment; Background: added new DTC companies, admin edits; Background: Added benefit/harm statement per CMS final rule
Genetic Testing for Prenatal Screening and Diagnostic TestingMOL.CU.112.AN/ACriteria: clarification of intent edits - in Prenatal diagnostic testing based on family history section added 'based on the inheritance pattern of the disorder in question' , in fetal infectious disease section updated language to medically necessary, admin edit; Note: deleted reference to Human platelet and Red Blood Cell Antigen Genotyping, as this referral is no longer needed; Background: format edit, added benefit/harm statement per CMS final rule; references: updated
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.AN/ACriteria: admin edits, clarification of intent edits; CPT code table: removed retired code-0204U; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Alpha-1 Antitrypsin Deficiency TestingMOL.TS.124.AN/ACriteria: admin edit. CPT table: admin edits; Background: updated. Test information: admin edits; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule, formatted selected relevant publications but not change to content; References: removed introduction, updated.
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.AN/ABilling and Reimbursement: updated name of referenced guideline on coding
APOE Variant Analysis for Alzheimer Disease TestingMOL.TS.128.AN/ACriteria: admin edits. Background: management updated. Guidelines and Evidence: Added benefit/harm statement per CMS final rule, deleted ABIM/ACMG/Choosing Wisely block as information no longer available; References: admin edit and updated
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.AN/ACriteria - Billing and Reimbursement section: clarification of intent edit - Added clarification for repeat panel billing; Added clarification regarding one panel per lifetime rule; CPT code table: admin edits; Criteria: admin edits, added in Other Considerations for diagnostic testing of AJ conditions; Background: updated; Test information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Ataxia-Telangiectasia Genetic TestingMOL.TS.130.AN/ACriteria: admin edits, removed section on prenatal testing since this is addressed by clinical use guideline; CPT code table: admin edits; Background: updated; Test Information: admin edits; Guidelines and Evidence: removed intro, added benefit/harm statement per CMS final rule; References: removed intro and updated.
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.AN/ACriteria: admin updates, (Billing and Reimbursement) updated name of referenced guideline on coding & updated most common genes: CPT Code Table: admin update; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)MOL.TS.150.AN/ACriteria: admin edits to intro statement and Billing & Reimbursement; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, added an ACOG/SMFM consensus statement; References: updated; CPT Code Table: admin update
Cystic Fibrosis Genetic TestingMOL.TS.158.AN/ACriteria: clarification of intent edit in deletion/duplication section stating that member must be symptomatic or at high risk of being a carrier to have del/dup testing (not for population carrier screening), deleted note and added Other Considerations section to refer to related policies for indications not addressed in this guideline, admin edits in intro and KFM sections; CPT Code Table: admin update; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Duchenne and Becker Muscular Dystrophy TestingMOL.TS.161.AN/ACriteria: clarification of intent and admin edits; CPT code table: admin edits; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, admin edits; References: updated
Early Onset Familial Alzheimer Disease Genetic TestingMOL.TS.162.AN/ACriteria: admin edits. Billing and Reimbursement: updated name of referenced guideline on coding; Procedures addressed and CPT code table: admin edit; Background: admin edits and updated management; Test information: admin edits; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, removed intro and admin edits; References: removed intro and updated.
Familial Adenomatous Polyposis Genetic TestingMOL.TS.168.AN/ACriteria: admin edits. Introduction and Procedures addressed: admin edits; Background: admin edits; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, removed introduction, admin edit; References: updated and removed intro
Familial Malignant Melanoma Genetic TestingMOL.TS.170.AN/ACriteria: admin update; CPT code table: admin edits; Background: updated; Guidelines and Evidence: intro removed, added benefit/harm statement per CMS final rule, updated; References: removed intro, updated
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.AN/ACriteria: admin edits; CPT code table: updated; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, added AAP guidelines for evaluation of ID/DD and autism; References: updated
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.AN/ACriteria: admin edits, Billing and Reimbursement: updated name of referenced guideline on coding; Background: updated; Guidelines and evidence: admin edits, removed introduction, added NCCN guidelines for neuroendocrine and  adrenal tumors and for kidney cancer, added ASCO guideline (PMID: 38759122), Added benefit/harm statement per CMS final rule, References: removed introduction and updated.
HFE Hemochromatosis Genetic TestingMOL.TS.183.AN/ACriteria: added introduction; Background: updated, Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Li-Fraumeni Syndrome Genetic TestingMOL.TS.193.AN/ACriteria: admin edits, removed information on prenatal testing as this is addressed by a different guideline, added information on Hereditary (Germline) Testing After Tumor (Somatic) Testing to "Other Considerations" block; Intro and CPT table: admin edits. Test Information: admin edit. Guidelines and Evidence: removed intro, admin edits, updated, removed one references, added benefit/harm statement per CMS final rule; References: removed intro, updated.
Lynch Syndrome Tumor Screening - Second-TierMOL.TS.199.AN/ACriteria: admin update, separated MLH1 and BRAF criteria w/ no change to criteria; CPT code table: admin update; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Mammaprint 70-Gene Breast Cancer Recurrence AssayMOL.TS.200.AN/ACriteria: admin edit. Guidelines and Evidence: removed introduction, admin edits, updated, incorporated current EviCore HTA, added benefit/harm statement per CMS final rule; References: removed introduction, admin edits, and updated.
MUTYH Associated Polyposis Genetic TestingMOL.TS.206.AN/ACriteria: admin edits. Introduction and Procedures addressed: admin edits; Background: admin edits; Guidelines and Evidence: removed introduction, admin edit, added benefit/harm statement per CMS final rule; References: updated and removed intro
Non-Invasive Prenatal ScreeningMOL.TS.209.AN/ACriteria: admin edits to introduction, in NIPS for single gene testing section, added referral to Human Platelet and Red Blood Cell Antigen Genotyping guideline for fetal Rh(D) testing while other indications remain EIU; CPT code table: added new PLA code 0489U (UNITY Fetal Risk Screen); Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated health tech assessment, other updates; References: updated
Oncotype DX for Breast Cancer PrognosisMOL.TS.211.IN/ACriteria: admin edit. Guidelines and Evidence: removed introduction, updated ESMO and NICE, admin edits, added benefit/harm statement per CMS final rule; References: removed introduction, updated.
Peutz-Jeghers Syndrome Genetic TestingMOL.TS.216.AN/ACriteria: admin edits. Procedures addressed: admin edits; Test information; admin edit; Guidelines and evidence: updated, added benefit/harm statement per CMS final rule; References: updated
Prosigna Breast Cancer Prognostic Gene Signature AssayMOL.TS.222.AN/ACriteria: admin edit. Background: admin edit; Test Information: admin edit; Guidelines and Evidence: updated, incorporated current EviCore HTA, removed introduction, admin edits, added benefit/harm statement per CMS final rule; References: removed introduction and updated.
PTEN Hamartoma Tumor Syndromes  Genetic TestingMOL.TS.223.AN/ACriteria: admin edit, clarification of intent, added cross-reference to guideline for germline after somatic testing; Procedures addressed: admin edits; Background: admin edits; Guidelines and evidence: removed intro, admin edits, added benefit/harm statement per CMS final rule; References: removed intro and updated.
Spinal Muscular Atrophy Genetic TestingMOL.TS.225.AN/ACriteria: admin & clarification of intent edits, added section to refer to related policies for indications not addressed in this guideline; Background: updated; Test Information: updated; Guidelines and Evidence: updated, added 2024 ENMC consensus statement on SMN2 testing, Added benefit/harm statement per CMS final rule; References: updated
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic TestingMOL.TS.227.AN/ACriteria: admin edits, Billing and Reimbursement: updated name of referenced guideline on coding; CPT table: admin edits; Background: updated; Guidelines and Evidence: removed introduction, admin edits, updated, added benefit/harm statement per CMS final rule; References: updated.
EndoPredict for Breast Cancer PrognosisMOL.TS.234.AN/ACriteria: admin edit. Guidelines and Evidence: removed introduction, admin edits, updated ESMO and NICE, updated selected relevant publications and incorporated EviCore HTA, added benefit/harm statement per CMS final rule; References: removed introduction and updated.
Breast Cancer Index for Breast Cancer PrognosisMOL.TS.248.AN/ACriteria; admin edits. Introduction: admin edit; Background: updated; Test information: admin edits; Guidelines and Evidence: removed introduction, admin edits, updated, added benefit/harm statement per CMS final rule; References: removed introduction, updated.
PALB2 Genetic Testing for Breast Cancer RiskMOL.TS.251.AN/ATITLE CHANGE: Removed "breast". Now says PALB2 Genetic Testing for Cancer Risk; CPT code table: admin edits; Criteria: admin edit; Background: updated; Guidelines and Evidence: Added new ASCO/SSO guideline, removed ESMO guideline, Added benefit/harm statement per CMS final rule, updated; References: updated
Oncotype DX Breast DCISMOL.TS.255.AN/ACriteria: admin edit. Background: admin edits; Test Information: admin edits; Guidelines and Evidence: removed introduction, updated, added benefit/harm statement per CMS final rule; References: removed intro, updated
Confirmatory Genetic TestingMOL.CU.256.AN/ACriteria: clarification of intent edit to specify what constituted a disease-causing mutation and the paths through which that information could be established for the purposes of confirmatory testing; Background: Added benefit/harm statement per CMS final rule
Maturity-Onset Diabetes of the Young (MODY) Genetic TestingMOL.TS.258.AN/ACriteria: admin update; CPT code table: admin updates: Billing and Reimbursement: updated name of referenced guideline on coding; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Mitochondrial Disorders Genetic TestingMOL.TS.266.AN/ACriteria: clarification of intent edits to Select Mitochondrial Disorders table, added MT-ND1 mutation to list of Associated Genes/Mitochondrial DNA mutations for Leber Hereditary Optic Neuropathy (per International LHON guideline cited in guideline); CPT code table: added MT-ND1 Targeted Mutation Analysis (81479)
Ehlers-Danlos Syndrome Genetic TestingMOL.TS.267.AN/ACriteria: admin edit, removed section on prenatal testing as this is in a different guideline, clarification of intent for testing (added newer gene, AEBP1, for classic-like EDS). CPT/Procedures addressed: admin edits; Background: updated; Test Information: removed information on multigene panel testing; Guidelines and Evidence: updated, removed intro; added benefit/harm statement per CMS final rule; References: admin edits and updated.
Hereditary Connective Tissue Disorder Genetic TestingMOL.TS.268.AN/ACriteria: admin edit, clarification of intent for testing (added newer gene, AEBP1, for classic-like EDS), billing and Reimbursement: updated name of referenced guideline on coding; CPT code table: admin edits; Background: updated; Guidelines and Evidence: updated, removed introduction, added benefit/harm statement per CMS final rule; References: updated.
ThyroSeqMOL.TS.270.IN/ACriteria: clarification of intent edit - added statements regarding no previous successful testing on the same nodule and rendering lab must be a qualified provider
PancraGENMOL.TS.271.AN/ACriteria: admin update; Background: updated; Test Information: updated; Guidelines and Evidence: updated, added benefit/harm statement per CMS final rule; References: updated
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.AN/ABilling and Reimbursement: updated name of referenced guideline on coding; CPT code table: updated HCSPS code from S3840 to S3844
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.AN/ACriteria: admin edit; Introduction and CPT code table: admin edit; Background: updated; Test Information: added reused content for KFM; Guidelines and Evidence: removed intro, admin edits, added benefit/harm statement per CMS final rule, updated; References: removed intro, updated.
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.AN/ACriteria: admin updates; Billing and Reimbursement: updated name of referenced guideline on coding; CPT Code Table: admin updates; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Genetic Testing for Variants of Uncertain Clinical SignificanceMOL.CU.292.AN/ACriteria: in the General coverage section, previous testing - admin edit to align language with other guidelines; Background: Added benefit/harm statement per CMS final rule;
Legius Syndrome Genetic TestingMOL.TS.302.AN/ACriteria: admin edits. Procedures addressed: admin edits; Background: admin edits; Guidelines and Evidence: deleted intro and admin edit, added benefit/harm statement per CMS final rule; References: deleted intro, admin edit, updated
Medical Necessity Review Information RequirementsMOL.AD.304.AN/ACriteria: updated name of referenced guideline on coding
Hemoglobinopathies Genetic TestingMOL.TS.308.AN/ACriteria: deleted prenatal test criteria as this is addressed by another guideline, Added Other Considerations section to direct to appropriate guideline if testing is part of a carrier screening panel, admin edits; CPT code table: admin edits; Background: updated; Test Information: admin edits; Guidelines and Evidence: updated, added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introduction
Friedreich Ataxia Genetic TestingMOL.TS.309.AN/ACriteria: admin edits. Procedures addressed: admin edit; Background: updated; Test information: admin edit; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, admin edits, removed introduction; References: updated, removed introduction
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.AN/ACriteria: admin edit. Billing and Reimbursement: updated name of referenced guideline on coding, Procedures addressed: admin edits; Test information: admin edit; Guidelines and Evidence: removed intro, updated, added benefit/harm statement per CMS final rule, restructured Selected Relevant Publications; References: removed intro, updated
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.AN/ACriteria: admin edit. Billing and Reimbursement: updated name of referenced guideline on coding; Introduction: admin edit; Background: updated, admin edit; Guidelines and Evidence: removed introduction; Added benefit/harm statement per CMS final rule, restructured Selected Relevant Publications section; References: removed intro, updated.
Medically Necessary Laboratory TestingMOL.CS.333.AN/ACriteria - Billing and Reimbursement section: updated terminology from 'post-service medical necessity review' to 'records review post claim for medical necessity'; Guidelines and Evidence: Added benefit/harm statement per CMS final rule; References: updated
Chromosomal Microarray for Solid TumorsMOL.TS.344.AN/ACriteria: admin edit; Introduction and CPT code table: admin edits; Test Information: admin edit; Guidelines and Evidence: removed intro, added benefit/harm statement per CMS final rule, updated, admin edits; References: removed intro and updated
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.AN/ACriteria: admin edits, updated table, Billing and Reimbursement: updated name of referenced guideline on coding; Background: admin edits. Guidelines and Evidence: Updated FARF section, added benefit/harm statement per CMS final rule, updated reference order.
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.AN/ACriteria: Oropharyngeal Cancer section clarification of intent edit updating language in medical necessity criteria and Billing and Reimbursement to be clearer that members may have both p16 IHC and direct HPV testing (no clinical decision making changes), admin edit, Criteria and CPT code table: added new PLA code 0502U (QuantiVirus HPV E6/E7 mRNA Test for Cervical Cancer); Test Information: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, admin edit, deleted introduction; References: updated, admin edit, deleted introduction
Inherited Thrombophilia Genetic TestingMOL.TS.370.AN/ACriteria: clarified language regarding use of test to direct therapy; Billing and Reimbursement: admin edit; Background: updated; Test Information: updated, including new mutation nomenclature; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introduction
Infectious Disease Laboratory TestingMOL.CU.398.AN/ACriteria: admin and clarification of intent edits (added a sentence to the General Coverage Guidance to better define the meaning of the phrase "Newer methods must be proven to perform better than existing standard of care medical management options"); added Bacteria, Viruses, Fungus, and Parasite Metagenomic Sequencing, Spinal Fluid (MSCSF) to EIU panel list; CPT code table: added new PLA codes 0480U (Bacteria, Viruses, Fungus, and Parasite Metagenomic Sequencing, Spinal Fluid (MSCSF)), 0483U (Ciprofloxacin Susceptibility of Neisseria gonorrhoeae),  0484U (Macrolide Resistance of Mycoplasma genitalium) Test Information: updated; Guidelines & Evidence: updated (including updated version of IDSA/ASM guideline); References: updated.
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.AN/ACriteria: admin edits; Background: updated; Test Information: updated; Guidelines and Evidence: updated; References: updated
Cardiomyopathy and Arrhythmia Genetic TestingMOL.TS.410.AN/ACriteria: admin edit (updated guideline to refer to for additional panel code guidance in Billing & Reimbursement); Procedure Code Table: added S3865 and S3866; Guidelines and Evidence: Added benefit/harm statement per CMS final rule
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AAdded 0516U, 0476U; Deleted 0078UCriteria: Added AvertD; removed reference to GeneSight Psychotropic Testing guideline from "Other Considerations" since that guideline has been retired; CPT Code table: Added AvertD; Criteria and CPT code table: Added new PLA codes MyGenVar Pharmacogenomics Test (0516U), RightMed Mental Health Gene Report (0476U), RightMed Mental Health Medication Report (0477U); Deleted retired code 0078U (INFINITI Neural Response Panel)
Lynch Syndrome Genetic TestingMOL.TS.197.AN/ACriteria: clarification of intent - restructured to clarify LS genetic testing for indications outside of individuals with MSI/IHC + cancers; CPT Code Table: admin edits; Background: updated; Test Information: updated; Guidelines and Evidence: updated; Added benefit/harm statement per CMS final rule; References: updated
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.AN/ACriteria: clarification of intent - added criteria and B&R requirements for X-linked intellectual disability panels to clarify that these are not considered comprehensive ASD/ID/DD panels and are therefore approvable (supported by American Academy of Pediatrics and American College of Medical Genetics and Genomics guidelines), updated guideline names as needed in Other Considerations and Table: Common neurodevelopmental disorder genes, associated conditions, and applicable guidelines.
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.AN/ACriteria: removed prenatal KFM testing section as this is managed by a clinical use guideline; in Billing and Reimbursement section: updated approvable genes tested individually based on frequency data in Classic NS based on an expert authored review, admin updates, updated name of referenced guideline on coding; updated intro with NSD abbreviation; CPT code table: admin updates; Background: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule; References: updated
Genetic Testing by Multigene PanelsMOL.CU.116.AN/ACriteria: renamed Billing and Reimbursement section to Other Considerations, deleted coding requirements as this is addressed by Laboratory Billing and Reimbursement guideline, updated name of  referenced guideline to Laboratory Billing and Reimbursement; Background: updated; Test Information: admin edit; Guidelines and Evidence: updated, removed CMS section as billing/coding is addressed by Laboratory Billing and Reimbursement guideline, Added benefit/harm statement per CMS final rule, admin edit; References: updated


Retired Guideline:


Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) 
Bloom Syndrome Genetic TestingMOL.TS.132.AN/ARetired due to infrequent use
Canavan Disease Genetic TestingMOL.TS.145.AN/ARetired due to infrequent use
Gaucher Disease Genetic TestingMOL.TS.173.AN/ARetired due to infrequent use
Niemann-Pick Disease Types A and B Genetic TestingMOL.TS.207.AN/ARetired due to infrequent use
Niemann-Pick Disease Type C Genetic TestingMOL.TS.208.AN/ARetired due to infrequent use
Tay-Sachs Disease Genetic TestingMOL.TS.226.AN/ARetired due to infrequent use
Laboratory Claim ReimbursementMOL.CS.105.AN/AReplaced by new Laboratory Billing and Reimbursement guideline
Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in MinorsMOL.CU.298.AN/AInformation and criteria within were added to guideline Genetic Testing to Predict Disease Risk MOL.CU.115.A
Laboratory Procedure Code RequirementsMOL.AD.391.AN/AReplaced by new Laboratory Billing and Reimbursement guideline

​



Revisions From 06.02.52ah:

10/01/2024

This version of the policy is a result of code updates effective 10/01/2024. 


The following procedure codes were added to the policy:


0476U, 0477U, 0478U, 0480U, 0481U, 0483U, 0484U, 0485U, 0486U, 0487U, 0488U, 0489U, 0493U, 0494U, 0495U, 0496U, 0497U, 0498U, 0499U, 0500U, 0501U, 0502U, 0504U, 0505U, 0506U, 0507U, 0508U, 0509U, 0510U, & 0516U


Narrative for the following procedure code was revised:


0403U​



Revisions From 06.02.52ag​​​​​:
07/01/2024This version of the policy will become effective on 07​/01/2024.

Effective 07/01/2024, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0020M, 0452U, 0453U, 0454U, 0456U, 0460U, 0461U, 0465U, 0466U, 0467U, 0469U, 0470U, 0473U, 0474U, and 0475U


Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

0455U, 0463U, and 0471U 
 

REVISED

  • 03 PLA codes had non-substantive revisions: 0047U, 0260U, and 0264U

DELETED 

  • 02 existing PLA codes are being retired: 0204U and 0353U

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On July 01st, 2024, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2024. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

07/01/2024 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52ag)

Executive Summary of Changes

There is 01 new guideline. 135 existing guidelines have been revised (including 10 with substantive criteria changes). Eight guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Cardiomyopathy and Arrhythmia Genetic Testing​
​Criteria Updates (Substantive):

  1. Pharmacogenomic Testing for Drug Toxicity and Response
  2. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  3. Chromosomal Microarray Testing For Developmental Disorders
  4. Prader-Willi Syndrome Testing
  5. Somatic Mutation Testing-Solid Tumors
  6. Gastrointestinal Pathogen Panel (GIPP) Molecular  Testing
  7. Molecular Respiratory Infection Pathogen Panel (RIPP) Molecular Testing
  8. Whole Genome Sequencing
  9. Human Immunodeficiency Virus Laboratory Testing
  10. Investigational and Experimental Laboratory Testing

   
Criteria Updates (Non-Substantive):

  1. Rett Syndrome Testing
  2. Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing.PA/CS.
  3. Flow Cytometry
  4. Immunohistochemistry (IHC)
  5. Sexually Transmitted and Other Reproductive Tract Infection Testing
  6. UroVysion FISH for Bladder Cancer
  7. Genetic Testing for Cancer Susceptibility and Hereditary Cancer Syndromes
  8. Genetic Testing for Carrier Status
  9. Genetic Testing for Prenatal Screening and Diagnostic Testing
  10. Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer
  11. Genetic Testing to Diagnose Non-Cancer Conditions
  12. Genetic Testing to Predict Disease Risk
  13. Preimplantation Genetic Screening and Diagnosis
  14. Afirma Thyroid Cancer Classifier Tests
  15. AlloMap Gene Expression Profiling For Heart Transplant Rejection
  16. Alpha-1-Antitrypsin Deficiency Testing
  17. Angelman Syndrome Testing
  18. APOE Variant Analysis for Alzheimer Disease
  19. Ashkenazi Jewish Carrier Screening
  20. Ataxia-Telangiectasia Genetic Testing
  21. Bloom Syndrome Genetic Testing
  22. CADASIL Genetic Testing
  23. Canavan Disease Genetic Testing
  24. HLA Typing for Celiac Disease
  25. Charcot-Marie-Tooth Neuropathy Genetic Testing
  26. Chromosome Analysis for Blood and Bone Marrow Cancers
  27. ConfirmMDx for Prostate Cancer Risk Assessment
  28. Cystic Fibrosis Genetic Testing
  29. Dentatorubral-Pallidoluysian Atrophy Genetic Testing
  30. Duchenne & Becker Muscular Dystrophy Testing
  31. Early Onset Familial Alzheimer Disease (EOFAD.) Genetic Testing
  32. SEPT9 Methylation Analysis for Colorectal Cancer (Formerly Sept9 Methylation Analysis for Colorectal Cancer)
  33. Expanded Carrier Screening Panels
  34. Familial Adenomatous Polyposis Genetic Testing
  35. Familial Hypercholesterolemia Genetic Testing
  36. Familial Malignant Melanoma Genetic Testing
  37. FMR1-Related Disorders (Fragile X) Genetic Testing
  38. Gaucher Disease Genetic Testing
  39. Hereditary Cancer Syndrome Multigene Panels
  40. Hereditary Hemochromatosis Genetic Testing
  41. HIV Tropism Testing for Maraviroc Response
  42. Huntington Disease Genetic Testing
  43. Li-Fraumeni Syndrome Genetic Testing
  44. Liquid Biopsy Testing
  45. Lynch Syndrome Genetic Testing
  46. Lynch Syndrome Tumor Screening - Second-Tier
  47. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  48. Marfan Syndrome Genetic Testing
  49. MUTYH Associated Polyposis Genetic Testing
  50. Niemann Pick Disease Types A & B Testing
  51. Niemann Pick, Type C Testing
  52. Non-Invasive Prenatal Screening
  53. OncotypeDX for Breast Cancer Prognosis
  54. OncotypeDX for Colorectal Cancer Recurrence Risk
  55. PCA3 Testing for Prostate Cancer
  56. Peutz-Jeghers Syndrome Genetic Testing
  57. Prenatal Aneuploidy FISH Testing
  58. Prosigna Breast Cancer Prognostic Gene Signature Assay
  59. PTEN Hamartoma Tumor Syndromes Genetic Testing
  60. Spinal Muscular Atrophy Genetic Testing
  61. Tay-Sachs Disease Testing
  62. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing
  63. Tissue of Origin Testing for Cancer of Unknown Primary
  64. Von Hippel-Lindau Disease Genetic Testing
  65. EndoPredict for Breast Cancer Prognosis
  66. Exome Sequencing
  67. Cxbladder
  68. BRCA Analysis
  69. BCR-ABL Negative Myeloproliferative Neoplasm Testing
  70. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  71. Breast Cancer Index for Breast Cancer Prognosis
  72. NETest (Wren Laboratories)
  73. PALB2 Genetic Testing for Breast Cancer Risk
  74. DecisionDX Uveal Melanoma
  75. OncotypeDX Breast DCIS (I/E)
  76. Confirmatory Genetic Testing
  77. Epilepsy Genetic Testing
  78. Maturity-Onset Diabetes of the Young Testing
  79. ThyGenX and ThyraMIR miRNA Gene Expression Classifier
  80. SelectMDx
  81. Mitochondrial Disorders Genetic Testing
  82. Ehlers Danlos Syndrome Genetic Testing
  83. Hereditary Connective Tissue Disorder Genetic Testing
  84. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  85. ThyroSeq
  86. PancraGEN
  87. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  88. Polymerase Gamma (POLG) Related Disorders Genetic Testing
  89. DermTech Pigmented Lesion Assay
  90. Multiple Endocrine Neoplasia Type 1 Genetic Testing
  91. Multiple Endocrine Neoplasia Type 2 Genetic Testing
  92. Hereditary Pancreatitis Genetic Testing
  93. Limb-Girdle Muscular Dystrophy Genetic Testing
  94. Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental Disorders
  95. Facioscapulohumeral Muscular Dystrophy Genetic Testing
  96. Genetic Testing for Known Familial Mutations
  97. Genetic Testing for Variants of Uncertain Clinical Significance
  98. Decipher Prostate Cancer Classifier
  99. Genomic Prostate Score (formerly OncotypeDX for Prostate Cancer)
  100. Prolaris
  101. Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors
  102. Neurofibromatosis Type 1 Genetic Testing
  103. Legius Syndrome Genetic Testing
  104. AlloSure for Kidney Transplant Rejection
  105. Hemoglobinopathies Genetic Testing
  106. Friedreich's Ataxia Genetic Testing
  107. Hereditary Ataxia Multigene Panel Testing
  108. Spinocerebellar Ataxia Genetic Testing
  109. Myotonic Dystrophy Type 1 Genetic Testing
  110. CHARGE Syndrome Genetic Testing
  111. Lyme Disease Testing
  112. Chromosomal Microarray for Solid Tumors
  113. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  114. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  115. Human Platelet and Red Blood Cell Antigen Genotyping
  116. Human Papillomavirus (HPV) Molecular Testing
  117. Pathology Testing with Mohs Micrographic Surgery
  118. Special Circumstances Influencing Coverage Determinations
  119. Inherited Thrombophilia Genetic Testing
  120. Noonan Spectrum Disorder Genetic Testing
  121. Laboratory Procedure Code Requirements
  122. Multi-Cancer Early Detection Screening
  123. Infectious Disease Laboratory Testing
  124. Urinary Tract Infection Molecular Testing
  125. Nail Disorder Infectious Disease Testing, Including Onychomycosis​
 
Retired Guideline:

  1. Somatic Mutation Testing - Hematological Malignancies
  2. Chromosomal Microarray for Prenatal Diagnosis
  3. Long QT Syndrome Genetic Testing
  4. Arrhythmogenic Right Ventricular Cardiomyopathy Genetic Testing
  5. Hypertrophic Cardiomyopathy Genetic Testing
  6. Dilated Cardiomyopathy Genetic Testing
  7. Brugada Syndrome Genetic Testing
  8. Genesight​

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):




New Guidelines:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) Reason for Change
Cardiomyopathy and Arrhythmia Genetic TestingMOL.TS.410.AS3861, 81413, 81414, 0237U, 81439New molecular test-specific guideline addressing testing for inherited cardiomyopathies and arrhythmiasNew guideline



​Criteria Updates (Substantive):

 

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Reason for Change
Rationale / supporting guideline for clinically significant updates 
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.A0034U, 0169UCriteria: NUDT15, TPMT, DPYD were previously coverable as single gene tests under FDA labels – we have changed our process to allow targeted tests (not large panels, but a small number of genes) to be coverable if all of the individual components of the panel are medically necessary and the test is billed with a single panel code; we removed the following tests from I&E status (now addressed by general criteria, with all but TYMS approvable with criteria): 5-Fluorouracil (5-FU) Toxicity and Chemotherapeutic Response [Proprietary panel of DPYD and TYMS gene variants to assess risk of 5-fluorouracil toxicity from ARUP Laboratory] CPT 81232 & 81346; NT (NUDT15 and TPMT) Genotyping Panel from RPRD Diagnostics CPT: 0169U; Thiopurine Methyltransferase (TPMT) and Nudix Hydrolase (NUDT15) Genotyping from Mayo Clinic CPT: 0034U, and NAT2 (changes made based on FDA drug labels that recommend testing of these genes);

Updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) and reclassified some tests from EIU to not medically necessary to align with definitions published by eviCore; language updates, as needed;

Reorganized criteria into sections for Targeted Pharmacogenomic Tests vs. Pharmacogenomic Panel Tests

Genesight Psychotropic Test is now addressed by this guideline, although it remains E/I/U.

Procedure codes table: updated. Background: updated. Test Information: section added. References: updated; clarification of intent edits throughout.		content clarification/informationFDA Labels for impacted drugs:
Mercaptopuring (Purixan) TPMT:  https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205919s003lbl.pdf
Azathioprine (Imuran) TPMT, NUDT15: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016324s039lbl.pdf
5Fluorouracil DPYD:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf
Amifampridine Phosphate (Firdipase) NAT2 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.A Criteria: added coverage criteria for ALS Multigene panels in symptomatic individuals with a family history of ALS in a first degree relative

Moved “Criteria" section to the beginning of the guideline for streamlined reviews; In Other Considerations - added a cross-reference to Pharmacogenomic Testing for Drug Toxicity and Response guideline; admin edits

Billing and Reimbursement: added a B&R section to align with the coverage criteria; Background: admin edit, updated table, updated management; Guidelines and Evidence: added two selected relevant publications regarding genetic testing for individuals with ALS and another regarding presymptomatic genetic testing; References: updated and added two.		professional society updateRoggenbuck J, Eubank BHF, Wright J, Harms MB, Kolb SJ; ALS Genetic Testing and Counseling Guidelines Expert Panel. Evidence-based consensus guidelines for ALS genetic testing and counseling. Ann Clin Transl Neurol. 2023;10(11):2074-2091. doi:10.1002/acn3.51895) and in consultation with our external SMEs at the University of Washington
Chromosomal Microarray Testing For Developmental DisordersMOL.TS.150.A81228, 81229, 81349Criteria: Added criterion for major congenital cardiac anomaly not specific to a well-delineated genetic syndrome for symptomatic individuals (including stillbirths), clarification of intent edits.

Added criteria from Chromosomal Microarray for Prenatal Diagnosis and restructured to accommodate; All sections: added relevant info so guideline applies to CMA testing in the prenatal and postnatal setting

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, ensured readability and updated language, admin updates; Guidelines & Evidence: Updated. References: Updated.

TITLE CHANGE: Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)		professional society updateWilde AAM, Semsarian C, Márquez MF, et al. European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) Expert Consensus Statement on the state of genetic testing for cardiac diseases. Europace. 2022;euac030. doi:10.1093/europace/030
Prader-Willi Syndrome TestingMOL.TS.217.A81331, 81228, S3870, 81229, 81349, 88271Criteria: Added new indication to methylation testing and deletion testing sections for neonatal hypotonia and feeding problems

Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin edits (added abbreviation and "genetic" to introduction), Background: updated; Test information: updated; Guidelines and Evidence: updated; References: updated.		Recommendation from expert authored reviewDriscoll DJ, Miller JL, Schwartz S, Cassidy SB. Prader-Willi Syndrome. 1988 Oct 6 [Updated 2023 Nov 2]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023. Available at: http://www.ncbi.nlm.nih.gov/books/NBK1330/0
Somatic Mutation Testing-Solid TumorsMOL.TS.230.A81450; Added new PLA codes 0444U, 0448UCriteria: Added confirmed or suspected diagnosis of myelodysplastic syndrome (MDS) as indication for a multigene panel

Added criteria from Somatic Mutation - Hematological Malignancies as these guidelines have been combined (and made required edits and additions throughout), TITLE CHANGE: to Somatic Mutation Testing

Clarification of intent edit specifying that clonoSEQ is approvable at diagnosis and once (added) for assessment after primary treatment, Clarification of intent edit to Note  regarding methodology for MSI testing (molecular vs non-molecular), Admin edit in Other Considerations. Clarification of intent edits in Billing & Reimbursement regarding billing of panels for hematologic malignancies.

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, ensured readability and updated language, as needed, due to the moving of sections; CPT Code table: added new PLA codes 0444U and 0448U and added MYD88 mutation analysis 81305, BTK gene analysis 81233, PLCG gene analysis 81320 and Leukostrat CDx FLT3 Assay 0023U; References: updated		professional society updateNCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes. V3.2023 https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf
Gastrointestinal Pathogen Panel (GIPP) Molecular  TestingMOL.CS.277.A87505, 87506, 87507, 0369UCriteria: Criteria: expanded acute diarrhea indications to acute diarrhea or moderate to severe GI infection to be aligned with CMS and added ICD code table to reflect appropriate diagnosis codes for this indication, expanded Immunocompromise ICD table to be aligned with CMS

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore.		editorialCMS Moderate/Severe GI infection codes and immunocompromise codes: A58710: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58710&ver=50&keyword=87505&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1
Molecular Respiratory Infection Pathogen Panel (RIPP) Molecular TestingMOL.CS.293.I87636, 87637, 87631, 87632, 87633, 0202U, 0115U, 0225U, 0223U, 0373U, 0240U, 0241UCriteria: Amended coverage of panels of 6 or more organisms to immunocompromised or inpatient individuals regardless of age (previously allowed large panels in pediatric patients regardless of immune status or site of testing) – supported by IDSA guidelines and EviCore Health technology assessment that found no clinical utility evidence for using large panels in children 

Expanded Immunocompromise ICD table to be aligned with CMS

Clarification of intent edit in billing and reimbursement to strengthen language regarding billing only for medically necessary organisms regardless of panel performed; Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; Guidelines and Evidence: incorporated current EviCore HTA; References: updated		Evidence form peer reviewed literatureUyeki T, Bernstein H, Bradley J, et al. Clinical practice guidelines by the Infectious Diseases Society of America: 2019 update on diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza. Clin Infect Dis. 2019;68(6):e1-e47;

2023 EviCore Health Technology Assessment evidence grade D  for multipathogen panels in pediatric population

CMS immunocompromise codes: A58710: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58710&ver=50&keyword=87505&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1
Whole Genome SequencingMOL.TS.306.I81425, 81426, 81427, 0213U, 0212U, 0267U, 0265U, 0094U, 0425U, 0426UCriteria: Added coverage for Genome sequencing in the outpatient pediatric population with medical necessity requirements similar to exome sequencing

Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections, updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; added 'Rendering laboratory is a qualified provider of service per the Health Plan policy.' ; added Billing and Reimbursement section

TITLE CHANGE: Genome Sequencing		Professional Society update; Literature ReviewACMG: Manickam K, McClain MR, Demmer LA, et al. Exome and genome sequencing for pediatric patients with congenital anomalies or intellectual disability: an evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(11):2029-2037. doi: 10.1038/s41436-021-01242-6

Meta-analysis:
Chung CCY, Hue SPY, Ng NYT, et al. Meta-analysis of the diagnostic and clinical utility of exome and genome sequencing in pediatric and adult patients with rare diseases across diverse populations. Genet Med. 2023;25(9):100896. doi: 10.1016/j.gim.2023.100896)

Clark MM, Stark Z, Farnaes L, et al. Meta-analysis of the diagnostic and clinical utility of genome and exome sequencing and chromosomal microarray in children with suspected genetic diseases. NPJ Genom Med. 2018;3(1). doi: 10.1038/s41525-018-0053-8
Human Immunodeficiency Virus Laboratory TestingMOL.CS.321.A87901, 87906, 0219UCriteria: Added indication for InSTI genotyping prior to antiretroviral therapy when there is suspicion that infection was transmitted from a partner with InSTI failure or if the individual previously received PrEP with cabotegravir. This was previously E/I/U

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language, as needed, due to the moving of sections. Background: Updated. Test Information: Updated. Guidelines & Evidence: Updated. References: Updated.		professional society updateGandhi RT, Bedimo R, Hoy JF, Landovitz RJ, Smith DM, Eaton EF, Lehmann C, Springer SA, Sax PE, Thompson MA, Benson CA, Buchbinder SP, Del Rio C, Eron JJ Jr, Günthard HF, Molina JM, Jacobsen DM, Saag MS. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2023 Jan 3;329(1):63-84. doi: 10.1001/jama.2022.22246
Investigational and Experimental Laboratory TestingMOL.CU.117.Iadded 0349U, 0440UThroughout guideline: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; Added new PLA codes:  Epi+Gen CHDTM (0439U); PrecisionCHDTM (0440U), added Bladder EpiCheck (81599); Removed 4q25 atrial fibrillation risk genotype (81479) since now addressed in Cardiomyopathy and Arrhythmia guideline (still EIU).

TITLE CHANGE: updated title to Experimental, Investigational, or Unproven Laboratory Testing;		content clarification/informationNew CPT codes

 
Criteria Updates (Non-Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Reason for Change
What is the expected impact?
Rett Syndrome TestingMOL.TS.224.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews. In MECP2 sequencing clarification of intent edit added -ID & DD to approvable diagnoses in females after negative Fragile X and microarray testing

CPT code table: updated; Background: updated; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing.PA/CS.MOL.AD.101.B Criteria: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Background: updated external link; References: updated.		Content clarification/ InformationNone
Flow CytometryMOL.CS.103.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Immunohistochemistry (IHC)MOL.CS.104.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections; Clarification of intent edit regarding claims for IHC for skin lesions

Guidelines and Evidence: Added section for "Biopsies of HPV-associated lower anogenital squamous lesions"; References: Added and updated		Content clarification/ InformationNone
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language, as needed, due to the moving of sections

clarification of intent edit to Billing & Reimbursement section for billing components of a panel.		Content clarification/ InformationNone
UroVysion FISH for Bladder CancerMOL.CS.108.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews.

Background: updated; Test information: admin edits; Guidelines and evidence; updated, admin edits; References: updated.		Content clarification/ InformationNone
Genetic Testing for Cancer Susceptibility and Hereditary Cancer SyndromesMOL.CU.109.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, admin editContent clarification/ InformationNone
Genetic Testing for Carrier StatusMOL.CU.110.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; References; updatedContent clarification/ InformationNone
Genetic Testing for Prenatal Screening and Diagnostic TestingMOL.CU.112.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; admin updatesContent clarification/ InformationNone
Genetic Testing for the Screening, Diagnosis, and Monitoring of CancerMOL.CU.113.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, admin editContent clarification/ InformationNone
Genetic Testing to Diagnose Non-Cancer ConditionsMOL.CU.114.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, admin updateContent clarification/ InformationNone
Genetic Testing to Predict Disease RiskMOL.CU.115.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; ensured readability and updated language, admin updateContent clarification/ InformationNone
Preimplantation Genetic Screening and DiagnosisMOL.CU.119.A Criteria: clarification of medical necessity language to align with definitions published by eviCore. Background: updated terminology

Guidelines & Evidence: updated, admin edit; References: updated		Content clarification/ InformationNone
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore, updated language to ensure readability after moving sectionsContent clarification/ InformationNone
AlloMap Gene Expression Profiling For Heart Transplant RejectionMOL.TS.123.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarified medical necessity language as needed to align with published eviCore definitions

Test Information: admin edit; References: updated		Content clarification/ InformationNone
Alpha-1-Antitrypsin Deficiency TestingMOL.TS.124.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore; admin edit

Background: admin edit		Content clarification/ InformationNone
Angelman Syndrome TestingMOL.TS.126.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarification of intent edits to clarify that genetic testing can be approved even in the presence of a non-genetic cause if clinical suspicion of a gene mutation remains high, admin edits;

Test Information: updated reused content; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
APOE Variant Analysis for Alzheimer DiseaseMOL.TS.128.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCoreContent clarification/ InformationNone
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Ataxia-Telangiectasia Genetic TestingMOL.TS.130.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Bloom Syndrome Genetic TestingMOL.TS.132.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
CADASIL Genetic TestingMOL.TS.144.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language.

Background: added AHA information; Test information: admin edit; Guidelines and Evidence; added AHA scientific statement, updated; References: updated.		Content clarification/ InformationNone
Canavan Disease Genetic TestingMOL.TS.145.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
HLA Typing for Celiac DiseaseMOL.CS.146.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore

Guidelines and Evidence: Updated. References: Updated.		Content clarification/ InformationNone
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, defined abbreviation; clarified that genetic testing can be approved even in the presence of a non-genetic cause for the member's neuropathy if the suspicion for a genetic mutation remains high.

Guidelines and Evidence: admin edits.		Content clarification/ InformationNone
Chromosome Analysis for Blood and Bone Marrow CancersMOL.TS.151.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews.

Test information: updated; Guidelines and evidence: updated, reorganized NCCN guidelines, admin edit; References: updated.		Content clarification/ InformationNone
ConfirmMDx for Prostate Cancer Risk AssessmentMOL.TS.153.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; clarified medical necessity language to align with definitions published by eviCore

Background: updated statistics; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
Cystic Fibrosis Genetic TestingMOL.TS.158.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Dentatorubral-Pallidoluysian Atrophy Genetic TestingMOL.TS.159.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin edit.Content clarification/ InformationNone
Duchenne & Becker Muscular Dystrophy TestingMOL.TS.161.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
Early Onset Familial Alzheimer Disease (EOFAD.) Genetic TestingMOL.TS.162.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
SEPT9 Methylation Analysis for Colorectal Cancer (Formerly Sept9 Methylation Analysis for Colorectal Cancer)MOL.TS.164.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore;

Procedure code table: updated. Background: updated; Test information: admin edits; Guidelines and Evidence: updated and reformatted; References: updated.		Content clarification/ InformationNone
Expanded Carrier Screening PanelsMOL.TS.165.AAdded 0449UCriteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, added new PLA code 0449U to CPT code tableContent clarification/ InformationNone
Familial Adenomatous Polyposis Genetic TestingMOL.TS.168.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections, admin editContent clarification/ InformationNone
Familial Hypercholesterolemia Genetic TestingMOL.TS.169.A Criteria: In the Exclusions section - Changed testing for cholesterol treatment decisions in the absence of FH symptoms from I&E to not medically necessary to align with eviCore published definitions, moved “Criteria" section to the beginning of the guideline for streamlined reviews; added an introduction for readability

Background: admin edit		Content clarification/ InformationNone
Familial Malignant Melanoma Genetic TestingMOL.TS.170.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language as needed, admin editContent clarification/ InformationNone
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, updated language from "females" to "individuals assigned female at birth";

References: updated links		Content clarification/ InformationNone
Gaucher Disease Genetic TestingMOL.TS.173.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore.Content clarification/ InformationNone
Hereditary Hemochromatosis Genetic TestingMOL.TS.183.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
HIV Tropism Testing for Maraviroc ResponseMOL.CS.185.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language.

Throughout: updated "patient" to "individual"; Guidelines and Evidence: updated, admin edit; References: updated		Content clarification/ InformationNone
Huntington Disease Genetic TestingMOL.TS.188.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
Li-Fraumeni Syndrome Genetic TestingMOL.TS.193.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Liquid Biopsy TestingMOL.TS.194.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; Other Non-CDx Indications section - updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore and  updated language, as needed, for readability and clarity, admin edit.

CPT code table: removed 81445 & 81455, added 81462, 81463, 81464, removed duplicate 81270 code; Billing and Reimbursement: updated; Background: updated. Test Information: updated; Guidelines and Evidence: updated; References: updated.		Content clarification/ InformationNone
Lynch Syndrome Genetic TestingMOL.TS.197.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, admin updatesContent clarification/ InformationNone
Lynch Syndrome Tumor Screening - Second-TierMOL.TS.199.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Marfan Syndrome Genetic TestingMOL.TS.202.A Criteria: Moved "Criteria" section to the beginning of the guideline for streamlined reviews; removed Known familial mutation section - addressed by clinical use guidelines; admin edit.

Test information: admin edit and updated title of cross-referenced guideline; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
MUTYH Associated Polyposis Genetic TestingMOL.TS.206.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Niemann Pick Disease Types A & B TestingMOL.TS.207.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language; Procedure code table: updatedContent clarification/ InformationNone
Niemann Pick, Type C TestingMOL.TS.208.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language; Procedure code table: updatedContent clarification/ InformationNone
Non-Invasive Prenatal ScreeningMOL.TS.209.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; To align with definitions published by eviCore: 1) NIPS for microdeletions and single gene diseases - updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U), 2) NIPS for aneuploidy - updated medically necessary phrasingContent clarification/ InformationNone
OncotypeDX for Breast Cancer PrognosisMOL.TS.211.I Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
OncotypeDX for Colorectal Cancer Recurrence RiskMOL.TS.213.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
PCA3 Testing for Prostate CancerMOL.TS.215.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language

Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
Peutz-Jeghers Syndrome Genetic TestingMOL.TS.216.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Prenatal Aneuploidy FISH TestingMOL.CS.218.A Criteria:  Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarification of medical necessity language to align with definitions published by eviCore", admin edit; Introduction: admin edit

Test information: admin edits; References: admin edits.		Content clarification/ InformationNone
Prosigna Breast Cancer Prognostic Gene Signature AssayMOL.TS.222.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
PTEN Hamartoma Tumor Syndromes Genetic TestingMOL.TS.223.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections.Content clarification/ InformationNone
Spinal Muscular Atrophy Genetic TestingMOL.TS.225.A Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language in exclusions section (copy number and targeted testing for purposes of prognosis in SMA) from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCore, ensured readability and updated languageContent clarification/ InformationNone
Tay-Sachs Disease TestingMOL.TS.226.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language

Background: admin edits; Test information: admin edit; Guidelines and Evidence: added ACMG practice resource, updated, admin edits; References: updated		Content clarification/ InformationNone
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic TestingMOL.TS.227.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, ensured readability and updated language.Content clarification/ InformationNone
Tissue of Origin Testing for Cancer of Unknown PrimaryMOL.TS.228.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin edit

Guidelines and Evidence: updated; References: updated.		Content clarification/ InformationNone
Von Hippel-Lindau Disease Genetic TestingMOL.TS.233.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin update;

Throughout: amended condition name to von Hippel-Lindau disease or VHL for consistency		Content clarification/ InformationNone
EndoPredict for Breast Cancer PrognosisMOL.TS.234.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Exome SequencingMOL.TS.235.I Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, Prenatal exome: updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCore, and updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language due to sections moving

Clarification of intent edit - moved criteria bullet, removed redundant info, added clarification of intent edit regarding previous testing; added 'Rendering laboratory is a qualified provider of service per the Health Plan policy.';  Billing and Reimbursement: Reorganized and removed redundant information and non billing information.		Content clarification/ InformationNone
CxbladderMOL.TS.236.Aadded 0420UCriteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore.

Added CPT code for Cxbladder Detect+ (0420U); Background: added info on Cxbladder Detect+; Test information: added info on Cxbladder Detect+ and admin edit; Guidelines and Evidence: updated, incorporated current EviCore health technology assessment, admin edits; References: updated.		Content clarification/ InformationNone
BRCA AnalysisMOL.TS.238.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections; clarification of intent editsContent clarification/ InformationNone
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language to ensure readability and updated language, as needed, due to the moving of sections; Background: updated. Guidelines & evidence: updated; References: updated.Content clarification/ InformationNone
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.A Criteria: no updates. Guidelines and Evidence: added ESMO guideline, updated NCCN year of publication and one statement, added one publication to Selected Relevant Publications; References: updated.Content clarification/ InformationNone
Breast Cancer Index for Breast Cancer PrognosisMOL.TS.248.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections. Content clarification/ InformationNone
NETest (Wren Laboratories)MOL.TS.250.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore.

Test information: updated; Guidelines and evidence: added Polish Network of Neuroendocrine Tumours publication, incorporated current EviCore health technology assessment; References: updated		Content clarification/ InformationNone
PALB2 Genetic Testing for Breast Cancer RiskMOL.TS.251.A Criteria: Moved “Criteria"section to the beginning of the guideline for streamlined reviews.Content clarification/ InformationNone
DecisionDX Uveal MelanomaMOL.TS.254.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; Decision Dx-UM: aligned medical necessity language; DecisionDx -PRAME and UMSeq: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Background: admin edits; Guidelines and Evidence: updated, incorporated EviCore health technology assessment, admin edits; References: updated.		Content clarification/ InformationNone
OncotypeDX Breast DCIS (I/E)MOL.TS.255.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCoreContent clarification/ InformationNone
Confirmatory Genetic TestingMOL.CU.256.A Criteria: Updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; updated examples of E/I/U vs. not medically necessary tests per eviCore clinical guidelines.Content clarification/ InformationNone
Epilepsy Genetic TestingMOL.TS.257.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore, ensured readability and updated language, as needed, due to the moving of sections.Content clarification/ InformationNone
Maturity-Onset Diabetes of the Young TestingMOL.TS.258.A Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; Rare single gene section: updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCorecontent clarification/informationNone
ThyGenX and ThyraMIR miRNA Gene Expression ClassifierMOL.TS.259.I Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore

Test information: updated; Guidelines and Evidence: updated NCCN, admin edits; References: update		content clarification/informationNone
SelectMDxMOL.TS.264.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, added introduction section to Criteria section.content clarification/informationNone
Mitochondrial Disorders Genetic TestingMOL.TS.266.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections; updated criteria section header from "Targeted Mutation Analysis" to "Targeted Mutation Analysis or Single Gene Analysis" since these criteria also addresses TYMP gene sequencing; added POLG disorders to table with reference out to POLG Disorders guideline, admin edits in table and Billing and Reimbursement section

Background: admin edit, update; Test Information: admin edit; Guidelines and Evidence: updated, admin edit; References: updated. 		content clarification/informationNone
Ehlers Danlos Syndrome Genetic TestingMOL.TS.267.A Criteria: Format updates: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections. Minor clarification of intent edit in "Other Considerations".content clarification/informationNone
Hereditary Connective Tissue Disorder Genetic TestingMOL.TS.268.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore, in the "Criteria" section; clarification of intent edits in multi-gene panel criteria and "Other considerations"; updated language, as needed, due to the moving of sections.content clarification/informationNone
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, Updated panels from not medically necessary to E/I/U, clarification of intent update, admin edits in KFM section (updated biologic to biological), updated name of referenced guideline

Background: updated; Test Information: admin edit; Guidelines and Evidence: updated, admin edits; References: updated		content clarification/informationNone
ThyroSeqMOL.TS.270.I Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ThyroSeq CRC: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U); ThyroSeq: clarified medical necessity language to align with definitions published by eviCore, admin update

Guidelines and Evidence: updated, incorporated EviCore health tech assessment; References: updated		content clarification/informationNone
PancraGENMOL.TS.271.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews. Replaced "biologic" with "biological".  

Background: updated; Guidelines and Evidence: "selected relevant publications" updated; References: updated. Clarification of intent edit to Billing and Reimbursement. Procedure code table: updated.		content clarification/informationNone
Polymerase Gamma (POLG) Related Disorders Genetic TestingMOL.TS.276.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections.

Guidelines and Evidence: updated FDA information; References: updated.		content clarification/informationNone
DermTech Pigmented Lesion AssayMOL.TS.282.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin updatecontent clarification/informationNone
Multiple Endocrine Neoplasia Type 1 Genetic TestingMOL.TS.285.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language, admin edit in Other considerations sectioncontent clarification/informationNone
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languagecontent clarification/informationNone
Hereditary Pancreatitis Genetic TestingMOL.TS.287.A Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; CLDN2, PNLIP, and CEL Analysis: updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCorecontent clarification/informationNone
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewscontent clarification/informationNone
Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental DisordersMOL.CS.289.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin edit.

Background: updated; Test information: updated; Guidelines and evidence: admin edits, updated; References: updated.		content clarification/informationNone
Facioscapulohumeral Muscular Dystrophy Genetic TestingMOL.TS.290.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updatecontent clarification/informationNone
Genetic Testing for Known Familial MutationsMOL.CU.291.A Criteria: admin updatescontent clarification/informationNone
Genetic Testing for Variants of Uncertain Clinical SignificanceMOL.CU.292.A Criteria: admin updatecontent clarification/informationNone
Decipher Prostate Cancer ClassifierMOL.TS.294.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; Decipher Prostate Biopsy: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Genomic Prostate Score (formerly OncotypeDX for Prostate Cancer)MOL.TS.295.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin editcontent clarification/informationNone
ProlarisMOL.TS.297.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin editcontent clarification/informationNone
Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in MinorsMOL.CU.298.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; admin updatecontent clarification/informationNone
Neurofibromatosis Type 1 Genetic TestingMOL.TS.301.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, ensured readability and updated language; deleted information on prenatal testing for KFM as this is addressed by clinical use guidelines; changed "patient" to "individual", updated name of referenced guideline

Background: changed "patients" to "individuals". Guidelines & Evidence: Updated (admin edit). References: updated		content clarification/informationNone
Legius Syndrome Genetic TestingMOL.TS.302.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewscontent clarification/informationNone
AlloSure for Kidney Transplant RejectionMOL.TS.307.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Throughout: updated name of test from 'AlloSure' to 'AlloSure Kidney'; Test Information: updated; Guidelines and Evidence: updated, incorporated EviCore HTA; References; updated		content clarification/informationNone
Hemoglobinopathies Genetic TestingMOL.TS.308.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; Procedure code table: Updated.content clarification/informationNone
Friedreich's Ataxia Genetic TestingMOL.TS.309.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updatecontent clarification/informationNone
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews.content clarification/informationNone
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languagecontent clarification/informationNone
Myotonic Dystrophy Type 1 Genetic TestingMOL.TS.312.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, ensured readability and updated language. Procedure code table: Updated.content clarification/informationNone
CHARGE Syndrome Genetic TestingMOL.TS.324.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; removed references from criteria and added a phrase referring to the table in the diagnosis section of the background, replaced "biologic" with "biological", admin edit to intro, removed information on prenatal testing and known familial mutation as this is addressed by clinical use guidelines; admin edit to add emphasis to the fact that individual may meet "ONLY ONE" of the criteria included in this section; adjusted formatting of table of criteria.

Background: updated, including terminology; Test information: admin edit; Guidelines and Evidence; admin edits; References: updated. TITLE CHANGE: CHARGE Syndrome and CHD7 Disorder Genetic Testing		content clarification/informationNone
Lyme Disease TestingMOL.CS.332.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of intent update to language to add the exception mentioned in the Billing & Reimbursement section for NAAT testing on synovial fluid to inform therapeutic decisions for seropositive individuals, to be considered on a case-by-case basis.

Background: Updated. Test Information: Updated. Guidelines & Evidence: Updated. References: Updated.		content clarification/informationNone
Chromosomal Microarray for Solid TumorsMOL.TS.344.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, clarification of medical necessity language to align with definitions published by eviCorecontent clarification/informationNone
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A Criteria:  Moved “Criteria" section to the beginning of the guideline for streamlined reviews, clarification of medical necessity language to align with definitions published by eviCorecontent clarification/informationNone
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language; clarification of intent edits.content clarification/informationNone
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarified medical necessity language to align with published eviCore terms/definitions; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.ARemoved 0354UCriteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language, as needed, due to the moving of sections; Deleted 0354U (retired PLA code) from Criteria and CPT code table.content clarification/informationNone
Pathology Testing with Mohs Micrographic SurgeryMOL.CS.363.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languagecontent clarification/informationNone
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.A Criteria: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, clarification of intent edit in IL HB 3817 bill; Added NY S01196A, CA SB496, and PA SB 8 billscontent clarification/informationNone
Inherited Thrombophilia Genetic TestingMOL.TS.370.A Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; For MTHFR: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language;

Guidelines & Evidence: updated.		content clarification/informationNone
Laboratory Procedure Code RequirementsMOL.AD.391.A Criteria: added "When a prior authorization request is submitted for a group of procedure codes and at least one procedure code requires prior authorization, all submitted procedure codes that are under management by the Program (in any form) will be reviewed regardless of the authorization requirements for each code."content clarification/informationNone
Multi-Cancer Early Detection ScreeningMOL.TS.396.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; CPT code table: updated;

Background: updated; Test Information: updated; Guidelines and evidence: updated; References; updated.		content clarification/informationNone
Infectious Disease Laboratory TestingMOL.CU.398.A Criteria: Updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore. Procedure code table: Updated; Added 0140U-0142U and 0370U to procedure code table since these are addressed by general criteriacontent clarification/informationNone
Urinary Tract Infection Molecular TestingMOL.CS.403.ARemoved 0416UCriteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; clarification of intent updates to both "Criteria" and "Billing and Reimbursement" to make it more clear that single-organism testing for UTIs is also E/I/U, not just panels;

Deleted 0416U (retired PLA code) from Criteria and CPT code table		content clarification/informationNone
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; nucleic acid testing for onychomycosis, nail dystrophy, and other nail disorders changed from "not medically necessary" to E/I/U.content clarification/informationNone​


 
Retired Guideline:​


Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.AN/AGuideline is retired - testing now addressed by Somatic Mutation Testing (MOL.TS.230)Retired guideline
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.AN/AGuideline is retired - Information on Prenatal microarray has been added into the Chromosomal Microarray for Developmental Disorders (Prenatal and Postnatal) guideline (MOL.TS.150)Retired guideline
Long QT Syndrome Genetic TestingMOL.TS.196.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Arrhythmogenic Right Ventricular Cardiomyopathy Genetic TestingMOL.TS.281.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Hypertrophic Cardiomyopathy Genetic TestingMOL.TS.189.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Dilated Cardiomyopathy Genetic TestingMOL.TS.284.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Brugada Syndrome Genetic TestingMOL.TS.261.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
GenesightMOL.TS.340.AN/AGuideline is retired - testing now addressed by  Pharmacogenomic Testing for Drug Toxicity and Response (MOL.CU.118)Retired guideline
​



Revisions From 06.02.52af:

04/01/2024

This version of the policy is a result of code updates effective 04/01/2024. 

 

The following procedure codes were added to the policy:

0439U, 0440U, 0444U, 0448U, and ​0449U


The following procedure codes were deleted from this policy because they have been termed:

0354U and 0416U​


Revisions From 06.02.52ae:
01/01/2024This version of the policy will become effective on 01/01/2024.

Effective 01/01/2024, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0420U, 0421U, 0422U, 0423U, 0424U, 0425U, 0426U, 0428U, 0433U, 0434U, 0437U, 0438U,
81457, 81458, 81459, 81462, 81463, 81464


Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

0429U, 87523, 0848T, 0849T, 0850T, 0851T, 0852T, 0853T​


REVISED

02 PLA codes have been revised to add specimen types, which are non-substantive changes: 0351U & 0356U 

81171, 81172, 81243, 81244


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On January 01st, 2024, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2024. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

01/01/2024 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52ae)

Executive Summary of Changes

There are 03 new guidelines. 72 existing guidelines have been revised (including 11 with substantive criteria changes). Two guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Infectious Disease Laboratory Testing
  2. Urinary Tract Infection Molecular Testing
  3. Nail Disorder Infectious Disease Testing, Including Onychomycosis​

​Criteria Updates (Substantive):

  1. Genitourinary Conditions Molecular Testing (NEW TITLE: Sexually Transmitted and Other Reproductive Tract Infection Testing)
  2. Cystic Fibrosis Testing
  3. Lynch Syndrome Genetic Testing
  4. Non-Invasive Prenatal Screening
  5. Somatic Mutation Testing-Solid Tumors
  6. Somatic Mutation Testing - Hematological Malignancies
  7. BRCA Analysis 
  8. Facioscapulohumeral Muscular Dystrophy Genetic Testing 
  9. Special Circumstances Influencing Coverage Determinations
  10. Noonan Spectrum Disorder Genetic Testing
  11. Investigational and Experimental Laboratory Testing
   
Criteria Updates (Non-Substantive):

  1. Genetic Testing to Diagnose Non-Cancer Conditions
  2. Pharmacogenomic Testing for Drug Toxicity and Response
  3. Afirma Thyroid Cancer Classifier Tests
  4. AlloMap Gene Expression Profiling For Heart Transplant Rejection
  5. APOE Variant Analysis for Alzheimer Disease
  6. Ashkenazi Jewish Carrier Screening
  7. Ataxia-Telangiectasia Genetic Testing
  8. Bloom Syndrome Genetic Testing
  9. Canavan Disease Genetic Testing
  10. Charcot-Marie-Tooth Neuropathy Genetic Testing
  11. Chromosomal Microarray for Prenatal Diagnosis
  12. Chromosomal Microarray Testing For Developmental Disorders
  13. Duchenne & Becker Muscular Dystrophy Testing
  14. Early Onset Familial Alzheimer Disease (EOFAD.) Genetic Testing
  15. Expanded Carrier Screening Panels
  16. Familial Adenomatous Polyposis Genetic Testing
  17. Familial Malignant Melanoma Genetic Testing
  18. Hereditary Cancer Syndrome Multigene Panels
  19. Hypertrophic Cardiomyopathy Genetic Testing
  20. Li-Fraumeni Syndrome Genetic Testing
  21. Long QT Syndrome Genetic Testing
  22. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  23. MUTYH Associated Polyposis Genetic Testing
  24. Niemann Pick Disease Types A & B Testing
  25. Niemann Pick, Type C Testing
  26. Spinal Muscular Atrophy Genetic Testing
  27. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing
  28. Exome Sequencing
  29. BCR-ABL Negative Myeloproliferative Neoplasm Testing
  30. Maturity-Onset Diabetes of the Young Testing
  31. ThyGenX and ThyraMIR miRNA Gene Expression Classifier
  32. Brugada Syndrome Genetic Testing
  33. Mitochondrial Disorders Genetic Testing
  34. Ehlers Danlos Syndrome Genetic Testing
  35. Hereditary Connective Tissue Disorder Genetic Testing
  36. ThyroSeq
  37. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  38. Arrhythmogenic Right Ventricular Cardiomyopathy Genetic Testing
  39. DermTech Pigmented Lesion Assay
  40. Dilated Cardiomyopathy Genetic Testing
  41. Multiple Endocrine Neoplasia Type 1 Genetic Testing
  42. Multiple Endocrine Neoplasia Type 2 Genetic Testing
  43. Limb-Girdle Muscular Dystrophy Genetic Testing
  44. Molecular Respiratory Infection Pathogen Panel (RIPP) Molecular Testing
  45. Legius Syndrome Genetic Testing
  46. Whole Genome Sequencing
  47. Hemoglobinopathies Genetic Testing
  48. Friedreich's Ataxia Genetic Testing
  49. Hereditary Ataxia Multigene Panel Testing
  50. Spinocerebellar Ataxia Genetic Testing
  51. Medically Necessary General Laboratory Testing
  52. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  53. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  54. Human Platelet and Red Blood Cell Antigen Genotyping
  55. Human Papillomavirus (HPV) Molecular Testing
  56. Inherited Thrombophilia Genetic Testing
  57. Liquid Biopsy Testing
  58. Hereditary Pancreatitis Genetic Testing
  59. Flow Cytometry
  60. Date of Service and Authorization Period Effective Date
  61. Epilepsy Genetic Testing
 
Retired Guideline:

  1. BRCA Ashkenazi Jewish Founder Mutation Testing
  2. Macula Risk​

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) Reason for Change
Infectious Disease Laboratory TestingMOL.CU.398.A0086U, 0311U, 0010U, 0301U, 0302U, 0323U, 0152U, 0112U, 0109U, Infectious disease MAAA codes (81490-81599, 0002M-0018M); Other Infectious disease PLA codes (ending in U); Infectious Disease HCPCS codes (beginning with G, P, S, or U)New clinical use guideline addressing molecular testing for infectious disease, not otherwise addressed in an eviCore clinical guideline.New guideline
Urinary Tract Infection Molecular TestingMOL.CS.403.A0321U, 87480, 87481, 87482, 87490, 87491, 87492, 87496, 87510, 87511, 87512, 0416U, 87528, 87529, 87530, 87531, 87532, 87533, 87797, 87798, 87799, 87800, 87801, 87555, 87556, 87557, 87563, 87590, 87591, 87592, 0371U, 0372U, 87640, 87641, 87650, 87651, 87652, 87653, 87660, 87661, 0374U, 87500New claims guideline addressing molecular testing for diagnosis of urinary tract infections, identification of causative pathogens in UTI, and assessment of antibiotic resistance in UTI. New guideline
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.A87149, 87150, 87153, 87480, 87481, 87482, 87800, 87801, 87797, 87798, 87799, 87650, 87651, 87652, 87653, 87640, 87500New claims guideline addressing molecular testing in the evaluation and management of  infectious causes of nail disorders, including onychomycosis. New guideline


​Criteria Updates (Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Reason for Change
Rationale / supporting guideline for clinically significant updates 
Genitourinary Conditions Molecular Testing (NEW TITLE: Sexually Transmitted and Other Reproductive Tract Infection Testing)MOL.CS.106.A0402U; Added 0330UCriteria: added new section for multiple organism detection panels, added new 0330U to code table in BV section as I/E, clarification of intent edit to introduction redirecting to other guidelines when needed, additional clarification of intent edits throughout to remove most uses of "genitourinary conditions" (except in relation to NOS organisms and symptoms), removed HPV block in criteria as this testing is addressed by a separate guideline;

Billing and Reimbursement: Clarification of intent edit to BV section (changed "procedure codes in table above" to "proprietary laboratory analysis (PLA) codes in table above"), removed HPV block in criteria as this testing is addressed by a separate guideline; TITLE CHANGE: Sexually Transmitted and Other Reproductive Tract Infection Testing;
Procedure codes table: updated; Test Information: updated; Guidelines & Evidence: updated; References: updated		content clarification/informationMiller JM, Binnicker MJ, Campbell S, et al. A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2018 Update by the Infectious Disease Society of America and the American Society for Microbiology. Clin Infect Dis. 2018;67(6):e1-e94. doi: 10.1093/cid/ciy381
Cystic Fibrosis TestingMOL.TS.158.A81223Criteria: for Carrier Testing- removed requirement to have a negative targeted mutation panel prior to sequencing

Background: updated; Test Information: updated; Guidelines and Evidence; updated; References: updated		professional society updateSavant A, Lyman B, Bojanowski C, Upadia J. Cystic Fibrosis. 2001 Mar 26 [Updated 2023 Mar 9]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023

Deignan JL, Gregg AR, Grody WW et al. Updated recommendations for CFTR carrier screening: A position statement of the American College of Medical Genetics and Genomics (ACMG). June 2023. Available at: https://www.gimjournal.org/article/S1098-3600(23)00880-8/fulltext
Lynch Syndrome Genetic TestingMOL.TS.197.A81403, 0238U, 81294, 81292, 81297, 81295, 81300, 81298, 81319, 81317 Criteria: added 2 criteria in the predisposition/asymptomatic section (can now approve for asymptomatic individuals if their family member's IHC results are unavailable and they have 1. A first degree relative with colorectal or endometrial cancer diagnosed before age 50. 2. A first degree relative with colorectal or endometrial cancer and another synchronous or metachronous Lynch syndrome-associated tumor), removed references to turcot and muir-torre as these are outdated terms, Figure A: updated related NCCN quote, updated to separate out Billing & Reimbursement section.

Billing and Reimbursement: Updated language in Billing and Reimbursement section; Background: updated; Guidelines and Evidence: updated; References: updated.		professional society updateNCCN Clinical Practice Guidelines in Oncology: Genetics/Familial High-Risk Assessment: Colorectal. Version 1.2023. Accessed 2 June 2023. Available at http://www.nccn.org/professionals/physician_gls/pdf/genetics_colon.pdf)
Non-Invasive Prenatal ScreeningMOL.TS.209.A81420, 81507, 0327UCriteria: updated to allow for approval of twin pregnancies; clarification of intent edits (added bullet regarding how repeat testing following low fetal fraction will be considered on a case-by-case basis);

Billing and Reimbursement: added ICD code table and updated language to align with coverage of twin pregnancy testing; Guidelines and Evidence: updated; References: updated		professional society updateDungan JS, Klugman S, Darilek S, et al. Noninvasive prenatal screening (NIPS) for fetal chromosome abnormalities in a general-risk population: An evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2023;25(2): 100336 doi: 10.1016/j.gim.2022.11.004
Somatic Mutation Testing-Solid TumorsMOL.TS.230.A81201, 81210, 81163, 81165, 81216, 81235, 0037U, 0334U, 81273, 81272, 81275, 81276, 81287, 0211U, 81292, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81479, 88271, 81295, 81298, 0048U, 0172U, 81311, 81191, 81192, 81193, 81194, 0022U, 0244U, 81307, 81314, 0250U, 81309, 81317, 0111U, 81321, 81347, 81445, 81455, 0379U, 81345, 0154U, 0155U, 81351, 81352Criteria: Substantive criteria updates:
1. Inclusion of MSI as an approvable tumor marker. 
2. Updated criteria related to ovarian cancer. Previously required "recurrent or relapsed" ovarian cancer to approve a panel. Now can be approved for any ovarian cancer  
3. Updated criteria related to cutaneous melanoma. Could previously approve a tumor marker panel for Stage IV cutaneous melanoma. Now, a panel could also be approved for recurrent cutaneous melanoma regardless of stage
Non-substantive changes: updated to separate out Billing & Reimbursement section, removed table of common cancer types and associated markers and references to the table, but coverage of those cancer types will not change as they meet the 5 gene minimum for panel coverage, clarification of intent edits.

Background: admin update. Guidelines and Evidence: updated, removed specific CDx tests from FDA section. References: updated		professional society update1. Bartley AN, Mills AM, et al. Mismatch repair and microsatellite instability testing for immune checkpoint inhibitor therapy: guideline From the College of American Pathologists in collaboration with the Association for Molecular Pathology and Fight Colorectal Cancer. Arch Pathol Lab Med. 2022.146(10):1194-1210. doi: 10.5858/arpa.2021-0632-CP

2. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Ovarian Cancer/ Including Fallopian Tube Cancer/ and Primary Peritoneal Cancer. V2.2023. Available at: https://www.nccn.org/

3. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Melanoma: Cutaneous. V2.2023. Available at: https://www.nccn.org/
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.A81170, 81401, 81175, 81176, 81206, 81207, 81208, 0016U, 81219 , 81168, 81218, 81237, 81236, 88271, 0046U, 81245, 81246, 81450, 81120, 81121, 81278, 0027U, 0017U, 81279, 81270, 81272, 81273, 81338, 81339, 0040U, 0050U, 0171U, 0049U, 81310, 81311, 81334, 81347, 81455, 81348, 81345, 81351, 81352, 81360, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81479, 88271Criteria: updated criterion for AML from 'diagnosed' to 'confirmed or suspected diagnosis of AML' since testing can be performed for work-up of this malignancy, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; removed table of common cancer types and associated markers and references to the table, but coverage of those cancer types will not change as they meet the 5 gene minimum for panel coverage, clarification of intent edits

Guidelines and evidence: updated; References: updated		professional society updateNational Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia. V4.2023. Available at: https://www.nccn.org/ 
BRCA AnalysisMOL.TS.238.A81166, 81165, 81167, 81216, 81164, 81163, 81162 Criteria: Clinically substantive: added criteria to BRCA full sequencing to include coverage for breast cancer at age 50 or younger (previously 45 and younger) and two primary breast cancers (previously approved for 3 primaries or 2 primaries where one was diagnosed before 50), added criteria for AJ founder mutations (previously managed by a separate guideline - no change in clinical management), Non-substantive: admin edits, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section;

CPT code table: added AJ founder CPT code (81212), Background: updated, admin update; Test Information: added AJ founder mutation test info, admin update; Guidelines and Evidence: updated; References: updated		professional society updateNational Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. V.3.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/genetics_bop.pdf 
Facioscapulohumeral Muscular Dystrophy Genetic TestingMOL.TS.290.A81404, 81479Criteria: removed "absence of ptosis" from criteria, clarification of intent edit: added description of ocular muscle involvement

Background: updated; References; updated		evidence update from peer reviewed literaturePreston M, Tawil R, and Wang L. Facioscapulohumeral muscular dystrophy. 1999 Mar 8 [Updated 2020 Feb 6]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023

Loonen TGJ, Horlings CGC, Vincenten SCC, et al. Characterizing the face in facioscapulohumeral muscular dystrophy. J Neurol.  2021;268(4):1342-1350
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.AallFederal legislation: no update.
State mandates: admin update. Applicable laws: reformatted - separated sections into “Biomarker Bills" (presented as a list) and “Other Applicable Bills" (retained descriptions) for clarification purposes; removed descriptions for the bills under the “Biomarker Bills" section.

Biomarker Bills – added Arkansas HB 1121, Georgia HB 85, Kentucky HB 180, Louisiana SB 104, Maryland HB 1217, Nevada AB 155, New Mexico HB 73, Oklahoma SB 513, Rhode Island HB 7587, Texas SB 989

Other Applicable Bills – added AR HB 1042 (and description) and IL HB 2109 (and description).

References: Added references and links for all of the added states		content clarification/informationUpdated in accordance with state mandates:

Biomarker bills added:
AR: https://legiscan.com/AR/bill/HB1121/2023
GA: https://legiscan.com/GA/bill/HB85/2023
KY: https://legiscan.com/KY/bill/HB180/2023
LA: https://legiscan.com/LA/bill/SB104/2023
MD: https://legiscan.com/MD/bill/HB1217/2023
NV: https://legiscan.com/NV/bill/AB155/2023
NM: https://legiscan.com/NM/bill/HB73/2023
OK: https://legiscan.com/OK/bill/SB513/2023
RI: https://legiscan.com/RI/bill/H7587/2022
TX: https://legiscan.com/TX/bill/SB989/2023

Other Applicable bills:
AR:  https://www.arkleg.state.ar.us/Bills/Detail?id=HB1042&chamber=House&ddBienniumSession=2023/2023R

IL: https://legiscan.com/IL/bill/HB2109/2021
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.A81442Criteria: Substantive update: In two places, updated "Nuchal edema (e.g. increased nuchal translucency, increased nuchal fold, or cystic hygroma)" to "Nuchal edema (e.g. increased nuchal translucency, increased nuchal fold, or cystic hygroma) and/or hydrops fetalis", updated intro and admin edits, Added "other considerations" block, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section;

Background: updated; Test information: updated, Guidelines and Evidence: updated; References: updated.		evidence update from peer reviewed literatureGripp KW and Rauen KA. Costello Syndrome. 2006 Aug 29 [Updated 2019 Aug 29]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023;

Wagner T, Fahham D, Frumkin A, et al. The many etiologies of nonimmune hydrops fetalis diagnosed by exome sequencing. Prenat Diagn. 2022 Jun;42(7):881-889;

Quinn AM, Valcarcel BN, Makhamreh MM, et al. A systematic review of monogenic etiologies of nonimmune hydrops fetalis. Genet Med. 2021 Jan;23(1):3-12)
Investigational and Experimental Laboratory TestingMOL.CU.117.IADDED: 0410U, 0405U, 0406U, 0413U, 0414U, 0403U, 0794T, 0418U,
DELETED: 81225, 81226, 81227, 81240, 81241, 81355,  0386U, 0371U, 0372U, 0374U, 0321U, 0330U, 0086U, 0311U, 0010U, 0301U, 0302U, 0323U, 0152U, 0112U, 0109U		Criteria reformatted into an alpha-numeric list (no categories); CPT code table: alphabetical order realigned to test list
 
ADDED: AvantectTM Pancreatic Cancer Test (0410U); BTG Early Detection of Pancreatic Cancer (0405U), CyPath Lung (0406U), DH Optical Genome Mapping/Digital Karyotyping Assay (0413U), LungOI (0414U), Macula Risk (81401, 81479), MyProstateScore 2.0 (0403U), Pharmaco-oncologic Algorithmic Treatment Ranking (0794T), PreciseDx Breast Biopsy Test (0418U)

DELETED: Cardiac DNA Insight (81225, 81226, 81227, 81240, 81241, 81355, 81400, 81401, 81479, no longer on the market); Envisage (0386U, retired code). Removed and placed in new Urinary Tract Infection Molecular Testing guideline (CS guideline, not managed for PA ONLY): Qlear UTI CPT: 0371U; Qlear UTI - Reflex ABR CPT: 0372U; Urogenital Pathogen with Rx Panel (UPX) CPT: 0374U; Bridge Urinary Tract Infection Detection and Resistance Test CPT: 0321U. Removed and placed into Sexually Transmitted and Other Reproductive Tract Infection Testing guideline (CS guideline, not managed for PA ONLY): Bridge Women's Health Infectious Disease Detection Test CPT: 0330U. Removed and Placed into new Infectious Disease Laboratory Testing Clinical Use guideline (CS guideline, not managed for PA ONLY): Accelerate PhenoTest BC kit CPT: 0086U; Accelerate PhenoTest BC kit, AST configuration CPT: 0311U; Bacterial Typing by Whole Genome Sequencing CPT: 0010U; Bartonella ddPCR and Digital ePCR CPT 0301U, 0302U; Johns Hopkins Metagenomic Next Generation Sequencing Assay for Infectious Disease Diagnostics CPT: 0323U; Karius Test CPT: 0152U; MicroGenDX qPCR & NGS For Infection, CPT: 0112U; MycoDART Dual Amplification Real Time PCR Panel for 4 Aspergillus species CPT: 0109U.

EDITS to descriptors for Oncuria Detect (0365U), Oncuria Monitor (0366U), Oncuria Predict (0367U), ColoScapeTM Colorectal Cancer Detection (0368U), KawasakiDx (0389U), CARDIO inCode-Score (CIC-SCORE) (0401U)		Content clarification/ InformationNone
      
      
      
      
      
      
      



​Criteria Updates (Non-Substantive):​
​
Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) 
Genetic Testing to Diagnose Non-Cancer ConditionsMOL.CU.114.A Criteria: admin edit
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AAdded 0411U, 0419UCriteria: reformatted "Companion or Complementary Diagnostic Testing" section and clarified coverage for testing when it is required by a health plan with the following bullet: "Documentation is provided that the requested testing is required to obtain health plan coverage for the medication being considered for treatment"; added new PLA codes IDgenetix (0411U) and Tempus nP (0419U) to the criteria (non-covered panels) and CPT code table
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.A Criteria: updated terminology (Hurthle cell neoplasm is no longer called oncocytic carcinoma), no changes to clinical decision making, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated; Test Information: updated to align with manufacturer's current test offerings; Guidelines and Evidence: updated; References: updated
AlloMap Gene Expression Profiling For Heart Transplant RejectionMOL.TS.123.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section
APOE Variant Analysis for Alzheimer DiseaseMOL.TS.128.A Criteria: added "other considerations" block with cross reference to Pharmacogenomic guideline for FDA required testing for therapy selection. Background; updated. References; updated.
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section. Background: updated; Guidelines and Evidence: updated; References: updated
Ataxia-Telangiectasia Genetic TestingMOL.TS.130.A Criteria: admin edit; Guidelines and Evidence: admin edit. References: updated.
Bloom Syndrome Genetic TestingMOL.TS.132.A Criteria- clarification of intent edits - Added a section for symptomatic individuals to the targeted testing criteria. Added "no previous del/dup for BLM gene" in Del/dup criteria, removed "diagnostic testing of symptomatic individuals" from del/dup and stated "meets criteria for BLM sequencing" (where criteria for diagnostic testing is stated). Background: admin edit; Guidelines: updated ACMG recommendation and separated from ACOG recommendation; References: updated.
Canavan Disease Genetic TestingMOL.TS.145.A Criteria: admin edit to intro; Background: admin edit; Guidelines and Evidence: admin edit, updated; References: updated
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.A Criteria: admin edit to intro, updated to separate out Billing & Reimbursement section. Added "Other Considerations" block regarding broad panels. Updated language in Billing and Reimbursement section. Background; updated, admin edit; Guidelines and Evidence: updated. References; updated. TITLE CHANGE:  Charcot-Marie-Tooth Neuropathy Genetic Testing
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: admin update; Guidelines and Evidence: updated; References: updated
Chromosomal Microarray Testing For Developmental DisordersMOL.TS.150.A Criteria: admin updates, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated; Guidelines and Evidence: updated; References: updated
Duchenne & Becker Muscular Dystrophy TestingMOL.TS.161.A Criteria: admin edits, added in "rendering laboratory" bullet to each criteria section, added in for DMD seq that del/dup criteria should be met; Background: admin edits; Guidelines and Evidence: admin edit References: updated
Early Onset Familial Alzheimer Disease (EOFAD.) Genetic TestingMOL.TS.162.A Criteria: admin update, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section. Background; updated, References; updated
Expanded Carrier Screening PanelsMOL.TS.165.A Criteria: Admin edit -updated examples of targeted testing, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated terminology, admin edits; Test Information: updated; Guidelines and Evidence: updated, admin edits; References: updated
Familial Adenomatous Polyposis Genetic TestingMOL.TS.168.A Criteria: added in "Other considerations" section a statement related to testing for somatic mosaicism, added in for APC del/dup that sequencing criteria should be met; Background: admin edits; Test info: admin edit, Guidelines and Evidence: added ACMG, removed retired guideline, admin edits References: updated
Familial Malignant Melanoma Genetic TestingMOL.TS.170.A Criteria: admin edit in "other considerations"; Guidelines and Evidence: updated; References: updated
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.A Criteria: clarification of intent - removed note that was redundant (already mentioned in criteria), updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated tables of genes. Guidelines and Evidence; updated. References; updated.
Hypertrophic Cardiomyopathy Genetic TestingMOL.TS.189.A Criteria: admin edit to intro, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated. Guidelines and Evidence: admin edit to intro, updated; References: updated.
Li-Fraumeni Syndrome Genetic TestingMOL.TS.193.A Criteria: admin edits, clarification of intent in del/dup section (added "meets criteria for TP53 sequence analysis"). Background; updated. Guidelines and Evidence: updated; References: updated..
Long QT Syndrome Genetic TestingMOL.TS.196.A Criteria: admin updates, clarification of intent edit in del/dup section, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated. Guidelines and Evidence: admin edit to intro, updated; References: updated.
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section. Guidelines and Evidence: updated; References; updated
MUTYH Associated Polyposis Genetic TestingMOL.TS.206.A Criteria: in targeted testing- added "possible" before the criteria for "Northern European," (clarification of intent edit), admin edits; Background: admin update; Guidelines and Evidence: updated, admin update; References: updated
Niemann Pick Disease Types A & B TestingMOL.TS.207.A Criteria: admin edit in intro, clarification of intent in del/dup section adding that member meets criteria for SMPD1 sequencing; Background; updated. Guidelines and Evidence: updated; References; updated. TITLE CHANGE: Niemann-Pick Disease Types A and B Genetic Testing.
Niemann Pick, Type C TestingMOL.TS.208.A Criteria: admin edit in intro, clarification of intent of testing in sequencing paragraph (moved abnormal biomarker requirement from previous testing to Diagnostic Testing for Symptomatic Individuals) and reorganized the list to clarify that 1 or more of the clinical findings were required, clarification of intent in del/dup section (member meets criteria for NPC sequencing and removed redundant information and added no previous del/dup testing), throughout criteria changed NPC1 and NPC2 to NPC and changed Niemann-Pick C to NPC. Background; updated.  References; updated. TITLE CHANGE: Niemann-Pick Disease Types C Genetic Testing.
Spinal Muscular Atrophy Genetic TestingMOL.TS.225.A Criteria: clarification of intent edits to exclusions (updated 'approved' to 'medically necessary'), admin edit in note; Background: updated; Guidelines and Evidence: updated; References: updated; TITLE CHANGE: updated to Spinal Muscular Atrophy Genetic Testing
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic TestingMOL.TS.227.A Criteria: added introduction, admin edits, updated to separate out Billing & Reimbursement section, Updated language in Billing and Reimbursement section. Background: added intro and admin edit. Guidelines and evidence: added intro, updated. admin edit; References: updated.  TITLE CHANGE: updated to Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing.
Exome SequencingMOL.TS.235.I Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: admin edit; Guidelines and Evidence: updated; References: updated
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section
Maturity-Onset Diabetes of the Young TestingMOL.TS.258.A Criteria: admin edit, clarification of intent -added need to meet criteria for HNF1A testing to obtain HNF4A testing, separated out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background updated; Guidelines and Evidence: 2 new society guidelines; References: updated.
ThyGenX and ThyraMIR miRNA Gene Expression ClassifierMOL.TS.259.I Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section
Brugada Syndrome Genetic TestingMOL.TS.261.A Criteria: admin update to intro and clarification of intent in del/dup section (added meets criteria for full sequence analysis of SCN5A); Background; updated; Guidelines and Evidence; admin edit to intro, updated; References: updated
Mitochondrial Disorders Genetic TestingMOL.TS.266.AAdded 0417UCriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; CPT code table: added Genomic Unity Comprehensive Mitochondrial Disorders Analysis (0417U) and billing and reimbursement criteria to clarify coverage.
Ehlers Danlos Syndrome Genetic TestingMOL.TS.267.A Criteria: admin updates- updated names of other referenced guidelines & introduction wording. Background updated; Guidelines and Evidence: updated- admin edit in selected relevant publications section; References: updated.
Hereditary Connective Tissue Disorder Genetic TestingMOL.TS.268.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section, introduction added, table updated, admin/formatting update; Background: added introduction section before procedure table, admin edit; Guidelines and Evidence: added introduction block. References: updated; TITLE CHANGE: Hereditary Connective Tissue Disorder Genetic Testing
ThyroSeqMOL.TS.270.I Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section
Arrhythmogenic Right Ventricular Cardiomyopathy Genetic TestingMOL.TS.281.A Criteria: admin edit to intro, clarification of intent in del/dup section, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section. Background: updated and clarified that diagnostic criteria are from ARVC Task Force. Test info: updated. Guidelines and Evidence: admin edit to intro, updated. References: updated.
DermTech Pigmented Lesion AssayMOL.TS.282.A Criteria: admin update to introduction ; Background: added introduction section before procedure table; Test Information: updated; Guidelines and Evidence: updated; References: updated
Dilated Cardiomyopathy Genetic TestingMOL.TS.284.A Criteria: admin edit to intro, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Guidelines and Evidence: admin edit to intro, updated. References: updated.
Multiple Endocrine Neoplasia Type 1 Genetic TestingMOL.TS.285.A Criteria: admin edit to intro; clarification of intent edits - added "no known familial mutation" in previous testing in sequencing section and added "meets criteria for MEN1 sequence analysis" in del/dup section; Background; updated; Guidelines and Evidence: admin edits. References; updated.
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.A Criteria: clarification of intent edits -added "No known familial mutation" to RET targeted mutation analysis section and added "Meets criteria for RET targeted mutation analysis" to RET sequencing section, admin edit to intro; Background: updated; Guidelines and Evidence: admin edits; References: updated
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.A Criteria: updated introduction, admin edit, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Guidelines and Evidence: updated. References; updated.
Molecular Respiratory Infection Pathogen Panel (RIPP) Molecular TestingMOL.CS.293.I Criteria: admin edit - 'virus' updated to 'pathogen' Throughout: replaced 'patient' with 'individual' except in direct quotes; Guidelines and evidence: admin edit; References: updated intro, admin edit. TITLE CHANGE: Respiratory Infection Pathogen Panel (RIPP) Molecular Testing
Legius Syndrome Genetic TestingMOL.TS.302.A Criteria: added "Rendering laboratory is a qualified provider of service per the Health Plan policy" to KFM section as clarification of intent, admin edit in intro. Background: updated "patient" to "individual" and "variant" to "mutation". Guidelines and Evidence: updated intro. References: updated.
Whole Genome SequencingMOL.TS.306.A Criteria: admin edit updating language in Exclusions and Other Considerations section from 'not covered' to 'not medically necessary', no clinically significant changes; Guidelines and Evidence: updated, admin edit; References: updated
Hemoglobinopathies Genetic TestingMOL.TS.308.A Criteria: clarification of intent edit in a section header, no clinically significant changes; Background: updated, admin edits; Test Information: admin edit; Guidelines and Evidence: updated; References: updated
Friedreich's Ataxia Genetic TestingMOL.TS.309.A Criteria: clarification of intent edits - changed "No mutation identified by previous analysis" to "Member does not have a known mutation in both copies of the FXN gene" in GAA repeat analysis section, added "Meets criteria for GAA trinucleotide repeat analysis" to sequencing and del/dup sections; Background; updated; Guidelines and Evidence: admin edits. References; updated.
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section. Background: updated, References: updated.
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section
Medically Necessary General Laboratory TestingMOL.CS.333.A Criteria: added introduction statement; Guidelines and Evidence: admin edit; References: added introduction statement
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A Criteria: added specification of the criteria relating to PCR-based microsatellite instability (MSI), added "Other Considerations" section - referring to the Somatic mutation-Solid tumor guideline when MSI is performed by NGS as part of a panel; Background: admin update. Test info: admin update. Guidelines and Evidence: updated, admin update; References: updated
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.A Criteria: updated note about MDS and added reference, updated reference citations in table, added JAGN1 to SCN in table, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section. Background; admin edits. Guidelines and Evidence: admin edits. References; updated.
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A Criteria: admin edit, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated Table: Selected Red Blood Cell Antigens; Guidelines and Evidence: updated; References: updated
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.A Criteria: admin edit; Guidelines and Evidence: updated; References: updated
Inherited Thrombophilia Genetic TestingMOL.TS.370.A Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Guidelines and Evidence: updated and reorganized; References: updated
Liquid Biopsy TestingMOL.TS.194.I Criteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section: CPT code table: PLA code updates - added new (LiquidHALLMARK 0409U); deleted retired (0397U Agilent Resolution ctDx FIRST 0397U)
Hereditary Pancreatitis Genetic TestingMOL.TS.287.A Criteria: updated "acute recurrent" to "recurrent acute" in 3 places in Criteria and throughout guideline, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: updated; References; updated. CPT Code Table: Removed CFTR targeted mutation analysis from CPT code table - not addressed by guideline
Flow CytometryMOL.CS.103.A Criteria: clarification of intent edits (added statement that IHC and flow cytometry should not be performed on the same sample to align with Immunohistochemistry guideline);
Billing and Reimbursement: Clarification of intent statement (claims with IHC and flow cytometry codes will be subject to med nec review). Added additional code to ICD table for CPT 88182 indications.
Date of Service and Authorization Period Effective DateMOL.AD.314.A Criteria: clarification of intent edit (Updated last bullet to clarify and define billable event)
Epilepsy Genetic TestingMOL.TS.257.A Criteria: admin edits; separated billing and reimbursement info and added to a separate guideline section, reformatted single gene vs multigene panel criteria (no changes to criteria); Background: admin edit; Guidelines and Evidence: updated; References: updated



Retired Guideline:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
BRCA Ashkenazi Jewish Founder Mutation TestingMOL.TS.135.AN/ARetired test-specific guideline.
Criteria and test information incorporated into BRCA Analysis (MOL.TS.238);
No change in coverage 		Retired guideline
Macula RiskMOL.TS.300.AN/ARetired test-specific guideline.
Test now managed by Investigational and Experimental Laboratory Testing (MOL.CU.117);
No change in coverage		Retired guidelin​


Revisions From 06.02.52ad:

10/01/2023

This version of the policy is a result of code updates effective 10/01/2023. 

 

The following procedure codes were added to the policy:

0403U, 0405U, 0409U, 0410U, 0411U, 0413U, 0414U, 0417U, 0418U, and 0419U​


Narrative for the following procedure code was revised:

0269U, 0271U, 0272U, 0274U, 0277U, 0278U, 0362U, 0389U, and 0401U


The following procedure codes were deleted from this policy because they have been termed:


0386U and 0397U ​


Revisions From 06.02.52ac:
07/01/2023This version of the policy will become effective on 07/01/2023.

Effective 07/01/2023, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0388U, 0389U, 0391U, 0392U, 0395U, 0396U, 0397U, 0398U, 0400U, and 0401U

REVISED

0013U

DELETED 

0053U

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Effective 07/01/2023, precertification requests for GPS Cancer™ test offered by NantHealth will be managed through Company's vendor program of Lab Managment with eviCore. 

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On July 01st, 2023, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2023. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

07/01/2023 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52ac)

Executive Summary of Changes


There is one new guideline. 38 existing guidelines have been revised (including 08 with substantive criteria changes). No guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Multi-Cancer Early Detection Screening

​Criteria Updates (Substantive):

  1. Somatic Mutation Testing-Solid Tumors
  2. Molecular Respiratory Infection Pathogen Panel (RIPP) Testing
  3. Whole Genome Sequencing
  4. Exome Sequencing
  5. Somatic Mutation Testing - Hematological Malignancies
  6. Special Circumstances Influencing Coverage Determinations
  7. Immunohistochemistry (IHC)
  8. Investigational and Experimental Laboratory Testing

Criteria Updates (Non-Substantive):

  1. Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing
  2. Flow Cytometry
  3. Genitourinary Conditions Molecular Testing
  4. UroVysion FISH for Bladder Cancer
  5. Pharmacogenomic Testing for Drug Toxicity and Response
  6. Angelman Syndrome Genetic Testing
  7. CADASIL Genetic Testing
  8. HLA Typing for Celiac Disease
  9. Cystic Fibrosis Genetic Testing
  10. Marfan Syndrome Genetic Testing
  11. Non-Invasive Prenatal Screening
  12. PCA3 Testing for Prostate Cancer
  13. Prader-Willi Syndrome Genetic Testing
  14. Prenatal Aneuploidy FISH Testing
  15. Tay-Sachs Disease Genetic Testing
  16. BRCA Analysis
  17. BCR-ABL Negative Myeloproliferative Neoplasm Genetic Testing
  18. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  19. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  20. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  21. Polymerase Gamma (POLG) Related Disorders Genetic Testing
  22. Molecular Gastrointestinal Pathogen Panel (GIPP) Testing
  23. Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental Disorders
  24. Neurofibromatosis Type 1 Genetic Testing
  25. Medical Necessity Review Information Requirements
  26. Date of Service and  Authorization Period Effective Date
  27. Human Immunodeficiency Virus Laboratory Testing
  28. Lyme Disease Testing
  29. Human Papillomavirus (HPV) Molecular Testing
  30. Pathology Testing with Mohs Micrographic Surgery​

Retired Guideline:

  • None 

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):



New Guidelines:

Guideline Name

Guideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Multi-Cancer Early Detection ScreeningMOL.TS.396.A81599, 81479
New guideline for management of multi-cancer early detection screening tests (MCEDs)New Guideline​



​Criteria Updates (Substantive):

Guideline Name
Guideline #
Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Rationale / supporting guideline for clinically significant updates
Somatic Mutation Testing-Solid TumorsMOL.TS.230.A81455Criteria: Added medical necessity criteria for Tumor Mutation Burden (TMB) testing

Guidelines and Evidence: updated; CPT Code Table: added new PLA code 0379U (Solid Tumor Expanded Panel, Quest Diagnostics)		professional society updateNational Comprehensive Cancer Network. NCCN Guidelines for Treatment of Cancer by Site. Available at: https://www.nccn.org/professionals/physician_gls/#sitehttps://www.nccn.org/professionals/physician_gls/#site [multiple individual guidelines]

Vega DM, Yee LM, McShane LM, et al. Aligning tumor mutational burden (TMB) quantification across diagnostic platforms: phase II of the Friends of Cancer Research TMB Harmonization Project. Ann Oncol. 2021;32(12):1626-1636
Molecular Respiratory Infection Pathogen Panel (RIPP) TestingMOL.CS.293.I87633Criteria: Updated criteria for panels of fewer than 6 pathogens. These panels are now coverable for individuals with acute respiratory symptoms, regardless of age/immunocompetency given the need to include SARS-CoV-2, flu, and RSV in most cases. Clarified intent of additional criteria to apply to larger panels (6 or more pathogens). Also updated Criteria to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section.

ICD table: Added new code Z79.6X Long term (crnt) use of immunomodulator & immunosuppressant; CPT Code Table: added Respiratory Pathogen with ABR (RPX) 0373U		evidence update from peer reviewed literatureUyeki T, Bernstein H, Bradley J, et al. Clinical practice guidelines by the Infectious Diseases Society of America: 2019 update on diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza. Clin Infect Dis. 2019;68(6):e1-e47

Green DA, Hitoaliaj L, Kotansky B, Campbell SM, Peaper DR. Clinical utility of on-demand multiplex respiratory pathogen testing among adult outpatients. J Clin Microbiol. 2016;54(12):2950-2955,

Ramanan P, Bryson AL, Binnicker MJ, Pritt BS, Patel R. Syndromic panel-based testing in clinical microbiology. Clin Microbiol Rev. 2017;31(1):e00024-17
Whole Genome SequencingMOL.TS.306.I81425, 81426, 81427, 0213U, 0212U, 0267U, 0265U, 0094UCustomized guideline that links out to the Independence website for rapid whole genome sequencing (rWGS) medical necessity criteriaclient requestN/A
Exome SequencingMOL.TS.235.I81415, 81416, 81417, 0215U, 0214UCustomized guideline that links out to the Independence website for rapid exome sequencing (rWES) medical necessity criteriaclient requestN/A
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.A0364UCriteria: added medical necessity criteria for clonoSeq MRD (minimal residual disease) assay based on ESMO and NCCN recommendations

CPT Code Table: added clonoSeq (0364U); Guidelines and Evidence: updated; References: updated		professional society updateDimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(3):309-322.

National Comprehensive Cancer Network. NCCN Biomarkers Compendium. Available at: http://www.nccn.org/professionals/biomarkers/

National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma. V1.2023. Available at: www.nccn.org
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.Avaries by stateCriteria: Added the following states and bills: Delaware state mandate, IL HB 5334, LA SB 154, WSR 21-16-076, CT SB 358;

Background: updated		content clarification/informationNew state legislation regarding prior authorization requirements and/or approval of specified tests in specified patient populations.
Immunohistochemistry (IHC)MOL.CS.104.A88341, 88342, 88344Criteria: previously had a flat unit denial, updated with specific unit limits, added non-covered indications. Also updated with specific billing and reimbursement rules. Updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section.evidence update from peer reviewed literatureSee References in guideline
Investigational and Experimental Laboratory TestingMOL.CU.117.IAdded 0368U, 0386U, 0371U, 0372U, 0374UAdded:
ColoScape Colorectal Cancer Detection (0368U)
Envisage (0386U), Qlear UTI (0371U)
Qlear UTI - Reflex ABR (0372U)
Urogenital Pathogen with Rx Panel (UPX) (0374U)

Moved:
clonoSEQ Assay (81479, now 0364U; moved to Somatic Mutation – Hematological Malignancies and is now covered with criteria)


Deleted HERmark (no longer on the market); ProMark (81479)		content clarification/information 


Criteria Updates (Non-Substantive):
Guideline Name​
Guideline #Procedure Code ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Medicare: Hierarchy for Applying Coverage Decisions for Laboratory TestingMOL.AD.101.BN/ACriteria: clarification of intent edits

Background: updated; References: updated		content clarification/information
Flow CytometryMOL.CS.103.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement sectioncontent clarification/information
Genitourinary Conditions Molecular TestingMOL.CS.106.AN/ACriteria: In GU Symptoms and NOS Codes ICD tables: Updated B37.3 to new code B37.3X (Candidiasis of vulva and vagina); admin edits, clarified ICD code N94.1 should be N94.1X, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement sectioncontent clarification/information
UroVysion FISH for Bladder CancerMOL.CS.108.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section.

Background: updated; Test Information: updated; Guidelines and evidence: updated; References: updated.		content clarification/information
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AAdded 0380UCriteria: added PersonalisedRX 0380U to I&E panels list (new PLA code)

CPT Code Table: added 0380U; References updated		content clarification/information
Angelman Syndrome Genetic TestingMOL.TS.126.AN/ACriteria: updated known familial mutation language, in UPD, Imprinting Center Defect Analysis, Sequencing and Del/Dup sections, removed restating of clinical criteria for testing and stated "Meets clinical criteria for SNRPN/UBE3A methylation analysis"

Background: updated; References: updated. GUIDELINE TITLE: updated from Angelman syndrome testing to Angelman Syndrome Genetic Testing		content clarification/information
CADASIL Genetic TestingMOL.TS.144.AN/ACriteria: added "Rendering laboratory is a qualified provider of service per the Health Plan policy."

Background: updated; Guidelines and Evidence: updated; References: updated.		content clarification/information
HLA Typing for Celiac DiseaseMOL.CS.146.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section.content clarification/information
Cystic Fibrosis Genetic TestingMOL.TS.158.AN/ACriteria: admin edit

GUIDELINE TITLE: updated from 'Cystic Fibrosis Testing' to 'Cystic Fibrosis Genetic Testing'		content clarification/information
Marfan Syndrome Genetic TestingMOL.TS.202.AN/ACriteria: updated language of known familial mutation sections to add "that would detect the familial mutation"

Guidelines and Evidence: updated; Test Info: updated; References: updated		content clarification/information
Non-Invasive Prenatal ScreeningMOL.TS.209.AN/ACriteria: added introduction, updated language "Prenatal diagnosis by amniocentesis or CVS following NIPS is generally only indicated when NIPS results are abnormal " to "Prenatal diagnosis by amniocentesis or CVS following NIPS is indicated when NIPS results are screen positive, inconclusive or uninterpretable," updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section

Background: updated; Guidelines and Evidence: updated; References: updated		content clarification/information
PCA3 Testing for Prostate CancerMOL.TS.215.AN/ACriteria: added introduction

Guidelines and Evidence: updated; References; updated		content clarification/information
Prader-Willi Syndrome Genetic TestingMOL.TS.217.AN/ACriteria: updated known familial mutation language, in UPD and Imprinting Center Defect Analysis sections removed restating of clinical criteria for testing and stated "Meets clinical criteria for SNRPN methylation analysis"

Background: updated; Guidelines and Evidence: updated; References: updated. GUIDELINE TITLE: updated from Prader-Willi syndrome testing to Prader-Willi Syndrome Genetic Testing		content clarification/information
Prenatal Aneuploidy FISH TestingMOL.CS.218.AN/ACriteria: updated to separate out Billing & Reimbursement section, removed ICD code table - clarified claims rules being enforced. Updated language in Billing and Reimbursement sectioncontent clarification/information
Tay-Sachs Disease Genetic TestingMOL.TS.226.AN/ACriteria: added introduction.

Background: updated; Guidelines and Evidence: updated; References: updated; GUIDELINE TITLE: updated from Tay-Sachs Disease Testing to Tay-Sachs Disease Genetic Testing		content clarification/information
BRCA AnalysisMOL.TS.238.AN/ACriteria: updated billing and reimbursement cross-referenced guideline language.content clarification/information
BCR-ABL Negative Myeloproliferative Neoplasm Genetic TestingMOL.TS.240.AN/ACriteria: added word "genetic" to introduction statement.

Background: updated. Guidelines and Evidence: updated. References: updated. GUIDELINE TITLE: BCR-ABL Negative Myeloproliferative Neoplasm "Genetic" Testing		content clarification/information
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.AN/ACriteria: clarification of intent edits - added the TP53 founder mutation as an example, change variant allele frequency to at least 30%.

CPT table: updated; Background: updated; Guidelines and Evidence: updated; References: updated		content clarification/information
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.AN/ACriteria: clarification of intent edits, added "Rendering laboratory is a qualified provider of service per the Health Plan policy." to known familial mutation section, expanded note to address and refer to genome sequencing guideline

Background: updated; Test Information: updated; Guidelines and Evidence: updated; References: updated		content clarification/information
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.AN/ACriteria: added introduction and updated language of known familial mutation sections to add "that would detect the familial mutation(s)"

Background: updated; Guidelines and Evidence: updated; References: updated		content clarification/information
Polymerase Gamma (POLG) Related Disorders Genetic TestingMOL.TS.276.AN/ACriteria: added introduction.

Background: updated; Guidelines and Evidence: updated, admin edits; References: updated		content clarification/information
Molecular Gastrointestinal Pathogen Panel (GIPP) TestingMOL.CS.277.AAdded 0369UCriteria: clarification of intent of coverage for larger panels, updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section and added new PLA code to language; ICD table: Add new code Z79.6X Long term (crnt) use of immunomodulator & immunosuppressant

CPT Code Table: added GI assay (Gastrointestinal Pathogen with ABR) 0369U		content clarification/information
Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental DisordersMOL.CS.289.AN/ACriteria: clarification of intent edits

Background: updated; Guidelines and Evidence: updated; References: updated		content clarification/information
Neurofibromatosis Type 1 Genetic TestingMOL.TS.301.AN/ACriteria: clarification of intent edits; added "Rendering laboratory is a qualified provider of service per the Health Plan policy." in two places.

Background; updated; Guidelines and Evidence: updated; References: updated		content clarification/information
Medical Necessity Review Information RequirementsMOL.AD.304.AN/ACriteria: admin editscontent clarification/information
Date of Service and  Authorization Period Effective DateMOL.AD.314.AN/ACriteria: clarification of intent editscontent clarification/information
Human Immunodeficiency Virus Laboratory TestingMOL.CS.321.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section; Background: admin editcontent clarification/information
Lyme Disease TestingMOL.CS.332.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement section

Background: updated; References; updated		content clarification/information
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement sectioncontent clarification/information
Pathology Testing with Mohs Micrographic SurgeryMOL.CS.363.AN/ACriteria: updated to separate out Billing & Reimbursement section. Updated language in Billing and Reimbursement sectioncontent clarification/information



Retired Guideline:

  • None ​




Revisions From 06.02.52ab:

04/01/2023

This version of the policy is a result of code updates effective 04/01/2023. 

 

The following procedure codes were added to the policy:

 

0364U, 0368U, 0369U, 0370U, 0371U, 0372U, 0373U, 0374U, 0378U, 0379U, 0380U, and m0386U​

 

Narrative for the following procedure code was revised:

 

​0022U​


Revisions From 06.02.52aa:
01/01/2023This version of the policy will become effective on 01/01/2023.

Effective 01/01/2023, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0355U, 0356U, 0362U, 0363U, 81418, 81441, 81449, 81451, & 81456


Attachment B (Procedure Codes Requiring Prepayment Reviews)
​

87468, 87469, 87478, 87484, 0760T, 0761T, 0762T, & 0763T​


REVISED

81445, 81450, & 81455

-------------------------------------------------------------------------------------------------------------

Effective 01/01/2023, procedure code 84999 will not be part of this policy and Company's vendor program of Lab Managment with eviCore. 

--------------------------------------------------------------------------------------------------------------


On January 01st, 2023, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2023. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

01/01/2023 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52aa)

Executive Summary of Changes


There is one new guideline. 60 existing guidelines have been revised (including 08 with substantive criteria changes). Two guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Laboratory Procedure Code Requirements 

​Criteria Updates (Substantive):

  1. Breast Cancer Index for Breast Cancer Prognosis
  2. Lynch Syndrome Genetic Testing
  3. BRCA Analysis
  4. Multiple Endocrine Neoplasia Type 1 (MEN1)
  5. Somatic Mutation Testing-Solid Tumors
  6. Special Circumstances Influencing Coverage Determinations
  7. Investigational and Experimental Molecular/Genomic
  8. Human Platelet and Red Blood Cell Antigen Genotyping​

Criteria Updates (Non-Substantive):

  1. Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing
  2. Genitourinary Conditions Molecular Testing
  3. Unique Test Identifiers for Non-Specific Procedure Codes
  4. Genetic Testing by Multigene Panels
  5. Pharmacogenomic Testing for Drug Toxicity and Response
  6. Ashkenazi Jewish Carrier Screening
  7. Ataxia-Telangiectasia
  8. BRCA Ashkenazi Jewish Founder Mutation Testing
  9. HLA Typing for Celiac Disease
  10. Chromosomal Microarray for Prenatal Diagnosis
  11. Chromosomal Microarray Testing For Developmental Disorders
  12. Cystic Fibrosis Testing
  13. Duchenne & Becker Muscular Dystrophy Testing
  14. Early Onset Familial Alzheimer Disease (EOFAD) Genetic Testing
  15. Familial Adenomatous Polyposis Testing
  16. Familial Malignant Melanoma Genetic Testing
  17. FMR1-Related Disorders (Fragile X) Genetic Testing
  18. Hereditary Hemochromatosis Testing
  19. Huntington Disease Testing
  20. Hypertrophic Cardiomyopathy Testing
  21. Li-Fraumeni Syndrome Testing
  22. Long QT Syndrome Testing
  23. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  24. MUTYH Associated Polyposis Testing
  25. Niemann Pick Disease Types A & B Testing
  26. Peutz-Jeghers Syndrome Testing
  27. Prosigna Breast Cancer Prognostic Gene Signature Assay
  28. PTEN Hamartoma Tumor Syndromes Testing
  29. Spinal Muscular Atrophy Testing
  30. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Testing
  31. Von Hippel-Lindau Disease Testing
  32. EndoPredict for Breast Cancer Prognosis
  33. Exome Sequencing
  34. PALB2 Genetic Testing
  35. Maturity-Onset Diabetes of the Young (MODY) Testing
  36. Hereditary Connective Tissue Disorder Testing
  37. Multiple Endocrine Neoplasia Type 2 (MEN2)
  38. Hereditary Pancreatitis Genetic Testing
  39. Limb-Girdle Muscular Dystrophy Genetic Testing
  40. Facioscapulohumeral Muscular Dystrophy Genetic Testing
  41. Medical Necessity Review Information Requirements
  42. Hemoglobinopathies Genetic Testing
  43. Friedreich's Ataxia Genetic Testing
  44. Hereditary Ataxia Multigene Panel Testing
  45. Spinocerebellar Ataxia Genetic Testing
  46. Somatic Mutation Testing - Hematological Malignancies
  47. Human Immunodeficiency Virus Laboratory Testing
  48. Lyme Disease Testing
  49. Inherited Bone Marrow Failure Syndrome Testing
  50. Human Papillomavirus (HPV) Molecular Testing
  51. Noonan Spectrum Disorder Testing
  52. Hereditary Cancer Syndrome Multigene Panels​

Retired Guideline:

  1. Molecular Pathology Tier 2 Molecular CPT Codes
  2. ProMark Proteomic Prognostic Test​


Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):



New Guidelines: 


Guideline ​NameGuideline #Procedure Codes Addressed by GuidelineSummary of change  (to be reviewed in conjunction with actual GL) What is the expected impact?
Laboratory Procedure Code RequirementsMOL.AD.391.AallNew administrative guideline addressing correct CPT coding requirements for molecular laboratory assays. This guideline will replace, and expand on, Molecular Pathology Tier 2 Molecular CPT Codes (MOL.AD.102)N/A


Criteria Updates (Substantive):

Guideline Name
Guideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Rationale / supporting guideline for clinically significant updates What is the expected impact?
Breast Cancer Index for Breast Cancer PrognosisMOL.TS.248.A Criteria: Per ASCO guideline recommendation, updated to allow for coverage in individuals with 0-3 positive lymph nodes to determine benefit of extended endocrine therapy

Background: admin edits
 
Guidelines and Evidence, References: updated
professional society updateASCO 2022 Guideline: Andre F, Ismaila N, Allison K, et al. Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2022 Jun 1;40(16):1816-1837more approvals
Lynch Syndrome Genetic TestingMOL.TS.197.A Criteria: Per NCCN recommendation, added colorectal cancer diagnosed under 50 as a criterion (without the need for tumor testing first); clarified CRC at any age with abnormal tumor testing meets criteria; clarified footnote +++: only MLH1 hypermethylation testing (not BRAF) is indicated in endometrial cancers.

Added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline.

Background, References; Guidelines and Evidence and Test Information: admin edits, updated.
professional society updateNCCN Genetics/Familial High-Risk Assessment: Colorectal, Version 1.2022; https://www.nccn.org/professionals/physician_gls/pdf/genetics_colon.pdfmore approvals
BRCA AnalysisMOL.TS.238.A Criteria: updated to allow for testing in patients with triple negative breast cancer diagnosed at any age (previously at 60 years or younger); added "At least two close blood relatives (on the same side of the family) with either breast cancer or a confirmed diagnosis of prostate cancer at any age".

Additional clarification of intent criteria edits: In personal history of prostate cancer section, amended “close relative with breast cancer at <50 years" to “50 years or younger."; updated language from "two breast primary tumors" to "multiple primary tumors." 

Replaced Scope section with an “Other Considerations" section and added cross-guideline references. 

Background, Guidelines and Evidence, and References: updated.
professional society updateNCCN for Genetic/Familial High Risk Assessment: Breast, Ovarian, and Pancreatic  v.2.2022, https://www.nccn.org/professionals/physician_gls/pdf/genetics_bop.pdfmore approvals
Multiple Endocrine Neoplasia Type 1 (MEN1)MOL.TS.285.A Criteria: expanded diagnostic testing--added "Individual with recurrent hyperparathyroidism, multigland parathyroid disease, gastrinoma, or multiple neuroendocrine tumors (NETs) at any age"; and added parathyroid adenomas to list of tumors ("i.e., Individual under the age of 30 years with parathyroid adenomas, PHPT, pancreatic precursor lesions, or pancreatic islet tumor regardless of family history")

Added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline.

Background; updated and reorganized.

Guidelines and Evidence, References: updated.
professional society updateNCCN Clinical Practice Guidelines in Oncology. Neuroendocrine and Adrenal Tumors. Version 1.2022. https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf  and The Endocrine Society Brandi ML, Agarwal SK, Perrier ND, Lines KE, Valk GD, Thakker RV. Multiple Endocrine Neoplasia Type 1: Latest Insights. Endocr Rev. 2021;42(2):133-170more approvals
Somatic Mutation Testing-Solid TumorsMOL.TS.230.AAdded 0334U (Guardant360
TissueNext)		Criteria:  Per NCCN recommendations, added the following cancers in "tumor marker panels" section for diagnosis-based coverage (previously covered under minimum biomarker criterion):  locally advanced or metastatic ampullary adenocarcinoma; recurrent, unresectable, or metastatic salivary gland tumors; anaplastic gliomas/glioblastoma.  Also, grading/terminology clarification: updated "infiltrative glioma" to adult low-grade (WHO grade 1 or 2) glioma. 

Added "Other Considerations" section with cross-referenced guidelines, updated table of "common cancer types and associated tumors markers".

Background: admin edits.
Test Info: updated and reorganized
Updated Guidelines and Evidence, References

Added 0334U (Guardant360 TissueNext) to the CPT code table
professional society updateNCCN Recommendations: ampullary adenocarcinoma (https://www.nccn.org/professionals/physician_gls/pdf/ampullary.pdf) recurrent, unresectable, or metastatic salivary gland tumors (https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf ); anaplastic gliomas/glioblastoma (https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf)no change
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.A Applicable laws section added to address legislation in AZ, CA, IL, LA and WA; clarifying edit in Introduction (changed 'override' to 'override or supplement').

References: updated.
content clarification/informationState laws governing prior auth and coverage requirementsmore approvals​

Investigational and Experimental Molecular/GenomicMOL.CU.117.IAdded: 0301U;  0302U; 0332U; 0333U; 0335U; 0336U; 0343U; 0340U; 0341U; Deleted 0056U, 0014U, 0013UNew tests added to the I/E list:
Bartonella ddPCR and Digital ePCR (0301U, 0302U)
EpiSwitch CiRT (0332U)
FM/a fibromyalgia (81599)
HelioLiver Test (0333U)
IriSight Prenatal Analysis – Proband (0335U); IriSight Prenatal Analysis – Comparator (0336U)
miR Sentinel Prostate Cancer Test (0343U)
PrismRA (81479 or 81599)
ProMark Proteomic Prognostic Test (81479)
Single Cell Prenatal Diagnosis (SCPD) Test (0341U)
TruGraf Kidney (81479)

Deleted MatePair tests (0056U, 0014U, 0013U) – PLA codes retired

Updated the following: Mi-Prostate Score (changed name to MyProstateScore and added CPT code 81599); Molecular Microscope MMDx—Heart (0087U) – description; Percepta Genomic Sequencing Classifier (81479) – test name; Signatera  (0340U) – PLA code and test description
content clarification/informationN/Ano change
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A Criteria: clarified by adding detail on platelet refractoriness indications

Guidelines and Evidence: admin edit, updated

References: updated
content clarification/informationN/Ano change


Criteria Updates (Non-Substantive):

Guideline Name
Guideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
What is the expected impact?
Medicare: Hierarchy for Applying Coverage Decisions for Laboratory TestingMOL.AD.101.B Criteria: clarified terminology by updating "claims" to "claims rules", added Billing and Reimbursement hierarchy for improved transparency; Background: updated with NCCI information; References: updatedcontent clarification/informationno change
Genitourinary Conditions Molecular TestingMOL.CS.106.AAdded 0352U and 0353UCriteria: Xpert Xpress MVP (0352U) added to BV section as a non-coverable test; Guidelines and Evidence: updated; References: updated; CPT code table updated: Added 0352U and 0353Ucontent clarification/informationno change
Unique Test Identifiers for Non-Specific Procedure CodesMOL.AD.107.A Criteria: Language clarificationcontent clarification/informationno change
Genetic Testing by Multigene PanelsMOL.CU.116.A Criteria: added "All requested procedures must follow correct coding practices. Any procedure codes that do not meet these standards will not be reimbursable, even if medical necessity criteria for the associated test(s) are met. See the guideline Laboratory Procedure Code Requirements for general coding requirements.", reorganized content for clarification; Background: updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AAdded 0349U, 0348U, 0350U, 0347U to tableCriteria: Added 0349U, 0348U, 0350U, 0347U to  "Criteria: Investigational and/or Experimental Panel Tests" - these are new PLA codes, the coverage has not changed. The tests have always been I/E; CPT code table: Added 0349U, 0348U, 0350U, 0347U content clarification/informationno change
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.A Criteria: updated gene name for familial dysautonomia in table; Guidelines and Evidence: updated with 2021 ACMG carrier screening statement; References: updatedcontent clarification/informationno change
Ataxia-TelangiectasiaMOL.TS.130.A Criteria: added "Rendering laboratory is a qualified provider of service per the Health Plan policy" to each section. Background, Test Information, and References: updatedcontent clarification/informationno change
BRCA Ashkenazi Jewish Founder Mutation TestingMOL.TS.135.A Criteria: replaced "note" with a new "Other Considerations" section with cross-guideline  reference for BRCA Analysis guideline. Background, Guidelines and Evidence, and References: updatedcontent clarification/informationno change
HLA Typing for Celiac DiseaseMOL.CS.146.A Criteria: admin update; ICD code table updated "R74.0 to R74.X"; Background: language updatedcontent clarification/informationno change
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.A Criteria: updated heading "Exclusions and other considerations" to "Chromosomal Microarray Exclusions and Considerations", format updated with no significant content change;  Background: updated and reorganized; Test Information: updated; References updated.content clarification/informationno change
Chromosomal Microarray Testing For Developmental DisordersMOL.TS.150.A Criteria: updated heading "Exclusions and other considerations" to "Chromosomal Microarray Exclusions and Considerations", format updated with no significant content change; Background: updated and reorganized; Test Information: updated; References updated.content clarification/informationno change
Cystic Fibrosis TestingMOL.TS.158.A Criteria: Reorganized sections with no significant content change; Background: updated; Test Information: updated and reorganized; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Duchenne & Becker Muscular Dystrophy TestingMOL.TS.161.A Criteria: admin edits. Background: updated; Guidelines and Evidence: updatedcontent clarification/informationno change
Early Onset Familial Alzheimer Disease (EOFAD) Genetic TestingMOL.TS.162.A Criteria: admin edit; Background, Guidelines and Evidence, Test Information, and References: updated.content clarification/informationno change
Familial Adenomatous Polyposis TestingMOL.TS.168.A Criteria: added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline; Background: updated, Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Familial Malignant Melanoma Genetic TestingMOL.TS.170.A Criteria: updated section title "Other Considerations" and updated verbiage for cross-referenced Hereditary Cancer Syndrome Multigene Panels guideline. Background: reorganized; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.A Criteria: admin edit; Background and Test Information: updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Hereditary Hemochromatosis TestingMOL.TS.183.A Criteria: updated language in KFM previous testing section ("inclusive of the KFM" was updated to "that would detect the KFM"), no substantive changes; Background: updated; Test info: reorganized; References: updatedcontent clarification/informationno change
Huntington Disease TestingMOL.TS.188.A Criteria: admin edit only; Background: updated and reorganized; Test information: reorganized; Guidelines and Evidence and References: updatedcontent clarification/informationno change
Hypertrophic Cardiomyopathy TestingMOL.TS.189.A Criteria: updated language in KFM previous testing section  ("inclusive of the KFM" was updated to "that would detect the KFM"). Background: reorganized; Guidelines and Evidence: updated; References: updated content clarification/informationno change
Li-Fraumeni Syndrome TestingMOL.TS.193.A Criteria: clarification of intent update to language RE being diagnosed with hypodiploid ALL before age 21; added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline. Background: reorganized; References: updatedcontent clarification/informationno change
Long QT Syndrome TestingMOL.TS.196.A Criteria: updated language in KFM previous testing section  ("inclusive of the KFM" was updated to "that would detect the KFM"). Background: reorganized; Guidelines and Evidence: updated; References; updated content clarification/informationno change
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.A Criteria: admin updates; Guidelines & Evidence: updated; References: updatedcontent clarification/informationno change
MUTYH Associated Polyposis TestingMOL.TS.206.A Criteria: updated language in KFM previous testing section  ("inclusive of the KFM" was updated to "that would detect the KFM"), added "Other Considerations" section to cross-reference Hereditary Cancer Syndrome Multigene Panels guideline, no substantive changes; Background: updated and reorganized; Test info: reorganized; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Niemann Pick Disease Types A & B TestingMOL.TS.207.A Criteria: updated introduction; Background: reorganized; Guidelines and Evidence, Test Information, References: updated.content clarification/informationno change
Peutz-Jeghers Syndrome TestingMOL.TS.216.A Criteria: admin edit, added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline. Background: updated and reorganized; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Prosigna Breast Cancer Prognostic Gene Signature AssayMOL.TS.222.A Criteria: admin edits; Guidelines & Evidence: updated; References: updatedcontent clarification/informationno change
PTEN Hamartoma Tumor Syndromes TestingMOL.TS.223.A Criteria: added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline; Background: updated and reorganized; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Spinal Muscular Atrophy TestingMOL.TS.225.A Criteria: admin edit; Background: updated and reorganized; Test Information: updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel TestingMOL.TS.227.A Criteria: added "Rendering laboratory is a qualified provider for service per Health Plan policy" to the deletion/duplication section, admin edits; Background: reorganized and updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Von Hippel-Lindau Disease TestingMOL.TS.233.A Criteria: added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline; Background, Guidelines and Evidence and References: updated.content clarification/informationno change
EndoPredict for Breast Cancer PrognosisMOL.TS.234.A Criteria: admin edit; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Exome SequencingMOL.TS.235.A Criteria: clarification of intent edit for exome reanalysis from 'updated knowledge' to 'updated clinical information or expanded scientific knowledge'; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
PALB2 Genetic TestingMOL.TS.251.A Criteria: added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline; Background and Test Information: reorganized and updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Maturity-Onset Diabetes of the Young (MODY) TestingMOL.TS.258.A Criteria: clarification of intent edits - collapsed two sections of panel billing criteria (billed with panel code vs without, all other elements were identical) and moved all billing/coding information to the Billing and Reimbursement section, reorganized Introduction section, admin edits in non-covered gene section; Background: updated and reorganized; Test Information: updated and reorganized; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Hereditary Connective Tissue Disorder TestingMOL.TS.268.A Criteria: admin edit (updated syndrome name in table); Background: updated; Test Information: reorganized;  References: updatedcontent clarification/informationno change
Multiple Endocrine Neoplasia Type 2 (MEN2)MOL.TS.286.A Criteria: added "Other Considerations" section with cross-reference to Hereditary Cancer Syndrome Multigene Panels guideline; Background: reorganized; Test Information: reorganized; Guidelines and Evidence: updated; References: updated content clarification/informationno change
Hereditary Pancreatitis Genetic TestingMOL.TS.287.A Criteria: clarification of intent edit in Known Familial Mutation section adding no genetic testing 'that would detect the familial mutation', admin edits; Background: updated and reorganized; Guidelines and Evidence: updated; Test Information: updated; References: updated.content clarification/informationno change
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.A Criteria: admin update; Background: updated and reorganized; Test Information: reorganized; Guidelines and Evidence: updated; References: updated content clarification/informationno change
Facioscapulohumeral Muscular Dystrophy Genetic TestingMOL.TS.290.A Criteria: updated "No previous genetic testing for the known familial mutation" to "No previous genetic testing that would detect the familial mutation", added "Rendering laboratory is a qualified provider of service per the Health Plan policy." to the D4Z4 Methylation Analysis and SMCHD1 Analysis sections. Test Information: updated; References: updatedcontent clarification/informationno change
Medical Necessity Review Information RequirementsMOL.AD.304.A Criteria: Clarification of intent edit - added section on when procedures codes are not provided to clarify how these cases are handled.content clarification/informationno change
Hemoglobinopathies Genetic TestingMOL.TS.308.A Criteria: admin edits only; Background: updated and reorganized; Test Info: admin edits;  References: updatedcontent clarification/informationno change
Friedreich's Ataxia Genetic TestingMOL.TS.309.A Criteria: admin edit to exclusion and other considerations note. Background: reorganized and updated; Guidelines and Evidence, Test Information, References: updatedcontent clarification/informationno change
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.A Criteria: clarification of intent edit: in Billing and Reimbursement section, added statement regarding appropriate methodology for testing; Background: updated and reorganized; Test Information: updated and reorganized;  References: updatedcontent clarification/informationno change
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.A Criteria: admin edit, clarification of intent edit in billing and reimbursement, updated cross-guideline reference in billing and reimbursement section; Background: updated and reorganized; Test Information: updated and reorganized; References: updatedcontent clarification/informationno change
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.A Criteria: admin edits, added an "Other Considerations" section and moved cross-referenced guidelines from beginning of criteria section here; Background: added introduction; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Human Immunodeficiency Virus Laboratory TestingMOL.CS.321.A Criteria: language admin updates, removed CPT code tables in criteria section and replaced with list of CPT codes. Background: updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Lyme Disease TestingMOL.CS.332.A Criteria: admin update. Background: updated; Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change
Inherited Bone Marrow Failure Syndrome TestingMOL.TS.360.A Criteria: admin edits, updated information in table of "select inherited bone marrow failure syndromes";  Background: updated; Test Info: updated and reorganized; Guidelines & Evidence: updated and admin edits (terminology - dyskeratosis congenita is now called telomere biology disorders), reorganized, References: updatedcontent clarification/informationno change
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.AAdded CPT 0354UCriteria: no content change - Added PreTect HPV-Proofer' 7 (CPT 0354U) as one of the I/E tests under screening for cervical cancer; Test Information: admin edit; Guidelines and Evidence: updated; References: updated; CPT code table: Added PreTect HPV-Proofer' 7 (CPT 0354U)content clarification/informationno change
Noonan Spectrum Disorder TestingMOL.TS.371.A Criteria: admin edits; Background, Guidelines and Evidence, and References: updatedcontent clarification/informationno change
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.A Criteria: admin edit. Guidelines and Evidence: updated; References: updatedcontent clarification/informationno change


Retired Guideline:

Guideline Name
Guideline #Procedure Codes Addressed by GuidelineProcedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Molecular Pathology Tier 2 Molecular CPT CodesMOL.AD.102.A81400 - 81408N/ARetired guideline, replaced by new Laboratory Procedure Code Requirements (MOL.AD.391)Replaced by more comprehensive guideline
ProMark Proteomic Prognostic TestMOL.TS.296.A81479N/ARetired test specific guideline; Requests will now be managed by the Investigational and Experimental guideline (MOL.CU.117)Test is no longer mentioned in NCCN guideline, no website updates since 2019, no new publications identified in eviCore health technology assessment​

​

Revisions From 06.02.52z:

10/01/2022

This version of the policy is a result of code updates effective 10/01/2022. 

The following procedure codes were added to the policy:

 

0332U

0333U

0334U

0335U

0336U

0339U

0340U

0341U

0343U

0345U

0347U

0348U

0349U

0350U

0352U

0353U

0354U

 

Narratives for the following procedure codes were revised:

 

0276U

0296U

 

The following procedure codes were deleted due to termination of these codes:

 

0012U

0013U

0014U

0056U​


Revisions From 06.02.52y:
07/01/2022This version of the policy will become effective on 07/01/2022.

Effective 07/01/2022, the following procedure code coding updates are part of this policy:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0326U, 0329U, & 0331U

Attachment B (Procedure Codes Requiring Prepayment Reviews)
​

0323U, 0327U, & 0330U

REVISED

 0229U & 0016M

---------------------------------------------------------------------------------------------------------------


On July 01st, 2022, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2022. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

07/01/2022 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52y)

Executive Summary of Changes


There are no new guidelines. 37 existing guidelines have been revised (including 05 with substantive criteria changes). One guideline was retired. See the below tables for details.

Below is a summary of the guideline changes

​Criteria Updates (Substantive):

  1. Flow Cytometry
  2. Investigational and Experimental Molecular/Genomic
  3. Human Platelet and Red Blood Cell Antigen Genotyping
  4. Neurofibromatosis Type 1 Genetic Testing
  5. Spinal Muscular Atrophy Testing​

Criteria Updates (Non-Substantive):

  1. Genitourinary Conditions Molecular Testing 
  2. AlloMap Gene Expression Profiling For Heart Transplant Rejection
  3. ConfirmMDx for Prostate Cancer Risk Assessment
  4. Liquid Biopsy Testing
  5. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  6. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  7. DecisionDX-UM
  8. ThyroSeq
  9. Molecular Respiratory Infection Pathogen Panel (RIPP) Testing
  10. Inherited Thrombophilia Genetic Testing
  11. Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing
  12. Pharmacogenomic Testing for Drug Toxicity and Response
  13. Preimplantation Genetic Screening and Diagnosis
  14. Afirma Thyroid Cancer Classifier Tests
  15. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  16. CADASIL Testing
  17. Chromosomal Microarray for Prenatal Diagnosis
  18. Chromosomal Microarray Testing For Developmental Disorders
  19. HIV Tropism Testing for Maraviroc Response
  20. Prader-Willi Syndrome Testing
  21. Rett Syndrome Testing
  22. Tay-Sachs Disease Testing
  23. PALB2 Genetic Testing
  24. Mitochondrial Genetic Testing
  25. Ehlers Danlos Syndrome Testing
  26. Genetic Testing for Autism
  27. Genetic Testing for Nonsyndromic Hearing Loss and Deafness
  28. POLG
  29. Molecular Gastrointestinal Pathogen Panel (GIPP) Testing
  30. Chromosome Analysis
  31. CHARGE Syndrome Genetic Testing
  32. BCR-ABL Negative Myeloproliferative Neoplasm Testing

Retired Guideline:

  1. BCR-ABL Testing for Chronic Myeloid Leukemia

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):



​Criteria Updates (Substantive):

Guideline Name
Guideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Rationale / supporting guideline for clinically significant updates 
Flow CytometryMOL.CS.103.A88182, 88184, 88185, 88187, 88188, 88189Criteria: limits updated; ICD Code tables updated and added; table of non-approval ICD codes added. content clarification/informationHoffmann D and Kim B.  Limited flow cytometry panels on bone marrow specimens reduce costs and predict negative cytogenetics. Am J Clin Path. 2014; 141: 94-101; Rajab, A. and Porwit, A. Screening Bone Marrow Samples for Abnormal Lymphoid Populations and Myelodysplasia-Related Features with One 10-color 14-Antibody Screening Tube. Cytometry Part B 2015; 88B: 253-260; Oberley MJ, Fitzgerald S, Yang DT, Morgan A, Johnson J, Leith C. Value-based flow testing of chronic lymphoproliferative disorders: a quality improvement project to develop an algorithm to streamline testing and reduce costs. Am J Clin Pathol. 2014; 142(3):411-8; Williams-Voorbeijtel D, Sanchez F, Roth CG. Aligning the flow cytometric evaluation with the diagnostic need: an evidence-based approach. J Clin Pathol. 2017 Sep; 70(9):740-744.
Investigational and Experimental Molecular/GenomicMOL.CU.117.I81403, 0306U, 0307U, 0311U, 0313U, 0314U, 0315U, 0317U, 0318U, 0321U, 0319U, 0320U Criteria: Deleted “Fetal RHD genotyping using maternal plasma (e.g. SensiGene) CPT: 81403" because it is now addressed by Human Platelet and Red Blood Cell Antigen Genotyping guideline, still I&E. Added 0306U (Invitae PCM Tissue Profiling and MRD Baseline Assay), 0307U (Invitae PCM MRD Monitoring), 0311U (Accelerate PhenoTest® BC kit, AST configuration), 0313U (PancreaSeq® Genomic Classifier), 0314U (DecisionDx DiffDx™- Melanoma), 0315U (DecisionDx-SCC), 0317U (LungLB), 0318U (EpiSign Complete), 0321U (Bridge Urinary Tract Infection Detection and Resistance Test), 0319U (Clarava), 0320U (Tuteva). Background: admin edits; UPDATED TITLE: Investigational and Experimental Laboratory Testingcontent clarification/informationN/A
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A81403Criteria: added section on fetal RhD by cfDNA in maternal plasma and noted as I&E (no updates in clinical decision making - previously in the I&E policy), admin updates; Guidelines and Evidence: updated, admin edits; References: updatedcontent clarification/informationN/A
Neurofibromatosis Type 1 Genetic TestingMOL.TS.301.A81403, 81408, 81479Criteria: updated per 2021 International Consensus Panel diagnostic criteria (added choroidal abnormality to Lisch Nodule criterion, amended description of bony abnormalities; Background: updated and added information on new FDA approved treatment; Test information: updated; Guidelines and Evidence: added international consensus panel 2021 statement and NSGC 2020 statement; References: updatedcontent clarification/informationLegius E, Messiaen L, Wolkenstein P, et al. Revised diagnostic criteria for neurofibromatosis type 1 and Legius syndrome: an international consensus recommendation. Genet Med. 2021;23(8):1506-1513. doi: 10.1038/s41436-021-01170-5
Spinal Muscular Atrophy TestingMOL.TS.225.A0236U, 81329, 81336, 81337, 81479Criteria: Removed "Neurogenic EMG" from criterion for diagnostic testing given that it is no longer standard in a workup for SMA, added newborn screening confirmation testing as a criterion given the availability of medications at the newborn stage and updated headers to clarify intent of this criteria section. Clarification of intent edit - Reworded criterion to refer to 'medication' in general as opposed to specific drugs. Background: Updated; Guidelines and Evidence: Updated and added relevant guidelines and new FDA approved medications; References updated content clarification/informationEMG: Mercuri E, Finkel RS, Muntoni F, et al. Diagnosis and management of spinal muscular atrophy: Part 1: Recommendations for diagnosis, rehabilitation, orthopedic and nutritional care. Neuromuscul Disord. 2018;28(2):103-115. doi:10.1016/j.nmd.2017.11.005;    NBS: Human Resources & Services Administration. Recommended
Uniform Screening Panel. 2020 Feb. Available at: https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.htmlhttps://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.html. AND American College of Medical Genetics and Genomics. Newborn
Screening ACT Sheet: [Exon 7 Deletion (Pathogenic Variant) in Survival Motor
Neuron Gene (SMN1)] Spinal Muscular Atrophy (SMA). 2020. Available at: https://www.acmg.net/PDFLibrary/SMA-ACT-Sheet.pdf )


Criteria Updates (Non-Substantive):

Guideline Name
Guideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Genitourinary Conditions Molecular Testing MOL.CS.106.AN/ACriteria: clarification of intent edits, non-substantive; Guidelines and Evidence: numerous updates incorporating new version of 2021 CDC Guidelines for STIs.content clarification/information
AlloMap Gene Expression Profiling For Heart Transplant RejectionMOL.TS.123.AN/ACriteria: admin updates. Background: updatedcontent clarification/information
ConfirmMDx for Prostate Cancer Risk AssessmentMOL.TS.153.AN/ACriteria: admin updates, clarification of intent: updated the word "focal" to "unifocal" to distinguish for reviewers the difference between multifocal and unifocal; Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
Liquid Biopsy TestingMOL.TS.194.IN/ACriteria: admin updates. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.A81523Criteria: Added a Billing and Reimbursement Considerations section that provides billing guidance for new MammaPrint test 81523; CPT Code Table: Added Mammaprint NGS test 81523content clarification/information
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.AN/ACriteria: admin updates. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
DecisionDX-UMMOL.TS.254.AN/ACriteria: admin updates. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
ThyroSeqMOL.TS.270.IN/ACriteria: added ThyroSeq CRC as I&E, clarified that medical necessity criteria in the guideline applied to the ThyroSeq GC assay; Test  Info: updated and added ThyroSeq CRC indications; Guidelines and Evidence: updated NCCN and selected relevant publications section; References: updatedcontent clarification/information
Molecular Respiratory Infection Pathogen Panel (RIPP) TestingMOL.CS.293.I0151UCPT code 0151U (BioFire FilmArray Pneumonia Panel) removed throughout guideline - code retiredcontent clarification/information
Inherited Thrombophilia Genetic TestingMOL.TS.370.AN/ACriteria: admin updatecontent clarification/information
Medicare: Hierarchy for Applying Coverage Decisions for Laboratory TestingMOL.AD.101.BN/ACriteria: admin update; Background: admin updates throughoutcontent clarification/information
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.A82542, 83789, 82657CPT code table: removed 82542, 83789, 82657 since they are out of scope for molecular clients; Background: admin updates. Criteria: admin updatescontent clarification/information
Preimplantation Genetic Screening and DiagnosisMOL.CU.119.AN/ACriteria: admin updates. Background: updated Guidelines and Evidence and references.content clarification/information
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.AN/ACriteria: admin updates; Background: admin updates; Guidelines and Evidence: updated NCCN; References: updatedcontent clarification/information
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.AN/ACriteria: admin updates, updated language "inclusive of the known family mutation" to "that would detect the  familial mutation". Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
CADASIL TestingMOL.TS.144.AN/ACriteria: admin updates, added "that would detect the familial mutation" to Known Familial Mutation section. Background: updated; Guidelines and Evidence updated; References updated. UPDATED GUIDELINE TITLE.  CADASIL Genetic Testingcontent clarification/information
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.A81349Criteria: clarification of intent: updated Exclusions and Other Considerations to include 81349 in the following  "More than one type of microarray analysis (i.e. if 81228 is performed, neither 81229 nor 81349 is  medically necessary "content clarification/information
Chromosomal Microarray Testing For Developmental DisordersMOL.TS.150.A81349Criteria: clarification of intent: updated Exclusions and Other Considerations to include 81349 in the following  "More than one type of microarray analysis (i.e. if 81228 is performed, neither 81229 nor 81349 is  medically necessary "content clarification/information
HIV Tropism Testing for Maraviroc ResponseMOL.TS.185.AN/ACriteria: admin updates; Background: updated; Guidelines and Evidence updated; References updated. Changed guideline from test specific to claims and updated Guideline ID to MOL.CS.185.A (was MOL.TS.185.A) to reflect that change.content clarification/information
Prader-Willi Syndrome TestingMOL.TS.217.AN/ACriteria: admin updates. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
Rett Syndrome TestingMOL.TS.224.AN/ACriteria: added "Rendering laboratory is a qualified provider of service per the Health Plan policy" in three places, clarified intent of testing stating the testing is covered if the member or pregnancy is at-risk based on the inheritance pattern (in two places), and added "that would detect the familial mutation" to Known Familial Mutation section. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
Tay-Sachs Disease TestingMOL.TS.226.AN/ACriteria: clarified language in Known Familial Mutation section adding no genetic testing 'that would detect the familial mutation'; Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
PALB2 Genetic TestingMOL.TS.251.AN/ACriteria: admin updates.content clarification/information
Mitochondrial Genetic TestingMOL.TS.266.AN/ACriteria: admin updates;  Background: updated; Test Information: updated; References: updatedcontent clarification/information
Ehlers Danlos Syndrome TestingMOL.TS.267.AN/ACriteria: admin updates; Background: admin updates,content clarification/information
Genetic Testing for AutismMOL.TS.269.AN/ACriteria: admin updates. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
Genetic Testing for Nonsyndromic Hearing Loss and DeafnessMOL.TS.273.AN/ACriteria: admin edit; Background: updated; Test information: updated; References: updatedcontent clarification/information
POLGMOL.TS.276.AN/ACriteria: admin edit in the sequencing section clarifying that member has had no previous POLG sequencing; Background: updated; Test info: updated; Guidelines and Evidence: updated FDA label info; References: updatedcontent clarification/information
Molecular Gastrointestinal Pathogen Panel (GIPP) TestingMOL.CS.277.A0097UCriteria: Admin edits only, removed retired PLA code 0097U here and throughout; Background: added clinical information about GI infectious disease; References: updatedcontent clarification/information
Chromosome AnalysisMOL.CS.289.AN/ACriteria: admin updates. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information
CHARGE Syndrome Genetic TestingMOL.TS.324.AN/ACriteria: added "that would detect the familial mutation" to Known Familial Mutation section. Background: updated.content clarification/information
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.AN/ACriteria: admin updates - updated last bullet point to state "and/or" instead of "or", added Billing and reimbursement consideration section to provide guidance for billing of panel code, if requested. Background: updated; Guidelines and Evidence updated; References updatedcontent clarification/information​


Retired Guideline:

Guideline Name
Guideline #Procedure Codes Addressed by GuidelineProcedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
BCR-ABL Testing for Chronic Myeloid LeukemiaMOL.TS.131.A81170, 81206, 81207, 81208, 0016U, 88271, 0040U, 81401None; codes moved to different guidelineRetired, Requests will be now be addressed by Somatic Mutation Testing - Hematological Malignancies MOL.TS.313.Aeditorial


​Revisions From 06.02.52x:

04/01/2022

This version of the policy is a result of code updates effective 04/01/2022. 

Following procedure c​​odes were added to the policy:

0306U, 0307U, 0311U, 0313U, 0314U, 0315U, 0317U, 0318U, 0319U, 0320U, & 0321U

 

 

Narrative for the following procedure code was revised in this policy:

 

0022U 

 

 

Following procedure codes were deleted from this policy due to termination of the codes:

 

0097U & 0151U​


Revisions From 06.02.52w:
01/01/2022This version of the policy will become effective on 01​/01/2022.

Effective 01/01/2022, the following procedure code coding updates are part of this policy:

ADDED

Attachment A

81349, 81523, 0285U, 0286U, 0287U, 0288U, 0289U, 0290U, 0291U, 0292U, 0293U, 0294U, 0296U, 0297U, 0298U, 0299U, 0300U

 

Attachment B

87154, 0301U, 0302U

 

REVISED

Attachment A

81228, 81229, 0090U

 

Attachment B

0152U

 

DELETED

Attachment A

0208U


---------------------------------------------------------------------------------------------------------------

On January 01st, 2022, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2022. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

01/01/2022 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52w)

Executive Summary of Changes


There are 02 new guidelines. 54 existing guidelines have been revised (including 17 with substantive criteria changes). Eight guideline were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Noonan Spectrum Disorder Genetic Testing
  2. Inherited Thrombophilia Genetic Testing​

​Criteria Updates (Substantive):

  1. Familial Adenomatous Polyposis Testing
  2. BRCA Ashkenazi Jewish Founder Mutation Testing
  3. Cystic Fibrosis Testing
  4. BRCA Analysis
  5. MUTYH Associated Polyposis Testing
  6. Multiple Endocrine Neoplasia Type 1 (MEN1)
  7. Liquid Biopsy Testing
  8. Li-Fraumeni Syndrome Testing
  9. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  10. Somatic Mutation Testing-Solid Tumors
  11. Somatic Mutation Testing - Hematological Malignancies
  12. Investigational and Experimental Molecular/Genomic
  13. Familial Malignant Melanoma Testing
  14. Laboratory Claim Reimbursement
  15. BCR-ABL Testing for Chronic Myeloid Leukemia
  16. Hereditary Cancer Syndrome Multigene Panels
  17. Exome Sequencing​
Criteria Updates (Non-Substantive):

  1. Genetic Testing via Multi Gene Panels
  2. Alpha-1-Antitrypsin Deficiency Testing
  3. Ashkenazi Jewish Carrier Screening
  4. Canavan Disease Testing
  5. Charcot-Marie-Tooth Neuropathy Testing Panel
  6. Chromosomal Microarray for Prenatal Diagnosis
  7. Dentatorubral-Pallidoluysian Atrophy Testing
  8. Early Onset Familial Alzheimer Disease (EOFAD) Genetic Testing
  9. Familial Hypercholesterolemia Genetic Testing
  10. FMR1-Related Disorders (Fragile X) Genetic Testing
  11. Gaucher Disease Testing
  12. Huntington Disease Testing
  13. Hypertrophic Cardiomyopathy Testing
  14. Lynch Syndrome Genetic Testing
  15. Niemann Pick Disease Types A & B Testing
  16. Niemann Pick, Type C Testing
  17. Peutz-Jeghers Syndrome Testing
  18. Spinal Muscular Atrophy Testing
  19. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Testing
  20. PALB2 Genetic Testing
  21. Genetic Testing for Epilepsy
  22. Brugada Syndrome Genetic Testing
  23. Ehlers Danlos Syndrome Testing
  24. Molecular Gastrointestinal Pathogen Panel (GIPP) Testing
  25. Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy
  26. Genetic Testing for Dilated Cardiomyopathy
  27. Multiple Endocrine Neoplasia Type 2 (MEN2)
  28. Genetic Testing for Limb Girdle Muscular Dystrophy
  29. Genetic Testing for Facioscapulohumeral Muscular Dystrophy
  30. Legius Syndrome Genetic Testing
  31. Hereditary Ataxia Multigene Panel Testing
  32. Spinocerebellar Ataxia Genetic Testing
  33. Myotonic Dystrophy Type 1 Genetic Testing
  34. Ataxia-Telangiectasia
  35. Bloom Syndrome Testing
  36. PTEN Hamartoma Tumor Syndromes Testing
  37. Molecular Respiratory Infection Pathogen Panel (RIPP) Testing​
Retired Guidelines:

  1. MTHFR Variant Analysis for Hyperhomocysteinemia
  2. Factor II/Prothrombin Testing for Thrombophilia
  3. Factor V Leiden Testing for Thrombophilia
  4. Mammostrat Breast Cancer Recurrence Assay
  5. MGMT Testing for Malignant Glioma Alkylating Agent Response
  6. Acute Myeloid Leukemia (AML) Genetic Testing
  7. ABL Tyrosine Kinase Sequencing for Chronic Myeloid Leukemia 
  8. my Choice CDx​

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:
Guideline Name​
Guideline #Procedure Codes Addressed by GuidelineSummary of change  (to be reviewed in conjunction with actual GL) 
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.A81400; 81401; 81403; 81404; 81405; 81406; 81407; 81408; 81479; 81442New guideline to provide more specific medical necessity criteria than available through clinical use guideline.
Inherited Thrombophilia Genetic TestingMOL.TS.370.A81240; 81241; 81291New guideline. Incorporates and replaces 3 existing guidelines: Factor II/Prothrombin Testing for Thrombophilia; Factor V Leiden Testing for Thrombophilia; and MTHFR Variant Analysis for Hyperhomocysteinemia; harmonizes language of F2 and F5 coverage criteria and incorporates updated guidelines and recommendations 

Criteria Updates (Substantive):
Guideline Name
Guideline #Procedure Codes Addressed by GuidelineProcedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Familial Adenomatous Polyposis TestingMOL.TS.168.A81203, 81202, 8120181203, 81202, 81201Criteria: Updated verbiage from "more than 10 cumulative adenomas" to "at least 10 cumulative adenomas" in two places to align with most recent version of NCCN, added criteria for serrated polyposis testing to align with MUTYH guideline as well as NCCN, additional admin edits; Background: updated and expanded; Test Info and G&E: updated; UPDATED TITLE: Now "Familial Adenomatous Polyposis Genetic Testing"professional society update
BRCA Ashkenazi Jewish Founder Mutation TestingMOL.TS.135.A8121281212Criteria: Admin edits and added introduction, in the diagnostic testing section updated “Personal history of high-grade prostate cancer (Gleason score at least 7) at any age," to  “Personal history of a confirmed diagnosis of prostate cancer at any age," removed the bullet stating “Personal history of metastatic (radiographic evidence of or biopsy-proven disease) or intraductal prostate cancer," in the predisposition testing section, updated “High-grade (Gleason score at least 7), metastatic, or intraductal prostate cancer" to “A confirmed diagnosis of prostate cancer" per NCCN and updated “Close blood relative (1st, 2nd, or 3rd degree) with a known founder mutation in a BRCA1/2 gene," to “Close blood relative (1st, 2nd, or 3rd degree) with a known Ashkenazi Jewish founder mutation in a BRCA1/2 gene,", and in the note section updated “Full gene sequencing of BRCA1/2 may be indicated if no founder mutations are detected by 81212. See BRCA Analysis guideline for criteria" to “Full gene sequencing of BRCA1/2 may be indicated if no founder mutations are detected by testing performed under CPT code 81212. See BRCA Analysis guideline for criteria." Background: added information to background, updated references, removed references 11 & 12 as these were only cited in criteria section.professional society update
Cystic Fibrosis TestingMOL.TS.158.A81220, 81221, 81223, 81222, 8122481220, 81221, 81223, 81222, 81224Criteria: Deleted Prenatal diagnosis sections as these requests are more efficiently addressed by Prenatal Diagnosis clinical use guideline, moved fetal echogenic bowel (previously under prenatal dx) to diagnostic testing section, in CFTR sequencing section reorganized previous testing requirements so they could more clearly apply to the different test indications (carrier vs diagnostic), removed requirement to start with mutation panel testing for diagnostic purposes, removed requirement that one FDA-approved mutation was sufficient when testing was being performed for therapy selection, updated T/TG tract nomenclature (exon 9 replaces exon 8 as sequence location), additional admin edits;  Background: updated diagnostic category terminology and patient registry statistics; Test info: updated mutation nomenclature; G&E: added ACMG 2020 Technical standard, reorganized ACOG Committee Opinion, References: updated; Throughout: updated names of other guidelines referenced withinexternal review recommendation
BRCA AnalysisMOL.TS.238.A81166; 81165; 81215; 81167; 81216; 81217; 81164; 81163; 8116281166; 81165; 81215; 81167; 81216; 81217; 81164; 81163; 81162Criteria: updated: “No previous BRCA1/2 testing inclusive of the familial mutation" to “No previous genetic testing that would identify the familial mutation,"; under personal history, updated “High-risk, very-high-risk, regional, or metastatic prostate cancer (radiographic evidence of or biopsy-proven disease)," to “Prostate cancer at any age with metastatic (radiographic evidence of or biopsy-proven disease), intraductal/cribriform histology, high-risk, or very-high-risk group," per NCCN; updated: “Diagnosed with three primary breast cancers at any age" to “Diagnosed with three or more primary breast cancers at any age"; under personal & family history combination, updated “Diagnosed ≤50 years of age with at least one close blood relative with breast cancer diagnosed at any age" to "Diagnosed ≤50 years of age with at least 1 close blood relative (first-, second-, or third- degree) with breast cancer, ovarian cancer, pancreatic cancer, and/or a confirmed diagnosis of prostate cancer, at any age," and deleted “Diagnosed ≤50 years of age with at least one close blood relative with high grade (Gleason score at least 7) or intraductal prostate cancer diagnosed at any age,"; updated “At least 2 close blood relatives (first-, second-, or third- degree on same side of family) with breast cancer at any age" to “At least three breast cancer diagnoses at any age in patient and close blood relatives (first-, second-, or third- degree on same side of family),"; updated “Male close blood relative (first-, second-, or third- degree) with breast cancer," to “Male close blood relative (first- or second- degree) with breast cancer," changed “Metastatic or intraductal prostate cancer (radiographic evidence of or biopsy proven disease) in at least 1 close blood relative (first-, second-, or third- degree)," to “Metastatic (radiographic evidence of or biopsy proven disease), intraductal, cribriform histology, or high- or very-high risk group prostate cancer in at least 1 close blood relative (first-, second-, or third- degree)"; updated “A close blood relative (first-, second-, or third-degree ) with a triple negative breast cancer (ER-, PR-, Her2-) occurring at age 60 or younger," to “A close blood relative (first- or second-degree ) with a triple negative breast cancer (ER-, PR-, Her2-) occurring at age 60 or younger,"; updated “Personal history of high-grade prostate cancer (Gleason score at least 7) at any age" to “Personal history of confirmed diagnosis of prostate cancer at any age" in two places, added “with the exception of an affected relative with pancreatic or prostate cancer. A member will meet criteria if the affected relative with pancreatic cancer or prostate cancer (metastatic, intraductal/cribriform, or high- or very-high-risk group per NCCN) is a first-degree relative. If the relative with prostate or pancreatic cancer is a second-degree relative, additional family history is needed to support testing of the member, and" to the presymptomatic/asymptomatic testing for individuals, admin edits. Background: updated, added information to background, updated references.professional society update
MUTYH Associated Polyposis TestingMOL.TS.206.A81479, 81403, 81406, 8140181479, 81403, 81406, 81401Criteria: added introduction, updated verbiage from ">10 cumulative adenomas" to "at least 10 cumulative adenomas" in 3 places to align with most recent version of NCCN, removed references from criteria. Background, Test Info and G&E: : updated; UPDATED TITLE - now "MUTYH-Associated Polyposis Genetic Testing"professional society update
Multiple Endocrine Neoplasia Type 1 (MEN1)MOL.TS.285.A81404, 81405, 8140381404, 81405, 81403Criteria: in diagnostic testing for symptomatic individuals: expanded criteria to allow for combination of personal and family history per NCCN NET guideline, in KFM section, changed "no previous genetic testing of MEN1" to "no previous genetic testing that would detect the familial mutation", changed block title from "MEN1 Full Gene Sequencing" to "MEN1 Sequence Analysis".  Background: updated; G&E: updated NCCN guidelines. UPDATED TITLE - now "Multiple Endocrine Neoplasia Type 1 Genetic Testing"professional society update
Liquid Biopsy TestingMOL.TS.194.INumerous (see guideline)NoneCriteria: Added criteria to the CDX section that state the member does not have a germline mutation or a close family member with a germline mutation that is the target of the requested companion diagnostic test; Deleted Other Considerations section, moving Guardant360 info to a billing and reimbursement section under Guardant 360 criteria, added a full I&E block to address all other indications for testing, defined the LDT abbreviation in the Guardant360 LDT section; Test Info: added bullet explaining difference between CDx and nonCDx assayscontent clarification/information
Li-Fraumeni Syndrome TestingMOL.TS.193.A81479, 81353, 81351, 81352NoneCriteria: clarification of intent edits - in KFM section, changed "No previous genetic testing of TP53" to "No previous genetic testing that would detect the familial mutation", changed "TP53 Sequencing" to "TP53 Sequence Analysis", in the previous testing section for TP53 Sequence Analysis changed "no  previous duplication/deletion analysis" to "No known familial mutation", in sequencing under chompret criteria changed "(e.g., sarcoma, CNS tumor, breast cancer, osteosarcoma, adrenocortical carcinoma, leukemia, or lung bronchoalveolar cancer) " to "(e.g., soft tissue sarcoma, osteosarcoma, CNS tumor, breast cancer,  adrenocortical carcinoma)" in two places to align with NCCN, changed "individual with multiple tumors (except multiple breast tumors), two of which are LFS tumor spectrum..." to "individual with multiple tumors (except multiple breast tumors), two of which belong to LFS  tumor spectrum", removed LFL abbreviation under "Predisposition Testing for Presymptomatic/Asymptomatic Individuals" section, changed "No previous deletion analyses of TP53" to "No previous deletion/duplication analysis of TP53" in Deletion/Duplication Analysis section. Background: updated and expanded; References: updated; UPDATED TITLE - now "Li-Fraumeni Syndrome Genetic Testing"content clarification/information
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A88341, 88342, 81301NoneCriteria: Added gastric cancer and small bowel adenocarcinoma to the list of cancer types that are approvable (these were previously approvable under the NCCN criterion), additional admin edits; Background: updated; References: updatedcontent clarification/information
Somatic Mutation Testing-Solid TumorsMOL.TS.230.ANumerous (see guideline)Added 0172U (myChoice)Criteria: Added "Locally advanced, metastatic, or recurrent pancreatic cancer" into the list of broadly covered cancer types. This was moved from the list of cancer types that had to have 5 or more genes from the table. Also added "Recurrent or relapsed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, OR" Added criteria to the CDX panel section that state the member does not have a germline mutation or a close family member with a germline mutation that is the target of the requested companion diagnostic test. Removed pancreatic cancer and associated genes from table in criteria section since pancreatic cancer is now covered for individuals with "Locally advanced, metastatic, or recurrent pancreatic cancer"  (No clinical change as these cancers were coverable under NCCN criterion. These were added to the list of coverable diagnoses for reviewer efficiency); Admin edit in Billing and Reimbursement section; Added myChoice to CPT code table (will now be managed under CDx criteria within and separate guideline will be retired).content clarification/information

ation
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.ANumerous (see guideline)Added AML codes given the inclusion of that test-specific guideline into this one. No changes to coverage.Criteria: Added criteria to the CDX panel section that state the member does not have a germline mutation or a close family member with a germline mutation that is the target of the requested companion diagnostic test. Criteria: Added "The member has a diagnosis of acute myeloid leukemia (AML)" given that we combined the AML guideline into this with no change in coverage though. Admin edit to table in Criteria. Background: NCCN updated; References Updated Accordingly. CPT code table updated with addition of AML information Guidelines and Evidence: updated and reformattedcontent clarification/information
Investigational and Experimental Molecular/GenomicMOL.CU.117.INumerous (see guideline)Added 84999, S3854; 0258U, 0260U, 0262U, 0264U, 0266UCriteria and CPT code table: added Mammostrat (84999, S3854); Added Mind.Px (0258U), Augusta Optical Genome Mapping (0260U), OncoSignal 7 Pathway Signal (0262U), Praxis Optical Genome Mapping (0264U), Praxis Transcriptome (0266U)content clarification/information
Familial Malignant Melanoma TestingMOL.TS.170.A81479, 81403, 81404NoneCriteria: added introduction, added a block for single gene sequencing and deletion/duplication analysis which states "Due to the low diagnostic yield of single gene sequencing and deletion/duplication analysis, this testing is not reimbursable under these coverage guidelines, and added a block for multigene panel testing which states "For multigene panel testing, please see the guideline titled "Hereditary Cancer Syndrome Multigene Panels". guideline: updated background; updated G&E section and added a reference, updated reference section. UPDATED TITLE - now  "Familial Malignant Melanoma Genetic Testing" content clarification/information
Laboratory Claim ReimbursementMOL.CS.105.ANumerous (see guideline)Added G0327Criteria: Added "ABN (Advanced Beneficiary Notice) Modifiers GX, GY, GA, or GZ are present on the claim indicating that the test is expected to be non-covered." to the factors that may prompt post-service medical necessity review. Added "Procedure code modifiers used to provide supplemental details about a service" to the automated clinical policy edits section. Clarified language;  CPT code table: Added new G0327 code  content clarification/information
BCR-ABL Testing for Chronic Myeloid LeukemiaMOL.TS.131.A81170, 81206, 81207, 81208, 0016U, 88271, 0040U, 81401Added 81401 for ABL1 Targeted Mutation Analysis (however coverage for this testing did not change, just the guideline associated with it)Criteria: Admin edits and added introduction, updated terminology from 'BCR-ABL1 kinase domain' to 'ABL kinase domain' to align with CPT code description - updated in criteria and throughout the guideline. Updated criteria for BCR-ABL1 transcript level testing based on current NCCN recommendations. Now allow testing at diagnosis. Also broadened some additional criteria. Under ABL1 Kinase Domain criteria, added criterion for individuals with PH+ALL given the addition of the ABL1 Kinase guideline into this one; Guideline and References: updated.content clarification/information
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.ANumerous (see guideline)NoneCriteria: Added "Member has a personal history of invasive cutaneous melanoma and a first degree biological relative diagnosed with pancreatic cancer (multi syndrome panel must include CDKN2A)" per NCCN recommendations, updated names of other guidelines referenced in the criteria section; G&E: updated NCCN and added new technical standards from ACMG; References: updatedcontent clarification/information
Exome SequencingMOL.TS.235.A81415, 81416, 81417, 0215U, 0214UNoneCriteria: added introduction, changed "A genetic etiology is considered the most likely explanation for the phenotype, based on EITHER of the following:" to "A genetic etiology is considered the most likely explanation for the phenotype, based on ONE of the following:", changed "One major and two or more minor anomalies affecting different organ systems*, OR " to "One major and two or more minor anomalies affecting different organ systems*, or" and added a third bullet point in this subsection stating "Unexplained epileptic encephalopathy (onset before three years of age) and no prior epilepsy multigene panel testing has been performed, OR" -- this addition is based on input from subject matter experts and references of PMID: 29314763 and PMID: 29992546. Guideline: updated background and referencescontent clarification/information

Criteria Updates (Non-Substantive):
Guideline NameGuideline #Procedure Codes Addressed by GuidelineProcedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Genetic Testing via Multi Gene PanelsMOL.CU.116.ANumerous (see guideline)noneCriteria: Admin edit. Clarification of intent edit to note that lifetime max applied to germline panel testing; G&E: added 2020 and 2021 ACMG technical standards on NGS and panel testing; reorganized and reformatted; References: updated; updated PLA code language in CPT code table to establish a range: "Various Molecular* PLA codes (ending in U)"content clarification/information
Alpha-1-Antitrypsin Deficiency TestingMOL.TS.124.A82104, 81479, 81332noneCriteria: Admin edits, Added blocks for PI typing/targeted mutation testing and for sequence analysis, added verbiage "Rendering laboratory is a qualified provider of service per the Health Plan Policy" in two blocks about testing. Background: updated, updated referencescontent clarification/information
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.ANumerous (see guideline)noneCriteria: Reformatted and admin edits, Moved billing-related bullets to the Billing and Reimbursement section. Clarified language in section on single gene testing. Background: Updated; References: updatededitorial
Canavan Disease TestingMOL.TS.145.A81479, 81403, 81200noneCriteria: Admin edits, Added " Rendering laboratory is a qualified provider of service per the Health Plan policy" in three places. Background: updated and added management section; G&E: updated ACOG  guideline; References: updated. UPDATED TITLE: Now Canavan Disease Genetic Testingcontent clarification/information
Charcot-Marie-Tooth Neuropathy Testing PanelMOL.TS.148.A81400-81408, 81479, 81448, 81324, 81326, 81325noneCriteria: Admin edits and updated KFM language; Background and Test info: expanded and reorganized; G&E: updated; References: updatedcontent clarification/information
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.A81228, 81229noneCriteria: Admin edits and added introduction statement. Background: references updated; test information updated.content clarification/information
Dentatorubral-Pallidoluysian Atrophy TestingMOL.TS.159.A81177noneCriteria: admin edits, added " Rendering laboratory is a qualified provider of service per the Health Plan policy." to the end of criteria. Background: updated and reorganized; UPDATED TITLE: Now Dentatorubral-Pallidoluysian Atrophy Genetic Testingcontent clarification/information
Early Onset Familial Alzheimer Disease (EOFAD) Genetic TestingMOL.TS.162.A81403, 81405, 81406,  81479noneCriteria: added introduction, Clarification of intent edit in previous testing sections of APP and PSEN2 to read: PSEN1 sequencing and deletion/duplication analysis were performed, and no mutations were detected, AND". Background: updated and reorganized; References: updated; UPDATED TITLE: Now Early Onset Familial Alzheimer Disease Genetic Testingcontent clarification/information
Familial Hypercholesterolemia Genetic TestingMOL.TS.169.A81401, 81403, 81405, 81406, 81407; 81479Added 81479 (panels)Criteria: Clarification of intent edit - Removed MEDPED diagnostic criteria from panel testing criteria as MEDPED does not allow for 'possible' or 'probable' FH diagnosis, updated section headers, added 'Rendering laboratory is a qualified provider of service per the Health Plan policy' statement to each criteria section; Background and Test Info: updated; G&E: updated and restructured; References: updatedcontent clarification/information
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.A81243, 81244noneCriteria: admin edits, updated "premature ovarian failure" to "primary ovarian insufficiency" for consistency with rest of guideline and current literature. Background: updated and reorganized; References: updated.content clarification/information
Gaucher Disease TestingMOL.TS.173.A81251, 81403, 81479noneCriteria: added introduction and updated KFM language, Added "Rendering laboratory is a qualified provider of service per the Health Plan policy in three places". Updated language regarding previous KFM testing. Background: updated and reorganized; G&E: updated, removed retired guideline; UPDATED TITLE: Now Gaucher Disease Genetic Testingcontent clarification/information
Huntington Disease TestingMOL.TS.188.A81271, 81274noneCriteria: added "Rendering laboratory is a qualified provider of service per the Health Plan policy." to criteria; Background: updated and expanded; Test Info: updated; G&E: added ACMG technical standard; References: updatedcontent clarification/information
Hypertrophic Cardiomyopathy TestingMOL.TS.189.A81400-81408, 81479, 81439, S3865, S3866noneCriteria: Admin edits, Updated "Presence of pathognomonic histopathologic features of HCM" to "Presence of the following pathognomonic histopathologic features of HCM" (clarification of intent). Background: updated and reorganized; G/E: updated; References: updated; UPDATED TITLE: Now Hypertrophic Cardiomyopathy Genetic Testingcontent clarification/information
Lynch Syndrome Genetic TestingMOL.TS.197.ANumerous (see guideline)noneCriteria: added introduction and updated KFM language. Background: updated and expanded; References: updated.content clarification/information
Niemann Pick Disease Types A & B TestingMOL.TS.207.A82657, 81479, 81403, 81479, 81330noneCriteria: Admin edits, updated KFM language; Background: updated and reorganized; References: updatedcontent clarification/information
Niemann Pick, Type C TestingMOL.TS.208.A81403, 81479, 81404, 81406noneCriteria: Admin edits, updated KFM language; Background: updated and reorganized; Test Info: updated; References: updated; . UPDATED TITLE: Now Niemann-Pick Disease Type C Testingcontent clarification/information
Peutz-Jeghers Syndrome TestingMOL.TS.216.A81404, 81403, 81405noneCriteria: Admin edits and added introduction section and removed this verbiage "STK11 (LKB1) gene testing may be considered for individuals with a suspected or known clinical diagnosis of Peutz-Jeghers syndrome, or a known family history of a STK11 (LKB1) mutation" from the introductory language, updated "PJS" to "STK11" in one place, the third bullet point in gene sequencing section the "AND" was changed to "OR" [clarification of intent]. Background, G&E and References: updated; UPDATED TITLE: Now "Peutz-Jeghers Syndrome Genetic Testing"content clarification/information
Spinal Muscular Atrophy TestingMOL.TS.225.A0236U, 81329, 81336, 81337, 81479noneCriteria: Admin edits and added introduction. KFM section reordered; Background: updated and reorganized; References: updatedcontent clarification/information
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel TestingMOL.TS.227.A81400-81408, 81479, 81410, 81411noneCriteria: Admin edits and updated language in KFM previous testing section; Background and Test Info: updated and reorganized; G&E: updated and reorganized; References: updatededitorial
PALB2 Genetic TestingMOL.TS.251.A81307, 81308, 81479noneCriteria: Admin edits, added introduction, and updated KFM language. Background: updated and reorganized; deleted Special Considerations section on multigene panels as these are addressed by the Hereditary Cancer Syndrome Multigene Panels guideline; G&E: added new ACMG new guideline and updated; References: updatedcontent clarification/information
Genetic Testing for EpilepsyMOL.TS.257.A81185, 81189, 81188, 81400-81408, 81479, 81419, 0231U, 0232UnoneCriteria: updated CPT code examples for panels, no significant changes. Admin edit to Table 1; Background, Test info and G&E: updated and reorganized; References: updated;  UPDATED TITLE: Now Epilepsy Genetic Testing (throughout guideline).content clarification/information
Brugada Syndrome Genetic TestingMOL.TS.261.A81414, S3861, 81403, 81413, 0237U, 81479, 81407noneCriteria: minor formatting change. Updated KFM language - Now states "No previous genetic testing that would detect the familial mutation". Background: updated and reorganized; References updatedcontent clarification/information
Ehlers Danlos Syndrome TestingMOL.TS.267.A81400-81408, 81479noneCriteria: Admin edits, added introduction, and updated KFM language, Updated “Carrier Screening for an Autosomal Recessive EDS" to “Diagnostic Testing and Carrier Screening for an Autosomal Recessive EDS", updated “EDS Gene Analysis" to “EDS Single Gene Analysis", updated “Exceptions and other considerations" to “Exceptions and Other Considerations". Background: updated and reorganized; References: updated; UPDATED TITLE: Now "Ehlers-Danlos Syndrome Genetic Testing"content clarification/information
Molecular Gastrointestinal Pathogen Panel (GIPP) TestingMOL.CS.277.A0097U, 87505, 87506, 87507noneCriteria: Updated Table name in Criteria to match the table name. Admin edit to ICD code tables (removed the 10 from "ICD10"; Background: admin edit/clarification; G&E: added IDSA 2018 lab guideline and ACG 2021 C diff guideline, reorganized; References: updatedcontent clarification/information
Genetic Testing for Arrhythmogenic Right Ventricular CardiomyopathyMOL.TS.281.A81400-81408, 81479, 81439noneCriteria: Admin edits and updated KFM language, Now states "No previous genetic testing that would detect the familial mutation" ; Background: updated and reorganized; Test Info: updated and reorganized; G&E: updated; References: updated; UPDATED TITLE: Now Arrhythmogenic Right Ventricular Cardiomyopathy Genetic Testing.content clarification/information
Genetic Testing for Dilated CardiomyopathyMOL.TS.284.A81400-81408, 81479, 81439noneCriteria: Admin edits and updated KFM language, now states "No previous genetic testing that would detect the familial mutation" ;  Background: updated and reorganized; Test Info: updated; References: updated; UPDATED TITLE now  Dilated Cardiomyopathy Genetic Testingcontent clarification/information
Multiple Endocrine Neoplasia Type 2 (MEN2)MOL.TS.286.A81403, 81404, 81405, 81406noneCriteria: Updated KFM language, changed "RET Full Gene Sequencing" to "RET Sequence Analysis". Background: updated and reorganized; G&E: updated NCCN guidelines, changed "variant" to "mutation" throughout document. UPDATED TITLE: Now Multiple Endocrine Neoplasia Type 2 Genetic Testingcontent clarification/information
Genetic Testing for Limb Girdle Muscular DystrophyMOL.TS.288.A81400-81408, 81479, 81443noneCriteria: Admin edits and updated KFM language;  Background: updated and reorganized;  UPDATED TITLE: Now Limb Girdle Muscular Dystrophy Genetic Testingcontent clarification/information
Genetic Testing for Facioscapulohumeral Muscular DystrophyMOL.TS.290.A81404, 81479noneCriteria: updated section title from "D4Z4 Deletion and Haplotype Analysis" to "D4Z4 Targeted Analysis and Haplotyping". Background: updated and added information on DNMT3B to background; reorganized; References; updated; UPDATED TITLE: Now Facioscapulohumeral Muscular Dystrophy Genetic Testingcontent clarification/information
Legius Syndrome Genetic TestingMOL.TS.302.A81479, 81403, 81405noneCriteria: Updated section title "SPRED1 Sequencing" to "SPRED1 Sequence Analysis", updated section title "SPRED1 Deletion/Duplication" to "SPRED1 Deletion/Duplication Analysis", added the following to deletion/duplication section "Rendering laboratory is a qualified provider of services per the Health Plan policy." Background: updated and reorganized; References: updatedcontent clarification/information
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.A0216U, 0217U, 81479, 81443noneCriteria: Admin edits. Background: updated and reorganized; changed one row of verbiage in CPT code table, G&E: updated and reorganized; Test Info: removed KFM section; References: updated; UPDATED TITLE - now "Hereditary Ataxia Multigene Panel Genetic Testing"content clarification/information
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.ANumerous (see guideline)noneCriteria; Admin edits and updated KFM language. Background: updated and reorganized; G&E: updated and reorganized; Updated names of guidelines referenced withincontent clarification/information
Myotonic Dystrophy Type 1 Genetic TestingMOL.TS.312.A81239, 81234noneCriteria: Admin edits and updated KFM language; Background: updated verbiage in CPT code table to correlate with AMA descriptions, added information on prevalence with an additional references, clarified test information section, updated references throughout and at end of document, Reorganized guidelinecontent clarification/information
Ataxia-TelangiectasiaMOL.TS.130.A81403, 81408, 81479noneCriteria: Admin edits and updated KFM language; Background: updated and reorganized; Clarification of intent edits. References updated.  UPDATED TITLE: Now Ataxia-Telangiectasia Genetic Testingcontent clarification/information
Bloom Syndrome TestingMOL.TS.132.A81209, 88245, 81403, 81479noneCriteria: clarification of intent edits. Admin edits and updated KFM language. Updated "unexplained severe intrauterine growth retardation that persists throughout infancy and childhood" to unexplained severe intrauterine growth deficiency (less than 10th percentile) that persists throughout infancy and childhood" as society guidelines states SGA is <10th%; in 6 places, updated "an unusually small individual (less than 5th percentile..." to "An individual with moderate-to-severe  growth deficiency..." as this is verbiage used in GeneReviews. Background: updated and reorganized; References: updated; UPDATED TITLE - now "Bloom Syndrome Genetic Testing"content clarification/information
PTEN Hamartoma Tumor Syndromes TestingMOL.TS.223.A0235U, 81323, 81322, 81321noneCriteria: Admin edits and updated KFM language, Updated "No previous genetic testing of PTEN" to "No previous sequencing of PTEN" to clarify intent. Background: updated and reorganized; G&E: updated; References: updated; UPDATED TITLE: New title is "PTEN Hamartoma Tumor Syndromes Genetic Testing"content clarification/information
Molecular Respiratory Infection Pathogen Panel (RIPP) TestingMOL.CS.293.INumerous (see guideline)noneCriteria: Clarification of intent edits - rearranged for more defined separation between medical necessity. exclusions, and billing and reimbursement requirements; Test Info: admin edits; G&E: updated and reorganized; References: updatedcontent clarification/information

Retired Guidelines:
Guideline Name
Guideline #Procedure Codes Addressed by GuidelineProcedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with actual GL) 
MTHFR Variant Analysis for HyperhomocysteinemiaMOL.TS.205.A81291none; code moved to different guidelineRetired - consolidated into the new Inherited Thrombophilia guideline
Factor II/Prothrombin Testing for ThrombophiliaMOL.TS.166.A81240none; code moved to different guidelineRetired - consolidated into the new Inherited Thrombophilia guideline
Factor V Leiden Testing for ThrombophiliaMOL.TS.167.A81241none; code moved to different guidelineRetired - consolidated into the new Inherited Thrombophilia guideline
Mammostrat Breast Cancer Recurrence AssayMOL.TS.201.A84999, S3854none; codes moved to different guidelineRetired - moved into I&E guideline
MGMT Testing for Malignant Glioma Alkylating Agent ResponseMOL.TS.203.A81287none; code moved to different guidelineRetired; now addressed by Pharmacogenomic testing for Drug Toxicity guideline
Acute Myeloid Leukemia (AML) Genetic TestingMOL.TS.274.A81401, 81170none; codes moved to different guidelineRetired - incorporated into the existing guideline Somatic Mutation Testing - Hematological Malignancies 
ABL Tyrosine Kinase Sequencing for Chronic Myeloid Leukemia MOL.TS.121.A81401, 81170none; codes moved to different guidelineRetired - incorporated into the existing guideline BCR-ABL Testing for Chronic Myeloid Leukemia, MOL.TS.131.A
my Choice CDxMOL.TS.341.A0172Unone; code moved to different guidelineRetired - Requests for this test are now addressed by the Companion Diagnostic testing section of Somatic Mutation Testing - Solid Tumors (MOL.TS.230.A)​


Revisions From 06.02.52v:

10/01/2021

This version of the policy is a result of code updates effective 10/01/2021.


Procedure code 0168U was deleted.

Following procedure codes were added:

0258U
0260U
0262U
0264U
0265U
0266U
0267U
0268U
0269U
0270U
0271U
0272U
0273U
0274U
0275U
0276U
0277U
0278U
0282U


Revisions From 06.02.52u:
07/01/2021This version of the policy will become effective on 07/01/2021.

Effective 07/01/2021, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing pre-service and prepayment reviews through the vendor):

0250U, 0252U, 0253U, & 0254U

---------------------------------------------------------------------------------------------------------------

On July 01st, 2021, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2021. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
07/01/2021 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52u)

Executive Summary of Changes


There are 05 new guidelines. 29 existing guidelines have been revised (including 13 with substantive criteria changes). Seven guideline were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Special Circumstances Influencing Coverage Determinations
  2. Human Papillomavirus (HPV)  Molecular Testing​
  3. Human Platelet and Red Blood Cell Antigen Genotyping
  4. Mohs Micrographic Surgery
  5. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing

Criteria Updates (Substantive):

  1. ConfirmMDx for Prostate Cancer Risk Assessment
  2. Genitourinary Conditions Molecular Testing 
  3. In-vitro testing for HIV
  4. Genetic Testing for Prenatal Screening and Diagnostic Testing
  5. Investigational and Experimental Molecular/Genomic
  6. Afirma Thyroid Cancer Classifier Tests
  7. Hereditary Hemochromatosis Testing
  8. Liquid Biopsy Testing – Solid Tumors
  9. Tay-Sachs Disease Testing
  10. Somatic Mutation Testing-Solid Tumors
  11. BCR-ABL Negative Myeloproliferative Neoplasm Testing
  12. Mitochondrial Genetic Testing
  13. Somatic Mutation Testing - Hematological Malignancies​

Criteria Updates (Non-Substantive)

  1. Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing
  2. Immunohistochemistry (IHC)
  3. UroVysion FISH for Bladder Cancer
  4. Prenatal Aneuploidy FISH Testing
  5. Molecular Respiratory Infection Pathogen Panel (RIPP) Testing
  6. Lyme Disease Testing
  7. Pharmacogenomic Testing for Drug Toxicity and Response
  8. Preimplantation Genetic Screening and Diagnosis
  9. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  10. Angelman Syndrome Testing
  11. Chromosomal Microarray Testing For Developmental Disorders
  12. Prader-Willi Syndrome Testing
  13. Exome Sequencing
  14. Genetic Testing for Autism
  15. Genetic Testing for Nonsyndromic Hearing Loss and Deafness
  16. myChoice CDx​

Retired Guidelines:

  1. HIV Genotype and Phenotype Testing
  2. Leber Hereditary Optic Neuropathy (LHON) Genetic Testing
  3. Mitochondrial DNA Deletion Syndromes
  4. Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS) Genetic
  5. Neurogenic Muscle Weakness, Ataxia, and Retinitis Pigmentosa (NARP)
  6. Mitochondrial Neurogastrointestinal Encephalopathy (MNGIE) 
  7. Myoclonic Epilepsy with Ragged Red Fibers (MERRF)​

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:
Guideline Name
Guideline #Procedure Code ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
If evidence/society/external reviewer update, provide supporting reference(s) or information. 
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.AAll laboratory procedure codes under managementNew administrative guideline addressing special circumstances, including
state and federal legislation, which may impact eviCore criteria. 		editorialN/A
Human Papillomavirus (HPV)  Molecular TestingMOL.CS.362.A87624, G0476, 0096U, 87623, 87625, 88341, 88342, 88364, 0500TNew claims guideline that combines  HPV testing for cervical cancer screening (previously addressed as part of the Genitourinary Conditions Molecular Testing guideline) and coverage criteria for HPV testing in oropharyngeal cancers; established HPV molecular testing for other indications as not medically necessary; updates cervical cancer screening HPV genotyping age range from 30-65 to 25-65 per American Cancer Society and American Society for Colposcopy and Cervical Pathology recommendationprofessional society updateThe American Cancer Society. Cervical cancer screening for individuals at
average risk: 2020 guideline update from the American Cancer Society. Updated
July 30, 2020. Available at:
https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21628;   Perkins RB,  Guido RS, Castle PE, et al., 2019 ASCCP Risk-Based Management Consensus
Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors.
J Low Genit Tract Dis.  2020;24(2):102-131. doi: 10.1097/LGT.0000000000000525
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A0084U, 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 0221U, 0180U, 0181U, 0182U, 0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 0222U, 0198U, 0199U, 0200U  0201U 0001U 0246U 81479 81403New test specific guideline with coverage criteria for molecular testing for red blood cell antigens and human platelet antigens; previously addressed by clinical use guidelineseditorialN/A
Mohs Micrographic SurgeryMOL.CS.363.A88342, 88341, 88344, 88305, 88331, 88332New claims guideline with coverage criteria for Mohs Micrographic Surgery; previously addressed by clinical use guidelineeditorialN/A
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.A81479New test specific guideline with coverage criteria for molecular testing for inherited bone marrow failure syndromes; previously addressed by clinical use guideline.editorialN/A

Criteria Updates (Substantive):
Guideline Name
Guideline #Procedure Code ImpactedSummary of change  (to be reviewed in conjunction with actual guideline (GL) Reason for Change
ConfirmMDx for Prostate Cancer Risk AssessmentMOL.TS.153.A81551Criteria: clarified African ancestry. Now says "African descent (including African American and Caribbean of African ancestry)". Included focal HGPIN as an example of a negative biopsy since those individuals are clinical treated the same as individuals with a negative biopsy.content clarification/information
Genitourinary Conditions Molecular Testing MOL.CS.106.A81513, 81514Added criteria section for Bacterial Vaginosis, removed HPV as it is a test-specific guideline now. Alphabetized CPT code table, criteria, and G/E sections. Added BV section and 2 new related CPT codes. Reorganized references to align.content clarification/information
In-vitro testing for HIVMOL.CS.321.AS3645, 0219UCriteria: Added HIV Genotyping section. Updated billing and reimbursement section in the NAT section to clarify quantitative and qualitative NAT testing. Updated CPT codes and organized them in a table in the criteria section. Updated Background, Test Information, and G&E. Added S3645, 0219U.content clarification/information
Genetic Testing for Prenatal Screening and Diagnostic TestingMOL.CU.112.AnoneCriteria: Removed "Blood antigen incompatibility testing" section because we now have a test specific guideline to address this testing in more detail. Updated references accordingly.content clarification/information
Investigational and Experimental Molecular/GenomicMOL.CU.117.I0017MAdded AlloSure Heart CPT 81479; Added AlloSure Lung CPT 81479; Added Lymph2Cx Lymphoma Molecular Subtyping Assay CPT 0017M; Expanded Bako's Onychodystrophy DNA Test entry to any PCR Fungal screen for Onychomycosis and used the Bako test as an example, CPT 87481,87798content clarification/information
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.A0208UCriteria: Moved “Afirma MTC testing will be reimbursed if it is performed as part of the GSC as outlined above, and "The Afirma MTC testing must be billed as part of the Afirma GSC" to a newly created Billing and Reimbursement section for clarification. Updated the name of the Afirma Malignancy Classifier section to reflect that it only addresses BRAF testing. Updated G&E and References.content clarification/information
Hereditary Hemochromatosis TestingMOL.TS.183.A81256, 81479Criteria: restructured-added criteria for del/dup analysis, for KFM testing added 'inclusive of familial mutation' to clarify previous HFE testing, added requirement for known mutation in diagnostic section, updated language in diagnostic testing requirements to clarify lab result requirementscontent clarification/information
Liquid Biopsy Testing – Solid TumorsMOL.TS.194.I0242UCriteria: added introduction. Companion DX section criteria modified with addition of member's specific cancer type as an approval indication. Updated and renamed "Guardant 360" section to reflect that it is for non-CDx indications. Updated G&E section and References. Added Guardant 360 CDx (0242U) to CPT code tablecontent clarification/information
Tay-Sachs Disease TestingMOL.TS.226.A81403, 81255, 81406, 83080Criteria: clarification of intent edits - full reorganization into separate diagnostic and carrier screening sections with more detail about ethnic-specific testing requirements for clarification purposes only; G&E: updated and reorganized into eviCore standard; Background, Test Info, and References; updatedcontent clarification/information
Somatic Mutation Testing-Solid TumorsMOL.TS.230.A0244UCriteria: clarification of intent edits, added companion diagnostic panel section that mirrors the Cdx language in related policies, removed NCCN biomarker compendium as criterion, added billing and reimbursement section codifying reimbursement when multiple or repeat panels are requested; Test info: added section explaining tumor mutational burden; G&E: made sure everything was current; References: added new for TMB, updated all NCCN versions after verifying content; Added 0244Ucontent clarification/information
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.A81175; 81219; 81403; 81237; 81236; 81279; 0017U; 81270; 81120; 81121; 81338; 81339; 81347; 81348; 81479; 81357Criteria update: DNMT3A added to list of genes. CPT table, background, reference (in document and at end of document), G&E updated.content clarification/information
Mitochondrial Genetic TestingMOL.TS.266.A81403; 81401; 81404; 81405; 81440; 81460; 81465Criteria: Updated to include test specific criteria for individual mitochondrial disorders so that we can streamline by retiring individual guidelines. All classic mitochondrial-related disorders will be addressed by this guideline. Added a table of individuals disorders, CPT codes, Symptoms, and mutations; Expanded criteria to include KFM testing, targeted mutation analysis; References: updated. Updated Title to Mitochondrial Disorders Genetic Testingcontent clarification/information
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.A81175; 81176; 81170; 81219; 81168; 81218; 81237; 81236; 81245; 81246; 81120; 81121; 81279; 81270; 81272; 81273; 81311; 81334; 81345; 81450; 81347; 81455; 81348; 81351; 81352; 81357; 81360; 0171U; 81400; 81401; 81402; 81403; 81404; 81405; 81406; 81407; 81408; 81479; 88271Criteria: Added CDx criteria section. Added additional criteria to Billing and Reimbursement section regarding previous testing as well as panel codes. Updated headings in Criteria section to be more descriptive.content clarification/information

Criteria Updates (Non-Substantive):
Guideline Name
Guideline #Procedure Code ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Medicare: Hierarchy for Applying Coverage Decisions for Laboratory TestingMOL.AD.101.BAll Laboratory Procedure Codes under ManagementClarification of intent edits in Hierarchy language to make sure policy was inclusive of PA and claims cases; updated links, References: updatedcontent clarification/information
Immunohistochemistry (IHC)MOL.CS.104.A88341; 88432; 88434Criteria: clarification of intent. Added ", and an approximate frequency by which the maximum threshold would be reached." Updated background.content clarification/information
UroVysion FISH for Bladder CancerMOL.CS.108.A88121; 88120Criteria: added introduction. Policy: updated to eviCore standard, incorporated info from ER.content clarification/information
Prenatal Aneuploidy FISH TestingMOL.CS.218.A88271; 88274; 88275Criteria: non-sub change of adding introduction statement. Policy: added information to definition, updated references and formatted to eviCore standard.content clarification/information
Molecular Respiratory Infection Pathogen Panel (RIPP) TestingMOL.CS.293.I0202U; 0151U; 0115U; 0225U; 87636; 87637; 87631; 87632; 87633; 0223U; 0240U; 0241U; RETIRED: 0098U, 0099U, 0100U Criteria: Added "All organisms tested as part of a respiratory panel, viral or else, will be
considered part of 87631-3 regardless of the code description." to billing and reimbursement section to clarify intent. G&E: Updated headings to align with eviCore standards. Removed 0098U, 0099U, 0100U from the CPT code table and the criteria section because the PLA codes were retired		content clarification/information
Lyme Disease TestingMOL.CS.332.A87475; 87476Criteria: Added: "Nucleic acid detection of B. burgdorferi performed on synovial fluid to inform therapeutic decisions for seropositive patients in whom a diagnosis of Lyme arthritis is suspected will be considered for reimbursement on a case-by-case basis." Policy: Updated G&E and referencescontent clarification/information

Retired Guidelines:
Guideline Name
Guideline #Summary of change  (to be reviewed in conjunction with actual GL) Reason for Change
HIV Genotype and Phenotype TestingMOL.TS.184.InoneRetired: CPT codes managed by eviCore and previously addressed by this guideline have been added to In-vitro Testing for HIV guideline. Therefore, this guideline is no longer needed.
Leber Hereditary Optic Neuropathy (LHON) Genetic TestingMOL.TS.192.AnoneRetired - related test specific mitochondrial guidelines have been combined into Mitochondrial Genetic Testing (MOL.TS.268) guideline
Mitochondrial DNA Deletion SyndromesMOL.TS.244.AnoneRetired - related test specific mitochondrial guidelines have been combined into Mitochondrial Genetic Testing (MOL.TS.268) guideline
Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS) GeneticMOL.TS.204.AnoneRetired - related test specific mitochondrial guidelines have been combined into Mitochondrial Genetic Testing (MOL.TS.268) guideline
Neurogenic Muscle Weakness, Ataxia, and Retinitis Pigmentosa (NARP)MOL.TS.245.AnoneRetired - related test specific mitochondrial guidelines have been combined into Mitochondrial Genetic Testing (MOL.TS.268) guideline
Mitochondrial Neurogastrointestinal Encephalopathy (MNGIE) MOL.TS.243.AnoneRetired - related test specific mitochondrial guidelines have been combined into Mitochondrial Genetic Testing (MOL.TS.268) guideline
Myoclonic Epilepsy with Ragged Red Fibers (MERRF)MOL.TS.242.AnoneRetired - related test specific mitochondrial guidelines have been combined into Mitochondrial Genetic Testing (MOL.TS.268) guideline

Revisions From 06.02.52t:

04/01/2021

This version of the policy is effective as of 04/01/2021, and is in place due to coding updates.

 

Effective 04/01/2021, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing pre-service and prepayment reviews through the vendor):

 

0242U, 0244U, 0245U, & 0246U

 

Effective 01/01/2021, the following procedure codes have been deleted from this policy due to coding updates:

 

0098U, 0099U, & 0100U​


Revisions From 06.02.52s:
01/01/2021This version of the policy will become effective on 01/01/2021.

Effective 01/01/2021, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing pre-service and prepayment reviews through the vendor):

0017M, 0228U , 0229U , 0230U , 0231U , 0232U , 0233U , 0234U , 0235U , 0236U , 0237U , 0238U , 0239U , 81351, 81353, 81419, 81529, 81546, 81554

Effective 01/01/2021, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

81168, 81191, 81192, 81193, 81194, 81278, 81279, 81338, 81339, 81347, 81348, 81352, 81357, 81360, 81513, 81514

Effective 01/01/2021, the following procedure code has been deleted from this policy due to coding updates:

81545
---------------------------------------------------------------------------------------------------------------

On January 01st, 2021, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2021. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
01/01/2021 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52s)

Executive Summary of Changes


There are 05 new guidelines. 34 existing guidelines have been revised (including 21 with substantive criteria changes). Fifteen guideline were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  2. Chromosomal Microarray for Solid Tumors
  3. Medically Necessary Laboratory Testing
  4. Lyme Disease Testing
  5. In-vitro testing for HIV

Retired Guidelines:

  1. Lynch Syndrome Tumor Screening -First-Tier
  2. CYP2C19 Variant Analysis for Clopidogrel Response
  3. CYP2C9, VKORC1, and CYP4F2 Testing for Warfarin Response
  4. CYP2D6 Variant Analysis for Drug Response
  5. DPYD Variant Analysis for 5-FU Toxicity
  6. HLA.B*1502 Variant Analysis for Carbamazepine and Oxcarbazepine Response
  7. HLA.B*5701 Genotyping for Abacavir Hypersensitivity
  8. TPMT Testing for Thiopurine Drug Response
  9. UGT1A1 Mutation Analysis for Irinotecan Response
  10. SensiGene
  11. KRAS Testing for Anti-EGFR Response in Metastatic Colorectal Cancer
  12. BRAF Testing for Colorectal Cancer
  13. BRAF Testing for Melanoma Kinase Inhibitor Response
  14. EGFR Testing for Non-Small Cell Lung Cancer TKI Response
  15. FoundationOne CDx

Criteria Updates (Substantive):

  1. BRCA Analysis
  2. BRCA Ashkenazi Jewish Founder Mutation Testing
  3. HLA Typing for Celiac Disease
  4. Decipher Prostate Cancer Classifier
  5. Genetic Testing for Autism
  6. Genetic Testing to Diagnose Non-Cancer Conditions
  7. Genitourinary Conditions Molecular Testing 
  8. Hereditary Cancer Syndrome Multigene Panels
  9. Investigational and Experimental Molecular/Genomic
  10. Li-Fraumeni Syndrome Testing
  11. Liquid Biopsy Testing – Solid Tumors
  12. Long QT Syndrome Testing
  13. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  14. Multiple Endocrine Neoplasia Type 2 (MEN2)
  15. Pharmacogenomic Testing for Drug Toxicity and Response
  16. Somatic Mutation Testing-Solid Tumors
  17. Tay-Sachs Disease Testing
  18. myChoice CDx
  19. Laboratory Claim Reimbursement
  20. Exome Sequencing
  21. Somatic Mutation Testing - Hematological Malignancies

Criteria Updates (Non-Substantive)

  1. Chromosomal Microarray Testing For Developmental Disorders
  2. Early Onset Familial Alzheimer Disease (EOFAD) Genetic Testing
  3. Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy
  4. Genetic Testing for Dilated Cardiomyopathy
  5. Genetic Testing for Epilepsy
  6. Genetic Testing for Known Familial Mutations
  7. Genetic Testing for Non-Medical Purposes
  8. Genetic Testing to Predict Disease Risk
  9. Hypertrophic Cardiomyopathy Testing
  10. OncotypeDX for Breast Cancer Prognosis
  11. Hereditary Ataxia Multigene Panel Testing
  12. Molecular Respiratory Infection Pathogen Panel (RIPP) Testing
  13. Flow Cytometry​

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:
Guideline (GL) NameGuideline #
Procedure Code(s) Impacted
Summary of change  (to be reviewed in conjunction with actual GL) 
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A81301, 88341, 88342New test specific guideline for tests previously addressed by Lynch Syndrome First Tier Testing. This guideline is broader in scope. The additional indications were previously addressed by an existing clinical use guideline Screening, Diagnosis, and Monitoring of Cancer.
Chromosomal Microarray for Solid TumorsMOL.TS.344.A81277New test-specific guideline. Previously addressed  by clinical use guideline Screening, Diagnosis, and Monitoring of Cancer.
Medically Necessary Laboratory TestingMOL.CS.333.AAll delegated lab service procedure codes are subject to this guideline.New claims studio guideline to provide general medical necessity criteria when a test specific guideline or an existing clinical use guideline is not applicable to the test requested. 
Lyme Disease TestingMOL.CS.332.A87475, 87476New claims studio guideline. Previously addressed by the Laboratory Claims Reimbursement guideline
In-vitro testing for HIVMOL.CS.321.A87534, 87535, 87536, 87537, 87538, 87539New claims studio guideline. Previously addressed by the Laboratory Claims Reimbursement guideline

Retired Guidelines:
Guideline (GL) NameGuideline #Summary of change  (to be reviewed in conjunction with actual GL) Reason for Change
If evidence/society/external reviewer update, provide supporting reference(s) or information. 
Lynch Syndrome Tumor Screening -First-TierMOL.TS.198.ARetiring editorialReplaced by Microsatellite Instability and Immunohistochemistry Testing in Cancer. This new guideline includes the same criteria from Lynch Syndrome Tumor Screening - First Tier; however, it is broader in nature and includes additional indications that were previously coverable using the existing clinical use guideline Screening, Monitoring, and Diagnosis of Cancer. 
CYP2C19 Variant Analysis for Clopidogrel ResponseMOL.TS.155.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
CYP2C9, VKORC1, and CYP4F2 Testing for Warfarin ResponseMOL.TS.156.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
CYP2D6 Variant Analysis for Drug ResponseMOL.TS.157.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
DPYD Variant Analysis for 5-FU ToxicityMOL.TS.160.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
HLA.B*1502 Variant Analysis for Carbamazepine and Oxcarbazepine ResponseMOL.TS.186.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
HLA.B*5701 Genotyping for Abacavir HypersensitivityMOL.TS.187.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
TPMT Testing for Thiopurine Drug ResponseMOL.TS.229.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
UGT1A1 Mutation Analysis for Irinotecan ResponseMOL.TS.231.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Pharmacogenomic Testing for Drug Toxicity and Response. This is being done to streamline guidelines and the clinical review process.
SensiGeneMOL.TS.275.ARetiring editorialThis guideline is being retired and incorporated into the Investigational and Experimental guideline.This is being done because the test is no longer available. Also, there are now other tests for fetal RhD genotyping  using maternal plasma, and we wanted to make it clear that the I&E determination applied to all, and not just this branded test.
KRAS Testing for Anti-EGFR Response in Metastatic Colorectal CancerMOL.TS.291.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Somatic Mutation - Solid Tumors. This is being done to streamline guidelines and the clinical review process.
BRAF Testing for Colorectal CancerMOL.TS.133.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Somatic Mutation - Solid Tumors. This is being done to streamline guidelines and the clinical review process.
BRAF Testing for Melanoma Kinase Inhibitor ResponseMOL.TS.134.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Somatic Mutation - Solid Tumors. This is being done to streamline guidelines and the clinical review process.
EGFR Testing for Non-Small Cell Lung Cancer TKI ResponseMOL.TS.163.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Somatic Mutation - Solid Tumors. This is being done to streamline guidelines and the clinical review process.
FoundationOne CDxMOL.TS.303.ARetiring editorialThis guideline is being retired and incorporated into the broader clinical use guideline Somatic Mutation - Solid Tumors. This is being done to streamline guidelines and the clinical review process.​

Criteria Updates (Substantive):
Guideline Name
Guideline #Procedure Code ImpactedSummary of change  (to be reviewed in conjunction with actual guideline (GL) Reason for Change
BRCA AnalysisMOL.TS.238.A81215, 81217, 81165, 81166, 81216, 81167, 81162, 81163, 81164Criteria: Clarified the intent of this policy for Ashkenazi Jewish individuals and removed the redundant note regarding known familial mutations (KFM) and founder mutation since it is in the test info section; per NCCN guidelines expanded type of prostate (intraductal) cancer and specified type of pancreatic (exocrine) cancer to be indications for testing and expanded limited family history indication to include limited or unknown family history; Clarification of intent change: reformatted criteria adding ancestry section to more clearly address medical necessity criteria for testing in Ashkenazi Jewish individuals with negative founder mutation testing; Clarification of intent change: amended KFM language to state no previous BRCA testing inclusive of known familial mutation; Added note referring to Hereditary Cancer Syndrome Multigene Panels policy if BRCA was part of a panel.content clarification/information
BRCA Ashkenazi Jewish Founder Mutation TestingMOL.TS.135.A81212Criteria: per NCCN guidelines specified types of prostate and pancreatic cancers to be indications for testingcontent clarification/information
HLA Typing for Celiac DiseaseMOL.TS.146.ANone impactedCriteria: Added clarifying criteria regarding individuals at increased risk of having celiac disease who are eligible for testing. Also added a billing and reimbursement section, along with an ICD code table. Made this a Claims Studio policy. Retired for all clients who have a Prior Authorization only program, since this code is only managed in claims.content clarification/information
Decipher Prostate Cancer ClassifierMOL.TS.294.A81542Criteria: IMPORTANT COVERAGE CHANGE added coverage criteria for men post-RP with adverse features per ASCO and NCCN guideline recommendations; professional society update
Genetic Testing for AutismMOL.TS.269.A81171, 81172, 81400-81408, 81479, 81471, 81470Title Change: Genetic Testing for Autism, Intellectual Disability, and Developmental Delay; Criteria: expanded to address requests for autism spectrum disorders, intellectual disability and developmental delay testing. Additional indications addressed are non-coverable; content clarification/information
Genetic Testing to Diagnose Non-Cancer ConditionsMOL.CU.114.ANone impactedCriteria: special circumstances section for genetic testing after newborn screening added to provide clarity and direction for reviewers; previously reviewed using the general criteria within this policy or an appropriate test specific policycontent clarification/information
Genitourinary Conditions Molecular Testing MOL.CS.106.ANone impactedFor Chlamydia and Gonorrhea: Added CDC 2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the US Clinical Practice Guidelines in the guidelines and evidence (guidelines and evidence section) and added an associated criterion for each to ensure clarity in coverage for testing for adults prescribed PrEP for HIV.  In guidelines and evidence section, updated USPSTF recommendations regarding gonorrhea. In guidelines and evidence section and references section, removed 2012 American Society for Colposcopy and Cervical Pathology (ASCCP) and replaced with updated American Cancer Society guidelines for the prevention and Early Detection of Cervical Cancer. In Candida criteria section, based on SME review, further defined complicated VVC in individuals with immunosuppression or diabetes mellitus. In low risk HPV criteria section, removed ASCCP guidelines; however, this testing is still not supported by ACOG, so no change in non-coverage. In criteria/billing section for M. Genitalium, changed allowed units to 3 to align with CMS.professional society update
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.A0129U, 0102U, 81228, 81229, 0101U, 0157U-0162U, 81432, 81433, 81479, 81435-81438, 0103U, 0130U-0138UExpanding coverage of multi-gene panels to specific cancer diagnoses and family histories. Broader coverage than our previous guideline aligning closer to NCCN recommendations.professional society update
Investigational and Experimental Molecular/GenomicMOL.CU.117.I0140U, 0141U, 0142UCriteria: removed pharmacogenomic panels section and associated tests. Removed all CustomNext+RNA tests as well as RNAinsight tests since they are now addressed by the cancer panel policy. Removed 0140-142U as they are no longer I/E and should be covered. Removed the following tests since they do now appear to be on the market anymore: OncoDefender, BreastOncPx, NexCourse Breast, Pervenio Lung NGDTest, ProstaVysion, Rosetta Kidney Cancer Test, Rosetta Lung Cancer Test, RosettaGX Reveal, BrevaGen, Renal Transplant Monitoring, SmartGut. Remove the following because the PLA was deleted: RNA Sequencing by NGS.  Added PredictSURE IBD Test, Vita Risk, CNGnome, PreciseDx Breast Cancer Test, Signatera,  Prospera, and Fetal RHD genotyping using maternal plasma (e.g. SensiGene) and MethylDetox Profile. Updated CPT code table to reflect changes to policy. Added CPT code in text next to each test to provide clarity. Updated CPT code table to reflect edits to guidelinecontent clarification/information
Li-Fraumeni Syndrome TestingMOL.TS.193.A81405, 81479, 81403Criteria update: expanded criteria to include pediatric patients (21 y) with hypodiploid ALL per NCCN guidelines and GeneReviews.  Guidelines and Evidence: updated NCCN and GeneReview; References: updatedprofessional society update
Liquid Biopsy Testing – Solid TumorsMOL.TS.194.IAdded additional codes for hematological malignancy associated genes; however, no impact to decision making. Policy name change: Liquid Biopsy Testing (policy updated to apply to all liquid biopsy tests, not only those for solid tumors); Criteria: Added section allowing approval for companion diagnostic liquid biopsy tests and removed section referring to EGFR liquid biopsy policy, as the companion diagnostics (CDx) section addresses this; CPT code table-added codes pertaining to hematological  malignancies, Added 0177U;  content clarification/information
Long QT Syndrome TestingMOL.TS.196.ANone impactedCriteria: removed presymptomatic testing criteria at suggestion of SME due to no clinical management changes after testing in presymptomatic individuals, also aligns with eviCore's clinical criteria for other inherited cardiac disease panel guidelines; CPT Code Table: updated content to include descriptors for possible tier 2 codes to align with eviCore standard; Background and test Info: updates and admin changes; Guidelines and evidence updated and reformatted. References: updatedexternal review recommendation
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.A81521Criteria: Added coverage for "1-3 involved ipsilateral axillary lymph nodes" per NCCN and ASCO recommendations. Guidelines and evidence: removed literature review section and clinical trial references; updated format to eviCore standard. Policy: updated professional society guidelines. Updated references. Updated information on test information re: meaning of high-risk/low risk for 5 year recurrence rate.professional society update
Multiple Endocrine Neoplasia Type 2 (MEN2)MOL.TS.286.A81403-81406Criteria: added Personal history of other MEN2-related tumor diagnosed before age 35 years per external SME recommendation and supported by the literature. Rarity of the disorder, high incidence of non thyroid tumors such as pheochromocytoma, and well-delineated management guidelines for MEN2 patients suggest opening up criteria will provide better care without resulting in a significant change in approvals or denialsexternal review recommendation
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.ANone impactedCriteria: Updated to include test specific criteria for individual pharmacogenomic tests so that we could retire individual policies and all pharmacogenomic tests will be addressed by this policy. Also included CPT codes for each test in the body of the text as well as the table.content clarification/information
Somatic Mutation Testing-Solid TumorsMOL.TS.230.A0211UCriteria update: Updated coverable cancer diagnoses (cancers known to meet eviCore's requirement for 5 or more individual coverable markers) in the multi-gene panel section, Removed NCCN biomarker compendium as a criterion, as this information is addressed clearly in publicly available NCCN guidelines; Added FDA-approved CDx criteria and added F1CDx to table and removed text directing to different guideline; added note that policy applies to DNA and RNA testing by NGS. Updated language referring to liquid biopsy testing guideline to reflect new name (previously Liquid Biopsy - Solid Tumors); CPT code table: Added PLA code 0211U.content clarification/information
Tay-Sachs Disease TestingMOL.TS.226.ANone impactedCriteria: clarification of intent edit - removed "No known HEXA mutation in family" from previous testing in targeted mutation analysis for common mutations section. This will allow for individuals who are Ashkenazi Jewish to have common mutation testing even if they have a known familial mutation given how common mutations are. This will also align this policy with the other Ashkenazi Jewish policies.content clarification/information
myChoice CDxMOL.TS.341.ANone impactedCriteria: restructured to align with FDA labeling changes and emphasize FDA label requirements instead of a set of clinical criteria, as this has been amended twice by the FDA in past several months;content clarification/information
Laboratory Claim ReimbursementMOL.CS.105.ANone impactedUpdated CPT code table to include full scope of molecular laboratory procedure codes. Added automated clinical policy edits section for transparency. Updated language in NCCI coding edits section. Added industry standard edits section and reorganized content accordingly. content clarification/information
Exome SequencingMOL.TS.235.A81415, 81416, 81417, 0215U, 0214UCriteria: Added Genomic Unity Exome Plus Analysis section for coverage based on new PLA codes; Guidelines and Evidence: added 2020 ACMG statement on fetal exome sequencing. content clarification/information
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.ANone impactedCriteria: updated coverable cancer diagnoses known to meet eviCore's requirement for 5 or more individual coverable markers in the multigene panel section, removed NCCN biomarker compendium as a criterion as this information is addressed clearly in publicly available NCCN guidelines, added table of genes and associated treatments in criteria section; Updated language referring to liquid biopsy guideline to reflect new name of that guideline: Liquid Biopsy Testing (previously Liquid Biopsy Testing - Solid Tumors); content clarification/information

Criteria Updates (Non-Substantive):
Guideline (GL) NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Chromosomal Microarray Testing For Developmental DisordersMOL.TS.150.ANone impactedCriteria: clarified criteria language regarding when it is appropriate for individuals with developmental delay or intellectual disability to have microarray testing.content clarification/information
Early Onset Familial Alzheimer Disease (EOFAD) Genetic TestingMOL.TS.162.ANone impactedCriteria: Clarification in known familial mutation (KFM) criteria, added "inclusive of the familial mutation" to the previous testing section and deleted previous testing criteria under predictive testing because they were redundant, added "Rendering laboratory is a qualified provider of service per the Health Plan policy" to KFM section for consistency.  content clarification/information
Genetic Testing for Arrhythmogenic Right Ventricular CardiomyopathyMOL.TS.281.ANone impactedCriteria: clarification-KFM previous testing must be inclusive of the familial mutation content clarification/information
Genetic Testing for Dilated CardiomyopathyMOL.TS.284.ANone impactedCriteria: clarification--KFM previous testing must be inclusive of the familial mutation; also included more examples of non genetic causes of DCM that should be ruled out (now includes infection, toxin exposure, metabolic disease, autoimmune disease, tachyarrythmia, sarcoidosis, and coronary artery disease).content clarification/information
Genetic Testing for EpilepsyMOL.TS.257.ANone impactedCriteria: CPT Code Table: added CPT Tier 1 codes for gene CACNA1A and organized Tier 2 codes into eviCore standard. content clarification/information
Genetic Testing for Known Familial MutationsMOL.CU.291.ANone impactedCriteria: clarification - expanded to include criteria for both diagnostic and presymptomatic members, added limit of testing once per lifetime, Added note to see Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors guideline if test is for member younger than 18 years.content clarification/information
Genetic Testing for Non-Medical PurposesMOL.CU.111.ANone impactedCriteria: removed lab and test trade names from criteria and left test type descriptions only for ease of keeping the policy updated in an ever increasing market for non-medical tests; content clarification/information
Genetic Testing to Predict Disease RiskMOL.CU.115.ANone impactedCriteria: updated KFM section of 'special circumstances' criteria to mirror KFM criteria in the Known Familial Mutation clinical use guideline for consistency; Added note to see Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors guideline for predictive / KFM tests in members under age 18.content clarification/information
Hypertrophic Cardiomyopathy TestingMOL.TS.189.ANone impactedCriteria: clarification - - previous KFM testing must be inclusive of the known familal mutation. Also added clarification of the myocardial wall thickening in children to account for  the fact that it may not be 15mm. Now says "Myocardial wall thickening of greater than or equal to 15mm (1.5cm) in adults, or >2 standard deviations for age in children" content clarification/information
OncotypeDX for Breast Cancer PrognosisMOL.TS.211.INone impactedCriteria: Clarification of language for positive node coverage. content clarification/information
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.ANone impactedCriteria: Added PLA codes 0216U and 0217U as acceptable panels codes for billing. content clarification/information
Molecular Respiratory Infection Pathogen Panel (RIPP) TestingMOL.CS.293.INone impactedCriteria: Added 0202U and 0223U to the list of codes in this statement "No more than one respiratory virus panel should be necessary on a single date of service. Therefore, only one unit of the same panel code will be reimbursable and two different panel codes (87631, 87632, 87633, 0202U, or 0223U) cannot be billed on the same date of service." 
content clarification/information
Flow CytometryMOL.CS.103.ANone impactedCriteria: Added B21, B22, B23 into ICD10 code table per expert review. external review recommendation

Revisions From 06.02.52r:
10/01/2020This version of the policy became effective on 10/01/2020.

Effective 10/01/2020, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

0016M, 0203U, 0204U, 0205U, 0208U, 0209U, 0211U, 0212U, 0213U, 0214U, 0215U, 0216U, 0217U, 0218U, 0219U, 0220U​

Effective 10/01/2020 the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0221U & 022U

​

Revisions From 06.02.52q:
07/01/2020This version of the policy will become effective on 07/01/2020.

Effective 07/01/2020, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing pre-service and prepayment reviews through the vendor):

0172U, 0173U, 0175U, & 0179U

Effective 07/01/2020, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0177U, 0180U, 0181U, 0182U, 0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 1098U, 0199U, 0200U, 0201U

-- Procedure code 0068U has a revision to the name of the laboratory/manufacturer for the testing, but not the actual code narrative/descriptor.

---------------------------------------------------------------------------------------------------------------

On July 01st, 2020, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2020. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
07/01/2020 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52q)
Executive Summary of Changes


There are 04 new guidelines. 40 existing guidelines have been revised (including 13 with substantive criteria changes). Five guideline were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

1. Date of Service and Authorization Period Effective Date
2. CHARGE Syndrome Genetic Testing
3. GeneSight Psychotropic Test
4. myChoice CDx

Retired Guidelines:
1. AssureMDx Testing for Bladder Cancer
2. Mylema Prognostic Risk Signature (MyPRS)
3. RosettaGX Reveal
4. Corus CAD for Obstructive Coronary Artery Disease
5. Phamacogenomic Testing Panels for Major Depressive Disorders

Criteria Updates (Substantive):
  1. Investigational and Experimental Molecular/Genomic
  2. Pharmacogenomic Testing for Drug Toxicity and Response
  3. Afirma Thyroid Cancer Classifier Tests
  4. Chromosome Analysis for Blood, Bone Marrow, and Solid Tumor Cancers
  5. Familial Hypercholesterolemia Genetic Testing
  6. Gaucher Disease Testing
  7. HLA.B*1502 Variant Analysis for Carbamazepine Response
  8. Immunohistochemistry (IHC)
  9. UroVysion FISH for Bladder Cancer
  10. Non-Invasive Prenatal Testing
  11. Molecular Gastrointestinal Pathogen Panel (GIPP) Testing
  12. CYP2C9 and VKORC1 Testing for Warfarin Response
  13. Genitourinary Conditions Molecular Testing


Criteria Updates (Non-Substantive):
  1. ABL Tyrosine Kinase Sequencing for Chronic Myeloid Leukemia
  2. Alpha-1-Antitrypsin Deficiency Testing
  3. BRCA Analysis
  4. Breast Cancer Index for Breast Cancer Prognosis
  5. Chromosome Analysis
  6. Cystic Fibrosis Testing
  7. DPYD Variant Analysis for 5-FU Toxicity
  8. EndoPredict for Breast Cancer Prognosis
  9. Familial Adenomatous Polyposis Testing
  10. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  11. Leber Hereditary Optic Neuropathy (LHON) Genetic Testing
  12. Legius Syndrome Genetic Testing
  13. Li-Fraumeni Syndrome Testing
  14. Lynch Syndrome Genetic Testing
  15. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  16. Mitochondrial DNA Deletion Syndromes
  17. Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS) Genetic
  18. Mitochondrial Genetic Testing
  19. Mitochondrial Neurogastrointestinal Encephalopathy (MNGIE)
  20. Myoclonic Epilepsy with Ragged Red Fibers (MERRF)
  21. Neurofibromatosis Type 1 Genetic Testing
  22. Neurogenic Muscle Weakness, Ataxia, and Retinitis Pigmentosa (NARP)
  23. OncotypeDX for Breast Cancer Prognosis
  24. Prosigna Breast Cancer Prognostic Gene Signature Assay
  25. Somatic Mutation Testing-Solid Tumors
  26. Whole Exome Sequencing
  27. FoundationOne CDx


Other Note:(I/E = investigational & experimental) --

See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:
Guideline Name
Guideline #
Procedure Code Impacted
Summary of change  (to be reviewed in conjunction with actual GL) 
Reason for Change
What is the expected impact on approvals/denials?
Date of Service and Authorization Period Effective DateMOL.AD.314.ANone specifically - administratve policyNew administrative guideline no change
CHARGE Syndrome Genetic TestingMOL.TS.324.ANon-specific codes - however, currently addressed by clinical use guideline so nothing new to impact coverageNew test specific guideline. Previously addressed by clinical use guideline. no change
GeneSight Psychotropic TestMOL.TS.340.ANumerous - however, currently addressed by different policy so nothing new to impact coverageNew guideline. Previous one was broad and included information for all panels for major depressive disorder. Given the increasing publications and questions from clients, the decision was made to create a GeneSight specific guideline to clarify eviCore's position. no change
myChoice CDxMOL.TS.341.ANon specific code - however, currently addressed by different policy so nothing new to impact coverageNew test specific guideline. Previously addressed by clinical use guideline. no change

Retired Guidelines:
Guideline Name
Guideline #
Procedure Code Impacted
Summary of change  (to be reviewed in conjunction with actual GL) 
Reason for Change
What is the expected impact on approvals/denials?
AssureMDx Testing for Bladder CancerMOL.TS.205.ANon specific procedure codeTest does not appear to be on the market anymore. Test was added to our clinical use guideline in the case that it comes back on the market, it will still be I/E. no change
Mylema Prognostic Risk Signature (MyPRS)MOL.TS.237.ANon specific procedure codeTest does not appear to be on the market anymore. Test was added to our clinical use guideline in the case that it comes back on the market, it will still be I/E. no change
RosettaGX RevealMOL.TS.283.ANon specific procedure codeTest does not appear to be on the market anymore. Test was added to our clinical use guideline in the case that it comes back on the market, it will still be I/E. no change
Corus CAD for Obstructive Coronary Artery DiseaseMOL.TS.154.A81493Test is not on the market anymore. The lab closed down. no change
Phamacogenomic Testing Panels for Major Depressive DisordersMOL.TS.272.ANone- this is being replaced by a new guideline and our existing clinical use guideline that will address all codesThis version was broad and addressed more than Genesight. This created confusion among reviewers and clients. Therefore, we created a new GeneSight specific guideline and reworded our clinical use Pharmacogenomic guideline to address other panels to clarify. no change

Criteria Updates (Substantive):
Guideline Name
Guideline #
Procedure Code Impacted
Summary of change  (to be reviewed in conjunction with actual GL) 
Reason for Change
If evidence/society/external reviewer update, provide supporting reference(s) or information. 
Investigational and Experimental Molecular/GenomicMOL.CU.117.I0170U added to tableUpdated FDA Clearance verbiage; Added Clarifi; Added myPRS, AssureMDx, and Rosetta Reveal given that the tests do not appear to be offered anymore and we wanted to remove test-specific policies -  however, given that we are not certain that the tests are gone for good, we wanted to keep them in the manual in case they come back upevidence update from peer reviewed literatureNumerous evidence reviews for the various tests that are in the I/E policy
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.A0169U added to tableCriteria update: Added DRD4 dopamine D4 receptor p450 into the non-covered list. Deleted KRAS for response to erlotinib for NSCLC. Also added "For somatic mutation testing in hematological malignancies, see the guideline, Somatic Mutation Testing - Hematological Malignancies."; Revamped the entire policy; clearly stated panels are I/E. Moved list of panels to this policy from I/E. Added NT (NUDT15 and TPMT) Genotyping Panel from RPRD Diagnostics (0169U)evidence update from peer reviewed literatureNumerous evidence reviews for the various tests that are in the pharmacogenomic clinical use guideline
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.ANoneCriteria: Removed billing redirection to different code given that this code is still being used and many clients have contracts built around this code. It also allows for visibility into what test is being performed. Updated Background. Updated Test Information; Updated Guidelines and Evidence. Updated References.content clarification/informationEdits made to ensure policy reflects billing and claims practices; updates based on professional society statements
Chromosome Analysis for Blood, Bone Marrow, and Solid Tumor CancersMOL.TS.151.ANoneCriteria: language clarification limiting policy to bone marrow chromosome analysis; Title change: Chromosome Analysis for Blood and Bone Marrow Cancers; Language edits throughout: focused policy on chromosome analysis of bone marrow by karyotype to reflect the medical necessity criteria: CPT code table: deleted solid tumor karyotype codes and microarray code;  Test Information: deleted microarray information; References: updated; Admin edits; throughoutcontent clarification/informationPolicy edited for clarification and focus to single sample type
Familial Hypercholesterolemia Genetic TestingMOL.TS.169.ANoneCriteria: removed MEDPED diagnostic criteria, as this is diagnostic criteria set without a category for probable or possible FH (the medical criteria we deem necessary for testing); Background: expanded with additional information; Test information: updated gene/mutation information; G&E: updated to 2019 NICE guidance on FH. Added Canadian Cardiovascular Society position statement; References: updatedcontent clarification/informationEdits to criteria for clarity and efficiency of review; updates based on current professional society guidelines (NICE, Canadian Cardiovascular Society) 
Gaucher Disease TestingMOL.TS.173.ANoneCriteria: allow GBA sequencing as a first tier test; Throughout: use common mutation analysis instead of targeted mutation analysis and use glucocerebrosidase instead of glucosylceremidase as these represent more commonly used terms;  CPT code table: updated name of panel test to align with AMA name; Background: language clarifications and update; Guidelines and Evidence: updated; Test Information: language update; References: updatedexternal review recommendationEdits made to assure alignment with current AMA code descriptions and current clinical practice with regard to terminology and testing practices
HLA.B*1502 Variant Analysis for Carbamazepine ResponseMOL.TS.186.ANoneCriteria: add coverage prior to the initiation of oxcarbazepine therapy in addition to carbamazepine therapy; Background: added into on oxcarbazepine;  Guidelines and Evidence: updated CPIC guideline, added literature review on oxcarbazepine coverage, updated FDA labeling info with oxcarbazepine info; References: updated, new addedevidence update from peer reviewed literatureEdits made to align with FDA prescribing information 
Immunohistochemistry (IHC)MOL.CS.104.ANoneCriteria: increased maximum units for 88341 to 13 to align with CMSexternal review recommendationThis aligns with CMS MUEs
UroVysion FISH for Bladder CancerMOL.CS.108.ANoneCriteria: added billing and reimbursement section to indicate that 88271 is not reimbursed for this test; Background updated; Guidelines and Evidence Added and Updated, literature review section redone; References added and Updatedcontent clarification/informationLabs were beginning to bill 88271 and this is not appropriate.
Non-Invasive Prenatal TestingMOL.TS.209.AAdded 0168U to tableCriteria: edited language to clarify "prenatal" cell-free DNA. No changes to criteria; Test Information: updated terminology, clarified language RE microdeletions. Added Other considerations section to clarify that maternal serum screening should not be performed concurrently. Added Vanadis NIPT 0168U to tablecontent clarification/informationReviewers were beginning to see maternal serum screening tests being sent with non invsive prenatal screening tests. These two tests should not be run concurrently; therefore, we clarified in policy.
Molecular Gastrointestinal Pathogen Panel (GIPP) TestingMOL.CS.277.ANoneCriteria: Added 0097U into text in criteria (same as 87507 criteria), Added "Molecular GIPP testing should not be performed as test-of-cure. Therefore, it is not medically necessary to repeat testing for the same illness." Added language to clarify that only one GIPP test can be performed on the same date of service or within a week of the initial test. Updated ICD10 code table from D81.0 to D81.X.content clarification/informationOutside subject matter expert reviewer suggested these items needed clarification in the guideline.
CYP2C9 and VKORC1 Testing for Warfarin ResponseMOL.TS.156.ANoneCriteria: added other considerations section that states "CYP2C9 and VKORC1 testing for all other indications is addressed by the Pharmacogenomic Testing for Drug Toxicity and Response guideline." to direct readers to clinical use guideline for additional indications for clarification purposes.content clarification/informationWe wanted it to be clear that this guideline only addresses the warfarin use. Any other indications should be reviewed using a clinical use guideline.
Genitourinary Conditions Molecular TestingMOL.CS.106.ANoneCriteria for 87563 M.Genitalium addedevidence update from peer reviewed literatureWith the addition of a specific CPT code, we wanted to ensure appropriate coverage for this testing.

Criteria Updates (Non-Substantive)
Guideline Name
Guideline #
Procedure Code Impacted
Summary of change  (to be reviewed in conjunction with actual GL) 
Reason for Change
What is the expected impact on approvals/denials?
ABL Tyrosine Kinase Sequencing for Chronic Myeloid LeukemiaMOL.TS.121.ANoneCriteria: defined abbreviations for clarification purposes only. Guidelines and Evidence Updated; References Updatedcontent clarification/informationno change
Alpha-1-Antitrypsin Deficiency TestingMOL.TS.124.ANoneCritera: admin edit; Admin edits; Background updated; References updated.content clarification/informationno change
BRCA AnalysisMOL.TS.238.ANoneCriteria: updated citation numbers only; G&E: updated USPSTF guideline, added ACMG statement; References: updatedcontent clarification/informationno change
Breast Cancer Index for Breast Cancer PrognosisMOL.TS.248.ANoneCriteria: changed word “sample” to “tumor” to clarify in the previous testing section. Removed "with or without knowledge of the Breast Cancer Index test" in the multiple tumor section for clarification purposes; Guidelines and Evidence: update NCCN, peer reviewed literature updated based on November 2019 evidence review; References: updatedcontent clarification/informationno change
Chromosome AnalysisMOL.CS.289.ANoneCriteria: wording edit but no changes to criteria; Background, Test Info, G&E: language updated and clarified; References: updated, outdated ref deleted.content clarification/informationno change
Cystic Fibrosis TestingMOL.TS.158.ANoneCriteria: sequencing for carrier screening: amended language for clarification: partner of individual diagnosed with CAVD was edited to partner of individual diagnosed with CFTR-related CAVDcontent clarification/informationno change
DPYD Variant Analysis for 5-FU ToxicityMOL.TS.160.ANoneCriteria: added statement that as this is germline testing it is not necessary more than once; Background: added 'gene' to section title for clarification, updated variant nomenclature, added statement that all variants thought to reduce enzyme activity are not well studied and do not have FDA-recommended dosing changes; Test information: updated variant nomenclature;  References: updatedcontent clarification/informationno change
EndoPredict for Breast Cancer PrognosisMOL.TS.234.ANoneCriteria: changed word “sample” to “tumor” to clarify in the previous testing section. Removed "with or without knowledge of the Endopredict test result" in the multiple testing section to clarifycontent clarification/informationno change
Familial Adenomatous Polyposis TestingMOL.TS.168.ANoneCriteria: Updated language to clarify AFAP is not a clinical diagnosis. No substantive changes.content clarification/informationno change
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.ANoneCriteria; No substantive changes, added the statement "Clinically indicated germline testing is still appropriate for patients meeting testing guidelines regardless of tumor profiling results" to exclusions andother considerations; Background: updated, typos corrected; Test Info: language clarifications; G&E: NCCN updated; References: updatedcontent clarification/informationno change
Leber Hereditary Optic Neuropathy (LHON) Genetic TestingMOL.TS.192.ANoneCriteria: No substantive change, moved "no evidence of paternal transmission" higher in the criteria hierarchy, clarified previous testing req in KFM to be previous testing for familial mutation; Background: updated terminology and clinical classification, statistics, and management recommendations; Test Info: updated statistics; G&E: added International consensus statement from 2017, removed unavailable source; References: updatedcontent clarification/informationno change
Legius Syndrome Genetic TestingMOL.TS.302.ANoneCriteria: minor changes in wording of KFM and SPRED1 sequencing sections for clarity, no substantive changes; Test info: Admin edits, language clarificationcontent clarification/informationno change
Li-Fraumeni Syndrome TestingMOL.TS.193.ANoneCriteria: no substantove changes, separated Diagnostic testing in symptomatic individuals, Chompret Criteria, bullet # 1 into sub-bullets for clarity and ease of interpretationcontent clarification/informationno change
Lynch Syndrome Genetic TestingMOL.TS.197.ANoneCriteria: Added (see Figure A) for endometrial cancers that had previous tumor testing to clarify that genetic testing should be performed based on tumor results.content clarification/informationno change
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.ANoneCriteria: changed word “sample” to “tumor” to clarify in the previous testing section. Removed "with or without knowledge of the MammaPrint test result" in the multiple testing section to clarify; NCCN Updated.content clarification/informationno change
Mitochondrial DNA Deletion SyndromesMOL.TS.244.ANoneCriteria: added 'no evidence of paternal transmission' to diagnostic testing criteria, clarified language; Background and Test info: expanded with additional phenotype, mutation, and test information; G&E: updated, added Gene Review from 2019, deleted source no longer available; References: updatedcontent clarification/informationno change
Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS) GeneticMOL.TS.204.ANoneCriteria: Added 'No evidence of paternal transmission' to the targeted mutation analysis section to clarify when this testing is appropriate. Updated wording of this in other sections. Background updated; Guidelines and evidence updated; References Updatedcontent clarification/informationno change
Mitochondrial Genetic TestingMOL.TS.266.ANoneCriteria: Added "suggestive of a mitochondrial disorder" to clarify symptoms required. Edited word choice for paternal transmission for clarification. Updated Background; Guidelines and Evidence Updated; References Updated.content clarification/informationno change
Mitochondrial Neurogastrointestinal Encephalopathy (MNGIE)MOL.TS.243.ANoneCriteria: clarified previous testing wording. No substantive updates. Background updated. Guidelines and evidence updated. References Updatedcontent clarification/informationno change
Myoclonic Epilepsy with Ragged Red Fibers (MERRF)MOL.TS.242.ANoneCriteria: Added "Member has not had previous whole mtDNA sequencing performed" to whole mtDNA seq section. Also updated paternal transmission language, updated language RE previous testing section of KFM criteria to make it clear that no previous testing that would detect the familial mutation could be performed. Background Updated; Guidelines and Evidence Updated; References Updatedcontent clarification/informationno change
Neurofibromatosis Type 1 Genetic TestingMOL.TS.301.ANoneCriteria: non-substantive edit clarifying language for KFM testing; Background, Test Information and G&E updated; References updated and new addedcontent clarification/informationno change
Neurogenic Muscle Weakness, Ataxia, and Retinitis Pigmentosa (NARP)MOL.TS.245.ANoneCriteria: Added "No evidence of paternal transmission" in targeted mutation section and reworded the statement in whole mtDNA sequencing section, In KFM section, clarified language that previous testing could not have identified the familial mutation. Background updated; Guidelines and Evidence Updated; References Updatedcontent clarification/informationno change
OncotypeDX for Breast Cancer PrognosisMOL.TS.211.INoneCriteria: changed word “sample” to “tumor” to clarify in the previous testing section. Removed "with or without knowledge of the OncotypeDX test result" in the multiple testing section to clarifycontent clarification/informationno change
Prosigna Breast Cancer Prognostic Gene Signature AssayMOL.TS.222.ANoneCriteria: changed word “sample” to “tumor” to clarify in the previous testing section. Removed "with or without knowledge of the Prosigna test result" in the multiple testing section to clarifycontent clarification/informationno change
Somatic Mutation Testing-Solid TumorsMOL.TS.230.ANoneCriteria: no substantive changes, added CPT code 81276 for KRAS mutations in metastatic colorectal cancer in 'Common cancer types and associated tumor markers' table. Added a note that states "This guideline addresses molecular markers only. It is intended to address those markers that are detected by next generation sequencing technology and those that are present on NGS panels. It does not address microsatellite instability (MSI), immunohistochemistry (IHC), or other markers that may be detected through other methods such as FISH, chromosomal microarray, routine chromosome analysis, etc."; Background: removed list of test names; G&E: update NCCN quote; References: update NCCNcontent clarification/informationno change
Whole Exome SequencingMOL.TS.235.ANoneCriteria: removed word "whole" from whole exome sequencing to align with industry standard per expert opinion. Also changed word biochemical to laboratory to account for additional tests that would indicate inborn error of metabolism that would not be biochemical in nature. Background: Removed word "whole" from whole exome sequencing throughout the policy. References Updated. Titles Updated to Exome Sequencing.content clarification/informationno change
FoundationOne CDxMOL.TS.303.ANoneCriteria: Added a note that states "This guideline addresses molecular markers only. It is intended to address those markers that are detected by next generation sequencing technology and those that are present on NGS panels. It does not address microsatellite instability (MSI), immunohistochemistry (IHC), or other markers that may be detected through other methods such as FISH, chromosomal microarray, routine chromosome analysis, etc."; Guidelines and Evidence: updated NCCN; References: updatedcontent clarification/informationno change

Revisions From 06.02.52p:
01/01/2020
    This version of the policy went through a code update process effective 04/01/2020:
    • Narratives for procedure codes 0154U and 0155U were revised.
    • Procedure codes 0169U, 0170U and 0171U were added to Attachment A of this policy.
    • Procedure code 0168U was added to Attachment B of this policy.

Revisions From 06.02.52o:
01/01/2020This version of the policy will become effective on 01/01/2020.

Effective 01/01/2020, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing pre-service and prepayment reviews through the vendor):

0153U
0156U
0157U
0158U
0159U
0160U
0161U
0162U
81277
81307
81308
81522
81542
81552

Effective 01/01/2020, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0140U
0141U
0142U
0151U
0152U
0154U
0155U
81309
87563

Effective 01/01/2020, the following procedure codes have been deleted:

0009M, 0081U

Effective 01/01/2020, the narratives for the following procedure codes have been revised:

0011M, 81350, 81404, 81406, and 81407
---------------------------------------------------------------------------------------------------------------

On January 01st, 2020, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2020. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
01/01/2020 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52o)
Executive Summary of Changes


There are seven new guidelines. 40 existing guidelines have been revised (including 18 with substantive criteria changes). One guideline was retired. See the below tables for details.

Procedure code 0098U is changing from an eligible position to the position of experimental/investigational and, therefore, not covered.
Below is a summary of the guideline changes

New Guidelines:
  1. Spinocerebellar Ataxia Genetic Testing
  2. Friedreich Ataxia Genetic Testing
  3. Hereditary Ataxia Multigene Panel Testing
  4. Whole Genome Sequencing
  5. Hemoglobinopathies Genetic Testing
  6. Myotonic Dystrophy Type 1 Genetic Testing
  7. Somatic Mutation Testing - Hematological Malignancies


Retired Guidelines:

  1. Fragile X Associated Tremor/Ataxia Syndrome Testing


Criteria Updates (Substantive):
  1. BCR-ABL Testing for Chronic Myeloid Leukemia
  2. BRAF Testing for Colorectal Cancer
  3. BRAF Testing for Melanoma Kinase Inhibitor Response
  4. BRCA Analysis
  5. CYP2D6 Variant Analysis for Tamoxifen, Tetrabenazine, or Eliglustat
  6. Cystic Fibrosis Testing
  7. Early Onset Familial Alzheimer Disease (EOFAD.) Genetic Testing
  8. Fragile X Syndrome Testing
  9. Genetic Testing for Hereditary Pancreatitis
  10. Genitourinary Conditions Molecular Testing (Previously Sexually Transmitted Infections: Molecular)
  11. Hereditary Hemochromatosis Testing
  12. Investigational and Experimental Molecular/Genomic
  13. KRAS Testing for Anti-EGFR Response in Metastatic Colorectal Cancer
  14. Molecular Gastrointestinal Pathogen Panel (GIPP) Testing
  15. Multiple Endocrine Neoplasia Type 1 (MEN1)
  16. Niemann Pick, Type C Testing
  17. Spinal Muscular Atrophy Testing
  18. Laboratory Claim Reimbursement

Criteria Updates (Non-Substantive)
  1. APOE Variant Analysis for Alzheimer Disease
  2. Ashkenazi Jewish Carrier Screening
  3. Ataxia-Telangiectasia
  4. Chromosomal Microarray for Prenatal Diagnosis
  5. Factor II/Prothrombin Testing for Thrombophilia
  6. Genetic Testing for Carrier Status
  7. Genetic Testing for Epilepsy
  8. Genetic Testing for Facioscapulohumeral Muscular Dystrophy
  9. Genetic Testing for Known Familial Mutations
  10. Genetic Testing for Limb Girdle Muscular Dystrophy
  11. Genetic Testing for Non-Medical Purposes
  12. Genetic Testing to Diagnose Non-Cancer Conditions
  13. Hypertrophic Cardiomyopathy Testing
  14. Li-Fraumeni Syndrome Testing
  15. Marfan Syndrome Genetic Testing
  16. Maturity-Onset Diabetes of the Young (MODY) Testing
  17. Molecular Pathology Tier 2 Molecular CPT Codes
  18. Pharmacogenomic Testing for Drug Toxicity and Response
  19. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Testing
  20. TPMT Testing for Thiopurine Drug Response
  21. UGT1A1 Mutation Analysis for Irinotecan Response
  22. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing


    Other Note:(I/E = investigational & experimental) --

    See the tables below that follow (which provide more details for the guideline changes):

New Guidelines:
Guideline Name
Guideline #
Summary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.ANew Guideline - covered with criteriaNew Guideline. This was always covered with criteria; however, was addressed by a clinical use policy.
Friedreich Ataxia Genetic TestingMOL.TS.309.ANew Guideline - covered with criteriaNew Guideline. This was always covered with criteria; however, was addressed by a clinical use policy.
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.ANew Guideline - covered with criteriaNew Guideline. This was always covered with criteria; however, was addressed by a clinical use policy.
Whole Genome SequencingMOL.TS.306.ANew Guideline - I/ENew Guideline. This was always Investigational and/Experimental; however, it was addressed by a clinical use guideline.
Hemoglobinopathies Genetic TestingMOL.TS.308.ANew Guideline - covered with criteriaNew Guideline. This was always covered with criteria; however, was addressed by a clinical use policy.
Myotonic Dystrophy Type 1 Genetic TestingMOL.TS.312.ANew Guideline - covered with criteriaNew Guideline. This was always covered with criteria; however, was addressed by a clinical use policy.
Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.ANew Guideline - covered with criteriaNew Guideline. This was always covered with criteria; however, was addressed by a clinical use policy.

Retired Guidelines:
Guideline Name
Guideline #
Summary of change  (to be reviewed in conjunction with actual GL) Reason for Change
Fragile X Associated Tremor/Ataxia Syndrome TestingMOL.TS.171.ARetire GuidelineThe information from this guideline was incorporated into the Fragile X Testing guideline. The same gene causes both conditions. The new title is FMR1-Related Disorders Genetic Testing

Criteria Updates (Substantive):
Guideline Name
Guideline #
Summary of change  (to be reviewed in conjunction with actual GL) Reason for Change 
BCR-ABL Testing for Chronic Myeloid LeukemiaMOL.TS.131.ACriteria: added criteria for BCR-ABL1 kinase domain sequencing as per NCCN recommendations; Terminology updated;  Background: updated with new information; Test information: added BCR-ABL1 kinase domain sequence information;  Guidelines and Evidence: NCCN updated; References: updatedCriteria added per NCCN
BRAF Testing for Colorectal CancerMOL.TS.133.ACriteria: Added indication for predictive purposes. Deleted statement that testing is I/E for "BRAF mutation testing for the purpose of decision making regarding the use of anti EGFR agents" Guideline and evidence updated. References updated. Background updated.To better align with standard of care as these tests are being performed prior to medication selection in many cases. Also to better align with eviCore tumor marker policy which allows testing of biomarkers if level of evidence of 2A in NCCN. 
BRAF Testing for Melanoma Kinase Inhibitor ResponseMOL.TS.134.ACriteria: removed requirement for specific drug treatment consideration, as this is more of a first line test; Background: Broadened scope of test to BRAF V600 mutations, as more than V600E are tested;reworked language to take emphasis off of specific drugs; Test information: updated statistics, deleted detailed info regarding specific drugs and companion diagnostics but included a list of currently approved drugs as examples;  Guidelines and Evidence: updated NCCN with latest version 2.2019; References: updatedTo better align with standard of care as these tests are being performed prior to medication selection in many cases. Also to better align with eviCore tumor marker policy which allows testing of biomarkers if level of evidence of 2A in NCCN. 
BRCA AnalysisMOL.TS.238.ACriteria: Added "Diagnosed with three primary breast cancers at any age" as a criterion per NCCN. Criteria: moved "BRCA1/2 mutation detected by tumor profiling in the absence of germline mutation analysis" from personal history section to a separate bullet to avoid the unaffected individuals from obtaining testing based on that history. Added other considerations section to direct reader to pharmacogenomic or somatic mutation testing policy for other indications. G&E updated; References updatedCriteria added per NCCN. Other changes were done to clarify
CYP2D6 Variant Analysis for Tamoxifen, Tetrabenazine, or EliglustatMOL.TS.157.ACriteria: Removed statement that all other indications are I/E and added a statement that directs reader to Pharmacogenomic policy for additional indications given that CYP2D6 may be indicated based on the FDA labels on some drugs and be coverable under our clinical use pharm policy. Updated background. Updated ReferencesCYP2D6 is included in the FDA label for some drugs. Therefore, the guideline was updated to account for this and directs reader to the clinical use guideline for indications not addressed specially in the guideline.
Cystic Fibrosis TestingMOL.TS.158.ACriteria: expanded criteria to individuals with clinical CF diagnosis who need testing for identification of correct mutation-specific FDA approved therapy, expanded KFM criteria to diagnostic testing for symptomatic individuals, expanded  Intron 8 poly T analysis criteria to allow testing for individuals who have R117H, clarified criterion in sequencing section "Infants with an elevated IRT value on newborn screening and 0 or 1 mutations identified on standard panel testing" (previously said 'negative' panel); Background: updated statistics, FDA-approved medication list, added new terminology (CFSP-ID or CF screen positive - inconclusive diagnosis);  Guidelines and Evidence: updated ACOG, ASRM/SMRU, and CF Foundation recommendations; References: updatedFDA-approved indications were not originally addressed in the guideline, but testing for this indication was previously approvable under the clinical use pharmacogenomics policy.
Early Onset Familial Alzheimer Disease (EOFAD.) Genetic TestingMOL.TS.162.ACriteria: Added coverage criteria for multigene panels based on expert review and opinion on how testing is currently requested and performed; Updated backgroundBased on subject matter expert review regarding how testing is currently requested and performed;
Fragile X Syndrome TestingMOL.TS.172.ACriteria: Added "Males
and females 50 years of age or older with white matter lesions on MRI in the middle
cerebellar peduncles and/or brain stem, or Males
and females 50 years of age or older with FXTAS-related neurologic, cognitive, or
behavioral difficulties," as criterion for testing based on expert review and suggestions as well as clinical features of the condition. Revamped the entire policy to include FXTAS as well as premature ovarian failure (POI) as indications. Also clarified that for carrier screening, the individual has to be 18 years of age or older and at risk of inheriting the mutation based on their family history. Changed title to reflect changes. FMR1-Related Disorders (Fragile X) Genetic Testing.		Based on subject matter expert review as well as clinical features of the condition
Genetic Testing for Hereditary PancreatitisMOL.TS.287.ACriteria: extensive revisions to allow for panel testing which is current standard practice per expert review, restrict single gene testing to PRSS1 - the most commonly mutated gene, amend genes included on the I&E list (remove CASR and CPA1, add PNLIP and CEL) based on current literature, Added billing and reimbursement section to address panel testing;  Guidelines and Evidence: update United European Gastroenterology guideline, update list of risk factor genes; References: updatedCurrent standard practice per subject matter expert
Genitourinary Conditions Molecular Testing (Previously Sexually Transmitted Infections: Molecular)MOL.CS.106.AUpdated chlamydia (87490 and 87491) and gonorrhea (87590 and 87591) testing criteria to continue to allow for 3 units per DOS, but removed the modifier 59 requirement for additional units over 1. This aligns eviCore with CMS MUEs for these tests.This aligns eviCore with CMS MUEs for these tests.
Hereditary Hemochromatosis TestingMOL.TS.183.ACriteria: added criteria for sequencing and del/dup in tiered fashion for higher sensitivity in members of non-northern European ancestry; Title and language throughout the policy updated from 'hereditary hemochromatosis' to 'HFE hemochromotosis' to reflect current clinical terminology; CPT table: added HFE sequencing and del/dup; Test information: added bullet about HFE sequencing and  del/dup; Background and References: updatedTesting methodogies were not originally included in guideline.
Investigational and Experimental Molecular/GenomicMOL.CU.117.IRemoved WGS and Rapid WGS since they are in test-specific policy; Removed GeneSightRx Psychotropic since this is in test-specific policy; Removed ColoPrint,  miRInform Pancreas Test, and C-GAAP because they are off the market; Updated names of Rosetta Kidney (previously mi-Kidney), Rosetta Lung (previously mi-Lung), Mitomic Prostate Test (previously Prostate Core Mitomic Test); Added Clonoseq; Added Accelerate PhenoTest, Molecular Microscope MMDx-Heart, Molecular Microscope MMDx-Kidney into text; Updated lab for BREVAGen; Added the following PLA codes into table and text: 0109U, 0112U, 0113U, 0114U, 0118U, 0120U, 0130U, 0131U, 0132U, 0133U, 0134U, 0135U, 0136U, 0137U, 0138UEvidence reviews indicated tests were I/E.
KRAS Testing for Anti-EGFR Response in Metastatic Colorectal CancerMOL.TS.191.ACriteria update: removed medication requirements. Now indicated in individuals with metastatic colorectal cancer with no other requirement. Background updated. G&E updated; References updatedTo better align with standard of care in that these tests are being performed prior to medication selection in many cases. Also to better align with or tumor marker policy which allows testing of biomarkers if level of evidence of 2A in NCCN. 
Molecular Gastrointestinal Pathogen Panel (GIPP) TestingMOL.CS.277.AICD10 codes added A09 (Infectious gastroenteritis and colitis, unspecified), A04.9 (Bacteria intestinal infection, unspecified), or K52.9 (Noninfective gastroenteritis and colitis, unspecified).Ensuring that policy accurately reflects claims rules
Multiple Endocrine Neoplasia Type 1 (MEN1)MOL.TS.285.ACriteria: added "Any person under the age of 30 with PHPT, pancreatic precursor lesions, or pancreatic islet tumor regardless of family history" as an indication for testing; Background updated; Guidelines and Evidence Updated; References Updated and standardizedBased on expert review as well as clinical features of the condition
Niemann Pick, Type C TestingMOL.TS.208.ACriteria: Clarify biochemical testing does not need to be on cultured skin fibroblasts, as this test is no longer used; Background: updated with new statistics and diagnostic tool (NP-C suspicion index), Test Information: updated to reflect current clinical practice with regard to biochemical testing (oxysterols and filipin);  Guidelines and Evidence: updated with International NP-C Disease Registry recommendations from 2018; References: UpdatedTo reflect current clinical practice with regard to biochemical testing
Spinal Muscular Atrophy TestingMOL.TS.225.ACriteria: Added Zolgensma indication for SMN2 testing, added section for c.859G>C Analysis, added c.859G>C Analysis as I/E for prognostic purposes only. Updated wording for one criterion for SMN2 deletion/duplication analysis to state "Documentation is provided that SMN2 copy number is needed to obtain insurance approval for either Spinraza or Zolgensma" to ensure that the testing is being performed for the purpose of using the medication. Updated Background and Guidelines and Evidence (Zolgensma information added); References added/updatedZolgensma is now FDA approved for individuals with SMA. This needed to be addressed in the guideline given that some payers will require genetic testing prior to approving this medication.
Laboratory Claim ReimbursementMOL.CS.105.IExtended PLA range in table to 0138U, Removed 0001M given that it was previously deleted by the AMA, Clarified background information. Renamed Voluntary Prior Authorization section to "Pre-Service Review of Procedures that Do Not Require Prior Authorization" and reworded this section to clarify the procedure for when codes are submitted for groups of codes and at least one requires PA.Clarification and/or update purposes only

Criteria Updates (Non-Substantive):
Guideline Name
Guideline #
Summary of change  (to be reviewed in conjunction with actual GL) Reason for Change 
APOE Variant Analysis for Alzheimer DiseaseMOL.TS.128.ACriteria change: terminology update only; Background and Test Information: updated terminology from variant to allele; Guidelines and Evidence: added ACMG Choosing Wisely; References: updatedClarification and/or update purposes only
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.ACriteria update: Updated the term "testing" to "carrier screening" for accuracy. Guidelines and evidence updated; References updated; CPT code table updatedClarification and/or update purposes only
Ataxia-TelangiectasiaMOL.TS.130.ACriteria: clarification of language re who can get del/dup testing when one mutation has been identified through sequencing; several language clarifications throughout, no substantive changesClarification and/or update purposes only
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.ACriteria: language edits and billing and reimbursement CPT code additions but no substantive changes; Background: updated with new references; Guidelines and Evidence: Updates with 2016 ACOG practice bulletin; References: updatedClarification and/or update purposes only
Factor II/Prothrombin Testing for ThrombophiliaMOL.TS.166.ACriteria: reformatted, but no substantive changes; Guidelines and Evidence: updated and expanded with ACMG 2018 technical standard; References: updatedClarification and/or update purposes only
Genetic Testing for Carrier StatusMOL.CU.110.ACriteria: removed "Exclusions for multiplex carrier screening tests" given that coverage criteria for carrier screening using 81443 is  listed in expanded carrier screening policy. Updated referencesClarification and/or update purposes only
Genetic Testing for EpilepsyMOL.TS.257.ACriteria: wording updated/added for clarification purposes only. No changes to criteria. Background updated. References updated. CPT codes updated in table at the bottom.Clarification and/or update purposes only
Genetic Testing for Facioscapulohumeral Muscular DystrophyMOL.TS.290.ACriteria: clarified language regarding D4Z4 methyation analysis result needed to proceed to SMCHD1 by amending negative to low methylation with a cut-off value added for reference (<25%); CPT Code Table: clarify descriptions to better align with AMA descriptions; Background and Test Information: minor changes in language; References: typo correctedClarification and/or update purposes only
Genetic Testing for Known Familial MutationsMOL.CU.291.ACriteria changes: none substantive - corrected typo, added 'biological' to statement about 1st, 2nd and 3rd degree relatives; References: updated to include version numbers of NCCN guidelines.Clarification and/or update purposes only
Genetic Testing for Limb Girdle Muscular DystrophyMOL.TS.288.ACriteria change: clarification of previous genetic testing to allow previous single gene test or previous different panel test as long as causative mutation or mutations were not identified; Background: minor edits, additional info added;   Guidelines and Evidence: new literature added; References: updated and reorderedClarification and/or update purposes only
Genetic Testing for Non-Medical PurposesMOL.CU.111.ACriteria changes: nothing substantive, Updated common trade names. deleted tests that are no longer on the market and added additional news ones.Clarification and/or update purposes only
Genetic Testing to Diagnose Non-Cancer ConditionsMOL.CU.114.ACriteria: updated "child" to "individual" to allow for testing affected adults for similar purposes under the special circumstances sectionClarification and/or update purposes only
Hypertrophic Cardiomyopathy TestingMOL.TS.189.ACriteria: In billing and reimbursement section, updated list of single genes allowed for stacked billing to those in Gene Review that reach a 4% frequency or higher; Intro: updated CPT code table to include panels and only those 4 genes for which stacked code billing is allowed; Background: minor clarification edits; G&E updated; References addedClarification and/or update purposes only
Li-Fraumeni Syndrome TestingMOL.TS.193.ACriteria: clarified that an individual with a LFS tumor spectrum tumor must have a first degree relative who meets Classic LFS criteria or Chompret criteria as listed elsewhere in the criteria section; G&E updated;References updatedClarification and/or update purposes only
Marfan Syndrome Genetic TestingMOL.TS.202.ACriteria update: Clarified Z score included 2.0 for aortic root enlargement. Also spelled out the greater than and less than symbols. Background updatedClarification and/or update purposes only
Maturity-Onset Diabetes of the Young (MODY) TestingMOL.TS.258.ACriteria update: Clarified no "MODY" mutation was known; Background updatedClarification and/or update purposes only
Molecular Pathology Tier 2 Molecular CPT CodesMOL.AD.102.ACriteria: added the following "Laboratories may not self-assign tests to Tier 2 codes that are not specifically listed as analytes by the AMA." Updated background and references.Clarification and/or update purposes only
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.ICriteria: Added statement "For somatic mutation testing in solid tumor tissue, see the guideline Somatic Mutation Testing - Solid Tumors" to direct readers to that policy for somatic testing. Added Complementary to title of criteria section to clarify that this is included in the policy. Added the word germline to the first sentence of the policy to clarify that this policy is for germline testing.Clarification and/or update purposes only
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel TestingMOL.TS.227.ACriteria: amended list of genes eligible for consideration for reimbursement if billed using stacked codes to limit to genes with mutation frequency of 2% or higher in TAAD according to Gene Review; Background and Test Information: updated with newer clinical information and terminology; Guidelines and Evidence: updated with info in evidence strength and corrected error in a direct quote;  References: updatedClarification and/or update purposes only
TPMT Testing for Thiopurine Drug ResponseMOL.TS.229.ACriteria: admin edits only, no substantive change; Test information: updated FDA resources; Guidelines and Evidence: Updated FDA label info for 6-mercaptopurine; References: updatedClarification and/or update purposes only
UGT1A1 Mutation Analysis for Irinotecan ResponseMOL.TS.231.ACriteria: No substantive changes (wording change from testing to variant analysis only). Entire guideline updated to reflect "variant" instead of "mutation".Background updated.Clarification and/or update purposes only
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.ACriteria: KFM section updated to clarify that 'No previous testing' would have to include the KFM.  Updated block in criteria, renamed to "Other Considerations" and now says "Genetic testing for ALS, in the absence of a known familial mutation, is considered investigational and experimental and, therefore, not eligible for reimbursement" in order to allow for expansion analysis for KFM testing. Background updated; Guidelines and evidence updates; References updatedClarification and/or update purposes only

Revisions From 06.02.52n:
10/01/2019This version of the policy became effective on 10/01/2019.

Effective 10/01/2019, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

0111U, 0113U, 0114U, 0118U, 0120U, 0129U, 0130U, 0131U, 0132U, 0133U, 0134U, 0135U, 0136U, 0137U

Effective 10/01/2019, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0109U, 0112U, and 0115U

Effective 10/01/2019, the following procedure codes have been deleted:

0104U

Revisions From 06.02.52m:
07/01/2019This version of the policy will become effective on 07/01/2019.

Effective 07/01/2019, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

0084U
0087U
0088U
0089U
0090U
0094U
0101U
0102U
0103U
0104U

Effective 07/01/2019, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0086U
0096U
0097U
0098U
0099U
0100U

Effective 07/01/2019, the following procedure codes have been deleted:

0057U

---------------------------------------------------------------------------------------------------------------

On July 01st, 2019, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2019. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
07/01/2019 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52m)


Executive Summary of Changes


There are 07 new guidelines. 36 existing guidelines have been revised (including 26 with substantive criteria changes). Two guidelines were retired. See the below tables for details.
Below is a summary of the guideline changes


New Guidelines:

1. Neurofibromatosis Type 1 Genetic Testing
2. Legius Syndrome Genetic Testing
3. AlloSure for Kidney Transplant Rejection
4. AssureMDx Testing for Bladder Cancer
5. FoundationOne CDx
6. Molecular Respiratory Infection Pathogen Panel (RIPP) Testing
7. Medical Necessity Review Information Requirements


Retired Guidelines:

1. BRCA Sequencing for Drug Treatment Response in Ovarian Cancer
2. EGFR Liquid Biopsy - Erlotinib and Osimertinib Response


Criteria Updates (Substantive):
    1. Afirma Gene Expression Classifier for Thyroid Cancer
    2. AlloMap Gene Expression Profiling For Heart Transplant Rejection
    3. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
    4. Ashkenazi Jewish Carrier Screening
    5. BCR-ABL Negative Myeloproliferative Neoplasm Testing
    6. BRCA Analysis
    7. BRCA Ashkenazi Jewish Founder Mutation Testing
    8. CADASIL Testing
    9. ConfirmMDx for Prostate Cancer Risk Assessment
    10. DecisionDX-Uveal Melanoma
    11. Dentatorubral Pallidoluysian Atrophy Testing
    12. EGFR Testing for Non-Small Cell Lung Cancer TKI Response
    13. Expanded Carrier Screening Panels
    14. Familial Hypercholesterolemia Genetic Testing
    15. Flow Cytometry
    16. Genitourinary Conditions Molecular Testing
    17. Hereditary (germline) testing after tumor (somatic) testing
    18. Investigational and Experimental Molecular/Genomic Testing
    19. Liquid Biopsy Testing – Solid Tumors
    20. Lynch Syndrome Tumor Screening -Second-Tier
    21. Mammaprint 70-Gene Breast Cancer Recurrence Assay
    22. Pharmacogenomic Testing for Drug Toxicity and Response
    23. Preimplantation Genetic Screening and Diagnosis
    24. Prenatal Aneuploidy FISH Testing
    25. Rett Syndrome Testing
    26. Spinal Muscular Atrophy Testing

Criteria Updates (Non-Substantive)
    1. CYP2D6 Variant Analysis for Drug Response
    2. Duchenne & Becker Muscular Dystrophy Testing
    3. Factor II/Prothrombin Testing for Thrombophilia
    4. Genetic Testing by Multi Gene Panels
    5. Long QT Syndrome Testing
    6. Lynch Syndrome Genetic Testing
    7. Tumor Marker Testing - Solid Tumors
    8. Whole Exome Sequencing
    9. Genetic Testing for Dilated Cardiomyopathy
    10. ThyraMIR and ThyGenX miRNA Gene Expression Classifier


    Other Note: (I/E = investigational & experimental) --

    See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:

Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.301.ANeurofibromatosis Type 1 Genetic Testing New policy - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.302.ALegius Syndrome Genetic Testing New policy - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.307.AAlloSure for Kidney Transplant Rejection New policy - Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.TS.305.AAssureMDx Testing for Bladder Cancer New policy - Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.TS.303.AFoundationOne CDxNew policy - covered with criteriaChange in coverage. This was previously addressed by our Tumor Marker Testing - Solid Tumors guideline and covered for individuals with NSCLC. Given the FDA approval of this test as a companion diagnostic for 5 cancer types, we added coverage criteria for the 4 additional cancer types included in the FDA label (breast, ovarian, colorectal, and melanoma)
MOL.CS.293.AMolecular Respiratory Infection Pathogen Panel (RIPP) TestingNew policy - Claims studioThese codes are managed through claims only. Policy developed to address overuse of large panels by restricting testing to appropriate populations such as those who are immunocompromised. 
MOL.AD.304.AMedical Necessity Review Information RequirementsNew administrative policyAn overarching policy that describes what information is needed for case review to help keep cases moving through the PA process and avoid being put on hold for lack of information.

Retired Guidelines

Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.138.ABRCA Sequencing for Drug Treatment Response in Ovarian CancerRetiredThis testing is addressed by the pharmacogenomic policy. The frequent additional FDA approved indications for this test made this policy redundant to the pharmacogenomic policy.
MOL.TS.195.FEGFR Liquid Biopsy - Erlotinib and Osimertinib ResponseRetiredThis testing is now addressed in the broader EGFR policy since we expanded coverage of EGFR testing via liquid biopsy to other platforms.

Criteria Changes (Substantive)

Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.122.AAfirma Gene Expression Classifier for Thyroid Cancer Entire guideline updated to reflect new GSC test as well as the addition of the Xpression Atlas add on test. In billing section, added that CPT code 81545 is not appropriate for GSC and should only be used for the billing of the GEC.Xpression Atlas is I/E based on evidence review, this is reflected in criteria section.
MOL.TS.123.AAlloMap Gene Expression Profiling For Heart Transplant Rejection Criteria - added "Medical records indicate that member has been under the care of the ordering provider within the past 30 days​" PA requests were coming in with clinic notes from 6 months prior. This criterion addition clarifies need to ensure the member's health status is current and that this testing is appropriate for them at a higher level than individual sub-criteria that impose date-limits on the information reviewed. Minimal to no impact expected on approvals/denials.
MOL.TS.125.AAmyotrophic Lateral Sclerosis (ALS) Genetic Testing Criteria: added targeted expansion analysis of C9orf72 as I&E (policy previously addressed only sequencing and known family mutation); Test information: added targeted expansion analysis as one of the possible test types; References: updatedTargeted expansion analysis is a possible test type that we had not included previously in the policy. Reviewers requested the information be added. For completeness, it was added. 
MOL.TS.129.AAshkenazi Jewish Carrier Screening Criteria: Added "The individual is of Ashkenazi Jewish ancestry" as an indication under single gene testing to clarify that testing is indicated in individuals of AJ ancestry. This criterion was to added to clarify that Ashkenazi Jewish individuals could obtain this testing. Previously was not directly stated in the guideline.
 MOL.TS.240.ABCR-ABL Negative Myeloproliferative Neoplasm Testing Criteria: Updated to include testing for JAK2 V617K testing for individuals without a definitive diagnosis of MPN. Updated G&E and ReferencesThis was to better align with current practice and to ensure that the appropriate individuals obtained testing. Criteria updated per review and recommendation of clinical expert.
MOL.TS.238.ABRCA Analysis Criteria: as per NCCN recommendation added to Personal and Family History Combination criteria ‘Dx with breast cancer at any age and relative with metastatic prostate cancer’ and ‘Dx with breast cancer at any age and relative with pancreatic cancer’, In Personal and Family HX Combo section, second to last bullet "Personal history of high-grade prostate cancer (Gleason score at least 7) at any age with ≥1 close blood relatives (on the same side of the family) with ovarian cancer at any age, pancreatic cancer at any age, metastatic prostate cancer (radiographic evidence of or biopsy proven disease) at any age, or breast cancer <50 years, and/or", added male breast cancer to the list given that the original list was intended to include those relatives with a high probability of having a BRCA mutation and men with breast cancer should be included in that list, For document clarity and efficiency, reorganized the presymptomatic criteria to remove specific criteria combinations and add that the member needed to have a first or second degree relative who meets at least one of the ‘personal history’ or ‘personal and family history combination’ criteria already listed; Guidelines and Evidence: For document efficiency removed detailed listing of NCCN criteria and replaced with a summary paragraph and deleted  NCCN definitions of close blood relative, limited family history, and comprehensive genetic testingCriteria updated to better align with NCCN.
 MOL.TS.135.ABRCA Ashkenazi Jewish Founder Mutation TestingCriteria Update: For asymptomatic individuals, 1) clarify that both the member and the affected relative are Ashkenazi Jewish and 2) update family history of prostate cancer to delete requirement for members with additional cancer diagnoses per NCCN guidelines, plus additional clarification edits; References: updatedCriteria updated to better align with NCCN and to clairfy ethnicity requirement
MOL.TS.144.ACADASIL TestingBackground, Test information, G&E and References updates. Criteria - added age requirement (age 18 or older) for predictive testing. Added deletion/duplication testing section. Removed requirement for skin biopsy, given that it is invasive testing. Based on expert review and to better align with how testing is done clinically.Criteria updated to reflect expert review as well as to remove the requirement of an invasive skin biopsy test.
MOL.TS.153.AConfirmMDx for Prostate Cancer Risk AssessmentLiterature section added, references updated. Criteria: Additional indications added under section "member is considered higher risk for prostate cancer" to better align with available literature and society recommendations.Additions to criteria were all based on review of available literature regarding what indications are considered higher risk.
MOL.TS.254.ADecisionDX-Uveal Melanoma G&E and Literature review updated, and References updated. DecisionDX-UM Seq information added; DecisionDX-UM Seq added into Criteria section as I/E. Clarified that DecisionDX PRAME is I/E. Based on evidence review of available peer reviewed literatureBased on evidence review of available peer reviewed literature
MOL.TS.159.ADentatorubral Pallidoluysian Atrophy Testing Background, G&E, References Updated. Criteria: clarified type of repeat testing under previous testing section. Added "Brain MRI demonstrating cerebellar and brain stem atrophy" for diagnostic testing for individuals less than 20 years. Added "Brain MRI demonstrating cerebellar and brain stem atrophy and Dementia/psychiatric disturbance" into list of symptoms for diagnostic testing for individuals 20 years of age of older. Better align with clinical practice and the symptoms exhibited by patients at different ages.Updated to better align with clinical practice and the symptoms exhibited by patients at different ages based on review and recommendation of clinical expert.
MOL.TS.163.AEGFR Testing for Non-Small Cell Lung Cancer TKI ResponseBackground and References Updated. Criteria: Added osimertinib as an indication for targeted mutation testing. removed the requirement that the cell type had to be nonsquamous. Testing exceptions removed based on recommendation of subject matter expert and to better align with broader molecular profiling coverage found in NSCLC panel policy, Added Other Considerations section to allow coverage for EGFR liquid biopsy;Criteria section updated to reflect the coverage of EGFR testing via liquid biopsy on any platform. Other updates were based on clinical expert review and to better align with broader molecular profiling coverage found in NSCLC panel policy
MOL.TS.165.AExpanded Carrier Screening Panels Criteria: Included criteria for expanded carrier screening panels being billed with new CPT code 81443 added in 2019.Addition of a new CPT code in 2019 for expanded carrier screening prompted the addition of criteria.
MOL.TS.169.AFamilial Hypercholesterolemia Genetic Testing Criteria: criteria added for multigene panels since most labs offer this testing in panels. Also added 'if performed' after the previous testing to clarify targeted or single gene testing was not required to be performed first. Background, G&E and references updatedCriteria updated to reflect the current offerings available for the testing. Most laboratories offer this testing as a panel.
MOL.CS.103.AFlow Cytometry Background and References updated. Criteria updated. Limits for certain indications (for some, up to 27 flow cytometry markers) were updated per expert review and recommendation. The limit for post service review was also updated from 14 to 20 per expert review and recommendation.Criteria updated per review and recommendation of clinical expert.
MOL.CS.106.AGenitourinary Conditions Molecular Testing updated HPV testing criteria based on updated USPSTF guidelineCriteria updated based on updated USPSTF guidelines stating that cervical cytology alone should be performed in women aged 21-29. HPV screening is not recommended in this age group.
MOL.CU.246.AHereditary (germline) testing after tumor (somatic) testing Criteria change: variant frequency in tumor reduced to 33% (from 50%) to reflect likely frequency of a germline mutation in tumor tissue; CPT code table updated with specific gene codes for known familial variants; References updated; Admin updatesCriteria updated per review and recommendation of clinical expert.
MOL.CU.117.IInvestigational and Experimental Molecular/Genomic TestingRemoved PancraGEN and Allosure; Added INFINITI, TOXLOK, BBDRisk, and miR-31now, OncotypeDx AR-V7,  added SmartGut; Added Envisia, Percepta, BioFire® FilmArray® Respiratory Panel (RP), BioFire® Diagnostics, BioFire® FilmArray® Respiratory Panel 2 (RP2), BioFire® DiagnosticsAdded tests that are considered I&E based on evidence review. Removed tests that are now addressed by test-specific policy.
MOL.TS.194.ILiquid Biopsy Testing – Solid Tumors Criteria: Added coverage for Guardant360 panels for NSCLC; Added EGFR section that directs reader to EGFR policy for targeted mutation testing. Other consideration section - all other liquid biopsy I/E. Background updated; Test Information updated; Guidelines and Evidence updated (NCCN); References updatedBased on NCCN recommendations, clinical expert recommentaion, and literature review
MOL.TS.199.ALynch Syndrome Tumor Screening -Second-Tier Criteria change: criteria amended for coverage of 'BRAF V600 codon' mutations, not just 'BRAF V600E' based on expansion of reported mutations at this hot spot; Guidelines and evidence updated; References updatedUpdates based on clinical expert recommendation and review of literature.
MOL.TS.200.AMammaprint 70-Gene Breast Cancer Recurrence Assay Criteria updated to reflect eviCore's new coverage guideline criteria. Tumor size and characteristics are slightly different. Amongst other criteria, new guideline has the following criteria "tumor size > 0.5cm, ER+, HER2 negative"Coverage for this testing was updated based on review of peer reviewed literature and published society guidelines. For most clients, this testing was previously I/E. IBC was previously covering this testing; however, the criteria has changed slightly to align with eviCore's general coverage guideline. 
MOL.CU.118.IPharmacogenomic Testing for Drug Toxicity and ResponseCriteria:  Removed "Testing is NOT being performed as part of a panel of genes, AND" since we are now covering the pharmacogenomic panel FoundationOne CDxA new test-specific guideline for FoundationOne  CDx was written based on the FDA approval as a companion diagnostic. This is a panel of genes. Therefore, this statement was no longer relevant.
MOL.CU.119.APreimplantation Genetic Screening and Diagnosis Updated references; Criteria - added PGD for VUS is not medically necessary to align with other clinical policies. Added clarification that familial mutations need to be known in order to perform PGDTo clarify coverage for VUS since it was not specified previously. VUS are addressed by a clinical use guideline; however, for clarification, this specific information was added to this guideline
MOL.CS.218.APrenatal Aneuploidy FISH Testing Since codes are managed in claims only, this was made into a claims studio policy. Removed from all clients that are not claims studio clients. Criteria: Removed requirement that results are needed in less than 1 week for pregnancy management; Added claims rules with an ICD code tableCriteria updated per review and recommendation of clinical expert. These codes are managed through claims only. Therefore, we made this a claims studio policy and added claims rules for transparency
MOL.TS.224.ARett Syndrome TestingDiagnostic criteria added to background. Criteria: Added females with autism and negative Fragile X and CMA as an indication for testing per ACMG society guidelines.Criteria updated to reflect ACMG guidelines
MOL.TS.225.ASpinal Muscular Atrophy Testing Criteria: Removed "Non-diagnostic results from SMN1 exon 7 deletion testing (not homozygous SMN1 deletion) in the diagnostic setting, AND" from previous testing given the new CPT codes are for either methodology; SMN1 sequencing, updated 'and' to 'or' to allow for individuals with nondiagnostic SMN1 exon deletion testing to move onto sequencing. Updated to better align with clinical practice and the addition of a CPT code that could be for either methodology.

Criteria Changes (Non-Substantive)

Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.157.ACYP2D6 Variant Analysis for Drug Response Removed CPT code 0028U and added 0070U through 0076U; Criteria - removed mention of CPT code 0028U. Added: "Additional CYP2D6 tests, denoted by CPT codes 0071U–0076U, are typically not medically necessary. Requests for these tests will be reviewed on a case by case basis."No substantive criteria changes. Updates were done due to addition of PLA codes.
MOL.TS.161.ADuchenne & Becker Muscular Dystrophy Testing Background, G&E, and References Updated. Criteria - Previous testing methods clarifiedNo substantive criteria changes. Updates were done for clarification purposes only
MOL.TS.166.AFactor II/Prothrombin Testing for Thrombophilia Criteria: Defined recurrent pregnancy loss as 2 or more failed clinical pregnancies per ASRM and added referenceNo substantive criteria changes. Updates were done for clarification purposes only
MOL.CU.116.AGenetic Testing by Multi Gene Panels Criteria: removed statement regarding WGS being I/E. This testing for most plans is still I/E; however, it is addressed in other policies. Added statement regarding deletion/duplication portion of panels and when the billing of 81228/81229 would be appropriate for del/dup testingNo substantive criteria changes. Updates were done for clarification purposes and to ensure consistency among eviCore clinical reviewers.
MOL.TS.196.ALong QT Syndrome TestingCriteria: Added billing and reimbursement section to clarify redirection to panel code and procedure if laboratory cannot redirectNo substantive criteria changes. Updates were done for clarification purposes only
MOL.TS.197.ALynch Syndrome Genetic Testing Criteria Change: added exclusion of FAP as a diagnosis higher in the criteria list so it applies to both predisposition and diagnostic testing (previously only in predisposition section) and added clarifying comment in Table 1 that Per NCCN guidelines, only MLH1 promoter mutation analysis is recommended for endometrial tumors when IHC testing has indicated a loss of MLH1 protein; Background updated; References updated; Admin editsNo substantive criteria changes. Updates were done for clarification purposes only
MOL.TS.230.ATumor Marker Testing - Solid Tumors Title change "Somatic Mutation Testing - Solid Tumors"; updated language throughout policy. Removed FoundationOne CDx from CPT code table since new test-specific policy is available; Added FoundationOne CDx block to direct reader to that test-specific policy.No substantive criteria updates. Directs reader to FoudationOne CDx policy
MOL.TS.235.AWhole Exome SequencingCriteria: added Prenatal WES as I&E based on literture review, deletion/duplication testing by WES called I&E in other considerations section; deleted WGS as this is addressed for most clients in the I&E Policy; Guidelines and Evidence updated; References updatedNo substantive criteria changes. Updates were done for clarification purposes only. Deletion/Duplication testing and prenatal WES was always considered I/E. However, we clarified it in the policy.
MOL.TS.284.AGenetic Testing for Dilated Cardiomyopathy Updated background, Updated criteria section to account for various modalities to establish a diagnosis. Updated billing and reimbursement section to account for billing of panels and the inability of some labs to redirect. Updated G&E and ReferencesNo substantive criteria changes. Updates were done for clarification purposes only.
MOL.TS.259.IThyraMIR and ThyGenX miRNA Gene Expression ClassifierUpdated the policy throughout to reflect the new name of ThyGenX. It is now called ThyGeNEXT. No substantive criteria changes.

Revisions From 06.02.52l:
01/01/2019This version of the policy will become effective on 01/01/2019.

Effective 01/01/2019, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

81163
81164
81165
81166
81167
81173
81174
81185
81186
81189
81190
81286
81289
81306
81336
81337
81443
81518
0081U
(Note: On 12/28/2018 PLA Procedure code 0081U, effective 01/01/2019, was added to this policy in Notification).

Effective 01/01/2019, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

81171
81172
81177
81178
81179
81180
81181
81182
81183
81184
81187
81188
81204
81233
81234
81236
81237
81239
81271
81274
81284
81285
81305
81312
81320
81329
81333
81343
81344
81345

Effective 01/01/2019, the narratives for the following procedure codes have been revised:

81162
81212
81215
81216
81217
81244
81287
81327
81400
81401
81403
81404
81405
81407


Effective 01/01/2019, the following procedure codes have been deleted:

81211
81213
81214


Effective 01/01/2019, the following management changes will take place for genomic testing codes that are already in effect & part of eviCore Lab Management Program for the Company:

-- This procedure code will be managed through prepayment review only:

81287

-- These procedure codes will be managed through precertification in addition to prepayment reviews:

81202
81221
81248
81252
81253
81258
81293
81296
81299
81302
81303
81304
81318
81322
81326
81350
81362
S3844
S3850

---------------------------------------------------------------------------------------------------------------

On January 2nd, 2019, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the precertification and/or prepayment review processes starting on January 2nd, 2019. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
01/02/2019 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52l)



Executive Summary of Changes

There are 20 new guidelines. 93 existing guidelines have been revised (including 32 with criteria changes); however 61 of these were changes in the background sections of the guidelines only. See the below tables for details. Two guidelines were retired.
Below is a summary of the guideline changes

New Guidelines:

1. Genetic Testing for Autism
2. Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy
3. DermTech Pigmented Lesion Assay
4. RosettaGX Reveal
5. Genetic Testing for Dilated Cardiomyopathy
6. Multiple Endocrine Neoplasia Type 1 (MEN1)
7. Multiple Endocrine Neoplasia Type 2 (MEN2)
8. Genetic Testing for Hereditary Pancreatitis
9. Genetic Testing for Limb Girdle Muscular Dystrophy
10. Chromosome Analysis for Reproductive Disorders, Prenatal testing, and Developmental Disorders
11. Genetic Testing for Facioscapulohumeral Muscular Dystrophy
12. Genetic Testing for Known Familial Mutations
13. Genetic Testing for Variants of Uncertain Clinical Significance
14. Decipher Prostate Cancer Classifier
15. OncotypeDX for Prostate Cancer
16. ProMark
17. Prolaris
18. Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors
19. Macula Risk
20. EGFR Liquid Biopsy - Erlotinib and Osimertinib Response


Retired Guidelines:

1. Gene Expression Profiling Tests for Prostate Cancer
2. Prenatal Chromosome Analysis


Criteria Updates:

1. Angelman Syndrome Testing
2. BRAF Testing for Melanoma Kinase Inhibitor Response
3. BRCA Analysis
4. BRCA Ashkenazi Jewish Founder Mutation Testing
5. Chromosomal Microarray Testing For Developmental Disorders
6. ConfirmMDx for Prostate Cancer Risk Assessment
7. Cystic Fibrosis Testing
8. Ehlers Danlos Syndrome Testing
9. Hereditary Connective Tissue Disorder Testing
10. Investigational and Experimental Molecular/Genomic Testing
11. Li-Fraumeni Syndrome Testing
12. Lynch Syndrome Tumor Screening - First-Tier
13. Maturity-Onset Diabetes of the Young (MODY) Testing
14. Non.Invasive Prenatal Testing
15. PALB2 Genetic Testing
16. Peutz-Jeghers Syndrome Testing
17. Prader-Willi Syndrome Testing
18. Lynch Syndrome Genetic Testing
19. Acute Myeloid Leukemia (AML) Genetic Testing
20. Brugada Syndrome Genetic Testing
21. Genetic Testing for Non-Medical Purposes
22. Genetic Testing to Predict Disease Risk
23. Laboratory Claim Reimbursement
24. Marfan Syndrome Genetic Testing
25. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Testing
26. Genetic Testing for Cancer Susceptibility and Hereditary Cancer Syndromes
27. Genetic Testing for Carrier Status
28. Genetic Testing for Prenatal Screening and Diagnostic Testing
29. Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer
30. Genetic Testing to Diagnose Non-Cancer Conditions
31. ThyGenX and ThyraMIR miRNA Gene Expression Classifier
32. ThyroSeq


Background Updates only (no criteria updates):

See details for these changes in the table below.

Other Changes: (I/E = investigational & experimental) --

See the tables below that follow (which provide more details for the guideline changes):

New Guidelines:
Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.269.AGenetic Testing for AutismNew guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline. Panels are, however, considered not medically necessary and not reimbursable.
MOL.TS.281.A Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy New guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.282.ADermTech Pigmented Lesion AssayNew guideline - remained Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.TS.283.A RosettaGX RevealNew guideline - remained Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.TS.284.A Genetic Testing for Dilated CardiomyopathyNew guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.285.A Multiple Endocrine Neoplasia Type 1 (MEN1) New guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.286.A Multiple Endocrine Neoplasia Type 2 (MEN2)New guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.287.A Genetic Testing for Hereditary Pancreatitis New guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.288.AGenetic Testing for Limb Girdle Muscular DystrophyNew guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.CS.289.A Chromosome Analysis for Reproductive Disorders, Prenatal testing, and Developmental DisordersNew Claims Studio guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline for Claims Studio clients.
MOL.TS.290.AGenetic Testing for Facioscapulohumeral Muscular DystrophyNew guideline - covered with criteriaTesting has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.CU.291.A Genetic Testing for Known Familial Mutations New clinical use guidelineNew clinical use guideline
MOL.CU.292.A Genetic Testing for Variants of Uncertain Clinical Significance New clinical use guidelineNew clinical use guideline
MOL.TS.294.ADecipher Prostate Cancer ClassifierNew guideline- remained Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a broader Gene Expression Profiling Tests for Prostate Cancer guideline. This is a test specific guideline.
MOL.TS.295.A OncotypeDX for Prostate Cancer New guideline - remained Investigational and/or experimental; updated OncotypeDX CPT to 0047UThis testing has always been I/E. However, it was previously addressed by a broader Gene Expression Profiling Tests for Prostate Cancer guideline. This is a test specific guideline.
MOL.TS.296.A ProMarkNew guideline - remained Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a broader Gene Expression Profiling Tests for Prostate Cancer guideline. This is a test specific guideline.
MOL.TS.297.A ProlarisNew guideline - remained Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a broader Gene Expression Profiling Tests for Prostate Cancer guideline. This is a test specific guideline.
MOL.CU.298.A Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors New clinical use guidelineNew clinical use guideline
MOL.TS.300.A Macula RiskNew guideline - remained Investigational and/or experimentalThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.TS.195.FEGFR Liquid Biopsy - Erlotinib and Osimertinib ResponseNew guideline - covered with criteriaNew guideline

Retired Guidelines:
Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.239.A Gene Expression Profiling Tests for Prostate CancerRetired - guideline addressed 4 different tests. These 4 tests were separated into different test-specific guidelinesRetired - guideline addressed 4 different tests. These 4 tests were separated into different test-specific guidelines
MOL.TS.219.APrenatal Chromosome AnalysisRetiredRetired guideline. This was replaced for Claims Studio clients with the new Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developemental Disorders guideline. This new guideline is broader.

Criteria Updates:
Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.126.A Angelman Syndrome TestingCriteria: updated to allow both CMA and FISH testing for detection of deletions (previously FISH only) as per updated evidence; Test info update, reference updatesPrevious test strategy document used as source for recommended/approvable tests was retired and not replaced; Criteria were amended to reflect current recommendations of expert authored review and disease advocacy society.
MOL.TS.134.A BRAF Testing for Melanoma Kinase Inhibitor ResponseCriteria: exclusions section removed (testing indications for multiple cancer types); New FDA indication for Mekinist; References updatedExclusions for cancer types were removed as FDA  recommends testing BRAF in cancer types other than melanoma.
MOL.TS.238.A BRCA AnalysisCriteria: Diagnostic testing updated to expand coverage to members with personal history of pancreatic cancer and members with breast cancer who have family history of high-grade prostate cancer;  KFM updated to add: If the familial mutation is not one of the three Ashkenazi Jewish mutations, then known familial mutation analysis for that mutation should be performed in addition to the founder mutation panel. Criteria added to personal and family hx section under Initial breast cancer diagnosis at any age and one or more of the following: "A close blood relative (first-, second-, or third- degree) with a triple negative breast cancer (ER-, PR-, Her2-) occurring at age 60 or younger, and/or". Also updated the criteria for individuals with a personal history of high grade prostate cancer and additional family history to align with the new NCCN guidelines.Expanded diagnostic testing and known family mutation testing coverage to align more closely with current NCCN recommendations 
MOL.TS.135.ABRCA Ashkenazi Jewish Founder Mutation TestingCriteria Diagnostic Testing update: coverage expanded to personal history of high-grade prostate cancer without additional family historyExpanded diagnostic testing coverage to align more closely with current NCCN recommendations 
MOL.TS.150.A Chromosomal Microarray Testing For Developmental Disorders Administrative edits; Criteria change: allow for fetal loss at 20 weeks or later per ACOG and MFM Society rec (prev. 3rd trimester); Guidelines and evidence updated; references updatedCriteria for chromosome testing after fetal loss updated to align with ACOG and Maternal Fetal Medicine Society recommendations
MOL.TS.153.A ConfirmMDx for Prostate Cancer Risk AssessmentCriteria update: added HOXB13 (G84E mutation carriers) to list of genes associated with increased risk of prostate cancer per NCCN guidelines; Guidelines and Evidence and reference updates.Updated criteria to align with NCCN recommendations 
MOL.TS.158.A Cystic Fibrosis TestingCriteria update: Removed pancreatitis as an indication and entered note to direct reader to hereditary pancreatitis policy; removed redundant carrier testing criteria; clarified family history criterion for prenatal testing criteria, updated definition of intermediate sweat chloride to 30-59mmol/L in all age groups (per 2017 CFF guideline); additional admin updates, Test info and Guidelines and Evidence updates, reference updatesCriteria amended to 1) reflect creation of new pancreatitis guideline; 2) align with new clinical diagnostic criteria for sweat chloride levels in patients across all ages; 3) clarified other criteria 
MOL.TS.267.A Ehlers Danlos Syndrome TestingUpdated background; Reordered references; Criteria updated to clarify. Also added the following criterion as a covered indication for vEDS testing "Member has one minor criterion for vEDS and a family history of arterial rupture, colonic rupture, uterine rupture, or carotid-cavernous sinus fistula (CCSF)" Clarified that panel testing is addressed in the HCTD guidelines. Removed tiering of testing and updated sequencing to reflect that change. Verbiage changed from "Analysis" to "Sequencing".Criteria expanded for vascular EDS testing based on evidence review and recommendation of clinical expert.
MOL.TS.268.A Hereditary Connective Tissue Disorder TestingCPT code table updated; Admin edits; Updated criteria to clarify the non-covered indications and expanded indications for testing of individuals suspected of having a connective tissue disorderCriteria amended to include individuals suspected to have connective tissue disorder in addition to those with a diagnosis to more fully capture members who will benefit from change in medical management based on test results. Guideline was reviewed by national clinical expert.
MOL.CU.117.I Investigational and Experimental Molecular/Genomic TestingAdded Allosure; Added PCR Fungal Screen for Onychomycosis; removed CPT codes from text; Added test names and CPT codes to table at beginning of guideline; removed macula risk since we have test specific guideline; Also removed 87506 and 87507 since it is addressed by GIPP Claims Studio guideline. For all versions of I/E policy, added CPTs 0053U, 0055U, 0056U, 0057U and 0060U and associated test information.Added tests that are considered I&E based on evidence review (AlloSure); removed tests that now have criteria or are now addressed by a test-specific guideline (Macula Risk).
MOL.TS.193.A Li-Fraumeni Syndrome TestingUpdates to "sequence analysis" section. Version number and year updated in NCCN reference; Criteria: Added the following indication to diagnostic testing Individual with a tumor from LFS tumor spectrum and one or more biologic relatives (1st, 2nd, or 3rd degree) with a clinical diagnosis of LFS/LFL (according to criteria above) and no known family mutation or no testing to dateExpanded diagnostic testing criteria to include specific personal and family history combination as this was not included previously.
MOL.TS.198.ALynch Syndrome Tumor Screening - First-TierRemoved "Lynch Syndrome tumor screening may be considered for individuals with Lynch syndrome-related cancer according to the revised Bethesda criteria and guidelines from the National Comprehensive Care Network (NCCN)." and the list of LS cancers from criteria since it was not an actual list of criteria. NCCN guideline information updated.Removed redundant information in the criteria section. However, no change to criteria
MOL.TS.258.A Maturity-Onset Diabetes of the Young (MODY) TestingCriteria change: age at diagnosis changed from 25 or younger to younger than 35 years; background updated with new Gene Review; Policy format standardized; reference links updatedCriteria for age at diagnosis amended based on peer reviewed literature (25 to 35)
MOL.TS.209.A Non.Invasive Prenatal TestingAdded single gene testing into CPT code table; Criteria update: Clarified that microdeletion testing is I/E; added single gene testing is I/E. Rearranged the guidelines and evidence section. 1.In the Guidelines section, under the ISPD section (near the end), their is a statement that says "options 4-9 below", this was removed since the statement did not include 4-9.I&E classification of microdeletion NIPT clarified; Single Gene NIPT added as I/E per literature review
MOL.TS.251.APALB2 Genetic TestingCodes added under procedure table. Content added under g & e section. Content added under criteria for deletion/duplication testing. Updates to references.Added criteria for deletion/duplication testing 
MOL.TS.216.A Peutz-Jeghers Syndrome TestingCriteria section reformatted into our standard template, but no change to clinical coverage for testing; reference update.Criteria section restructured to align with standard format; no change in coverage
MOL.TS.217.A Prader-Willi Syndrome TestingCriteria Change: allow CMA or FISH for deletion analysis (previously FISH only) per updated Gene Review; Test info update, reference updatesPrevious test strategy document used as source for recommended/approvable tests was retired and not replaced; Criteria were amended to reflect current recommendations of expert authored review and disease advocacy society.
MOL.TS.197.A Lynch Syndrome Genetic TestingUpdated references and NCCN; Added the following criteria under other LS related cancers: Endometrial cancer diagnosed at any age with abnormal tumor testing indicative of a mutation in a mismatch repair geneTumor testing is performed on endometrial cancers. This criteria was updated to reflect possible results from tumor testing
MOL.TS.274.A Acute Myeloid Leukemia (AML) Genetic Testingadministrative edits; Updated CPT code table, added 0046U, 0049U, 0050U; removed eviCore name in billing and reimbursement consideration section and updated to say "the laboratory will be redirected to the appropriate panel code(s)."The language was updated to remain consistent with other guidelines. No changes to coverage criteria.
MOL.TS.261.A Brugada Syndrome Genetic TestingIncidence added. Verbiage updated. Criteria language updated "No previous sequence analysis of SCN5A"Criteria updated to clarify previous testing section
MOL.CU.111.A Genetic Testing for Non-Medical PurposesRemoved the language "Test-specific policies" from criteria from header since the list was not a list of actual policies. Also updated language to clarify that the testing is not reimbursable. Now says "The following types of testing are not considered medically necessary and therefore, not eligible for reimbursement:"Background information updates; Criteria language updated, but no changes to coverage.
MOL.CU.115.A Genetic Testing to Predict Disease RiskUpdated criteria: test specific guideline section to remove reference to guideline manualCriteria language updated, but no changes to coverage.
MOL.CS.105.ILaboratory Claim ReimbursementCPT code additions- MAAA up to 0013M, PLA up to 0060U, 0500T addded,G0464  deleted ; admin edits for clarification; criteria edits- reworded the following for clarity,edits did not change For Maximum Units per Date of Service-- 1.The allowable daily maximum units for a procedure code are not reliant on medical necessity policy. They may only be addressed in this table and nowhere else in any other policy. 2. Total billed units are calculated based on the combined number of times a procedure code is billed on a single date of service. This applies to codes billed with multiple units on a single claim line, units reported on separate claims lines on the same claim, or multiple units reported on separate claims for that date of service. All maximum unit rules are applied per date of service and do not allow additional units simply because they are billed on separate claim lines. For CCI Code Pair edits, 1. changed heading and criterion to reflect updated name " NCCI PTP Coding Edits" and 2. added "should commonly be billed together" for clarityCriteria amended for clarity purposes; no change to coverage
MOL.TS.202.A Marfan Syndrome Genetic TestingCriteria: updated for consistency only to include 'Rendering laboratory is a qualified provider of service per the Health Plan policy." ; guidelines and evidence and references updated.Criteria updated to align with eviCore standard; no change in coverage
MOL.TS.227.A Thoracic Aortic Aneurysms and Dissections (TAAD) Panel TestingCPT code table updated; CSANZ CV Genetic Dz Council guideline added; References updated; small clarifying addition to criteria language (KFM section) - no change operationally to criteriaCriteria updated to clarify language regarding known familial mutation testing, no change to coverage
MOL.CU.109.A Genetic Testing for Cancer Susceptibility and Hereditary Cancer SyndromesUpdated word "policy" to "guideline" and removed reference to list of test-specific guidelines in the guideline manual;Background information updates; Criteria language updated, but no changes to coverage.
MOL.CU.110.A Genetic Testing for Carrier StatusAdded language and applicable references. Added three references under Routine Carrier Screening section; Removed reference to list of test-specific guidelines in the guideline manuaBackground information updates; Criteria language updated, but no changes to coverage.
MOL.CU.112.AGenetic Testing for Prenatal Screening and Diagnostic TestingUpdated word "policy" to "guideline" and removed reference to list of test-specific guidelines in the guideline manual; Updated ACOG referenceBackground information updates; Criteria language updated, but no changes to coverage.
MOL.CU.113.A Genetic Testing for the Screening, Diagnosis, and Monitoring of CancerUpdated word policy to guideline and removed reference to list of test-specific guidelines in the guideline manualBackground information updates; Criteria language updated, but no changes to coverage.
MOL.CU.114.A Genetic Testing to Diagnose Non-Cancer ConditionsChanged verbiage from "carrier status" to "mutation status". Updated word "policies" to "guidelines" and removed reference to table of contents in guideline manual.Background information updates; Criteria language updated, but no changes to coverage.
MOL.TS.259.I ThyGenX and ThyraMIR miRNA Gene Expression ClassifierGuidelines and evidence updated; References updated; coverage criteria addedBackground information updates; coverage changed. Testing previously I/E. Now covered with criteria.
MOL.TS.270.IThyroSeqGuidelines and evidence updated; References updated; coverage criteria addedBackground information updates; Testing previously I/E. Now covered with criteria.

Background Updates only (no criteria updates):
Guideline ID
Guideline Name
Executive Summary of change 
Reasoning/evidence to support the change
MOL.TS.122.A Afirma Gene Expression Classifier for Thyroid CancerUpdated entire guideline to address GEC or GSC version of the Afirma classifier test; Guidelines and Evidence and References sections updated; no criteria changes affecting eligibility or reimbursement.Laboratory is in the process of transitioning test platforms; guidelines were updated to accommodate either platform during this time 
MOL.CS.106.A Genitourinary Conditions Molecular TestingGuidelines and evidence section added. No criteria changesBackground information updates; no criteria changes
MOL.TS.149.A Chromosomal Microarray for Prenatal DiagnosisAdministrative editsAdministrative edits only
MOL.TS.257.A Genetic Testing for EpilepsyGuidelines and Evidence updated; References Updated; Table in criteria updated to include guideline name and number. No criteria changes re eligibility for testing.Updated and expanded table within criteria; no change to eligibility
MOL.TS.125.AAmyotrophic Lateral Sclerosis (ALS) Genetic TestingBackground updated; references added and updated; table amended to include only the most common ALS genes; no criteria changesBackground information updates; no criteria changes
MOL.TS.240.A BCR-ABL Negative Myeloproliferative Neoplasm TestingUpdated NCCN guidelinesBackground information updates; no criteria changes
MOL.TS.131.A BCR-ABL Testing for Chronic Myeloid LeukemiaUpdated the year of the NCCN section. Updated the version and year of the NCCN reference in reference #2. added 0040U to CPT code tableCPT code updates; background information updates; no criteria changes
MOL.TS.133.A BRAF Testing for Colorectal CancerUpdated the year under the NCCN section. Updated referencesBackground information updates; no criteria changes
MOL.TS.138.ABRCA Sequencing for Drug Treatment Response in Ovarian CancerStatistics and reference updates; no criteria changesBackground information updates; no criteria changes
MOL.TS.248.B Breast Cancer Index for Breast Cancer PrognosisAdded St. Gallens Guidelines and updated referencesBackground information updates; no criteria changes
MOLTS.148.A Charcot-Marie-Tooth Neuropathy TestingCPT codes for known familial mutation analysis added to the table of procedures addressedCPT code updates; no criteria changes
MOL.TS.154.A Corus CAD for Obstructive Coronary Artery Disease)References updated only; no criteria changesBackground information updates; no criteria changes
MOL.TS.236.ACxbladderUpdated NCCN; added MAAA codes 0012M, 0013MCPT code updates; background information updates; no criteria changes
MOL.TS.155.A CYP2C19 Variant Analysis for Clopidogrel ResponseClinical Trials information added; no change in criteriaBackground information updates; no criteria changes
MOL.TS.156.A CYP2C9 and VKORC1 Testing for Warfarin ResponseCPT code added; Bullets added in first few sectionsCPT code updates; background information updates; no criteria changes
MOL.TS.157.A CYP2D6 Variant Analysis for Drug ResponseGuidelines and evidence updated; References updated; no criteria changesBackground information updates; no criteria changes
MOL.TS.254.A DecisionDX-Uveal MelanomaAdded NCCN Uveal Melanoma guideline; updated references; no criteria changesBackground information updates; no criteria changes
MOL.TS.234.A EndoPredict for Breast Cancer PrognosisUpdated Guidelines and evidence section and referencesBackground information updates; no criteria changes
MOL.TS.168.A Familial Adenomatous Polyposis TestingGuidelines and Evidence and reference update; no criteria changesBackground information updates; no criteria changes
MOL.TS.169.A Familial Hypercholesterolemia TestingReference links updatedBackground information updates; no criteria changes
MOL.TS.170.AFamilial Malignant Melanoma TestingNCCN version & year updated in the reference section.Background information updates; no criteria changes
MOL.TS.172.AFragile X Syndrome TestingTest Information, Guidelines and Evidence, and References updated; no criteria changes.Background information updates; no criteria changes
MOL.CU.246.A Hereditary (germline) testing after tumor (somatic) testingNCCN updated; Reference links updatedBackground information updates; no criteria changes
MOL.TS.182.A Hereditary Cancer Syndrome Multigene PanelsVersion number and year updated in NCCN reference.Background information updates; no criteria changes
MOL.CU.185.A HIV Tropism Testing for Maraviroc ResponseReference links updatedBackground information updates; no criteria changes
MOL.TS.187.A HLA-B*5701 Genotyping for Abacavir HypersensitivityUpdated language in backgound & updated reference links.Background information updates; no criteria changes
MOL.TS.189.A Hypertrophic Cardiomyopathy TestingGuidelines and evidence updated; References updated; no criteria changesBackground information updates; no criteria changes
MOL.CS.104.A Immunohistochemistry (IHC)Updated an NCCN reference.Background information updates; no criteria changes
MOL.TS.191.A KRAS Testing for Anti.EGFR Response in Metastatic Colorectal CancerGuidelines and Evidence and References updated; no criteria changesBackground information updates; no criteria changes
MOL.TS.192.A Leber Hereditary Optic Neuropathy (LHON) Genetic Testinggrammatical edits onlyAdministrative edits only
MOL.TS.194.ILiquid Biopsy Testing – Solid TumorsAdded 0011M to the CPT code tableCPT code updates; background information updates; no criteria changes
MOL.TS.196.A Long QT Syndrome TestingGuidelines and evidence updated: added 2015 ESC guideline; updated references; no criteria changesBackground information updates; no criteria changes
MOL.TS.199.ALynch Syndrome Tumor Screening -Second-TierUpdated NCCN reference; Updated guidelines and evidence sectionBackground information updates; no criteria changes
MOL.TS.200.I Mammaprint 70-Gene Breast Cancer Recurrence AssayUpdated Guidelines and Evidence section and ReferencesBackground information updates; no criteria changes
MOL.TS.201.A Mammostrat Breast Cancer Recurrence AssayAnnual update; no criteria changesannual updates; no criteria changes
MOL.TS.244.A Mitochondrial DNA Deletion Syndromesclarifying edits to backgroundBackground information updates; no criteria changes
MOL.TS.204.A Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS) Geneticmultiple admin edits to definition section; no criteria changesBackground information updates; no criteria changes
MOL.TS.243.A Mitochondrial Neurogastrointestinal Encephalopathy (MNGIE)Reference 3 updated with journal name and year updated to 2011; Updated background with clarifying informationBackground information updates; no criteria changes
MOL.AD.102.A Molecular Pathology Tier 2 Molecular CPT CodesAdmin editsAdministrative edits only
MOL.TS.206.A MUTYH Associated Polyposis TestingAdmin edits; Guidelines and evidence updated; Reference updates; no criteria changesBackground information updates; no criteria changes
MOL.TS.242.A Myoclonic Epilepsy with Ragged Red Fibers (MERRF)Updated to add clarifying language to backgroundBackground information updates; no criteria changes
MOL.TS.245.ANeurogenic Muscle Weakness, Ataxia, and Retinitis Pigmentosa (NARP)Background updated; admin edits; references updatedBackground information updates; no criteria changes
MOL.TS.208.A Niemann Pick, Type C Testingadmin edit in test information section for clarificationAdministrative edits only
MOL.TS.255.A OncotypeDX Breast DCISNCCN updated; added 0045U into CPT code tableCPT code updates; background information updates; no criteria changes
MOL.TS.211.I OncotypeDX for Breast Cancer PrognosisNCCN updated; References updatedBackground information updates; no criteria changes
MOL.TS.213.A OncotypeDX for Colorectal Cancer Recurrence RiskRemoved reference to Palmetto as well as text in document. Reference not available anymore; updated reference linksBackground information updates; no criteria changes
MOL.TS.215.A PCA3 Testing for Prostate CancerReference links updatedBackground information updates; no criteria changes
MOL.TS.223.A PTEN Hamartoma Tumor Syndromes TestingUpdated verbiage. Version number and year update in NCCN reference.Background information updates; no criteria changes
MOL.TS.264.A SelectMDxReferences updated only; no criteria changesBackground information updates; no criteria changes
MOL.TS.164.A Sept9 Methylation Analysis for Colorectal CancerStatistics updated; Guidelines and Evidence and references updated (NCCN added); no criteria changes.Background information updates; no criteria changes
MOL.TS.226.A Tay Sachs Disease TestingPrenatal enzyme activity testing removed from test information section (no longer offered); no criteria editsBackground information updates; no criteria changes
MOL.TS.228.A Tissue of Origin Testing for Cancer of Unknown PrimaryUpdated the years for some of the references (NCCN); updated CPT code descriptorsBackground information updates; no criteria changes
MOL.TS.229.A TPMT Testing for Thiopurine Drug ResponseReplaced reference. Updated Guidelines.Background information updates; no criteria changes
MOL.TS.230.A Tumor Marker Testing.Solid Tumorsadded 0048U MSK-impact to CPT table; Added FDA information for Foundation and Oncomine into Guidelines and evidence sectionCPT code updates; background information updates; no criteria changes
MOL.TS.231.A UGT1A1 Mutation Analysis for Irinotecan ResponseGuidelines and Evidence updated; References updated; no criteria changesBackground information updates; no criteria changes
MOL.AD.107.AUnique Test IdentifierMinor edits & an update to reference #1.Background information updates; no criteria changes
MOL.TS.233.A Von Hippel Lindau Disease TestingNew study added to Guidelines and Evidence; reference added; no criteria changesBackground information updates; no criteria changes
MOL.TS.222.A Prosigna Breast Cancer Prognostic Gene Signature AssayUpdated CPT code table name to reflect proprietary name instead of CPT code descriptionTo maintain consistency across guidelines
MOL.TS.266.A Mitochondrial Genetic TestingDeleted duplicate EFNS 2009 guideline; administrative edits; references updatedAdministrative edits 
MOL.TS.272.A Pharmacogenomic Testing Panels for Major Depressive DisorderAdministrative editsAdministrative edits
MOL.TS.235.AWhole Exome SequencingAdded "or preconceptual (utilizing in-vitro fertilization with preimplantation genetic diagnosis)" to background bullet; CPT code descriptors updatedBackground information updates; no criteria changes

Revisions From 06.02.52k:
10/01/2018This version of the policy is effective as of 10/01/2018.

Effective 10/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):
    0067U, 0069U, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0078U, 0079U

Effective 10/01/2018, the following procedure code has been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):
    0068U

Effective 10/01/2018, the following CPT code has been deleted from Attachment A for this policy because of their termination by AMA:
    0028U

Revisions From 06.02.52j:
07/02/2018Note: On 6/29/2018 this Notification was updated to reflect 07/01/2018 coding updates.

Effective 07/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

0045U, 0047U, 0048U, 0050U, 0053U, 0055U, 0056U, 0057U, 0060U

Effective 07/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0046U, 0049U

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This version of the policy will become effective on 07/02/2018.

On July 2nd, 2018, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the precertification and/or prepayment review processes starting on July 2nd, 2018. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.
07/02/2018 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52j)


Please note that this version of the update for the guidelines communicates, among other detailed changes, Company's continued noncoverage of the following test types, since they are experimental/investigational:
  • NuSwab®, Vaginitis Plus (VG+) (A vaginae, BVAB-2, Megasphaera Type 1)
  • OneSwab® (A vaginae, Megasphaera Type 1 and 2, BVAB-2)
  • SureSwab® Vaginosis, Vaginitis Plus (G vaginalis, A vaginae, Megasphaera species)

Executive Summary of Changes

There are 11 new guidelines. Twenty-eight have been revised (including criteria changes); however some of these were not major criteria changes. See the below table for details. Two guidelines were retired and one was replaced with a more comprehensive eviCore guideline.
Below is a summary of the guideline changes

New Guidelines:

1. Acute Myeloid Leukemia (AML) Genetic Testing
2. Mitochondrial Genetic Testing
3. Ehlers Danlos Syndrome Testing
4. Genetic Testing for Nonsyndromic Hearing Loss and Deafness
5. Hereditary Connective Tissue Disorder Testing
6. PancraGEN
7. Pharmacogenomic Testing Panels for Major Depressive Disorder
8. Polymerase Gamma (POLG) Related Disorders Genetic Testing
9. SensiGene Fetal RHD Genotyping
10. Molecular Gastrointestinal Pathogen Panel (GIPP) Testing
11. ThyroSeq

Retired Guidelines:

1. PathfinderTG (replaced with eviCore guideline PancraGEN)
2. ScoliScore for Adolescent Idiopathic Scoliosis Prognosis (test is no longer on the market)

Other Changes: (I/E = investigational & experimental) --

See the table below that follows:
Guideline ID​Guideline NameExecutive Summary of change Reasoning/evidence to support the change
MOL.TS.274.AAcute Myeloid Leukemia Genetic TestingNew Guideline; covered with criteriaThis testing has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.266.AMitochondrial Genetic TestingNew Guideline; covered with criteriaThis testing has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.267.AEhlers Danlos Syndrome TestingNew Guideline; covered with criteriaThis testing has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.273.AGenetic Testing for Nonsyndromic Hearing Loss and DeafnessNew Guideline; covered with criteriaThis testing has always been medically necessary when criteria are met; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.268.AHereditary Connective Tissue Disorder TestingNew Guideline; covered with criteriaThis testing has always been covered with criteria; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.271.APancraGENNew Guideline; maintains I/EThis testing has always been I/E and was previously marketed under the name Pathfinder TG. However, IBC deferred to their own policy. This guideline will replace IBCs PathfinderTG guideline.
MOL.TS.272.APharmacogenomic Testing Panels for Major Depressive DisorderNew Guideline; maintains I/EThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.TS.276.APolymerase Gamma (POLG) Related Disorders Genetic TestingNew Guideline; covered with criteriaThis testing has always been covered with criteria; however, it was previously addressed by a clinical use guideline. This is a test-specific guideline.
MOL.TS.275.ASensiGene Fetal RHD GenotypingNew Guideline; maintains I/EThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.CS.277.AMolecular Gastrointestinal Pathogen Panel (GIPP) TestingNew Claim Studio GuidelineNew guideline as volume for this test is increasing.
MOL.TS.270.AThyroSeqNew Guideline; maintains I/EThis testing has always been I/E. However, it was previously addressed by a clinical use guideline. This is a test specific guideline.
MOL.CU.118.IPharmacogenomic Testing for Drug Toxicity and ResponseAdded companion diagnostic testing criteria and information into the background; Added Catechol-O-Methyltransferase (COMT) Genotype from Mayo Clinic (CPT 0032U);Cytochrome P450 1A2 Genotype from Mayo Clinic (CPT 0031U);IFNL3 rs12979860 gene variant (CPT 81283);Focused Pharmacogenomics Panel from Mayo Clinic (CPT 0029U);Seratonin Receptor Genotype (HTR2A and HTR2C) from Mayo Clinic (CPT 0033U);Thiopurine Methyltransferase (TPMT) and Nudix Hydrolase (NUDT15) Genotyping from Mayo Clinic (CPT 0034U);Warfarin Response Genotype from Mayo Clinic (CPT 0030U) These are tests that have new tier 1 or PLA codes. Therefore, we specifically listed them in the criteria as being not reimbursable for clarity. The companion diagnostic testing information was added to clarify when this testing is appropriate; however, there was no change to how these cases are currently addressed.
MOL.TS.217.APrader-Willi Syndrome Testingone instance of "and" updated to "or" under FISH analysis in criteriaThe original intent was for this to be an "or" and not an "and". This was corrected.
MOL.TS.157.ACYP2D6 Variant Analysis for Drug ResponseAdded 0028U PLA code and then added "CYP2D6 Genotype Cascade Mayo Clinic (0028U) is considered investigational/experimental and, therefore, not eligible for reimbursement." to the exclusion sectionA new PLA code for this test was published and eviCore considers I/E. Therefore, the guideline was updated to reflect that determination.
MOL.TS.159.ADentatorubral Pallidoluysian Atrophy Testing Removed "examination by …." from criteriaeviCore removed this requirement (an examination by a specialist prior to testing) from many guidelines unless society recommendations included examinations by a specialist as a requirement prior to testing.
MOL.TS.163.AEGFR Testing for Non-Small Cell Lung Cancer TKI ResponseAdded "For patients whose disease progresses either on or after TKI therapy, repeat EGFR testing to identify the emergence of a T790M mutation may be considered to determine whether further treatment with osimertinib would be indicated." into criteria section. Background and references updatedThis is in line with FDA product labeling
MOL.TS.238.ABRCA AnalysisAdded personal history of metastatic prostate cancer as indication; changed AJ woman to say AJ individual since males would be eligible for testingNCCN updated their guidelines to include metastatic prostate cancer as an indication for BRCA Analysis. eviCore updated this guideline to reflect that change
MOL.CU.117.IInvestigational and Experimental Molecular/Genomic Testingadded general coverage guidance and reorganized the background sections; added the phrase "do not meet the above criteria and are not eligible for reimbursment" to the introductions to each test type in criteria; Added PAI-1. Removed 15U and 4UCurrent evidence reviews reflected I/E determinations for these specific tests so they were added to this guideline
MOL.TS.148.ACharcot-Marie-Tooth Neuropathy Testing PanelAdded information regarding various CMT testing to broaden guideline beyond panels. Updated the title to reflect the broader guideline. New title is Charcot-Marie-Tooth Neuropathy Testing. Updated CPT code table due to new panel code 81448.Single gene and narrow panel testing has always been medically necessary when criteria are met but was previously addressed by a clinical use guideline. This testing has been added to this test specific guideline for clarity. Large, broad panels are still considered I/E in most cases.
MOL.TS.130.AAtaxia Telangiectasia Removed examination by …. from criteriaeviCore removed this requirement (an examination by a specialist prior to testing) from many guidelines unless society recommendations included examinations by a specialist as a requirement prior to testing.
MOL.TS.198.ALynch Syndrome Tumor Screening - First TierUpdated Guidelines and Evidence section. Added Keytruda information into the background. Added criteria for individuals being considered for Keytruda usage. Removed age restriction for endometrial cancer in criteria sectionCriteria updates reflect current society recommendations, product labeling, and current standard of care
MOL.TS.135.ABRCA Ashkenazi Jewish Founder MutationAdded personal history of metastatic prostate cancer as indicationNCCN updated their guidelines to include metastatic prostate cancer as an indication for BRCA Analysis. eviCore updated this guideline to reflect that change
MOL.CS.106.ASexually Transmitted Infections: MolecularUpdated title to Genitourinary Conditions Molecular Testing to more accurately reflect the content of the guideline, added HIV positive status to indications for Chlamydia, and added more information about lack of evidence to support bacterial vaginosis testing as medically necessaryOne lab provider is being particularly persistent regarding appeals for BV. We wanted to provide additional clarifying statements in the guideline to support our clients during appeals. In addition, added HIV positive status to indications for asymptomatic chlamydia testing for clarity.
MOL.TS.251.APALB2 Genetic TestingUpdated title to PALB2 Genetic Testing for Breast Cancer Risk; updated CPT description to clarify that it is for sequencingThe title was updated to reflect the testing was for breast cancer rather than Fanconi anemia.
MOL.TS.161.ADuchenne & Becker Muscular Dystrophy TestingRemoved "Clinical Consultation" from header in criteria since that criteria was removed in a previous updateeviCore removed the criteria in a previous update; however the header was not removed.
MOL.TS.194.ILiquid Biopsy Testing –Solid TumorsAdded 81310 and 81270 to CPT code table at the topThese two genes were being seen in review of liquid biopsy cases for solid tumors. Therefore, we added them to the table at the top
MOL.TS.227.AThoracic Aortic Aneurysms and Dissections (TAAD) Panel Testing The following statement was added: "This guideline addresses testing specifically for TAAD. Additional indications are addressed in the ​Hereditary Connective Tissue Disorder Testing guideline.​"eviCore has a new guideline for hereditary connective tissue disorders. Given that the CPT codes may be the same, it was important to state in the TAAD guideline that additional indications were addressed in the other guideline
MOL.TS.230.ATumor Marker Testing Solid Tumors Updated table at the end to include Guideline IDsThis was to provide clarity regarding which guideline was relevant
MOL.TS.126.AAngelman Syndrome Testing Criteria: changed the title to the Known Familial Mutation section; however, neither criteria nor meaning changed; change personal history to Diagnostic Testing for Symptomatic Individuals in criteria section to stay consistent; separated out family history criteria into UBE3A and imprinting center defects to clarify. However, no criteria changes were made.Criteria was reorganized to make clearer; however, no criteria content changes were made
MOL.TS.146.ACeliac Disease Testing Removed "Consideration for genetic testing for celiac-associated HLA variants DQ2 and DQ8 is determined according to diagnostic guidelines from the American Gastroenterological Association, NIH Consensus Development Conference Statement on Celiac Disease, American College of Gastroenterology, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.2-5" from criteria section since it was redundant. This was redundant in the criteria section. We list the criteria and do not need to state where it came from since this information is in the guidelines and evidence section
MOL.TS.165.AExpanded Carrier Screening Panels Removed lab specific list since it they change so frequently; Added Guideline IDs into the coverage table for clarity. This was to provide clarity regarding which guideline was relevant
MOL.TS.182.AHereditary Cancer Syndrome Multigene PanelsAdded Guideline IDs into the coverage table for clarity.This was to provide clarity regarding which guideline was relevant
MOL.TS.248.BBreast Cancer Indexadded a missing "and" into criteria to clarifyThe intent was to have an "and" in this spot. Therefore, it was added for clarity
MOL.TS.257.AGenetic Testing for EpilepsyAdded Guideline ID's into the coverage table for clarity.This was to provide clarity regarding which guideline was relevant
MOL.TS.125.AAmyotrophic Lateral Sclerosis Genetic Testing CPT code table broader in nature; added "therefore, not reimbursable" to seq/del/dup criteria to clarify that it is not reimbursable.Minor updates; No changes to criteria
MOL.CS.105.ILaboratory Claim ReimbursementAdded a "supporting documents" section at the end of the document directing clients that supporting documents are available at a client specific linkAdded so that all of client's supporting resources are available at the same link. Please note that all of the supporting documents have not been added at this link yet.
MOL.TS.172.AFragile X Syndrome TestingAdded the word “unexplained” to the developmental delay criteria to clarify that testing in cases where there is a known cause for the developmental delay is not reimbursable. This was added to clarify criteria.
MOL.TS.214.IPathFinderTGRETIREDThis was an IBC guideline that was directly written from the current IBC policy. However, eviCore created a new guideline that will replace this. See PancraGEN guideline.
MOL.TS.2487.AScoliScore for Adolescent Idiopathic Scoliosis PrognosisRETIREDTest is no longer on the market
MOL.TS.123.AAlloMap Gene Expression Profiling for Heart Transplant RejectionMoved exclusions to end of criteria sections; placed frequency considerations to after tableMinor updates; No changes to criteria
MOL.TS.166.AFactor II/Prothrombin Testing for ThrombophiliaRemoved this paragraph from criteria "Consideration for Factor II (prothrombin) G20210A genetic testing for thrombophilia is determined according to guidelines from the American College of Medical Genetics, the College of American Pathology, the National Society of Genetic Counselors, and the American College of Obstetricians and Gynecologists. "This was redundant in the criteria section. We list the criteria and do not need to state where it came from since this information is in the guidelines and evidence section

Revisions From 06.02.52i:
04/01/2018This version of the policy is effective as of 04/01/2018.

Effective 04/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

0036U, 0037U, 0012M, 0013M

Effective 04/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

0040U

The following CPT codes have been deleted from Attachment A for this policy because of their termination by AMA:

0015U

The following CPT codes have been deleted from Attachment B for this policy because of their termination by AMA:

0004U

Revisions From 06.02.52h:
01/02/2018This version of the policy will become effective on 01/02/2018.
Below is a summary of the guideline changes

New Guidelines:

1. NETest
2. PALB2 Genetic Testing
3. DecisionDX-UM
4. OncotypeDX Breast DCIS
5. OncotypeDX for Breast Cancer Prognosis
6. Confirmatory Genetic Testing
7. Genetic Testing for Epilepsy
8. Maturity-Onset Diabetes of the Young (MODY) Testing
9. ThyGenX and ThyraMIR miRNA Gene Expression Classifier
10. Brugada Syndrome Genetic Testing
11. SelectMDx
12. ScoliScore for Adolescent Idiopathic Scoliosis Prognosis
13. EndoPredict for Breast Cancer Prognosis

Retired Guidelines:

1. DecisionDx-UM (IBC specific version)
2. Brugada Syndrome Known Familial Mutation Analysis
3. Brugada Syndrome Sequencing
4. Brugada Syndrome Multigene Panels
5. EndoPredict (IBC specific version)

Criteria Changes:

1. Sexually Transmitted Infections: Molecular
2. BRCA Sequencing for Drug Treatment Response - Ovarian Cancer
3. Investigational and Experimental Molecular/Genomic
4. CYP2D6 Variant Analysis for Tamoxifen, Tetrabenazine, or Eliglustat
5. Genetic Testing via Multi Gene Panels
6. Fragile X Syndrome Testing
7. Li-Fraumeni Syndrome Testing
8. DPYD Variant Analysis for 5-FU Toxicity
9. Whole Exome Sequencing
10. Hereditary Cancer Syndrome Multigene Panels
11. Molecular Pathology Tier 2 Molecular CPT Codes
12. Corus CAD for Obstructive Coronary Artery Disease
13. Alpha-1-Antitrypsin Deficiency Testing
14. AlloMap Gene Expression Profiling For Heart Transplant Rejection
15. Duchenne & Becker Muscular Dystrophy Testing
16. Angelman Syndrome Testing

Effective 01/01/2018, narratives for the following procedure codes have been revised in this policy due to coding updates:

81257, 81432, 81439

Effective 01/01/2018, the following procedure codes have been deleted in this policy due to coding updates:

87470, 87477, 87515

Effective 01/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment A for this policy and will be undergoing precertification and prepayment reviews through the vendor):

81230, 81231, 81232, 81238, 81249, 81259, 81269, 81283, 81328, 81335, 81346, 81361, 81363, 81364, 81448, 81520, 81521, 81541, 81551, 0026U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0011M

Effective 01/01/2018, the following procedure codes have been added in this policy due to coding updates (these codes have been added to Attachment B for this policy and will be undergoing prepayment reviews through the vendor):

81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81175, 81176, 81247, 81248, 81258, 81334, 81362, 87634, 87662, 0027U, 0500T

Effective 10/05/2017 this policy has been updated to the new policy template format.
1/1/2025
1/1/2025
06.02.52
Medical Policy Bulletin
Commercial
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No