Notification

eviCore Lab Management Program (Independence)


Notification Issue Date: 11/30/2018

This 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 (in the POLICY HISTORY Section).

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

See the tables below that follow in the POLICY HISTORY Section below (which provide more details for the guideline changes).


Medical Policy Bulletin


Title:eviCore Lab Management Program (Independence)

Policy #:06.02.52l

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, 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 decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions and limitations of the member’s contract.

PRECERTIFICATION/PREAPPROVAL

The Company requires precertification/preapproval 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 precertification/preapproval. In addition to the requirement for precertification/preapproval, the procedure codes listed in Attachment A will undergo prepayment review.

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 REVIEW

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 through CareCore National, LLC d/b/a eviCore healthcare (eviCore).

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 review. The procedure codes listed in Attachment B do not require precertification/preapproval.

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: https://www.evicore.com/healthplan/IBC.

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 precertification and/or prepayment review as follows:
  • Precertification/preapproval 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 determination 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 Obstetrics 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: https://www.evicore.com/healthplan/IBC Accessed November 27th, 2018.





Coding

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

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

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

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

CPT Procedure Code Number(s)

See Attachments A and B


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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


Cross References

Attachment A: eviCore Lab Management Program (Independence)
Description: Procedure Codes Requiring Precertification/Preapproval and Prepayment Review

Attachment B: eviCore Lab Management Program (Independence)
Description: Procedure Codes Requiring Prepayment Review




Policy History

Revisions for 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 for 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 for 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

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

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 IDGuideline 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 for 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 for 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.


Version Effective Date: 01/01/2019
Version Issued Date: 12/31/2018
Version Reissued Date: N/A

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