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Updated Lab Management Clinical Guidelines

December 1, 2020

Effective January 1, 2021, updated Independence Lab Management Clinical Guidelines will be used by eviCore healthcare (eviCore), an independent company.

Independence requires precertification and/or prepayment coverage reviews through eviCore for genetic/genomic tests, certain molecular analyses, and cytogenetic tests for all commercial Independence members. eviCore will use the updated Lab Management Clinical Guidelines to determine the medical necessity for these tests. For the current guidelines, go to eviCore's Independence Resources web page.

New policy for the eviCore Lab Management Program for Medicare Advantage members

As a reminder, effective January 1, 2021, Independence is expanding its utilization management program for genetic/genomic tests, certain molecular analyses, and cytogenetic tests for all Independence Medicare Advantage members. We are working with eviCore healthcare (eviCore), an independent specialty benefit management company, to manage precertification and/or prepayment coverage reviews for these tests.

For more information on the program, please refer to the following Medicare Advantage policy #MA06.034: eviCore Lab Management Program, which was posted as a Notification on December 1, 2020, and will go into effect on January 1, 2021.

To view the Notification for this policy, visit our Medical and Claim Payment Policy Portal.

Lab management policy and guidelines

You can now review Medical Policy #06.02.52s: eviCore Lab Management, which was posted as a Notification on December 1, 2020, and goes into effect January 1, 2021. The policy includes a summary of the guideline changes and a link to the Lab Management Program Clinical Guidelines that eviCore uses during the precertification and prepayment review processes, as well as a listing of procedure codes that require precertification and/or prepayment review.

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

To view the Notification for this policy, visit our Medical and Claim Payment Policy Portal.

Requesting precertification

You can initiate precertification for genetic/genomic tests in one of the following ways:

  • NaviNet® web portal. Select eviCore from the Authorizations option in the Independence Workflows menu.
  • Telephone. Call eviCore directly at 1-866-686-2649.

Summary of Lab Management Clinical Guidelines changes effective January 1, 2021

There are five new guidelines. Thirty-four existing guidelines have been revised (including 21 with substantive criteria changes). Fifteen guidelines were retired.

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

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