Notification



Notification Issue Date:



Policy Attachment


Attachment to Policy # 06.02.35w


Attachment:C

Policy #:06.02.35w

Description:Services that are Considered Experimental/Investigational

Title:Genetic Testing (Independence Administrators)


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 following procedure codes and genetic testing services are considered experimental/investigational and, therefore, not covered. The peer-reviewed literature does not support at least one of the following for the testing:
  • The analytical validity and/or
  • The clinical validity and/or
  • Direct effect on the management and clinical care of the individual being tested based upon the test's results (i.e. clinical utility).
Code
81227
81230
81231
81291
81355
G9143
S3800
S3852
S3861
0004M
0006M
0007M

Tier 02 CPT codes, (81400 - 81408), for molecular diagnostic services are nonspecific in nature. The individual tests, (not an all-inclusive list), listed in this table may be reported with Tier 02 genetic testing CPT codes. These tests are considered experimental/investigational and, therefore, not covered. The peer-reviewed literature does not support at least one of the following for the testing:
  • The analytical validity and/or
  • The clinical validity and/or
  • Direct effect on the management and clinical care of the individual being tested based upon the test's results (i.e. clinical utility).
Tier 02 CPT CodeTests
81400LCT (lactase-phlorizin hydrolase) (eg, lactose intolerance) 13910 C>T variant
81400N48K variant DPYD (dihydropyrimidine dehydrogenase) (eg, 5-fluorouracil/5-FU and capecitabine drug metabolism)
81401TYMS (thymidylate synthetase) (eg, 5-fluorouracil/5-FU drug metabolism)
81406full gene sequence PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer)

These tests are considered experimental/investigational and, therefore, not covered. The peer-reviewed literature does not support at least one of the following for the testing:
  • The analytical validity and/or
  • The clinical validity and/or
  • Direct effect on the management and clinical care of the individual being tested based upon the test's results (i.e. clinical utility).

This list represents services that are considered E/I but lack a specific CPT or HCPCS code. Because Not Otherwise Classified (NOC), unlisted, and miscellaneous codes can be reported with many services, the intent of this section is to provide direction only for the specific genetic testing services listed below.
NOC, Unlisted,Miscella-neous
Code(s)
Name or Type of Tests
81479
84999
89240
Whole Exome Sequencing
81479
84999
89240
Genome-Wide (or Whole-Genome) Scanning/Sequencing (other than when specifically considered medically necessary in this medical policy)
81479
84999
89240
Mitochondrial DNA (mtDNA) Whole-Genome Scanning/Sequencing
81599
81479
84999
89240
MitoMet® Mitochondrial/Metabolic Microarray Analysis
81599
81479
84999
89240
NuclearMitoDx™ (formerly MitoNucleomeDx)
81599
81479
84999
89240
Mitochondrial Disorders Panel
81599
81479
84999
89240
BreastNext™ Next-Gen Cancer Panel
81599
81479
84999
89240
OvaNext™ Next-Gen Cancer Panel
81599
81479
84999
89240
ColoNext™
81599
81479
84999
89240
CancerNext™ Next-Gen Cancer Panel
81599
81479
84999
89240
Counsyl Universal Genetic Test


These tests are considered experimental/investigational and, therefore, not covered. The peer-reviewed literature does not support at least one of the following for the testing:
  • The analytical validity and/or
  • The clinical validity and/or
  • Direct effect on the management and clinical care of the individual being tested based upon the test's results (i.e. clinical utility).

Code
81504


This list represents services that are considered E/I but lack a specific CPT or HCPCS code. Because Not Otherwise Classified (NOC), unlisted, and miscellaneous codes can be reported with many services, the intent of this section is to provide direction only for the specific genetic testing services listed below.

NOC, Unlisted,Miscella-neous
Code(s)
Tests
84999
88299
Oncotype DX Colon Cancer Assay
For more information on this test, see the Multigene Expression Assays for Predicting Recurrence in Colon Cancer policy 06.02.32.
81599
81479
84999
89240
  • Cancer Type ID
  • Pathwork
81479GeneSight Psychotropic panel by Assurex Health
81599
81479
84999
89240
Corus CAD

Miscellaneous
Code
0011M
0012M
0013M
0005U
0008U
0009U
0010U
0013U
0014U
0018U
0019U
0026U
0029U
0030U
0031U
0032U
0033U
0034U
0036U
0037U
0045U
0047U
0048U
0050U
0053U
0055U
0056U
0060U
0067U
0068U
0069U
0078U
0079U
0086U
0087U
0088U
0089U
0090U
0094U
0097U
0099U
0100U
0101U
0102U
0103U
0109U
0111U
0112U
0113U
0114U
0115U
0118U
0120U
0129U
0130U
0131U
0132U
0133U
0134U
0135U
0136U
0137U
0138U
0140U
0141U
0142U
0151U
0152U
0153U
0156U
0157U
0158U
0159U
0160U
0161U
0162U
81283
81327
81328
81346
81410
81411
81415
81416
81417
81422
81425
81426
81427
81430
81431
81435
81436
81440
81445
81448
81450
81455
81460
81465
81470
81471
81542
87506
87507
81432
81433
81434
81437
81438
81442
81493
81525
81540
81541
87623




Version Effective Date: 01/01/2020
Version Issued Date: 12/31/2019
Version Reissued Date: N/A

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