Commercial Medical Policy Update for September 4, 2024

Reviewed by Avalon 2nd Quarter 2024 CAB. 

Description, Related Policies, Policy Guidelines, and References updated. Removed “Postnatal” from when covered #3 for clarity. Added 3.D to when covered: “For individuals with a suspected inherited seizure disorder”. Updated when not covered as follows for clarity: “Postnatal CMA testing is considered not medically necessary when a chromosomal trisomy is suspected.” Removed 96040 and S0265 from Billing/Coding section. Medical Director review 7/2024.

Deleted terminated CPT code 0354U from Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated related policies, policy guidelines and references. Edited “when covered” statement #3 for clarification and Note 4. Added PLA codes 0113U and 0403U to Billing/Coding section.

Code 0444U added to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Proposal for archival.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. No change to policy statement. Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated description, policy guidelines and reference sections. Added Note 1.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. No change to policy statement. Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Policy Guidelines and References updated. When Covered section edited to remove erroneous second reference to Note 1 from coverage criteria 1. Note 1 updated from the 23 variants previously recommended by ACMG to now reference to the 2023 ACMG recommended 100 common variant set. Now reads: “Note 1: Common variant testing for CFTR mutations must include the American College of Medical Genetics’ (ACMG) CFTR carrier screening variant set (n=100). Please see the “Guidelines and Recommendations” section of this policy for a table of ACMG’s CFTR minimum variant set.” Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. Codes 90640 and S0265 removed from Billing/Coding section, Note 2 under When Covered section updated to reflect changes to definition of a genetic panel within R2162. Now reads: “Note 2: For 2 or more gene tests being run on the same platform, please refer to Laboratory Procedures Medical Policy AHS - R2162.” Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated list of Related Policies. Removed Table of Terminology. Note 1 and Policy Guidelines updated.  No change to policy intent. References updated. Medical Director review 7/2024. References added.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Policy Guidelines and References. Note 2 in When Covered section updated to now read: “For 2 or more gene tests being run on the same platform, please refer to AHS-R2162 Laboratory Procedures Medical Policy.” No change to policy statement. Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Description, Policy Guidelines and References updated. When Covered section edited for clarity, no change to policy statement. Updates to Billing/Coding section: codes 90640 and S0265 removed, note updated to reflect changes to definition of a genetic panel within R2162. Now reads: “Note: For 2 or more gene tests being run on the same platform, please refer to Laboratory Procedures Medical Policy AHS - R2162.” Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. Note 1 under When Covered section updated to reflect changes to definition of a genetic panel within R2162. Now reads: “Note 1: For 2 or more gene tests being run on the same platform, please refer to Laboratory Procedures Medical Policy AHS - R2162.” Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. No change to policy statement. Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. Updates to When Covered section: added “or family history” to coverage criteria 2.b., now reads: “b. For an individual with a personal or family history of pediatric hypodiploid acute lymphoblastic leukemia.” , added new coverage criteria 2.c.: “c. For individuals who have been diagnosed with any cancer before 30 years of age and for whom a pathogenic or likely pathogenic TP53 variant has been identified on tumor-only genomic testing.” Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References.  Removed codes 96040 and S0265 from the Billing/Coding section. New Note 2 added to the When Covered section: “Note 2: For 2 or more gene tests being run on the same platform, please refer to AHS-R2162 Laboratory Procedures Medical Policy.” No change to policy statement. Medical Director review 7/2024.

Reviewed by Avalon Q2 2024 CAB. Updated related policies, policy guidelines and references. Under “when covered” section, added coverage criteria statement #2. Edited Note 2 to clarify 2 tests. Added CPT code 81404 to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Added related policies section. Under “When Covered” section, added coverage criteria #3 item b; edited and added items #3 item d. i.-v. Added Note 3, edited Note 2. Updated policy guidelines and recommendations. Deleted CPT codes 96040, S0265 from Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Description, Policy Guidelines and References sections updated. Codes 96040 and S0265 removed from Billing/Coding section. Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Policy Guidelines and References updated. Genetic Counseling section renamed to Genetic Counseling Considerations and updated to state: "Reimbursement of genetic counseling is outside the scope of BCBSNC lab policies. However, reimbursement of some genetic testing may be dependent on genetic counseling having been performed: any genetic counseling provided will be considered during review of a health plan laboratory policy where genetic counseling is a required component. Genetic counseling documentation consists of written documentation of the counseling elements provided to the member. General expectations that should be documented with genetic counseling include explanation of the following: the testing process, what the tests can and cannot do, and how well the tests work. Furthermore, discussion should include what different results mean to the tested individual, including discussing how knowing the test results may affect the individual’s emotions and mental health, as well as how knowing the results may affect the individual’s family. Additionally, diagnostic and treatment options based on results should be discussed. Ideally, when a multigenerational family history is available, this history should be documented and summarized." Panel Reimbursement section updated to include definition of a genetic panel and coding considerations were added and/or adjusted. Added new bullet point 2: “Multi-gene panels must contain the genes specified in the AMA CPT coding description.” Former bullet 2, now bullet 3, updated. Previously read: “If there is not a specific next generation sequencing (NGS) procedure code that represents the requested test, the procedure may be represented by a maximum of ONE unit of 81479 [unlisted molecular pathology procedure] (i.e., 81479 X 1 should account for all remaining gene testing) OR all genes tested on the panel must be represented by ALL appropriate Molecular Pathology Tier 1 or 2 procedure codes (with exception of 81479 x 1 only being listed once if it appropriately represents more than one gene in the panel).” Now reads: “If there is not a specific next generation sequencing (NGS) procedure code that represents the requested test, a maximum of ONE unit of 81479 [unlisted molecular pathology procedure] may be billed.” Former bullet 4, now bullet 5, updated. Previously read: “If ALL codes that represent the testing of the panel are not submitted, reimbursement is not allowed due to incorrect coding process, as neither laboratory nor clinical reviewer should assign meaning to incomplete unspecified panel codes.” Now reads: “If incorrect codes are submitted to represent panel testing, reimbursement is not allowed for ALL codes submitted due to incorrect coding process.” Medical Director review 7/2024.

Added PLA code 0453U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Under “When Covered” section added coverage criteria #2 item f. Updated related policies section, policy guidelines and added references. Extensive updates to guidelines and recommendations section. Added new notes 2 and 3. Added CPT codes 0474U and 0475U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated related policies, Note 2 table, policy guidelines, recommendations and references. Added PLA codes 0473U, 0409U, 0329U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated related policies and policy guidelines. Added PLA codes 0467U and 0470U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated policy guidelines and references. Edited Note.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024.Updated description, policy guidelines and references. Updated related policies section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Description, policy guidelines, and references updated. No change to policy statement. Medical Director review 7/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Description, Policy Guidelines and References sections updated. New coverage criteria number 14 added to When Covered section: “When formulary coverage allows a pharmacotherapy that is dependent on a known genetic status (e.g., APOE testing prior to lecanemab-irmb treatment), gene specific testing is considered medically necessary.” Code 81406 added to Billing/Coding section. Medical Director review 7/2024.

Added PLA code 0454U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated policy guidelines and references. Edited Note. Under “when covered” section, added coverage criteria item h.

Reviewed by Avalon Q2 2024 CAB. Medical Director review 7/2024. Updated related policies, policy guidelines, guidelines and recommendations. Edited “when not covered” section for clarity and edited Note. Added PLA code 0471U.

Reviewed by Avalon Q2 2024 CAB. Medical Director review 7/2024. Updated related policies, policy guidelines and references. Updated Note from 5 to 2 tests. Added PLA code 0448U to Billing/Coding section.

Updated when covered section to decrease age requirement from 18 years and older to 15 years and older based on recent FDA guidelines. Changed “patient” to “individual” throughout the policy. Medical Director review 8/2024.

Reviewed by Avalon 2nd Quarter 2024 CAB. Updated Description, Policy Guidelines, and References. No change to policy statement. Medical Director review 7/2024.

Added CPT codes 0452U and 0465U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2024 CAB. Medical Director review 7/2024. Updated related policies, policy guidelines and references.

When Covered section criteria I. a) edited for clarity and now reads: “Individual has a temporary contraindication to receiving an implantable cardioverter defibrillator (ICD) or has had an ICD removed for a systemic infectious process or other temporary contraindication, and ICD placement will be scheduled once the temporary contraindication is treated or managed”. No change to policy statement. Medical Director review 8/2024.