CPT Code 0345U for GeneSight Testing
CPT code 0345U is not the appropriate code for GeneSight testing. The evidence provided does not reference CPT code 0345U in relation to GeneSight pharmacogenomic testing, and this specific code does not appear in any of the available guidelines or research literature regarding GeneSight billing 1.
Understanding GeneSight Coding
GeneSight testing should be billed using the appropriate molecular pathology or proprietary laboratory analysis (PLA) codes designated specifically for this test by the American Medical Association. The coding landscape for molecular diagnostics has evolved significantly, with the AMA's CPT Editorial Panel developing specific codes for pharmacogenomic testing that include all analytical services performed 1.
Key Coding Principles
Molecular diagnostic tests require specific CPT codes that account for the complexity of the testing, not generic procedure codes 1.
The current coding system has moved away from "stacked coding" (billing for individual procedures) toward comprehensive codes that capture the entire test 1.
Inclusion of a code in the CPT manual does not automatically guarantee insurance coverage or reimbursement - medical necessity must still be demonstrated 1.
Billing Requirements for Pharmacogenomic Testing
All molecular tests must be supported with medical necessity using appropriate diagnostic codes (ICD-10), and specific documentation in the medical record is necessary to provide support for the test 1.
Documentation Essentials
Document the clinical indication for testing (e.g., treatment-resistant depression, adverse medication reactions) 2, 3.
Include evidence of failed medication trials or significant side effects that justify pharmacogenomic testing 4, 5.
The billing physician must certify that services were personally furnished or supervised, which has implications for how the test interpretation is billed 1.
Coverage and Reimbursement Considerations
Coverage for pharmacogenomic testing varies significantly between Medicare, Medicaid, and private insurers, with no uniform policy 1.
Payer-Specific Issues
Medicare and private insurers evaluate whether the test provides more accurate diagnostic information and improves health outcomes before determining coverage 1.
Pharmacogenomic tests may require prior authorization or may only be covered in specific clinical contexts 1.
Some insurers may require testing to occur within clinical trials or under coverage with evidence development (CED) frameworks 1.
Common Pitfalls to Avoid
Do not use generic laboratory codes or incorrect CPT codes, as this will result in claim denials and potential compliance issues 1.
Verify the specific CPT or PLA code designated for GeneSight testing with the test manufacturer or current CPT manual 1.
Avoid billing for services not actually performed or supervised - this constitutes a false claim 1.
Ensure that any split interpretation arrangements (if involving multiple providers) are properly structured to comply with Anti-Kickback Law and Stark Law requirements 1.
Check with individual payers regarding their specific coverage policies for GeneSight testing before ordering, as policies vary widely 1.