Venous and Arterial Thrombosis Risk Testing
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Laboratory coverage and reimbursement criteria for testing related to venous and arterial thrombosis risk (including protein C, protein S, antithrombin III, and select genetic testing) for Blue Cross Blue Shield of Illinois members and participating providers.
New policy establishing reimbursement criteria for venous and arterial thrombosis risk testing.
Coverage Criteria — Venous and Arterial Thrombosis Risk Testing
Reimbursable Indications — Protein C/S/Antithrombin testing
Plasma testing for protein C, protein S, and antithrombin III deficiency may be reimbursable for individuals without recurrent VTE risk factors when ANY of the following apply:
Assays should be performed at least 6 weeks after the acute thrombotic event and while the patient is not taking anticoagulants; perform plasma assays of amount and function prior to any molecular testing.
Reimbursable Indications — Specific clinical syndromes
Other reimbursable specific situations:
Assays should be performed at least 6 weeks after the acute thrombotic event and while the patient is not taking anticoagulants; perform plasma assays of amount and function prior to any molecular testing. Genetic testing for Factor V Leiden and Prothrombin G20210A is recommended in addition to plasma testing when hereditary thrombophilia is suspected.
Plasma testing for protein C, protein S, and antithrombin III deficiency may be reimbursable for individuals without recurrent venous thromboembolism (VTE) risk factors when any one of several clinical scenarios is met. Reimbursable scenarios include: individuals 50 years of age with any deep venous thrombosis (DVT); DVT occurring in unusual sites (for example, hepatic, mesenteric, or cerebral veins); DVT with a strong family history of thrombotic disease; DVT in individuals who are pregnant or taking oral contraceptives; first- and second-degree relatives of individuals with DVT before age 50; women under 50 who smoke and have had a myocardial infarction; targeted testing before starting oral contraceptives when indicated by personal or family history of DVT; and pediatric patients with arterial ischemic stroke. Assays for protein C, protein S, and antithrombin III for warfarin-induced skin necrosis or neonatal purpura fulminans may also be reimbursable.
Explicit non-reimbursable items include venous thrombosis risk testing for superficial venous thrombosis (including superficial thrombophlebitis and varicosities), all activated protein C/aPC resistance assays, and DVT risk testing as part of a pre-transplant evaluation. These specific exclusions reflect the policy position that such testing is not considered medically necessary under this coverage criteria and may be denied if submitted.
Covered Indications and Recommended Testing
Evaluation for inherited or acquired thrombophilia; warfarin-induced skin necrosis or neonatal purpura fulminans
Evaluation for inherited or acquired thrombophilia is covered when at least one of the reimbursable clinical scenarios applies; testing for warfarin-induced skin necrosis or neonatal purpura fulminans is also covered as noted.
Genetic testing for Factor V Leiden and Prothrombin G20210A is recommended in addition to plasma testing when hereditary thrombophilia is suspected. Plasma assays should be performed at least 6 weeks after the acute event and while the patient is not on anticoagulants; perform plasma amount and function assays prior to molecular testing.
Procedure and Billing Codes
Provider Actions, Documentation, and Billing Notes
Reimbursement and coding note — Plan applicability
The Plan has implemented certain lab management reimbursement criteria. Not all requirements apply to each product. Providers should verify member coverage and review Plan documents for eligible coverage for services rendered.
- Not all lab management reimbursement criteria apply to every product — check the member's plan documents (Certificates of Coverage, benefit booklets, Summary Plan Descriptions) for applicability.
PROVIDER ACTIONS — general responsibilities
Providers are responsible for submission of accurate documentation of services performed and for ensuring claims are coded using current, valid code sets. Submit supporting clinical documentation upon request.
- Use HIPAA-approved code sets (CPT, HCPCS, ICD-10-CM/PCS, NDC) and follow national coding guidance (AMA CPT, CMS NCCI, UB, CPT Assistant).
- Claims are subject to code edit protocols and plan, contract, and policy review; additional documentation may be requested.
- If a conflict exists between this policy and the member's plan document or provider contract, the plan document or provider contract governs, respectively.
PROVIDER ACTIONS — documentation for plasma assays
Providers must submit accurate and complete documentation and coding for plasma assays when seeking reimbursement for testing related to protein C, protein S, and antithrombin III deficiencies.
- Document timing of testing relative to the acute thrombotic event — assays should be performed at least 6 weeks after the event and while the patient is not on anticoagulants (see Note 1).
- Indicate whether assays are for amount or function and provide results prior to any molecular/genetic testing.
- Include relevant clinical history: age at event, site of thrombosis (e.g., unusual sites), family history (first- or second-degree relatives), pregnancy or contraceptive use, smoking history, presence of warfarin-induced skin necrosis or neonatal purpura fulminans, and whether testing is part of pre-transplant evaluation.
- Include any prior genetic testing for Factor V Leiden and Prothrombin G20210A when applicable.
PROVIDER ACTIONS — claims and denial guidance for venous thrombosis testing
Claims for venous thrombosis risk testing for superficial venous thrombosis (including superficial thrombophlebitis and varicosities), all activated protein C/aPC resistance assays, and DVT risk testing as part of a pre-transplant evaluation are not reimbursable. Providers should expect denials for these services unless plan documents explicitly state otherwise.
- Venous thrombosis risk testing for superficial venous thrombosis is not reimbursable.
- All activated protein C/aPC resistance assays are not reimbursable.
- DVT risk testing performed as part of a pre-transplant evaluation is not reimbursable.
- When submitting claims for covered thrombophilia testing, include clinical justification aligning with reimbursable indications (e.g., age <50 with DVT, DVT in unusual sites, strong family history, pregnancy or oral contraceptive use with DVT, first- or second-degree relatives of individuals with early DVT, women <50 who smoke with MI, pediatric arterial ischemic stroke, warfarin-induced skin necrosis, neonatal purpura fulminans).
Testing Frequency and Timing Requirements
Not Covered / Exclusions
The following tests and situations are considered not reimbursable / not medically necessary under this policy: testing for superficial venous thrombosis (including superficial thrombophlebitis and varicosities); activated protein C/aPC resistance assays (all such assays); and DVT risk testing performed as part of a pre-transplant evaluation. Claims submitted for these tests or contexts may be denied.
Background and Clinical Context
Inherited and acquired thrombophilias can increase the risk of venous and arterial thrombosis. Testing approaches described in this policy include plasma functional and antigen assays for protein C, protein S, and antithrombin III, and targeted genetic testing when hereditary thrombophilia is suspected. The policy notes that assay timing affects validity (for example, assays should be performed at appropriate intervals relative to the acute event and anticoagulant use), and that plasma assays should be performed prior to molecular testing.
Definitions
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