Antiprothrombin Antibody Testing
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This policy governs coverage of antiprothrombin antibody testing (laboratory tests for antibodies to prothrombin and related phosphatidylserine/prothrombin complex) for Aetna members; it states Aetna's coverage stance and provides supporting background and references for clinicians and reviewers.
No material clinical or coverage changes in this revision.
Coverage Determination
inv-01: Not covered — experimental and investigational
Covered when ALL of the following are met:
Policy statement
Aetna considers antiprothrombin antibody testing experimental and investigational because its clinical value has not been established. Accordingly, antiprothrombin antibody testing is not eligible for coverage or reimbursement under this policy.
Studies of phosphatidylserine-dependent antiprothrombin antibodies (aPS/PT) report mixed findings regarding clinical utility. For example, Sugiura-Ogasawara et al. (2004) concluded that aPS/PT antibodies are not useful markers for high-risk women with recurrent miscarriages, while other reports have explored associations with pregnancy loss and potential diagnostic value but without consensus across studies.
Because the clinical significance and reproducibility of antiprothrombin antibody assays remain unestablished, testing for antiprothrombin antibodies is deemed investigational and is not considered medically necessary for diagnosis, risk stratification, or management decisions.
Clinical Contexts Studied
inv-20: Clinical contexts where antiprothrombin or aPS/PT antibodies have been studied (APS, thrombosis, pregnancy loss), background on study settings
Clinical contexts in which antiprothrombin or phosphatidylserine-dependent antiprothrombin (aPS/PT) antibodies have been studied include the following:
Background: APS features and antibody testing
British Committee for Standards in Haematology commentary on specificity
Mixed study findings and guideline recommendation
FIRMA collaborative study on assay variability
inv-21: Evaluation for antiphospholipid syndrome, thrombotic risk assessment, and investigation of recurrent pregnancy loss as addressed in cited literature and guidelines.
Literature and guideline-based considerations relevant to evaluation for antiphospholipid syndrome (APS), thrombotic risk assessment, and recurrent pregnancy loss:
References: British Committee for Standards in Haematology; ACOG (2005); listed references
Inter-laboratory discordance and reproducibility concerns
Conflicting obstetric study results
Policy conclusion and references
Relevant Codes
| 85300-85306 | Clotting inhibitors or anticoagulants; antithrombin III, activity, antithrombin III, antigen assay, protein C, antigen, protein C, activity, protein S, total, or protein S, free. |
| 86147 | Cardiolipin (phospholipid) antibody, each Ig class. |
| 86148 | Anti-phosphatidylserine (phospholipid) antibody. |
| 86880 | Antihuman globulin test (Coombs test); direct, each antiserum. |
| D68.61 | Antiphospholipid syndrome. |
| N96 | Recurrent pregnancy loss. |
| O26.20-O26.23 | Pregnancy care for patient with recurrent pregnancy loss. |
Provider Responsibilities & Billing Notes
Coding References for Test Claims
Providers should report tests using the CPT/HCPCS codes listed for antiphospholipid and related antibody testing. When submitting claims, include the most specific code available and any required modifiers or diagnosis pointers.
- Report the most specific CPT/HCPCS code from the list when performing antiphospholipid/antiprothrombin-related testing.
- Include relevant ICD-10 diagnosis codes (e.g., D68.61, N96, O26.20–O26.23) to support medical necessity where applicable.
Denial Risk for Experimental Testing
Aetna considers antiprothrombin antibody testing experimental and investigational because its clinical value has not been established. Claims for testing deemed experimental/investigational may be denied.
- Testing for antiprothrombin antibodies is classified as experimental/investigational under this policy.
- Expect reimbursement denials when services are billed for antiprothrombin antibody testing without coverage justification.
Provider Responsibility & Coverage Enforcement Note
Clinical Policy Bulletins assist in administering plan benefits and do not constitute medical advice or a description of complete plan benefits. Treating providers are responsible for medical advice and treatment decisions.
- Use the CPB as a reference for coverage policy; verify member plan specifics and prior authorization requirements separately.
- Document clinical rationale and relevant diagnoses when submitting claims for review.
Who May Order & Ordering Notes
Ordering authority not specified in policy excerpts
The policy excerpts do not define who may order antiprothrombin antibody testing; the document focuses on testing modality and evidence rather than ordering-provider restrictions.
No provider-type ordering restrictions stated
No specific ordering-provider restrictions are listed in the provided excerpts.
Tests Not Covered
Antiprothrombin antibody testing — including assays for antibodies to prothrombin and the phosphatidylserine–prothrombin (PS/PT) complex — is considered not covered because it is classified as experimental and investigational due to unproven clinical value.
Testing for phosphatidylserine-dependent antiprothrombin antibodies may have limited utility in some research contexts or select clinical investigations, but published work (e.g., Sugiura-Ogasawara et al., 2004) found these antibodies were not useful markers for identifying high-risk women with recurrent miscarriage.
Testing Frequency Guidance
Background and Rationale
Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by circulating antiphospholipid antibodies and clinical manifestations such as venous or arterial thromboses, thrombocytopenia, and pregnancy morbidity. Most patients with APS have lupus anticoagulant and anticardiolipin antibodies; other antibodies, including antiprothrombin and phosphatidylserine/prothrombin complex antibodies (aPS/PT), have been described but their clinical significance, reproducibility, and role in routine diagnostic criteria remain uncertain. For these reasons, antiprothrombin antibody testing is not supported as a standard diagnostic test for APS.
Key Terms
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