J1655, Injection, tinzaparin sodium, 1000 iu
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Karyotype or chromosomal testing results on products of conception (POC) when cytogenetic evaluation is performed; for POC testing laboratories should document sample source and maternal cell contamination assessment when applicable (studies discuss MCC and methods to detect it).
- Thyroid testing: TSH and TPO-antibody results when performed for women with RPL (ESHRE 2023 recommendation).
- When IVIG or other immunotherapies are used for RPL, documentation that the patient is an informed, consenting participant in an IRB-approved randomized clinical trial (per ASRM guidance) if used for experimental indication.
- When considering heparin/aspirin therapy for antiphospholipid antibody–positive patients: documentation of persistent aPL positivity and clinical history consistent with RPL to justify therapy.
Key Coverage Criteria
- H1299R Factor V (FV) variant (rs1800595): pooled analysis showed the variant was “slightly associated with RPL albeit without significance … demonstrated that there is no clear association between the FV H1299R variant and RPL.” (Capra et al, 2022) — indicating limited/uncertain utility of testing.
- Maternal ApoE genotyping: “ε4 allele was found to confer an increased risk of RPL compared to the ε3 allele … Subgroup analysis ... revealed that these associations were restricted to the Asian population.” (Cargnin et al, 2023) — suggesting possible relevance of ApoE genotyping in Asian women.
- Measurement of endometrial B cells: systematic review/meta-analysis “highlighted a potential association between women with IRPL and increased levels of endometrial B cells” and noted that “flow cytometry technique appeared to be preferred over immunohistochemistry for identifying those differences.” (Angelo-Dias et al, 2022)
- Endometrial biopsies for evaluation of luteal phase defect in members with recurrent pregnancy loss.
- Recurrent pregnancy loss defined as 2 or more consecutive spontaneous abortions (clinical definition used by policy).
- Factor V Leiden genetic testing for members with recurrent pregnancy loss who have an abnormal activated protein C (APC) resistance assay result.
1 Active Policy
AETNA-CPB-0348, Recurrent Pregnancy Loss
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