Does J1645 require prior authorization?

Yes, J1645 requires prior authorization (medium confidence). Conditional coverage; review criteria to confirm PA need.

What is the Medicare reimbursement rate for J1645?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J1645`, Injection, dalteparin sodium, per 2500 iu

HCPCS/CPT

Prior Authorization

Prior Auth Required

Conditional coverage; review criteria to confirm PA need (medium confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

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).

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.

Documentation of clinical rationale and prior evaluations showing exclusion of other causes where the policy/guidelines recommend against routine use of certain tests (e.g., rationale for any thrombophilia testing, MTHFR testing, ETA, ANA testing) or justification if such tests are nevertheless ordered.

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.

2 Active Policies

HEALTHNET_OR-HNOR-DALTEPARIN-FRAGMIN-CP-PHAR-225-2E7A73DFE8, Dalteparin (Fragmin); CP.PHAR.225

AETNA-CPB-0348, Recurrent Pregnancy Loss

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J1645, Injection, dalteparin sodium, per 2500 iu