Lantidra (donislecel-jujn) — Coverage Determination
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This policy governs coverage determinations for Lantidra (donislecel-jujn) for treatment of adults with Type 1 diabetes with recurrent severe hypoglycemia, and applies to Wellmark Blue Cross and Blue Shield members under the payer's benefit plans.
No material clinical or coverage changes in this revision.
Coverage Determination
Not Medically Necessary — All Indications
Coverage determination
Applies to treatment of Type 1 diabetes and other indications.
According to the FDA label, Lantidra has important limitations of use. There is no evidence of benefit for patients whose diabetes is well controlled with insulin therapy or for patients with hypoglycemic unawareness who can prevent repeated severe hypoglycemic events using intensive diabetes management (including insulin, devices, and education). The label also recommends against repeated intraportal infusions in patients with prior portal vein thrombosis unless thrombosis was limited to second- or third-order branches, and notes there is no evidence to support use in patients with liver disease, renal failure, or prior renal transplant.
Lantidra (donislecel-jujn) is considered not medically necessary for all indications, including treatment of Type 1 diabetes, due to insufficient evidence to determine clinical efficacy and significant safety concerns.
Suggested Codes for Reporting
Provider Requirements and Billing
Prior authorization and billing — Lantidra considered not medically necessary; if billed use C9399 or J3590
Lantidra is considered not medically necessary for all indications; if the therapy or related services are billed, report the drug/biologic using unclassified HCPCS level II codes C9399 or J3590 and include appropriate procedure and diagnosis codes per payer billing rules.
FDA labeled use and limitations for Lantidra
FDA-labeled indication: Lantidra is indicated for adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education; use requires concomitant immunosuppression.
- Indicated only for adults with T1D with current repeated severe hypoglycemia despite intensive diabetes management and education.
- Should be used with concomitant immunosuppression to prevent islet graft rejection.
- Limitations of use: no evidence of benefit for patients whose diabetes is well controlled with insulin therapy or who can prevent repeated severe hypoglycemia with intensive management; repeated intraportal infusions not recommended after prior portal thrombosis unless limited to second- or third-order branches; no evidence supporting use in patients with liver disease, renal failure, or prior renal transplant.
Billing and coding guidance — report using CPT, HCPCS (C9399/J3590), revenue and ICD codes
Report provider services using appropriate CPT procedure codes, HCPCS level II codes (C9399, J3590), revenue codes, and ICD diagnostic codes as applicable when submitting claims for Lantidra-related services.
Denial trigger — Lantidra denied for all indications as not medically necessary
Coverage determinations deny Lantidra for all indications as not medically necessary due to insufficient evidence of clinical efficacy and significant safety concerns; billing without coverage may be denied.
- Policy statement: Lantidra is not medically necessary for all indications, including Type 1 diabetes.
- Denials may be issued because evidence does not establish clinical benefit and safety risks are significant.
Product Background
Lantidra is an allogeneic pancreatic islet cell therapy derived from deceased donor pancreatic cells that is administered via intraportal infusion (one to three infusions may be performed) and requires concomitant lifelong immunosuppression to prevent graft rejection. It was studied in small open‑label trials and demonstrated variable durations of insulin independence but raised substantial safety concerns, including serious adverse reactions, infections, malignancies, and procedure‑related complications; these risks underlie the policy determination of no coverage for all indications.
Key Definitions
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