CurrentCignaPolicy IP0191

Fish Oil Triglycerides (Omegaven)

Defines medical necessity criteria, authorization durations, coding, FDA indication, dosing and limitations for Omegaven (fish oil triglycerides) for Cigna-administered health benefit plans, focused on pediatric treatment of parenteral nutrition-associated cholestasis (PNAC).

Policy Summary

PayerCigna

PolicyFish Oil Triglycerides (Omegaven)

Policy CodePolicy IP0191

Change TypeNo material change

Effective DateFeb 1, 2023

Next Review DateFeb 1, 2024

Key ActionObtain authorization consistent with Cigna policy when treating PNAC in patients <18 years; initial and reauthorization approvals up to 12 months each.

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria in this policy.

1Covered Indication (pediatric PNAC)

1HCPCS code listed

12Authorization duration (initial & reauth)

Coverage Summary

Coverage stance: covered_with_criteria for Omegaven when used to treat pediatric parenteral nutrition-associated cholestasis (PNAC). Scope summary: Defines medical necessity criteria, authorization durations, coding, FDA indication, dosing and limitations for Omegaven (fish oil triglycerides) for Cigna-administered health benefit plans, focused on pediatric treatment of parenteral nutrition-associated cholestasis (PNAC). Receipt of sample product does not satisfy coverage criteria.

Initial Therapy

Covered when ALL of the following are met:

Diagnosis of Parenteral nutrition-associated cholestasis (PNAC)
Age: Individual is less than 18 years of age

Operational note: Receipt of sample product does not satisfy coverage criteria.

Continuation of Therapy

Covered when ALL of the following are met:

Initial criteria are met

Treatment duration / authorization

Initial approval durationUp to 12 months

Reauthorization durationUp to 12 months

Treatment endpoint / discontinue thresholdAdminister until direct bilirubin (DBil) < 2 mg/dL or patient no longer requires PN

Continuation requirementContinuation covered when initial criteria are met

Not Medically Necessary / Experimental or Unproven

Use is considered experimental, investigational or unproven for any other indication, including:

Prevention of Parenteral nutrition-associated cholestasis (PNAC)
Omegaven is not indicated for prevention of PNAC.
Other indications: Any indication other than treatment of PNAC in individuals <18 years

Denial Risk

Claims for prevention of PNAC are not covered

Claims for Omegaven for prevention of PNAC or other non‑approved indications may be denied as experimental/investigational. Providers should be aware that requests for use to prevent PNAC or for any indication other than treatment of PNAC in individuals <18 years are considered not medically necessary and may be denied.

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Prior authorization required when coverage criteria apply

Obtain authorization consistent with Cigna policy when treating PNAC in patients <18 years; initial and reauthorization approvals up to 12 months each.

B4187

Documentation Required

Document diagnosis and age

Document diagnosis of PNAC and that the patient is <18 years of age to support medical necessity.

Documentation Required

Monitor triglyceride levels

Monitor serum triglyceride levels during treatment; if hypertriglyceridemia thresholds are exceeded, stop infusion for 4 hours and recheck per FDA guidance and consider dose reduction.

Neonates/infants: triglycerides > 250 mg/dL
Older children: triglycerides > 400 mg/dL

Operational dosing thresholds for clinicians and billing teams: Pediatric Omegaven dose 1 g/kg/day (maximum daily dose). Initial infusion rate should not exceed 0.05 mL/min for the first 15–30 minutes and the maximum infusion rate should not exceed 1.5 mL/kg/hour (0.15 g/kg/hour). Discontinue or stop infusion and reassess for hypertriglyceridemia; continue Omegaven until the treatment endpoint of direct bilirubin (DBil) < 2 mg/dL or the patient no longer requires parenteral nutrition.

Clinical Evidence & Guidance

Evidence: FDA indication — Indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Guideline note — ASPEN does not recommend a specific lipid source over another; for patients with PNAC ASPEN recommends reducing soybean oil–based lipid and consideration of fish oil–based lipid or mixed fish/soybean lipid.

Dosing & infusion quick-reference

Recommended pediatric dose1 g/kg/day (maximum daily dose)

Initial infusion rate≤ 0.05 mL/min for first 15–30 minutes

Maximum infusion rate≤ 1.5 mL/kg/hour (0.15 g/kg/hour)

Recommended infusion duration8–24 hours depending on clinical situation

Hypertriglyceridemia action thresholdsStop if triglycerides >250 mg/dL (neonates/infants) or >400 mg/dL (older children); hold 4 hours and recheck

Background & Definitions

Background: This policy supports medical necessity review for the fish oil triglyceride product Omegaven for the treatment of pediatric parenteral nutrition-associated cholestasis (PNAC). Receipt of sample product does not satisfy coverage criteria.

Definitions: Parenteral nutrition-associated cholestasis (PNAC): Parenteral nutrition-associated cholestasis.