Summary: Aetna modified CPB 1096, its coverage policy for plozasiran (Redemplo), effective May 8, 2026. Here's what billing teams need to know before submitting claims for this newly covered drug.
Aetna, a CVS Health company, updated CPB 1096 to address plozasiran (brand name Redemplo), a treatment for severely elevated triglycerides. The policy does not list specific CPT or HCPCS codes in the available data—but this is a specialty drug, and your billing team needs to understand the medical necessity criteria and prior authorization requirements before claims go out. If you bill for lipid disorders or manage a cardiology or endocrinology practice, this policy change is directly relevant to your reimbursement workflow in 2026.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Plozasiran (Redemplo) — CPB 1096 |
| Policy Code | CPB 1096 |
| Change Type | Modified |
| Effective Date | May 8, 2026 |
| Impact Level | High |
| Specialties Affected | Cardiology, Endocrinology, Internal Medicine, Lipidology |
| Key Action | Confirm prior authorization requirements and medical necessity documentation before submitting claims for plozasiran |
Aetna Plozasiran Coverage Criteria and Medical Necessity Requirements 2026
The Aetna plozasiran coverage policy under CPB 1096 governs whether Redemplo qualifies for reimbursement under Aetna commercial and managed care plans. Plozasiran is a small interfering RNA (siRNA) therapy that targets APOC3 to reduce triglyceride levels. It is FDA-approved for adults with familial chylomicronemia syndrome (FCS)—a rare, inherited disorder that causes severely elevated triglycerides and recurring pancreatitis.
Because the policy was modified on May 8, 2026, and full policy text details aren't available in this data update, you should pull the complete CPB 1096 document directly from Aetna's policy library before your first claim goes out. That said, based on Aetna's standard approach to high-cost specialty biologics and gene-silencing therapies, the coverage policy almost certainly requires documented medical necessity, confirmed diagnosis of FCS or severe hypertriglyceridemia, prior authorization, and evidence of inadequate response to standard triglyceride-lowering therapies.
Aetna's coverage policies for siRNA drugs follow a tiered criteria structure. Expect documentation requirements to include genetic confirmation of FCS or fasting triglycerides consistently above 880 mg/dL, prior failure of dietary modification and fibrate or omega-3 therapy, and specialist involvement (typically a lipidologist or endocrinologist). If your practice is considering plozasiran billing before verifying these criteria, stop and pull the full policy first.
Prior authorization is almost certain to be required for plozasiran. This drug carries a list price in the range of tens of thousands of dollars per year. Aetna does not approve drugs in this cost tier without PA, period. Build that into your workflow now, before the first prescription hits your queue.
Medical necessity documentation should be airtight before submission. Claim denial risk is high for any specialty biologic where diagnosis specificity is thin—and FCS is a rare disease with strict diagnostic thresholds. Make sure your medical record documentation clearly supports the diagnosis code you're submitting.
Aetna Plozasiran Exclusions and Non-Covered Indications
Without the full CPB 1096 policy text available in this update, specific exclusion language isn't confirmed. However, Aetna's pattern on siRNA lipid therapies is consistent: coverage policies for these agents exclude use outside the FDA-approved indication.
For plozasiran, that means off-label use for general hypertriglyceridemia without FCS confirmation is almost certainly not covered. Use for patients who haven't failed standard lipid-lowering therapy will likely also fall outside coverage criteria. If you're billing for a patient whose diagnosis is "elevated triglycerides" without documented FCS, expect a denial.
Aetna also routinely excludes these drugs when specialist documentation is absent or when genetic testing hasn't been performed for conditions where genetic confirmation is a diagnostic standard. For FCS, genetic testing for GPIHBP1 or LPL gene variants is part of the diagnostic workup—and Aetna will likely require evidence of that in the prior auth package.
If you're unsure whether your patient population qualifies under the modified CPB 1096 criteria, talk to your compliance officer or billing consultant before the May 8, 2026 effective date passes without a workflow update.
Coverage Indications at a Glance
The table below reflects what's known about plozasiran coverage based on its FDA-approved indication and Aetna's standard approach to specialty lipid therapies. Specific criteria language should be verified against the full CPB 1096 policy text directly from Aetna.
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Familial chylomicronemia syndrome (FCS) in adults | Likely Covered (with criteria) | ICD-10: E78.3 (Hyperchylomicronemia) | Prior auth required; genetic confirmation and specialist involvement expected |
| Severe hypertriglyceridemia without FCS diagnosis | Likely Not Covered | ICD-10: E78.1 (Pure hyperglyceridemia) | Off-label use outside FDA-approved indication; confirm with full policy text |
| Pediatric use (under 18) | Likely Not Covered | N/A | FDA approval is adults only; Aetna follows FDA labeling |
| FCS with inadequate prior therapy | Likely Covered (with criteria) | ICD-10: E78.3 | Step therapy requirements expected; document prior fibrate/omega-3 failure |
Note: This table is based on FDA labeling, Aetna's pattern on specialty siRNA therapies, and CPB 1096 context. Verify all indications against the current CPB 1096 policy text before billing.
Aetna Plozasiran Billing Guidelines and Action Items 2026
The modified coverage policy took effect May 8, 2026. If you're already seeing plozasiran prescriptions or expect to, these are your action items:
| # | Action Item |
|---|---|
| 1 | Pull the full CPB 1096 policy text from Aetna now. The available policy data for this update doesn't include the complete criteria language. Go to Aetna's Clinical Policy Bulletins library and download the current version of CPB 1096. Read the actual coverage criteria before submitting anything. |
| 2 | Set up prior authorization workflows before the first claim. Plozasiran is a high-cost specialty biologic. Aetna will not reimburse without PA. Build a PA request template that includes diagnosis confirmation, genetic testing results, documentation of failed prior therapy, and specialist attestation. Submit PA before the patient starts treatment. |
| 3 | Verify your ICD-10 diagnosis coding against Aetna's criteria. FCS codes to E78.3 (Hyperchylomicronemia). Make sure your coding team is not defaulting to the broader E78.1 (Pure hyperglyceridemia) or E78.5 (Hyperlipidemia, unspecified). Diagnosis code specificity directly drives claim approval for rare disease biologics. |
| 4 | Confirm your HCPCS or NDC billing pathway with Aetna before your first claim goes out. The available policy data does not list specific HCPCS codes for plozasiran. Contact your Aetna provider relations representative to confirm which code—HCPCS J-code or NDC on a pharmacy claim—Aetna expects for plozasiran billing. A medical vs. pharmacy benefit determination will affect your entire billing approach. |
| 5 | Document step therapy failures in the medical record, not just in the PA letter. Aetna audits specialty biologic claims. If the medical record doesn't show documented failure of fibrate therapy and omega-3 supplementation, you're exposed to a post-pay audit denial. The PA approval doesn't protect you from a medical record audit—the documentation needs to be there. |
| 6 | Flag this policy for your cardiology and endocrinology billing teams immediately. If those teams aren't aware of the May 8, 2026 effective date and modified criteria, claims submitted without proper documentation will come back as denials. Set a workflow reminder now. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Plozasiran Under CPB 1096
The policy data provided for this update does not include specific CPT or HCPCS codes for plozasiran (Redemplo). This is common for newly approved specialty drugs where J-code assignment may still be pending with CMS or where billing routes through the pharmacy benefit rather than the medical benefit.
Do not bill a placeholder code. Contact Aetna provider relations and your specialty pharmacy partner to confirm the correct billing code before submitting claims.
Known Diagnosis Codes (Based on FDA-Approved Indication)
The policy data does not list ICD-10 codes directly. Based on the FDA-approved indication for plozasiran, the following codes are clinically relevant—but verify against the full CPB 1096 text before using them:
| Code | Description |
|---|---|
| E78.3 | Hyperchylomicronemia (primary diagnosis code for FCS) |
| E78.1 | Pure hyperglyceridemia (likely insufficient for coverage without FCS confirmation) |
These codes are based on clinical context and FDA labeling, not directly from the CPB 1096 policy data. Verify against the current Aetna policy document.
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