Aetna modified CPB 1066 for donanemab-azbt (Kisunla), effective October 19, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated CPB 1066 — its coverage policy for donanemab-azbt (Kisunla) — for commercial medical plans. This policy governs HCPCS J0175 (injection, donanemab-azbt, 2 mg) along with a cluster of diagnostic codes including PET imaging (CPT 78811, 78814), brain MRI (CPT 70551–70553), and CSF biomarker testing (CPT 0445U, 0459U). The criteria are detailed and the financial exposure is real — get your team aligned before claims go out the door.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Donanemab-azbt (Kisunla) — CPB 1066 |
| Policy Code | CPB 1066 |
| Change Type | Modified |
| Effective Date | October 19, 2025 |
| Impact Level | High |
| Specialties Affected | Neurology, Geriatrics, Psychiatry, Neuropsychiatry, Infusion Services |
| Key Action | Audit your precertification workflow for J0175 and confirm all documentation criteria are met before submitting claims |
Aetna Donanemab-azbt Coverage Criteria and Medical Necessity Requirements 2025
The Aetna donanemab-azbt coverage policy applies to commercial plans only. Medicare members follow a separate path — see Aetna's Medicare Part B criteria for that population.
Precertification is required for all Aetna participating providers. Call (866) 752-7021 or fax (888) 267-3277 to submit prior authorization requests. Without it, your claim for J0175 is dead on arrival.
The site of care matters here too. Aetna's Site of Care Utilization Management Policy applies to Kisunla infusions. If your practice hasn't confirmed approved infusion settings with Aetna, do that before scheduling the first dose.
Age and Staging Requirements
To establish medical necessity, a member must be 50 or older — OR under 50 with a documented genetic mutation in APP (CPT 81406), PSEN1 (CPT 81405), or PSEN2, or other clinical evidence of early-onset AD.
Beyond age, the member must have Clinical Stage 3 (cognitive impairment with early functional impact) or Clinical Stage 4 (dementia with mild functional impact) Alzheimer's disease. Stage 5 and beyond are not covered. This is a narrow window — document the clinical stage explicitly in your records.
The member must also show objective evidence of cognitive impairment at baseline. At least one standardized score is required:
| # | Covered Indication |
|---|---|
| 1 | CDR-GS of 0.5 or 1 |
| 2 | MMSE score of 21–30 |
| 3 | MoCA score of 16 or higher |
Document which tool was used and the exact score. Aetna will ask.
Amyloid Confirmation
Amyloid pathology must be confirmed. Members need either a positive amyloid PET scan (CPT 78811 or 78814, using tracers such as florbetapir F18 [A9586] or flutemetamol F18 [Q9982]) or a positive CSF biomarker profile (CPT 0445U or 0459U). A lumbar puncture for CSF collection bills under CPT 62270.
If neither test is in the chart, the claim will deny. There is no workaround.
Prescriber Requirements
The prescription must come from — or be written in consultation with — a geriatrician, neurologist, psychiatrist, or neuropsychiatrist. A primary care physician ordering this independently won't meet Aetna's billing guidelines. Flag this in your intake workflow now.
Continuation Criteria
Aetna also sets renewal criteria. Continuation of Kisunla requires documented tolerability, treatment plan adherence, and ongoing MRI monitoring for amyloid-related imaging abnormalities (ARIA). Renewal requests without updated MRI reports (CPT 70551–70553) will not pass. Build that MRI cadence into your authorization renewal timeline.
Aetna Donanemab-azbt Exclusions and Non-Covered Indications
This section is where most claim denials will happen. Aetna lists six hard exclusions. Any one of them disqualifies a member.
Members are not eligible if they have:
| # | Excluded Procedure |
|---|---|
| 1 | A suspected neurodegenerative cause of cognitive impairment other than AD — including frontotemporal lobar degeneration (FTLD) or Lewy body disease that lacks AD biomarkers (positive amyloid PET or CSF profile) |
| 2 | More than four cerebral microbleeds, cortical superficial siderosis, or major vascular cognitive impairment confirmed on MRI |
| 3 | Cerebral contusion, encephalomalacia, brain aneurysm or vascular malformation, CNS infection (ICD-10 A80.0–A89), or brain tumor (ICD-10 C71.0–C71.9) |
| 4 | History of TIA, stroke, uncontrolled hypertension, or seizures within the past 12 months |
| 5 | Bleeding disorder not under adequate control — platelet count below 50,000 or INR above 1.5 (ICD-10 D69.0–D69.9) |
| 6 | Immunologic disorder requiring immunoglobulins, monoclonal antibodies, immunosuppressants, or plasmapheresis (ICD-10 D80.0–D80.9) |
Combination therapy with any other amyloid beta-directed antibody is also excluded. Aducanumab (J0172) and lecanemab (J0174) cannot be used alongside Kisunla. If a member is on either, they don't qualify until that treatment stops.
The real issue here is documentation. These exclusions require MRI data, lab values, and a clean medical history review. If your pre-auth packet doesn't address each of these, expect a denial — or worse, a post-payment audit.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| AD, Clinical Stage 3 or 4, age ≥50, amyloid-confirmed | Covered | J0175, G30.0–G30.9 | Prior auth required; CDR-GS, MMSE, or MoCA score required |
| Early-onset AD (<50) with APP, PSEN1, or PSEN2 mutation | Covered | J0175, CPT 81405, 81406, G30.0–G30.9 | Genetic testing or clinical documentation required |
| AD with amyloid confirmed by PET | Covered | CPT 78811, 78814, A9586, Q9982, A9598 | PET must use approved radiotracer |
| AD with amyloid confirmed by CSF biomarkers | Covered | CPT 0445U, 0459U, 62270 | Positive β-amyloid and phospho-tau or total tau required |
| AD — Clinical Stage 5 or beyond | Not Covered | — | Outside approved staging window |
| Non-AD neurodegeneration (FTLD, Lewy body without AD biomarkers) | Not Covered | — | Excluded by policy |
| Combination with aducanumab (J0172) or lecanemab (J0174) | Not Covered | J0172, J0174 | Combination therapy explicitly excluded |
| Members with >4 cerebral microbleeds or cortical superficial siderosis on MRI | Not Covered | CPT 70551–70553 | MRI findings disqualify member |
| Members with active CNS infection or brain tumor | Not Covered | A80.0–A89, C71.0–C71.9 | Hard exclusion |
| Members with uncontrolled bleeding disorder (platelets <50K or INR >1.5) | Not Covered | D69.0–D69.9 | Hard exclusion |
| Members with immunologic disorder requiring immunosuppression | Not Covered | D80.0–D80.9 | Hard exclusion |
Aetna Donanemab-azbt Billing Guidelines and Action Items 2025
The effective date is October 19, 2025. If you bill J0175 for Aetna commercial members, these steps apply now.
| # | Action Item |
|---|---|
| 1 | Confirm precertification before every infusion. Call (866) 752-7021 or fax (888) 267-3277. No auth, no reimbursement. This is not a retrospective process. |
| 2 | Verify site of care approval. Aetna's Site of Care UM Policy applies to Kisunla infusions. Confirm the approved infusion setting before scheduling. Office-based infusion, hospital outpatient, and home infusion may not all be approved for your patient's plan. |
| 3 | Include the clinical staging documentation in every prior auth packet. Aetna needs the CDR-GS, MMSE, or MoCA score. Write the number, the tool used, and the date of assessment. Vague clinical notes won't clear medical necessity review. |
| 4 | Attach amyloid confirmation results to the auth request. Either a PET report (billing CPT 78811 or 78814 with tracer codes A9586, Q9982, or A9598) or a positive CSF biomarker result (CPT 0445U or 0459U from a lumbar puncture under CPT 62270). No confirmation, no approval. |
| 5 | Screen for all six exclusion criteria before submitting. Run a checklist against the member's chart: MRI findings, bleeding labs, immunologic history, vascular event history within the last 12 months, and current AD therapy. If exclusion criteria apply, do not submit — the denial will create more work than catching it upfront. |
| 6 | Confirm prescriber specialty. The ordering provider must be a geriatrician, neurologist, psychiatrist, or neuropsychiatrist, or the order must reference a qualifying consultant. Document the consultation if the prescriber is in a different specialty. |
| 7 | Build MRI monitoring into your renewal workflow. Continuation auth requires MRI surveillance for ARIA. Bill the monitoring MRI under CPT 70551, 70552, or 70553 depending on contrast protocol. Have the report ready when you submit for renewal. |
| 8 | Check for active combination therapy. If the member is currently receiving lecanemab (J0174) or aducanumab (J0172), Kisunla is not covered. Verify current AD therapy at intake — this is an easy denial to avoid. |
If your practice has a mix of commercial and Medicare Advantage Aetna plans, talk to your compliance officer before October 19, 2025. The Medicare criteria differ, and applying the wrong coverage policy to the wrong plan type is a fast path to a claim denial — or a recoupment.
| 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 Donanemab-azbt Under CPB 1066
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J0175 | HCPCS | Injection, donanemab-azbt, 2 mg |
Supporting Diagnostic and Administrative CPT Codes
| Code | Type | Description |
|---|---|---|
| 0445U | CPT | β-amyloid (Abeta42) and phospho-tau (181P) (pTau181), electrochemiluminescent immunoassay (ECLIA), cerebrospinal fluid |
| 0459U | CPT | β-amyloid (Abeta42) and total tau (tTau), electrochemiluminescent immunoassay (ECLIA), cerebrospinal fluid |
| 62270 | CPT | Spinal puncture, lumbar, diagnostic |
| 70551 | CPT | MRI, brain (including brain stem); without contrast material |
| 70552 | CPT | MRI, brain; with contrast material(s) |
| 70553 | CPT | MRI, brain; without contrast material, followed by contrast material(s) and further sequences |
| 78608 | CPT | Brain imaging, PET; metabolic evaluation |
| 78811 | CPT | PET imaging; limited area (e.g., head/neck) |
| 78814 | CPT | PET with concurrently acquired CT for attenuation correction and anatomy |
| 81401 | CPT | Molecular pathology procedure, Level 2 — APOE (apolipoprotein E) |
| 81405 | CPT | Molecular pathology procedure, Level 6 — PSEN1 (presenilin 1) full gene sequence |
| 81406 | CPT | Molecular pathology procedure, Level 7 — APP (amyloid beta precursor protein) full gene sequence |
| 96365 | CPT | Intravenous infusion administration, initial |
| 96366 | CPT | Intravenous infusion administration, each additional hour |
| 96367 | CPT | Intravenous infusion administration, additional sequential infusion |
| 96368 | CPT | Intravenous infusion administration, concurrent |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| G30.0–G30.9 | Alzheimer's disease (primary covered diagnosis) |
| G31.1, G31.10–G31.14 | Other degenerative diseases of nervous system, NEC |
| G23.0–G23.9 | Other degenerative diseases of basal ganglia |
| C71.0–C71.9 | Malignant neoplasm of brain (exclusion) |
| D69.0–D69.9 | Purpura and other hemorrhagic conditions (exclusion — bleeding disorder) |
| D80.0–D80.9 | Immunodeficiency with predominantly antibody defects (exclusion) |
| A80.0–A89 | Viral and prion infections of the CNS (exclusion) |
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