Aetna modified CPB 1001 for sirolimus protein-bound particles (Fyarro), effective September 26, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated Clinical Policy Bulletin 1001 covering HCPCS code J9331 (injection, sirolimus protein-bound particles, 1 mg) and related chemotherapy administration codes — CPT 96413 through 96417 — for commercial medical plan members. This change affects oncology and surgical oncology practices billing Fyarro for malignant neoplasms of soft tissue, retroperitoneum, and peritoneum. If your team handles Fyarro billing for any of these diagnoses, this coverage policy update requires your attention before the September 26, 2025 effective date.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Sirolimus Protein-Bound Particles for Injectable Suspension Albumin-Bound (Fyarro) |
| Policy Code | CPB 1001 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Medical Oncology, Surgical Oncology, Gynecologic Oncology, Infusion/Specialty Pharmacy |
| Key Action | Confirm precertification is in place for all Fyarro claims billed under J9331 before September 26, 2025 |
Aetna Fyarro Coverage Criteria and Medical Necessity Requirements 2025
CPB 1001 Aetna's coverage policy for Fyarro is not a straightforward open-coverage situation. Precertification is required for every Aetna participating provider and every member in an applicable plan design. No precertification, no reimbursement — that's the practical reality here.
The covered indication is narrow. Aetna covers sirolimus protein-bound particles for injectable suspension albumin-bound when the medical necessity criteria for malignant neoplasms of connective and soft tissue, retroperitoneum, and peritoneum are met. The ICD-10-CM diagnosis codes that map to covered indications include C48.0, C48.1, C48.2, C48.8, C49.4, C49.5, C49.8, C49.9, and C55. The FDA-approved indication for Fyarro is advanced malignant perivascular epithelioid cell tumor (PEComa) — a rare soft tissue sarcoma. This is reflected directly in the ICD-10 codes Aetna lists under this policy.
Prior authorization — which Aetna calls precertification here — runs through a dedicated phone and fax line. Call (866) 752-7021 or fax (888) 267-3277. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal. Get those forms submitted before you schedule an infusion. A claim denial on Fyarro is a significant revenue hit — this drug carries substantial per-unit cost.
The policy applies to commercial medical plans only. For Medicare criteria, Aetna directs providers to its Medicare Part B step therapy page. If you treat patients with dual coverage or Medicare Advantage plans through Aetna, verify which criteria set applies before billing J9331.
Aetna Fyarro Exclusions and Non-Covered Indications
The policy doesn't publish a lengthy exclusion list, but the coverage boundary is clear: indications outside the listed ICD-10-CM codes are not supported under this CPB. That means off-label use of Fyarro — outside of advanced malignant PEComa or the specific soft tissue and peritoneal malignancies listed — will not meet medical necessity under CPB 1001.
ICD-10 code D49.2 (neoplasm of unspecified behavior of bone, soft tissue, and skin) and Z85.831 (personal history of malignant neoplasm of soft tissue) appear in the policy's code set. These are surveillance and history codes. Billing J9331 against D49.2 or Z85.831 as the primary diagnosis without an active malignancy code will likely trigger a claim denial. Use these codes only as secondary diagnoses where clinically appropriate and supported by documentation.
Aetna's policy explicitly does not address Medicare criteria here. Don't apply these commercial medical necessity criteria to Medicare claims. Treat those as a separate workflow entirely.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Malignant neoplasm of retroperitoneum | Covered (if medical necessity criteria met) | C48.0, J9331 | Precertification required |
| Malignant neoplasm of specified parts of peritoneum | Covered (if medical necessity criteria met) | C48.1, C48.2, J9331 | Precertification required |
| Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum | Covered (if medical necessity criteria met) | C48.8, J9331 | Precertification required |
| Malignant neoplasm of connective and soft tissue of abdomen | Covered (if medical necessity criteria met) | C49.4, J9331 | Precertification required |
| Malignant neoplasm of connective and soft tissue of pelvis | Covered (if medical necessity criteria met) | C49.5, J9331 | Precertification required |
| Malignant neoplasm of overlapping/unspecified connective and soft tissue | Covered (if medical necessity criteria met) | C49.8, C49.9, J9331 | Precertification required |
| Malignant neoplasm of uterus, part unspecified | Covered (if medical necessity criteria met) | C55, J9331 | Precertification required |
| Neoplasm of unspecified behavior of soft tissue | Secondary/surveillance only | D49.2 | Do not use as primary Dx for active treatment claims |
| Personal history of malignant neoplasm of soft tissue | Secondary/surveillance only | Z85.831 | Do not use as primary Dx for active treatment claims |
| Off-label indications outside listed ICD-10 codes | Not covered under CPB 1001 | — | Does not meet medical necessity criteria |
| Medicare patients (Aetna Medicare Advantage) | Separate criteria apply | — | See Aetna Medicare Part B step therapy criteria |
Aetna Fyarro Billing Guidelines and Action Items 2025
Fyarro billing under CPB 1001 is high-stakes. The drug is expensive, the indication is narrow, and Aetna's precertification requirement leaves zero room for process errors. Here are the specific steps your team needs to take.
| # | Action Item |
|---|---|
| 1 | Submit precertification requests before September 26, 2025 for any pending Fyarro cases. Call (866) 752-7021 or fax (888) 267-3277. If you have patients currently receiving Fyarro or scheduled to start, get those authorizations confirmed against the updated policy before the effective date. |
| 2 | Pull the Statement of Medical Necessity form from Aetna's Specialty Pharmacy Precertification portal. This is a separate form from standard prior authorization requests. Your billing team and clinical staff both need to know where it lives and who completes it. |
| 3 | Verify your charge capture maps J9331 correctly to a covered ICD-10-CM diagnosis. The covered codes are C48.0, C48.1, C48.2, C48.8, C49.4, C49.5, C49.8, C49.9, and C55. If your charge capture system auto-populates diagnosis codes, confirm none of these claims are defaulting to D49.2 or Z85.831 as the primary diagnosis on active treatment claims. |
| 4 | Pair J9331 with the correct chemotherapy administration CPT codes. Fyarro is administered by IV infusion. The appropriate administration codes are CPT 96413 (initial chemotherapy administration), 96414 (concurrent), 96415 (each additional hour), 96416 (initiation of prolonged infusion), and 96417 (each additional sequential infusion). Don't bill hydration-only codes (96360–96368) as the primary administration code for chemotherapy — use the chemotherapy administration series and append hydration codes only when separately identifiable and documented. |
| 5 | Separate commercial from Medicare workflows today. If your practice sees both Aetna commercial and Aetna Medicare Advantage patients on Fyarro, build a clear split in your authorization tracking. CPB 1001 governs commercial claims. Medicare Advantage plans follow Aetna's Part B step therapy criteria. Mixing these is a fast path to denials on both sides. |
| 6 | Document medical necessity in the clinical record before every claim. Aetna will review precertification requests against CPB 1001's criteria. Sparse documentation — a diagnosis code without supporting pathology, imaging, or prior treatment history — will delay or deny authorization. Your clinical team should know what Aetna is looking for before the authorization request goes out. |
If you're uncertain how this policy applies to your patient mix or your specific plan contracts, talk to your compliance officer before September 26, 2025. The cost exposure on a denied Fyarro claim makes this worth the conversation.
| 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 Fyarro Under CPB 1001
HCPCS Code Covered When Selection Criteria Are Met
| Code | Type | Description |
|---|---|---|
| J9331 | HCPCS | Injection, sirolimus protein-bound particles, 1 mg |
Chemotherapy Administration CPT Codes
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique; concurrent infusion |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique; each additional hour |
| 96416 | CPT | Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump |
| 96417 | CPT | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour |
IV Infusion / Hydration CPT Codes (Related to the CPB)
| Code | Type | Description |
|---|---|---|
| 96360 | CPT | Intravenous infusion, hydration; initial, 31 minutes to 1 hour |
| 96361 | CPT | Intravenous infusion, hydration; each additional hour |
| 96365 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour |
| 96366 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; each additional hour |
| 96367 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; additional sequential infusion of a new drug/substance, up to 1 hour |
| 96368 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; concurrent infusion |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C48.0 | Malignant neoplasm of retroperitoneum |
| C48.1 | Malignant neoplasm of specified parts of peritoneum |
| C48.2 | Malignant neoplasm of peritoneum, unspecified |
| C48.8 | Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum |
| C49.4 | Malignant neoplasm of connective and soft tissue of abdomen |
| C49.5 | Malignant neoplasm of connective and soft tissue of pelvis |
| C49.8 | Malignant neoplasm of overlapping sites of connective and soft tissue |
| C49.9 | Malignant neoplasm of connective and soft tissue, unspecified |
| C55 | Malignant neoplasm of uterus, part unspecified |
| D49.2 | Neoplasm of unspecified behavior of bone, soft tissue, and skin |
| Z85.831 | Personal history of malignant neoplasm of soft tissue |
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