Aetna modified CPB 0929, its coverage policy for Lutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto), effective November 22, 2025. Here's what billing teams need to know.
Aetna, a CVS Health company, updated CPB 0929 to govern medical necessity criteria for both Lutathera (HCPCS A9513) and Pluvicto (HCPCS A9607) under commercial medical plans. The revised coverage policy expands and refines the indications for both radiopharmaceuticals — including new criteria for neuroendocrine tumor subtypes, carcinoid syndrome, and pheochromocytoma/paraganglioma for Lutathera, and metastatic castration-resistant prostate cancer (mCRPC) for Pluvicto. If your practice bills these agents, or your revenue cycle team processes claims for oncology infusion centers, this update directly changes your prior authorization documentation requirements.
Quick Reference: Aetna CPB 0929 Policy Change Summary
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy Title | Lutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) |
| Policy Code | CPB 0929 |
| Change Type | Modified |
| Effective Date | November 22, 2025 |
| Impact Level | High |
| Specialties Affected | Oncology, Nuclear Medicine, Urology, Gastroenterology, Endocrinology |
| Key Action | Update prior authorization documentation to match revised medical necessity criteria for both A9513 and A9607 before submitting claims against this policy |
Aetna Lutathera and Pluvicto Coverage Criteria and Medical Necessity Requirements 2025
CPB 0929 Aetna defines separate medical necessity pathways for Lutathera and Pluvicto. Get these criteria wrong and your claim denial risk is high — these are expensive agents, and Aetna's criteria are specific.
Lutetium Lu 177 Dotatate (Lutathera) — HCPCS A9513
Aetna covers Lutathera for a maximum of four doses per indication. Every covered indication requires somatostatin receptor-positive disease. That SSTR-positive confirmation is non-negotiable — document it in the prior auth request every time.
GI Tract NETs (Carcinoid Tumors) — ICD-10 C7A.x, C7B.x, E34.x
Aetna covers four doses for somatostatin receptor-positive GI NETs when the member has recurrent, locoregional advanced disease and/or distant metastases. The member must also meet at least one of these: clinically significant tumor burden, or disease progression on octreotide LAR (J2353) or lanreotide (J1930, J1932).
The "or" is important here. For GI NETs, you don't need prior progression on somatostatin analogs if the tumor burden is clinically significant. That's a more permissive threshold than what you'll see for pancreatic NETs.
Pancreatic NETs — ICD-10 C25.4
For pancreatic NETs, Aetna requires both criteria to be met simultaneously. The member must have symptomatic disease, clinically significant tumor burden, or progressive disease — and must have progressed on octreotide LAR or lanreotide. There's no workaround on the prior treatment requirement here.
Lung and Thymus NETs (Carcinoid Tumors)
This is where the coverage policy gets granular. For locoregional unresectable disease, Aetna requires prior progression on octreotide LAR or lanreotide. For distant metastatic disease, the member must have progressed on somatostatin analogs and meet at least one of four additional criteria: clinically significant tumor burden with low-grade (typical carcinoid) histology, evidence of disease progression, intermediate-grade (atypical carcinoid) histology, or symptomatic disease.
Your clinical documentation needs to capture histology grade specifically. "Carcinoid tumor" alone won't clear the prior auth. Document whether it's typical or atypical carcinoid — that distinction directly maps to Aetna's criteria.
Well-Differentiated Grade 3 NETs with Favorable Biology
Aetna covers four doses for well-differentiated grade 3 unresectable locally advanced or metastatic NETs that show "favorable biology." Aetna defines this explicitly: relatively low Ki-67 (under 55%), slow-growing tumor, and positive SSTR-based PET imaging. The member must also show clinically significant tumor burden or evidence of disease progression.
This indication will generate denials if your documentation doesn't include Ki-67 values and PET imaging results. Build a prior auth checklist that captures both data points before submission.
Carcinoid Syndrome — ICD-10 E34.0–E34.6
For poorly controlled carcinoid syndrome, Aetna requires all three conditions: somatostatin receptor-positive NET of the GI tract, lung, or thymus; prior progression on octreotide LAR or lanreotide; and concurrent use of either octreotide LAR/lanreotide for persistent flushing or diarrhea, or telotristat (no specific HCPCS code listed) in combination with octreotide LAR/lanreotide for persistent diarrhea.
The concurrent medication requirement is a billing documentation issue, not just a clinical one. Your prior auth must show what the patient is currently taking — not just what they failed.
Pheochromocytoma/Paraganglioma — ICD-10 C74.10, D44.7
Aetna covers four doses when the member has locally unresectable disease or distant metastases. This is one of the simpler pathways in this policy — two clear qualifying criteria, no prior treatment requirement stated.
Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) — HCPCS A9607
Pluvicto covers metastatic castration-resistant prostate cancer (mCRPC) — ICD-10 C61. Aetna requires PSMA-positive imaging confirmed by gallium Ga-68 PSMA-11 (A9593 for UCSF-manufactured, A9594 for UCLA-manufactured). Prior authorization is required. The policy also references supporting codes for androgen deprivation therapy (ADT), including leuprolide (J1950–J1954, J9217–J9219), goserelin (J9202), histrelin (J1675, J9225, J9226), triptorelin (J3315, J3316), and degarelix (J9155), as well as docetaxel (J9171, J9172) — reflecting the typical prior treatment requirements for mCRPC.
Orchiectomy codes (CPT 54520, 54522, 54530, 54535, 54690) also appear in CPB 0929 as related codes. Surgical castration counts as ADT in Aetna's framework. If your patient had an orchiectomy rather than pharmacologic ADT, document it explicitly in the prior auth.
Aetna Lutathera and Pluvicto Exclusions and Non-Covered Indications
Aetna is explicit: Lutathera is experimental, investigational, or unproven for all indications not listed above. There's no gray zone. If the diagnosis doesn't match one of the five covered categories — GI NETs, pancreatic NETs, lung/thymus NETs, carcinoid syndrome, or pheochromocytoma/paraganglioma — Aetna will not cover A9513.
The same applies to Pluvicto outside its approved mCRPC indication. Off-label use of either agent will not clear medical necessity review under this coverage policy.
Coverage Indications at a Glance
| Indication | Drug | Status | Primary Codes | Key Criteria Notes |
|---|---|---|---|---|
| GI Tract NETs (carcinoid) | Lutathera (A9513) | Covered | C7A.x, C7B.x | SSTR-positive; recurrent/advanced/metastatic; tumor burden OR prior SSA failure |
| Pancreatic NETs | Lutathera (A9513) | Covered | C25.4 | SSTR-positive; symptomatic/burden/progressive AND prior SSA failure (both required) |
| Lung/Thymus NETs (carcinoid) | Lutathera (A9513) | Covered | C7A.x | SSTR-positive; locoregional unresectable or distant metastatic; SSA failure required; histology grade documented |
| Well-differentiated Grade 3 NETs | Lutathera (A9513) | Covered | C7A.x, C7B.x | Ki-67 <55%; SSTR PET positive; tumor burden or progression |
| Carcinoid Syndrome (poorly controlled) | Lutathera (A9513) | Covered | E34.0–E34.6 | SSTR-positive NET; SSA failure; concurrent octreotide/lanreotide or telotristat required |
| Pheochromocytoma/Paraganglioma | Lutathera (A9513) | Covered | C74.10, D44.7 | SSTR-positive; unresectable or distant metastases |
| Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Pluvicto (A9607) | Covered | C61 | PSMA-positive (A9593/A9594); prior ADT and taxane-based chemo criteria apply |
| All other indications | Both | Not Covered / Experimental | — | Aetna considers all other uses experimental or unproven |
Aetna Lutathera and Pluvicto Billing Guidelines and Action Items 2025
The effective date is November 22, 2025. Claims processed on or after that date fall under the revised CPB 0929 criteria. Here's what your team needs to do now.
| # | Action Item |
|---|---|
| 1 | Audit your prior auth template for A9513 immediately. For each covered indication, your PA request must document SSTR-positivity, disease stage, prior treatment history, and — for lung/thymus NETs — histology grade. Missing any one of these will generate a denial on the revised criteria. |
| 2 | Add Ki-67 and SSTR PET fields to your Grade 3 NET prior auth workflow. Aetna's coverage for well-differentiated Grade 3 NETs requires documented Ki-67 under 55% and positive SSTR-based PET imaging. If your current template doesn't capture these data points, update it before the November 22, 2025 effective date. |
| 3 | Confirm PSMA imaging source for all Pluvicto (A9607) prior auths. Aetna distinguishes between A9593 (UCSF-manufactured Ga-68 PSMA-11) and A9594 (UCLA-manufactured). Use the correct HCPCS code for the imaging study when submitting the PA. A code mismatch here creates unnecessary back-and-forth. |
| 4 | Document concurrent medications for carcinoid syndrome cases. Aetna requires active concurrent use of octreotide LAR (J2353), lanreotide (J1930 or J1932), or telotristat at the time of Lutathera treatment for carcinoid syndrome coverage. Your prior auth must reflect current medication status — not just treatment history. |
| 5 | Cross-check pancreatic NET claims for the "both criteria" requirement. GI NETs require one of two criteria; pancreatic NETs require both. This is a common place for prior auth submissions to fail. Train your team on the distinction before submitting any C25.4 claims under the revised policy. |
| 6 | Bill infusion administration correctly. Radiopharmaceutical therapy bills under CPT 79101. Chemotherapy infusion administration codes 96413–96417 also appear as related codes in CPB 0929. Confirm with your clinical team which administration code applies to each agent in your setting. |
| 7 | Check your reimbursement tracking for both agents post-November 22. Policy modifications sometimes trigger changes in how claims process in Aetna's adjudication system. Monitor your first round of post-effective-date remittances for any new denial patterns against either A9513 or A9607. |
If your practice sees high volume of NET or prostate cancer patients with Aetna commercial coverage, loop in your compliance officer before the effective date. The criteria differences between GI, pancreatic, and lung NETs are subtle enough to create systematic billing errors if your team doesn't get a focused review.
| 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 Lutathera and Pluvicto Under CPB 0929
HCPCS Codes Covered When Selection Criteria Are Met
| Code | Type | Description |
|---|---|---|
| A9513 | HCPCS | Lutetium Lu 177, dotatate, therapeutic, 1 millicurie |
| A9607 | HCPCS | Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie |
CPT Codes Related to CPB 0929
| Code | Type | Description |
|---|---|---|
| 54520 | CPT | Orchiectomy, simple (including subcapsular), with or without testicular prosthesis, scrotal or inguinal approach |
| 54522 | CPT | Orchiectomy, partial |
| 54530 | CPT | Orchiectomy, radical, for tumor; inguinal approach |
| 54535 | CPT | Orchiectomy, radical, for tumor; with abdominal exploration |
| 54690 | CPT | Laparoscopy, surgical; orchiectomy |
| 79101 | CPT | Radiopharmaceutical therapy, by intravenous administration |
| 84307 | CPT | Somatostatin |
| 84402 | CPT | Testosterone; free |
| 84403 | CPT | Testosterone; total |
| 96413 | CPT | Intravenous chemotherapy administration, up to 1 hour |
| 96414 | CPT | Intravenous chemotherapy administration, each additional hour |
| 96415 | CPT | Intravenous chemotherapy administration, each additional hour |
| 96416 | CPT | Intravenous chemotherapy administration, initiation of prolonged infusion |
| 96417 | CPT | Intravenous chemotherapy administration, each additional sequential infusion |
Key ICD-10-CM Diagnosis Codes Under CPB 0929
| Code | Description |
|---|---|
| C25.4 | Malignant neoplasm of endocrine pancreas |
| C61 | Malignant neoplasm of prostate |
| C73 | Malignant neoplasm of thyroid gland |
| C74.10 | Malignant neoplasm of medulla of unspecified adrenal gland (pheochromocytoma) |
| C7A.0–C7A.8 | Malignant neuroendocrine tumors |
| C7B.0–C7B.9 | Secondary carcinoid tumors |
| D32.0–D32.9 | Benign neoplasm of meninges (meningioma) |
| D44.7 | Neoplasm of uncertain behavior of aortic body and other paraganglia (paraganglioma) |
| E34.0–E34.6 | Carcinoid syndrome |
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