Lutathera (lutetium Lu 177 dotatate) — HCPCS A9513

Radioligand class — A9513 (Lutathera) vs A9607 (Pluvicto) CMS HCPCS verified May 2026

Two Novartis Lu-177 radioligands. Same isotope, completely different targets and indications. Don't cross the wires on the HCPCS.

Lu-177-based radioligand therapy is a fast-growing therapeutic class. As of May 2026, two products are FDA-approved and routinely billed in U.S. nuclear medicine departments: Lutathera (lutetium Lu 177 dotatate, A9513) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan, A9607). Both are manufactured by Novartis (via Advanced Accelerator Applications), share the same therapeutic isotope (Lu-177, beta-minus emitter, 6.7-day half-life), and use the same administration CPT (79101). They are not interchangeable.

Dosing & unit math FDA label verified May 2026

From the FDA-approved Lutathera prescribing information (BLA 208700, peds revision April 2024). Unit-of-billing is the millicurie (mCi), not the milligram.

Approved indications

• Adult GEP-NETs — somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut carcinoid tumors and pancreatic neuroendocrine tumors (pNETs)
• Pediatric GEP-NETs — same indication, patients 12 years and older (FDA approval April 23, 2024; first pediatric radioligand approval)

Dosing & schedule

Worked example — full 4-cycle course

Dose modifications

Per FDA label, dose reductions (to 3.7 GBq / 100 mCi) or treatment delays apply for specific hematologic, renal, and hepatic toxicities. Examples: platelets <75×10&sup9;/L, neutrophils <1×10&sup9;/L, creatinine clearance <40 mL/min, or grade 4 hepatic toxicity. Each held or reduced cycle should be documented at the visit; billing reflects the actually-administered mCi (e.g., a 100 mCi reduced dose bills as A9513 × 100 units, not 200).

Companion PET imaging gate

Before cycle 1, somatostatin receptor positivity must be confirmed by Ga-68 dotatate PET (NETSPOT, A9587) or Cu-64 dotatate PET (Detectnet, A9592). Lesion uptake must be at least equal to or greater than normal liver uptake on planar/SPECT or PET imaging per the FDA label. This is the gating clinical eligibility criterion and the single most common cause of Lutathera prior authorization denial.

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Lutathera is a radiopharmaceutical therapy. Use nuclear medicine therapy administration codes, not chemo or therapeutic infusion codes.

Modifiers CMS verified May 2026

JZ — routine on patient-specific radiopharmaceutical fills

Lutathera ships as a patient-specific individualized fill calibrated to the administration time. In practice, there is rarely physical waste in the conventional vial sense — the entire shipped activity is administered. Bill JZ on A9513 to attest "no discarded amount from a single-dose container," consistent with CMS's July 2023 single-dose container policy.

JW — only if dose is held or partially administered

If a dose is partially administered (e.g., infusion-reaction stop, line failure) and the remaining activity is discarded, report the discarded mCi on a separate JW line. Document the actually-administered activity from the dose calibrator log and the difference from the shipped fill. Both administered and wasted activity are reimbursable for single-dose container radiopharmaceuticals.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the radioligand administration. Routine pre-infusion clinical check (vitals, prior-cycle toxicity review, AU verification) is bundled into the admin code.

340B modifiers (JG, TB)

Lutathera is dispensed by certified nuclear medicine departments. 340B-acquired Lutathera in HOPD settings follows the current 340B modifier policy — verify against your MAC's published guidance and your hospital's 340B compliance team. Pass-through radiopharmaceuticals have specific 340B reporting nuances; do not assume parity with J-code biologics.

Modifier CT — companion PET imaging

If the companion Ga-68 dotatate or Cu-64 dotatate PET scan is performed on a non-NEMA-XR-29 compliant CT (rare in 2026), modifier CT applies to the PET CPT code line. Most modern PET/CT scanners are compliant and modifier CT is not needed.

ICD-10-CM by indication FY2026 verified May 2026

Lutathera is indicated for somatostatin receptor-positive GEP-NETs. Histology must be well-differentiated; receptor positivity must be documented by companion PET.

Site of care & place of service Verified May 2026

Lutathera is administered exclusively in certified nuclear medicine departments within hospital outpatient settings. Unlike conventional infused biologics or chemo, radioligand therapy is restricted to sites with an authorized user (AU) credentialed per NRC or Agreement State licensure to handle Lu-177, shielded infusion stations, radiation safety officer (RSO) oversight, and protocols for radioactive waste handling. There is no office-based (POS 11) or ambulatory infusion center (POS 49) administration pathway.

Claim form field mapping Novartis Patient Support 2026

Lutathera claims are typically submitted on UB-04 (837I) by the hospital outpatient department.

Payer policy snapshot Reviewed May 2026

All major payers require PA. The Ga-68 or Cu-64 dotatate PET + prior somatostatin analog history are universal gating requirements.

Step therapy & prior SSA

Long-acting somatostatin analog therapy — octreotide LAR (Sandostatin LAR) or lanreotide (Somatuline Depot) — is the standard first-line approach for SSTR+ GEP-NETs. Major payers require documentation of prior SSA therapy and either progression on SSA or symptom progression / hormonal symptoms warranting escalation. Lutathera does not replace SSA; per the FDA label, long-acting octreotide LAR is continued between Lutathera cycles (administered ~4 hours after each Lutathera dose for cycle 1, then per usual schedule). Document the prior SSA regimen, duration, and reason for escalation in the PA packet.

NCCN compendium support

Lutathera is included in the NCCN Neuroendocrine and Adrenal Tumors guideline as a recommended option (Category 2A) for progressive SSTR+ GEP-NETs. NCCN-supported off-label uses (e.g., bronchopulmonary carcinoid, paraganglioma in select cases) may be coverable under compendium-based PA but require additional documentation. Verify NCCN category against current edition.

Companion PET pre-authorization

The companion Ga-68 dotatate PET (NETSPOT) or Cu-64 dotatate PET (Detectnet) frequently requires its own PA, billed to the same payer typically on a separate authorization. Some payers will conditionally approve Lutathera contingent on a satisfactory companion PET report; others require the PET to be completed and submitted with the Lutathera PA packet. Coordinate with the nuclear medicine and radiation oncology teams to sequence the PET pre-PA workflow.

Medicare reimbursement CMS Q2 2026 (live)

A9513 is paid under OPPS for HOPD administration. Pass-through payment status applies for high-cost radiopharmaceuticals; verify the current OPPS Addendum B status indicator.

Coverage

No NCD specific to Lutathera or to peptide receptor radionuclide therapy generally. Coverage falls under MAC LCDs for nuclear medicine therapy services and the radiopharmaceutical pass-through framework. All MACs cover A9513 for FDA-approved on-label indications with appropriate ICD-10 (C7A.x or C25.4), somatostatin receptor positivity documented by Ga-68 / Cu-64 dotatate PET, and prior SSA history.

Code history

• A9513 — "Lutetium Lu 177, dotatate, therapeutic, 1 millicurie"; effective April 1, 2018 (post-FDA approval Q1 2018). Pre-permanent code period (Q1–Q2 2018) used C9408 (transitional pass-through C-code).
• C9408 — transitional pass-through C-code, retired Q3 2018 when A9513 became permanent.
• A9587 — "Gallium Ga-68 dotatate, diagnostic, 0.1 millicurie" (NETSPOT); companion diagnostic.
• A9592 — "Copper Cu-64, dotatate, diagnostic, 1 millicurie" (Detectnet, RadioMedix/Curium); alternate companion diagnostic, FDA approved September 2020.

Patient assistance — Novartis Patient Support Novartis verified May 2026

• Novartis Patient Support Center: 1-844-638-7222 / novartis.com/our-focus/patient-support — benefits investigation, prior authorization assistance, appeal support, site-of-care navigation
• Lutathera Co-Pay Assistance Program: commercial copay support for eligible commercially-insured patients; subject to annual cap (excludes Medicare, Medicaid, federal program patients)
• Novartis Patient Assistance Foundation, Inc.: free product for uninsured / underinsured patients meeting income requirements (501(c)(3))
• Foundations (Medicare patients): PAN Foundation (Neuroendocrine Cancer fund), HealthWell Foundation, Patient Access Network — verify open neuroendocrine cancer funds quarterly
• Carcinoid Cancer Foundation: patient navigation, peer support, and travel assistance for theranostics centers; carcinoid.org
• Travel & lodging: Novartis Patient Support coordinates with Healthcare Hospitality Network and Hope Lodge for patients traveling to certified Lutathera centers (many regions have only 1–2 sites)

Radiation safety & FDA-label warnings FDA label

FDA-label warnings & precautions

• Myelosuppression: grade 3+ lymphopenia / thrombocytopenia / neutropenia / anemia in the pivotal NETTER-1 trial. Monitor CBC at baseline, before each cycle, and 2–4 weeks post-cycle.
• Secondary MDS & acute leukemia: approximately 2–3% in published follow-up. Discuss in consent and monitor CBC long-term.
• Renal toxicity: monitor serum creatinine and eGFR; the amino acid co-infusion mitigates but does not eliminate proximal tubular dose. Hold or dose-reduce per FDA label for creatinine clearance changes.
• Hepatotoxicity: monitor LFTs; dose hold criteria per label.
• Neuroendocrine hormonal crisis: can occur in functional NETs (carcinoid syndrome, gastrinoma, insulinoma, glucagonoma). Pretreat with octreotide IV and/or hydration per local protocol; monitor for flushing, diarrhea, bronchospasm, hypotension or hypoglycemia after administration.
• Embryo-fetal toxicity: can cause fetal harm; counsel on contraception ×7 months post-treatment (females) and ×4 months (males).
• Infertility: may impair fertility; discuss fertility preservation referral before cycle 1.
• Radiation exposure to family / caregivers: patients are radioactive for several days post-administration. Provide written discharge instructions on close-contact restrictions, sleeping arrangements, public transit, and pediatric exposure mitigation per FDA label and your institution's RSO guidance.

Lutathera carries no FDA Boxed Warning, but the cumulative radiation, secondary malignancy risk, and family/caregiver exposure considerations make the discharge instruction packet a critical workflow element. Document discharge counseling and provide the standardized written sheet at every cycle.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Lutathera?

Lutathera (lutetium Lu 177 dotatate) is billed under HCPCS A9513 — "Lutetium Lu 177, dotatate, therapeutic, 1 millicurie." Note this is an A-code (radiopharmaceutical category), not a J-code. Each millicurie equals one billable unit and the standard 200 mCi dose bills as 200 units.

What administration CPT do I use for Lutathera?

CPT 79101 — "Radiopharmaceutical therapy by intravenous administration." This is a nuclear medicine therapy code, NOT a chemotherapy or therapeutic infusion code. Do NOT bill 96365 (therapeutic IV), 96413 (chemo IV), or 96374 (IV push).

Is companion PET imaging required before Lutathera?

Yes. Per FDA label and all major payer policies, somatostatin receptor positivity must be documented by Ga-68 dotatate PET (NETSPOT, HCPCS A9587) or Cu-64 dotatate PET (Detectnet, HCPCS A9592) before Lutathera initiation. Lesion uptake must be equal to or greater than normal liver uptake on planar/SPECT or PET imaging. Missing or absent companion PET documentation is the #1 cause of Lutathera prior authorization denial.

How many doses are in a Lutathera course?

Four doses of 7.4 GBq (200 mCi) administered approximately 8 weeks apart, for a cumulative dose of 29.6 GBq (800 mCi). Each dose is billed separately as A9513 × 200 units on the day of administration.

Is amino acid co-infusion required with Lutathera?

Yes. Per FDA label, IV amino acid solution (containing lysine and arginine for renal protection) must be started 30 minutes before Lutathera and continued for at least 3 hours after administration. The amino acid infusion reduces radiation exposure to the proximal renal tubules. Failure to document amino acid co-infusion is the #3 cause of Lutathera denial.

What ICD-10 codes do I use for Lutathera?

Indication is somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Primary codes include C7A.012 (ileal carcinoid — classic midgut NET), C7A.020 (appendix / large intestine / rectum), C7A.090 (foregut NET), and C25.4 (malignant neuroendocrine tumor of pancreas). Pair with secondary metastatic codes (C77–C79) where applicable. Well-differentiated histology is required; C7A.1 (poorly differentiated NEC) is NOT an appropriate indication.

What is the Medicare reimbursement for A9513?

A9513 is paid under the Medicare Hospital Outpatient Prospective Payment System (OPPS) for HOPD administration. As a high-cost radiopharmaceutical, A9513 receives OPPS pass-through payment (status indicator G) at ASP + 6%, similar to physician-administered drugs. Pass-through status is time-limited and was extended for radioligand therapies under recent CMS rulemaking. Verify the current OPPS Addendum B status indicator for A9513 each calendar year. Manufacturer WAC is approximately $56,000 per dose; the four-dose course costs approximately $224,000 in drug acquisition.

How is Lutathera different from Pluvicto?

Both are Novartis Lu-177 radioligand therapies. Lutathera (A9513) targets somatostatin receptor type 2 (SSTR2) using the DOTATATE peptide for GEP-NETs. Pluvicto (A9607) targets prostate-specific membrane antigen (PSMA) for metastatic castration-resistant prostate cancer (mCRPC). Both require companion diagnostic PET (Ga-68 dotatate for Lutathera; piflufolastat F 18 / Ga-68 gozetotide for Pluvicto), both use CPT 79101, and both follow OPPS pass-through frameworks. They are not interchangeable. See the radioligand class comparison.

Is Lutathera given with somatostatin analogs?

Yes. Long-acting octreotide LAR (Sandostatin LAR, J2354) or lanreotide (Somatuline Depot, J1930) is continued between Lutathera cycles. Short-acting octreotide is held 24 hours before each Lutathera dose. Per FDA label, octreotide LAR 30 mg IM is administered ≥4 hours after each Lutathera infusion on cycle days, with the standard q4-week SSA schedule resumed thereafter. The concurrent SSA bills under its own HCPCS (J2354 for octreotide LAR; J1930 for Somatuline Depot).

Source documents

1. FDA — LUTATHERA prescribing information (BLA 208700)
   FDA-approved label including April 2024 pediatric (12+) GEP-NET expansion; full prescribing information including dosing, W&P, radiation safety
2. DailyMed — LUTATHERA (lutetium Lu 177 dotatate)
   Setid 72d1a024-00b7-418a-b36e-b2cb48f2ab55 — labeler Advanced Accelerator Applications USA; label revision verified January 15, 2026 (updated 10/2024 with pediatric ≥12 expansion)
3. Strosberg J et al., NEJM 2017 — NETTER-1 phase 3 trial
   Pivotal RCT of 177Lu-DOTATATE vs high-dose octreotide LAR in midgut NETs (DOI: 10.1056/NEJMoa1607427); supports original 2018 FDA approval
4. Singh S et al., The Lancet 2024 — NETTER-2 phase 3 trial
   First-line 177Lu-DOTATATE + octreotide in higher-grade GEP-NETs; supports April 2024 pediatric ≥12 label expansion
5. Novartis — Lutathera HCP site & Patient Support
   Manufacturer billing guide, claim form mapping, copay assistance program, AU/RSO resources
6. CMS — Medicare Part B Drug ASP Pricing File
   Quarterly ASP file; A9513 listed under radiopharmaceuticals (A-code series)
7. CMS — OPPS Addendum A / Addendum B
   Hospital outpatient status indicators; check A9513 status quarterly (pass-through vs packaged)
8. SEER CanMED — HCPCS A9513 reference
9. NCCN Clinical Practice Guidelines — Neuroendocrine and Adrenal Tumors
   Compendium support for Lutathera in SSTR+ GEP-NETs (Category 2A)
10. UnitedHealthcare — Oncology Medication Clinical Coverage Policy (PRRT)
11. Aetna CPB 0913 — Peptide Receptor Radionuclide Therapy
12. U.S. NRC — Lu-177 medical use guidance & authorized user requirements
    Federal licensing and AU credentialing framework for Lu-177 therapy
13. FDA National Drug Code Directory
14. CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 22, 2026 — SME audit pass. Corrected Cu-64 dotatate HCPCS A9591 → A9592 throughout (A9591 is fluoroestradiol F-18 / Cerianna). Corrected PSMA-PET tracer A-codes in the A9513-vs-A9607 comparison table. Added DailyMed setid, NETTER-1 (NEJM 2017) and NETTER-2 (Lancet 2024) pivotal trial citations to source list. Page now reflects current 2026 CMS HCPCS Level II file.
• May 22, 2026 — Initial publication. ASP data: Q2 2026. First radioligand / radiopharmaceutical page in the catalog. Manufacturer source: Novartis Patient Support 2026. Includes pediatric (12+) GEP-NET indication added April 2024. Sister-product context: Pluvicto (A9607) cross-reference.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File and the OPPS Addendum B status indicator. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list, dosing, and radiation safety guidance are verified against the current FDA label revision. Authorized user and licensing context is verified against NRC guidance for Lu-177 medical use. We do not paraphrase from billing-software vendor blogs.