HCPCS code A9607: Lutetium Lu 177 vipivotide tetraxetan billing guide

Key Takeaways

HCPCS Code A9607 describes Lutetium Lu 177 vipivotide tetraxetan (Pluvicto), a PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer, billed at 1 mCi per unit.

A standard 200 mCi Pluvicto dose = 200 billing units; a modified 160 mCi dose = 160 billing units. Each millicurie is one reportable unit.

A9699 (not-otherwise-classified) must NOT be used for Pluvicto after September 30, 2022; A9607 is the only valid code from October 1, 2022 onward.

Pabau’s claims management software helps oncology billing teams track radiopharmaceutical units, attach required documentation, and submit A9607 claims accurately.

HCPCS code A9607 is the only billable code for Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in the United States. Practices billing this radiopharmaceutical after September 30, 2022 must use A9607; the prior catch-all code A9699 is no longer valid for this drug.

This guide covers the official descriptor, billing unit calculation, Medicare and Medicaid reimbursement pathways, prior authorization requirements, documentation standards, and the ICD-10 diagnosis codes routinely paired with A9607. It is written for oncology billing teams and hospital outpatient coders who need a single reference for accurate claims management on Pluvicto infusion days.

HCPCS code A9607: Descriptor, clinical context, and effective date

Official descriptor and code classification

The official HCPCS Level II descriptor for A9607, as established by CMS, is:

A9607: Lutetium lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie

• Code type: HCPCS Level II (A-code, radiopharmaceutical)
• CMS category: Diagnostic and Therapeutic Radiopharmaceuticals
• Effective date: October 1, 2022 (established via CMS HCPCS application summary Q2 2022)
• Brand name: Pluvicto (Novartis)
• Mechanism: PSMA-targeted radioligand therapy (RLT)
• FDA-approved indication: PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in adults who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy

CMS established A9607 in direct response to Novartis’s application following FDA approval of Pluvicto on March 23, 2022. Before October 1, 2022, providers submitted claims using A9699 (not-otherwise-classified radiopharmaceutical). North Carolina Medicaid confirmed that A9699 must not be used for Pluvicto after September 30, 2022.

Billing units and dosage calculation for A9607

The unit of service for A9607 is 1 millicurie (mCi). Every mCi administered equals one reportable billing unit. Errors occur when billing teams round or estimate rather than report the actual dispensed dose.

According to the Novartis official coding and billing guide, a standard Pluvicto dose of 200 mCi is billed as 200 units and a dose-modified administration of 160 mCi is billed as 160 units. The vial contains 7.4 GBq (200 mCi) of lutetium Lu 177 vipivotide tetraxetan in a 30 mL single-dose presentation.

The NDC associated with the 30 mL single-dose vial is 69488-0010-61 (11-digit billing format 69488001061); Medicare Part B claims typically require NDC reporting alongside the HCPCS code, though payers vary on format requirements.

Waste and the JW/JZ modifiers

Pluvicto is dispensed as a single-dose vial, so waste scenarios are uncommon under standard administration. However, if a dose is prepared and the patient cannot receive it, CMS waste-billing rules apply.

The JW modifier reports discarded drug from a single-dose container; the JZ modifier attests that no drug was wasted. Check current payer-specific policy before applying either modifier, as guidance continues to evolve and MAC-specific LCD policies differ.

Medicare and Medicaid reimbursement for HCPCS code A9607

Medicare Part B reimburses separately payable drugs and biologicals under the Outpatient Prospective Payment System (OPPS) at the Ambulatory Payment Classification (APC) rate. Pluvicto’s high cost and novel mechanism led CMS to assign A9607 pass-through payment status upon its October 2022 introduction, allowing separate additional reimbursement above the standard APC rate.

That pass-through status expired September 30, 2025. A9607 now pays under standard OPPS APC packaging and separate-payment rules; confirm the current APC and status-indicator assignment against the latest CMS OPPS files before billing.

Medicare’s statutory drug payment methodology for Part B drugs is Average Sales Price (ASP) plus 6%, though the effective payment rate is reduced by sequestration (currently ASP+4.3% for most drugs not on pass-through status). CMS recalculates ASP quarterly.

WAC (Wholesale Acquisition Cost) pricing serves as a temporary basis when ASP data is unavailable. AWP (Average Wholesale Price) is a benchmark used by some commercial payers but is not the Medicare payment basis. Always verify the current-quarter ASP rate through the CMS Physician Fee Schedule lookup before quoting a reimbursement figure.

Medicaid coverage and state variations

State Medicaid programs set their own coverage policies. North Carolina Medicaid confirmed A9607 coverage effective October 1, 2022, with an explicit directive that A9699 must not be submitted for Pluvicto after September 30, 2022. Nevada Medicaid issued a web announcement effective December 8, 2025 addressing HCPCS code A9607 coverage.

Coverage determinations, prior authorization thresholds, and reimbursement amounts differ by state. Billing teams should pull the most recent state-specific Medicaid fee schedule before submitting claims.

Hospital outpatient vs. physician office billing

A9607 is billed differently depending on the setting. Hospital outpatient departments use the UB-04 claim form and report under OPPS. Physician offices and freestanding infusion centers use the CMS-1500 claim form and report under the Medicare Physician Fee Schedule (MPFS).

The HIPAA compliance requirements for electronic claim transmission apply in both settings. Verify with your MAC whether your facility qualifies for hospital outpatient OPPS rates or falls under the MPFS for Pluvicto administration.

Prior authorization and payer requirements

Prior authorization (PA) for A9607 is required by most commercial payers. EmblemHealth added Pluvicto to its preauthorization list effective August 1, 2022, before the dedicated A9607 code was even active. Blue Cross MA (through Carelon/AIM) added A9607 to its Quality Care Cancer Program radiation oncology CPT and HCPCS code list.

Medicare does not require prior authorization for most Part B drugs under OPPS, but clinical documentation must support medical necessity at the time of service. Medicaid PA requirements vary by state.

Failing to obtain PA when a commercial payer requires it is the leading preventable denial reason for Pluvicto claims. Practice management workflows that flag PA requirements before the infusion date prevent same-day claim failures.

• Commercial payers: PA required in most cases; submit diagnosis, PSMA-PET imaging results, prior treatment history
• Medicare Part B: No PA required; clinical documentation supports medical necessity post-hoc
• Medicaid: PA requirements vary by state; verify with the relevant state agency before scheduling
• MAC-specific LCDs: Check for active Local Coverage Determinations that may specify additional eligibility criteria

Documentation requirements for A9607 claims

Because Pluvicto is a high-cost specialty drug with a narrow FDA indication, payers scrutinize documentation closely. A missing PSMA-PET result or incomplete prior treatment history is enough to trigger a denial or audit. Structured digital documentation workflows reduce the risk of missing elements at claim submission.

• Confirmed PSMA-positive status: PSMA-PET imaging report confirming PSMA expression
• Diagnosis and staging: Documentation of metastatic castration-resistant prostate cancer (mCRPC)
• Prior treatment history: Evidence of prior ARPI therapy (e.g. enzalutamide, abiraterone) and taxane-based chemotherapy
• Prescriber order: Physician order specifying dose (200 mCi standard or 160 mCi modified) and cycle number
• Pharmacy/dispensing record: Confirms actual millicuries dispensed, NDC, lot number, and date/time of calibration
• Administration record: Date of infusion, route, and supervising clinician
• Cycle tracking: Pluvicto is administered up to 6 cycles (every 6 weeks per FDA label); cycle number and scheduled date should be noted in the record

Keep dispensing records from the radiopharmacy as part of the billing file. The NDC number (69488-0010-61 for the 30 mL single-dose vial) must be reported on Medicare Part B claims. Some payers also require the lot number for radiopharmaceutical tracing purposes.

Maintaining these records within a compliant EHR integration system that links the dispensing record to the claim reduces retrieval time during audits.

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ICD-10 diagnosis codes paired with A9607

A9607 claims require a supporting ICD-10-CM diagnosis code that establishes medical necessity. Pluvicto’s FDA indication is narrow, so the diagnosis codes used are consistent across most claims. Using an incorrect or non-specific diagnosis code is a frequent denial trigger for specialty oncology drugs.

C61 is the primary diagnosis code for the overwhelming majority of A9607 claims. Metastatic disease is documented through secondary diagnosis codes. Some payers also require a PSMA-expression-related code or an imaging-related code to support prior authorization documentation, though coding for PSMA-PET results follows a separate pathway.

Refer to your MAC’s Local Coverage Determination for the complete list of covered ICD-10 codes. HIPAA-compliant claim transmission requires accurate code linkage between A9607 and its supporting diagnosis codes on the UB-04 or CMS-1500. For related oncology drug billing, see our guide to HCPCS code J9299 (nivolumab injection).

Administration CPT codes billed alongside A9607

A9607 covers only the drug itself. Pluvicto administration is a nuclear medicine procedure, not a standard chemotherapy infusion. It is reported under the radiopharmaceutical therapy administration code rather than the general IV infusion CPT family.

• 79101: Radiopharmaceutical therapy, by intravenous administration

CPT codes 96365, 96366, and 96401 describe general infusion and injection administration and do not apply to Pluvicto. Treatment-planning or dosimetry codes (77261-77263) may also be billed separately depending on payer policy and the level of physics or dosimetry work performed for the case.

In a hospital outpatient setting, administration services are bundled into the APC rate for the visit; CPT 79101 is still reported but payment is captured differently than in the physician office.

Confirm with your MAC and facility-specific billing policies how 79101 interacts with A9607 APC assignment. Practices managing high volumes of infusion billing can benefit from patient care management systems that track cycle numbers, administration dates, and remittance data in one place. Unclassified biologic claims follow a similar workflow — see our HCPCS code J3590 billing guide for reference.

Related HCPCS codes and transition from A9699

The table below shows where A9607 sits relative to the codes it replaced and neighboring radiopharmaceutical codes in the HCPCS Level II schedule — useful context for practices that first billed Pluvicto in mid-2022 under a temporary code.

North Carolina Medicaid explicitly confirmed that A9699 must not be used for Pluvicto claims submitted after September 30, 2022. Any retrospective claims for dates of service from October 1, 2022 onward must use A9607. If your practice billed Pluvicto under A9699 during the transition window, review those claims for potential resubmission.

The AAPC Codify HCPCS lookup provides current code properties and notes for A9607. The NLM Clinical Table Search API is a free programmatic resource for verifying HCPCS Level II code attributes. Practices using automated billing workflows can build code-expiration alerts to flag outdated codes before submission.

Buy-and-bill vs. specialty pharmacy acquisition for Pluvicto

Pluvicto’s radioactive nature and short shelf life (calibration-specific) make its acquisition pathway unique compared to standard oncology drugs. Two pathways exist, and the one you use affects how A9607 claims are structured. For another high-cost oncology injectable with similar acquisition considerations, see our HCPCS Code J9217 (leuprolide acetate) billing guide.

Buy-and-bill

Under the buy-and-bill model, the facility or practice purchases Pluvicto directly from Novartis through authorized radiopharmacies. The practice then bills A9607 on the claim, seeking reimbursement for the drug cost plus the administration service.

Medicare Part B reimburses at ASP+6% under this model. The practice assumes the cost of the drug until reimbursed, which creates cash-flow considerations given Pluvicto’s high acquisition cost.

Specialty pharmacy pathway

Some commercial payers direct Pluvicto through a specialty pharmacy benefit rather than the medical benefit. Under this pathway, the payer pays the specialty pharmacy directly for the drug, and the practice bills only for administration (the infusion CPT code). In this case, A9607 may not appear on the facility’s claim at all.

Confirm benefit category with each commercial payer during the PA process to avoid billing A9607 when the payer has already paid the pharmacy separately. Applying structured intake and treatment documentation helps practices track which pathway applies per patient per cycle.

Claim submission checklist for A9607

Use this checklist before submitting any A9607 claim. Denials on high-cost radiopharmaceuticals are expensive to work and most are preventable with thorough pre-submission review. Practices with structured practice management software can embed these checks into the claim preparation step.

1. Code verified: A9607 is the submitted code (not A9699 or any NOS code)
2. Unit count confirmed: Units reflect actual mCi administered per pharmacy dispensing record
3. NDC reported: NDC 69488-0010-XX submitted in the correct format per payer requirements
4. Diagnosis code linked: C61 (and applicable secondary codes) linked to A9607 on the claim
5. PA on file: PA number included on commercial claims; documentation available for audit
6. Administration CPT included: CPT 79101 (radiopharmaceutical therapy administration) reported separately
7. Setting confirmed: UB-04 for hospital outpatient; CMS-1500 for physician office
8. Modifier reviewed: JW/JZ modifier applied only if applicable per payer policy
9. ASP rate checked: Current-quarter ASP rate verified against the CMS quarterly ASP file or CMS publication

A9607 billing: Key points

Accurate billing for HCPCS code A9607 comes down to three things: using the correct code (not A9699), reporting the right number of billing units based on actual mCi administered, and attaching complete documentation before the claim goes out. For a drug with a per-cycle cost in the tens of thousands of dollars, denials are costly and appeals are time-consuming.

For another recently introduced injectable drug billing guide, see HCPCS Code J1306: Inclisiran 1 mg billing guide. Teams managing IV infusion schedules alongside radiopharmaceutical billing may also find the CPT code 96360 IV hydration billing guide, the HCPCS code E0748 billing guide, and the HCPCS Code Q9957 billing guide useful references.

Pabau’s claims management software helps specialty and oncology practices build structured documentation workflows, track high-cost drug claims by unit count, and flag incomplete records before submission.

If your billing team manages Pluvicto cycles alongside a full oncology or infusion schedule, revenue cycle management workflows built for high-cost drug billing reduce manual claim errors and keep A9607 submissions clean from day one.

Continue your research

Need a broader overview of HCPCS billing workflows? Claims management software covers how Pabau structures radiopharmaceutical and infusion billing from order through remittance.

Managing infusion documentation across multiple cycles? Patient intake software explains how Pabau standardizes clinical intake and treatment record collection for infusion practices.

Looking for CPT code references for oncology administration? CPT Code 96413 chemotherapy infusion billing guide covers how administration codes pair with high-cost oncology drug claims.

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