HCPCS Code A9607: Lutetium Lu 177 Vipivotide Tetraxetan, Therapeutic, 1 millicurie

Read our guide on HCPCS Code A9607 for billing Lutetium Lu 177 vipivotide tetraxetan (Pluvicto), a therapeutic radioligand for PSMA-positive prostate cancer, billed per 1 mCi.

Use Code

## **What is Lutetium Lu 177 vipivotide tetraxetan?** HCPCS code A9607 is defined as “Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie.” This radiopharmaceutical, marketed as Pluvicto, is a radioligand therapeutic agent approved by the FDA in March 2022 for use in adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). CMS assigned HCPCS code A9607, effective October 1, 2022; however, the code expired on September 30, 2025. During its active period, A9607 held transitional pass-through status under the Hospital Outpatient Prospective Payment System (OPPS), indicated by status indicator “G.” This temporary payment policy applied only when Pluvicto was administered to Medicare beneficiaries in the hospital outpatient setting. Pluvicto works by attaching Lutetium-177, a radioactive isotope, to a ligand that binds to PSMA-expressing tumor cells. This combination delivers targeted radiation directly to cancer cells, causing DNA damage and cell death while minimizing harm to normal tissue. In clinical practice, the therapy is given by intravenous administration and is often considered for patients who have progressed after androgen receptor pathway inhibition and taxane-based chemotherapy. Administration of A9607 is restricted to specialized nuclear medicine centers, where it is administered under strict radiation safety protocols. The drug is manufactured and distributed in the United States by Advanced Accelerator Applications USA. Billing is based on the exact amount used, with one unit equal to one millicurie (mCi). Due to its high cost and specialized use, payers closely review claims, making accurate documentation and unit reporting crucial for reimbursement.

## **HCPCS code A9607 documentation requirements** Medical records must demonstrate that use of Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is reasonable and necessary. At a minimum, documentation should include: - Patient demographics (name, date of birth, insurance ID, group number, dates of service). - The confirmed diagnosis of metastatic castration-resistant prostate cancer with PSMA-positive status, supported by diagnostic imaging or laboratory evidence. - A signed and dated order from the treating oncologist or nuclear medicine physician specifying intravenous use, dose in millicuries, frequency, and planned number of cycles. - List of prior therapies and treatment history, showing progression after androgen receptor pathway inhibition and taxane-based chemotherapy. - Clinical notes supporting the diagnosis and treatment decision, including laboratory and imaging results. - Prescriber and facility information (names and tax ID numbers). - Details of the treatment setting, confirming it is a facility authorized to handle therapeutic radiopharmaceuticals. - Documentation of informed consent, radiation safety precautions, and monitoring requirements. - Lot number, strength, and formulation of the drug dispensed. - The exact number of millicuries administered, converted into billable units (1 unit = 1 millicurie). - Setting of care and planned date of service. - Reference to the Pluvicto Prescribing Information and recommended dosage to confirm the treatment plan aligns with FDA-approved use.

## **Billing requirements of HCPCS code A9607** Accurate billing is essential given the cost and complexity of radiopharmaceutical therapies: - Bill one unit for each millicurie dispensed. For example, a 200 mCi dose is billed as 200 units. - Use CMS-1500 for professional claims and UB-04 for facility claims, with dates of service matching the treatment record. - Report the associated ICD-10-CM code along with additional secondary codes as required. - Include the National Drug Code (NDC) when required by the payer for drug identification and pricing. - Revenue codes commonly used for Pluvicto on UB-04 claims include 240 (all inclusive ancillary, general), 340 (nuclear medicine, general), 342 (nuclear medicine, therapeutic), 344 (nuclear medicine, therapeutic radiopharmaceuticals), and 636 (pharmacy, drugs requiring detailed coding). - Place of Service (POS) codes may be required to indicate where the service was provided. Commonly used codes include 11 (Office), 22 (On Campus–Outpatient Hospital), and 49 (Independent Clinic). - Charges should reflect the actual acquisition cost, and invoices may be requested for review. - Medicare and commercial payer coverage is limited to FDA-approved indications and often requires prior authorization.

## **Applicable modifiers for A9607** Modifiers help clarify how Lutetium Lu 177 vipivotide tetraxetan was used and ensure claims are processed correctly. - **JW**: Report unused drug or radiopharmaceutical that is discarded, with the amount wasted documented in the medical record. - **JZ:** Used when no drug is wasted, confirming that the entire dose was administered.

## **Other relevant codes** - **A9606**: Radium Ra-223 dichloride, therapeutic, per microcurie - **A9699**: Radiopharmaceutical, therapeutic, not otherwise classified