Pluvicto Billing: 79101, A9607 Units, PSMA PET, 340B

Pluvicto billing is two lines on a claim, and one of them carries 200 units and tens of thousands of dollars. That combination is why radiopharmaceutical therapy produces different denials from a photon course: unit edits, invoice requests, drug pricing that changes each quarter, and a prerequisite imaging study performed by someone else. With the July 2026 label expansion into hormone-sensitive disease roughly doubling the eligible population, more radiation oncology practices will bill it for the first time this year.

This post covers the claim from the label to the remittance, keeping the clinical content to what the claim needs.

If your practice is experienced with external beam but new to radiopharmaceuticals, the rules below are the ones that differ.

The label in 2026

The prescribing information revised July 2026 carries two indications. Section 1.1 covers PSMA-positive metastatic androgen pathway modulation-naive or -sensitive prostate cancer (the label’s term for metastatic hormone-sensitive disease) in combination with an androgen receptor pathway inhibitor; Novartis announced that approval on July 31, 2026, based on the PSMAddition trial. Section 1.2 covers PSMA-positive metastatic androgen pathway modulation-resistant disease after ARPI therapy, either before or after taxane chemotherapy, which consolidates the 2022 and 2025 approvals.

Two label sentences matter to the biller. Section 2.2: “Select patients with metastatic prostate cancer for treatment with PLUVICTO using LOCAMETZ or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.” Section 2.3: the recommended dosage for both indications is “7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity.” The vial contains 7.4 GBq (200 mCi) plus or minus 10 percent at administration time.

The claim, line by line

Element	What goes on the claim	Notes
Administration	CPT 79101, radiopharmaceutical therapy by intravenous administration, 1 unit per dose	The professional and technical components follow the site of service
Drug	HCPCS A9607, “Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie”	Units equal the millicuries administered; a full 7.4 GBq dose is 200 units
NDC	00078-1217 series, 30 mL single-dose vial	Report in the payer’s required format
Diagnosis	Prostate cancer with metastatic site codes as documented	Payer policies also look for ARPI or ADT concurrency in the record
Prerequisite in the record	PSMA PET report showing PSMA-positive disease	The PET agent (for example A9595, A9596 or A9608) is billed by the imaging provider on the imaging date, not on the therapy claim
Frequency	One dose every 6 weeks, up to 6 doses	Payer edits count doses and intervals

Bill the activity actually administered, documented on the dose record, not the nominal vial activity. Because the label allows plus or minus 10 percent, a dose record of 196 mCi is 196 units. Moda Health’s claim edit policy (reviewed September 1, 2026) states the limit most payers use: “200 billable units (7.4 GBq = 200 mCi) every 6 weeks for a total of 6 doses,” with initial authorization for 4 doses over 180 days and renewal for 2 more.

Who can bill it

The label’s section 2.1 says radiopharmaceuticals “should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.” In practice that means an authorized user on a radioactive materials license from the NRC or an agreement state, at a licensed location. A radiation oncologist with authorized user status can bill 79101 and A9607 from the practice; otherwise nuclear medicine or the hospital bills the therapy and the practice bills only its own visits. An appeal cannot fix a claim from an unlicensed site.

How Medicare prices A9607

Under the physician fee schedule A9607 is contractor-priced. The NGS (Wellpoint Federal) radiopharmaceutical fee schedule for jurisdictions J6 and JK lists A9607 at $283.16 per unit for January 1 to 14, 2026, $291.66 for January 15 to June 30, and $300.41 for July 1 to September 30, 2026, and says fees may be updated quarterly or annually. At the third-quarter rate a 200-unit dose allows about $60,082 before the beneficiary share and sequestration. Radiopharmaceuticals the contractor has not priced require invoice information on the claim, and other jurisdictions price separately.

In the hospital outpatient department a therapeutic radiopharmaceutical is paid separately under OPPS. The per-day packaging threshold often mentioned alongside it, $655 for 2026 and proposed at $665 for 2027, applies to diagnostic radiopharmaceuticals: it decides whether the PSMA PET agent is paid separately from the PET scan in the hospital, not how Pluvicto is paid.

340B modifiers

Since January 1, 2025, CMS requires every 340B covered entity, hospital-based or not, to report modifier TB on separately payable Part B drug lines for drugs acquired through the 340B program, and to stop using JG. The purpose is the Part B inflation rebate: 340B units are excluded from the rebate, so CMS needs to see them. The modifier does not change the OPPS payment today. For 2027 CMS has proposed paying 340B-acquired drugs at ASP minus 33.4 percent under OPPS, which would change the economics of hospital-administered Pluvicto considerably if finalized; a freestanding practice buying at commercial prices is not affected by that proposal.

MUE and denial patterns

A Medically Unlikely Edit is the maximum units of service a provider reports for a code for one beneficiary on one date of service; CMS publishes the tables quarterly and not every code has one. A payer’s unit edit will deny a line of 200 units if the limit was set from a different product or a per-dose assumption.

One billing company has published an example. In 2024 a Medicare Advantage plan denied authorized Pluvicto doses for exceeding the allowed quantity and mailed recoupment letters that reached patients. Repeated calls and supervisor escalation led the plan to compare its unit edit to Medicare, the FDA label and its own authorization criteria; it confirmed the error two weeks later, agreed to reprocess claims back to the prior October and stop recoupments, and about six weeks in had reprocessed more than $200,000. A unit denial on an authorized dose is a payer configuration problem, and the appeal should say so.

Denial pattern	Usual cause	What fixes it
Units exceed MUE or payer maximum	Payer limit set below 200 units, or units billed per dose instead of per mCi	Appeal with the label dose (7.4 GBq equals 200 mCi), the HCPCS descriptor (1 millicurie) and the authorization
Units billed as 1	Charge master built per dose	Correct the charge to units equal to mCi administered and rebill
Invoice requested	Contractor has no price loaded or is verifying	Attach the invoice; keep the dose record with the activity
Not medically necessary	No PSMA PET in the record, no ARPI or ADT documented, or dose 7 or interval under 6 weeks	Supply the PET report and treatment plan; confirm count and interval before scheduling
NDC and HCPCS mismatch	Wrong NDC format or a payer list carrying a wrong descriptor	Verify the payer’s code list; one national code list seen for this post carried the Lutathera descriptor beside A9607

What to do now

Confirm the authorized user and license for the site before the first order, and keep the license number with the payer enrollment file.
Build the charge as A9607 with units equal to millicuries administered and 79101 as one unit, with the dose record attached to the encounter.
Load your MAC’s current contractor price for A9607 each quarter and set the expected allowed amount from it; a three-quarter lag in 2026 would have understated expected payment by about 6 percent.
Capture the PSMA PET report and the ARPI or ADT plan at authorization, since both appear in payer criteria and payers ask for both after a medical necessity denial.
Track doses and intervals per patient, because authorization is typically 4 doses then 2, and a seventh dose or an early dose denies regardless of units.
Check units before the claim is sent. Iridium Suite’s claim scrubber checks every service line as it is entered against CCI edits, payer rules and radiation oncology frequency rules, so a 200-unit drug line is checked against the payer’s limit before the claim goes out; see the claim scrubber.
Report TB only when it is true, and watch the 2027 OPPS final rule for the 340B payment change if you administer in a hospital setting.

Pluvicto billing from a radiation oncology practice: 79101, A9607 units, the PSMA PET prerequisite and 340B modifiers