HCPCS
J9309
1 mg = 1 unit
Phase 1
Identify what you're billing
Polivy is always combo therapy. Identify the regimen first, then code the entire backbone.
DLBCL treatment landscape — ADC vs bispecifics NCCN verified May 2026
Polivy is the CD79b-targeted ADC. The bispecifics (Lunsumio, Columvi, Epkinly) target CD20 × CD3. Different mechanisms, different lines of therapy.
Polivy occupies a distinct niche in B-cell lymphoma billing — it's the only CD79b-directed antibody-drug conjugate, with a mechanism analogous to Adcetris (J9042, anti-CD30 ADC for Hodgkin). The bispecific T-cell engagers (Columvi, Epkinly, Lunsumio) work by a fundamentally different mechanism (T-cell-mediated tumor killing via CD20 × CD3 dual binding) and occupy later lines of therapy as monotherapy with step-up dosing. Polivy is an earlier-line combo backbone agent.
| Drug | HCPCS | Class | Target | Line | Dosing | ASP+6% (Q2 2026) |
|---|---|---|---|---|---|---|
| Polivy (polatuzumab vedotin) | J9309 |
ADC (MMAE payload) | CD79b | 1L (POLARIX) + R/R 3L+ | 1.8 mg/kg q21d × 6 (combo) | $137.227/mg |
| Rituxan (rituximab) | J9312 |
Anti-CD20 mAb | CD20 | 1L backbone (R-CHOP, R-CHP) | 375 mg/m² q21d | ~$10/mg (varies) |
| Columvi (glofitamab) | J9286 |
Bispecific T-cell engager | CD20 × CD3 | R/R DLBCL 3L+ (mono, fixed-duration) | Step-up: 2.5 / 10 / 30 mg q21d | Premium tier |
| Epkinly (epcoritamab) | J9321 |
Bispecific T-cell engager (SC) | CD20 × CD3 | R/R DLBCL 3L+ (mono, until PD) | SC step-up to 48 mg q1w/q2w/q4w | Premium tier |
| Lunsumio (mosunetuzumab) | J9350 |
Bispecific T-cell engager | CD20 × CD3 | R/R follicular lymphoma 3L+ | Step-up to 60 mg q21d | Premium tier |
Why this matters for billing: Polivy's POLARIX expansion in 2023 made it the first
novel agent added to the R-CHOP backbone in 20+ years. It is billed alongside the entire chemo regimen
on the same claim — expect concurrent PA on rituximab, cyclophosphamide, doxorubicin, and prednisone.
The bispecifics are billed solo as monotherapy, with REMS-style step-up dosing complexity but no concurrent
chemo. Different operational workflows entirely.
Other ADCs for B-cell lymphomas
- Adcetris (brentuximab vedotin, J9042): anti-CD30 ADC; used for Hodgkin lymphoma and CD30+ peripheral T-cell lymphomas. Same MMAE payload as Polivy.
- Zynlonta (loncastuximab tesirine, J9359): anti-CD19 ADC; R/R DLBCL after ≥2 prior therapies. Competing salvage option.
Dosing by combination regimen FDA label Apr 2023
Polivy is never given as monotherapy. Identify the combo regimen and bill the full backbone.
1.8 mg/kg IV every 21 days × 6 cycles — both indications
Standard dose is the same across indications: 1.8 mg/kg IV every 21 days for 6 cycles. What differs is the combination backbone.
| Indication | Combo regimen | Schedule | FDA approval |
|---|---|---|---|
| 1L DLBCL NOS & HGBCL with IPI ≥2 (POLARIX) | Polivy + R-CHP: rituximab 375 mg/m² + cyclophosphamide 750 mg/m² + doxorubicin 50 mg/m² + Polivy 1.8 mg/kg + prednisone 100 mg/day × 5 days | q21d × 6 cycles; rituximab continued cycles 7–8 (mono) | April 19, 2023 (sBLA based on POLARIX Phase III) |
| R/R DLBCL after ≥2 prior systemic therapies | Polivy + BR: bendamustine 90 mg/m² days 1–2 + rituximab 375 mg/m² day 1 + Polivy 1.8 mg/kg day 1 | q21d × 6 cycles | June 10, 2019 (accelerated, GO29365 trial) |
Worked example — first cycle billing for 75 kg POLARIX patient
# Patient: 75 kg, 1L DLBCL, IPI=3, starting POLARIX
Calculated dose: 75 × 1.8 = 135 mg
Vials needed (30 mg each): 5 vials = 150 mg
Drug administered: 135 mg → bill 135 units J9309
Drug discarded: 15 mg → bill 15 units J9309 with JW
# Same-day claim lines (cycle 1, day 1)
J9309 × 135 units (administered, no modifier or JZ if no waste)
J9309 × 15 units, modifier JW (discarded)
96413 (chemo IV initial, Polivy 90-min first dose)
96415 (each addl hr, first-dose 90-min runs >1 hr)
+ Rituxan, cyclophosphamide, doxorubicin claim lines
+ Prednisone 100 mg PO days 1–5 (separate Rx, not infusion claim)
# Year totals (POLARIX, 75 kg patient)
Total Polivy units billed: 6 cycles × 135 mg = 810 mg administered + ~90 mg waste
Total Polivy drug cost (Q2 2026 ASP+6%): ~$111,154 before sequestration
Calculated dose: 75 × 1.8 = 135 mg
Vials needed (30 mg each): 5 vials = 150 mg
Drug administered: 135 mg → bill 135 units J9309
Drug discarded: 15 mg → bill 15 units J9309 with JW
# Same-day claim lines (cycle 1, day 1)
J9309 × 135 units (administered, no modifier or JZ if no waste)
J9309 × 15 units, modifier JW (discarded)
96413 (chemo IV initial, Polivy 90-min first dose)
96415 (each addl hr, first-dose 90-min runs >1 hr)
+ Rituxan, cyclophosphamide, doxorubicin claim lines
+ Prednisone 100 mg PO days 1–5 (separate Rx, not infusion claim)
# Year totals (POLARIX, 75 kg patient)
Total Polivy units billed: 6 cycles × 135 mg = 810 mg administered + ~90 mg waste
Total Polivy drug cost (Q2 2026 ASP+6%): ~$111,154 before sequestration
Dose modifications
- Grade 2 peripheral neuropathy: withhold until improvement to grade ≤1; resume at 1.4 mg/kg
- Grade 3+ peripheral neuropathy: permanently discontinue Polivy
- ANC <1,000/µL or platelets <75,000/µL: withhold all therapy until recovery
- Grade 4 hematologic toxicity recurrent: reduce to 1.4 mg/kg or discontinue
POLARIX R-CHP regimen detail NEJM 2022 + FDA Apr 2023
The 2023 1L DLBCL approval is the major billing volume driver. R-CHP replaces R-CHOP for IPI ≥2 patients.
The POLARIX trial (Tilly et al., NEJM 2022) randomized 879 previously untreated DLBCL patients with International Prognostic Index (IPI) score 2–5 to either standard R-CHOP or Polivy + R-CHP. Polivy + R-CHP showed improved 2-year progression-free survival (76.7% vs 70.2%, HR 0.73). FDA approved the indication on April 19, 2023.
| Drug | Dose | Day | Cycles | Notes |
|---|---|---|---|---|
| Polivy (polatuzumab vedotin) | 1.8 mg/kg IV | Day 1 | 1–6 | Replaces vincristine; first dose 90 min, subsequent 30 min |
| Rituximab | 375 mg/m² IV | Day 1 | 1–8 | Continued as monotherapy cycles 7–8 |
| Cyclophosphamide | 750 mg/m² IV | Day 1 | 1–6 | Standard CHP backbone |
| Doxorubicin (Adriamycin) | 50 mg/m² IV | Day 1 | 1–6 | "H" in R-CHP |
| Prednisone | 100 mg PO daily | Days 1–5 | 1–6 | Oral; not part of infusion claim |
| Vincristine | OMITTED | — | — | Polivy replaces vincristine — avoids neurotoxicity overlap |
Why Polivy replaces vincristine: Both vincristine (V in CHOP) and the MMAE payload of
Polivy cause peripheral neuropathy. Adding Polivy to R-CHOP would compound neurotoxicity unacceptably.
POLARIX swaps the V for the ADC, preserving the chemo backbone while introducing CD79b-targeted cytotoxic
delivery. This is a clean substitution from a billing standpoint — no vincristine claim line on
cycles 1–6.
G-CSF support is frequently added
Myelosuppression (neutropenia, thrombocytopenia) is common with R-CHP + Polivy. Most institutions add prophylactic G-CSF (filgrastim, pegfilgrastim, or biosimilar) starting with cycle 1. This is a separate claim line (G-CSF biosimilars include Q5101, Q5108, Q5111, Q5120, Q5125 depending on product).
Eligibility — IPI ≥2 only
FDA approval is restricted to patients with International Prognostic Index score ≥2 (intermediate-high or high risk). IPI is calculated from age >60, ECOG ≥2, LDH elevated, >1 extranodal site, and Ann Arbor stage III/IV. Document IPI in the chart and on the PA submission — payers deny if IPI is missing or <2.
Don't bill POLARIX for low-IPI DLBCL. Patients with IPI 0–1 should receive
standard R-CHOP, not Polivy + R-CHP. Off-label use will be denied and is not supported by POLARIX
(subgroup analysis showed no benefit at IPI <2).
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
50242-104-01 / 50242-0104-01 |
30 mg lyophilized single-dose vial — 1 vial per carton | Only available presentation; reconstitute with 7.2 mL sterile water for injection → 20 mg/mL |
Only one vial size is available. All weight-based dosing produces partial-vial waste
unless the dose calculation happens to land on a 30 mg multiple. Examples: 60 kg patient at 1.8 mg/kg
= 108 mg → 4 vials = 120 mg, 12 mg waste. 75 kg = 135 mg → 5 vials = 150 mg, 15 mg waste.
90 kg = 162 mg → 6 vials = 180 mg, 18 mg waste. Bill JW on virtually every claim.
Storage and stability: Refrigerated unopened vials at 2–8°C. After
reconstitution, use within 8 hours at 2–8°C or within 4 hours at room temperature. Do not freeze.
Do not shake during reconstitution — swirl gently.
Phase 2
Code the claim
Chemo admin codes apply (96413/96415). First dose runs 90 minutes, subsequent 30 minutes.
Administration codes CPT verified May 2026
Polivy is billed under chemotherapy administration codes (it's a complex ADC with cytotoxic payload).
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for every Polivy infusion. Subsequent doses (30-min infusion) fit cleanly within 1-hour window. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Add for cycle 1 only — first dose runs 90 minutes, exceeding the 1-hour 96413 window. Bill 96413 + one unit of 96415. |
96417 |
Chemotherapy admin, IV infusion; each additional sequential infusion (different drug) | For other drugs in R-CHP regimen given in sequence after Polivy — rituximab, cyclophosphamide, doxorubicin each get their own admin code. |
96365 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Polivy is a complex monoclonal antibody-drug conjugate with cytotoxic payload — chemo admin codes apply per AMA classification. |
Cycle 1 vs subsequent cycles: Cycle 1 runs 90 minutes (Polivy infusion only) →
bill 96413 + 96415. Cycles 2–6 run 30 minutes if cycle 1 was tolerated → bill 96413 alone.
Document infusion time in the chart for both clinical and audit purposes.
Multi-drug regimen sequencing: R-CHP is given as sequential infusions on day 1.
Typical order: rituximab (slow first dose), then cyclophosphamide, then doxorubicin, then Polivy.
Each gets its own admin code. The first drug uses 96413 (initial), subsequent drugs use 96417 (sequential).
Document infusion times for each.
Modifiers CMS verified May 2026
JW — required on virtually every Polivy claim
Effective July 1, 2023, CMS requires either the JZ or JW modifier on every single-dose container claim. Because Polivy comes only in a 30 mg vial and dosing is weight-based at 1.8 mg/kg, partial-vial waste occurs at virtually every patient weight. Bill JW with the discarded mg on a separate claim line.
| Patient weight | Calculated dose | Vials | Vial total | Waste (JW units) |
|---|---|---|---|---|
| 50 kg | 90 mg | 3 vials | 90 mg | 0 (bill JZ) |
| 60 kg | 108 mg | 4 vials | 120 mg | 12 mg |
| 70 kg | 126 mg | 5 vials | 150 mg | 24 mg |
| 75 kg | 135 mg | 5 vials | 150 mg | 15 mg |
| 80 kg | 144 mg | 5 vials | 150 mg | 6 mg |
| 90 kg | 162 mg | 6 vials | 180 mg | 18 mg |
| 100 kg | 180 mg | 6 vials | 180 mg | 0 (bill JZ) |
JZ — only when dose exactly matches a 30 mg multiple
JZ applies when no drug is discarded. For Polivy, this only happens when the calculated dose lands exactly on a 30 mg multiple (50 kg = 90 mg, 100 kg = 180 mg, etc.). For most patient weights, you'll bill JW instead. One of JZ or JW must be on every J9309 claim.
Common error: Forgetting to bill the JW waste line. CMS audits flag missing waste
documentation on weight-based ADC claims. Bill the administered dose on one line (no modifier or JZ if no
waste) and the discarded portion on a second line with JW. Wasted drug is reimbursable but must be reported.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when significant, separately identifiable evaluation and management is performed on the same day as infusion. Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Polivy, follow your MAC's current 340B modifier policy. Genentech's billing guide does not provide 340B-specific instructions.
ICD-10-CM by indication FY2026 verified May 2026
DLBCL is the only indication. Use site-specific 5th character; document IPI ≥2 for 1L use.
| ICD-10 | Description | Notes |
|---|---|---|
C83.30 | DLBCL, unspecified site | Most common when nodal site not specified |
C83.31 | DLBCL, lymph nodes of head/face/neck | Site-specific |
C83.32 | DLBCL, intrathoracic lymph nodes | Site-specific |
C83.33 | DLBCL, intra-abdominal lymph nodes | Site-specific |
C83.34 | DLBCL, lymph nodes of axilla and upper limb | Site-specific |
C83.35 | DLBCL, lymph nodes of inguinal region and lower limb | Site-specific |
C83.36 | DLBCL, intrapelvic lymph nodes | Site-specific |
C83.37 | DLBCL, spleen | Site-specific |
C83.38 | DLBCL, lymph nodes of multiple sites | Site-specific |
C83.39 | DLBCL, extranodal and solid organ sites | Includes extranodal involvement |
C83.7x | Burkitt lymphoma | Off-label; PA likely required |
C85.20 | Mediastinal (thymic) large B-cell lymphoma, unspecified | PMBCL — off-label for Polivy |
C85.9x | Non-Hodgkin lymphoma, unspecified type | Generally insufficient — specific DLBCL Dx required |
1L use requires IPI ≥2 documentation. ICD-10 alone is not sufficient for POLARIX
regimen approval. Submit IPI calculation in the chart note and PA documentation. Most payers require
attestation that IPI ≥2.
R/R use requires ≥2 prior systemic therapies. Include treatment history with
line-of-therapy documentation in the PA submission. Not approved for 2L (only after 2 prior lines).
Site of care & place of service Verified May 2026
Polivy is typically administered in inpatient or comprehensive cancer center outpatient settings due to regimen complexity (multi-drug R-CHP or BR backbone, infusion-reaction monitoring, and same-day myelosuppression management). Pure office-based oncology infusion suites do administer Polivy regimens but require infrastructure for managing complex multi-drug chemo days.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Comprehensive cancer center HOPD | 22 | UB-04 / 837I | Common for POLARIX regimen |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Common; some commercial UM |
| Physician oncology office | 11 | CMS-1500 / 837P | Acceptable with chemo infusion infrastructure |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable with multi-drug capability |
| Inpatient (cycle 1 monitoring) | 21 | UB-04 / 837I | Sometimes for first-cycle high-risk patients |
| Patient home | 12 | — | Not appropriate — multi-drug chemo regimen |
Less site-of-care steering than for monotherapy ICIs. Polivy is part of a multi-drug
chemo backbone — payers generally accept HOPD/comprehensive cancer center settings without aggressive
site-of-care UM, since the regimen complexity justifies the setting.
Claim form field mapping Genentech 2026
From Genentech Access Solutions HCP coding & coverage guide.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 50242-0104-01 + ML + total reconstituted volume (e.g., 7.5 mL for 5 vials × 1.5 mL withdrawn) |
| HCPCS J9309 + JW (most claims) | 24D (drug line) | JW for waste line; administered units on separate line (no modifier or JZ if zero waste) |
| Drug units (administered) | 24G | Actual mg administered (e.g., 135 for 75 kg patient) |
| Drug units (waste, separate line) | 24G | Discarded mg with JW modifier |
| CPT 96413 (admin line) | 24D | Chemo IV initial |
| CPT 96415 (cycle 1 only) | 24D | Each addl hr (90-min first dose runs over 1 hr) |
| ICD-10 | 21 | C83.3x site-specific |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
All major payers require PA. IPI documentation for 1L; line-of-therapy documentation for R/R.
Payer policy snapshot + PA criteria Reviewed May 2026
Concurrent PA on Polivy + the rest of the R-CHP or BR backbone. DLBCL pathology and IPI/line-of-therapy documentation required.
| Payer | PA? | Key criteria | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | DLBCL pathology + IPI ≥2 (1L) or ≥2 prior systemic therapies (R/R); concurrent PA on combo agents | Limited (regimen complexity justifies HOPD) |
| Aetna CPB + Medical Drug policies |
Yes | FDA-labeled indication only; NCCN-aligned; IPI documentation for 1L | Yes (separate Site-of-Care policy applies broadly) |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN B-cell lymphoma guidelines + FDA label | Plan-specific |
| Medicare (LCDs) MAC-specific |
No (FFS); MA plans yes | Coverage for FDA-labeled indications with appropriate ICD-10 | N/A (FFS) |
Key PA documentation
- Pathology report confirming DLBCL NOS or HGBCL diagnosis
- IPI score with components (age, ECOG, LDH, extranodal sites, Ann Arbor stage) for 1L POLARIX use
- Prior treatment history with response and lines documented for R/R use (must be ≥2 prior systemic regimens)
- Concurrent PA on combo backbone (rituximab, cyclophosphamide, doxorubicin for R-CHP; bendamustine + rituximab for BR)
- Baseline labs (CBC, LFTs, neuropathy assessment) per FDA label requirements
Step therapy
Generally NOT required for 1L POLARIX use (FDA-labeled). Some payers require failure of standard R-CHOP or contraindication to vincristine before approving Polivy + R-CHP — verify per-payer. For R/R DLBCL, ≥2 prior systemic therapies must be documented (this is the FDA label requirement, not a step therapy add-on).
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9309
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$137.227
per mg / per unit
135 mg dose (75 kg)
$18,525.65
135 units × ASP+6%
162 mg dose (90 kg)
$22,230.77
162 units × ASP+6%
Total POLARIX regimen drug cost (Polivy only, 75 kg patient): 6 cycles × 135 mg
= 810 mg administered = ~$111,154 Polivy cost across the 6-cycle regimen (Medicare
ASP+6%, before sequestration). Plus rituximab, cyclophosphamide, doxorubicin claim lines on each cycle
and rituximab maintenance for cycles 7–8. After ~2% sequestration: ~$108,800 actual paid for
Polivy alone.
Coverage
No NCD specific to polatuzumab vedotin. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9309 for FDA-approved on-label indications (1L DLBCL with IPI ≥2 per POLARIX, and R/R DLBCL after ≥2 prior systemic therapies) with appropriate ICD-10 and regimen documentation.
Code history
- J9309 — permanent code, effective January 1, 2020 (initial FDA approval was June 2019; pre-permanent-code period used unclassified J3490/J9999)
Patient assistance — Genentech Access Solutions Genentech verified May 2026
- Genentech Access Solutions: 1-866-422-2377 (Monday–Friday, 6 AM–5 PM PT) — benefits investigation, prior authorization assistance, appeal support
- Genentech Oncology Co-pay Card: commercial copay support; eligible commercially-insured patients pay $0 up to $25,000 per year (excludes Medicare, Medicaid, federal program patients)
- Genentech Patient Foundation: free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to PAN Foundation, HealthWell, CancerCare, Leukemia & Lymphoma Society Co-Pay Assistance Program — verify open lymphoma funds quarterly
- Web: genentech-access.com/hcp/brands/polivy.html
Need to model what a specific patient will actually pay across the full 6-cycle POLARIX regimen after
copay assistance, deductible, coinsurance, and OOP max?
Run a CareCost Estimate — J9309 pre-loaded.
Phase 4
Fix problems
Peripheral neuropathy assessment, JW waste documentation, and IPI documentation are the top three.
Peripheral neuropathy — the dose-limiting toxicity FDA label W&P
Approximately 64% of patients develop peripheral neuropathy. Cumulative, dose-limiting, may persist after discontinuation.
~64% incidence in clinical trials. Peripheral neuropathy from the MMAE (monomethyl
auristatin E) cytotoxic payload is the most common adverse event and the primary dose-modification
driver. Both sensory and motor manifestations occur. Effects can be cumulative across cycles and may
persist for months after discontinuation.
Required assessment at each dose
FDA label requires neurologic assessment before each Polivy infusion. Document any new or worsening symptoms (numbness, tingling, weakness, loss of reflexes). Use a standardized scale (CTCAE) for grading.
| CTCAE grade | Symptoms | Action |
|---|---|---|
| 1 | Asymptomatic; mild paresthesia | Continue at full dose; monitor closely |
| 2 | Moderate symptoms; limiting instrumental ADLs | Withhold until improvement to ≤1; resume at 1.4 mg/kg |
| 3 | Severe; limiting self-care ADLs | Permanently discontinue Polivy |
| 4 | Life-threatening | Permanently discontinue Polivy; supportive care |
Why POLARIX uses R-CHP not R-CHOP
Vincristine (V in CHOP) also causes peripheral neuropathy. Adding Polivy to R-CHOP would compound neurotoxicity unacceptably. POLARIX deliberately swaps vincristine for Polivy — preserving the chemo backbone while delivering CD79b-targeted cytotoxic payload without doubling up on neurotoxic agents. Patients with prior or concurrent exposure to other neurotoxic drugs (taxanes, platinum) require even closer monitoring.
Other clinically significant adverse events
- Infusion reactions: can occur during or up to 24 hours after infusion. First dose run at 90 min with monitoring; subsequent at 30 min if first was tolerated.
- Myelosuppression: grade 3+ neutropenia ~46%, thrombocytopenia ~24%. G-CSF support commonly added.
- Serious infections: including opportunistic infections; consider PJP and HSV/VZV prophylaxis per institutional protocols.
- Progressive multifocal leukoencephalopathy (PML): rare but reported. New neurologic symptoms warrant immediate workup.
- Tumor lysis syndrome: high tumor burden patients should receive TLS prophylaxis (allopurinol/rasburicase, hydration) in cycle 1.
- Hepatotoxicity: elevated transaminases/bilirubin; monitor LFTs.
- Embryo-fetal toxicity: contraception required during and for 3 months (women) / 5 months (men) after last dose.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| IPI not documented (1L denial) | POLARIX PA submitted without IPI calculation | Submit IPI components (age, ECOG, LDH, extranodal, stage) with score ≥2 attestation. Retroactive PA possible. |
| Line of therapy not documented (R/R denial) | Missing prior treatment history | Submit complete treatment history with regimens, response, dates. Must show ≥2 prior systemic regimens. |
| JW waste line missing | Wasted drug not reported on weight-based claim | Add JW line with discarded units. Required since 7/1/2023 on every claim with waste. |
| JZ/JW missing entirely | Single-dose vial claim without modifier | Resubmit with JZ (no waste) or JW (waste). One must be on every J9309 claim. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415 (cycle 1 only). Polivy is ADC with cytotoxic payload — chemo admin codes apply. |
| Concurrent backbone agent denied | R-CHP combo agents (rituximab, cyclophosphamide, doxorubicin) PA missing | Submit concurrent PA on all combo agents. Approval of Polivy alone is insufficient for the regimen. |
| Off-label indication | Polivy ordered for non-DLBCL or for IPI <2 1L use | Confirm FDA-labeled indication. Only DLBCL NOS / HGBCL with IPI ≥2 (1L) or ≥2 prior therapies (R/R). |
| Pathology report missing | Generic NHL ICD-10 (C85.9x) without DLBCL pathology | Submit pathology report confirming DLBCL NOS or HGBCL with CD20+ B-cell phenotype. |
| 96415 missing on cycle 1 | Only 96413 billed for first 90-min infusion | Add 96415 (each addl hr) for cycle 1 only. Subsequent cycles run 30 min and don't need 96415. |
Frequently asked questions
What is the HCPCS code for Polivy?
Polivy (polatuzumab vedotin-piiq) is billed under HCPCS J9309 — "Injection,
polatuzumab vedotin, 1 mg." Each milligram equals one billable unit. Standard dosing is 1.8 mg/kg IV
every 21 days for 6 cycles, in combination with R-CHP for 1L DLBCL or with bendamustine + rituximab
for R/R DLBCL.
How many units do I bill for a Polivy dose?
Bill the actual mg administered as units. For a 75 kg patient at 1.8 mg/kg, that's 135 mg = 135 units. Polivy comes only in a 30 mg single-dose vial, so a 135 mg dose requires 5 vials (150 mg total) with 15 mg waste — bill JW for 15 units of waste on a separate claim line.
What administration CPT do I use for Polivy?
CPT 96413 — chemo IV initial. Add 96415 for cycle 1 only (first dose
runs 90 minutes, exceeding the 1-hour 96413 window). Cycles 2–6 run 30 minutes if cycle 1 was
tolerated and need only 96413.
Do I bill JZ or JW for Polivy?
Bill JW on virtually every Polivy claim. Polivy comes only in a 30 mg vial and dosing is
weight-based at 1.8 mg/kg, so partial-vial waste occurs at most patient weights. Bill the administered
units on one line and the discarded units on a second line with JW. JZ only applies when
the dose lands exactly on a 30 mg multiple (e.g., 50 kg = 90 mg, 100 kg = 180 mg).
What is the Medicare reimbursement for J9309?
For Q2 2026, the Medicare Part B payment limit for J9309 is $137.227 per mg (ASP + 6%). A 135 mg dose (75 kg patient) reimburses at approximately $18,525.65; a 162 mg dose (90 kg patient) at approximately $22,230.77. Total Polivy drug cost across the 6-cycle POLARIX regimen for a 75 kg patient: ~$111,154 before sequestration.
What is the POLARIX regimen?
POLARIX is the Phase III trial that established Polivy + R-CHP as a 1L treatment for previously untreated DLBCL with IPI ≥2. The regimen is rituximab + cyclophosphamide + doxorubicin + Polivy + prednisone, every 21 days for 6 cycles, with rituximab continued for cycles 7–8. Polivy replaces vincristine in the standard R-CHOP backbone. FDA approved this indication on April 19, 2023.
How does Polivy compare to bispecific antibodies for DLBCL?
Polivy is a CD79b-targeted antibody-drug conjugate (ADC), not a bispecific. It's used in 1L DLBCL combo therapy (POLARIX) and in 3L+ R/R DLBCL with bendamustine + rituximab. The CD20 × CD3 bispecifics for DLBCL — Columvi (J9286, glofitamab) and Epkinly (J9321, epcoritamab) — are used in R/R DLBCL after ≥2 prior therapies, typically as monotherapy with step-up dosing. Lunsumio (J9350, mosunetuzumab) is a CD20 × CD3 bispecific for R/R follicular lymphoma. Polivy's role is earlier in the DLBCL treatment sequence (often 1L) versus the bispecifics' later-line monotherapy positioning.
What is the peripheral neuropathy risk with Polivy?
Peripheral neuropathy occurred in approximately 64% of patients in clinical trials and is the dose-limiting toxicity. The MMAE (vedotin) payload causes sensory and motor neuropathy that can be cumulative and may persist after discontinuation. Assess at each dose; for grade 2, withhold and resume at 1.4 mg/kg; for grade 3+, permanently discontinue. POLARIX deliberately replaces vincristine in R-CHOP to avoid neurotoxic overlap.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Genentech Access Solutions — Polivy Coding & Coverage HCP page
- FDA Polivy Prescribing Information
- Tilly et al. — Polatuzumab Vedotin in Previously Untreated DLBCL (POLARIX)
- FDA — April 19, 2023 approval announcement (1L DLBCL)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9309 reference
- NCCN Clinical Practice Guidelines — B-Cell Lymphomas
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna CPB — Antineoplastic Agents (covers polatuzumab vedotin)
- FDA National Drug Code Directory
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
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indications | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
Genentech, payer documents, NCCN guidelines — all linked above). Editorial review in progress. Until that review is complete, treat this as a draft reference
and verify each cited source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: Genentech Access Solutions 2026. FDA label: April 2023 POLARIX 1L expansion (BLA 761121). Two FDA-approved indications: 1L DLBCL with IPI ≥2 (POLARIX, Polivy + R-CHP) and R/R DLBCL after ≥2 prior systemic therapies (Polivy + BR).
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list is verified against the current FDA label revision and NCCN B-Cell Lymphoma Guidelines. We do not paraphrase from billing-software vendor blogs.