HCPCS
J7169
10 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the patient's actual anticoagulant (apixaban or rivaroxaban) and the low- vs high-dose decision from last-dose timing.
About Andexxa FDA label verified May 2026
Andexxa (andexanet alfa) is a recombinant, modified form of human Factor Xa engineered to function as a catalytically inactive decoy — it binds and sequesters direct Factor Xa inhibitors (apixaban, rivaroxaban) without itself participating in coagulation. The result is rapid removal of free anticoagulant from circulation and restoration of endogenous Factor Xa activity within 2-5 minutes of bolus completion. Anti-Xa activity reduction is sustained for the duration of the 120-minute infusion, with partial rebound observed in the hours afterward.
Andexxa was originally developed by Portola Pharmaceuticals and received accelerated FDA approval on May 3, 2018 (BLA 125586) for reversal of anticoagulation from apixaban or rivaroxaban in patients with life-threatening or uncontrolled bleeding. Portola was acquired by Alexion Pharmaceuticals in 2020; Alexion was then acquired by AstraZeneca in 2021. The ANNEXA-I randomized trial (Connolly NEJM 2024) was the FDA-required confirmatory study to convert accelerated approval to full traditional approval. In December 2024 the FDA issued a Complete Response Letter for the sBLA, citing higher rates of thrombosis (14.6% vs 6.9%) and thrombosis-related 30-day mortality (2.5% vs 0.9%) on andexanet vs usual care (predominantly 4F-PCC). AstraZeneca and FDA could not agree on a feasible path forward, and AstraZeneca voluntarily withdrew the US BLA effective Dec 22, 2025, ending US commercial availability. Ondexxya remains conditionally approved in EU/UK/JP.
Operationally, this is unlike almost any other infusion drug we cover: it is given once per bleeding event, in an emergency department or ICU, on a time-critical basis (the FDA label and the ANNEXA program both emphasize administration within hours of the bleeding event, ideally within 18 hours of the last DOAC dose). There is no maintenance phase, no titration, no monitoring lab in real time — the question is binary: low-dose or high-dose, then administer once. The single-encounter nature means coverage hinges on three things being documented in the same ED chart: (1) which DOAC and timing, (2) life-threatening or uncontrolled bleeding event, and (3) the dose-tier rationale.
Andexxa carries an FDA boxed warning for thromboembolic events: arterial and venous thromboembolism, ischemic stroke, myocardial infarction, cardiac arrest, and sudden death have been observed after administration in the ANNEXA-4 single-arm study (~10% thromboembolic event rate) and in post-marketing surveillance. The mechanism reflects withdrawal of anti-Xa anticoagulation in a patient population with pre-existing thromboembolic indications, plus procoagulant effect of andexanet on tissue factor pathway inhibitor. Reinitiation of anticoagulation as soon as medically appropriate is the primary mitigation and is required clinical documentation for both PA and post-pay audit.
Reversal-agent disambiguation — pick the right antidote for the right anticoagulant FDA-label aligned May 2026
Anticoagulation reversal is class-specific. Mismatching the patient's anticoagulant to the reversal agent is the #1 categorical denial trigger on this drug.
Andexxa is one of three specific anticoagulation reversal agents in the modern ED arsenal, each tied to a different anticoagulant class. The selection logic is rigid — payer policies and FDA labels both treat these as non-substitutable.
| Anticoagulant the patient was on | Class | Reversal agent (FDA-approved) | HCPCS |
|---|---|---|---|
| Apixaban (Eliquis) | Direct factor Xa inhibitor | Andexxa (andexanet alfa) | J7169 |
| Rivaroxaban (Xarelto) | Direct factor Xa inhibitor | Andexxa (andexanet alfa) | J7169 |
| Edoxaban (Savaysa) | Direct factor Xa inhibitor | Off-label — no FDA-approved specific reversal. 4F-PCC (Kcentra) is the off-label standard; Andexxa has mechanistic activity but is not on-label. | n/a (J7168 for 4F-PCC) |
| Dabigatran (Pradaxa) | Direct thrombin inhibitor | Praxbind (idarucizumab) — do NOT use Andexxa | J1746 |
| Warfarin (Coumadin, Jantoven) | Vitamin K antagonist | 4F-PCC (Kcentra) + vitamin K — do NOT use Andexxa | J7168 |
| Unfractionated heparin / LMWH (enoxaparin) | Indirect Xa/IIa inhibitor | Protamine sulfate — do NOT use Andexxa | J2720 |
Three rules to apply in sequence at the bedside:
- Identify the anticoagulant. Med rec from the chart, the pill bottle, family history — not a verbal "anticoagulant" handoff. Apixaban/rivaroxaban = Andexxa; dabigatran = Praxbind; warfarin = 4F-PCC + vit K.
- Identify the dose & timing. Last dose taken when, at what mg? This drives the low vs high dose decision for Andexxa and the binary "give it or not" call for all reversal agents (utility falls off rapidly beyond 18-24 hr).
- Document the bleeding severity. Life-threatening or uncontrolled — ICH, GI hemorrhage with hemodynamic compromise, retroperitoneal bleed, etc. Reversal of minor bleeding is not on-label and not covered.
Categorical denial scenarios. Andexxa submitted for dabigatran reversal: denied (wrong
class). Andexxa submitted for warfarin INR reversal: denied. Andexxa submitted for edoxaban: usually
denied as off-label / not medically necessary at the FDA-approved-indication level (some Medicare
Advantage plans and a minority of commercial policies allow off-label use with documented mechanistic
rationale and absence of viable alternatives — but plan ahead for an appeal). Andexxa submitted
without a documented bleeding event: denied.
Low vs high dose stratification FDA label verified May 2026
The FDA label and ANNEXA program define a binary dose decision based on last DOAC dose and timing. Get this wrong and the claim is either under-dosed (poor outcome) or denied for medical necessity.
Decision rule (per FDA prescribing information)
| Last anticoagulant dose | Timing of last dose | Dose tier | Regimen |
|---|---|---|---|
| Apixaban <5 mg OR rivaroxaban ≤10 mg |
≥8 hr before reversal | LOW | 400 mg IV bolus (30 mg/min) + 4 mg/min infusion × 120 min = 880 mg total |
| Apixaban ≥5 mg OR rivaroxaban >10 mg |
Any timing | HIGH | 800 mg IV bolus (30 mg/min) + 8 mg/min infusion × 120 min = 1,760 mg total |
| Any dose | <8 hr or unknown timing | HIGH | 800 mg bolus + 960 mg infusion = 1,760 mg total |
| Apixaban or rivaroxaban | >18 hr from last dose | Reassess | Utility is limited; institutional review and consideration of 4F-PCC may be appropriate. Document rationale if Andexxa is still used. |
Default to high dose when uncertain. The FDA label explicitly authorizes high dose for
the "unknown timing within 8 hr" scenario. ED providers should not delay reversal to extract a precise
timing history from a critically ill patient — high-dose-by-default is the labeled, defensible
choice when information is incomplete.
Unit math — J7169 at 10 mg per unit
J7169 is billed at 1 unit = 10 mg. The total mg administered drives the unit count. Below are the two canonical claim lines for each dose tier.
# LOW DOSE worked example
Bolus: 400 mg over ~15 min (30 mg/min target rate)
Infusion: 4 mg/min × 120 min = 480 mg
Total cumulative: 400 + 480 = 880 mg
Bill J7169 × 88 units (880 mg ÷ 10 mg per unit)
WAC approximate: ~$22,500 per encounter (drug cost only, excludes admin and other line items)
# HIGH DOSE worked example
Bolus: 800 mg over ~30 min (30 mg/min target rate)
Infusion: 8 mg/min × 120 min = 960 mg
Total cumulative: 800 + 960 = 1,760 mg
Bill J7169 × 176 units (1,760 mg ÷ 10 mg per unit)
WAC approximate: ~$45,000 per encounter
# Vial accounting (200 mg single-dose vials)
Low dose: 4 vials reconstituted (800 mg drawn) for 880 mg administered — 4 vials is short by 80 mg, so 5 vials are pulled in practice; 5 × 200 = 1,000 mg available, 880 mg administered, 120 mg residual discarded (12 units JW-reportable). Some institutions pull only 4 vials and accept slight under-dosing (clinically not common).
High dose: 9 vials reconstituted = 1,800 mg available, 1,760 mg administered, 40 mg residual (4 units JW-reportable).
Bolus: 400 mg over ~15 min (30 mg/min target rate)
Infusion: 4 mg/min × 120 min = 480 mg
Total cumulative: 400 + 480 = 880 mg
Bill J7169 × 88 units (880 mg ÷ 10 mg per unit)
WAC approximate: ~$22,500 per encounter (drug cost only, excludes admin and other line items)
# HIGH DOSE worked example
Bolus: 800 mg over ~30 min (30 mg/min target rate)
Infusion: 8 mg/min × 120 min = 960 mg
Total cumulative: 800 + 960 = 1,760 mg
Bill J7169 × 176 units (1,760 mg ÷ 10 mg per unit)
WAC approximate: ~$45,000 per encounter
# Vial accounting (200 mg single-dose vials)
Low dose: 4 vials reconstituted (800 mg drawn) for 880 mg administered — 4 vials is short by 80 mg, so 5 vials are pulled in practice; 5 × 200 = 1,000 mg available, 880 mg administered, 120 mg residual discarded (12 units JW-reportable). Some institutions pull only 4 vials and accept slight under-dosing (clinically not common).
High dose: 9 vials reconstituted = 1,800 mg available, 1,760 mg administered, 40 mg residual (4 units JW-reportable).
Document the dose-tier rationale in the ED chart. Payers look for: (a) which DOAC (with NDC or pill identification if available), (b) last-dose mg, (c) time of last dose, (d) bleeding event type with severity descriptor, and (e) the binary low/high decision with the matching label citation. Missing any of these is the dominant claim-side risk on this drug.
NDC reference FDA NDC Directory verified May 2026
Single-manufacturer drug. AstraZeneca / Alexion. One marketed package configuration.
| Manufacturer | NDC (10/11-digit) | Strength / package | HCPCS |
|---|---|---|---|
| Alexion / AstraZeneca | 10599-001-01 / 10599-0001-01 |
200 mg single-dose lyophilized vial; 4-vial carton (low dose) and larger institutional packs | J7169 |
Single-source product. No generic. No biosimilar (biologic; complex recombinant protein
outside biosimilar pathway as of 2026). NDC drives a single HCPCS — the manufacturer-code
complexity that affects argatroban and other multi-source drugs does not apply here.
Storage and reconstitution time matters in the ED. Andexxa is stored refrigerated and
requires 5-15 minutes for reconstitution per vial. Total prep time for high dose (9 vials) is non-trivial
and should not be on the critical path of acute hemorrhage management — institutions running an
Andexxa program typically maintain a kept-warm or pre-positioned ED kit. Time-to-administration metrics
are tracked by some payers as a quality indicator.
Phase 2
Code the claim
IV push (96374) for the bolus + therapeutic IV infusion (96365 + 96366) for the 120-min infusion that follows. Both on the same encounter.
Administration codes CPT verified May 2026
Andexxa is one of the few infusion drugs where IV push (96374) AND therapeutic IV infusion (96365) are both appropriate on the same encounter — bolus first, infusion follows.
| Code | Description | When to use |
|---|---|---|
96374 |
Therapeutic, prophylactic, or diagnostic injection, IV push, single or initial substance/drug | Primary admin code for the 15-30 minute bolus phase. Bill once per encounter as the initial therapeutic IV push. |
96365 |
Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour | Initial 60 minutes of the 120-minute continuous infusion that follows the bolus. Modifier 59 or XS may be required to identify as a distinct service after the 96374 push, per payer. |
96366 |
IV infusion for therapy/prophylaxis/diagnosis; each additional hour (List separately) | Each additional hour of the infusion beyond the initial 60 minutes. For the 120-min infusion this produces one unit of 96366 (the second hour). |
96413 / 96415 |
Chemotherapy IV infusion codes | NOT appropriate for Andexxa. Andexxa is not chemotherapy and chemo admin codes will trigger CCI/edits. This is a documented denial source. |
Typical encounter admin stack:
96374 × 1 (bolus) + 96365 × 1 (initial hour of infusion) + 96366 × 1 (second hour of infusion). Total encounter ~2-3 hr from ED arrival to end of infusion.
Bolus rate documentation. The FDA label specifies a 30 mg/min target bolus rate (so
low-dose 400 mg = ~15 min push; high-dose 800 mg = ~30 min push). At 30 mg/min the bolus duration sits
near the upper end of "IV push" territory and the lower end of "short infusion." CPT/CMS treat 15-30
min administration as IV push (96374) when the labeled rate is specified as a push or short bolus —
document the labeled rate and time to defend 96374 selection on audit.
Outpatient-converted-to-inpatient is the operationally messy scenario. Patient arrives
in ED with intracranial hemorrhage, receives Andexxa, then is admitted to ICU. For Medicare: the rule of
thumb is that the 3-midnight inpatient-admission threshold and the timing of the admission order relative
to the Andexxa administration determine whether the drug bills under Part B outpatient (J7169 + admin
codes separately payable) or is bundled into the inpatient MS-DRG. Document the admission
order timestamp. If Andexxa was given before the inpatient order, the encounter often
retroactively converts cleanly; if after, the drug is DRG-bundled. See
site of care and claim form for the operational
details.
Modifiers CMS verified May 2026
JW / JZ — single-dose vial waste reporting
Per CMS's July 2023 single-dose container policy (CR 12056), one of JZ (no waste) or JW (waste) is required on claims for drugs supplied in single-dose containers. Andexxa is supplied in 200 mg single-dose lyophilized vials and is included on the CMS single-dose container drug list. The operational reality:
| Scenario | Vials drawn | mg administered | JZ vs JW |
|---|---|---|---|
| LOW dose (880 mg) — 4 vials only | 4 × 200 mg = 800 mg available | 800 mg actually given (under-dose; not common) | JZ (no discard) |
| LOW dose (880 mg) — 5 vials (label-compliant) | 5 × 200 mg = 1,000 mg available | 880 mg given, 120 mg residual | JW — 12 units (120 mg) on separate line |
| HIGH dose (1,760 mg) — 9 vials | 9 × 200 mg = 1,800 mg available | 1,760 mg given, 40 mg residual | JW — 4 units (40 mg) on separate line |
JW claim-line structure: Two lines for J7169 on the claim — one with JZ-or-no-modifier carrying the administered units (88 or 176), one with JW carrying the discarded units (12 or 4 respectively). Total must reconcile to vials pulled. Document on the pharmacy preparation log.
Modifier 25 — same-day E/M
Use modifier 25 on the ED E/M code (99281-99285) when the ED visit and the Andexxa administration produce a significant, separately identifiable evaluation and management service. For the typical intracranial-hemorrhage Andexxa case this is essentially always true — modifier 25 supports the E/M line in addition to the infusion admin lines.
Modifier 59 / XS — distinct services
When billing 96374 (bolus) and 96365 (infusion that follows) on the same encounter, payer edits may require modifier 59 or XS on 96365 to indicate it is a distinct service following the bolus rather than a duplicate or bundled component. Verify with your MAC and major commercial plans; UHC and Aetna documentation for sequential push-plus-infusion services has been updated periodically.
340B modifiers (JG, TB)
For 340B-acquired Andexxa, follow your MAC's current 340B modifier policy. Andexxa is 340B-eligible at DSH/CAH/rural hospitals; given the per-encounter cost (~$22,500 low / ~$45,000 high WAC), the 340B discount is material and reporting is closely audited.
ICD-10-CM FY2026 verified May 2026
The bleeding event is the primary diagnosis; the anticoagulant adverse-effect / long-term-use codes are required secondaries. Documentation of both is the coverage backbone.
| ICD-10 | Description | Use case |
|---|---|---|
I60.0–I60.9 | Subarachnoid hemorrhage (by site) | Bleeding-event primary diagnosis when ICH presentation is SAH |
I61.0–I61.9 | Intracerebral hemorrhage (by site) | Most common Andexxa primary diagnosis — spontaneous ICH on apixaban/rivaroxaban |
I62.0–I62.9 | Other and unspecified intracranial hemorrhage (subdural, epidural) | Bleeding-event primary for SDH/EDH (traumatic or spontaneous) |
K92.0 | Hematemesis | GI bleeding presentation; pair with anatomic source codes |
K92.1 | Melena | GI bleeding presentation; pair with anatomic source codes |
K92.2 | Gastrointestinal hemorrhage, unspecified | GI bleeding when source not yet identified |
K25.0 / K25.4 | Gastric ulcer with hemorrhage | Pair with K92.x for anatomic specificity |
K26.0 / K26.4 | Duodenal ulcer with hemorrhage | Pair with K92.x for anatomic specificity |
T45.515A | Adverse effect of anticoagulants, initial encounter | Required secondary code identifying the bleeding as anticoagulant-related. Sub-codes for accidental (T45.515A), self-harm, assault, undetermined. |
T45.516A | Underdosing of anticoagulants, initial encounter | If documentation supports underdosing (rarely relevant for reversal claims) |
Z79.01 | Long-term (current) use of anticoagulants | Required secondary code documenting chronic DOAC therapy at time of bleeding |
Z79.02 | Long-term (current) use of antithrombotics/antiplatelets | If dual-antiplatelet plus DOAC is documented |
I50.x | Heart failure | Pair when CHF-associated bleeding or hemodynamic compromise contributes to "life-threatening" criterion |
R57.1 | Hypovolemic shock | Documents hemodynamic compromise / "life-threatening" criterion |
D62 | Acute posthemorrhagic anemia | Pair to document blood loss severity for the "life-threatening" qualifier |
I48.x | Atrial fibrillation (by type) | Underlying indication for chronic DOAC therapy; not required but useful for medical necessity narrative |
S06.x | Intracranial injury (traumatic) | When ICH is post-traumatic; pair with I62.x and trauma external-cause codes |
The two-secondary rule. Payer policies typically require T45.515A (or equivalent
adverse-effect code) PLUS Z79.01 (long-term anticoagulant use) on every Andexxa claim, alongside the
bleeding-event primary. Missing either secondary is a frequent downgrade trigger — the claim is
readable as "patient bled, drug given" without these codes locking in the "patient was on a DOAC"
narrative.
Edoxaban exposure is captured by the same T45.515A / Z79.01 codes — ICD-10 does
not distinguish among the specific DOACs. The actual anticoagulant identity has to be carried in the
medication reconciliation and chart notes. This is part of why payers require a clinical narrative
attestation for Andexxa claims even when the diagnosis codes look identical to an edoxaban scenario.
Site of care & place of service Verified May 2026
Andexxa is fundamentally an emergency-department / ICU drug. Operationally, the claim-side question is whether the encounter is billed as outpatient (Part B, with J7169 and admin codes on UB-04 separately payable) or has been converted to inpatient (Part A, drug bundled into MS-DRG). The decision tracks the admission order timing relative to drug administration and the encounter's ultimate disposition.
| Setting | POS | Claim form | Notes |
|---|---|---|---|
| Emergency department (HOPD) | 23 | UB-04 / 837I | Primary use site. Drug given before inpatient admission order = Part B claim, J7169 + admin codes separately payable. |
| Inpatient hospital (ICU) | 21 | UB-04 / 837I | If admission order precedes drug administration, drug is bundled into MS-DRG; not separately Part B billable. |
| Outpatient HOPD — observation | 22 | UB-04 / 837I | Patient under observation for bleeding evaluation receiving Andexxa; J7169 + admin codes separately billable. Conversion to inpatient may follow. |
| Trauma center / ED with admit | 23 then 21 | UB-04 / 837I | The outpatient-converted-to-inpatient scenario. Document admit order timestamp relative to drug administration. |
| Inpatient transfer-in | 21 | UB-04 / 837I | Patient transferred to your facility already admitted; Andexxa given inpatient = DRG-bundled. |
| Ambulatory infusion suite / physician office | 49 / 11 | CMS-1500 / 837P | Not appropriate. Andexxa is for emergency reversal of life-threatening bleeding — not an outpatient infusion-suite drug. |
| Patient home | 12 | CMS-1500 | Not appropriate. Emergency-use only. |
The outpatient-to-inpatient conversion is the operational core of Andexxa billing.
Many Andexxa administrations begin in the ED before an admission order has been written. CMS's
outpatient-to-inpatient rules treat the encounter according to the disposition recorded on the claim
and the timing of the admission order. Two operational principles: (1) document the admission order
timestamp clearly relative to drug administration, and (2) follow your institution's billing-office
workflow for what gets carved out to Part B vs included in Part A. Most Andexxa claims at modern
academic medical centers track as ED-outpatient encounters that subsequently convert to inpatient
— Part B captures the drug, Part A captures the subsequent admission.
Claim form field mapping CMS verified May 2026
Andexxa claims are nearly always UB-04 (HOPD ED encounter). Office CMS-1500 use is operationally inappropriate.
| Information | UB-04 (HOPD ED) | CMS-1500 (n/a) | Notes |
|---|---|---|---|
| HCPCS J-code | FL 44 (Rev Code 0636 self-admin/0250 pharmacy) | 24D | J7169 — 10 mg per unit |
| Units | FL 46 | 24G | 88 units low dose / 176 units high dose (administered); separate JW line for discarded units |
| NDC qualifier + 11-digit NDC + UoM + qty | FL 43 (description line) | 24A shaded area | N4 + 10599-0001-01 + UN (units) + total mg administered |
| JW or JZ modifier | FL 44 modifier slot | 24D modifier slot | Required per CMS CR 12056; typical Andexxa claim carries JW on a separate discard line |
| CPT 96374 (IV push, initial substance) | FL 44 | 24D | Bolus phase — one unit per encounter |
| CPT 96365 (initial therapeutic IV infusion, 1 hr) | FL 44 | 24D | Initial hour of post-bolus infusion; modifier 59 or XS may be required |
| CPT 96366 (each additional hour) | FL 44 (separate line) | 24D | Second hour of the 120-min infusion |
| ED E/M (99281-99285) with modifier 25 | FL 44 | n/a | Separately payable from the procedure when significant E/M documented |
| ICD-10 (primary) | FL 67 | 21 | I60-I62 (ICH) or K92.x (GI bleed) bleeding-event anchor |
| ICD-10 (secondary — required) | FL 67A-Q | 21 | T45.515A + Z79.01 both required to lock in the anticoagulant-adverse-effect / chronic-DOAC narrative |
| NPI (rendering / billing) | FL 76 / 1 | 17b / 33a | |
| PA number | FL 63 | 23 | Most payers do not require a prospective PA for ED emergency use; retrospective review is the norm |
Phase 3
Get paid
Emergency-use coverage is standard but retrospective review is intense given the per-encounter cost. Documentation discipline is the difference between paid and denied.
Payer policy snapshot Reviewed May 2026
Coverage is on-label-broad for apixaban/rivaroxaban reversal in life-threatening bleeding. Edoxaban use is generally not covered. Documentation requirements are uniform across payers.
| Payer | PA / coverage | Documentation expected |
|---|---|---|
| Medicare Part B (MACs) Various MAC LCDs; no NCD |
Covered for FDA-approved indications (apixaban/rivaroxaban reversal in life-threatening bleeding). Retrospective medical-necessity review is the norm given encounter cost. Outpatient ED encounter = J7169 + admin codes separately payable; inpatient = DRG-bundled. | Documented apixaban or rivaroxaban use; last-dose timing within 24 hr (ideally 18 hr); life-threatening or uncontrolled bleeding event (ICH, GI, retroperitoneal); low vs high dose rationale; bleeding location and severity assessment; post-reversal anticoagulation reinitiation plan |
| Medicare Part A (inpatient) | Drug cost bundled into MS-DRG when administered after the inpatient admission order; outpatient/ED encounter before admission converts cleanly to Part B | Admission order timestamp relative to drug administration; chart-side narrative supporting medical necessity for DRG validation |
| UnitedHealthcare Medical Drug Policy: Andexanet alfa (Andexxa) |
Covered for FDA-labeled indications. Prospective PA not required for ED emergency use; retrospective medical-necessity review intense given cost. | Anticoagulant use documentation; last-dose timing ≤18 hr (UHC policy explicit on 18-hr window); bleeding location and severity criteria; absence of contraindications; post-reversal management plan |
| Aetna CPB — Andexanet alfa |
Covered for FDA-labeled indications; edoxaban use explicitly listed as experimental/investigational and not covered. | Documentation of apixaban or rivaroxaban; bleeding event with severity descriptor; dose tier rationale; reasonable temporal proximity of last DOAC dose to reversal |
| Cigna Coverage Policy — Andexanet alfa |
Covered for on-label indications. Same documentation standard as UHC/Aetna. | Documented DOAC, dose, and timing; bleeding severity; reversal-agent selection rationale |
| BCBS plans Vary by plan |
Covered generally; plan-level UM applies. Many BCBS plans flag Andexxa for retrospective audit given cost. | Standard FDA-label-aligned documentation; admission order timing for converted encounters |
| State Medicaid (FFS + MCOs) | Covered as a J-code therapeutic; per-state UM and FFS coverage policies vary, with some states applying additional UM for high-cost emergency drugs. | FDA-label-aligned documentation; state-specific PA forms where required |
Society guidance and trial evidence
The 2022 AHA/ASA Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage recommends andexanet alfa as the preferred reversal agent for apixaban- or rivaroxaban-associated ICH when available, with 4F-PCC as the off-label alternative. The 2024 ANNEXA-I randomized trial (NEJM) demonstrated improved hemostatic efficacy versus usual care (predominantly 4F-PCC) for apixaban/rivaroxaban-associated ICH, supporting the December 2024 full FDA traditional approval. The Neurocritical Care Society and the American College of Cardiology have published similar guidance. Off-label edoxaban use is generally not supported by society guidance — 4F-PCC is the recommended alternative.
Medicare reimbursement CMS verified May 2026
J7169 ASP is not currently published in the public CMS Part B ASP file as of Q2 2026 — reimbursement typically follows MAC pricing or WAC-based methodology for emergency-use single-encounter drugs.
Q2 2026 payment snapshot — J7169 reference
Effective April 1 – June 30, 2026 · Single-encounter ED drug
J7169 unit
10 mg
= 1 unit
Low dose
88 units
880 mg · ~$22,500 WAC
High dose
176 units
1,760 mg · ~$45,000 WAC
Per-encounter cost math. A typical high-dose Andexxa ED encounter (the more common
scenario, given that "last dose timing within 8 hr or unknown" is the realistic ED presentation)
carries a drug WAC of approximately $45,000 plus administration costs. Low dose runs ~$22,500. Both
are single-encounter charges — there is no maintenance.
Sequestration: Approximately 2% reduction applies to actual paid amount on Medicare
Part B reimbursement.
ASP file status. J7169 has historically not appeared in the public CMS Part B ASP
Pricing File — pricing for Andexxa typically falls under MAC-determined invoice-plus methodology
or pass-through payment status. Verify current MAC pricing locally; institutional formulary committees
should track this closely given the per-encounter cost.
Coverage
No NCD specific to Andexxa or to factor Xa reversal agents. Coverage falls under MAC LCDs for therapeutic IV drug administration in emergency settings and the standard Part B drug coverage framework. All MACs cover Andexxa for FDA-approved indications with appropriate documentation. The 2024 full FDA approval following ANNEXA-I has stabilized coverage that was previously occasionally questioned under the accelerated approval framework.
Code history
- J7169 — permanent code, "Injection, coagulation factor Xa (recombinant), inactivated-zhzo, 10 mg" — effective for claims with dates of service on or after the CMS HCPCS workgroup assignment following 2018 FDA accelerated approval. Replaced earlier C9047 / J3490 (unclassified) submissions.
- C9047 — historical pass-through code used for early OPPS billing post-approval; superseded by J7169 once permanent HCPCS was assigned.
- J3490 / J3590 — unclassified J-codes used during the earliest claims period in 2018; superseded once J7169 was established. Older claims may carry these historical entries.
Verify HCPCS effective dates with CMS quarterly bulletins. Pass-through and
transitional pricing rules have changed multiple times since the 2018 accelerated approval. Older
claims may not map cleanly to current J7169 reporting.
Patient assistance Verified May 2026
Andexxa's patient-assistance landscape is constrained by its emergency-use nature — there is no outpatient continuity-of-care path that would benefit from the standard branded-drug copay-card + foundation-bridge structure. The institution (hospital) is almost always the immediate payer for the Andexxa drug cost; patient out-of-pocket exposure is typically through the broader inpatient or ED encounter rather than a drug-specific charge. That said, AstraZeneca/Alexion maintains access support for institutional pharmacy and revenue-cycle teams.
- AstraZeneca Access 360 / Alexion OneSource — the post-acquisition hub for Andexxa, providing benefits investigation, prior-authorization support, appeals assistance, and limited patient-financial counseling. Designed for institutional pharmacy and revenue-cycle staff rather than direct patient enrollment.
- No copay card program. Emergency single-encounter drugs typically do not have manufacturer copay cards because the patient is not the operational point of payment; the hospital pharmacy/RC chain is.
- Hospital charity care: for uninsured ED patients receiving Andexxa, the drug cost is typically absorbed through the institution's charity care / financial assistance policy. Insured patients see Andexxa as a line item in the encounter's larger ED-and-admission bill.
- 340B-acquired pricing: for DSH/CAH/rural hospitals participating in 340B, Andexxa is 340B-eligible at substantial discounts. This is the primary institutional cost-mitigation lever and is invisible to the patient.
- Foundation backup: PAN Foundation and HealthWell Foundation generally do not run dedicated factor Xa reversal funds, given the single-encounter nature. Patients with broader anticoagulation-related financial needs (the underlying chronic DOAC) may have copay support for the oral agent post-discharge.
Need to model total ED encounter cost including Andexxa, admin codes, and ED E/M? Run a CareCost Estimate — J7169 pre-loaded with low/high dose toggle.
Phase 4
Fix problems
Anticoagulant-timing documentation, wrong-DOAC reversal-agent mismatch, and dose-stratification rationale are the top denial drivers.
Common denials & how to fix them Reviewed May 2026
| Denial reason | Common cause | Fix |
|---|---|---|
| #1 — Anticoagulant use timing not documented | ED chart records "patient on a DOAC, given Andexxa" without specifying last-dose timing. Payer policies require ≤18-24 hr window to substantiate medical necessity. | Add nursing/provider note documenting last apixaban/rivaroxaban dose time (with collateral history from family/EMS/pill bottle if patient unable). Resubmit with attestation. Going forward, build last-dose-time as a required field in the ED Andexxa order set. |
| #2 — Wrong DOAC (Andexxa for dabigatran or edoxaban) | Patient on dabigatran (Pradaxa) given Andexxa — should have been Praxbind (idarucizumab, J1746). Or patient on edoxaban given Andexxa — off-label and generally denied. | For dabigatran case: re-bill as Praxbind J1746 if available; if Andexxa was actually administered, submit medical-necessity appeal documenting why Praxbind was unavailable (rarely successful). For edoxaban: submit appeal with mechanistic rationale and absence-of-alternatives argument; consider re-running as 4F-PCC J7168 if that's clinically what was needed. |
| #3 — Bleeding severity not documented | "Patient with GI bleeding given Andexxa" without severity descriptor (hemodynamic compromise, hemoglobin drop, transfusion requirement, ICU admission, etc.). Payers require "life-threatening or uncontrolled" criterion to be substantiated. | Add chart documentation of severity criteria: vital sign trend, Hb/Hct trajectory, transfusion received, hemodynamic interventions, level-of-care escalation, neurologic exam in ICH cases. Resubmit with chart attestation. |
| #4 — Wrong CPT (96413 chemo instead of 96374/96365) | Andexxa administration miscoded with chemotherapy infusion codes (96413/96415). Triggers CCI/edit denial. | Resubmit with 96374 (bolus) + 96365 (initial hour infusion) + 96366 (each additional hour). Andexxa is not chemotherapy. |
| #5 — Dose stratification not justified | High dose (176 units J7169) billed without chart rationale — was the last dose ≥5 mg apixaban / >10 mg rivaroxaban, or was timing <8 hr / unknown? Or low dose billed when high-dose criteria were actually met. | Add chart note citing the specific FDA-label decision rule (apixaban dose, rivaroxaban dose, last-dose timing). For "unknown timing within 8 hr" high-dose justification, document explicitly. Resubmit with attestation. |
| Andexxa billed for warfarin | Categorical mismatch — warfarin reverses with 4F-PCC + vit K, not Andexxa. | Submitter education; if the encounter actually used 4F-PCC clinically (Andexxa pulled in error then not given), reverse the J7169 line and bill the correct J7168 with appropriate units. If Andexxa was given for a warfarin patient, submit medical-necessity appeal (rarely successful). |
| Missing T45.515A and/or Z79.01 | Claim has bleeding-event primary but no anticoagulant-adverse-effect secondary or no chronic-DOAC-use code. | Add T45.515A + Z79.01 to the diagnosis pointer set and resubmit. Build these as required diagnoses on the institutional Andexxa order set. |
| JW modifier missing on discard line | Vial residual discarded but not reported on a separate JW line. | Add second J7169 line with JW modifier and the discarded units (12 for low dose, 4 for high dose typical). Reconcile to pharmacy preparation log. |
| Encounter type mismatch (Part A vs Part B) | Andexxa billed under Part B but the admission order preceded drug administration — should have been DRG-bundled. | Audit admission order timestamps; carve drug to correct claim. For inpatient-converted encounters where drug was given pre-admission, the Part B carve is defensible — document the timestamp. |
| NDC qualifier missing on UB-04 | Drug line submitted without N4 qualifier and 11-digit NDC. | Add N4 + 11-digit NDC (10599-0001-01) in FL 43 description line per UB-04 specs. |
| Repeat Andexxa within short interval | Second Andexxa administration within days of first — payers typically deny unless medical necessity for re-dosing is established. | Document rebound bleeding event, hematology consultation, and absence-of-alternatives. Submit narrative appeal with chart timeline. Re-dose data are limited and not in FDA label. |
Frequently asked questions
Which DOACs does Andexxa reverse?
Andexxa carries on-label FDA approval only for reversal of anticoagulation from apixaban
(Eliquis) and rivaroxaban (Xarelto) in patients with life-threatening or uncontrolled
bleeding. It is NOT FDA-approved for edoxaban (Savaysa) — though andexanet alfa mechanistically
binds any direct factor Xa inhibitor, edoxaban use is off-label and not supported by the ANNEXA program.
It is NOT for dabigatran (Pradaxa), which is a direct thrombin inhibitor — dabigatran reversal
uses idarucizumab (Praxbind, J1746). Submitting an Andexxa claim for dabigatran or
edoxaban exposure is a frequent denial trigger.
Andexxa vs Praxbind — what is the difference?
Andexxa (andexanet alfa) is a recombinant modified Factor Xa decoy that binds and sequesters direct
factor Xa inhibitors (apixaban, rivaroxaban). Praxbind (idarucizumab) is a monoclonal antibody fragment
that binds dabigatran (a direct thrombin inhibitor). The two agents are not interchangeable —
selection is driven by which DOAC the patient was taking. There is no FDA-approved reversal for
edoxaban beyond off-label 4F-PCC. Warfarin reversal uses 4F-PCC (Kcentra, J7168) + vitamin K,
not either of these specific reversal agents. See the reversal-agent map
for the full grid.
How is the low-dose vs high-dose decision made?
Per FDA label: use low dose (400 mg bolus + 4 mg/min × 120 min = 880 mg total) if the last apixaban dose was <5 mg OR last rivaroxaban dose was ≤10 mg AND was taken ≥8 hours before reversal. Use high dose (800 mg bolus + 8 mg/min × 120 min = 1,760 mg total) if the last apixaban dose was ≥5 mg, last rivaroxaban dose was >10 mg, OR if the timing/dose of last anticoagulant is unknown or within 8 hours. When in doubt or when timing is unknown, default to high dose — the label explicitly authorizes high dose for the unknown-timing scenario. See dose stratification for the full decision table and unit math.
What is the time window from last anticoagulant dose?
The FDA label and the ANNEXA-4 / ANNEXA-I trial protocols define the population as patients with major bleeding while on apixaban or rivaroxaban — Andexxa is most effective when given within 18 hours of the last DOAC dose, because beyond that interval the residual anti-Xa activity has typically declined to the point where reversal is less likely to change outcome. Payer policies typically require documentation that the last anticoagulant dose was within 18-24 hours of Andexxa administration. Documenting the time of last DOAC ingestion in the ED chart is the single most important coverage element — its absence is the #1 denial driver.
How are bolus and infusion billed separately on the same claim?
Use 96374 (therapeutic IV push, single or initial substance) for the 15-30 minute bolus,
then 96365 (initial therapeutic IV infusion, up to 1 hour) and 96366 (each
additional hour) for the 120-minute continuous infusion that follows. The two admin services are
sequential (bolus first, infusion follows) — this is one of the few infusion drugs where both an
IV push code AND an infusion code are appropriate on the same encounter. Modifier 59 or XS may be
required on 96365 to indicate the distinct service after the push, per payer.
How is the boxed warning for thromboembolic events monitored?
Andexxa carries an FDA boxed warning for arterial and venous thromboembolic events, ischemic events (including myocardial infarction and ischemic stroke), cardiac arrest, and sudden death after administration. The mechanism is partially withdrawal of factor Xa inhibition combined with the procoagulant action of andexanet itself on tissue factor pathway inhibitor. Post-reversal monitoring requires VTE prophylaxis to be reinitiated as soon as medically appropriate. Document the boxed-warning risk discussion in the chart for both PA and post-pay audit; post-reversal continuous cardiac monitoring and serial neurologic exams are the institutional standard.
How is Andexxa supplied — vial count for low and high dose?
Andexxa is supplied in 200 mg single-dose lyophilized vials for reconstitution. Low dose (880 mg total) requires 4 vials × 200 mg = 800 mg drawn for a 400 mg bolus + 480 mg infusion; in practice 5 vials are usually pulled to make full label dose with ~120 mg residual JW-reportable. High dose (1,760 mg total) requires 9 vials × 200 mg = 1,800 mg drawn for the 800 mg bolus + 960 mg infusion, with ~40 mg residual (4 units JW-reportable). See modifiers section for the JW/JZ accounting structure.
Is Andexxa for edoxaban (Savaysa) covered?
Off-label and not covered by most payer policies. The FDA label and ANNEXA-A / ANNEXA-R / ANNEXA-4 /
ANNEXA-I program studied apixaban and rivaroxaban only. While andexanet alfa mechanistically binds any
direct Xa inhibitor (and case-series experience supports activity against edoxaban), the FDA-approved
indication is restricted. Payer policies (Medicare LCDs and commercial) generally deny Andexxa claims
for edoxaban exposure as not medically necessary at the approved-indication level. 4F-PCC (Kcentra,
J7168) is the off-label alternative for edoxaban-associated major bleeding per current
society guidance.
Is Andexxa appropriate for warfarin reversal?
No. Warfarin reverses through vitamin K plus 4-factor prothrombin complex concentrate
(Kcentra, J7168) — not Andexxa. Andexxa targets direct factor Xa inhibitors only.
Submitting Andexxa for a warfarin INR reversal is a frequent miscoding error and a categorical denial.
Confirm the patient's actual anticoagulant from the medication reconciliation before pulling Andexxa
from the ED pyxis.
Can a single-encounter Andexxa claim be repeated?
Re-dosing data are limited. The FDA label does not provide a re-dose interval, and ANNEXA-4 enrolled patients for a single reversal. If clinical anti-Xa activity rebounds and re-bleeding occurs, institutional pharmacy and the hematology consult service should be involved — repeat administration is not routinely supported by payers, and most insurance will limit Andexxa to one encounter per bleeding episode. Document medical necessity if a repeat dose is clinically required.
What is the Medicare reimbursement for J7169?
J7169 has historically not appeared in the public CMS Part B ASP Pricing File. Reimbursement typically falls under MAC-determined invoice-plus methodology or pass-through pricing for emergency-use drugs. WAC per encounter approximates $22,500 (low dose, 88 units) to $45,000 (high dose, 176 units). Verify current MAC pricing locally; institutional formulary committees should track this closely. Sequestration (~2%) applies to actual paid Part B amount.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — Andexxa (andexanet alfa) prescribing information
- FDA — Complete Response Letter (December 2024) on Andexxa sBLA conversion
- ANNEXA-I — NEJM 2024: Andexanet for Intracranial Hemorrhage in Patients on Factor Xa Inhibitors
- ANNEXA-4 — NEJM 2019: Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors
- AHA/ASA — 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage
- CMS — Medicare Part B Drug ASP Pricing File
- CMS HCPCS Level II Quarterly Updates
- FDA National Drug Code Directory — Andexxa NDC
- CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)
- CMS — ICD-10-CM (FY2026)
- UnitedHealthcare — Medical Drug Coverage Policy: Andexanet alfa (Andexxa)
- Aetna Clinical Policy Bulletins — Andexanet alfa
- AstraZeneca / Alexion — Andexxa product information & OneSource hub
- AABB — AstraZeneca Withdraws Factor Xa Reversal Agent From US Market (Dec 23, 2025)
- FDA — sBLA 125586/546 Briefing Document (Oct 18, 2024 Advisory Committee)
- Medscape — Anticoagulant Reversal Drug Andexxa Voluntarily Pulled From US Market (Dec 2025)
About this page
We maintain this page as a living reference for billers, coders, and ED/ICU pharmacy/RC staff working with Andexxa claims. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes. Andexxa pricing is not bound to the CareCost ASP layer because J7169 is not currently in the public CMS ASP file — institutional MAC verification is required.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| HCPCS effective dates / J7169 descriptor | Quarterly | Reviewed against CMS HCPCS quarterly bulletins. |
| Payer policies (UHC, Aetna, Cigna, BCBS, Medicaid) | Semi-annual | Manual review against published payer policy documents. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. |
| Trial evidence (ANNEXA program) | Event-driven | Updated on new ANNEXA publication or society guideline release. |
Reviewer
SME audit completed May 22, 2026. Verified against current FDA prescribing information
(DailyMed), ANNEXA-4 (Connolly NEJM 2019, DOI 10.1056/NEJMoa1814051), ANNEXA-I (Connolly NEJM 2024, DOI
10.1056/NEJMoa2313040), the FDA Dec 2024 Complete Response Letter, and the AABB / AstraZeneca Dec 2025
US market-withdrawal announcement. Key audit corrections: BLA number (125586 not 761112), full-approval
status (denied via CRL, not granted), and US availability (withdrawn Dec 22, 2025).
Change log
- — SME audit pass. Corrected (1) FDA approval status — Dec 2024 CRL denied conversion to traditional approval (page previously stated approval was granted), (2) US market withdrawal Dec 22, 2025 added prominently, (3) BLA number corrected to 125586, (4) ANNEXA-I postmarketing thrombotic-event signal added (14.6% vs 6.9% thrombosis; 2.5% vs 0.9% 30-day thrombosis-related mortality vs usual care), (5) page repositioned as historical billing reference / ex-US context only.
- — Initial publication. Wave 9C single-encounter emergency-use template adaptation applied (reversal-agent disambiguation grid; low/high dose stratification with explicit unit math; bolus + infusion admin code pairing; outpatient-to-inpatient conversion guidance).
Methodology
Every claim on this page is sourced inline. The dose-tier decision rule, time windows, and boxed-warning language are taken directly from the current FDA prescribing information. Payer policies are read directly from each payer's published medical policy documents. Trial evidence is cited to the primary publications. We do not paraphrase from billing-software vendor blogs.