Bivalirudin (Angiomax) — HCPCS J0583

About bivalirudin (Angiomax) FDA label verified May 2026

A direct thrombin inhibitor used as a heparin alternative during PCI, including in patients with HIT or HITTS undergoing PCI.

Bivalirudin (originator brand Angiomax) is a synthetic 20-amino-acid peptide that directly and reversibly inhibits thrombin (Factor IIa) by occupying both its catalytic and substrate-recognition sites. Unlike heparin, bivalirudin works independently of antithrombin and does not cross-react with HIT antibodies — this is the basis for its use as a heparin alternative in patients with heparin-induced thrombocytopenia (HIT) or HIT with thrombosis syndrome (HITTS) who require percutaneous coronary intervention (PCI). The drug was originally developed by Biogen and approved as Angiomax under NDA 20-873 in December 2000 by The Medicines Company; the originator brand has since been discontinued post patent-expiration and the U.S. market is now served by multiple generic manufacturers including Sandoz, Hospira (Pfizer), Maia, Mylan (Viatris), and Accord Healthcare.

The FDA-labeled indication is for use as an anticoagulant in patients undergoing PCI, including patients with or at risk of HIT/HITTS, and for provisional use with glycoprotein IIb/IIIa inhibitors. Bivalirudin is dosed by weight as a single IV bolus followed by a continuous IV infusion that runs for the duration of the procedure, titrated to an activated clotting time (ACT) target of approximately 300–350 seconds. Half-life is roughly 25 minutes in patients with normal renal function and is prolonged in renal impairment; there is no specific reversal agent, but the short half-life and partial dialyzability (~25%) provide intrinsic mitigation.

Why this page is defensive. For the drug's primary indication — anticoagulation during PCI — bivalirudin is functionally never separately payable. The CMS OPPS Addendum B assigns HCPCS J0583 Status Indicator N ("Items and services packaged into APC rates") for the hospital outpatient setting, which means the drug cost is embedded in the APC payment for the PCI procedure and no separate Part B line will produce incremental payment. In the inpatient setting, bivalirudin acquisition cost is captured in the MS-DRG payment for the admission (typically MS-DRG 246–251 PCI DRGs). The page exists to answer "you cannot bill this separately," to help billing staff push back when clinicians or vendors suggest carving out the drug, and to document the rare scenarios where separate payment might apply.

Dosing & ACT targets FDA label verified May 2026

Continuous IV infusion titrated to activated clotting time (ACT) during PCI. Per the Wave 7D template adaptation for continuous-titration anticoagulants, this section includes a dedicated target-range table.

Weight-based dosing matrix

Target coagulation lab range — ACT during PCI

Worked example — PCI in 80 kg patient (general or HIT/HITTS)

NDC reference FDA NDC Directory verified May 2026

Originator Angiomax discontinued; multiple generic manufacturers. Representative NDCs below — verify against the dispensed product NDC from your pharmacy for every claim.

Administration codes CPT verified May 2026

Bolus + continuous infusion typically map to 96374 (IV push) for the bolus and 96365/96366 (therapeutic IV infusion, non-chemo) for the hourly drip only in the rare scenario where the drug is not bundled into a procedural payment. In the dominant PCI use case, the cath lab procedure code (e.g., 92920–92944 PCI series for hospital outpatient or the ICD-10-PCS 027x codes for inpatient) drives payment and bivalirudin is packaged or bundled.

Modifiers CMS verified May 2026

Mostly N/A given OPPS SI=N + MS-DRG bundling. JW/JZ exist on paper but rarely matter for bivalirudin because the drug is packaged or bundled and no separately payable line is produced.

JW — in the rare separately-payable scenario

JW reports the discarded portion of a single-dose vial. If bivalirudin were genuinely billed standalone under J0583 outside a bundled procedural or inpatient context (rare — see site of care and FAQ for the narrow scenarios), partial-vial waste would be the norm because the 250 mg vial size rarely matches the weight-based dose. In the dominant PCI use case, JW is moot: there is no separately payable J0583 line on which to bill waste.

JZ — same caveat

JZ identifies no waste from a single-dose vial. Applies in the same narrow standalone-billing scenario as JW. The CMS July 2023 single-dose container policy requires one of JZ or JW on every separately payable J-code claim — but bivalirudin in PCI is not a separately payable claim, so the requirement is rarely engaged.

340B (JG / TB)

340B modifier reporting policies vary by setting and MAC. For hospital outpatient PCI where the drug is packaged (SI=N), 340B reporting is governed by current OPPS rules — consult your MAC and OPPS Addendum B current quarter for the applicable JG or TB requirement on packaged drugs, recognizing that the modifier does not change the payment outcome (still packaged).

ICD-10-CM by indication FY2026 verified May 2026

Cardiac diagnosis codes drive the PCI encounter; pair with HIT-specific D75.82 when bivalirudin is selected because of HIT or HITTS.

Site of care — bivalirudin is packaged in PCI CMS OPPS Q2 2026 + MS-DRG FY2026

Per the Wave 7D template adaptation for OPPS SI=N / DRG-bundled drugs, this section opens with the explicit not-separately-payable callout, then summarizes how each setting handles bivalirudin.

How MS-DRG bundling works for inpatient PCI

For an inpatient PCI admission, the entire stay — including pharmacy acquisition cost of bivalirudin used during the procedure — is paid via the MS-DRG. The relevant DRGs for fiscal year 2026 (effective October 1, 2025 – September 30, 2026) are:

• MS-DRG 246 — Percutaneous cardiovascular procedures with drug-eluting stent with MCC or 4+ vessels/stents
• MS-DRG 247 — Percutaneous cardiovascular procedures with drug-eluting stent without MCC
• MS-DRG 248 — Percutaneous cardiovascular procedures with non-drug-eluting stent with MCC or 4+ vessels/stents
• MS-DRG 249 — Percutaneous cardiovascular procedures with non-drug-eluting stent without MCC
• MS-DRG 250 — Percutaneous cardiovascular procedures without coronary artery stent with MCC
• MS-DRG 251 — Percutaneous cardiovascular procedures without coronary artery stent without MCC

AMI-driven PCI may instead map to MS-DRG 280–285 (AMI with/without major complications) when the principal diagnosis is the infarction and the PCI is a secondary procedure. Either way, bivalirudin is captured in the DRG; it does not appear as a separately payable line item.

How OPPS Status Indicator N works for hospital outpatient PCI

Each calendar year CMS publishes OPPS Addendum B, which assigns a Status Indicator to every HCPCS code used in hospital outpatient billing. Status Indicator N is defined as "Items and services packaged into APC rates" — CMS does not make a separate payment for the item; instead its cost is built into the APC payment for the procedure with which it is reported. For HCPCS J0583, SI=N means bivalirudin used during a PCI is paid for via the APC assigned to the PCI procedure (e.g., the APC for HCPCS 92928 PCI with stent), and any J0583 line submitted on the same claim will be processed but will not generate incremental payment.

Claim form field mapping CMS verified May 2026

For hospital outpatient PCI (UB-04) and the rare standalone-billing scenario (CMS-1500). In the dominant use case, the only meaningful J0583 entries are informational (revenue code 0250/0636 with packaged status), not payment-generating.

UB-04 / 837I (hospital outpatient and inpatient PCI)

CMS-1500 / 837P (exceptional standalone outpatient infusion only)

Payer policy snapshot Reviewed May 2026

Commercial payers broadly follow Medicare's packaging logic on bivalirudin in PCI: drug cost is part of the procedural rate, not a separately negotiated line. Coverage centers on the PCI procedure and on HIT-specific medical necessity.

Step therapy

There is no meaningful step therapy on bivalirudin in PCI because the drug is selected at the bedside in the cath lab for the duration of the procedure, and payment is captured in the procedural bundle regardless of which anticoagulant is used. For HIT/HITTS patients undergoing PCI, bivalirudin and argatroban are clinically acceptable alternatives; selection is driven by physician preference, ACT predictability, and renal status rather than payer step-therapy logic.

Guideline support

Bivalirudin is supported in the ACC/AHA/SCAI PCI guidelines as an alternative to unfractionated heparin during PCI (with or without GP IIb/IIIa inhibitor "bailout"). For HIT or HITTS patients undergoing PCI, the CHEST and ACCP HIT/Antithrombotic guidelines and the ACC/AHA STEMI guidelines support a direct thrombin inhibitor (bivalirudin preferred for PCI; argatroban for non-procedural HIT). Guideline support does not change the payment mechanics (still packaged/bundled in PCI).

Medicare reimbursement CMS Q2 2026 (live)

ASP from the CMS Part B Drug ASP Pricing File. Refreshes automatically each quarter. ASP is relevant for the rare separately-payable scenario and for institutional cost analytics — in the dominant PCI use case, payment flows through the APC or MS-DRG, not the J-code line.

OPPS Status Indicator N — the operative rule

For HCPCS J0583, the CMS OPPS Addendum B assigns Status Indicator N — "Items and services packaged into APC rates." This means that for any hospital outpatient PCI encounter where bivalirudin is administered, the drug acquisition cost is captured in the APC payment assigned to the PCI procedure (e.g., the APC for HCPCS 92928 PCI with stent). A J0583 line on the same claim is processed but produces no incremental payment; CMS does not pay separately for SI=N drugs. This is the single most important fact about J0583 billing.

MS-DRG bundling — the inpatient operative rule

Under the Inpatient Prospective Payment System (IPPS), bivalirudin used during an inpatient PCI is paid via the assigned MS-DRG (typically MS-DRG 246–251 for PCI-driven admissions, or MS-DRG 280–285 for AMI-driven admissions where PCI is secondary). There is no separately payable Part B line for J0583 on an inpatient claim — the J-code is reported only on the outpatient claim form, and on inpatient claims the drug is captured via revenue code with chargemaster pricing rolled into the DRG payment.

Sequestration

Where J0583 is separately payable (the rare standalone scenario), the standard ~2% sequestration reduction applies, bringing effective reimbursement to roughly ASP + 4.3%. For the packaged or bundled use cases, sequestration is applied at the procedural payment level (APC or MS-DRG), not the drug line.

Coverage and code history

• J0583 — permanent CMS HCPCS Level II code, "Injection, bivalirudin, 1 mg"
• No NCD specific to bivalirudin; coverage falls under cath lab procedural NCDs and MAC LCDs for PCI and acute coronary syndromes
• Code is stable; descriptor and unit basis have not changed since assignment
• Next ASP update: July 1, 2026 for Q3 2026 (Q3 ASP file release scheduled per CMS quarterly schedule)

Patient assistance Verified May 2026

Bivalirudin is a generic acute-care drug administered in the cath lab or inpatient setting; there is no manufacturer copay or PAP program in the conventional sense.

• No manufacturer patient assistance program (PAP) for bivalirudin. The originator brand Angiomax (The Medicines Company / Sandoz) is discontinued, and the U.S. market is now served entirely by multiple generic manufacturers. Generic acute-care injectables typically have no PAP because the drug is administered in a facility under a facility / professional payment, not dispensed at retail or specialty pharmacy.
• No copay card. No commercial copay assistance program exists for J0583. Patient out-of-pocket exposure flows through the facility coinsurance and deductible for the PCI procedure, not a drug-specific copay.
• Hospital financial assistance. For uninsured or underinsured patients, hospital-based financial assistance / charity care programs (required by 501(r) for non-profit hospitals) are the primary patient-facing safety net for PCI-related costs that include bivalirudin's bundled cost.
• Foundations (cardiac). PAN Foundation, HealthWell Foundation, and the American Heart Association's patient programs maintain disease-state funds for cardiac conditions intermittently; verify open funds quarterly. These do not pay for bivalirudin as a drug line but may offset patient OOP for the PCI admission or follow-up.
• 340B for the hospital. Hospitals participating in 340B may purchase generic bivalirudin at 340B-discounted pricing for inpatient and outpatient use, affecting facility economics rather than patient OOP.

Common denials & how to fix them Reviewed May 2026

Most "denials" here are expected denials — the system correctly rejects the J0583 line because it is packaged or bundled. The fix is to stop submitting the line, not to chase the appeal.

Frequently asked questions

Can I bill J0583 separately during PCI?

No. For hospital outpatient PCI, HCPCS J0583 carries OPPS Status Indicator N (packaged) — drug cost is embedded in the APC payment for the PCI procedure and a separate J0583 line will be denied or zero-paid. For inpatient PCI, bivalirudin acquisition cost is bundled into the MS-DRG payment (typically MS-DRG 246–251 PCI DRGs); there is no separately payable Part B line. Bivalirudin used during PCI is functionally never separately payable.

What if bivalirudin is used outside PCI — pure HIT anticoagulation?

Very rare. The FDA-labeled bivalirudin indication is for PCI, including in patients with HIT or HITTS undergoing PCI. Use outside the PCI procedural window is off-label and uncommon — most non-procedural HIT anticoagulation uses argatroban. If bivalirudin is genuinely infused outside any bundled procedural or inpatient stay context (extremely unusual), Part B separate payment under J0583 may apply, but verify with the MAC and confirm no procedure or DRG bundling encompasses the infusion.

Bivalirudin vs Argatroban in HIT — which one and when?

Argatroban (J0883 non-ESRD / J0884 ESRD on dialysis) is the standard direct thrombin inhibitor for non-procedural HIT anticoagulation in the ICU and ward setting, titrated to aPTT. Bivalirudin (J0583) is the standard direct thrombin inhibitor for HIT or HITTS patients undergoing PCI, given as a weight-based bolus plus infusion during the cath lab procedure and titrated to ACT. The two are not interchangeable — argatroban for ICU HIT, bivalirudin for HIT patients needing PCI.

What is OPPS Status Indicator N?

Status Indicator N in the OPPS Addendum B identifies an item or service whose payment is packaged into the payment for another service. For J0583, SI=N means the drug cost is embedded in the APC payment for the PCI procedure to which it is associated. CMS does not pay separately for SI=N items — submitting a separate J0583 line will be processed but will not generate incremental payment, and most institutions suppress the line.

What about ASC PCI billing?

Limited PCI is performed in ambulatory surgical centers, but where it occurs the ASC payment system applies similar packaging logic — bivalirudin used as a procedural ancillary is packaged into the ASC facility payment for the covered procedure. Office-based cath labs are essentially nonexistent in current practice. The packaging conclusion holds across hospital outpatient, hospital inpatient, and ASC settings.

Does the ACT target affect billing?

No. The ACT target of 300–350 seconds during PCI is purely a clinical and titration parameter — there is no billing trigger or modifier tied to coagulation lab values. Document ACT timings and values in the cath lab record for clinical and audit purposes, but do not attempt to use ACT data points on the claim form.

Is there ANY separately payable scenario for J0583?

Only when bivalirudin is administered outside of any bundled procedural or inpatient stay context — for example, a hypothetical isolated outpatient continuous infusion in a Part B–billing physician office for non-procedural anticoagulation in a HIT patient. This is exceptionally rare in real practice. Verify the absence of an encompassing APC, DRG, or other bundle before billing J0583 as a separately payable Part B drug claim line, and expect MAC scrutiny.

What HCPCS code is bivalirudin billed under and what is the unit basis?

HCPCS J0583 — "Injection, bivalirudin, 1 mg." One milligram equals one billable unit. The code is a permanent CMS HCPCS Level II code and is used for the rare separately-payable scenarios; it is the same code used for ASP reporting even when the drug is bundled in the actual payment for the PCI procedure or admission.

What ICD-10 codes apply to bivalirudin use?

Indication-specific. PCI encounters are coded primarily by the cardiac diagnosis: I21.x for acute STEMI/NSTEMI, I20.0 for unstable angina, I25.x for chronic ischemic heart disease, and Z51.81 for encounter for therapeutic drug monitoring where applicable. For HIT-specific use add D75.82 (heparin-induced thrombocytopenia). The procedural ICD-10-PCS codes (027x for coronary artery dilation) drive the inpatient MS-DRG that absorbs bivalirudin cost.

Source documents

1. FDA — ANGIOMAX (bivalirudin) prescribing information (NDA 20-873)
   FDA-approved label; full prescribing information including PCI dosing, HIT/HITTS use, renal adjustment
2. DailyMed — Bivalirudin Injection [Fresenius Kabi] Prescribing Information
   Representative current generic label (Fresenius Kabi, revised September 15, 2025); all bivalirudin labels on DailyMed (Sandoz, Hospira, Mylan, Accord, Meitheal, etc.)
3. CMS — OPPS Addendum B (current quarter)
   Status Indicator assignments by HCPCS code; J0583 = SI=N (packaged)
4. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026; J0583 ASP for the rare separately-payable scenarios
5. CMS — MS-DRG Classifications and Software (FY2026)
   MS-DRG 246–251 PCI DRGs and 280–285 AMI DRGs; basis for inpatient bundling
6. ACC/AHA/SCAI — 2021 Guideline for Coronary Artery Revascularization
   Procedural anticoagulation guidance including bivalirudin during PCI
7. ACC/AHA — STEMI and NSTE-ACS guidelines
   Procedural anticoagulation in primary PCI for acute MI
8. CHEST — Antithrombotic Therapy / HIT guidelines
   Direct thrombin inhibitor selection for HIT and HITTS (argatroban vs bivalirudin)
9. CMS — HCPCS Level II Quarterly Updates
10. FDA National Drug Code Directory
11. CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)
    Single-dose container waste-reporting policy — rarely engaged for bivalirudin due to packaging/bundling

Refresh cadence

Change log

• May 23, 2026 — SME audit pass: real DailyMed setid linked (Fresenius Kabi, revised September 15, 2025), reviewer block updated. HCPCS J0583, OPPS SI=N packaging, DRG bundling, and ACT-titrated PCI dosing pattern all verified. No factual corrections required.
• May 22, 2026 — Initial publication. ASP data: Q2 2026. OPPS SI=N (packaged) and MS-DRG 246–251 bundling documented per Wave 7D HIT-format research memo. Page authored as defensive billing reference per Wave 7D template adaptation for OPPS SI=N / DRG-bundled drugs.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. OPPS Status Indicator assignment is read directly from the current OPPS Addendum B. MS-DRG list is read from the IPPS final rule for the current fiscal year. Indication list and dosing are verified against the current FDA label revision and current generic-product labels. We do not paraphrase from billing-software vendor blogs.

About this page

We maintain this page as a living defensive-billing reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. OPPS Status Indicator assignment and MS-DRG list are reviewed each cycle. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.