`J0583` Bivalirudin

Injection, bivalirudin, 1 mg

Medicare coverage: Carrier judgment
Status: active (October 2026 file)

Medically Unlikely Edits (effective October 1, 2026)

Practitioner: max 250 units per day (clinical), rationale: Clinical: Data
Outpatient hospital: max 1250 units per day (clinical), rationale: Clinical: Data
DME supplier: max 0 units per day (clinical), rationale: CMS Policy

Medicare pricing for J0583

Medicare Part B drug payment limit (ASP, October 2026)

J0583 payment limit: $0.165 per 1 MG, effective October 1, 2026 through December 31, 2026, based on 2Q26 ASP data. Coinsurance 20%.

NDCs that bill under J0583 (CMS ASP NDC-HCPCS crosswalk, October 2026)

16729-0275-67 Bivalirudin, Accord Healthcare Inc: 2500 billing units per package (10 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE)
83634-0400-10 Bivalirudin, Avenacy Inc.: 2500 billing units per package (10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE)
72572-0035-10 Bivalirudin, Civica, Inc.: 2500 billing units per package (10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE)
55111-0652-37 Bivalirudin, Dr. Reddy's Laboratories Inc.: 2500 billing units per package (10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION in 1 VIAL, SINGLE-DOSE)
55150-0210-10 Bivalirudin, Eugia US LLC: 2500 billing units per package (10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE)
63323-0562-10 Bivalirudin, FreseniUS Kabi USA, LLC: 2500 billing units per package (10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE)
63323-0562-15 Bivalirudin, FreseniUS Kabi USA, LLC: 2500 billing units per package (10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE)
71288-0427-11 Bivalirudin, Meitheal Pharmaceuticals Inc.: 2500 billing units per package (10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE)
71288-0427-92 Bivalirudin, Meitheal Pharmaceuticals Inc.: 2500 billing units per package (10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE)
67457-0256-10 Bivalirudin, Mylan Institutional LLC: 2500 billing units per package (10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE)
00781-3158-95 Bivalirudin, Sandoz Inc.: 2500 billing units per package (10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE)
00781-9158-95 Bivalirudin, Sandoz Inc.: 2500 billing units per package
70436-0025-82 Bivalirudin, Slate Run Pharmaceuticals: 2500 billing units per package (10 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON)

Physician Fee Schedule (CY 2026, RVU26D)

Status E: excluded from the PFS by regulation.

Payer policies and prior authorization for J0583

1 of 1 payer prior-auth lists that name J0583 require prior authorization or set conditions: Rocky Mountain Health Plans.

Payer	Plan	State	Prior auth	Conditions	Since	Source
Rocky Mountain Health Plans	Rocky Mountain Medicare Advantage D-SNP	CO	prior auth required		Feb 1, 2025	Rocky Mountain Health Plans Medicare Advantage Dual-Special Needs Plans – prior authorization Effective February 1, 2025

Payer coverage policies that name J0583

J0583 appears in 1 coverage policy from Aetna.

Payer	Policy	Role in policy	Reviewed	Document
Aetna	Injectable Medications (0020)	listed, no stance (range J0278-J2543)	Mar 5, 2026	payer document

Recent prior-auth changes

Apr 1, 2025: PA removed, UnitedHealthcare
Mar 1, 2025: PA added, UnitedHealthcare
Jan 1, 2025: PA removed, UnitedHealthcare

Medicaid fee-for-service

AZ: $0.17 (outpatient_hospital), effective Jul 1, 2026
IL: $31.00 (practitioner), effective Apr 1, 2026
IN: $0.13 (professional, Advanced Practice Nurse (85%), non-facility), effective Jul 1, 2025
KS: $0.17 (default), effective Jul 1, 2026
KY: $0.00 (asc), effective Jan 1, 2026
NE: $0.16 (injectables), effective Jul 1, 2026
OH: $0.12 (provider_administered_drugs), effective Jul 1, 2026
OK: $0.17 (physician, non-facility), effective Jul 1, 2026
TX: $0.16 (nurse_practitioner_clinical_nurse_specialist, Nurse Practitioner/Clinical Nurse Specialist, non-facility), effective Sep 1, 2026
VA: $0.16 (medical), effective Jul 1, 2026
VT: $0.00 (outpatient_hospital_opps), effective Feb 1, 2026
WA: $0.17 (professional_administered_drugs), effective Jul 1, 2026
WY: $0.00 (outpatient_hospital_apc, Children's Hospitals), effective Apr 1, 2026

From payers' published prior-auth lists, coverage policies and state Medicaid fee schedules, updated Oct 16, 2026. The role is what the policy's own code table or text says about the code. Not a guarantee of coverage or payment; verify with the payer. CPT® is a registered trademark of the American Medical Association.

J0583 Bivalirudin