PRAXBIND Can Be Ordered Through These Approved Distributors

Supply Information

  • Each order consists of a carton containing two 2.5 g/50 mL vials (1 complete dose)
  • NDC number 0597-0197-05

New Technology
Add-On Payment (NTAP)
Status is Available

PRAXBIND was granted NTAP status beginning on October 1, 2016, effective until September 30, 2018.

Hospitals may be granted an additional reimbursement of up to $1,750 by the CMS when PRAXBIND exceeds the Medicare Severity Diagnosis-Related Groups (MS-DRG) payment amount.

Summary of Codes

Code Type Inpatient
Setting
Outpatient Setting
Procedure ICD-10-PCS codes:
  • [XW04331]: Introduction of Idarucizumab, Dabigatran Reversal Agent into Central Vein, Percutaneous Approach, New Technology Group 1
  • [XW03331]: Introduction of Idarucizumab, Dabigatran Reversal Agent into Peripheral Vein, Percutaneous Approach, New Technology Group 1
Appropriate CPT codes for the drug administration:
  • [96375] or [96374], if infusion lasts <15 min
  • [96365] if infusion lasts >15 min
HCPCS HCPCS codes are not typically used in this setting
  • [J3490]: Unclassified drugs
  • [J3590]: Unclassified biologics (non-Medicare)
  • [C9399]: Unclassified drugs or biologics (Medicare only)
Revenue [025X]: Drugs and Biologics (to identify PRAXBIND)
  • [025X]: Drugs and Biologics (to identify PRAXBIND)
  • [0636]: Drugs Requiring Detailed Coding
Diagnosis Appropriate ICD-10 code Appropriate ICD-10 code

Additional Considerations Based on Hospital Setting

Inpatient

The payment amount will be based on the hospital's costs for the inpatient stay, not on the dosage of PRAXBIND administered.

  • The additional payment is capped at $1,750 per inpatient stay. See calculation below >
  • For eligibility, hospitals must bill using the appropriate ICD-10 procedure code. See codes >
  • Hospitals should report their charges for PRAXBIND using revenue code series [025X] (General Pharmacy) on inpatient claims

The charges reported by hospitals will affect the total costs of an inpatient stay, which Medicare uses to calculate NTAPs for eligible cases; therefore, it is important for hospitals to report charges for PRAXBIND at appropriate levels and report these charges whenever PRAXBIND is used.

Calculating NTAP for PRAXBIND

When applicable, the additional payment will be calculated case by case. NTAP reimbursements for inpatient stays shall be limited to the lesser of:

50% of the average NTAP cost, as calculated by the CMS ($1,750 for PRAXBIND)
OR
50% of the hospital's costs in excess of the applicable MS-DRG payment for the case*
=
NTAP reimbursement calculated on a case-by-case basis, and capped at $1,750

*If the costs of a given case do not exceed the hospital's MS-DRG payment, additional payment for PRAXBIND will not be provided.

Outpatient

In order to receive separate payment for PRAXBIND within the outpatient setting, hospitals may bill using the below:

  • C-codes: Used only on Medicare hospital outpatient and ambulatory surgical center (ASC) claims
  • Miscellaneous J-code: May be required by most non-Medicare payers
  • Revenue code: Requirements may vary in the hospital outpatient setting
  • CPT code: Used for PRAXBIND administration procedure depending on the length of the infusion

Hospital billing codes

See reference table

INDICATIONS AND USAGE FOR PRAXBIND

Praxbind® (idarucizumab) is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:

  • For emergency surgery/urgent procedures
  • In life-threatening or uncontrolled bleeding

IMPORTANT SAFETY INFORMATION FOR PRAXBIND

WARNINGS AND PRECAUTIONS

Thromboembolic Risk

  • Dabigatran-treated patients have underlying diseases predisposing them to thromboembolic events. Reversing dabigatran therapy exposes patients to thrombotic risk. Consider resumption of anticoagulant therapy as soon as medically appropriate.

Re-elevation of Coagulation Parameters

  • Elevated coagulation parameters (eg, activated partial thromboplastin time or ecarin clotting time) have been observed in a limited number of PRAXBIND-treated patients. If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed, or if patients requiring a second emergency surgery/urgent procedure have elevated coagulation parameters, an additional full dose may be considered.

Hypersensitivity Reactions

  • There is insufficient clinical experience evaluating risk of hypersensitivity to idarucizumab, but a possible relationship could not be excluded. Risk of hypersensitivity (eg, anaphylactoid reaction) to idarucizumab or excipients needs to be weighed cautiously against the potential benefit. If serious allergic reaction occurs, immediately discontinue PRAXBIND and institute appropriate treatment.

Risk in Patients With Hereditary Fructose Intolerance

  • PRAXBIND contains 4 g sorbitol as an excipient. When prescribing PRAXBIND in patients with hereditary fructose intolerance, consider the total daily amount of sorbitol/fructose consumption from all sources, as serious adverse reactions (eg, hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure, and death) may occur.

ADVERSE REACTIONS

  • The most frequently reported adverse reaction in ≥5% of idarucizumab-treated healthy volunteers was headache (5%). The most frequently reported adverse reactions in ≥5% of patients were constipation (7%) and nausea (5%).
  • Treatment-emergent antibodies with low titers were observed in 4% of healthy subjects and 2% of patients treated with idarucizumab.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation

  • PRAXBIND should be given to a pregnant woman only if clearly needed. Caution should be exercised when PRAXBIND is administered to a nursing woman.

CL-PB-100001 April 2018

Please click here for full Prescribing Information for PRAXBIND.