Coding, coverage, and reimbursement

Payers typically reimburse hospitals for use of DALVANCE in the outpatient setting

DALVANCE is generally eligible for separate payment by Original Medicare, fee-for-service Medicaid, and most commercial health insurance plans when administered in the Emergency Department (ED), or an outpatient setting of care.

Outpatient IV treatment can be administered in6:

  • ED/observation unit
  • Hospital-affiliated infusion centers
  • Freestanding infusion centers
  • Physician offices

A new permanent J-code has been issued for DALVANCE

Code

J0875

Description:
Injection, dalbavancin, 5 mg

Billing Units:
Reported as 100 units for a single-use vial

NDC Number: 57970-100-01

Permanent J-codes may help facilitate payment and simplify claims documentation and processing.

The permanent J-code will replace Miscellaneous J-codes (J3490 or J3590) and C-9443 that have been used to bill for DALVANCE prior to 2016.

Reimbursement Tools

Frequently Asked Reimbursement Questions

Guide to the most frequently asked questions about ED and outpatient coverage, prior authorization, and Medicare coverage.

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Reimbursement At-A-Glance

Reference guide to coverage, coding, and payment for DALVANCE by setting of care and payor.

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Co-pay Assistance Program

Details on the DALVANCE CONNECTS Co-pay Assistance Program.

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Coding and Billing Reference Guide

Step-by-step coding and billing reference guide for DALVANCE using J and C codes.

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DALVANCE CONNECTS℠ and Patient Assistance Program Enrollment Form

Form designed for enrollment in DALVANCE CONNECTS with Patient Assistance Program Form included.

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Please note, the above statements are not a guarantee of coverage or reimbursement. Always check with the patient’s insurer to determine unique coverage policy and billing requirements prior to rendering services.

Next: DALVANCE CONNECTS

Reimbursement Specialist

For assistance with the reimbursement process—prior authorizations, benefit verification, coverage, coding, and payment for DALVANCE—get help from a reimbursement specialist.

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INDICATION & USAGE

DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION
Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).

Use in Specific Populations

Please see Full Prescribing Information.

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IMPORTANT SAFETY INFORMATION
Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

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Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).

Use in Specific Populations
  • There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women. DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.
  • In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen of DALVANCE is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.
  • Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

Please see Full Prescribing Information.