Billing and Reimbursement for KIMYRSA™ (oritavancin)

The Centers for Medicare & Medicaid Services (CMS) has issued a permanent product-specific J-code (J2406) with pass-through status for Kimyrsa Injection.

Permanent Product-Specific J Code Supports Billing and Reimbursement

Effective, October 1, 2021, Kimyrsa is covered under new code J2406 (Injection, oritavancin (kimyrsa), 10mg). This unique J-code recognizes the distinct value of KIMYRSA, simplifies billing and coding, and enables reimbursement for KIMYRSA in all outpatient treatment settings. 1

Pass-through Status Protects Access to KIMYRSA

Pass-through status is intended to protect Medicare beneficiaries’ access to innovative drugs, biologics, and medical devices in hospital outpatient departments (HOPDs). 2

Pass-through status ensures that KIMYRSA will be reimbursed at WAC+3%, regardless of any changes in Medicare payment for other drugs under the Hospital Outpatient Prospective Payment System (OPPS). 3* KIMYRSA is not subject to the ASP-22.5% payment reduction applied to drugs purchased through the 340B program. 4

KIMYRSA’s is protected under pass-through status through September 2024. 5

* WAC+3% reimbursement applies until ASP data is available

CMS=Centers for Medicare & Medicaid Services

“Wholesale Acquisition Cost” or WAC is a list price available to the wholesale class of trade and does not include discounts, rebates, or other price concessions.

 

Healthcare Common Procedure Coding System (HCPCS) Codes

 
The following are the drug codes for appropriate billing. Medicare, private payers, and state Medicaid programs require UB-04 (CMS-1450) claim forms (for Hospital Outpatient setting) or CMS-1500 (for Freestanding Infusion Center setting) to report the following codes and amount of product used to facilitate appropriate reimbursement.

 

The following are the billing units for KIMYRSA™ (oritavancin).

 

Accurate reporting of the KIMYRSA™ HCPCS code, as well as the quantity administered to each patient, is required for appropriate reimbursement. When completing a UB-04/ CMS 1450 or CMS 1500 form for KIMYRSA™, payers may also require the following information:

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Some payers may also require prescribing information, FDA-approval letter, support of medical necessity and a drug purchase invoice.

For additional information regarding coding and reimbursement, please:

Refer to the KIMYRSA Reimbursement Guide

Contact the KIMYRSA Support Program
1-844-KIMYRSA (1-844-546-9772)
Email: KIMYRSASupportProgram@labcorp.com
Monday-Friday 8:00 AM to 8:00 PM, ET

1. Centers for Medicare & Medicaid Services. CMS website. MLN Matters MM11814 Revised July 2020. Update of the Hospital Outpatient Prospective Payment System (OPPS). https://www.cms.gov/files/document/mm11814.pdf. Accessed August 19, 2021; Centers for Medicare & Medicaid Services. CMS website. MLN Matters MM11842 Revised July 2020. Update of the Ambulatory Surgical Center Prospective Payment System (ASC). https://www.cms.gov/files/document/mm11842.pdf. Accessed August 19, 2021.

2. H. Rep. No. 106-479, at 867 (1999); Social Security Act (SSA) § 1833(t)(6).

3. SSA § 1833(t)(6)(C(i), (D)(i)

4. 5 Fed. Reg. 85866, 85869 (Dec. 29, 2020)

5. SSA § 1833(t)(6)(c)(i)

Content provided for informational purposes only. This information does not guarantee coverage or payment. Codes, coverage, and payment may vary from setting to setting, and from insurer to insurer. The provider submitting a claim is solely responsible for the accuracy of the codes submitted and for compliance with all coverage and reimbursement policies.

Decisions to prescribe KIMYRSA™ are by providers working with their patients. The KIMYRSA™ Assistance Program provides information about KIMYRSA™ and about assistance that may be available to patients who meet certain criteria, including that they are not insured by a federal health care program. More information is available through the KIMYRSA™ Assistance Program.

Melinta Therapeutics, LLC, does not guarantee, and assumes no responsibility for the quality, availability, or scope of the KIMYRSA™ Assistance Program services. Melinta Therapeutics, LLC, reserves the right to rescind, revoke, or amend this offer at any time without notice. Void where prohibited by law.

*INDICATION AND USAGE

  • Both KIMYRSA and ORBACTIV® are oritavancin products that are indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of oritavancin and other antibacterial drugs, oritavancin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • KIMYRSATM and ORBACTIV® are not approved for combination use and have differences in dose strength, duration of infusion, and preparation instructions, including reconstitution and dilution instructions and compatible diluents. Please see the full Prescribing Information for each product.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for approximately 120 hours (5 days) after oritavancin administration.
  • Oritavancin products are contraindicated in patients with known hypersensitivity to oritavancin.

Warnings and Precautions

  • Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours. For patients who require aPTT monitoring within 120 hours of oritavancin dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.
  • Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products. Discontinue infusion if signs of acute hypersensitivity occur. Closely monitor patients with known hypersensitivity to glycopeptides.
  • Infusion related reactions: Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products, including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.
  • Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
  • Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT/INR for up to 12 hours. Patients should be monitored for bleeding if concomitantly receiving oritavancin products and warfarin.
  • Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.
  • Prescribing oritavancin products in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

  • The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in ≥2 patients receiving KIMYRSA were hypersensitivity, pruritus, chills and pyrexia.

Please see Full Prescribing Information for ORBACTIV®.

Please see Full Prescribing Information for KIMYRSA.

*INDICATION AND USAGE

Both KIMYRSA and ORBACTIV® are oritavancin products that are indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be

IMPORTANT SAFETY INFORMATION

ContraindicationsUse of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin