CMS Assigns J-Code for the Antibiotic Kimyrsa

The Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-code (J2406) for Melinta Therapeutics’ Kimyrsa (oritavancin), a lipoglycopeptide antibiotic, effective October 1, 2021. This code allows the product to be reimbursed when dispensed in the outpatient setting. Kimyrsa is approved to treat acute bacterial skin and skin structure infections in a single, one-hour, 1,200 mg infusion. The FDA approved the therapy on March 12, 2021, for the treatment of adult patients with Gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA).

At the same time, CMS has granted transitional pass-through status for Kimyrsa in the hospital outpatient department setting. Pass-through status is intended to protect Medicare beneficiaries’ access to innovative drugs and ensures that Kimyrsa will be reimbursed at average sales price for three years. Drugs with pass-through status are not subject to the payment reduction applicable to drugs purchased through the 340B program.

Christine Ann Miller

“We intentionally designed Kimyrsa to provide patients with more flexibility and accessibility in acute bacterial skin and skin structure infection treatment. These achievements are one more significant step toward our vision that all patients who need our therapies will be able to receive them,” Christine Ann Miller, Melinta’s president and chief executive officer, said in a statement.

Bacterial skin and skin structure infections affect about 14 million patients in the United States each year.