Shares in San Diego-based Heron Therapeutics, Inc. (NASDAQ: HRTX) were slightly lower Friday, as the commercial-stage biotechnology company announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through status for ZYNRELEF (bupivacaine and meloxicam) extended-release solution, which will be established for three years beginning on April 1, for separate reimbursement outside of the surgical bundle payment in the Hospital Outpatient Department (HOPD) setting of care. This CMS approval makes ZYNRELEF the only local anesthetic with separate reimbursement in the hospital outpatient market.
CMS grants pass-through status to certain new and innovative medical devices, drugs, and biological products. Drugs that are administered in the HOPD and Ambulatory Surgical Center (ASC) settings can have pass-through and be reimbursed accordingly by Medicare. By having pass-through status, ZYNRELEF will be separately reimbursed by Medicare at Average Sales Price (ASP) +6% in both the HOPD and ASC settings of care.
In the ASC setting, since January 1, 2022, ZYNRELEF, under C-code C9088, has been reimbursed at ASP+6% due to recent changes in Medicare non-opioid pain management drugs and biologicals payment policies. Based on third party claims data, 72% of ZYNRELEF indicated procedures were performed in the outpatient settings in 2021, with 59% in the HOPD market and 13% in the ASC setting of care.
ZYNRELEF is approved by the U.S. Food and Drug Administration (FDA) for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.
HRTX shares lost eight cents, or 1.4%, to $5.58.