Heron Therapeutics Inc (NASDAQ: HRTX) has received approval from Medicare and Medicaid Services (CMS) for a ZYNRELEF transitional pass-through status. The company will establish this for about three years from April 1. This move means that ZYNRELEF, a local anesthetic, is the only one that has a different compensation in the outpatient market.
ZYNRELEF will receive reimbursement for the HOPD and ASC spaces
CMS usually gives this status to some new innovative biological products, drugs, and medical devices. As per Medicare, drugs that healthcare providers give in the Ambulatory Surgical Center and Hospital Outpatient Department (HOPD) could receive a pass-through designation.
The pass-through title means that ZYNRELEF will receive separate reimbursement from Medicare at a +6% ASP (Average Sale Price) for ASC (Ambulatory Surgical Center) and HOPD setting.
From January 1, the drug has had a +6% reimbursement in ASC settings as per the regulations. This change is because of new policies in Medicare regarding payment for biologics and non-opioid-based drugs for pain management.
Moreover, reports indicate that procedures utilizing ZYNRELEF are about 72% in outpatient settings. These findings were reported in 2021 and accounted for 13% in ASC and 59% in HOPD settings.
According to Heron Therapeutics’ CEO and Chairman, Barry Quart, this is a crucial milestone as its main competitor doesn’t receive reimbursement from this status. He also points out that most of it is utilized in HOPD settings.
The move will benefit patients who have undergone surgery
Quart adds that the pass-through designation will help patients searching for therapies to alleviate postoperative pain by improving their access to ZYNRELEF, as healthcare institutions now have fair reimbursement.
The FDA has approved the use of ZYNRELEF in adults. Physicians use it for periarticular and soft tissue installation to give patients pain relief for 72 hours following surgical procedures on the abdomen, ankle, and foot.
However, manufacturers warn patients that the compound has NSAIDs. For this reason, it could increase the likelihood of tears, ulcers, and gastrointestinal bleeding. It can also raise a heart attack likelihood and thus death. This side effect is in relation to the duration and amount of ZYNRELEF a patient takes. In addition, surgeons can not use it for heart bypass surgery.
