Medicare and Medicaid Propose New EXPAREL Reimbursement for Outpatient Surgery from Jan 1, 2025

Pacira BioSciences, Inc., a leader in non-opioid pain management and regenerative health, has announced that the Centers for Medicare and Medicaid Services (CMS) issued its proposed rule for the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for 2025. This rule includes provisions for Medicare reimbursement for non-opioid pain management, which could significantly impact treatment options in both hospital outpatient (HOPD) and ambulatory surgical center (ASC) settings starting January 1, 2025.

The proposed rule is set to implement the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, a legislation passed as part of the Consolidated Appropriations Act of 2023. The NOPAIN Act mandates separate CMS payments for qualifying non-opioid drugs and devices used in HOPD and ASC settings. Among the drugs covered under the proposed rule is EXPAREL® (bupivacaine liposome injectable suspension), which is one of six non-opioid medications eligible for separate Medicare reimbursement.

Frank D. Lee, Chief Executive Officer of Pacira, expressed satisfaction with the inclusion of EXPAREL in the proposed rule. He emphasized that this decision comes after years of advocacy for policy reforms aimed at increasing patient and provider access to non-opioid treatments. Mr. Lee highlighted that EXPAREL is the only single-dose product approved for both local and regional analgesia across various surgical procedures, which could greatly benefit clinicians aiming for long-lasting pain control in outpatient settings upon finalization of the rule.

Under the proposed rule, Medicare payment rates for covered non-opioid drugs in HOPD and ASC environments will be set at the average sales price (ASP) plus 6%. The proposed separate CMS payment rates for the six non-opioid drugs are detailed as follows:
- EXPAREL: $1.41 per billing unit
- Zynrelef: $0.73 per billing unit
- Xaracoll: $0.85 per billing unit
- Ketorolac tromethamine injection: $0.70 per billing unit
- Dextenza: $117.01 per billing unit
- Omidria: $97.12 per billing unit

It is important to note that these payment rates are subject to change and may be updated in the final rule later this year.

EXPAREL is approved for use in producing postsurgical local analgesia in patients aged six years and older through wound infiltration. It is also approved for regional analgesia in adults via an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa, and an adductor canal block. However, its safety and efficacy have not been established for use in other nerve blocks. To date, EXPAREL has been utilized in over 14 million patients across the United States.

Pacira BioSciences is dedicated to expanding non-opioid options for pain management and addressing conditions related to the sympathetic nervous system, such as cardiac electrical storm, chronic pain, and spasticity. Alongside EXPAREL, the company offers two other commercial-stage non-opioid treatments: ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis knee pain and ioveraº®, a handheld device for drug-free pain control through cold temperature application to targeted nerves.

Pacira BioSciences remains committed to redefining the role of opioids in pain management by providing effective non-opioid alternatives. This proposed rule by CMS marks a significant step toward achieving that goal, potentially expanding the use of non-opioid pain treatments in various medical settings.