Pacira BioSciences Receives CMS Approval for Exparel J-Code

With the NOPAIN Act mandate to go into effect at the beginning of next year, Pacira BioSciences recently announced that CMS granted a new product specific Healthcare Common Procedure Coding System J-Code for Exparel (bupivacaine liposome injectable suspension). Should Exparel be administered in an office setting or for office-based surgeries, the J-Code enables separate reimbursement.

J-codes are specific codes for reimbursing Medicare Part B drugs, such as Exparel, by commercial insurance plans, Medicare, Medicare Advantage, and other government payers. These codes standardize the process of submitting claims and receiving payment, making billing and reimbursement more efficient. Additionally, some commercial insurers mandate the use of a J-code for payment.

Exparel is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia in adults. Bupivacaine is delivered via multivesicular liposomes. The liposomal vehicle delivers medication over a desired time period, and this local anesthetic that can be used in the peri- or postsurgical setting.

Set to begin Jan. 1, 2025, the NOPAIN Act mandates that Medicare cover a range of non-opioid pain management treatments, with specific provisions designed to enhance reimbursement for these therapies. Also known as Non-Opioids Prevent Addiction in the Nation Act, it is a legislative measure aimed at reducing reliance on opioids for pain management among Medicare beneficiaries. By expanding access to non-opioid treatments, the act seeks to combat the growing epidemic of opioid use disorder (OUD), which has led to substantial healthcare costs and serious health risks for seniors.

The current state of reimbursement for hospital outpatient departments and ambulatory surgery centers is based on a set amount of money or payment rate, otherwise known as bundled payment rates. The bundled rate is calculated to cover all drugs and services used to complete a procedure. Using lower-cost therapies such as opioids for acute and surgical pain management can improve margins for hospitals and health systems receiving these bundled payments.

Higher-cost agents are typically disincentivized with the current bundled rate agreements, but when these agents are associated with a code that grants separate payment, their use is expected to increase.

This initiative is particularly crucial for patients recovering from outpatient surgical procedures, as it encourages the use of alternative pain management options that are less likely to lead to addiction or misuse. The act highlights the necessity of providing seniors with safer pain relief options, ultimately aiming to reduce the estimated $33 billion annual expenditure on OUD-related healthcare costs among Medicare beneficiaries.

The act does specify a variety of non-opioid treatments that will be reimbursed, thereby promoting their use in managing pain without the risks associated with opioids. Key treatments include Exparel, Omidria, Dextenza, Ketorolac tromethamine injection, Xaracoll, Zynrelef and On-Q Pump.

By prioritizing non-opioid alternatives, the act not only addresses the immediate concerns associated with opioid prescriptions but also fosters a broader cultural change toward safer, evidence-based pain management strategies.

As Medicare begins to implement these changes in January 2025, beneficiaries can expect increased access to non-opioid treatments, potentially leading to better health outcomes and reduced incidence of opioid-related complications.