— Product-specific C-code for ambulatory surgical center procedures and D-code for dental
procedures to take effect January 1, 2019 —
— Important reimbursement milestone that will expand patient access to non-opioid strategies
for postsurgical pain —
PARSIPPANY, N.J., Nov. 02, 2018 (GLOBE NEWSWIRE) — Pacira Pharmaceuticals, Inc. (NSDQ: PCRX) today announced that the Centers for Medicare and Medicaid Services (CMS) has finalized a policy to provide separate Medicare reimbursement for EXPAREL® (bupivacaine liposome injectable suspension) when administered in ambulatory surgical centers (ASCs) through establishment of the product-specific billing code of C9290. This code, which will provide payment for EXPAREL at average sales price (ASP) + 6%, sets national Medicare reimbursement rates for EXPAREL administered in ASCs. In addition, the American Dental Association has established a separate D-code (D9613) to reimburse for EXPAREL infiltration in oral surgery procedures. Both codes become effective on January 1, 2019.
“We are pleased to receive separate reimbursement from Medicare in the ASC, and also to receive the unique D-code for EXPAREL from the ADA. We believe these developments will significantly simplify the reimbursement process for clinicians and facilities utilizing the product, thus improving patient access and accelerating the transition of certain procedures to the ambulatory surgical center setting,” said Dave Stack, Chairman and Chief Executive Officer of Pacira. “We expect the reinstatement of C9290—the original C-code for EXPAREL, which is still utilized by some commercial payers— to facilitate a more efficient rollout among commercial payers as they standardize around Medicare rates and practices. Further, we believe the D-code will meaningfully enhance the use of EXPAREL in oral surgery procedures, where young adult patients are often exposed to an opioid for the first time.”
Healthcare providers and suppliers use the Healthcare Common Procedure Coding System (HCPCS) code set to identify items and services on claims submitted to Medicare and other payors. HCPCS codes, such as the unique C code describing EXPAREL (C9290, injection, bupivacaine liposome) are used to report drugs, biologicals, and devices used in hospitals and ambulatory surgical settings.
EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. It has been used in over 4 million patients across the United States to date.
About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company dedicated to advancing and improving postsurgical outcomes for acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL. Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesias. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
Forward Looking Statements
Any statements in this press release about the company’s future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of the company’s sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL and the company’s other products; the size and growth of the potential markets for EXPAREL and the company’s ability to serve those markets; the company’s plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; the company’s plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical trials in support of an existing or potential DepoFoam-based product; the company’s commercialization and marketing capabilities; the company’s and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the “Risk Factors” of the company’s most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
CONTACT: Company Contacts: Pacira Investor Contact: Susan Mesco (973) 451-4030 [email protected] Pacira Media Contact: Coyne Public Relations Alyssa Schneider (973) 588-2270 [email protected]
