Baudax Bio Secures Permanent J-Code (J1738) for ANJESO from Centers for Medicare and Medicaid Services

Effective October 1, 2020, New Code Expected to Expand Reimbursement

MALVERN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Centers for Medicare and Medicaid Services (CMS) established a new permanent J-code for ANJESO (meloxicam) injection facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. The code, J1738 (Injection, meloxicam, 1 mg), published online on the CMS website at https://www.cms.gov/files/document/2020-hcpcs-application-summary-quar ... (page 25) will take effect on October 1, 2020 and it is expected to replace the previously issued C-code.

“We are very pleased that ANJESO will have its own product-specific J-code beginning on October 1, 2020,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “This J-code brings us one step closer to ensuring greater patient access to non-opioid alternatives by providing outpatient providers and physician offices with a uniform code and clearer reimbursement pathway when administering ANJESO and further supports our efforts during our ongoing launch.”

J codes are routine reimbursement codes assigned to outpatient and physician administered “buy and bill” products under Medicare Part B. With the J-code taking effect in October, all hospital outpatient departments, ambulatory surgery centers and physician offices in the United States will have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of ANJESO insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans.

CMS announced the new J-code for ANJESO in July, allowing time for Medicare Administrative Contractors as well as Medicare Advantage plans and commercial payers to program the new code into their systems in advance of the October 1, 2020 effective date. 

About ANJESO

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal is a registered trademark of Alkermes Pharma Ireland Limited (APIL).