Celularity Receives Healthcare Common Procedure Coding System (HCPCS) Q Code Approval from the U.S. Centers for Medicare & Medicaid Services for Biovance® 3L
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Insights
The assignment of a HCPCS Q code to Celularity's Biovance® 3L by the Centers for Medicare & Medicaid Services (CMS) is a significant development for the company. This coding facilitates billing and reimbursement processes for healthcare providers, potentially increasing the product's adoption in office settings for wound care treatment. From an economic standpoint, the ease of reimbursement is a key factor in a product's market penetration. With the Q code in place, physicians are more likely to use Biovance® 3L, given the streamlined pathway to cover their costs.
Furthermore, for Celularity, this could lead to an increase in sales volume, as ease of access often correlates with higher product demand. However, the financial impact will depend on the adoption rate among physicians and the reimbursement level set by CMS. The long-term benefits for Celularity hinge on the product's clinical outcomes and cost-effectiveness compared to alternative treatments. If Biovance® 3L demonstrates superior results, it could become a standard in wound care, substantially impacting Celularity's market share and financial performance.
The approval of a HCPCS Q code for a regenerative medicine product such as Biovance® 3L is indicative of its clinical significance and potential benefits in wound healing. As a tri-layer allograft derived from placental tissue, Biovance® 3L is designed to act as a scaffold that promotes tissue restoration in various types of wounds. The effectiveness of such advanced biomaterial products is often scrutinized through clinical trials and real-world outcomes. Positive patient outcomes can lead to increased trust and usage within the medical community.
It's important to note that while the Q code is a positive regulatory milestone, the actual impact on patient care and Celularity's business will be measured by the product's efficacy and cost-benefit ratio in comparison to existing wound care treatments. Superior clinical results can lead to a paradigm shift in wound management, potentially making Biovance® 3L a preferred treatment option.
Understanding the market dynamics for wound care products is essential when assessing the potential business impact of CMS's HCPCS Q code assignment for Biovance® 3L. The wound care market is highly competitive, with numerous products vying for market share. The introduction of a new reimbursement code can serve as a differentiator, making Biovance® 3L more appealing to healthcare providers.
Market adoption is influenced by factors such as product awareness, clinical evidence and reimbursement policies. Celularity's ability to effectively communicate the benefits of Biovance® 3L and navigate the reimbursement landscape will be critical in capturing market share. Successful market penetration could result in increased revenue and a stronger position within the wound care segment. Conversely, if the product does not live up to expectations or if competitors launch superior alternatives, the anticipated growth could be stifled.
Nationally Established Q Code Will Further Support the Use of Biovance® 3L by Physicians to Treat Wound Care Patients in Office Settings
FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) Q code for Biovance® 3L, a tri-layer allograft derived from placental tissue intended for use as a biological membrane covering barrier or wrap that acts as a scaffold for restoration of functional tissue in partial- and full-thickness, acute and chronic wounds. The designated HCPCS Q code is Q4283 and is available starting April 1, 2024.
"The HCPCS Q code approval by CMS further recognizes Biovance® 3L as an important therapeutic option for the treatment of wounds,” said Dr. Robert J. Hariri, M.D., Ph.D., Celularity CEO, chairman and founder. “The medical community has been rapidly adopting this product, and the HCPCS Q code approval paves the way for Biovance® 3L to realize additional growth, enabling the potential to impact more lives. As one of our leading biomaterial products, we are excited about the potential impact this approval may have on Celularity’s performance throughout the remainder of 2024 and beyond. We will continue to innovate in this important part of our business and look forward to providing future updates.”
The Healthcare Common Procedure Coding System (HCPCS) is produced by the Centers for Medicare and Medicaid Services (CMS). HCPCS is a group of standardized codes that represent medical procedures, supplies, products, and services. The codes are used to facilitate the processing of health insurance claims by Medicare and other insurers. The Q codes are established to identify drugs, biologicals, and medical equipment or services not identified by national HCPCS Level II codes but for which codes are needed for Medicare claims processing. HCPCS code modifiers are established internally by CMS to facilitate accurate Medicare claims processing.
Biovance 3L’s unique tri-layer membrane construction is designed for improved handling and ease of use as a covering, barrier, or wrap to surgical sites. The three-dimensional design provides more surface area, allows for suturing as required, and serves as a cell-friendly structure that promotes cell attachment within hours.
About Celularity
Celularity Inc. (NASDAQ: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity believes that, by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of The U.S. Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include , without limitation, the ability of physicians to utilize Biovance® 3L for the treatment of wound care patients in office settings, the timing for reimbursement to commence, the effectiveness of Biovance® 3L as a treatment option for wounds, the impact of Biovance® 3L on patient lives, the adoption of Biovance® 3L by the medical community, the ability of Celularity to meet physician demand and its impact on Celularity’s performance throughout the remainder of 2024 and beyond, and Celularity’s ability to innovate its biomaterials business, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: Celularity’s liquidity situation; the volatility in Celularity’s stock price; inherent risks in biotechnological development, including with respect to the development of novel biomaterial therapies; ; along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Investor Contact:
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
Media Contacts:
Ali Nagy / Michaela Fawcett
KCSA Strategic Communications
anagy@kcsa.com / mfawcett@kcsa.com
FAQ
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