CMS Proposes New Payment Structure for Skin Substitutes, Regenerative Medicine Companies Welcome Reform
核心洞察
The Centers for Medicare & Medicaid Services (搜索) (CMS) has proposed a new per-square-centimeter payment methodology for skin substitutes (搜索) based on FDA classification under the CY 2026 Physician Fee Schedule.
Leading regenerative medicine companies Organogenesis and BioStem Technologies applaud the reform, believing it will curb abuse and reduce rapid escalation in Medicare spending while ensuring consistent payment across care sites.
The proposed changes recognize clinical differentiation of PMA products and aim to expand access to innovative wound healing technologies that have been proven to reduce life-threatening amputations (搜索).
The Centers for Medicare & Medicaid Services (搜索) (CMS) has unveiled a significant reform to skin substitute payment policies under the Calendar Year 2026 Physician Fee Schedule, introducing a per-square-centimeter payment methodology based on FDA classification that has garnered strong support from leading regenerative medicine companies.
Industry Leaders Welcome Payment Reform
Organogenesis Holdings Inc., a prominent regenerative medicine company, expressed strong approval for the proposed changes. Gary S. Gillheeney, Sr., President, CEO, and Chair of the Board for Organogenesis, stated: "We are pleased CMS is proposing a per centimeter square payment methodology based on FDA classification for skin substitutes (搜索) in both the physician office and hospital outpatient department settings."
The company believes the new payment structure will address significant issues in the current system. "We believe this new payment structure will curb abuse under the current system, and the resulting rapid escalation in Medicare spending, while ensuring a much-needed consistent payment approach across sites of care," Gillheeney explained.
Recognition of Clinical Value and Innovation
A key aspect of the proposed reform is its recognition of clinical differentiation among different product categories. CMS has acknowledged the distinct value of PMA (Premarket Approval) products, which represents a significant development for the industry.
"We are also pleased CMS has recognized the clinical differentiation of PMA products and has taken steps to expand access to these innovative wound healing technologies to ensure patients receive the most appropriate therapy, which have been proven to reduce life-threatening amputations (搜索) and complications," Gillheeney noted.
Stakeholder Engagement and Future Optimization
BioStem Technologies, another major player in the wound care space, has also voiced support for the reform initiative. Jason Matuszewski, CEO and Chairman of the Board of BioStem, emphasized the company's commitment to working with stakeholders during the implementation process.
"We continue to support reforming the reimbursement framework for skin substitutes (搜索), as addressing the rising Medicare spend in this category has long been a priority for CMS," Matuszewski said. "We look forward to working closely with CMS, providers and industry stakeholders during the 60-day comment period to optimize the methodology for skin substitute reimbursement, with a goal of achieving a solution that appropriately recognizes value across the healthcare system."
Investment in Clinical Evidence
The reform comes at a time when companies are actively investing in clinical research to demonstrate the value of their technologies. BioStem Technologies continues to advance its clinical development program, with Matuszewski noting: "We continue to invest in randomized controlled trials across multiple indications, and we believe BioStem will be better positioned to drive continued market adoption with reported data for our BioREtain (搜索)® technology."
The company expects to announce initial results from these trials later this year, which are designed to demonstrate the clinical superiority of their proprietary BioREtain (搜索)® technology.
Long-term Market Implications
Industry leaders view the proposed changes as promoting stability and growth in the wound care market. Organogenesis, with more than forty years of leadership in regenerative medicine and a diverse portfolio spanning multiple FDA categories, believes it is well-positioned for future growth in the evolving market landscape.
"We remain committed to working with CMS and other stakeholders to further refine the proposed policies to promote long-term stability and continue to expand access to PMA products that patients need and deserve, all while reducing the overall cost to Medicare," Gillheeney concluded.
The reform represents a significant shift toward value-based reimbursement in the wound care sector, with companies expressing optimism that the changes will ultimately benefit chronic wound care by promoting investment in innovation and improving outcomes for patients who depend on these treatments.