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Venture Medical Position on CMS and MAC Skin Substitute Proposals
Venture Medical, LCC is sharing our position on the CY2026 Medicare Physician Fee Schedule and our future recommendations.
MISSOULA, MT / ACCESS Newswire / August 3, 2025 / The proposed changes to skin substitute reimbursement and coverage in the CY2026 Medicare Physician Fee Schedule (PFS) and Future Effective Local Coverage Determinations (LCDs) are unprecedented and have sparked alarm across the advanced wound care community-particularly among mobile and office-based providers. These proposals, while nominally aimed at consistency and cost control, are based on flawed assumptions and methodologies that will result in reduced access, disrupted clinical practice, and long-term harm to patients and innovation. At Venture Medical we have been working for many months to help chart a course from the current unsustainable system to one which is rational and workable for patients, providers, industry and CMS. As many of you are preparing your comments on these policies, we wanted to share a summary of the direction in which we think the wound care community should be pushing. If you would like to discuss further, please reach out to us.
Rescind the Future Effective LCDs
Originally designed to control cost-now redundant after CMS pricing product selection harms access, limits clinician choice, and stifles reliance on RCTs ignores the value of real-world evidence (RWE) and other valid harmful for wounds like VLUs, PUs and surgical wounds where RCTs are limited or update cycles span years-unworkable for a dynamic clinical field.
Recommendations for the Future:
Support Clinical FlexibilityProducts billed "incident to" clinician services should be selected by the clinician like other incident-to are best positioned to select appropriate products based on evidence, experience, and patient new products from the market discourages new product innovation and restricts accessIncentivize evidence development with enhanced payments 8-application cap is not evidence-based and should also be for a National, Uniform LCD FrameworkEstablish consistent rules and documentation standards across all wound regional disparities and overly prescriptive policies-maximize clinical flexibility for ASP Model with a Higher Fixed-Fee RateASP-based pricing is highly variable ($7-$13,117/cm²), unpredictable, and misaligned with clinical reimbursement creates artificial hierarchies not tied to comparative model for 2026: single flat fee (e.g., $600-$1000/cm²) based on economic modelingFix Reimbursement RatesCMS used only HOPD data-other sites of care must be included in rate modeling supports a base rate of $550-$711/cm².Raise non-facility physician application fees to >$500 for equity across care settingsModerate overzealous audit activitySupport Innovation with Evidence-Based EnhancementsEstablish favorable payment enhancements for products which can demonstrate high comparative effectiveness via RCT or RWE - similar to pass-through conceptPush for birth tissue product legislation tied to 2025 Health Services biologics pathway for future tissue products.
SOURCE: Venture Medical LLC
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