CMS Issues 2026 OPPS/ASC Final Rule — Big Changes Ahead for Wound Care

On November 21, 2025, CMS released its final rule for the Calendar Year 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System (ASC).

This update affects nearly 4,000 hospitals and about 6,000 ASCs, modifying payment rates for outpatient and ASC services, adjusting quality-reporting programs, revising which procedures can be done outpatient vs inpatient, and (most relevant for wound care) changing how skin substitute products are reimbursed under Medicare.

For hospitals and ASCs that meet quality-reporting requirements, CMS increased OPPS and ASC base payment rates by 2.6% for 2026.

But arguably the biggest shift for wound-care providers is how skin substitutes will be handled.

What’s New for Skin Substitutes — What It Means for Wound Care

What CMS Changed

• Skin substitutes are no longer “packaged” into procedure payments. Until now, when a skin substitute was used in a wound application procedure (like for diabetic foot ulcers or venous leg ulcers), Medicare bundled the cost of the product with the cost of the procedure. That changes in 2026.

• Instead, CMS will pay for skin substitute products separately, recognizing them as supplies rather than just part of the procedure.

• CMS has established new payment categories (called APCs: Ambulatory Payment Classifications) for skin substitutes based on how the product is regulated by the Food and Drug Administration (FDA). That includes distinctions between 361 human-cell/tissue products (HCT/Ps), 510(k)-cleared devices, and PMA-approved devices.

• For 2026, all skin substitute categories will share a single flat payment rate. CMS set that rate at approximately $127.14 per cm² when used under OPPS/ASC.
  
  

What That Means

• If you are a clinician, hospital, or ASC using skin substitutes (for example, amniotic membranes, acellular dermal matrices, or extracellular matrix products) for wound care, these products will now be billed separately from the procedure to apply them. That means clearer, itemized billing and potentially more transparent cost tracking.

• The flat rate payment model (per cm²) means that reimbursement will be standardized, regardless of which skin substitute product you use (as long as it falls into one of the FDA-defined categories). This could simplify billing and make costs more predictable for providers and payers.

• Because all qualifying products get the same rate, there may be increased incentive for competition: providers and manufacturers may choose products based on clinical performance or value rather than price alone. CMS has explicitly said that this change is intended to encourage innovation and toward products with improved clinical evidence.

• For Medicare and payers, this may lead to substantial cost savings. The unbundling of skin substitutes, paying them separately rather than hiding them inside procedure payments, may reduce excessive utilization or overpricing, and improve oversight.
  
  

What Wound Care Providers Should Do Next

If you’re a clinician, wound-care center, or ASC:

• Review which of your wound-care products qualify as “skin substitutes” under the new CMS categories (361 HCT/P, 510(k), PMA).

• Update your coding and billing procedures to distinguish the product supply from the application procedure. Make sure to bill the skin substitute separately when required.

• Understand that reimbursement will likely be per cm², so accurate documentation of the wound size and amount of substitute applied becomes more critical.

• Evaluate product choice not only on cost, but on clinical effectiveness, patient outcomes, and long-term value, since the reimbursement is standard.

• Monitor any guidance published by CMS or your Medicare Administrative Contractor (MAC) for local implementation nuances or coding updates.
  
  

Why This Matters for Wound Care & Regenerative Medicine

This policy change reflects a broader shift in how payers view regenerative and advanced wound-care products: as distinct, valuable supplies — not just part of a procedure. By standardizing payment across product types, CMS is incentivizing innovation, transparency, and clinical value instead of pricing escalation.

For providers, this could mean simpler billing, predictable reimbursement, and a renewed focus on choosing wound-care products based on therapeutic benefit. For product developers and supply-oriented businesses (like your own), this could level the playing field and encourage development of effective, evidence-based solutions.

See also

CMS Finalizes Historic Payment Overhaul for Skin Substitutes: What You Need to Know for 2026
The $10 Billion Question: How CMS's New Skin Substitute Crackdown Will Reshape the Wound Care Industry
When to Use Skin Substitutes or Grafts for Non-Healing Wounds
Stem Cells, Exosomes, and Biologics: Do They Work in Wound Care?

More Information

For more information on the latest effective wound care, contact us to set up a time for a call.

Sources

1. Calendar Year 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Final Rule (CMS-1834-FC) https://www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center

2. Calendar Year (CY) 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2026-medicare-physician-fee-schedule-final-rule-cms-1832-f

3. CMS reclassifies certain skin substitutes and dramatically cuts payment under Medicare Part B https://healthindustrywashingtonwatch.com/post/102lvjz/cms-reclassifies-certain-skin-substitutes-and-dramatically-cuts-payment-under-med

4. CMS Proposes Major Reimbursement Shifts for Skin Substitutes and Outpatient Services in 2026 https://www.sharedhealthservices.com/post/cms-proposes-major-reimbursement-shifts-for-skin-substitutes-and-outpatient-services-in-2026

5. The wait is over: The CY 2026 OPPS final rule is finally here https://www.mcdermottplus.com/blog/regs-eggs/the-wait-is-over-the-cy-2026-opps-final-rule-is-finally-here/

6. CMS Releases CY 2026 Hospital OPPS and Ambulatory Surgical Center Final Rule https://www.hklaw.com/en/insights/publications/2025/11/cms-releases-cy-2026-hospital-opps-and-ambulatory-surgical-center

7. Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency https://www.federalregister.gov/documents/2025/07/17/2025-13360/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical

8. CY 2026 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule Summary https://www.hematology.org/advocacy/federal-rule-summaries/cy-2026-medicare-and-medicaid-programs-hospital-outpatient-prospective-payment

* This blog is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.