In July 2026, the Centers for Medicare and Medicaid published proposed rules for the calendar year (CY) 2027 with provisions that may be of interest to wound care programs and clinicians. CMS is collecting comments on the following proposed rules until August 31, 2026.
The Proposed Updates to the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs Year 2027 advances modest payment increases (2.4%), maintains separate reimbursement for skin substitutes and extends non-opioid payment incentives. If the rules are finalized, wound care and HBOT programs should prepare for continued emphasis on data reporting, compliance with quality measures, and potential operational benefits from increased rural and non-teaching hospitals reimbursement rates.
Key points relevant to wound care and hyperbaric oxygen therapy (HBOT) clinics are summarized below.
Overall Payment Updates
- Hospital Outpatient Prospective Payment System (OPPS) Update:
- CMS proposes a 2.4% increase in the outpatient departments fee schedule for CY 2027.
- This is derived from a 3.2% inpatient hospital market basket increase, reduced by a 0.8% productivity adjustment.
- Total OPPS payments are projected to reach $110.9 billion, approximately $9.5 billion higher than CY 2026.
- Proposed conversion factors:
- For CY 2027, the proposed OPPS conversion factor is $102.004.
- Additional related conversion factors include:
- Reduced OPPS conversion factor for hospitals subject to the 340B remedy offset: $102.004 × 0.9707 = $99.015.
- Reduced OPPS conversion factor for hospitals failing to meet Hospital OQR Program requirements: $102.004 × 0.9805 = $100.015.
- Projected Facility Impact:
- Urban hospitals: Estimated 1.9% increase in payments.
- Rural hospitals: Estimated 6.4% increase in payments.
- Teaching status:
- Non-teaching hospitals are expected to see a 6.4% increase,
- Major teaching hospitals may experience a 2.4% decrease.
- Ownership:
- Proprietary hospitals are projected to see a 10.6% increase,
- Voluntary hospitals a 2.0% increase,
- Government-owned hospitals a 0.8% decrease.
Proposed Provisions Relevant to Wound Care
Skin Substitutes / Cellular and/or Tissue Based Products - CTP / Cellular, Acellular, and Matrix-like Products - CAMPs
For CY 2027, CMS proposes to maintain the skin substitute payment policy finalized for CY 2026 without modification. The key elements are as follows:
- Payment Continuation:
- The per‑unit payment rate of $127.14/cm² is proposed to remain in effect for all three Ambulatory Payment Classifications (APCs):
- APC 6000: Premarket Approval (PMA) Skin Substitute Products
- APC 6001: FDA 510(k) Skin Substitute Products
- APC 6002: 361 HCT/P Skin Substitute Products
- Rationale: CMS states that insufficient utilization and pricing data are available to justify revising the rates. Updated use patterns reflecting the CY 2026 policy changes will not be available until CY 2026 claims are analyzed for CY 2028 rulemaking. Early rate changes could cause payment instability or volatility.
- Payment Methodology:
- Rates are based on the most recent Average Sales Price (ASP) data when available.
- If ASP data are unavailable, CMS will use Mean Unit Cost (MUC) data; if MUC is unavailable, Wholesale Acquisition Cost (WAC) or 89.6% of Average Wholesale Price (AWP) will be used.
- The policy applies across physician office, hospital outpatient, and ASC settings.
- ASC Payment Alignment: Skin substitute supplies provided as part of a covered surgical procedure in ASCs will continue to be paid separately using the OPPS rate, identified by payment indicator S2 (“Skin substitute supply group; paid separately when provided integral to a surgical procedure on ASC list”).
- Pass‑Through Payment Classification:
- Skin substitutes with an approved Biologics License Application (BLA) are treated under transitional drug pass‑through payment status.
- Those with FDA PMA or 510(k) clearance are evaluated under transitional device pass‑through payment status.
- These products are included in the CY 2027 pass‑through spending estimates for drugs, biologicals, and devices.
Non‑Opioid Pain Management Policy
The CY 2025–CY 2027 updates to the Non‑Opioid Pain Management Policy under Section 4135 of the Consolidated Appropriations Act (CAA), 2023 establish a temporary payment framework for non‑opioid treatments for pain relief furnished in the Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings.
Key proposed policy elements:
- Separate (Additional) Payment Requirement
- From January 1, 2025 through December 31, 2027, CMS must provide temporary separate payments for qualifying non‑opioid drugs, biologicals, and medical devices rather than packaging them into the procedure payment.
- This applies under both OPPS (42 CFR 419.43(k)) and ASC (42 CFR 416.174) payment systems.
- Definition and Qualification Criteria
- A qualifying non‑opioid treatment for pain relief is a drug, biological, or device that:
- Does not act on opioid receptors.
- Is used to reduce postoperative pain or provide regional analgesia.
- Has FDA approval or clearance (or exemption) under the Federal Food, Drug, and Cosmetic Act.
- Demonstrates the ability to replace, reduce, or avoid intra‑ or postoperative opioid use through clinical trial data or peer‑reviewed evidence.
- CMS reviews submitted evidence during rulemaking to confirm qualification.
- Payment Limitation
- The separate payment cannot exceed 18 percent of the outpatient departments fee schedule amount for the associated service(s).
- The limitation is calculated using the volume‑weighted average of the top five procedures in which the product is used, applied per date of service.
- For new products without claims data, CMS estimates the limitation based on expected clinical use patterns.
- Exclusion from Packaging Policies
- Qualifying non‑opioid products are excluded from C‑APC packaging and the drug packaging threshold, ensuring independent reimbursement.
- A zero‑dollar offset is maintained because these products are new or their costs are not yet reflected in procedure rates.
- Quarterly Evaluation Process
- Beginning in CY 2026, CMS evaluates and approves additional qualifying non‑opioid products quarterly rather than annually.
- Examples of Qualifying Products (CY 2027 Proposed List)
- Drugs/Biologicals: Exparel (J0666), Omidria (J1097), Dextenza (J1096), Zynrelef (J0668), Ketorolac (J1885), Caldolor (J1741), Journavx (C9818).
- Devices: ON‑Q Pump (C9804), ambIT Pump (C9806/C9816), SPRINT Peripheral Nerve Stimulator (C9807), Cryo Nerve Block Therapy (C9808), Iovera System (C9809), IceMan (C9810), Game Ready System (C9817), SonoPlex/SonoBlock/SonoTap Needles (C9812), InfiltraLong Catheter (C9813), SonoLong/E‑Cath (C9814), CADD‑Solis Pump (C9815), Sapphire Pump (C9811).
- Budget Neutrality and Transparency
- Payments are made in a budget‑neutral manner under section 1833(t)(2)(E) of the Act.
- CMS publishes payment limitation calculations in a public use file for transparency.
The Hospital Outpatient Quality Reporting (OQR) Program
The Hospital Outpatient Quality Reporting (OQR) Program requires subsection (d) hospitals, as defined under section 1886(d)(1)(B) of the Act, to collect and submit quality data on measures selected by the Secretary of Health and Human Services. The data must be reported in the form, manner, and timeframe specified by the Secretary.
Key proposed requirements and policies include:
- Reporting Obligation and Penalty
- Hospitals must submit required quality data to receive the full Outpatient Prospective Payment System (OPPS) annual payment update.
- Failure to meet reporting requirements results in a 2.0‑percentage‑point reduction to the OPD fee schedule increase factor (the annual payment update factor).
- The reduced payment is applied through a reporting ratio (for CY 2027, 0.9805), which proportionally decreases national unadjusted payment rates, copayments, and outlier calculations.
- Validation Requirements
- Hospitals must achieve an overall reliability score of at least 75 percent for chart‑abstracted measure validation and, beginning with validation affecting the CY 2030 payment determination, for electronic clinical quality measure (eCQM) validation.
- CMS selects hospitals for validation (up to 400 HOPDs proposed beginning with CY 2027 data).
- Each selected HOPD must submit medical documentation for up to 32 cases per measure annually (8 cases per quarter).
- Hospitals may request an educational review or reconsideration if they disagree with validation results.
Other Relevant Provisions
- Prior Authorization Expansion:
- CMS proposes to expand prior authorization to include additional Botulinum Toxin Injection services effective July 1, 2027.
- 340B Drug Payment Adjustment:
- For CY 2027, CMS proposes to pay ASP minus 33.4% for 340B-acquired drugs, offset by an 8.44% increase in non-drug service payments to maintain budget neutrality.
- Examples of 340B drugs include:
- Antineoplastics and Adjunctive Therapies
- Hematopoietic Agents
- Endocrine and Metabolic Agents
- Passive Immunizing and Treatment Agents
- Gastrointestinal Agents
- Psychotherapeutic and Neurological Agents
- Analgesics
- Neuromuscular Agents
Economic and Operational Implications for Wound Care and HBOT Clinics if Proposed Policy is Finalized
- Reimbursement Stability:
- The 2.4% OPPS/ASC increase and continued separate payment for skin substitutes support financial predictability for wound care programs.
- Quality Reporting Compliance:
- Clinics must ensure adherence to OQR requirements to avoid payment penalties.
- Non-Opioid Incentives:
- Encourages integration of non-opioid analgesic modalities in wound and post-HBOT care.
- Rural and Nonteaching Facilities:
- Expected to benefit most from the proposed payment increases, potentially improving access to wound and HBOT services in underserved areas.