On August 25, 2026, the U.S. Food and Drug Administration (FDA) convened a major public meeting at its White Oak campus and via global webcast: the FDA-Led Patient-Focused Drug Development (PFDD) Meeting for Nonhealing Chronic Wounds (Docket No. FDA-2026-N-5057). Formally announced in the Federal Register on May 29, 2026 (FR Doc. 2026-10752), the all-day forum brought together leadership from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), patients suffering from diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure injuries, clinical investigators, and wound-care product developers.
Across the wound-care industry, cellular and tissue-based product (CTP) manufacturers, and market-access teams navigating Medicare reimbursement, the meeting ignited immediate speculation:
Does FDA's patient-focused meeting signal a breakthrough that could unfreeze or reset Medicare's contentious skin-substitute payment methodology? And what happens to pricing, reimbursement, and inflation penalties if a manufacturer develops a future wound biologic under a Section 351 Biologics License Application (BLA) rather than a Section 361 tissue listing or a 510(k) device clearance?
The direct regulatory and payment reality is defined by a fundamental divide between clinical trial endpoints and Medicare reimbursement rulemaking:
- Today's PFDD meeting does not alter Medicare skin-substitute payment rates. PFDD forums are designed strictly to capture patient-reported outcomes (PROs), symptom burdens, and clinical trial endpoint preferences for CDER and CDRH review divisions. They hold zero statutory authority over Medicare payment rates, Healthcare Common Procedure Coding System (HCPCS) code structures, or physician fee schedules.
- CMS-1848-P does not rewrite CY 2026 sheet-form payment, but it does propose a payment change for non-sheet products. In the Calendar Year (CY) 2027 Medicare Physician Fee Schedule proposed rule (CMS-1848-P; FR Doc. 2026-14327; 91 FR 43842–44557; comments closing September 14, 2026), CMS restates the CY 2026 policy: ASP methodology under section 1847A is limited to skin substitutes licensed under section 351 of the PHS Act, and certain other groups are paid as incident-to supplies. CMS-1848-P's principal skin-substitute payment proposal is to nationally price non-sheet form products (currently MAC-priced) consistent with sheet-form supply rates. That is an extension of national pricing, not a silent freeze of every skin-substitute rate.
- CMS proposes to carve Section 351 BLAs into Part B inflation rebates. Under proposed 42 CFR 427.101(b)(5), CMS would narrow the skin-substitute exclusion from the Inflation Reduction Act's Part B inflation-rebate program. Traditional 361 tissue products and device-cleared CTPs would remain excluded. A future skin substitute licensed as a drug or biological product under section 351 of the Public Health Service Act would become a Part B rebatable drug, with manufacturer rebates and a possible beneficiary coinsurance adjustment under 42 CFR 427.201 if Average Sales Price (ASP) increases faster than inflation. CMS states that no 351-licensed skin substitute exists today.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CHRONIC WOUND PFDD VS. CMS-1848-P REGULATORY & PAYMENT MATRIX │
├─────────────────────────────────────┬────────────────────────────────────────────────────────┤
│ Parameter │ Regulatory & Statutory Reality │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ FDA PFDD Meeting Date │ August 25, 2026 (10:00 AM – 4:30 PM ET; White Oak) │
│ FDA PFDD Docket & Notice │ Docket No. FDA-2026-N-5057; FR Doc. 2026-10752 │
│ FDA PFDD Written Comment Deadline │ October 26, 2026 │
│ CMS Proposed Rule Notice │ CMS-1848-P; FR Doc. 2026-14327; 91 FR 43842–44557 │
│ CMS-1848-P Public Comment Deadline │ September 14, 2026 (60-day comment window) │
│ Skin-Substitute Payment Status │ CY 2026: ASP 1847A limited to 351 products; others │
│ │ paid as incident-to supplies (not PE-RVU packaging) │
│ CY 2027 Proposed Supply Extension │ Nationally price non-sheet products like sheet forms │
│ Proposed 42 CFR 427.101(b)(5) Rule │ Carves IN future PHS Act 351 biologics into Part B │
│ │ Inflation Rebates; keeps 361 / devices EXCLUDED. │
│ Current 351 Skin Substitutes Count │ EXACTLY ZERO (Confirmed by CMS in proposed rule) │
└─────────────────────────────────────┴────────────────────────────────────────────────────────┘
Below, we analyze the clinical endpoint questions posed at today's PFDD meeting, dissect CMS-1848-P's proposed inflation-rebate amendments, map the three-track regulatory architecture for wound-care products (361 HCT/P vs. 510(k)/PMA vs. 351 BLA), and establish the critical comment timelines facing biopharma and medtech executives.
What FDA Actually Examined at Today's PFDD Meeting
The August 25, 2026 PFDD meeting was co-led by CDER and CDRH leadership, reflecting the interdisciplinary nature of wound-healing modalities that bridge biologics, drugs, biomaterials, and therapeutic devices.
According to the official meeting agenda (FDA Media 194309), welcome remarks are from CDER Patient-Focused Drug Development Director Robyn Bent, R.N., M.S., opening remarks from CDRH Director Michelle Tarver, M.D., Ph.D., and closing remarks from Maryjoy Mejia, M.D., Medical Officer in CDER's Office of New Drugs, Division of Dermatology and Dentistry.
The forum was organized around three focused clinical sessions:
- Session 1: Daily Impacts of Living with Nonhealing Chronic Wounds: Capturing the physical, emotional, and functional burden of chronic ulcers, including chronic intractable pain, persistent exudate and wound drainage, malodor, mobility restriction, and sleep disruption.
- Session 2: Current Treatment Approaches and Unmet Needs: Evaluating the real-world utility of debridement, compression, offloading devices, advanced dressings, cellular and tissue-based products, and systemic antibiotics.
- Session 3: Patient Perspectives on Clinical Trials: Identifying barriers to enrollment, visit burden, and which results patients want trials to measure.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ FDA PFDD SESSION STRUCTURE & CORE CLINICAL INQUIRY │
├───────────────────────┬───────────────────────────────┬──────────────────────────────────────┤
│ Session │ Agency Focus │ Key Discussion Prompts │
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────┤
│ Session 1: │ Disease Symptoms & Daily │ • How do chronic pain, wound odor, │
│ Daily Impacts │ Functional Limitations │ and drainage restrict daily life? │
│ │ │ • What activities are hardest? │
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────┤
│ Session 2: │ Current Management & │ • Which symptoms do current CTPs, │
│ Current Treatments │ Therapeutic Gaps │ dressings, or therapies fail? │
│ │ │ • What are worst treatment burdens? │
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────┤
│ Session 3: │ Patient Perspectives on │ • What does "effective treatment" │
│ Clinical Trials │ Clinical Trials │ mean (full closure, less drainage, │
│ │ │ less pain, better sleep)? │
│ │ │ • Would a treatment still help if it │
│ │ │ did not fully close the wound? │
└───────────────────────┴───────────────────────────────┴──────────────────────────────────────┘
The Pivotal Endpoint Question: "Healing" vs. Partial Benefit
FDA's 2006 guidance Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment treated complete wound closure—skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits two weeks apart—as the primary efficacy endpoint for products intended to heal chronic ulcers. That document is still the agency's published development guidance for this class; PFDD questions do not replace it.
In the discussion questions published for today's meeting (FDA Media 194328), FDA asked patients, in their own words:
In your own words, what does "healing" mean to you? What would healing look or feel like?
And:
What does "effective treatment" mean to you? Examples may include full closure, less drainage, less pain, fewer dressing changes, easier walking, and better sleep. Would a treatment still be helpful to you if it did not fully close the wound but improved your daily life?
As detailed in our analysis of patient-reported outcome endpoints and trial-to-payer evidence translation, this question is patient-experience input, not a change to FDA's 2006 complete-closure primary-endpoint guidance and not a Medicare payment rule. Converting PFDD testimony into an actionable CDER endpoint guidance is a multi-year process.
CMS-1848-P: Non-Sheet Products Would Join National Pricing; 351 Rebates Are Separate
While FDA was gathering patient testimony at White Oak, the economic framework governing wound care remains anchored in CMS rulemaking.
In the CY 2027 Physician Fee Schedule Proposed Rule (CMS-1848-P; published July 16, 2026; 91 FR 43842–44557), CMS addressed the payment status of skin substitutes (also referred to in rulemaking as cellular and tissue-based products, or CTPs, for skin wounds):
- CY 2026 payment architecture, restated: In the CY 2026 PFS final rule (90 FR 49496, 50009, as restated in CMS-1848-P), CMS limited application of the ASP payment methodology under section 1847A to skin substitutes licensed as a drug or biological product under section 351 of the PHS Act, and modified payment for certain other groups as incident-to supplies. That is a separate supply payment, not packaging of the product into the application procedure's practice-expense RVUs.
- Non-sheet national pricing proposal: CMS-1848-P's skin-substitute payment section proposes, for CY 2027, to nationally price non-sheet form skin substitutes consistent with sheet-form payment rates, because CMS now views resource costs per cm² of wound surface treated as comparable. These products were contractor-priced in CY 2026.
- What this proposed rule does not do: CMS-1848-P does not republish a new national per-square-centimeter rate for sheet-form products, and it does not reopen ASP-plus-six-percent payment for 361 or device skin substitutes. Trade blogs disagree on a 2026 per-cm² figure; quote the CY 2026 PFS final if a dollar rate is needed.
The 351 Carve-In: How Future BLAs Enter Part B Inflation Rebates
The most critical long-term regulatory development in CMS-1848-P is CMS's proposed amendment to 42 CFR 427.101(b)(5), governing the Medicare Part B Drug Inflation Rebate Program established under Section 11101 of the Inflation Reduction Act (codified at Section 1847A(i) of the Social Security Act).
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CMS-1848-P PROPOSED AMENDMENT TO 42 CFR 427.101(b)(5) │
├─────────────────────────────────────┬────────────────────────────────────────────────────────┤
│ Regulatory Element │ Proposed Regulatory Language & Policy Interpretation │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Existing 42 CFR 427.101(b)(5) │ Skin substitutes are broadly EXCLUDED from the │
│ │ definition of a "Part B rebatable drug." │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Proposed 42 CFR 427.101(b)(5) │ Skin substitutes remain excluded EXCEPT products that │
│ │ are licensed as a drug or biological product under │
│ │ Section 351 of the Public Health Service Act. │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Operational Consequence for 351 BLA │ • Included in Part B Rebatable Drugs. │
│ │ • Subject to quarterly manufacturer inflation rebates │
│ │ if ASP growth exceeds CPI-U. │
│ │ • Triggers beneficiary coinsurance adjustment under │
│ │ 42 CFR 427.201 (reducing patient copays below 20%). │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ CMS Baseline Census Statement │ "Currently, there are no skin substitute products that │
│ │ are licensed as a drug or biological product under │
│ │ section 351 of the PHS Act." │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Implementation Impact Constraint │ Proposal will NOT impact Rebate Reports for Q4 2026 │
│ │ or earlier historical rebate periods. │
└─────────────────────────────────────┴────────────────────────────────────────────────────────┘
Why CMS Is Establishing This Forward-Looking Carve-In
In the preamble to CMS-1848-P, CMS explains the rationale for amending 42 CFR 427.101(b)(5):
When the IRA was enacted, skin substitutes were excluded from the Part B inflation rebate program because marketed products were overwhelmingly Section 361 HCT/Ps or 510(k)/PMA devices, not 351 biologics.
CMS now says the CY 2025 exclusion at § 427.101(b)(5) is overly broad once CY 2026 limited ASP methodology to 351-licensed products. The proposed revision would keep 361 and device skin substitutes excluded, while making clear that a future 351-licensed skin substitute would be a Part B rebatable drug.
Under the proposed rule:
- A future 351 BLA would not remain in the skin-substitute rebate exclusion.
- Whether that product is paid under ASP 1847A (the CY 2026 limitation already points that way) is a payment question distinct from whether it is rebatable.
- If ASP increases faster than CPI-U, the manufacturer would owe inflation rebates and the beneficiary coinsurance adjustment under § 427.201 could apply.
- If CMS later pays a 351 product under section 1847A, ASP reporting and HCPCS timing become operational issues; see CMS-10110 ASP reporting and J-code timing for buy-and-bill biologics. Those clocks are not created by today's PFDD meeting.
(Note: Regranex [becaplermin], a recombinant human platelet-derived growth factor approved under NDA 020723, is a prescription topical drug, not a CMS incident-to skin substitute.)
The Three-Track Regulatory & Payment Architecture for Wound Products
CY 2026 payment rules plus the proposed 351 rebate carve-in produce three different Medicare exposures. The rebate track is still a proposal in CMS-1848-P.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ THREE-TRACK REGULATORY, PAYMENT & REBATE ARCHITECTURE FOR WOUND CARE │
├───────────────────────┬──────────────────────────┬──────────────────────┬────────────────────┤
│ Regulatory Pathway │ FDA Review & Oversight │ Medicare PFS Payment │ Part B Inflation │
│ │ Center │ (CY 2026 restated) │ Rebate Exposure? │
├───────────────────────┼──────────────────────────┼──────────────────────┼────────────────────┤
│ Track 1: │ CBER (21 CFR Part 1271) │ Incident-to supply │ EXCLUDED │
│ Section 361 HCT/P │ • Minimal manipulation │ payment (not ASP │ (current 427.101 │
│ (Amniotic, placental, │ • Homologous use only │ 1847A; not packaged │ (b)(5)) │
│ umbilical tissues) │ • Registration/listing │ into PE RVUs) │ │
├───────────────────────┼──────────────────────────┼──────────────────────┼────────────────────┤
│ Track 2: │ CDRH │ Same incident-to │ EXCLUDED │
│ 510(k) / PMA Device │ • Substantial equivalence│ supply methodology │ │
│ (synthetic matrices, │ • Device QMSR / 820 │ for covered groups │ │
│ collagen dressings) │ • Premarket notification │ │ │
├───────────────────────┼──────────────────────────┼──────────────────────┼────────────────────┤
│ Track 3: │ CDER / CBER │ CY 2026 limited ASP │ INCLUDED if │
│ Section 351 BLA │ • Full BLA review │ 1847A to 351- │ CMS-1848-P is │
│ (living cell therapies│ • Pivotal evidence │ licensed products │ finalized │
│ / recombinant biologics) │ │ │ │
└───────────────────────┴──────────────────────────┴──────────────────────┴────────────────────┘
The commercial paradox is real but narrower than a blanket ASP-plus-six-percent story: 351 licensure is the only track CMS already carved out for section 1847A payment, and CMS-1848-P would add inflation-rebate exposure to that same future class. 361 and device products stay on the supply methodology, with non-sheet products proposed to join national pricing in CY 2027.
Critical Comment Deadlines: September 14 vs. October 26, 2026
Regulatory affairs and reimbursement leaders must carefully separate the two active comment dockets:
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ UPCOMING WOUND-CARE PUBLIC COMMENT DEADLINES │
├───────────────────────────────┬───────────────────────────────┬──────────────────────────────┤
│ Regulatory Action │ Target Docket & Agency │ Formal Public Comment Close │
├───────────────────────────────┼───────────────────────────────┼──────────────────────────────┤
│ CMS-1848-P Proposed Rule │ File Code: CMS-1848-P │ September 14, 2026 │
│ (CY 2027 Physician Fee Sched) │ Centers for Medicare & Med. │ │
│ │ │ │
│ Core Focus: Skin-substitute supply payment, non-sheet packaging, and 427.101(b)(5) rebates. │
├───────────────────────────────┼───────────────────────────────┼──────────────────────────────┤
│ FDA PFDD Public Docket │ Docket No. FDA-2026-N-5057 │ October 26, 2026 │
│ (Nonhealing Chronic Wounds) │ Food and Drug Administration │ (11:59 PM Eastern Time) │
│ │ │ │
│ Core Focus: Patient testimony, partial healing endpoints, PRO tools, and trial participation.│
└───────────────────────────────┴───────────────────────────────┴──────────────────────────────┘
Manufacturers seeking to influence 2027 reimbursement rates, non-sheet packaging rules, or the 351 rebate carve-in must submit formal comments to CMS by September 14, 2026.
Organizations seeking to shape FDA clinical trial guidance, endpoint acceptance, and patient-reported outcome measures have until October 26, 2026 to submit clinical data and patient survey findings to the FDA docket.
Frequently Asked Questions
Does today's FDA PFDD meeting change Medicare reimbursement for skin substitutes?
No. Today's PFDD meeting is an FDA-sponsored clinical and patient-experience initiative led by CDER and CDRH. FDA has no jurisdiction over Medicare payment methodology, fee schedules, or billing codes. Medicare reimbursement is determined exclusively through CMS rulemaking in the Physician Fee Schedule.
Are there any Section 351-licensed skin substitutes subject to Medicare Part B inflation rebates today?
No. In the proposed rule CMS-1848-P, CMS states: "currently there are no skin substitute products licensed as a drug or biological product under section 351 of the PHS Act." The proposed amendment to 42 CFR 427.101(b)(5) would make a future 351-licensed skin substitute a Part B rebatable drug if finalized. It would not affect Rebate Reports for the fourth quarter of 2026 or earlier.
When do comments close for CMS-1848-P versus the FDA PFDD docket?
Public comments for CMS-1848-P (the CY 2027 Physician Fee Schedule proposed rule) close on September 14, 2026. Written comments for the FDA PFDD chronic wound docket (FDA-2026-N-5057) remain open until October 26, 2026.
Would a wound treatment that improves pain or drainage without full closure satisfy FDA?
Not on the strength of today's PFDD questions. FDA's 2006 chronic cutaneous ulcer guidance still treats complete wound closure as the primary efficacy endpoint for products intended to heal chronic ulcers. The posted discussion questions ask what "healing" and "effective treatment" mean to patients, including whether a therapy would still help if it did not fully close the wound. That is patient-experience input, not a new approval endpoint.
Sources
- FDA Public Meeting Announcement: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds (August 25, 2026)
- Federal Register Meeting Notice: Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments (FR Doc. 2026-10752)
- FDA PFDD Meeting Agenda PDF: Nonhealing Chronic Wounds Agenda (FDA Media 194309)
- FDA PFDD Discussion Questions PDF: Nonhealing Chronic Wounds Discussion Questions (FDA Media 194328)
- FDA Wound Product Development Guidance (2006): Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment
- Federal Register CMS-1848-P Proposed Rule: Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule (FR Doc. 2026-14327; 91 FR 43842–44557)
- CMS CY 2027 PFS Proposed Rule Fact Sheet: Calendar Year (CY) 2027 Medicare Physician Fee Schedule Proposed Rule Fact Sheet
- CMS Skin Substitutes Payment Page: Skin Substitutes (Physician Fee Schedule Overview)
- eCFR 42 CFR Part 427 Subpart B: Medicare Part B Drug Inflation Rebate Program
