P — Prior Authorization
Coverage confirmed before the visit, not after it
We confirm coverage and medical policy alignment before each visit.
Home / For Providers / Wound Care
Example serviceAdvanced wound care infrastructure, built to withstand scrutiny.
We manage qualification, documentation, care coordination, billing oversight, audit readiness, and more — turning LCD complexity into defensible revenue.
The problem
Highly reimbursable — and highly scrutinised.
Advanced wound care using cellular and tissue-based products is highly reimbursable — and highly scrutinised. Medicare LCD requirements are complex, documentation standards are unforgiving, and minor inconsistencies can trigger denials, audits, or costly clawbacks months after payment. Most practices enter this space clinically prepared but operationally underbuilt, leaving significant revenue exposed to regulatory risk.
The solution
Seven pillars. Read the left-hand column: they spell PROTECT.
Clinical appropriateness is your side of the line. Everything under it — the qualification, the paperwork, the utilisation discipline, the audit file — is ours. That is the whole framework, and the letters are not an accident.
R — Revenue Optimization
Workflows built so payment isn't interrupted
We structure workflows to avoid payment disruptions.
O — Operational Infrastructure
The non-clinical machinery underneath the program
We manage the non-clinical processes that support a compliant wound care program.
T — Treatment Coordination
Someone is watching the case, not just the visit
We track scheduling, utilisation and case progression, so gaps surface while they are still fixable.
E — Evidence-Based Charting
Documentation written in the LCD's own language
We align documentation with LCD requirements to support medical necessity.
C — Compliance Oversight
Utilisation kept inside the policy, month by month
We keep services and utilisation aligned with Medicare and payer policy.
T — Total Audit Readiness
Records structured for defence, not reaction
We prepare every case for review — structuring records for defence, not reaction.
How it's priced — Pay-Per-Service
Our Pay-Per-Service model gives you access to compliance and revenue support without fixed overhead. You pay only for the services performed, making it easy to start, scale, and maintain disciplined oversight without adding internal staff.
It is a deliberately different commercial model from the flat monthly rate on our back-office staffing line. A wound program's volume moves; a fixed headcount cost doesn't. This one follows the work.
The ground underneath it
What skin substitutes are, and what the payer actually requires.
The rest of this page is the detail the framework above exists to handle.
What they are
Skin substitutes — Cellular and Tissue-Based Products (CTPs) — are biologic materials derived from human, animal or synthetic sources. Many allograft products are derived from amniotic membrane or other human tissue. They're regulated as human tissue products, not as drugs or traditional devices.
They're designed to provide a scaffold for tissue regeneration, support cellular migration and wound healing, reduce inflammation, and accelerate closure of chronic wounds.
When they're indicated
Chronic wounds are a significant clinical and financial burden. The wound types that commonly qualify for advanced therapies are diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), pressure injuries (Stage III/IV), and certain surgical or traumatic wounds. When standard of care fails to achieve adequate healing progress, providers may escalate to advanced modalities including CTPs.
What payers require
Medicare and most commercial payers require documentation that:
- The wound is chronic — typically 4+ weeks in duration
- Standard of care has been provided and documented
- The wound has failed to achieve adequate healing progress
- The wound meets size and clinical criteria under the applicable Local Coverage Determination (LCD)
Standard of care typically means debridement, offloading (for DFUs), compression (for VLUs), infection control and a moist wound environment. Failure to document standard of care is a common audit trigger.
How reimbursement works
It depends on site of service. In a physician office (PFS), the product is billed separately — often ASP-based or invoice-based depending on classification — and the application procedure is billed via CPT code. In hospital outpatient (OPPS), product and procedure reimbursement may be bundled or packaged depending on status indicator.
The key variables are product cost, wound size in square centimetres applied, number of applications, and payer-specific rules. Improper billing or overutilisation can trigger post-payment review.
LCDs are the rulebook
Local Coverage Determinations, issued by regional MACs, define covered wound types, required duration of standard of care, documentation elements, frequency limitations, maximum number of applications, and non-covered indications. LCD compliance is mandatory for Medicare reimbursement — and failure to align documentation with LCD language is one of the primary causes of denials and recoupments.
The scrutiny is real, and it is increasing
Skin substitute utilisation has drawn federal oversight because of rapid growth in expenditures, variability in product pricing, outlier billing patterns and insufficient documentation of medical necessity. The bodies involved are MACs, Unified Program Integrity Contractors (UPICs), the OIG and the DOJ. Post-payment audits can result in recoupment if documentation doesn't support medical necessity.
Common audit triggers: excessive application frequency, large cumulative graft sizes, lack of documented standard of care, template-based or cloned documentation, and inconsistent wound measurements. Higher-dollar cases attract disproportionately more scrutiny — in those, minor documentation deficiencies can produce substantial recoupments.
Revenue without compliance structure becomes financial liability. Wound Care 101 — Paradygm Health Group
Where practices are exposed
- Inadequate patient qualification screening
- Missing or inconsistent wound measurements
- Failure to document prior standard of care
- Overutilisation relative to LCD guidance
- Poor coordination between clinical and billing teams
- Lack of audit-ready record organisation
Most compliance failures here don't come from improper clinical intent. They come from inconsistent documentation language, incomplete eligibility verification, gaps between clinical and billing teams, no utilisation tracking, and reactive rather than proactive audit preparation.
What we build instead
A defensible program needs pre-treatment eligibility verification, LCD-driven documentation templates, utilisation monitoring, accurate wound measurement tracking, billing aligned to payer rules, and ongoing audit preparedness. Programs that succeed long-term treat documentation and compliance as infrastructure — not as an afterthought.
Built into the workflow from day one, those safeguards let a practice participate in advanced wound care with significantly greater confidence: fewer denials, fewer clawbacks, audits withstood, revenue that holds.
A successful program stands on two pillars — clinical appropriateness, and documentation and compliance integrity. Without both, the financial and regulatory risk can outweigh the opportunity.
Stop the revenue risk
Advanced wound care deserves advanced infrastructure.
Running a skin-substitute program, or thinking about it? We'll review how your qualification, documentation and utilisation controls would hold up — before a MAC does it for you.