By Counterforce Health Team in StrataGraft (allogeneic cultured keratinocytes & fibroblasts in murine collagen-dsat) —

Myths vs. Facts: Getting StrataGraft Covered by Humana in Ohio (Appeals, PA Requirements, and Common Mistakes)

Answer Box: StrataGraft requires prior authorization from Humana Medicare Advantage for adults 18+ with deep partial-thickness thermal burns. Submit PA via Humana provider portal with wound measurements, photos, and medical necessity documentation. If denied, appeal within 60 days through Humana's internal process, then request Ohio external review within 180 days. Common mistake: billing as pharmacy (Part D) instead of medical benefit (Part B). Start today: confirm your Humana plan type and gather burn documentation.

Table of Contents

Why Myths About StrataGraft Coverage Persist

StrataGraft—a bioengineered skin substitute made from allogeneic cultured keratinocytes and fibroblasts in murine collagen—represents cutting-edge burn treatment. But its novelty breeds confusion about coverage requirements, especially with Humana Medicare Advantage plans in Ohio.

These myths persist because StrataGraft straddles multiple benefit categories (Part B medical vs. Part D pharmacy), involves complex billing codes (HCPCS J7353), and requires coordination between burn centers, insurance companies, and specialty billing teams. Patients often receive conflicting information from different sources, while clinicians may not be familiar with payer-specific requirements that differ from traditional wound care.

The stakes are high: StrataGraft can significantly improve healing outcomes for severe burns, but denials are common when the wrong benefit channel is used or documentation doesn't meet Humana's specific criteria. Let's separate fact from fiction.

Myth vs. Fact: 8 Common Misconceptions

Myth 1: "If my doctor prescribes StrataGraft, Humana has to cover it"

Fact: Prior authorization is mandatory for StrataGraft under Humana Medicare Advantage plans. Even with a prescription, coverage depends on meeting specific medical necessity criteria, proper billing through Part B (not Part D), and following step therapy requirements that took effect in 2025.

Myth 2: "StrataGraft is billed like a regular prescription drug"

Fact: StrataGraft must be billed as a medical benefit under Medicare Part B using HCPCS code J7353 (per square centimeter). Attempting to bill through pharmacy benefits (Part D) will result in automatic rejection. The product is administered in hospital outpatient or burn center settings, not dispensed by pharmacies.

Myth 3: "Any burn qualifies for StrataGraft coverage"

Fact: Humana specifically covers StrataGraft only for adults 18+ with deep partial-thickness thermal burns where autografting is clinically indicated. Superficial burns, full-thickness burns, non-thermal injuries, or chronic wounds don't meet FDA labeling requirements and will be denied.

Myth 4: "I can appeal directly to Ohio insurance regulators first"

Fact: You must exhaust Humana's internal appeals process before requesting external review through the Ohio Department of Insurance. Ohio's external review is available within 180 days of Humana's final denial, but internal appeals come first.

Myth 5: "Step therapy doesn't apply to burn treatments"

Fact: Starting in 2025, Humana implemented Part B step therapy requirements for some physician-administered drugs. Documentation must show why less expensive alternatives failed or are contraindicated before StrataGraft approval.

Myth 6: "Prior authorization decisions take weeks"

Fact: Humana must issue standard PA decisions within 15 business days. For urgent burn cases meeting expedited criteria, decisions are required within 24 hours. However, incomplete documentation can delay the process significantly.

Myth 7: "Medicare Advantage plans can't deny FDA-approved treatments"

Fact: While Humana must cover all Medicare-covered services when medically necessary, they can require prior authorization, step therapy, and specific documentation. FDA approval doesn't guarantee automatic coverage without meeting payer-specific criteria.

Myth 8: "Appeals rarely succeed for expensive treatments like StrataGraft"

Fact: Well-documented appeals with proper medical necessity evidence have reasonable success rates. Humana's overall Medicare Advantage PA denial rate is approximately 3.5%—among the lowest of major insurers—but denials often result from documentation gaps rather than blanket coverage exclusions.

What Actually Influences Approval

Medical Necessity Criteria

Humana evaluates StrataGraft requests based on:

  • Patient age: Must be 18 or older per FDA labeling
  • Burn type: Deep partial-thickness thermal burns only
  • Clinical indication: Autografting must be clinically indicated
  • Wound characteristics: Precise measurements in square centimeters for J7353 billing
  • Treatment setting: Qualified burn center or hospital outpatient facility

Documentation Requirements

Submit comprehensive records including:

  • ICD-10 diagnosis codes (T21-T31 series for thermal burns)
  • Clinical photographs with measurement scale
  • Total body surface area (TBSA) calculations
  • Prior treatment history and outcomes
  • Surgical plan with estimated units needed
  • Medical necessity narrative explaining why StrataGraft is preferred over alternatives

Billing and Administrative Factors

  • Correct benefit channel: Part B medical, not Part D pharmacy
  • Proper coding: HCPCS J7353 with appropriate modifiers
  • Provider type: Must be enrolled Humana provider
  • Facility requirements: Appropriate site of care for advanced wound treatment
From our advocates: We've seen cases where burn centers submitted identical clinical information but received different outcomes based solely on billing channel. One facility initially billed through pharmacy (automatic denial), then resubmitted correctly through medical benefits with identical documentation and received approval within 48 hours. The lesson: billing pathway matters as much as clinical justification.

Avoid These 5 Preventable Mistakes

1. Wrong Benefit Channel

Mistake: Submitting StrataGraft requests through pharmacy benefits (Part D) Fix: Always bill as Part B medical benefit using facility billing (UB-04) or physician billing (CMS-1500)

2. Incomplete Wound Documentation

Mistake: Vague descriptions like "severe burn" without measurements Fix: Include precise square centimeter measurements, depth assessment, TBSA calculation, and clinical photos with scale

3. Missing Prior Therapy Documentation

Mistake: No evidence of step therapy compliance or contraindications Fix: Document all prior treatments attempted, duration, outcomes, and specific reasons for failure or intolerance

4. Delayed Prior Authorization

Mistake: Requesting PA after StrataGraft application Fix: Submit PA request as soon as StrataGraft is being considered, before any procedures

5. Inadequate Medical Necessity Justification

Mistake: Generic statements about burn severity Fix: Provide detailed rationale for why StrataGraft is superior to alternatives for this specific patient's clinical situation

Quick Action Plan: 3 Steps to Take Today

Step 1: Verify Your Humana Plan and Benefits

  • Locate your Humana Medicare Advantage member ID card
  • Call Humana customer service (number on your card) to confirm your plan covers Part B medical benefits
  • Ask specifically about prior authorization requirements for HCPCS code J7353
  • Request current skin and tissue substitute policy documents

Step 2: Gather Essential Documentation

Contact your burn center's medical records department to obtain:

  • Complete burn assessment notes with measurements
  • Clinical photographs of the wound
  • Documentation of any prior treatments attempted
  • Surgical consultation notes recommending StrataGraft
  • Current wound care plan and treatment goals

Step 3: Coordinate with Your Care Team

  • Ensure your burn surgeon understands Humana's PA requirements
  • Confirm the facility will bill through medical benefits, not pharmacy
  • Request expedited PA if your clinical situation is urgent
  • Ask for a copy of the PA submission for your records

Appeals Process in Ohio

If Humana denies your StrataGraft request, Ohio residents have multiple appeal options:

Internal Appeals (Required First Step)

  • Timeline: File within 60 days of denial notice
  • Decision time: 30 days for standard, 7 days for expedited
  • How to file: Humana member portal, phone, or written request
  • What to include: Denial letter, additional clinical evidence, physician attestation

Ohio External Review

After exhausting internal appeals, request external review through the Ohio Department of Insurance:

  • Timeline: Within 180 days of final internal denial
  • Process: Independent Review Organization (IRO) evaluation
  • Decision time: 30 days standard, 72 hours expedited
  • Binding: If overturned, Humana must provide coverage

Federal Medicare Appeals

For Medicare Advantage plans, you also have access to federal appeal levels:

  • Independent Review Entity (IRE)
  • Administrative Law Judge (ALJ)
  • Medicare Appeals Council
  • Federal District Court

Contact 1-800-MEDICARE for guidance on federal appeal procedures.

Humana Resources

Ohio Insurance Department

Federal Resources

StrataGraft Clinical Information

About Coverage Support: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling appropriate medical evidence and meeting procedural deadlines.

When navigating complex coverage situations like StrataGraft approvals, having expert support can make the difference between denial and approval. Counterforce Health specializes in understanding payer-specific workflows and producing appeals that meet both clinical and administrative requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with Humana and consult with your healthcare team about appropriate treatment options. For personalized assistance with appeals or coverage questions, contact the Ohio Department of Insurance Consumer Services Division at 1-800-686-1526.

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