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

StrataGraft Coverage by Humana in North Carolina: Prior Authorization Guide, Appeals Process, and Decision Tree

Answer Box: StrataGraft Coverage by Humana in North Carolina

StrataGraft requires prior authorization for Humana Medicare Advantage coverage in North Carolina, with approval typically taking 15 business days for adults with deep partial-thickness thermal burns when properly documented. The fastest path to approval: (1) Have your burn center submit a PA request through Humana's provider portal with wound measurements and clinical photos, (2) If denied, file an internal appeal within 60 days, and (3) For final denials, use North Carolina's Smart NC external review process within 120 days. Start with Humana's member portal to check your specific plan's requirements.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Patient Responsibility
  6. Denials and Appeals
  7. North Carolina External Review
  8. Specialty Pharmacy and Billing
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is StrataGraft Covered by Humana?

StrataGraft is covered under Medicare Part B (medical benefit), not Part D (pharmacy) for Humana Medicare Advantage members. The treatment requires prior authorization and is billed using HCPCS code J7353 per square centimeter of wound area.

Coverage Detail Information Source
Benefit Type Medicare Part B (medical) Humana Medicare Coverage
Age Requirement Adults 18+ only (FDA indication) FDA Label Information
Diagnosis Codes ICD-10 codes T21-T31 (thermal burns) CMS Coverage Database
Billing Code HCPCS J7353 per square centimeter CMS HCPCS Codes

Which Humana Plans Cover StrataGraft?

Most Humana Medicare Advantage plans cover StrataGraft when medically necessary, but coverage varies by specific plan. Contact Humana member services at the number on your insurance card to verify your plan's coverage.

Prior Authorization Process

Who Submits the Prior Authorization?

Your burn center or treating facility must submit the PA request—patients cannot submit these requests directly. The healthcare provider uses Humana's provider portal or fax system to submit required documentation.

Required Documentation

The PA submission must include:

  • Wound measurements (precise square centimeters)
  • Clinical photographs showing burn depth and extent
  • Medical necessity justification with treatment rationale
  • ICD-10 diagnosis codes for thermal burns (T21-T31)
  • Site of care verification (qualified burn center or wound facility)
Tip: Ensure your burn center takes detailed measurements and photos before submitting the PA request, as incomplete documentation is a common reason for delays.

Timing and Urgency

Standard Processing Times

Review Type Timeline When to Use
Standard PA 15 business days Non-urgent cases
Expedited PA 24-72 hours Clinical urgency documented
Peer-to-Peer 1-3 business days After initial denial

Expedited Reviews

Expedited reviews are available for urgent cases when clinical urgency is properly documented. Your provider must demonstrate that a delay would seriously jeopardize your health or ability to regain function.

Medical Necessity Criteria

FDA-Approved Indications

StrataGraft is FDA-approved for deep partial-thickness thermal burns in adults when autografting is clinically indicated. The product is intended to promote regeneration and reduce or avoid autograft at the treated site.

Step Therapy Requirements

Step therapy requirements began in 2025. Documentation of contraindications to alternative treatments is required, and documented treatment failures from any location count toward these requirements.

Clinician Corner: Medical Necessity Letter

When preparing a medical necessity letter, include:

  • Patient diagnosis with specific ICD-10 codes
  • Burn characteristics (depth, percentage of total body surface area, location)
  • Prior treatments attempted and outcomes
  • Clinical rationale for StrataGraft over alternatives
  • Treatment goals and expected outcomes
  • Supporting literature from FDA labeling and peer-reviewed studies

Costs and Patient Responsibility

Medicare Part B Cost-Sharing

For Humana Medicare Advantage members, StrataGraft follows standard Part B cost-sharing:

  • Deductible: $240 (2024)
  • Coinsurance: 20% after deductible
  • Annual out-of-pocket maximum: Varies by plan
Note: Some Humana Medicare Advantage plans may have different cost-sharing structures. Check your specific plan documents for exact amounts.

Financial Assistance Options

Contact the StrataGraft manufacturer, Mallinckrodt, about potential patient assistance programs. Many specialty treatment manufacturers offer support for eligible patients.

Denials and Appeals

Common Denial Reasons

Denial Reason How to Address Required Documentation
Insufficient documentation Resubmit with complete wound measurements and photos Clinical photos, precise measurements
Not medically necessary Request peer-to-peer review with burn specialist Medical necessity letter, clinical guidelines
Age restriction Verify patient is 18+ Date of birth verification
Wrong billing Ensure facility billing, not pharmacy Correct claim submission

Internal Appeals Process

Level 1: Standard Internal Appeal

  • Timeline: 60 days to file; 30-day decision (7 days expedited)
  • How to file: Call 1-800-MEDICARE or use Humana member portal
  • Required: Copy of denial letter, supporting medical records

Level 2: Independent Review Entity (IRE)

  • Timeline: 30 days standard; 72 hours expedited
  • Reviewer: MAXIMUS Federal Services conducts independent medical review
  • Threshold: $180 minimum (2024 figure) for Level 3+ appeals

North Carolina External Review

When External Review Applies

Important: North Carolina residents with Humana Medicare Advantage must use federal Medicare appeals, not North Carolina's state external review process. However, if you have a fully-insured commercial Humana plan, you can use North Carolina's Smart NC external review.

Smart NC Process for Commercial Plans

If you have a commercial Humana plan (not Medicare Advantage):

  1. Exhaust internal appeals with Humana first
  2. Submit external review request within 120 days of final denial
  3. Use Smart NC form available at NC Department of Insurance
  4. Decision timeline: 45 days for standard review, 72 hours for expedited

Smart NC Contact: 1-855-408-1212 for free advocacy assistance.

When dealing with complex insurance appeals, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by identifying denial reasons and drafting point-by-point rebuttals aligned to payer policies.

Specialty Pharmacy and Billing

How StrataGraft is Dispensed

StrataGraft is dispensed through Humana's specialty pharmacy network but billed as a medical benefit—not pharmacy benefit—at qualified facilities like hospitals, ambulatory surgery centers, or physician offices.

Billing Requirements

  • Billing form: CMS-1500 or UB-04 (not pharmacy NCPDP)
  • Place of service: Hospital, ASC, or qualified office setting
  • Units: Exact wound area in square centimeters
  • Modifiers: Use -JW for wastage, -59 for distinct procedures
Important: Only one entity (facility or physician) should bill for the product to avoid duplicate claim denials. Clarify billing responsibility upfront.

Troubleshooting Common Issues

Portal and System Problems

If Humana's provider portal is down or forms are missing:

  • Alternative submission: Fax PA requests to Humana's medical management department (verify current fax number)
  • Status checks: Call Humana provider services at 800-282-4548
  • Backup portal: Use Availity (payer ID 61101 professional/61102 facility)

Missing Documentation

Common missing items that delay approval:

  • Precise wound measurements in square centimeters
  • High-quality clinical photographs
  • Complete medical necessity justification
  • Correct ICD-10 diagnosis codes
  • Provider NPI and taxonomy information

Frequently Asked Questions

How long does Humana prior authorization take for StrataGraft in North Carolina? Standard PA requests take 15 business days. Expedited reviews are completed within 24-72 hours when clinical urgency is documented.

What if StrataGraft is denied as "not medically necessary"? Request a peer-to-peer review with a burn specialist. Provide detailed medical necessity documentation including FDA labeling and clinical guidelines supporting use.

Can I request an expedited appeal in North Carolina? Yes, for Medicare Advantage plans, expedited appeals are processed within 72 hours. For commercial plans, Smart NC offers expedited external review within 72 hours for urgent cases.

Does step therapy apply if I failed treatments outside North Carolina? Yes, documented treatment failures from any location count toward step therapy requirements. Ensure your provider submits complete documentation of prior treatments and outcomes.

Why was my case transferred to specialty pharmacy? StrataGraft requires specialty handling due to its biological nature and storage requirements. However, it's still billed as a medical benefit through your treatment facility.

What happens if my Humana plan changes mid-treatment? Contact Humana member services immediately to ensure continued coverage. You may need a new prior authorization under the new plan's requirements.

Counterforce Health specializes in helping patients navigate these complex coverage scenarios by analyzing plan policies and crafting targeted appeals that address specific payer requirements.

From Our Advocates

"We've seen cases where initial StrataGraft denials were overturned simply by including precise wound measurements and high-quality photographs that clearly demonstrated burn depth. The key is thorough documentation from the start—it saves weeks of back-and-forth appeals." This reflects common patterns we observe, though individual outcomes vary.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and plan specifics. Always consult your healthcare provider and insurance plan directly for personalized guidance.

Need Help? Contact North Carolina's Health Insurance Smart NC at 1-855-408-1212 for free consumer assistance with insurance appeals and external reviews.

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.