How to Get Increlex (Mecasermin) Covered by Humana in New Jersey: Complete Approval Guide with Forms and Timelines
Quick Answer: Increlex Coverage by Humana in New Jersey
Increlex (mecasermin) requires prior authorization from Humana Medicare Advantage plans. To get approved, you need: (1) confirmed severe primary IGF-1 deficiency diagnosis from a pediatric endocrinologist, (2) documented lab values showing IGF-1 ≤3 SD below normal and normal GH stimulation test, and (3) a comprehensive safety monitoring plan for hypoglycemia. Submit via CoverMyMeds portal with complete clinical documentation. If denied, New Jersey offers external review through Maximus Federal Services within 120 days. First step today: Contact your pediatric endocrinologist to confirm your diagnosis meets FDA criteria and request IGF-1/GH lab results.
Table of Contents
- How to Use This Guide
- Eligibility Triage: Do You Qualify?
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- If You're Likely Eligible
- If You're Possibly Eligible
- If You're Not Yet Eligible
- If Your Request is Denied
- Common Denial Reasons & How to Fix Them
- New Jersey External Review Process
- Clinician Corner: Medical Necessity Letter
- Costs and Patient Support Programs
- FAQ
- Sources & Further Reading
How to Use This Guide
This guide helps patients and families navigate Humana's prior authorization process for Increlex (mecasermin) in New Jersey. Start with the eligibility triage below to determine your likely approval path, then follow the specific section that matches your situation.
Important: This is educational information only, not medical advice. Always work with your pediatric endocrinologist and contact Humana directly to verify current requirements.
Eligibility Triage: Do You Qualify?
Answer these questions to determine your approval likelihood:
1. Diagnosis confirmed?
- ✅ Severe primary IGF-1 deficiency diagnosed by pediatric endocrinologist
- ❌ Suspected but not confirmed, or diagnosed by non-specialist
2. Age requirements met?
- ✅ Between 2-18 years old with open growth plates
- ❌ Under 2 or over 18, or closed growth plates
3. Required lab values documented?
- ✅ IGF-1 levels ≤3 SD below normal for age/sex
- ✅ Normal GH stimulation test (peak ≥7-10 ng/mL)
- ❌ Missing IGF-1 or GH testing
4. Height criteria met?
- ✅ Height ≤3 SD below normal (severe short stature)
- ❌ Mild to moderate short stature only
5. Other causes ruled out?
- ✅ GH deficiency, malnutrition, chronic disease excluded
- ❌ Secondary causes not yet investigated
Results:
- All ✅ = Likely Eligible: Proceed to approval checklist
- Most ✅ = Possibly Eligible: Complete missing requirements
- Many ❌ = Not Yet Eligible: Work with endocrinologist on diagnosis
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Humana MA plans | Humana PA Search Tool | Humana Provider Portal |
| Age Limit | 2-18 years, open growth plates | FDA prescribing information | FDA Label |
| Specialist Requirement | Pediatric endocrinologist prescription | Insurance policy criteria | Verify with plan |
| IGF-1 Testing | ≤3 SD below normal for age/sex | Lab report from certified facility | Clinical documentation |
| GH Testing | Peak ≥7-10 ng/mL on stimulation | Endocrinology testing results | Clinical records |
| Safety Plan | Hypoglycemia monitoring protocol | Treatment plan documentation | Provider notes |
| Submission Method | CoverMyMeds electronic portal | CoverMyMeds | Humana requirements |
| Appeal Deadline | 65 days from denial notice | Denial letter instructions | CMS regulations |
Step-by-Step: Fastest Path to Approval
1. Confirm Diagnosis (Patient + Endocrinologist)
- Request complete IGF-1 and GH stimulation test results
- Verify height measurements are ≤3 SD below normal
- Timeline: 1-2 weeks for lab scheduling
2. Gather Required Documentation (Clinic Staff)
- Medical records showing diagnosis confirmation
- All lab values with normal ranges and dates
- Prior treatment history (if any)
- Timeline: 3-5 business days
3. Submit Prior Authorization (Provider)
- Use CoverMyMeds portal for electronic submission
- Include all clinical documentation
- Timeline: Same-day submission possible
4. Track Decision (Patient/Provider)
- Humana aims for decisions within 1 business day for complete requests
- Monitor via provider portal or member services
- Timeline: 24-72 hours typically
5. If Approved (Pharmacy)
- Coordinate specialty pharmacy delivery
- Schedule initial safety training
- Timeline: 3-7 days for first shipment
6. If Denied (Patient + Provider)
- Review denial reason within 65 days
- Prepare appeal with additional documentation
- Timeline: Begin appeal process immediately
7. Monitor and Renew (Ongoing)
- Track growth response and safety parameters
- Submit renewal requests annually
- Timeline: Begin 30 days before current approval expires
If You're Likely Eligible
Document Checklist:
- Pediatric endocrinologist consultation notes
- IGF-1 lab values (with normal ranges for age/sex)
- GH stimulation test results
- Height measurements and growth charts
- Documentation excluding secondary causes
- Proposed dosing and monitoring plan
- Insurance card and member ID
Submission Path: Your endocrinologist should submit via CoverMyMeds with complete clinical justification. Most approvals for well-documented cases occur within 24-72 hours.
If You're Possibly Eligible
Tests to Request:
- Complete IGF-1 and IGFBP-3 levels
- GH stimulation test (if not done)
- Genetic testing for IGF-1 deficiency
- Comprehensive metabolic panel to exclude secondary causes
What to Track:
- Growth velocity measurements
- Response to any prior treatments
- Family history of growth disorders
- Timeline to re-apply: 4-6 weeks after completing testing
If You're Not Yet Eligible
Alternatives to Discuss:
- Growth hormone therapy (if GH deficient)
- Nutritional optimization
- Treatment of underlying conditions
- Clinical trial opportunities
Prepare for Exception Requests: If standard criteria aren't met but clinical need is compelling, work with your endocrinologist to prepare a detailed medical necessity letter addressing why standard alternatives are insufficient.
If Your Request is Denied
Appeal Path Chooser:
Internal Appeal (First Level)
- File within 65 days of denial notice
- Submit via Humana appeals process
- Include additional clinical documentation
- Timeline: 7 days for standard, 72 hours for expedited
Peer-to-Peer Review
- Request direct physician consultation
- Your endocrinologist speaks with Humana medical director
- Often resolves complex cases quickly
- Timeline: Can be scheduled within 1-2 business days
External Review (New Jersey IHCAP)
- Available after internal appeals exhausted
- File within 120 days through Maximus Federal Services
- Independent medical review at no cost
- Timeline: 45 days standard, 48 hours expedited
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "Not primary IGF-1 deficiency" | Submit genetic testing results and exclude GH deficiency | IGF-1 generation test, normal GH stimulation |
| "Insufficient lab documentation" | Provide age/sex-adjusted IGF-1 values | Certified lab report with percentiles |
| "Missing safety plan" | Detail hypoglycemia monitoring protocol | Treatment plan template |
| "Not medically necessary" | Demonstrate growth failure despite optimal nutrition | Growth charts, nutritional assessment |
| "Experimental/investigational" | Reference FDA approval for primary IGF-1 deficiency | FDA prescribing information |
New Jersey External Review Process
If Humana denies your internal appeals, New Jersey's Independent Health Care Appeals Program (IHCAP) provides an independent medical review through Maximus Federal Services.
How to File:
- Register at njihcap.maximus.com
- Upload required documents within 120 days of final denial
- Include signed consent forms and medical records
- Submit electronically or mail to: Maximus Federal-NJ IHCAP, 3750 Monroe Ave Suite 705, Pittsford, NY 14534
Timeline:
- Standard Review: Decision within 45 days
- Expedited Review: Decision within 48 hours for urgent cases
- Cost: Free to patients (insurers pay all fees)
Success Factors: Include comprehensive clinical documentation showing medical necessity and addressing the original denial reasons. The independent physicians reviewing your case will consider all submitted evidence.
For questions, call the IHCAP hotline at 1-888-866-6205.
Clinician Corner: Medical Necessity Letter
Essential Elements for Increlex Approval:
Patient Information:
- Age, weight, height with percentiles
- Diagnosis with ICD-10 codes
- Duration and severity of growth failure
Clinical Justification:
- IGF-1 levels with lab normal ranges
- GH stimulation test results
- Exclusion of secondary causes (malnutrition, chronic disease)
- Previous treatments attempted and outcomes
Safety Monitoring Plan:
- Hypoglycemia prevention and management protocol
- Dosing schedule (starting at 0.04-0.08 mg/kg BID)
- Monitoring frequency and parameters
- Emergency contact information
Supporting Evidence:
- FDA prescribing information
- Published treatment guidelines
- Growth velocity predictions with treatment
From Our Advocates: In our experience helping families navigate Increlex approvals, the most successful cases include detailed growth charts spanning at least 6-12 months, comprehensive lab work excluding all secondary causes, and a clear safety monitoring plan addressing hypoglycemia risk. One family's initial denial was overturned within days after submitting genetic testing confirming primary IGF-1 deficiency—documentation that clearly distinguished their case from more common GH deficiency.
Costs and Patient Support Programs
Estimated Costs:
- Retail price: ~$16,000 per 4 mL vial
- Typical treatment: 2-4 vials monthly depending on weight and dose
Support Options:
- Ipsen Cares Patient Support Program: May offer copay assistance and prior authorization support (verify current eligibility at manufacturer website)
- Foundation Grants: Research rare disease foundations for potential assistance
- State Programs: New Jersey may have additional support for rare disease medications
Contact your specialty pharmacy to explore all available cost reduction options.
At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific rebuttal letters. Our platform analyzes denial reasons and drafts point-by-point responses aligned to each plan's own policies, significantly improving approval rates for complex specialty medications like Increlex.
FAQ
How long does Humana prior authorization take for Increlex? Humana aims for decisions within 1 business day for complete electronic submissions. Complex cases may take up to 72 hours.
What if Increlex is not on Humana's formulary? You can request a formulary exception through Humana's standard process, providing medical necessity documentation showing why formulary alternatives are inappropriate.
Can I request an expedited review? Yes, if delay would seriously jeopardize your health or ability to function. Your doctor must provide a statement supporting the urgency.
Does step therapy apply to Increlex? Some plans may require trying growth hormone first if GH deficiency hasn't been definitively ruled out. Your endocrinologist should document why GH therapy is inappropriate.
What happens if I move out of New Jersey during treatment? Your Humana coverage should continue, but appeal rights would follow your new state's regulations. Contact member services to confirm.
How often do I need to renew prior authorization? Typically annually, with documentation of continued medical necessity and growth response to treatment.
Can my pediatrician prescribe Increlex instead of an endocrinologist? Most insurance plans require prescription by or consultation with a board-certified pediatric endocrinologist due to the complexity of diagnosis and monitoring.
What if Humana requires me to try other treatments first? Work with your endocrinologist to document why alternatives like growth hormone or nutritional interventions are inappropriate for primary IGF-1 deficiency.
Sources & Further Reading
- Humana Prior Authorization Search Tool
- Humana Medicare Part D Appeals Process
- CoverMyMeds Electronic Prior Authorization
- New Jersey IHCAP External Review Portal
- NJ Department of Banking and Insurance - Appeals
- FDA Increlex Prescribing Information
- Increlex Coverage Criteria Examples
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements directly with Humana and consult with your healthcare providers for medical decisions. For personalized assistance with insurance appeals, Counterforce Health specializes in turning denials into approvals through targeted, evidence-based appeal letters.
For additional consumer assistance in New Jersey, contact the Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or the IHCAP hotline at 1-888-866-6205.
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