By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (mecasermin) Covered by Blue Cross Blue Shield in California: Complete Appeals Guide with Templates

Answer Box: Getting Increlex (mecasermin) Covered by Blue Cross Blue Shield California

Fastest path to approval: Your pediatric endocrinologist must submit prior authorization with documented severe primary IGF-1 deficiency (height ≤ -3.0 SDS, IGF-1 ≤ -3.0 SDS, normal/elevated GH levels). If denied, file an internal appeal within 180 days, then request California Independent Medical Review (IMR) through DMHC. Success rates for specialty drug IMRs in California average 50-80%. First step today: Contact your doctor to gather IGF-1 labs, growth charts, and GH stimulation test results for the PA submission.

Table of Contents

  1. Understanding the Denial
  2. Fixing Common Issues Before Appeal
  3. First-Level Internal Appeal
  4. Peer-to-Peer Review Strategy
  5. California Independent Medical Review (IMR)
  6. Appeal Letter Templates
  7. Tracking Your Appeal
  8. Coverage Requirements at a Glance
  9. Costs & Financial Assistance
  10. FAQ

Understanding the Denial

When Blue Cross Blue Shield California denies Increlex (mecasermin), the reason typically falls into one of these categories:

Common Denial Codes & Meanings:

  • Prior authorization required: Your doctor didn't submit PA paperwork first
  • Not medically necessary: Missing documentation for severe primary IGF-1 deficiency criteria
  • Step therapy: Plan requires trying growth hormone therapy first (even though this may be inappropriate for true IGF-1 deficiency)
  • Non-formulary: Increlex isn't on your plan's preferred drug list
  • Quantity limits exceeded: Dosing exceeds plan's maximum allowed
Critical: Read your denial letter carefully for specific appeal deadlines. Blue Cross Blue Shield California typically allows 180 days for commercial plans to file internal appeals, but this can vary by plan type.

Fixing Common Issues Before Appeal

Before launching a formal appeal, check if these fixable issues caused the denial:

Missing Documentation Checklist

  • Recent IGF-1 lab results showing levels ≤ -3.0 SDS
  • Growth hormone stimulation test results (normal/elevated)
  • Growth charts with height ≤ -3.0 standard deviation scores
  • Bone age X-ray confirming open growth plates
  • Pediatric endocrinologist consultation notes
  • Documentation excluding secondary causes (thyroid, nutrition labs)

Coding Issues

Sometimes the denial stems from incorrect billing codes. Increlex should be billed with:

  • HCPCS Code: J2170 (mecasermin injection)
  • ICD-10: E34.3 (Short stature due to endocrine disorder)

Contact your doctor's office to verify correct coding was used.

First-Level Internal Appeal

Step-by-Step Internal Appeal Process

1. Gather Required Documents (Week 1)

  • Original denial letter
  • Complete medical records supporting diagnosis
  • Pediatric endocrinologist letter of medical necessity
  • Lab reports and imaging studies

2. Submit Appeal (Week 1-2) Blue Cross Blue Shield California accepts appeals via:

  • Provider portal: Most efficient method
  • Fax: (verify current fax number with customer service)
  • Mail: Appeals Department address on your denial letter

3. Timeline Expectations

  • Standard appeals: 30 calendar days for decision
  • Expedited appeals: 72 hours (for urgent medical situations)
  • No response: If BCBS doesn't respond within timeframes, the appeal is automatically approved

Medical Necessity Letter Requirements

Your pediatric endocrinologist's letter must include:

  1. Diagnosis confirmation: Severe primary IGF-1 deficiency with specific lab values
  2. Exclusion of alternatives: Why growth hormone therapy failed or is inappropriate
  3. Clinical rationale: Reference to FDA prescribing information and pediatric endocrine guidelines
  4. Safety monitoring plan: Hypoglycemia prevention and management protocols
  5. Treatment goals: Expected outcomes and monitoring parameters

Peer-to-Peer Review Strategy

If your appeal is initially denied, request a peer-to-peer review between your pediatric endocrinologist and the plan's medical director.

Preparation Checklist for Your Doctor

Key Talking Points:

  • Distinguish severe primary IGF-1 deficiency from growth hormone deficiency
  • Emphasize normal/elevated GH stimulation test results
  • Reference specific FDA indications for Increlex
  • Discuss failed or inappropriate alternative therapies

Documentation to Have Ready:

  • Growth velocity charts showing <2 cm/year growth
  • IGF-1 levels consistently below -3.0 SDS
  • Evidence of excluded secondary causes
  • Previous treatment history and outcomes
From our advocates: We've seen peer-to-peer reviews succeed when the pediatric endocrinologist clearly explains why this isn't standard growth hormone deficiency and why Increlex is the only appropriate therapy for this rare condition. Having the actual lab values and growth charts readily available during the call makes a significant difference.

California Independent Medical Review (IMR)

If your internal appeal fails, California's Independent Medical Review offers a powerful second chance. According to DMHC data, Blue Shield of California had a 55.3% overturn rate for medical necessity denials in 2023, with an additional 25.5% reversed by the plan—over 80% success rate overall.

How to Request IMR

1. Eligibility Requirements

  • Must have completed internal appeal process first
  • Denial based on medical necessity or experimental/investigational status
  • Request within 6 months of final internal denial

2. Filing Process

  • Online: healthhelp.ca.gov
  • Phone: DMHC Help Center at 888-466-2219
  • Mail: Submit IMR application with supporting documents

3. Timeline

  • Standard IMR: 45 days for decision
  • Expedited IMR: 72 hours for urgent cases
  • Cost: Free to patients (insurer pays review costs)

IMR Success Factors

Independent medical experts reviewing your case will look for:

  • Clear documentation of severe primary IGF-1 deficiency diagnosis
  • Evidence that standard therapies are inappropriate or have failed
  • Compliance with FDA-approved indications for Increlex
  • Detailed clinical rationale from pediatric endocrinologist

Appeal Letter Templates

Internal Appeal Letter Template

[Date]
Blue Cross Blue Shield of California
Appeals Department
[Address from denial letter]

Re: Appeal for Coverage of Increlex (mecasermin)
Member: [Name], ID: [Number], DOB: [Date]
Claim/Reference Number: [From denial letter]

Dear Appeals Review Team:

I am formally appealing the denial of coverage for Increlex (mecasermin) for [patient name], who has been diagnosed with severe primary IGF-1 deficiency by pediatric endocrinologist Dr. [Name].

**Medical Necessity Documentation:**

1. **Confirmed Diagnosis**: Patient meets FDA criteria for severe primary IGF-1 deficiency:
   - Height SDS: [value] (≤ -3.0 required)
   - IGF-1 level: [value] (≤ -3.0 SDS required)
   - GH stimulation test: [value] (normal/elevated, confirming this is not GH deficiency)

2. **Exclusion of Secondary Causes**: All potential secondary causes have been ruled out with normal thyroid function ([values, date]) and adequate nutrition status ([values, date]).

3. **Treatment Rationale**: Per FDA prescribing information, Increlex is indicated for children ≥2 years with severe primary IGF-1 deficiency who have normal or elevated GH levels. Standard growth hormone therapy is inappropriate for this condition.

4. **Safety Protocols**: Comprehensive hypoglycemia monitoring plan has been established with patient/caregiver education and glucose monitoring equipment.

**Supporting Documentation Attached:**
- Pediatric endocrinologist consultation letter
- Laboratory results (IGF-1, GH stimulation, thyroid, nutrition)
- Growth charts and bone age X-ray
- FDA prescribing information excerpt
- Hypoglycemia management plan

This treatment is medically necessary and appropriate per established clinical guidelines. I respectfully request reconsideration of coverage.

Sincerely,
[Signature]
[Contact Information]

Peer-to-Peer Request Script

"I'm calling to request a peer-to-peer review for [patient name], member ID [number]. We have a pediatric patient with severe primary IGF-1 deficiency who was denied coverage for Increlex. Our pediatric endocrinologist has documentation showing this meets FDA criteria and is distinct from growth hormone deficiency. When can we schedule the peer-to-peer call?"

Tracking Your Appeal

Appeal Log Template

Date Action Taken Method Confirmation # Follow-up Date Status
[Date] Submitted internal appeal Portal/Fax [Number] [+30 days] Pending
[Date] Called for status update Phone [Ref] [+7 days] In review

When to Escalate

Contact California regulators if:

  • Blue Cross Blue Shield misses appeal deadlines
  • You're not receiving timely responses
  • The process seems unfair or discriminatory

California DMHC Help Center: 888-466-2219 File complaint online: healthhelp.ca.gov

Coverage Requirements at a Glance

Requirement Criteria Documentation Needed Source
Age ≥2 years old Birth certificate/medical records FDA Label
Height ≤ -3.0 standard deviation scores Growth charts, pediatric measurements BCBS Policy
IGF-1 Level ≤ -3.0 SDS or <2.5th percentile Laboratory results BCBS Policy
GH Testing Normal or elevated levels GH stimulation test results BCBS Policy
Specialist Pediatric endocrinologist Consultation notes and prescription BCBS Policy
Growth Plates Open epiphyses Bone age X-ray FDA Label

Costs & Financial Assistance

Increlex can cost approximately $16,000 per 4 mL vial. Financial assistance options include:

Manufacturer Support

  • Ipsen Cares Program: Patient assistance for eligible families
  • Contact: Visit Ipsen Cares website (verify current eligibility)

California State Programs

  • Medi-Cal: May cover Increlex with proper prior authorization
  • California Children's Services (CCS): For children with qualifying conditions

Foundation Grants

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation (verify current programs)
Note: Counterforce Health helps patients and clinicians navigate insurance denials by creating targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals that align with your specific plan's requirements, potentially improving your chances of approval.

FAQ

Q: How long does Blue Cross Blue Shield California prior authorization take? A: Standard PA decisions are made within 14 days for non-urgent requests, 72 hours for urgent cases. If no response is received within these timeframes, the request is automatically approved.

Q: What if Increlex is non-formulary on my plan? A: Request a formulary exception through your doctor. Include medical necessity documentation and evidence that formulary alternatives are inappropriate for severe primary IGF-1 deficiency.

Q: Can I request an expedited appeal? A: Yes, if your doctor certifies that waiting for standard appeal timelines could seriously jeopardize your health. Expedited appeals must be decided within 72 hours.

Q: Does step therapy apply if I haven't tried growth hormone? A: Step therapy requiring growth hormone first may be inappropriate for true severe primary IGF-1 deficiency, since these patients have normal/elevated GH levels. Your doctor can request a step therapy exception.

Q: What's the success rate for Increlex appeals in California? A: California IMR data shows 50-80% success rates for specialty drug appeals, particularly when proper documentation supports medical necessity and FDA-approved indications.

Q: How do I know if my plan is regulated by DMHC or CDI? A: Most HMOs and managed care plans (including most Blue Shield plans) are DMHC-regulated. Check your member handbook or call customer service to confirm your regulatory pathway.

Q: Can I get help with my appeal? A: Yes. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing your specific plan's policies and creating targeted rebuttals. California also has free consumer assistance through the DMHC Help Center.

Q: What happens if all appeals fail? A: Consider manufacturer patient assistance programs, foundation grants, or working with your doctor to explore alternative treatment approaches while continuing to document medical necessity for future appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage determinations. For personalized assistance with insurance appeals, consider consulting with healthcare advocates or legal professionals experienced in insurance law.

For additional help navigating insurance coverage challenges, the California Department of Managed Health Care provides free consumer assistance at 888-466-2219 or healthhelp.ca.gov.

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