By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (Mecasermin) Covered by Blue Cross Blue Shield in Georgia: Coding, Appeals & Prior Authorization Guide

Quick Answer: Getting Increlex Covered in Georgia

Eligibility: Children with severe primary IGF-1 deficiency meeting strict diagnostic criteria. Fastest path: Submit prior authorization with complete diagnostic documentation (height ≤-3 SD, IGF-1 ≤-3 SD, normal GH levels). First step today: Contact your Blue Cross Blue Shield plan to confirm current PA form and submission portal. Georgia advantage: If denied, you have robust external review rights through the Georgia Department of Insurance within 60 days of final internal denial.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Increlex (mecasermin) typically falls under medical benefit coverage rather than pharmacy benefit for most Blue Cross Blue Shield plans. This means:

  • Billing path: Office administration using HCPCS J2170
  • Prior authorization: Required through medical management, not pharmacy
  • Coverage determination: Based on medical necessity criteria, not formulary tier
  • Appeals: Follow medical benefit appeal process
Note: Some Blue Cross plans may require specialty pharmacy dispensing even when covering under medical benefit. Always verify your specific plan's pathway.

The coding strategy directly impacts approval success. Counterforce Health helps healthcare providers navigate these complex coding requirements by analyzing payer-specific policies and generating targeted prior authorization requests that align with each plan's unique criteria.

ICD-10 Mapping for IGF-1 Deficiency

Primary Diagnosis Codes

E34.321 - Primary insulin-like growth factor-1 (IGF-1) deficiency

  • Most specific code for severe primary IGF-1 deficiency
  • Supports medical necessity for Increlex
  • Required documentation: IGF-1 levels ≤-3 SD for age/sex

E34.322 - Secondary insulin-like growth factor-1 (IGF-1) deficiency

  • Use when IGF-1 deficiency is secondary to another condition
  • May require additional justification for Increlex vs. treating underlying cause

Supporting Diagnosis Codes

E34.3 - Short stature due to endocrine disorder

  • Height ≤-3 SD for age and sex
  • Growth velocity documentation helpful

Z87.891 - Personal history of nicotine dependence (if applicable)

  • Can support medical necessity by ruling out nutritional causes

Documentation Requirements for Coding

Your medical record must include:

  • Height measurements: Current height in cm and percentile/SD for age
  • IGF-1 laboratory results: With reference ranges and SD calculations
  • Growth hormone levels: To exclude GH deficiency
  • Thyroid function: TSH within normal limits
  • Nutritional assessment: Evidence of adequate nutrition

Product Coding: HCPCS J2170 and NDC Units

HCPCS Code Details

J2170 - Injection, mecasermin, 1 mg

  • Each unit = 1 mg of mecasermin administered
  • Subcutaneous administration
  • Weight-based dosing calculation required

NDC and Vial Information

Increlex NDC: 54436-0231-01 (verify current NDC)

  • Concentration: 10 mg/mL
  • Vial size: 4 mL (40 mg total)
  • NDC units: Reported in mL administered

Dosing Calculation Example

For a 25 kg child on 0.08 mg/kg twice daily:

  • Per-dose calculation: 25 kg × 0.08 mg/kg = 2.0 mg
  • HCPCS units per dose: 2 units (J2170)
  • Volume per dose: 2.0 mg ÷ 10 mg/mL = 0.2 mL
  • NDC units per dose: 0.2 units
Critical: Always document patient weight on dosing date and show calculation in medical record.

Clean Prior Authorization Anatomy

Essential Components

  1. Patient demographics with correct member ID
  2. Prescribing physician (pediatric endocrinologist preferred)
  3. Diagnosis codes: E34.321 as primary
  4. Clinical documentation:
    • Height: [X] cm (≤-3 SD)
    • IGF-1: [X] ng/mL (≤-3 SD for age)
    • GH: [X] ng/mL (normal/elevated)
    • TSH: [X] mIU/L (normal)
  5. Dosing details: Starting at 0.04 mg/kg BID, max 0.12 mg/kg BID
  6. Safety plan: Hypoglycemia monitoring and meal timing protocol
  7. HCPCS/NDC: J2170 with calculated units

Medical Necessity Letter Template

"[Patient] is a [age]-year-old child with severe primary IGF-1 deficiency confirmed by:

  • Height of [X] cm (≤-3 SD for age)
  • IGF-1 level of [X] ng/mL (≤-3 SD for age)
  • Normal GH response of [X] ng/mL
  • Normal thyroid function (TSH [X])
  • Adequate nutritional status

Increlex is FDA-approved and the only available treatment for this rare condition. Alternative treatments (growth hormone, nutritional support) are not appropriate as the patient has normal GH levels and adequate nutrition. The requested dose of [X] mg/kg BID is within FDA-approved parameters."

Frequent Coding Pitfalls

Unit Conversion Errors

  • Wrong: Billing J2170 units based on vial size (40 units)
  • Right: Billing actual mg administered (e.g., 2 units for 2 mg dose)

Mismatched Diagnosis Codes

  • Wrong: Using E23.0 (hypopituitarism) for primary IGF-1 deficiency
  • Right: E34.321 for primary IGF-1 deficiency with supporting labs

Missing Weight Documentation

  • Wrong: Static dosing without weight updates
  • Right: Current weight with date and dose recalculation

Incomplete Safety Documentation

  • Wrong: No mention of hypoglycemia risk
  • Right: Detailed monitoring plan and caregiver education

Verification with Blue Cross Blue Shield

Before Submission Checklist

  1. Confirm current PA form: Blue Cross plans update forms regularly
  2. Verify submission method: Online portal vs. fax vs. mail
  3. Check formulary status: Medical vs. pharmacy benefit pathway
  4. Review plan-specific criteria: Age limits, lab thresholds, prescriber requirements

Key Blue Cross Resources

  • Provider portal: Anthem.com (for Georgia Blue Cross Blue Shield)
  • PA forms: Available through provider portal
  • Coverage policies: Search "mecasermin" or "Increlex" in medical policies
  • Member services: Use provider line for submission guidance
Tip: Save screenshots of current PA forms and criteria - they can change quarterly.

Appeals Playbook for Georgia

Internal Appeal (First Level)

Timeline: 30 days from denial date to file Process: Submit through Blue Cross member portal or mail Required documents:

  • Original denial letter
  • Medical necessity letter
  • Updated clinical documentation
  • Peer-reviewed literature supporting use

External Review (Georgia DOI)

Timeline: 60 days from final internal denial Authority: Georgia Office of Commissioner of Insurance Process: Submit application to Georgia DOI Consumer Services Cost: Free to consumer Phone: 1-800-656-2298

Required for external review:

  • Completed Georgia external review application
  • Copy of final internal denial letter
  • All supporting medical records
  • Statement explaining why service is medically necessary

Expedited Appeals

Available when delay could seriously jeopardize patient health. Can be filed concurrently with internal appeal if urgent.

When dealing with complex appeal requirements, Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed rebuttals that address each payer's specific criteria and procedural requirements.

Common Denial Reasons & Fixes

Denial Reason Fix Strategy
"Not primary IGF-1 deficiency" Submit GH stimulation test results showing normal/elevated GH
"Inadequate growth failure documentation" Provide serial height measurements over 6+ months
"Missing safety monitoring plan" Detail hypoglycemia monitoring protocol and caregiver education
"Experimental/investigational" Cite FDA approval date (2005) and indication
"Step therapy required" Document contraindications to GH therapy or failure of adequate nutrition

Quick Audit Checklist

Before submission, verify:

  • Patient weight documented on dosing date
  • HCPCS units match mg administered (not vial contents)
  • Primary diagnosis E34.321 with supporting labs
  • IGF-1 and GH levels with reference ranges
  • Prescriber is pediatric endocrinologist (preferred)
  • Dosing within FDA parameters (≤0.12 mg/kg BID)
  • Hypoglycemia monitoring plan documented
  • Current Blue Cross PA form used
From our advocates: We've seen the most success when providers include a simple calculation table showing patient weight, prescribed mg/kg dose, total mg per dose, and resulting HCPCS units. This transparency helps reviewers verify dosing accuracy quickly and builds trust in the request.

FAQ

How long does Blue Cross Blue Shield PA take in Georgia? Standard PA decisions: 15 business days. Expedited (urgent): 72 hours. Submit complete documentation to avoid delays.

What if Increlex is non-formulary? Most Blue Cross plans cover Increlex under medical benefit, not pharmacy formulary. If denied as non-formulary, request medical benefit review.

Can I request an expedited appeal? Yes, if continued delay poses serious health risk. Available for both internal and external appeals in Georgia.

Does step therapy apply to Increlex? Some plans require trial of growth hormone first, but this can be overridden if patient has normal GH levels (primary IGF-1 deficiency).

What's the maximum dose Blue Cross will cover? FDA maximum is 0.12 mg/kg twice daily. Higher doses are not approved and unlikely to be covered.

How often do I need reauthorization? Typically annually, with growth velocity and safety monitoring documentation required.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage varies by plan. Always consult your healthcare provider and verify current requirements with your specific Blue Cross Blue Shield plan. For appeals assistance, contact Georgia DOI Consumer Services at 1-800-656-2298.

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