By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (mecasermin) Covered by Cigna in Ohio: Coding, Appeals, and External Review Guide

Quick Answer: Getting Cigna to Cover Increlex (mecasermin) in Ohio

Increlex (mecasermin) requires Cigna prior authorization with specific clinical documentation. Your pediatric endocrinologist must submit: ICD-10 code E34.321 (Primary IGF-1 deficiency), lab values showing IGF-1 ≤-3.0 SDS, growth charts with height ≤-3.0 SDS, and normal/elevated growth hormone tests. If denied, you have 180 days to appeal internally, then external review through Ohio's Department of Insurance within another 180 days. Start today: Call your clinic to ensure they have complete growth records and recent IGF-1 labs, then have them submit the PA request through Cigna's provider portal.

Table of Contents

  1. Understanding Increlex Coverage with Cigna
  2. ICD-10 Coding for Severe Primary IGF-1 Deficiency
  3. Medical vs. Pharmacy Benefit: HCPCS and NDC Codes
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Appeals Process in Ohio
  7. Cost Assistance and Resources
  8. Pre-Submission Checklist

Understanding Increlex Coverage with Cigna

Increlex (mecasermin) is a specialty medication for severe primary IGF-1 deficiency in children. Cigna typically manages this drug through their specialty pharmacy network, often Express Scripts/Accredo, and requires prior authorization regardless of your specific plan.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Cigna Provider Portal
Formulary Status Specialty tier, medical benefit Member portal or call 1-800-88CIGNA
Age Limits ≥2 years with open growth plates FDA Label
Prescriber Requirement Pediatric endocrinologist preferred Cigna medical policy
Renewal Annual review required After 12 months of therapy

Note: Self-funded employer plans may have different requirements but often follow similar processes.

ICD-10 Coding for Severe Primary IGF-1 Deficiency

The correct diagnosis code is crucial for approval. Use ICD-10 code E34.321 (Primary insulin-like growth factor-1 deficiency) as the primary diagnosis.

Supporting Documentation Requirements

Your medical records must clearly document:

  • Height measurements: Standard deviation score (SDS) ≤ -3.0 using WHO growth charts
  • IGF-1 lab values: Basal IGF-1 SDS ≤ -3.0 (adjusted for age, sex, and pubertal stage)
  • Growth hormone testing: Normal or elevated GH via stimulation tests (clonidine, arginine)
  • Exclusion of secondary causes: Rule out malnutrition, liver disease, or GH deficiency
Tip: Include bone age assessment showing delay < -2.0 SDS using Greulich-Pyle standards to strengthen your case.

Alternative Codes to Avoid

Don't use these codes as primary diagnoses, as they may trigger denials:

  • E23.0 (Hypopituitarism) - suggests GH deficiency instead
  • R62.52 (Short stature) - too general
  • E45 (Malnutrition) - indicates secondary IGF-1 deficiency

Medical vs. Pharmacy Benefit: HCPCS and NDC Codes

Increlex is covered under medical benefit (not pharmacy benefit) because it's a physician-administered injection requiring monitoring.

Billing Codes

Code Type Code Description Units
HCPCS J2170 Injection, mecasermin, 1 mg Per 1 mg
NDC 15054-1040-05 10 mg/mL, 4 mL vial 40 mg total per vial
CPT 96372 Subcutaneous injection Per administration

Dosing and Quantity Calculations

Starting dose: 0.04-0.08 mg/kg twice daily, increasing to maximum 0.12 mg/kg twice daily if tolerated.

Monthly vial calculation:

  • Formula: [dose (mg/kg) × 2 doses/day × 30 days × weight (kg)] ÷ 40 mg/vial
  • Example for 20 kg child at 0.08 mg/kg: (0.08 × 2 × 30 × 20) ÷ 40 = 2.4 vials/month (round up to 3)

Counterforce Health helps patients and clinicians streamline these complex calculations and ensure accurate billing submissions that reduce back-and-forth with insurers.

Clean Prior Authorization Request

Required Clinical Information

Your pediatric endocrinologist should include:

  1. Patient demographics: Full name, DOB, member ID, policy number
  2. Diagnosis: ICD-10 E34.321 with supporting clinical narrative
  3. Lab values: IGF-1 and IGFBP-3 levels with reference ranges and SDS calculations
  4. Growth data: Current height, weight, BMI with SDS scores; growth velocity
  5. GH testing: Stimulation test results showing normal/elevated response
  6. Treatment history: Previous therapies tried and failed (if any)
  7. Dosing plan: Weight-based calculation with administration schedule
  8. Monitoring plan: Safety assessments for hypoglycemia risk

Medical Necessity Letter Template

"This [age]-year-old patient has severe primary IGF-1 deficiency confirmed by height SDS of [value] ≤ -3.0 and IGF-1 SDS of [value] ≤ -3.0. Growth hormone stimulation testing revealed [results], excluding GH deficiency. Secondary causes including malnutrition and liver disease have been ruled out through [specific tests]. Increlex (mecasermin) is FDA-approved and medically necessary for this rare condition affecting fewer than 1 in 100,000 children."

Common Coding Pitfalls

Unit Conversion Errors

  • Wrong: Billing 1 unit for entire vial
  • Right: Billing 40 units for one 4 mL vial (1 mg = 1 unit)

Missing Modifiers

Add modifier JA or JB if administering multiple routes of injection on the same day, per CMS guidelines.

Diagnosis Mismatches

Ensure your ICD-10 code matches the clinical documentation. Cigna's automated systems flag inconsistencies between E34.321 and growth charts showing normal height.

Appeals Process in Ohio

If Cigna denies your initial request, Ohio provides strong consumer protections through structured appeal rights.

Internal Appeals Timeline

Level Filing Deadline Cigna Response Time
Level 1 180 days from denial 30 days (72 hours if urgent)
Level 2 60 days from Level 1 denial 30-60 days

Submit appeals to: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422

External Review (Ohio Department of Insurance)

After exhausting internal appeals, you can request an independent medical review:

  • Filing deadline: 180 days from final internal denial
  • Cost: Free to patients
  • Timeline: 30 days standard, 72 hours for urgent cases
  • Contact: Ohio DOI Consumer Services at 1-800-686-1526

The external review decision is binding on Cigna if it overturns the denial.

From our advocates: We've seen families succeed by emphasizing the rare disease nature of severe primary IGF-1 deficiency in their appeals. Include peer-reviewed studies showing the drug's efficacy and safety profile, plus documentation of the child's quality-of-life impact from growth failure. Independent reviewers often overturn denials when presented with comprehensive clinical evidence that wasn't properly evaluated initially.

Ohio Step Therapy Protections

Under Ohio Revised Code 3901.832, Cigna must approve exceptions to step therapy if:

  • The preferred drug is contraindicated per FDA labeling
  • Patient has tried and failed the insurer's preferred alternative
  • Patient is stable on current therapy from a previous plan
  • The alternative is inappropriate for the patient's condition

Cost Assistance and Resources

Manufacturer Support

Ipsen offers the CARES patient assistance program providing $0 copay for commercially insured patients. Contact your specialty pharmacy or clinic to enroll.

Additional Resources

  • UHCAN Ohio (Universal Health Care Action Network): Consumer advocacy and appeal assistance
  • Ohio Department of Insurance: Consumer complaint portal for coverage disputes
  • Counterforce Health: Specialized platform that helps turn insurance denials into targeted, evidence-backed appeals for specialty medications like Increlex

Pre-Submission Checklist

Before submitting your prior authorization:

✓ Patient information: Insurance card, member ID, policy details
✓ Clinical documentation: Complete growth charts spanning ≥6 months
✓ Lab results: IGF-1, IGFBP-3 with reference ranges and SDS calculations
✓ GH testing: Stimulation test results with methodology
✓ Imaging: Bone age X-ray with radiologist interpretation
✓ Specialist consultation: Pediatric endocrinology evaluation and recommendation
✓ Dosing calculation: Weight-based dose with monthly vial requirements
✓ Safety plan: Hypoglycemia monitoring and emergency protocols

Verification Steps

  1. Confirm coverage: Call Cigna member services to verify specialty drug benefits
  2. Check network: Ensure your pediatric endocrinologist is in-network
  3. Specialty pharmacy: Verify Express Scripts/Accredo as your assigned pharmacy
  4. Portal access: Confirm prescriber can submit through Cigna's provider portal

Frequently Asked Questions

How long does Cigna prior authorization take for Increlex?
Standard reviews take 2-3 business days; expedited reviews are completed within 24 hours for urgent medical situations.

What if Increlex is non-formulary on my plan?
Request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Include clinical guidelines supporting off-formulary use.

Can I request an expedited appeal in Ohio?
Yes, if delaying treatment would seriously jeopardize your health. Both Cigna and Ohio's external review process offer expedited timelines (72 hours).

Does step therapy apply if I've never tried growth hormone?
Possibly. However, if GH is contraindicated or inappropriate for primary IGF-1 deficiency, request a step therapy override using Ohio's protections.

What happens if my child turns 18 during treatment?
Coverage may continue if growth plates remain open and clinical benefit is documented. Discuss transition planning with your endocrinologist.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on your specific insurance plan and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals and prior authorization, consider contacting the Ohio Department of Insurance Consumer Services Division at 1-800-686-1526.

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