By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (mecasermin) Covered by Humana in Florida: Prior Authorization, Appeals & Approval Strategies

Quick Answer for Florida Patients: Humana covers Increlex (mecasermin) under strict prior authorization requiring pediatric endocrinology oversight, severe primary IGF-1 deficiency diagnosis (height SDS ≤-3.0, IGF-1 SDS ≤-3.0), and documented hypoglycemia monitoring plan. Submit PA through Humana Clinical Pharmacy Review with complete lab documentation. If denied, you have 65 days to appeal under Medicare Part D rules. First step: verify your plan's formulary status and gather IGF-1/GH test results before scheduling with pediatric endocrinology.

Table of Contents

  1. Humana Plan Types & Increlex Coverage
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Requirements
  5. Medical Necessity Criteria
  6. Common Denial Reasons & Solutions
  7. Florida Appeals Process
  8. Cost Considerations
  9. Frequently Asked Questions

Humana Plan Types & Increlex Coverage

Humana's coverage of Increlex (mecasermin) varies significantly by plan type in Florida. Understanding your specific plan structure is crucial for navigating the approval process.

Medicare Advantage Plans

Humana's Medicare Advantage plans in Florida typically cover Increlex under their medical benefit (Part B) rather than the pharmacy benefit (Part D). This means the drug may be billed through buy-and-bill procedures at specialty clinics rather than traditional pharmacy dispensing.

Key implications for Medicare Advantage members:

  • Prior authorization required through Humana's medical drug management process
  • Coverage follows Humana's Increlex coverage policy (effective 7/1/2024, updated 2/19/2025)
  • Appeals follow federal Medicare Part D timelines: 65 days to file, 7 days for standard decisions

Commercial Plans (Employer-Sponsored)

For employer-sponsored plans, Increlex coverage depends on the specific contract negotiated between Humana and the employer. Most commercial plans include specialty drug coverage with prior authorization requirements.

Florida Medicaid (Healthy Horizons)

Humana's Florida Medicaid plans cover Increlex through their Preferred Drug List (PDL) with prior authorization. Submissions must be faxed to 877-486-2621 or mailed to Humana Pharmacy Operations, P.O. Box 14601, Lexington, KY 40512.

Formulary Status & Tier Placement

Checking Your Plan's Coverage

Before beginning treatment, verify Increlex's status on your specific plan:

  1. Visit Humana's Medicare Drug List tool
  2. Sign in or select your exact plan
  3. Search for "Increlex" or "mecasermin"
  4. Note the tier, quantity limits, and PA requirements
Important: Formulary status is plan-specific. Even within Humana, different contracts may have different coverage rules.

Typical Formulary Placement

When covered, Increlex is typically placed on:

  • Specialty Tier (highest cost-sharing tier)
  • Non-formulary status requiring exception requests
  • Medical benefit coverage (not traditional pharmacy)

If Increlex doesn't appear on your formulary, you can request non-formulary coverage through Humana Clinical Pharmacy Review.

Prior Authorization Requirements

Core Documentation Requirements

Humana's prior authorization for Increlex requires comprehensive clinical documentation:

Requirement Documentation Needed Source
Diagnosis Severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies FDA Label
Age/Growth Height SDS ≤-3.0, open epiphyses, bone age X-ray Growth charts, radiology reports
Laboratory IGF-1 SDS ≤-3.0, normal/elevated GH testing Lab reports with reference ranges
Prescriber Pediatric endocrinologist oversight Specialist consultation notes
Safety Plan Hypoglycemia monitoring protocol Treatment plan documentation

Submission Process

For Medicare Advantage/Part D Plans:

  • Submit through Humana's electronic PA portal (if available)
  • Fax to Clinical Pharmacy Review (number on formulary page)
  • Include all supporting documentation

For Florida Medicaid Plans:

  • Fax: 877-486-2621
  • Mail: Humana Pharmacy Operations, P.O. Box 14601, Lexington, KY 40512

Decision Timelines

  • Standard review: 7 calendar days for benefits decisions
  • Expedited review: 72 hours if delay could seriously jeopardize health
  • Payment appeals: 14 calendar days

Specialty Pharmacy Requirements

CenterWell Specialty Pharmacy

Humana operates CenterWell Specialty Pharmacy, which provides:

  • Mail-order dispensing to Florida addresses
  • Prior authorization coordination
  • Hypoglycemia counseling and monitoring support
  • Financial assistance program navigation

Network Requirements

Florida Humana members must use in-network specialty pharmacies. Using out-of-network pharmacies typically means paying full retail cost (approximately $16,000 per 4 mL vial).

To find in-network specialty pharmacies:

  1. Use Humana's "Find a Pharmacy" tool
  2. Filter for "specialty" status
  3. Confirm they stock Increlex before transferring prescriptions

Medical Necessity Criteria

Severe Primary IGF-1 Deficiency (SPIGFD)

Humana's approval requires meeting all of the following criteria:

Growth Parameters:

  • Height SDS ≤-3.0 for age and sex
  • Poor growth velocity (typically <-1 to -2 SDS)
  • Open epiphyses confirmed by X-ray

Laboratory Requirements:

  • IGF-1 SDS ≤-3.0 for age and sex (persistent)
  • Normal or elevated GH on stimulation testing
  • Exclusion of secondary causes (thyroid function, nutritional status)

Clinical Exclusions:

  • Not due to GH deficiency, malnutrition, or hypothyroidism
  • No active or suspected malignancy
  • No closed epiphyses

Hypoglycemia Monitoring Plan

Insurance approval requires a documented safety protocol including:

  • Administration within 20 minutes of meals/snacks
  • Dose withholding when child cannot eat normally
  • Caregiver education on hypoglycemia recognition and treatment
  • Regular endocrinology follow-up every 3-6 months

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient IGF-1 documentation Submit complete lab reports with age/sex-adjusted reference ranges IGF-1 with SDS calculation
GH deficiency not ruled out Provide GH stimulation test results showing normal/elevated levels Endocrine testing reports
Secondary causes not excluded Submit thyroid function, nutritional assessment, growth history TSH, free T4, clinical notes
Non-specialist prescriber Transfer care to pediatric endocrinologist Specialist consultation
Missing safety plan Document hypoglycemia monitoring protocol Treatment plan with safety measures

Strengthening Your Appeal

When facing a denial, include:

  • Point-by-point rebuttal addressing each denial reason
  • Additional clinical documentation supporting medical necessity
  • Peer-reviewed literature on IGF-1 deficiency treatment
  • Prescriber letter explaining why alternatives are inappropriate

Counterforce Health specializes in turning insurance denials into evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft targeted rebuttals that align with payer-specific requirements.

Florida Appeals Process

Medicare Part D Appeals (Most Common)

Level 1: Redetermination (Humana)

  • Deadline: 65 days from denial notice
  • Decision time: 7 days (standard), 72 hours (expedited)
  • How to file: Humana member portal or mail/fax

Level 2: Independent Review Entity (IRE)

  • Deadline: 60 days from Level 1 decision
  • Decision time: 7 days (standard), 72 hours (expedited)
  • Process: Automatic referral to independent reviewer

Level 3: Administrative Law Judge (OMHA)

  • Deadline: 60 days from Level 2 decision
  • Minimum amount: $180 (2024)
  • Process: Formal hearing with federal judge

Florida State Resources

For additional help with appeals:

  • Florida Division of Consumer Services: 1-877-MY-FL-CFO (877-693-5236)
  • Online complaint portal: Submit insurance concerns through Florida Department of Financial Services
  • External review: Available after exhausting internal appeals
From our advocates: "We've seen Florida families succeed by requesting expedited reviews when a child's growth window is closing. Document any delay in treatment as potentially harmful to maximize function, and most reviewers will prioritize the case within 72 hours instead of the standard 7-day timeline."

Cost Considerations

Typical Cost-Sharing

Even with coverage, Increlex involves significant out-of-pocket costs:

  • Specialty tier coinsurance: Often 25-40% of drug cost
  • Annual out-of-pocket maximums: Vary by plan
  • Deductible requirements: May apply before coverage begins

Financial Assistance Options

Manufacturer Support:

Foundation Grants:

  • Patient advocacy organizations may offer assistance for rare disease treatments
  • Applications often require financial documentation and clinical justification

Frequently Asked Questions

How long does Humana prior authorization take in Florida? Standard decisions take 7 days for benefits, 14 days for payment appeals. Expedited reviews are completed within 72 hours when medical urgency is documented.

What if Increlex is non-formulary on my plan? Request a formulary exception through Humana Clinical Pharmacy Review with clinical justification that covered alternatives are inappropriate or harmful.

Can I use any specialty pharmacy in Florida? No, you must use Humana's in-network specialty pharmacies. CenterWell Specialty Pharmacy is typically the preferred option for mail-order delivery.

Does step therapy apply to Increlex? Step therapy requirements vary by plan. Most policies require documentation that GH therapy is inappropriate before approving Increlex for primary IGF-1 deficiency.

What happens if my appeal is denied? You can escalate through five appeal levels under Medicare Part D, ending with federal court review. Each level has specific deadlines and requirements.

How often must prior authorization be renewed? Typically every 6-12 months, requiring updated growth measurements, continued open epiphyses, and documentation of adequate growth response (≥4 cm/year).

Can I request a peer-to-peer review? Yes, your pediatric endocrinologist can request to speak directly with Humana's medical director to discuss the case and provide additional clinical context.

What if I'm traveling outside Florida? Humana's national network should provide coverage, but confirm with member services before traveling. Emergency supplies may be available through network pharmacies in other states.

Getting Increlex approved by Humana in Florida requires thorough preparation, complete documentation, and persistence through the appeals process when necessary. The key is working closely with a pediatric endocrinologist who understands both the clinical requirements and insurance landscape.

For families facing denials, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing plan policies and crafting point-by-point rebuttals aligned to each payer's specific rules.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and procedures are subject to change.

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