By Counterforce Health Team in Acthar Gel (repository corticotropin injection) —

UnitedHealthcare's Coverage Criteria for Acthar Gel in Florida: What Counts as "Medically Necessary"?

Answer Box: Getting Acthar Gel Covered by UnitedHealthcare in Florida

UnitedHealthcare requires prior authorization for Acthar Gel with strict medical necessity criteria. Coverage is primarily limited to infantile spasms in children under 2 years old (4-week approval) and select conditions like opsoclonus-myoclonus syndrome. Most other uses require documented failure of high-dose corticosteroids first.

Fastest path to approval: 1) Confirm your specific indication meets UHC's narrow criteria, 2) Document failed steroid therapy with dates/doses/outcomes, 3) Submit PA through UHC Provider Portal with comprehensive clinical notes. For denials, Florida allows internal appeals (180 days) plus external review through the state Department of Financial Services.

Table of Contents

Policy Overview: How UHC Manages Acthar Gel

UnitedHealthcare treats Acthar Gel (repository corticotropin injection) as a high-cost specialty medication requiring mandatory prior authorization across all plan types in Florida. The drug is managed under UHC's "Repository Corticotropin Injection" medical policies, which apply strict medical necessity criteria regardless of FDA labeling.

Key policy principles:

  • Prior authorization required for all indications
  • Step therapy mandated for most conditions (corticosteroids first)
  • Coverage limited to narrow, evidence-based indications
  • Short authorization periods with restricted reauthorization

The policy applies to UHC commercial plans, Medicare Advantage, and Medicaid managed care products in Florida. OptumRx administers pharmacy benefits for many UHC plans and lists Acthar under "Prior Authorization – Select" drugs.

Indication Requirements: What Qualifies for Coverage

Covered Indications (Commercial Plans)

UnitedHealthcare's commercial medical necessity policy covers Acthar Gel for only these conditions:

1. Infantile Spasms (West Syndrome)

  • Patient must be under 2 years old
  • Initial authorization: 4 weeks only
  • No reauthorization permitted – continuation requires appeal
  • Must use multi-dose vial (not SelfJect injector) for intramuscular administration

2. Opsoclonus-Myoclonus Syndrome (Kinsbourne Syndrome)

  • Documented neurologic diagnosis required
  • Initial authorization: 3 months
  • Reauthorization possible with documented clinical improvement

Explicitly Excluded Conditions

UHC's policy states that Acthar is "not medically necessary" for these FDA-labeled conditions because corticosteroids are equally effective and less costly:

  • Multiple sclerosis exacerbations
  • Rheumatic disorders (rheumatoid arthritis, lupus)
  • Collagen diseases (dermatomyositis, scleroderma)
  • Dermatologic conditions (severe psoriasis, pemphigus)
  • Allergic states and ophthalmic diseases
  • Respiratory conditions and edematous states
Note: Even with FDA approval for these conditions, UHC routinely denies coverage as "not medically necessary." Appeals with strong clinical justification may overturn these denials.

Step Therapy & Medical Exceptions

Required Prior Therapies

For any condition except infantile spasms, UHC requires documented trial and failure of:

  • High-dose corticosteroids (prednisone, methylprednisolone, IV steroids)
  • Condition-specific standard therapies
  • Alternative ACTH preparations when available

Medical Exception Criteria

Step therapy may be bypassed if you document:

  • Contraindication to steroids (severe psychiatric history, uncontrolled diabetes, active infection)
  • Previous intolerance with specific adverse events and dates
  • Clinical urgency where delay could cause irreversible harm
  • Prior failure of adequate steroid courses with objective evidence

Documentation Requirements

For each prior therapy, include:

  • Exact medication name and strength
  • Dosing schedule and duration
  • Dates of treatment
  • Objective response measures
  • Specific reasons for discontinuation
  • Any hospitalizations or complications

Quantity Limits and Dosing Restrictions

Authorization Durations

Indication Initial Approval Reauthorization Maximum Course
Infantile spasms 4 weeks Denied (appeal required) Case-by-case
Opsoclonus-myoclonus 3 months Allowed with response Varies
MS exacerbation* 3 weeks New episodes only Per episode

*MS coverage varies by plan; many commercial plans exclude as "not medically necessary"

Dosing Requirements

UHC requires dosing consistent with FDA labeling:

  • Infantile spasms: 150 units/m² daily (divided doses) for 2 weeks, then taper
  • Adult conditions: 40-80 units IM/SC every 24-72 hours
  • Route restrictions: IM required for infantile spasms; SelfJect injector contraindicated in children

Required Diagnostics and Documentation

Essential Clinical Data

For Infantile Spasms:

  • EEG showing hypsarrhythmia or modified hypsarrhythmia
  • Video documentation of spasms (when possible)
  • Developmental assessment and milestones
  • Growth parameters and nutritional status
  • Neurology consultation notes

For Other Conditions:

  • Condition-specific imaging (MRI for MS, joint imaging for arthritis)
  • Laboratory values (inflammatory markers, organ function tests)
  • Specialist consultation confirming diagnosis
  • Functional status assessments

Documentation Timeline

All diagnostic data must be:

  • Recent (within 30-90 days for acute conditions)
  • Objective (quantified when possible)
  • Complete (include normal values for context)
  • Legible (typed reports preferred)

Site of Care and Specialty Pharmacy Rules

Pharmacy Benefit vs. Medical Benefit

Acthar Gel may be covered under either:

  • Pharmacy benefit (NDC billing through specialty pharmacy)
  • Medical benefit (J-code billing in clinic/hospital)

Coverage pathway depends on your specific UHC plan design. Check your formulary or call the number on your insurance card to confirm.

Specialty Pharmacy Requirements

When covered under pharmacy benefit:

  • Must use UHC-contracted specialty pharmacy
  • Cannot fill at retail pharmacies
  • Requires coordination with prescriber for PA submission
  • May have specific shipping/storage requirements
Tip: Counterforce Health helps patients and providers navigate specialty pharmacy requirements and streamline prior authorization submissions for complex drugs like Acthar Gel.

Evidence to Support Medical Necessity

Clinical Guidelines and Literature

Strong appeals reference:

  • FDA prescribing information with specific indication language
  • Peer-reviewed studies showing efficacy in your patient's condition
  • Professional society guidelines (American Academy of Neurology, American College of Rheumatology)
  • Drug compendia for off-label uses (Micromedex, Lexicomp)

Patient-Specific Factors

Emphasize unique clinical circumstances:

  • Severity of condition with objective measures
  • Risk of permanent damage without treatment
  • Comorbidities making alternatives inappropriate
  • Previous response to Acthar if applicable
  • Quality of life impact with functional assessments

Sample Medical Necessity Narrative

"[Patient Name] is a [age]-year-old with [specific diagnosis] who requires Acthar Gel due to inadequate response to standard therapies. Previous treatment with high-dose methylprednisolone [dose/duration] resulted in [specific outcome] with [adverse effects]. The patient's [objective findings] indicate [severity], and delay in appropriate treatment risks [specific complications]. Acthar Gel is FDA-approved for this indication and represents the most appropriate therapy given [patient-specific factors]. Expected treatment duration is [timeframe] with monitoring via [specific parameters]."

Common Denial Reasons & How to Fix Them

Denial Reason Documentation to Include Action Steps
"Not medically necessary" Guidelines supporting use, failed alternatives Submit detailed appeal with literature
"Step therapy not met" Prior therapy records with dates/outcomes Document each failed treatment completely
"Insufficient clinical information" Complete specialist notes, labs, imaging Request peer-to-peer review
"Experimental/investigational" FDA labeling, published studies Cite specific indication approval
"Exceeds quantity limits" Dosing rationale, specialist recommendation Justify dose with clinical need

Appeals Process in Florida

Internal Appeals

Timeline: 180 days from denial notice Process: Submit through UHC Provider Portal or mail Required documents:

  • Original denial letter
  • Complete medical records
  • Physician letter of medical necessity
  • Supporting literature/guidelines

External Review

Florida provides independent external review for commercial plans through the Department of Financial Services:

  • Deadline: 4 months after final internal denial
  • Cost: Free to consumers
  • Process: State contracts with independent medical reviewers
  • Success rate: Approximately 50% overturn rate for specialty drug appeals
From our advocates: We've seen successful appeals where families documented every detail of prior treatments and worked closely with their neurologist to explain why Acthar was uniquely necessary. The key was showing not just that other treatments failed, but why Acthar's specific mechanism was medically appropriate for their child's condition.

Expedited Appeals

For urgent medical situations:

  • Timeline: 72 hours for determination
  • Criteria: Delay would "seriously jeopardize" health
  • Documentation: Physician statement of urgency required

Costs and Patient Assistance

Financial Support Options

Mallinckrodt Patient Support Program:

Additional Resources:

  • State pharmaceutical assistance programs
  • Disease-specific foundations
  • Hospital charity care programs

Cost Considerations

Acthar Gel costs approximately $38,000-$40,000 per vial. Without insurance coverage, the full treatment course can exceed $150,000, making financial assistance crucial for most families.

FAQ

How long does UHC prior authorization take in Florida? Standard PA decisions typically take 5-10 business days. Urgent requests may be expedited to 24-72 hours with proper clinical justification.

What if Acthar Gel is non-formulary on my plan? Non-formulary drugs require additional documentation but can be covered through medical necessity appeals. Work with your prescriber to submit a comprehensive clinical justification.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health or ability to regain maximum function. Your physician must document the urgency in writing.

Does step therapy apply if I failed treatments outside Florida? Yes, UHC accepts documentation of prior therapy failures from any state, provided you have complete medical records with dates, doses, and outcomes.

What happens if my appeal is denied? You can request external review through Florida's Department of Financial Services within 4 months of the final internal denial. This independent review is binding on UHC.

How does Counterforce Health help with Acthar Gel appeals? Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing denial letters, plan policies, and clinical notes to create evidence-backed rebuttals aligned with payer-specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific insurance plan and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals in Florida, contact the Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO (877-693-5236).

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