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

How to Get Acthar Gel Covered by UnitedHealthcare in Ohio: Appeals, Forms, and Step Therapy Overrides

Answer Box: Getting Acthar Gel Covered in Ohio

UnitedHealthcare requires prior authorization for Acthar Gel (repository corticotropin injection) with strict step therapy requirements. In Ohio, you have 180 days to file an external review after internal appeals are exhausted. Your fastest path: 1) Verify your specific UHC plan's formulary status, 2) Document failed corticosteroid trials with detailed dosing/duration/outcomes, 3) Submit PA with specialist notes and FDA labeling citations. Start today by calling UHC member services and requesting the specific prior authorization form for repository corticotropin injection.

Table of Contents

  1. Why Ohio State Rules Matter for Your Acthar Gel Appeal
  2. UnitedHealthcare's Coverage Requirements
  3. Step Therapy Protections and Medical Exceptions
  4. Turnaround Standards and Timelines
  5. External Review Process in Ohio
  6. Appeals Playbook: Internal to External Review
  7. Common Denial Reasons and How to Fix Them
  8. When to Escalate to Ohio Regulators
  9. FAQ: Acthar Gel Coverage in Ohio

Why Ohio State Rules Matter for Your Acthar Gel Appeal

Ohio's insurance laws provide important protections that can help you get Acthar Gel covered, even when UnitedHealthcare initially denies your claim. The state requires insurers to follow specific timelines and provides an independent external review process through the Ohio Department of Insurance.

Key Ohio protections include:

  • 180-day window for external review requests after internal appeals
  • Expedited review (72 hours) for urgent medical conditions
  • Independent Review Organizations (IROs) that can overturn insurer denials
  • Consumer assistance hotline: 1-800-686-1526
Note: These protections apply to state-regulated plans. Self-funded employer plans follow federal ERISA rules but often use similar processes voluntarily.

Understanding how to leverage these state-level protections can significantly improve your chances of approval, especially for high-cost specialty medications like Acthar Gel where insurers apply strict utilization management.

UnitedHealthcare's Coverage Requirements

UnitedHealthcare, through its OptumRx pharmacy benefits, maintains strict prior authorization criteria for Acthar Gel across all plan types.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all indications UHC Provider Portal
Formulary Tier Tier 3 with PA/step therapy OptumRx formulary booklets
Step Therapy High-dose corticosteroids required first Repository corticotropin policy
Age Restrictions Under 2 years for infantile spasms FDA labeling requirements
Quantity Limits Initial approval periods vary by indication Plan-specific coverage determinations
Site of Care IM/SC injection, outpatient preferred Medical necessity criteria

Approved Indications (Limited)

UnitedHealthcare typically covers Acthar Gel only for:

  • Infantile spasms (West syndrome) in patients under 2 years old
  • Opsoclonus-myoclonus syndrome with documented neurologic diagnosis
  • Select cases requiring case-by-case medical review

Many other FDA-labeled uses (like MS exacerbations) are often deemed "not medically necessary" and require strong appeals with specialist support.

Step Therapy Protections and Medical Exceptions

Ohio follows standard step therapy practices, but you can request medical exceptions when corticosteroids have failed or are contraindicated.

Required Documentation for Step Therapy Override

For each prior therapy, document:

  • Medication name and strength
  • Exact dosing schedule and duration
  • Start and stop dates
  • Objective response measures (seizure frequency, EDSS scores, etc.)
  • Reason for discontinuation (adverse events, lack of efficacy, contraindications)

Medical Exception Criteria

You can bypass step therapy if:

  • Contraindications exist (psychiatric history, uncontrolled diabetes, active infections)
  • Prior adequate failure with documented evidence
  • Clinical urgency where delay could cause irreversible harm
  • Previous successful treatment with Acthar Gel
Clinician Corner: When documenting steroid failure, include specific details like "Patient failed prednisone 60mg daily for 14 days with continued seizure clusters (>5 daily) and developed severe mood changes requiring hospitalization."

Turnaround Standards and Timelines

Understanding Ohio's required response times helps you know when to escalate.

UnitedHealthcare Internal Timeline Requirements

Review Type Initial Decision Internal Appeal Expedited Cases
Pre-service PA 15 calendar days 30 calendar days 72 hours
Post-service claims 30 calendar days 60 calendar days 72 hours
Urgent/concurrent 72 hours 72 hours 24 hours

When to Request Expedited Review

Request expedited processing if:

  • Delay could seriously jeopardize your health
  • Ongoing treatment needs continuation
  • Terminal diagnosis with time-sensitive care needs
  • Emergency or urgent medical situation

Your prescriber must certify the urgency in writing for expedited review approval.

External Review Process in Ohio

When UnitedHealthcare's internal appeals are exhausted, Ohio's external review process provides an independent second opinion.

Step-by-Step External Review Filing

  1. Verify Eligibility: Must involve medical necessity or clinical judgment (not pure contract exclusions)
  2. File Within 180 Days: Submit written request to UnitedHealthcare within 6 months of final internal denial
  3. Complete Documentation: Include all medical records, denial letters, and new supporting evidence
  4. IRO Assignment: Ohio Department of Insurance assigns an Independent Review Organization
  5. Submit Additional Info: You have 10 business days to provide extra documentation to the IRO
  6. Receive Decision: Standard review within 30 days; expedited within 72 hours
  7. Binding Result: If approved, UnitedHealthcare must immediately cover the treatment

Required Forms and Contacts

  • External Review Request: Submit to your UnitedHealthcare plan (address on denial letter)
  • Ohio DOI Assistance: Call 1-800-686-1526 for help navigating the process
  • Online Portal: Use Ohio's External Review System for tracking

Appeals Playbook: Internal to External Review

Level 1: Internal Appeal (60 days from denial)

What to include:

  • Written appeal letter citing specific policy language
  • New clinical evidence or studies
  • Specialist consultation notes
  • FDA labeling excerpts supporting your diagnosis
  • Documentation of steroid failures with objective measures

Submission methods:

  • UnitedHealthcare provider portal (fastest)
  • Fax to number on denial letter
  • Certified mail to appeals address

Level 2: Peer-to-Peer Review

Before escalating, request a peer-to-peer review where your prescribing physician speaks directly with a UnitedHealthcare medical director. This often resolves complex cases quickly and can overturn denials based on clinical nuance.

Level 3: External Review (Ohio DOI)

If internal appeals fail, file for external review within 180 days. The Independent Review Organization will conduct a fresh medical necessity review using current clinical standards and evidence-based guidelines.

From our advocates: "We've seen Ohio external reviews overturn UnitedHealthcare denials for Acthar Gel when families provided comprehensive documentation of steroid failures and included recent EEG results showing continued seizure activity. The key is presenting a complete clinical picture that demonstrates medical necessity according to current treatment guidelines."

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
Step therapy not met Detail complete steroid history Doses, dates, responses, adverse events
Not medically necessary Add specialist support + guidelines Neurologist notes, FDA language, peer-reviewed studies
Insufficient clinical information Provide comprehensive medical picture Diagnosis confirmation, EEGs, treatment response data
Age/indication mismatch Verify FDA-approved uses Prescription with proper ICD-10 codes
Quantity/duration limits Justify treatment plan Monitoring schedule, expected outcomes

Sample Appeal Language

"Patient has documented infantile spasms (ICD-10: G40.4) with EEG-confirmed hypsarrhythmia. High-dose prednisolone (4mg/kg/day for 14 days) failed to control seizures, with patient experiencing >10 spasms daily and developmental regression. Per FDA labeling and current epilepsy guidelines, Acthar Gel represents standard-of-care therapy when corticosteroids prove ineffective."

When to Escalate to Ohio Regulators

Contact the Ohio Department of Insurance if:

  • UnitedHealthcare misses required response deadlines
  • You believe the denial violates Ohio insurance law
  • The external review process isn't working properly
  • You need help understanding your appeal rights

Ohio Department of Insurance Consumer Services

For complex cases, consider contacting UHCAN Ohio (Universal Health Care Action Network) for consumer advocacy support.

Costs and Financial Assistance

Acthar Gel costs tens of thousands of dollars per vial, making financial assistance crucial:

  • Mallinckrodt Patient Support: ActharSupport.com offers copay assistance and case management
  • Foundation grants: Organizations like HealthWell Foundation may provide assistance for eligible patients
  • Ohio Medicaid: Expanded coverage may be available for qualifying families

Even with insurance approval, out-of-pocket costs can be substantial, so explore all assistance options early in the process.

FAQ: Acthar Gel Coverage in Ohio

How long does UnitedHealthcare PA take in Ohio? Standard prior authorization decisions are due within 15 calendar days. Expedited reviews must be completed within 72 hours when medical urgency is documented.

What if Acthar Gel is non-formulary on my plan? Non-formulary medications can still be covered through medical exception processes. You'll need strong clinical justification and documentation of formulary alternative failures.

Can I request expedited appeal if my child has infantile spasms? Yes, infantile spasms qualify for expedited review due to the time-sensitive nature of seizure control and developmental impact. Your neurologist must certify the urgency.

Does step therapy apply if we tried steroids in another state? Yes, properly documented steroid trials from other states should satisfy UnitedHealthcare's step therapy requirements. Ensure you have complete records including dosing and response data.

What happens if the external review is denied? External review decisions are binding on UnitedHealthcare, but you retain rights to file complaints with Ohio regulators or pursue other legal remedies if you believe the process was flawed.

How do I get help navigating this process? Call the Ohio Department of Insurance consumer hotline at 1-800-686-1526 for free assistance. Counterforce Health also helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific policies.

Checklist: What to Gather Before You Start

Before beginning your Acthar Gel appeal, collect:

  • Insurance card and policy information
  • Complete medical records for your condition
  • Documentation of all prior steroid treatments (dates, doses, responses)
  • Recent diagnostic tests (EEGs, imaging, lab work)
  • Specialist consultation notes
  • UnitedHealthcare denial letter(s)
  • FDA labeling information for Acthar Gel
  • Contact information for your prescribing physician

Having this information organized will streamline both the initial prior authorization process and any necessary appeals.

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's own rules, pulling the right medical evidence and citations to support your case.

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 plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with Ohio insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.

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