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

Blue Cross Blue Shield California Coverage for Acthar Gel: Medical Necessity Criteria, Prior Authorization, and Appeals Guide

Answer Box: Getting Acthar Gel Covered in California

Blue Cross Blue Shield California requires prior authorization for Acthar Gel with documented failure of corticosteroids first. The fastest path: Have your doctor submit a PA request through the provider portal with complete clinical notes showing corticosteroid trial failure or contraindications. If denied, file an Independent Medical Review (IMR) through California's DMHC—appeals succeed in 50-65% of specialty drug cases. Start today: Call Blue Shield member services to confirm your specific plan's PA requirements and get the current forms.

Table of Contents

  1. Policy Overview: How Blue Cross Blue Shield Covers Acthar Gel
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity Limits and Renewal Requirements
  5. Required Documentation and Evidence
  6. Specialty Pharmacy Requirements
  7. Appeals Process: Internal to IMR
  8. Common Denial Reasons and Solutions
  9. Costs and Patient Support Options
  10. FAQ

Policy Overview: How Blue Cross Blue Shield Covers Acthar Gel

Blue Cross Blue Shield of California treats Acthar Gel (repository corticotropin injection) as a specialty drug requiring prior authorization across all plan types—commercial HMO, PPO, and Medi-Cal managed care. The medication is typically non-formulary or placed on the highest specialty tier due to its significant cost (often tens of thousands per vial).

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all uses Blue Shield PA List Official Policy
Step Therapy Must try corticosteroids first Provider portal criteria PA Guidelines
Specialty Pharmacy Must use in-network specialty pharmacy Member handbook Plan Documents
Appeals Deadline 180 days from denial Member rights booklet California Law
IMR Available Free external review through DMHC DMHC Help Center State Regulation

The key difference between Blue Shield's HMO and PPO plans lies in referral requirements—HMO members typically need a specialist referral before the PA process begins, while PPO members can have their primary care doctor submit the request directly.

Medical Necessity Requirements

Blue Cross Blue Shield California follows indication-specific criteria based on FDA labeling and clinical guidelines. The strongest coverage exists for two primary conditions:

Infantile Spasms (West Syndrome)

  • Age restriction: Children under 2 years old only
  • Specialist requirement: Must be prescribed by or in consultation with pediatric neurologist
  • Documentation needed:
    • Confirmed diagnosis with EEG findings
    • Evidence of hypsarrhythmia or modified hypsarrhythmia
    • Prior corticosteroid trial (unless contraindicated)
  • Approval period: Initial 4 weeks, renewable up to 3 months with documented clinical benefit

Multiple Sclerosis Exacerbations

  • Indication: Acute MS relapses only (not maintenance therapy)
  • Step therapy: Must document failure, intolerance, or contraindication to high-dose corticosteroids
  • Specialist involvement: Neurologist consultation strongly preferred
  • Duration limits: Typically 2-3 weeks maximum per episode
Clinician Corner: For both indications, the medical necessity letter should explicitly state why corticosteroids are inappropriate. Common acceptable reasons include: previous severe psychiatric reaction, uncontrolled diabetes worsened by steroids, active serious infection, or documented anaphylaxis to corticosteroids.

Step Therapy and Exception Pathways

Step therapy is nearly universal for Acthar Gel coverage. Blue Shield requires documented trials of less expensive alternatives before approval.

Required First-Line Therapies

For Infantile Spasms:

  • Oral prednisolone (2 mg/kg/day for 2+ weeks) OR
  • ACTH (if available and tried) OR
  • Vigabatrin (depending on etiology)

For MS Exacerbations:

  • High-dose IV methylprednisolone (1g daily × 3-5 days) OR
  • Oral prednisone equivalent (1 mg/kg up to 80mg daily)

Medical Exception Criteria

You can bypass step therapy by documenting:

  • Contraindications: Serious infection, poorly controlled diabetes, severe osteoporosis
  • Previous intolerance: Documented psychiatric effects, severe hypertension, or allergic reactions
  • Clinical urgency: Rapidly progressive disease where delay could cause irreversible harm

Exception requests must include specific details—not just "patient cannot tolerate steroids" but rather "patient developed acute psychosis requiring hospitalization when treated with prednisone 60mg daily in March 2024."

Quantity Limits and Renewal Requirements

Blue Shield enforces FDA-based dosing limits with strict quantity controls:

Dosing Maximums

  • Infantile Spasms: 150 units/m²/day (divided twice daily)
  • MS Exacerbations: 80-120 units daily for 2-3 weeks
  • General conditions: 40-80 units every 24-72 hours

Renewal Criteria

  • Clinical response documentation: Objective improvement measures (seizure reduction, EDSS scores)
  • Ongoing medical necessity: Continued specialist involvement
  • Dose justification: Any increases above standard dosing require additional medical rationale
  • Safety monitoring: Documentation of side effect monitoring and management
Note: Prescriptions exceeding these limits are automatically flagged for clinical review and often denied without compelling justification.

Required Documentation and Evidence

Essential Clinical Records

For Initial Authorization:

  1. Diagnosis confirmation with ICD-10 codes
  2. Complete medication history including dates, doses, duration, and outcomes of prior therapies
  3. Specialist consultation notes (neurologist for MS/IS cases)
  4. Laboratory values if relevant to contraindications
  5. Treatment plan with expected duration and monitoring schedule

For Appeals and IMR:

  • Peer-reviewed literature supporting Acthar Gel use for your specific indication
  • Clinical guideline citations from recognized medical societies
  • Detailed failure documentation of step therapy attempts
  • Physician attestation of medical necessity

Evidence Sources That Strengthen Cases

  • FDA prescribing information for labeled indications
  • American Academy of Neurology guidelines for MS treatment
  • Child Neurology Society recommendations for infantile spasms
  • Published case series or clinical trials relevant to your condition

Specialty Pharmacy Requirements

Acthar Gel must be dispensed through Blue Shield's contracted specialty pharmacies. Using an out-of-network pharmacy will result in claim denial and full patient responsibility for costs.

In-Network Options

  • Accredo Specialty Pharmacy (most common)
  • CVS Specialty
  • Walgreens Specialty Pharmacy

Coordination Steps

  1. Provider submits PA through Blue Shield portal
  2. Upon approval, prescription is sent to designated specialty pharmacy
  3. Patient enrollment in specialty pharmacy program (includes injection training)
  4. Delivery coordination with refrigerated shipping
  5. Ongoing monitoring through specialty pharmacy clinical team

The specialty pharmacy will handle insurance billing, patient education, and side effect monitoring—but the prescribing physician remains responsible for clinical management and renewal authorizations.

Appeals Process: Internal to IMR

California offers exceptionally strong appeal rights through a two-tiered system that has helped many patients access Acthar Gel after initial denials.

Internal Appeal (Grievance)

  • Timeline: Must be filed within 180 days of denial
  • Response time: 30 days for standard appeals, 72 hours for urgent
  • Required documents: Denial letter, additional clinical evidence, physician statement
  • Submission: Online portal, fax, or mail to Blue Shield

Independent Medical Review (IMR)

California's IMR system offers strong success rates for specialty drugs like Acthar Gel:

  • Success rates: 57.9% overturn rate for medical necessity denials (2024 Anthem data)
  • Specialty drug appeals: Historical success rates of 50-65% for chronic conditions
  • Timeline: 45 days for standard, 72 hours for expedited
  • Cost: Free to patients
  • Authority: DMHC-appointed independent physicians make binding decisions
From Our Advocates: "We've seen several Acthar Gel cases succeed at IMR after initial denials, particularly when families provided comprehensive documentation of steroid failures and specialist support. The key was showing that less expensive alternatives were truly inadequate for the child's specific seizure pattern. While outcomes vary, California's IMR process gives patients a real second chance when the medical evidence is strong."

Step-by-Step: Filing an IMR

  1. Complete internal appeal with Blue Shield (required first step)
  2. Wait for decision or 30-day deadline
  3. Contact DMHC Help Center at (888) 466-2219
  4. Submit IMR application online at healthhelp.ca.gov
  5. Provide medical records and specialist support letters
  6. Await independent physician review (45 days maximum)
  7. Receive binding decision that Blue Shield must follow

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Evidence
"Step therapy not completed" Document corticosteroid trials Pharmacy records, physician notes showing dates/doses/outcomes
"Not medically necessary" Provide specialist support Neurologist letter explaining why Acthar is specifically needed
"Experimental/investigational" Cite FDA approval Copy of FDA label for your indication
"Quantity exceeds limits" Justify dosing Body surface area calculations, specialist dosing rationale
"Formulary alternative available" Document failures Detailed records of steroid trials and intolerance

Costs and Patient Support Options

Even with insurance approval, Acthar Gel costs can be substantial. Multiple support programs exist:

Manufacturer Support

  • Acthar Support and Access program offers copay assistance
  • Eligibility: Commercial insurance patients (not government plans)
  • Benefit: Potential reduction to $10 copay per prescription
  • Application: Through Acthar.com or (888) 435-2284

Foundation Grants

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs

California residents may qualify for additional assistance through Covered California premium subsidies or Medi-Cal if income-eligible.

Counterforce Health helps patients navigate these complex coverage decisions by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific coverage criteria, then helps draft point-by-point rebuttals aligned with your insurer's own rules. For medications like Acthar Gel, having the right clinical evidence and procedural approach can make the difference between approval and denial.

FAQ

How long does Blue Shield PA take for Acthar Gel in California? Standard prior authorization decisions are made within 5 business days. Urgent requests (for conditions requiring immediate treatment) must be decided within 24-72 hours.

What if Acthar Gel is non-formulary on my plan? You can request a formulary exception by documenting that all formulary alternatives have failed or are contraindicated. Submit the same clinical evidence required for standard PA.

Can I request an expedited appeal if my child's seizures are worsening? Yes. California law requires expedited appeals for urgent situations. Contact Blue Shield immediately and emphasize the urgent medical need.

Does step therapy apply if I failed steroids outside California? Yes, as long as you have documentation of the trials. Out-of-state medical records are acceptable evidence for Blue Shield's step therapy requirements.

What happens if IMR approves Acthar Gel but Blue Shield still delays? IMR decisions are legally binding. If Blue Shield doesn't comply within 5 business days, contact the DMHC Help Center at (888) 466-2219 for enforcement action.

Are there age limits for Acthar Gel coverage? For infantile spasms, coverage is typically limited to children under 2 years old. For other indications, age restrictions vary by specific condition and clinical circumstances.

How often can I appeal the same denial? You get one internal appeal per denial. If new clinical information becomes available (new specialist opinion, additional failed therapies), you can submit a new PA request.

What if my doctor won't help with the appeal? Consider seeking a second opinion from a specialist familiar with Acthar Gel. Neurologists experienced with rare seizure disorders or MS often have more success with these authorizations.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria can change. Always verify current requirements with your specific Blue Shield plan and consult your healthcare provider for medical decisions. For personalized assistance with coverage appeals, Counterforce Health provides specialized support in turning insurance denials into successful authorizations through evidence-based appeal strategies.

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