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

The Complete Requirements Checklist to Get Acthar Gel Covered by Aetna CVS Health in Pennsylvania (2024 Forms, Appeals, and Timeline)

Answer Box: Getting Acthar Gel Covered by Aetna CVS Health in Pennsylvania

Acthar Gel requires prior authorization from Aetna CVS Health for all indications. Submit via CVS Caremark PA Portal, fax to 1-888-836-0730, or call (866) 752-7021. Standard review takes 5-7 business days; expedited reviews are decided within 72 hours for urgent cases. If denied, Pennsylvania's Independent External Review process has overturned 50% of appealed denials in 2024. Start today: Verify your plan type (medical vs. pharmacy benefit) and gather documentation of prior corticosteroid failures.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Appeals Process in Pennsylvania
  11. Printable Checklist

Who Should Use This Checklist

This guide is designed for Pennsylvania patients and their healthcare providers seeking Aetna CVS Health coverage for Acthar Gel (repository corticotropin injection). You'll need this checklist if you're dealing with:

  • Infantile spasms in children under 2 years old
  • Multiple sclerosis exacerbations requiring ACTH therapy
  • Select rheumatologic, nephrologic, or dermatologic conditions per FDA labeling
  • Prior authorization denials that need appeals

Expected outcome: With proper documentation and adherence to Aetna's criteria, most medically appropriate requests for FDA-approved indications can be approved, especially for infantile spasms where Acthar is often first-line after corticosteroid failure.

Member & Plan Basics

Coverage Verification Checklist

✅ Active Aetna CVS Health coverage - Check member portal or call number on ID card
✅ Plan type identification - Medical benefit vs. pharmacy benefit (affects submission process)
✅ Deductible status - High-cost specialty drugs may apply to medical deductible
✅ Prior authorization requirement confirmed - Acthar Gel is on Aetna's 2025 precertification list

Plan-Specific Considerations

Plan Type Coverage Notes Submission Method
Commercial PPO/HMO Standard PA required CVS Caremark Portal
Medicare Advantage May have additional step therapy Same portal + Medicare forms
Medicaid (if applicable) State-specific criteria may apply Verify with plan

Clinical Criteria Requirements

FDA-Approved Indications

Aetna typically covers Acthar Gel for these FDA-approved indications:

Primary Coverage (Most Likely Approved):

  • Infantile spasms - Monotherapy in children under 2 years
  • Multiple sclerosis exacerbations - Acute episodes in adults

Secondary Coverage (Requires Strong Documentation):

  • Rheumatic disorders (psoriatic arthritis, RA, ankylosing spondylitis)
  • Nephrotic syndrome (when corticosteroids fail)
  • Severe dermatologic conditions (Stevens-Johnson syndrome, severe psoriasis)

Step Therapy Requirements

✅ Document prior corticosteroid trials with:

  • Specific medications tried (prednisone, prednisolone, methylprednisolone)
  • Dosages and duration of treatment
  • Clinical outcomes and failure reasons
  • Adverse reactions or contraindications

✅ Age-appropriate considerations

  • For infantile spasms: Often first-line after vigabatrin failure
  • For MS: May be used when high-dose steroids are contraindicated

Coding and Billing Information

Required Codes

Code Type Code Description Notes
HCPCS J-Code J0801 Injection, corticotropin, up to 40 units 1 billing unit = up to 40 units
NDC Codes 63004-8710-01 80 units/mL, 5mL vial Most common formulation
ICD-10 G40.824 Infantile spasms without intractable epilepsy Primary indication
ICD-10 G35 Multiple sclerosis Secondary indication
CPT 96372 Therapeutic injection, IM Administration code

Quantity Limits

  • Standard limit: 35 mL per 21 days for most indications
  • Infantile spasms: May require higher quantities initially
  • Documentation needed: Weight-based dosing calculations

Documentation Packet

Medical Necessity Letter Components

Your physician's letter should include:

✅ Patient demographics - Name, DOB, weight (for pediatric dosing)
✅ Confirmed diagnosis with ICD-10 code
✅ FDA indication alignment - Reference specific labeled use
✅ Prior therapy documentation - What was tried, for how long, why it failed
✅ Clinical rationale - Why Acthar is medically necessary now
✅ Dosing plan - Specific units, frequency, duration
✅ Monitoring plan - Follow-up schedule and safety monitoring
✅ Contraindication screening - No porcine allergy, uncontrolled infections, etc.

Required Attachments

For Infantile Spasms:

  • Recent EEG showing hypsarrhythmia or spasm pattern
  • Developmental assessment
  • Prior medication trial records
  • Growth charts and current weight

For Multiple Sclerosis:

  • MRI reports showing active lesions
  • Neurologist consultation notes
  • Prior steroid trial documentation
  • EDSS scores if available

For Other Indications:

  • Specialist consultation (rheumatologist, nephrologist, dermatologist)
  • Relevant lab work or imaging
  • Biopsy results (if applicable)
  • Treatment history from other specialists
Clinician Corner: Counterforce Health helps automate medical necessity letters by analyzing payer criteria and generating targeted appeals with proper evidence citations. Their platform can identify the specific documentation Aetna requires and draft point-by-point rebuttals for denials.

Submission Process

Primary Submission Methods

Option 1: CVS Caremark PA Portal (Fastest)

  • Access through Aetna provider portal
  • Upload documents directly
  • Real-time status tracking
  • Confirmation numbers provided

Option 2: Fax Submission

  • Fax to: 1-888-836-0730
  • Include cover sheet with patient demographics
  • Keep fax confirmation for records

Option 3: Phone Submission

  • Call: (866) 752-7021 for Acthar Gel
  • Have all documentation ready
  • Request confirmation number

Timeline Expectations

Review Type Timeline When to Use
Standard Review 5-7 business days Non-urgent requests
Expedited Review 72 hours Life-threatening situations
Renewal Review 30-45 days Ongoing therapy

Specialty Pharmacy Routing

CVS Caremark Specialty Process

✅ Enrollment required - Complete form at CVSCaremarkSpecialtyRx.com
✅ Provider coordination - Prescriber must send to CVS Specialty
✅ Patient consent - Required for specialty drug shipments
✅ Delivery setup - Home or clinic delivery options

Transfer from Other Pharmacies

  1. Contact CVS Specialty: 1-800-237-2767
  2. Provide current pharmacy info and prescription details
  3. Verify insurance coverage and PA status
  4. Confirm delivery address and timing preferences

After Submission: What to Expect

Confirmation and Tracking

✅ Record confirmation number from submission
✅ Check status regularly via portal or phone
✅ Respond promptly to requests for additional information
✅ Coordinate with specialty pharmacy once approved

Common Follow-Up Requests

  • Additional clinical notes or lab results
  • Peer-to-peer review with medical director
  • Formulary exception documentation
  • Updated dosing calculations

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Incomplete step therapy documentation - Always include specific dates, dosages, and failure reasons for prior treatments
  2. Missing specialist involvement - Ensure appropriate specialist (pediatric neurologist for infantile spasms, neurologist for MS) is involved in care
  3. Inadequate medical necessity justification - Link clinical need directly to FDA-approved indication with supporting literature
  4. Incorrect coding - Verify ICD-10 codes match the specific indication and use proper HCPCS codes
  5. Insufficient monitoring plan - Include detailed safety monitoring and follow-up schedule

Pro Tips for Success

Tip: Submit PA requests 7-10 days before current medication runs out to avoid therapy gaps.
Note: For infantile spasms, emphasize the time-sensitive nature of treatment and developmental impact of delayed therapy.

Appeals Process in Pennsylvania

If your initial request is denied, Pennsylvania offers robust appeal options with high success rates.

Internal Appeals with Aetna CVS Health

Level 1 Internal Appeal:

  • Deadline: 180 days from denial date
  • Method: Submit via portal, mail, or phone 1-855-240-0535
  • Timeline: 30 days for standard, 72 hours for expedited
  • Required: Denial letter, new clinical evidence, physician support

Level 2 Internal Appeal:

  • Deadline: 60 days from Level 1 denial
  • Process: Independent internal review
  • Timeline: 30 days for decision

Pennsylvania External Review Process

Pennsylvania's Independent External Review program, launched in January 2024, has achieved a 50.1% overturn rate in its first year, helping over 250 patients get coverage for initially denied treatments.

Eligibility Requirements: ✅ Completed Aetna's internal appeals process
✅ Received Final Adverse Benefit Determination letter
✅ Commercial, marketplace, or employer-sponsored plan (not Medicaid/Medicare)

Submission Process:

  • Deadline: 4 months from final internal denial
  • Method: Online at pa.gov/reviewmyclaim (fastest)
  • Cost: Free to patients
  • Timeline: 45 days for standard, 72 hours for expedited

Required Documents:

  • Final denial letter from Aetna
  • Medical records supporting necessity
  • Physician certification for expedited requests
  • Completed external review application
From Our Advocates: "We've seen several Acthar Gel denials overturned through Pennsylvania's external review process, particularly when families provided comprehensive documentation of failed alternatives and clear medical necessity. The key is submitting a complete package that directly addresses the original denial reasons while highlighting the FDA-approved indication and specialist support."

When to Escalate Further

If external review is unsuccessful, contact:

  • Pennsylvania Insurance Department Consumer Services: 1-877-881-6388
  • Pennsylvania Health Law Project: For additional advocacy support
  • Counterforce Health: For specialized appeal assistance and evidence-based rebuttals

Printable Checklist

Pre-Submission Checklist

Patient Information:

  • Insurance card and member ID verified
  • Plan type identified (medical vs. pharmacy benefit)
  • Prior authorization requirement confirmed

Clinical Documentation:

  • FDA-approved indication confirmed
  • Prior therapy failures documented with dates and dosages
  • Specialist consultation completed
  • Medical necessity letter drafted
  • Supporting labs/imaging gathered
  • ICD-10 and HCPCS codes verified

Submission:

  • Preferred submission method selected
  • All required forms completed
  • Documents uploaded or faxed
  • Confirmation number recorded
  • Follow-up calendar reminders set

Post-Submission:

  • Status checked within 48 hours
  • Specialty pharmacy enrollment completed
  • Delivery arrangements confirmed
  • Appeal strategy prepared if needed

Frequently Asked Questions

How long does Aetna CVS Health PA take for Acthar Gel in Pennsylvania? Standard reviews take 5-7 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Acthar Gel is non-formulary on my plan? Request a formulary exception with documentation showing medical necessity and failure of formulary alternatives.

Can I request an expedited appeal in Pennsylvania? Yes, both Aetna internal appeals and Pennsylvania external reviews offer expedited processing for urgent medical situations.

Does step therapy apply if I failed treatments in another state? Yes, document all prior therapy failures regardless of where treatment occurred. Include pharmacy records and physician notes.

What's the success rate for Acthar Gel appeals? While Aetna-specific data isn't available, Pennsylvania's external review program has a 50% overturn rate, and appeals with proper documentation often succeed.

Cost and Financial Assistance

Acthar Gel is a high-cost specialty medication, with single vials often costing tens of thousands of dollars. Financial assistance options include:

  • Mallinckrodt Patient Support Program: Copay assistance and free drug programs
  • CVS Caremark Specialty Pharmacy: Patient assistance program coordination
  • Pennsylvania CHIP/Medicaid: For eligible families
  • Foundation grants: Various rare disease foundations offer assistance

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage details. Prior authorization requirements and appeal processes may change. Verify current procedures with your insurer and the Pennsylvania Insurance Department.

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based medical necessity letters and targeted payer strategies. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes for specialty medications like Acthar Gel.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.