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

How to Get Acthar Gel Covered by Aetna CVS Health in North Carolina: Complete Appeals Guide with Forms and Timelines

Quick Answer: Getting Acthar Gel Covered by Aetna CVS Health in North Carolina

Acthar Gel requires prior authorization from Aetna CVS Health for all indications. For North Carolina residents, the fastest path to approval involves: (1) Submit a complete PA request with detailed clinical documentation proving corticosteroid failure or contraindications, (2) If denied, file an internal appeal within 180 days with specialist support letters, and (3) Request external review through Smart NC if internal appeals fail. Most successful appeals include comprehensive medical necessity letters from specialists and document specific failed therapies. Start today by gathering your denial letter, medical records, and contacting your prescribing physician.

Table of Contents

  1. Understanding Your Denial Letter
  2. Coverage Requirements at a Glance
  3. Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Step-by-Step Appeals Process
  6. North Carolina External Review with Smart NC
  7. Appeal Templates and Scripts
  8. Cost-Saving Options
  9. When to Escalate
  10. FAQ

Understanding Your Denial Letter

When Aetna CVS Health denies coverage for Acthar Gel, your denial letter contains critical information that determines your next steps. Look for these key elements:

Denial Reason Codes: Common codes include "prior authorization required," "step therapy not completed," "non-formulary medication," or "not medically necessary." Each requires different documentation for appeals.

Appeal Deadlines: You typically have 180 days from the denial date to file an internal appeal with Aetna. For urgent situations, expedited appeals must be decided within 72 hours.

Benefit Type: Acthar Gel may be covered under your medical benefit (for in-office administration) or pharmacy benefit (for self-administration). This affects which forms and processes apply.

Tip: Keep all denial letters, explanation of benefits (EOB), and correspondence in one folder. You'll need these for appeals and external review.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all indications Complete PA form with clinical notes Aetna Policy
Age Restrictions Under 2 years for infantile spasms Birth certificate, medical records FDA Label
Specialist Requirement Neurologist for MS/infantile spasms Referral letter, specialist notes Aetna PA Criteria
Step Therapy Failed corticosteroids required Treatment history, adverse reactions CVS Caremark Policy
Dosing Limits 150 U/m²/day for infantile spasms Body surface area calculation FDA Prescribing Information

Fastest Path to Approval

Step 1: Gather Required Documentation

Who does it: Patient and clinic staff Timeline: 1-2 business days Documents needed: Insurance card, complete medical history, prior therapy records, specialist referrals

Step 2: Submit Complete Prior Authorization

Who does it: Prescribing physician How to submit: CVS Caremark PA Portal or fax to 1-888-836-0730 Timeline: 5-7 business days for standard review Key requirement: Detailed medical necessity letter documenting corticosteroid failure

Step 3: Request Peer-to-Peer Review (If Needed)

Who does it: Prescribing physician How to request: Call Aetna provider line at 1-844-460-8767 Timeline: Scheduled within 3-5 business days Preparation: Have patient chart, treatment history, and clinical guidelines ready

Step 4: File Internal Appeal (If Denied)

Who does it: Patient or authorized representative How to submit: Aetna member portal or mail to address on denial letter Timeline: Decision within 30 days (expedited: 72 hours) Required: Denial letter, additional medical evidence, specialist support letter

Step 5: External Review Through Smart NC (If Needed)

Who does it: Patient How to submit: Smart NC External Review Form Timeline: 45 days standard, 72 hours expedited Cost: Free

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Step therapy not completed Provide evidence of corticosteroid failure/intolerance Treatment dates, adverse reactions, contraindications
Not medically necessary Submit comprehensive medical necessity letter Specialist evaluation, FDA indication confirmation, treatment goals
Non-formulary medication Request formulary exception Clinical rationale why alternatives are inappropriate
Quantity/dosing limits exceeded Justify dosing per FDA label Body surface area calculations, specialist dosing rationale
Experimental/investigational Cite FDA approval and guidelines FDA label, clinical practice guidelines, peer-reviewed studies

Step-by-Step Appeals Process

Internal Appeals with Aetna CVS Health

Level 1 Appeal (First Internal)

  • Deadline: 180 days from denial
  • Decision timeline: 30 days standard, 72 hours expedited
  • How to file: Online portal, phone (1-855-240-0535), or mail
  • Required documents: Denial letter, medical records, prescriber statement

Level 2 Appeal (Second Internal)

  • Deadline: 60 days from Level 1 denial
  • Decision timeline: 30 days
  • Review process: Independent medical reviewer
  • Additional evidence: Can submit new clinical information

Clinician Corner: Medical Necessity Letter Checklist

When writing a medical necessity letter for Acthar Gel, include:

✓ Patient's specific diagnosis with ICD-10 codes ✓ Previous treatments tried with dates, dosages, and outcomes ✓ Reasons for failure (ineffective, adverse reactions, contraindications) ✓ Clinical rationale for Acthar Gel over alternatives ✓ Treatment goals and expected outcomes ✓ Dosing justification per FDA labeling ✓ Monitoring plan and safety considerations

Evidence-based citations to include:

  • FDA Prescribing Information for approved indications
  • Relevant clinical practice guidelines (verify current versions)
  • Peer-reviewed studies supporting use in patient's condition

North Carolina External Review with Smart NC

If Aetna CVS Health denies your internal appeals, North Carolina residents can request an independent external review through Smart NC, part of the NC Department of Insurance.

Eligibility Requirements

  • Completed all internal appeals with Aetna (or qualified for expedited review)
  • Denial based on medical necessity or experimental treatment determination
  • State-regulated health plan (not self-funded employer plans, unless opted in)

How to File

  1. Download the form: Smart NC External Review Request
  2. Gather documents: Final internal denial letter, medical records, additional clinical evidence
  3. Submit within 120 days of final internal denial
  4. Contact Smart NC at 1-855-408-1212 for free advocacy support

Timeline and Process

  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases
  • Cost: Free to consumers
  • Decision: Binding on Aetna - if overturned, coverage must be provided within 3 business days
From our advocates: "We've seen several Acthar Gel denials overturned through Smart NC's external review process when patients provided comprehensive documentation of corticosteroid failures and specialist support letters. The key is submitting all available clinical evidence and clearly explaining why alternatives aren't appropriate for the patient's specific condition."

Appeal Templates and Scripts

Patient Phone Script for Aetna CVS Health

"Hello, I'm calling about a prior authorization denial for Acthar Gel. My member ID is [NUMBER]. I received a denial letter dated [DATE] and would like to understand the specific reasons and start the appeal process. Can you transfer me to someone who can help with appeals?"

Follow-up questions to ask:

  • What specific clinical criteria weren't met?
  • Can I request a peer-to-peer review for my doctor?
  • What additional documentation would support approval?
  • What are my appeal deadlines and options?

Medical Necessity Letter Template

[Available through Counterforce Health, a platform that helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific rules.]

Key sections to include:

  1. Patient demographics and diagnosis
  2. Treatment history and failures
  3. Clinical rationale for Acthar Gel
  4. Expected outcomes and monitoring plan
  5. Supporting evidence and guidelines

Cost-Saving Options

Manufacturer Support Programs

  • Acthar Patient Support & Reimbursement (PSR): Provides coverage support, copay assistance, and appeals help
  • Contact: 1-888-435-2284 or acthar.com/acthar-patient-support
  • Eligibility: Varies by insurance type and income

Financial Assistance

  • Patient Access Network Foundation: Grants for specialty medications
  • HealthWell Foundation: Copay assistance for eligible conditions
  • North Carolina pharmaceutical assistance programs: Contact Smart NC for local resources

Alternative Coverage Options

If appeals fail, consider:

  • Medicaid expansion (North Carolina expanded in 2024)
  • Marketplace plans during open enrollment
  • Clinical trials through ClinicalTrials.gov

When to Escalate

File a Complaint with North Carolina Regulators

Contact the NC Department of Insurance if:

  • Aetna doesn't respond within required timeframes
  • You suspect improper denial practices
  • Appeals process isn't followed correctly

How to file: 1-855-408-1212 or ncdoi.gov/consumers/file-complaint

Consider consulting an attorney if:

  • Multiple appeals have been denied despite strong clinical evidence
  • Delays are causing serious health consequences
  • You suspect bad faith insurance practices

FAQ

Q: How long does Aetna CVS Health prior authorization take in North Carolina? A: Standard PA decisions are made within 5-7 business days. Expedited requests (for urgent medical situations) must be decided within 72 hours.

Q: What if Acthar Gel is non-formulary on my plan? A: You can request a formulary exception by providing clinical documentation that formulary alternatives are inappropriate or ineffective for your condition.

Q: Can I request an expedited appeal if my condition is worsening? A: Yes, if a delay would seriously jeopardize your health or ability to regain function, you can request expedited internal and external reviews with much faster timelines.

Q: Does step therapy apply if I failed corticosteroids outside North Carolina? A: Yes, treatment failures from other states count if properly documented. Provide complete medical records showing the therapy tried, duration, and reason for discontinuation.

Q: What happens if Smart NC external review upholds the denial? A: The external review decision is binding, ending the administrative appeals process. You may still have legal options to pursue through the courts.

Q: How can Counterforce Health help with my appeal? A: Counterforce Health analyzes your denial letter, plan policy, and clinical notes to identify the specific denial basis and draft targeted appeals with the right medical evidence and citations tailored to your plan's requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and appeal processes may vary. Always consult with your healthcare provider about treatment decisions and verify current requirements with your insurance plan. For personalized assistance with appeals, contact Smart NC at 1-855-408-1212.

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