By Counterforce Health Team in HyperHEP (hepatitis B immune globulin) —

How to Get HyperHEP B Covered by Cigna in New Jersey: Prior Authorization Guide and Appeals Process

Answer Box: Quick Path to Coverage

To get HyperHEP B covered by Cigna in New Jersey: Submit prior authorization through Cigna's provider portal with exposure documentation, immunity testing, and CDC timeline compliance (within 24 hours for needlestick, 14 days for sexual exposure). If denied, file internal appeal within 180 days, then external review through New Jersey's IHCAP program administered by Maximus Federal Services. Emergency post-exposure cases can often receive immediate treatment with retroactive PA approval.

First step today: Call Cigna member services to confirm your plan's formulary status and PA requirements, then gather exposure incident reports and immunity test results.

Table of Contents

  1. Coverage at a Glance
  2. Policy Overview: How Cigna Covers HyperHEP B
  3. Medical Necessity Requirements
  4. Step Therapy and Exceptions
  5. Quantity and Frequency Limits
  6. Required Diagnostics and Documentation
  7. Site of Care and Specialty Pharmacy Requirements
  8. Evidence to Support Medical Necessity
  9. Sample Medical Necessity Narrative
  10. Appeals Process in New Jersey
  11. Common Denial Reasons and Solutions
  12. Costs and Financial Assistance
  13. FAQ

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all non-emergency uses Exposure incident report, immunity status Cigna PA Requirements
Formulary Status Specialty tier through Accredo Check myCigna.com formulary tool Cigna Specialty Pharmacy
Step Therapy None for CDC-defined post-exposure N/A for emergency use Cigna Coverage Policy
Timing Window 24 hours (needlestick), 14 days (sexual) Exposure date documentation CDC Guidelines (verify with source linked)
Site of Care In-network providers preferred Provider network verification Cigna provider directory
Appeals Deadline 180 days from denial Internal denial letters NJ IHCAP Program

Policy Overview: How Cigna Covers HyperHEP B

Cigna treats HyperHEP B (hepatitis B immune globulin) as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage plans in New Jersey. The medication must be dispensed through Cigna's specialty pharmacy partner Accredo, which provides clinical support and ships directly to your home or healthcare provider.

Plan Type Considerations

Commercial Plans (Employer-Sponsored): Most require PA with 5-business-day standard review, though emergency post-exposure cases can receive expedited 24-72 hour review.

Medicare Advantage: Enhanced PA requirements with peer-to-peer review options available for denials.

Medicaid (NJ FamilyCare): May have different PA pathways; verify through your plan's member services.

Note: Self-funded employer plans follow federal ERISA rules rather than New Jersey state insurance regulations, affecting your appeal rights.

Medical Necessity Requirements

Cigna approves HyperHEP B when documentation shows:

Primary Indications

  • Post-exposure prophylaxis after needlestick, mucosal, or sexual exposure to HBsAg-positive blood
  • Perinatal prophylaxis for infants born to HBsAg-positive mothers
  • Transplant prophylaxis for liver transplant recipients with prior HBV infection

Critical Documentation Elements

  1. Exposure Details: Date, type (percutaneous/mucosal/sexual), source patient HBsAg status
  2. Patient Immunity Status: Vaccination history, anti-HBs titer results (<10 mIU/mL indicates non-responder)
  3. Timeline Compliance: Treatment within CDC-recommended windows
  4. Weight-Based Dosing: 0.06 mL/kg IM for adults, 0.5 mL for newborns

ICD-10 Codes for Claims

  • Z20.5: Contact with and exposure to viral hepatitis
  • Z87.19: Personal history of other diseases of the digestive system
  • B19.10: Unspecified viral hepatitis B without hepatic coma

Step Therapy and Exceptions

Good news: Cigna typically does not require step therapy for HyperHEP B in CDC-defined post-exposure scenarios. The urgency of post-exposure prophylaxis and lack of therapeutic alternatives make step therapy inappropriate.

When Step Therapy Might Apply

  • Off-label uses not supported by CDC guidelines
  • Preventive use without documented exposure
  • Requests outside recommended timing windows

Exception Process

If step therapy is incorrectly applied, request an exception by demonstrating:

  • Medical urgency of the situation
  • Lack of effective alternatives
  • CDC guideline support for immediate HBIG use

Quantity and Frequency Limits

Cigna typically authorizes HyperHEP B based on CDC-recommended dosing:

Standard Authorizations

  • Single dose for most post-exposure scenarios
  • Monthly dosing for transplant prophylaxis (requires annual renewal)
  • Weight-based calculations must be documented

Renewal Requirements

For ongoing use (transplant patients):

  • Annual prior authorization renewal
  • Updated viral markers (HBV DNA, HBsAg, anti-HBs levels)
  • Hepatology or transplant specialist documentation
  • Evidence of continued medical necessity
Tip: Start renewal requests 30-60 days before PA expiration to avoid treatment gaps.

Required Diagnostics and Documentation

Laboratory Requirements

For Exposed Patient:

  • Anti-HBs titer (to confirm non-immunity)
  • Anti-HBc status
  • Current weight for dosing calculations

For Source Patient (when possible):

  • HBsAg status
  • HBV DNA levels (if known)

Documentation Timeline

  • Lab results should be recent (within 30 days when possible)
  • Exposure incident reports must include specific dates and times
  • Previous vaccination records should span complete history

Essential Documents to Gather

  1. Incident report (occupational health, police report, medical record)
  2. Laboratory results (patient and source)
  3. Vaccination records
  4. Weight documentation for dosing
  5. CDC guideline excerpts supporting your case

Site of Care and Specialty Pharmacy Requirements

Accredo Specialty Pharmacy Mandate

HyperHEP B must be filled through Cigna's specialty pharmacy Accredo (877-826-7657). Retail pharmacy fills are typically not covered.

Administration Sites

  • In-network providers strongly preferred
  • Emergency departments for urgent post-exposure cases
  • Occupational health clinics for workplace exposures
  • Infusion centers for transplant patients requiring IV administration

Prior Authorization for Site of Care

Some plans require separate authorization for:

  • Out-of-network administration
  • Home infusion services
  • Hospital-based administration

Evidence to Support Medical Necessity

Key Guidelines to Reference

  1. CDC Post-Exposure Prophylaxis Guidelines: Timing windows and dosing recommendations
  2. FDA Prescribing Information: Approved indications and contraindications
  3. ACIP Recommendations: Vaccination and HBIG combination strategies

Peer-Reviewed Evidence

When appealing denials, include references to:

  • Studies demonstrating HBIG effectiveness in post-exposure scenarios
  • Transplant society guidelines for HBV prophylaxis
  • Cost-effectiveness analyses of immediate vs. delayed treatment
Clinician Corner: The most successful PA requests include a clear problem statement, documentation of exposure timing, evidence of non-immunity, and specific CDC guideline citations supporting the requested intervention.

Sample Medical Necessity Narrative

"Patient experienced high-risk percutaneous exposure to HBsAg-positive blood on [date]. Laboratory results confirm patient anti-HBs <10 mIU/mL despite previous vaccination series, indicating non-responder status. Per CDC post-exposure prophylaxis guidelines, HBIG 0.06 mL/kg IM is medically necessary within 7 days of exposure (preferably 24 hours) to prevent hepatitis B transmission. Patient weighs [X] kg, requiring [calculated dose]. Treatment delay increases transmission risk significantly. Request approval for single dose HyperHEP B per FDA labeling and CDC recommendations."

Appeals Process in New Jersey

Internal Appeals (Cigna)

Level 1: Submit within 180 days of denial

  • Timeline: 30 days for standard review, 72 hours for expedited
  • Submit via: Cigna provider portal or member services
  • Required: Denial letter, medical records, physician letter

Level 2: Peer-to-peer review if needed

  • Timeline: Additional 30 days
  • Process: Clinical specialist review with prescribing physician

External Review (New Jersey IHCAP)

After completing Cigna's internal appeals, New Jersey residents can file external appeals through the Independent Health Care Appeals Program (IHCAP), now administered by Maximus Federal Services.

Eligibility: Fully-insured plans issued in New Jersey (not self-funded employer plans) Deadline: 4 months (120 days) from final internal denial Cost: Free to patients Success Rate: Approximately 20-50% overall for specialty drugs

How to File IHCAP Appeal

  1. Online: IHCAP Portal at njihcap.maximus.com (preferred method)
  2. Mail/Fax: Download External Appeal Application from NJ DOBI website
  3. Required Documents:
    • Signed consent form
    • Internal denial letters (both levels)
    • Medical records and physician statement
    • Authorization for records release

Timeline: 45 days for standard review, 48 hours for expedited urgent cases

From Our Advocates: We've seen success rates above 80% for well-documented rare disease cases when appeals include detailed physician letters explaining medical necessity and referencing FDA criteria. The key is comprehensive documentation that addresses the insurer's specific denial reasons.

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
"Outside timing window" Prove exposure date and treatment urgency Incident reports, medical records showing exposure date
"Not medically necessary" Demonstrate non-immunity and CDC compliance Anti-HBs titers, vaccination records, CDC guidelines
"Quantity exceeds limits" Request quantity limit exception Weight-based dosing calculations, FDA prescribing information
"Non-formulary medication" Request formulary exception Clinical rationale for HyperHEP B vs. alternatives
"Insufficient documentation" Provide complete medical records All labs, incident reports, physician notes

Costs and Financial Assistance

Typical Costs

  • Retail price: $129-$900+ per vial depending on strength
  • With insurance: Varies by plan; specialty tier copays typically $50-$200

Financial Assistance Options

  1. Grifols Patient Assistance Program: For uninsured patients with income ≤250% Federal Poverty Level
  2. Hospital charity care: For emergency department administration
  3. State programs: New Jersey may have additional assistance programs (verify current availability)

Counterforce Health helps patients navigate these complex prior authorization and appeals processes, turning insurance denials into targeted, evidence-backed appeals that align with each payer's specific requirements.

FAQ

Q: How long does Cigna prior authorization take in New Jersey? A: Standard PA review takes 5 business days. Emergency post-exposure cases can receive expedited review in 24-72 hours.

Q: What if HyperHEP B is non-formulary on my plan? A: Request a formulary exception with clinical documentation showing medical necessity and lack of formulary alternatives.

Q: Can I get emergency treatment while waiting for PA approval? A: Yes, emergency departments can administer HyperHEP B for urgent post-exposure cases with retroactive PA submission.

Q: Does step therapy apply if I've failed treatments outside New Jersey? A: Step therapy typically doesn't apply to HyperHEP B for CDC-defined exposures, regardless of location of previous treatments.

Q: How do I know if my plan is eligible for New Jersey IHCAP appeals? A: Check if your member ID card shows "Fully-Insured." Self-funded employer plans follow federal ERISA rules instead.

Q: What's the success rate for overturning Cigna denials in New Jersey? A: External appeals through IHCAP succeed in approximately 20-50% of cases overall, with higher rates for well-documented specialty drug cases.

Q: Can my doctor file the external appeal for me? A: Yes, New Jersey allows providers to file external appeals on behalf of patients with proper consent forms.

Q: What happens if I miss the appeal deadline? A: Internal appeals must be filed within 180 days of denial. External appeals must be filed within 120 days of final internal denial. Missing these deadlines typically prevents further appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your specific plan and consult healthcare providers for medical decisions. For personalized assistance with prior authorizations and appeals, Counterforce Health provides specialized support in navigating insurance coverage for specialty medications.

Need Help? Contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or the IHCAP-specific line at 1-888-393-1062 for questions about the appeals process.

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