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

UnitedHealthcare's Coverage Criteria for HyperHEP in New Jersey: What Counts as "Medically Necessary"?

Answer Box: Getting HyperHEP Covered by UnitedHealthcare in New Jersey

UnitedHealthcare requires prior authorization for HyperHEP (hepatitis B immune globulin) based on documented exposure and timing. Medical necessity requires: (1) exposure to HBsAg-positive blood/fluids within 7 days, (2) patient susceptibility (unvaccinated or non-immune), and (3) proper dosing (0.06 mL/kg IM). Submit PA through OptumRx with exposure documentation, vaccination history, and CDC guideline references. If denied, file internal appeal within 180 days, then external review through New Jersey's IHCAP within 4 months. Start today: Call UnitedHealthcare at the number on your card to initiate prior authorization.

Table of Contents

  1. Policy Overview: How UnitedHealthcare Covers HyperHEP
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity and Frequency Limits
  5. Required Documentation and Diagnostics
  6. Site of Care and Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process in New Jersey
  10. Common Denial Reasons and Solutions
  11. Costs and Patient Assistance
  12. FAQ

Policy Overview: How UnitedHealthcare Covers HyperHEP

UnitedHealthcare covers HyperHEP (hepatitis B immune globulin) across most plan types—commercial PPO/HMO, Medicare Advantage, and ACA Marketplace plans—but requires prior authorization for non-emergency use. The coverage determination follows UnitedHealthcare's immune globulin policy, which emphasizes CDC guidelines and appropriate clinical indications.

Plan Type Considerations

  • Commercial plans: Standard PA required; expedited review available for urgent cases
  • Medicare Advantage: Similar PA requirements with CMS oversight
  • ACA Marketplace: May have additional formulary restrictions
Note: Self-funded employer plans (ERISA) may have different appeal rights than fully-insured New Jersey plans.

Medical Necessity Requirements

UnitedHealthcare defines medical necessity for HyperHEP based on documented exposure scenarios and patient immune status. The key criteria include:

Primary Indications (FDA-Approved)

  1. Post-exposure prophylaxis after percutaneous or mucosal exposure to HBsAg-positive blood
  2. Sexual exposure to HBsAg-positive individual
  3. Perinatal exposure (infants born to HBsAg-positive mothers)
  4. Household exposure with ongoing contact risk

Patient Eligibility Criteria

  • Susceptible individuals: Unvaccinated, incompletely vaccinated, or vaccine non-responders
  • Timing: Exposure within 7 days (preferably within 24 hours for maximum efficacy)
  • Documentation: Clear exposure history with source patient HBsAg status when available
Tip: Emergency department exposures often receive automatic approval, but outpatient scenarios require more detailed documentation.

Step Therapy and Exception Pathways

UnitedHealthcare may require step therapy for hepatitis B immune globulin products, meaning preferred HBIG formulations must be tried first. However, exceptions are readily available when:

Medical Exception Criteria

  • Documented intolerance to preferred HBIG products
  • Clinical contraindications to formulary alternatives
  • Time-sensitive exposure requiring immediate treatment
  • Provider clinical judgment supporting HyperHEP specifically

Exception Documentation

Submit a brief clinical letter explaining why HyperHEP is preferred over formulary alternatives. Common reasons include:

  • Previous adverse reaction to other HBIG products
  • Facility stocking preferences for emergency use
  • Patient-specific factors (weight, injection site preferences)

Quantity and Frequency Limits

UnitedHealthcare follows FDA dosing guidelines without imposing arbitrary quantity restrictions:

Standard Dosing Limits

Patient Population Dose Maximum Quantity
Adults/Children 0.06 mL/kg IM Based on weight calculation
Neonates 0.5 mL IM Single dose within 12 hours
Repeat exposure 0.06 mL/kg IM New PA required for each exposure

Renewal Requirements

  • Single exposure: No renewal needed for standard post-exposure prophylaxis
  • Multiple exposures: Each incident requires separate PA and documentation
  • Ongoing risk: Vaccination series initiation required alongside HBIG

Required Documentation and Diagnostics

Successful PA approval requires comprehensive exposure and patient documentation:

Essential Documentation Checklist

  • Exposure details: Date, type (percutaneous/mucosal), source patient status
  • Patient immune status: Vaccination history, anti-HBs levels if available
  • Clinical rationale: Why HBIG is necessary over vaccination alone
  • Timing justification: Why treatment falls within effective window
  • Prescriber attestation: Clinical necessity statement

Laboratory Requirements

While not always required for emergency scenarios, include when available:

  • Source patient HBsAg status
  • Patient anti-HBs levels (if previously tested)
  • Liver function tests (if clinically indicated)

Site of Care and Specialty Pharmacy Requirements

UnitedHealthcare typically allows HyperHEP administration in multiple settings:

Approved Administration Sites

  • Hospital emergency departments (preferred for urgent exposures)
  • Urgent care centers with appropriate staffing
  • Primary care offices with emergency protocols
  • Occupational health clinics for workplace exposures

Pharmacy Routing

  • OptumRx specialty pharmacy for planned administrations
  • Hospital pharmacy for emergency department use
  • Retail pharmacy may be approved for urgent cases
Important: Verify network status of administration facility to avoid out-of-network charges.

Evidence to Support Medical Necessity

Strengthen your PA request with evidence-based references:

Key Clinical Guidelines

  1. CDC Guidelines: Hepatitis B post-exposure prophylaxis recommendations
  2. FDA Labeling: HyperHEP prescribing information
  3. ACIP Recommendations: Hepatitis B vaccination and post-exposure management

Supporting Literature

Reference peer-reviewed studies demonstrating HBIG efficacy, particularly for:

  • Time-sensitive post-exposure prophylaxis
  • High-risk exposure scenarios
  • Combination therapy with hepatitis B vaccine

Sample Medical Necessity Letter

Template for Provider Use:

"This request is for HyperHEP (hepatitis B immune globulin) for [PATIENT NAME] following documented exposure to hepatitis B on [DATE]. The patient experienced [EXPOSURE TYPE] with confirmed HBsAg-positive source. Patient vaccination status: [COMPLETE/INCOMPLETE/UNKNOWN].

Per CDC guidelines, HBIG administration within 7 days of exposure provides optimal protection for susceptible individuals. The requested 0.06 mL/kg dose aligns with FDA labeling and ACIP recommendations. Concurrent hepatitis B vaccination series will be initiated.

Clinical necessity is based on: (1) documented high-risk exposure, (2) patient susceptibility, and (3) time-sensitive nature requiring immediate passive immunization. This treatment is essential to prevent hepatitis B infection and its potential complications."

Appeals Process in New Jersey

If UnitedHealthcare denies your HyperHEP request, New Jersey offers robust appeal protections:

Internal Appeals (UnitedHealthcare)

  1. File within 180 days of denial notice
  2. Submit through: Member portal, phone, or written request
  3. Timeline: Standard review within 30 days; expedited within 72 hours for urgent cases
  4. Required documents: Original PA request, denial letter, additional clinical evidence

External Review (New Jersey IHCAP)

After completing internal appeals:

  1. Deadline: 4 months (120 days) from final internal denial
  2. Process: File with New Jersey IHCAP
  3. Cost: $25 filing fee
  4. Timeline: Decision within 45 days (48 hours for expedited)
  5. Outcome: Binding decision on UnitedHealthcare
Key Resource: Contact IHCAP at 1-888-393-1062 for assistance with external appeals.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
"Outside time window" Document exposure date and cite 7-day efficacy window
"Vaccination status unclear" Provide immunization records or antibody levels
"Non-preferred product" Request step therapy exception with clinical justification
"Insufficient documentation" Submit complete exposure report and provider attestation
"Not medically necessary" Reference CDC guidelines and peer-reviewed evidence

Costs and Patient Assistance

Financial Support Options

  • Manufacturer assistance: Check Grifols patient support programs for eligibility
  • Copay assistance: May be available for commercially insured patients
  • Hospital charity care: For emergency department administrations
  • New Jersey pharmaceutical assistance: State programs for qualified residents

Cost Considerations

HyperHEP costs vary significantly:

  • Retail cash price: $129-$900+ per vial depending on strength
  • Insurance copay: Typically $20-$100 for covered administrations
  • Out-of-pocket maximum: Applies to annual deductible and limits

FAQ

Q: How long does UnitedHealthcare prior authorization take for HyperHEP? A: Standard PA decisions within 72 hours; expedited review within 24 hours for urgent exposures.

Q: Can I get HyperHEP at any hospital emergency department? A: Yes, most EDs stock HBIG for emergency use, though specific brands may vary. UnitedHealthcare typically covers medically necessary emergency administrations.

Q: What if I'm exposed outside New Jersey but have UnitedHealthcare coverage here? A: Coverage follows your plan terms regardless of exposure location. File PA based on your New Jersey UnitedHealthcare policy.

Q: Do I need HyperHEP if I've been vaccinated against hepatitis B? A: Depends on your antibody levels and vaccination completion. Fully immune individuals (anti-HBs >10 mIU/mL) typically don't need HBIG.

Q: Can my doctor request a peer-to-peer review? A: Yes, providers can request peer-to-peer discussions with UnitedHealthcare medical directors for complex cases.

Q: What happens if my appeal is denied? A: After internal appeals, you can file for external review through New Jersey IHCAP, which provides independent medical review.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements like those for HyperHEP. Our platform analyzes denial letters, identifies specific coverage criteria, and generates targeted appeals that address payer requirements point-by-point. For healthcare providers managing frequent prior authorizations, Counterforce Health streamlines the process with evidence-backed templates and payer-specific workflows.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with UnitedHealthcare and consult healthcare providers for medical decisions. For assistance with New Jersey insurance appeals, contact the Department of Banking and Insurance at 1-800-446-7467.

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