Answer Box: Getting HyperHEP (Hepatitis B Immune Globulin) Covered by Cigna in California

HyperHEP requires prior authorization from Cigna, with approval based on documented post-exposure prophylaxis within 7 days of hepatitis B exposure. Submit through Cigna's provider portal with exposure details, immunity status, and CDC guideline citations. If denied, file an internal appeal within 180 days, then request California's Independent Medical Review (IMR) through DMHC for binding external review. Success rates for specialty drug appeals reach 55-68% in California's IMR system.

First step today: Contact your doctor to document the exposure incident and submit PA through Cigna's portal at cignaforhcp.com with complete clinical justification.

Table of Contents

1. Patient Profile: Sarah's Needlestick Exposure
2. Pre-Authorization Preparation
3. Initial Submission to Cigna
4. The Denial and What Went Wrong
5. Building the Appeal Case
6. California IMR Success
7. What We'd Do Differently
8. Templates and Checklists

Patient Profile: Sarah's Needlestick Exposure

Sarah, a 28-year-old nurse at a Sacramento hospital, sustained a deep needlestick injury from a hollow-bore needle while drawing blood from a patient with known hepatitis B. The incident occurred on a Tuesday evening, and she reported to occupational health the following morning.

Key factors in Sarah's case:

• Cigna HMO through her employer
• Previous hepatitis B vaccination series completed 3 years ago
• Recent anti-HBs titer: 8 mIU/mL (below protective level of 10 mIU/mL)
• Source patient: HBsAg positive with high viral load
• Exposure: Deep percutaneous injury with visible blood

Sarah's case represents a textbook indication for HyperHEP under CDC post-exposure prophylaxis guidelines - a non-responder to vaccination with high-risk occupational exposure.

Pre-Authorization Preparation

The occupational health clinic gathered comprehensive documentation before submitting to Cigna:

Essential Documentation Collected

Exposure Documentation:

• Incident report with exact time, needle type, and injury depth
• Source patient's HBsAg and HBV DNA results
• Occupational health evaluation notes

Patient Immunity Status:

• Complete vaccination records from employee health
• Recent anti-HBs titer results (8 mIU/mL)
• Documentation of non-responder status

Clinical Justification:

• Weight-based dosing calculation: 0.06 mL/kg IM (Sarah: 65 kg = 3.9 mL dose)
• CDC guideline citations for HBIG + vaccine in non-responders
• Timeline justification (within 24 hours of exposure)

From our advocates: In cases like Sarah's, we've seen the strongest approvals when clinics submit a complete packet upfront rather than responding to requests for additional information. Plans often deny incomplete submissions as "insufficient documentation."

Initial Submission to Cigna

The clinic submitted Sarah's prior authorization through Cigna's provider portal on Wednesday morning, 18 hours post-exposure.

Coverage at a Glance

Requirement	What it means	Where to find it	Timeline
Prior Authorization	Required for specialty tier	myCigna.com formulary search	5 business days standard
Specialty Pharmacy	Must fill through Accredo	877-826-7657	After PA approval
Medical Necessity	CDC guideline compliance	Provider clinical notes	With PA submission
Timing Window	Within 7 days post-exposure	Incident documentation	Critical for approval

The submission included:

• PA request form with ICD-10 code Z20.5 (contact with hepatitis B)
• Clinical summary citing CDC recommendations
• All supporting laboratory and incident documentation
• Request for expedited review due to time-sensitive nature

The Denial and What Went Wrong

Despite comprehensive documentation, Cigna denied the request within 48 hours with the reason: "Alternative therapy available - hepatitis B vaccine recommended."

Common Denial Reasons for HyperHEP

Denial Reason	How to Overturn	Required Evidence
"Alternative therapy available"	Document vaccine non-responder status	Anti-HBs titers <10 mIU/mL after complete series
"Timing outside window"	Provide exact exposure timeline	Incident report with timestamps
"Insufficient exposure risk"	Detail high-risk exposure type	Source HBsAg status, needle type, injury depth
"Not medically necessary"	Cite CDC/ACIP guidelines	Peer-reviewed references, FDA labeling

The denial letter failed to acknowledge Sarah's documented non-responder status, focusing only on the availability of hepatitis B vaccine as an alternative.

Building the Appeal Case

Sarah's clinic filed an internal appeal within Cigna's 180-day deadline, strengthening their case with additional evidence.

Medical Necessity Letter Checklist

The appeal included a detailed physician letter addressing:

• Problem statement: Non-responder to HBV vaccine with high-risk occupational exposure
• Prior treatments: Complete vaccination series with inadequate antibody response
• Clinical rationale: CDC guidelines recommend HBIG + vaccine for non-responders
• Guideline citations: ACIP recommendations and FDA labeling
• Dosing justification: Weight-based calculation per manufacturer guidelines
• Risk of non-treatment: Potential chronic hepatitis B infection and liver complications

Appeals Playbook for Cigna in California

Level 1: Internal Appeal

• Deadline: 180 days from denial date
• Timeline: 30 days for pre-service, 60 days for post-service
• Submission: Provider portal or mail to address on denial letter
• Required: Complete medical records, physician letter, guideline citations

Level 2: California IMR

• Eligibility: After internal denial or 30-day non-response
• Deadline: No specific limit, but prompt filing recommended
• Process: Submit through DMHC online portal
• Timeline: 45 days standard, 72 hours expedited
• Cost: Free to patients

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each plan's specific requirements.

California IMR Success

When Cigna upheld their initial denial, Sarah's case proceeded to California's Independent Medical Review (IMR) through the Department of Managed Health Care (DMHC).

IMR Documentation Package

The clinic submitted:

• Complete internal appeal file
• Additional peer-reviewed literature on HBIG efficacy
• Comparative cost analysis showing prophylaxis vs. treatment costs
• Expert opinion from infectious disease specialist

IMR Outcome: The independent medical reviewer overturned Cigna's denial within 30 days, finding that HyperHEP was medically necessary based on established guidelines for post-exposure prophylaxis in vaccine non-responders.

California IMR Success Statistics

California's IMR system shows favorable outcomes for specialty drug appeals:

• Overall approval rate: Approximately 73% of requested services approved
• Specialty drug success: 55-68% of medical necessity denials overturned
• Timeline: Most decisions within 45 days (expedited in 72 hours)
• Binding decision: Plans must authorize approved services

What We'd Do Differently

Reflecting on Sarah's case, several strategies could have prevented the initial denial:

Fastest Path to Approval Strategy

1. Pre-submission peer-to-peer: Request medical director review before formal PA
2. Emphasize non-responder status: Lead with vaccination failure documentation
3. Include cost-benefit analysis: Compare prophylaxis vs. treatment costs
4. Request expedited review: Cite time-sensitive nature of post-exposure prophylaxis
5. Submit complete packet: Include all supporting evidence with initial request
6. Use specific language: Reference exact CDC guideline sections and FDA labeling
7. Document urgency: Emphasize narrow window for effective prophylaxis

When to Escalate

Contact California regulators if:

• Cigna fails to meet appeal timelines
• Denials appear inconsistent with medical evidence
• Pattern of inappropriate denials emerges

DMHC Help Center: 888-466-2219 Online complaint filing: healthhelp.ca.gov

Templates and Checklists

Patient Phone Script for Cigna

"Hello, I'm calling about prior authorization for HyperHEP for post-exposure hepatitis B prophylaxis. My member ID is [number]. Can you tell me the current status of this request and what additional information might be needed? This is time-sensitive due to the exposure timeline."

Clinic Staff Peer-to-Peer Request Script

"I'm requesting a peer-to-peer review for HyperHEP prior authorization for a healthcare worker with documented vaccine non-responder status following high-risk occupational exposure. The patient meets CDC criteria for HBIG, and we have complete documentation including incident reports and serology."

Checklist: What to Gather Before Starting

Patient Information:

• Insurance card and member ID
• Complete vaccination records
• Recent anti-HBs and HBsAg results
• Employment/exposure documentation

Clinical Documentation:

• Incident report with timestamps
• Source patient HBsAg status
• Occupational health evaluation
• Weight for dosing calculation

Supporting Evidence:

• CDC guideline excerpts
• FDA labeling information
• Peer-reviewed literature
• Cost-benefit analysis

FAQ

How long does Cigna prior authorization take in California? Standard PA decisions take up to 5 business days, with expedited reviews completed within 24-72 hours for urgent cases like post-exposure prophylaxis.

What if HyperHEP is non-formulary on my Cigna plan? Request a formulary exception with medical necessity documentation. California law supports step-therapy overrides and formulary exceptions for medically appropriate treatments.

Can I request an expedited appeal in California? Yes, both Cigna internal appeals and California IMR offer expedited processes for urgent medical situations, typically decided within 72 hours.

Does step therapy apply if I've failed hepatitis B vaccine? Document vaccine non-responder status with anti-HBs titers <10 mIU/mL after complete series. This typically satisfies step therapy requirements.

What's the success rate for HyperHEP appeals in California? California's IMR system shows 55-68% success rates for specialty drug appeals, with higher rates when strong clinical evidence supports medical necessity.

Who pays for California IMR reviews? IMR reviews are free to patients. Insurers bear the cost of the independent medical review process.

Costs and Savings Options

Manufacturer Support:

• Grifols patient assistance programs (income-based eligibility)
• Hospital charity care programs for uninsured patients

State Resources:

• California's emergency Medicaid for qualifying exposures
• Workers' compensation coverage for occupational exposures

Foundation Grants:

• HealthWell Foundation hepatitis B fund
• Patient Access Network Foundation specialty drug assistance

At Counterforce Health, we help patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by creating targeted appeals that align with each plan's specific policies and evidence requirements.

Sources and Further Reading

• CDC Hepatitis B Post-Exposure Prophylaxis Guidelines
• Cigna Prior Authorization Requirements
• California DMHC Independent Medical Review
• HyperHEP Prescribing Information
• ACIP Hepatitis B Vaccination Guidelines

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Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with healthcare providers and insurance representatives for specific coverage determinations and medical guidance. Coverage policies and procedures may vary by plan and change over time.

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