By Counterforce Health Team in Berinert (C1-esterase inhibitor, IV) —

How to Get Berinert (C1-esterase inhibitor, IV) Covered by Humana in New York: Complete Guide to Prior Authorization, Appeals, and Coding

Answer Box: Getting Berinert Covered by Humana in New York

Berinert (C1-esterase inhibitor, IV) requires prior authorization from Humana for hereditary angioedema (HAE) treatment. Fastest path: Have your doctor submit a PA request with HAE diagnosis (ICD-10: D84.1), lab results showing low C4 and C1-INH levels, and documentation of acute attacks. If denied, you can file a New York State external appeal within 4 months, with decisions in 24-72 hours for urgent drug appeals. Start today: Call Humana at the number on your card to verify PA requirements and request forms.

Table of Contents

  1. Coverage Overview: Medical vs. Pharmacy Benefit
  2. ICD-10 Coding for HAE Documentation
  3. Product Coding: HCPCS, NDC, and Unit Calculations
  4. Prior Authorization Requirements
  5. Common Denial Reasons and Solutions
  6. New York State Appeals Process
  7. Cost Support and Patient Assistance
  8. Verification Checklist
  9. Frequently Asked Questions

Coverage Overview: Medical vs. Pharmacy Benefit

Humana typically covers Berinert under the medical benefit (Medicare Part B or the medical side of Medicare Advantage) rather than as a pharmacy benefit drug. This is because Berinert is an IV infusion given under physician supervision for acute HAE attacks.

How This Affects You

If covered under medical benefit:

  • Billed using HCPCS J-code J0597
  • 20% coinsurance after Part B deductible (traditional Medicare)
  • Medicare Advantage plans may have different copays
  • Must use in-network infusion centers or hospitals

Site of care options:

  • Hospital outpatient departments
  • Physician offices with infusion capability
  • Specialty infusion centers
  • Home infusion (with proper training and setup)
Note: Verify your specific Humana plan's benefit structure by calling the member services number on your insurance card.

ICD-10 Coding for HAE Documentation

Proper diagnosis coding is essential for Berinert coverage. The primary code for hereditary angioedema is:

Primary Diagnosis Code:

  • D84.1 – Defects in the complement system

This code should be used for all HAE-related services, including:

  • Diagnostic testing (C4, C1-INH levels)
  • Acute treatment with Berinert
  • Prophylactic therapies

Supporting Documentation Requirements

Your medical record should include:

Diagnostic Evidence:

  • Low C4 levels (typically <50% of normal)
  • Low C1-INH antigenic levels OR low functional activity
  • Family history of HAE (when available)
  • Genetic testing results (if performed)

Attack Documentation:

  • Location of swelling (face, extremities, abdomen, larynx)
  • Severity and duration
  • Triggers (if identified)
  • Response to treatment
  • Impact on daily activities

Additional ICD-10 codes for specific presentations:

  • R22.x (localized swelling by body region)
  • R10.9 (abdominal pain for GI angioedema)
  • J38.4 (laryngeal edema for airway involvement)

Product Coding: HCPCS, NDC, and Unit Calculations

HCPCS Coding

Berinert is billed using HCPCS code J0597:

  • J0597: Injection, C1-esterase inhibitor (human), Berinert, 10 units

Dosing and Unit Calculations

FDA-approved dosing:

  • 20 IU per kilogram of body weight
  • Given as IV injection over approximately 5 minutes

Vial information:

  • Each vial contains 500 IU
  • Reconstituted with 10 mL sterile water
  • Single-use vial only

Billing unit calculation:

  1. Calculate total dose: Patient weight (kg) × 20 IU/kg
  2. Round up to whole vials needed
  3. Convert to billing units: 1 HCPCS unit = 10 IU
  4. Example: 70 kg patient needs 1,400 IU = 3 vials = 150 billing units

Common NDC Numbers

  • 63833-0825-02 (500 IU vial)
Important: Always document any medication waste due to single-use vial requirements. Some payers allow billing for discarded medication with appropriate modifiers.

Prior Authorization Requirements

Humana requires prior authorization for Berinert across most plans. Here's what you need to prepare:

Required Documentation

Clinical Information:

  • Confirmed HAE diagnosis with supporting lab results
  • Attack frequency and severity history
  • Prior treatment attempts and responses
  • Weight-based dosing calculation
  • Planned site of administration

Provider Information:

  • Prescribing physician details
  • Specialty (preferably allergy/immunology)
  • DEA and NPI numbers

Typical Authorization Periods

  • Initial approval: 6-12 months
  • Renewal requirements: documented ongoing need and appropriate use
  • Quantity limits: Often 1,000 billing units per 28 days (approximately 4 attacks)

Submitting Your Request

  1. Online portal: Most efficient method through Humana's provider portal
  2. Fax: Check your specific plan's PA fax number
  3. Phone: For urgent requests, call Humana's utilization management department

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Insufficient HAE diagnosis Submit complete lab workup C4, C1-INH levels, genetic testing
Use for prophylaxis Clarify acute treatment indication Attack logs, emergency room visits
Quantity limit exceeded Document attack frequency Detailed attack diary, severity scores
Site of care not appropriate Justify chosen location Clinical rationale for hospital vs. home
Step therapy required Document trial failures Prior medication history, adverse effects

Medical Necessity Letter Template

Your physician should include:

  • Patient demographics and HAE type
  • Clinical history of attacks (frequency, severity, locations)
  • Previous treatments tried and outcomes
  • Specific rationale for Berinert
  • Dosing plan based on current weight
  • Monitoring and safety plan

New York State Appeals Process

New York offers robust appeal rights when Humana denies coverage for specialty medications like Berinert.

Internal Appeal with Humana

Timeline: 65 days from denial notice to file Decision time: 30 days for pre-service, 60 days for post-service How to file: Online portal, phone, or written request

External Appeal Through New York DFS

If Humana upholds the denial, you can request an external review:

Eligibility: Final adverse determination from Humana Timeline: 4 months to file after internal appeal decision Cost: $25 fee (waived for Medicaid or financial hardship)

Expedited appeals for urgent drugs:

  • Standard: 72 hours for life/health risk
  • Non-formulary drugs: 24 hours for expedited requests

Filing Your External Appeal

  1. Gather documents:
    • Humana denial letters
    • Internal appeal decision
    • Medical records and physician letters
    • Clinical literature supporting Berinert use
  2. Submit to New York DFS:
    • Online portal (preferred): DFS External Appeal Portal
    • Include physician certification of medical necessity
    • Request expedited review if appropriate
  3. Follow up:
    • Respond quickly to requests for additional information
    • Track deadlines and keep copies of all submissions
Free Help Available: Community Health Advocates (CHA) provides free assistance with appeals in New York. Call 888-614-5400 for support with your case.

Cost Support and Patient Assistance

Manufacturer Support Programs

CSL Behring Patient Assistance:

  • Copay assistance for eligible patients
  • Patient support services for insurance navigation
  • Training programs for self-administration

Additional Resources

Foundation Support:

  • HAE Association patient assistance programs
  • State pharmaceutical assistance programs
  • Medicare Extra Help for Part D costs

Financial Hardship Options:

  • Hospital charity care programs
  • Manufacturer compassionate use programs
  • State emergency medication funds

Verification Checklist

Before submitting your prior authorization:

Patient Information:

  • Current Humana member ID and plan type
  • Accurate weight and contact information
  • Emergency contact details

Clinical Documentation:

  • HAE diagnosis confirmed with ICD-10 D84.1
  • Lab results (C4, C1-INH levels) in chart
  • Attack history documented
  • Previous treatment attempts recorded

Coding Verification:

  • HCPCS J0597 confirmed for current year
  • NDC number matches ordered product
  • Unit calculations verified (10 IU = 1 billing unit)
  • Site of care documented and appropriate

Submission Requirements:

  • All required forms completed
  • Physician signature and date current
  • Supporting literature included if needed
  • Submission method confirmed (portal vs. fax)

Frequently Asked Questions

How long does Humana prior authorization take for Berinert? Standard requests typically take 15-30 days. Urgent requests can be expedited to 72 hours with proper clinical justification.

What if Berinert isn't on my Humana formulary? Since Berinert is usually covered under the medical benefit, formulary status may not apply. However, you can request a formulary exception if needed.

Can I appeal if I'm denied for step therapy requirements? Yes. Document previous treatment failures or contraindications to preferred agents. New York's external appeal process can override step therapy requirements when medically inappropriate.

Does Humana cover home administration of Berinert? Coverage varies by plan. Some Humana plans prefer home infusion for cost management, while others require facility administration. Check your specific plan benefits.

What's the difference between Medicare Part B and Part D coverage? Part B covers physician-administered drugs like Berinert in clinical settings. Part D covers retail pharmacy drugs. Berinert is typically a Part B drug.

How do I find HAE specialists in New York who work with Humana? Use Humana's provider directory to search for allergists or immunologists. The HAE Association also maintains a physician finder tool.

What if I need Berinert while traveling? Contact Humana before traveling to understand out-of-network coverage. Emergency treatment is typically covered, but prior authorization may be needed for ongoing care.

Can my doctor request a peer-to-peer review? Yes. If denied, your physician can request to speak directly with Humana's medical director to discuss the clinical rationale for Berinert.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to identify the denial basis and draft point-by-point rebuttals aligned to each plan's specific requirements. We pull the right citations and weave them into appeals with required clinical facts, helping achieve cleaner submissions that reduce back-and-forth with payers.

For additional support with your Berinert coverage challenge, visit Counterforce Health to learn how our platform can help strengthen your appeal with payer-specific documentation and evidence.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and state. Always verify current requirements with your specific Humana plan and consult with your healthcare provider for medical decisions. For official appeals guidance, contact the New York Department of Financial Services or Community Health Advocates.

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