By Counterforce Health Team in Helixate (antihemophilic factor, rFVIII) —

How to Get Helixate (Antihemophilic Factor VIII) Covered by Cigna in New York: Coding, Appeals, and State Resources

Answer Box: Getting Helixate Covered by Cigna in New York

Important Update: Helixate FS and Kogenate FS are discontinued in the United States as of 2022-2023. Cigna no longer covers these products on their formulary. Your fastest path to coverage: Work with your hemophilia treatment center to transition to a preferred alternative like Advate, Kovaltry, or Jivi. Submit prior authorization through Express Scripts/Accredo using ICD-10 code D66 and HCPCS J7192. If denied, New York residents can file an external appeal through the Department of Financial Services within 4 months. Start today by calling Cigna at 1-800-244-6224 to confirm your plan's preferred factor VIII products.

Table of Contents

  1. Critical Update: Product Discontinuation
  2. Coding Basics: Medical vs. Pharmacy Benefit
  3. ICD-10 Mapping for Hemophilia A
  4. Product Coding: HCPCS, J-Codes, and NDCs
  5. Clean Request Anatomy
  6. Common Coding Pitfalls
  7. Verification with Cigna Resources
  8. Appeals Process in New York
  9. Pre-Submission Checklist
  10. FAQ

Critical Update: Product Discontinuation

Helixate FS and Kogenate FS are no longer available in the United States. Bayer discontinued Kogenate FS production in 2022, with supplies depleted by late 2022-2023. Helixate FS was discontinued even earlier, in 2017-2019.

Cigna's 2024 formulary status: Both products are removed from coverage due to discontinuation. You'll need to transition to a preferred alternative:

  • Preferred factor VIII products: Advate, Kovaltry, Jivi, NovoEight, Nuwiq, Xyntha, Eloctate, Esperoct, Altuviiio
  • Coverage pathway: All require prior authorization through Express Scripts/Accredo
  • Patient action: Contact your hemophilia treatment center immediately to select and authorize a replacement therapy
Note: If you're currently on Helixate/Kogenate FS, don't wait for your supply to run out. Begin the transition process now to avoid treatment gaps.

Coding Basics: Medical vs. Pharmacy Benefit

Factor VIII products like Helixate alternatives typically fall under the medical benefit (not pharmacy) because they're administered by injection and often require special handling.

Medical Benefit Path:

  • Billed using HCPCS J-codes
  • Requires prior authorization through medical management
  • Processed through Cigna's specialty pharmacy (usually Accredo)
  • Subject to medical deductibles and coinsurance

Key difference: Unlike oral medications that go through Express Scripts pharmacy benefits, factor VIII products are managed as specialty injectables under medical coverage with different approval workflows.

ICD-10 Mapping for Hemophilia A

Primary diagnosis code: D66 - Hereditary factor VIII deficiency (Hemophilia A)

Documentation Requirements for D66

Your medical records must include:

  • Laboratory confirmation: Factor VIII activity levels <40% (severe cases <1%)
  • Clinical symptoms: Spontaneous bleeding, hemarthrosis, prolonged bleeding with minor trauma
  • Hereditary status: Family history or genetic testing confirming inherited condition
  • Severity classification: Mild (5-40%), moderate (1-5%), or severe (<1%) hemophilia A

Supporting Documentation Words

Include these terms in clinical notes to support coding:

  • "Hereditary factor VIII deficiency confirmed by laboratory testing"
  • "Recurrent hemarthrosis requiring factor replacement therapy"
  • "Spontaneous bleeding episodes despite previous treatment"
  • "Factor VIII activity level [specific percentage]"
Important: Do not use D66 for carrier status (use Z14.02) or acquired factor VIII deficiency (use D68.311).

Product Coding: HCPCS, J-Codes, and NDCs

HCPCS J-Code

J7192 - Factor VIII (antihemophilic factor, recombinant), per IU

Billing Units Calculation

  • 1 billing unit = 1 International Unit (IU)
  • Formula: Total billing units = total IUs administered
  • Example: 1,500 IU dose = 1,500 units of J7192

Common NDC Numbers (for reference)

Since Helixate FS is discontinued, here are NDCs for preferred alternatives:

Product Strength NDC
Advate 250 IU 00944-2949-02
Kovaltry 250 IU 50419-488-01
Jivi 250 IU 50419-110-58
Critical: Always use the actual NDC from the product label at time of billing, as NDCs change with manufacturing updates.

Clean Request Anatomy

Example Prior Authorization Request

Patient Information:

  • Name, DOB, Cigna member ID
  • Prescribing physician and NPI
  • Hemophilia treatment center details

Clinical Documentation:

  • Diagnosis: Hemophilia A (ICD-10: D66)
  • Lab results: Factor VIII activity level: <1% (severe)
  • Treatment history: Previous factor concentrates used, response, any inhibitor development
  • Current bleeding pattern: Frequency of spontaneous bleeds, joint involvement
  • Requested therapy: Advate 1000 IU vials, quantity needed per month
  • Administration plan: Prophylactic dosing 3x weekly, home infusion

Billing codes:

  • HCPCS: J7192
  • Units: Based on prescribed IU per dose
  • Diagnosis: D66

Counterforce Health helps patients and providers create comprehensive prior authorization requests by analyzing payer policies and generating evidence-backed appeals that address specific denial criteria point-by-point.

Common Coding Pitfalls

Unit Conversion Errors

  • Wrong: Billing vials instead of IUs (e.g., billing 2 units for 2 vials of 1000 IU each)
  • Right: Billing total IUs administered (e.g., 2000 units for 2000 IU total dose)

Mismatched Codes

  • Wrong: Using plasma-derived factor VIII codes for recombinant products
  • Right: J7192 for all recombinant factor VIII products

Missing Documentation

  • Wrong: Submitting PA without factor VIII activity levels
  • Right: Include comprehensive lab results and bleeding history

NDC Verification

  • Wrong: Using discontinued Helixate FS NDCs
  • Right: Current NDC from approved alternative product packaging

Verification with Cigna Resources

Before Submitting

  1. Check formulary status: Log into myCigna portal or call 1-800-244-6224
  2. Verify preferred alternatives: Confirm which factor VIII products are tier 1 or 2
  3. Confirm specialty pharmacy requirement: Most factor VIII must be filled through Accredo
  4. Review quantity limits: Check monthly supply restrictions

Cigna PA Submission Methods

  • Electronic: CoverMyMeds, ExpressPAth, or EHR integration
  • Fax: 1-866-873-8279
  • Phone: 1-800-882-4462
  • Accredo provider portal: For specialty pharmacy PAs
Tip: Electronic submissions typically process faster than fax submissions.

Appeals Process in New York

Internal Appeals (Cigna)

  • Timeline: 180 days from denial to file
  • Levels: First-level and second-level internal review
  • Expedited option: 72-hour turnaround for urgent cases
  • Submit via: Cigna member portal, phone, or mail

External Appeals (New York DFS)

New York residents have strong appeal rights through the Department of Financial Services:

  • Timeline: 4 months after final internal denial
  • Process: Independent medical expert reviews case
  • Decision: Binding on Cigna
  • Cost: $25 maximum (waived for Medicaid/financial hardship)
  • Expedited: 72 hours for urgent cases, 24 hours for drug denials

How to file: Submit through the DFS online portal or mail required forms.

New York State Resources

  • Consumer Assistance Program: Community Health Advocates at 888-614-5400
  • DFS External Appeals Database: Search prior hemophilia drug decisions for precedent
  • Alternative: Medicaid enrollees can request Fair Hearing instead of external appeal

When appeals are successful, Counterforce Health has seen that providing specific medical literature and addressing payer policies point-by-point significantly improves overturn rates, especially for rare disease therapies.

Pre-Submission Checklist

Required Documents

  • Current Cigna insurance card and member ID
  • Complete hemophilia diagnosis documentation
  • Factor VIII activity lab results
  • Bleeding episode history (past 6-12 months)
  • Prior factor concentrate trials and outcomes
  • Inhibitor screening results (if applicable)
  • Prescriber's medical necessity letter
  • Preferred alternative product selection

Coding Verification

  • ICD-10 code D66 confirmed in medical record
  • HCPCS J7192 for billing
  • Correct NDC for chosen alternative product
  • Accurate IU calculation for billing units
  • Administration site and frequency documented

Submission Details

  • Prior authorization form completed
  • Electronic submission method selected
  • Specialty pharmacy (Accredo) contacted if required
  • Follow-up timeline established with provider office
From our advocates: "The most successful hemophilia factor approvals include comprehensive bleeding diaries and clear documentation of why the specific product and dose are medically necessary. Don't rush the initial submission—a complete request often gets approved faster than multiple incomplete attempts."

FAQ

How long does Cigna prior authorization take for factor VIII products? Standard review is 14 calendar days. Expedited review (for urgent medical needs) is 72 hours. Electronic submissions typically process faster than fax.

What if my preferred factor VIII product isn't on Cigna's formulary? Request a formulary exception with clinical justification. Document why preferred alternatives are inappropriate (allergic reaction, inhibitor development, etc.).

Can I get an expedited appeal in New York? Yes. If delaying treatment endangers your health, request expedited internal appeal (72 hours) or expedited external appeal through DFS (24-72 hours).

Does step therapy apply to factor VIII products? Less commonly than other drugs, but some plans require trying preferred products first. Document any prior factor concentrate failures or contraindications.

What if I'm traveling and need factor VIII outside New York? Contact Cigna's 24/7 customer service for emergency authorization. Keep documentation of your hemophilia diagnosis and current treatment plan when traveling.

How do I search for similar successful appeals in New York? Use the DFS External Appeals Database and search terms like "hemophilia," "factor VIII," or specific product names to find precedent cases.

Can my doctor do a peer-to-peer review with Cigna? Yes. Request peer-to-peer review when PA is denied. Your hematologist can speak directly with Cigna's medical director to explain medical necessity.

What if Cigna requires Accredo specialty pharmacy but I prefer my local pharmacy? Most factor VIII products require specialty pharmacy due to storage and handling requirements. You can request an exception, but approval is uncommon unless your local pharmacy meets specialty certification requirements.

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 change frequently. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals and prior authorizations, consider working with advocacy services like Counterforce Health, which specializes in turning insurance denials into successful, evidence-backed appeals.

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