By Counterforce Health Team in Gamifant (emapalumab-lzsg) —

How to Get Gamifant (Emapalumab) Covered by Blue Cross Blue Shield in Michigan: Coding, Appeals, and Prior Authorization Guide

Quick Answer: Blue Cross Blue Shield of Michigan requires prior authorization for Gamifant (emapalumab) starting September 2025. Success requires proper ICD-10 coding (D76.1 for HLH), documented HLH-2004 criteria, prior therapy failures, and complete infection workup. Submit through provider portals like Availity or NovoLogix. If denied, you have 127 days to file an external review with Michigan DIFS. Start by gathering your HLH diagnosis documentation and prior treatment records today.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Gamifant (emapalumab-lzsg) is exclusively billed as a medical benefit drug in the United States. This IV infusion medication cannot be dispensed through retail or mail-order pharmacies, making it ineligible for pharmacy benefit processing.

Medical Benefit Pathway:

  • Billed using HCPCS J-code J9210
  • Administered in outpatient hospital or clinic settings
  • Requires prior authorization through medical benefit channels
  • Covered under the patient's medical insurance, not prescription drug plan

Why This Matters: Blue Cross Blue Shield of Michigan processes Gamifant claims through their medical benefit system, not pharmacy benefits. This affects which forms you use, which portals handle submissions, and how appeals are processed.

ICD-10 Mapping and Documentation

Accurate diagnosis coding is critical for Gamifant approval. The primary ICD-10 code is D76.1 (Hemophagocytic lymphohistiocytosis).

Documentation Requirements

Your medical record must clearly establish the HLH diagnosis using HLH-2004 criteria:

Required: 5 of 8 criteria OR genetic confirmation:

  1. Fever
  2. Splenomegaly
  3. Cytopenias (≥2 lineages: hemoglobin, platelets, neutrophils)
  4. Hypertriglyceridemia and/or hypofibrinogenemia
  5. Hemophagocytosis in bone marrow/spleen/lymph node
  6. Low or absent NK-cell activity
  7. Ferritin ≥500 ng/mL
  8. Elevated soluble IL-2 receptor (sCD25)
Tip: Ensure your hematologist/oncologist explicitly documents "hemophagocytic lymphohistiocytosis" in the medical record, not just "HLH" or related symptoms.

Supporting Documentation Words

Include these key phrases in medical records to support D76.1 coding:

  • "Confirmed hemophagocytic lymphohistiocytosis per HLH-2004 criteria"
  • "Primary HLH refractory to conventional therapy"
  • "Failed etoposide/dexamethasone protocol"
  • "Meets 5+ HLH diagnostic criteria"

Product Coding: HCPCS, J-Codes, and NDC

HCPCS J-Code

J9210: "Injection, emapalumab-lzsg, 1 mg" — each billable unit equals 1 mg of drug administered.

NDC Numbers by Vial Size

Report the specific NDC matching the vial administered:

  • 10 mg/2 mL vial: 66658-501-01
  • 50 mg/10 mL vial: 66658-505-01
  • 100 mg/20 mL vial: 66658-510-01

Units Calculation

Dosing: Initial dose is 1 mg/kg IV twice weekly (every 3-4 days), adjustable up to 10 mg/kg based on response.

Billing Example:

  • Patient weight: 70 kg
  • Dose: 70 mg (1 mg/kg)
  • Billable units: 70 (one unit per mg)
  • HCPCS: J9210 x 70 units
  • NDC: 66658-505-01 (if using 50 mg vial + 10 mg vial)

Additional Procedure Codes

  • CPT 96365: IV infusion procedure
  • Modifier UD: Required for 340B-acquired drugs

Clean Prior Authorization Request

Blue Cross Blue Shield of Michigan requires prior authorization for Gamifant starting September 3, 2025, across commercial, Medicare Plus Blue, BCN commercial, and BCN Advantage plans.

Required Submission Elements

Patient Information:

  • ICD-10 diagnosis code: D76.1
  • Prescribed by hematology/oncology specialist
  • Dosing regimen and anticipated duration

Clinical Documentation:

  • Established HLH diagnosis with HLH-2004 criteria
  • Prior therapy history (etoposide, dexamethasone, cyclosporine)
  • Documentation of refractory, relapsed, or progressive disease
  • Infection screening results (tuberculosis, viral panel)

Submission Portals:

  • Commercial plans: Availity provider portal
  • Medicare Plus Blue/BCN Advantage: NovoLogix or OncoHealth portals
Note: Requests missing infection workup or prior therapy documentation face high denial rates.

Common Billing Pitfalls

Unit Conversion Errors

  • Wrong: Billing per vial instead of per mg
  • Right: Each mg = 1 unit of J9210

Vial Wastage Misreporting

  • Document actual drug administered vs. vial contents
  • Follow CMS single-use vial wastage rules
  • Report wastage separately if required

Exceeding Maximum Units

  • Weekly limit: 2,300 mg per week maximum
  • Verify dosing doesn't exceed plan-specific quantity limits

Missing Modifiers

  • Add "UD" modifier for 340B-acquired drugs
  • Include appropriate site-of-service codes

Blue Cross Blue Shield Michigan Verification

Before submitting your prior authorization:

  1. Verify plan participation: Check if the patient's specific Blue Cross plan requires PA for Gamifant
  2. Confirm submission portal: Commercial vs. Medicare plans use different systems
  3. Review current PA criteria: Policies may update; verify requirements at BCBSM Provider Information
  4. Check formulary status: Confirm Gamifant's tier and any step therapy requirements

Contact Information

  • Provider Services: (verify current number with BCBSM)
  • Prior Authorization Support: Available through provider portals
  • Urgent Reviews: Contact BCBSM directly for expedited processing

Appeals Process in Michigan

If Blue Cross Blue Shield denies your Gamifant request, Michigan offers robust appeal rights under the Patient's Right to Independent Review Act.

Internal Appeal Timeline

  • Submit within: 180 days of denial
  • BCBSM response time: 30 days (preservice) or 60 days (post-service)

External Review with Michigan DIFS

After internal denial, you have 127 days to file an external review with the Michigan Department of Insurance and Financial Services.

Standard Review:

  • Timeline: 60 days maximum (often faster)
  • Form: Health Care Request for External Review
  • Contact: 877-999-6442

Expedited Review:

  • Timeline: 72 hours for urgent cases
  • Requirements: Physician letter stating delay would harm patient
  • Qualification: When normal timeline would seriously jeopardize health

Required Documents for Appeal

  • Copy of Blue Cross denial letter
  • Medical records supporting HLH diagnosis
  • Prior therapy documentation
  • Physician letter of medical necessity
From our advocates: "We've seen Michigan external reviews overturn denials when the clinical documentation clearly establishes HLH diagnosis and prior therapy failures. The key is submitting a complete package with all infection screening results and detailed treatment history. Don't let an initial denial discourage you—Michigan's independent review process is thorough and fair."

Quick Audit Checklist

Before submitting your Gamifant prior authorization or claim:

✓ Diagnosis Coding

  • ICD-10 D76.1 clearly documented
  • HLH-2004 criteria met and recorded
  • Specialist (hematology/oncology) involved

✓ Prior Therapy Documentation

  • Conventional HLH therapy attempted (etoposide/dexamethasone)
  • Reasons for failure/intolerance documented
  • Treatment dates and outcomes recorded

✓ Infection Workup Complete

  • Tuberculosis screening performed and documented
  • Viral monitoring plan established (EBV, CMV, adenovirus)
  • Active infections excluded
  • Prophylaxis protocols in place

✓ Billing Accuracy

  • J9210 units calculated correctly (1 mg = 1 unit)
  • Appropriate NDC reported for vial size used
  • Infusion procedure codes included (CPT 96365)
  • Modifiers applied if applicable (UD for 340B)

✓ Submission Requirements

  • Correct portal used (Availity, NovoLogix, or OncoHealth)
  • All required forms completed
  • Supporting documentation attached

Coverage at a Glance

Requirement Details Source
Prior Authorization Required starting Sept 3, 2025 BCBSM Alert
ICD-10 Code D76.1 (Hemophagocytic lymphohistiocytosis) AAPC ICD-10
HCPCS Code J9210 (1 mg = 1 unit) CMS HCPCS
Specialist Required Hematology/Oncology BCBSM PA Criteria
Appeal Deadline 127 days for external review Michigan DIFS

FAQ

How long does Blue Cross Blue Shield Michigan prior authorization take? Standard reviews typically take 14-30 days. Expedited reviews for urgent cases can be processed within 72 hours if clinical urgency is documented.

What if Gamifant is non-formulary on my plan? Even if non-formulary, you can request a formulary exception by demonstrating medical necessity and prior therapy failures. Document why alternative treatments are inappropriate.

Can I request an expedited appeal in Michigan? Yes. If waiting for standard review would seriously jeopardize your health, you can request expedited external review through Michigan DIFS, decided within 72 hours.

Does step therapy apply if I've tried treatments outside Michigan? Prior therapy from any location counts toward step therapy requirements, provided it's properly documented in your medical records.

What happens if my external review is approved? The decision is binding. Blue Cross Blue Shield must cover the treatment as directed by the Independent Review Organization.

How much does Gamifant cost without insurance? Gamifant is a high-cost specialty biologic. Contact Sobi's patient assistance program through Gamifant Cares for potential financial support options.

When facing insurance challenges with rare disease treatments like Gamifant, having the right documentation and understanding the process can make all the difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific rebuttal letters. Their platform analyzes denial reasons and drafts targeted appeals using the right clinical evidence and procedural requirements for each insurance plan.

If you need assistance navigating the prior authorization or appeals process for Gamifant, consider working with experienced advocates who understand Michigan's specific requirements and Blue Cross Blue Shield's policies. The key is thorough preparation and persistent advocacy for medically necessary treatments.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For questions about Michigan insurance appeals, contact the Department of Insurance and Financial Services at 877-999-6442.

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