By Counterforce Health Team in Xembify (immune globulin, SC) —

How to Get Xembify (Immune Globulin) Covered by Humana in Michigan: Complete Approval Guide with Forms and Appeal Scripts

Answer Box: Getting Xembify Covered by Humana in Michigan

Xembify (subcutaneous immune globulin) requires prior authorization from Humana, with approval typically taking 7-30 days. In Michigan, you have strong appeal rights through DIFS external review within 127 days of denial.

Fastest path to approval:

  1. Gather documentation: Low IgG labs, infection history, prior IVIG/SCIG trials
  2. Submit PA request via Humana provider portal with complete medical necessity letter
  3. If denied, request peer-to-peer review within 5 days, then formal appeal

Start today: Call your prescriber to request a medical necessity letter and recent lab results. Michigan patients have excellent external review options if initial appeals fail.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical Necessity Requirements
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Playbook for Michigan
  6. Scripts and Templates
  7. Cost Assistance Options
  8. When to Escalate to Michigan DIFS
  9. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Xembify requests Humana provider portal Humana PA List
Formulary Status Preferred for Part B medical benefit 2024 Humana formulary Humana Step Therapy List
Step Therapy May require Gamunex-C trial first (Part D) Plan documents Humana Coverage Policy
Diagnosis Required Primary immunodeficiency with low IgG Lab results + clinical notes Molina PA Criteria
Appeal Deadline 65 days from denial (Medicare plans) Denial letter Humana Appeals Process

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who does it: Your immunologist or prescribing physician
Timeline: 1-2 weeks to gather
Required: Recent IgG, IgA, IgM levels showing IgG below normal range, plus infection history documentation

2. Document Prior Treatment Failures

Who does it: Clinic staff pulls records
Timeline: 3-5 business days
Required: Evidence of inadequate response to previous IVIG or other SCIG products, or medical contraindications to IVIG

3. Calculate Weight-Based Dosing

Who does it: Prescriber
Timeline: Same day as prescription
Required: Current height/weight, BMI calculation, and dose justification using FDA dosing guidelines

4. Submit Prior Authorization Request

Who does it: Prescriber or clinic staff
Timeline: Submit within 1-2 days of completing documentation
How: Via Humana provider portal with complete medical necessity letter and supporting documents

5. Track Your Request

Who does it: Patient or clinic
Timeline: Check status after 7-10 days
How: Call Humana member services or check provider portal for updates

6. Prepare for Potential Denial

Who does it: Patient and prescriber
Timeline: Be ready to respond within 5 days
Action: Request peer-to-peer review immediately if denied

7. File Formal Appeal if Needed

Who does it: Patient or authorized representative
Timeline: Within 65 days of denial
How: Submit additional clinical evidence and address specific denial reasons

Medical Necessity Requirements

Humana requires comprehensive documentation proving medical necessity for Xembify coverage. Here's what your prescriber needs to include:

Laboratory Evidence Required:

  • Total serum IgG below age-adjusted normal range (typically <700 mg/dL for adults)
  • IgA and IgM levels for context
  • Poor vaccine response documented with pre- and post-immunization titers

Clinical Documentation:

  • Confirmed primary immunodeficiency diagnosis with appropriate ICD-10 codes
  • History of recurrent bacterial infections (pneumonia, sinusitis, bronchitis)
  • Documentation that infections don't respond adequately to prophylactic antibiotics
  • Exclusion of secondary causes of hypogammaglobulinemia
Clinician Corner: Your medical necessity letter should follow this structure: (1) Patient demographics and diagnosis, (2) Laboratory evidence of immunodeficiency, (3) Clinical history of infections, (4) Prior treatment attempts and outcomes, (5) Rationale for Xembify specifically, (6) Proposed dosing and monitoring plan.

Prior Treatment Documentation: If requesting Xembify as first-line therapy, explain why IVIG is contraindicated (poor venous access, infusion reactions, etc.). If switching from another product, document inadequate response or adverse effects.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Insufficient lab evidence" Submit complete immunology workup Recent IgG/IgA/IgM levels, vaccine titers
"No prior IVIG trial documented" Provide step therapy exception request Letter explaining contraindications to IVIG
"Dosing exceeds guidelines" Justify with clinical literature Weight-based calculations, FDA dosing guide
"Diagnosis not established" Strengthen diagnostic documentation Immunologist consultation, genetic testing if available
"Alternative products available" Show medical necessity for Xembify Comparison of products, patient-specific factors
Tip: Address every single point mentioned in the denial letter. Don't assume reviewers will infer missing connections.

Appeals Playbook for Michigan

Michigan residents have excellent appeal rights through the Department of Insurance and Financial Services (DIFS). Here's your roadmap:

Internal Appeals with Humana

Timeline: Must file within 65 days of denial
Decision time: 30 days for medical appeals, 7 days for Part D drug appeals
How to file: Online through Humana member portal or by mail

Required documents:

  • Copy of denial letter
  • Additional clinical evidence
  • Updated medical necessity letter addressing denial reasons

Peer-to-Peer Review

When to request: Immediately after denial, before formal appeal
Timeline: Must request within 5 days of denial
Process: Your prescriber speaks directly with Humana medical director

Script for prescriber: "I'm requesting a peer-to-peer review for [patient name] regarding the Xembify denial. The patient has documented primary immunodeficiency with recurrent infections despite adequate antibiotic therapy, and SCIG is medically necessary due to [specific reason]."

Michigan DIFS External Review

If Humana's internal appeal fails, Michigan's external review process is your strongest option:

Timeline: File within 127 days of final denial
Cost: Free to patients
Decision time: 56-60 days standard, 72 hours for expedited appeals

How to file: Submit DIFS External Review Request online or call 877-999-6442

Expedited appeals: Available when delay would risk serious harm. Requires physician certification of urgency.

Note: DIFS external review decisions are binding on insurers. If they rule in your favor, Humana must provide coverage.

Scripts and Templates

Patient Script for Calling Humana

"Hi, I'm calling about a prior authorization request for Xembify that was submitted by my doctor. My member ID is [number]. Can you tell me the status and what additional information might be needed? If it was denied, I'd like to understand the specific reasons and request a peer-to-peer review."

Email Template for Clinic Staff

Subject: Urgent: Xembify PA Documentation Request

"Dear [Provider Name],

We need the following documents for [Patient Name]'s Xembify prior authorization:

  • Recent IgG/IgA/IgM lab results (within 6 months)
  • Documentation of recurrent infections
  • Previous IVIG/SCIG treatment records
  • Current height/weight for dosing calculations

Please send within 48 hours to avoid delays. Let me know if you need help gathering any of these items.

Thanks, [Your name]"

Cost Assistance Options

Manufacturer Support:

Foundation Grants:

  • Patient Access Network Foundation covers immune globulin therapies
  • HealthWell Foundation provides grants for primary immunodeficiency treatments

State Programs:

When to Escalate to Michigan DIFS

Contact Michigan DIFS if you experience:

  • Unreasonable delays in prior authorization decisions
  • Repeated denials despite meeting medical necessity criteria
  • Procedural violations in the appeals process

Contact: 877-999-6442 or file a complaint online

What to include:

  • Timeline of events
  • All correspondence with Humana
  • Clinical documentation supporting medical necessity

FAQ

How long does Humana prior authorization take in Michigan? Standard decisions take up to 30 days for medical benefits, 7 days for Part D drugs. Expedited requests are decided within 72 hours when urgency is documented.

What if Xembify is non-formulary on my plan? Request a formulary exception with your prior authorization. Include medical necessity documentation showing why preferred alternatives aren't appropriate.

Can I request an expedited appeal in Michigan? Yes, both Humana and Michigan DIFS offer expedited appeals when delays would risk serious harm. Your doctor must certify the urgency.

Does step therapy apply if I've used IVIG outside Michigan? Previous treatment history should be honored regardless of location. Submit complete records from your prior state.

What's Humana's denial rate for immune globulin? Humana's overall PA denial rate is approximately 3.5% for Medicare Advantage plans, among the lowest of major insurers. Most denials result from incomplete documentation rather than medical necessity disagreements.

How much does Xembify cost without insurance? Retail prices range from approximately $196 for 5mL (1g) to $1,889 for 50mL (10g). Annual costs can exceed $100,000, making insurance coverage essential.

From our advocates: We've seen several Michigan patients successfully overturn initial Xembify denials by working closely with their immunologists to strengthen the infection history documentation. The key was providing specific dates, cultures, and antibiotic responses rather than general statements about "recurrent infections." This level of detail made the difference in both peer-to-peer reviews and DIFS external appeals.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies the specific coverage gaps, and generates evidence-backed appeals that address each payer's unique requirements. For complex cases like immune globulin coverage, having the right clinical evidence and procedural knowledge can make the difference between approval and denial.

If you're struggling with a Xembify denial from Humana, Counterforce Health can help you build a stronger appeal by pulling the right medical literature, formatting your clinical documentation, and ensuring you meet all of Humana's specific requirements.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about your specific medical needs and work with qualified professionals for insurance and legal matters. Coverage policies change frequently—verify current requirements with your insurer and state regulators.

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