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

Xembify Approval with Blue Cross Blue Shield in Michigan: Answers to the Most Common Questions

Answer Box: Getting Xembify Covered by Blue Cross Blue Shield in Michigan

Xembify (immune globulin, SC) requires prior authorization from Blue Cross Blue Shield of Michigan for primary immunodeficiency. Your fastest path to approval: (1) Have your doctor submit a PA request with your PID diagnosis, low IgG labs, and infection history via the BCBSM provider portal; (2) Include documentation of any failed IVIG/SCIG trials; (3) If denied, file an internal appeal within 180 days, then request external review through Michigan DIFS within 127 days. Standard PA decisions take 5-7 business days; expedited reviews available for urgent cases.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Support
  6. Denials and Appeals
  7. Renewals and Ongoing Coverage
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Quick Reference Glossary

Coverage Basics

Is Xembify Covered by Blue Cross Blue Shield of Michigan?

Yes, but with restrictions. Xembify requires prior authorization under BCBSM's specialty medication policies. It's typically covered for primary immunodeficiency (PID) when medical necessity criteria are met, including documented low immunoglobulin levels and recurrent infections.

Which Blue Cross Plans Cover Xembify?

  • Commercial PPO/HMO plans: Yes, with PA
  • Medicare Plus Blue: Yes, with PA and possible step therapy
  • BCN Advantage: Yes, with PA
  • Blue Cross Complete (Medicaid): Coverage varies; check specific plan documents
Note: As of November 1, 2024, BCBSM updated immune globulin preferences, with Gammagard listed as preferred. Xembify may require additional step therapy documentation.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician's office must submit the PA request. Patients cannot submit directly. The process involves:

  1. Download the PA form from the BCBSM provider portal
  2. Complete patient details: Name, DOB, Member ID, provider NPI
  3. Include clinical information: ICD-10 codes (D80-D84 for PID), CPT/HCPCS codes (J1569 for Xembify)
  4. Submit via: NaviNet portal, designated fax, or provider phone line

Required Documentation Checklist

Document Type What to Include Source
Patient History PID diagnosis, infection frequency, hospitalizations Clinical notes
Laboratory Results IgG levels below normal range, vaccine responses Lab reports
Prior Treatments IVIG/SCIG trials with dates, doses, outcomes Medical records
Treatment Plan Proposed dosing, frequency, monitoring plan Physician order

Timing and Urgency

Standard Review Timeline

  • Initial PA decision: 5-7 business days
  • Peer-to-peer review: Additional 3-5 days if requested
  • Internal appeal: 30 days for standard, 72 hours for expedited

Expedited Reviews

Request expedited review when:

  • Patient's health would be seriously compromised by delay
  • Current IVIG access is being discontinued
  • Severe, recurrent infections are occurring

How to request: Call BCBSM provider services and specify "expedited PA for medical urgency." Include physician documentation of clinical urgency.

Medical Necessity Criteria

Primary Immunodeficiency Requirements

Based on BCBSM's PA guidelines, Xembify approval requires:

Diagnosis Documentation:

  • Confirmed PID with appropriate ICD-10 codes (D80-D84)
  • IgG levels below laboratory reference range
  • History of recurrent, severe bacterial infections

Clinical Evidence:

  • At least 2 serious infections in past 12 months, OR
  • 1 severe infection requiring hospitalization in past 6 months
  • Poor response to standard antibiotic therapy

Prior Treatment History:

  • Documentation of previous IVIG trials (if applicable)
  • Reasons for IVIG failure or contraindication
  • Response to any previous immune globulin therapy

Step Therapy Considerations

Some BCBSM plans require trial of preferred immune globulin products before Xembify approval. As of late 2024, Gammagard is listed as preferred. Your doctor may need to document:

  • Medical reasons Gammagard cannot be used
  • Specific adverse reactions to preferred products
  • Clinical superiority of Xembify for your condition

Costs and Financial Support

Typical Out-of-Pocket Costs

  • Commercial plans: Specialty tier copay ($50-$200) or coinsurance (20-40%)
  • Medicare plans: Part B coinsurance (20%) after deductible
  • Medicaid plans: Usually minimal copay ($1-$5)

Financial Assistance Options

Xembify Connexions Patient Support:

  • Copay assistance for eligible commercial patients
  • Prior authorization support
  • Specialty pharmacy coordination
  • Contact: Xembify.com patient support

Additional Resources:

  • Patient Advocate Foundation: Financial assistance applications
  • HealthWell Foundation: Grants for immune deficiency treatments
  • Michigan Medicaid: Coverage for qualifying low-income patients

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Address Documentation Needed
Insufficient medical records Submit complete clinical history Detailed infection timeline, lab results
Step therapy not met Document preferred drug failures Adverse event reports, efficacy data
Dosing exceeds guidelines Provide clinical justification Weight-based calculations, trough levels
Non-formulary status Request formulary exception Comparative effectiveness evidence

Michigan Appeals Process

Internal Appeal (Level 1):

  • Deadline: 180 days from denial
  • Timeline: 30 days for standard, 72 hours for expedited
  • How to file: BCBSM member portal or written request

External Review (Level 2):

Michigan Advantage: DIFS offers expedited external appeals decided within 72 hours for urgent medical needs with physician documentation.

Appeal Script for Patients

"I'm calling to file an internal appeal for the denial of Xembify for my primary immunodeficiency. My member ID is [ID number]. The denial was dated [date], and I have new clinical information that supports medical necessity. I'd like to request an expedited review due to my ongoing severe infections."

Renewals and Ongoing Coverage

When to Reauthorize

Most BCBSM plans require annual reauthorization for Xembify. Your doctor should submit renewal requests:

  • 60 days before current authorization expires
  • Include updated IgG trough levels
  • Document clinical response and infection reduction
  • Note any dosing adjustments needed

Renewal Documentation

  • Clinical progress notes showing treatment response
  • Laboratory monitoring (IgG levels, infection markers)
  • Adverse event reporting (if any)
  • Continued medical necessity justification

Specialty Pharmacy Requirements

BCBSM Specialty Network

Blue Cross Blue Shield of Michigan uses Walgreens Specialty Pharmacy as their primary specialty network partner, not Accredo. For Xembify:

Prescription Transfer Process

If your prescription was sent to an out-of-network pharmacy:

  1. Call BCBSM member services to confirm network requirements
  2. Contact Xembify Connexions for prescription transfer assistance
  3. Verify coverage before first fill to avoid claim denials

Troubleshooting Common Issues

Portal and Form Problems

Provider portal down?

  • Use backup fax submission to PA department
  • Call provider services for alternative submission methods
  • Keep confirmation numbers for all submissions

Missing forms?

  • Download current PA forms from BCBSM provider resources
  • Verify you're using the most recent version (forms updated regularly)

Communication Issues

No response to PA submission?

  • Standard processing is 5-7 business days
  • Call provider services to check status
  • Request expedited review if clinically appropriate

Conflicting information?

  • Get all guidance in writing via secure portal
  • Reference specific policy numbers in communications
  • Document all phone conversations with dates and representatives

When facing complex coverage challenges, Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting evidence-backed rebuttals tailored to each plan's specific requirements.

Quick Reference Glossary

Prior Authorization (PA): Insurance approval required before coverage begins Quantity Limit (QL): Maximum amount covered per time period
Step Therapy (ST): Requirement to try preferred drugs first Peer-to-Peer (P2P): Direct physician-to-physician coverage discussion Letter of Medical Necessity (LMN): Detailed clinical justification document Formulary: List of covered medications by insurance plan ICD-10: Medical diagnosis codes required for billing HCPCS: Healthcare procedure codes for drugs and services

Sources & Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical advice. Coverage policies change frequently—always verify current requirements with your specific Blue Cross Blue Shield plan and consult your healthcare provider for medical decisions. For additional insurance assistance in Michigan, contact DIFS at 877-999-6442.

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