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

How to Get Xembify (Immune Globulin, SC) Covered by Aetna CVS Health in Pennsylvania: Forms, Appeals, and Templates

Answer Box: Xembify (immune globulin subcutaneous) requires prior authorization from Aetna CVS Health in Pennsylvania. Submit precertification via phone (866) 752-7021 or fax (888) 267-3277 with a Statement of Medical Necessity documenting primary immunodeficiency diagnosis, prior treatment failures, and clinical need. If denied, Pennsylvania's new external review program has overturned about 50% of appealed denials in 2024. Start by gathering your denial letter, insurance card, and medical records showing infections despite prior therapy.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory precertification before Xembify can be dispensed Aetna precertification lists 2024 Precert List (PDF)
Medical Necessity Must document primary immunodeficiency with lab evidence and infection history Clinical Policy Bulletin #0206 Aetna IVIG/SCIG Policy
Step Therapy May require trial/failure of preferred immunoglobulin products first Formulary guidelines Aetna Specialty Guidelines
Site of Care Home or clinic administration per utilization management policy Site of care requirements Aetna Drug Infusion Policy
Appeals Deadline 180 days for internal appeals; 4 months for PA external review Member handbook and denial letters PA Insurance Dept

Read the Denial Letter

When Aetna CVS Health denies your Xembify request, the denial letter contains critical information for your appeal strategy:

Decode the reason codes:

  • "Not medically necessary" typically means insufficient documentation of primary immunodeficiency diagnosis or infection history
  • "Non-formulary" indicates Xembify isn't on your plan's preferred drug list
  • "Step therapy required" means you must try preferred alternatives first
  • "Quantity limit exceeded" suggests dosing above plan parameters

Extract key deadlines:

  • Internal appeals: Usually 180 days from denial date
  • External review: 4 months from final denial letter in Pennsylvania
  • Expedited appeals: Available for urgent medical situations

Determine benefit type:

  • Medical benefit: Processed under your health insurance (most common for Xembify)
  • Pharmacy benefit: Managed by CVS Caremark specialty pharmacy
Tip: Keep the original denial letter—you'll need it for appeals and Pennsylvania's external review process.

Fixable Causes

Many Xembify denials can be overturned by addressing documentation gaps:

Missing Clinical Documentation:

  • Complete immunoglobulin lab results (IgG, IgA, IgM levels)
  • ICD-10 diagnosis codes for primary immunodeficiency
  • Detailed infection history with dates and treatments
  • Vaccine response testing results

Coding Issues:

  • Ensure correct CPT/HCPCS codes for subcutaneous immunoglobulin
  • Verify NDC numbers match Xembify specifications
  • Confirm site of administration coding

Prior Authorization Errors:

  • Submit to correct Aetna department (medical vs. pharmacy benefit)
  • Include all required forms and physician signatures
  • Meet specific formatting requirements for clinical notes
Clinician Corner: The Statement of Medical Necessity should include: confirmed PID diagnosis with genetic/lab evidence, quantified infection frequency before treatment, prior IVIG/SCIG failures with specific adverse events or inadequate response, target IgG trough levels, and monitoring plan per Aetna's clinical criteria.

First-Level Appeal

Pennsylvania patients have strong appeal rights with Aetna CVS Health. Here's your step-by-step approach:

1. Gather Required Documents

  • Original denial letter
  • Complete medical records showing PID diagnosis
  • Lab results (pre-treatment IgG levels, infection markers)
  • Prior treatment history and failures
  • Physician letter of medical necessity

2. Submit Your Appeal

  • Phone: (866) 752-7021 for commercial plans
  • Fax: (888) 267-3277 with appeal form
  • Online: Through Aetna member portal (verify current link)
  • Deadline: 180 days from denial date

3. Include Evidence-Based Arguments

  • FDA approval for primary immunodeficiency treatment
  • Clinical guidelines supporting subcutaneous administration
  • Documented failures of alternative therapies
  • Cost-effectiveness compared to IVIG or hospitalizations

Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing the denial basis and drafting point-by-point rebuttals aligned to the plan's own rules, pulling the right citations and weaving them into appeals with required clinical facts.

Peer-to-Peer Review

Aetna offers peer-to-peer (P2P) reviews where your prescribing physician can discuss the case directly with an Aetna medical director:

How to Request:

  • Include P2P request in your appeal submission
  • Specify physician availability and contact information
  • Prepare clinical talking points in advance

P2P Preparation Checklist:

  • Review Aetna's specific coverage criteria for immunoglobulins
  • Prepare concise summary of diagnosis and prior failures
  • Have lab values and infection history readily available
  • Reference relevant clinical guidelines and FDA labeling

Expected Timeline:

  • P2P typically scheduled within 5-7 business days of request
  • Decisions often rendered within 24-48 hours after call

Pennsylvania External Review

Pennsylvania launched its own external review program in January 2024, offering patients a powerful appeals tool. In the program's first year, about 50% of appealed denials were overturned.

Eligibility Requirements:

  • Must complete Aetna's internal appeals process first
  • Receive "Final Adverse Benefit Determination" letter
  • Apply within 4 months of final denial date
  • Not applicable to Medicare or Medicaid plans

How to Submit:

  • Online: Via Pennsylvania Insurance Department website
  • Forms: Download from PA.gov external review page
  • Required: Physician Certification Form completed by prescriber

Timeline:

  • Standard Review: 45 days from IRO assignment
  • Expedited Review: 72 hours for urgent cases
  • Additional Evidence: 15 days to submit supporting documents

Success Factors:

  • Clear medical necessity documentation
  • Evidence of prior treatment failures
  • Alignment with FDA-approved indications
  • Cost-benefit analysis when relevant

Appeal Letter Templates

Opening Statement: "I am writing to formally appeal Aetna's denial of coverage for Xembify (immune globulin subcutaneous) for [Patient Name], Policy #[Number]. This medication is medically necessary for the treatment of primary immunodeficiency disease as documented by [Physician Name]."

Medical Necessity Section: "[Patient Name] has a confirmed diagnosis of [specific PID condition] with laboratory evidence including IgG levels of [value] mg/dL (normal range 700-1600). Despite previous treatment with [prior therapies], the patient continues to experience recurrent infections including [list specific infections with dates]."

Prior Authorization Criteria Response: "Per Aetna Clinical Policy Bulletin #0206, this request meets all criteria: (1) Confirmed PID diagnosis with genetic/lab evidence [attach results], (2) History of recurrent bacterial infections [document], (3) Inadequate response to prior therapy [detail failures], (4) Appropriate dosing based on weight and clinical response."

Closing: "Given the documented medical necessity and alignment with Aetna's own coverage criteria, I request immediate approval of Xembify therapy. Please contact me at [phone] with any questions."

Tracking and Escalation

Appeal Tracking Log:

  • Submission date and method
  • Aetna reference numbers
  • Follow-up call dates and outcomes
  • Additional documentation submitted
  • Decision dates and next steps

When to Escalate:

  • No response within stated timeframes
  • Repeated denials without clinical justification
  • Process violations or unfair treatment

Pennsylvania Insurance Department Complaint:

  • File online at PA.gov
  • Include all correspondence and documentation
  • Request investigation of claims handling practices

Win-Rate Boosters

Clinical Evidence:

  • Reference FDA labeling for primary immunodeficiency
  • Cite peer-reviewed studies on SCIG effectiveness
  • Include specialty society guidelines (AAAAI, ESID)
  • Document functional improvement measures

Economic Arguments:

  • Compare costs to repeated hospitalizations
  • Calculate IVIG infusion center expenses vs. home SCIG
  • Reference reduced infection-related medical costs

Quality of Life Factors:

  • Home administration convenience
  • Reduced infusion reactions compared to IVIG
  • Improved treatment adherence
  • Return to work/school capabilities
From Our Advocates: We've seen success when families document specific infection episodes with dates, treatments, and outcomes. One case involved a patient with 8 documented bacterial infections over 6 months despite adequate IVIG dosing. The appeal included emergency room records, antibiotic prescriptions, and missed work documentation. Aetna approved Xembify within 72 hours of the peer-to-peer review, recognizing the clear treatment failure pattern.

If Appeals Fail

Alternative Options:

  • Formulary Exception: Request coverage of non-preferred drug
  • Step Therapy Override: Document contraindications to preferred alternatives
  • Compassionate Use: Contact Grifols for patient assistance programs
  • Xembify Connexions: Copay assistance up to $10,000 annually for eligible patients

Patient Assistance Programs:

  • Xembify Connexions: Call 1-844-699-3624 for copay cards and patient assistance
  • Income-Based Programs: Up to 400% Federal Poverty Level eligibility
  • Foundation Grants: Research rare disease foundations for additional support

Legal Considerations:

  • Consult with healthcare attorneys for persistent denials
  • Document all communications for potential bad faith claims
  • Consider state insurance commissioner complaints

Counterforce Health specializes in turning denials into approvals by identifying the specific denial basis and crafting targeted rebuttals with the right clinical evidence and procedural requirements.

FAQ

How long does Aetna CVS Health prior authorization take in Pennsylvania? Standard PA decisions are typically rendered within 24-48 hours according to Aetna, with over 95% of eligible requests reviewed within 24 hours.

What if Xembify is non-formulary on my plan? Submit a formulary exception request with documentation of medical necessity and prior treatment failures. Pennsylvania's external review program covers non-formulary denials.

Can I request an expedited appeal? Yes, expedited appeals are available for urgent medical situations. Pennsylvania's external review offers 72-hour decisions for urgent cases.

Does step therapy apply if I've tried other immunoglobulins outside Pennsylvania? Yes, document all prior therapy attempts regardless of location. Include medical records showing inadequate response or adverse events.

What counts as medical necessity for Xembify? Per Aetna policy: confirmed primary immunodeficiency diagnosis, documented recurrent infections, inadequate response to prior therapy, and appropriate dosing based on clinical parameters.

How much does Xembify cost without insurance? Retail cash prices range from approximately $196 for 5mL/1g to $1,889 for 50mL/10g vials, but patient assistance programs can significantly reduce costs.

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 company for specific coverage questions. Pennsylvania residents should verify current appeal deadlines and procedures with the Pennsylvania Insurance Department.

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