By Counterforce Health Team in Krystexxa (pegloticase) —

How to Get Krystexxa (Pegloticase) Covered by Blue Cross Blue Shield of Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Krystexxa Approved by BCBS Texas

Blue Cross Blue Shield of Texas requires prior authorization for Krystexxa (pegloticase) with specific clinical criteria: documented refractory gout, failed trials of allopurinol and febuxostat, persistent serum uric acid ≥6 mg/dL, and normal G6PD testing. Submit through the Availity Authorization portal with complete medical necessity documentation. If denied, you have 180 days to appeal internally, followed by external review through an Independent Review Organization (IRO) in Texas. First step today: Gather your insurance card, recent lab results, and documentation of failed gout medications, then contact your rheumatologist to initiate the prior authorization process.

Table of Contents

  1. Understanding BCBS Texas Coverage Requirements
  2. Pre-Authorization Preparation
  3. Submission Process and Required Documents
  4. Common Denial Reasons and How to Address Them
  5. Appeals Process: Internal and External Review
  6. Medical Necessity Letter Template
  7. Cost Assistance and Support Programs
  8. When to Escalate to State Regulators
  9. Frequently Asked Questions

Understanding BCBS Texas Coverage Requirements

Blue Cross Blue Shield of Texas (BCBSTX) maintains strict prior authorization requirements for Krystexxa (pegloticase), reflecting the drug's high cost—approximately $30,000 per infusion—and specialized administration requirements.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for most fully insured and ASO plans BCBSTX PA List 2024
Formulary Status Varies by plan; often non-preferred specialty Check member portal or call member services
Step Therapy Must fail allopurinol and febuxostat first Medical policy documentation required
G6PD Testing Mandatory screening before first infusion Lab report must be submitted with PA
Prescriber Requirement Rheumatologist or consultation required Documentation of specialty involvement
Billing Code J2507 (per 1 mg); 8 units per vial Correct coding prevents claim denials

Key Clinical Criteria

BCBSTX follows national standards for Krystexxa approval, requiring documentation of:

  • Chronic refractory gout diagnosis (ICD-10: M1A.09X0 or similar)
  • Failed trials of both allopurinol and febuxostat at maximum tolerated doses
  • Persistent hyperuricemia with serum uric acid ≥6 mg/dL
  • Normal G6PD levels (contraindicated if deficient)
  • Rheumatology involvement in care decisions
Note: Methotrexate co-therapy is increasingly required or strongly recommended by many plans to improve treatment outcomes and reduce infusion reactions.

Pre-Authorization Preparation

Success with BCBS Texas starts with thorough preparation. Missing documentation is the leading cause of initial denials.

Essential Documents Checklist

Patient Information:

  • Insurance card with member ID and group number
  • Photo identification
  • Complete contact information

Clinical Documentation:

  • Recent rheumatology consultation notes
  • Diagnosis confirmation with ICD-10 codes
  • Complete medication history with dates, doses, and outcomes
  • Laboratory results: serum uric acid trends, G6PD testing, complete metabolic panel
  • Documentation of gout flares, tophi, or functional limitations

Prior Therapy Documentation:

  • Allopurinol trial: dose, duration, reason for discontinuation
  • Febuxostat trial: dose, duration, reason for discontinuation
  • Other urate-lowering therapies attempted (if applicable)
  • Contraindications or intolerances to standard therapies

G6PD Testing Requirements

All patients must be screened for G6PD deficiency before starting Krystexxa, as the medication is contraindicated in G6PD-deficient individuals due to risk of severe hemolytic anemia. This screening:

  • Can be done with a simple blood draw
  • Only needs to be performed once
  • Must show normal (non-deficient) results
  • Should be completed before submitting the prior authorization

Submission Process and Required Documents

Step-by-Step Submission Guide

1. Verify Coverage and Benefits

  • Log into Availity Essentials to confirm PA requirements
  • Check member's specific plan benefits and formulary status
  • Verify provider network participation

2. Complete Prior Authorization Forms

  • Access forms through the BCBSTX provider portal
  • For pharmacy benefits: Submit via CoverMyMeds
  • For medical benefits (J2507 billing): Use Availity Authorization & Referrals

3. Prepare Medical Necessity Letter

  • Include specific clinical criteria (see template below)
  • Address each denial risk factor proactively
  • Attach supporting clinical documentation

4. Submit Complete Package

  • Electronic submission preferred (faster processing)
  • Include all required attachments
  • Request confirmation of receipt

Expected Timeline

  • Standard review: 30 calendar days from receipt
  • Expedited review: 72 hours for urgent cases
  • Incomplete submissions: Additional 14-day delay for missing information
Tip: Submit requests 2-4 weeks before planned treatment start date to allow for processing and potential appeals.

Common Denial Reasons and How to Address Them

Understanding why BCBS Texas denies Krystexxa requests helps you build a stronger initial submission or appeal.

Top Denial Reasons and Solutions

Denial Reason How to Address Required Documentation
Insufficient trial of XOIs Document adequate allopurinol AND febuxostat trials Medication history with doses, dates, outcomes
Missing G6PD testing Submit normal G6PD lab results Recent lab report showing non-deficient status
Serum uric acid not elevated Provide recent SUA ≥6 mg/dL Lab results within 30 days of submission
Not prescribed by rheumatologist Include rheumatology consultation Specialist evaluation and recommendation
Lack of medical necessity Strengthen clinical documentation Detailed symptom history, functional impact
Missing methotrexate plan Address MTX co-therapy or contraindications Treatment plan or medical contraindication

Strengthening Your Submission

For step therapy requirements:

  • Document specific doses and durations of failed therapies
  • Include reasons for discontinuation (side effects, lack of efficacy)
  • Provide lab evidence of persistent hyperuricemia despite treatment

For medical necessity:

  • Quantify gout flare frequency and severity
  • Document functional limitations and quality of life impact
  • Include photographs of tophi if present (with patient consent)

Appeals Process: Internal and External Review

When BCBS Texas denies your Krystexxa request, Texas law provides strong appeal rights with specific timelines and processes.

Internal Appeal Process

Timeline: Must file within 180 days of denial notice

Required Forms:

  • BCBSTX Appeal Request Form
  • Authorized Representative Form (if applicable)

Submission Methods:

  • Online: BCBSTX member portal
  • Fax: Number provided in denial letter
  • Mail: Address specified in denial notice

Decision Timeline:

  • Standard: 30 calendar days
  • Expedited: 72 hours (if health at risk)

External Review (IRO)

If your internal appeal is denied, Texas provides independent external review through an Independent Review Organization.

Key Details:

  • Deadline: 4 months (120 days) from internal appeal denial
  • Cost: Free to patient (insurer pays IRO fees)
  • Decision timeline: 20 business days (5 days for urgent cases)
  • Binding result: If IRO approves, BCBSTX must provide coverage

IRO Process:

  1. Request IRO form from BCBSTX (included with final denial)
  2. Submit completed form with all supporting documentation
  3. IRO conducts independent medical review
  4. Receive binding decision
Important: The IRO process is available for fully insured plans. ERISA self-funded employer plans follow federal appeal rules instead.

Getting Help with Appeals

Texas Resources:

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742
  • IRO Information Line: 1-866-554-4926

Medical Necessity Letter Template

A comprehensive medical necessity letter addresses all BCBS Texas requirements systematically.

Template Structure

[Date]
[Medical Director]
Blue Cross Blue Shield of Texas
[Address from denial letter]

Re: Medical Necessity for Krystexxa (pegloticase) - J2507
Patient: [Full Name]  DOB: [Date]  Policy: [Number]
Diagnosis: Chronic refractory gout (ICD-10: M1A.09X0)

Dear Medical Director,

I am requesting authorization for Krystexxa (pegloticase) for my patient with severe, refractory chronic gout who has failed standard urate-lowering therapies.

CLINICAL HISTORY:
[Patient] is a [age]-year-old [gender] with chronic gout diagnosed [date]. Despite optimal medical management, [he/she] continues to experience:
- Frequent gout flares ([frequency])
- Persistent hyperuricemia (recent SUA: [value] mg/dL on [date])
- [Tophi/functional limitations/quality of life impact]

FAILED THERAPIES:
1. Allopurinol: [dose] daily for [duration] - discontinued due to [reason]
2. Febuxostat: [dose] daily for [duration] - discontinued due to [reason]
3. [Other agents if applicable]

SUPPORTING CRITERIA:
- G6PD testing: Normal (non-deficient) on [date]
- Rheumatology consultation completed [date]
- Methotrexate co-therapy: [planned/contraindicated because...]
- All oral urate-lowering agents discontinued per protocol

MEDICAL NECESSITY:
Krystexxa represents the only FDA-approved treatment for refractory gout when oral agents have failed. [Patient's] persistent symptoms and hyperuricemia despite maximal conventional therapy meet established criteria for pegloticase therapy.

Please contact me at [phone] for any additional clinical information.

Sincerely,
[Physician name and credentials]
[Contact information]

Key Documentation to Attach

  • Complete office notes from recent visits
  • Laboratory results (SUA trends, G6PD, metabolic panel)
  • Rheumatology consultation report
  • Medication trial documentation
  • Functional assessment or quality of life measures

Cost Assistance and Support Programs

Even with insurance approval, Krystexxa's high cost may create financial barriers. Several programs can help reduce out-of-pocket expenses.

Manufacturer Support

Amgen By Your Side offers comprehensive support:

  • Prior authorization assistance
  • Appeals support
  • Financial assistance programs
  • Patient education resources

Contact: Visit amgenbyyourside.com or call the program directly.

Additional Resources

  • Patient Access Network Foundation: Copay assistance for qualifying patients
  • Good Days: Financial assistance for chronic disease treatments
  • State pharmaceutical assistance programs: Check Texas-specific programs
From our advocates: "One patient reduced their monthly copay from $1,200 to $50 by combining manufacturer assistance with a foundation grant. The key was applying early and providing complete financial documentation. While outcomes vary by individual circumstances, exploring all available programs often yields significant savings."

When to Escalate to State Regulators

If BCBS Texas fails to follow proper procedures or denies coverage inappropriately, Texas regulators can intervene.

Texas Department of Insurance (TDI)

Contact TDI when:

  • Insurer misses appeal deadlines
  • Proper procedures aren't followed
  • You need help understanding your rights

How to file a complaint:

  • Online: TDI website complaint portal
  • Phone: 1-800-252-3439
  • Include all documentation and correspondence

Office of Public Insurance Counsel (OPIC)

OPIC provides free consumer assistance and can help navigate complex appeals.

Contact: 1-877-611-6742

Frequently Asked Questions

Q: How long does BCBS Texas take to review Krystexxa prior authorizations? A: Standard reviews take up to 30 calendar days. Expedited reviews (when health is at risk) must be completed within 72 hours.

Q: What if Krystexxa isn't on my formulary? A: You can request a formulary exception by demonstrating medical necessity and failure of preferred alternatives. The same clinical criteria apply.

Q: Can I get an expedited appeal if my gout is severe? A: Yes, if delays would jeopardize your health. Document the urgency clearly and request expedited review at both internal and external appeal levels.

Q: Does step therapy apply if I failed these medications with a different insurer? A: Yes, documented failures with any insurer count toward step therapy requirements. Provide complete records from previous treatments.

Q: What happens if the IRO approves my appeal? A: The decision is binding. BCBS Texas must provide coverage and cannot deny for the same medical reason again.

Q: Do I need to see a rheumatologist in Texas specifically? A: No, but you need rheumatology involvement in your care. Out-of-state specialists are acceptable if properly documented.

Q: How much does Krystexxa cost without insurance? A: Approximately $30,000 per infusion, with treatment typically requiring 12-26 infusions annually. Total annual costs can exceed $700,000.

Q: What if my employer plan is self-funded (ERISA)? A: ERISA plans follow federal appeal rules, not Texas IRO processes. Check with your benefits administrator for specific procedures.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-backed strategies tailored to each payer's specific requirements. Our platform streamlines the prior authorization process by identifying denial patterns and generating targeted rebuttals that align with plan policies.

Getting Krystexxa covered by BCBS Texas requires patience, thorough documentation, and persistence. While the process can be complex, understanding the requirements and following proper procedures significantly improves your chances of approval. Counterforce Health specializes in helping patients navigate these challenging coverage decisions with data-driven appeal strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan benefits and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with BCBS Texas directly.

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