By Counterforce Health Team in Krystexxa (pegloticase) —

How to Get Krystexxa (Pegloticase) Covered by Florida Blue Cross Blue Shield: Complete Prior Authorization and Appeals Guide 2025

Answer Box: Getting Krystexxa Covered by Florida Blue Cross Blue Shield

Florida Blue requires prior authorization for Krystexxa (pegloticase) with strict step-therapy and lab requirements. You must document failure of xanthine oxidase inhibitors (allopurinol/febuxostat), G6PD screening, and persistent serum uric acid >6 mg/dL. Submit via provider portal with rheumatology documentation. Standard approval takes 14 business days; expedited review available for urgent cases. If denied, appeal within 180 days citing medical necessity and Florida's step-therapy override laws (HB 459).

First step today: Have your rheumatologist gather failure documentation for prior gout therapies and order G6PD testing if not completed.

Table of Contents

  1. Why Florida Rules Matter for Krystexxa Coverage
  2. Florida Blue Prior Authorization Requirements
  3. Turnaround Standards and Timelines
  4. Step Therapy Protections Under Florida Law
  5. Appeals Playbook for Florida Blue
  6. External Review Process
  7. Practical Scripts and Templates
  8. Cost Assistance and Support Programs
  9. FAQ: Common Questions
  10. Sources and Further Reading

Why Florida Rules Matter for Krystexxa Coverage

Florida's insurance landscape combines federal ACA protections with state-specific rules that can help you get expensive specialty drugs like Krystexxa approved. Under Florida HB 459 (effective July 2022), insurers cannot impose excessive step-therapy requirements and must provide override pathways for chronic conditions like refractory gout.

Florida Blue (Blue Cross Blue Shield of Florida) dominates the state's insurance market with about 36% coverage. As an independent Blue plan, they follow both national Blue Cross standards and Florida-specific regulations. This creates multiple pathways to challenge denials and secure coverage.

Key Florida advantages:

  • Step-therapy override rights for chronic conditions
  • 180-day appeal windows (longer than many states)
  • External review through Florida Department of Financial Services
  • Strong continuity-of-care protections for ongoing treatments

Florida Blue Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Krystexxa requests Provider portal/CoverMyMeds Florida Blue PA Policy
Age Restriction Patient must be ≥18 years old Medical policy PH-0158 Policy Document
G6PD Screening Required for high-risk ancestry groups Lab documentation needed Policy Document
Step Therapy 3+ months XOI or uricosuric failure Medical records required Policy Document
Quantity Limits Max 2 vials (16 units) every 28 days J2507 billing requirements Policy Document
Initial Authorization 6 months Renewable annually Policy Document

Detailed Coverage Criteria

Florida Blue requires all of the following for Krystexxa approval:

Basic Requirements:

  • Patient age 18 or older
  • No G6PD deficiency (screening required for African, Mediterranean, Southern European, Middle Eastern, or Southern Asian ancestry)

Clinical Requirements (must meet at least one):

  • Documented contraindication, intolerance, or clinical failure on ≥3-month trial of maximum-tolerated xanthine oxidase inhibitors (allopurinol, febuxostat) OR uricosurics (probenecid)
  • ≥1 non-resolving subcutaneous tophi
  • Radiographic damage attributable to gout
  • ≥2 gout flares per year inadequately controlled by colchicine, NSAIDs, or corticosteroids
Clinician Corner: The policy specifically looks for serum uric acid levels not achieving <6 mg/dL despite maximum-tolerated therapy. Document specific doses tried and duration of therapy, along with lab values showing persistent hyperuricemia.

Turnaround Standards and Timelines

Standard Review Process

  • Standard PA decisions: 14 business days from complete submission
  • Expedited review: 72 hours with physician urgency certification
  • Renewal requests: Submit 30 days before expiration
  • Appeal timeline: 180 days from denial notice

Submission Methods

  1. Provider Portal: Availity.com (preferred method)
  2. CoverMyMeds: Online PA platform
  3. Fax: Check current number in provider manual (verify with source linked below)
  4. Phone: 1-877-719-2583 for PA status inquiries

Timeline Tip: Submit PA requests at least 21 days before planned treatment start to allow for potential appeals.

Step Therapy Protections Under Florida Law

Florida's HB 459 provides significant protections against excessive step-therapy requirements. For chronic conditions like refractory gout, insurers must grant overrides when:

Override Criteria

  • Patient previously completed step therapy for the requested drug under a prior health plan within 90 days
  • Drug is medically necessary per prescriber documentation
  • Step therapy drug lacks FDA approval for the patient's condition
  • Clinical evidence shows step therapy would be ineffective or cause adverse effects

Documentation for Override Requests

Your rheumatologist should include:

  • Diagnosis: ICD-10 codes for chronic gout (M1A.xx series)
  • Prior failures: Specific medications, doses, duration, and reasons for discontinuation
  • Lab evidence: Serum uric acid trends showing inadequate control
  • Clinical impact: Tophi presence, joint damage, or frequent flares
From Our Advocates: We've seen cases where patients were initially denied Krystexxa because their prior allopurinol trial was only 2 months. The appeal succeeded when the rheumatologist documented that the patient developed severe skin reactions after 6 weeks, making further titration medically inadvisable. Always document both efficacy failures and tolerance issues.

Appeals Playbook for Florida Blue

Level 1: Internal Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard; 72 hours for expedited
  • Submission: Provider portal, fax, or mail
  • Required: Denial letter, medical records, prescriber statement

Level 2: External Review

  • Deadline: 4 months after final internal denial
  • Timeline: 45 days for standard; 72 hours for urgent cases
  • Cost: Free to patient
  • Authority: Florida Department of Financial Services

Key Appeal Strategies

Medical Necessity Arguments:

  • Emphasize refractory nature of gout despite optimal conventional therapy
  • Document impact on quality of life and functional status
  • Include photos of tophi if present
  • Reference ACR gout management guidelines supporting pegloticase use

Procedural Arguments:

  • Challenge step-therapy requirements under Florida HB 459
  • Cite continuity-of-care protections if switching from another plan
  • Question any quantity limit denials with clinical justification

External Review Process

When Florida Blue's internal appeals are exhausted, you can request external review through the Florida Department of Financial Services (DFS).

External Review Requirements

  • Must exhaust internal appeals first (unless insurer fails to follow proper procedures)
  • Request within 4 months of final internal denial
  • Disputed amount typically >$500 (met with Krystexxa's ~$30,000 per dose cost)
  • Available for medical necessity disputes and non-formulary drugs

How to Request External Review

  1. Contact DFS: Call 1-877-693-5236 for forms and guidance
  2. Submit documentation: Include denial notices, medical records release, and supporting clinical evidence
  3. Independent review: Unaffiliated medical experts review your case
  4. Binding decision: If overturned, Florida Blue must cover the treatment

External Review Success Factors:

  • Strong clinical documentation from rheumatology specialist
  • Clear evidence of conventional therapy failures
  • Reference to FDA labeling and clinical guidelines
  • Documentation of disease progression or complications

Practical Scripts and Templates

Patient Phone Script for Florida Blue

"Hello, I'm calling about prior authorization for Krystexxa, HCPCS code J2507, for refractory chronic gout. My doctor says this requires PA. Can you tell me:

  1. What specific forms are needed?
  2. What clinical documentation is required?
  3. How long does the review take?
  4. Is there an expedited process if my condition is urgent?

My member ID is [ID number] and my rheumatologist is Dr. [Name]."

Clinic Staff Script for Peer-to-Peer Review

"I'm requesting a peer-to-peer review for [Patient Name] regarding denial of Krystexxa coverage. The patient has refractory tophaceous gout despite maximum-tolerated allopurinol and febuxostat therapy. We have documented serum uric acid levels consistently >8 mg/dL and progressive joint damage. The treating rheumatologist is available for clinical discussion. When can we schedule this review?"

Medical Necessity Letter Template

Key elements to include:

  • Patient demographics and diagnosis (ICD-10 codes)
  • Detailed history of prior gout therapies and outcomes
  • Current clinical status and serum uric acid levels
  • Rationale for Krystexxa based on ACR guidelines
  • Monitoring plan and expected outcomes
  • Risk-benefit analysis and contraindications to alternatives

Cost Assistance and Support Programs

While pursuing insurance coverage, explore these financial assistance options:

Manufacturer Support

  • Krystexxa Connect: Patient support program from Amgen
  • Copay assistance: May reduce out-of-pocket costs for eligible patients
  • Prior authorization support: Dedicated team to help with PA submissions

Foundation Assistance

  • Patient Access Network (PAN) Foundation: Provides copay assistance for gout medications
  • Good Days: Offers financial assistance for chronic disease treatments
  • HealthWell Foundation: May have programs covering rheumatology medications
Note: Foundation assistance typically requires insurance coverage approval first, then helps with copays and deductibles.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, targeted rebuttals aligned to each payer's specific policies. Our platform analyzes denial letters and plan policies to identify the exact approval pathway, then drafts point-by-point appeals with the right clinical evidence and procedural requirements.

FAQ: Common Questions

Q: How long does Florida Blue prior authorization take for Krystexxa? A: Standard PA decisions take 14 business days from complete submission. Expedited review is available in 72 hours with physician urgency certification.

Q: What if Krystexxa is non-formulary on my Florida Blue plan? A: You can request a formulary exception through the Coverage Exception Request Form, providing medical necessity documentation and evidence of alternative therapy failures.

Q: Can I request an expedited appeal for Krystexxa denial? A: Yes, if your condition poses immediate health risks (such as rapidly progressive joint damage or frequent severe flares), you can request expedited internal and external appeals.

Q: Does Florida's step therapy law apply to Krystexxa coverage? A: Yes, Florida HB 459 provides override protections for chronic conditions. If you've documented failure of conventional gout therapies, you may qualify for a step-therapy exemption.

Q: What happens if I switch to Florida Blue from another insurer while on Krystexxa? A: Florida's continuity-of-care laws and the federal No Surprises Act may provide transitional coverage. Contact Florida Blue immediately to request continuation of your current therapy.

Q: Can my primary care doctor prescribe Krystexxa, or does it require a specialist? A: While Florida Blue's policy doesn't explicitly require rheumatology, most approvals are more successful with specialist documentation given the drug's complexity and monitoring requirements.

Q: What should I do if Florida Blue denies my external review request? A: External review decisions are typically final and binding. However, you can file complaints with the Florida Office of Insurance Regulation if you believe proper procedures weren't followed.

Q: Are there quantity limits on Krystexxa coverage? A: Yes, Florida Blue limits coverage to maximum 2 vials (16 billable units under J2507) every 28 days, which aligns with the standard dosing protocol of 8 mg IV every 2 weeks.

Through Counterforce Health's platform, healthcare providers can access specialized tools that streamline the prior authorization and appeals process, significantly improving approval rates for complex specialty medications like Krystexxa by ensuring all payer-specific requirements are properly addressed.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Florida Blue and consult with your healthcare provider and insurance representative for the most up-to-date information specific to your situation. For additional assistance with insurance issues in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

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