By Counterforce Health Team in Crysvita (burosumab) —

Renewing Crysvita (Burosumab) Approval with Humana in California: Timeline, Documentation, and Appeals

Answer Box: Renewing Crysvita (Burosumab) with Humana in California

Fastest path to renewal: Start 60 days before your current authorization expires. Submit lab results showing serum phosphorus response, clinical notes documenting symptom improvement, and adherence records through your provider's Humana portal. If denied, file an internal appeal within 60 days, then request California's Independent Medical Review (IMR) through the DMHC Help Center at 888-466-2219. First step today: Contact your prescriber to schedule labs and begin documenting treatment response for your renewal packet.

Table of Contents

  1. When to Start Your Renewal Process
  2. Evidence Update Requirements
  3. Building Your Renewal Packet
  4. Timeline and Submission Process
  5. If Your Coverage Lapses
  6. Annual Plan Changes to Monitor
  7. Appeals Process for California
  8. Patient Assistance During Gaps
  9. Personal Renewal Tracker
  10. FAQ

Renewal Triggers: When to Start Early

Humana typically grants initial Crysvita (burosumab) authorizations for 6 months, with renewals approved for 12-month periods when therapeutic response is documented. Start your renewal process 60-90 days before expiration to avoid treatment interruptions.

Start early if you notice:

  • Your prescription refill count is approaching the authorized limit
  • You receive a "prior authorization expiring" notice from Humana
  • Your pharmacy indicates coverage will end soon
  • You're approaching the 6-month mark on your initial approval
Tip: Set a calendar reminder for 75 days before your authorization expires. This gives you buffer time if additional documentation is needed.

Evidence Update: Documenting Treatment Response

Your renewal success depends on demonstrating clinical benefit from Crysvita therapy. Serum phosphorus monitoring provides the primary evidence of therapeutic response.

Required Lab Values

Monthly monitoring schedule:

  • Fasting serum phosphorus: Measured 2 weeks post-dose for first 3 months, then as appropriate
  • Comprehensive metabolic panel: Every 3-6 months including calcium, alkaline phosphatase, creatinine
  • Parathyroid hormone (PTH): Before and during treatment
  • Vitamin D status (25(OH)D): At baseline and intermittently

Target outcomes for renewal:

  • Serum phosphorus within normal range for age
  • Stable or improved alkaline phosphatase levels
  • No evidence of nephrocalcinosis on renal imaging
  • Maintained or improved functional status

Clinical Response Documentation

Your provider should document:

  • Symptom improvements: Reduced bone/joint pain, fewer fractures, improved mobility
  • Rickets Severity Scale (RSS) scores: Baseline vs. current measurements
  • Adherence records: On-time injections, missed doses with explanations
  • Adverse events: Any side effects and management strategies

Building Your Renewal Packet

Must-Include Documents

Clinical Documentation:

  • Letter of medical necessity from prescribing physician
  • Recent lab results (within 30 days of submission)
  • Clinical notes showing treatment response
  • Imaging studies if applicable (renal ultrasound, bone X-rays)

Insurance Documentation:

  • Current Humana member ID card
  • Previous authorization approval letter
  • Prescription history showing adherence

Medical Necessity Letter Structure

Your physician's letter should address:

  1. Diagnosis confirmation: X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia with appropriate ICD-10 codes
  2. Treatment history: Duration of Crysvita therapy and response
  3. Clinical improvement: Specific metrics (lab values, symptom scores, functional improvements)
  4. Continued need: Why ongoing therapy remains medically necessary
  5. Monitoring plan: Schedule for ongoing lab work and clinical assessments
Clinician Corner: Include specific serum phosphorus values with dates. Example: "Patient's fasting serum phosphorus improved from 1.8 mg/dL (below normal range 2.5-4.5 mg/dL) at baseline to 3.2 mg/dL after 6 months of Crysvita therapy, demonstrating clear therapeutic benefit."

Timeline and Submission Process

Submission Methods

Provider Portal (recommended):

Alternative Methods:

  • Fax: Use Humana's Clinical Pharmacy Review fax line (verify current number)
  • Phone: Call Humana Clinical Pharmacy Review directly
  • Mail: Submit to address on current authorization letter

Expected Timeline

  • Electronic submission: 1-2 business days response
  • Standard submission: Up to 30 days for Part C decisions
  • Expedited requests: 72 hours when medically urgent

Track your request:

  • Humana members receive determination letters by mail
  • Providers get notifications through the portal
  • Call member services if no response within expected timeframe

If Your Coverage Lapses

Immediate Steps

  1. Contact your provider immediately to request expedited resubmission
  2. Call Humana member services to request expedited review for urgent medical need
  3. Document the gap - save all communications about the lapse
  4. Explore bridge options while awaiting approval

Bridge Therapy Options

Kyowa Kirin Cares Programs:

  • Patient Assistance Program for uninsured patients
  • Co-pay assistance for commercially insured patients
  • Contact: 833-KK-CARES (833-552-2737)

Clinical Considerations:

  • Consult your physician about temporary treatment modifications
  • Monitor serum phosphorus more frequently during gaps
  • Document any symptom changes during interruption

Annual Plan Changes to Monitor

Formulary Updates

Humana updates formularies monthly. Check current drug lists for:

  • Tier placement changes
  • New prior authorization requirements
  • Quantity limit modifications
  • Step therapy requirements

2025 Medicare Part D Changes

Out-of-pocket cap: New $2,000 annual limit eliminates the coverage gap Payment plans: Monthly installment options for high-cost medications Coverage verification: Re-confirm Crysvita's tier placement annually

Note: These changes may affect your cost-sharing but shouldn't impact medical necessity requirements for Crysvita coverage.

Appeals Playbook for California

Internal Appeals with Humana

Timeline: 60 days from denial date to file Required documents:

  • Appeal request form or written letter
  • Copy of original denial
  • Additional clinical documentation supporting medical necessity
  • Provider attestation if applicable

California Independent Medical Review (IMR)

If Humana upholds its denial, California residents can request an IMR through the Department of Managed Health Care.

Eligibility: After internal appeal denial or 30 days without response Timeline: File within 6 months of final denial Success rate: 50-60% success rate for specialty drug appeals Process: Independent physicians review your case; decision is binding on Humana

How to file:

Required documents:

  • IMR application
  • All Humana denial letters
  • Complete medical records
  • Physician statement supporting medical necessity

Patient Assistance During Gaps

Manufacturer Support Programs

Kyowa Kirin Cares Patient Assistance Program:

Co-pay Assistance Program:

  • Helps with out-of-pocket costs for commercially insured patients
  • Covers eligible cost-sharing up to program maximum
  • Contact case managers at 833-552-2737

When dealing with insurance challenges, Counterforce Health helps patients and providers turn denials into targeted appeals by analyzing denial letters and crafting evidence-backed responses aligned with payer policies.

Personal Renewal Tracker

Authorization Details:

  • Current expiration date: ___________
  • Authorization number: ___________
  • Approved dose/frequency: ___________

Key Dates:

  • Start renewal process (75 days before expiration): ___________
  • Lab work scheduled: ___________
  • Provider appointment: ___________
  • Submission deadline: ___________

Documentation Checklist:

  • Recent serum phosphorus levels
  • Comprehensive metabolic panel
  • Provider letter of medical necessity
  • Clinical notes showing response
  • Adherence records
  • Previous authorization letter

Contact Information:

  • Prescriber office: ___________
  • Humana member services: ___________
  • Pharmacy: ___________

FAQ

How long does Humana take to approve Crysvita renewals in California? Electronic submissions typically receive responses within 1-2 business days. Standard submissions may take up to 30 days for Medicare Advantage plans.

What if Crysvita moves to a higher formulary tier? Contact your provider to request a formulary exception based on medical necessity. Document why alternative treatments are inappropriate for your condition.

Can I request an expedited renewal if my coverage is about to expire? Yes, if there's urgent medical need. Your provider should indicate "expedited review requested" and provide clinical justification for urgency.

What counts as adequate treatment response for renewal? Improvement or normalization of serum phosphorus levels, documented symptom improvement (reduced pain, fewer fractures), and stable or improved functional status.

Does California's IMR process cost anything? No, there's no fee to request an IMR in California. The state covers all costs of the independent medical review.

How often do I need lab monitoring during Crysvita therapy? Monthly fasting serum phosphorus for the first 3 months, then as clinically appropriate. Comprehensive panels every 3-6 months with annual renal imaging.

What happens if I miss doses during a coverage gap? Document any missed doses and symptom changes. Your provider may need to restart at a lower dose or increase monitoring frequency when treatment resumes.

Can I switch to a different Humana plan if Crysvita coverage changes? During open enrollment, you can switch Medicare plans. Compare formularies and prior authorization requirements before changing.

This guide provides educational information about insurance coverage processes and should not replace personalized medical advice. For specific coverage questions, contact Humana directly or consult with your healthcare provider. California residents can get free help with insurance appeals through the DMHC Help Center at 888-466-2219.

Sources & Further Reading

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