By Counterforce Health Team in Ofev (nintedanib) —

How to Get Ofev (nintedanib) Covered by Humana in California: Complete Appeal Guide with Forms and Templates

Answer Box: Getting Ofev Covered by Humana in California

Ofev (nintedanib) requires prior authorization from Humana Medicare Advantage plans in California. If denied, you have 65 days to appeal and California offers a 73% success rate through Independent Medical Review (IMR). First step: Have your pulmonologist submit a coverage determination request with HRCT scan, pulmonary function tests, and diagnosis confirmation (IPF or SSc-ILD). If denied, file an internal appeal within 65 days, then escalate to California DMHC's IMR process for external review.

Table of Contents

Understanding Humana's Prior Authorization Requirements

Ofev (nintedanib) is a specialty medication that requires prior authorization for all Humana Medicare Advantage plans. The drug costs approximately $13,000-$15,000 per month and is used to treat idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Coverage at a Glance

Requirement What it means Where to find it Source
Prior Authorization Required before coverage Humana PA Search Tool Humana Provider Portal
Formulary Status Tier 5 specialty drug Humana Drug List Plan documents
Diagnosis Codes J84.112 (IPF), M34.81 (SSc-ILD) Medical records ICD-10 coding
Appeal Deadline 65 days from denial Denial notice Medicare regulations
Specialist Required Pulmonologist attestation PA submission Humana policy

Humana processes 95% of electronic prior authorization requests within one business day, but complex cases like Ofev may take longer due to the extensive documentation requirements.

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Documents Needed
Lack of specialist confirmation Submit pulmonologist letter Board-certified pulmonologist note with NPI
Missing diagnostic imaging Provide HRCT chest scan Radiology report showing >10% fibrosis
Insufficient PFT documentation Include serial lung function tests FVC ≥40% predicted, DLCO values
No prior therapy documentation Document treatment history Records of failed/contraindicated alternatives
Diagnosis not confirmed Clarify ICD-10 coding Clear IPF or SSc-ILD diagnosis
Tip: Humana's denial rate for Medicare Advantage is only 3.5%, but when denials occur, they're often due to incomplete documentation rather than medical necessity concerns.

Step-by-Step: Fastest Path to Approval

  1. Verify PA requirement (Provider): Check Humana's PA Search Tool using "Ofev" or "nintedanib"
  2. Gather documentation (Patient/Clinic): Collect HRCT scan, PFTs, specialist notes, and prior treatment records
  3. Submit PA request (Provider): Use Availity portal, CoverMyMeds, or fax to 877-486-2621 within 1-2 business days
  4. Follow up (Patient): Call Humana at 800-555-2546 if no response within 3 business days
  5. If denied, file appeal (Patient/Provider): Submit redetermination request within 65 days using official forms
  6. Request peer-to-peer (Provider): Schedule clinical review call with Humana pharmacist if initial appeal fails
  7. Escalate to California IMR (Patient): File with DMHC if internal appeals are exhausted

Expected timeline: Initial PA decision in 1-3 business days; appeal decisions in 7 days standard (72 hours expedited).

Appeals Playbook for Humana in California

Level 1: Plan Redetermination

  • Deadline: 65 days from denial notice
  • Decision time: 7 days (72 hours if expedited)
  • How to file: Humana member portal or mail to address on denial form
  • Required: Completed redetermination form, medical records, physician letter

Level 2: Independent Review Entity (IRE)

  • Deadline: 60 days from plan denial
  • Decision time: 7 days standard
  • Automatic: Humana forwards if they uphold denial
  • Cost threshold: Must meet Medicare's minimum amount

California External Review (IMR)

For Humana HMO plans regulated by California DMHC:

  • File with: DMHC Help Center at 888-466-2219
  • Success rate: 73% overturn rate for specialty drug denials
  • Timeline: 45 days standard, 72 hours expedited
  • Cost: Free to patients

Medical Necessity Letter Template

When appealing an Ofev denial, your pulmonologist should include these key elements:

[Physician Letterhead]
[Date]

Humana Medicare Appeals
[Address from denial notice]

Re: [Patient Name], ID: [Member ID] - Appeal for Ofev (nintedanib) Coverage

Dear Appeals Review Team,

I am requesting reconsideration for coverage of Ofev (nintedanib) 150mg BID for my patient diagnosed with [IPF/SSc-ILD] (ICD-10: J84.112/M34.81).

**Clinical History:**
- HRCT [date]: Shows [>10% lung fibrosis/specific findings]
- PFTs [dates]: FVC [%] predicted, showing [decline pattern]
- Diagnosis confirmed: [IPF/SSc-ILD] per ATS/ERS criteria

**Medical Necessity:**
Ofev is FDA-approved first-line therapy that reduces FVC decline by 50% in clinical trials. Patient has progressive disease despite [list prior treatments/contraindications]. Without treatment, patient faces respiratory failure and potential mortality.

**Supporting Evidence:**
- SENSCIS trial data for SSc-ILD
- INPULSIS trials for IPF
- ATS/ERS treatment guidelines

Attached: HRCT report, PFTs, clinic notes, denial notice.

Respectfully,
[Physician name, credentials, NPI]

Clinician Corner: Documentation Checklist

  • Problem statement: Clear diagnosis with ICD-10 codes
  • Prior treatments: Document failures, intolerances, or contraindications
  • Clinical rationale: Reference FDA labeling and clinical trials
  • Monitoring plan: Liver function tests, GI side effect management
  • Guideline support: ATS/ERS IPF guidelines, FDA prescribing information

California's External Review Process

California residents have unique appeal rights through the Department of Managed Health Care (DMHC). After exhausting Humana's internal appeals, you can request an Independent Medical Review (IMR).

How to File an IMR

  1. Eligibility: Internal appeal denied or 30 days passed without response
  2. Application: Submit online at healthhelp.ca.gov or call 888-466-2219
  3. Documentation: Include all denial letters, medical records, and physician statements
  4. Timeline: 45 days for standard review, 72 hours for urgent cases
  5. Decision: Binding on Humana if overturned
From our advocates: We've seen California IMR overturn Humana denials for specialty drugs when patients submit comprehensive pulmonologist letters with serial PFT data showing progression. The key is demonstrating that Ofev meets FDA-approved indications with proper diagnostic workup. Success rates are particularly high when the clinical evidence clearly supports progressive fibrotic disease.

The IMR process is free and has a 73% success rate for specialty drug appeals in California.

Costs and Financial Assistance

While pursuing coverage appeals, several programs can help with Ofev costs:

Manufacturer Support

Medicare Programs

  • Extra Help: Low-income subsidy for Medicare Part D
  • State Pharmaceutical Assistance Programs: California may offer additional support

When to Escalate to State Regulators

If Humana violates appeal timelines or procedures, contact:

DMHC (for HMO plans)

California Department of Insurance (for PPO plans)

  • Phone: 800-927-4357
  • Website: insurance.ca.gov
  • Scope: Non-HMO health plans

Organizations like Counterforce Health specialize in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific policies.

Frequently Asked Questions

How long does Humana prior authorization take for Ofev in California? Humana processes 95% of electronic PA requests within 1 business day, but complex cases may take 2-3 days. Appeals are decided within 7 days (72 hours if expedited).

What if Ofev is not on Humana's formulary? Request a formulary exception through your prescriber. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I get expedited review for urgent cases? Yes, if delay would seriously jeopardize your health. Your doctor must attest to urgency. Expedited appeals are decided within 72 hours.

Does California's IMR cost anything? No, Independent Medical Review is free for patients. Humana pays the review costs.

What happens if I start Ofev before approval? You may face full retail costs ($13,000-$15,000/month). However, you can submit claims for retroactive coverage if the appeal is successful.

How do I know if my Humana plan is regulated by DMHC? Most HMO plans are DMHC-regulated. Check your member handbook or call Humana member services to confirm.

Can family members file appeals on my behalf? Yes, with written authorization. Healthcare providers can also file appeals for their patients.

What if I miss the 65-day appeal deadline? Contact Humana to request a "good cause" extension. Valid reasons include not receiving the denial notice or serious illness preventing timely filing.

For patients navigating these complex processes, Counterforce Health offers specialized support in transforming insurance denials into successful appeals by identifying specific denial reasons and crafting targeted responses using the right clinical evidence and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always consult your healthcare provider and insurance plan for current requirements and procedures. For personalized assistance with complex appeals, consider consulting organizations that specialize in insurance advocacy.

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