By Counterforce Health Team in Ofev (nintedanib) —

How to Get Ofev (nintedanib) Covered by Cigna in Michigan: ICD-10 Codes, Prior Authorization, and Appeal Scripts

Answer Box

To get Ofev (nintedanib) covered by Cigna in Michigan: Your pulmonologist must submit prior authorization using Michigan's standardized PA form (FIS 2288) with ICD-10 code J84.112 (IPF) or M34.81 (SSc-ILD), HRCT confirming fibrosis, and PFTs showing FVC ≥40% predicted. Cigna has 15 days to respond (72 hours if expedited). Submit via CoverMyMeds or EviCore. If denied, appeal within 180 days citing medical necessity per FDA labeling and ATS/ERS guidelines. Michigan's DIFS offers external review within 127 days after final denial.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Ofev Coverage
  3. Product Coding: HCPCS, J-Code, and NDC Overview
  4. Clean Request Anatomy: PA Submission Example
  5. Common Denial Reasons and Documentation Fixes
  6. Verification Steps with Cigna Resources
  7. Michigan-Specific Appeals Process
  8. Pre-Submission Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Ofev (nintedanib) is an oral specialty medication that typically falls under pharmacy benefit coverage rather than medical benefit. This means your claim will be processed through Cigna's pharmacy network (Express Scripts/Accredo) using NDC codes rather than HCPCS J-codes commonly used for infused therapies.

However, proper ICD-10 diagnosis coding remains critical for establishing medical necessity, regardless of which benefit processes your claim. The diagnosis code must align with FDA-approved indications and Cigna's coverage criteria.

Note: Some plans may cover oral specialty drugs under the medical benefit when administered in clinical settings, but Ofev is typically self-administered at home.

ICD-10 Mapping for Ofev Coverage

Primary ICD-10 Codes for Ofev

Condition ICD-10 Code Documentation Requirements
Idiopathic Pulmonary Fibrosis J84.112 HRCT showing UIP pattern, PFTs with FVC decline
Systemic Sclerosis-Associated ILD M34.81 Confirmed systemic sclerosis with lung involvement
Progressive Fibrosing ILD J84.170 ≥2 fibrosis claims + progression evidence

Documentation Words That Support Coding

When documenting for ICD-10 coding, include these specific terms in clinical notes:

  • For J84.112 (IPF): "usual interstitial pneumonia pattern," "progressive fibrosis," "FVC decline," "honeycombing on HRCT"
  • For M34.81 (SSc-ILD): "systemic sclerosis," "scleroderma," "NSIP pattern," "interstitial lung disease"
  • For J84.170 (Progressive Fibrosing ILD): "progressive phenotype," "worsening fibrosis," "functional decline"

Product Coding: HCPCS, J-Code, and NDC Overview

NDC Codes and Product Information

Primary NDC Codes:

HCPCS Coding

For rare instances where Ofev might be billed under medical benefit:

  • HCPCS Code: J8499 ("Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified")

Units and Billing Math

  • Standard dosing: 150 mg twice daily = 300 mg daily
  • 30-day supply: 60 capsules (150 mg strength)
  • Billing units: Typically billed per capsule or per day's supply
Tip: Most Cigna plans process Ofev through specialty pharmacy (Accredo) using NDC codes, not J-codes.

Clean Request Anatomy: PA Submission Example

Here's what a complete prior authorization request should include:

Required Elements for Cigna PA

Patient Information:

  • Name, DOB, Cigna member ID
  • Primary diagnosis: J84.112 (Idiopathic pulmonary fibrosis)
  • Prescribing physician: Board-certified pulmonologist

Clinical Documentation:

  • HRCT report showing UIP pattern with fibrosis quantification
  • Recent PFTs: FVC ≥40% predicted, DLco results
  • Disease progression evidence (serial FVC decline ≥5-10%)
  • Prior therapy history (if applicable for SSc-ILD)

Prescription Details:

  • Ofev (nintedanib) 150 mg capsules
  • Directions: One capsule by mouth twice daily with food
  • Quantity: 60 capsules for 30-day supply
  • NDC: 00597-0145-60

Common Denial Reasons and Documentation Fixes

Denial Reason Required Fix Documentation Needed
Missing specialist attestation Pulmonologist must be prescriber Board certification verification
Insufficient HRCT documentation Submit complete radiology report UIP/fibrosis pattern description
PFTs below threshold Confirm FVC ≥40% predicted Recent PFT with % predicted values
Undocumented prior therapy For SSc-ILD: show mycophenolate trial Dates, doses, outcomes, or contraindications
Not medically necessary Cite FDA labeling and guidelines ATS/ERS guidelines with medical rationale

Medical Necessity Letter Template

Your pulmonologist's letter should include:

  1. Patient demographics and insurance information
  2. Specific ICD-10 diagnosis with date of diagnosis
  3. Complete HRCT findings from radiology report
  4. Recent PFT results showing FVC ≥40% predicted
  5. Prior therapy rationale (especially for SSc-ILD)
  6. Monitoring plan for hepatic function
  7. Guidelines citations (FDA labeling, ATS/ERS recommendations)

Verification Steps with Cigna Resources

Before submitting your PA request:

Check Coverage Status

  1. Verify Ofev is on Cigna's formulary
  2. Confirm tier placement and copay requirements
  3. Review coverage criteria (CNF_416)

Submission Portals

  • Primary: CoverMyMeds electronic PA
  • Alternative: EviCore by Evernorth for Cigna/Express Scripts
  • Fax backup: Use Michigan PA form to appropriate Cigna fax line

Timeline Verification

  • Standard PA: 15-day response requirement (Michigan law)
  • Expedited PA: 72-hour response for urgent cases
  • Automatic approval: If Cigna doesn't respond within statutory timeframes

Michigan-Specific Appeals Process

Internal Appeals with Cigna

First-Level Internal Appeal:

  • Deadline: 180 days from denial date
  • Response time: 30 days (72 hours if expedited)
  • Required: Copy of denial letter, additional clinical evidence
  • Submit via: Cigna member portal or appeals fax line

Second-Level Internal Appeal:

  • Automatic: If first-level appeal denied
  • Timeline: Additional 30 days for Cigna response
  • Peer-to-peer: Request physician-to-physician review

External Review Through Michigan DIFS

If Cigna upholds the denial after internal appeals:

Michigan External Review Process:

  • Deadline: 127 days after final internal denial
  • Submit to: Michigan DIFS External Review Request
  • Response time: 60 days standard, 72 hours expedited
  • Cost: Free to patient
  • Decision: Binding on Cigna

Required Documents:

  • Final denial letter from Cigna
  • All medical records supporting medical necessity
  • Completed DIFS external review form
  • Physician letter for expedited review (if applicable)

Contact Information

  • DIFS Consumer Hotline: 877-999-6442
  • Online: Michigan.gov/DIFS external review portal
  • Expedited requests: Require physician certification of health jeopardy

Pre-Submission Audit Checklist

Before submitting your Ofev prior authorization:

Clinical Documentation ✓

  • ICD-10 code matches FDA indication (J84.112, M34.81, or J84.170)
  • HRCT report includes fibrosis/UIP pattern description
  • PFTs show FVC ≥40% predicted (recent within 60 days)
  • Pulmonologist credentials verified
  • Prior therapy documented (especially for SSc-ILD)

Administrative Requirements ✓

  • Michigan PA form (FIS 2288) completed
  • Correct NDC code listed (00597-0145-60 for 150mg)
  • Dosing matches FDA labeling (150mg BID with food)
  • Patient insurance information accurate

Submission Details ✓

  • Electronic submission via CoverMyMeds preferred
  • Backup fax option identified
  • Expedited status certified if urgent
  • Follow-up plan established for 15-day response window

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific rules. For complex cases like Ofev coverage, we pull the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—while tracking deadlines and procedural requirements for Michigan's unique appeals process.

FAQ: Ofev Coverage with Cigna in Michigan

Q: How long does Cigna take to approve Ofev PA in Michigan? A: Michigan law requires Cigna to respond within 15 days for standard requests, 72 hours for expedited. If they don't respond, the PA is automatically approved.

Q: What if Ofev isn't on Cigna's formulary? A: Request a formulary exception through the same PA process, providing medical necessity documentation and explaining why covered alternatives aren't appropriate.

Q: Can I appeal if I'm currently stable on Ofev? A: Yes, Cigna's policy allows continuation approvals for patients showing beneficial response (stable FVC, improved 6-minute walk distance, fewer exacerbations).

Q: Does Michigan require step therapy for Ofev? A: Cigna's policy doesn't mandate step therapy for IPF, but may require prior mycophenolate trial for SSc-ILD. Check your specific plan documents.

Q: What counts as "expedited" for 72-hour review? A: Your physician must certify that delay would jeopardize your life, health, or ability to regain maximum function. Acute disease progression typically qualifies.

For additional support with Ofev coverage challenges, Counterforce Health provides specialized appeal assistance, helping you navigate Cigna's specific requirements while meeting Michigan's procedural deadlines.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Consult your healthcare provider and insurance plan documents for personalized guidance. For official Michigan insurance regulations, visit Michigan.gov/DIFS.

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