By Counterforce Health Team in Zanzalintinib (XL092) [investigational] —

Getting Zanzalintinib (XL092) Covered by Cigna in Pennsylvania: Complete Coding and Appeals Guide

Answer Box: Your Path to Coverage

Zanzalintinib (XL092) is an investigational cancer drug requiring special approval from Cigna. In Pennsylvania, you'll need: (1) Your doctor submits a prior authorization with clinical trial documentation or compassionate use approval from Exelixis, (2) if denied, file internal appeals within 180 days, then (3) request Pennsylvania's external review within 60 days of final denial. Pennsylvania's new external review program overturns about 50% of denials. Start today: Ask your oncologist to download Cigna's prior authorization form from their provider portal and gather your treatment history documentation.

Table of Contents

Coding Basics: Medical vs. Pharmacy Coverage

Zanzalintinib (XL092) sits in a unique coverage category as an investigational drug. Unlike approved cancer medications, it doesn't follow standard pharmacy benefit pathways.

Medical Benefit Path:

  • Used when the drug is administered in a clinical setting
  • Requires HCPCS J-codes for billing
  • Often applies to investigational drugs in clinical trials
  • May have different prior authorization requirements

Pharmacy Benefit Path:

  • Applies to oral medications dispensed by specialty pharmacies
  • Uses NDC numbers for identification
  • Subject to formulary restrictions and step therapy
  • Currently not applicable to Zanzalintinib since it lacks FDA approval
Note: Since Zanzalintinib is investigational, most coverage will route through medical benefits with special prior authorization requirements.

ICD-10 Mapping for Cancer Diagnoses

Your diagnosis code drives coverage decisions. Cigna requires specific ICD-10 codes that align with your cancer type and Zanzalintinib's investigational indications.

Common Cancer ICD-10 Codes for TKI Therapy

Cancer Type ICD-10 Code Documentation Keywords
Non-Small Cell Lung Cancer C34.10-C34.90 NSCLC, adenocarcinoma, squamous cell
Renal Cell Carcinoma C64.1, C64.2, C64.9 Clear cell RCC, metastatic kidney cancer
Hepatocellular Carcinoma C22.0 Primary liver cancer, HCC
Breast Cancer (metastatic) C50.911, C50.912 Triple-negative, HER2-positive
Colorectal Cancer C18.9, C19, C20 Advanced CRC, metastatic

Documentation Support: Your medical records should include specific language that supports the ICD-10 code:

  • Disease stage and progression status
  • Prior treatment failures or intolerances
  • Molecular markers or genetic testing results
  • Performance status and treatment goals
Tip: Ask your oncologist to document why standard approved therapies are inadequate for your specific cancer subtype.

HCPCS and Billing Codes for Investigational Drugs

Since Zanzalintinib lacks FDA approval, it doesn't have assigned permanent billing codes. Here's how providers should handle coding:

Billing Code Strategy

HCPCS Codes to Use:

  • J3490 - "Unclassified drugs" (most common for investigational agents)
  • J9999 - "Not otherwise classified, antineoplastic drugs" (cancer-specific)

NDC Number:

  • No assigned NDC for Zanzalintinib
  • Use manufacturer lot numbers or protocol identifiers when available
  • Document "investigational agent" clearly in claims

Units and Dosing:

  • Bill per protocol-specified dose
  • Include administration codes if given in clinical setting
  • Document exact mg/dose for accurate billing
Important: Always verify current coding guidance with CMS HCPCS updates as investigational drugs may receive temporary codes.

Building a Clean Prior Authorization Request

A well-structured PA request significantly improves approval odds. Here's what Cigna requires for investigational drugs:

Essential Documentation Components

1. Clinical Rationale Section:

  • Patient's specific cancer diagnosis with staging
  • Why FDA-approved alternatives are inappropriate
  • Expected clinical benefit based on trial data
  • Treatment goals and monitoring plan

2. Regulatory Documentation:

  • FDA Expanded Access or IND number (if applicable)
  • Exelixis compassionate use program approval
  • Clinical trial enrollment documentation
  • IRB approval letters

3. Supporting Evidence:

  • Published study data on Zanzalintinib
  • Peer-reviewed literature supporting use
  • Specialty society guidelines (when available)
  • Prescriber qualifications and expertise

Timeline Expectations

Request Type Cigna Review Time Notes
Standard PA 72 hours Most common pathway
Urgent/Expedited 24 hours Life-threatening situations
Peer-to-Peer Review 48-72 hours After initial denial

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals. Their platform helps clinicians identify the specific denial basis and craft appeals aligned to each payer's own rules, potentially saving valuable time in complex cases like investigational drug approvals.

Common Coding Pitfalls to Avoid

These frequent mistakes can delay or derail approval:

Unit Conversion Errors:

  • Mismatching dose units (mg vs. vials)
  • Incorrect quantity calculations
  • Missing administration frequency

Code Mismatches:

  • Using specific J-codes for unapproved drugs
  • Selecting wrong ICD-10 specificity level
  • Omitting required modifiers

Documentation Gaps:

  • Missing start date justification
  • Inadequate prior therapy documentation
  • Unclear treatment duration

Submission Timing:

  • Filing PA after treatment starts
  • Missing Cigna's 72-hour review window
  • Incomplete supporting documents
Pro Tip: Double-check all numerical entries and ensure your ICD-10 code precisely matches your documented diagnosis.

Verifying Codes with Cigna Resources

Before submitting, cross-check your coding with Cigna's current requirements:

Provider Resources:

  • Cigna Healthcare Provider Portal - Current PA forms and requirements
  • Express Scripts coverage policies for specialty drugs
  • Medical policy bulletins for investigational treatments

Verification Steps:

  1. Confirm current PA form version
  2. Check specialty drug coverage policies
  3. Verify required supporting documentation
  4. Review any recent policy updates

Contact Points:

  • Provider services line on your ID card
  • Express Scripts prior authorization department
  • Cigna medical policy team for investigational drugs

Appeals Process in Pennsylvania

Pennsylvania offers robust appeal rights, especially for investigational treatments.

Internal Appeals with Cigna

Level 1 Internal Appeal:

  • File within 180 days of denial
  • Decision within 30 days (15 for pre-service)
  • Include additional clinical evidence
  • Request peer-to-peer review if appropriate

Level 2 Internal Appeal:

  • Available if Level 1 is denied
  • Same timeline and documentation requirements
  • Often involves different medical reviewers

Pennsylvania External Review

Pennsylvania's new external review program, launched in 2024, provides significant leverage for patients:

Eligibility:

  • Must complete Cigna's internal appeals first
  • Applies to medical necessity and experimental treatment denials
  • Available for investigational drug coverage disputes

Filing Process:

Success Rates: In 2024, Pennsylvania's external review program overturned approximately 50% of appealed denials, with 259 successful reversals out of 517 cases filed.

Timeline:

  • Standard reviews: 45 days maximum
  • Expedited reviews: 72 hours for urgent cases
  • Binding decision on insurance company
Pennsylvania Advantage: The state's new external review program offers faster resolution and higher success rates compared to the previous federal process.

For complex appeals involving investigational drugs, Counterforce Health can help identify the specific denial basis and craft evidence-backed rebuttals that align with Cigna's own coverage policies, potentially improving your chances in both internal and external reviews.

Pre-Submission Checklist

Before submitting your Zanzalintinib prior authorization:

Patient Information:

  • Current Cigna member ID and policy details
  • Complete contact information
  • Primary care physician information

Clinical Documentation:

  • Pathology report with specific cancer diagnosis
  • Staging and progression documentation
  • Complete prior treatment history with outcomes
  • Current performance status assessment

Coding Verification:

  • Correct ICD-10 code for primary cancer diagnosis
  • Appropriate HCPCS code (J3490 or J9999)
  • Accurate dosing and unit calculations
  • Required modifier codes if applicable

Regulatory Requirements:

  • Exelixis compassionate use approval (if applicable)
  • Clinical trial enrollment documentation
  • FDA IND or Expanded Access numbers
  • IRB approval letters

Supporting Evidence:

  • Published Zanzalintinib study data
  • Peer-reviewed literature supporting use
  • Specialty guideline references
  • Prescriber specialty qualifications

FAQ: Coverage Questions

How long does Cigna prior authorization take for investigational drugs in Pennsylvania? Standard reviews are completed within 72 hours, while urgent cases receive decisions within 24 hours. Complex investigational drug requests may require peer-to-peer review, adding 48-72 hours to the process.

What if Zanzalintinib is not on Cigna's formulary? As an investigational drug, Zanzalintinib isn't on any standard formulary. Coverage requires prior authorization with clinical trial participation or compassionate use approval from Exelixis.

Can I request an expedited appeal for cancer treatment? Yes, Pennsylvania allows expedited external reviews for urgent health situations. These are decided within 72 hours and apply when treatment delays could jeopardize your health.

Does step therapy apply to investigational cancer drugs? Step therapy typically doesn't apply to investigational agents since they're not formulary medications. However, Cigna may require documentation of prior FDA-approved therapy failures.

What happens if my external review is successful? If Pennsylvania's external review overturns the denial, Cigna must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.

How much does external review cost in Pennsylvania? Pennsylvania's external review program is free to consumers. You don't pay any fees to file or pursue the independent review process.

Can I get help with my appeal in Pennsylvania? Yes, Pennsylvania offers free assistance through the Pennsylvania Health Law Project and other consumer advocacy organizations. The Pennsylvania Insurance Department also provides guidance at 1-877-881-6388.

What if I'm in a clinical trial for Zanzalintinib? Clinical trial participants typically receive the drug at no cost through the study sponsor. However, related medical services may still require insurance coverage and prior authorization.

From our advocates: "We've seen investigational drug appeals succeed when families gather comprehensive documentation upfront – including trial eligibility letters, prior treatment summaries, and clear timelines. One case involved a patient whose appeal was initially denied but succeeded on external review after presenting detailed molecular profiling that supported the investigational approach. The key was showing why standard treatments weren't appropriate for that specific cancer subtype."

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements with your specific plan. Coverage policies and appeal procedures may change; confirm current requirements with official sources before submitting requests.

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