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

How to Get Zanzalintinib (XL092) Covered by Blue Cross Blue Shield in New York: Appeals Guide and State Protections

Answer Box: Getting Zanzalintinib (XL092) Covered in New York

Zanzalintinib (XL092) is investigational and typically not covered by Blue Cross Blue Shield outside clinical trials. However, New York residents have strong appeal rights through the Department of Financial Services external review process. First step: Request a formulary exception from BCBS with clinical documentation. If denied, file an external appeal within 4 months—decisions come within 72 hours for urgent cases. Community Health Advocates (888-614-5400) provides free guidance for New York residents.

Table of Contents

Why New York State Rules Matter

New York has some of the nation's strongest insurance consumer protections, which apply to Blue Cross Blue Shield plans operating in the state. These rules can override more restrictive internal BCBS policies, giving you additional leverage when seeking coverage for investigational drugs like Zanzalintinib.

Key New York advantages:

  • Binding external appeals through the Department of Financial Services
  • 72-hour urgent appeal decisions for cancer treatments
  • Step therapy override protections with specific medical necessity criteria
  • Continuity of care rights when transitioning between providers or plans
Note: Self-funded employer plans (ERISA) may not be subject to all state regulations, though many voluntarily follow similar processes.

Coverage Requirements at a Glance

Requirement Status What It Means Source
Prior Authorization Required Must submit clinical justification before coverage BCBS NY Provider Portal
Formulary Status Non-formulary Requires exception request with documentation Formulary Exception Form
Step Therapy May apply Override available for contraindications/failures NY Step Therapy Law
Medical Necessity Required Must demonstrate clinical need and lack of alternatives DFS External Appeal
Appeals Deadline 4 months From final denial to external review filing NY DFS Appeals Process

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Patient and provider team
Timeline: 1-2 days

  • Insurance card and member ID
  • Complete medical records showing diagnosis
  • Documentation of prior treatment failures or contraindications
  • Prescriber's clinical rationale letter

2. Submit Formulary Exception Request

Who: Prescribing physician
Timeline: Same day submission

3. Request Prior Authorization (if required)

Who: Provider or specialty pharmacy
Timeline: 1-3 business days

  • Submit through BCBS NY provider portal
  • Include all supporting clinical documentation
  • Request expedited review if urgent

4. Monitor Decision Timeline

Who: Patient advocacy team
Timeline: 15-30 days standard, 72 hours expedited

  • Track submission confirmation
  • Follow up if no response within expected timeframe
  • Prepare appeal documentation if denied

5. File Internal Appeal (if denied)

Who: Patient or authorized representative
Timeline: Within appeal deadline (typically 60 days)

  • Submit written appeal with additional evidence
  • Include updated clinical information
  • Request peer-to-peer review

6. File External Appeal with NY DFS

Who: Patient or representative
Timeline: Within 4 months of final denial

7. Await Binding Decision

Who: Independent medical reviewer
Timeline: 30 days standard, 72 hours urgent

  • Decision is final and binding on BCBS
  • If approved, insurer must provide coverage
  • Fee refunded if successful

New York's Step Therapy Protections

New York law provides specific protections against unreasonable step therapy requirements, which strengthen your position when requesting Zanzalintinib coverage.

Automatic Override Criteria (effective January 1, 2026):

  • Contraindication: Required drug likely to cause adverse reaction
  • Ineffectiveness: Expected to be ineffective based on clinical history
  • Previous trial: Patient already tried required drug unsuccessfully
  • Adherence barrier: Would create significant barrier to medication adherence
  • Patient stability: Currently stable on prescribed medication

Additional Protections:

  • Plans cannot require trials of more than two drugs in same therapeutic category
  • Step therapy periods cannot exceed 30 days without clinical justification
  • No repeat requirements for previously completed step therapy within past year
Tip: When requesting an override, cite specific New York Insurance Law provisions and document how your situation meets override criteria.

External Review Process

New York's external appeal system provides a powerful avenue for overturning BCBS denials, particularly for investigational treatments with strong clinical evidence.

Eligibility Requirements

  • Completed internal appeals process (or received waiver)
  • Treatment deemed "not medically necessary" or "experimental/investigational"
  • Request filed within 4 months of final denial

Filing Process

  1. Download External Appeal Application
  2. Submit with $25 fee (waived for financial hardship/Medicaid)
  3. Include comprehensive supporting documentation
  4. Fax to 1-888-990-3991 or mail to DFS

Review Timeline

  • Standard cases: 30 days
  • Urgent cases: 72 hours (with physician attestation of serious health threat)
  • Decision: Final and binding on insurer

Counterforce Health specializes in helping patients navigate these complex appeal processes, turning insurance denials into targeted, evidence-backed appeals that align with payer-specific requirements and state regulations.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Zanzalintinib Requests

Clinical Rationale Must Include:

  • Specific cancer diagnosis with ICD-10 codes
  • Disease stage and progression status
  • Prior treatment history and outcomes
  • Contraindications to standard therapies
  • Clinical trial data supporting Zanzalintinib use
  • Treatment goals and monitoring plan

Supporting Evidence:

  • Peer-reviewed studies from Zanzalintinib STELLAR program
  • FDA guidance on investigational drug access
  • Relevant oncology society treatment guidelines
  • Patient-specific factors justifying investigational use

Documentation Best Practices:

  • Reference specific BCBS medical policy numbers
  • Cite New York step therapy override criteria
  • Include comparative effectiveness data
  • Document urgency if applicable for expedited review
From our advocates: "We've seen investigational drug appeals succeed when providers clearly articulate why approved alternatives are inadequate and include robust clinical trial data. The key is connecting the patient's specific situation to the available evidence base."

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Investigational/Experimental" File formulary exception citing medical necessity Clinical trial data, lack of alternatives, treatment history
"Not FDA Approved" Request compassionate use consideration Physician attestation, disease progression, failed standard therapies
"Step Therapy Required" File override request per NY law Document contraindications or previous failures
"Not Medically Necessary" Prepare for external appeal Comprehensive clinical rationale, peer-reviewed evidence
"Quantity/Frequency Limits" Submit dosing justification Clinical guidelines, patient-specific factors, monitoring plan

When to Escalate

Contact New York Regulators

If BCBS fails to follow proper procedures or timelines:

New York Department of Financial Services

Community Health Advocates

  • Free assistance: 888-614-5400
  • Help with appeal preparation and filing
  • Available to all New York residents

Red Flags Requiring Escalation

  • Missing appeal deadlines or procedural requirements
  • Failure to provide required forms or information
  • Inappropriate denial reasons not based on medical policy
  • Violation of New York step therapy or continuity protections

Frequently Asked Questions

Q: How long does BCBS prior authorization take in New York?
A: Standard requests: 15-30 days. Expedited requests (with physician urgency attestation): 72 hours. Source: NY DFS regulations

Q: What if Zanzalintinib is completely non-formulary?
A: File a formulary exception request with clinical documentation. If denied, you can appeal through NY's external review process, which has binding authority over BCBS decisions.

Q: Can I request an expedited appeal for cancer treatment?
A: Yes, if your physician provides written documentation that delay would seriously threaten your health. Expedited external appeals must be decided within 72 hours.

Q: Does step therapy apply if I failed treatments in another state?
A: New York law prohibits requiring repeat step therapy for drugs previously tried within the past year, regardless of location. Document your treatment history carefully.

Q: What happens if BCBS approves but later tries to revoke coverage?
A: New York continuity of care protections provide 90-day transition periods. You also have appeal rights for coverage termination decisions.

Q: Are there cost assistance programs for investigational drugs?
A: Since Zanzalintinib is investigational, costs are typically covered by the clinical trial sponsor. For compassionate use, contact Exelixis directly about patient assistance programs.

Q: What if my employer plan is self-funded (ERISA)?
A: Self-funded plans may not be subject to all New York state requirements, but many follow similar processes voluntarily. Check your plan documents or contact your benefits administrator.

Q: How successful are external appeals in New York?
A: New York's external appeal system has a strong track record of overturning denials when supported by solid medical evidence, particularly for cancer treatments with clinical trial data.

This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan terms. For personalized guidance, consult with your healthcare provider and insurance plan directly.

Need help navigating the appeals process? Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by identifying denial patterns and crafting evidence-backed responses aligned with payer-specific requirements.

Sources & Further Reading

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