By Counterforce Health Team in Tecentriq (atezolizumab) —

Blue Cross Blue Shield North Carolina Coverage Criteria for Tecentriq (Atezolizumab): Complete Prior Authorization Guide

Answer Box: Getting Tecentriq Covered by BCBS North Carolina

Tecentriq (atezolizumab) requires prior authorization from Blue Cross Blue Shield of North Carolina for all plan types. To get approved: (1) Submit PA request with FDA-approved indication, clinical notes, and required biomarker testing (PD-L1 for NSCLC), (2) Document any prior therapy failures or contraindications, and (3) Use BCBS NC's specialty pharmacy network. If denied, you have 65 days for internal appeal, then 120 days for external review through North Carolina's Smart NC program. Start with your prescriber gathering complete clinical documentation today.

Table of Contents

  1. Policy Overview: BCBS North Carolina Plan Types
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Quantity Limits & Renewal Requirements
  5. Required Diagnostics & Testing
  6. Specialty Pharmacy & Site of Care Rules
  7. Evidence for Medical Necessity
  8. Sample Medical Necessity Letter
  9. Common Denial Reasons & Solutions
  10. Appeals Process in North Carolina
  11. Cost Support Options
  12. Frequently Asked Questions

Policy Overview: BCBS North Carolina Plan Types

Blue Cross Blue Shield of North Carolina classifies Tecentriq (atezolizumab) as a specialty medication requiring prior authorization across all plan types—Individual marketplace, Fully Insured commercial, Medicare Advantage, and State Health Plan members.

Coverage varies by plan structure:

  • HMO plans: Stricter network requirements; must use designated specialty pharmacies
  • PPO plans: More flexibility but still require PA approval
  • Medicare Advantage: Additional CMS requirements may apply
  • State Health Plan: Separate criteria document available through BCBS NC provider portal

All BCBS NC plans follow utilization management protocols that prioritize lower-cost sites of care when medically appropriate. This means Tecentriq infusions may need to occur at preferred outpatient centers rather than hospital-based facilities unless medically contraindicated.

Note: Self-funded employer plans may have different criteria. Check your specific plan documents or contact member services to confirm coverage rules.

FDA Indication Requirements

Tecentriq coverage aligns with FDA-approved indications and recognized compendia uses. BCBS North Carolina typically covers these approved uses:

Covered Indications

  • Non-small cell lung cancer (NSCLC): Adjuvant after surgery (stage II-III) and metastatic disease
  • Extensive-stage small cell lung cancer (ES-SCLC): In combination with chemotherapy
  • Hepatocellular carcinoma (HCC): With bevacizumab for unresectable/metastatic disease
  • Urothelial carcinoma: Various settings per FDA labeling

Documentation Required

  • ICD-10 diagnosis codes matching approved indications
  • Pathology reports confirming cancer type and staging
  • Clinical notes supporting medical necessity
  • Treatment history showing indication-specific requirements met

Off-label uses require additional clinical justification and may face higher denial rates. Consider consulting Counterforce Health for assistance with complex off-label authorization requests, as their platform specializes in turning insurance denials into evidence-backed appeals.

Step Therapy & Medical Exceptions

BCBS North Carolina implements step therapy protocols that vary by cancer type and line of treatment:

NSCLC Step Therapy Requirements

Line of Therapy Required Prior Treatments Exceptions
First-line (advanced/metastatic) Usually requires platinum-based chemotherapy failure PD-L1 ≥50% as monotherapy; negative ALK/EGFR mutations
Adjuvant (post-surgery) No step therapy required Must document complete resection
Second-line Must document platinum chemotherapy progression Medical contraindications to platinum agents

HCC & Other Indications

  • HCC: No step therapy for first-line use with bevacizumab
  • ES-SCLC: Must be used in combination with approved chemotherapy regimens

Medical Exception Pathways

Document these circumstances to bypass step therapy:

  • Contraindications to required prior therapies
  • Previous intolerance with specific adverse events noted
  • Urgent clinical need with supporting documentation
  • Previous failure outside the BCBS NC network (requires records transfer)

Quantity Limits & Renewal Requirements

BCBS North Carolina applies quantity limits based on FDA-approved dosing:

Standard Dosing Limits

  • 840 mg every 2 weeks (most common)
  • 1200 mg every 3 weeks
  • 1680 mg every 4 weeks

Renewal Process

  • Initial approval: Typically 3-6 months
  • Reauthorization required: Every 6-12 months with updated clinical documentation
  • Response assessment: Must demonstrate stable disease or improvement
  • Continuation criteria: Ongoing medical necessity and tolerability

Documentation for renewal:

  • Recent imaging showing disease status
  • Clinical notes documenting tolerance and response
  • Updated performance status assessment

Required Diagnostics & Testing

NSCLC-Specific Requirements

PD-L1 testing is mandatory for NSCLC indications:

  • Use FDA-approved immunohistochemistry assay
  • Report tumor proportion score (TPS) as percentage
  • Include pathology report with PA submission
  • Testing must be performed at certified laboratory

Biomarker Testing Requirements

  • ALK/EGFR mutation status (NSCLC first-line)
  • Microsatellite instability (MSI) if clinically indicated
  • Tumor mutation burden may be requested for certain indications

Laboratory Monitoring

Submit baseline values with initial PA request:

  • Complete blood count
  • Comprehensive metabolic panel
  • Liver function tests
  • Thyroid function (baseline)

Specialty Pharmacy & Site of Care Rules

Mandatory Specialty Pharmacy Network

BCBS North Carolina requires Tecentriq dispensing through approved specialty pharmacies:

  • Must verify network participation before prescribing
  • Patient cannot use out-of-network specialty pharmacies
  • Prescriptions automatically routed to designated providers

Site of Care Requirements

Preferred administration sites to control costs:

  • Hospital-affiliated outpatient infusion centers
  • Freestanding infusion centers
  • Physician office-based infusion (if equipped)

Higher-cost sites require additional justification:

  • Inpatient hospital administration
  • Emergency department infusion
  • Home infusion services

Network Verification

  • Use BCBS NC provider portal to confirm network status
  • Verify both specialty pharmacy and infusion site participation
  • Document medical necessity if non-preferred site required

Evidence for Medical Necessity

Required Clinical Documentation

Primary evidence sources:

  • FDA prescribing information for approved indications
  • NCCN Guidelines for cancer treatment recommendations
  • Peer-reviewed literature supporting use in specific clinical scenarios
  • Drug compendia (e.g., Micromedex, Lexicomp) for off-label uses

Structured Documentation Approach

  1. Clinical presentation: Diagnosis, staging, performance status
  2. Treatment history: Prior therapies, responses, toxicities
  3. Rationale: Why Tecentriq is appropriate choice
  4. Monitoring plan: Response assessment and safety monitoring
  5. Treatment goals: Expected outcomes and duration
Tip: Cite specific guideline recommendations and include page numbers or section references when possible. This strengthens the medical necessity argument significantly.

Sample Medical Necessity Letter

Template Structure for Prescribers

Patient: [Name, DOB, Member ID]
Diagnosis: [ICD-10 code and description]
Requested medication: Tecentriq (atezolizumab) [dose and frequency]

Clinical presentation: This [age]-year-old patient presents with [specific cancer type and stage] diagnosed on [date]. Current performance status is [ECOG score]. Disease characteristics include [relevant pathology findings, biomarkers].

Prior treatment history: Patient has received [list prior therapies] with [outcomes - progression, intolerance, contraindications]. [Specific dates and response durations].

Medical necessity rationale: Tecentriq is indicated for [FDA-approved indication] based on [cite specific FDA labeling section]. Patient meets criteria including [list relevant criteria from BCBS policy]. Treatment aligns with NCCN Guidelines recommendation [cite specific page/category].

Treatment plan: Tecentriq [dose] every [frequency] with monitoring including [specific assessments]. Expected treatment duration [timeframe] with response evaluation every [interval].

Clinical references:

  1. FDA prescribing information for Tecentriq
  2. NCCN Clinical Practice Guidelines in Oncology
  3. [Additional peer-reviewed citations as appropriate]

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing PD-L1 testing Submit pathology report with TPS score FDA-approved IHC assay results
Insufficient prior therapy Document previous treatments and outcomes Treatment records, progression imaging
Non-preferred site of care Justify medical necessity for location Clinical notes supporting site choice
Off-label indication Provide compendia or literature support Peer-reviewed evidence, guidelines
Missing biomarker testing Complete required mutation analysis ALK/EGFR results for NSCLC

Quick Fixes for Common Issues

  • "Not medically necessary": Strengthen clinical rationale with specific guideline citations
  • "Experimental/investigational": Confirm FDA-approved indication and provide labeling reference
  • "Step therapy not met": Document contraindications or previous failures with specific details

Appeals Process in North Carolina

Internal Appeals (BCBS North Carolina)

Timeline: 65 days from denial notice
Process: Submit through member portal or written request
Required documents:

  • Original denial letter
  • Additional clinical documentation
  • Updated medical necessity letter
  • Supporting literature/guidelines

External Review (Smart NC)

Timeline: 120 days after final internal denial
Contact: Smart NC at 1-855-408-1212
Process:

  1. Complete external review request form
  2. Submit clinical records and denial letters
  3. Independent Review Organization (IRO) evaluation
  4. Decision within 45 days (expedited: 72 hours)

Success factors for external review:

  • Strong clinical documentation
  • Clear FDA indication alignment
  • Comprehensive treatment history
  • Relevant guideline support
From our advocates: We've seen external reviews succeed when families organize all medical records chronologically and highlight specific guideline recommendations that support the treatment. The IRO reviewers appreciate clear, well-documented cases that directly address the original denial reasons.

Expedited Appeals

Available for urgent clinical situations:

  • Life-threatening conditions
  • Severe symptom management needs
  • Risk of permanent impairment

Timeline: 72 hours for expedited external review

Organizations like Counterforce Health can help families navigate complex appeals by analyzing denial letters and crafting targeted, evidence-backed responses that address specific payer criteria.

Cost Support Options

Manufacturer Programs

Genentech Access Solutions:

  • Copay assistance for eligible patients
  • Free drug programs for uninsured/underinsured
  • Prior authorization support services
  • Appeals assistance and documentation

Foundation Support

  • Patient Access Network Foundation
  • HealthWell Foundation
  • CancerCare Financial Assistance

Eligibility typically requires:

  • Diagnosis confirmation
  • Insurance coverage (for copay programs)
  • Income documentation
  • US residency

State Programs

North Carolina offers additional support through:

  • Medicaid expansion (effective 2024)
  • North Carolina Health Insurance Pool (for high-risk patients)
  • Hospital charity care programs

Frequently Asked Questions

Q: How long does BCBS North Carolina prior authorization take?
A: Standard PA decisions are issued within 14 days. Expedited requests (urgent medical need) are processed within 72 hours.

Q: What if Tecentriq isn't on my formulary?
A: Request a formulary exception with medical necessity documentation. Non-formulary drugs often require step therapy completion or medical contraindications to preferred alternatives.

Q: Can I request an expedited appeal in North Carolina?
A: Yes, for urgent situations where delays could jeopardize health. Both internal (BCBS) and external (Smart NC) expedited processes are available with 72-hour decision timelines.

Q: Does step therapy apply if I failed treatments outside North Carolina?
A: Yes, but you must provide documentation of previous treatments and outcomes. Transfer medical records to your current provider for PA submission.

Q: What counts as "medical necessity" for Tecentriq?
A: FDA-approved indication, appropriate clinical scenario, documented need based on diagnosis and staging, and alignment with recognized treatment guidelines.

Q: How do I find BCBS North Carolina's current PA forms?
A: Access the provider portal at bluecrossnc.com or contact provider services. Forms are updated regularly and vary by plan type.

Q: What if my doctor isn't familiar with the PA process?
A: Share this guide with your healthcare team. Many practices also work with prior authorization specialists or services like Counterforce Health to streamline complex approvals.

Q: Can I appeal to the state if external review fails?
A: External review decisions are binding for medical necessity determinations. However, you may file complaints about process violations with the North Carolina Department of Insurance.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses. Their platform identifies specific denial reasons and drafts point-by-point rebuttals aligned with each payer's criteria, significantly improving approval rates for complex medications like Tecentriq.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, specific plan terms, and current policies. Always consult with healthcare providers and insurance representatives for personalized guidance. Coverage criteria and appeal processes may change; verify current requirements with official sources.

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