By Counterforce Health Team in Keytruda (pembrolizumab) —

How to Get Keytruda (Pembrolizumab) Covered by Humana in New York: Complete PA Guide and Appeal Scripts

Answer Box: Getting Keytruda (Pembrolizumab) Covered by Humana in New York

Humana Medicare Advantage plans require prior authorization (PA) for Keytruda, covering it as a Part B medical benefit at 80% after deductible. You'll need FDA-approved biomarker testing (PD-L1, MSI-H, or TMB-H), staging documentation, and medical necessity letters. Start by having your oncologist submit PA via Humana's provider portal—85% of requests are approved within one business day. If denied, you have 65 days to appeal internally, then can escalate to New York's external review system through the Department of Financial Services.

Table of Contents

  1. Humana's Coverage Policy for Keytruda
  2. FDA Indication and Biomarker Requirements
  3. Step Therapy and Medical Exceptions
  4. Prior Authorization Documentation Checklist
  5. Site of Care and Infusion Requirements
  6. Medical Necessity Letter Guidelines
  7. Appeals Process in New York
  8. Cost Coverage and Patient Support
  9. FAQ

Humana's Coverage Policy for Keytruda

Humana Medicare Advantage plans list Keytruda (pembrolizumab) as a preferred drug on their 2025 formulary with prior authorization requirements. As an IV infusion therapy, Keytruda falls under Medicare Part B coverage—not Part D prescription benefits.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all indications Humana PA List 2025
Formulary Status Preferred (Tier 1-2) MyHumana portal
Part B Coverage 80% after $257 deductible (2025) CMS Part B benefits
Patient Coinsurance 20% (~$1,300-$2,100 per dose) Varies by plan
Reauthorization Every 6-12 months Policy effective through 8/20/2025

Cost Reality Check: At approximately $23,591 per dose, your 20% coinsurance could reach $4,700+ per treatment without supplemental coverage. Many Humana Medicare Advantage plans cap annual out-of-pocket costs, providing significant protection.

FDA Indication and Biomarker Requirements

Keytruda's approval hinges on specific biomarkers that must be documented in your medical record before treatment begins. Missing or inadequate testing is the #1 reason for denials.

Required Biomarker Testing

For Non-Small Cell Lung Cancer (NSCLC):

  • PD-L1 TPS ≥50%: First-line monotherapy (no EGFR/ALK/ROS1 mutations)
  • PD-L1 TPS ≥1%: Post-platinum therapy or combination treatment
  • Must exclude: EGFR, ALK, ROS1 mutations (targeted therapy required first)

For Other Solid Tumors:

  • MSI-H/dMMR: Universal eligibility for metastatic disease
  • TMB-H ≥10 mutations/Mb: Advanced tumors after prior therapy
  • PD-L1 CPS ≥1: Cervical, gastroesophageal junction cancers
Tip: Order biomarker testing immediately upon diagnosis. FDA-approved assays are required—not laboratory-developed tests.

Step Therapy and Medical Exceptions

Humana's 2026 Part B step therapy list may require trying alternative immunotherapies before Keytruda approval, particularly for NSCLC where Libtayo (cemiplimab) might be preferred first-line.

Medical Exception Pathways

Automatic Exceptions:

  • Contraindication to preferred drug
  • Previous intolerance with documented adverse events
  • Drug interaction with current medications
  • Clinical superiority for your specific tumor type

Documentation for Exceptions:

  • Prior therapy failure records
  • Allergy/intolerance documentation
  • Oncologist letter citing medical rationale
  • Supporting literature (NCCN guidelines, clinical trials)

Prior Authorization Documentation Checklist

Your oncologist needs comprehensive documentation to secure approval. Missing elements cause delays or denials.

Essential Documents

Clinical Information:

  • Pathology report with ICD-10 diagnosis codes
  • TNM/AJCC staging documentation
  • Biomarker test results (PD-L1/MSI-H/TMB-H)
  • Performance status assessment (ECOG 0-2)
  • Treatment history and prior therapy failures

Administrative Requirements:

  • Prescriber NPI and contact information
  • Planned dosing regimen (200mg q3w or 400mg q6w)
  • Estimated treatment duration
  • Site of care specifications
From our advocates: "We've seen Keytruda approvals delayed by weeks simply because the biomarker report didn't specify the FDA-approved assay used. Always request the lab include the specific test name and methodology in their report."

Site of Care and Infusion Requirements

Keytruda must be administered in qualified outpatient settings by licensed healthcare professionals. Humana follows CMS Part B guidelines without additional site-of-care restrictions specific to New York.

Approved Administration Sites:

  • Hospital outpatient infusion centers
  • Oncology clinic infusion suites
  • Physician office-based infusion
  • Ambulatory surgery centers with infusion capability

HCPCS Billing Code: J9271 (injection, pembrolizumab, 1 mg)

Medical Necessity Letter Guidelines

A compelling medical necessity letter addresses Humana's specific coverage criteria while building a clinical case for Keytruda.

Letter Structure Template

Opening: State patient diagnosis, stage, and FDA-approved indication for Keytruda.

Biomarker Documentation: "Tumor testing confirms [PD-L1 TPS X%/MSI-H/TMB-H ≥10 mut/Mb] via [specific FDA-approved assay], meeting FDA criteria for pembrolizumab."

Treatment Rationale: Reference NCCN Category 2A guidelines and cite specific clinical trials (KEYNOTE studies) supporting use.

Prior Therapy: Document previous treatments, response, and reasons for discontinuation or progression.

Urgency: If applicable, note disease progression or limited alternative options requiring expedited review.

Monitoring Plan: Outline safety monitoring and response assessment schedule.

Appeals Process in New York

New York offers robust patient protections through a two-tier appeal system with external review options.

Internal Appeals with Humana

Timeline: 65 days from denial notice Standard Review: Up to 30 days for decision
Expedited Review: 72 hours for urgent medical needs

Submit via:

New York External Review

If Humana upholds the denial, escalate to the New York Department of Financial Services within 4 months.

External Review Process:

  • Filing Fee: $25 (waived for Medicaid/financial hardship)
  • Timeline: 30 days standard, 72 hours expedited
  • Decision: Binding on Humana
  • Success Rate: External reviews frequently overturn cancer drug denials with proper documentation

Required Documents:

  • Humana's final denial letter
  • Medical records and biomarker testing
  • Physician attestation of medical necessity
  • Supporting literature (NCCN guidelines, clinical studies)
Note: Community Health Advocates at 888-614-5400 provides free assistance with New York insurance appeals.

Cost Coverage and Patient Support

Beyond insurance coverage, several programs can reduce your out-of-pocket costs for Keytruda.

Financial Assistance Options

Merck Patient Assistance:

  • KEYTRUDA Bridge Program: Free drug during appeals/delays
  • Income-based eligibility for uninsured/underinsured patients

Medicare Coverage:

  • Part B: 80% coverage after $257 deductible
  • Medigap: May cover 20% coinsurance
  • Medicaid Dual: Potential $0-$8 copay

State Resources:

  • New York's Essential Plan: Low-cost coverage for income-eligible residents
  • Hospital charity care programs

FAQ

How long does Humana prior authorization take for Keytruda in New York? Humana processes 85% of requests within one business day, with standard reviews taking up to 14 days and expedited reviews completed in 72 hours for urgent cancer cases.

What if my biomarker testing doesn't meet Humana's requirements? Request repeat testing with FDA-approved assays. For tumors with low biopsy yield, document medical necessity for treatment based on available tissue and clinical presentation.

Can I appeal if Keytruda is non-formulary on my Humana plan? Yes, request a formulary exception through your prescriber. Document medical necessity and lack of suitable formulary alternatives.

Does step therapy apply if I've tried other immunotherapies outside New York? Medical records from any state count toward step therapy requirements. Provide documentation of prior treatments and outcomes.

How do I request expedited review for urgent cancer progression? Have your oncologist submit expedited PA with documentation of disease progression, limited treatment options, and health risk from delay.

What's the difference between Humana's internal appeal and New York's external review? Internal appeals are reviewed by Humana staff, while external reviews use independent medical experts appointed by New York DFS. External decisions are binding on Humana.

Getting the right insurance coverage for cancer treatment shouldn't add stress to an already challenging time. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements, pulling the right medical citations and weaving them into appeals that meet procedural requirements while tracking deadlines.

For complex cases requiring additional support, Counterforce Health provides specialized expertise in payer-specific workflows and produces letters that meet coverage determination requirements, helping reduce the back-and-forth between patients, providers, and insurance companies.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical advice. Coverage policies vary by plan and change over time. Always verify current requirements with Humana member services and consult your healthcare team for medical decisions. For official New York insurance regulations and appeal rights, visit the NY Department of Financial Services.

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