By Counterforce Health Team in Kymriah (tisagenlecleucel) —

Getting Kymriah (tisagenlecleucel) Covered by Blue Cross Blue Shield in New York: Prior Authorization, Appeals, and Cost Relief

Answer Box: Your Path to Kymriah Coverage in New York

Blue Cross Blue Shield (BCBS) in New York requires prior authorization for Kymriah (tisagenlecleucel) in 2024. To get coverage, your doctor must submit clinical documentation showing FDA-approved indication, prior treatment failures, and CD19 positivity. If denied, you have 45 days to file an external appeal through NY Department of Financial Services, which has binding authority. First step today: Call the number on your insurance card to verify your specific plan's requirements and start the prior authorization process with your treatment team.

Table of Contents

Understanding Blue Cross Blue Shield Coverage Requirements

Kymriah (tisagenlecleucel) is a groundbreaking CAR-T cell therapy that requires your own immune cells to be collected, genetically modified, and reinfused. With a list price around $373,000-$475,000, Blue Cross Blue Shield plans in New York have established specific coverage criteria to ensure appropriate use.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before treatment BCBS provider portal or member services BCBS NY Policy
FDA-Approved Indication B-cell ALL (≤25 years) or DLBCL/FL adults Treatment center verification FDA Label
Certified Treatment Center Must receive care at REMS-certified facility Hospital CAR-T program FDA REMS Program
CD19 Positivity Tumor must express CD19 target Pathology report required Medical records
Prior Therapy Documentation Evidence of treatment failure/intolerance Clinical notes and imaging Treatment history

Blue Cross Blue Shield plans in New York typically cover Kymriah under the medical benefit (not pharmacy benefit) since it's administered by healthcare professionals. The therapy requires coordination between your oncologist, the CAR-T center, and BCBS's utilization management team.

Step-by-Step: Fastest Path to Approval

1. Verify Your Coverage and Benefits

Who does it: You or your care team
What's needed: Insurance card, member ID
How to submit: Call member services number on your card
Timeline: Same day
Action: Confirm your plan covers Kymriah and understand your cost-sharing (deductible, coinsurance, out-of-pocket maximum).

2. Get Referred to a Certified CAR-T Center

Who does it: Your oncologist
What's needed: Clinical evaluation and referral
How to submit: Direct physician referral
Timeline: 1-2 weeks for consultation
Action: Only REMS-certified centers can administer Kymriah. Your current oncologist may need to coordinate with a specialized center.

3. Complete Pre-Authorization Submission

Who does it: CAR-T center or your oncologist
What's needed: Complete clinical documentation package
How to submit: Electronic prior authorization (ePA) preferred via Surescripts or CoverMyMeds
Timeline: Submit 7-14 days before planned treatment
Action: Ensure all required documentation is included to avoid delays.

4. Await Initial Determination

Who does it: BCBS utilization management
What's needed: Review of submitted materials
Timeline: 72 hours for standard review, 24 hours for urgent
Action: Your treatment team will be notified of approval or denial.

5. If Approved: Coordinate Treatment

Who does it: CAR-T center and BCBS specialty pharmacy network
What's needed: Treatment scheduling and drug delivery coordination
Timeline: 2-6 weeks for cell collection, manufacturing, and infusion
Action: Work with your treatment team to schedule the multi-step process.

6. If Denied: File Internal Appeal Immediately

Who does it: You or your treatment team
What's needed: Appeal form and additional clinical evidence
How to submit: BCBS appeals department (phone, fax, or portal)
Timeline: File within 180 days of denial
Action: Don't wait—appeal deadlines are strict in New York.

7. If Still Denied: File External Appeal with New York State

Who does it: You (patient)
What's needed: External appeal form and supporting documents
How to submit: NY Department of Financial Services
Timeline: File within 45 days of final internal denial
Action: This is your binding, independent review opportunity.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Not medically necessary" Provide evidence of relapsed/refractory disease Recent imaging, lab results, treatment failure documentation
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA approval letter, NCCN guidelines, peer-reviewed studies
"Not at certified center" Transfer to REMS-certified facility Referral to qualified CAR-T center
"CD19 status unknown" Submit pathology confirmation Flow cytometry or immunohistochemistry report
"Insufficient prior therapy" Document treatment failures or contraindications Detailed treatment history, adverse event records
"Missing conditioning regimen plan" Provide complete treatment protocol Lymphodepletion chemotherapy plan from CAR-T center
From our advocates: We've seen patients initially denied for "insufficient documentation" get approved within days after their CAR-T center submitted a comprehensive treatment timeline showing two prior failed therapies and current disease progression. The key was including specific dates, drug names, and measurable disease response data rather than general statements about treatment failure.

Appeals Playbook for New York

New York offers some of the strongest patient protection laws in the country for insurance appeals. Here's your roadmap:

Internal Appeals (Required First Step)

  • Timeline: 180 days to file from denial date
  • Standard review: 30 days for decision
  • Expedited review: 72 hours if urgent (24 hours for urgent drug requests)
  • How to file: Contact BCBS appeals department using number on your ID card
  • Required: Appeal form, medical records, physician letter supporting medical necessity

External Appeals (New York State)

After receiving a "final adverse determination" from BCBS, you can request an independent review through the New York Department of Financial Services.

Key advantages of New York's system:

  • Binding decision on your insurer
  • Independent medical experts review your case
  • Expedited process available (3 days for urgent cases)
  • Low cost ($25 maximum, waived for financial hardship)
  • High success rates for cancer therapies with strong clinical support

To file an external appeal:

  1. Download the external appeal form from NY DFS website
  2. Include all medical records and physician support letters
  3. Submit within 45 days of final internal denial
  4. Request expedited review if treatment is urgent

Contact for external appeals: New York Department of Financial Services, Consumer Protection Division

Costs & Financial Assistance Options

Kymriah's high cost means even insured patients may face significant out-of-pocket expenses. Here are your options for financial relief:

For Patients with Commercial Insurance

Kymriah Cares Copay Assistance Program

  • Eligible patients pay as little as $25 per month
  • Novartis covers up to $15,000 per calendar year
  • Eligibility: US residents with private (non-government) insurance
  • How to apply: Call 1-844-459-6742 or enroll through your treatment center
  • Not eligible: Medicare, Medicaid, or other government insurance beneficiaries

Additional Financial Support

Novartis Patient Assistance Foundation

  • For uninsured or underinsured patients
  • May provide medication at no cost for qualifying patients
  • Apply at pap.novartis.com

Hospital Financial Assistance

  • Most CAR-T centers offer charity care programs
  • May cover facility fees, physician services, and supportive care
  • Ask your treatment center's financial counselor about options

State and Federal Programs

  • New York State of Health marketplace plans
  • Medicaid expansion coverage in New York
  • Medicare coverage for eligible patients

Counterforce Health helps patients navigate complex prior authorization and appeals processes for specialty medications like Kymriah. Their platform can help identify specific denial reasons and draft targeted appeals using evidence-based arguments aligned with your insurer's own policies.

Scripts for Key Conversations

Calling Blue Cross Blue Shield Member Services

"Hi, I'm calling about prior authorization requirements for Kymriah, which is tisagenlecleucel. My member ID is [number]. Can you tell me:

  • Does my plan cover this medication?
  • What's my cost-sharing responsibility?
  • What prior authorization forms does my doctor need to submit?
  • How long does the review process typically take?
  • Can you email me the specific medical policy for CAR-T therapies?"

Requesting Expedited Review

"My doctor has determined that Kymriah is medically urgent for my condition. I'm requesting an expedited prior authorization review. Can you please:

  • Flag this as urgent/expedited
  • Confirm the 24-hour timeline for urgent drug reviews
  • Provide the direct fax number for urgent submissions
  • Give me a confirmation number for this expedited request"

Peer-to-Peer Review Request (for providers)

"I'm requesting a peer-to-peer review for my patient who needs Kymriah for relapsed DLBCL. The patient has failed two prior lines of therapy and meets all FDA criteria. When can I schedule a call with your medical director to discuss the clinical rationale?"

When to Escalate Beyond Your Insurer

If you've exhausted internal appeals and need additional support, New York offers several escalation options:

New York Department of Financial Services

  • File complaints about insurance practices
  • Request external appeals for coverage denials
  • Consumer hotline: 1-800-342-3736

Community Health Advocates (CHA)

  • Free insurance counseling for New Yorkers
  • Helpline: 888-614-5400
  • Can assist with filing appeals and understanding your rights

Legal Resources

  • Consider consulting a healthcare attorney for high-value denials
  • Some attorneys work on contingency for insurance bad faith cases
  • Document all communications with your insurer

Congressional Representatives

  • Contact your federal representatives for Medicare/federal program issues
  • State legislators for insurance regulation concerns

Frequently Asked Questions

How long does Blue Cross Blue Shield prior authorization take in New York? Standard reviews take up to 72 hours, while expedited/urgent reviews are completed within 24 hours. Submit complete documentation to avoid delays.

What if Kymriah is not on my Blue Cross Blue Shield formulary? Since Kymriah is typically covered under the medical benefit (not pharmacy benefit), formulary status may not apply. However, you can request a formulary exception if needed, requiring physician documentation that no covered alternatives would be effective.

Can I request an expedited appeal in New York? Yes, both internal appeals with BCBS and external appeals through NY Department of Financial Services offer expedited processes for urgent medical situations. Decisions can be made within 24-72 hours.

Does step therapy apply to Kymriah? BCBS typically requires documentation of prior therapy failures rather than mandating specific step therapy protocols, since Kymriah is indicated for relapsed/refractory disease after standard treatments have failed.

What happens if I move during treatment? Notify BCBS immediately about address changes. If you move to another state, coverage may transfer to that state's Blue Cross Blue Shield plan, but policies and networks may differ.

Can I get Kymriah at any hospital? No, Kymriah must be administered at FDA REMS-certified centers with specialized CAR-T programs. Your BCBS plan should cover treatment at in-network certified facilities.

How much will I pay out-of-pocket? Your cost depends on your specific plan's deductible, coinsurance, and out-of-pocket maximum. Many patients reach their annual out-of-pocket limit with high-cost therapies like Kymriah. Contact member services for your exact cost-sharing details.

What if my external appeal is denied in New York? External appeal decisions are binding and final. Limited options include administrative review for procedural errors or legal action in rare cases of insurer bad faith.

This guide provides general information and should not replace personalized medical or legal advice. Coverage policies and requirements may vary by specific Blue Cross Blue Shield plan and can change over time. Always verify current requirements with your insurer and treatment team.

For additional support navigating insurance approvals for specialty medications, Counterforce Health offers tools and expertise to help patients and providers build stronger prior authorization requests and appeals.

Sources & Further Reading

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