By Counterforce Health Team in Darzalex / Darzalex Faspro (daratumumab) —

How to Get Darzalex Covered by Blue Cross Blue Shield in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Darzalex Approved by Blue Cross Blue Shield in New York

Darzalex requires prior authorization from all Blue Cross Blue Shield plans in New York. Submit your PA request using plan-specific forms with complete documentation: multiple myeloma diagnosis (ICD-10 C90.0), prior therapy failures, and medical necessity justification. If denied, New York offers expedited 72-hour appeals for oncology drugs and external review through the Department of Financial Services. First step today: Contact your BCBS plan to obtain their current PA form and submission requirements.

Table of Contents

  1. Coverage Requirements Overview
  2. Prior Authorization Process
  3. Required Documentation and Coding
  4. Common Denial Reasons and Solutions
  5. Appeals Process in New York
  6. Cost Support Options
  7. When to Escalate
  8. FAQ

Coverage Requirements Overview

Blue Cross Blue Shield plans in New York—including Anthem, Highmark BCBS WNY, Empire BCBS HealthPlus, and Excellus—require prior authorization for Darzalex due to its specialty drug classification and high cost (typically several thousand dollars per dose).

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Must be approved before treatment starts Plan-specific PA forms 24-72 hours
Age Requirement Patient must be 18+ (unless pediatric indication) Clinical criteria documents N/A
Diagnosis Documentation Multiple myeloma or AL amyloidosis with ICD-10 codes Medical records, pathology reports Submit with PA
Prior Therapy Requirements Documentation of failed/contraindicated alternatives Treatment history, physician notes Submit with PA
Site of Care Office/outpatient infusion center approval Facility credentialing Varies

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Identify Your Specific BCBS Plan (Patient/Clinic)
    • Check your insurance card for the exact plan name
    • Different NY BCBS plans have different forms and requirements
    • Expected timeline: 5 minutes
  2. Obtain the Correct PA Form (Clinic Staff)
  3. Gather Required Documentation (Clinic)
    • Complete medical records with diagnosis confirmation
    • Prior therapy documentation and failure/intolerance reasons
    • Current labs and staging information
    • Expected timeline: 30-60 minutes
  4. Complete PA Form Thoroughly (Prescriber)
    • Include all required fields: patient demographics, diagnosis codes, drug details
    • Attach medical necessity letter
    • Sign and date all required sections
    • Expected timeline: 20-30 minutes
  5. Submit via Correct Channel (Clinic Staff)
    • Fax to plan-specific number or submit through online portal
    • Include all supporting documentation
    • Keep confirmation receipt
    • Expected timeline: 5 minutes
  6. Request 72-Hour Emergency Supply (Pharmacy)
    • Most NY BCBS plans allow emergency supply while PA is pending
    • Contact plan's pharmacy services line
    • Expected timeline: Same day
  7. Follow Up Within 24-48 Hours (Clinic)
    • Call plan to confirm receipt and processing status
    • Be prepared to provide additional information if requested
    • Expected timeline: 10 minutes

Required Documentation and Coding

Medical Coding Essentials

ICD-10 Diagnosis Codes:

  • C90.00 - Multiple myeloma, unspecified
  • C90.01 - Multiple myeloma in remission
  • C90.02 - Multiple myeloma in relapse
  • E85.81 - Light chain (AL) amyloidosis (when applicable)

HCPCS/J-Codes for Billing:

  • J9145 - Injection, daratumumab, 10 mg (Darzalex IV)
  • J9144 - Injection, daratumumab, 10 mg and hyaluronidase-fihj (Darzalex Faspro SC)
Tip: One unit equals 10 mg. For a 1,800 mg Darzalex Faspro dose, bill 180 units.

Medical Necessity Documentation

Your physician's letter should include:

  • Confirmed multiple myeloma diagnosis with staging
  • Prior therapies attempted and reasons for failure/discontinuation
  • Contraindications to alternative treatments
  • Clinical rationale for Darzalex based on NCCN Guidelines
  • Planned dosing schedule and monitoring plan

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Lack of medical necessity Submit detailed physician letter with clinical rationale Treatment history, disease progression notes, NCCN guideline references
Step therapy not completed Document contraindications or failures of preferred agents Adverse reaction reports, inefficacy documentation
Missing prior authorization Resubmit with complete PA form All required forms and supporting documents
Off-label use concerns Provide evidence-based justification Peer-reviewed studies, FDA labeling, specialty guidelines
Site of care restrictions Request exception for office-based administration Facility accreditation, safety protocols
From our advocates: We've seen denials overturned when physicians clearly document why standard multiple myeloma treatments like lenalidomide or bortezomib weren't suitable—whether due to prior failure, intolerance, or specific contraindications. The key is being specific about what was tried and exactly why it didn't work.

Appeals Process in New York

Internal Appeals Timeline

Standard Appeal:

  • Filing deadline: 180 days from denial notice
  • Decision timeline: 30 days
  • Submission: Use same forms and channels as original PA

Expedited Appeal (for urgent cases):

  • Filing deadline: Immediately upon denial
  • Decision timeline: 72 hours
  • Required: Physician attestation of medical urgency

Peer-to-Peer Review Strategy

Request a peer-to-peer review where your oncologist speaks directly with the insurance medical director:

Preparation checklist:

  • Have patient chart and recent imaging available
  • Prepare 3-5 key clinical points supporting medical necessity
  • Reference specific NCCN guideline recommendations
  • Document the conversation outcome in patient record

External Review Process

If your internal appeal is denied, New York offers robust external review rights:

New York External Appeal Process:

  • Filing deadline: 4 months after final internal denial
  • Cost: Free (or $25 maximum, waived for financial hardship)
  • Decision timeline: 30 days standard, 72 hours expedited
  • Submit to: New York Department of Financial Services
  • Overturn rate: Approximately 50% for oncology cases

Required documents for external appeal:

  • Copy of internal appeal denial
  • All medical records supporting your case
  • Physician statement of medical necessity
  • Relevant medical literature or guidelines

Cost Support Options

Manufacturer Support Programs

Johnson & Johnson offers patient assistance for eligible patients, including:

  • Copay assistance programs for commercially insured patients
  • Patient assistance programs for uninsured/underinsured patients
  • Reimbursement support and appeals assistance

Additional Financial Resources

State and Federal Programs:

  • New York State of Health marketplace plans with premium tax credits
  • Medicaid expansion coverage for income-eligible adults
  • Medicare Part B coverage for those 65+ or disabled

Non-Profit Assistance:

When to Escalate

Contact these resources if standard appeals aren't successful:

New York Department of Financial Services:

Community Health Advocates:

  • Free insurance counseling and appeals assistance
  • Helpline: (888) 614-5400
  • Serves all New York residents regardless of insurance type

Legal Support:

FAQ

How long does Blue Cross Blue Shield PA take in New York? Most BCBS plans in New York process standard prior authorizations within 24-72 hours. Expedited reviews for urgent cases are completed within 24 hours.

What if Darzalex isn't on my formulary? Request a formulary exception by demonstrating medical necessity and providing evidence that preferred alternatives are inappropriate for your specific case.

Can I get an expedited appeal for Darzalex? Yes. New York law requires expedited appeals (72-hour decision) for oncology drugs when delay could jeopardize your health. Your physician must attest to the medical urgency.

Does step therapy apply if I'm treatment-naive? Many BCBS plans require trying preferred agents first unless contraindicated. Document any medical reasons why standard treatments aren't appropriate.

What happens if both internal and external appeals are denied? You can file a complaint with the New York Department of Financial Services and consider legal consultation. Some patients also qualify for manufacturer assistance programs.

How much does Darzalex cost without insurance? Cash prices typically range from $3,000-$7,000 per dose depending on the formulation and dose required. Counterforce Health can help navigate insurance approval processes to avoid these out-of-pocket costs.

Can I switch BCBS plans during open enrollment for better coverage? Yes, but pre-existing condition exclusions are prohibited under the ACA. Compare formularies and prior authorization requirements during open enrollment periods.

Sources & Further Reading

Counterforce Health transforms insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals. Our platform identifies denial basis and pulls the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—while tracking deadlines and procedural requirements to help patients, clinicians, and pharmacies get prescription drugs approved. Learn more about our services.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult with your healthcare provider for medical decisions. For personalized insurance assistance, contact Community Health Advocates at (888) 614-5400.

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