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

How to Get Darzalex Covered by Humana in New York: Step Therapy Laws, Appeals Process, and Prior Authorization Guide

Answer Box: Getting Darzalex Covered by Humana in New York

Darzalex (daratumumab) requires prior authorization from Humana Medicare Advantage plans in New York. If denied, you can appeal internally and request external review through the New York Department of Financial Services (DFS) within four months. New York's step therapy reform law (effective January 2026) limits how insurers can require "fail first" protocols for multiple myeloma treatments. First step today: Contact your oncologist to submit a prior authorization request with complete medical documentation, including diagnosis, prior treatments, and clinical rationale for Darzalex.

Table of Contents

Why New York State Rules Matter

New York's insurance laws provide stronger protections than federal minimums, especially for specialty cancer treatments like Darzalex (daratumumab). These state rules apply to Humana Medicare Advantage plans operating in New York, creating additional appeal rights and limiting how insurers can restrict access to medically necessary treatments.

The interaction between federal Medicare rules and New York state law means you have multiple avenues for challenging denials. While Medicare sets baseline coverage standards, New York's external appeal process and step therapy reforms provide enhanced patient protections that can override plan restrictions.

Key difference: New York allows external appeals through the Department of Financial Services for medical necessity denials, while federal Medicare appeals go through different review entities. This gives New York patients an additional independent review option that's often faster and more patient-friendly.

Prior Authorization Turnaround Standards

Standard Timeline Requirements

Humana's Response Times:

  • Non-urgent requests: 30 days for Medicare Advantage medical services
  • Urgent requests: 72 hours for expedited decisions
  • Drug formulary exceptions: 7 days standard, 72 hours expedited

New York's Enhanced Protections

Starting January 1, 2026, New York's step therapy reform law requires insurers to respond to exception requests within:

  • 72 hours for non-emergency requests
  • 24 hours for emergency situations
Important: If Humana doesn't respond within the required timeframe, your request is automatically approved under New York law.

What qualifies as urgent for Darzalex:

  • Active multiple myeloma requiring immediate treatment
  • Progression on current therapy
  • Severe side effects from required step therapy drugs
  • Risk of hospitalization without treatment

Step Therapy Protections in New York

New York's groundbreaking step therapy reform law (effective January 2026) significantly improves access to Darzalex for multiple myeloma patients. The law prohibits insurers from requiring patients to:

Prohibited Step Therapy Requirements

  1. Try more than two medications in a therapeutic category before accessing prescribed treatment
  2. Use non-FDA approved drugs or treatments not supported by evidence-based guidelines
  3. Continue step therapy longer than 30 days or beyond current medical guidelines
  4. Repeat step therapy if completed within the last 365 days (unless new safety concerns arise)

Automatic Exception Criteria

Humana must grant step therapy exceptions if:

  • The required drug is expected to be ineffective based on your medical history
  • Step therapy poses significant barriers or may cause predictable negative reactions
  • You're stable on current treatment
  • Your physician provides attestation that required drugs have been tried and failed

Physician Attestation Power: Under the new law, your doctor's written statement that you've tried and failed step therapy drugs must be accepted as sufficient evidence by Humana.

Continuity of Care During Treatment

New York's continuity of care laws protect patients undergoing multiple myeloma treatment when their oncologist leaves Humana's network or coverage changes occur.

90-Day Protection Period

If your oncologist terminates their contract with Humana, you're entitled to:

  • Continue seeing your current provider for up to 90 days
  • Maintain current treatment regimen including Darzalex infusions
  • Same copayment structure as in-network care

How to activate: Contact Humana immediately when notified of provider termination. Request continuity of care in writing, referencing New York Insurance Law sections 3217-d(c) and 4306-c(c).

Grace Periods for Premium Payments

New York provides a 30-day grace period for premium payments, including COBRA-like continuation coverage for dependents up to age 29. This prevents treatment interruption due to billing issues.

External Review and Complaints Process

New York's external appeal system is among the strongest in the nation, with binding decisions by independent medical experts.

When You're Eligible for External Review

After Humana issues a final denial on internal appeal, you can request external review for:

  • Medical necessity denials
  • Experimental/investigational determinations
  • Out-of-network service denials

Filing Requirements

  • Deadline: Within 4 months of final adverse determination
  • Forms: New York External Appeal Application
  • Documentation: Denial letters, medical records, physician attestation
  • Fee: Maximum $25 (waived for financial hardship or Medicaid enrollees)

Expedited External Review

Available when delay poses serious health risks:

  • Standard decisions: 72 hours
  • Drug formulary denials: 24 hours for ongoing therapy

Success rates: New York's external appeal system has historically overturned many oncology drug denials when proper medical evidence is submitted.

Practical Scripts for Appeals

Patient Phone Script for Humana

"I'm calling about a prior authorization denial for Darzalex for multiple myeloma treatment. I'd like to request an expedited internal appeal and need information about submitting additional medical documentation. Can you provide the appeals fax number and confirm the deadline? I also want to understand my rights under New York's continuity of care law."

Physician Peer-to-Peer Request Script

"I'm requesting a peer-to-peer review for my patient's Darzalex prior authorization denial. The patient has relapsed/refractory multiple myeloma with documented progression on [prior therapies]. Per NCCN guidelines and New York's step therapy law, this represents appropriate next-line therapy. When can we schedule the clinical discussion?"

Appeal Letter Key Phrases

Reference these specific elements in written appeals:

  • "Medically necessary per NCCN Guidelines for Multiple Myeloma"
  • "Patient has failed/is intolerant to [specific prior therapies]"
  • "Treatment delay poses risk of disease progression"
  • "Request expedited review due to active cancer diagnosis"
  • "Per New York step therapy reform law, automatic exception criteria are met"

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all Darzalex formulations Medical necessity letter, diagnosis codes Humana PA List
Formulary Status Specialty tier (verify current) Prescription, insurance card Humana Formulary
Step Therapy May be required (exceptions available) Prior therapy documentation New York Step Therapy Law
Site of Care Typically oncology clinic/hospital Provider network verification Humana Provider Directory
Diagnosis Codes Multiple myeloma (C90.x), AL amyloidosis ICD-10 documentation Medical records
Appeals Deadline 60 days from denial Denial letter, medical records Medicare regulations

Common Denial Reasons and Solutions

Denial Reason How to Overturn Key Documentation
"Not medically necessary" Submit NCCN guideline citations, disease progression evidence Imaging, lab results, prior therapy failures
"Step therapy not completed" Request exception under NY law, physician attestation Documentation of prior treatments tried
"Off-label use" Cite FDA labeling for approved indications, medical literature Clinical studies, physician rationale
"Quantity limits exceeded" Justify dosing based on patient weight/BSA, clinical protocols Dosing calculations, treatment plan
"Site of care restriction" Request exception for specialized oncology care Provider credentials, facility accreditation

When to Escalate Your Case

Contact these resources when Humana appeals are unsuccessful:

Community Health Advocates (CHA)

  • Phone: 1-888-614-5400 (Monday-Friday, 9 AM-4 PM)
  • Email: [email protected]
  • Services: Free assistance with appeals, legal support, documentation help

New York Department of Financial Services

  • External Appeals: File online through DFS Portal
  • Consumer Complaints: For procedural violations or delayed responses
  • Database: Search previous external appeal decisions for precedents

When to call CHA immediately:

  • Humana denies your internal appeal
  • You need help preparing external appeal documentation
  • Treatment delays are causing health deterioration
  • You're facing financial hardship due to coverage denial

For patients navigating complex insurance denials, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each plan's specific rules, helping patients and clinicians get prescription drugs approved more efficiently.

FAQ: Darzalex Coverage with Humana

Q: How long does Humana prior authorization take for Darzalex in New York? A: Standard requests take up to 30 days, but urgent requests must be decided within 72 hours. Under New York's new step therapy law (2026), exception requests get 72-hour standard or 24-hour emergency response times.

Q: What if Darzalex is non-formulary on my Humana plan? A: You can request a formulary exception with medical necessity documentation. New York residents also have external appeal rights through DFS if the internal exception is denied.

Q: Can I request expedited review for Darzalex? A: Yes, if treatment delay poses serious health risks. Active multiple myeloma, disease progression, or risk of hospitalization typically qualify for expedited review.

Q: Does step therapy apply if I've already tried other treatments? A: Under New York's 2026 law, if you've completed step therapy within 365 days or your physician attests to prior failures, step therapy cannot be re-imposed.

Q: What happens if my oncologist leaves Humana's network? A: New York's continuity of care law provides 90 days to continue treatment with your current provider at in-network rates while you transition care.

Q: How much does Darzalex cost with Humana coverage? A: Costs vary by plan, but specialty tier copays typically range from $100-500+ per treatment. Manufacturer copay assistance and foundation grants may be available to reduce out-of-pocket costs.

Q: Can I appeal a Humana denial outside of Medicare's process? A: Yes, New York residents can use the state's external appeal system through DFS, which provides an additional independent review option beyond federal Medicare appeals.

Q: What medical records do I need for a successful appeal? A: Key documents include: diagnosis confirmation, prior therapy documentation (drugs tried, dates, outcomes), current disease status (labs, imaging), physician letter explaining medical necessity, and treatment goals.

From our advocates: "We've seen multiple myeloma patients successfully overturn Darzalex denials by combining strong medical documentation with New York's patient protection laws. The key is getting your oncologist to clearly document why Darzalex is medically necessary now, not just that it's a reasonable option. Plans respond well to specific clinical data showing disease progression or intolerance to other treatments."

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan details, and medical necessity determinations. Always consult with your healthcare provider and insurance plan for specific coverage questions. For personalized assistance with insurance appeals and coverage issues, Counterforce Health provides specialized support in navigating complex prior authorization and appeals processes.

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