By Counterforce Health Team in Kymriah (tisagenlecleucel) —

How to Get Kymriah (tisagenlecleucel) Covered by Humana in Ohio: Appeals, Timelines, and State Protections

Answer Box: Getting Kymriah Covered by Humana in Ohio

Kymriah (tisagenlecleucel) typically requires prior authorization from Humana, with decisions in 72 hours standard or 24 hours expedited. Ohio's step therapy law provides strong exemption protections if you've failed other CAR-T therapies or have contraindications. If denied, you have 65 days to appeal internally, then 180 days for Ohio's external review process.

Your first step today: Have your oncologist submit a prior authorization request through Humana's provider portal with complete medical necessity documentation, including CD19 positivity, prior treatment failures, and certification from a qualified treatment center.

Table of Contents

  1. Why Ohio State Rules Matter for CAR-T Coverage
  2. Prior Authorization Turnaround Standards
  3. Step Therapy Protections in Ohio
  4. Continuity of Care During Transitions
  5. External Review and Appeals Process
  6. Practical Scripts for Humana Calls
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons and Solutions
  9. When to Escalate to State Regulators
  10. FAQ: Kymriah Coverage in Ohio

Why Ohio State Rules Matter for CAR-T Coverage

Ohio's insurance regulations provide crucial protections that work alongside Humana's policies, particularly for high-cost specialty therapies like Kymriah. Unlike self-funded employer plans governed by federal ERISA law, state-regulated plans (including many Humana Medicare Advantage and individual market plans) must follow Ohio's consumer protection standards.

Key Ohio advantages for CAR-T patients:

  • Strong step therapy exemptions under Ohio Revised Code 3901.832 with 48-hour urgent decisions
  • External review rights through independent medical experts if Humana denies coverage
  • Continuity of care protections ensuring ongoing cancer treatment during plan transitions

The distinction matters because Humana operates multiple lines of business in Ohio. Medicare Advantage plans follow federal timelines but often incorporate state-level protections voluntarily, while individual and small group plans are fully subject to Ohio law.

Prior Authorization Turnaround Standards

Humana's Decision Timelines

Request Type Standard Timeline Expedited Timeline
Prior Authorization 72 hours 24 hours if delay harms health
Formulary Exception 72 hours 24 hours
Medicare Part D Appeal 7 days standard 72 hours expedited

Source: Humana Prior Authorization Guidelines

Ohio Step Therapy Response Requirements

Under Ohio law, step therapy exemption requests must receive responses within:

  • 48 hours for urgent care situations
  • 10 calendar days for non-urgent requests
  • Automatic approval if Humana doesn't respond within these timeframes

For Kymriah, most requests qualify as urgent given the aggressive nature of relapsed/refractory B-cell malignancies.

Step Therapy Protections in Ohio

Ohio Revised Code Section 3901.832 requires Humana to grant step therapy exemptions when specific criteria are met—particularly relevant since some plans may require trying other CAR-T therapies first.

Automatic Exemption Criteria

Your oncologist can request an exemption if:

  1. Contraindication exists: Kymriah is contraindicated per FDA prescribing information
  2. Prior failure documented: You tried and failed the required drug under current or prior insurance due to lack of efficacy or adverse events
  3. Clinical stability: You're stable on Kymriah (if prescribed previously) and switching would be detrimental

Documentation Requirements

Include in your exemption request:

  • Medical records showing treatment failures or contraindications
  • FDA prescribing information supporting the contraindication claim
  • Clinical notes documenting disease progression or adverse effects
  • Laboratory values and imaging supporting medical necessity
Tip: Ohio's step therapy law is among the strongest nationally. If Humana claims an exemption doesn't apply, reference ORC 3901.832 directly and request clinical peer review.

Continuity of Care During Transitions

Ohio's continuity of care protections ensure ongoing cancer treatment coverage when switching between Humana plans or if your oncologist leaves Humana's network.

Coverage During Plan Changes

Medicaid/Medicare transitions: Active chemotherapy and related treatments (including CAR-T therapy) continue until completion of the planned treatment course, not just for a fixed number of days.

Commercial plan changes: Automatic 90-day in-network benefits if you had 3+ visits with the same oncologist in the prior 6 months, extendable for active cancer treatment courses.

How to Request Continuity Coverage

  1. Submit transition form within 30 days of plan change
  2. Provide treatment plan documentation from your oncologist
  3. Include prior authorization approvals from previous insurer
  4. Request single case agreement for out-of-network providers if needed

Reference: Ohio Continuity of Care Requirements

External Review and Appeals Process

If Humana denies your Kymriah coverage, Ohio provides a robust appeals pathway through independent medical review.

Internal Appeals Timeline

  1. Submit appeal within 65 days of denial notice
  2. Humana's response: 30 days for pre-service decisions, 60 days for payment disputes
  3. Required documents: Original denial letter, medical records, prescriber letter

Ohio External Review Process

After exhausting internal appeals, you have 180 days to request external review:

Standard review: Decision within 30 days Expedited review: Decision within 72 hours (not available for retrospective claims)

The external review is conducted by independent medical experts and is binding on Humana if they overturn the denial.

How to File External Review

Contact the Ohio Department of Insurance:

  • Phone: 1-800-686-1526
  • Process: Submit request to Humana, who forwards to Ohio DOI
  • Cost: No fee to you; Humana pays for the review

Source: Ohio External Review Process

Practical Scripts for Humana Calls

Patient Script for Prior Authorization Status

"Hi, I'm calling to check the status of a prior authorization request for Kymriah, NDC number [insert from prescription]. My member ID is [ID number]. This is for CAR-T therapy for relapsed B-cell acute lymphoblastic leukemia. Can you tell me what additional documentation is needed and confirm the timeline for decision?"

Clinic Staff Script for Peer-to-Peer Review

"I'm requesting an urgent peer-to-peer review for Kymriah prior authorization denial. The patient has relapsed/refractory [specific diagnosis] with CD19 positivity confirmed. They've failed [list prior therapies] and meet all FDA-approved indications. We're a certified CAR-T center. What's the next available appointment with your medical director?"

Coverage Requirements at a Glance

Requirement Details Documentation Needed
FDA Indication B-cell precursor ALL (≤25 years) or DLBCL/FL (adults) Pathology report, medical records
CD19 Positivity Must be confirmed by flow cytometry or immunohistochemistry Lab results, pathology report
Prior Therapies Failed ≥2 lines for ALL, ≥2 lines for DLBCL Treatment history, response documentation
Certified Center Must be administered at approved CAR-T facility Center certification, treatment plan
REMS Compliance Enrollment in Risk Evaluation and Mitigation Strategy REMS documentation

Sources: FDA Kymriah Label, Humana Coverage Policies

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
"Not medically necessary" Submit comprehensive treatment history showing failure of standard therapies, disease progression documentation
"Experimental/investigational" Provide FDA approval documentation, cite specific indication from prescribing information
"Not at certified center" Confirm treatment facility is on FDA's approved CAR-T centers list
"Missing CD19 testing" Submit flow cytometry or immunohistochemistry results confirming CD19 expression
"Insufficient prior therapy" Document specific regimens tried, dates, response rates, reasons for discontinuation

When to Escalate to State Regulators

Contact Ohio Department of Insurance if:

  • Humana violates response timelines for step therapy exemptions
  • External review request is improperly denied
  • You suspect unfair claims practices

Ohio Department of Insurance Consumer Services

  • Phone: 1-800-686-1526
  • Online: insurance.ohio.gov
  • What to include: Member ID, denial letters, timeline documentation, correspondence with Humana

For Medicare Advantage issues, you can also contact:

  • Medicare: 1-800-MEDICARE (1-800-633-4227)
  • OSHIIP: Ohio Senior Health Insurance Information Program for Medicare guidance

FAQ: Kymriah Coverage in Ohio

How long does Humana prior authorization take for Kymriah in Ohio? Standard decisions within 72 hours, expedited within 24 hours if delay would harm your health. Under Ohio law, step therapy exemptions must be decided within 48 hours for urgent cases.

What if Kymriah is not on Humana's formulary? Request a formulary exception along with prior authorization. Humana must respond within 72 hours with medical necessity documentation from your oncologist.

Can I get expedited review if my condition is urgent? Yes. CAR-T candidates with rapidly progressing disease qualify for expedited review. Your oncologist should clearly document medical urgency in the request.

Does Ohio's step therapy law apply to Medicare plans? Ohio step therapy protections apply to state-regulated plans. Medicare Advantage plans follow federal rules but may voluntarily adopt similar protections.

What happens if I'm stable on Kymriah but change insurance? Ohio's continuity of care law protects ongoing cancer treatment. Submit transition documentation within 30 days of plan change to maintain coverage.

How much does external review cost in Ohio? External review is free to patients. Humana pays the cost of independent medical review.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-backed advocacy. Our platform analyzes denial letters and plan policies to create targeted rebuttals that align with payer-specific requirements, improving approval rates for complex therapies like CAR-T treatments.

When navigating Humana's coverage requirements for Kymriah in Ohio, having the right documentation and understanding state-specific protections can make the difference between approval and denial. Counterforce Health's comprehensive approach ensures your appeal addresses both medical necessity criteria and procedural requirements specific to Ohio's regulatory environment.

Sources & 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 specifics, and medical necessity determinations. Always consult with your healthcare provider and insurance plan directly for coverage questions specific to your situation.

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