By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Humana in Virginia: Complete Appeal Guide with Forms and Timelines

Answer Box: Getting Tegsedi (Inotersen) Covered by Humana in Virginia

Tegsedi (inotersen) requires prior authorization from Humana Medicare Advantage and Part D plans. The fastest path to approval involves three key steps: (1) Ensure your prescriber enrolls in the FDA's Tegsedi REMS program and submits baseline lab results, (2) Submit a complete prior authorization request with confirmed hATTR diagnosis via genetic testing, and (3) If denied, file an expedited appeal within 65 days by calling 1-800-451-4651. Virginia residents have additional external review rights through the State Corporation Commission Bureau of Insurance within 120 days of final denial using Form 216-A.

Table of Contents

  1. Understanding Your Denial Letter
  2. Coverage Requirements at a Glance
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Playbook for Humana in Virginia
  6. Medical Necessity Letter Checklist
  7. Virginia External Review Process
  8. Cost Savings and Patient Assistance
  9. FAQ: Most Common Questions
  10. When to File a Complaint

Understanding Your Denial Letter

When Humana denies coverage for Tegsedi (inotersen), the denial letter will specify the reason. Common denial codes include:

  • Prior authorization required - Most frequent for specialty medications
  • Not medically necessary - Often due to incomplete documentation
  • REMS enrollment missing - FDA requirement for Tegsedi prescribers
  • Lab monitoring plan absent - Required for thrombocytopenia and kidney function
  • Off-label use - Tegsedi is only FDA-approved for hATTR polyneuropathy
Tip: Look for the specific denial reason code and the appeals deadline (typically 65 days for Medicare Part D). This determines your next steps and timeline.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana plans 2025 Medicare PA List Humana Policy
REMS Enrollment Prescriber must be certified Tegsedi REMS Program FDA Requirement
hATTR Diagnosis Genetic testing + polyneuropathy Medical records, genetic report FDA Label
Baseline Labs Platelets ≥100K, kidney function Lab results within 30 days REMS Protocol
Age Requirement 18+ years Patient demographics FDA Approval

Step-by-Step: Fastest Path to Approval

1. Confirm REMS Enrollment (Prescriber Action)

Your doctor must enroll in the Tegsedi REMS program before prescribing. This includes completing training on monitoring requirements for thrombocytopenia and kidney problems.

2. Gather Required Documentation

  • Genetic testing confirming TTR mutation
  • Baseline platelet count (≥100,000/μL within 30 days)
  • Kidney function tests (creatinine, eGFR)
  • Polyneuropathy staging (PND score, NIS score if available)

3. Submit Prior Authorization

Submit via Humana provider portal or fax using forms from the 2025 Medicare PA list. Include all documentation from step 2.

4. If Denied, File Expedited Appeal

Call 1-800-451-4651 within 65 days. Request expedited review if waiting would harm your health. Humana must decide within 72 hours for expedited appeals.

5. Prepare for Peer-to-Peer Review

Your prescriber should be ready to discuss medical necessity, prior treatments tried, and why Tegsedi is specifically needed for your hATTR polyneuropathy.

6. Virginia External Review (If Needed)

If Humana upholds the denial, file external review with Virginia's Bureau of Insurance within 120 days using Form 216-A.

7. Track Everything

Keep records of all submissions, phone calls, and deadlines. Virginia law requires insurers to respond promptly to external review decisions.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
REMS enrollment missing Prescriber completes certification REMS enrollment confirmation
Insufficient diagnosis Provide genetic testing results TTR gene mutation report, biopsy if available
Missing lab monitoring Submit baseline and monitoring plan Recent platelet count, kidney function tests
Off-label use Confirm hATTR polyneuropathy indication Neurology consultation, staging assessment
Alternative not tried Document contraindications/failures Prior therapy records, adverse event notes

Important: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Appeals Playbook for Humana in Virginia

Internal Appeals (Level 1)

  • Deadline: 65 days from denial notice
  • Standard timeline: 7 days for Humana decision
  • Expedited timeline: 72 hours if health at risk
  • How to file: Call 1-800-451-4651 or submit via Humana member portal
  • Required: Denial letter, medical records, prescriber statement

Medicare Part D Appeals (Level 2)

  • Deadline: 60 days from Level 1 denial
  • Timeline: 7 days standard, 72 hours expedited
  • Process: Automatic referral to Independent Review Entity (IRE)
  • Cost: No fee for members

Virginia External Review

  • Deadline: 120 days from final internal denial
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Form: Form 216-A to Bureau of Insurance
  • Contact: 1-877-310-6560 for guidance

Medical Necessity Letter Checklist

Your prescriber's letter should include:

Clinical Problem:

  • Confirmed hATTR with polyneuropathy
  • Genetic testing results (specific TTR mutation)
  • Current functional status and symptoms

Prior Treatments:

  • Previous medications tried and outcomes
  • Reasons for discontinuation (ineffective, intolerable)
  • Contraindications to alternatives like patisiran

Clinical Rationale:

  • Why Tegsedi is medically necessary
  • Expected benefits based on clinical trials
  • Monitoring plan for safety (platelets, kidney function)

Supporting Evidence:

Clinician Note: Emphasize that Tegsedi is the only antisense oligonucleotide approved for hATTR polyneuropathy and may be preferred over RNA interference therapies in certain clinical situations.

Virginia External Review Process

Virginia provides robust external review rights through the State Corporation Commission Bureau of Insurance. This independent process can overturn wrongful denials.

Eligibility

  • Must complete Humana's internal appeals first
  • Denial must be based on medical necessity or experimental treatment
  • Virginia-issued plan or opted-in self-funded plan

Filing Process

  1. Download Form 216-A from the Bureau of Insurance
  2. Complete all sections including medical record release
  3. Mail to: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
  4. Call 1-877-310-6560 for guidance before submitting

What Happens Next

  • Bureau verifies eligibility within 5 business days
  • Case assigned to Independent Review Organization (IRO)
  • Board-certified physicians review all evidence
  • Decision is binding on Humana

Expedited Review

Available if waiting could seriously harm your health. Requires physician certification using Form 216-C. Decision within 72 hours.

Virginia residents also have access to the Managed Care Ombudsman (1-877-310-6560) who can help resolve issues informally before formal appeals.

Cost Savings and Patient Assistance

Even with coverage approval, Tegsedi can be expensive. Consider these options:

Manufacturer Support

  • Contact Ionis/Akcea for patient assistance programs
  • Verify current availability (manufacturer discontinued U.S. sales September 2024)

Medicare Extra Help

State Programs

  • Virginia Pharmaceutical Assistance Program for eligible seniors
  • Contact Virginia Department for Aging at 1-800-552-3402

Pharmacy Options

  • Specialty pharmacies may offer payment plans
  • Compare costs across Humana's preferred network

Counterforce Health's platform also helps identify manufacturer assistance programs and coordinates with specialty pharmacies to reduce administrative burden on patients and providers.

FAQ: Most Common Questions

How long does Humana prior authorization take for Tegsedi? Standard PA decisions take up to 14 days. Expedited requests (when health is at risk) are decided within 72 hours.

What if Tegsedi isn't on Humana's formulary? You can request a formulary exception through the same appeals process. Provide medical necessity documentation showing why covered alternatives won't work.

Can I get expedited appeals in Virginia? Yes, both Humana and Virginia external review offer expedited timelines when delays could harm your health. Your doctor must certify the urgency.

What happens if I miss the 65-day appeal deadline? Contact Humana immediately. They may accept late appeals for good cause (hospitalization, emergency). Virginia external review has a separate 120-day deadline.

Does step therapy apply to Tegsedi? Some plans require trying other hATTR treatments first. Document any contraindications or prior failures with alternatives like patisiran or tafamidis.

Who can help me navigate the appeals process? Virginia's Managed Care Ombudsman (1-877-310-6560) provides free assistance. The Bureau of Insurance also offers guidance on external reviews.

When to File a Complaint

If Humana violates appeal timelines or procedures, file a complaint with Virginia regulators:

Virginia State Corporation Commission

Medicare (for Part D issues)

When to Escalate

  • Humana misses appeal deadlines
  • Denied access to external review
  • Procedural violations in the appeals process
  • Discrimination or unfair treatment
From our advocates: "We've seen many Virginia patients succeed with Tegsedi appeals by staying organized and persistent. Keep detailed records, meet every deadline, and don't hesitate to use Virginia's external review process—it's designed to give you a fair second opinion from independent medical experts."

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact qualified legal counsel for specific legal questions. Insurance policies and state regulations may change; verify current requirements with official sources.

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