By Counterforce Health Team in Tegsedi (inotersen) —

How to Renew Tegsedi (Inotersen) Coverage with Humana in Michigan: Complete Renewal Guide

Answer Box: Renewing Tegsedi (Inotersen) with Humana in Michigan

Renewal Requirements: Tegsedi requires annual renewal with Humana Medicare Part D in Michigan. Start the process 60-90 days before your current authorization expires. Key requirements: updated clinical visit within 12 months, continued REMS enrollment, current lab monitoring (platelet counts, kidney function), and provider attestation of ongoing benefit.

First Step Today: Check your current authorization expiration date on your Humana member portal or by calling customer service at 1-800-HUMANA1. Contact your prescribing specialist to schedule a renewal visit if you haven't been seen recently.

Michigan Appeals: If renewal is denied, you have 65 days to appeal. Michigan offers expedited external review through DIFS within 72 hours for urgent cases.

Table of Contents

Renewal Triggers: When to Start

Start Early: 60-90 Days Before Expiration

Humana typically issues Tegsedi authorizations for 12 months. Don't wait until the last minute—renewals require extensive documentation and can take 30+ days to process.

Signs you should start your renewal process immediately:

  • Current authorization expires within 90 days
  • You haven't had a specialist visit in 9+ months
  • Your REMS certification needs updating
  • Lab monitoring has been inconsistent
  • You've missed any required safety monitoring
Tip: Set a calendar reminder 90 days before your authorization expires. This gives you buffer time for any documentation delays or appeals if needed.

Check Your Current Status

Before starting renewal, verify:

  • Current authorization end date (check Humana member portal)
  • REMS enrollment status at tegsedirems.com
  • Recent lab results (platelet count, kidney function)
  • Last specialist visit date

Evidence Update Requirements

Clinical Response Documentation

Your renewal must demonstrate that Tegsedi continues to provide clinical benefit. Required evidence includes:

Neurological Assessment Updates:

  • Polyneuropathy Disability (PND) score
  • Neuropathy Impairment Score (NIS) if available
  • Functional assessments (10-meter walk test, grip strength)
  • Patient-reported symptom changes
  • Activities of daily living assessment

Laboratory Monitoring Compliance:

  • Weekly platelet counts (must be >100×10⁹/L for continued dosing)
  • Bi-weekly kidney function tests (creatinine, eGFR, urinalysis)
  • Documentation of any dose adjustments due to lab abnormalities

Adverse Events and Safety Profile

Your prescriber must document:

  • Any adverse reactions experienced
  • How side effects were managed
  • Confirmation that benefits outweigh risks
  • Adherence to weekly injection schedule
From our advocates: "One patient's renewal was initially denied because their platelet count had dropped to 85 during treatment, requiring dose reduction. However, the appeal succeeded when their neurologist provided detailed documentation showing the platelet count stabilized at safe levels with bi-weekly dosing, and the patient's neuropathy symptoms continued to improve despite the dose adjustment."

Renewal Documentation Packet

Must-Include Documents

Clinical Documentation:

  • Updated specialist consultation note (within 12 months)
  • Current neurological examination findings
  • Laboratory monitoring summary
  • Treatment response assessment
  • Confirmation of continued medical necessity

REMS Compliance:

  • Current REMS enrollment verification
  • Safety monitoring compliance documentation
  • Prescriber REMS certification status

Insurance Forms:

  • Humana prior authorization renewal form
  • Provider attestation of continued benefit
  • Updated diagnosis confirmation (ICD-10: E85.1 for hATTR)

Letter of Medical Necessity Structure

Your prescriber's renewal letter should include:

  1. Patient identification and diagnosis confirmation
  2. Treatment history and duration on Tegsedi
  3. Current clinical status and response to therapy
  4. Safety monitoring compliance and results
  5. Medical necessity for continuation
  6. Alternative treatment considerations
Clinician Corner: Include specific metrics in your renewal letter. Instead of "patient is doing well," write "PND score improved from 3 to 1 over 12 months of treatment, with patient now able to walk unassisted for distances >100 meters."

Timeline and Submission Process

90 days before expiration:

  • Schedule renewal appointment with specialist
  • Request updated lab work if needed

60 days before expiration:

  • Complete specialist visit
  • Gather all required documentation
  • Submit renewal request to Humana

30 days before expiration:

  • Follow up on renewal status
  • Prepare appeal if needed

Submission Methods

Provider Portal: Most efficient method

  • Log into Humana provider portal
  • Submit via prior authorization section
  • Attach all supporting documents

Phone: 1-800-HUMANA1 (providers can call dedicated PA line)

Fax: Submit to Humana's prior authorization fax (verify current number with customer service)

Expected Processing Time: 7-14 days for standard review, 24-72 hours for expedited requests

If Coverage Lapses: Bridge Options

Immediate Steps if Authorization Expires

  1. Contact your specialty pharmacy immediately to discuss emergency supply options
  2. Verify REMS compliance - you must maintain enrollment even during coverage gaps
  3. Submit expedited renewal request with Humana
  4. Explore patient assistance programs

Patient Assistance Options

Manufacturer Support:

  • Akcea Therapeutics patient assistance program
  • May provide temporary supply during coverage gaps
  • Contact through REMS-certified specialty pharmacy

Specialty Pharmacy Coordination:

  • Limited emergency supplies (7-30 days) may be available
  • Requires active appeal or renewal in progress
  • Must maintain safety monitoring
Note: Never stop Tegsedi abruptly without medical supervision. The REMS program requires continued monitoring even during temporary interruptions.

Counterforce Health helps patients navigate complex renewal processes by analyzing denial letters and crafting targeted appeals with the right evidence and documentation. Their platform specializes in turning insurance denials into successful approvals for specialty medications like Tegsedi.

Annual Changes to Monitor

Formulary Updates

Humana updates formularies annually, typically effective January 1. Changes that could affect your Tegsedi coverage:

Tier Changes:

  • Tegsedi typically remains in Specialty Tier (Tier 4)
  • Cost-sharing may change annually
  • Prior authorization requirements may be modified

Coverage Restrictions:

  • Quantity limits could be adjusted
  • Step therapy requirements might change
  • Specialty pharmacy networks may be updated

Plan Design Shifts

What to Re-verify Annually:

  • Current formulary status
  • Prior authorization requirements
  • Preferred specialty pharmacies
  • Cost-sharing amounts
  • Coverage policies and criteria
Tip: Review your plan's Summary of Benefits and Coverage (SBC) each year during open enrollment to identify any changes affecting specialty drug coverage.

Appeals Process in Michigan

Internal Appeals with Humana

Timeline: 65 days from denial date to file appeal

Required Information:

  • Copy of denial letter
  • Updated medical documentation
  • Provider letter supporting medical necessity
  • Any additional clinical evidence

Michigan External Review

If Humana upholds their denial, Michigan offers robust external review through the Department of Insurance and Financial Services (DIFS).

Standard External Review:

  • File within 127 days of final internal denial
  • Decision within 60 days
  • Independent medical review by experts

Expedited External Review:

  • Available for urgent medical needs
  • 72-hour decision timeline
  • Requires physician letter stating urgency
  • Only available for pre-service denials

Contact DIFS:

The external review decision is binding on Humana and often succeeds when proper documentation is provided.

Renewal Tracking Template

Personal Renewal Checklist

90 Days Before Expiration:

  • Current authorization end date: ___________
  • Specialist appointment scheduled: ___________
  • REMS status verified: ___________

60 Days Before Expiration:

  • Specialist visit completed: ___________
  • Updated labs obtained: ___________
  • Renewal packet submitted: ___________

30 Days Before Expiration:

  • Humana decision received: ___________
  • Appeal filed (if needed): ___________
  • Bridge therapy arranged (if needed): ___________

Key Contacts Log

  • Specialist office: ___________
  • Specialty pharmacy: ___________
  • Humana customer service: 1-800-HUMANA1
  • REMS program: 1-844-483-4736

FAQ

How long does Humana take to process Tegsedi renewals? Standard renewals typically take 7-14 days. Expedited reviews are processed within 24-72 hours when urgency is documented.

What if my REMS certification lapses during renewal? You must maintain REMS enrollment continuously. Contact the REMS program immediately at 1-844-483-4736 to restore certification before submitting your renewal.

Can I request an expedited renewal if my authorization is about to expire? Yes, if interruption would cause serious health consequences. Your prescriber must provide documentation supporting the urgent need.

What happens if Humana changes Tegsedi's formulary status? You'll receive 30 days' notice of formulary changes. You can request a formulary exception or transition to an alternative therapy if needed.

Does step therapy apply to Tegsedi renewals? Typically no, if you're already established on therapy. However, verify this hasn't changed in your current plan year.

How do I know if my renewal was approved? Check your Humana member portal, or you'll receive written notification. Your specialty pharmacy will also be notified directly.

What's the success rate for Tegsedi appeals in Michigan? While specific statistics aren't published, Michigan's external review process has a strong track record for specialty drug appeals when proper medical documentation is provided.

Can I switch specialists during renewal? Yes, but ensure the new prescriber is REMS-certified and familiar with hATTR treatment. Transfer all medical records to maintain continuity of documentation.

This article is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. For official Michigan insurance appeals information, visit Michigan DIFS.

When facing complex renewal challenges, Counterforce Health provides specialized support in crafting evidence-based appeals that address payer-specific requirements and maximize approval chances for specialty medications like Tegsedi.

Sources & Further Reading

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