By Counterforce Health Team in Opsumit (macitentan) —

How to Get Opsumit (Macitentan) Covered by Humana in New York: Complete Guide with Forms, Timelines, and Appeal Strategies

Answer Box: Quick Path to Opsumit Coverage

Getting Opsumit (macitentan) covered by Humana in New York requires prior authorization with specific PAH documentation. Submit right heart catheterization results, WHO functional class documentation, and evidence of failed step therapy through your prescribing specialist. If denied, you have 65 days to file internal appeals and can access New York's external review process through the Department of Financial Services within 4 months. Start today: Have your pulmonologist submit the prior authorization request through Humana's provider portal with complete hemodynamic data and prior therapy failures.

Table of Contents

  1. Coverage Basics: Is Opsumit Covered by Humana?
  2. Prior Authorization Process: Who Submits and How
  3. Timeline: How Long Does Approval Take?
  4. Medical Necessity Criteria: What Documentation Is Required
  5. Costs and Financial Assistance
  6. Denials and Appeals: Your Rights in New York
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Common Problems and Solutions
  10. Frequently Asked Questions

Coverage Basics: Is Opsumit Covered by Humana?

Humana covers Opsumit (macitentan) for Medicare Advantage and commercial plans, but prior authorization is required for all plans. Some Humana plans have removed PAH therapies from their 2025-2026 formularies, making appeals more common.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing Humana PA portal Humana Policy
Formulary Status May be non-formulary on some plans Humana drug list Plan documents
Step Therapy Must try preferred ERAs first Plan-specific requirements PA criteria
Specialty Pharmacy Must use CenterWell or approved network CenterWell Specialty Network requirements
REMS Requirements No longer required (discontinued April 2025) FDA REMS update FDA guidance
Important Update: The FDA discontinued Opsumit's REMS program in April 2025, eliminating mandatory pregnancy testing enrollment. However, some insurers still request outdated REMS documentation—this should be challenged in appeals.

Prior Authorization Process: Who Submits and How

Your prescribing physician (typically a pulmonologist or cardiologist) must submit the prior authorization request. Patients cannot submit PA requests directly for specialty medications.

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic Staff)
  2. Gather Required Documentation (Prescriber)
    • Right heart catheterization results with hemodynamics
    • WHO functional class assessment
    • Prior therapy failure documentation
    • Timeline: 1-2 business days
  3. Submit PA Request (Prescriber)
  4. Follow Up (Clinic Staff)
    • Check status after 3-5 business days
    • Request expedited review if clinically urgent
    • Timeline: 2-3 minutes per follow-up
  5. Prepare for Peer-to-Peer (Prescriber)
    • If initial denial, request clinical review call
    • Have patient chart and guidelines ready
    • Timeline: 30-45 minutes

Timeline: How Long Does Approval Take?

Standard prior authorization: 7-15 business days for Medicare plans, up to 30 days for commercial plans. Humana has committed to deciding 95% of electronic PA requests within one business day by January 2026.

Expedited requests: 72 hours when medical urgency is documented by the prescriber.

New York Advantage: If Humana doesn't respond within required timeframes, you can file a complaint with the New York Department of Financial Services to enforce compliance.

Medical Necessity Criteria: What Documentation Is Required

Clinical Requirements

Diagnosis Documentation:

  • Confirmed WHO Group 1 pulmonary arterial hypertension
  • ICD-10 codes: I27.0 (primary PAH), I27.2 (other secondary PAH)
  • Right heart catheterization showing:
    • Mean PAP ≥25 mmHg at rest
    • PCWP ≤15 mmHg
    • PVR >3 Wood units

Functional Status:

  • WHO Functional Class II-III documentation
  • Six-minute walk distance (if available)
  • Echocardiogram results

Step Therapy Requirements:

  • Trial and failure of generic ambrisentan or bosentan (unless contraindicated)
  • Documentation of adverse effects or inadequate response
  • Contraindications to calcium channel blockers (if applicable)

Clinician Corner: Medical Necessity Letter Checklist

When writing your medical necessity letter, include:

✓ Patient's specific PAH etiology with supporting diagnostic tests
✓ Hemodynamic data from right heart catheterization
✓ Functional class progression and symptom severity
✓ Prior ERA therapy failures with specific reasons (hepatotoxicity, fluid retention, etc.)
✓ Treatment goals and expected outcomes with macitentan
✓ Monitoring plan including liver function tests
✓ Literature support from AHA/ACC PAH guidelines or ESC/ERS guidelines

For female patients of childbearing potential, document:

  • Negative pregnancy test results
  • Contraception counseling and method
  • Monthly pregnancy testing plan

Costs and Financial Assistance

Insurance Coverage

Opsumit typically falls on specialty tiers (Tier 4-5) with higher cost-sharing. Expect:

  • Medicare Part D: 25-33% coinsurance during coverage gap
  • Commercial plans: $50-200+ monthly copay or 20-40% coinsurance

Patient Assistance Programs

J&J withMe Oral PAH Savings Program (Commercial Insurance Only)

Medicare Patients:

  • Cannot use manufacturer copay cards
  • May qualify for Medicare Extra Help (Low Income Subsidy)
  • Contact Medicare at 1-800-MEDICARE for eligibility

Denials and Appeals: Your Rights in New York

Common Denial Reasons & How to Overturn Them

Denial Reason How to Fix Required Documentation
"Not medically necessary" Provide hemodynamic data and functional class Right heart cath, 6MWD, WHO class
"Step therapy not met" Document ERA failures with specific adverse effects Prior therapy notes, lab abnormalities
"REMS not enrolled" Cite FDA discontinuation (April 2025) FDA REMS update link
"Non-formulary" Request formulary exception with medical necessity Comparative efficacy data, contraindications to alternatives

Appeals Process in New York

Level 1: Internal Appeal (Required First Step)

  • Deadline: 65 days from denial notice for Medicare plans
  • Timeline: 30 days for standard review, 72 hours for expedited
  • How to file: Call Humana member services or submit online
  • Required: Copy of denial letter, prescriber's medical necessity letter

Level 2: Independent Review

  • Medicare plans: File with MAXIMUS (federal contractor)
  • Timeline: 7 days standard, 72 hours expedited
  • Cost: Free

Level 3: New York External Appeal

  • Who qualifies: After exhausting internal appeals
  • Deadline: 4 months from final internal denial
  • Timeline: 30 days standard, 72 hours for urgent cases
  • Cost: $25 maximum (waived for financial hardship)
  • File with: New York Department of Financial Services
From Our Advocates: "We've seen several New York patients successfully overturn Humana denials by emphasizing the FDA's REMS discontinuation and providing detailed hemodynamic data. The key is showing that generic ERAs caused specific, documented adverse effects that macitentan is less likely to cause."

New York Consumer Assistance

Community Health Advocates (CHA)

  • Free insurance counseling and appeal assistance
  • Helpline: 888-614-5400
  • Serves all New York residents with insurance problems

Renewal Requirements

Most Humana plans require annual reauthorization for Opsumit. Your prescriber will need to submit:

  • Updated functional assessment
  • Current lab results (liver function tests)
  • Documentation of continued medical necessity
  • Evidence of treatment response or stability

Timeline for renewal: Submit 30-45 days before current authorization expires to avoid treatment gaps.

Specialty Pharmacy Requirements

Humana requires Opsumit to be dispensed through CenterWell Specialty Pharmacy or approved network pharmacies. Your prescription will automatically be transferred from retail pharmacies.

What to expect:

  • Initial phone consultation with specialty pharmacist
  • Coordination with your prescriber for lab monitoring
  • Home delivery (typically 30-day supplies)
  • Clinical support and adherence monitoring

Contact CenterWell at the number provided on your transfer notice if you have questions about the process.

Common Problems and Solutions

Problem: "Portal shows PA pending for weeks"
Solution: Have your prescriber call Humana provider services directly to check for missing documentation.

Problem: "Denied for outdated REMS requirements"
Solution: Submit appeal citing FDA's April 2025 REMS discontinuation with official FDA link.

Problem: "Pharmacy says drug isn't covered"
Solution: Verify the pharmacy is in Humana's specialty network and has received the PA approval.

Frequently Asked Questions

How long does Humana prior authorization take for Opsumit in New York?
Standard requests: 7-15 business days. Expedited requests when urgent: 72 hours. By 2026, Humana commits to 95% of electronic PA decisions within one business day.

What if Opsumit is non-formulary on my Humana plan?
You can request a formulary exception by demonstrating medical necessity and why preferred alternatives aren't suitable. This requires detailed clinical documentation from your prescriber.

Can I request an expedited appeal if I'm hospitalized?
Yes. If your condition is deteriorating or you're at risk of serious adverse health consequences, request expedited review. Your prescriber must certify the urgency.

Does step therapy apply if I failed ERAs outside New York?
Yes, prior therapy failures from other states count toward step therapy requirements. Ensure your new prescriber has complete records from your previous physician.

What's the difference between Medicare and commercial Humana appeals?
Medicare follows federal timelines (65 days to appeal) and uses MAXIMUS for independent review. Commercial plans may have different deadlines and use New York's external appeal process directly.

How much does Opsumit cost with Humana coverage?
Costs vary by plan tier. Specialty medications typically have 20-40% coinsurance or high copays ($100-300+). Medicare patients may face coverage gaps where they pay 25% of the drug cost.

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by transforming insurance denials into targeted, evidence-backed appeals. Their platform specializes in turning payer policies and clinical documentation into successful coverage outcomes for specialty medications like Opsumit.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes can change. Always verify current requirements with Humana and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals in New York, contact Community Health Advocates at 888-614-5400 or visit the New York Department of Financial Services consumer assistance page.

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