By Counterforce Health Team in Opsumit (macitentan) —

How to Get Opsumit (macitentan) Covered by Cigna in North Carolina: Complete Appeals Guide with Forms and Timelines

Answer Box: To get Opsumit (macitentan) covered by Cigna in North Carolina, you need prior authorization with WHO Group 1 PAH confirmed by right heart catheterization, WHO functional class II-IV documentation, and specialist prescribing. If denied, exhaust Cigna's internal appeals first, then file for North Carolina's Smart NC external review within 120 days. Start by having your PAH specialist complete Cigna's PA form with comprehensive clinical documentation including hemodynamic data, functional assessment, and prior therapy history.

Table of Contents

  1. Quick Eligibility Check
  2. Documentation Requirements
  3. Fastest Path to Approval
  4. Common Denial Reasons & Solutions
  5. Appeals Process for North Carolina
  6. Cost Support Options
  7. When to Escalate
  8. FAQ

Quick Eligibility Check

Use this decision tree to determine your likelihood of Cigna coverage for Opsumit (macitentan) in North Carolina:

Likely Eligible ✅

  • Confirmed WHO Group 1 PAH by right heart catheterization
  • WHO functional class II, III, or IV with documented symptoms
  • Prescribed by PAH specialist (cardiologist, pulmonologist, or PH specialist)
  • Prior trial or contraindication to generic ambrisentan (Cigna's preferred ERA)
  • Pregnancy excluded and contraception documented (if applicable)

Possibly Eligible ⚠️

  • PAH diagnosis but missing recent hemodynamic data
  • WHO functional class I (may need additional justification)
  • General cardiologist prescribing without PAH specialist consultation
  • No documented trial of preferred alternatives

Not Yet Eligible ❌

  • Non-Group 1 pulmonary hypertension (left heart disease, lung disease, chronic thromboembolic)
  • No right heart catheterization confirming PAH
  • Pregnancy not excluded in women of reproductive potential

Documentation Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all ERAs including Opsumit Cigna provider portal or PA form Cigna ERA Policy
WHO Group 1 PAH Right heart cath confirmation Hemodynamic report from procedure Cigna PA Criteria
WHO Functional Class II-IV preferred for coverage Clinical assessment by specialist WHO-FC Documentation Guide
Specialist Prescribing Cardiologist, pulmonologist, or PH specialist Provider credentials and consultation notes Cigna Preferred Specialty Management
Step Therapy Trial of preferred ERA (ambrisentan) unless contraindicated Medication history and intolerance documentation Cigna PSM Policy

Essential Clinical Documentation

Your PAH specialist must provide:

Hemodynamic Confirmation:

  • Mean pulmonary artery pressure ≥ 25 mmHg
  • Pulmonary capillary wedge pressure ≤ 15 mmHg
  • Pulmonary vascular resistance > 3 Wood units
  • Date of right heart catheterization

Functional Assessment:

  • Current WHO functional class with specific activity limitations
  • 6-minute walk distance or exercise capacity
  • BNP/NT-proBNP levels
  • Recent echocardiogram showing RV assessment

Treatment History:

  • Complete list of prior PAH therapies with dates, doses, and outcomes
  • Specific documentation of ambrisentan trial/contraindication/intolerance
  • Rationale for choosing Opsumit over formulary alternatives

Fastest Path to Approval

Step 1: Verify Coverage (Patient/Clinic Staff)

Call Cigna member services using the number on your insurance card and ask:

  • "Is Opsumit (macitentan) on my 2024 formulary?"
  • "What prior authorization requirements apply?"
  • "Are there step therapy requirements?"

Step 2: Gather Documentation (PAH Specialist)

Collect within past 6 months:

  • Right heart catheterization report
  • WHO functional class assessment
  • 6-minute walk test results
  • BNP/NT-proBNP lab results
  • Echocardiogram with RV function
  • Complete PAH medication history

Step 3: Complete Prior Authorization (Specialist Office)

Submit via:

  • Cigna provider portal (fastest)
  • CoverMyMeds/Evernorth platform
  • Fax to Express Scripts (verify current number with Cigna)

Expected timeline: 5 business days for standard review, 24-72 hours for urgent cases.

Step 4: Pregnancy Safety Documentation (If Applicable)

For women of reproductive potential, include:

  • Negative pregnancy test within 1 month of starting
  • Documented contraception counseling and plan
  • Agreement to ongoing pregnancy monitoring
Note: The Opsumit REMS program was discontinued in April 2025, but pregnancy exclusion and contraception remain required per FDA labeling.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"No specialist management" Provide PAH specialist credentials Letter from cardiologist/pulmonologist confirming ongoing care
"Step therapy not completed" Document ambrisentan trial/contraindication Medication history with specific dates, doses, and intolerance details
"Insufficient functional limitation" Clarify WHO functional class Detailed activity assessment with specific examples of limitations
"Diagnosis not confirmed" Submit hemodynamic data Right heart catheterization report with complete measurements
"Not medically necessary" Provide guideline support Cite current PAH treatment guidelines and patient-specific factors

Appeals Process for North Carolina

Cigna Internal Appeals

First-Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • Method: Cigna member portal, phone, or written request
  • Timeline: 30 days for standard, 72 hours for expedited
  • Required: Original denial letter, additional medical records, physician letter

Peer-to-Peer Review:

  • Request via Cigna provider line
  • PAH specialist discusses case directly with Cigna medical director
  • Often resolves complex cases before formal appeal

North Carolina Smart NC External Review

If Cigna's final internal appeal is denied:

Eligibility:

  • State-regulated Cigna plan (most individual/small group plans qualify)
  • Denial based on medical necessity
  • Completed Cigna's internal appeals process

How to File:

  1. Download External Review Request Form
  2. Include: Final Cigna denial letter, medical records, internal appeal documentation
  3. Submit within 120 days of final denial

Submission Options:

  • Mail: Insurance Benefit Systems Administrators, PO Box 2917, Shawnee Mission, KS 66201-1317
  • Fax: 919-807-6865

Timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours (for urgent conditions)

Outcome: If approved, Cigna must provide coverage within 3 business days. Decision is binding on the insurer.

Tip: Contact Smart NC's helpline at 1-855-408-1212 for free assistance completing forms and navigating the process.

Counterforce Health Partnership

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to identify specific denial reasons and draft point-by-point rebuttals aligned with Cigna's own coverage rules. For complex PAH cases like Opsumit appeals, they pull appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines while ensuring all required clinical facts are included.

Cost Support Options

Manufacturer Support

  • Janssen CarePath: Patient assistance programs for eligible patients
  • Bridge programs: Temporary coverage during PA/appeal process
  • Copay assistance: May reduce out-of-pocket costs for commercially insured patients

Foundation Support

  • Patient Access Network Foundation: PAH-specific assistance programs
  • HealthWell Foundation: Copay assistance for qualifying patients
  • Good Days: Chronic disease financial support

State Programs

  • North Carolina Medicaid expansion (effective 2024): May provide additional coverage options
  • State pharmaceutical assistance programs: Check with NC Department of Health and Human Services

When to Escalate

File a Complaint with North Carolina

Contact the NC Department of Insurance if:

  • Cigna fails to meet appeal deadlines
  • Inappropriate denial patterns
  • Procedural violations

Contact: NC Department of Insurance Consumer Services
Phone: 855-408-1212

Federal Options

For Medicare Advantage plans:

  • Medicare.gov complaint system
  • Centers for Medicare & Medicaid Services

FAQ

How long does Cigna prior authorization take for Opsumit in North Carolina?
Standard PA review takes about 5 business days. Expedited reviews for urgent cases are completed within 24-72 hours.

What if Opsumit is non-formulary on my Cigna plan?
You can request a formulary exception with clinical rationale that formulary alternatives were ineffective or detrimental.

Can I request an expedited appeal in North Carolina?
Yes, both Cigna internal appeals and Smart NC external reviews offer expedited pathways for urgent medical conditions that could jeopardize life or health.

Do I need to try ambrisentan first?
Cigna typically requires trial of generic ambrisentan (preferred ERA) unless contraindicated, not tolerated, or clinically inappropriate for your specific case.

What counts as medical necessity for Opsumit?
WHO Group 1 PAH confirmed by right heart catheterization, symptomatic functional limitation (WHO FC II-IV), specialist management, and appropriate therapy history per current PAH guidelines.

How much does the Smart NC external review cost?
The external review process is free for consumers. Your health plan pays the Independent Review Organization fees.

What if I'm pregnant or could become pregnant?
Opsumit is contraindicated in pregnancy. You must have a negative pregnancy test before starting and use effective contraception during treatment and for one month after stopping.

Can I get temporary coverage while appeals are pending?
Ask your prescriber about manufacturer bridge programs or patient assistance that may provide medication during the PA/appeal process.

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 and insurance plan for specific coverage determinations. For personalized assistance with complex appeals, consider partnering with Counterforce Health, which specializes in evidence-based insurance appeals for specialty medications.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.