By Counterforce Health Team in Opsumit (macitentan) —

How to Get Opsumit (macitentan) Covered by Cigna in California: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Opsumit Covered by Cigna in California

Cigna requires prior authorization for Opsumit (macitentan) with specific PAH criteria. Your fastest path: 1) Confirm WHO Group I PAH diagnosis with right heart catheterization data, 2) Document failed trials of preferred ERAs (ambrisentan/bosentan), 3) Submit PA via CoverMyMeds or fax to 1-866-873-8279 with medical necessity letter. If denied, California residents can file a free Independent Medical Review (IMR) through DMHC, which overturns ~61% of denials. Start today by gathering your catheterization report and prior therapy records.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding and Documentation Requirements
  5. Medical Necessity Letter Components
  6. Submission Process
  7. Specialty Pharmacy Routing Through Accredo
  8. After Submission: What to Expect
  9. Appeals Process in California
  10. Common Denial Prevention Tips
  11. Costs and Patient Assistance
  12. Printable Requirements Checklist

Who Should Use This Guide

This comprehensive checklist is designed for California residents with Cigna coverage (commercial, Medicare Advantage, or Medicaid managed care) who need Opsumit (macitentan) for pulmonary arterial hypertension. Whether you're a patient navigating your first prior authorization or a clinician preparing an appeal, this guide covers Cigna's specific requirements and California's unique appeal rights.

Expected outcome: With proper documentation, Cigna approvals for Opsumit typically process within 72 hours for standard requests. If initially denied, California's Independent Medical Review system has a 61% overturn rate for medical necessity denials.

Member & Plan Basics

Coverage Verification Steps

Before starting your prior authorization:

  1. Confirm active Cigna coverage via myCigna.com or member services
  2. Check formulary tier - Opsumit is typically Tier 3-4 specialty
  3. Verify deductible status - specialty drugs may have separate deductibles
  4. Review quantity limits - usually 30-day supply initially

Plan Types and Requirements

Plan Type PA Required? Step Therapy? Specialty Pharmacy?
Cigna Commercial PPO/HMO Yes Often (ambrisentan first) Yes (Accredo)
Cigna Medicare Advantage Yes Plan-specific Yes (Accredo)
Cigna Medicaid (managed) Yes Varies by state contract Yes

Source: Cigna PA policies

Clinical Criteria for Approval

Primary Requirements

Diagnosis Documentation:

  • Confirmed WHO Group I pulmonary arterial hypertension
  • Right heart catheterization showing mean PAP ≥20-25 mmHg, PAWP ≤15 mmHg, PVR ≥2-3 Wood units
  • Exclusion of other WHO groups (left heart disease, lung disease, CTEPH)

Functional Status:

  • NYHA/WHO Functional Class II-III symptoms
  • Six-minute walk distance (if available)
  • Documentation of activity limitation

Prescriber Requirements:

  • Pulmonologist or cardiologist experienced in PAH management
  • Board certification preferred

Step Therapy Requirements

Most Cigna plans require documented trial and failure of:

  1. Calcium channel blockers (if vasoreactive on acute testing)
  2. Preferred endothelin receptor antagonist (typically ambrisentan)
  3. PDE5 inhibitor (sildenafil or tadalafil) may be required

Failure criteria include inadequate symptom control, disease progression, or documented intolerance with specific adverse events.

Clinician Corner: Document specific dates, doses, duration, and outcomes for each prior therapy. "Patient tried ambrisentan 5mg daily for 3 months with persistent Class III symptoms and 6MWD decline from 350m to 280m" is more compelling than "failed ambrisentan."

Coding and Documentation Requirements

ICD-10 Codes for PAH

Code Description Notes
I27.0 Primary pulmonary hypertension Most common for idiopathic PAH
I27.21 Pulmonary arterial hypertension Idiopathic/heritable PAH
I27.2 Other secondary pulmonary hypertension Associated PAH
I27.81 Cor pulmonale (chronic) Secondary PAH with right heart involvement

HCPCS and NDC Information

  • Primary NDC: 66215-501-30 (10 mg tablets)
  • HCPCS J-code: J3590 (unclassified biologics) if billed under medical benefit
  • Typical quantity: 30 tablets per 30 days
  • Units: Each tablet = 1 unit

Source: J&J ICD-10 Support

Medical Necessity Letter Components

Essential Elements

Your medical necessity letter should include:

  1. Patient identification and confirmed PAH diagnosis with catheterization data
  2. Current functional class with specific symptom description
  3. Prior therapy trials with dates, doses, and outcomes
  4. Clinical rationale for Opsumit specifically
  5. Treatment goals and monitoring plan
  6. Pregnancy prevention documentation (if applicable)

Sample Template Language

"[Patient] is a [age]-year-old [gender] with WHO Group I pulmonary arterial hypertension confirmed by right heart catheterization on [date] showing mPAP [value] mmHg, PAWP [value] mmHg, and PVR [value] Wood units. The patient is currently NYHA Functional Class III with dyspnea and fatigue occurring with less than ordinary activity."

"Previous therapy with ambrisentan 10mg daily for 4 months resulted in inadequate symptom control with persistent Class III symptoms and decline in 6-minute walk distance. Opsumit (macitentan) is FDA-approved for PAH to reduce disease progression and hospitalizations, making it clinically appropriate for this patient's refractory symptoms."

Pregnancy Prevention Documentation

Since the Opsumit REMS program was discontinued in April 2025, you no longer need REMS enrollment documentation. However, pregnancy prevention remains critical:

  • For women of reproductive potential: Document negative pregnancy test and effective contraception counseling
  • For pregnant women: Opsumit is contraindicated
  • For males: Consider counseling about potential effects on spermatogenesis

Source: FDA Opsumit Label

Submission Process

Electronic Submission (Preferred)

  1. CoverMyMeds - integrates with most EHR systems
  2. SureScripts - real-time PA processing
  3. Cigna provider portal - direct submission option

Fax Submission

Fax number: 1-866-873-8279

Required information:

  • Patient demographics and Cigna ID
  • Prescriber NPI and contact information
  • Complete medical necessity letter
  • Supporting documentation (cath report, prior therapy records)
  • Prescription details with NDC, quantity, and refills

Common Rejection Reasons

  • Missing right heart catheterization data
  • Inadequate step therapy documentation
  • Incomplete prescriber information
  • Missing ICD-10 code or incorrect diagnosis
  • Unsigned medical necessity letter

Specialty Pharmacy Routing Through Accredo

Once approved, Cigna automatically routes Opsumit prescriptions to Accredo specialty pharmacy.

Enrollment Process

  1. Automatic transfer occurs for approved prescriptions
  2. Accredo contacts patient within 24-48 hours
  3. Complete enrollment via phone at 844-516-3319
  4. Set up patient portal at myAccredoPatients.com

What to Expect

  • Free home delivery with temperature-controlled shipping
  • Clinical support from specialized pharmacists
  • Refill reminders and adherence monitoring
  • Copay assistance coordination if eligible

Source: Accredo Referral Information

After Submission: What to Expect

Timeline for Decisions

  • Standard PA: 72 hours for electronic submissions
  • Fax submissions: 3-5 business days
  • Expedited requests: 24 hours with clinical urgency documentation

Status Tracking

  • Confirmation number provided upon submission
  • CoverMyMeds dashboard for real-time status
  • Cigna provider portal status updates
  • Patient can check via myCigna app or website

Appeals Process in California

California offers robust appeal rights through two regulatory agencies depending on your plan type.

Internal Appeals with Cigna

Timeline: 180 days from denial date Process: Submit written appeal with additional clinical documentation Decision: 30 days for standard, 72 hours for expedited

California Independent Medical Review (IMR)

California residents have access to free external review through the Department of Managed Health Care (DMHC) for most HMO and managed care plans.

Success rates: DMHC overturns approximately 61% of health plan denials overall, with 55.3% success rate for medical necessity denials.

Eligibility:

  • Must complete internal appeal first (or wait 30 days)
  • Denial based on medical necessity, experimental/investigational status
  • No cost to patient

Process:

  1. File IMR application at healthhelp.ca.gov
  2. Submit supporting documents (denial letter, medical records, physician statement)
  3. Independent expert review by PAH specialist
  4. Decision within 45 days (7 days for expedited)
  5. Binding decision - insurer must comply if overturned

DMHC Help Center: 888-466-2219

Source: California Chronic Care Coalition IMR Results

From our advocates: We've seen PAH patients succeed in California IMR by submitting multiple specialist opinions and recent clinical trial data showing Opsumit's effectiveness for their specific PAH subtype. The key is demonstrating that denial contradicts current PAH management guidelines and FDA-approved indications.

Common Denial Prevention Tips

Five Pitfalls to Avoid

  1. Incomplete catheterization data - Always include specific pressures and resistance calculations
  2. Vague step therapy documentation - Document specific drugs, doses, duration, and objective failure measures
  3. Missing functional class - Use NYHA/WHO terminology with specific activity limitations
  4. Unsigned letters - Electronic signatures acceptable, but stamps are not
  5. Wrong ICD-10 codes - Use specific PAH codes, not generic pulmonary hypertension

Documentation Best Practices

  • Use objective measures when possible (6MWD, BNP levels, echo parameters)
  • Reference guidelines from AHA/ACC, ESC/ERS, or CHEST
  • Include progression data showing worsening despite current therapy
  • Document contraindications to preferred agents when applicable

Costs and Patient Assistance

Manufacturer Support

Opsumit Assist Program

  • Copay assistance for eligible commercial patients
  • Patient assistance program for uninsured/underinsured
  • Phone: 1-866-228-3546
  • Website: jnjwithme.com/opsumit

Foundation Grants

  • Pulmonary Hypertension Association assistance programs
  • Patient Access Network (PAN) Foundation
  • Good Days (formerly Chronic Disease Fund)

State Programs

California residents may qualify for additional assistance through Covered California or Medi-Cal programs.

Printable Requirements Checklist

Before You Start:

  • Active Cigna coverage verified
  • Right heart catheterization report available
  • Prior therapy documentation collected
  • Current functional class assessed

Clinical Documentation:

  • WHO Group I PAH diagnosis confirmed
  • Catheterization shows mPAP ≥20-25 mmHg, PAWP ≤15 mmHg
  • NYHA/WHO Functional Class II-III documented
  • Step therapy completed or contraindicated
  • Prescriber is pulmonologist or cardiologist

Submission Requirements:

  • Medical necessity letter signed and dated
  • Correct ICD-10 code included (I27.0, I27.21, I27.2, or I27.81)
  • Prescription details with NDC 66215-501-30
  • Pregnancy prevention documented (if applicable)
  • Supporting documents attached

Post-Submission:

  • Confirmation number recorded
  • Status tracking method established
  • Accredo enrollment completed (if approved)
  • Appeal timeline noted (180 days for internal, 6 months for IMR)

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and creating targeted, evidence-backed appeals. Our platform identifies specific denial reasons and drafts point-by-point rebuttals aligned with each payer's policies, significantly improving approval rates for specialty medications like Opsumit.

For personalized assistance with your Cigna prior authorization or appeal, visit www.counterforcehealth.org to learn how our platform can strengthen your submission with payer-specific workflows and clinical evidence integration.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may vary by specific plan design and can change over time. Always verify current requirements with your insurance plan and consult with your healthcare provider regarding treatment decisions. For personalized assistance with California insurance appeals, contact the DMHC Help Center at 888-466-2219.

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