By Counterforce Health Team in Opsumit (macitentan) —

How to Get Opsumit (Macitentan) Covered by Aetna CVS Health in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Opsumit Approved by Aetna CVS Health in North Carolina

Opsumit (macitentan) requires prior authorization from Aetna CVS Health for pulmonary arterial hypertension (PAH) treatment. The fastest path: (1) Complete the Aetna Rx PA form with WHO Group 1 PAH diagnosis, step therapy documentation, and REMS enrollment, (2) Submit via Availity portal or fax to 1-888-267-3277, (3) If denied, appeal internally within 180 days, then request external review through Smart NC within 120 days. Standard decisions take 30-45 days; expedited appeals 72 hours.

Table of Contents

Verify Your Plan and Coverage

Before starting your Opsumit prior authorization, confirm your Aetna CVS Health plan details:

Check Your Coverage:

  • Log into your Aetna member portal to verify your prescription benefits
  • Confirm CVS Caremark manages your pharmacy benefits (most Aetna plans)
  • Review your 2024 Drug Guide for Opsumit's formulary status

Plan Type Matters:

  • State-regulated commercial plans: Follow this guide and can use Smart NC external review
  • Self-funded employer plans: May have different appeal rights (check your Summary Plan Description)
  • Medicare Advantage: Use separate Medicare appeal forms and timelines
Note: North Carolina residents with state-regulated plans have strong consumer protections through the Department of Insurance's Smart NC program.

Required Forms and Documentation

Primary Prior Authorization Form

Aetna Rx Precertification Form (GR-68988)

Required Clinical Documentation

Document Type Specific Requirements Purpose
PAH Diagnosis WHO Group 1 PAH confirmed by right heart catheterization, ICD-10 code Establishes medical necessity
Functional Class NYHA/WHO Class II-III documentation, 6-minute walk test results Shows disease severity
Step Therapy Prior ERA trial (ambrisentan/bosentan) with doses, duration, failure reasons Meets formulary requirements
REMS Enrollment Opsumit REMS program confirmation, pregnancy testing documentation FDA safety requirement
Medical Necessity Letter Physician attestation citing 2019 CHEST PAH guidelines, FDA labeling Clinical justification

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should include:

  • Problem: Confirmed WHO Group 1 PAH diagnosis with hemodynamic parameters
  • Prior treatments: Specific ERA medications tried, doses, duration, and reasons for discontinuation
  • Clinical rationale: Why Opsumit is medically necessary for this patient
  • Guideline citations: Reference FDA labeling and current PAH treatment guidelines
  • Monitoring plan: Follow-up schedule and safety monitoring

Submission Portals and Methods

Electronic Submission (Preferred)

Availity Portal

  • URL: www.availity.com
  • Requires provider registration
  • Upload PA form, clinical notes, and supporting documentation
  • Fastest processing time

CoverMyMeds

  • Alternative electronic submission platform
  • Integrated with many EHR systems
  • Real-time status updates

Manual Submission

Fax: 1-888-267-3277 Phone: 1-855-240-0535 (M-F, 8am-6pm CT) for drug-specific criteria

Tip: Electronic submission through Availity typically processes faster than fax submissions.

Fax Numbers and Mailing Addresses

Primary Contact Information

Prior Authorization Fax: 1-888-267-3277 Appeals Fax: 1-866-249-6155 Provider Services: 1-866-814-5506

Mailing Address for Appeals: Aetna Pharmacy Appeals Unit P.O. Box 14079 Lexington, KY 40512

Cover Sheet Best Practices

Include on your fax cover sheet:

  • Patient name and member ID
  • "URGENT: Opsumit (macitentan) Prior Authorization"
  • Total number of pages
  • Your callback number for questions

CVS Specialty Pharmacy Enrollment

Opsumit must be dispensed through CVS Specialty Pharmacy for most Aetna plans.

Enrollment Process

  1. Complete Enrollment Form: Download the Opsumit enrollment form
  2. Select CVS Specialty: Check the CVS/specialty box on the form
  3. Submit to J&J withMe: Fax to 866-279-0669
  4. Patient Portal Access: Register at jnjwithme.com for support services

Transfer from Another Pharmacy

  • Contact J&J withMe at 866-228-3546
  • Prescriber resubmits enrollment form specifying CVS Specialty
  • Coordinate with current pharmacy for seamless transition

For patients and clinicians dealing with complex insurance approvals, Counterforce Health offers specialized support in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify denial reasons and draft point-by-point rebuttals aligned with payer policies.

Support Phone Lines

Member Services

General Aetna Member Services: 1-800-CVS-CARE CVS Pharmacy Questions: 1-888-792-3862 (TTY: 711)

  • Hours: Mon-Fri 7 AM-11 PM ET, Sat 7 AM-9:30 PM ET, Sun 8 AM-6 PM ET

Provider Services

Provider Services: 1-866-814-5506 Credentialing: 1-800-353-1232 (TTY: 711)

What to Ask When You Call

  • "What is the status of my Opsumit prior authorization?"
  • "What additional documentation is needed?"
  • "Can I request a peer-to-peer review with the medical director?"
  • "What are the specific step therapy requirements?"

North Carolina Appeals and External Review

Internal Appeals with Aetna

Timeline: File within 180 days of denial Decision: 30 days (standard), 72 hours (expedited) Submission: Aetna member portal, mail, or fax

Smart NC External Review

If Aetna denies your internal appeal, North Carolina residents can request external review through Smart NC.

Eligibility:

  • State-regulated commercial plan (not self-funded)
  • Denial based on medical necessity or experimental treatment determination
  • Exhausted internal appeals (or qualify for expedited review)

Process:

  1. Contact Smart NC: Call 1-855-408-1212 for free advocacy and form assistance
  2. Submit Request: Within 120 days of final internal denial
  3. Decision Timeline: 45 days (standard), 72 hours (expedited)
  4. Binding Result: If approved, Aetna must provide coverage within 3 business days
From Our Advocates: We've seen many Opsumit denials overturned through Smart NC external review when patients provide comprehensive documentation of PAH diagnosis, prior treatment failures, and current functional limitations. The key is thorough documentation and meeting all procedural requirements.

Smart NC Resources

  • Phone: 1-855-408-1212
  • Website: ncdoi.gov
  • Services: Free advocacy, form assistance, appeals guidance

Common Denial Reasons and Fixes

Denial Reason How to Overturn Key Documents
Missing REMS enrollment Complete Opsumit REMS program REMS confirmation, pregnancy testing records
Step therapy not met Document prior ERA failures Pharmacy records, clinical notes on side effects/inadequate response
Insufficient functional class documentation Provide WHO/NYHA classification 6-minute walk test, functional assessment, hemodynamics
Non-formulary status Request formulary exception Medical necessity letter, alternative contraindications
Quantity limit exceeded Justify dosing requirements FDA labeling, specialist recommendation

Appeal Letter Template

When writing your appeal, include:

  • Clear statement: "I am appealing the denial of Opsumit (macitentan)"
  • Member ID and claim number
  • Medical necessity justification
  • References to Aetna's own medical policy
  • Request for expedited review if urgent

FAQ

How long does Aetna CVS Health PA take in North Carolina? Standard prior authorization decisions take 30-45 days. Expedited requests for urgent medical situations are decided within 72 hours.

What if Opsumit is non-formulary on my plan? You can request a formulary exception with your doctor's supporting documentation. If denied, appeal internally then through Smart NC external review.

Can I get Opsumit from a retail pharmacy? No, Aetna CVS Health requires specialty medications like Opsumit to be dispensed through CVS Specialty Pharmacy.

Does step therapy apply if I failed ERAs outside North Carolina? Yes, document prior failures regardless of where treatment occurred. Include pharmacy records and clinical notes from all providers.

What's the difference between expedited and standard appeals? Expedited appeals are for urgent situations where delays could jeopardize health. They're decided within 72 hours vs. 30 days for standard appeals.

How much does Opsumit cost with Aetna coverage? Costs vary by plan. After approval, expect specialty tier copays. Check manufacturer copay assistance programs and patient support through J&J withMe.

For complex cases requiring detailed appeals strategy, healthcare providers and patients can leverage specialized services like Counterforce Health, which helps transform insurance denials into successful approvals through evidence-based appeal documentation.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult your healthcare provider for medical decisions and verify current forms and procedures with your insurance company and state regulators. Coverage decisions depend on individual medical circumstances and plan terms.

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