By Counterforce Health Team in Opsumit (macitentan) —

How to Get Opsumit (macitentan) Covered by Blue Cross Blue Shield in Virginia: Complete PA Guide & Appeals Process

Answer Box: Getting Opsumit (macitentan) Covered by Blue Cross Blue Shield in Virginia

Fastest Path: Opsumit requires prior authorization from Blue Cross Blue Shield in Virginia. Your pulmonologist must submit PA documentation including WHO Group 1 PAH diagnosis, step therapy compliance, and pregnancy testing records. If denied, Virginia offers external review through the State Corporation Commission with a 49% overturn rate for medical/surgical denials.

First Step Today: Have your specialist gather all clinical documentation and submit the PA request through Anthem's provider portal or designated fax line. Contact Counterforce Health for assistance with evidence-backed appeals if needed.

Table of Contents

  1. Blue Cross Blue Shield Virginia Plan Types & Coverage
  2. Opsumit Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Network & Dispensing
  5. Common Denial Reasons & Solutions
  6. Virginia Appeals Process
  7. Cost Considerations & Patient Support
  8. Step-by-Step Approval Guide
  9. FAQ: Common Questions

Blue Cross Blue Shield Virginia Plan Types & Coverage

In Virginia, Anthem Blue Cross Blue Shield (part of Elevance Health) dominates the commercial market with about 43% share. Your plan type affects how Opsumit coverage works:

Commercial Plans (HMO/PPO/EPO)

  • Prior authorization required for all plan types
  • Specialty pharmacy dispensing mandatory
  • Appeals follow commercial timelines (30 days internal, 120 days for external review)

Medicare Plans

  • Follow Medicare Part D guidelines with additional Anthem requirements
  • May have different formulary tiers than commercial plans

Medicaid Managed Care

  • Virginia expanded Medicaid in 2019, improving access
  • Opsumit coverage follows state Medicaid guidelines plus Anthem's clinical criteria
Note: Self-funded employer plans may opt into Virginia's external review process but aren't required to. Check with HR if your denial involves an employer plan.

Opsumit Formulary Status & Tier Placement

Current Status (2024-2025) Opsumit (macitentan) is covered on Anthem Blue Cross Blue Shield Virginia formularies as a specialty drug with prior authorization required. It's typically placed on a non-preferred specialty tier, meaning higher out-of-pocket costs than preferred alternatives.

Coverage Requirements

  • Specialty drug classification
  • Prior authorization mandatory
  • Step therapy requirements (must try preferred agents first)
  • Quantity limits: 30 tablets per 30 days standard
  • Specialty pharmacy dispensing only

Alternative Agents Anthem prefers these PAH medications before approving Opsumit:

  • Ambrisentan (generic endothelin receptor antagonist)
  • Bosentan (generic ERA)
  • Sildenafil (PDE5 inhibitor)

Prior Authorization Requirements

Clinical Documentation Must Include

Diagnosis Requirements

  • Confirmed WHO Group 1 pulmonary arterial hypertension (PAH)
  • Right heart catheterization results
  • Current NYHA/WHO functional class (II-IV)
  • ICD-10 codes for PAH

Step Therapy Documentation

  • Documented trials of preferred agents (ambrisentan, bosentan, or sildenafil)
  • Reasons for discontinuation (inadequate response, intolerance, contraindications)
  • Duration of each trial and clinical outcomes

Specialist Requirements

  • Prescription from pulmonologist or cardiologist
  • Specialist attestation of medical necessity
  • Treatment goals and monitoring plan

Pregnancy Testing & REMS While the FDA discontinued the formal Opsumit REMS program in April 2025, pregnancy testing remains mandatory:

  • Pre-treatment negative pregnancy test
  • Monthly pregnancy tests during treatment
  • Effective contraception documentation
  • Post-treatment pregnancy test (one month after stopping)

Submission Process

Provider Portal: Submit through Anthem's online provider portal for fastest processing Fax Submission: Use Anthem's designated PA fax line (verify current number with provider services) Required Forms: Complete Anthem's non-oncology specialty drug PA form

Tip: Incomplete submissions are the most common cause of delays. Include all required documentation with your initial request.

Specialty Pharmacy Network & Dispensing

Network Requirements Opsumit must be dispensed through Anthem's contracted specialty pharmacy network. Common partners include:

  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Other Anthem-approved specialty pharmacies

Patient Enrollment Process

  1. Prescriber e-prescribes to designated specialty pharmacy
  2. Specialty pharmacy contacts patient for enrollment
  3. Insurance verification and PA confirmation
  4. Patient counseling on risks and adherence
  5. Home delivery coordination

NCPDP Information For Accredo: NCPDP ID 4436920 (verify with current provider directory)

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Step therapy not met Document failed trials of preferred agents Prior therapy records, discontinuation reasons
Insufficient diagnosis documentation Provide complete PAH workup Right heart cath, specialist notes, functional class
Missing pregnancy testing Submit current testing records Monthly pregnancy tests, contraception plan
Off-label use Confirm WHO Group 1 PAH indication Diagnostic confirmation, specialist attestation
Quantity limit exceeded Justify higher dose/quantity Clinical rationale, dosing guidelines

Virginia Appeals Process

Virginia provides robust appeal rights through the State Corporation Commission Bureau of Insurance.

Internal Appeals (First Level)

  • Timeline: 30 days for standard appeals, 72 hours for urgent
  • Deadline: File within 180 days of denial
  • Process: Submit through Anthem member portal or written request

External Review (Independent Review)

  • Eligibility: After completing internal appeals
  • Timeline: 45 days for standard, 72 hours for expedited
  • Success Rate: 49% overturn rate for medical/surgical denials (2023 data)
  • Cost: Free to consumers
  • Deadline: 120 days from final internal denial

How to File External Review

  1. Complete Form 216-A (External Review Request)
  2. Submit to Virginia SCC Bureau of Insurance
  3. Include all medical records and correspondence
  4. Bureau assigns Independent Review Organization (IRO)

Contact Information

From Our Advocates: "We've seen Virginia external reviews succeed when patients include comprehensive step therapy documentation and specialist letters explaining why Opsumit is uniquely necessary. The key is showing you've genuinely tried and failed other options."

Cost Considerations & Patient Support

Manufacturer Support

  • Janssen CarePath patient assistance program
  • Copay cards for eligible patients (verify income limits)
  • Free drug programs for uninsured patients

Virginia State Programs

  • Medicaid expansion covers adults up to 138% of federal poverty level
  • Virginia's uninsured rate dropped to 6.4% in 2023

Typical Costs

  • Specialty tier copays range from $50-$500+ per month
  • Annual costs can reach five figures without insurance
  • Deductibles apply before copay assistance in most plans

Step-by-Step: Fastest Path to Approval

Step 1: Gather Documentation (Patient & Clinic)

Timeline: 1-2 weeks

  • Insurance card and policy details
  • Complete PAH diagnostic workup
  • Prior therapy records from all providers
  • Current pregnancy test (if applicable)

Step 2: Specialist Consultation (Clinic)

Timeline: 1-2 weeks

  • Pulmonologist or cardiologist evaluation
  • Functional class assessment
  • Treatment plan documentation
  • Medical necessity letter

Step 3: Prior Authorization Submission (Clinic)

Timeline: Same day

  • Submit via Anthem provider portal
  • Include all required documentation
  • Request expedited review if urgent

Step 4: Follow Up (Patient & Clinic)

Timeline: 3-7 business days

  • Monitor for additional information requests
  • Respond promptly to any queries
  • Track approval status

Step 5: Specialty Pharmacy Setup (Patient)

Timeline: 2-3 days after approval

  • Enroll with designated specialty pharmacy
  • Complete patient counseling
  • Arrange delivery

Step 6: Appeal if Denied (Patient & Clinic)

Timeline: Start immediately

  • File internal appeal within 180 days
  • Gather additional supporting evidence
  • Consider Counterforce Health assistance for evidence-backed appeals

Step 7: External Review if Needed (Patient)

Timeline: Within 120 days of final denial

  • File Form 216-A with Virginia SCC
  • Submit comprehensive medical records
  • Await IRO decision (45 days)

FAQ: Common Questions

How long does Anthem PA take in Virginia? Standard prior authorizations: 3-7 business days. Expedited reviews (with clinical urgency): 72 hours. Complex cases may take up to 14 days.

What if Opsumit is non-formulary on my plan? Even non-formulary drugs can be covered through formulary exceptions. Your doctor must demonstrate medical necessity and that preferred alternatives are inappropriate.

Can I request expedited appeal? Yes, if your doctor certifies that waiting could seriously jeopardize your health. Virginia allows expedited external review within 72 hours for urgent cases.

Does step therapy apply if I failed medications outside Virginia? Yes, step therapy requirements follow the patient, not the state. Document all prior trials regardless of where they occurred.

What counts as "medical necessity" for Opsumit? WHO Group 1 PAH diagnosis, functional class II-IV symptoms, failed trials of preferred agents, and specialist attestation that Opsumit is clinically appropriate.

How much does external review cost in Virginia? External review is free to consumers. Virginia doesn't charge for this service.

Can I get help with my appeal? Yes. The Virginia SCC Consumer Services provides free guidance. Organizations like Counterforce Health specialize in evidence-backed appeals for specialty drugs.

What if my employer plan is self-funded? Self-funded plans may opt into Virginia's external review process. If not, federal external review through HHS may be available. Check with HR first.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific rules, pulling the right citations and clinical evidence to support your case.

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 company for the most current requirements. Coverage policies change frequently, and individual circumstances vary. For personalized assistance with prior authorization or appeals, contact your healthcare team or a qualified patient advocacy service.

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