By Counterforce Health Team in Opsumit (macitentan) —

Coding That Helps Get Opsumit (macitentan) Approved in New York with Blue Cross Blue Shield (ICD-10, HCPCS/J-Code, NDC)

Answer Box: Getting Opsumit Approved with Blue Cross Blue Shield in New York

Fastest path to approval: Use ICD-10 code I27.0 (primary PAH) or I27.21 (secondary PAH), document NYHA functional class II-III, and ensure pregnancy testing compliance per current FDA labeling (REMS discontinued April 2025). Submit via electronic prior authorization with cardiology/pulmonology specialist attestation. First step today: Contact your Blue Cross Blue Shield plan to confirm specific formulary requirements and PA submission portal. New York patients have strong external appeal rights through the Department of Financial Services if initially denied.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for PAH Documentation
  3. Product Coding: HCPCS, J-Codes, and NDC
  4. Clean Request Anatomy
  5. Frequent Pitfalls and Unit Conversions
  6. Verification with Blue Cross Blue Shield Resources
  7. Quick Audit Checklist
  8. New York Appeals Process
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Understanding how Blue Cross Blue Shield processes Opsumit (macitentan) claims depends on whether it's covered under your pharmacy benefit or medical benefit.

Pharmacy Benefit Path

Most Opsumit prescriptions are processed through the specialty pharmacy benefit since it's an oral medication for self-administration. This requires:

  • Standard NDC coding
  • Pharmacy-specific prior authorization forms
  • 90-day quantity limits (90 tablets per 90 days per Blue Cross Blue Shield policies)
  • Specialty pharmacy network compliance

Medical Benefit Path

In rare cases where Opsumit is administered in clinical settings or through specific programs, medical benefit coding applies:

  • HCPCS J-codes (typically J3490 for unclassified drugs)
  • Prior authorization required regardless of administration method
  • CPT codes for administration if applicable
Note: Most Blue Cross Blue Shield plans in New York process Opsumit through the pharmacy benefit. Always verify with your specific plan.

ICD-10 Mapping for PAH Documentation

Accurate ICD-10 coding is critical for Opsumit approval. Blue Cross Blue Shield requires specific pulmonary arterial hypertension documentation.

Primary ICD-10 Codes

ICD-10 Code Description When to Use Documentation Keywords
I27.0 Primary pulmonary hypertension Idiopathic PAH, heritable PAH "Primary PAH," "idiopathic," "heritable"
I27.21 Secondary pulmonary arterial hypertension Drug-induced, toxin-induced, associated PAH "Secondary PAH," "associated with," "drug-induced"
I27.22 Pulmonary hypertension due to left heart disease Group 2 PH (not typically covered for Opsumit) "Left heart disease," "Group 2"
I27.23 Pulmonary hypertension due to lung diseases Group 3 PH (not typically covered) "Lung disease," "hypoxia," "Group 3"
I27.24 Chronic thromboembolic pulmonary hypertension Group 4 PH "CTEPH," "chronic thromboembolic"

Documentation Requirements

For successful prior authorization, clinical notes must include:

  • Diagnosis confirmation: Right heart catheterization results showing mean PAP ≥20 mmHg
  • Functional class: NYHA Class II or III documentation
  • Exclusion of other causes: Evidence ruling out Groups 2-5 pulmonary hypertension
  • Specialist evaluation: Cardiology or pulmonology consultation notes
Tip: Use specific language like "WHO Group 1 pulmonary arterial hypertension" in clinical documentation to clearly distinguish from other forms of pulmonary hypertension.

Product Coding: HCPCS, J-Codes, and NDC

NDC Numbers for Opsumit

  • 10 mg tablets: NDC 50458-593-30 (30-count bottle)
  • 10 mg tablets: NDC 50458-593-90 (90-count bottle)

HCPCS/J-Code Billing

When billing under medical benefit:

  • Primary code: J3490 (Unclassified drugs)
  • Units: Based on prescribed strength and quantity
  • Modifier considerations: -JW for drug amount discarded (if applicable)

Unit Conversion Math

For J3490 billing:

  • Standard unit = per mg or per dose (verify with specific Blue Cross Blue Shield plan)
  • 10 mg tablet = 10 units if billed per mg
  • Monthly supply (30 tablets) = 300 units
Important: Always verify unit definitions with your specific Blue Cross Blue Shield plan, as interpretations can vary between affiliates.

Clean Request Anatomy

Example Prior Authorization Request

Patient Information:

  • Name, DOB, Member ID
  • Primary diagnosis: I27.0 (Primary pulmonary hypertension)
  • NYHA functional class: II

Clinical Justification:

  • Right heart catheterization date and results
  • Prior therapy trials and outcomes
  • Contraindications to alternative therapies
  • Pregnancy testing compliance (females of reproductive potential)

Prescriber Information:

  • Cardiologist or pulmonologist credentials
  • NPI number and contact information
  • Electronic signature and date

Medication Details:

  • Opsumit (macitentan) 10 mg daily
  • NDC: 50458-593-90
  • Quantity: 90 tablets per 90 days
  • Refills: 3 (for initial 1-year approval)

Frequent Pitfalls and Unit Conversions

Common Coding Errors

  1. Wrong ICD-10 code: Using I27.22 (Group 2 PH) instead of I27.0 or I27.21 for PAH
  2. Missing functional class: Failing to document NYHA Class II-III
  3. Incorrect NDC: Using discontinued or wrong strength NDC numbers
  4. Unit conversion errors: Miscalculating J-code units for medical benefit billing
  5. REMS confusion: Referencing discontinued REMS program instead of current pregnancy testing requirements

Pregnancy Testing Documentation Pitfalls

Since the FDA discontinued Opsumit REMS in April 2025, avoid these errors:

  • ❌ Stating "enrolled in REMS program"
  • ✅ Documenting "pregnancy testing per FDA labeling requirements"
  • ❌ Using old REMS forms
  • ✅ Providing current pregnancy test results and contraception counseling

Quantity Limit Issues

  • Standard limit: 90 tablets per 90 days
  • Common error: Requesting 30-day supplies (may trigger unnecessary reviews)
  • Solution: Always request 90-day supplies to align with formulary limits

Verification with Blue Cross Blue Shield Resources

Pre-Submission Verification Checklist

  1. Confirm formulary status: Check your specific Blue Cross Blue Shield plan's formulary
  2. Verify NDC coverage: Ensure the specific NDC is covered
  3. Review PA requirements: Confirm current prior authorization criteria
  4. Check provider network: Verify prescriber is in-network specialist
  5. Validate submission method: Confirm electronic PA portal or fax requirements

Key Resources to Verify

  • Plan-specific formulary documents
  • Medical policy bulletins
  • Provider portal PA requirements
  • Pharmacy benefit summaries
Note: Blue Cross Blue Shield operates 33 independent plans. Requirements may vary between New York affiliates like Empire Blue Cross Blue Shield and Excellus BlueCross BlueShield.

Quick Audit Checklist

Before submitting your Opsumit prior authorization:

Clinical Documentation ✓

  • ICD-10 code matches PAH diagnosis (I27.0 or I27.21)
  • NYHA functional class II-III documented
  • Right heart catheterization results included
  • Specialist (cardiology/pulmonology) evaluation complete
  • Pregnancy testing documented (if applicable)
  • Prior therapy trials and outcomes noted

Coding Accuracy ✓

  • Correct NDC number (50458-593-30 or 50458-593-90)
  • Appropriate quantity (90 tablets/90 days)
  • J-code units calculated correctly (if medical benefit)
  • No reference to discontinued REMS program

Administrative Requirements ✓

  • PA form completed by in-network specialist
  • Electronic submission via plan portal (preferred)
  • All required attachments included
  • Patient demographics match insurance card exactly

New York Appeals Process

If your Opsumit prior authorization is denied, New York offers robust appeal rights.

Internal Appeals (Blue Cross Blue Shield)

  • Timeline: 30-60 days from denial notice
  • Expedited option: Available for urgent medical needs
  • Required: Must complete internal appeal before external review

External Appeals (New York Department of Financial Services)

  • Timeline: 4 months from final internal denial to file
  • Process: File through DFS portal or mail to PO Box 7209, Albany, NY 12224
  • Cost: $25 fee (refunded if successful, waived for financial hardship)
  • Decision timeframe: 30 days standard, 72 hours expedited

Free Help Available

Community Health Advocates provides free assistance at 888-614-5400 for New York residents navigating insurance appeals.

When specialty drug access becomes complex, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each plan's specific requirements.

FAQ

How long does Blue Cross Blue Shield prior authorization take for Opsumit in New York? Standard PA decisions are typically made within 72 hours to 15 business days. Expedited reviews (for urgent medical needs) are processed within 72 hours.

What if Opsumit is not on my Blue Cross Blue Shield formulary? Request a formulary exception by demonstrating medical necessity and documenting failed trials with formulary alternatives. Include clinical evidence supporting Opsumit's unique benefits for your specific case.

Can I get an expedited appeal if my Opsumit is denied? Yes, if your physician certifies that following standard appeal timelines could seriously jeopardize your health. New York allows expedited external appeals with 72-hour decision timelines.

Do pregnancy testing requirements still apply after REMS was discontinued? Yes, pregnancy testing and contraception requirements remain in effect under FDA labeling requirements, even though the formal REMS program ended in April 2025.

What ICD-10 code should be used for drug-induced PAH? Use I27.21 (Secondary pulmonary arterial hypertension) for drug-induced or toxin-induced PAH, with additional documentation of the causative agent.

How do I verify my Blue Cross Blue Shield plan's specific requirements? Contact member services using the number on your insurance card, or log into your plan's member portal to access current formulary and PA requirements specific to your coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and specific plan terms. Always consult with your healthcare provider and insurance plan for personalized guidance. For complex prior authorization challenges, consider working with specialists like Counterforce Health who can help navigate payer-specific requirements and develop targeted appeal strategies.

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