By Counterforce Health Team in Entresto (sacubitril/valsartan) —

How to Get Entresto (Sacubitril/Valsartan) Covered by Cigna in North Carolina: Prior Authorization Forms, Appeals, and Coding Guide

Quick Answer: Getting Entresto Covered by Cigna in North Carolina

Cigna requires prior authorization for Entresto (sacubitril/valsartan) in 2024. You'll need documentation of heart failure diagnosis (ICD-10 I50.22), proof of ACE inhibitor or ARB failure/intolerance, and clinical justification. Submit PA requests via Cigna's provider portal or fax to 1-866-873-8279. If denied, appeal within 180 days internally, then use North Carolina's Smart NC external review program within 4 months. First step today: Gather your heart failure diagnosis, LVEF results, and prior medication history to start the PA process.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Heart Failure
  3. Product Coding: NDC and HCPCS Overview
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Verification with Cigna Resources
  7. Appeals Process in North Carolina
  8. Quick Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Entresto (sacubitril/valsartan) is almost always billed under the pharmacy benefit as an oral tablet. Understanding this distinction is crucial for proper coding and reimbursement.

Pharmacy Benefit Path (Standard)

  • Use NDC codes for billing
  • Submit through retail, mail-order, or specialty pharmacy
  • Prior authorization required through pharmacy benefit management
  • No HCPCS J-codes needed for typical dispensing

Medical Benefit Path (Rare)

  • Only for unusual circumstances (inpatient use, feeding tube administration)
  • Requires NDC plus possibly J3490 (Unclassified drugs)
  • Must obtain payer pre-authorization and specific billing guidance
  • Submit on HCFA 1500 form with detailed justification
Note: Always verify the patient's specific benefit structure before submitting claims. Most Cigna plans process Entresto through Express Scripts pharmacy management.

ICD-10 Mapping for Heart Failure

Precise ICD-10 coding is essential for Entresto prior authorization approval. Payers require specific documentation of heart failure type and left ventricular ejection fraction (LVEF).

Primary ICD-10 Codes for Entresto Coverage

Heart Failure Type ICD-10 Code Documentation Required Entresto Indication
Chronic Systolic HF (HFrEF) I50.22 LVEF <40-50%, chronicity documented Primary indication
Acute Systolic HF I50.21 LVEF <40-50%, acute episode Yes, during acute phase
Heart Failure with Improved EF I50.32 Baseline and current LVEF, clinical status Possible, needs rationale
Combined HF I50.4x Systolic + diastolic components, LVEF Case-by-case basis
Unspecified HF I50.9 Avoid when EF data available Insufficient for approval

Documentation Requirements

  • Quantitative LVEF value from echocardiogram or equivalent imaging
  • Date of diagnostic study and facility where performed
  • Heart failure classification (NYHA Class I-IV if available)
  • Duration of diagnosis and previous hospitalizations
  • Current symptoms and functional status
Tip: Use I50.22 (Chronic systolic heart failure) for most Entresto prior authorization requests. This aligns with FDA labeling and clinical guidelines for HFrEF patients.

Product Coding: NDC and HCPCS Overview

NDC Codes for Entresto

Entresto products have strength-specific NDC codes that must match the prescribed formulation:

  • 24/26 mg tablets: 55513-301-30
  • 49/51 mg tablets: 55513-302-30
  • 97/103 mg tablets: 55513-303-30

HCPCS J-Code Information

Entresto does not have a dedicated HCPCS J-code since it's an oral medication. J-codes typically apply to injectable or infused drugs administered by healthcare providers.

  • Standard billing: Use NDC only for pharmacy benefit claims
  • Unusual circumstances: May use J3490 (Unclassified drugs) with prior payer approval for non-oral administration
  • Medical necessity: Required documentation if billing under medical benefit

Units and Quantity Calculations

  • Standard dosing: One tablet twice daily (BID)
  • Monthly supply: 60 tablets per 30 days
  • Insurance quantity limits: Usually align with 30-day supplies
  • Submit NDC in 11-digit HIPAA format with zero-padding

Clean Prior Authorization Request

A successful Entresto PA request includes specific clinical and administrative elements that demonstrate medical necessity and compliance with Cigna's coverage criteria.

Essential Documentation Checklist

Clinical Information:

  • Heart failure diagnosis with ICD-10 code I50.22
  • Current LVEF measurement (<40% typically required)
  • NYHA functional class and symptom severity
  • Previous heart failure hospitalizations or emergency visits

Step Therapy Documentation:

  • ACE inhibitor trial: Drug name, dose, duration, reason for discontinuation
  • ARB trial: Alternative if ACE inhibitor contraindicated
  • Failure/intolerance evidence: Lack of efficacy, adverse reactions, contraindications
  • Clinical notes supporting inability to continue previous therapy

Prescriber Information:

  • Cardiologist or heart failure specialist preferred
  • Clinical rationale for Entresto specifically
  • Treatment goals and monitoring plan
  • Contraindication screening completed

Sample Medical Necessity Statement

"Patient has chronic systolic heart failure (I50.22) with LVEF 30% documented by echocardiogram on [date]. Previous trial of lisinopril 20mg daily for 8 weeks resulted in persistent dry cough requiring discontinuation. Subsequently tried losartan 50mg daily for 6 weeks with inadequate symptom control and no improvement in functional status. Patient remains NYHA Class III with frequent shortness of breath limiting daily activities. Entresto is indicated per AHA/ACC/HFSA guidelines for HFrEF patients who remain symptomatic despite optimal medical therapy."

Common Coding Pitfalls

Frequent Documentation Errors

Missing LVEF Documentation

  • Problem: Using I50.9 (unspecified HF) when ejection fraction data exists
  • Solution: Always include quantitative LVEF and use appropriate systolic/diastolic codes

Inadequate Step Therapy Evidence

  • Problem: No documentation of ACE inhibitor or ARB trial
  • Solution: Provide specific drug names, doses, durations, and reasons for discontinuation

Incorrect NDC Coding

  • Problem: Using wrong strength-specific NDC code
  • Solution: Verify NDC matches prescribed Entresto formulation exactly

Insufficient Clinical Rationale

  • Problem: Generic "heart failure" without specificity
  • Solution: Include NYHA class, symptoms, hospitalizations, and guideline-based justification

Unit Conversion Issues

  • Prescription: Entresto 97/103mg BID
  • Monthly quantity: 60 tablets (30-day supply)
  • NDC: 55513-303-30 (must match 97/103mg strength)
  • Days supply: 30 (critical for quantity limit compliance)

Verification with Cigna Resources

Before submitting your Entresto prior authorization, verify current requirements through official Cigna channels.

Key Verification Steps

  1. Check formulary status: Confirm Entresto tier placement and restrictions
  2. Review PA criteria: Download current prior authorization form and requirements
  3. Verify submission method: Portal, fax (1-866-873-8279), or phone (1-800-882-4462)
  4. Confirm deadlines: Standard review (72 hours) vs. expedited timelines
  5. Document plan specifics: Coverage may vary between Cigna commercial and Medicare plans

Official Cigna Resources

  • Provider precertification portal
  • Current formulary documents (verify year and plan type)
  • Coverage policy bulletins for cardiovascular medications
  • Appeals and disputes procedures

Appeals Process in North Carolina

If Cigna denies your Entresto prior authorization, North Carolina offers a robust appeals process including state-level external review.

Cigna Internal Appeals

First-Level Appeal:

  • Deadline: 180 days from denial notice
  • Submission: Written appeal with supporting documentation
  • Timeline: 30 days for PA denials, 60-75 days for post-service
  • Address: Cigna Appeals Unit (verify current address on insurance card)

Required Documents:

North Carolina External Review (Smart NC)

If Cigna's internal appeal is denied, North Carolina's Smart NC program provides independent medical review.

Key Features:

  • Deadline: 4 months from final internal denial
  • Scope: Medical necessity, appropriateness, experimental treatment determinations
  • Timeline: 45 days standard, 72 hours expedited
  • Binding: Decision is final for both patient and insurer

How to Access Smart NC:

  • Phone: 1-855-408-1212 (free advocacy and guidance)
  • Website: NC Department of Insurance Smart NC
  • Forms: External review request available online
  • Support: Staff assistance with documentation and submission
From our advocates: We've seen many Entresto denials overturned through North Carolina's external review process, especially when providers submit comprehensive clinical evidence showing ACE inhibitor intolerance and current heart failure guidelines supporting ARNI therapy. The key is thorough documentation of the step therapy failures and clear medical necessity rationale.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by identifying denial reasons and drafting point-by-point rebuttals aligned with payer policies.

Quick Audit Checklist

Before submitting your Entresto prior authorization or appeal, review these critical elements:

Clinical Documentation ✓

  • Heart failure diagnosis with specific ICD-10 code (I50.22 preferred)
  • Current LVEF measurement with date and facility
  • NYHA functional class and symptom documentation
  • Complete medication history with ACE inhibitor/ARB trials

Administrative Requirements ✓

  • Correct NDC code matching prescribed strength
  • Prior authorization form completed fully
  • Provider NPI and contact information
  • Patient insurance ID and group number

Step Therapy Evidence ✓

  • ACE inhibitor trial documented (drug, dose, duration)
  • Reason for discontinuation specified (intolerance/failure)
  • ARB trial if ACE inhibitor contraindicated
  • Clinical notes supporting medication changes

Submission Details ✓

  • Submitted within required timeframes
  • All supporting documents attached
  • Correct submission method (portal/fax/phone)
  • Follow-up plan for tracking approval status

FAQ

How long does Cigna prior authorization take for Entresto in North Carolina? Standard PA reviews take up to 72 hours for urgent requests, 15 days for non-urgent. Expedited reviews are available if delay would jeopardize health.

What if Entresto is non-formulary on my Cigna plan? Request a formulary exception with clinical documentation showing medical necessity. Include evidence that formulary alternatives are inappropriate or ineffective.

Can I get expedited approval if I'm hospitalized for heart failure? Yes, expedited PA review is available for urgent clinical situations. Your provider should specify the urgency when submitting the request.

Does step therapy apply if I failed ACE inhibitors outside North Carolina? Yes, previous medication trials from other states count toward step therapy requirements. Provide documentation from your previous healthcare providers.

What counts as ACE inhibitor "failure" for Entresto approval? Failure includes lack of efficacy (no symptom improvement), intolerance (cough, angioedema), or contraindications (hyperkalemia, renal dysfunction).

How much does Entresto cost with Cigna coverage? Costs vary by plan tier and deductible status. Check your specific formulary tier and copay/coinsurance amounts. Manufacturer copay assistance may be available.

Can my pharmacist help with the prior authorization? Many specialty pharmacies assist with PA submissions. However, clinical documentation must come from your prescribing physician.

What happens if Smart NC external review denies coverage? The external review decision is binding. Additional options may include seeking care through alternative pathways or exploring manufacturer patient assistance programs.

For patients and providers navigating complex coverage requirements, Counterforce Health offers specialized support in transforming insurance denials into successful appeals through evidence-based advocacy and payer-specific workflows.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with your specific Cigna plan and consult healthcare providers for medical decisions. For official appeals guidance in North Carolina, contact Smart NC at 1-855-408-1212.

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