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

How to Get Entresto (Sacubitril/Valsartan) Covered by Blue Cross Blue Shield in North Carolina: Complete PA Guide and Appeals Process

Answer Box: Getting Entresto Covered by Blue Cross Blue Shield in North Carolina

Blue Cross Blue Shield of North Carolina requires prior authorization for Entresto (sacubitril/valsartan), with specific criteria including documented heart failure with LVEF ≤40%, NYHA class II-IV symptoms, and prior ACE inhibitor or ARB trial. First step today: Gather your echocardiogram report showing LVEF, medication history documenting ACE/ARB trial outcomes, and contact your prescriber to submit the PA form via the Blue Cross NC provider portal or fax 844-376-2318 (Medicaid plans). If denied, you can appeal internally within 180 days, then request external review through Smart NC within 120 days.

Table of Contents

Blue Cross Blue Shield NC Policy Overview

Blue Cross Blue Shield of North Carolina operates several plan types that handle Entresto coverage differently:

Healthy Blue (Medicaid Plans): Requires prior authorization with specific clinical criteria. Coverage applies to NC Medicaid and NC Health Choice beneficiaries (ages 6-18) enrolled on the service date.

Commercial and Medicare Plans: Entresto appears on most formularies but may have quantity limits, step therapy requirements, or tier restrictions. Specific PA criteria for these plans aren't publicly detailed, requiring verification through the provider portal.

Federal Employee Program (FEP): Generally follows standard Blue Cross formulary guidelines with potential PA requirements.

All Blue Cross NC plans provide prior authorization request tools through their provider portal, with quarterly updates to PA requirements.

Medical Necessity Requirements

Core Eligibility Criteria

For Healthy Blue Medicaid plans, Entresto approval requires:

  • Chronic heart failure diagnosis with NYHA functional class II-IV symptoms
  • Left ventricular ejection fraction (LVEF) ≤40% documented via echocardiogram
  • No history of angioedema related to ACE inhibitor or ARB therapy
  • Current ACE inhibitor/ARB replacement: If patient is currently on these medications, Entresto must replace them

Age and Population Requirements

  • Eligible for patients enrolled in NC Medicaid or NC Health Choice (ages 6-18)
  • EPSDT (Early and Periodic Screening, Diagnostic, and Treatment) exceptions may apply for medical necessity cases

Contraindication Screening

Documentation must confirm absence of:

  • Previous angioedema with ACE inhibitors or ARBs
  • Concurrent use of aliskiren (Tekturna) in diabetic patients
  • Pregnancy (contraindicated)

Step Therapy and Exception Pathways

Required Prior Therapy Documentation

While Healthy Blue Medicaid plans don't explicitly require step therapy failure, best practice includes documenting:

  1. ACE inhibitor or ARB trial history with specific medications, doses, and duration
  2. Clinical outcomes from prior therapy (symptom response, adverse effects, contraindications)
  3. Washout period confirmation (36 hours minimum when switching from ACE inhibitors)

Medical Exception Criteria

Exceptions to standard requirements may include:

  • Documented intolerance to ACE inhibitors (e.g., persistent cough, hyperkalemia)
  • Contraindications to standard therapy (e.g., angioedema history)
  • Clinical deterioration despite optimal medical therapy

When requesting exceptions, reference the 2022 AHA/ACC/HFSA Heart Failure Guidelines, which establish Entresto as preferred over ACE inhibitors/ARBs for symptomatic heart failure with reduced ejection fraction (Class I, Level B-R recommendation).

Quantity Limits and Renewal Rules

Initial Authorization Parameters

  • Quantity per 30 days: Specified on PA form based on prescribed dosing
  • Therapy length options: Up to 365 days available for initial authorization
  • NDC codes covered: 39046, 39047, 39048

Reauthorization Requirements

Continuing therapy requires documentation of:

  • Clinical benefit (symptom stabilization or improvement)
  • Ongoing NYHA class II-IV heart failure with LVEF ≤40%
  • Adherence monitoring and safety assessments

Required Diagnostics and Documentation

Essential Clinical Documentation

Echocardiogram Requirements:

  • Complete report showing LVEF ≤40%
  • Imaging within 6 months (verify with current plan requirements)
  • Alternative cardiac imaging acceptable if echocardiogram unavailable

Heart Failure Documentation:

  • NYHA functional class assessment (II-IV)
  • Appropriate ICD-10 diagnosis codes (typically I50.x series)
  • Symptom documentation supporting functional limitations

Medication History:

  • Complete list of current cardiac medications
  • Prior ACE inhibitor/ARB trials with outcomes
  • Documented reasons for therapy changes

Special Circumstances Documentation

Heart Failure with Improved Ejection Fraction (HFimpEF): Patients with previously documented LVEF ≤40% that improved to >40% may still qualify with historical documentation.

Pediatric Considerations: For NC Health Choice beneficiaries (ages 6-18), additional EPSDT medical necessity documentation may be required.

Specialty Pharmacy Requirements

Dispensing Requirements

  • Network pharmacy use required for covered benefits
  • Self-administered specialty drugs fall under pharmacy benefit with PA requirements
  • No specific specialty pharmacy mandate beyond standard network requirements

Submission Process

For Healthy Blue Plans:

  • Fax: 844-376-2318
  • Phone: Pharmacy PA Center at 844-594-5072 (Healthy Blue) or 833-777-3698 (Healthy Blue Care Together)
  • Provider portal: Access through Blue Cross NC provider website

Evidence to Support Medical Necessity

Clinical Guidelines and References

Primary Guidelines:

  • 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure
  • FDA prescribing information for Entresto (sacubitril/valsartan)
  • ACC/AHA Stage C heart failure management recommendations

Key Clinical Evidence:

  • PARADIGM-HF trial data showing cardiovascular mortality reduction
  • Real-world evidence studies demonstrating symptom improvement
  • Comparative effectiveness vs. ACE inhibitors in heart failure populations

Peer-Reviewed Literature

When crafting medical necessity letters, cite:

  • Randomized controlled trials comparing Entresto to standard therapy
  • Meta-analyses of ARNI therapy in heart failure
  • Professional society position statements on optimal heart failure management

Sample Medical Necessity Letter

Template Structure

"Patient [Name], DOB [Date], presents with chronic heart failure (NYHA Class [II/III/IV]) and reduced ejection fraction (LVEF [%] documented by echocardiogram on [Date]). Previous therapy with [ACE inhibitor/ARB name] at [dose] for [duration] resulted in [outcome/adverse effect]. Current symptoms include [specific limitations] despite optimal medical therapy including [list current medications].

Based on 2022 AHA/ACC/HFSA guidelines (Class I, Level B-R), sacubitril/valsartan (Entresto) is preferred over ACE inhibitors/ARBs for patients with symptomatic HFrEF. The patient meets criteria with documented LVEF ≤40%, appropriate functional class, and [prior therapy history]. Expected benefits include reduced cardiovascular mortality and heart failure hospitalizations as demonstrated in PARADIGM-HF trial.

Request approval for Entresto [dose] twice daily with appropriate monitoring plan including renal function, electrolytes, and clinical response assessment."

Appeals Process for North Carolina

Internal Appeals with Blue Cross NC

Timeline: 180 days from denial date Submission methods:

  • Blue Cross NC member/provider portal
  • Written appeal with denial letter and supporting documentation
  • Include updated clinical information addressing denial reasons

Smart NC External Review Process

After internal appeals are exhausted, North Carolina residents can request external review through Smart NC:

Eligibility Requirements:

  • State-regulated plan (not self-funded employer plans unless opted in)
  • Denial based on medical necessity or experimental treatment determination
  • Internal appeals completed (or expedited review qualification)

Timeline: 120 days from final internal denial Review Process:

  • Standard review: 45-day decision timeline
  • Expedited review: 72-hour decision for urgent cases
  • Contact: 1-855-408-1212 for free guidance

Success Rates: External reviews show 40-60% success rates for specialty drugs when supported by comprehensive clinical documentation.

From our advocates: We've seen Entresto approvals succeed when providers include specific LVEF values, detailed medication trial histories, and clear documentation of functional limitations. One case involved a patient initially denied due to "insufficient heart failure documentation" – the appeal succeeded by submitting the complete echocardiogram report showing LVEF 35% and detailed notes documenting NYHA Class III symptoms despite optimal ACE inhibitor therapy.

Common Denial Reasons and Solutions

Denial Reason Documentation Solution Source to Include
Insufficient heart failure documentation Complete echo report with LVEF percentage Echocardiogram report
No prior ACE/ARB trial documented Medication history with specific drugs, doses, outcomes Chart notes, medication lists
Missing NYHA class assessment Functional assessment documenting symptom limitations Clinical notes with activity tolerance
Concomitant ACE inhibitor use Confirmation of medication switch/washout period Updated medication reconciliation
Dosing exceeds recommendations Prescriber justification for dose selection Clinical rationale letter

Costs and Patient Assistance

Manufacturer Support Programs

Novartis Patient Assistance:

  • Entresto Savings Card for eligible commercially insured patients
  • Patient Assistance Program for uninsured/underinsured individuals
  • Verify eligibility at Novartis patient support website

State and Foundation Resources

North Carolina Resources:

  • Smart NC consumer assistance (1-855-408-1212)
  • NC Department of Insurance consumer guides
  • Medicaid expansion (effective 2024) may expand coverage options

National Foundation Support:

  • Patient Advocate Foundation copay relief programs
  • HealthWell Foundation cardiovascular disease fund
  • Good Days (formerly Chronic Disease Fund) heart failure assistance

At Counterforce Health, we specialize in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to craft compelling appeals that address payer-specific criteria.

FAQ

How long does Blue Cross NC prior authorization take? Standard PA requests: up to 15 business days. Urgent requests: 72 hours. Medicaid plans may have different timelines – verify with your specific plan.

What if Entresto is non-formulary on my plan? Request a formulary exception by demonstrating medical necessity and providing clinical justification. Include documentation of failed formulary alternatives and supporting guidelines.

Can I request expedited appeals in North Carolina? Yes, both Blue Cross NC internal appeals and Smart NC external reviews offer expedited processes for urgent medical situations where delays could seriously jeopardize health.

Does step therapy apply if I failed ACE/ARB therapy outside North Carolina? Medical records from any location are acceptable. Provide complete documentation of prior therapy trials regardless of where treatment occurred.

What happens if Smart NC external review denies my appeal? The IRO decision is binding on the insurer. If approved, coverage must begin within 3 business days. If denied, that concludes the administrative appeals process.

How do I find my specific Blue Cross NC plan's formulary? Access your plan's formulary through the Blue Cross NC member portal or contact customer service using the number on your insurance card.

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 plan terms, clinical circumstances, and current policies. Always consult with your healthcare provider and insurance company for personalized guidance. For official appeals assistance in North Carolina, contact Smart NC at 1-855-408-1212.

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