By Counterforce Health Team in Jynarque (tolvaptan) —

How to Get Jynarque (Tolvaptan) Covered by Humana in Pennsylvania: Complete Guide with ICD-10 Codes and Appeal Forms

Quick Answer: To get Jynarque (tolvaptan) covered by Humana in Pennsylvania, you need: (1) ADPKD diagnosis with ICD-10 code Q61.2, (2) Mayo Classification 1C-1E or eGFR decline ≥5 mL/min/year, (3) nephrologist enrolled in REMS program, and (4) prior authorization through Humana's clinical pharmacy review. If denied, you have 65 days to appeal through Medicare's process (not Pennsylvania's state review). Start by gathering imaging results, lab trends, and REMS enrollment confirmation.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for ADPKD
  3. NDC Codes and Billing Requirements
  4. Clean Prior Authorization Anatomy
  5. Common Coding Pitfalls
  6. Humana Verification Resources
  7. Appeals Process in Pennsylvania
  8. Pre-Submission Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Jynarque (tolvaptan) is an oral medication that falls under your pharmacy benefit, not the medical benefit. This is crucial for proper billing and prior authorization.

Key Distinctions:

  • Pharmacy Benefit: Uses NDC (National Drug Code) numbers for billing
  • Medical Benefit: Uses HCPCS J-codes (which Jynarque does NOT have)
  • Coverage: Medicare Part D or Humana's prescription drug coverage
Important: Jynarque has no HCPCS J-code because J-codes are reserved for injectable or infused medications administered in clinical settings. Attempting to bill with a J-code will result in automatic denial.

ICD-10 Mapping for ADPKD

The primary diagnosis code for autosomal dominant polycystic kidney disease is Q61.2 ("Polycystic kidney, adult type").

Documentation Words That Support Q61.2 Coding:

  • "Autosomal dominant polycystic kidney disease"
  • "ADPKD with rapid progression"
  • "Multiple bilateral renal cysts consistent with ADPKD"
  • "Family history of polycystic kidney disease"
  • "PKD1 or PKD2 genetic mutation confirmed"

Supporting Codes You May Also Need:

  • N18.3-N18.6: Chronic kidney disease stages 3-5 (if applicable)
  • I10: Essential hypertension (common in ADPKD)
  • Z87.441: Personal history of urinary calculi (if relevant)

NDC Codes and Billing Requirements

Jynarque comes in specific dose combinations with unique NDC numbers:

Strength NDC Number Typical Use
15 mg/15 mg 59148-110-13 Starting dose
30 mg/15 mg 59148-117-13 Titration
45 mg/15 mg 59148-114-13 Standard maintenance
60 mg/30 mg 59148-111-13 Higher maintenance
90 mg/30 mg 59148-116-13 Maximum dose

Critical Billing Requirements:

  • REMS Program: Both prescriber and patient must be enrolled in the FDA-mandated REMS program
  • Specialty Pharmacy: Must be dispensed through certified specialty pharmacies only
  • Quantity Limits: Typically 56 tablets per 28 days (split dosing regimen)
  • Days Supply: Calculate based on twice-daily dosing schedule

Clean Prior Authorization Anatomy

A successful Humana prior authorization for Jynarque includes these elements:

Essential Documentation Checklist:

✅ Patient Information: Name, DOB, Humana member ID, policy number
✅ Diagnosis: ICD-10 Q61.2 with supporting imaging or genetic testing
✅ Prescriber: Nephrologist enrolled in Jynarque REMS program
✅ Clinical Justification: Mayo Classification 1C-1E OR eGFR decline ≥5 mL/min/year
✅ Baseline Labs: Normal liver function (ALT, AST, bilirubin within 30 days)
✅ Current eGFR: Must be ≥25 mL/min/1.73 m² to qualify
✅ NDC and Dosing: Specific strength and titration plan

Submission Methods:

  • Online: Through Humana's provider portal (preferred)
  • Fax: 877-486-2621 (verify current number)
  • Phone: Clinical Pharmacy Review at 800-555-2546

Common Coding Pitfalls

Pitfall #1: Using Wrong Benefit Type

Problem: Trying to bill Jynarque under medical benefit with J-codes
Fix: Always use pharmacy benefit with NDC numbers

Pitfall #2: Incomplete Mayo Classification Documentation

Problem: Stating "rapid progression" without specific Mayo Class
Fix: Include imaging data showing Mayo Classification 1C, 1D, or 1E with calculations

Pitfall #3: Missing REMS Enrollment

Problem: Prescriber not enrolled in REMS program
Fix: Complete REMS enrollment at Jynarque REMS website before submitting PA

Pitfall #4: Outdated Lab Values

Problem: Using liver function tests older than 30 days
Fix: Obtain fresh baseline labs within 30 days of PA submission

Humana Verification Resources

Before submitting, verify requirements through these official channels:

  • Formulary Check: Humana Pharmacy Portal (verify current link)
  • PA Status: Provider portal or member services
  • Clinical Criteria: Download current Humana medical policies for tolvaptan
Tip: Humana's PA denial rate for Medicare Advantage is approximately 3.5%, among the lowest of major insurers. Most denials result from incomplete documentation rather than medical necessity disputes.

Appeals Process in Pennsylvania

Critical Note: Pennsylvania's state external review process does NOT apply to Medicare Advantage or Part D plans like Humana. You must use the federal Medicare appeals process.

Medicare Appeal Timeline:

  1. Internal Appeal: 65 days from denial notice
  2. Reconsideration: Request through Medicare within 60 days
  3. Administrative Law Judge: If amount in controversy ≥$180 (2024)
  4. Medicare Appeals Council: Further review if needed

Required Forms and Contacts:

  • Medicare Appeals: Visit Medicare.gov or call 1-800-MEDICARE
  • Expedited Appeals: Available for urgent situations (72-hour decision)

For patients and clinicians navigating complex insurance denials, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, identifies specific denial criteria, and drafts point-by-point rebuttals using the right medical evidence and payer-specific requirements.

Pre-Submission Audit Checklist

Before submitting your Jynarque prior authorization:

Clinical Documentation Review:

  • ICD-10 Q61.2 clearly documented
  • Mayo Classification 1C-1E with supporting imaging data
  • eGFR trend showing ≥5 mL/min/year decline (if using eGFR criteria)
  • Current eGFR ≥25 mL/min/1.73 m²
  • Baseline liver function tests ≤30 days old

Administrative Requirements:

  • Prescriber enrolled in REMS program
  • Patient enrolled in REMS program
  • Correct NDC number for prescribed strength
  • Specialty pharmacy identified and ready to dispense
  • All forms completed with legible information

Submission Details:

  • Humana member ID and policy number verified
  • Prior authorization form signed and dated
  • All supporting documents attached (imaging, labs, notes)
  • Submission method confirmed (portal, fax, or phone)
From our advocates: "We've seen Humana approvals come through in as little as 48 hours when all REMS requirements and Mayo Classification documentation are submitted upfront. The key is having your nephrologist confirm REMS enrollment before starting the PA process—this single step prevents most delays."

FAQ

Q: How long does Humana's prior authorization process take?
A: Standard decisions are typically made within 7 days for Part D medications. Expedited reviews can be completed within 72 hours if medically urgent.

Q: What if Jynarque isn't on Humana's formulary?
A: Request a formulary exception along with your prior authorization. Include a detailed medical necessity letter explaining why alternative treatments are inappropriate.

Q: Can I appeal if my eGFR is below 25 mL/min/1.73 m²?
A: FDA labeling and most payer policies exclude patients with eGFR <25. Focus on alternative ADPKD management options with your nephrologist.

Q: Does step therapy apply to Jynarque?
A: Typically no, since Jynarque is the only FDA-approved medication to slow ADPKD progression. However, insurers may require documentation of standard supportive care (ACE inhibitors, blood pressure management).

Q: What happens if I'm denied?
A: You have 65 days to file an internal appeal with Humana. For Medicare plans, use the federal appeals process, not Pennsylvania's state external review.

Q: How much does Jynarque cost without insurance?
A: Cash prices typically run around $16,000 per month. Check manufacturer copay assistance programs and patient foundation grants for potential savings.

When dealing with complex prior authorizations and appeals, Counterforce Health helps patients and clinicians navigate payer-specific requirements, ensuring that appeals address the exact denial reasons with appropriate clinical evidence and procedural compliance.

Sources & Further Reading

This article is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department at 1-877-881-6388.

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