By Counterforce Health Team in Myalept (metreleptin) —

How to Get Myalept (Metreleptin) Covered by Humana in Pennsylvania: Complete Requirements Checklist with Forms and Appeals

Quick Answer: Getting Myalept Covered by Humana in Pennsylvania

Myalept (metreleptin) requires prior authorization from Humana and REMS program enrollment. For Pennsylvania members, follow these three steps: 1) Ensure your doctor completes Humana's pharmacy prior authorization form with confirmed generalized lipodystrophy diagnosis (ICD-10: E88.12), 2) Enroll in the Myalept REMS program (both prescriber and patient must be certified), and 3) Use CenterWell Specialty Pharmacy for dispensing. Appeals follow Medicare rules, not Pennsylvania's state external review process. Start today by calling Humana at 1-866-488-5995 for pharmacy prior authorizations.

Table of Contents

Who Should Use This Guide

This guide helps Pennsylvania residents with Humana Medicare Advantage or Part D plans get Myalept (metreleptin) covered. You'll need this if:

  • Your doctor prescribed Myalept for generalized lipodystrophy
  • Humana denied your initial request
  • You're preparing a first-time prior authorization
  • Your pharmacy said the medication requires special approval

Expected outcome: With proper documentation and REMS enrollment, most medically appropriate Myalept requests get approved. Humana's Medicare Advantage denial rate is relatively low at 3.5%, but specialty medications require thorough documentation.

Member & Plan Basics

Coverage Requirements

Active Humana Coverage Required:

  • Medicare Advantage (Part C) with prescription benefits
  • Standalone Part D prescription plan
  • Current premium payments and active member status

Authorization Status: Myalept requires prior authorization for all Humana plans through at least September 2025, according to Humana's Medicare prior authorization list.

Plan Type Verification: Check your insurance card or call the member services number on your card to confirm your specific plan type and pharmacy benefits.

Clinical Criteria Requirements

FDA-Approved Indication

Myalept is only approved for generalized lipodystrophy as an adjunct to diet. Coverage requires:

  • Confirmed diagnosis: Congenital or acquired generalized lipodystrophy
  • Not covered: Partial lipodystrophy, general obesity, or metabolic syndrome alone
  • Clinical evidence: Documented loss of adipose tissue affecting multiple body regions

Diagnostic Confirmation

Your medical records must document:

Physical findings:

  • Generalized loss of subcutaneous fat (face, limbs, trunk)
  • Muscular hypertrophy appearance
  • Hepatomegaly or fatty liver disease

Laboratory abnormalities:

  • Severe hypertriglyceridemia (often >500 mg/dL)
  • Insulin resistance or diabetes mellitus
  • Low leptin and adiponectin levels

Imaging studies: DXA scan or MRI showing near-total absence of subcutaneous fat tissue.

Coding & Documentation Requirements

Required ICD-10 Codes

Primary diagnosis:

  • E88.12 - Generalized lipodystrophy (covers both congenital and acquired forms)

Supporting codes (if applicable):

  • E11.x - Type 2 diabetes mellitus
  • E78.x - Hyperlipidemia
  • K75.8 - Nonalcoholic fatty liver disease

Drug Identification

NDC/Billing codes: Myalept is billed under pharmacy benefits with manufacturer-specific NDC codes. Your specialty pharmacy will handle coding for dispensing.

Units and dosing: Document weight-based dosing calculations and administration schedule in clinical notes.

Required Documentation Packet

Provider Letter of Medical Necessity

Your doctor's letter must include:

Patient identification:

  • Name, date of birth, Humana member ID
  • Prescriber NPI and contact information

Clinical justification:

  • Confirmed generalized lipodystrophy diagnosis
  • Previous treatments tried and failed (dietary interventions, standard diabetes/lipid medications)
  • Current metabolic complications requiring leptin replacement
  • Expected clinical benefits and monitoring plan

Treatment details:

  • Specific Myalept dosing based on patient weight
  • Administration schedule and monitoring frequency
  • Duration of therapy request

Required Attachments

Clinical documentation:

  • Office notes confirming generalized lipodystrophy diagnosis
  • Laboratory results (lipid panel, glucose/insulin, liver function)
  • Imaging studies (DXA or MRI showing fat loss)
  • Previous treatment records and outcomes

REMS documentation:

  • Completed prescriber enrollment form
  • Patient enrollment confirmation
  • REMS training certificates
Tip: Organize documents chronologically and include a cover sheet listing all attachments. This helps reviewers quickly locate required information.

Submission Process

Humana Prior Authorization Forms

Primary submission method: Use Humana's pharmacy prior authorization process.

Contact information:

  • Phone: 1-866-488-5995 (Medicare pharmacy prior authorizations)
  • Fax: Use fax number provided on Humana's current PA form (verify with source linked above)
  • Online: Submit via Humana provider portal

Required Fields That Cause Rejections

Common missing information:

  • Incomplete member ID or incorrect format
  • Missing prescriber NPI number
  • Unsigned forms or missing dates
  • Insufficient clinical justification
  • REMS enrollment status not confirmed

Timeline: Standard prior authorization decisions typically take up to 72 hours for urgent requests, longer for standard reviews.

Specialty Pharmacy Requirements

CenterWell Specialty Pharmacy

Humana's preferred vendor: CenterWell Specialty Pharmacy is Humana's owned specialty pharmacy and typically required for Myalept.

Contact information:

  • Phone: 1-800-486-2668 (TTY: 711)
  • Hours: Monday–Friday 8 a.m.–11 p.m., Saturday 8 a.m.–6:30 p.m. EST
  • Fax: 1-877-405-7940

Transfer Process

From another pharmacy:

  1. Call CenterWell at the number above
  2. Provide current pharmacy information and prescription details
  3. CenterWell coordinates the transfer and REMS verification
  4. Confirm your preferred delivery address

Shipment verification: CenterWell provides tracking information and requires signature confirmation for Myalept deliveries due to REMS requirements.

After Submission: What to Expect

Confirmation and Status Tracking

Record these details:

  • Prior authorization reference number
  • Submission date and method
  • Representative name (if submitted by phone)
  • Expected decision timeline

Status checking: Call Humana member services or check the online portal for updates. Keep your reference number handy.

Decision Timeline

Standard review: Up to 14 days for non-urgent requests Expedited review: 72 hours if medically urgent (request this when submitting if appropriate)

Common Denial Prevention Tips

Five Pitfalls to Avoid

  1. Incomplete REMS enrollment: Both prescriber and patient must be fully enrolled before submission
  2. Wrong indication: Ensure diagnosis is generalized (not partial) lipodystrophy with proper ICD-10 coding
  3. Missing prior treatments: Document previous dietary interventions and standard medications tried
  4. Insufficient clinical evidence: Include laboratory results and imaging confirming fat loss
  5. Outdated forms: Use current Humana prior authorization forms and verify submission methods
From our advocates: We've seen cases where initial denials were overturned simply by resubmitting with complete REMS documentation. The key is ensuring both the prescriber and patient have active REMS enrollment before the pharmacy prior authorization is processed. This single step prevents many unnecessary delays.

Appeals Process for Pennsylvania Members

Important: Medicare Rules Apply

Pennsylvania's state external review does NOT apply to Humana Medicare Advantage plans. Medicare Advantage appeals follow federal Medicare rules, not state insurance department processes.

Internal Appeal (Redetermination)

Timeline: 65 days from denial notice to file with Humana How to submit: Follow instructions in your denial letter or call Humana member services Required: Include additional clinical documentation addressing the denial reason

External Review (Independent Review Entity)

Timeline: 60 days after internal appeal denial to request Medicare's Independent Review Entity (IRE) Submission: Use Medicare's external appeal portal at externalappeal.cms.gov or follow instructions in your denial letter Forms: Use federal Medicare forms, not Pennsylvania state forms

For guidance navigating Medicare appeals, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by identifying denial reasons and drafting point-by-point rebuttals aligned to plan policies.

Costs and Financial Assistance

Manufacturer Support

Chiesi Total Care: Contact Chiesi's patient support program for:

  • Insurance navigation assistance
  • Copay support programs (eligibility restrictions may apply)
  • Clinical support and medication counseling

REMS program support: The Myalept REMS program provides resources for both patients and prescribers at 1-855-669-2537.

Additional Resources

Medicare Extra Help: Low-income Medicare beneficiaries may qualify for prescription drug cost assistance through Medicare's Low Income Subsidy program.

Quick Reference Checklist

Before Submitting:

  • Confirmed generalized lipodystrophy diagnosis with ICD-10 E88.12
  • Prescriber enrolled in Myalept REMS program
  • Patient enrolled in Myalept REMS program
  • Laboratory results documenting metabolic abnormalities
  • Imaging studies showing generalized fat loss
  • Documentation of previous treatment failures
  • Current Humana prior authorization form completed
  • CenterWell Specialty Pharmacy contacted for dispensing

After Submission:

  • Prior authorization reference number recorded
  • Expected decision date noted
  • Follow-up reminder set for status check
  • Appeal timeline noted (65 days for internal appeal)

FAQ

How long does Humana prior authorization take for Myalept in Pennsylvania? Standard reviews take up to 14 days; expedited reviews (for urgent medical situations) are completed within 72 hours.

What if Myalept is non-formulary on my Humana plan? Humana covers Myalept for FDA-approved indications with prior authorization. Non-formulary status doesn't prevent coverage if medical necessity is established.

Can I request an expedited appeal in Pennsylvania? Yes, if your health condition poses a serious threat, you can request expedited review at both the internal appeal and external review levels.

Does step therapy apply to Myalept? Humana may require documentation that standard treatments (dietary interventions, diabetes medications) were tried before approving Myalept.

What happens if I move from Pennsylvania to another state? Your Humana coverage continues, but appeal rights may change depending on your new state's regulations. Medicare Advantage appeals always follow federal rules regardless of state.

How do I check if my prescriber is REMS-enrolled? Contact the Myalept REMS program at 1-855-669-2537 or visit MyaleptREMS.com to verify enrollment status.

Can I use a different specialty pharmacy besides CenterWell? Humana typically requires CenterWell for specialty medications, but exceptions may be possible. Contact Humana member services to discuss alternatives.

What if I paid out-of-pocket during the appeal? If your appeal is successful, Humana may reimburse out-of-pocket costs. Keep all receipts and submit reimbursement requests according to plan procedures.

Sources & Further Reading

Disclaimer: This information is for educational purposes and is not medical advice. Coverage decisions depend on individual medical circumstances and plan terms. For personalized assistance with insurance appeals and prior authorizations, Counterforce Health provides specialized support in turning denials into successful appeals through evidence-based advocacy. Always consult your healthcare provider for medical decisions and your insurance plan for specific coverage details.

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