By Counterforce Health Team in Lutathera (lutetium Lu-177 dotatate) —

How to Get Lutathera Covered by Humana in California: Prior Authorization Forms, Appeal Process & Success Strategies

Answer Box: Getting Lutathera Covered by Humana in California

Lutathera (lutetium Lu-177 dotatate) requires prior authorization from Humana and is covered under Medicare Part B as a medical benefit. Key requirements include SSTR-positive PET imaging and documented failure/progression on somatostatin analogs like octreotide or lanreotide. If denied, California residents have strong appeal rights through Independent Medical Review (IMR) with no patient cost and binding decisions.

Fastest path to approval:

  1. Gather SSTR-positive Gallium-68 or Copper-64 dotatate PET scan results
  2. Document prior somatostatin analog therapy trials and outcomes
  3. Submit PA via Humana Provider Portal or fax to Medication Intake Team

First step today: Call Humana Customer Service (number on your ID card) to confirm your plan's specific PA requirements and preferred specialty pharmacy network.

Table of Contents

Understanding Humana's Coverage Framework

Plan Types & Coverage Implications

Humana offers several plan types in California, each with different coverage rules for Lutathera:

Medicare Advantage (MAPD): Most common for Lutathera patients. Covers the drug under Part B medical benefit, not Part D pharmacy benefit. Requires prior authorization and administration at radiation safety-certified facilities.

Commercial Plans: Less common for this patient population but may have different PA criteria and specialty pharmacy requirements.

Dual Eligible Special Needs Plans (D-SNPs): Coordinate Medicare and Medi-Cal benefits with specific formulary rules.

Note: Lutathera is billed under HCPCS code A9513 at 200 units per standard 7.4 GBq dose, making it a Part B medical claim rather than a Part D pharmacy claim.

Network & Referral Requirements

Since Lutathera requires administration at specialized nuclear medicine facilities, verify that your treatment center is:

  • In-network with your Humana plan
  • Certified for radiation safety and radiopharmaceutical administration
  • Approved by Humana for PRRT (peptide receptor radionuclide therapy)

Use Humana's Find a Provider tool to confirm network status before scheduling treatment.

Formulary Status & Tier Placement

Current Coverage Status (2024-2025)

According to Humana's Medicare Preauthorization List, Lutathera requires prior authorization across Medicare Advantage plans. The drug is subject to Part B step therapy requirements, meaning:

  • Preferred agents: Long-acting somatostatin analogs (octreotide LAR, lanreotide)
  • Non-preferred status: Lutathera requires documented trial and failure/progression on preferred agents first

Alternative Agents

If Lutathera is denied, Humana typically covers these alternatives with less restrictive PA:

  • Octreotide LAR (Sandostatin LAR)
  • Lanreotide (Somatuline Depot)
  • Everolimus (for pancreatic NETs)
Important: Pluvicto (lutetium Lu-177 vipivotide tetraxetan) is for prostate cancer, not gastroenteropancreatic NETs, and is not an alternative to Lutathera.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
PA Required Must get approval before treatment Humana Medicare PAL Official PA List
SSTR+ Imaging Gallium-68 or Copper-64 PET scan showing uptake Nuclear medicine reports FDA Label Requirements
Step Therapy Try somatostatin analogs first Treatment history documentation Part B Step Therapy List
GEP-NET Diagnosis Confirmed gastroenteropancreatic neuroendocrine tumor Pathology reports with ICD-10 codes Medical Records
Certified Facility Radiation safety-approved treatment center Facility credentials State Licensing

Clinical Documentation Checklist

Required for PA submission:

  • SSTR-positive PET scan (Gallium-68 or Copper-64 dotatate)
  • Pathology confirming GEP-NET diagnosis with ICD-10 codes
  • Documentation of somatostatin analog therapy (octreotide/lanreotide)
  • Evidence of disease progression or inadequate response
  • Treatment plan with dosing schedule (typically 4 cycles, 8 weeks apart)
  • Facility certification for radiopharmaceutical administration

Medical Necessity Criteria

Based on Humana's coverage policy framework, approval typically requires:

  1. Confirmed diagnosis of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors
  2. SSTR-positive imaging demonstrating uptake in tumor sites
  3. Prior therapy documentation showing trial of long-acting somatostatin analogs
  4. Disease progression on conventional therapy or intolerance to alternatives
  5. Appropriate candidate for PRRT with adequate organ function

Specialty Pharmacy Network

CenterWell Specialty Pharmacy

Humana's owned specialty pharmacy, CenterWell Specialty Pharmacy, is typically the preferred distributor for complex therapies like Lutathera. However, because Lutathera requires specialized radiopharmacy handling and direct delivery to treatment facilities, the process differs from typical specialty drugs.

Distribution Process

  1. PA approval must be obtained first
  2. Treatment facility coordinates with approved radiopharmacy
  3. Drug shipment scheduled for specific treatment date
  4. Administration billed under medical benefit, not pharmacy benefit

To identify the correct specialty pharmacy network for your plan:

  • Use Humana's Pharmacy Finder
  • Call CenterWell Specialty Pharmacy directly
  • Verify with your treatment facility's pharmacy coordinator

Patient Setup Steps

  1. Enroll with CenterWell or designated specialty pharmacy
  2. Complete benefits investigation and PA submission
  3. Coordinate delivery timing with treatment schedule
  4. Confirm insurance coverage and patient responsibility

Cost-Share Dynamics

Part B Medical Benefit Structure

Under Humana Medicare Advantage plans, Lutathera costs are governed by:

Typical cost-sharing for Part B drugs:

  • Fixed copay (e.g., $50-$100 per treatment) OR
  • Coinsurance (e.g., 4-10% of allowed amount)
  • Counts toward plan's maximum out-of-pocket (MOOP) limit

Important distinction: Lutathera costs do NOT count toward Part D pharmacy out-of-pocket caps (like the $2,000 IRA cap) because it's a Part B medical benefit.

Financial Assistance Options

Manufacturer Support:

  • Novartis patient assistance programs (verify current eligibility)
  • Copay assistance for eligible commercial patients

Foundation Grants:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • CancerCare Co-Payment Assistance

State Resources:

  • California's Health Insurance Counseling & Advocacy Program (HICAP)
  • Medi-Cal coordination for dual eligible patients

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

1. Verify Coverage (Patient/Clinic)

  • Call Humana Customer Service (number on ID card)
  • Confirm PA requirements for your specific plan
  • Identify preferred specialty pharmacy network
  • Timeline: Same day

2. Gather Documentation (Clinic)

  • SSTR-positive PET scan reports
  • Pathology confirming GEP-NET diagnosis
  • Treatment history with somatostatin analogs
  • Current imaging showing progression
  • Timeline: 1-2 weeks

3. Submit PA Request (Provider)

  • Use Humana Provider Portal (preferred method)
  • Alternative: Fax to Medication Intake Team (verify current fax)
  • Include all clinical documentation
  • Timeline: Same day submission

4. PA Review (Humana)

  • Standard review: 72 hours after complete submission
  • Expedited review: 24 hours for urgent cases
  • Timeline: 1-3 business days

5. Coordinate Treatment (All parties)

  • Schedule with certified facility
  • Arrange drug delivery timing
  • Confirm insurance authorization
  • Timeline: 1-2 weeks after approval

Required Forms

Primary form: Medicare Medication Preauthorization Request

  • Available through Humana Provider Portal
  • Must include member ID, DOB, and specific drug details
  • Requires prescriber signature and clinical justification

Supporting documentation:

  • Clinical notes with diagnosis and ICD-10 codes
  • SSTR PET imaging reports
  • Prior therapy documentation
  • Treatment plan and facility information

Common Approval Patterns

What Strong Submissions Include

Based on successful PA patterns, effective submissions typically contain:

Clinical Narrative Structure:

  1. Patient presentation: Age, diagnosis, staging, symptoms
  2. Prior treatments: Specific somatostatin analogs tried, doses, duration
  3. Treatment outcomes: Biochemical markers, imaging progression
  4. Rationale for Lutathera: Why alternatives are insufficient
  5. Treatment plan: Dosing schedule, monitoring plan, expected outcomes

Supporting Evidence:

  • NCCN Guidelines reference for NET treatment
  • FDA labeling for Lutathera indications
  • Peer-reviewed literature supporting PRRT efficacy
  • Multidisciplinary team recommendation

Peer-to-Peer Review Strategy

If initial PA is denied, request a peer-to-peer review:

  • Nuclear medicine physician or oncologist discussion
  • Focus on medical necessity and guideline adherence
  • Provide additional clinical context not in written submission

Appeals Process in California

Internal Appeal (Level 1: Redetermination)

Deadline: 65 days from Notice of Denial Timeline:

  • Standard: 7 calendar days
  • Expedited: 72 hours (if health harm imminent)

How to submit:

  • Use "Request for Redetermination" form
  • Fax: 877-486-2621
  • Online: Humana member portal
  • Phone: 800-867-6601 (expedited requests)

Who can file: Member, appointed representative, or prescribing physician

California Independent Medical Review (IMR)

California residents have unique appeal rights through the Department of Managed Health Care (DMHC):

Eligibility: After exhausting Humana's internal appeal for denials based on:

  • Medical necessity
  • Experimental/investigational status
  • Specialty drug coverage disputes

Process:

  1. Complete Humana internal appeal first
  2. Contact DMHC at 888-466-2219 within 6 months of final denial
  3. Submit IMR application (no cost to patient)

Timelines:

  • Standard IMR: 45 days
  • Expedited IMR: 7 days (72 hours for urgent)

Outcome: Binding decision on Humana; independent physician experts review

From our advocates: In complex cases involving rare disease treatments like Lutathera, we've seen California's IMR process effectively overturn denials when strong clinical evidence is presented. The key is comprehensive documentation showing medical necessity and guideline adherence—outcomes aren't guaranteed, but the independent review process provides a valuable second opinion.

FAQ

Q: How long does Humana PA take for Lutathera in California? A: Standard review is typically 72 hours after complete submission. Expedited review (for urgent cases) is usually completed within 24 hours.

Q: What if Lutathera is denied as "not medically necessary"? A: File an internal appeal within 65 days, then pursue California's Independent Medical Review (IMR) if upheld. Focus on SSTR-positive imaging and documented progression on somatostatin analogs.

Q: Can I request an expedited appeal if treatment is delayed? A: Yes, if delay could cause serious harm to your health. Mark requests "EXPEDITED" and call 800-867-6601. Provide clinical justification for urgency.

Q: Does step therapy apply if I've failed somatostatin analogs outside California? A: Yes, prior therapy documentation from any state is acceptable. Provide treatment records showing dates, doses, and evidence of progression or intolerance.

Q: What counts as SSTR-positive imaging for PA approval? A: Gallium-68 or Copper-64 dotatate PET scans showing uptake in neuroendocrine tumor sites. Octreotide scans may be acceptable but confirm with Humana.

Q: Is Lutathera covered under Part D pharmacy benefits? A: No, Lutathera is covered under Part B medical benefits because it's physician-administered. Costs count toward your plan's medical out-of-pocket maximum, not Part D pharmacy caps.

Q: What if my treatment facility isn't in Humana's network? A: Request a network exception if no in-network facility can provide PRRT. This may require additional documentation of medical necessity and facility qualifications.

Q: How many Lutathera cycles does Humana typically approve? A: Standard FDA-approved regimen is 4 cycles given 8 weeks apart. Additional cycles may require separate PA with documented clinical benefit.

For patients and clinicians navigating complex prior authorization requirements, Counterforce Health helps 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 payer-specific requirements.

When working with Humana on Lutathera approvals, Counterforce Health's platform can help identify the specific denial basis—whether PA criteria, step therapy, or medical necessity—and provide the right clinical evidence and citations to support your appeal.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with insurance appeals and coverage issues in California, contact the Department of Managed Health Care at 888-466-2219 or visit healthhelp.ca.gov.

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