How to Get Turalio (Pexidartinib) Covered by Humana in New York: Coding, Prior Authorization, and Appeals Guide
Answer Box: Getting Turalio Covered by Humana in New York
Turalio (pexidartinib) requires prior authorization from Humana for tenosynovial giant cell tumor (TGCT) when surgery isn't an option. First step today: Ensure your prescriber is REMS-certified and gather baseline liver function tests. Submit PA via Humana's provider portal at 866-461-7273 with ICD-10 code M12.2 (diffuse TGCT) or D48.19 (localized), NDC 73626-010-01, and documentation proving surgical contraindications. If denied, New York Medicare beneficiaries must follow federal Medicare appeals, not state DFS external review. Timeline: 30 days for standard PA decisions, 72 hours for expedited requests.
Table of Contents
- Coding Basics: Medical vs. Pharmacy Benefit
- ICD-10 Mapping for TGCT
- Product Coding: NDC and Billing
- Clean Prior Authorization Request
- Common Coding Pitfalls
- Verification with Humana
- Appeals Process in New York
- Quick Audit Checklist
- FAQ
Coding Basics: Medical vs. Pharmacy Benefit
Turalio (pexidartinib) is an oral specialty drug that falls under the pharmacy benefit (Medicare Part D), not the medical benefit (Part B). This distinction is crucial for proper billing and coverage determination.
Key Coverage Points:
- Medicare Part D coverage: Turalio is covered under prescription drug benefits, not incident-to-physician services
- No J-code assigned: As an oral therapy, Turalio doesn't have a HCPCS J-code for physician administration
- NDC-based billing: Claims are submitted using National Drug Code (NDC) numbers through pharmacy channels
Note: Unlike injectable oncology drugs that may qualify for Medicare Part B coverage, oral therapies like Turalio are processed through Part D regardless of the specialty nature or cost.
ICD-10 Mapping for TGCT
Accurate diagnosis coding is essential for Humana's medical necessity review. The primary ICD-10 codes for tenosynovial giant cell tumor are:
Primary Codes
- M12.2 - Villonodular synovitis (pigmented villonodular synovitis): Use for diffuse-type TGCT affecting larger joints
- D48.19 - Neoplasm of uncertain behavior of connective and other soft tissue: Appropriate for localized/nodular TGCT, particularly in hands and fingers
Documentation Requirements
Your medical records should include:
- Anatomical location (specific joint or tendon sheath affected)
- Type specification (localized vs. diffuse)
- Functional impact (pain levels, range of motion limitations, daily activity restrictions)
- Imaging confirmation (MRI findings showing characteristic features)
- Histopathologic confirmation when available
Tip: Document why surgery is contraindicated or not feasible. Common reasons include tumor location near critical structures, patient comorbidities making surgery high-risk, or extensive diffuse disease.
Product Coding: NDC and Billing
NDC Numbers for Turalio
- 200 mg capsules: NDC 73626-011-01 (120-count bottle)
- 125 mg capsules: NDC 73626-010-01 (120-count bottle)
Billing Considerations
Dosing calculations are critical for quantity limits:
- Standard dosing: 400 mg twice daily (800 mg total daily dose)
- Typical 28-day supply: 224 capsules (using 200 mg strength)
- Always verify current NDC numbers with product packaging
REMS Program Impact:
- Only 30-day supplies allowed for first three months
- Prescriber and pharmacy must be REMS-certified
- Patient enrollment required before dispensing
Clean Prior Authorization Request
Required Documentation Checklist
Patient Information:
- Humana member ID and Medicare number
- Complete demographic details
- Prescribing physician NPI and specialty
Clinical Documentation:
- ICD-10 diagnosis code (M12.2 or D48.19)
- Radiology reports (MRI preferred) confirming TGCT
- Pathology results if available
- Documentation of surgical contraindications
REMS Compliance:
- Prescriber REMS certification confirmation
- Baseline liver function tests (ALT, AST, bilirubin)
- Patient enrollment form completion
- Hepatotoxicity monitoring plan
Submission Process
Contact Humana at 866-461-7273 for PA submissions. Required elements include:
- Complete Humana PA form (verify current version)
- Supporting clinical notes within 6 months
- Clear statement of medical necessity
- Dosing rationale and treatment duration
Common Coding Pitfalls
Frequent Errors to Avoid
Pitfall | Impact | Solution |
---|---|---|
Using generic soft tissue tumor codes | PA denial for lack of specificity | Use M12.2 or D48.19 specifically |
Missing surgical contraindication documentation | Denial for not meeting FDA indication | Document why surgery isn't feasible |
Incomplete REMS enrollment | Dispensing delays | Complete all REMS steps before PA submission |
Wrong NDC for dosing | Quantity limit issues | Verify NDC matches prescribed strength |
Missing baseline labs | REMS non-compliance | Include LFTs dated within 30 days |
Documentation Words That Support Coding
- For M12.2: "diffuse," "villonodular," "synovitis," "joint involvement"
- For D48.19: "localized," "nodular," "tendon sheath," "uncertain behavior"
- For medical necessity: "severe morbidity," "functional limitations," "not amenable to surgery"
Verification with Humana
Cross-Check Your Submission
Before submitting, verify these elements with Humana's provider resources:
Coverage Verification:
- Confirm Turalio is on formulary (typically Tier 5 specialty)
- Check for quantity limits (usually 30-day supply maximum)
- Verify prior authorization requirements haven't changed
Policy Alignment:
- Review current Humana medical policy for Turalio criteria
- Ensure documentation meets all listed requirements
- Confirm REMS compliance expectations
Appeals Process in New York
Important: New York Medicare beneficiaries with Humana plans must use the federal Medicare appeals process, not the New York State Department of Financial Services external review.
Medicare Appeals Timeline
Level | Timeline | Process |
---|---|---|
Redetermination | 60 days to file | Humana internal review |
Reconsideration | 60 days to file | Independent QIC review |
ALJ Hearing | 60 days to file | Administrative law judge |
Appeals Council | 60 days to file | Medicare Appeals Council |
Expedited Appeals
For urgent medical needs, request expedited review:
- Timeline: 72-hour decision requirement
- Criteria: Waiting could seriously jeopardize health
- Documentation: Physician letter supporting urgency
From our advocates: "We've seen Turalio appeals succeed when prescribers clearly document why surgery failed or isn't possible, include recent MRI showing disease progression, and emphasize functional decline. The key is connecting clinical evidence to Humana's specific coverage criteria rather than general medical necessity arguments."
Quick Audit Checklist
Pre-Submission Review:
- Correct ICD-10 code selected (M12.2 or D48.19)
- NDC number matches prescribed strength
- REMS certification confirmed for prescriber and pharmacy
- Baseline liver function tests included
- Surgical contraindications clearly documented
- Radiology reports attached (MRI preferred)
- Patient enrollment in REMS program completed
- Humana member ID and Medicare number verified
- All required forms completed and signed
Post-Submission:
- Confirmation number or reference obtained
- Follow-up date scheduled (typically 5-7 business days)
- Patient notified of submission status
- Appeal strategy prepared if denial occurs
The Role of Counterforce Health
Navigating the complex prior authorization process for specialty drugs like Turalio can be overwhelming for both patients and providers. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical documentation to craft point-by-point rebuttals aligned with each payer's specific requirements.
For medications like Turalio, Counterforce Health helps ensure all REMS requirements are properly documented, surgical contraindications are clearly articulated, and the appeal includes the right mix of FDA labeling, peer-reviewed studies, and payer-specific criteria. This systematic approach significantly improves approval rates for complex specialty drug cases.
FAQ
Q: How long does Humana take to decide on Turalio prior authorization? A: Standard PA decisions are made within 14 days of receiving complete documentation. Expedited requests are decided within 72 hours if urgency is demonstrated.
Q: What if Turalio isn't on Humana's formulary? A: Submit a formulary exception request along with your PA, demonstrating medical necessity and lack of suitable alternatives. Include clinical evidence supporting Turalio's unique benefits for TGCT.
Q: Can I get a 90-day supply of Turalio? A: No, the REMS program limits dispensing to 30-day supplies for the first three months of therapy. After that period, longer supplies may be possible if approved by the plan.
Q: What happens if my prescriber isn't REMS-certified? A: Turalio cannot be prescribed or dispensed without REMS certification. Your prescriber must complete the required training and enrollment before any PA submission.
Q: Do I need to pay anything while waiting for PA approval? A: Contact Humana about coverage during the review period. Some plans provide temporary coverage for continuing therapy, but policies vary.
Q: What if I move from New York to another state? A: Your Humana Medicare plan travels with you, but state-specific appeal rights may change. The federal Medicare appeals process remains the same regardless of location.
Sources & Further Reading
- Humana Medicare Prior Authorization List - Current PA requirements
- Turalio REMS Program - Prescriber and patient enrollment
- FDA Turalio Prescribing Information - Official labeling and safety information
- Medicare Appeals Process - Federal appeals guidance
- Daiichi Sankyo Access Central - Manufacturer coverage support
This information is for educational purposes only and is not medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For additional help with insurance appeals and prior authorizations, Counterforce Health provides specialized support for complex specialty drug cases.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.