How to Get Tremfya (Guselkumab) Covered by UnitedHealthcare in Michigan: Prior Authorization, Appeals, and Coding Guide
Answer Box: Getting Tremfya Covered by UnitedHealthcare in Michigan
UnitedHealthcare requires prior authorization for Tremfya (guselkumab) through OptumRx, with step therapy requirements for most indications. Michigan residents have strong appeal rights through DIFS if denied. Your fastest path to approval: 1) Gather documentation of failed TNF inhibitors or conventional therapies, 2) Submit PA request with specialist prescription and ICD-10 codes (L40.0 for plaque psoriasis, L40.5x for psoriatic arthritis), 3) If denied, file internal appeal within 180 days, then external review with Michigan DIFS within 127 days.
Table of Contents
- Coverage Requirements at a Glance
- Medical vs. Pharmacy Benefit Pathways
- Essential ICD-10 Codes and Documentation
- HCPCS J-Codes and NDC Information
- Step-by-Step Prior Authorization Process
- Common Denial Reasons and Solutions
- Appeals Process in Michigan
- Billing Verification and Audit Checklist
- Cost Assistance Programs
- FAQ
Coverage Requirements at a Glance
| Requirement | Details | Source |
|---|---|---|
| Prior Authorization | Required for all indications | UnitedHealthcare Policy |
| Step Therapy | Must try/fail conventional therapy or TNF inhibitors | UnitedHealthcare Policy |
| Specialist Requirement | Prescribed by relevant specialist | UnitedHealthcare Policy |
| Combination Restrictions | No concurrent targeted immunomodulators | UnitedHealthcare Policy |
| Internal Appeal Deadline | 180 days from denial | Standard UHC policy |
| Michigan External Review | 127 days after final internal denial | Michigan DIFS |
Medical vs. Pharmacy Benefit Pathways
Tremfya's coverage pathway depends on the formulation and administration setting:
Subcutaneous Injections (most common):
- Typically covered under pharmacy benefit
- Self-administered at home
- Requires OptumRx prior authorization
- NDC codes: 57894-0640-01, 57894-0640-06, 57894-0651-02
Intravenous Infusion (select indications):
- Covered under medical benefit
- Administered in clinical settings
- Uses HCPCS J-code J1628
- NDC: 57894-0650-02 (200-mg/20-mL vial)
Note: The benefit pathway affects your cost-sharing, prior authorization process, and appeal rights. Confirm with UnitedHealthcare which benefit applies to your specific prescription.
Essential ICD-10 Codes and Documentation
Primary Diagnosis Codes
Plaque Psoriasis:
- L40.0 (Psoriasis vulgaris) - most specific for classic plaque psoriasis
Psoriatic Arthritis:
- L40.50 (Arthropathic psoriasis, unspecified)
- L40.51 (Distal interphalangeal psoriatic arthropathy)
- L40.52 (Psoriatic arthritis mutilans)
- L40.53 (Psoriatic spondylitis)
- L40.54 (Psoriatic juvenile arthropathy)
Inflammatory Bowel Disease:
- K50.x series for Crohn's disease (specify location)
- K51.x series for ulcerative colitis (specify extent)
Critical Documentation Elements
For psoriasis and psoriatic arthritis, include:
- Body Surface Area (BSA) percentage
- Disease impact on daily function
- Joint involvement (number, location, pattern)
- Previous therapies and outcomes
- Nail, scalp, or intertriginous involvement
For IBD indications, document:
- Disease location and extent (endoscopy/imaging)
- Activity indices (Mayo score, CDAI)
- Complications (fistulas, strictures, bleeding)
- Previous treatment failures
Tip: Use the most specific ICD-10 code available. Avoid unspecified codes like L40.9 when detailed documentation supports a more precise diagnosis.
HCPCS J-Codes and NDC Information
Billing Codes
HCPCS J-Code: J1628 (Injection, guselkumab, 1 mg)
- Effective since January 1, 2019
- One billable unit = 1 mg of medication
Required Modifiers for IV Administration:
- JA - IV infusion administration
- JZ - No product discarded from single-dose container
NDC Codes by Formulation
| Formulation | NDC Code | Description |
|---|---|---|
| SC injection | 57894-0640-01 | 100 mg/mL prefilled syringe |
| SC injection | 57894-0640-06 | 100 mg/mL prefilled syringe (6-pack) |
| SC injection | 57894-0651-02 | 100 mg/mL prefilled pen |
| IV infusion | 57894-0650-02 | 200 mg/20 mL vial |
Units Calculation
Common dosing for psoriasis/psoriatic arthritis:
- 100 mg subcutaneously at weeks 0, 4, then every 8 weeks
- Bill as 100 units per injection
IBD dosing varies by indication:
- Induction and maintenance schedules differ
- Verify exact dosing with FDA labeling
Step-by-Step Prior Authorization Process
Step 1: Gather Required Documentation
Patient responsibility:
- Insurance card and member ID
- Complete list of previous treatments
- Current lab results if applicable
Provider responsibility:
- Specialist consultation notes
- Previous therapy documentation (drugs, dates, outcomes)
- Diagnosis confirmation with ICD-10 codes
Step 2: Complete PA Request
Submit through OptumRx or UnitedHealthcare provider portal with:
- Completed prior authorization form
- Clinical notes supporting diagnosis
- Documentation of step therapy compliance
- Prescriber specialty verification
Step 3: Monitor Decision Timeline
- Standard review: Up to 15 business days
- Urgent requests: 72 hours with physician attestation
- Check status via provider portal or phone
Step 4: If Approved
- Verify authorization details (quantity, refills, duration)
- Confirm pharmacy can fill prescription
- Schedule patient follow-up for monitoring
Step 5: If Denied
- Review denial letter for specific reasons
- Gather additional documentation if needed
- File internal appeal within 180 days
Common Denial Reasons and Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Missing step therapy | Document failed conventional/TNF therapy | Drug names, dates, outcomes, intolerances |
| Insufficient severity | Provide objective severity measures | BSA, joint counts, activity scores |
| Wrong specialist | Get referral to appropriate specialist | Dermatology, rheumatology, or GI consultation |
| Combination therapy | Discontinue other biologics | Medication reconciliation, stop dates |
| Billing unit errors | Verify NDC and units match dosing | Correct NDC, accurate unit calculation |
From our advocates: We've seen denials overturned when providers include specific details about why standard treatments failed - not just that they were tried, but the exact adverse effects or lack of response that made continuation impossible. This clinical narrative often makes the difference between approval and denial.
Appeals Process in Michigan
Internal Appeals (UnitedHealthcare)
First Level - Reconsideration:
- File within 180 days of denial
- Submit via provider portal or mail
- Decision within 30 days (pre-service) or 60 days (post-service)
Second Level - Appeal:
- Available if first level denied
- Include additional clinical evidence
- May request peer-to-peer review
External Review (Michigan DIFS)
Eligibility:
- Must complete UnitedHealthcare's internal process
- File within 127 days of final internal denial
- Available for medical necessity disputes
How to File:
- Complete DIFS External Review Request form
- Include final denial letter and supporting documents
- Submit online, by mail, or fax to DIFS
- DIFS assigns Independent Review Organization (IRO)
Timelines:
- Standard review: 60 days maximum
- Expedited review: 72 hours (requires physician urgency letter)
Contact Information:
- Phone: 877-999-6442 (toll-free)
- Online: Michigan DIFS External Review Portal
Important: Michigan's 127-day deadline is longer than the federal 120-day standard, giving you extra time to prepare your external review request.
Billing Verification and Audit Checklist
Pre-Submission Review
- Correct NDC matches prescribed formulation
- Units calculation aligns with actual dosing
- ICD-10 codes are most specific available
- Prior authorization number included
- No concurrent biologic therapies billed
- Prescriber specialty documented
Common Billing Errors to Avoid
- Unit mismatches between claim and administration
- Wrong NDC for subcutaneous vs. intravenous
- Missing prior authorization reference number
- Billing during manufacturer sample period
- Combination therapy claims
Verification Resources
- UnitedHealthcare provider portal for PA status
- OptumRx formulary lookup tool
- NDC verification through FDA Orange Book
- HCPCS code verification through CMS
Cost Assistance Programs
Janssen CarePath Program:
- Copay assistance for eligible patients
- Maximum annual benefit varies by plan type
- Cannot be used with government insurance
- Apply at JanssenCarePath.com
Patient Assistance Program:
- Free medication for qualifying uninsured patients
- Income-based eligibility requirements
- Requires physician enrollment
Foundation Grants:
- Independent charitable foundations
- Disease-specific assistance available
- Income and insurance status requirements vary
Note: Inform your healthcare provider if you're using manufacturer assistance, as this may affect prior authorization requirements and billing procedures.
FAQ
How long does UnitedHealthcare prior authorization take for Tremfya in Michigan? Standard PA requests take up to 15 business days. Urgent requests with physician attestation are processed within 72 hours.
What if Tremfya isn't on my UnitedHealthcare formulary? Non-formulary medications may still be covered through the prior authorization process, but typically require stronger medical necessity documentation and step therapy compliance.
Can I request an expedited appeal in Michigan? Yes, both UnitedHealthcare (for urgent clinical situations) and Michigan DIFS (with physician urgency letter) offer expedited review processes.
Does step therapy apply if I failed treatments in another state? Yes, documented treatment failures from other states count toward step therapy requirements. Ensure your new provider has complete treatment records.
What happens if my appeal is denied by Michigan DIFS? You may pursue judicial review in Michigan state court within 60 days of the DIFS decision, though this requires legal representation.
How do I know if Tremfya is covered under medical or pharmacy benefits? Contact UnitedHealthcare member services with the specific NDC code. Subcutaneous formulations typically fall under pharmacy benefits, while IV infusions are usually medical benefits.
About Counterforce Health
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed rebuttals that address specific payer requirements. For medications like Tremfya, we identify the exact denial basis—whether it's step therapy, medical necessity, or quantity limits—and draft point-by-point appeals using the right clinical evidence and procedural requirements.
The system pulls appropriate citations from FDA labeling, peer-reviewed studies, and recognized guidelines, weaving them into appeals that meet UnitedHealthcare's specific criteria and Michigan's procedural requirements. This approach helps reduce the back-and-forth between providers and payers, getting patients access to needed treatments faster.
Sources & Further Reading
- UnitedHealthcare Tremfya Prior Authorization Policy
- Michigan DIFS Appeals Process
- Michigan External Review Request Portal
- Tremfya FDA Prescribing Information
- Janssen CarePath Patient Support
- UnitedHealthcare Provider Portal
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider for medical decisions. For assistance with insurance appeals in Michigan, contact DIFS at 877-999-6442.
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