By Counterforce Health Team in Humira (adalimumab) —

How to Get Humira (adalimumab) Covered by Blue Cross Blue Shield in California: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Humira Coverage

Blue Cross Blue Shield California requires prior authorization for Humira (adalimumab) with step therapy to preferred biosimilars like Hadlima. To get coverage: 1) Have your specialist submit a PA form with documented failure/intolerance of methotrexate and two preferred biologics, 2) Include TB/hepatitis B screening results and disease severity scores, 3) If denied, file internal appeal within 180 days, then request DMHC Independent Medical Review. Success rates for medically necessary treatments exceed 55% at the IMR level. Start with Blue Shield's PA forms.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humira prescriptions Blue Shield provider portal PA Policy
Step Therapy Must fail methotrexate + 2 preferred biologics Policy documents Blue Shield Formulary
Age Requirement 18+ years for most indications PA criteria Policy Details
Specialty Pharmacy Must use designated specialty pharmacy Formulary tier requirements Specialty Drug List
Safety Screening TB and hepatitis B/C testing required FDA labeling requirements PA Criteria

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis and Severity (Patient + Doctor)

  • What to do: Verify you have an FDA-approved indication (RA, psoriatic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, ankylosing spondylitis, or uveitis)
  • Documentation needed: ICD-10 codes, disease activity scores (e.g., DAS28 for RA, CDAI for Crohn's)
  • Timeline: Same day as appointment
  • Source: FDA Humira Label

2. Document Prior Therapy Failures (Doctor)

  • What to do: Compile records showing inadequate response or intolerance to methotrexate and at least two preferred biologics
  • Documentation needed: Drug names, doses, duration (minimum 6 weeks each), specific reasons for discontinuation
  • Timeline: 1-2 business days to gather records
  • Source: Blue Shield Step Therapy Requirements

3. Complete Safety Screenings (Patient)

  • What to do: Get TB testing (QuantiFERON or PPD) and hepatitis B panel (HBsAg, anti-HBc, anti-HBs)
  • Documentation needed: Lab results showing negative TB and hepatitis B screening
  • Timeline: 2-3 days for lab results
  • Source: Blue Shield PA Criteria

4. Submit Prior Authorization (Doctor's Office)

5. Follow Up on Decision (Patient + Doctor)

  • What to do: Call Blue Shield member services to confirm receipt and check status
  • Timeline: Within 3 business days of submission
  • Next step: If approved, coordinate with specialty pharmacy; if denied, proceed to appeals

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Step therapy not completed Document contraindications or failures of required drugs Prior therapy records with specific failure reasons
Missing safety screening Submit complete TB and hepatitis B test results Lab reports dated within 3 months
Insufficient disease severity Provide objective disease activity scores DAS28, CDAI, PASI scores, imaging results
Biosimilar preferred Request formulary exception with clinical justification Evidence of biosimilar failure or contraindication
Age restriction Confirm FDA-approved indication for patient's age FDA labeling for pediatric indications if applicable
From Our Advocates: We've seen many Humira appeals succeed when patients document specific adverse reactions to biosimilars, such as injection site reactions or loss of disease control. Objective measures like increased inflammatory markers or hospitalization records strengthen these cases significantly.

Appeals Playbook for California

Internal Appeal (First Level)

  • Deadline: 180 days from denial notice
  • How to file: Submit written appeal to Blue Shield with additional clinical evidence
  • Timeline: 30 days for plan decision (expedited: 72 hours for urgent cases)
  • Required: Denial letter, physician statement, updated medical records
  • Source: Blue Shield Appeals Process

DMHC Independent Medical Review (External Appeal)

  • When to use: After internal appeal denial or if plan takes too long
  • How to file: Submit IMR application to DMHC Help Center
  • Contact: 1-888-466-2219 or online application
  • Timeline: 45 days standard, 72 hours expedited
  • Success rate: 55-68% of medical necessity denials overturned
  • Cost: Free to patients
  • Source: DMHC IMR Process

For comprehensive support with insurance appeals and prior authorization documentation, Counterforce Health helps patients and clinicians turn denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned with plan policies.

When Biosimilars Are Preferred

Blue Shield California has increasingly favored adalimumab biosimilars (Hadlima, Simlandi) over brand-name Humira, offering $0 copays for biosimilars starting in 2025. To get brand Humira covered when biosimilars are preferred:

Exception Criteria:

  • Clinical failure on biosimilar with objective evidence (disease activity scores, lab values)
  • Adverse reactions to biosimilar not present with Humira
  • Anti-drug antibody formation to biosimilar
  • Patient stability on Humira with high risk of flare if switched

Documentation Strategy:

  • Before/after disease activity comparisons
  • Hospitalization or ER visit records related to biosimilar failure
  • Immunogenicity testing results if available
  • Detailed timeline of symptom changes with biosimilar

Clinician Corner: Medical Necessity Documentation

Essential Elements for PA Submission

  1. Patient identification: Full name, DOB, Blue Shield ID number
  2. Diagnosis with ICD-10 codes: M05.40-M06.9 (RA), K50 (Crohn's), K51 (UC), L40.0 (psoriasis)
  3. Disease severity: Baseline activity scores, functional limitations, quality of life impact
  4. Prior therapy history:
    • Methotrexate: dose, duration, reason for discontinuation
    • Two preferred biologics: specific agents, doses, trial lengths, outcomes
  5. Safety screening results: TB testing, hepatitis B panel, CBC
  6. Treatment plan: Humira dosing, monitoring schedule, goals

Strengthening Medical Necessity Arguments

  • Reference FDA labeling for approved indications
  • Cite disease-specific guidelines (ACR for RA, AGA for IBD)
  • Include objective measures: inflammatory markers, imaging, endoscopy results
  • Document extra-articular or extra-intestinal manifestations when present

Costs & Patient Assistance

Humira Complete Support

  • Copay assistance: Up to $5 per month for eligible commercial patients
  • Eligibility: Not available for government insurance (Medicare, Medicaid)
  • How to apply: HumiraComplete.com or 1-800-4HUMIRA
  • Income limits: Household income up to $100,000

California-Specific Programs

  • Covered California subsidies: Available for marketplace plans based on income
  • Medi-Cal coverage: Prior authorization required but generally covered for eligible conditions
  • Patient Advocate Foundation: Free case management for appeals
  • Contact: 1-800-532-5274

FAQ

How long does Blue Cross Blue Shield prior authorization take in California? Standard PA decisions are made within 72 hours, with expedited reviews completed in 24 hours for urgent cases. The new Salesforce integration (testing in 2025) may reduce this to real-time approvals for many cases.

What if Humira is non-formulary on my Blue Shield plan? Submit a formulary exception request with clinical justification. If denied, you can appeal internally and then request DMHC Independent Medical Review, which has a 55-68% overturn rate for medically necessary treatments.

Can I request an expedited appeal if I'm hospitalized? Yes, if delay would seriously jeopardize your health or ability to regain function, request expedited review. DMHC provides 72-hour decisions for urgent IMR cases.

Does step therapy apply if I was stable on Humira before moving to California? Document your prior stability and clinical improvement on Humira. Plans may grant exceptions for patients stable on therapy where switching poses significant clinical risk.

What's the difference between Blue Shield of California and Anthem Blue Cross? Both are independent Blue Cross Blue Shield plans in California with similar PA requirements but different forms and submission processes. Check your ID card to confirm your specific carrier.

How much does Humira cost without insurance in California? List price is approximately $6,000-$7,000 per two-pen carton. With biosimilar competition, some plans now offer $0 copay biosimilar alternatives through specialty pharmacies.

If you're facing complex prior authorization challenges or need help preparing a comprehensive appeal, Counterforce Health specializes in transforming insurance denials into successful approvals through evidence-based appeal strategies.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan directly for coverage determinations. For additional assistance with appeals in California, contact the DMHC Help Center at 1-888-466-2219.

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