[Date]

Humana – Appeals Department
[Plan/Address from Denial Letter]
Fax: [Fax if available]

Re: First-Level Appeal and Request for Retroactive Authorization
Member: [Patient Name], [DOB]
Member/Subscriber ID: [Member ID]
Claim Number(s): [Claim Number]
Service Dates: [Service Dates]
Rendering Provider: [Provider Name], [Provider NPI]
Procedure Code: J1745 (Infliximab injection, 10 mg)
Denial Reason: “Prior authorization required” (Denial Category: prior_auth)
Insurance Type: Commercial

To Whom It May Concern:

I am submitting this appeal on behalf of [Patient Name] to request reversal of Humana’s denial and issuance of retroactive authorization for infliximab (J1745) administered on the above service dates for the diagnosis and clinical findings described in Humana’s denial letter. The denial cites “Prior authorization required.” This is an administrative denial rather than a medical necessity determination. The patient’s condition, as documented in the denial letter and medical record, meets Humana’s own preferred-drug framework for infliximab, and is fully supported by Level I evidence and federal coverage benchmarks. We respectfully request expedited review, retroactive authorization, and reprocessing of the claim.

Administrative basis for overturning the denial and granting retroactive authorization
- Humana designates infliximab (J1745) as a preferred agent for autoimmune disorders, including rheumatoid arthritis (RA). Humana’s policy explicitly lists “Preferred J1745 AND Remicade Preferred J1745 AND Simponi Aria Preferred,” signaling that when clinical criteria are met, access should be facilitated rather than blocked on a technicality. Source: https://docushare-web.apps.external.pioneer.humana.com/Marketing/docushare-app?file=4513964
- Humana’s step therapy guidance likewise lists infliximab as preferred for RA under autoimmune disorders: “Inflectra Preferred Q5103 Remicade Preferred J1745 Simponi Aria Preferred J1602,” with step criteria applied to ensure appropriate use—not to deny coverage to clinically appropriate patients after care is rendered. Source: https://docushare-web.apps.external.pioneer.humana.com/Marketing/docushare-app?file=3525873
- Humana’s Part B preferred drug list (while labeled for Medicare) is instructive for commercial coverage logic and again lists Infliximab Preferred J1745 for “Immunologic drugs – autoimmune disorders (arthritis, psoriasis, inflammatory bowel disease),” noting that preferred status aligns with step therapy criteria. Source: https://assets.humana.com/is/content/humana/2026%20Part%20B%20step%20therapy%20preferred%20drug%20listpdf

Taken together, Humana’s own materials confirm that infliximab J1745 is a covered, preferred therapy for RA when criteria are met. The instant denial is purely procedural for lack of prior authorization—not a determination that infliximab is non-covered or not medically necessary. In such circumstances, retroactive authorization is appropriate to prevent harm and ensure continuity of care, particularly where the records demonstrate active disease consistent with policy criteria.

Medical necessity and urgency, supported by high-level evidence
- Foundational RCT evidence (ATTRACT): In patients with active RA despite methotrexate, repeated infliximab infusions with methotrexate produced substantial clinical benefit and halted radiographic progression; at 54 weeks, 52% achieved ACR20 versus 20% with methotrexate alone (p<0.001). This trial mirrors standard J1745 dosing intervals. Source: https://pubmed.ncbi.nlm.nih.gov/11096166/
- Systematic review and economic evaluation (NIHR): Confirms the efficacy of biologic DMARDs, including infliximab, for RA, with significant reductions in disease activity and improvements in outcomes, supporting use after conventional DMARD failure. Source: https://pubmed.ncbi.nlm.nih.gov/24399231/
- UK NIHR systematic review and economic evaluation: Infliximab yields clinically meaningful improvements in function and quality of life; meta-analyses show strong ACR20 odds ratios versus placebo and cost-effectiveness in appropriate patients. Source: https://pubmed.ncbi.nlm.nih.gov/17049139/
- Meta-analysis of infliximab efficacy and safety: Demonstrates robust ACR20 responses and favorable safety profile in moderate-to-severe RA with sustained benefits at one year. Source: https://pubmed.ncbi.nlm.nih.gov/19771491/
- Systematic review in early RA: Shows infliximab reduces disease progression with substantial ACR50 rates and low discontinuation for toxicity—underscoring the harm of delaying therapy. Source: https://pubmed.ncbi.nlm.nih.gov/18473014/
- Comparative meta-analysis across infliximab formulations and other biologics: IV infliximab (J1745) is equivalent in efficacy and safety to other TNF inhibitors, validating it as a standard option without basis for unique access barriers. Source: https://pubmed.ncbi.nlm.nih.gov/33305638/
- Biosimilar/biologic comparative analysis: No significant efficacy or safety differences between infliximab-biosimilar and other biologics in active RA—supporting broad access to TNF inhibitors, including J1745. Source: https://pubmed.ncbi.nlm.nih.gov/24832836/
- Real-world dosing flexibility: Dose-modification review shows infliximab dose escalations up to 10 mg/kg maintain efficacy with low serious adverse event rates, supporting clinical appropriateness and adaptability to patient needs. Source: https://pubmed.ncbi.nlm.nih.gov/25638015/
- Observational evidence: Infliximab with methotrexate reduces inflammation and slows radiographic progression, with meaningful remission rates in persistent RA. Source: https://pubmed.ncbi.nlm.nih.gov/19707407/

Collectively, this Level I evidence base establishes infliximab as a standard-of-care biologic for moderate-to-severe RA with active disease despite conventional therapy. In RA, delays in biologic treatment risk irreversible joint damage and disability. Denial based on a procedural prior authorization technicality is incongruent with the strength of evidence and the patient’s documented clinical need.

Regulatory context supporting coverage
- CMS Billing and Coding Article A52423 confirms coverage of infliximab (J1745) for FDA-approved indications such as RA when medically necessary, outlining billing/coding parameters that complement LCDs. Source: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52423
- CMS LCD L35677 provides coverage indications and medical necessity criteria for infliximab in RA (e.g., moderate-to-severe active disease), demonstrating national, regulator-backed standards for coverage. Source: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=35677&ver=88

While CMS policies are Medicare-focused and not binding on commercial plans, they are persuasive benchmarks that commercial carriers, including Humana, routinely mirror for biologics. Aligning this appeal with CMS standards further supports overturning an administrative denial for a therapy widely recognized as medically necessary in RA.

Addressing the stated denial reason and step-therapy criteria
- The denial is solely for “Prior authorization required.” It is not a clinical determination against infliximab. Humana’s policies identify J1745 infliximab as preferred for RA when criteria are met. The diagnosis and clinical findings described in Humana’s denial letter are consistent with the populations studied in the cited trials and reviews, and with typical step-therapy frameworks (e.g., active disease despite conventional DMARD therapy). If any additional documentation of prior DMARD use or disease activity is needed, it is available and can be furnished promptly upon request. Given the strong medical necessity and Humana’s own preferred-drug designation, we request retroactive authorization and claim reprocessing.
- To avoid further care disruption and potential harm, we also request that Humana apply continuity-of-care principles so that the patient is not penalized for a procedural oversight when all substantive medical-necessity criteria are met.

Requested remedy
1) Overturn the denial based on administrative grounds and issue retroactive authorization for J1745 infliximab as rendered on [Service Dates].
2) Reprocess and pay the associated claim(s) in accordance with the member’s benefits.
3) Confirm that the member will not be held financially responsible for services that are medically necessary and covered under Humana policy.
4) If Humana requires any additional step-therapy or clinical documentation, please notify us and we will supply it immediately for expedited review.

Acknowledgment of evidence scope
The provided research did not identify state-specific mandates or case law precedents; however, the comprehensive clinical evidence and CMS coverage framework, combined with Humana’s own preferred-drug listings for J1745, provide a robust basis to grant this appeal.

Thank you for your prompt, favorable reconsideration. Please contact our office at [Phone] or [Secure Fax] for any additional information or if an expedited peer-to-peer is preferred.

Sincerely,

[Provider Name], [Credentials]
[Title/Department]
[Practice/Facility Name]
[NPI: Provider NPI]
[Address]
[Phone] | [Fax] | [Email]

Citations and evidence sources
- Humana – Specialty Drugs Category Specialty Drugs. Source: https://docushare-web.apps.external.pioneer.humana.com/Marketing/docushare-app?file=4513964
- Humana – Injectable drugs and biologics step therapy requirement for …. Source: https://docushare-web.apps.external.pioneer.humana.com/Marketing/docushare-app?file=3525873
- Humana – Medicare Part B step therapy requirement for … Preferred Drug List. Source: https://assets.humana.com/is/content/humana/2026%20Part%20B%20step%20therapy%20preferred%20drug%20listpdf
- ATTRACT RCT: Infliximab and methotrexate in RA. Source: https://pubmed.ncbi.nlm.nih.gov/11096166/
- Systematic review/economic evaluation (NIHR) – biologic DMARDs efficacy. Source: https://pubmed.ncbi.nlm.nih.gov/24399231/
- Systematic review/economic evaluation – TNF inhibitors including infliximab. Source: https://pubmed.ncbi.nlm.nih.gov/17049139/
- Meta-analysis – infliximab efficacy and safety in RA. Source: https://pubmed.ncbi.nlm.nih.gov/19771491/
- Systematic review – infliximab in early RA. Source: https://pubmed.ncbi.nlm.nih.gov/18473014/
- Systematic review/meta-analysis – SC infliximab vs adalimumab, etanercept, IV infliximab. Source: https://pubmed.ncbi.nlm.nih.gov/33305638/
- Bayesian meta-analysis – infliximab-biosimilar vs other biologics. Source: https://pubmed.ncbi.nlm.nih.gov/24832836/
- Observational study – infliximab in RA. Source: https://pubmed.ncbi.nlm.nih.gov/19707407/
- Dose modification review – anti-TNF dosing in RA. Source: https://pubmed.ncbi.nlm.nih.gov/25638015/
- CMS Article A52423 – Infliximab and biosimilars (Billing and Coding). Source: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52423
- CMS LCD L35677 – Infliximab. Source: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=35677&ver=88

Attachments
- Humana denial letter
- Clinical notes and laboratory/imaging supporting diagnosis and disease activity as referenced in denial letter
- Prior therapy history and step-therapy documentation (if requested)
- Published literature PDFs or links as cited above