DenialHelp for Partners
Patient-paid AI appeals infrastructure for the procedures, devices, and diagnostics that fall outside pharmacy benefits ePA networks. For early conversations with patient-access, market-access, and commercial leadership at specialty manufacturers.
The problem
Prior-authorization denials and incomplete appeal packets can delay access to specialty drugs, durable medical equipment, structural cardiology, advanced diagnostics, and rare-disease therapies.
Existing hub-services partners cover pharmacy ePA submission but stop short of a source-backed medical-necessity appeal narrative. That artifact may improve review quality, but payer outcomes vary with the plan, evidence, clinical review, and governing rules.
What DenialHelp does
- AI-assisted appeal drafting across the clinical workflows in the current product catalog. The direct Anthropic subscription route is restricted to locally de-identified inputs and is not treated as BAA-covered; PHI-capable processing is separately vendor-gated.
- Bundled PDF packet — cover sheet, narrative appeal letter, OCR'd supporting documents with bookmarks. Single deliverable the patient or prescriber mails/faxes/portals.
- Patient-direct intake. No EHR integration required. Works from any portal, any payer, any state.
- Pro-tier prescriber product (launched 2026-05-22): prescriber-signed narrative attachment for prior authorization. Same drug-agnostic breadth.
Engagement structure
Sponsorship engagements use the Personal Services Safe Harbor (42 CFR § 1001.952(d)). Flat per-case fee or annual subscription; the appeal output is provably independent of funding source via audit-logged, deterministic recommendation hashing (mitigation pattern for OIG AO 22-19). Drug-agnostic appeal logic is contractually warranted and externally auditable.
- Written agreement with FMV-justified compensation set in advance
- Eligibility independent of patient's therapy choice
- Patient consent flow disclosing sponsorship before generation
- De-identified aggregate outcome reporting; no PHI flows back to sponsor
- Right of audit by sponsor's independent compliance counsel
Compliance posture
- HIPAA BAA in place with AWS, Google Workspace, and Paubox
- SOC 2 Type I engagement in progress (2026)
- Privacy Officer: Michael John Ryan (founder)
- HIPAA Security Rule controls documented; audit log retention 6+ years
- Encryption at rest (LUKS) + in transit (TLS-enforced)
- RFC 8058 one-click unsubscribe across all outbound email
Where DenialHelp fits
Specialty pharma in oncology, rare disease, cardiology, and CNS. Medical devices in diabetes (pumps + CGMs), neurostimulation, structural cardiology. Diagnostics in oncology and rare disease. Niche: anything outside the pharmacy-benefit ePA networks where denial narrative materially drives access.
Start a conversation
Email partners@denialhelp.com for an initial discovery call. Please include:
- Your role and the product/therapy area you support
- Approximate denial volume or pain points you're seeing
- Any compliance/legal counsel you'd want present on a follow-up
DenialHelp, LLC — Delaware C-corp — 1111B S Governors Ave # 50985, Dover DE 19904 — EIN 36-5178090