KNOWLEDGE BASE

Resources

Clinical protocols, billing guides, IFUs, and regulatory documentation for every Ventana product. All materials are for healthcare provider use.

PDFActiGraft

ActiGraft® Instructions for Use

Complete IFU for chairside whole blood clot preparation. Covers collection protocol, application technique, and contraindications.

GuideActiGraft

ActiGraft® NCD 270.3 Coverage Summary

Medicare National Coverage Determination 270.3 — blood-derived products for chronic non-healing wounds. 20-week coverage for diabetic wounds.

PDFAmchoPlast

AmchoPlast™ Instructions for Use

Triple-layer dHAICM allograft application protocol. Includes wound bed preparation, sizing guide, and tissue tracking sticker requirements.

ProtocolMicrolyte SAM

Microlyte® SAM™ Clinical Protocol

Synthetic antimicrobial matrix application guide. Covers wound geometry conformance, ionic silver mechanism, and dressing change intervals.

GuideArobella QWTS

Arobella Qoustic Wound Therapy — Clinical Guide

Low-frequency ultrasound saline-mist debridement protocol. Includes treatment parameters, session frequency, and biofilm disruption endpoints.

PDFOasis

Oasis® Wound Matrix IFU

Porcine SIS extracellular matrix application protocol. Includes caramelization warning, heat source precautions, and rehydration steps.

GuideMaiden Collagen

Maiden Collagen ECM3 Application Guide

Type-I bovine collagen foundation dressing protocol. Covers granulation tissue support, sizing selection, and multi-layer application.

ProtocolOmeza OCM

Omeza® OCM™ Clinical Protocol

Omega fatty-acid collagen matrix for refractory wounds. Includes vial preparation, 16-unit billing structure, and refractory wound criteria.

Guide

HCPCS Code Reference — Full Product Catalog

Complete HCPCS and CPT code mapping for all Ventana products. Includes Q4316, Q4102, A2005, A2014, G0465/G0460, A6021/A6023, and CPT 97610.

Guide

MAC-Aware Reimbursement Guide

Regional MAC policies for skin substitute reimbursement. Covers Novitas, CGS, Palmetto, WPS, NGS, and First Coast MAC jurisdictions.

Guide

Place of Service (POS) Code Reference

POS 11 (Office), POS 22 (Outpatient Hospital), POS 31/32 (SNF). Reimbursement rate differences and documentation requirements by setting.

GuideOmeza OCM

Omeza OCM — Box 19 Invoice Requirement

Step-by-step guide for attaching the $2,050 per-vial invoice to CMS-1500 Box 19. Most MACs require invoice with claim to avoid rejection.

GuideActiGraft

ActiGraft® G0465 / G0460 Billing Guide

Preparation (G0465) vs. application (G0460) code distinction. Facility rate $1,829.23 vs. non-facility rate $890.18. Modifier guidance included.

Guide

CAMP Skin Substitute Billing Overview

Comprehensive billing guide for Cellular and/or Acellular Matrix Products. Covers Q4316, Q4102, A6021/A6023 with MAC-specific documentation requirements.

Guide

IVR Submission — Step-by-Step Training

Complete walkthrough for submitting an IVR through the Ventana portal. Covers patient ID entry, product selection, modifier notes, and approval workflow.

Protocol

Wound Assessment Documentation Guide

HIPAA-compliant wound documentation protocol. Covers wound dimensions, depth classification, exudate type, and photographic documentation standards.

Protocol

Tissue Tracking & Chain of Custody

HCT/P §361 tissue tracking requirements for AmchoPlast and other allograft products. Includes sticker placement, lot number recording, and audit trail.

Guide

Sales Representative Onboarding Guide

Product portfolio overview, IVR submission process, compliance requirements, and territory management for Ventana BioSciences representatives.

Guide

HIPAA Compliance — PHI Handling Guide

Patient Health Information handling requirements for IVR submissions. Covers de-identification, minimum necessary standard, and breach notification.

PDF

FDA 510(k) Clearance Documentation

FDA clearance summaries for Microlyte SAM, Arobella QWTS, Maiden Collagen, and Oasis Wound Matrix. Includes predicate device comparisons.

Guide

HCT/P §361 Regulatory Framework

FDA HCT/P Section 361 compliance requirements for AmchoPlast and allograft products. Covers donor eligibility, processing standards, and labeling.

Guide

CMS Reimbursement Disclosure Policy

CMS disclosure requirements: reimbursement is not guaranteed. Providers are responsible for verifying specific MAC policies. Sales Agreement payment terms.

Need a specific document?

Contact your Ventana representative for product-specific IFUs, clinical studies, or custom billing guides.

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