Reimbursement During Clinical Trials

Most medical devices undergoing FDA clearance/approval are eligible for medical device reimbursement during the clinical trial. RPI has extensive, unprecedented experience with assisting clinical investigators with submitting claims during clinical trials, fully documented and in compliance with governmental guidelines.

Seeking medical device reimbursement during the clinical trial may provide early revenue opportunties. More importantly, reimbursement during clinical trials provides an opportunity to develop a charge history for the new technology; thereby, allowing parallel regulatory and reimbursement data collection.

Clinical Trial Reimbursement Services

In the past 12+ years we have developed reimbursement for over 3 dozen clinical trials. The type of product for each trial is listed as follows:

  • Cardiac Assist Device – Bridge to Heart Transplant
  • Carotid Artery Stent I
  • Carotid Artery Stent II
  • Carotid Artery Stent III
  • Drug Eluting Coronary Stent in De Novo Lesions and In-stent Restenosis
  • Drug Eluting Coronary Stent System
  • Urethral Stent
  • Drug Coated Urethral Stent
  • Microwave Uroplasty – Treatment of Benign Prostatic Hyperplasia
  • Breast Cancer Microwave Therapy
  • Implantable Endobronchial Valve for Emphysema Palliation
  • Adjustable Laparascopic Band for Weight Loss (Bariatric) Surgery
  • Diabetic Foot Ulcer Treatment Chamber
  • Implantable Infusion Pump for Chronic, Interactable Pain
  • Autologous Chondrocyte Cartilage Repair System
  • Pancreatic Islet Cell Encapsulation for Transplantation
  • Osseointegrated Prosthesis for Conductive and Mixed Hearing Loss
  • Stent for Treatment of Iliac Artery Lesion
  • Stent for Treatment of Carotid Artery Lesion
  • Stent for Treatment of Coronary Artery Lesion
  • Minimally Invasive Heart Valve Repair
  • Minimally Invasive Heart Valve Replacement
  • Membrane for Repair of Cardiac Foramen Defect
  • Programmable Implantable Infusion Pump for Chronic, Intractable Pain
  • LVA

Success Stories
Clinical Trial Reimbursement

We have recently been involved with several IDE studies for a Fortune 100 company. These activities have included:

  • Reimbursement presentations to participating sites.
  • Creation of a Reimbursement Guide which explains Coding.
  • Coverage and Payment within a clinical trial.

Successfully managed site submissions and approvals to individual CMS contractors during the transition from carriers and fiscal intermediaries to MAC’s.

Providing long-term reimbursement hotline assistance.

Secured early and consistent reimbursement for new incisionless gastrointestinal surgical technique using unlisted CPT code as a temporary reimbursement strategy, until new specific CPT code can be secured through the AMA’s CPT application process.

Overturned private payer claim denials for asthma drug management test.

Identified cost saving value propositions for ECG disposable lead system designed to reduce Hospital Acquired Infections (HAIs)

Secured early and consistent reimbursement for selective interventional radiation therapy for metastatic colorectal cancer. Prior to RPI’s involvement, this procedure was routinely denied by payers on the basis of “experimental and investigational status”.