Consulting Services / Reimbursement for Clinical Trials

Many clinical trial procedures and expenses are eligible for reimbursement and coverage. The Pinnacle can help your organization develop a strategic reimbursement plan to maximize all available reimbursement opportunities. We will work with carriers, fiscal intermediaries and DMERC's to seek the approval required for reimbursement under clinical trials and will work with your organization to submit and track reimbursement claims. The Pinnacle will develop the tools and mechanisms necessary for your organization to receive the appropriate reimbursement throughout the clinical trial process. Our services include:

  • Clinical Trial Reimbursement Coding and Coverage
  • Clinical Trial Coverage Approval and Tracking
  • Strategic Reimbursement Planning and Positioning

Clinical Trial Reimbursement Coding and Coverage

Many clinical trials are eligible for reimbursement and coverage for specific procedures and other incurred expenses. The Pinnacle Health Group works with providers submitting claims for services that meet requirements in the National Coverage Decision for clinical trials. The Pinnacle team works to ensure that appropriate modifiers and diagnosis are provided to ensure payment for patients who meet the coverage criteria. We also recommend the appropriate coding necessary to ensure timely and appropriate payment for clinical trial services and costs. The Pinnacle team determines items and services that are reimbursable services under the regulations and that appropriate coding is provided on the claim.

The Pinnacle team assists manufacturers to better understand the appropriate rules and regulations and to develop programs to ensure clinical trial sites understand the appropriate coding and payment methodologies to apply to enrolled patients. When requesting reimbursement under the clinical trial regulations, medical records and documentation are required from the provider. The Pinnacle Team develops appropriate tools and tracking mechanisms to ensure reporting requirements are met and payments for claims are appropriate.

Clinical Trial Coverage Approval and Tracking

Each clinical trial site must obtain approval to claim reimbursement from the Medicare program prior to claims submission. The Pinnacle team works directly with manufacturers to ensure approval by carriers, fiscal intermediaries and DMERCs when seeking reimbursement under the clinical trial. Requesting authorization, approval of the appropriate number of trial subjects, appropriate informed consent language and tracking are all required as part of the coverage regulations. The Pinnacle team works to assure that each site is compliant with reimbursement regulations.

Inadvertently denied clinical trial claims are frequent and require direct contact with the payer to ensure appropriate adjudication and future processing. The Pinnacle team develops tracking systems and customized mechanisms to gain authorization for the clinical trial site, tracks the number of subjects to request additional approval when necessary, and ensures appropriate payment for denied claims under the coverage regulations.

Strategic Reimbursement Planning and Positioning

The most appropriate time to develop a comprehensive plan for appropriate coding and coverage of your new medical technology is typically during the clinical trial period.. The Pinnacle team will develop a strategic plan to outline coverage and coding and to help implement the tactical steps necessary to obtain coding for ICD-9-CM, HCPCS, CPT, HOPPS, or other necessary payments. Proactive planning ensures appropriate reimbursement as quickly as possible following the clinical trial.

The Pinnacle team's strategic plans consist of:

  • Review of current regulations
  • Review of coverage for similar products/devices
  • Review of payment policy history
  • New coding application requirements
  • Review of advocacy requirements to ensure reimbursement
  • Development of coverage strategy
  • Development of coding strategy
  • Development of interim coding references
  • Strategy to integrate reimbursement strategy with strategic marketing plan

The Pinnacle Health Group continuously monitors federal and state policy changes and proposals and will help to implement the strategic plan, develop and continuously update the plan based upon governmental and regulatory changes and provide educational programs to support the plan.

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