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Important Announcement - Clinical Trials Services

Guidelines for Coverage Analysis Submission

Required Documents:

• Current Protocol
• Informed Consent document in IUPUI format
• Sponsor budget
• Itemized budget
• Billing Grid with billing plan
• Clarian Vendor Charge Form
• Supporting documentation

I. Coverage analysis initiation
    Responsible Party: Investigator

1. Investigator receives a proposed study from a sponsor and a billing grid is created by the coordinator, PI or person preparing the budget that represents the schedule of events.



2. The billing grid is completed identifying each service the sponsor is paying for and signifies this with an S. Services that are identified as billable to Medicare are designated with a M. All other services will be designed with an R (these are services that are research, but not billable to Medicare and are not explicitly stated as being paid for by the sponsor, ie. Informed consent, adverse events, concomitant meds). An * will be placed after any service that has a charge of $500 or more.



S=Billing Sponsor M=Billing Medicare

R=Research Activity, non-billable *=Service $500 or greater



3. 3. Principal Investigator will review the billing grid and sign it.



4. The preliminary billing grid will be emailed to the Clinical Trials Services at cto@iu.edu.

II. Clinical Trials Services review of Coverage Analysis
     Responsible Party: Clinical Trials Services

1. Clinical Trials Services does the following:


a) Reviews protocol to assure all services are listed on the billing grid.

b) Double check the billing codes based on the Informed Consent and Sponsor budget

c) Reviews all services designated M* to ensure that there is solid foundation for the service being standard of care or performed for patient safety and to determine if a National Coverage Determination or a Local Coverage Determination exists which excludes coverage for the service. The analyst will use objective material as evidence that has either been gathered from the Investigator or researched by the analyst.



2. If the analyst agrees with the investigators assignment of billing codes, the
   analyst will sign the billing grid and send it back to the investigator.
   



3. If there is disagreement regarding the billing grid, the analyst will meet with
   Investigator and discuss the coverage status of the service.  If a resolution is
   not met with this meeting, Clinical Trials Services will send a query to the local Medicare
   Medical Director for further guidance.

III. Budget Development
       Responsible Party: Clinical Trials Services

1. Once the coverage analysis process is approved, budget negotiation should be
   finalized with the sponsor. The budget negotiations should coincide with the
   coverage analysis.

IV. Submission of study with corrected Informed Consent Form to IRB
      Responsible Party: Investigator or Clinical Trials Services

1. Submission of study to IRB for review. If informed consent changes are requested based on the coverage analysis, these changes must be included in the IRB submission or an amendment will be required. A copy of the IRB approved informed consent will be forwarded to Clinical Trials Services.

V. Contract Execution
     Responsible Party: Clinical Trials Services

1. After the study is IRB approved, the Informed Consent, Clarian Vendor Charge Form and approved billing grid will be checked along with the contract to assure all documents match, the contract will be executed.