Research Development Services (RDS) provides support for obtaining approval for use of AU Medical Center, Clinics, Ancillary Services, Medical Records, and Patients (recruited from or using these services) that will be used during the conduct of a research study. 

RDS provides support for accessing the following
hospital resources and services for research purposes:

  • Using AU Medical Center facilities including hospitals and clinics for research visits

  • Liaison for AU Medical Center to establish processes for scheduling research visits or procedures within AU Medical Center locations

  • Supporting research budget development through Medicare cost analysis, Coverage Analysis, and prices for AU Medical Centers and AU Medical Associates

  • Requesting Hospital services such as Radiology, Pathology, Clinical Research Pharmacy,Tumor Bank, Blood Bank, etc., for research

  • Accessing data in the Electronic Medical Record (EMR) and within hospital databases

  • Chart Reviews: Indicate use of AU Medical Center resources on the IRBNet Core Data form, then notify RDS at CTSRDS@augusta.edu including the following information: IRB number, study title, name of PI
  • Studies with billable hospital services are required to use OnCore.
  • A study with a billable hospital service will be assigned a code, known as the CPI number.  This is required for scheduling any hospital services.

What is Coverage Analysis?

  • An analysis of a proposed clinical trial to determine which clinical procedures and/ or services can be billed to insurance and which cannot be billed to insurance. 
  • Helps identify financial liability of enrolled subjects
  • Provides true cost estimate to guide research budget development
  • Based on billing rules, not clinical intent
  • demonstrates due diligence

Why do we need to complete a Coverage Analysis? 

  • Mitigating risk
  • Facilitating billing compliance 
  • Minimizing billing errors
  • Assist with better negotiation of sponsor budgets
  • Patient protection

What is needed to complete a Coverage Analysis? 

  • Protocol
  • Informed Consent 
  • If appropriate investigational drug/device brochures, case report forms, lab manuals and other key documents. 
  • Drafy clinical trial agreement and budget

Who Decides What is Covered? 

  • Statutes 
  • Centers for Medicare & Medicaid Services (CMS) makes a National Coverage Determination (NCD) that sets policy for all contractors 
  • Regional CMS Contractors make a Local Coverage Determination (LCD) that sets coverage policy for all providors in that region. 
  • Palmetto GBA 
  • NCD's and LCD's can be found on CMS.gov

Important Resources for Coverage Analysis 

  • Study clinic visit where visit and all procedures are billed to the study:
      • Call Research Study Line at 6-5500
      • Provide patient info (MRN, DOB)
      • Reason for Visit/Chief Complaint: "Study"
      • The Payer: "Study/Research Plan"
      • The Guarantor: CPI# for the study

  • Routine clinic visit with study procedures
      • Call Research Study Line at 6-5500 and ask that a study visit be created
      • Inform scheduler as to the procedures to be billed to the study
      • If the study is paying for the lab, obtain the account number for lab (MRN + 4 digits) to enter on Pathology Request Form

  • If no clinic visit but labs are needed:
      • Call Research Study Line at 6-5500 and ask that a "lab only" visit be created
      • The Payer is the "Study/Research Plan"
      • The Guarantor is the Study CPI#
      • Obtain account number (MRN + 4 digits) to put on the Pathology Request Form
      • Ask Scheduler to "arrive" patient in the system
      • Submit tube(s) with Pathology Request Form
        If after hours, ask lab staff for "down time" label to be put on tube(s).  Provide study CPI#.  Email Sandy Bragg at sabragg@augusta.edu.

  • Radiology Procedure for billing to the study:
      • Order is written in PowerChart
      • Enter in "Order Comments' tab "Bill to Study" and provide study CPI#
      • MD "fires" the order
      • To schedule, call Radiology at 1-9729, state what services are needed, Payer is "Study/Research Plan," and the Guarantor is the study CPI#

  • Inpatient Study Stay, if study pays for everything
      • Admitting physician submits the Advance Directive
      • States everything is to be billed to the study

  • Inpatient Study Stay, if some items are to be billed to the study
      • Email Cindy Wasserlein at cwasserlein@augusat.edu, 706-446-5924, or Tracy Everett at teverett@augusta.edu, 706-828-6412 
      • Provide the patient name/medical record number, date of inpatient stay item(s) to be billed to the study, and study CPI#
  • Study contact receives bill and verifies charges
  • Check request is generated by study staff
  • If bill is inaccurate, contact Cindy Wasserlein (AUMA) at cwasserlein@augusta.edu, ext. 706-446-5924, or Tracy Everett at teverett@augusta.edu, 706-828-6412
  • Revised bill will be sent if required 

    How can investigators and research staff avoid study billing pitfalls?
  • Work closely with RDS to see that your study is set up correctly
  • Be sure your research team follows established study scheduling and billing processes
  • Know who is responsible for reviewing study bills for your study
  • Contact RDS with questions at CTSRDS@augusta.edu 
  • Submit a signed ICD with a coversheet to Health Information Management Services (HIMS) along with RDS coversheet
  • Submit research notes with coversheet
  • Indicate study visit # (cycle # and day if applicable), unscheduled visit or adverse event treatment, other study specific information
  • HIMS scans to the Clinical Trials section of the EMR for each subject

online programs, databases, and staff directory 

I2B2 computer image
PowerTrials image

 


Contact Us

Research Development Services
Health Sciences Campus
AU Medical Center, BB-8513
1120 15th Street
Augusta, GA 30912
   706-721-6247  
   ctsrds@augusta.edu