Research Development Services

Research Development Services (RDS) provides support for obtaining approval for use of »Æ¹Ï¶ÌÊÓƵ 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

Contact Us

Research Development Services

Medical Center BB-8513

1120 15th Street
Augusta, GA 30912

706-721-6247

ctsrds@augusta.edu

Important Information

AU Medical Center Approval Process

  • 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.

 

Coverage Analysis

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
  • Draft 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 providers in that region.
  • Palmetto GBA 
  • NCD's and LCD's can be found on

 

Scheduling AU Medical Center Services

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

  • Contact 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#

 

Billing for AU Medical Center Research Services

  • 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

Importance of Medical Record Compliance

  • 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

icon Our Staff

photo of Niju Philip, MS, CCRC

Niju Philip, MS, CCRC

  • Director, Research Development Services
  • Study Billing Grids
  • Study Approval Information

706-721-7740

photo of Vacant

Vacant

  • Director, Clinical Translational Finance

706-721-6247

photo of Rosie Rhodes, MBA

Rosie Rhodes, MBA

  • Senior Clinical Research Billing Analyst

706-721-4058

photo of Sunil Halder

Sunil Halder

  • Clinical Research Operations Coordinator

706-721-4328

photo of Kim Moore

Kim Moore

  • Clinical Research Billing Analyst

706-721-8179