Research Development Services

Research Development Services (RDS) provides support for obtaining approval for use of Augusta University 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 CMS.gov

Important Resources for Coverage Analysis

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