Clinical Trial Billing –
Updated Procedures
Kay M. Perry
Pam Sabrsula
June 2010
Today’s Class Will Cover…
• Reminder about the Billing Rules &
Billing Grids
• Procedural Updates:
– Research Activity Billing Trigger
– UHS Monthly Report
Basic Billing Rules
Do Not Double Bill
SPONSOR
INSURANCE
Do not bill for items or services
promised for free in the ICF
Consent
Form
Beyond That….
• Can usually bill standard of care
services/items & research-related
complications
– Unless sponsor agreed to pay in
the CTA
• Medicare has some additional
specific rules, as do commercial
payors
A “Clinical Trial Billing Rules”
course is available in the
Knowledge Center!
(There is one on Budgeting also!)
A Reminder about Pro Fees
vs. Tech Fees
Pro Fees vs. Tech Fees
In a UT Med
Radiologist:
Facility:
clinic: Global
Professional
(Pro Fee &Technical
Tech
Component
Component
Fee in one)
(UT Med)
(e.g. University
Hospital)
Be sure to budget for both
Be sure to think about the
billing for both
Be sure to reconcile for both
(PS: UHS does not negotiate its rates)
Billing Grids
Yes, still required!
Templates online at:
http://research.uthscsa.edu/ocr/clinical.shtml
A Few Things Learned Along
the Way….
• Please list “office visit” if there is one
– Some studies pay for it, some don’t
– Pro fee may be assessed by UTMed even
though the PI is performing
• Please use CPT terminology, if known,
in addition to common parlance
– e.g., to you it’s a “6-minute walk test”
but to the billing system it may be
“Pulmonary Function Test” or “Simple
Exercise Test”
UT Medicine Forms
Hopefully You Will Recall that
Two Forms were Introduced
in 2009
1. Study Information Form
2. Patient Enrollment Form
• Forms used to create Research
Accounts in EPIC billing system
Research Activity Billing
Trigger “RABT” Form
• Required for studies:
– With UT Medicine billing
– With UHS when you will pay UHS for
some services (due to monthly reporting
requirement)
– Other studies with clinical services where
the study pays a provider/facility for a
service (for Reconciliation purposes)
“RABT” Form
• Primarily replaces other UT Medicine
forms, but also gives details of services
(dates, etc.)
Additional Details Required
Services Information:
• Billing Grid Week or Visit #
(e.g., Visit 1, Visit 2, etc.)
• Sunrise Visit # (a.k.a. IDX
Admit #)
• Date
• Description
• Location/Specialty/Provider
• Affiliated Billing Entity
• Bill to: R or T
Reconciliation:
• Invoice Date
• Invoice #
• Date Invoice Paid
Working with the File
• One workbook for the entire study
• One tab for each participant
– On the first tab, complete study
information only
– Then copy the tab to create a new one
for each participant
Working with the File, continued
• Monthly UHS report – header fills in
automatically, but must copy and
paste for each month’s services
The RABT and UT Medicine
• Email the file to UT Medicine:
UTMSAResearchBilling@uthscsa.edu
(will change to a SharePoint site in near future)
• When a new study has been started or
a new participant enrolled – tell them
in your email
• If a participant is taken off the study,
notify UT Medicine via email with
participant name and study name
UHS Monthly Report
The RABT and UHS
• Send the monthly report to Joan
Thomas at joan.thomas@uhs-sa.com
• You can send the entire file, or make a
.pdf of the monthly report sheet
Other Studies/Locations
• Primary concern is reconciliation
Reconciliation
Reconciliation:
During Study and Prior to Closing
• Did study team receive all invoices from
affiliates, UT Medicine, etc.?
– If not, they probably billed the
patient/insurance
• Did study department actually pay the
invoices?
• Balance study patient care expenses to a
total of each patient’s costs
What research personnel need
to do:
1. Continue creating billing grids
2. Copy the billing grid into the RABT
spreadsheet if required
3. Send RABT to UT Medicine
4. Reconcile costs, payments, etc. to grids
5. Send monthly report to UHS using RABT
Effective July 1st – you do NOT have to go back
in time to create a RABT for your studies
(unless you want to)!
References
• http://research.uthscsa.edu/ocr/clinical.shtml
• HOP 7.7.1
• Drugs:
– NCD for Routine Costs in Clinical Trials (310.1)
– Medicare Claims Processing Manual, Chapter 32,
Section 69
• Devices:
– Medicare Benefit Policy Manual Chapter 14,
Section 20
– http://www.trailblazerhealth.com/Policies/Devices
/Default.aspx (TrailBlazers is Texas’ Medicare
contractor)
Questions?
Kay M. Perry, JD, Regulatory Analyst for Research Operations
PerryK3@uthscsa.edu
(210) 567-0651
Pam Sabrsula, Project Coordinator
sabrsula@uthscsa.edu
(210) 567-1338