Written by Rose Bothner, Project Manager, Clinical Conductor CTMS
In clinical research, the billing compliance process applies regulatory and financial considerations to allocating charges associated with research related services to the appropriate payer. Both research organizations and healthcare organizations who conduct research studies must accurately identify charges that are allocated to sponsors, Medicare, third party payers and other financial entities. To make things more complicated, all of this must be done in a manner that is compliant with federal and state regulations. Failure to comply with these regulations can result in fines, additional regulatory oversight, and loss in study opportunities.
If you’re thinking there’s a better way than managing all of this manually, you’re correct! Great CTMS applications offer several features to assist organizations in achieving compliance and streamlining their billing processes. Those features include:
- A cost allocation grid to record Medicare Coverage Analysis decisions and justifications for each study procedure
- A billing review workflow which enables the user to validate study research charges for correct payer designations, consistency with hospital billing data, and approval of research charges for sponsor invoicing.
- An EMR integration of the billing grid to ensure that the hospital billing allocations are current and accurate. The automated data transfer provides improved data accuracy, operational efficiencies, and the ability to synchronize updates to the billing grid in response to protocol amendments.
If this is what you need at your organization, start looking for the CTMS vendors who have these features and ask to see how they work for your organization. Here’s what you should look for and ask about:
What to look for – Billing grid capabilities:
- CA decision and justification capturing capabilities
- The ability to record sponsor invoicing requirements
- Billing designation recording
- The ability to record Medicare codes and modifiers
- Unique billing grids for individual study arms
What to look for – Billing review workflow:
- The ability to compare and reconcile patient visit CTMS billing data with hospital billing data
- Functionality that lets you amend visit billing data to add omitted patient activity or remove erroneous billing data
- Visit activity records that are prevented from invoicing without billing review approval
- A full audit history of all billing data adjustments including original data reference and adjustment justifications
- The ability to place items on hold for investigation
- Security privileges that are assigned to only authorized users
What to look for – Integration capabilities:
- Provides accurate billing designations to clinical billing staff to ensure that research charges are allocated to the correct payer
- Real-time updates and billing designations according protocol amendments
- Simple communication between regulatory, research and clinical billing personnel