According to the estimates, over $2 billion were recovered under the False Claims Act cases in 2020. Every year, a significant number of clinical trial sponsors are legally penalized and face delays in their research study results owing to errors in budget and billing compliance. Some even jeopardize their studies by constantly getting flagged by the relevant authorities for inappropriate billing and budgeting practices.
So to avoid the issue of compliance in a clinical trial, it’s essential that organizers consider the key factors prior to the study activation. If you seek to learn more about avoiding billing compliance issues in clinical trials, then continue to read this guide below.
What is Budget & Billing Compliance?
Budget and billing compliance for clinical trial organizers is a guideline that aims at improving the financial management of clinical research.
By enforcing billing and budgeting protocols, the compliance ensures that clinical trial participants are not charged unfairly, no financial discrepancies are reported towards the end of the trial, and sponsors don’t cut costs in a manner that’s against protocols.
What Causes Trouble?
As mentioned above, over $2 billion were recovered by the Justice Department in 2020 against clinical trials’ false budgeting and billing. Here are some reasons for that error to have occurred:
- Double Billing: Clinical trial organizers sometimes mistakenly or deliberately double-bill a single item.
- Mistakenly Charging an Absent Participant: Some participants are mistakenly charged despite their absence from the trial site.
- Unawareness of Insurer’s Routine Costs: Medical insurers such as Medicare and Medicaid have different coverage policies. Unawareness of the organizer’s part can result in billing errors.
- Not Charging for Uncovered Items/ Services: A financial discrepancy can also occur if the organizers mistakenly do not charge an uncovered item service during the trial.
Repercussions of Clinical Budgeting Errors
Here are some of the consequences of failing to meet compliance:
- Legal Penalties
- Mismanaged Finances
- Burden on Participants
- Delayed Clinical Trial Outcomes
How To Prevent Billing Compliance Errors?
If you wish to avoid compliance issues in your clinical research, then here are some ways:
- Make a comprehensive budget at the beginning.
- Draft a detailed Informed Consent Form (ICF).
- Thoroughly understand each insurer’s policies.
- Digitally document your invoices on EDC systems.
Improved Billing Compliance, Talk To Us!
At Clinical Pursuit, we have been facilitating clinical trial organizers with a robust clinical trial data management solution. We have tools to help you with decentralized clinical trials, generate invoices, and improve budget and billing compliance.