Research Billing Compliance Caveats

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Jan 29, 2019

Research Billing Compliance Caveats

Posted By:Maria Chester     /     Under: billing compliance


An important component to building and negotiating clinical trial study budgets is establishing a sound billing structure, which, in itself, requires an understanding of the nuances between clinical research billing from traditional hospital billing. Research directors and research financial specialists, especially, should understand these differences and be able to develop and follow specific processes and best practices in order to maintain billing compliance for their research programs.

Review the key differences between hospital billing and research billing listed below to ensure the financial department at your organization can ascertain the potential pitfalls of clinical research billing compliance.

1. Budgeting – Coverage Analysis

Performing a coverage analysis is unique to clinical research billing and vital in maintaining billing compliance. The coverage analysis outlines all clinical procedures as they are detailed in the protocol, and, in order to determine what is billable to third party payors (routine care) and billable to the sponsor (research related).

The coverage analysis is also key in the post-award management phase of the study, serving as a tool for hospital billing and registration staff to know what procedures will be billed to third-party payors versus those billed to the clinical trials office and, subsequently, the trial sponsor.

2. Patient Encounters

As determined in your coverage analysis, some procedures the patient will undergo will be considered routine care while others may be conducted purely for the research study (research related). As such, two separate billing pathways must be established when the patient presents at study registration. If the proper processes are put in place and rigorously followed, registration will be able to successfully navigate the billing pathways to use per the coverage analysis form.

3. Billing Coding

The Center for Medicare and Medicaid Services, or CMS, has specific requirements for items that must be included on bills associated with clinical research subjects. ICD-10-CM Z00.6 code, Q0/Q1 modifiers, and National Clinical Trial number must be included on claims sent to CMS for research subjects. Therefore, hospital staff who are responsible for coding research subject claims must be educated on these requirements in order to maintain compliance with CMS.

4. Reconciliation

Insurance and research reimbursements are most often tracked within two different systems – a hospital billing system for routine care reimbursements, and a clinical trials management system (CTMS) for research related reimbursements from a sponsor – although some research staff without CTMS programs often still use spreadsheets for manual tracking.

Once a payment from third party payors is received, it is processed as per the customary hospital billing policy. However, when a research payment is received, the payment should be reconciled by the research department within the established tracking system to ensure that the sponsor is reimbursing the site properly for subject visits and procedures.

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About GuideStar Research
GuideStar works with hospitals, health systems and physician practices across the country
to optimize clinical research programs. From helping incorporate a clinical trial strategy to providing support services, our service delivery is based on operational and financial best practices to ensure success.

Maria Chester

Post by Maria Chester -

Maria came to GuideStar with more than 15 years of experience in healthcare, and 11 years of experience in clinical research. Before serving as Vice President, Operations at GuideStar, Maria began her career in clinical research at the LSUHSC Scott Cancer Center as the Lead CRA for the MB-CCOP as well as Research Nurse at Ochsner Medical Center-Kenner, then Clinical Research Director for a 3-hospital consortium. Her zeal for research and diverse knowledge make her an asset to GuideStar and our sites. She holds a BSN from Louisiana State University Health Sciences Center.

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