Research Grants and Sponsored Awards provides services for studies conducted by Presbyterian Healthcare Services investigators:
- Assistance with budget preparation, as necessary and appraisal of the final budget included in the sponsored agreement
- Financial activity tracking
- Comparison of research documents where the language used in the documents may impact patient billing efforts
- Collaboration with Contracting for research agreements for accounting, financial audit and reporting implications both internal and external
- Assistance with preparation of a Coverage Analysis (a requirement for all studies with billable patient services) for billing compliance
- Provide limited assistance with sponsor billing
- Coordinate patient study billing with research staff and Patient Financial Services
- Review of effort reporting by research staff certifying to federal granting agencies that the effort required as a condition of the award has actually been completed and set up of charge to research project account
- Receive and record sponsor payments
Research Grant Compliance
Research grant compliance is highly regulated - laws and regulations governing grant accounting, effort reporting, and clinical research billing are complex and continuously evolving.
Grant Accounting and Effort Reporting
Research grants and sponsored awards often include funding for time and effort related to performing the research project. Awards that are directly or indirectly funded by a governmental entity often require time and effort to be tracked, recorded, and certified. Non-governmental agreements can also include language requiring time tracking. Time sheets are provided to facilitate effort reporting when required by the sponsored awards. Assistance is provided to ensure that all costs charged to governmental awards are allowable and incurred within required timeframes.
Research Patient Billing Compliance
Billing for services provided for research poses significant legal and financial risks to an organization if not performed properly.
A common misconception is that clinical research services are limited to those items and services that are only performed for research purposes. However, any service or item that is listed in the protocol is considered to be research related and must be considered for proper coding and billing. It is a common practice for study sponsors to agree to pay for certain (routine or standard of care) services and / or study drugs or devices directly without charging the study site. It is generally understood that those services and items paid for by the sponsor must not billed to the patient or any third party payor (insurance company.) What is less commonly understood are the billing requirements related to the “routine” care and services provided for the medical management of research patients.
In order to meet the Centers for Medicare & Medicaid Services requirements for claims processing for routine care provided to study subjects a Coverage Analysis (document that outlines the financially responsible party for services rendered during a trial) must be provided prior to enrolling any patients into the trial. It serves both as a means of communicating information to billing personnel in Patient Financial Services as well as a mechanism to document the determination for financial responsibility by payors. Completion of a Coverage Analysis is a coordinated effort that requires participation of the clinical research staff conducting the study.
Providers not Employed by Presbyterian
Did you know that even when a procedure or test is considered to be “routine care” for a patient participating in a clinical trial, special billing rules may apply? As of January 1, 2014, the Centers for Medicare & Medicaid Services (CMS) require clinical trial numbers to be present on all claims related to clinical trial services.
If your study participants will be referred to a PHS facility for any test or procedure, PHS must be aware of the patient’s participation and certain details related to the study to ensure that these claims are properly billed.