Solutions for Research Billing Compliance

By Ryan Meade | Managing Director, Aegis Compliance & Ethics Center
December 8th, 2016

Summary: Learn methods your organization can use to safeguard against billing compliance risks, such as a Medicare Coverage Analysis or “billing grid” to track research-related services.

Estimated reading time: 2 minutes

Health care providers undertaking clinical research studies face the increasingly challenging task of developing and maintaining compliance safeguards and structures. Managing clinical research billing risks is essential if providers expect to prevent incorrect billing. This would include billing for services that are already paid for by the sponsor (double billing), services promised free in the informed consent, services for research purposes only, services that are part of a non-qualifying clinical trial, or billing Medicare Advantage Plans for services that should be billed to the Medicare Administrative Contractor.

There are several ways to safeguard against these risks. The development of a Medicare Coverage Analysis or “billing grid” can provide a critical tool for tracking research-related services. Additionally, the effective mapping of a clinical research claims management process is key in a comprehensive approach to research billing. User-friendly databases are absolutely essential to any program designed to manage risk related to clinical research billing (CRB).

Building a CRB program

There are three primary components of a compliant CRB program:

1. There must be strong coordination. No single person is responsible for everything, and it really does require a team working together for a research billing program to be a success.

2. Effective communication is critical. It is important to have an easy exchange of information and to have transparent access to study documents throughout the process.

3. Collaboration among the stakeholders is essential. There are many hurdles to overcome with terminology and appreciation for information needs so that disparate specialty areas can establish workflows. This requires an openness to learn, and patience beyond measure.

None of these things happen overnight. It is important to pilot ideas for clinical research claims management and be ready to modify the plan based on what is learned. This is a highly complex process requiring expertise from multiple areas within an institution, and it simply takes time to get it right.

Medicare considerations

To determine coverage for research billing, providers must consider the federal rules from the Centers for Medicare Services (CMS), as well as the local rules from the Medicare Administrative Contractor. Even when the study plans to enroll only a few Medicare patients, the CMS rules provide a good framework for designing a base billing grid.

Medicare requires a three-part process for clinical research services coverage:

  • Does the study “qualify” for coverage?
  • What items and services are “routine costs”?
  • Do Medicare rules allow coverage of specific “routine costs” within a research study?

Once this is determined, study documents must also be reviewed to determine:

  • What is paid for by the sponsor?
  • What is promised free in informed consent?

These questions must be asked and best practice is to record the answers and your reasoning in the Coverage Analysis. While building a research billing compliance initiative often requires hard work, the good news is that the Coverage Analysis can be built from the study calendar already required for the study.

To learn more about the clinical research billing process, click the link below to download the free eBook “Building a Successful Clinical Research Billing Initiative.


This article was originally published on June 22, 2012.

About the Author

Ryan is a partner in the law firm of Meade, Roach & Annulis, and also a managing director of Aegis Compliance & Ethics Center. Ryan focuses his legal practice and consulting work on regulatory compliance matters for health care organizations, concentrating principally on Medicare/Medicaid billing compliance and clinical research regulatory laws. Ryan was recently appointed to the faculty of Loyola University Chicago School of Law as the Director of Regulatory Compliance Studies. In Ryan's new role he is responsible not only for developing and teaching a new curriculum for law students in health care compliance but is also overseeing Loyola's online masters program in health care compliance and launching its online masters in research regulatory compliance.

Website: Aegis Compliance & Ethics Center

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