Maximizing clinical research billing compliance: One site’s journey to success

12 minute read

Research billing compliance is a critical facet of the healthcare landscape, playing a pivotal role in ensuring ethical and transparent financial practices within the realm of medical research. At its core, research billing compliance refers to the adherence to regulatory standards and guidelines governing the billing and financial aspects of clinical trials and research studies. This compliance is essential to maintain the integrity of research findings, protect the rights of study participants, and uphold the trust of the public and funding bodies.

In 1995, the Centers for Medicare & Medicaid Services (CMS) issued a national coverage determination (NCD) related to routine costs associated with clinical trials.[1] This decision expanded Medicare coverage for certain routine patient care costs incurred during participation in clinical trials, recognizing the importance of clinical research and the need to facilitate patient access to innovative treatments. In 2000, CMS further refined its policy by issuing an additional NCD regarding the coverage of routine costs in clinical trials.[2] This decision aimed to clarify and broaden the coverage of items and services provided to Medicare beneficiaries participating in clinical trials. The intent was to encourage broader participation in clinical trials and ensure beneficiaries could access promising treatments without facing financial barriers.

NCDs reflected a growing recognition of the role clinical trials play in advancing medical knowledge and improving patient care. By providing coverage for certain costs associated with participation in trials, CMS aimed to support the inclusion of Medicare beneficiaries in clinical research studies. Furthermore, as of July 2007, Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in clinical trials.[3] The coverage requirements for routine costs of qualifying clinical trials services are found as part of the NCD guidelines.[4] These steps further align healthcare policy with the evolving landscape of medical research and treatment development.

Noncompliance with research billing regulations can have serious implications. It may result in financial penalties, loss of research funding, legal consequences, and damage to an institution’s reputation. Additionally, investigators and institutions could face audits, investigations, or suspension from participating in federally funded research programs.[5] It is crucial to adhere to billing compliance to ensure ethical and legal conduct in research activities. Indeed, several organizations have faced legal action under the False Claims Act for issues related to clinical research billing.[6] One notable example is Duke University, which settled a case in 2019 for $112.5 million. The settlement resolved allegations that Duke submitted falsified data to the National Institutes of Health and the Environmental Protection Agency for research grants.[7] It is crucial to note that legal cases and settlements can vary; organizations may take corrective actions to prevent future violations.

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