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Conventional care: A compliance challenge for research services

Lynn N. Asher (lynn@lnaconsult.com) is Principal at L.N. Asher in Dallas, TX.

The terms “standard of care” and “conventional care” are commonly used interchangeably in research but have distinct meanings. The confusion often comes from the overlapping definitions of the two terms. A service that is standard of care may not meet the higher threshold for conventional care. Standard of care can be the practice of an individual physician, a recognized treatment for a medical condition, or a comment on research contracts that an item is not included in the total payment because the sponsor has determined it is part of standard medical practice.

Conventional care, as defined by Centers for Medicare & Medicaid Services (CMS), are items or services that are “typically provided absent a clinical trial.”[1] These services are covered as part of the routine costs of qualifying clinical trials with the caveat that all other Medicare rules apply. If the items or services would not be covered outside of a clinical trial, payment may not be made during a clinical trial. A determination needs to be made for each potentially billable service if it is being performed for clinical management or data collection and then, finally, whether coverage is supported under Medicare rules.

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