Learn more about new Medicare coverage related to investigational device exemption (IDE) studies effective 1/1/15.
Federal oversight of the academic health center (AMC) research enterprise has expanded in recent years, in part, to some well publicized incidents in research involving human subjects. Regulations cover an increasingly broad spectrum of research operations and touch all research processes from human subjects to budgeting, billing and reimbursement.
There are no signs that the intensity of the regulatory environment is abating. Rather, governmental rules and regulations are multiplying. Along with other AMC, Lifespan leaders view compliance as an ongoing and evolving function particularly with regards to clinical trials.
Compliance programs for clinical trials comprise multiple elements that include budgeting, billing, training, auditing and monitoring. One of the most critical areas of concern is the billing of services for subjects in clinical trials. In response, Lifespan is in the process of creating a new clinical trials billing process with the addition of the newly created position of manger, clinical trial billing compliance, Deborah Temple, who can be reached at firstname.lastname@example.org.
Clinical trial billing issues apply only to studies that involve human subjects and consist of more than just survey activities, chart review, or the creation of a limited data set. If your study does not have human subjects, or consists only of surveys, chart review or limited data sets, then you do not need to be concerned with these billing rules.
For all other studies with human subjects, if you can answer "YES" to the questions below, then you must apply the clinical trials billing rules to the items/procedures that are performed as part of the study: