Directly observed therapy (DOT) is considered the global standard of care for the treatment of tuberculosis (TB). Adherence to a drug regimen is critical for the treatment of TB and DOT is a method in which a health care worker or other designated individual observes a patient swallow each dose of the prescribed medication. The practice has been shown to have positive outcomes on rates of relapse and development of acquired drug resistance. VDOT is a similar practice facilitated through video technology, allowing the treatment provider to remotely observe a patient taking prescribed medication. VDOT can be particularly useful for rural communities, where providing treatment for geographically dispersed patients can be logistically and financially challenging.
A local health officer in rural Minnesota recently contacted the Network seeking information on the legal landscape surrounding VDOT for TB in the state — whether it is permitted and what laws and regulations may be implicated by its use.
The Network researched the issue and concluded that VDOT is likely permitted in Minnesota. While VDOT is not expressly addressed in Minnesota statutes, it appears to fit within the statutory definition of “directly observed therapy” under Minnesota state law. The definition states that the health professional or designee “observes a person ingesting prescribed medications,” but does not explicitly state that the observation must take place in person. Given that VDOT is a novel approach not expressly addressed in Minnesota statutes and regulations, the Network encouraged the requester to work closely with the Minnesota Department of Health to ensure compliance with all state laws.
Other Minnesota statutes that would likely be implicated by VDOT include Minnesota’s statutes regarding electronic recording, electronic health records, and medical assistance reimbursement. Local health departments implementing VDOT will need to decide if observation will occur in real-time, or if patients will be allowed to record themselves administering treatment for later review. The recording of DOT would not appear to violate Minnesota’s recording statutes, as long as proper consent is obtained. A program using real-time observation will need to determine if the interaction will be recorded and stored; any program that uses recorded video will need to determine whether recordings will become part of a patient’s health record. It also appears that VDOT would qualify as a covered service for medical assistance reimbursement under Minnesota state law.
For more information on VDOT, see the table created by the Network’s Western Region on the legal permissibility of VDOT in the states within that region.