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Video Directly Observed Therapy for Tuberculosis: Legal and Practical Issues

posted on Wed, Jan 21 2015 4:12 pm by Brittney Crock Bauerly

The ongoing Ebola epidemic in West Africa highlights the need for strengthened health systems and tools to combat infectious disease across the globe. While Ebola continues to warrant global attention, this recent public health emergency invites further discussion and focus on tools to combat other less-publicized, deadly diseases as well.

While many people think of tuberculosis (TB) as a disease of the past, TB remains one of the world’s deadliest communicable diseases and is second only to HIV/AIDS as the greatest killer worldwide due to a single infectious agent. In 2013, an estimated 9 million people fell ill with TB, and an estimated 1.5 million people died from the disease. Many people may be surprised to learn that approximately one-third of the world’s population is infected with the bacteria that causes TB, though only ten-percent of those infected will develop the active form of the disease during their lifetime. The disease is still prevalent in the United States as well—9,582 cases of active TB were reported to the CDC in 2013.

The high global death toll for TB is especially concerning given that most deaths from TB are preventable with proper treatment. TB is generally treatable and curable with a course of antibiotic treatment that lasts for six to nine months. Patients who do not complete their drug regimen as prescribed are at risk for developing and transmitting dangerous, drug-resistant TB. To help people adhere to their treatment regimens, directly observed therapy (DOT) is considered the global standard of care. DOT is a method in which a health care worker or other designated individual watches the patient swallow every dose of the prescribed medication.

In-person DOT can be time-consuming and costly, especially in rural communities where a health care worker may have to travel a significant distance for home visits. It may also be inconvenient for patients, who need to be accessible to the health care worker every time they take their medication. Declining public health resources have increased the need for local health departments (LHDs) to develop cost-effective and innovative strategies to monitor patient compliance with treatment regimens.

Telemedicine may provide an innovative and effective means to monitor patient adherence to TB treatment regimens. Some LHDs in the United States and elsewhere have piloted the use of video directly observed therapy (VDOT) in which health care workers observe patients taking their TB medication remotely via a smartphone, videophone, or tablet. VDOT allows for monitoring of medication via video without routine in-person visits from health care workers. Results from these pilot programs suggest that VDOT is a cost-effective and reliable method of ensuring treatment compliance. Patients as well as providers participating in these programs have also reported a high level of satisfaction with use of the technology.

There appears to be growing interest and traction among LHDs to utilize this technology. Successful implementation of this technology will require close attention to state legal frameworks and to practical concerns identified in pilot programs thus far. Legal and practical issues that LHDs will need to consider include:

Legal Permissibility. As an initial matter, LHDs will need to determine whether VDOT is legally permissible under their existing state statutes and regulations, such as those relating to TB case management and telemedicine. The Network has done some initial work in assessing the legal permissibility of VDOT for several states.

Real-Time or Recorded Video. LHDs will need to decide whether they will perform VDOT with a live real-time interaction, or whether they will allow patients to record themselves taking their daily prescriptions for later review by a health care worker.

Health Records. A program utilizing real-time video will need to consider whether the live interaction will be recorded and retained, and a program utilizing recorded video will also need to consider whether those video recordings will be retained as part of the patient’s health record. In the alternative, the electronic communication could be documented in writing in the patient’s health record.

Recording Authority. LHDs will need to determine what consent may be required to record an electronic communication under state recording statutes.

Reimbursement. LHDs will want to determine whether VDOT would qualify as a covered service for reimbursement purposes under private insurance or applicable government programs.

Privacy and Security. LHDs will need to utilize technology that has privacy and security settings that would protect patients’ private data.

VDOT appears to an effective method to increase patients’ adherence to treatment and a method favored by both patients and providers. The use of this emerging technology could result in substantial cost savings for LHDs as well. To ensure successful implementation of this technology, LHDs should consult legal counsel to ensure compliance with all applicable laws and regulations implicated by VDOT. State health departments may also facilitate the use of VDOT by LHDs. Several states, including California, Kentucky and Washington, have produced guidance on the use of VDOT, which may be helpful models for other state health departments to consider.

The use of telemedicine to monitor patient compliance with treatment appears very promising and has potential applications for other types of diseases as well. With the world’s attention focused on infectious disease with the recent Ebola outbreak, now is the time for health departments to focus on strengthening their tools to combat other deadly infectious diseases as well.

This blog post was developed by Brittney Crock Bauerly, J.D., Staff Attorney for the Network for Public Health Law–Northern Region at the Public Health Law Center at William Mitchell College of Law.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this post does not constitute legal advice or legal representation. For legal advice, readers should consult an attorney in their state.

Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not necessarily represent the views of, and should not be attributed to, RWJF.

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