On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20. Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.” To determine the timing and locations of inspections, in accordance with the White House Guidelines for Opening Up America Again, the FDA will utilize the COVID-19 Advisor Rating System. The system “uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data.” The resumption of inspections “will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments.” Additionally, for safety reasons the FDA will pre-announce inspections, though retail tobacco inspections will not be pre-announced when they are resumed. Critically, the resumption of on-site inspections signals that despite the continuation of the public health emergency, the federal government intends to again prioritize compliance and enforcement review when safe and appropriate.
It is worth noting that certain agencies have continued enforcement actions during the height of the COVID-19 pandemic. For instance the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has entered into four different resolutions related to disability discrimination. In late June, OCR entered a settlement resolution with Tennessee resulting from a complaint that the state’s crisis standards of care discriminated based on disability. It was alleged that Tennessee’s guidelines “would unlawfully disqualify individuals with advanced neuromuscular disease, metastatic cancer, traumatic brain injury, dementia, and other disabilities from use of a ventilator in times of scarcity.” OCR provided technical assistance to Tennessee, which according to a press release from OCR updated the crisis standards of care and:
- Clarified that resource-intensity and duration of need on the basis of age or disability should not be used as criteria for the allocation or re-allocation of scarce medical resources. This protects patients who require additional treatment resources due to their age or disability from automatically being given a lower priority to receive life-saving care;
- Removed language permitting the use of a patient’s long-term life expectancy as a factor in the allocation and re-allocation of scarce medical resources, instead indicating that providers should consider only risk of imminent mortality;
- Added language stating that reasonable modifications to the use of the state’s primary instrument for assessing likelihood of short-term survival should be made when necessary for accurate use with patients with underlying disabilities. Such reasonable modifications ensure that people with disabilities are evaluated based on their actual mortality risk, not disability-related characteristics unrelated to their likelihood of survival;
- Removed categorical exclusion criteria that prohibited people with disabilities from receiving care on the basis of their diagnosis, and required individualized assessments of patients based on the best available objective medical evidence; and
- Incorporated language stating that hospitals should not re-allocate personal ventilators brought by a patient to an acute care facility to continue pre-existing personal use with respect to a disability. Under this language, long term ventilator users will be protected from having a ventilator they take with them into a hospital setting taken from them to be given to someone else.
Norton Rose Fulbright attorneys will continue to monitor the increase of enforcement activity as the public health emergency continues.
The U.S. Centers for Disease Control (CDC) has released guidance entitled Key Considerations for Transferring Patients to Relief Healthcare Facilities when Responding to Community Transmission of COVID-19 in the United States. The guidance is intended to assist state and local emergency medical planners and healthcare facilities. Additional details about the specific elements in the guidance can be found in the Medical Operations Coordination Cells Toolkit. The guidelines address considerations regarding “the transfer of patients, staff, and supplies between healthcare facilities to optimize patient care, balance resources, and minimize use of crisis care standards.” The guidelines also spotlight the Texas Regional Medical Operations Coordinating Center (MOCC). Specifically, the CDC states the MOCC strengthened the framework of Texas’s trauma system by:
- Providing situational awareness.
- Supporting integration of public health, acute health care, and disaster management functions.
- Providing actionable data from consolidating public health and acute health care data sources.
- Coordinating healthcare delivery in hot spots.
- Managing drive-through testing.
- Balancing staff workload across health systems and organizations.
- Ensuring safe and high-quality patient care by transferring within the system where care was optimal.
Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse related to the COVID-19 pandemic.