The U.S. Department of Health and Human Services Office for Civil Rights recently reminded health care providers that they may not allow media and film crews access to facilities where patients’ protected health information (PHI) is exposed without prior authorization from the patient.
PHI can include a patient’s name, medical record number, notes about their care, heart and lung function monitors, oral communication, and presence in a unit dedicated to a specific condition, such as COVID-19. Under the Health Insurance Portability and Accountability Act privacy rule, patients must give prior authorization before they are filmed; masking or obscuring patients’ faces or PHI after filming and before broadcasting the footage is not sufficient.
The Food and Drug Administration (FDA) updated a March 16 policy to increase oversight on COVID-19 antibody tests. These tests detect antibodies to the SARS-CoV-2 virus, which indicate a person’s exposure to COVID-19, and can aid in tracking the virus’ spread and identifying potential convalescent plasma donors.
The initial policy enabled manufacturers to distribute unauthorized, self-validated antibody tests as long as manufacturers do not advertise them as standalone diagnosis methods. In response to an increase in false and wrongly advertised tests, FDA now will allow manufacturers to market self-validated antibody tests for just a short period of time. Manufacturers now must submit requests for emergency use authorizations (EUAs) and validation results within 10 days of notifying the agency of their validation testing or from May 4, whichever is later.
FDA created two EUA templates — one for commercial manufacturers and one for high-complexity labs certified under the Clinical Laboratory Improvement Amendments — seeking FDA authorization.
The agency on May 8 issued an EUA to Rutgers Clinical Genomics Laboratory for the first diagnostic test that uses home-collected saliva samples. This is the second at-home option FDA has approved. The agency in April approved the first diagnostic test with a home collection option, the Laboratory Corporation of America COVID-19 RT-PCR Test, which uses a nasal swab and saline.
The agency also issued FAQs on testing for SARS-CoV-2, including information about at-home tests and EUAs for test kits.
Temporary Independent Clinical Diagnostic Labs
To increase COVID-19 testing capacity, Medicare-enrolled pharmacies and other suppliers may enroll temporary as independent clinical diagnostic laboratories by calling the provider enrollment hotline for the Medicare Administrative Coordinator serving their enrollment area.
New Research Highlights Racial Disparities in COVID-19
Research from the Missouri Hospital Association (MHA) calls for urgent policy action to mitigate health care disparities in communities hit hardest by COVID-19, including culturally responsive education, testing, and contact tracing.
MHA analyzed ZIP code–level data on confirmed cases and demographic composition. On April 20, the region’s 19 ZIP codes with a majority black population had a combined rate near 400 COVID-19 cases per 100,000 residents, while the 68 ZIP codes with fewer than 5 percent black residents had 127 cases per 100,000 residents. ZIP codes with a majority black population accounted for 16 percent of the region’s population and 34 percent of its confirmed COVID-19 cases.
MHA warned against the use of COVID-19 data to further stigmatize black communities. “Those narratives run the risk of perpetuating a story that connects disease to blackness and black culture rather than naming and disrupting the trajectory of cultural-historical and contemporary internal and external social factors that shape black communities and resident health.”
To disrupt that trajectory, MHA leaders recommended culturally tailored public health education initiatives. Local examples included PrepareSTL, a regional communications campaign that deployed community health workers to provide culturally appropriate messages on COVID-19 mitigation, and an expansion of testing sites in African American neighborhoods. “COVID-19 could prove to be a catalyst for the medical community in embracing the importance of social determinants of health,” MHA leaders concluded.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.
Contact Senior Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.