For long-term care (“LTC”) facilities such as assisted living facilities and nursing homes, the high risk of spread once coronavirus disease 2019 (“COVID-19”) enters a facility means such facilities must take immediate action to protect residents, families, and healthcare personnel from severe infections, hospitalizations, and death. One such action that many States are taking is mandatory testing for the residents and employees of LTC facilities. Specifically, several states, including West Virginia, South Carolina and Florida, are now requiring mandatory testing of residents and employees of skilled nursing and assisted living facilities. Other states have similar proposed legislation in the works, including Pennsylvania, and it is likely that the number of states implementing such measures will continue to grow in the coming weeks and months. The White House has also indicated that the federal government may mandate testing nationwide for all nursing home residents and employees. While widespread testing of residents is an appropriate measure to protect the populations most vulnerable to the disease, mandatory testing raises the issue of whether and how to obtain informed consent from residents, many of whom use a medical powers of attorney (“MPOA”) for decisions regarding their care.
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HHS Clarification on PREP Act Impact on State Licensing Laws: What it Means for Pharmacists’ COVID-19 Testing Capabilities
On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.” In its guidance, HHS granted licensed pharmacists immunity when administering or ordering FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and Preparedness Act (PREP Act) when taking such actions. The PREP Act confers immunity for covered persons, from claims arising out of state law. For more background information about the April 8, 2020 HHS guidance, see our previous post available here.
Missouri Encourages COVID-19 Diagnostic Testing but Urges Caution with Serological/Antibody Testing
Due to expanded COVID-19 diagnostic testing availability, the Missouri Department of Health and Senior Services (MDHSS) is encouraging providers to test both symptomatic and asymptomatic individuals, if the clinician’s medical judgment determines it is necessary. At the same time, MDHSS also posted words of caution regarding the use of serological testing, which is not considered diagnostic for COVID-19 but rather detects antibodies which could reveal exposure to SARS-CoV- 2 (the virus which causes COVID-19) or a different infection, including other strains of coronavirus, altogether. The recent MDHSS COVID-19 Serological Testing Quick Facts (Quick Facts) cautions that:
Treating COVID-19 Patients: Evaluating College Dorms, Professional Arenas, Fitness Centers and Convention Centers
As many of you are aware, the Centers for Medicare and Medicaid Services (CMS) along with many states have waived licensing and other requirements to allow healthcare providers to use non-hospital space to treat COVID-19 and non-COVID-19 patients, conduct testing and perform other clinical operations. Healthcare providers across the country are exploring options to increase…