Coronavirus update for April 20, 2020.
Centers for Medicare & Medicaid Services
- CMS has issued guidance on providing non-essential non-COVID-19 care to patients without symptoms of COVID-19 in regions with low and stable incidence of COVID-19. It views this guidance as part of phase one of the administration’s plan to reopen the U.S. economy. See CMS’s news release on this guidance here and the guidance itself here. Under this guidance, individual states will determine for themselves when it is appropriate to begin the “reopening” process. As a practical matter, only Oklahoma, Texas, and Alaska, to our knowledge, have identified concrete dates for commencing the delivery of the described non-essential care.
- To ensure appropriate tracking, response, and mitigation of COVID-19 in nursing homes, CMS is reinforcing an existing requirement that nursing homes must report communicable diseases, health care-associated infections, and potential outbreaks to state and local health departments. In rulemaking that will follow, CMS is requiring facilities to report this data to the Centers for Disease Control and Prevention and Control (CDC) in a standardized format and frequency defined by CMS and CDC. See CMS’s announcement of its intentions; a memo CMS has sent to state Medicaid agencies; and additional CDC guidance.
- In February, CMS published a rule that would change certain requirements for pre-admission screening and resident review (PASRR) to reflect updates in diagnostic criteria for mental illness and intellectual disability. Because of the COVID-19 emergency, the agency is extending the deadline for stakeholder comment from the current April 20 – today – to May 20.
Department of Health and Human Services
- HHS has published in the Federal Register a notice to inform the public that it is exercising its discretion in how it applies the privacy, security, and breach notification rules under HIPAA and that its Office of Civil Rights will not impose penalties for non-compliance with the regulatory requirements under the HIPAA rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nation-wide public health emergency.
Food and Drug Administration
- The FDA has issued a statement on the various approaches it is currently pursuing to accelerate the development of treatments for COVID-19.
- The FDA has issued a memorandum to manufacturers of face masks, health care personnel, hospital purchasing departments, distributors, and other stakeholders regarding face masks intended for use by the general public, as opposed to health care professionals. The memo addresses the purpose of such masks, how they must be labeled to prevent unauthorized and inappropriate uses, and how they must be labeled to prevent potentially harmful uses.
- The FDA has issued a temporary policy for the compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 crisis.
- The FDA has issued an emergency use authorization (EUA) for a certain commercial product used to reduce pathogens and inflammatory mediators from the bloodstream of adult patients with COVID-19 and who have been admitted to a hospital intensive care unit with confirmed or imminent respiratory failure.
- The FDA has issued an EUA for a specific commercial qualitative test for the detection of nucleic acids from COVID-19 in nasopharyngeal, nasal, and mid-turbinate nasal swab specimens, bronchoalveolar lavage fluid, and sputum from individuals who are suspected of COVID-19.
Federal Emergency Management Agency
- FEMA has published a notice of exemptions to an April 10 regulation addressing the prioritization and allocation of certain scarce or threatened health and medical resources for domestic use. In the notice, FEMA details specific circumstances under which the ban against the export of certain scarce or threatened materials will not be enforced.