Health Reform WK-EDGE Emergency declarations; more aggressive actions to control coronavirus
Thursday, April 16, 2020

Emergency declarations; more aggressive actions to control coronavirus

By Rebecca Mayo, J.D.

Emergency declarations by both the President of the United States and HHS areallowing for greater flexibility and funds to fight the rapidly spreading COVID-19.

As the spread of 2019 Novel Coronavirus Disease (COVID-19) continues, the President, HHS, and CMS are working together and taking aggressive actions to contain the outbreak. The President declared a national emergency and stated that his team is working to eliminate every obstacle necessary to deliver care to people who need it. In furtherance of that mission, the Secretary of HHS issued a declaration providing liability immunity for activities related to medical countermeasures against COVID-19. Additionally, CMS has revised its infection control guidance for nursing homes to restrict all non-essential individuals from entering nursing homes during this critical time.

National emergency. To help assist in the efforts to contain the COVID-19 outbreak, the president officially declared a national emergency, which opened up access to up to $50 billion to assist states and territories and localities in their efforts to fight the virus. In a speech announcing the declaration, the President urged every state to set up emergency operation centers immediately and asked every hospital to activate its emergency preparedness plan. The deceleration also conferred broad new authority to HHS to immediately waive provisions of applicable laws and regulations to give doctors, hospitals, and health care providers maximum flexibility to respond to the virus and care for patients.

PREP Act declaration. The Secretary of HHS issued a declaration under the Public Health Services Act to provide liability immunity for activities related to medical countermeasures against COVID-19. The declaration is scheduled to be published in the Federal Register on March 17, 2020. The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary to issue a declaration to provide liability immunity to certain individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (covered countermeasures) except for claims involving willful misconduct. The Secretary had previously declared that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease COVID-19 constituted a public health emergency, which allowed the Secretary to make this Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Under this declaration, covered countermeasures would include any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19.

Nursing home restrictions. CMS revised its guidance for infection control in nursing homes again to tighten restrictions on visitation. Under the new guidance, facilities should restrict visitation of all visitors and non-essential health care personnel except for certain compassionate care situations. However, CMS notes that states may impose stricture requirements through a governor’s executive order and this would not make them out of compliance with CMS requirements. Individuals that enter in compassionate situations should still be carefully screened for potential infection or exposure and if allowed to enter, they should be required to use personal protective equipment (PPE) and should perform hand hygiene. Communal dining and all group activities should also be canceled, and residents should practice social distancing and perform frequent hand hygiene. All staff should be screened for fever and respiratory symptoms at the beginning of their shift and screening should remain ongoing for staff and residents. (CMS Letter to State Survey Agency Directors, Ref: QSO-20-14-NH, March 13, 2020).

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