CMS Issues Guidance on the Importance of Timely Use of COVID-19 Therapeutics

On November 22, 2022, the Centers for Medicare & Medicaid Services (CMS) issued guidance on the importance of providing timely use of COVID-19 therapeutics to patients who test positive for the virus. The guidance said that treatments, including both monoclonal antibodies and oral antiviral drugs, can prevent serious illness and save the lives of high-risk individuals who would otherwise be at risk of severe complications. Every patient who tests positive for COVID-19 should be evaluated to determine whether the use of an available therapeutic is appropriate.

CMS said nursing homes, in particular, should review and reinforce their infection control protocols as fall and winter are when respiratory infections are more commonly transmitted. Nursing homes should also ensure residents receive (in consultation with their physician and family) appropriate treatment if they test positive for COVID-19.

The Food and Drug Administration (FDA) authorized Paxlovid (nirmatrelvir and ritonavir) and Lagevrio in December 2021 as COVID-19 therapeutics. Monoclonal antibody treatments are also available. On March 7, 2022, the Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response opened direct ordering of oral antivirals to long-term care pharmacies to facilitate increased access for long-term care residents who are at increased risk for developing severe COVID-19. Facilities that are at risk of seeing an outbreak of COVID-19 may consider contacting their long-term care pharmacy to discuss ordering in advance an appropriate supply of oral antivirals to have on hand given the importance of expeditious treatment.

CMS said that staying up to date with COVID-19 vaccinations, including boosters, is the best defense against severe illness, hospitalization, and death from the virus. CMS requires nursing homes to educate residents and staff on the risks and benefits of the vaccines, offer to administer the vaccine, and report resident and staff vaccination data to the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network.

The effective date of the guidance is immediately, and CMS said the memo does not reflect new survey guidance nor policy, and is to be considered a reference memo, only.

The new guidance can be read in full here.

Compliance Perspective

Issue

The vulnerable nature of the nursing home population combined with the inherent risks of congregate living in a healthcare setting have required extra effort to limit COVID-19 exposure and to prevent its spread in nursing homes. Providers and suppliers, especially those delivering care in congregate care settings, should ensure their patients and residents are protected against transmission of COVID-19 within their facilities, and are receiving appropriate treatment if they test positive for the virus.

Discussion Points

    • Review infection control policies and procedures to ensure that all guidelines for preventing the spread of COVID-19 are in place and being followed. Also review policies on resident and staff vaccinations. Update policies and procedures as needed.
    • Educate staff on the importance of infection control and COVID-19 vaccinations and boosters. Also educate appropriate staff on COVID-19 therapeutics and appropriate treatment for residents who are at risk.
    • Periodically audit to ensure that all staff are following proper infection control procedures. Also audit to ensure staff are reporting resident and staff vaccination data to CDC’s National Healthcare Safety Network, and that if a resident tests positive for COVID-19, he or she is provided available therapeutics as appropriate.

*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*

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