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Recent case reports document that some patients with normal immune response who have completed a 5-day course of Paxlovid for laboratory-confirmed infection and have recovered can experience recurrent illness 2 to 8 days later, including patients who have been vaccinated and/or boosted (were up to date with COVID-19 vaccination) (2-4). These cases of COVID-19 rebound had negative test results after Paxlovid treatment and had subsequent positive viral antigen and/or reverse transcriptase polymerase chain reaction (RT-PCR) testing. Both the recurrence of illness and positive test results improved or resolved (median of 3 days) without additional anti-COVID-19 treatment.

Based on information from the case reports, COVID-19 rebound did not represent reinfection with SARS-CoV-2 or the development of resistance to Paxlovid; also, no other respiratory pathogens were identified among known cases. Possible transmission of infection during COVID-19 rebound has been described however, it remains unknown whether the likelihood of transmission during rebound differs from the likelihood of transmission during the initial infection.

On Friday, March 13, 2020, the President declared a national emergency due to COVID-19 and subsequently many providers and suppliers have activated their emergency plans in order to address surge and coordinate response activities. Facilities that activate their emergency plans are exempt from the next required full-scale community-based or individual, facility-based functional exercise. Facilities must be able to demonstrate, through written documentation, that they activated their program due to the emergency.

The updated guidance only applies if a facility is still currently operating under its activated emergency plan or reactivated its emergency plan for COVID-19 in 2021 or 2022. Facilities which have resumed normal operating status (not under their activated emergency plans) are required to conduct their testing exercises based on the regulatory requirements for their specific provider or supplier type.

For Inpatient Providers (e.g., Hospitals & Critical Access Hospitals)
If the facility is still operating under its currently activated emergency plan during its specified 12-month cycle of testing exercises, any currently activated emergency plan will be recognized by surveyors as having met the full-scale exercise requirement for that 12-month cycle.

If the facility claimed the full-scale exercise exemption in 2020 and 2021 based on its activated emergency plan for COVID-19 response and has since resumed normal operating status, the inpatient provider/supplier is expected to complete its required full- scale exercise, unless it has reactivated its emergency plan for an actual emergency during its 12-month cycle for 2022.

For Outpatient Providers (e.g., Ambulatory Surgery Centers, Home Health, etc.)
If the facility claimed the full-scale exercise exemption in 2020 based on its activated emergency plan for COVID-19 response and has since resumed normal operating status, the outpatient provider/supplier is expected to complete its required full-scale exercise in 2022, unless it has reactivated its emergency plan for an actual emergency during its 12-month cycle for 2022.

If the facility claimed the full-scale exercise exemption in 2021 based on its activated emergency plan for COVID-19 response and has since resumed normal operating status, the outpatient provider/supplier is expected to complete its required full-scale exercise in 2024.

Testing exemptions apply only for the next-full scale exercises, not any exercises of choice. Facilities are expected to continue to conduct all exercises of choice.

CMS also updated its enforcement procedures for hospitals that fail to report data as required.

1. The first enforcement action will begin following one calendar week of non-compliance. Providers will have one calendar week to demonstrate compliance.
2. Providers failing to meet the reporting requirements within one calendar week following the first enforcement notification letter will receive a second enforcement notification letter. This notification will indicate that that the provider will have one calendar week to demonstrate compliance with the reporting requirements otherwise the provider will receive the third and final enforcement notification letter, as noted in step three.
3. Providers that have failed to meet the reporting requirements within one week following the second enforcement notification letter will receive a third and final enforcement notification letter. This notification will include a notice of termination to become effective within 30 days from the date of the notification. Failure to meet the reporting requirements within this 30- day timeframe may result in termination of the Medicare provider agreement.