On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, or after June 1, 2020; complaint investigations that are non-immediate jeopardy Medium; and annual recertification surveys required to be conducted within 15 months from a provider’s last recertification survey. CMS also intends to resolve enforcement actions suspended as a result of COVID-19. CMS will expand the Desk Review policy for Plans of Correction and will process enforcement cases that were started before March 23, 2020, on March 23, 2020 through May 31, 2020, and on or after June 1, 2020. The guidance issued by CMS also provides that Civil Monetary Penalties that were imposed and became payable during the period of March 23, 2020 and May 31, 2020, will be re-issued with a new due date that is 15 days from the date of the notice. Finally, CMS provides updated guidance on recommended re-prioritization of CLIA survey activities at the state’s discretion, including on-site surveys and enforcement actions. A CMS press release is available here.
The U.S. Centers for Disease Control (“CDC”) has released Interim Guidance for Rapid Antigen Testing for SARS-CoV-2. The guidance states that antigen tests are relatively inexpensive, can be used at the point-of-care, and currently authorized devices return results in approximately 15 minutes. The CDC states that the clinical performance of rapid antigen tests “largely depends on the circumstances in which they are used” and “are particularly helpful if the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest.” They can also be used for screening testing in high-risk congregate settings in order to prevent transmission in the setting. At this time, “[t]here are limited data to guide the use of rapid antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a previously confirmed case is still infectious.” Further, “any laboratory or testing site that intends to report patient-specific test results must first obtain a CLIA certificate and meet all requirements to perform that testing,” The CDC provides that the RT-PCR test remains the “gold standard” and a positive antigen test may require confirmation from a PT-PCR test.
On August 19, Senators Elizabeth Warren (D-MA), Tina Smith (D-MN), and Chris Murphy (D-CT) sent a letter to Secretary of HHS Alex Azar and CDC Director Robert Redford requesting information on their plans to collect and report information on COVID-19 cases linked to institutions of higher learning. Noting the “wide variation in their plans for residential life and in-person learning,” they urged coordination with state and local officials “to ensure complete, transparent, and timely national reporting of COVID-19 cases linked to institutions of higher education.” The letter references the recent infection outbreaks at the University of North Carolina at Chapel Hill and Oklahoma State University. The Senators asked for responses to the following questions:
- What further guidance do HHS and CDC plan to provide to institutions of higher education on how COVID-19 cases should be reported to state, local, and federal health officials, including the timeline for reporting suspected and confirmed cases, demographic data on each case, and how reporting should comply with applicable privacy laws?
- How do HHS and CDC plan to aggregate and publish data on cases linked to institutions of higher education at the national level? Will this public data include demographic information, including sex, age, race/ethnicity, and disability status? If HHS and CDC do not have plans for this data collection and publication, why not?
- To date, what guidance have HHS and CDC provided to state and local public health departments about the type of demographic data that should be collected and disclosed to the public related to COVID-19 cases linked to institutions of higher education?
- How do HHS and CDC plan to study outbreaks of COVID-19 linked to institutions of higher education to understand which mitigation efforts are most and least effective?
- Have HHS or CDC officials coordinated with officials from the Department of Education regarding COVID-19 data collection at institutions of higher education? If so, please describe the nature, dates, and individuals involved with this coordination.