HHS Issues New COVID-19 Reporting Guidance to Hospitals, Drawing Criticism

COVID-19 Update

The Big Picture

On July 10, the Department of Health and Human Services (HHS) issued new guidance to hospitals regarding reporting COVID-19-related data to the federal government, including data related to COVID-19 testing, hospital occupancy, and supply availability. The guidance quickly drew public criticism because it instructs hospitals to cease reporting COVID-19-related data to the Centers for Disease Control and Prevention (CDC) and instead report directly to HHS—a move that skeptics say is designed to bypass the CDC and limit the transparency of such data. Adding to these concerns, on July 15, CDC reportedly took down its COVID-19 dashboards for approximately 24 hours before restoring them on the afternoon of July 16.

Data experts, including the COVID Tracking Project,1 have indicated that the long-term implications of the new guidance are unclear—but voiced concerns that, last weekend, at least some data was missing. On July 17, Democratic members of the House Committee on Oversight and Reform sent a letter to HHS and CDC indicating that “removal of information from CDC’s website is particularly alarming at a time when infection rates and hospitalizations are rising across most of the country, and many hospitals are reportedly at or near capacity.”2 The letter requests that by July 31 HHS provide the House oversight subcommittee documents and information about the changes to the data reporting process.

HHS suggested in the guidance, however, that the new process will reduce reporting duplication and centralize requests from federal agencies to hospitals for COVID-19-related data. HHS plans to use the data to facilitate planning and resource allocation (for example, HHS has made decisions about how to distribute remdesivir based on hospitals’ COVID-19 cases). HHS indicates in July 20-released FAQs that HHS Protect includes the same hospital information as CDC’s system, along with other newly required data, and that CDC officials have access to both databases.

The guidance has raised questions about the connection between the various data reporting requirements hospitals and other COVID-19 testing sites are expected to meet. That includes states’ and localities’ use of the recently enacted $10.25 billion in funding to build testing capacity and improve data sharing across the health system (among other testing-related expenses). Although the new hospital guidance underscores questions about coordination of the COVID-19 response within the Administration, it does not appear to change hospitals’ and other testing sites’ obligation to report testing results to states and localities. Nor does the guidance alter states’ and localities’ responsibility to report COVID-19-related data to CDC and make such data publicly available. That is, hospitals—and all other testing sites—must continue to report COVID-19 testing data to local and state health departments, which are in turn required to report certain testing data to CDC. Therefore, the CDC dashboards should continue to be the most complete source of COVID-19 testing data from all labs (including hospitals) across the country. If the Administration does not integrate HHS Protect and CDC-reported information, there will not be a single source for national testing data and all hospital-specific data (such as information about bed occupancy and healthcare workforce staffing) being collected by these agencies.

A high-level overview of the differences between these data sources is shown in Figure 1 and following is an overview of the key COVID-19 testing and reporting guidance issued to date.

Figure 1. Snapshot of COVID-19-Related Data Reporting to HHS and CDC

$10.25 Billion ELC Testing Funding. The Paycheck Protection Program and Health Care Enhancement Act (best known as “Stimulus 3.5”) provided $10.25 billion in funding to state, territory and local public health departments for testing purposes. In mid-May, the Administration distributed this funding through CDC’s existing Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement, giving CDC substantial oversight of and involvement in how states and localities use this funding. Recipients are required to develop testing work plans and budgets that are approved by CDC. While each recipient has submitted plans that meet its local needs and circumstances, the grants mandate other CDC-required activities—including at least daily reporting of lab results to local and state public health departments that must be displayed on county and state websites and are subsequently transmitted to CDC. These reporting requirements include hospitals impacted by the July 11 HHS guidance as well as other lab testing sites. Earlier this month, ELC recipients were required to submit their testing plans for the remainder of the year, and CDC also posted each recipient’s previously submitted testing plans, which accounted for May through July 2020.  

CMS Guidance to Labs. In alignment with the CDC ELC testing goals, in June CMS issued guidance clarifying COVID-19 testing data requirements established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. All laboratories—including those based in hospitals—must report data, on a daily basis, to the appropriate state or local health department (based on the individual’s residence) for all testing completed, for each individual tested, within 24 hours of results being known or determined. Health departments then report certain elements of that data to the CDC and post it on public state and local health department websites (consistent with the CDC ELC requirements described above).

Hospital Reporting Guidance. The guidance issued on July 10 instructs hospitals to report not only data related  to testing but also to capacity and utilization directly to HHS by 5 p.m. each day. HHS acknowledges that many of these reporting elements may already be required by states and the HHS guidance allows hospitals to skip reporting this data directly to HHS if the hospital receives a written release from the state and written certification from their Assistant Secretary for Preparedness and Response (ASPR) Regional Administrator affirming that the state has an established, functioning data reporting stream that is delivering all of the required information to HHS on a daily basis. Although many hospitals will likely continue to have multiple reporting responsibilities to their state/local health departments and directly to the federal government, some hospitals have indicated that HHS’ guidance is a welcome reprieve from multiple federal government reporting requests.

Conclusion

While the testing guidance and requirements issued by the federal government to date should, in theory, provide researchers, policymakers and the general public with robust data about the state of the COVID-19 outbreak in the United States, that theory rests on a series of uncertain assumptions: first, that individuals have access to timely testing and results; second, that state and local public health systems are capable of—or are quickly becoming capable of—reliably sharing data across the health system and with the federal government in real time; third, that the federal government will integrate and make public different data sets being reported to CDC and HHS; and fourth, that the data is trusted by its users.

In the weeks and months ahead, we can expect the federal government’s testing efforts—related to data collection and more broadly—to be in the spotlight. As new and growing hotspots pop up around the country, so do reports of long wait times for test results, hindering not only the rapid detection of virus spread but also the effectiveness of contact tracing and other virus mitigation efforts. Health system capacity and efforts to return to work and school will continue to be top of mind for many congressional leaders, and questions about what is needed to bolster testing efforts will be a topic of debate for the COVID-19 stimulus package that Congress is negotiating now.


1 A volunteer organization launched by The Atlantic that collects and publishes data regarding the COVID-19 outbreak in the United States.

2 Obtained by Politico Pro. Available at: https://subscriber.politicopro.com/f/?id=00000173-5f1f-d3de-ab7b-5f3f1f230000.

manatt-black

ATTORNEY ADVERTISING

pursuant to New York DR 2-101(f)

© 2020 Manatt, Phelps & Phillips, LLP.

All rights reserved