Dive Brief:

• Months into the pandemic, the Trump administration is set to require labs to submit a much broader range of demographic COVID-19 testing data, including age, race, ethnicity, sex, patient zip code, type of test performed and the test's result, according to new guidance released Thursday.
• By August 1, all labs must be able to submit the new data fields to relevant state and local health departments within 24 hours of the results being determined to help with COVID-19 tracking, contact tracing, supply allocation and research. De-identified data will then be sent to the Centers for Disease Control and Prevention on a daily basis. Labs will not be required to report retroactive data.
• The U.S. is now performing between 400,000 and 500,000 tests a day, Trump administration testing czar Brett Giroir told reporters. As of May 31, the U.S. had run nearly 19 million tests, including 12 million in the month of May alone — a significant jump from previous levels but under the administration's 12.9 million goal that month. Over the last seven days, the rate of positive tests was less than 6% nationally.

Dive Insight:

Holistic data across all rungs of government and the private sector is key for a safe and phased reopening. All states are now in some phase of kick-starting their economies despite many unanswered questions about COVID-19, including whether someone who's contracted the disease can be re-infected and if the virus will resurge in the fall.

Congress and epidemiologists have been calling for a higher testing volume and broader range of data to get a clearer picture of the pandemic for months — especially racial data, as the coronavirus disproportionately impacts Black and non-white Americans, likely due to pre-existing health disparities and lower access to quality healthcare services.

Public health labs, which make up a small portion of overall testing, are the only sites reporting data on race to date, Giroir said. But only a fifth of public lab reports include such data, and public health labs make up only a tenth of overall testing results, meaning COVID-19 reporting on race has been a drop in the bucket so far.

Senator Patty Murray, D-Wash, and Rep. Frank Pallone, Jr., D-N.J., sent a letter to HHS on May 22 calling on the Trump administration to issue more comprehensive demographic data and criticizing how CDC has reported that information so far. Democrats proposed a bill earlier this year that would benchmark $50 million to help with the effort.

The guidance implements provisions of the CARES Act, passed in late March. Officials chalked the delay up to administrative procedure.

"We did this as quickly as possible," Giroir said.

HHS officials told reporters some of this newly-asked-for data was already being collected by labs, but they're rarely sending it to the public health agencies or the CDC in a usable format, complicating federal efforts to glean a clear picture of the pandemic and straining resources. Some agencies report receiving provider case reports in a PDF via email or using even older tech.

"There are some labs that are still faxing and having to create workarounds," CMS Chief Technology Officer Shannon Sartin told reporters.

Labs can report through three electronic mechanisms: directly to state and local governments through existing channels, which will then get de-identified data to the CDC; through a centralized platform, such as the Association of Public Health Labs' AIMS platform, which routes the data to appropriate state and local government and the CDC; and through state and regional health information exchanges.

The American Clinical Laboratory Association, which represents giants LabCorp and Quest Diagnostics, noted the importance of data collection in a non-committal statement on the guidance, but also said it's difficult for labs to get information to public health agencies if an ordering provider doesn't get it to them.

Labs often don't see the patient directly — specimens are usually collected in a hospital, doctor's office or drive-thru testing site — so they say it's hard for them to fill in the blanks.

"Fixing the current patchwork reporting system will require strong federal coordination and leadership," ACLA said.

FDA will enforce the guidance through a range of disincentives, from warning letters to injunctions to more serious criminal sanctions. Though HHS anticipates the large majority of labs will be able to meet the guidance with little effort and will be able to start reporting the new data fields before August, the deadline is two months down the road to make sure smaller, cash-strapped labs have time to come into compliance, Giroir said.

The data should arrive in standardized format using ONC criteria when possible, but labs are not required to structure the data using USCDI standards or send it using HL7 electronic lab reporting guidelines. The lack of standardization could put additional burden on HHS and the CDC if they're overloaded with more data in unspecified formats.

The dearth of a nationwide, interoperable reporting system has been a black mark against the Trump administration's pandemic response, critics say.

Unclear reporting requirements, overlapping guidance from state and local governments and incomplete patient data has stymied public health agencies from monitoring disease trends, building out contact tracing programs, anticipating supply chain demands and allocating and disbursing testing resources in an evidence-based way.

HHS also recommended Thursday that labs transmit results and patient information back to the ordering provider, so that the data can be integrated into a patient's health record to track outcomes and help follow-up care; and that labs transmit results directly to the patient by mail, email or via a patient portal by 24 hours of the result, instead of having patients wait days for results. Neither of those, however, is a requirement.