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HHS Laboratory Data Reporting Guidance for COVID-19 Testing

On June 4, 2020, the U.S. Department of Health and Human Services (HHS) issued new Laboratory Data Reporting Guidance for COVID-19 Testing (Guidance) and related Frequently Asked Questions. Under the Guidance, in addition to providing the results of COVID-19 testing, laboratories will be required to report demographic information, including the patient’s age, race, ethnicity, sex, residence zip code, and county. The Guidance further recommends reporting the patient’s name, street address, date of birth, ordering provider address, and ordering provider phone number to state and/or local public health departments, although this data would not be collected by the Centers for Disease Control and Prevention (CDC) or HHS. Data for each test completed must be submitted within 24 hours of the results being known or determined, providing public health officials with “nearly real-time data.

Reporting is required for both diagnostic and serologic testing, and the Guidance specifically includes laboratory testing that relies on home-based sample collection. Laboratories, defined to include “laboratories, non-laboratory testing locations, and other facilities or locations offering point-of-care testing or in-home testing related to SARS-CoV-2,” must comply with the new requirements by Aug. 1, 2020. The Guidance specifies that reporting should be made through existing channels to state or local public health departments that will, in turn, submit de-identified data to the CDC. 

According to HHS, “[t]he new reporting requirements will provide information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues.” HHS also indicated that the requirements may help officials understand and address disproportionate impacts of COVID-19 on certain demographic groups and ensure equitable access to testing.

Although this reporting requirement is being imposed by HHS, it is unclear what impact the new data may have at a national level. Under HHS’s COVID-19 Strategic Testing Plan issued on May 24, 2020, states are largely responsible for developing and implementing their own COVID-19 testing strategies.

©2020 Greenberg Traurig, LLP. All rights reserved. National Law Review, Volume X, Number 158


About this Author

 Charles C. Dunham, IV Shareholder Houston Health Care & FDA Practice Life Sciences & Medical Technology Regulatory & Compliance Corporate

Charles Dunham represents health care providers and other health-related entities in regulatory compliance, corporate formation and governance, business transactions and acquisitions, and commercial arrangements. He also advises private-equity firms and venture capitalists on investment in the health care industry and health regulatory due diligence reviews of target acquisitions and negotiated transaction documents.

Christopher Health Care & FDA Practice Greenberg Traurig's Houston

Christopher M. Koepke is a member of the Health Care & FDA Practice in Greenberg Traurig's Houston office.

Christopher has diverse and deep experience at the intersection of legal, scientific, and policy issues. Prior to joining the firm, Christopher served as regulatory counsel in the U.S. Food and Drug Administration (FDA) Office of Regulatory Policy, where he focused on policy development across numerous aspects of the FDA’s regulation of drugs and biologics. He also participated in responding to citizen petitions touching a broad array of topics. In addition, Christopher served within the Therapeutic Biologics and Biosimilars Staff (now OTBB), where he focused on policy development and licensure questions related to biologics and biosimilars.

Before joining FDA, Christopher worked in the Food, Drug, and Medical Device Regulatory Group in the D.C. office of another international law firm. He was also a judicial clerk at two federal appellate courts, as well as patent litigation associate.