Washington, D.C. — In a new letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) are seeking answers as to whether the agency adequately safeguards Clinical Laboratory Improvements Amendments (CLIA) lab accreditation from national security concerns. 

The Members are particularly concerned with national security concerns related to the Chinese military and the unethical use of human beings in research studies by entities of concern in China. 

BACKGROUND: 

Beijing Genomics Institute (BGI) is a firm based in Shenzhen used by the Chinese government to build and operate the China National GeneBank, “a vast and growing government-owned repository that includes genetic data drawn from millions of people around the world.” 

The Department of Defense in 2022 officially listed BGI as one of several “Chinese military companies” operating in the United States, and a 2021 U.S. intelligence assessment linked the company to the Beijing-directed global effort to obtain even more human DNA, including from the United States. 

On March 6, 2023, the Department of Commerce Bureau of Industry and Security added BGI Tech Solutions (Hongkong) Co. Ltd., to the “Entity List,” which identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States. 

It was added to the entity list “based upon information that indicates their collection and analysis of genetic data poses a significant risk of contributing to monitoring and surveillance by the government of China, which has been utilized in the repression of ethnic minorities in China. Information also indicates that the actions of these entities concerning the collection and analysis of genetic data present a significant risk of diversion to China’s military programs.” 

CMS accredited a laboratory owned by BGI in 2017-2019. It then provided a CLIA accreditation to an entity called BGI Tech Solutions (Hongkong) Co. Ltd., effective September 8, 2023, with an expiration date of September 7, 2025, and with the same address and the same point of contact listed in the previous BGI CLIA lab accreditation. 

CLICK HERE to read the letter.