Audit of CMS's Assessment of National Security Risks to Genomic Testing Data

CMS, one of the world's largest purchasers of health care, administers Medicare and Medicaid. In 1988, Congress enacted the Clinical Laboratory Improvement Amendments (CLIA). CLIA established "quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed." CMS is responsible for implementing CLIA, including laboratory registration, fee collection, onsite surveys, and enforcement. OIG is conducting this audit in response to congressional request, which expressed concerns to OIG that U.S. taxpayer money could potentially be used to pay for genetic testing at laboratories that have partnerships with foreign governments. OIG will determine whether CMS has established an effective enterprise risk management process and conducts risk assessments that consider emerging national security threats in accordance with Federal requirements.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Completed	Centers for Medicare & Medicaid Services	Audit of CMS's Assessment of National Security Risks to Genomic Testing Data	Office of Audit Services	A-18-20-06200	7/8/2021