By Requiring Emergency Preparedness Plans for Independent Labs, CMS Could Better Ensure That Medicare Enrollees Have Access to Infectious-Disease Diagnostic Testing During a Public Health Emergency

Why OIG Did This Audit

• A report published by the Pandemic Response Accountability Committee identified that Medicare paid more than $551 million for almost 8 million diagnostic tests for an emerging infectious disease at the beginning of a public health emergency (PHE) from February through August 2020. Almost 50 percent of these tests were performed at independent laboratories (labs). The report stated that various issues affected Medicare enrollees’ access to this diagnostic testing, including availability of tests and shortages in medical supplies used to administer tests.
• CMS established national emergency preparedness requirements for certain provider types to ensure adequate planning for natural and human-caused disasters, facility emergencies, and emerging infectious diseases. Independent labs are not one of these provider types.
• This audit assessed whether CMS should require independent labs to have emergency preparedness plans to ensure that diagnostic tests related to the cause of a PHE are available to enrollees.

What OIG Found

• By requiring emergency preparedness plans for independent labs, CMS could better ensure that enrollees have access to diagnostic testing related to an emerging infectious disease or a biological toxin that is the cause of a PHE.
• During the first 3 years of the PHE, independent labs performed the majority of enrollees’ diagnostic tests related to the emerging infectious disease, and some independent labs experienced testing process and staffing issues that may have affected enrollees’ access to tests.
• CMS does not have an emergency preparedness plan requirement for independent labs but has such a requirement for certain provider types that participate in Medicare.

What OIG Recommends

We recommend that CMS consider requiring independent labs that participate in Medicare to have emergency preparedness plans to better ensure that Medicare enrollees have access to diagnostic testing related to an emerging infectious disease or a biological toxin in the event of a future PHE.

CMS did not state whether it concurred with our recommendation but stated that it would take our findings and recommendations into consideration.