CMS's Emergency Preparedness Related to Clinical Laboratories During a Public Health Emergency

OBJECTIVE

Laboratory tests are a critically important part of early detection, diagnosis, monitoring, and treatment of disease. During public health emergencies or disasters, CMS has the authority to provide regulatory flexibilities and waivers to ensure that Medicare beneficiaries continue to have access to needed health care. To help health care providers and suppliers prepare for these emergencies or disasters, CMS adopted a final rule (the Emergency Preparedness Rule) in September 2016. The rule required those providers and suppliers to: (1) plan adequately for both natural and manmade disasters; (2) coordinate with Federal, State, Tribal, and regional and local emergency preparedness systems; and (3) adequately prepare to meet the needs of patients during disasters and emergency situations. The rule covers 17 facility types (e.g., hospitals, hospices, and long-term care facilities) but does not cover clinical laboratories. Continued laboratory testing during a public health emergency as well as timely and reliable testing for novel infectious diseases are important for the health of Medicare beneficiaries. Effective testing for novel infectious diseases (including COVID-19) are essential in helping to slow the spread of these diseases by identifying those who are infected and enabling treatment or isolation if needed. We will conduct an audit to determine whether CMS's emergency preparedness for clinical laboratories could be improved. Specifically, we will look at CMS's emergency preparedness to ensure that: (1) beneficiaries maintain access to all types of laboratory tests, including laboratory tests for novel infectious diseases during a public health emergency, and (2) laboratories have the ability to develop and deliver timely and accurate testing for novel infectious diseases during a public health emergency.

TIMELINE

REPORT PUBLISHED