<h2>Temporary Coverage of NIAID-Sponsored Clinical Trials for the Treatment or Prevention of COVID-19</h2> <p>Effective October 30, 2020, TRICARE regulations were temporarily changed to add coverage of clinical trials for the treatment or prevention of COVID-19 or its associated sequelae,&nbsp;if the U.S. National Institute of Allergy and Infectious Disease (NIAID) is either the trial sponsor or trial collaborator.&nbsp;Coverage for COVID-19 clinical trials will last through the end of the President’s declared national emergency for the COVID-19 pandemic.</p> <p>TRICARE will cost-share all medical care required as a result of participation in NIAID-sponsored studies, including necessary follow-up care and testing that takes place after the period of active treatment on protocol is completed. This includes purchasing and administering all approved pharmaceutical drugs (except for the NIAID-funded investigational agents) and all inpatient and outpatient care, including diagnostic, laboratory, rehabilitation, and home health services not otherwise reimbursed under an NIAID grant program, if the following conditions are met:</p> <ul> <li>The patient continues to meet entry criteria for said protocol;</li> <li>The institutional and individual providers are TRICARE-authorized providers.</li> <li>In addition to the above requirements, the following conditions must be met for participation in Phase I COVID-19 clinical trials. Attending physician, Primary Care Manager (PCM), or specialist referral to the trial, and the beneficiary’s subsequent acceptance to the trial fulfill these requirements.</li> <li>Standard treatment has been or would be ineffective, does not exist, or there is no superior non-investigational treatment alternative.&nbsp;</li> <li>The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative.&nbsp;</li> <li>The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise.</li> </ul> <p>The beneficiary’s participation in such a trial would be appropriate based upon the satisfaction of the above criteria.</p>