skip to main content


COVID-19 Clinical Trial Data Qualifies for CMS Quality Payment Program

April 22, 2020

In an effort to promote the reporting of clinical trial data and amplify the search for COVID-19 therapies, the Centers for Medicare & Medicaid Services (CMS) announced on April 20 that clinicians who participate in its Quality Payment Program (QPP) can now earn credit in the Merit-Based Incentive Payment System (MIPS) for participation in a clinical trial and reporting of the clinical information.

To receive credit for this new MIPS “COVID-19 Clinical Trials” improvement activity (IA_ERP_3), MIPS-eligible clinicians must attest to participation in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection, and must report their findings through a clinical data repository or clinical data registry.

According to CMS, this high-weighted improvement activity was added to provide an opportunity for clinicians across the country to receive credit in MIPS for work they are doing to find treatments for COVID-19 patients now and in the longer term. Clinicians could also pair the new “COVID-19 Clinical Trials” activity with the existing Participation in a 60-day or greater effort to support domestic or international humanitarian needs (IA_ERP_2) activity to earn full credit for the Improvement Activities performance category within MIPS.

Under the new, flexible improvement activity, clinical trial types could include designs that range from traditional double-blinded, placebo-controlled trials to more pragmatic or adaptive designs that flex to clinical workflow and clinical practice context. CMS’ ultimate goal is to support innovation and improve the collection of COVID-19 related data that clinicians have available to them from their day-to-day patient treatment. This data will then help to develop best practices to improve patient care as clinicians continue monitor and manage the spread of COVID-19.

To bring the results of this research to bear fruit much faster, CMS is encouraging clinicians to use an open source data collection tool, such as Oracle’s COVID-19 Therapeutic Learning System. The improvement activity is therefore applicable to MIPS eligible clinicians that are reporting their COVID-19 related patient data to a clinical data repository such as Oracle’s COVID-19 Therapeutic Learning System and clinicians participating in clinical trials such as the COVID-19 clinical trials being conducted by the National Institutes of Health (NIH).

Thus, to the extent that MIPS-eligible clinicians are participating in clinical trials, those clinicians are now able to not only speed the search for COVID-19 therapies by reporting their findings to a qualified clinical data repository or clinical data registry, but are also eligible for CMS’ newly announced COVID-19 MIPS improvement activity for 2020.

© Shipman & Goodwin LLP 2021. All Rights Reserved.