Activity Description

To receive credit for this improvement activity, a MIPS eligible clinician or group must: (1) participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection and report their findings through a clinical data repository or clinical data registry for the duration of their study; or (2) participate in the care of patients diagnosed with COVID-19 and simultaneously submit relevant clinical data to a clinical data registry for ongoing or future COVID-19 research. Data would be submitted to the extent permitted by applicable privacy and security laws.

Examples of COVID-19 clinical trials may be found on the U.S. National Library of Medicine website at www.clinicaltrials.gov. In addition, examples of COVID-19 clinical data registries may be found on the National Institute of Health website at www.search.nih.gov.

For purposes of this improvement activity, clinical data registries must meet the following requirements: (1) the receiving entity must declare that they are ready to accept data as a clinical registry; and (2) be using the data to improve population health outcomes. Most public health agencies and clinical data registries declare readiness to accept data from clinicians via a public online posting. Clinical data registries should make publically available specific information on what data the registry gathers, technical requirements or specifications for how the registry can receive the data, and how the registry may use, re-use, or disclose individually identifiable data it receives.

For purposes of credit toward this improvement activity, any data should be sent to the clinical data registry in a structured format, which the registry is capable of receiving. A MIPS-eligible clinician may submit the data using any standard or format that is supported by the clinician’s health IT systems, including but not limited to, certified functions within those systems. Such methods may include, but are not limited to, a secure upload function on a web portal, or submission via an intermediary, such as a health information exchange. To ensure interoperability and versatility of the data submitted, any electronic data should be submitted to the clinical data registry using appropriate vocabulary standards for the specific data elements, such as those identified in the United States Core Data for Interoperability (USCDI) standard adopted in 45 CFR 170.213.

Objective

Contribute to the development of clinically proven treatments for COVID-19.

Validation

Evidence of participation in the COVID-19 clinical trial. Include both of the following elements:

1. Clinical trial details – Details to verify participation in an acceptable COVID-19 clinical trial. The type of clinical trial could include designs ranging from the traditional double-blinded placebo-controlled trial to an adaptive design or pragmatic design that flexes to workflow and clinical practice context. It may be conducted in large organized clinical trials led by academic medical centers or healthcare systems. In addition, we intend for this activity to be applicable to eligible clinicians who are reporting their COVID-19 related patient data to a clinical data repository, such as Oracle’s COVID-19 Therapeutic Learning System (www.covid19.oracle.com); AND
2. Clinical data submission – Evidence of submission of clinical data to the clinical data repository or registry supporting the COVID-19 clinical trial (e.g., screenshot from the participating clinical data repository or clinical data registry).

Example(s): Data registries may include:

• Healthcare Worker Exposure Response & Outcomes (HERO) Registry: www.heroesresearch.org
• American Heart Association (AHA) COVID-19 cardiovascular disease (CVD) registry: www.heart.org

Information: For more information on the COVID-19 clinical trials we refer readers to the U.S. National Library of Medicine website at www.clinicaltrials.gov.