On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information. Clinicians who may earn this MIPS credit include physicians, physician assistants, nurse practitioners and others. MIPS is one of two options for clinicians to participate in Medicare’s QPP, and requires clinicians to report certain quality, cost and other data to Medicare. A clinician’s Medicare reimbursement may be reduced if the clinician does not meet certain quality and performance measures.

The improvement activity carries a high weight from a MIPS scoring perspective.  According to CMS, clinicians reporting this activity will “automatically earn half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category, which counts as 15 percent of the MIPS final score.” To receive credit, clinicians will need to attest that they participate in a clinical trial that utilizes a drug or biologic to treat a patient with a COVID-19 infection and report findings via a clinical data repository or registry for the duration of the study.

CMS does not specify a particular type of clinical trial that would qualify. The announcement notes that the research could be in the form of a traditional double-blind placebo-controlled trial or “an adaptive or pragmatic design that flexes to workflow and clinical practice.”  The announcement provides the following examples:

• clinical trials could include those conducted by the National Institute of Health; or
• clinicians could report through a clinical data repository, such as Oracle’s COVID-19 Therapeutic Learning System, which was donated by the company to the U.S. government to record the effectiveness of COVID-19 promising therapies.

According to CMS Administrator Seema Verma, this action “encourages clinicians to report data that will help us monitor the spread of the virus, find innovative medical solutions, and unleash scientific discovery as we seek to overcome this terrible disease.”