CMS Adds New COVID-19 Clinical Trials Improvement Activity to the Quality Payment Program

The Centers for Medicare & Medicaid Services (CMS) is leveraging the Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS) to encourage clinicians to contribute to scientific research and evidence to fight the 2019 Novel Coronavirus (COVID-19) pandemic. We’re continuing to release additional flexibilities for participation in MIPS to support clinicians on the front lines of the COVID-19 pandemic. As part of the recently announced Medicare interim final rule with comment we’ve added a new high weighted improvement activity to the 2020 QPP Improvement Activities Inventory that promotes participation in COVID-19 clinical trials and clinical reporting for COVID-19 related care.

To receive credit for the new COVID-19 clinical trials (IA_ERP_3) improvement activity, 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 report their findings through clinical data repository or clinical data registry for the duration of their study. We’ve added this improvement activity to provide an opportunity for clinicians to receive credit in MIPS for the important work they are doing across the country.

The COVID-19 clinical trials improvement activity is high weighted from a scoring perspective. Generally, this means that clinicians who report this improvement activity could 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. Clinicians would simply need to check a box and attest to one additional high weighted improvement activity or two medium weighted improvement activities to fulfill the requirements under the MIPS Improvement Activities performance category. For example, if you attest to both the new COVID-19 clinical trials improvement activity and the high weighted participation in a 60- day or greater effort to support domestic or international humanitarian needs (IA_ERP_2) improvement activity you would receive full credit for the MIPS Improvement Activities performance category.

We intend for this improvement activity to also be 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). Oracle has developed and donated a system to the U.S. government that allows clinicians and patients at no cost to record the effectiveness of promising COVID-19 drug therapies. Additional examples include:

The American Heart Association (AHA) Covid-19 Cardiovascular (CVD) registry, designed to facilitate rapid understanding of this disease and its cardiovascular complications.
The Healthcare Worker Exposure Response & Outcomes (HERO) Registry. The HERO Registry is a large, national clinical research community. The first study, the HERO-HCQ Trial, will invite 15,000 healthcare workers from the registry to evaluate whether hydroxychloroquine can prevent COVID-19 infections.

The new improvement activity provides flexibility in the type of clinical trial, which 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. The goal is to support innovation and improve the collection of COVID-19 related data that clinicians have available to them and develop best practices that can drive improvements in patient care as clinicians monitor and manage the spread of COVID-19 in their practices. Encouraging clinicians to use an open source data collection tool will bring the results of their research to the forefront of healthcare much faster, leading to improvements in care delivery and most importantly the health of COVID-19 patients.

For More Information