CMS Will Accept COVID-19 Clinical Trial Data for the Quality Payment Program 

April 24, 2020

To encourage clinicians who participate in the Quality Payment Program to contribute to scientific research and evidence to fight the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (“CMS”) recently announced that clinicians may earn credit in the Merit-Based Incentive Payment System (“MIPS”) for participation in a COVID-19 clinical trial and reporting clinical information by attesting to a new “COVID-19 Clinical Trials improvement activity”. This COVID-19 Clinical Trials improvement activity provides flexibility in the clinical trial type, which could include traditional double-blind placebo-controlled trials or adaptive or pragmatic designs that flex to workflow and clinical practice. Below are some key takeaways from CMS’ guidance:

How can clinicians receive credit for the new MIPS COVID-19 Clinical Trials improvement activity?

To receive credit for the MIPS COVID-19 Clinical Trials   improvement activity, clinicians must: (i) attest that they participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with COVID-19 and (ii) report, for the duration of the clinical trial, their findings through a clinical data repository or clinical data registry.

Where should clinicians report their research findings?

Clinical trials could include those conducted by the National Institute of Health. Clinicians could also report through a clinical data repository, such as Oracle’s COVID-19 Therapeutic Learning System . CMS is hopeful that, by having clinicians use an open source data tool to submit findings, research results may be brought to the forefront of health care much faster and COVID-19 health care delivery and treatment will improve.

How much credit will clinicians earn?

CMS notes that the COVID-19 Clinical Trials improvement activity carries a high weight from a scoring perspective. Clinicians who report clinical trial 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% of the MIPS final score.

The database of privately and publicly funded clinical studies currently being conducted on COVID-19 can be found here

Joshua M. Weaver
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The material contained in this email alert is for informational purposes only. It is not intended to be legal advice nor is it intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. The COVID-19 disaster, and the federal, state and local governmental response, is a fluid and rapidly involving situation, meaning the material contained herein may be subject to change.