CMS NEWS
FOR IMMEDIATE RELEASE April 20, 2020
Contact: CMS Media Relations (202) 690-6145 | CMS Media Inquiries
Trump Administration
Champions Reporting of COVID-19 Clinical Trial Data through Quality
Payment Program, Announces New Clinical Trials Improvement Activity
Improved availability
of data key to driving improvement in patient care and development of
innovative practices
The Centers for Medicare & Medicaid Services (CMS) is
encouraging clinicians who participate in the Quality Payment Program
(QPP), such as physicians, physician assistants, nurse practitioners, and
others, to contribute to scientific research and evidence to fight the
Coronavirus Disease 2019 (COVID-19) pandemic. Clinicians may now earn
credit in the Merit-based Incentive Payment System (MIPS), a
performance-based track of QPP that incentivizes quality and value, for
participation in a clinical trial and reporting clinical information by
attesting to the new COVID-19
Clinical Trials improvement activity. This action will
provide vital data to help drive improvement in patient care and develop
innovative best practices to manage the spread of COVID-19 within
communities.
“The best scientific and medical minds in the world are
working night and day to find treatments to combat Coronavirus,” said CMS
Administrator Seema Verma. “But without solid data, their efforts are
liable to run up against a brick wall. At the direction of President Trump,
CMS is supporting efforts of researchers to obtain solid, actionable data
to accelerate the development of new treatments and our understanding of
the coronavirus. Today’s 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.”
In order to receive credit for the new MIPS COVID-19 Clinical Trials improvement
activity, clinicians must attest that they 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.
The new improvement activity provides flexibility in the
type of clinical trial, which could include the traditional double-blind
placebo-controlled trial to an adaptive or pragmatic design that flexes
to workflow and clinical practice. It also carries a high weight from a
scoring perspective. This means that clinicians who report 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.
For example, clinical trials could include those conducted
by the National Institute of Health (NIH). Clinicians could also report
through a clinical data repository, such as Oracle’s COVID-19 Therapeutic
Learning System. 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. Having clinicians use
an open source data tool to submit their findings will bring the results
of their research to the forefront of healthcare much faster, leading to
improvements in care delivery and the ability to treat COVID-19 patients.
This action, along with the unprecedented regulatory
flexibilities recently introduced, is just one part of the agency’s
efforts to address the COVID-19 pandemic. CMS, in coordination with the
White House Coronavirus Task Force, remains committed to reducing
regulator burden and supporting clinicians, stakeholders, and the health
care community to identify unique solutions that enhance care for
patients and further mitigate the spread of the virus.
This action, and earlier CMS actions in response to the
COVID-19 virus, are part of the ongoing White House Task Force efforts.
To keep up with the important work the Task Force is doing in response to
COVID-19 click here www.coronavirus.gov. For
information specific to CMS, please visit the Current Emergencies Website.
To view a database of privately and publicly funded clinical
studies currently being conducted on corona virus visit: https://clinicaltrials.gov/
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