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CMS NEWS
FOR
IMMEDIATE RELEASE
April
21, 2020
Contact:
CMS Media Relations
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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