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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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