Although a few months old, it is nonetheless noteworthy that the U.S. Health and Human Services Centers for Medicare & Medicaid Services (CMS) now seeks to incentive participation 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 COVID-19 pandemic. But how does a provider connect to a clinical trial?
What does this mean for clinicians?
They 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 a clinical trial and reporting clinical information by attesting to the new COVID-19 Clinical Trials improvement activity.
What is MIPS?
The Merit-Based incentive Payment System (MIPS) is the program that will determine Medicare payment adjustments. Using a composite performance score, eligible clinicians (ECs) may receive a payment bonus, a payment penalty, or no payment adjustment.
Why is the federal government setting up this incentive?
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.
What are some underlying assumptions here?
Well, CMS Administrator Seems Verma commented, “The best scientific and medical minds in the world are working night and day to find treatments to combat Coronavirus.” She continued, “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.”
How does a provider 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 biologic 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.
How much flexibility is involved here?
According to the CMS communication, the new improvement activity offers flexibility in the type of clinical trial, which could include the traditional double-blind placebo-controlled trial to the adaptive or pragmatic design that flexes to workflow and clinical practice.
What is the research influence on scoring?
According to CMS, it’s significant. Clinicians who report this (clinical research) 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.
What is an example?
CMS offers an example that a clinical trial could be one conducted via the National Institutes of Health (NIH). Clinicians could also report through a clinical data repository, such as Oracle’s COVID-19 Therapeutic Learning System. Apparently, Oracle developed and donated the system to the U.S. government that allows clinicians and patients at no cost to record the effectiveness of promising COVID-19 drug therapies. Such an open source tool used for physicians to submit findings could generate faster research results, leading to improvements in care delivery and the ability to treat COVID-19 patients.
Are there other recent policy changes?
Yes, new unprecedented regulatory flexibilities. Moreover, CMS coordinates the White House Coronavirus Task force, remains committed to reducing regulatory 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 COVID-19.
For more information about ongoing White House Task Force efforts, see here; and for specific CMS information, visit the following website.
What is TrialSite Connect?
It is a network TrialSite is already building; the venture maintains a large global database of sites and sponsor needs. Already, many sponsors are approaching TrialSite about access to research sites. Stay tuned for the TrialSite Connect.
Can the TrialSite Connect network helps providers seeking to access clinical trials?