A new policy from CMS would encourage physicians to enroll COVID-19 patients into trials, addressing potential enrollment shortfalls as the virus ebbs in some communities and the number of new drug candidates continues to climb.
On Monday, CMS announced a new clinical trials improvement activity for clinicians who participate in the Quality Payment Program. Physicians can now earn credit in the Merit-Based Incentive Payment System (MIPS) for participating in a clinical trial and reporting clinical information.
CMS said the change would provide “vital data to help drive improvement in patient care and develop innovative best practices to manage the spread of COVID-19 within communities.”
To receive credit for the new MIPS COVID-19 clinical trials improvement activity, physicians must participate in a COVID-19 clinical trial that uses a drug or biologic and report the results via a clinical data repository or registry. Trials could include double-blind, placebo-controlled studies, adaptive trials, pragmatic studies or trials conducted by the National Institutes of Health (NIH).
CMS highlighted Oracle’s open-source COVID-19 Therapeutic Learning System as one method to report clinical data. Clinicians who report the activity will earn half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category.
The FDA has tried to encourage physicians to enroll patients in clinical trials for potential therapies. The agency has issued just one Emergency Use Authorization (EUA) for a therapeutic—chloroquine or hydroxychloroquine—but included the requirement that physicians use it only to treat patients who do not qualify for or cannot enroll in clinical trials.
HRI impact analysis
CMS’ incentive for providers could help address a potential shortfall in eligible patients that therapeutics manufacturers are likely to face if US cases drop off.
According to GlobalData, there are 82 candidates in Phase I through Phase III testing for COVID-19 with over 300 in discovery or preclinical phases of development. Those agents account for 1,000 clinical trials across the globe.
A previous analysis by HRI found that in some countries where the virus has subsided, the number of patients needed to enroll the trials far exceeded the number of positive cases. As a result, some trials have already been canceled or put on hold because of enrollment challenges.
As of April 12, among the 745 studies listed in ClinicalTrials.gov for COVID-19, 11 have been suspended or withdrawn, some citing a reduction in cases as the reason. Twenty of the studies have been completed and 23 have completed enrollment, with 654 studies recruiting or not yet recruiting patients.
According to CMS’ 2017 Quality Payment Program Reporting Experience, just over 1 million physicians participated in the MIPS program across the US. This could provide a new source of patients for these planned and recruiting clinical trials. New York state, which is the epicenter of the COVID-19 outbreak in the US, also accounts for the largest population of participating providers.
Less hard-hit regions also have a significant share of MIPS providers that could enroll new patients if a second or third wave arises. Specifically, California, Florida and Texas each account for 6% of total MIPS participants, followed by Illinois and Pennsylvania at 4% each.