NCATS Director of Clinical Innovation
Mike's Blog
2023 Can be a Return to CTSAs Addressing Healthcare’s ‘Wicked Problems’
By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation
January 5, 2023
Rob Califf’s keynote address at the Annual CTSA Program meeting last November was quite sobering and could be succinctly summarized as ‘US health is regressing.’ A recent long read in The Atlantic offers an equally sobering view on the general state of progress in the US across the technological spectrum. While the piece takes a broad brush to US science and technology, there are several relevant and interesting biomedical examples presented including smallpox and Operation Warp Speed. The overall theme of the article is that our progress has stalled even though our ‘inventions’ (what we in the biomedical fields would call ‘basic research’) continue to lead the world. The article identifies this ‘stall in progress’ as the translation of those inventions through to implementation (“The way individuals and institutions take an idea from one to 1 billion is the story of how the world really changes.”)
With a new year upon us, rather than recite the standard litanies of resolutions, it makes sense to contemplate some big picture ideas or concepts that the CTSA consortium can tackle (or at least take a bite of). While some have referred to this category as ‘big hairy problems’, I prefer the term ‘wicked problem’. As an aside, many issues we deal with may even qualify as ‘super wicked problems’ (“no central authority dedicated to finding a solution” and “policies irrationally impede future progress”). Since NCATS was specifically created to translate and reduce to practice, or rather, simply implement all the wonderful scientific discoveries that NIH enables, taking on wicked problems is the core of our mission. The CTSA program is one of our major mechanisms for doing just that.
Let me throw out three wicked problems, but I know CTSAs can offer many more. The first concept is an area that the CTSAs have some past experience with, namely metrics. MIPS is the Medicare Merit-based Incentive Payment System which influences reimbursement for nearly one million clinicians nationwide. Performance is evaluated in four domains including cost, quality, improvement activities, and promoting interoperability. The idea is to use performance measures to inform reimbursement. A recent analysis of the MIPS program has been published. Without going into much detail, their conclusion says it all: “Among US primary care physicians in 2019, MIPS scores were inconsistently associated with performance on process and outcome measures. These findings suggest that the MIPS program may be ineffective at measuring and incentivizing quality improvement among US physicians.” What could the CTSAs contribute here that can not only address CMS’ needs, but also promote overall better evaluation of healthcare delivery performance for all stakeholders?
The second idea is in the realm of drug pricing. NIH has received numerous inquiries about drug pricing and what we’re doing about it. Like many other aspects of our healthcare system, the pathway from drug manufacturer to patient involves a labyrinthine nightmare of various players that renders pricing nearly inscrutable. I’m leery that there is much to do in terms of making the cost of drug production cheaper (there are already plenty of incentives). Recently though, a new player has entered the field that is being intentionally disruptive. This suggests there may be opportunities to analyze and evaluate alternative strategies for drug delivery and pricing, and to assess those alternative strategies’ impacts on treatment compliance and adherence that can inform future decisions on drug pricing policy.
Lastly, a suggestion from a CTSA, specifically Dan Cooper at UCI: highlighted an article entitled, “Goodbye Electronic Health Record?” Whereas our current implementation of EHRs was developed primarily for billing purposes, less thought was given over to patient care and no thought at all to health care research. So, if there were to be a concerted effort to move towards EHR 2.0, what does that even look like, how would it be structured, and most importantly, what would the transition to 2.0 look like? While CTSAs may never be in position to engineer that overall transition (too many other stakeholders), CTSAs could serve a critical role in defining the requirements and interface of what 2.0 would encompass as well as demonstrate the advantages to the various stakeholders.
I look forward to discussing these concepts and any others that arise with you in the new year. Lastly, to finish out 2022, Congress settled on an Omnibus bill, and as a result, we are starting the new year with a full year’s budget, reflecting a 3.8% increase in CTSA appropriations from FY22.
We think that we know a man or a woman, when so much of what we know is actually that man's or that woman's situation, his or her place on the board of life. Move the pawn to the last row and see her rise in armor, sword in hand.
- Gene Wolfe, Home Fires
This Mike's Blog was featured in January 2023's Ansible. Subscribe to receive upcoming Ansible newsletters.