I’m sure many are planning for your annual Groundhog’s Day festivities. One less thing to be concerned with this Friday is that while the prior continuing resolution (CR) that NIH operated under was in effect, had been set to expire on February 2, this has now been superseded by another CR that moves the drop-dead date to March 8 (another Friday) for NIH, with a companion CR that goes until March 1. While this gives the appearance of the whole month of February to nail down the details for a full FY24 budget, Congress has plenty of other agenda items and pressing concerns to deal with. At the same time, even though February this year conveniently offers twenty-nine days, the actual scheduled legislatives work sessions are limited with the <a href="https://www.majorityleader.gov/uploadedfiles/2024_house_calendar_-_monthly_-_revised_jan_2024.pdf" target="_blank" rel="noopener noreferrer">House</a> and <a href="https://www.senate.gov/legislative/resources/pdf/2024_calendar.pdf" target="_blank" rel="noopener noreferrer">Senate</a> listing only ten working days each.&nbsp;Exactly how all of this will play out is uncertain at this time. There may be emerging chatter (ruminations, lamentations, etc.) of the implications for NIH. A recent <a href="https://www.cbo.gov/system/files/2024-01/59861-Sequestration.pdf" target="_blank" rel="noopener noreferrer">Congressional Budget office (CBO) letter</a> to the House Budget Committee lays out the various scenarios that could arise as a result of the Fiscal Responsibility Act of 2023 (FRA). You may recall that the <a href="https://www.cbo.gov/publication/59235" target="_blank" rel="noopener noreferrer">FRA was the resolution of the debt ceiling</a> debate last year. While the FRA suspended the debt ceiling until January 1, 2025, it also included language concerning overall federal spending and revenue.&nbsp;While I don’t recommend this reading material (unless you suffer from insomnia), there is a handy visual aid on page 3 of the CBO letter that provides possible scenarios that could play out depending on what Congress does (or does not do) between now and April 30th. There may be some head scratching as to how a 1% sequestration in the FRA can result in larger potential sequestrations. Ah, the vagaries and nuances of federal budgeting. Bear in mind that the 1% sequestration is based on the prior FY23 enacted budget and not the FY24 CRs we are operating under. Both the Department of Veterans Affairs (which is also exempt from sequestration), and Indian Health Services received advance appropriations for FY24 in amounts higher than FY23. There are some additional considerations related to the Federal Housing Administration as well as budget authority cancellations in FY24 relative to FY23 that also add to the overall discretionary (NIH is in the category of ‘discretionary’) funding total to which the 1% is applied. Finally, the Office of Management and Budget (OMB) has some latitude in distributing the sequester.&nbsp;So, with all that, bear in mind that no one knows at this point what will happen or how any of this plays out. Congress can do whatever they want, including waiving the FRA entirely (not likely, but still possible). Regardless of what you hear, NIH in general tends to follow the mantra, ‘hope for the best, but plan for the worst.’&nbsp;The budget is not just a collection of numbers, but an expression of our values and aspirations. - Jack Lew

By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation

So Where Do We Stand (or Fall)?

- Any -

Hopefully everyone has sufficiently recharged after the holidays, looking forward to the new year. As Lenin once remarked, “There are decades where nothing happens; and there are weeks where decades happen.” It would appear that 2024 is going to offer us weeks and weeks of decades. NIH is still without a budget, and while our current CR runs through February 2 (although 2/2 being a Friday, one can expect the cliffhanger to drag out over the weekend), there is another CR that runs through 1/19, so we might get an inkling of what we can expect before Groundhog Day. At the same time, there are quite a few other pressing items on Congress’s plate that need dealing with. And let’s not forget the presidential primary season kicks off in January (I dread my television viewing options at the gym in 2024).&nbsp;&nbsp;The start of a new year should be a time for new thinking and new directions. The CTSAs should be major players for new thinking and new directions for medicine and health care. We’re also nearly a quarter of the way into the current century and so it’s about time to consider how 21st century medicine will be conceptualized, or, closer to home, how this generation of academic medical leaders will be remembered. So far, it looks like we have some work to do. How are we dealing with the worsening antimicrobial resistance issue? By largely attempting to recapitulate science that is nearly 100 years old - discovering another new antibiotic. ‘Let’s replace current drugs losing potency with similar alternatives that are likely to eventually suffer the same fate as our existing limited options.’ What are we doing with AI? Mostly attempting to do everything we do now, but just a little faster, freeing up time for the really important stuff like filing more billing claims. Or for the academic medical researcher, discovering a new treatment for a common disease (with said disease quite possibly due to long term adherence to some other medical treatment) that can make a biotech CEO a billionaire (which is one reason why new antibiotics are so hard to produce since they are generally considered cheap and taken for short periods of time anyway, hence unlikely to be a blockbuster).&nbsp;&nbsp;It is against this background that I ran across this interesting <a href="https://metarationality.com/post-apocalyptic-health-care#interface" target="_blank" rel="noopener noreferrer">read</a>, which while undated appears to have been written around 2017 (and all the more intriguing since little has changed). The author describes a concept he calls ‘systematic interface’ where the system is “transparent on the outside, and black boxes on the inside. You don’t have to know anything about how they operate in order to use them” using FedEx and Amazon as examples. Health care systems, whether a hospital facility or an insurance company, are just the opposite. To the outside user they are largely opaque. How much will this procedure cost? ‘We can’t tell you until after it’s over.’ In order to navigate an opaque system, you basically need to know someone who knows someone who knows what to do and that person may still not be the one with any authority to make a decision.&nbsp;&nbsp;While it’s easy to dismiss these concerns as ‘above my paygrade,’ it’s important to keep these concepts in mind especially for the upcoming <a href="https://ccos-cc.ctsa.io/news/LHS-Collaborative-Workshop-2024" target="_blank" rel="noopener noreferrer">LHS Collaborative Workshop in May</a>. In order to realize the potential impact of CTSA activities, methodologies for rapid dissemination and implementation across our diverse and balkanized health care ecosystem are critical to avoid forcing everyone to continually reinvent wheels. At the same time, a medicine cabinet full of therapies that aren’t or can’t be used effectively will have little impact on how people feel, function, survive, and thrive. Any large system is resistant (mostly due to inertia) to change and so it becomes incumbent on us to provide compelling justification across multiple dimensions (patient outcomes, staff workload, economic, etc.) as well as simplified pathways for the transition.&nbsp;&nbsp;&nbsp;In many instances, investigators are solely focused on individual trees (an individual aspect of a single disease) without ever appreciating the forest (our complex health care ecosystem) around them. All too often, we assume that the <a href="https://en.wikipedia.org/wiki/Reductionism" target="_blank" rel="noopener noreferrer">methodological reductionist approach</a> which has been so successful for science (as well as science funding), is all that is necessary for translating science into implementable health care solutions. Unfortunately, while this sometimes leads to productive scientific research endeavors (as well as successful grant funding), it never quite seems to lead to cost effective health care solutions. For example, traditional approaches for studying monogenetic diseases direct efforts into understanding the genetics, the biochemistry, the physiology, and the natural history of that disease. Of course, much high-quality science emerges which is valuable as scientific knowledge but that doesn’t always offer direct implementable health care solutions for that condition. On the other hand, a readily implementable gene editing methodology (ideally, in utero), once a specific gene variation has been associated with a specific disease phenotype, would address a monogenetic disease even without full understanding of the underlying gene function or subsequent pathology.&nbsp;&nbsp;For the CTSAs to truly impact the health care ecosystem, we need to reimagine what health and health care can and should look like in the future as well as recognize and appreciate that the small incremental progress our individual work supports must align and contribute to a larger vision of better health as well as health care for everyone, a vision that the CTSA community understands, accepts, nurtures, and pursues, fearlessly and relentlessly.&nbsp;&nbsp;Happy New Year!&nbsp;&nbsp;<blockquote>You are under no obligation to remain the same person you were a year ago,&nbsp;a month ago, or even a day ago. You are here to create yourself, continuously.&nbsp;-Richard Feynman, Nobel laureate in physics&nbsp;&nbsp;</blockquote>

Orthogonal Perspectives 

NCATS Director of Clinical Innovation

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Michael G. Kurilla M.D., Ph.D.

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So, where do we stand now with regards to the federal budget? Last week, we saw much in the way of machinations and possibilities. We have now transitioned CRs throughout FY24 from months to weeks to now days. As you will recall, prior to last week, the USG was operating under two continuing resolutions with drop dead dates of 3/1 and 3/8. NIH was included in the later date. What has transpired is two new CRs with the previous 3/1 extended to 3/8 and the 3/8 extended to 3/22. There has also been some shifting of agencies between these two dates. The shift results from perceived progress towards passage of actual appropriation bills (six to be specific). When Congress operates as intended with regards to appropriations, there are twelve total, but separate bills (see <a href="https://appropriations.house.gov/fy2024-bills" target="_blank" rel="noopener noreferrer">this link</a> for the breakdown) that combined, cover the entire federal budget, excluding mandatory budget components (such as social security, Medicare/Medicaid, and interest on the federal debt). The 3/8 deadline is for six of those bills expected to be debated (and passed?) in the week ending 3/8 (I’m composing this blog entry on 3/1). Bear in mind that these bills don’t always align with specific Departments. While NIH is within the Labor/HHS bill (which makes sense) and under the 3/22 CR, the FDA is part of the Agriculture bill (full title: Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2024, and for other purposes.) which has a 3/1 deadline. Thus, your FDA colleagues may actually get a budget next week, while NIH will have a slightly longer March madness experience. As such, be prepared that this will delay funding decisions across NIH. Also bear in mind that by March, the majority of submitted NIH applications that could be awarded in this fiscal year will have completed reviews which allows NIH ICs to begin ‘end-of-year’ planning in terms of allocating their funding for the year. This delay in assessment along with increased pressure on grants management to make awards in a compressed timeframe creates additional hassles regardless of the final budget resolution for FY24. Finally, understand that Congress has complete authority to do whatever they choose which includes a full or partial shutdown, a full year CR, an actual FY24 budget (which can be for a subset of Federal agencies), or scrap the FRA (Fiscal Responsibility Act) and pass whatever budget they deem appropriate (although don’t become dyspneic over this option).&nbsp;And now for something completely different. Last week, I participated in the Learning Health System Collaborative Workshop Steering Committee meeting for the <a href="https://ccos-cc.ctsa.io/news/LHS-Collaborative-Workshop-2024" target="_blank" rel="noopener noreferrer">upcoming workshop</a> to be held in Charlotte, NC later in May. The LHS concept aligns nicely with both the CTSA Program as well as NCATS’ strategic priorities. Clearly, the work of CTSAs cannot contribute to overall public health impact if health care facilities cannot efficiently implement improvements in health care and health care delivery. Dissemination needs to be more than peer-reviewed journal articles and implementation needs to consider our diverse, but fragmented health care system.&nbsp;&nbsp;And then I ran across <a href="https://prospect.org/health/2024-02-27-scenes-from-bat-cave-steward-health-florida/" target="_blank" rel="noopener noreferrer">this</a> news item the next morning. Now it may be easy to dismiss this as an outlier, but it’s clear that this one health care system has fingers (tentacles?) not only Florida, but also Texas, Louisiana, Utah, and Massachusetts. At the same time, this is not a case of one bad apple, but rather an evolving situation with private equity injecting itself into the health care sector that has recently received quite a bit of attention: <a href="https://hms.harvard.edu/news/what-happens-when-private-equity-takes-over-hospital" target="_blank" rel="noopener noreferrer">here</a>, <a href="https://www.commonwealthfund.org/publications/explainer/2023/nov/private-equity-role-health-care" target="_blank" rel="noopener noreferrer">here</a>, and <a href="https://lowninstitute.org/the-rising-danger-of-private-equity-in-healthcare/" target="_blank" rel="noopener noreferrer">here</a>. While much of this may be regarded as ‘above my paygrade,’ one recent commentary noted that while private equity may be buying, it is quite enlightening to examine <a href="https://thehill.com/opinion/healthcare/4365741-private-equity-is-buying-up-health-care-but-the-real-problem-is-why-doctors-are-selling/" target="_blank" rel="noopener noreferrer">why physicians at least are selling in the first place</a>. &nbsp;&nbsp;Then there are <a href="https://www.bmj.com/content/384/bmj-2023-077391" target="_blank" rel="noopener noreferrer">recent findings</a> that examined oncology drugs approved by EMA between 1995 and 2020 assessed that of 458 drugs, a whopping 41% had negative or non-quantifiable benefit. Combine that with <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/prices-new-us-drugs-rose-35-2023-more-than-previous-year-2024-02-23/" target="_blank" rel="noopener noreferrer">this report</a> that median new drug prices rose 35% between 2022 and 2023 ($300k up from $222k). And then there’s the <a href="https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm" target="_blank" rel="noopener noreferrer">drug shortage</a> (mostly the relatively cheap stuff) which the FDA currently reports 138 entries with few resolutions. And now CDC is reporting <a href="https://www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html" target="_blank" rel="noopener noreferrer">constrained supplies of the Td/Tdap vaccine</a>, so you should advise your patients to avoid rusty nails.&nbsp;While there are few options for CTSAs to address these concerns, awareness is critical as these activities will have a profound effect on the public perception of health care (as well as health care professionals) in general due to conditions independent of ivy-covered professors within ivy covered walls and which may, in turn, negatively impact necessary and critical community engagement. In addition, these actions are likely to influence our ability to promote and engage with learning health systems in a manner that will enhance the health of our patients, rather than the financial health of the health care system owners. This should inform our reimagining 21st century health care.&nbsp;The only difference between death and taxes is thatdeath doesn't get worse every time Congress meets.- Will Rogers

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So Where Do We Stand (or Fall)?