Mike's Blog

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 this link 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).

And now for something completely different. Last week, I participated in the Learning Health System Collaborative Workshop Steering Committee meeting for the upcoming workshop 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. 

And then I ran across this 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: here, here, and here. 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 why physicians at least are selling in the first place.  

Then there are recent findings 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 this report that median new drug prices rose 35% between 2022 and 2023 ($300k up from $222k). And then there’s the drug shortage (mostly the relatively cheap stuff) which the FDA currently reports 138 entries with few resolutions. And now CDC is reporting constrained supplies of the Td/Tdap vaccine, so you should advise your patients to avoid rusty nails.

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.

The only difference between death and taxes is that

death doesn't get worse every time Congress meets.

- Will Rogers