All I Want For Christmas Is Proof

Proof
Some people gonna call you up
Tell you something that you already know
Proof
Sane people go crazy on you
Say “No man that was not
The deal we made
I got to go, I got to go”
Faith
Faith is an island in the setting sun
But proof, yes
Proof is the bottom line for everyone

–Lyrics from Proof by Paul Simon

In this year of digital health, er, market correction, it is critical to remember one thing:  if anyone is going to come out of the abyss, it is because their digital health product or service not only claims to actually do something useful, but actually does it.  To get to that promised land, said company must commit to proving the “it actually does something” part of the equation.  Professions of love are nice, evidence of love is better.  Just ask Taylor Swift, an expert on the subject.

I still speak to new companies every day that entertain the illusion that saying something is valuable makes it real.  I am amazed that I still have to suggest to companies that they better be thinking not just about proving their technology “works” but that it actually demonstrably does something of value as defined by the customer and not by themselves.  Big difference here:  technology itself, even if it has AI in the title, is merely adorable.  Delivering meaningful quality/cost/experiential results as backed by legitimate studies is priceless.  And legitimate studies mean those that a customer would look at and say “well, hey, that’s meaningful to me.”  Healthcare vendors need to expose what’s behind the curtain and why anyone with money should bother to look.

Just think:  all the data created by such studies can even go into informing your fancy, schmancy AI algorithms.

Marketing talk is cheap, evidence is where it’s at.  I walked around a conference floor recently at a large digital health event and every single booth said something pedantic on it, such as “Bringing the best data to clinical decision-making” or “Quality that Saves You Money” or “I’m Sexy and I Know It”.    OK, maybe not the last one, but it’s the implication of so many company slogans and guess what…not so much.  What so many of these companies are really saying, in the immortal words of Cheap Trick, is “I want you to want me.”  What they need to be saying is, in the also immortal words of The Main Ingredient, “Let Me Prove My Love to You.”

Nearly every digital health/health tech company I know is in the process of, thinking about, praying about raising money.  Given that investors with large bank accounts are now about as risk-oriented as those people who go to Vegas even though they don’t gamble (what is that about, anyway?), the only companies that are going to make it out the other side are those that commit to seriously demonstrate that their product/service actually delivers cost-savings, revenue creation or some other thing that their target customer must have.  Failure to prove the value-proposition with an arms-length, legitimately designed study will result in certain death for those companies.  They may circle the drain for an extended period casting around for a go-to-market strategy, but down the drain they will go.  They should have spent that time establishing quality evidence of positive effect.

Let me give you a couple examples of companies that have really committed to this to delivering meaningful data to their customers through well-designed studies.

 “Food as medicine” has been talked about for years now, but it’s been one of those categories that has limited data outside the academic realm.  With much attention to social determinants of health (food insecurity, nutrition’s impact on chronic conditions and cancer) and with rising obesity rates and the introduction of GLP-1s for mass consumption, the demand for solutions has brought way too many companies to the party.  Most of them don’t have much to say other than small talk.  The ones that will captivate the room will come to the party with data.  Foodsmart is a company that has done this and, as a result, has really grown.

Foodsmart calls itself an end-to-end food benefits management provider.  They deliver “food as medicine” to millions of Americans. Their programs serve people across commercial, Medicaid and Medicare payer programs and feature an array of product offerings including counseling by registered dieticians, tailored meals for chronic conditions, and access to discounted healthy foods for people with food insecurity. Virtually all of this is paid by customers, not the end users, which is a plus but also makes the burden of proof particularly important.

Foodsmart began early on to invest in the collection of evidence that their programs produce long-term clinical and financial results for the health plans, providers, and employers with whom it partners. With over 10+ years of member data from its 1.7M members, numerous peer reviewed journals have featured Foodsmart’s impressive clinical findings:

• In a recent RCT study by Kaiser Permanente and Tufts University, where Foodsmart was the primary intervention, patients saw:
  • a significant improvement in blood sugar levels, with an overall average HbA1C reduction of 0.32 points, in comparison to participants in the control group.
  • a large improvement in food security and nutrition security status: the odds of being food secure increased by about 230% and the odds of being nutrition secure increased by 370% for patients in the intervention group compared to the control group
• 42% of members with food insecurity become food-secure for periods longer than six months
• 33% of members with obesity lose >5% weight at 24 months. And that number is significantly higher – 55% – for Medicaid members.
• 33% of members with hypertension achieve blood pressure control over an average of 9 months.
• 36% of members with dyslipidemia returned to normal cholesterol levels.

So that’s great clinical stuff.  But what Foodsmart’s paying customers really want is cost savings.  As payers, if they are going to spend a dollar on something as complex as food science, they want to see several dollars flowing back in their direction.  The good news is that the the company’s clinical outcomes have proven to translate into positive financial ROI and this has been verified in multiple third-party-verified studies, to wit:

• A recent Medicaid matched pair-controlled claims study with Chorus Community Health Plan (CCHP) shows $43 Per Member Per Month (PMPM) gross savings ($33 PMPM net savings)
• Another matched pair-controlled claims study with Umpqua Medicaid found $60 gross savings ($30 PMPM net savings)
• A recent Commercial study performed by one of the largest health insurers saw $20 PMPM medical claims savings for members engaged in at least 1 telenutrition visit in 12 months post-launch
• A matched pair-controlled claims analysis performed by Optum demonstrated $40 PMPM savings for a Fortune 100 employer
• A matched pair-controlled claims analysis of a Fortune 500 employer population saw $38 PMPM savings

Because of the time-consuming and expensive investment in proof that the company has made, they are growing fast and added many new payer partnerships and >10 million eligible lives in 2023, among other things.

KelaHealth is another company that is putting its money where its evidence is.  The company describes itself as “… building an operating system for surgical care across the entire patient journey, with touchpoints ranging from the first clinic visit through discharge.”  Kela has developed AI models (yeah yeah, who hasn’t?) that integrate EHR patient data augmented with surgeon and device data to predict patient risk and identify factors contributing to sub-par outcomes. But what’s different is this:  they’re one of the few in this space closing the loop to demonstrate their models are improving patient outcomes.

KelaHealth recently announced the results of a real-time deployment of their AI models in Duke Colorectal Surgery workflows to reduce acute kidney injury (AKI) and readmissions in a new 12-month prospective study, which was published in the Journal of Surgical Research, a legitimate peer-reviewed publication.

Their hypothesis in this study was that AKI from colorectal surgery is associated with increased risk of death, shorter survival time, and development of chronic kidney disease (CKD), resulting in increased healthcare burden and unplanned readmissions costing $41 billion annually in the U.S. alone.¹ With 665 patients in the prospective, risk-based cohort, KelaHealth’s Surgical Intelligence Platform directly led to a 21% reduction in acute kidney injury (AKI) and a 24% reduction in costly readmissions following colorectal surgery compared to 3,617 historical case-matched patient encounters. These results demonstrated that the KelaHealth platform actually creates actionable intelligence (a true form of AI) that aligns the clinical and financial incentives of providers, payors, and industry partners, as well as the patients who, you know, don’t die because they got better care.

This wasn’t Kela’s first dance with Duke, which had done previous work using the Kela platform to tailor the utilization of certain medical devices to individualized patient risk predictions, with results highlighting a 41% reduction in surgical site infection (SSI) and $231-$458 per patient cost savings across 370 vascular surgery patients enrolled in the study.

Yes, these two companies invested money and years into demonstrating these results.  Yes, it was frustratingly slow and expensive.  But hey, they get to live another day and have a real chance at prosperity rather than slip under the waves as the tide recedes.  Both companies had success raising money in 2023 (yes, Virginia, there is a Santa Claus!) and both companies are finding new partners and clients amidst the digital health hunger games; Katniss and Peeta have nothing on these guys.

But this is a game everyone can win if they make the commitment to do so.  If you question whether your product can produce real, meaningful, PROVABLE results for customers, you should also question whether it’s time to find a new job.  All your customers want for Hanukah, Christmas, Kwanza and Festivus is proof – it’s the bottom line for everyone in more ways than one.