You've tried to at least recognize what the new programs ACCESS and TEMPO mean (at CMS and FDA, respectively, but they interact...)
Here's yet another big CMS demonstration/innovation program, MAHA ELEVATE.
I'll give a summary of Trey Rawles' article below. If you want to start with Trey's whole article, here it is.
https://www.onhealthcare.tech/p/cms-just-opened-a-100m-door-for-lifestyle?'
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And here's the cut-to-the-chase AI summary:
Trey Rawles argues that CMS’s new MAHA ELEVATE Model represents a quiet but consequential shift in Medicare policy that most investors will overlook. While the program’s $100 million budget—spread across up to 30 three-year cooperative agreements—is small relative to Medicare’s scale, its significance lies in what CMS is choosing to fund. For the first time, the CMS Innovation Center is explicitly testing functional and lifestyle medicine interventions—nutrition, physical activity, stress, sleep, and social connection—that are not currently covered by Original Medicare.
Rawles emphasizes that MAHA ELEVATE is not a coverage decision but an evidence-generation exercise designed to determine whether whole-person lifestyle interventions can improve outcomes and reduce costs for Medicare beneficiaries with chronic disease. Every proposal must include nutrition or physical activity, and three awards are reserved for dementia-focused interventions, signaling CMS’s priorities. Awards average roughly $1.1M per year, with CMS actively involved in program design, data collection, and quality oversight.
The strategic value extends far beyond the grant dollars. Winning an award provides CMS validation, access to Original Medicare beneficiaries, and—most importantly—a potential pathway to future Medicare coverage if strong cost and quality evidence emerges. Rawles argues that companies with documented scientific evidence, real-world outcomes data, HIPAA-ready infrastructure, and integrated, multi-modal interventions are best positioned to win, favoring mature digital health and lifestyle medicine platforms over early-stage wellness apps.
For investors, MAHA ELEVATE de-risks evidence generation for a historically under-reimbursed category and signals a broader CMS pivot toward prevention and lifestyle medicine as complements to conventional care.
Here's a time-travel article, back to May 2025, about what HHS wanted to achieve in chronic care innovation.
