Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE)

Analysis updated November 9, 2026

Strategic questions for your team

Can our organization document peer-reviewed evidence of safety and effectiveness for a specific whole-person functional or lifestyle medicine intervention targeting a chronic condition prevalent in our Original Medicare population — and can we build a credible cost savings plan showing Medicare FFS savings that exceed program delivery costs over a defined time horizon, using financial modeling, ROI analysis, or budget impact analysis with baseline enrollment assumptions and per-patient cost reductions?
Do we have the operational infrastructure to collect, securely store, and report beneficiary-level clinical, utilization, and cost data to CMS on a timely basis — including experience with protected health information (PHI) and personally identifiable information (PII) protocols and, optionally, a Certified Electronic Health Record Technology (CEHRT) product with a documented CHPL ID — and if not, do we have credible partner organizations or affiliations that can fill this gap before the Cohort 1 October 2026 launch?
How many Original Medicare fee-for-service beneficiaries can we realistically screen, find eligible, and enroll in our proposed intervention across our defined service area — and are those enrollment projections grounded in our current patient panel size, referral network capacity, and past program completion rates, recognizing that CMS will use our submitted estimates to set a binding minimum beneficiary target for our cooperative agreement?
Does our proposed intervention consist entirely of services NOT already covered by Original Medicare, and does it incorporate either nutrition or physical activity as a core component — or, if we are proposing a dementia-focused intervention, are we positioned to compete for one of the three reserved dementia award slots within the up-to-30 total cooperative agreements funded at approximately $100 million over three years?
What is our study design for creating a valid comparison group — whether through patient-level, provider-level, or site-level randomization, or a matched comparison using Medicare FFS enrollment and claims data — and can we articulate a defensible methodology that will satisfy CMS's requirement for cost and quality data collection sufficient to inform future Original Medicare coverage determinations or future CMMI model development?
Have we identified and secured commitments from all partner organizations needed to deliver the intervention, including those providing patient referrals, clinical oversight, and data collection support — and do we have executed letters of support, memoranda of understanding, or contracts ready to attach to our application, with partner costs fully reflected in our budget and budget narrative?
Do we have prior experience operating this intervention in a clinical or community setting — including documented quantitative outcomes on utilization, quality, cost, and patient experience — and can we credibly demonstrate that the population we previously served reflects or is representative of the broader Medicare FFS population, as required in Template 3 of the Project Narrative?
What is our organization's risk exposure if MAHA ELEVATE funding does not produce sufficient savings data to trigger future CMS coverage expansion — given that the model is explicitly a data-gathering and evaluation exercise with no guarantee of subsequent payment policy changes — and how does participation affect our obligations under any concurrent CMMI models we currently operate, given CMS's stated intent to apply overlap policies for organizations participating in multiple models?

Traps and concerns

Cooperative Agreement vs. Waiver Payment Confusion
MAHA ELEVATE funds participants via cooperative agreements — not Medicare payment waivers or shared savings arrangements. The ~$100 million pool spread across up to 30 awardees over 3 years implies an average of roughly $3.3 million per awardee over the performance period, but the NOFO requires applicants to build a Cost Savings Plan demonstrating that the intervention would reduce Medicare FFS spending if covered. Organizations that budget as if they will receive supplemental Medicare claims reimbursement on top of cooperative agreement dollars will face a structural revenue shortfall. The intervention must consist of services 'not already covered by Original Medicare,' meaning awardees cannot bill Medicare Part B simultaneously for the same services — a dual-billing trap that could trigger False Claims Act exposure if billing practices are not rigorously segregated.
Minimum Beneficiary Target as a Penalty Trigger
The NOFO explicitly states that CMS will use enrollment projections submitted in the application to 'determine a minimum beneficiary target for your program.' Organizations that inflate enrollment estimates to appear competitive during scoring — and then fail to meet those targets operationally — face potential clawback, performance default, or non-renewal for Cohort 2 (launching 2027). Because the target population is Original Medicare FFS beneficiaries only (excluding Medicare Advantage), organizations with predominantly MA-attributed patient panels may dramatically overstate their eligible population. A practice estimating 500 eligible patients from a mixed panel could realistically access fewer than 150 FFS beneficiaries, breaching its CMS-negotiated minimum and jeopardizing the full cooperative agreement value.
Dementia Set-Aside Creates Competitive Disadvantage
Three of the up to 30 awards are reserved specifically for dementia-focused interventions. Organizations not targeting dementia are competing for a maximum of 27 awards, compressing the competitive pool and increasing the risk that functionally strong proposals are eliminated on volume alone. More critically, dementia interventions face heightened IRB scrutiny, capacity-to-consent challenges, and proxy enrollment complexity under federal human subjects protections (45 CFR 46). Organizations targeting dementia without documented IRB protocols and surrogate consent procedures in their application — a required element under the Data Management Plan section — face disqualification or post-award compliance findings.
Peer-Reviewed Evidence Standard Disqualifies Proprietary Programs
The NOFO requires that all proposals be 'supported by peer-reviewed literature' and that applicants submit cited articles as PDF attachments with specific page-level callouts — hyperlinks are explicitly excluded from review. Functional and lifestyle medicine programs that rely on proprietary protocols, celebrity-branded wellness approaches, or unpublished internal data will fail this evidentiary threshold regardless of real-world outcomes. The requirement that cited PDFs be physically attached (not linked) means an applicant with 15 citations must manage a large attachment bundle through Grants.gov, creating a technical submission hazard where missing PDFs can render otherwise strong applications non-compliant. Organizations should stress-test their Grants.gov submission package well before the Cohort 1 deadline, which has already passed as of May 15, 2026.
Data Submission Infrastructure Gap at Award Launch
The Data Management Plan section requires beneficiary-level data collection and reporting to CMS, PHI/PII secure storage protocols, and documentation of clinical, cost, and utilization measures — all operationalized at October 2026 launch. Community-based organizations, senior living communities, and lifestyle medicine centers that lack Certified Electronic Health Record Technology (CEHRT) are technically eligible (CEHRT is 'not required'), but they must still transmit beneficiary-level data that links to Medicare FFS enrollment and claims. Without CEHRT or a contracted health IT partner, these organizations will need to build custom data pipelines in fewer than 90 days between Notice of Award (Fall 2026) and model launch (October 2026). The absence of a compliant data infrastructure at go-live creates audit risk, potential suspension of cooperative agreement disbursements, and inability to contribute to the cost and quality evidence base that is the model's primary statutory purpose.
Overlap Policy Exposure for Multi-Model Participants
The NOFO requires applicants to disclose all current and past CMMI model participation. CMS states it 'will determine overlaps policies for organizations that are seeking to participate in multiple models' — but those policies are not yet defined in the published NOFO. ACOs currently in REACH, Medicare Shared Savings Program (MSSP), or Primary Care First that apply to MAHA ELEVATE face retroactive overlap determinations that could restructure their financial arrangements mid-performance period. If CMS determines that MAHA ELEVATE cooperative agreement services overlap with services already incentivized under a shared savings track, the organization could be required to exit one model, forfeit earned savings, or absorb a retroactive payment adjustment — a risk that is entirely unquantifiable at application time.
Cost Savings Modeling Without Actuarial Infrastructure
The Cost Savings Plan is a required application element and must include baseline assumptions (Medicare prevalence rates, expected enrollment, baseline per-patient costs), savings assumptions with peer-reviewed backing (specific percentage cost reductions per patient, aggregate savings projections), and intervention delivery cost calculations to demonstrate net savings. Functional medicine centers, community organizations, and academic institutions without dedicated health economics staff are expected to produce what is essentially a Medicare actuarial model — but the NOFO provides no standardized financial modeling template, no benchmark cost figures, and no guidance on acceptable discount rates or time horizons. Organizations that submit weak or unsupported cost models risk low scores on what is likely a high-weighted evaluation criterion, and those selected with overly optimistic savings assumptions face reputational and regulatory exposure if post-award CMS evaluation finds their projections were not evidence-based.