MAHA ELEVATE: Executive Summary and Strategic Model Analysis

---

1. Executive Summary and Strategic Context

What Is This Model and What Problem Does It Solve?

The Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) Model is a CMMI-administered cooperative agreement funding program authorized under Section 1115A of the Social Security Act that will provide approximately $100 million in federal funding across up to 30 awards to test whole-person functional and lifestyle medicine (FLM) interventions in the Original Medicare fee-for-service (FFS) population.

The model addresses a specific and quantified market failure: in 2022, approximately 45% of people with Medicare had four or more chronic conditions, and those beneficiaries accounted for nearly 90% of total Medicare health care spending. Despite this concentration, the U.S. health system has structurally oriented itself around reactive, symptom-level treatment rather than upstream prevention. MAHA ELEVATE's foundational premise is that whole-person functional or lifestyle medicine interventions — including nutritional, psychological, and physical activity components — are not currently covered by Original Medicare, creating an evidence and coverage gap that prevents these potentially cost-reducing approaches from reaching scale in the FFS population.

The model's explicit dual purpose is: (1) generate a novel U.S. evidence base on cost and quality outcomes for FLM interventions in Medicare, and (2) use that evidence to inform future Original Medicare coverage determinations or future CMMI model designs. This is a data infrastructure investment as much as a care delivery experiment — CMS is not merely testing whether these interventions improve health, but is constructing the evidentiary foundation to justify broader policy action.

Strategic Significance for the Value-Based Care Market

MAHA ELEVATE represents a structural shift in how CMMI conceptualizes the boundaries of Medicare-covered care. Prior CMMI models have predominantly tested payment redesign for services already within the Medicare benefit structure — bundled payments, shared savings arrangements, episode-based models, and primary care transformation. MAHA ELEVATE is categorically different: it is funding the delivery of services explicitly outside current Medicare coverage to generate the evidence necessary to potentially bring those services inside the benefit.

This has significant downstream implications for VBC stakeholders:

• For ACOs and health systems currently participating in shared savings models, MAHA ELEVATE offers a mechanism to expand care delivery into the prevention and wellness space using federal cooperative agreement dollars, without those services counting against current Medicare FFS spending baselines in ways that would affect shared savings calculations.

• For functional, integrative, and lifestyle medicine practices, this is the first federal program that treats their clinical approach as a legitimate subject of rigorous Medicare-scale evaluation, rather than as outside the scope of conventional reimbursement.

• For Medicare Advantage plans, the evidence generated by MAHA ELEVATE cohorts will directly inform what supplemental benefits can be grounded in CMS-validated evidence, potentially strengthening or challenging current MA supplemental benefit offerings in nutrition, fitness, and wellness.

• For health systems and academic medical centers, the cooperative agreement structure — which requires peer-reviewed evidence of intervention efficacy, IRB experience, and CMS-compatible data infrastructure — sets a high entry bar that will likely concentrate awards among organizations with established research and clinical integration capacity.

The three reserved awards for dementia interventions signal a deliberate policy priority. Dementia is among the costliest chronic condition trajectories in Medicare, and the absence of disease-modifying pharmacological treatments for most patients makes lifestyle and preventive approaches particularly salient. Organizations with dementia care programs should treat this reservation as a targeted funding lane.

Political Context and Administrative Alignment

MAHA ELEVATE is explicitly branded within the Trump administration's Make America Healthy Again initiative, positioning it as part of a broader HHS-level effort under HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz to reorient federal health policy toward chronic disease prevention, nutrition, and lifestyle factors. This branding is not incidental — it signals that MAHA ELEVATE carries direct White House-level policy priority, which provides both funding durability and reputational risk for applicants if the political environment shifts.

The model's emphasis on nutrition, physical activity, sleep, stress management, harmful substance avoidance, and social connection as "critical areas of focus" reflects MAHA's ideological alignment with functional and integrative medicine frameworks, which have historically operated outside mainstream CMS reimbursement policy. Under prior CMS leadership, this alignment would have been unlikely to reach the level of a formal CMMI model. The current administration's willingness to use $100 million in CMMI cooperative agreement authority to validate these frameworks is a meaningful policy signal.

The use of Section 1115A authority — rather than the Medicare preventive services benefit or a standalone demonstration — is also strategically significant. Section 1115A gives CMMI broad authority to test payment and service delivery models that may not otherwise be reimbursable, and explicitly allows CMS to implement model findings at scale without additional Congressional action if the models reduce spending without reducing quality, or improve quality without increasing spending. This means a successful MAHA ELEVATE cohort could theoretically result in direct coverage expansion for validated FLM interventions.

Market Transformation Implications

The most consequential long-run implication of MAHA ELEVATE is that it converts previously anecdotal or small-scale evidence on FLM interventions into Medicare FFS cost and quality data — the specific currency CMS requires to justify coverage policy. The model's stated outcomes explicitly include informing "future Original Medicare coverage determinations," which means that organizations that win cooperative agreements are not merely delivering care — they are contributing to the evidence base that will determine whether their service category achieves permanent Medicare coverage.

This creates a strategic incentive structure: organizations that participate in Cohort 1 (launching October 2026) or Cohort 2 (launching in 2027) and generate strong cost and quality data will be positioned as the demonstrated delivery infrastructure for any coverage expansion that follows. First-mover advantage in CMMI model participation has historically translated into market positioning in subsequent permanent policy changes (e.g., ACO participants had structural advantages in MSSP design input).

The requirement that interventions be "support to, not in lieu of, conventional medicine" is a deliberate boundary that positions MAHA ELEVATE as complementary to, rather than competitive with, existing provider relationships and Medicare-covered services. This framing reduces political opposition from physician and hospital lobbying interests and makes the model more politically sustainable across potential future administrations.

---

2. Model Architecture and Payment Structure

Participation Structure and Eligibility

MAHA ELEVATE is structured as a cooperative agreement — a federal grant instrument — rather than a traditional CMMI payment model. This is a critical structural distinction: recipients receive federal funding to deliver services, rather than receiving modified Medicare payment rates or shared savings. There is no mandatory participation track, no risk corridor, and no repayment obligation in the conventional CMMI model sense. However, the cooperative agreement structure carries its own compliance obligations, including data reporting requirements, IRB standards, and CMS-collaborative program design.

Eligible applicant organizations span an unusually broad range of entity types:

Eligible Applicant Category
Private medical practices
Health systems and ACOs
Academic organizations
Functional, lifestyle, preventive, and integrative medicine centers
Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs)
Community-based organizations
State or local governments
Indian Health Service / Tribal Services / Urban Indian Programs
Senior living communities

Applicants may either deliver FLM services directly to patients or partner with other organizations to deliver services. This partnership model is explicitly supported — the application templates include a dedicated Table I: Partnership table and require the submission of formal partnership documents (letters of support, MOUs, contracts).

Selection criteria require applicants to demonstrate:

1. Delivery experience: The applicant or its partners must have prior experience delivering the proposed FLM interventions.
2. Safety and effectiveness: Interventions must be safe for the target Medicare population and supported by peer-reviewed literature. Cited articles must be submitted as PDF attachments with relevant text highlighted or specifically cited by page number, section, and paragraph — reviewers will not consider hyperlinks.
3. Data infrastructure: Applicants must demonstrate experience with beneficiary-level data collection and reporting to CMS, or demonstrate the capacity to build that capability. Certified Electronic Health Record Technology (CEHRT) is not required to be eligible but must be disclosed if held.
4. IRB experience: Applicants must demonstrate experience conducting ethical, patient-centered data collection with IRB oversight.

A critical selection input is the Cost Savings Plan, which requires applicants to submit financial modeling, return on investment analysis, or budget impact analysis demonstrating the intervention's potential to generate Medicare FFS savings that exceed program costs — though applicants are explicitly told they do not need to prove savings during the three-year cooperative agreement period. The cost savings plan must include: baseline assumptions (number of eligible Medicare patients, expected enrollment and completion rates, baseline costs); savings assumptions (percentage cost reduction per patient, aggregate savings, and supporting peer-reviewed evidence); and the calculated cost of delivering the intervention to demonstrate net savings potential.

Payment Methodology

MAHA ELEVATE does not operate through Medicare claims-based payment modifications. The payment mechanism is a cooperative agreement funding award drawn from CMMI's testing authority budget.

Payment Parameter	Detail
Total model budget	Approximately $100 million
Maximum number of awards	Up to 30 cooperative agreements
Performance period	3 years per cohort
Implied average award size	Approximately $3.3 million per award (calculated from $100M ÷ 30 awards)
Cohort 1 launch	October 2026
Cohort 2 launch	2027
Notice of Award timing	Fall 2026 (for Cohort 1)

Note on implied award size: The source documents do not specify per-award dollar amounts or minimum/maximum award floors and ceilings. The ~$3.3 million figure is derived from dividing the total $100 million budget by 30 awards and should be treated as a rough average rather than a specified range.

Awardees are not receiving modified Medicare payment rates for the FLM services they deliver. The cooperative agreement funds are intended to cover the cost of delivering services "not already covered by Original Medicare." This means:

• Medicare FFS continues to pay for covered services delivered to enrolled beneficiaries through normal claims pathways.
• The cooperative agreement funds cover the FLM services that are outside current Medicare coverage.
• CMS uses Medicare FFS enrollment and claims data to track beneficiary utilization, cost, and outcomes — this is the mechanism by which cost savings are measured.

Performance Measures, Data, and Quality Requirements

Awardees must work collaboratively with CMS to develop a plan covering data collection, quality measurement, recruitment, and cost containment. The cooperative agreement structure means CMS is an active partner in program design, not merely a passive payer.

The application templates define the data and quality infrastructure required:

Outcomes Measurement (Table G) requires applicants to specify for each targeted outcome:

• How the intervention affects the outcome mechanism
• Expected effect size
• Timeline for the effect
• Data source

Clinical examples explicitly cited in the application materials as evidence of effectiveness include: fewer emergency department visits, reduced hospitalizations, weight loss, lower HbA1c, and lower blood pressure. These serve as de facto signal indicators of the types of measurable outcomes CMS expects proposals to target.

Logic Model (Table H) requires applicants to map needs → inputs → activities → outputs → outcomes → impact, operationalizing the program theory.

Program-Level Historical Data (Table J) requires applicants to document their prior intervention experience across: enrollee demographics, intervention length, operational process measures, health outcome changes, and cost changes. This requirement ensures only organizations with demonstrated prior delivery experience — not purely theoretical programs — can submit credible applications.

Study Design Requirements: Applicants must address whether they will use randomization and, if so, at what level (patient-level, provider-level, or site-level). If randomization is not possible, applicants must describe how they will construct a valid comparison group, whether they can use Medicare FFS enrollment and claims data to build that group, and what comparison data they will report to CMS. CMS will use enrollment projections submitted in the application to set minimum beneficiary enrollment targets for each awardee.

Beneficiary Safeguards: The application requires explicit description of how the organization will monitor for harmful effects from the intervention and how it will mitigate or avoid harm.

Timeline Summary

Milestone	Date
Cohort 1 application deadline	May 15, 2026, 11:59 PM ET
Notice of Award (Cohort 1)	Fall 2026
Cohort 1 performance period launch	October 2026
Non-selected applicant notifications	After Cohort 1 recipients notified
Cohort 2 awards	2027
Cohort 2 performance period launch	2027

Mandatory Proposal Design Requirements

All proposals must satisfy specific structural requirements regardless of the applicant's chosen chronic condition or intervention type:

• Nutrition or physical activity must be incorporated into every proposal design — this is a non-waivable requirement.
• Three of the up to 30 awards are reserved for interventions specifically addressing dementia.
• All interventions must address services not already covered by Original Medicare.
• Interventions must be framed as supplements to, not replacements for, conventional medical care.
• Targeted chronic conditions and specific interventions are selected by the recipient — CMS does not prescribe a uniform intervention. This design flexibility is what distinguishes MAHA ELEVATE from most CMMI models, which typically mandate specific care delivery protocols.

The critical areas of focus explicitly named in the model design — nutrition, physical activity, sleep, stress management, harmful substance avoidance, and social connection — define the intervention universe without mandating specific protocols, giving applicants latitude to design within their demonstrated competencies while remaining within the model's thematic scope.