cms-2w2-27-001-93-779-v4.pdf

Notice of Funding Opportunity

Application due Friday, May 15, 2026

Make America Healthy Again:

Enhancing Lifestyle and Evaluating Value-Based Approaches Through Evidence (MAHA ELEVATE) Opportunity number: CMS-2W2-27-001

Contents

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 12

Step 2: Get Ready to Apply 31

Get registered 32

Find the application package 33

Step 3: Build Your Application 34

Application checklist 35

Application contents and format 36

Step 4: Understand Review, Selection, and Award 60

Application review 61

Award notices 63

Step 5: Submit Your Application 64

Application submission and deadlines 65

Step 6: Learn What Happens After Award 67

Post-award requirements and administration 68

Contacts and Support 70

Before you begin 3

Appendices 72

Endnotes 81

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on Friday, May 15, 2026.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 12

Basic information Centers for Medicaid & Medicare Services (CMS)

Center for Medicare and Medicaid Innovation (“CMS Innovation Center”)

Patient Care Models Group (PCMG)

Test innovative, evidence-based clinical approaches rooted in whole-person functional and lifestyle medicine that hold strong potential for improving health outcomes and reducing costs.

Have questions?

Go to Contacts and Support.

Key facts Opportunity name:

Make America Healthy Again – Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence

Opportunity number:

CMS-2W2-27-001

Assistance listing: 93.779

NOFO version: Original

Key dates Application submission deadline:

Friday, May 15, 2026

Required letter of intent deadline:

Friday, April 10, 2026

Informational webinar:

Tuesday, March 25, 2026

Additional dates may be posted on the MAHA ELEVATE website.

Expected award date:

October 2026

Expected earliest start date:

October 2026

See other submissions for other time frames that may apply to this NOFO.

Summary The Centers for Medicare & Medicaid Services (CMS), through its Centers for Medicare and Medicaid Innovation (CMMI or Innovation Center), is soliciting applications for the Make America Healthy Again: Enhancing Lifestyle & Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) Model. This voluntary, three-year service delivery model is designed to test evidence-based, whole-person functional or lifestyle medicine (“whole-person FLM”) approaches to care. Rather than treating diseases separately after they develop, MAHA ELEVATE takes a proactive, comprehensive approach that combines psychological, nutritional, and physical interventions with personalized, lifestyle-based strategies for prevention and early treatment.

Throughout this NOFO, we use the term “whole-person FLM” to represent a range of services or approaches often incorporated in lifestyle and functional medicine that are not currently covered under Medicare. It is important to clarify that CMS is not establishing a new industry standard through the use of this terminology. The term “whole-person FLM” as used in this NOFO does not represent an attempt by CMS to create, define, or establish any new industry-wide standard, practice guideline(s), or healthcare delivery model beyond the scope of this specific Innovation Center model and funding opportunity. Similarly, through this funding opportunity, CMS is not creating a new category of covered services for Medicare purposes. This term serves solely as a descriptive reference within this document to facilitate clear communication about the non-covered services being tested in this model and should not be interpreted as having any regulatory, coverage, or policy implications beyond the context of this specific Innovation Center model.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 5 https://www.cms.gov/priorities/innovation/innovation-models/maha-elevate https://www.cms.gov/priorities/innovation/innovation-models/maha-elevate

CMS will select a total of up to 30 Recipients to participate in MAHA ELEVATE.

The model will be split into two cohorts, one year apart (years 2026 and 2027).

Approximately $3.3 million in Cooperative Agreement Awards will be available to each selected recipient over a three-year period of performance for a total of up to a $100 million investment.

CMS will select recipients based on five key criteria:

• Whole-person FLM intervention design, including cost savings.

• Beneficiary recruitment and study design.

• Organizational and administrative capacity.

• Data management capabilities.

• Budget.

Highly competitive applicants must demonstrate several important strengths:

• Strong, evidence-based support for your proposed intervention(s) and proof of your own successful history of implementation of the intervention and cost savings.

• Ability to recruit large numbers of participants with a clear randomization plan and advanced data management capabilities.

Given the model’s minimum beneficiary targets and extensive data management requirements, applicants who do not directly provide clinical care are strongly encouraged to form partnerships with care entities or organizations that deliver clinical care. This collaboration helps ensure you can meet the full operational requirements of the program.

Step 1: Review the Opportunity 6

Funding details Funding type: Cooperative agreement, which means that both you and CMS will have roles in the project. Throughout the life of your project, we will be there to help and work with you.

Expected total funding for the program: $100 million, subject to the availability of funds.

Expected total awards: Up to 30

Funding range per applicant for the period of performance: Up to $3.3 million over a three-year performance period.

We will provide funding in up to nine disbursements over a three-year period of performance based on completing the milestones for each payment detailed in Table E: Operational Milestones. We will provide funding in two budget periods of 18 months each over a three-year period of performance.

The three-year period includes six months at the start to help you get ready.

Cohorts We will give out awards in two cohorts, with 15 awards in each cohort, for a total of up to 30 awards. If we give out fewer than 15 in the first cohort, we may give out more than 15 in the second cohort. You may apply to both cohorts. If you are selected in 2026, you can apply again in 2027 for a different intervention or chronic condition.

• The first cohort period of performance will start in October 2026.

• The second cohort period of performance will start in October 2027.

Additionally, three out of the 30 total awards are set aside specifically for programs focused on dementia and cognitive decline.

The two separate application deadlines are:

• Cohort 1: Friday, May 15, 2026 by 11:59 p.m. ET.

If you apply under the first cohort and are not awarded funds, you may apply again during the second cohort using the same application or an updated application.

Step 1: Review the Opportunity 7

Eligibility Eligible applicants Eligible applicants include any organization that meets the requirements outlined in this NOFO. Individuals are not eligible to apply.

Examples of eligible applicants may include, but are not limited to:

• Private medical practices.

• Health systems and Accountable Care Organizations (ACOs).

• Academic organizations.

• Functional, lifestyle, preventive, and integrative medicine centers.

• Community-based organizations (CBOs).

• Federally Qualified Health Centers (FQHCs).

• Rural Health Clinics (RHCs).

• Indian Health Service/Tribal Services/Urban Indian Programs (ITUs).

• Local and state governments.

Organizations spanning multiple states are eligible to apply.

Step 1: Review the Opportunity 8

Other eligibility requirements Organizations in all 50 states, District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands are eligible to apply.

Organizations must have experience integrating whole-person FLM into conventional medical care, resulting in demonstrated improvements in health, quality, and costs.

Requirement Narrative

Organization type CMS seeks to engage a broad range of organizations to promote diversity in testing whole-person FLM approaches.

To be eligible, you must demonstrate clinical oversight capabilities to ensure appropriate care delivery and beneficiary safety. However, as the applicant, you are not required to be a clinical entity. If you are not a clinical entity, but partner with one, you will need to submit a partnership document as described in the application template. CMS may require the submission of additional documentation regarding the partnership after application submission.

Valid TIN, NPI, CCN, or EIN

Your organization must be a legally recognized entity with a valid Tax Identification Number (TIN), National Provider Identifier (NPI), CMS Certification Number (CCN), and/or Employer Identification Number (EIN).

Original Medicare enrollment

We strongly recommend that your organization enroll in Original Medicare before you begin your project.

If you will provide covered Medicare services to patients as part of your overall proposed intervention, you must be enrolled in Medicare by model start.

If you are not enrolled in Medicare, you will need to verify your ability to enroll Medicare beneficiaries in your program through a partnership with a clinical entity or otherwise, as demonstrated by a memorandum of understanding or other partnership document.

Able to recruit beneficiary minimum and sample size

We will determine the minimum number of beneficiaries who must enroll in and complete your intervention. This is known as the minimum beneficiary target and is based on the intervention you propose and the size of the effect on patients that you expect to see. For more information, including some examples of minimum beneficiary targets, please see Appendix A.

Disbursement of some funding under this award will be tied to making progress toward meeting this target.

Step 1: Review the Opportunity 9

Requirement Narrative

CEHRT or other data capabilities

While Certified Electronic Health Record Technology (CEHRT) as defined for certain CMS programs in 42 CFR 414.1305 and 495.4 is not required, you must demonstrate past experience with data collection or the ability to accurately collect and report all required data from patient enrollees in a timely manner. You must demonstrate appropriate data privacy and security protections and an understanding of how to store and analyze data with model goals in mind. In addition, HHS Health IT Alignment requirements for use of health IT standards and certified health IT may apply, depending on health IT activities funded through the cooperative agreement. Please refer to the Grants Policy Statement, Appendix D: Administrative and National Policy Requirements, which describe HHS Health IT Alignment requirements, for further information.

You and your care delivery partners are solely responsible for obtaining any Institutional Review Board (IRB) procedures and approvals and any other permissions that may be required by federal or state law. You must comply with regulations for the protection of human subjects in 45 CFR Part 46 and obtain IRB approval as applicable.

Model overlaps Organizations participating in the Medicare Shared Savings Program are eligible to apply.

Organizations accepted to multiple active CMS Innovation Center models will be assessed for participation on a case-by-case basis.

Insured Your organization must have liability and/or malpractice insurance, as appropriate.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html

Completeness and responsiveness criteria We will review your application to make sure it meets the requirements found in Eligibility, Application contents and format, and Application submission and deadlines.

We won’t consider an application that:

• Is from an organization that doesn’t meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

• Is not submitted through Grants.gov.

The Division of Grants Management director or deputy director may choose to continue the review process for an ineligible application if it is in the best interests of the government to meet the objectives of the program.

Application limits Organizations can submit multiple proposals during the application period and receive multiple awards. However, CMS aims to fund a wide range of applicants for thorough testing. CMS may ask single applicant organizations to combine related proposals into a single, comprehensive proposal.

All applications must independently meet the following criteria:

• Distinct design: Each proposed whole-person FLM program or intervention must be substantively different from other submissions by the same organization and from existing Medicare Fee-For-Service (FFS) models and programs.

• Independent merit: Each proposal must demonstrate individual merit and scientific value worthy of separate testing and evaluation.

Cost sharing This program has no cost-sharing requirement, meaning you do not need to contribute to the costs of this project.

If you choose to include cost-sharing funds, it won’t change the way we score your application. If you receive an award, we will include your voluntary commitment in the award, and you must report on the funding.

Step 1: Review the Opportunity 11

Program description Purpose MAHA ELEVATE will enable small scale tests of the feasibility, impact, and scalability of new interventions in an Original Medicare[1] population. It will provide critical data to inform new coverage determinations or a potential future full-scale model that integrates such services into Original Medicare.

Given the limited evidence that currently exists for whole-person FLM in the Original Medicare population, MAHA ELEVATE aims to strengthen the evidence base through testing innovative health care approaches developed and implemented by a variety of health care organizations nationwide.

Testing small trials of various whole-person FLM interventions (complementing conventional medical care) will generate evidence that may support a larger, more generalizable test or new coverage determinations. It may also build toward transformation of the current health care system from reactive and symptom-focused, to one that emphasizes proactive strategies for chronic disease prevention and upstream disease management.

Lifestyle medicine focuses on preventing and treating chronic disease through evidence-based behavioral changes such as nutrition, physical activity, sleep, stress management, social connection, and avoidance of harmful substances.

Functional medicine uses a systems-based, individualized approach that aims to identify and address the root causes of illness by examining interactions among genetics, environment, and lifestyle.

Over time, we hypothesize that this approach will lead to a healthier population and lower health-care costs.[2]

Throughout this document, the term “intervention” refers to one or more interventions. “Program” refers to the entire project and all its components, while “intervention” refers to the specific services or activities delivered within that program.

Step 1: Review the Opportunity 12

Background Over the last 15 years, the Center for Medicare and Medicaid Innovation (the Innovation Center) has tested alternative payment models with the goal of improving quality and outcomes and/or reducing Medicare spending. The Innovation Center’s new 2025 vision is guided by three interrelated strategic pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition.

Consistent with the Innovation Center’s vision and strategic pillars, MAHA ELEVATE addresses one of the most urgent and costly challenges in American health care: the rising burden of chronic disease. In 2022, about 45% of Medicare beneficiaries had four or more chronic conditions[3], and beneficiaries with chronic conditions accounted for nearly 90% of total health care expenditures[4]. Despite the scale of the problem, care delivery remains largely reactive and focuses on symptom and disease management (secondary and tertiary) rather than identifying and addressing the root causes of illnesses (primary), leading to suboptimal health outcomes and unsustainable spending[5]. Through this model, CMS aims to address the core lifestyle and preventive elements of human behavior that are associated with the development of chronic disease.

Program requirements and expectations Program design Your program will test the idea that whole-person[6] FLM interventions—particularly those that incorporate nutrition and physical activity—can improve patient health and chronic condition management when integrated into daily life and care plans. We expect that prevention and management of chronic conditions will lead to a healthier population and lower health-care costs.[7]

You will identify the chronic condition that you wish to address in the Original Medicare population (also known as Medicare and Medicare Fee-For-Service or FFS). Chronic conditions may range from those requiring ongoing treatment and evaluation to complications or conditions that place a person at low or medium complexity or level of need. This could be a specific diagnosis or a set of persistent, troubling symptoms that have not yet been diagnosed. You may choose to address a set of diagnoses, such as metabolic disorders. You may include people who are at risk of developing the chronic condition but haven’t

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://www.cms.gov/priorities/innovation/about/cms-innovation-center-strategy-make-america-healthy-again https://www.cms.gov/priorities/innovation/about/cms-innovation-center-strategy-make-america-healthy-again yet, and you may determine other inclusion or exclusion criteria.You will also identify the intervention or set of interventions you will use to address your selected chronic condition. The model’s approach is shaped, in part, by insights from the American College of Lifestyle Medicine’s (ACLM) six foundational pillars for the effective prevention and management of chronic conditions, adapted to meet the model’s specific objectives:

• Nutrition—Evidence-based dietary interventions and nutritional counseling.

• Physical activity—Structured exercise programs and movement-based therapies.

• Restorative sleep—Sleep hygiene education and sleep disorder management.

• Stress management—Mindfulness, meditation, and stress reduction techniques.

• Avoidance of risky substances—Tobacco cessation, alcohol moderation, and substance abuse prevention.

• Positive social connections—Community engagement and social support interventions.

Your intervention must align with this framework, but you do not have to have a certification in functional or lifestyle medicine. You must incorporate nutrition[8] or physical activity as part of the program, and you can include any of the other areas if you choose.

We are looking for programs that incorporate whole-person FLM interventions to support, not replace, conventional medical care for a chronic condition. You may include a combination of whole-person FLM and conventional interventions, such as a nutrition intervention paired with support for medication adherence. (Covered services will be billed to Medicare and are not funded by the cooperative agreement.) Your program must include at least one service not covered by Original Medicare and must provide evidence of the intervention’s efficacy for the target population. You must ensure that patients are not harmed by your program, and you must be sure that they maintain choice in their care and treatment plans. You will recruit Original Medicare patients to join your program, and you will measure the impact of your program on those Medicare patients who complete the entire intervention. Although you may be providing services to many types of patients, you may only use the cooperative agreement funds for the portion of the program that serves Original Medicare patients.

Step 1: Review the Opportunity 14

We want to see how your intervention changes the patients’ clinical measures, health care utilization, and health care costs. Therefore, on at least a quarterly basis, you will submit beneficiary rosters which have key information about patients enrolled in the intervention(s) as detailed in Table B, Identifiers of beneficiaries and providers involved in the intervention, and Table C, Documentation of the interventions.

You will also need to collect data on a separate but similar group of eligible and interested patients. The best way to do this is to use randomized enrollment for your Medicare patients so that some receive your whole-person FLM intervention and some receive the conventional standard of care. This allows for the strongest measurement of your program and is what we prefer.

If you can’t randomize your patients, an alternative may be practice-, provider-, or site-level randomization. We can help you further design and implement randomization if needed.

After we receive your application, we can determine exactly how many Original Medicare patients you will need in your treatment group and your comparison group to allow us to measure your program’s impacts. For more details, see Appendix A. Programs with larger numbers of Original Medicare patients will be easier for us to measure, so you may wish to partner with other organizations to increase your potential. Your partners may help refer patients to you, or you may work with other organizations to deliver the FLM intervention to a larger group.

You will need to demonstrate successful experience delivering this intervention and cost savings by showing us your own data (including outcome data). You may show us data from a past or current program that did or did not include Original Medicare patients, and you may use the cooperative agreement to expand it to include Original Medicare as a new population.

Sharing your data allows us to see that you have an existing program and that you are able to collect the data we require.

You will also need to provide published, peer-reviewed evidence demonstrating the safety, efficacy, and cost effectiveness of your proposed intervention. While this evidence is not required to be based on your own work, it should be similar in scope.

Step 1: Review the Opportunity 15

Quality measures and data reporting elements If awarded, you will be required to collect and report patient-level data to CMS for program monitoring and/or evaluation purposes. We will provide technical assistance to help you efficiently collect and report data. You may use part of your funding under this award to collect and submit data to CMS. You are responsible for obtaining any other permissions from patients, your organization, or state/local entities that may be needed to collect, share, or analyze internal data and for complying with any applicable laws and model data policies related to such data collection and sharing. These procedures and approvals must not hinder cooperation with evaluation activities, data collection, or data sharing and submission to CMS or its contractors related to this award.

You must measure either a nutrition or physical activity metric, and a behavioral health metric for all patients receiving your intervention. You must also identify and track at least two clinical measure metrics that are evidence-based, practical, and directly related to your intervention. For example, if you are proposing a nutrition intervention to address weight loss, you may choose to routinely collect patient’s waist circumference and weight.

Step 1: Review the Opportunity 16

Table A below shows the required and optional data you will collect. Beyond the required measures, you can select from the optional domains to measure and track additional data to support your theory of change. We will work with you to finalize your chosen measures if we select your application.

Table A: Quality measures

Category Details

Required measures:

Nutrition or physical activity*

You will choose and track one.

Required measures:

Clinical measures

You will choose and track at least two clinical measures that are relevant, feasible to collect, and related to your intervention.

For example:

Intervention: Nutrition education for weight loss.

Clinical measures:

1. Waist circumference.

2. Weight.

Required measures:

Behavioral health

You will choose and track one.

Required measures:

Patient satisfaction

CMS will develop and track.

Optional measures:

• Sleep.

• Stress management.

• Avoidance of risky substances.

• Positive social connections.

You will choose and track if desired.

*If you choose nutrition or physical activity as a required domain, you may choose the other as optional.

Beginning in the first quarter of Model Year 1, you will be required to participate in monitoring activities that include but are not limited to:

• Submitting quarterly progress reports.

• Engaging with appropriate partners as necessary to develop strategies and draft agreements to link and share data.

• Communicating regularly with a CMS project officer.

Step 1: Review the Opportunity 17

• Regularly attending and participating in learning system events.

• Participating fully in technical assistance activities.

You must collect the following data elements to monitor your progress:

• Medicare identifiers. You must provide Medicare FFS patient and provider identifiers linkable to CMS claims and enrollment data. This is so you can longitudinally track all beneficiaries and providers involved in the intervention and control/comparison groups.

• Control/comparison group data. You are expected to provide data to CMS and its contractors on beneficiaries enrolled in the intervention and for a control or comparison group. We can help you identify the most appropriate control or comparison group based on the structure of the proposed intervention. We can also provide technical assistance related to data submission and reporting requirements.

• Qualitative and additional survey data. During the award, you and your program partners will be required to assist CMS and its contractors with survey and qualitative (interview, site visit, focus group, documents, observational) data collection. Individual Medicare beneficiaries enrolled in the intervention are not required to participate in any specific qualitative data-gathering activity. Data collection activities that may require your cooperation or participation may include:

◦ Arranging and granting interviews.

◦ Helping recruit for focus groups and individual interviews with model-associated staff and beneficiaries.

◦ Allowing and facilitating observations of any model-funded activities and care delivery settings.

◦ Providing documents such as beneficiary education and staff training materials.

◦ Facilitating surveys of staff and/or beneficiaries.

• Other site-level health, utilization, and referral data that are not captured in sources listed in the previous bullets. This may include information on care that patients receive from other providers that you have referred them to as part of the intervention. Such data may include referrals, patient follow-ups on recommended services, and interactions with related partners, organizations, or other data deemed necessary.

• Program documentation. Documents may include training materials, recruitment and educational materials, and other documents that you develop or use during your project.

Tables B through D show the required data elements and reporting frequency.

Step 1: Review the Opportunity 18

Table B: Identifiers of beneficiaries and providers involved in the intervention

Data elements Unit of analysis

Frequency of data reporting (required in bold and marked with asterisk)

Medicare identifiers linkable to CMS claims and enrollment data for beneficiaries (screened and enrolled for the intervention, and for the control/comparison group).

Patient level

• Baseline (if available).

• Pre-implementation (quarterly).

• Implementation (quarterly).*

Medicare identifiers (like TINs or NPIs) linkable to CMS claims data for providers participating in the intervention and control/comparison group (if applicable).

Provider level

• Baseline (if available)

• Pre-implementation (quarterly).

• Year 1 (quarterly).*

• After Year 1 (semiannual).*

Table C: Documentation of the intervention

Data elements Unit of analysis

Frequency of data reporting (required in bold and marked with asterisk)

Duration of beneficiary enrollment in intervention (start and stop dates;

frequency of contact).

Patient level

• Baseline (if available).

• Pre-implementation (quarterly).

• Implementation (quarterly).*

Nutrition and/or physical activity data and results on beneficiaries screened and follow-up data on those enrolled in the intervention as well as beneficiaries assigned to the control or comparison group.

Patient level

• Baseline (if available).

• Pre-implementation (quarterly).

• Year 1 (quarterly).*

• After Year 1 (semiannual).*

Referrals to partners (such as CBOs, fitness centers, nutritionists) or other providers (primary care, specialists) based on screening and assessment data, if applicable.

Patient level

• Year 1 (quarterly).

• After Year 1 (semi-annual).

Step 1: Review the Opportunity 19

Table D: Clinical data reporting

Data elements Unit of analysis

Frequency of data reporting (required in bold and marked with asterisk)

Data on two different clinical measures (such as blood pressure, weight and height, waist circumference, HbA1c levels, cholesterol levels) expected to change due to the intervention for all beneficiaries enrolled in the intervention and for beneficiaries in a control or comparison group.

Patient level

• Baseline (if available).

• Pre-implementation (quarterly).

• Year 1 (quarterly).*

• After year 1 (semiannual).*

All data collection, storage, and reporting must comply with applicable privacy and security laws and model data policies. Please see Data collection and sharing for further information and additional requirements.

Step 1: Review the Opportunity 20

Disbursement timelines for milestones Your cooperative agreement funding operates on a milestone-based system with two main components. The majority of your award—60% —depends on meeting operational milestones by specific deadlines outlined in Table E. You must hit all these targets on time to receive this funding; should an organization miss a milestone, they forego eligibility for all future disbursements.

The remaining 40% is tied to enrolling the minimum numbers of people described in Table F. We built in these critical milestones for recruitment targets to ensure that you make steady progress toward your enrollment goals. However, this portion offers flexibility since you can earn funding as targets are met.

To count toward your beneficiary targets, participants must meet three requirements:

• They must enroll in your program.

• They must be confirmed by CMS as eligible Medicare Fee-For-Service beneficiaries.

• They must complete the entire program.

Any beneficiaries who drop out before completion or cannot be verified by CMS will not count toward your target numbers.

This structure ensures you’re accountable for both operational efficiency and successful patient outcomes. You may use up to six months for pre-implementation activities at the start of the award. For example, you might use this time to build referral networks with partners. After six months, you should start enrolling patients into your program. If you haven’t started enrolling patients by 12 months post-award, your award may be terminated.

You may request that we modify this timeline for your award if, for example, your intervention lasts more than 12 months.

Step 1: Review the Opportunity 21

The following table is based on a $3 million award.

Table E: Operational milestones

Disbursement Percent Milestones

Initial ($1. 2 million) 40% Receipt of Notice of Award

14 months post-award ($150,000)

5% • Submitted 90% or more of beneficiary rosters on time.

• Participated in technical assistance (when applicable).

• Secured CMS IT systems access within six months post-award.

• Submitted TIN/NPI information in recipient portal within 6 months post-award

• Submitted cooperative agreement progress and financial reports.

◦ Enrolled at least 10% of beneficiary target. (Program completion is not required for this milestone.)

20 months post-award ($150,000)

5% • Submitted clinical data on time.

• Submitted 90% or more of beneficiary rosters on time.

• Completed at least 20% of your minimum beneficiary target, meaning they have enrolled and completed the program.*

• Submitted cooperative agreement progress and financial reports.

26 months post-award ($150,000)

5% • Submitted clinical data on time.

◦ Submitted 90% or more of beneficiary rosters on time.

• Submitted information to the evaluation contractor.

• Submitted cooperative agreement progress and financial reports.

32 months post-award ($150,000)

5% • Submitted clinical data on time.

◦ Submitted at least 90% of beneficiary rosters on time.

• Submitted information to the evaluation contractor.

Step 1: Review the Opportunity 22

Disbursement Percent Milestones

• Submitted cooperative agreement progress and financial reports.

• Completed at least 65% of the minimum beneficiary target.**

Total ($1,800,000) 60% • $1.2 million pre-implementation funding

• $600,000 milestone funding

*At 20 months, if you have not reached 20% of your minimum beneficiary target, your award may be terminated.

**At 32 months, if you have not reached 65% of your minimum beneficiary target, your award may be terminated.

Table F: Minimum beneficiary target quartiles

Percent of beneficiary target Percent of funding disbursed

25% 7.5% ($225,000)

50% 12.5% ($375,000)

75% 7.5% ($225,000)

100% 12.5% ($375,000)

Total 40% ($1,200,000)

We will disburse this target quartile funding after you meet each target during the award period. However, you cannot receive a disbursement if you fail to meet the previous operational milestone. For example, if you reach 50% of your beneficiary target at 29 months but you did not submit clinical data for your 26-month operational milestone, you will not receive the operational milestone disbursement nor the beneficiary target disbursement.

Step 1: Review the Opportunity 23

Evaluation CMS, with its evaluation contractor, will conduct a formal and concurrent evaluation of your intervention to assess whether it:

• Improved experience, clinical indicators, and outcomes for Medicare FFS beneficiaries.

• Decreased utilization of emergency department visits, acute care hospitalizations, and unplanned readmissions.

• Optimized spending.

We will investigate the effects of the intervention on patient-level outcomes and changes across the model by analyzing data across similar interventions in your cohort. The evaluation will use multiple sources (such as claims, clinical data you submit, and survey data collected by the evaluation contractor) to cross-verify and ensure that findings are reliable.

This evaluation is expected to cover the entirety of the project period. CMS acknowledges that individual beneficiaries cannot be compelled to participate in the evaluation.

We will evaluate you using the most rigorous evaluation design feasible. We will apply appropriate quantitative and qualitative mixed methods to examine program outcomes and the implementation processes that lead to successes or challenges.

Cooperative agreement terms Cooperative agreements require substantial CMS project involvement after an award is made. There are specific roles for both you and CMS. We may be in contact at least once a month, and more frequently when appropriate.

Your responsibilities

• Comply fully with CMS and any CMS contractors’ efforts to monitor and evaluate your project.

• Comply with the terms and conditions of the award.

• Work closely with CMS project staff to implement and monitor the project, and track its progress.

• Submit the performance measures requested.

• Submit all required performance assessments, evaluations, and financial reports included in the terms and conditions.

Step 1: Review the Opportunity 24

• Attend monthly calls with the CMS project or grants management specialist to discuss your project’s progress and challenges. The meetings will include key personnel and the project officer.

• Participate in any virtual meetings.

Our responsibilities

• Monitor the project’s performance and progress through data collection and reporting.

• Collaborate with you and provide substantial project planning and implementation input.

• Provide substantial input in evaluation activities.

• Provide feedback on your implementation to comply with the award terms and conditions.

• Monitor your performance based on the disbursement milestones and terms and conditions.

• Make recommendations for continuing the project.

• Review and approve marketing and website content before launch and updates.

• Review and approve all key personnel.

• Maintain regular communication with you through at least monthly conference calls along with technical assistance and consultation.

• Review and provide feedback on all required performance assessment reports.

• Review and approve all required submitted data.

• Provide a structured approach to sharing, integrating, and actively applying improvement concepts, tactics, and lessons learned.

Substantial involvement relates to programmatic involvement, not administrative oversight.

Statutory authority General authority to test model:

Section 1115A of the Social Security Act (the Act) (added by Section 3021 of the Affordable Care Act) (42 U.S.C. § 1315a) authorizes the Secretary of the Department of Health and Human Services to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, or CHIP expenditures while preserving or enhancing the quality of care.

Step 1: Review the Opportunity 25

Authority to waive Medicare program requirements:

Section 1115A(d)(1) of the Act authorizes the Secretary to waive such requirements of Titles XI and XVIII of the Act and of sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and certain provisions of section 1934 of the Act as may be necessary solely for purposes of carrying out the testing by the CMS Innovation Center of an innovative payment and service delivery model.

Fraud and abuse waivers and Safe Harbor authority:

Consistent with the authority under section 1115A(d)(1) of the Act, the Secretary may consider issuing waivers of certain fraud and abuse provisions in sections 1128A, 1128B, and 1877 of the Act. No fraud or abuse waivers are being issued in this NOFO; fraud and abuse waivers, if any, would be set forth in separately issued documentation. Any such waiver would apply solely to the individual MAHA ELEVATE recipient and could differ in scope or design from waivers granted for other recipients, programs, or models. MAHA ELEVATE recipients must comply with all applicable laws and regulations, except as explicitly provided in any such separately documented waiver issued pursuant to section 1115A(d)(1) specifically for the MAHA ELEVATE recipient.

In addition to or in lieu of a waiver of certain fraud and abuse provisions in sections 1128A and 1128B of the Act, CMS may determine that the anti-kickback statute safe harbor for CMS-sponsored model arrangements and CMS-sponsored model patient incentives (42 C.F.R. § 1001.952(ii)) is available to protect remuneration exchanged pursuant to certain financial arrangements or patient incentives ultimately permitted under MAHA- ELEVATE cooperative agreements. Any such patient incentives may include limitations on allowable costs. Again, no such determination is being issued in this NOFO. Such determination, if any, would be set forth in documentation separately issued by CMS.

Data collection and sharing:

Under 42 CFR § 403.1110(b), any entity participating in the testing of an Innovation Center model is required to collect and report such information, including “protected health information” as defined at 45 CFR § 160.103, determined necessary to monitor and evaluate the model. The MAHA ELEVATE model will require recipients to collect certain beneficiary-level information on beneficiaries who enroll in the recipient’s program as well as data for a control or comparison group, including identifying information, enrollment start and end dates, and clinical outcomes. Recipients will also be required to submit this data to CMS. The data will be used to monitor and evaluate the model. The recipient will be responsible for securing all appropriate authorizations necessary to collect, store, record, and share

Step 1: Review the Opportunity 26 beneficiary information in accordance with applicable federal, state, and local laws and regulations.

To submit this information to CMS, recipients will use the Health Data Reporting (HDR) tool or other tools developed by the Innovation Center for data collection. CMS is cautious of additional clinician reporting burden and will aim to utilize Innovation Center tools such as automated data pulls from electronic health records as feasible.

The recipient must establish and maintain appropriate administrative, technical, and physical safeguards to protect sensitive patient information, including Protected Health Information (PHI), consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules, 45 CFR Part 160 and Part 164, Subparts A, C, and E, even if the recipient is not a HIPAA covered entity or business associate, as well as comply with other applicable privacy and security requirements. These safeguards must ensure the confidentiality, integrity, and availability of all data collected under this cooperative agreement.

CMS intends to share certain limited individual beneficiary enrollment data with recipients to the extent permitted by law for purposes such as identifying which individuals are eligible to receive services from the recipient’s program.

CMS also intends to share de-identified cost and utilization data with recipients, as applicable. All recipients will receive de-identified total cost of care information and will work with CMS to identify other cost and utilization metrics that are relevant to their programs.

Please note: Any organization that is not a covered entity or business associate of a covered entity under HIPAA must obtain a valid patient authorization that meets the HIPAA authorization requirements set forth in 45 C.F.R. § 164.508 to enable CMS to share any PHI with the applicable organization. The organization will need to receive a completed HIPAA compliant authorization from each prospective patient and submit it to CMS for approval before enrolling the patient in the cooperative agreement program. Failure to do so may result in termination of the cooperative agreement. An organization that is a HIPAA covered entity or business associate may use the same approach involving authorizations or may follow an alternative process to request the CMS enrollment data for their health care operations as set forth in 45 C.F.R. § 164.506(c)(4).

Step 1: Review the Opportunity 27

Funding policies and limitations Changes in HHS regulations As of October 1, 2025, HHS adopted 2 CFR Part 200, with some exceptions included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75.

Limitations We do not allow the following costs:

• Pre-award costs.

• Meeting matching requirements for any other federal funds or local entities.

• Services, equipment, or supports that are the legal responsibility of another party under federal, state, or tribal law, such as vocational rehabilitation or education services.

• Services, equipment, or supports that are the legal responsibility of another party under any civil rights law, such as modifying a workplace or providing accommodations that are obligations under law.

• Goods or services not allocable to the project.

• Supplanting existing state, local, tribal, or private funding of infrastructure or services, such as staff salaries.

• Construction.

• Capital expenditures for improvements to land, buildings, or equipment that materially increase their value or useful life as a direct cost, except with our prior written approval.

• The cost of independent research and development, including their proportionate share of indirect costs. See 2 CFR 300.477.

• Funds related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order.

• Certain telecommunications and video surveillance equipment.

See 2 CFR 200.216.

• Other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government, funding awarded under this NOFO may not be used for:

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 28 https://www.ecfr.gov/current/title-2/part-200 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-C/section-200.216

◦ Paying the salary or expenses of any grant recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before the Congress or any state government, state legislature, or local legislature or legislative body.

◦ Lobbying, but recipients can lobby at their own expense if they can segregate federal funds from other financial resources used for lobbying.

For guidance on some types of costs that we restrict or do not allow, see 2 CFR Part 200 Subpart E—General Provisions for Selected Items of Cost.

Program-specific limitations

• Meals, food, or vouchers for meals or food. Please note: You may use other funding sources to provide food, meals, or vouchers as part of your program. Meals as part of a per diem allowance provided in conjunction with allowable travel are allowable.

• Controlled substances for substance abuse prevention.

• Any Schedule I controlled substances.

• Any substances that cannot legally be marketed as a dietary supplement, including but not limited to kratom and cannabidiol.

• Prescription drugs not approved by the FDA for use in the United States.

• Laboratory tests conducted in laboratories that do not have CMS Clinical Laboratory Improvement Amendments (CLIA) certification.

• Services that are covered by Medicare FFS and can be billed as a claim.

Note: A service that is offered in excess of current Medicare FFS limits or outside the dparameters of a current Medicare coverage determination is considered a non-covered service and may be funded by the cooperative agreement. Services covered by current Medicare coverage may not be funded from the cooperative agreement.

• Services provided to a person who is not enrolled in Original Medicare.

General policies

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 29 https://www.ecfr.gov/current/title-2/part-200/subject-group-ECFRed1f39f9b3d4e72 https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments

• If we receive more funding for this program, we will consider:

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

Indirect costs Indirect costs are those shared across multiple projects and not easily separated. Costs included in the indirect cost pool must not be charged as direct costs.

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. If you currently have an indirect cost rate approved by your cognizant federal agency, you may use that rate.

Method 2 — De minimis rate. If you do not have a negotiated indirect cost rate, you may elect to charge a de minimis rate (see 2 CFR 200.414(f)). This rate is 15% of modified total direct costs (MTDC). See the definition of MTDC (2 CFR 200.1). You can use this rate indefinitely.

Salary rate limitation The salary rate limitation in the current appropriations act applies to this program. As of January 2026, the salary rate limitation is $228,000.

Program income If you earn any money from your award-supported project activities (known as program income), you must use it for the purposes and under the conditions of the award.