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

MAHA ELEVATE Notice of Funding Opportunity

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

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Contents
Before you begin 3
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
Appendices 72
Endnotes 81
Contents 2

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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
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Before you begin 3

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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

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Basic information
Have questions?
Go to Contacts and
Support.
Centers for Medicaid & Medicare Services (CMS)
Center for Medicare and Medicaid Innovation (“CMS Innovation Center”)
Patient Care Models Group (PCMG) Key facts
Opportunity name:
Make America Healthy
Test innovative, evidence-based clinical approaches rooted in
Again – Enhancing
whole-person functional and lifestyle medicine that hold Lifestyle and Evaluating
Value-based Approaches
strong potential for improving health outcomes and reducing
Through Evidence
costs.
Opportunity number:
CMS-2W2-27-001
Assistance listing: 93.460
Summary
NOFO version: Original
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 & Key dates
Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE)
Application submission
Model. This voluntary, three-year service delivery model is designed to test
deadline:
evidence-based, whole-person functional or lifestyle medicine (“whole-person Friday, May 15, 2026
FLM”) approaches to care. Rather than treating diseases separately after they
Required letter of
develop, MAHA ELEVATE takes a proactive, comprehensive approach that
intent deadline:
combines psychological, nutritional, and physical interventions with Friday, April 10, 2026
personalized, lifestyle-based strategies for prevention and early treatment.
Informational webcast:
Thursday, April 2, 2026
Throughout this NOFO, we use the term “whole-person FLM” to represent a
range of services or approaches often incorporated in lifestyle and functional Additional dates may be
medicine that are not currently covered under Medicare. It is important to posted on the MAHA
ELEVATE website.
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 Expected award date:
not represent an attempt by CMS to create, define, or establish any new October 2026
industry-wide standard, practice guideline(s), or healthcare delivery model Expected earliest
beyond the scope of this specific Innovation Center model and funding start date:
opportunity. Similarly, through this funding opportunity, CMS is not creating a October 2026
new category of covered services for Medicare purposes. This term serves See other submissions for
solely as a descriptive reference within this document to facilitate clear other time frames that
communication about the non-covered services being tested in this model and may apply to this NOFO.
should not be interpreted as having any regulatory, coverage, or policy
implications beyond the context of this specific Innovation Center model.
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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.
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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.
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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.
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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, Your organization must be a legally recognized entity with a valid Tax
or EIN Identification Number (TIN), National Provider Identifier (NPI), CMS
Certification Number (CCN), and/or Employer Identification Number (EIN).
Original Medicare We strongly recommend that your organization enroll in Original Medicare
enrollment 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 We will determine the minimum number of beneficiaries who must enroll in
beneficiary minimum and complete your intervention. This is known as the minimum beneficiary
and sample size 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.
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Requirement Narrative
CEHRT or other data While Certified Electronic Health Record Technology (CEHRT) as defined for
capabilities 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.
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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.
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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.
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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
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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.
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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.
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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.
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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: You will choose and track one.
Nutrition or physical activity*
Required measures: You will choose and track at least two clinical measures
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: You will choose and track one.
Behavioral health
Required measures: CMS will develop and track.
Patient satisfaction
Optional measures: You will choose and track if desired.
• Sleep.
*If you choose nutrition or physical activity as a required
• Stress management. domain, you may choose the other as optional.
• Avoidance of risky substances.
• Positive social connections.
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.
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• 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.
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Table B: Identifiers of beneficiaries and providers involved in
the intervention
Frequency of data reporting
Unit of
Data elements (required in bold and marked with
analysis
asterisk)
Medicare identifiers linkable to CMS claims Patient • Baseline (if available).
and enrollment data for beneficiaries level
• Pre-implementation (quarterly).
(screened and enrolled for the intervention,
• Implementation (quarterly).*
and for the control/comparison group).
Medicare identifiers (like TINs or NPIs) Provider • Baseline (if available)
linkable to CMS claims data for providers level
• Pre-implementation (quarterly).
participating in the intervention and
• Year 1 (quarterly).*
control/comparison group (if applicable).
• After Year 1 (semiannual).*
Table C: Documentation of the intervention
Frequency of data reporting
Unit of
Data elements (required in bold and marked with
analysis
asterisk)
Duration of beneficiary enrollment in Patient • Baseline (if available).
intervention (start and stop dates; level
• Pre-implementation (quarterly).
frequency of contact).
• Implementation (quarterly).*
Nutrition and/or physical activity data and Patient • Baseline (if available).
results on beneficiaries screened and level
• Pre-implementation (quarterly).
follow-up data on those enrolled in the
• Year 1 (quarterly).*
intervention as well as beneficiaries
• After Year 1 (semiannual).*
assigned to the control or comparison
group.
Referrals to partners (such as CBOs, fitness Patient • Year 1 (quarterly).
centers, nutritionists) or other providers level
• After Year 1 (semi-annual).
(primary care, specialists) based on
screening and assessment data, if
applicable.
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Table D: Clinical data reporting
Frequency of data reporting
Unit of
Data elements (required in bold and marked with
analysis
asterisk)
Data on two different clinical measures Patient • Baseline (if available).
(such as blood pressure, weight and height, level
• Pre-implementation (quarterly).
waist circumference, HbA1c levels,
• Year 1 (quarterly).*
cholesterol levels) expected to change due
• After year 1 (semiannual).*
to the intervention for all beneficiaries
enrolled in the intervention and for
beneficiaries in a control or comparison
group.
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.
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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.
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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 5% • Submitted 90% or more of beneficiary rosters on time.
($150,000)
• 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 5% • Submitted clinical data on time.
($150,000)
• 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 5% • Submitted clinical data on time.
($150,000) ◦ 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 5% • Submitted clinical data on time.
($150,000) ◦ Submitted at least 90% of beneficiary rosters on
time.
• Submitted information to the evaluation contractor.
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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.
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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.
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• 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.
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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
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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).
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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:
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◦ 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.
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• 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. Find more about program income at 2 CFR 200.307.
Post-award requirements
Before you apply, make sure you understand the requirements that come with
an award.
See Step 6: Learn What Happens After Award for information on regulations
that apply, reporting, and more.
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Step 2:
Get Ready to Apply
In this step
Get registered 32
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Get registered
SAM.gov
You must have an active account with SAM.gov to apply. SAM.gov registration
can take several weeks. Begin that process today.
To register:
• Go to SAM.gov Entity Registration and select Get Started. From the same
page, you can also select the Entity Registration Checklist for the
information you will need to register.
• You must agree to the financial assistance general certifications and
representations [PDF] specifically. Those for contracts are different.
When you register, you will also receive your required Unique Entity Identifier
(UEI).
Once you register:
• You will have to maintain your registration throughout the life of any
award.
• If your organization has multiple UEIs, use the one associated with your
physical location.
Grants.gov
You must also have an active account with Grants.gov. You can see step-by-
step instructions at the Grants.gov Quick Start Guide for Applicants.
Need help? See Contacts and Support.
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Find the application
package
The application package has all the forms you need to apply. You can find it at
this NOFO’s Grants.gov opportunity page.
We recommend that you select the Subscribe button from the View Grant
Opportunity page for this NOFO to get updates.
If you can’t use Grants.gov to download application materials or have other
technical difficulties, including issues with application submission, contact
Grants.gov for assistance.
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Step 3:
Build Your Application
In this step
Application checklist 35
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Application checklist
Make sure that you have everything you need to apply:
Narratives
Component How to upload Page limit
Project summary Use the Project Abstract Summary form. 1 page
Project narrative Use the Project Narrative templates. 15 pages
Budget narrative Use the Budget Narrative Attachment form. 10 pages
Attachments
Insert each in a single Attachments form.
Component Page limit
Indirect cost rate agreement None
Proof of nonprofit status None
Table G: Outcome measures None
Table H: Logic model None
Organizational chart None
Resumes and job descriptions None
Table I: Partnerships and roles None
Partnership documents None
Table J: Program-level data None
Business assessment of applicant organization 12 pages
Peer-reviewed evidence—articles None
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Other required forms
Complete each required form in Grants.gov.
Component Page limit
Application for Federal Assistance (SF-424) None
Budget Information for Non-Construction Programs (SF-424A) None
Project/Performance Site Location None
Disclosure of Lobbying Activities (SF-LLL) None
Application contents
and format
We will provide instructions on how to build your application, including
document formats in the following sections. See completeness and
responsiveness criteria to understand what may disqualify your application
from consideration.
Your organization’s authorized organizational representative (AOR) must
certify and submit your application.
See requirements for Intergovernmental review, if any.
Project summary
Limit to one page. May be single spaced. Follow other formatting
requirements for the project narrative.
Write a one-page summary of your proposed project including its purpose and
outcomes. Do not include any proprietary or confidential information. We will
use this document for information sharing and public information requests if
you get an award. Include:
• The name of your organization.
• The names of any subrecipients or sub-awardee organizations, if
applicable.
• Project goals.
• Total budget amount.
• A description of how you will use funds.
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Project narrative
The project narrative is the most important part of your application and should
clearly describe your proposed project. You must address the proposed goals,
measurable objectives, and milestones in accordance with the instructions in
the following sections.
See the scoring criteria under each section to understand how reviewers will
assess and score your project narrative.
Required format for project narrative
Page limit: 15 pages
Endnotes are not included in the page limit.
File name: Project narrative
File format: PDF
Font size: 12-point font
Footnotes and text in graphics may be 10-point.
Font color: Black
Spacing for project abstract, tables, and footnotes: Single-spaced
Spacing for main content: Double-spaced
Margins: 1-inch
Page size: 8.5 x 11
Include consecutive page numbers throughout.
We recommend you use the four narrative templates attached in Appendix B
or available for download on our website. Do not use the example responses in
your own application. We will not score applications that use the wording in
our examples.
Your project narrative should include the following.
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Template 1:
Whole-person FLM intervention design
Questions Example responses
What is your hypothesis statement? We believe that offering 8 group nutrition counseling
sessions along with a five-tiered fitness program to
Medicare FFS patients with a BMI greater than 26 will lead
to an average reduction of 1-unit HbA1c and 15 lbs in
weight, resulting in long-term Medicare FFS savings of [X]
dollars.
What chronic condition(s) will you We are targeting a range of metabolic disorders, including
target? pre-diabetes, insulin resistance, and diabetes.
What is your proposed intervention The intervention is a weight-loss program that uses healthy
(e.g. what are the services provided)? eating and lifestyle counseling. It includes 22 sessions
(some in person and some virtual) over 6 months.
Participants can also join cooking classes and weight-loss
support groups during the program and for 6 months after
the counseling ends.
How frequently will patients receive The intervention includes 6 meetings over 6 months with a
the services, and over what time registered dietitian who works with primary care providers
period? in a group practice focused on lifestyle medicine. The
dietitian will create a meal plan for each participant based
on their health needs and may recommend other helpful
services, such as weight-loss support groups, cooking
classes, or supplements.
What existing evidence supports the Previous studies show that group nutrition counseling
assumption that your intervention provides both information and accountability to patients,
can create measurable improvements resulting in better adherence to a healthy diet and greater
for your patients? Include citations change in [outcome].
and discuss both:
Note regarding citations: These publications may be your
• Safety: There is no harm to the
own published research or the published research of others.
health or quality of life of Medicare
You will need to submit cited articles in PDFs as
beneficiaries or their communities.
attachments. The reviewers will not be able to consider
The intervention must be safe for
links in reviewing your application. For each cited PDF
the target population.
submitted as an attachment, you must make it easy for
• Effectiveness: Your intervention reviewers to locate your supporting evidence either by A)
directly improves health outcomes, highlighting the relevant text directly in the document OR
such as fewer emergency B) including a written narrative that explains exactly where
department visits, reduced
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Questions Example responses
hospitalizations, or chronic disease to find the supporting information (specific page numbers,
management improvements like sections, paragraphs, tables, or figures).
weight loss, lower HbA1c, or lower
blood pressure). This should
support the clinical measures you
propose.
What outcomes do you expect to Example 1: We expect HbA1c and total cholesterol levels to
change because of your intervention? drop by ___% within 6 months of starting the program. This
estimate is based on pilot data from a similar study using a
Attach a completed copy of Table G:
quasi-experimental design [citation].
Outcome measures.
Example 2: Within one year, we expect total Medicare FFS
Attach a completed copy of Table H:
costs to fall by ___% for all beneficiaries and by ___% for
Logic model.
those with complex chronic conditions. The average
spending for all Medicare FFS beneficiaries is about
$900–$1,000 per month (standard deviation
$1,000–$1,700). For the complex care subgroup, average
monthly costs are about $4,000 (standard deviation
$4,800), based on 2024 practice data.
As part of your Cost Savings Plan, Cost savings plans will be highly individual and dependent
explain how your intervention has the on your available data, so no example is provided.
strong potential to show Medicare
Note: You don’t need to prove cost savings during the three-
FFS savings that exceed the program
year cooperative agreement, but you must show a time
costs based on at least one of the
period when you expect your intervention will reduce health
following:
care spending in Original Medicare if it were covered.
• Financial modeling.
You must include:
• Return on investment analysis.
• Your baseline assumptions (how many Medicare
• Budget impact analysis.
patients have your selected chronic condition, how many
you think will participate and complete the intervention,
and the baseline costs for these patients).
• Your savings assumptions and evidence: the
percentage reduction in costs per patient and the
aggregate savings, and peer-reviewed evidence that
supports your assumptions and calculations, including
evidence from your existing program (attach PDFs
following citation guidelines).
• Your calculated cost of delivering the intervention to
show net savings.
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Questions Example responses
Note regarding citations: These publications may be your
own published research or the published research of others.
You will need to submit cited articles in PDFs as
attachments. The reviewers will not be able to consider
links in reviewing your application. For each cited PDF
submitted as an attachment, you must make it easy for
reviewers to locate your supporting evidence either by:
• Highlighting the relevant text directly in the document,
or
• Including a written narrative that explains exactly where
to find the supporting information (specific page
numbers, sections, paragraphs, tables, or figures).
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Scoring criteria (Template 1)
Criteria Points (Maximum = 45)
Interventions and outcomes: Clear link between the intervention, 10
population/condition, and expected outcomes.
Approach: The intervention takes a whole-person FLM approach 10
and includes nutrition and/or physical activity.
Cost savings plan: Savings plan demonstrates reasonable 10
expectation of generating savings in Original Medicare over time.
Description of evidence base: The attached publications provide 15
rigorous evidence demonstrating the intervention’s patient safety
and effectiveness scored by the following.
Strength and quality of study design (6 out 15 total points)
• Randomized designs are the strongest designs and will
receive the highest scores. If cohort research studies are
submitted, they must:
◦ Robustly account for confounding variables.
◦ Control for and limit selection bias.
◦ Have clear rules for who was included in the program and
avoid specially selecting patients who are more likely to
succeed.
Sample size (5 out of 15 total points)
• Preference will be given to studies of over 1,000 individuals
with demographics similar to Medicare beneficiaries (see
Appendix A for more details).
Direction and magnitude of effect (4 out of 15 total points)
• Study results should demonstrate improved clinical
outcomes, quality of care, and cost savings among individuals
with characteristics of Medicare beneficiaries. Larger,
clinically meaningful effects are preferred over statistically
significant effects (see Appendix A for more details).
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Template 2:
Beneficiary recruitment and study design
Questions Example responses
Who is your target population? Example 1: Medicare FFS beneficiaries with diet-sensitive
conditions (such as heart failure or chronic kidney disease)
Describe the criteria for determining
who were recently hospitalized. We will identify Medicare
whether a patient is eligible for the
FFS patients with diagnosis codes [list of ICD-10 codes] who
intervention, including tools, clinical
were hospitalized within the last 12 months.
indicators, and other factors you will
use to screen patients. Example 2: Medicare Fee-for-Service (FFS) beneficiaries
with uncontrolled diabetes who want to lose 10 pounds and
have struggled to lose weight in the past. We will use our
electronic health record to identify Medicare FFS patients
with a most recent HbA1c greater than 8% whose BMI is
greater than 26. We will then administer a 5-question
survey to those patients to assess their desire to lose
weight, their previous strategies to lose weight, and their
willingness to join our program.
How many beneficiaries do you Example 1: In a previous program, we screened 1,000
expect to screen, find eligible, and commercial patients; 500 (50%) were eligible, and 250
enroll? (25%) enrolled. We expect similar results among Medicare
beneficiaries through our primary care practice, which
Please include:
serves about 10,000 patients. Of these, 4,800 are age 65 or
• What these estimates are based
older and have Medicare FFS.
on.
Example 2: Last year, 100 people joined yoga classes each
• How many patients are currently
month at the local YMCA, and we believe about half were
served by your providers or
over 65. Although we don’t know how many have Medicare
organization.
FFS, most were overweight or obese and had chronic pain
Note: CMS will use your responses to or other health conditions. We plan to partner with 25
determine a minimum beneficiary additional YMCAs to expand participation. We aim to enroll
target for your program. See about 15,000 older adults each year, expecting 9,000 of
Appendix A for more information. them to have Medicare FFS. We will use rolling enrollment,
marketing, and provider referrals to increase participation
over time.
Provide the following information • Our recruitment area is within a 50 mile radius of
about your plan to recruit for the Baltimore City including three counties: Anne Arundel,
program: Baltimore, and Calvert counties. Referrals will come
from our network of 50 PCPs, 15 endocrinologists, and
• Service area (counties, cities,
10 nephrologists within our health system. Patients must
regions).
have at least one qualifying health condition and
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Questions Example responses
• Health care providers who will demonstrate willingness to participate in our program.
refer patients and limit on referrals We will use HbA1c and FPG clinical tests and a program
or services. interest survey to identify patients and assess their
needs.
• How you will assess patient needs.
• We plan to enroll 750 patients by September 1, 2027. If
• Your specific dates for reaching
enrollment is slow, we will expand our recruitment area
enrollment goals and backup plan
to include 3 more counties (Harford, Howard, and Cecil)
if enrollment is slower than
and increase our network within the health system. We
expected.
will provide education about our program and training
• How will you reach patients who
for our screening survey to all practices included.
haven’t used your program or
• Patients will receive a health system branded diet
similar services before.
tracker notebook and a T-shirt. We will maintain
• Strategies to keep people engaged
engagement through virtual and in-person check-in and
and prevent dropouts.
peer support groups.
• Anything you will offer to patients
• Our program served a mixed population (Medicare FFS,
to encourage participation
Medicaid, and Commercial) of 4,000 over the past 4
(rewards, health tools, etc.).
years and closely mirrors the Medicare FFS population.
• Based on your own past
Around 50% of our patients are over 65 and live in the
experience, why would you say
urban and surrounding communities. Our patients have
your enrollment goals are realistic?
similar rates of diabetes (XY%) and obesity (XY%) as the
• How does the population you national Medicare population. This similarity implies that
deliver(ed) your intervention to our intervention results could be expanded to other
reflect or represent the broader Medicare FFS beneficiaries across the country.
Medicare FFS population?
Please describe whether you will use • We plan to use a randomized design. Eligible patients
randomization and, if so, how. will be assigned to either the treatment or control group
for 12 months. Both groups will be discharged after 12
If using randomization:
months. We will use rolling enrollment to increase
• What type of randomization will
sample size, meaning patients may start at different
you use? E.g., patient-level,
times during the study period.
provider-level, site-level?
• Beneficiaries with diet-sensitive conditions (such as
• How will you assign patients to the
heart failure or chronic kidney disease) will be offered
intervention or control groups?
the intervention and enrolled for 6 months. A similar
provider practice within the same network will serve as
Will you use Medicare FFS enrollment
the comparison group. Both practices will screen
and claims data to create these
patients using the same criteria to ensure the groups are
similar. Patients in the comparison group will receive
standard care but not the intervention. This will help
create a strong comparison between groups of similar
patients.
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Questions Example responses
groups? If yes, how? If no, describe
the challenges to using these data.
• Will the control group receive any
part of the intervention, and if so,
when?
If randomization is not possible:
• How will you create a valid
comparison group?
• Can you use Medicare FFS
enrollment and claims data to build
that group?
• What comparison data will you
report to CMS?
• Will the comparison group be
exposed to any part of the
intervention?
Also describe whether all participants
will start the intervention at the same
time or if enrollment will happen on a
rolling basis.
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Scoring criteria (Template 2)
Criteria Points (Maximum = 20)
Beneficiary recruitment plan: You have a feasible plan to enroll 10
and retain enough patients:
• 200% or more of the minimum beneficiary target: 10 points.
• 150 to 199% of the minimum beneficiary target: 9 points.
• 125 to 149% of the minimum beneficiary target: 8 points.
• 100 to 124% of the minimum beneficiary target: 7 points.
• 90 to 99% of the minimum beneficiary target: 6 points.
• 80 to 89% of the minimum beneficiary target: 5 points.
• Less than 80%: 0 points.
Study Design: Your study design meets one of the following: 10
• Achievable randomization plan: 10 of 10 points.
• Randomized delayed enrollment for some patients to create a
control group: 8 of 10 points.
• Other plans to create a comparison group: 4 to 7 of 10 points.
• No randomization or comparison group: 0 of 10 points.
As part of its implementation contract, CMS or its contractor may
support study design improvements for otherwise promising
applications. NOTE: Any applicant that does not ultimately put
forward a plan to randomize or construct a comparison group
will not be selected for an award.
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Template 3:
Organization, administration, and capacity
Questions Example responses
Please describe your organization, Health Organization Inc, started as a private primary care
including any relevant background practice in Baltimore, MD and joined The Hospital System in
information. 2015. We serve more than 10,000 patients across 6
Maryland Counties and Baltimore City. Our leadership
Attach an organizational chart that
consists of:
names the Authorized Organizational
• Chief Executive Officer: [Name, Credentials]
Representative and identifies lines of
authority. • Chief Medical Officer: [Name, Credentials]
• Chief Financial Officer: [Name, Credentials]
Attach CVs or resumes of key
personnel. • Chief Compliance Officer: [Name, Credentials]
We maintain full compliance with HIPAA privacy and
security requirements as well as CMS enrollment,
participation, and quality reporting standards. Our formal
organizational charts, resumes, CVs, and professional
credentials are provided as attachments to demonstrate our
team’s qualifications.
List the name(s) and title(s) of [Name, Credentials] is our Chief Compliance officer and will
individual(s) responsible for ensuring be responsible for ensuring compliance with federal, state,
compliance with federal, state, and and local laws.
local laws.
Will you work with partner • Health Organization Inc. has successfully partnered with
organizations? a local physical therapy and massage clinic for three
years resulting in improved patient outcomes for chronic
If yes, briefly describe how you will
pain management and a 40% reduction in opioid
work with partner organizations for
prescriptions.
this program.
• Health Organization Inc. has experience with a two-year
• What is your past experience
pilot program with Mental Health Counseling practice
working with similar organizations?
achieving a 65% improvement in patient reported
• Attach a completed Table I:
anxiety and depression scores.
Partnership table.
Please see the attached partnership table detailing roles,
• Attach partnership documents,
responsibilities, and resource commitments. Also attached
such as contracts or memoranda of
are the memorandum(s) of understanding or agreement(s)
understanding.
and organizational charts showing partnership integration
points.
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Questions Example responses
Note: Ensure any required partner
costs are included in your budget and
budget narrative.
What is your prior experience in the Health Organization Inc. has implemented nutrition
implementation of the proposed education interventions for weight management over the
intervention? (It may have been in a past 6 years beginning with a pilot study in 2020 that
pilot study, less rigorous study served 150 patients with diabetes and obesity. Our
design, or a non-Medicare comprehensive approach combined group nutrition
population.) education classes and 15-minute individual nutrition
counseling sessions plus ongoing support via telehealth
• What challenges did you face, and
and secure group chat. Initially we focused on non-
how did you overcome them?
Medicare population of working adults aged 35-64 with
• Please summarize data (qualitative
BMI >30 and at least one comorbidity. The program evolved
and quantitative) that shows the
into a full-scale intervention serving over 800 patients
impact of your prior interventions
annually including Medicare beneficiaries.
on utilization, quality and cost of
• Challenge 1: Patient engagement and retention- initial
care, and patient experience.
dropout rate was 35% after first month
• How was the work managed?
◦ Solution: Incorporated evening and weekend
schedule sessions and peer support group that
increased retention to 78%
• Challenge 2: Physicians did not make sufficient nutrition
referrals due to busy schedules
◦ Solution: Used EHR data to identify diabetic patients
with high BMI, flagged their upcoming appointments,
and implemented a screening workflow where office
staff assessed patients and facilitated physician
referrals during visits.
Quantitative outcomes:
• Average weight loss: 8.2% of starting weight.
• HbA1c reduction: 0.9% among diabetics.
• Decrease in waist circumference: 59% saw > 3 inch
decrease.
• Healthcare utilization: EDU down 23%.
Qualitative outcomes:
• Patient satisfaction scores: 4.6/5 average rating.
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Questions Example responses
• 89% patients reported improved confidence in meal
planning.
• 56% maintained dietary changes and weight loss at 6
months after-program follow-up.
The intervention utilized a collaborative team approach with
our program director [Name, Credentials] who is a
registered dietician, clinical team of 2 certified nutritionists
and 2 community health workers, a program coordinator,
and a student volunteer who helped with screening and
analytics. We had monthly case reviews, situational
debriefs, quarterly outcome assessments, team training
events, and annual third-party patient experience vendor.
We receive technical support from our EHR vendor and
track data, schedule appointments, and communicate via
our EHR. Finally, we hold regular stakeholder meetings with
primary care providers and other committee members to
ensure program alignment with goals and continuous
quality improvement.
What is your experience conducting We have never sought approval from an institutional review
ethical, patient-centered data board. Our hospital system worked with [academic
collection that included the use of institution] on recruiting patients for an NIH-funded grant.
institutional review boards?
What coverage have you obtained for Two of our state Medicaid managed care organizations,
this intervention from any national or [Name 1] and [Name 2] cover four sessions of our nutrition
regional payer(s)? counseling for adults age 21+ if they have diabetes,
prediabetes, or a BMI over 30. They do not cover the virtual
Note: This would not include a
exercise group sessions.
company that covers its own product
or service for its own employees and/
or family members.
List any CMS models in which you are • Several primary care practices within our ACO were part
participating now or have in the past, of CPC and CPC+. Some of our providers are now
regardless of whether they included participating in GUIDE.
functional or lifestyle medicine.
Participation in other models will not
affect your score, but we will
determine overlaps policies for
organizations that are seeking to
participate in multiple models.
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Scoring criteria (Template 3)
Criteria Points (Maximum = 15)
Key personnel: Organization and key personnel are qualified to 5
deliver the intervention as described in the organization,
administration, and capacity plan. Resumes are provided.
Prior experience and capabilities: Organization has extensive 10
experience delivering and measuring the intervention and
describes resources required to deliver intervention.
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Data Management Plan
Description of data reporting plan
Please refer to additional details about data collection and reporting included
in the quality measures and data reporting section when writing responses to
the items below.
Questions Example Responses
What experience do you have Our CEHRT electronic health record can produce
collecting and reporting beneficiary- configurable reports, including patient identifiers and
level data to CMS? clinical measures. We have previously reported similar data
to CMS when we were part of Making Care Primary via
If none, what capabilities do you have
QRDA.
to do so?
How will you collect patient and We will use our electronic health record to produce reports
provider information for submission on both our enrolled treatment patients and our delayed-
to CMS? start control group patients. We have a vendor, [name], that
configures specialized reports from our EHR that we can
• Include any partnerships or
use for report submission.
affiliations that may assist with
data collection and submission.
What prior experience do you have Our yoga studio uses [name] software to track membership
collecting and securely storing information, including PII such as names, addresses, phone
protected health information (PHI) numbers, emergency contacts, and billing information. All
and personally identifiable of this is securely stored according to [vendor standards],
information (PII)? particularly because it includes stored credit card
information. We also offer a dashboard where members can
track their fitness goals, including PHI such as weight,
blood pressure, and self-reported mood. The dashboard is
managed by [vendor] who uses [safety standards], including
two-step identify verification to log in.
What experience do you have in Yoga center members who set specific weight loss goals
collecting and documenting your can currently have an instructor or coach measure their
chosen clinical, cost, and utilization weight on a digital scale and their waist circumference in
measures? centimeters and then log it into the dashboard. We have
been offering this option since 2018. We do not have
experience measuring cost or utilization directly.
How will you monitor for any We will use a screening tool to ask enrollees if they have
potential harmful effects from the any health conditions, such as hypertension, joint problems,
intervention? How will you mitigate cardiovascular disease, etc. We will ask enrollees to reach
or avoid harm? out to their primary care physician before starting our
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