Form CMS-10069 Medicare Waiver Demonstration Ajpplication

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

MEDICARE WAIVER
DEMONSTRATION
APPLICATION

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Form CMS-10069

Form Approved
OMB No. 0938-0880

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

MEDICARE WAIVER DEMONSTRATION APPLICANT DATA SHEET
Applicant Legal Name

Date Submitted

Address

Date Received by CMS

City

County

State

ZIP Code

Name, telephone number and address of person to be contacted on matters involving the application.

Descriptive Title of Applicant’s Project

Project Duration (mm/dd/yyyy)
From

To

Proposed Project

Type of Applicant

o Academic Institution
o Not for Profit Organization

o Individual
o Other, please specify

o Profit Organization

Areas Affected by Project (cities, counties, states)

Applicant’s Medicare Provider Number(s)

Applicant’s Employer Identification Number

Is The Applicant a Medicare Provider/Organization in Good Standing?

o Yes

o No

If “No,” attach an explanation

To the best of my knowledge and belief, all data in this application are true and correct, the document has been
duly authorized by the governing body of the applicant and the applicant will comply with the terms and conditions
of the award and applicable Federal requirements if awarded.
Type Name and Title of Authorized Representative

Telephone Number (include area code)

Signature of Authorized Representative

Date Signed (mm/dd/yyyy)

Form CMS-10069

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MEDICARE WAIVER DEMONSTRATION APPLICATION
This application provides an opportunity for eligible organizations to apply to participate in Medicare-waiver-only
demonstrations sponsored by the Centers for Medicare & Medicaid Services (CMS).
CMS conducts Medicare-waiver-only demonstrations to test innovations that have been shown to be successful
in improving access and quality and/or lowering health care costs. These demonstrations may involve new
benefits, fee-for-service or Medicare Advantage payment methodologies, and/or risk sharing arrangements that
are not currently permitted under Medicare statute.
Section 402 of Public Law 92-603 grants CMS the authority to waive Medicare payment and benefit statutes
to conduct these demonstrations. Demonstrations may also be initiated as a result of Congressional mandate.
BUDGET NEUTRALITY
Medicare-waiver-only demonstrations must be budget neutral. Budget neutrality means that the expected costs
under the demonstration cannot be more than the expected costs were the demonstration not to occur. Applicants
must supply information and assumptions supporting budget neutrality that CMS will use in preparing a waiver
package for submission to the President’s Office of Management and Budget (OMB). OMB must approve
Medicare waivers before implementing the demonstration.
DUE DATE
Applications will be considered timely if we receive on or before the due date specified in the “DATES” section
of the demonstration solicitation. Applications must be received by 5 P.M EST/EDT on the due date.
Only applications that are considered "timely" will be reviewed and considered by the technical review panel.
APPLICATION SUBMISSION
An unbound original and 2 copies plus an electronic copy (via email address provided in the solicitation)
must be submitted in a Microsoft Word or PDF format to the following address:
Department of Health and Human Services, Centers for Medicare & Medicaid Services, ATTN: (Insert project
officer name listed in demonstration solicitation and name of demonstration), Seamless Care Models
Group, Center for Medicare and Medicaid Innovation, Mail Stop WB-06-05, 7500 Security Boulevard,
Baltimore, Maryland, 21244.
Applications must be typed for clarity in 12 point font and 1 inch margins and should not exceed 40 double-spaced
pages, exclusive of the cover letter, executive summary, forms, and supporting documentation.
Because of staffing and resource limitations, and because we require an application containing an original signature,
we cannot accept applications by facsimile (FAX) transmission.
FOR FURTHER INFORMATION
Please contact the project officer listed in the demonstration solicitation and/or visit the CMS website at
http://innovation.cms.gov/initiatives/index.html . Additional information about the demonstration, for example, fact
sheets, design reports, solicitations, application materials, press releases, and question and answer documents
will be periodically posted on the website. Be sure to check the website frequently if applying for a
demonstration to be sure you have the most current information available.

Form CMS-10069

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MEDICARE WAIVER DEMONSTRATION APPLICATION
APPLICATION CONTENTS OUTLINE
To facilitate the review process, applications should be arranged in the following order:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Cover Letter
Medicare Waiver Demonstration Applicant Data Sheet
Executive Summary
Problem Statement
Demonstration Design
Organizational Structure & Capabilities
Performance Results
Payment Methodology & Budget Neutrality
Demonstration Implementation Plan
Supplemental Materials

CMS may provide start-up funds to cover implementation costs associated with the demonstration. If startup funding is available, it will be announced in the demonstration solicitation. If requesting start-up funds,
please include the Application for Federal Assistance Standard Forms 424 after the Medicare Waiver
Demonstration Applicant Data Sheet in the application and indicate the amount of funds requested in the
cover letter. The Application for Federal Assistance Standard Forms 424 can be found at
http://www.grants.gov/agencies/approved_standard_forms.jsp
APPLICATION REQUIREMENTS
We will use all the information you submit in the application review process. For specific details regarding the
demonstration for which you are applying, please refer to the solicitation. Your application must include the
following information.
Cover Letter: Please be sure to identify the demonstration, indicate the target population and geographic location
of the demonstration (for example, urban or rural), the CMS provider numbers assigned to the applicant, contact
person, and contact information.
Medicare Waiver Demonstration Applicant Data Sheet: Complete, sign, date, and return the Medicare
Waiver Demonstration Applicant Data Sheet found at the beginning of this application.
Executive Summary: Provide a 4 page summary of the key elements of the proposal (for example, Sections 4,
5, 6, 7, 8, 9 under “Application Contents Outline”).
Problem Statement: Describe Medicare’s current coverage and payment policy, and describe how or why
changes to current policy would lead to reductions in Medicare expenditures or improvements in Medicare
beneficiaries’ access to and/or quality of care. Provide local examples. Describe the policy rationale for the
proposal, who will benefit and why, and any previous experience with the proposed intervention.
Demonstration Design: Describe the intervention including the scope of services covered and/or benefit
design, and payment methodology including financial incentives and/or risk sharing arrangements. Indicate
how eligible beneficiaries will be identified, targeted, and enrolled in the demonstration (if applicable).
If applicable, describe the study design. Identify the intervention and comparison groups, and how Medicare
beneficiaries will be assigned to each group.
Describe the process for notifying beneficiaries about participation in the demonstration and provide copies of
informed consent, and beneficiary notification and communication materials to be used.

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MEDICARE WAIVER DEMONSTRATION APPLICATION
Organizational Structure & Capabilities: Describe your governance structure, and management and clinical
teams, and their prior success in implementing the proposed/similar intervention. Provide an organizational
chart that describes the functional and reporting lines of major departments and/or entities.
Demonstrate that infrastructure exists to implement and carry out the demonstration project. Provide copies of
reports from clinical, financial, and management information systems and describe how they will be used to
support implementation.
Provide copies of applicable Federal and State licenses. Indicate if the applicant is a Medicare provider in good
standing. Describe any other applicable accreditation, credentialing, and/or certification processes and results.
Provide documentation of your organization’s financial viability that will enable it to participate actively and
successfully in the demonstration; for example, a formal audit opinion from the past 3 years or the balance
sheet from the past 3 years with a summary description. If there are any financial concerns, explain how your
organization has resolved or will address these problems.
Performance Results: Describe your systems and processes for monitoring clinical, financial, and operational
performance. Identify key metrics collected, provide quantitative performance results, and describe how you
use this information to continuously improve quality, access and efficiency; correct deficiencies; and satisfy
beneficiaries, providers, and/or payers.
Payment Methodology & Budget Neutrality: Please indicate the proposed payment amount and method.
Proposed payments may be based on Medicare fee-for-service or Medicare Advantage rates, methodologies, or
some combination, and may involve risk sharing.
Describe in detail any risk sharing arrangements. Provide a revenue and expense statement by year for the life
of the demonstration.
Demonstrate that the proposed intervention is budget neutral. Provide expected, best, and worse case scenarios.
Include all supporting cost effectiveness, evidence, and assumptions used for the calculations.
Demonstration Implementation Plan: Describe your implementation strategy, including tasks, resources, and
timeline to implement the demonstration. Identify internal system and process modifications required to implement
the demonstration. Describe your recruitment strategy and contingency plans for achieving beneficiary participation
thresholds. Identify the individuals and staff responsible for implementing the demonstration and attach biographies.
Supplemental Materials: Include in this section copies of supporting materials requested or referenced
throughout the application.
EVALUATION PROCESS
We will convene technical review panels that may include outside experts, in addition to our staff to review all of
the applications. Panelists will receive a copy of the application along with a technical summary. Panelists will be
asked to numerically rate and rank the application using evaluation criteria contained in the demonstration solicitation.
Applicants should review the demonstration solicitation for the specific evaluation criteria to be used by panelists
to assess proposals, as well as additional information on the evaluation process and selection of awardees.

Form CMS-10069

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