Health Care Innovation Awards Frequently Asked Questions

**Disclaimer**: The frequently asked questions below are only applicable to the Health Care Innovation Awards awarded in 2012.

Health Care Innovation Awards Overview

What kinds of project proposals will the Health Care Innovation Awards Fund?

Project proposals should be focused on innovative approaches to improving health and lowering costs for high risk/high opportunity populations, including Medicare, Medicaid, and CHIP beneficiaries. Projects should propose using a service delivery/payment innovation that produces outcomes of better health, better care, and lower costs through continuous improvement. Further, projects may identify and test new ways to promote the development of a workforce of the future capable of delivering and supporting new care models.

While certain infrastructure innovation may also be included in a project proposal, the Health Care Innovation Awards will not fund specific components, devices, equipment, or personnel that are not integrated into the entire service delivery and payment model proposal. For example, clinical trials or research and development of drugs/devices would not meet the aims of the initiative. Free-standing training programs, without a direct relationship to service delivery/payment models would also fail to meet the aims of the initiative.

For more information about the types of project proposals the Health Care Innovation Awards is soliciting, please refer to the Funding Opportunity Announcement, Program Requirements section (pg.4-6) and the Funding Restrictions section (pg. 24-25).

Letter of Intent and Application Process

When is the Letter of Intent due?

For the first round of funding, the mandatory, non-binding Letter of Intent (LOI) is due by 11:59EST on Monday December 19, 2011.

Will CMS provide feedback on Letters of Intent?

No. Organizations submitting LOIs will receive an automated receipt notification confirming the date and time of submission. CMS is not able to provide feedback on individual LOIs. For specific questions on eligibility and program requirements, please reference the Funding Opportunity Announcement (FOA) and frequently asked questions for further clarification.

Where in the application should the Letter of Intent confirmation number be included?

Applicants should enter their LOI confirmation number into Box 4 "Applicant Identifier" of the SF-424 Application for Federal Assistance.

What are acceptable file formats for application attachments on grants.gov?

Any files uploaded or attached to the Grants.gov application must be of the following file formats and must contain a valid file format extension in the filename - Microsoft Word, Excel or PowerPoint, Corel WordPerfect, ASCII Text, Adobe PDF, or image formats (JPG, GIF, TIFF, or BMP only). Files containing password protection will not be accepted for processing and will be excluded from the application during the review process. The use of compressed file formats such as ZIP or RAR will not be accepted. The application must be submitted in a file format that can easily be copied and read by reviewers. It is recommended that scanned copies not be submitted through Grants.gov unless the applicant confirms the clarity of the documents. Pages cannot be reduced resulting in multiple pages on a single sheet to avoid exceeding the page limitation. All documents that do not conform to the above will be excluded from the application during the review process.

Do applicants need to have a CCR number in place before submitting a Letter of Intent?

The Health Care Innovation Awards application must be submitted through grants.gov. A Central Contracting Registration (CCR) and Data Universal Numbering System (DUNS) number will be required to complete the application process. For more information about the application process through grants.gov, the CCR, and/or DUNS number, please refer to the FOA pg. 12-13.

It is not necessary to include a CCR number when submitting a Letter of Intent; however CMS encourages all organizations to register in the CCR and obtain a DUNS number as soon as possible. Organizations must have a CCR and DUNS number in place in order to submit an application. CMS recommends allowing at least two weeks to complete the grants.gov application process.

If an organization is interested in applying for the second cycle of funding in August 2012, are they still required to submit an LOI by December 19, 2011?

No. The second round of awards is subject to the availability of remaining funds (if any) after CMS makes the first round of awards. CMS will announce Letter of Intent and application deadlines for the second funding cycle later in 2012, organizations interested in applying for the second cycle need not submit an LOI by December 19, 2011.

Can a potential applicant submit an LOI for the second round of funding under the Innovation Awards?

The December 19th deadline for non-binding LOIs for the Health Care Innovation Awards is intended for the first round of funding only. The second round of cooperative agreements would be awarded in August 2012 and would include as much of the remaining funding (if any) as the second round of applications warrant. CMS expects to release more information about the second round 2 of applications by April 2012.

Can potential applicants change the scope and other details of their proposed project between their Letter of Intent submission and their application for the Innovation Awards?

Yes. The Letter of Intent (LOI) is required to submit an application for the Innovation Awards; however, applicants are free to make changes between submission of the LOI and application. Please note that CMS will not provide feedback on proposed projects described in the LOI. Applicants may switch the lead organization and/or partner organizations proposed in the LOI, assuming all organizations are in agreement and working in partnership with one another. In the event changes to the proposal are made after the LOI submission, it is not necessary to update the LOI information; applications should include the most up-to-date original LOI confirmation number received upon submission.

Are proposals not selected during the first round of awards eligible to reapply for the second round?

Yes, such applicants are eligible to submit an application for the second round of funding under the Health Care Innovation Awards, if available.

If a proposal includes subcontracts to other institutions, do their documents count in the 40 page limit?

Applications must not be more than 40 pages in length which includes the project abstract, project and budget narratives, and the financial plan. Supporting materials are limited to 30 pages in length. These supporting materials include documentation related to financial projections, profiles of participating organizations, relevant letters of endorsement, etc. Standard forms described on Section IV.2.B. of the FOA are not included in this page limit. For more information, see Section IV.2.A., Content and Form of Application Submission of the FOA. These page limits apply to each application, regardless of the number of organizations that may be involved in the proposal.

Are letters of endorsement required for all subcontract sites?

Letters of endorsement are not required; however it is up to the applicant's discretion whether to include relevant endorsements in support of their proposal. Endorsements should be enclosed with the application and count toward 70 page total limit for the application. The endorsement should be signed by a person who is empowered to bind the endorsing organization if it will become a subcontractor.

Is each site Program Director required to submit a CV/biosketch?

The CV/biosketch of the proposed project director is required, but it is up to the applicant to provide additional evidence of the skill of the proposed staff to successfully carry out the project in a manner that it chooses. While no specific format is required from the CV/biosketch, applicants are encouraged to be concise in describing staff qualifications as this documentation counts toward the 70 page total limit for the application.

Where in the application should references be included?

That is up to the applicant. Applicants may include references in appendix or in the text of the proposal. References count toward the 70 page limit for the complete application.

Where in the application should the Abstract and Cover Letter be included?

NOTE: This guidance has been revised in response to confusion about the requirements stated in the FOA. This notice serves only to clarify the language found in the FOA and does not alter the preexisting requirements.]

The Cover Letter should be uploaded as part of the "Project Narrative Attachment Form." The Project Abstract (one page, single-spaced) may be uploaded separately under "Optional Documents" and should be titled "Project Abstract". ** CMS The cover letter and abstract do not count toward the 40-page limit.

Do the required standard forms count toward the application page limit?

No. Specific information regarding the form of application submission can be found in Section 2. "Content and Form of Application Submission" beginning on page 17 of the FOA (PDF).

Will CMS notify LOI submitters of their eligibility to submit an application for the Innovation Awards?

No. All applicants having met the December 19, 2011 deadline for submitting the mandatory, non-binding LOI are eligible to submit an application through grants.gov. Applicants who submitted their LOI(s) electronically using the online form should have received a randomly generated confirmation number upon submission. LOI submitters may have received a confirmation email; however this email is not necessary so long as a confirmation number was generated. Please retain your final LOI confirmation number for your records. The LOI confirmation number is required for application submission.

Is the SF-LLL Disclosure of Lobbying Activities Form required of all applicants?

Yes. The SF-LLL is required regardless of lobbying activity, if needed mark "not applicable" where asked to identify registered lobbyists.

Applicant Eligibility

Who is eligible to apply for the Health Care Innovation Awards?

Both not-for-profit and for profit organizations that are recognized as a single legal entity by the State in which it is incorporated are eligible to apply. The organization must have a unique tax identification number (TIN) and a governing body that may enter into a cooperative agreement with CMS.

Are there limitations on the ability of participants in existing Innovation Center initiatives or demonstrations to apply for and receive awards from the Innovation Awards?

All participants in existing Innovation Center initiatives or demonstrations are eligible to apply. However, the Innovation Center will not award grants to participants in existing Innovation Center initiatives or demonstrations that simply propose expanded funding for existing contracts or projects. The purpose of the Innovation Awards is to support innovations beyond those which have already been funded. An existing participant in Innovation Center initiatives or demonstrations may submit an innovative proposal in keeping with the objectives of the Innovation Challenge, and it will be evaluated according to the criteria and weighting described in the FOA.

Can an organization with one Tax Identification Number submit multiple applications and/or receive multiple awards from the Innovation Awards?

Yes.

Can States or other governments apply for the Health Care Innovation Awards?

[Note: This has been changed to clarify an earlier response, please refer to the FAQ below for more information.] Neither States nor any State agency or instrumentality of a State may apply for the Health Care Innovation Awards. By "State" we refer to the definition provided under 45 CFR 74.2 as "any of the several States of the U.S., the District of Columbia, the Commonwealth of Puerto Rico, (or) any territory or possession of the U.S." By territory or possession, we mean Guam, the U.S. Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands. Local governments within States may apply. Tribal governments may apply. Foreign governments, and entities within foreign countries may not apply.

Can state organizations apply to the Innovation Awards such as state hospitals or from state universities?

CMS will consider applications from State operated providers such as State hospitals that treat Medicaid, Medicare and/or CHIP beneficiaries. The applicant should make the case that the project, if funded, would not simply supplant State funding already provided to the institution. Similarly, CMS will consider applications from providers associated with state universities such as hospitals owned by a State university system or from universities owned by a State. *Note: for the purposes of this initiative, organizations that may be defined as State instrumentalities such as hospitals or universities are eligible to apply and receive awards; however, State governmental agencies and offices are not eligible to apply as prime awardees. For more information about possible roles for States and State agencies, please refer to the FAQ discussing State partnership opportunities.

In what capacity can States partner with applicants?

States may partner with other applicants to facilitate the design and implementation of a Health Care Innovation Awards proposal and to help to coordinate the implementation and operation of a project. For example, State personnel may become members of governing boards or advisory groups. However, States, State agencies and State programs cannot be funded through the Health Care Innovation Awards, either directly or indirectly. Therefore, States can be part of an application proposal as facilitator-conveners or advisors. For more information about the facilitator-convener role, please refer to the FAQ about the role of conveners.

What role can a convener organization play?

Applicants acting in the role as a convener can serve as "facilitator-conveners" or as "awardee-conveners."

  • Facilitator-conveners: could serve an administrative and technical assistance function for one or more entities described in the application. Facilitator-conveners can be part of an application, but will not be the direct-awardee applicant. In this arrangement, the facilitator convener would not receive any payment from CMS. The facilitator convener could share in the financial risk or cost savings from increased efficiencies experienced by designated awardee(s) through contracts between the convener and the awardee(s). No financial arrangements made among providers and other entities (including States) in connection with this program can be used to increase federal Medicaid matching funds.
  • Awardee-conveners: could serve as all the functions a facilitator convener could, but would be directly responsible for receiving and when appropriate, distributing funds among various entities in a proposed project. States and State offices and agencies are not eligible to serve as awardee-conveners.

Applications from conveners that foster the participation of a variety of Medicare, Medicaid, and/or CHIP beneficiaries, providers, payers, and other appropriate organizations in a consistent, organized and synergistic partnership, may be considered favorably.

Are other federal agencies eligible as conveners?

No, other Federal agencies cannot act as a convener for applicants.

Are other entities such as universities, community colleges, or 501(c)3 tax exempt organizations eligible to apply?

Yes, all these entities that have a unique tax identification number and a governing body are eligible to apply except for States.

May freely associated states such as Micronesia apply?

No, these states are foreign nations and are not eligible.

Are VA or DOD owned hospitals eligible to receive awards from the Innovation Awards?

VA or DOD owned hospitals and other Federal Governemnt departments can be partners in a proposed project; however, no hospitals and other providers owned by other U.S. Federal Government departments are eligible for Innovation Awards grant funding from CMS.

Is the District of Columbia eligible to apply?

For the purposes of this initiative the District of Columbia (D.C.) is considered a state. Like all other states, neither the D.C. government nor a D.C. government agency is eligible to apply as a direct awardee.

Is a national organization eligible to receive a direct award?

National organizations may apply if they meet the other requirements stated in the FOA.

Can medical societies or trade associations apply as a prime awardee?

Yes, they may apply if they meet the other requirements stated in the FOA.

Are Hospital Engagement Contractors (HECs) participating with the Partnership for Patients eligible to apply?

Partnership for Patients HECs may apply for the Innovation Awards. However, the proposed Innovation Awards project must be new, not simply a request to augment existing support and funding through the Partnership for Patients.

Can an organization submitting an application for the Innovation Awards respond to a future Request for Proposals (RFP) to provide operational support for the Health Care Innovation Awards?

Organizations who apply for funding under this FOA may respond to RFPs to support the awardee of this initiative (i.e. as an implementation, evaluation or technical assistance contractor). However conflicts of interest will be carefully considered in the contracting process.

Project Eligibility and Scope

Can Health Care Innovation Awards Funds be used for construction, renovations or other capital improvements?

The Department of Health and Human Services' Awarding Agency Grants Administration Manual (AAGAM), established by decisions of the Comptroller General, prohibits the use of funds to make permanent improvements to property not owned by the federal government, 71 Comp. Gen. 4 (1991), 47 Comp. Gen. 61 (1967) and 42 Comp. Gen. 480 (1961), as well as the purpose statute, 31 U.S.C. 1301(a).

Except for minor alteration and renovation (see below), an award recipient may not acquire a building or land, purchase a trailer or modular unit that will be used as real property, construct a new building, or modernize an existing building using award funds.

Minor alteration and renovation projects are permissible, if and only if, the work required is incidental to the purpose of the project and is required to use the space more effectively in order to meet program needs. Costs for a single minor alteration and renovation project may not exceed the lesser of $150,000 or 25% of the total direct costs to be awarded. Alteration and renovation of real property generally is defined as work required to change the interior arrangements or installed equipment in an existing facility so that it may be more effectively utilized for its currently designated purpose or be adapted for an alternative use to meet a programmatic requirement. Minor alterations and renovation may include activities (and related costs) that will result in:

  • Changes to physical characteristics (interior dimensions, surfaces, and finishes); internal environments (temperature, humidity, ventilation, and acoustics); or utility services (plumbing, electricity, gas, vacuum, and other laboratory fittings);
  • Installation of fixed equipment (including casework, fume hoods, large autoclaves, biological safety cabinets);
  • Replacement, removal, or reconfiguration of interior non-load bearing walls, doors, frames, or windows in order to place equipment in a permanent location;
  • Making unfinished shell space suitable for purposes other than human occupancy, such as storage of pharmaceuticals; or
  • Alterations to meet requirements for accessibility by physically disabled individuals.

In addition, if awarded, there will be specific pre-approval documentation requirements prior to commencing minor alteration and renovation.

Can a project proposal under the Innovation Awards target populations other than Medicare, Medicaid, or CHIP beneficiaries?

The Affordable Care Act established the Innovation Center to test innovative payment and service delivery models to reduce Medicare, Medicaid, and/or CHIP expenditures while preserving or enhancing the quality of care. Thus, successful Innovation Awards applicants will propose interventions that include one or more of those groups (Medicare, Medicaid, and/or CHIP) as their target population. However, applicants that propose interventions that positively impact other populations through quality improvement or lower costs, in addition to Medicare, Medicaid, and/or CHIP, are welcome to apply.

How many Medicare, Medicaid and/or CHIP beneficiaries should models propose to target if the proposed project directly or indirectly improves the quality of care and lowers costs for an additional population?

No specific amount or percentage of Medicare, Medicaid and/or CHIP beneficiaries are required for proposed projects to include. However, the project should be designed so interventions contribute to improving the health and lower the total cost of care through improvement for the targeted populations.

What can managed care plans such as Medicare Advantage, use Innovation Awards funding for?

The target population of the Innovation Awards includes Medicare, Medicaid, and/or CHIP beneficiaries, including all fee-for-service and managed care covered individuals. We encourage managed care organizations to propose innovative interventions, however, Innovation Awards funds cannot be used to supplant or enhance payment for services managed care plans are currently being paid for.

Can proposed projects for the Innovation Awards involve multiple geographic areas?

Yes.

Can potential applicants change the scope and other details of their proposed project between their Letter of Intent submission and their application for the Innovation Awards?

Yes. The Letter of Intent (LOI) is required to submit an application for the Innovation Awards; however, applicants are free to make changes between submission of the LOI and application. Please note that CMS will not provide feedback on proposed projects described in the LOI.

Can Innovation Awards funds be used to replace existing funding under State Medicaid programs?

No. The Innovation Awards is seeking to solicit new innovative approaches towards better care, better health and lower costs through improvement. Projects that propose to use funds to replace existing or expiring funding sources will not be considered favorably.

Will CMS consider funding proposals to continue or extend an idea tested through a prior CMS demonstration that has ended?

This initiative will fund applicants who propose compelling new models of service delivery/payment improvements that hold the promise of delivering the three-part aim of better health, better health care, and lower costs through improved quality. Participants of past CMS demonstrations may submit an application. All proposals are expected to meet the stated objectives of the Health Care Innovation Awards.

Are proposals requesting funding for infrastructure improvement eligible?

Infrastructure that supports the delivery of the three-part aim of better care, better health, and lower costs may be considered solely or part of potential projects funded by this Funding Opportunity Announcement (FOA). Preference will be given to infrastructure that directly informs and/or supports payment or service delivery models that can improve the quality of care and lower costs through improvement. Applications that demonstrate the most compelling connection between infrastructure and three-part aim outcomes will score higher during application review. For additional information on allowable infrastructure please consult pages 5-6 of the FOA.

Are Quality Improvement Organizations (QIOs) permitted to apply directly?

Yes, QIOs may apply if they meet the other requirements stated in the FOA. QIOs should apply for projects that are clearly outside the current QIO scope of work. QIOs should review their proposed application with the CMS Office of Clinical Standards & Quality QIO Program Office prior to submission of the application to clarify that the application does not propose a project that falls within the current QIO scope of work.

Evaluation and Monitoring

CLARIFICATION OF EVALUATION REQUIREMENTS FOR THE HEALTH CARE INNOVATION AWARDS

The Funding Opportunity Announcement for the Health Care Innovation Awards describes three separate and distinct forms of evaluation, namely:

  • Self-evaluation as projects are implemented;
  • Ongoing review of progress by an external implementation and monitoring contractor; and
  • Formal evaluation of the project's overall impact, findings, and sustainability, again by an external evaluation contractor.

Terms like "monitoring" and "evaluation" are commonly used to refer to all three of these forms of review, and the three forms of review are to some extent interdependent. As proposals are finalized, it might be useful to distinguish between these three separate evaluation processes by referring to them as

  • Performance Assessment (for Self-Evaluation);
  • Monitoring (for ongoing tracking of operations-actual implementation against plan); and
  • Program Evaluation (used to assess and interpret the findings of the model of care delivery, payment, and workforce design).

Awardees will be directly responsible for carrying out Performance Assessment, as described on pages 21 and 28 of the FOA. In addition, they will be "required to fully cooperate with the monitoring and evaluation contractors in reporting data that they require for the project evaluation" (21).

"Self-Evaluation," involves maintaining Performance Assessment or Quality Improvement metrics that demonstrate progress towards achieving the three-part aim of better health care, better health, and lower cost, such as improvements in preventive care, decreases in unnecessary utilization, improvements in clinical quality, patient outcomes, trends in the number and form of patient contacts, patients' perception of their care experience, and cost performance.

Monitoring is an ongoing process that tracks awardees' progress in implementing their models, achieving positive outcomes, and avoiding harm. The FOA asks for "a well-designed and credible plan to provide regular reporting of performance and quantitative data for monitoring the progress of the project, including information on staffing and staff development, quality of services delivered, numbers of people included in the program, frequency and nature of contacts with participants, and other process and quality data" (FOA 28).

More formal research methods will be used for Program Evaluation. Program Evaluation will be performed by an independent contractor hired by CMS and will interpret all findings from the project, assess impact (on all three domains of the three-part aim) and sustainability, and determine whether the lessons learned from the project can be applied elsewhere or whether they hold promise for use on a wider, even national scale (the project's "scalability).

As projects are implemented, awardees will be expected to provide Performance Assessment data to CMS and its contractors (as specified above and on page 21 of the FOA), who will 1) assess their progress in meeting program and operational goals, 2) begin to compare their findings to baseline metrics, where these are available, tracking changes in care delivery, performance assessment targets, or payment structure, their impact on the three-part aim, and their potential sustainability and 3) to inform evaluation design and learning support.

How will CMS evaluate models participating in the Health Care Innovation Awards?

Information about the evaluation is available on p. 32-33 of the FOA. For purposes of continuous program improvement and reporting progress improvement, each awardee must conduct their own evaluation of their respective project on the impact of the three-part aim and will be expected to submit progress reports on their performance. These progress reports will allow for the monitoring and evaluation of the effect of the intervention on the quality of care received, as well as health outcomes and cost savings.

In addition, CMS will contract with a third party entity to conduct an independent evaluation of the models. The evaluation will assess the impact of the models on the three-part aim of better care, better health, and lower costs. The independent evaluation will include multi-pronged data collection efforts, including qualitative and quantitative approaches. The evaluation will be sensitive to the continual need for rapid cycle and close-to-real time production of findings that can be used by awardees and policy makers to make decisions about programmatic changes throughout the life of the project. Additional information will also be available in a future communication for this initiative.

What are the monitoring requirements for models participating in the Health Care Innovation Awards?

CMS will monitor each project using methods including quarterly reports, phone contacts, and occasional site visits. Each cooperative agreement will have a CMS project officer to track the progress of the project. Project monitoring requirements will include, but not necessarily be limited to: quarterly reports, regular phone conferences, and in-person meetings.

CMS expects to hire an implementation contractor to assist in data collection and review of the progress of the awardee. The implementation contractor will cooperate with the evaluation contractor to coordinate any data collection. We expect that the monitoring report data will depend on the nature of the project. For example, a project with focus on diabetes care will have different metrics than a project dealing with community health workers. We expect to collect both process information such as the number of beneficiaries assisted, and clinical quality metrics depending on the nature of the project. Additional information about the CMS monitoring procedures will be available to awardees at a later time.

What is the frequency of expected progress reports for Health Care Innovation Awards participants?

Awardees must agree to cooperate with any Federal evaluation of the program and provide required quarterly, semi-annual (every six months), annual and final (at the end of the cooperative agreement period) reports in a form prescribed by CMS. Awardees must also agree to respond to requests that are necessary for the evaluation of the national efforts and provide data on key elements of their own cooperative agreement activities.

Will CMS be putting out RFP for contractors for evaluation & monitoring?

CMS is planning to contract with third party entities to assist CMS in various tasks related to data collection and program evaluation, including monitoring.

Can organizations generate profits through these Innovation Awards cooperative agreements?

For-profit firms may apply for the Innovation Awards, but they may not include any amount in their budget for requested funding above their expected direct and indirect costs. The CMS will not provide Innovation Awards funds to ensure a profit margin. Applicants can, however, generate program income by contracting with other organizations (hospitals, clinics, other purchasers, etc.) that pay for applicants' services. Please consult the OMB Circulars (http://www.whitehouse.gov/omb/circulars_default) for information about program income.

Are applicants expected to budget a certain percentage of funds for evaluation activities?

CMS does not require applicants to reserve a specific amount of their budgets for evaluation activities. It is up to the applicant to propose a budget that allows adequate funding for the self-evaluation plan they put forth. Please refer to the FOA and the Clarification of Evaluation Requirements for detailed requirements.

Is a control group a required component of the self-evaluation?

No. It is the responsibility of the applicant to propose the method of performance assessment (see Clarification of Evaluation Requirements above) best suited to effectively evaluate their unique program needs. Detailed requirements for the self-evaluation requirements can be found on page 21 of the FOA. The materials and information presented in Webinar 3 and 4 (available on the Health Care Innovation Awards main page) provide additional information on this topic.

Data and Technical Assistance

What types of technical assistance will CMS provide to awardees?

In order to support a broad range of models, CMS is prepared to offer technical assistance to awardees on a case-by-case basis. CMS anticipates contracting with an entity or entities to provide technical assistance, as needed, to awardees as they develop and implement their respective models. The technical assistance contractor(s) will be available to assist awardees to design, develop, rapidly implement, and sustain their models to meet this initiative's programmatic goals.

Will CMS provide data to awardees to help them achieve to help them successfully implement their proposed model?

CMS is open to discussing data needs with awardees and may provide data if appropriate to the particular care model or infrastructure activity. Applications should include information regarding project data needs.

Will CMS provide Medicare data to organizations that receive awards under the Innovation Awards?

The CMS recognizes that some applicants may be interested in receiving Medicare and Medicaid data to inform and measure their projects. CMS is open to discussing data needs with all awardees and may provide data, when feasible and appropriate to the particular care model or infrastructure activity. Existing rules for accessing data will be applied, including required data use agreements.

Application Selection and Funding Criteria

Will CMS consider funding proposals less than $1 million or greater than $30 million?

CMS expects to make awards ranging from $1 million to $30 million each, depending on the scope and nature of individual projects received; however CMS will consider exceptional proposals for funding that fall outside of that range.

How will the Innovation Awards application panels judge sustainability?

It is up to each applicant to make a strong case for the probable sustainability of the proposed project. The model should include the plan to sustain the activity beyond the three years of the grant support. Innovative payment approaches, including changes to existing funding mechanisms, may demonstrate model sustainability. Other examples of sustainability, as noted in Section 4.2 on page 6 of the FOA, include on-going public/private partnerships, multi payer payment strategies, or new funding opportunities. Further information is included in Section 5.2 , on page 23 of the FOA.

Does the Innovation Awards include any special set-asides for proposals that serve rural areas?

There are no set-asides for particular types of programs or applicants, and no scoring preference will be given on the basis of geography during the selection process. The CMS intends to fund projects in communities with a wide variety of geographic and socio-economic characteristics, including underserved urban and rural areas.

Does the Health Care Innovation Awards include any special set asides for small business or minority/veteran/women-owned business?

CMS seeks to engage a broad range of partners in this initiative and encourages small business and minority/veteran/women-owned and disadvantaged business to apply and/or partner with applicants; however this cooperative agreement does not contain a special set-aside for such organizations.

How will the award funds be disbursed?

The applicant should propose an operational budget that is based on their operational plans and expectations. Funds will be disbursed according on a schedule that corresponds to the needs articulated in the operational budget.

Is it possible that the cooperative agreement might differ in certain aspects from the application submitted?

Yes, it is possible that through negotiations between applicants and CMS, the final cooperative agreement may have some modifications to the original project proposal as defined in the application. CMS may propose altering the size, scope and/or amount of funding, including awarding funds for only parts of an applicant's proposal. All final details will be determined between the applicant(s) and CMS in the cooperative agreement, prior to disbursement of award funds.

What constitutes "improvement" for meeting stated objectives to show improvement within six months?

The CMS is expecting rapid implementation of proposed improvement activities, but recognizes that many models will first require efforts to build infrastructure and capacity to support improvement activity. Proposals will be expected to complete the infrastructure and capacity-related activities within six months of the award and start improving care as rapidly as possible. Preference will be given to projects that implement their care improvement activities faster than six months. The applicant must provide a preliminary operational plan that includes a draft work plan showing how it plans to ramp up to operational start and demonstrates the capacity to improve care within six months of receiving funding. The plan should also include roles and responsibilities of key partners and major milestones and dates for successfully executing the operational plan.

Can funding proposals include indirect or subcontracting costs?

Yes, funding proposals should include all costs, including indirect costs and subcontractor costs.

Are indirect costs included in the total award amount?

Yes. The dollar amount refers to the total size of the award over 3 years.

Applicants may submit budgets with indirect costs consistent with their Federally approved indirect cost rate. Proof of the approved rate must be provided with the budget narrative section of the application. If applicants do not have an indirect cost rate they may submit budgets with a 10% indirect cost rate. . However, the applicant must be in the process of receiving a Federally approved indirect cost rate and provide the approved rate within 60 days of receiving an award. Information about Federally approved indirect cost rates can be found at the following link: http://www.psc.gov/financial.html.

Are participants in the Health Care Innovation Awards limited to the Federal executive-level salary cap?

No.

Learning and Diffusion

Does an organization that develops a new technology or software while participating in the Health Care Innovation Awards retain the right to patent and/or sell their product?

As long as awardees comply with the provisions of the Bayh-Dole Act of 1980 (P.L. 96-517), as amended by the Technology Transfer Commercialization Act of 2000 (P.L. 106-404), and the implementing regulations at 37 CFR part 401, they have the right to retain title to any invention conceived or first actually reduced to practice using HHS grant funds. The principal objectives of these laws and the implementing regulations are to promote commercialization of federally funded inventions, while ensuring that inventions are used in a manner that promotes free competition and enterprise without unduly encumbering future research and discovery. The regulation requires the recipient to develop and commercialize the technology or use patent and licensing processes to transfer grant-supported technology to industry for development. Alternatively, unpatented research products or resources may be made available through licensing to vendors or other investigators. Sharing of copyrightable outcomes of research may be in the form of journal articles or other publications.

It is Department of Health and Human Services policy that the results and accomplishments of the activities that it funds should be made available to the public. Awardees are expected to make the results and accomplishments of their activities available to the research community and to the public at large. The full text of the Department of Health and Human Services Grants Policy statement referenced above is available online at http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf.

As part of this initiative, awardees will be expected to participate in a variety of shared-learning and dissemination activities.

Will the information from the webinars be made available online?

A recording and transcript for each webinar will be made available on our Health Care Innovations Awards page. To receive information about future webinars, sign-up to receive email updates from the Innovation Center.

What is meant by "Total Affected Spend" on the financial spreadsheet template provided in the FOA?

Total Affected Spend is calculated as Number of Program Participants multiplied by Total per Beneficiary per Year (PBPY) Cost of Care of Program Participants.

Can I submit an alternative financial spreadsheet to the financial plan template found in VIII. Appendix of the FOA?

All applicants are required to submit the financial plan template found in section VIII of the FOA; however applicants may also include additional spreadsheets and alternative representations of their financial plan as part of the budget narrative or as supplemental materials. Any additional charts or spreadsheets included still count toward the respective application page limits.

What is the distinction between "Current Program Census" and "Proposed Expansion" on the financial plan template provided in the FOA?

Some programs are planning on using the award funding to enhance the services they currently are offering to beneficiaries while others are planning on using the award funding to expand to new regional markets, service lines, populations, or other areas. Some may be doing both. Current Program Census asks applicants to forecast the impact the HCIC funding may have on the beneficiaries currently in its programs. For some applicants, where the funding is only being used to expand to new areas, the numbers in this section may be zero. Proposed Expansion refers to the impact applicants expect to have on the new populations targeted by the applicants interventions. More information is contained in the Webinar 3 materials.

If I am proposing an entirely new intervention or expanding an existing intervention to a new population, how is "Current Program Census" to be defined in the financial plan template?

If you are proposing an entirely new intervention or expanding an existing intervention to a new population, Current Program Census will be zero.

For Standard Form 424A "Budget Information- Non Construction Programs" is it necessary to submit a separate form for each of the project years with a separate budget?

No. The SF-424A should be filled out once for year 1 budget, with the exception of Section E "Budget Estimates of Federal Funds Needed for Balance of the Project" where you should input budgets for the first (b), second (c) years separately. We will ask for detailed budget information for years two and three towards the end of year 1 of the award period.

NOTE: In Section E "first" replies to first year after the first budget period (i.e. program year 2). Applicants should only complete columns (b) for the second program year and (c) for the third program year.

On the Financial Plan, should Use of Funds include Federal + Non-Federal Funds or just Federal Funds?

[NOTE: This guidance has been revised to align the financial plan requirements with those stated elsewhere in the FOA and with the standard instructions for filling out the SF-424A Budget Information for Non-Construction.]

The Use of Funds under the Financial Plan should include all funds required for your program. Please follow instructions on which funds where on the SF-424A.

On the Financial Plan, should the number of beneficiaries be cumulative or just the additional new participants you expect each year?

The number of beneficiaries should be cumulative.