Support Statement A_0920-1274

Goal of the project: The Million Hearts^® Hospitals & Health Systems Recognition Program aims to recognize institutions that are committing to implement, implementing, and/or have implemented strategies to prevent heart attacks, strokes, and other cardiovascular events. Hospitals and health systems voluntarily apply to receive recognition via an online application. Resulting data will be reviewed to ensure eligibility criteria are met. Qualifying institutions will receive the designation of “Million Hearts^® Hospital” or Million Hearts^® Health System” and be showcased on the Million Hearts^® website. Designees that have achieved outcomes by implementing Million Hearts^®strategies will receive additional emphasis.

Intended use of the resulting data: Million Hearts^® will use the resulting data for the purpose of recognizing institutions working to systematically improve the cardiovascular health of the population and communities they serve. It is important to highlight institutions that are using evidence-based strategies that promote improved cardiovascular health. This recognition program provides an incentive for institutions to continue practicing these strategies and it also brings these strategies to the attention of other institutions.

Methods to be used to collect: Data will be collected through the use of an electronic survey questionnaire. An interview guide will be used to obtain additional insights from the nominated designees.

The subpopulation to be studied: The subpopulation are 50 hospitals or health systems which seek to participate in the Million Hearts^® Hospitals & Health Systems Recognition Program annually.

JUSTIFICATION

A1. Circumstances Making the Collection of Information Necessary

This is an extension Information Collection Request (ICR). CDC requests OMB approval for an additional three years.

CDC’s authority to collect this information is provided by the Public Health Service Act (42 USC 241, (see Attachment 1).

Heart disease, stroke and other cardiovascular diseases (CVDs) kill over 80,000 Americans each year, accounting for one in every three deaths. CVD is the nation’s number one killer among both men and women and the leading cause of health disparities across the population. Million Hearts®, a national, public-private initiative co-led by the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS), was established to address this issue.

Whether migrating towards value-based reimbursement or simply striving for a significant impact in reducing the devastation of heart attacks and strokes, clinical organizations are positioned to improve the health of the population they serve by implementing high-impact, evidence-based strategies. Achieving a Million Hearts® Hospital / Health System designation signals a commitment to not only clinical quality, but population health overall.

Published studies suggest that hospitals that are designated by a recognition program demonstrate more positive outcomes for patients and staff than hospitals that are not designated by a recognition program. For example, a study by Kutney Lee et al.¹ⁱindicates that hospitals that received endorsement through the American Nurses Credentialing Center’s (ANCC) Magnet Recognition Program exhibited better outcomes for patients including lower mortality and greater patient satisfaction.

Recognition programs implemented by CDC have also had great success. For example, Champions of the Million Hearts® Hypertension Control Challenge (OMB No. 0920-0976) have implemented best-practice strategies to improve hypertension rates among their patient populations. CDC has publicly recognized 199 clinicians, practices, and/or health systems since 2012 and has gained insight into the strategies that practices were using to effectively gain a high rate of hypertension control among their patient populations. Rather than recognizing applicants for their hypertension control rates, the Million Hearts® Hospital & Health System Recognition Program will recognize applicants that are using multiple strategies to address cardiovascular outcomes in a variety of settings. Million Hearts® recognizes hospitals and health systems which have implemented strategies to improve the cardiovascular health among the populations and communities they serve through a focus on Building Healthy Communities, Optimizing Care, and Focusing on Health Equity.

Applicants to the Million Hearts® Hospital &Health System Recognition Program, will do one or more of the following:

A.) Commit to implement policies that promote cardiovascular health

B.) Attest to the current policies and practices they are implementing to promote cardiovascular health

C.) Provide documentation of current policies that they are implementing and provide data that shows positive health outcomes because of those policies being implemented

A2. Purpose and Use of the Information Collection

The Million Hearts® Hospitals & Health Systems designation engages, equips, and supports leading clinical institutions across the country, given their direct connection to people at risk for CVD, as well as those who have had a cardiac or cerebrovascular event and remain at risk for having a subsequent event.

This recognition program will recognize institutions working to systematically improve the cardiovascular health of the population and communities they serve through the priority areas of Building Healthy Communities, Optimizing Care, and Focusing on Health Equity. There is a fourth category that allows applicants to share their use of supplemental programs and innovations.

If Million Hearts® cannot implement this recognition program, then hospitals and health systems will not receive recognition for the evidence-based strategies that will promote improved cardiovascular health. Consequently, Million Hearts® would not be able to highlight these hospitals and health systems, the effectiveness of these evidence-based strategies, and/or the new programs and innovations that hospitals are applying to prevent CVD.

The Million Hearts® Hospitals & Health System Recognition Program application (Attachment 2a) will be collected for approximately 50 applicants per year. The estimate of anticipated applications is based from the number of applications received for the program since its launch in 2020. This program will be promoted through similar channels as the Hypertension Control Challenge, including the use of social media, newsletters, and webpage updates (Attachment 8).

Once renewal is granted for this revision package, applicants will complete the Million Hearts® Hospitals & Health Systems Recognition Program application (Attachment 2a), indicating the areas they are committing to implement Million Hearts® strategies; those strategies which they are currently implementing or have previously implemented; and those strategies for which they have achieved outcomes/results.

Nomination information will be collected electronically and will be reviewed on a quarterly basis through a web-based online portal. Applicants will apply by completing the application form that includes information about the Million Hearts® strategies that they are committing to implement, are currently implementing, or have already implemented and have achieved results. The application also includes resources that may be leveraged to implement the strategies. Estimated time to complete the form is 2 hours and 40 minutes (Table A. 12-A). The steps listed below outline the process for applying:

Applicants create a free account on an external web platform.
On this external web platform, the nominee will find the application for the Million Hearts® Hospitals & Health System Recognition Program.
After submitting a nomination on the challenge web platform, a confirmation email will be sent to the email address provided.

As mentioned above, the applicant will indicate whether they are committing, implementing, or have achieved outcomes/results with certain Million Hearts® strategies. A hospital may be in the process of implementing changes in support of benefit design outcomes, achieved results in blood pressure control, and committing to work with patients who have had a previous heart attack or stroke. The grid below lays out an example of a potential clinical entity’s status and corresponding data submission categories. The specific documentation requirements are detailed within the application.

Priority Area	Strategies	Phase (with required documentation categories noted)
Building Healthy Communities	Policies to decrease particle pollution exposure	Implementing – submit required attestation for those implementing
Optimizing Care	Referral to cardiac rehabilitation programs	Achieved – recommended outcomes for those achieving results
Focusing on Health Equity	1. People with lower incomes 2.People who live in rural areas or other ‘access deserts’	Committed – describe intended approach and outcomes for addressing cardiovascular health among those in rural areas and “access deserts”.
Supplemental Programs and Innovations	Describe supplemental efforts and/or innovations	Implementing – documentation supporting the efforts such as target population(s), policy or program materials, timeframe and measures being tracked

A funded partner will collect the data through applications via an online platform. The application will be hosted through a unique URL. Expected respondents are medical and health service managers. Applications for the Million Hearts® Hospitals & Health System Recognition Program will be accepted continuously. The funded partner will collect this information to determine which strategies the applicant is committing to implement, is currently implementing or has achieved outcomes/results. If the application is deemed complete, the candidate hospital or health system is vetted to ensure eligibility for designation (Attachment 6). All applicants with reported outcomes and a select number of those who are committing to implement or are implementing Million Hearts® strategies will be asked to participate in a semi-structured, qualitative interview. (Attachment 2b). The purpose of the interview is to obtain in-depth contextual information about the Million Hearts® strategies and facilitators to achieving improved cardiovascular outcomes among the applicant’s patient population. The interview will be guided by three opening questions. The interviewer will guide the remaining discussion to gain in depth information on those questions. A list of Million Hearts® Hospitals & Health System designees will be publicly available with their consent. Selected applicants’ practice name, city and state will be publicized post selection and pending the applicants’ consent. For organizations, consent to participate in the Million Hearts® Hospitals & Health System Recognition program is attested on the application form. Un-attested forms will be excluded from further review. Participation is voluntary.

A3. Use of Improved Information Technology and Burden Reduction

One hundred percent of responses will be collected electronically via an online platform. Electronic submission of data reduces burden time for the respondent compared to data collection via paper and pencil format. Having a centralized, consistent method to collect information helps to minimize errors and redundancy and is essential to the timely and accurate scoring of applications. Providing a web-based nomination system will:

Shorten the time for collection of information using check box responses and short descriptive opportunities through a one-step process.
Standardize the information collected.
Ensure all required data fields are filled out.

A4. Efforts to Identify Duplication and Use of Similar Information

CDC examined three cardiac care designation programs to identify any similarities with the Million Hearts® Hospital & Health System Recognition Program. The first program examined was the National Committee of Quality Assurance’s (NCQA) Heart/Stroke Recognition Program. Recognition is based on self-reporting of indicators including blood pressure control, use of aspirin or another antiplatelet, smoking and tobacco use cessation assistance, body mass index screening, and statin therapy for patients with cardiovascular disease. Another cardiac care designation program is the U.S. News & World Report: Best Hospitals for Cardiology & Heart Surgery. The designation criteria for this program include measures such as survival rates, patient safety, specialized staff and hospital reputation among other factors. The third program examined was the Care Chex program, which scores hospitals on quality measures such as overall mortality, overall complications, readmissions, inpatient quality, and patient safety. While the above mentioned programs measure factors which are important for cardiac care, they do not include criteria which are based on the Million Hearts® strategies as outlined in the (Million Hearts® Hospitals & Health System Recognition Program application (Attachment 2a).

A5. Impact on Small Businesses or Other Small Entities

Questions have been held to the absolute minimum required for the intended use of the data collection. Data is being collected to determine if respondents are committing to implement Million Hearts® strategies, currently implementing or have previously implemented and have achieved outcomes/results. Additionally, only 50 applications are anticipated out of a respondent universe of 5,500 and applying is voluntary.

A6. Consequences of Collecting the Information Less Frequently

Respondents will fill out and submit applications once for their initial designation. At any time, institutions may respond to the additional requested information and/or data required to demonstrate they have achieved outcomes for a given strategy. For example, applicants who indicate that they are committing to implement a particular Million Hearts® strategy may submit another application later to indicate that they are currently implementing that strategy or that they have achieved outcomes for that strategy. By not allowing applicants to apply, hospitals and health systems will not benefit from CDC’s fidelity processes. Additionally, if data is not collected as frequently, the applicant cannot receive and amplify potential designation. Additionally, the applicant will not benefit from the engagement and partnership that comes with this designation program.

A7. Special Circumstances Relating to the Guidelines of 5 CRF 1320.5

This request fully complies with the regulation of 5 CFR 1320.5.

A8. Comments in Response to the FRN and Efforts to Consult Outside the Agency

Part A: PUBLIC NOTICE

A 60-day Federal Register Notice was published in the Federal Register on October 21, 2024, Vol. 89, No. 203, pp. 84149-84151 (see Attachment 3a).

CDC received one non-substantive comment and one substantive comment. The CDC response to the substantive comment is provided (see Attachment 3b).

Part B: CONSULTATION

The Million Hearts® Hospitals & Health Systems Recognition Program was designed collaboratively by CDC and consultants working with the National Association of Chronic Disease Directors (NACDD). Ongoing collaboration and evaluation of the program and data collection instrument has occurred by the project team. Past hospital and health system applicants shared that the application was easy to follow and complete.

In 2023, the online application platform was changed to a new system to reduce webpage hosting costs and improve CDC oversight. The new online platform went live in April of 2024.

Table 1. External Consultations

Name	Title	Affiliation	Phone	Email	Role
OUTSIDE CONSULTANTS
Susan Svencer	Public Health Consultant	National Association of Chronic Disease Directors	(508) 982-7560	[email protected]	Receives and processes applications
Julia Schneider	Public Health Consultant	National Association of Chronic Disease Directors	(410) 840-6270	[email protected]	Receives and processes applications

Table 2. Consultations within CDC

Name	Title	Affiliation	Phone	Email	Role
Emma Scazzero	CDC Contractor	Peraton	(301) 974-4852	[email protected]	Ensures the application meets CDC standards
Cindy Allen	Information Security Officer	CDC/NCCDPHP/OD	(770) 488-5388	[email protected]	Ensures information security protections are enforced

A9. Explanation of Any Payment or Gift to Respondents

Respondents will receive no financial incentive for applying. Applicants who receive the Million Hearts® designation will receive public recognition by CDC.

A10. Protection of the Privacy and Confidentiality of Information Provided by Respondent

No sensitive or individual patient-specific information is collected as part of this program. The only personal identifiable information collected is for the business contact (name, email address, and phone number). As per the Privacy Narrative Forum (Attachment 8), NCCDPHP’s Information Systems Security Officer has reviewed this submission and has determined that the Privacy Act does not apply. A signed Privacy Impact Assessment (PIA) already exists for this work (Attachment 9).

CDC staff, the CDC contractor responsible for maintaining the online application platform, and two NACDD consultants maintain personal information for business contacts within the password protected online application platform. Applications that are downloaded by these team members are secured in password protected files to secure the personal information of the business contacts. The names and contact information of the business contacts are not shared beyond the project team without explicit permission from the business contacts, themselves.

CDC Spotlights featuring the work of designees only includes aggregate and summary information in reports and does not include information that may identify respondents. Any quotes from hospital or health system program staff used in recognizing the designee are provided voluntarily and with individual approval for use.

CDC hosts the data collection tool, a Web-based enterprise application maintained on a secure, DHHS/CDC server. It has a Certification and Accreditation and an Authority to Operate. The tool is an authenticated access data application so only designated users can access application data.

The password and other information kept by CDC are private and secure to the extent permitted by law. Administrators cannot view user password credentials.

A11. Institutional Review Board (IRB) and Justification for Sensitive Questions

CDC has determined that the project is not considered human subjects research and does not require IRB review (Attachment 4).

A12. Estimates of Annualized Burden Hours and Costs

Information is collected at the time of submission and exchanged periodically over the remaining three years. Expected respondents are medical & health service managers. On an annual basis, CDC estimates receipt of 50 application forms (Attachment 2a). Applications will be submitted electronically. The estimated burden per response is 2 hours and 40 minutes. Individuals from Leavitt Partners and a doctoral cardiac rehabilitation nurse from Rush University College of Nursing participated in the pilot testing of the Million Hearts® Hospital or Health System Program application. The interview guide was estimated at 30 minutes and has proven to stay within that timeframe as interviews were conducted.

Table A. 12-B displays the estimated time burden of completing the Million Hearts® Hospitals

Table A. 12-A. Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Medical & Health Service Manager	Recognition Program Application	50	1	160/60	134
Medical & Health Service Manager	Interview Guide	30	1	30/60	15
Total					149

Table A.12-B displays estimates of annualized cost to respondents for participating in the data collection. Estimates were derived using an average hourly wage from the Bureau of Labor Statistics.

Table A. 12-B. Estimated Annualized Cost to Respondents

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Hourly Wage Rate	Total Respondent Costs
Medical & Health Service Manager	Recognition Program Application	50	1	2 hours, 40/60	$50.13	$133.84
Medical & Health Service Manager	Interview Guide	30	1	30/60	$50.13	$25.07
Total						$158.91

A13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

No capital or maintenance costs are expected. There are no additional start-up, hardware or software costs.

A14. Annualized Cost to the Federal Government

Costs to the Federal government include the cost of CDC personnel time for project oversight and contractor costs for data site collection set up and maintenance. A summary of costs is presented in Table A.14-A. The total estimated annualized cost to the Government is $116,194.

Table A.14-A. Estimated Annualized Cost to the Government

Cost Type	Cost
CDC staff. 5% of GS-13 for system oversight	$6,129
Funded partner costs for online application platform	$10,065
Costs for a separate funded partner to provide day to day management and delivery of project	$100,000
Total	$116,194

There are no operational and maintenance costs associated with this project.

A15. Explanation for Program Changes or Adjustments

This is an extension package. There is no change in burden.

A16. Plans for Tabulation and Publication and Project Time Schedule

OMB approval is requested for three years. Anticipated data collection or nomination period will be ongoing for the three years. Designated hospitals and health systems will be announced on a quarterly basis.

Million Hearts® designees will be recognized on the Million Hearts® website and promoted via multiple communication channels (Attachment 7). The successes and outcomes of clinical entities which have achieved results will be given additional, focused emphasis in these communications and promotional materials. Communication channels:

Highlight in the Million Hearts® electronic newsletter;
Use of the Million Hearts® logo on institution’s website;
Use of an icon specific to those strategies where hospital has achieved results;
Template press materials and newsletter announcements;
Recognition through Million Hearts® communication and partner channels;
Access to resources and support, and opportunity to exchange implementation tips and problem-solve with other Million Hearts® Hospitals and Health Systems;
Connection to state health department Million Hearts® program

Statistical analyses planned for this project are descriptive and include identifying the number of nominations submitted; the type of providers nominated; and a simple computation of the strategies for which applicants are committing to implement, currently implementing, or have previously implemented and have achieved outcomes/results.

Table A.16. Estimated Time Schedule for Project Activities

Activity	Timeline
Promote the opportunity for hospitals and health systems to apply for the Million Hearts® Hospitals program	1-2 months after OMB approval
Data Collection	Ongoing during term of OMB approval
Selection of Million Hearts® Hospitals and Health Systems	Every 3 months
Announcement and publishing of Million Hearts® Hospitals and Health Systems	Every 3 months

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

The display of the OMB expiration date is appropriate.

A18. Exceptions to Certification for Paperwork Reduction Act Submission

There are no exceptions to the certification.

REFERENCES

i Kutney-Lee, A., Stimpfel, A. W., Sloane, D. M., Cimiotti, J. P., Quinn, L. W., & Aiken, L. H. (2015). Changes in Patient and Nurse Outcomes Associated with Magnet Hospital Recognition. Medical Care, 53(6), 550–557. http://doi.org/10.1097/MLR.0000000000000355

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Supporting Statement A: Million Hearts® Hospitals and Health Systems Recognition Program
Subject	Supporting Statement A template
Author	Centers for Disease Control and Prevention
File Modified	0000-00-00
File Created	2025-08-07