SS Part A (DPRP)_Final for ICRO_updated with new pub comments_04-05-24_final

Information Collection Request

CDC’s National Diabetes Prevention Program (National DPP) Diabetes Prevention Recognition Program

Revision

OMB No. 0920-0909; Exp. Date: 04/30/2024

Supporting Statement: Part A

Program official/project officer: Stephanie Gruss, PhD, MSW (NCCDPHP/DDT/PIB)

Centers for Disease Control and Prevention

Division of Diabetes Translation

Atlanta, Georgia

April 18, 2024

TABLE OF CONTENTS

1. JUSTIFICATION

A-1 Circumstances Making the Collection of Information Necessary

A-2 Purpose and Use of Information Collection

A-3 Use of Improved Information Technology and Burden Reduction

A-4 Efforts to Identify Duplication and Use of Similar Information

A-5 Impact on Small Businesses or Other Small Entities

A-6 Consequences of Collecting the Data Less Frequently

A-7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

A-8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside

the Agency

A-9 Explanation of Any Payment or Gift to Respondents

A-10 Protection of the Privacy and Confidentiality of Information Provided to Respondents

A-11 Institutional Review Board (IRB) and Justification for Sensitive Questions

A-12 Estimates of Annualized Burden Hours and Costs

A-13 Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

A-14 Annualized Cost to the Government

A-15 Explanation for Program Changes or Adjustments

A-16 Plans for Tabulation and Publication and Project Time Schedule

A-17 Reason(s) Display of OMB Expiration Date is Inappropriate

A-18 Exceptions to Certification for Paperwork Reduction Act Submissions

REFERENCES

ATTACHMENT

1 Authorizing Legislation PHSA

2A 60-Day Federal Register Notice

3 DPRP Standards 2024

4A DPRP Application Form and Instructions (screenshot)

4B DPRP Evaluation Data Collection Form (screenshot)

5 Table of Changes

6 IRB Exemption from Human Subjects Research

Summary Table

• Goal of the study. The goal of this information collection is to allow the Centers for Disease Control and Prevention (CDC) an additional three years of OMB approval to continue collecting the information needed to administer the Diabetes Prevention Recognition Program (DPRP) and to provide information needed by the Centers for Medicare & Medicaid Services (CMS) to support the Medicare Diabetes Prevention Program (MDPP) Expanded Model. Based on experience with the DPRP from 2012–2023, and feedback from applicant organizations and internal and external partners, CDC proposes to revise the DPRP Standards and the associated information collection.

• Intended use of the resulting data. Data will be used to evaluate the performance of organizations offering the National Diabetes Prevention Program (National DPP) lifestyle change program (LCP). High performing organizations that meet CDC standards specified in this data collection package achieve either Preliminary or Full CDC recognition. Recognition is pivotal to an organization's ability to ensure effective program delivery and bill private and public health insurers, and for MDPP implementation. Data will also be shared in aggregate form to inform technical assistance and enhance overall program outcomes.

• Methods to be used to collect information. CDC will collect participant-level, de-identified evaluation data directly from organizations twice per year via an automated Data Portal, matching the variables listed within the accompanying Excel spreadsheet. CDC calculates averages across participant cohorts to determine organizational-level performance. Participant-level performance is not assessed by CDC. CDC will collect one-time application data at the organizational level only. The subpopulation to be studied. The subpopulations for this data collection include CDC Division of Diabetes Translation (DDT) recipients and MDPP suppliers. Final responsibility for MDPP suppliers is that of CMS and not CDC.

• How data will be analyzed. Data analysis will include thematic and aggregate analysis of de-identified quantitative, and organizational qualitative, data using descriptive statistics (e.g., counts, means, range, standard deviation) for organizational-level recognition assessment. Aggregate findings will be provided to organizations via evaluation reports and could be used for annual reports or articles, in which case regression analyses would be used.

Overview

CDC’s Division of Diabetes Translation collects information needed to administer the National DPP’s quality assurance program, the DPRP (OMB No. 0920-0909, exp. 04/30/2024). Through the DPRP, CDC recognizes organizations that successfully deliver the evidence-based National DPP LCP to participants who have prediabetes or are at high risk for type 2 diabetes. The National DPP LCP is based on a structured yearlong lifestyle intervention shown to be effective in a clinical research trial and in subsequent translation studies which demonstrated the program’s effectiveness in communities and other real-world settings. The DPRP Standards, initially approved in 2011 and revised every three years in 2015, 2018, and 2021, specify criteria for the program and describe how organizations can achieve CDC recognition. Information currently submitted to CDC for recognition includes a one-time application form followed by biannual (every 6 months) transmission of evaluation data that allow CDC to assess each organization’s fidelity to the DPRP’s national quality standards and the progress achieved by participant cohorts. Full CDC recognition is awarded to qualifying organizations when program participants, in aggregate, achieve outcomes aligned to the comprehensive body of research studies.

The 2015 revision described changes in the DPRP Standards and information collection that allowed CDC to recognize organizations that used virtual technologies such as web-based tools and distance learning platforms to deliver the LCP. The 2015 revision also outlined corresponding changes to the information collection plan that allowed CDC to ensure that uniform evaluation criteria are applied to both in-person and virtual programs. Additional changes were made to clarify forms/instructions and to accommodate more user-friendly methods of transmitting required information to CDC.

The 2018 revision described changes that affect the annualized burden estimates. In the initial three-year approval period (OMB No. 0920-0909, exp. 11/30/2014), CDC collected DPRP evaluation data elements semi-annually (once every 6 months). In the second approval period, organizations submitted this information annually (once every 12 months), and the evaluation elements were more rigorous than in the 2011 PRA package. In the 2018 revision, CDC returned to semi-annual data collection to align with the CMS MDPP benefit to cover CDC-recognized organizations serving eligible Medicare beneficiaries beginning January 1, 2018. Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh §424.59) authorized CDC-recognized organizations to prepare for enrollment as MDPP suppliers in order to bill CMS. The current revision continues to be directly linked to the CMS MDPP Expanded Model; both are now working in tandem to more broadly scale the National DPP LCP. CMS continues to rely on CDC’s DPRP for quality assurance and data monitoring necessary to implement and evaluate the MDPP Expanded Model and to reimburse MDPP suppliers.

The 2021 revision (OMB No. 0920-0909, exp. 04/30/2024) continued to support the MDPP. This revision also permitted hemoglobin A1C as an optional outcome measure, as well as 150 minutes of physical activity minutes combined with 4% weight loss as an optional outcome measure- all leading to Full CDC recognition. The addition of optional measures was a direct result of stakeholder feedback and input from the scientific literature and DPRP data analyses, which indicated these additional metrics were equivalent to the 5% weight loss goal in terms of prevention or delay of type 2 diabetes.

In 2011, CDC received OMB approval to collect organizational and de-identified participant information needed to administer the DPRP (OMB No. 0920–0909, exp. 11/30/2014). In 2015, CDC renewed these Standards for three years (OMB No. 0920-0909, exp. 12/31/2017) to continue collecting information needed to manage the DPRP. As a result of the MDPP Expanded Model, authorized through the Social Security Act (42 U.S.C. 1302 and 1395hh §424.59), which specified that only organizations in good standing with the CDC’s DPRP were eligible to be MDPP suppliers,^1b MDPP reimbursement is directly tied to CDC Preliminary or Full recognition status. The 2018 Standards revision (OMB No. 0920–0909, exp. 02/28/2021) aligned with the CMS MDPP Expanded Model that became effective on January 1, 2018. The MDPP Expanded Model continues to scale the National DPP LCP to a high-risk population of Medicare beneficiaries ages 65 and over; this continued with the 2021 revision and the proposed 2024 revision.

In the current revision of the DPRP Standards, the following changes were made to better assist CDC-recognized organizations in achieving both Preliminary and Full CDC recognition. Based on these changes, CDC will:

• Revise the DPRP Standards to align with OMB-supported variables (with options) for race/ethnicity and a 6-point disability variable.

• Include a binomial yes/no application variable to allow for fast-tracking to Preliminary CDC recognition for organizations serving populations in areas of the US identified as having high social vulnerability based on the Social Vulnerability Index.

• Collect zip code information to provide more focused technical assistance.

• LCP and identify ways to support participants in accessing and participating in the program.

• Revise a few categories of variables to allow more specific data captures.

Overall, the twice-annual data collection process is being streamlined to permit automated, faster data entry by CDC-recognized organizations. OMB approval is requested for three years to continue to align with the CMS MDPP Expanded Model and to allow organizations an opportunity to further institutionalize and scale the evidence-based National DPP LCP. The seminal literature around lifestyle change for the prevention of type 2 diabetes has remained fairly consistent, and current literature, DPRP data analyses, and key stakeholder feedback support this current revision. Thus, CDC anticipates no need to fully revise the DPRP Standards for another three years.

Section A. Justification

1. Circumstances Making the Collection of Information Necessary

According to CDC’s 2022 National Diabetes Statistics Report, more than 37 million adult Americans (11.3%) are living with type 2 diabetes, and 96 million (38%) have prediabetes.^1a Diabetes is a disease in which blood glucose levels are above normal. Diabetes can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations. Prediabetes is a condition in which blood sugar is elevated but not high enough for a diagnosis of diabetes.^1a People with prediabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke. In 2017, the direct and indirect cost of the management and treatment of type 2 diabetes and its related complications in the US was estimated to be $327 billion.^1b Type 2 diabetes affects more than 25 percent of Americans aged 65 or older, and its prevalence is projected to increase approximately two fold for all US adults (ages 18-79) by 2050 if current trends continue.^1c CMS estimated that Medicare spent $42 billion more in the single year of 2016 on fee-for-service, non-dual eligible, over age 65 beneficiaries with diabetes than it would have spent if those beneficiaries did not have diabetes.^1b Providing a cost-effective way to prevent or delay the progression of prediabetes to type 2 diabetes can help improve quality of life for Americans and contain health care costs.^17,18

Fortunately, type 2 diabetes can be prevented. In 2001, results from the Diabetes Prevention Program (DPP), a research study led by the National Institutes of Health (NIH), showed a structured lifestyle intervention to be effective in preventing or delaying the onset of type 2 diabetes in participants with prediabetes when delivered on a one-on-one basis. In the DPP research trial, participants losing 5-7% body weight in the lifestyle intervention experienced a 58% lower incidence of type 2 diabetes than those who did not receive the lifestyle intervention.2 Subsequent studies to the DPP and other international studies showed that reduced type 2 diabetes incidence could be sustained for 15 or more years.^3-5 Effectiveness research demonstrated that the DPP curriculum, when modified slightly for delivery in a group setting by community-based organizations, helped program participants achieve the 5–7% weight loss needed to prevent or delay type 2 diabetes in individuals with prediabetes, and that such a program can be cost effective and cost saving.^6-10,23 Medicare actuarial analyses determined the program to be cost-saving as well.^1b Other studies where the lifestyle change program was delivered via the internet, with and without behavioral e-counseling, demonstrated effectiveness.^11,26-28,30

CDC established the National DPP, administered by DDT, to make the lifestyle intervention broadly available to individuals at high risk for type 2 diabetes. Key features of the evidence-based intervention that are known to be successful include: weight loss (5-7% of body weight), documentation of physical activity minutes (with a goal of ≥150 minutes per week), and attendance throughout the 12-month program (with two required phases, a minimum of 16 weekly sessions in months 1-6 and a minimum of 6 monthly sessions in months 7-12). The quality assurance arm of the National DPP, the DPRP, has shown—via analyses of its own dataset—that there is a dose/response relationship between attendance and weight loss, especially when attendance is maintained throughout the yearlong program.^19-22,31

The National DPP is authorized under Sections 301(a) and 1703(a) of the Public Health Service Act (Attachment 1). The National DPP was to include a program “to determine eligibility of entities to deliver community-based diabetes prevention services” and provide “evaluation, monitoring, and technical assistance” to those entities. In 2011, CDC established the DPRP as the evaluation and quality assurance arm of the National DPP.^2-11 The DPRP was created to recognize organizations that deliver the evidence-based National DPP LCP, via a 12-month in-person program, to individuals with prediabetes or at high risk for type 2 diabetes. Based on later promising scientific evidence from published studies, virtual programs were added in 2015. ^12-15,26-27 Key objectives of the DPRP include:

• Assure program quality, fidelity to scientific evidence, and broad use of the National DPP LCP throughout the United States.

• Monitor, evaluate, and provide technical assistance to entities that offer the program to assist staff in effective program delivery and in problem-solving to achieve and maintain recognition.

• Develop and maintain a registry of organizations recognized for their ability to effectively deliver the National DPP LCP to people at high risk for type 2 diabetes.

As authorized by the Public Health Service Act (Attachment 1), CDC is currently approved to collect information from organizations seeking recognition through the DPRP (OMB No. 0920-0909, exp. 04/30/2024). CDC is seeking a fourth revision for three years (May 1, 2024 through April 30, 2027). Two types of information have been and will continue to be collected from applicant organizations: a one-time DPRP Application Form (Attachment 4A), followed by the DPRP Evaluation Data Collection Form (Attachment 4B). The DPRP Application Form allows CDC to assess the applicant organization’s readiness to achieve CDC recognition and to maintain pertinent contact and organizational information. Upon application submission, organizations that have the capacity to deliver the National DPP LCP and agree to adhere to the DPRP Standards proceed to “Pending” recognition status. Once in pending, an organization agrees to submit evaluation data twice per year to CDC for review and analysis. The evaluation data elements consist of de-identified information about participants and the educational/coaching sessions delivered by the applicant organization. Collection of evaluation information allows CDC to assess the organization’s fidelity to the DPRP Standards and to provide technical assistance, as needed, for program improvement. “Full” recognition is awarded to organizations that fully meet the requirements described in the DPRP Standards within a specified time frame. In this fourth revision, collection of evaluation information will continue to permit CDC-recognized organizations that are also MDPP suppliers to bill CMS for their services once either “Preliminary” (meeting pending recognition requirements and participant retention goals) or “Full/Full Plus” recognition status is achieved. The original CMS RIN is #0938-AT02.

CDC seeks to extend OMB approval for DPRP data collection for three years, with revisions. Importantly, the DPRP Standards are being revised to align with OMB-supported variables (with options) for race/ethnicity and a 6-point disability variable. A binomial yes/no application variable will allow for fast-tracking to Preliminary CDC recognition for organizations serving populations in areas of the US identified as having high social vulnerability based on the Social Vulnerability Index. Zip code information will be collected to provide more focused technical assistance. A few variables have revised categories to allow more specific data captures. Overall, the twice-annual data collection process is being streamlined to permit automated, faster data entry by CDC-recognized organizations.

The revised 2024 DPRP Standards and data collection requirements will be effective for all new applicant organizations immediately upon receipt of OMB approval of this revision (estimated late-April 2024). In order to provide current CDC-recognized organizations an orderly transition from the 2021 DPRP Standards to the revised 2024 DPRP Standards, CDC will develop a transition plan, as program guidance, in early spring of 2024 that will allow organizations to adapt their reporting systems without unduly interrupting progress toward achievement of CDC recognition. A transition e-mail will be sent to organizations to inform them of the changes that will affect them and of the allowances that will be made for existing organizations during the first 6 months of the 2024 revision. CDC will offer technical assistance during this process to ease the burden.

CDC anticipates that information collection will continue throughout the lifetime of the DPRP. At this time, CDC requests an additional three years of OMB approval (May 1, 2024 through April 30, 2027) to collect the information needed to administer the DPRP and to continue to align with the MDPP Expanded Model.

2. Purpose and Use of the Data

The DPRP is a quality assurance program for organizations offering the National DPP LCP. The DPRP helps generate awareness of and demand for the program among people at high risk for developing type 2 diabetes, health care providers, and public and private payers, including CMS. CDC recognition assures physicians, other health care providers, and employers and insurers that they are referring people with prediabetes or at high risk for type 2 diabetes to organizations that are implementing the program with fidelity to the evidence.

DPRP information collected by CDC and aggregated at the organizational, state, regional, or national level is used for multiple purposes, including:

• To promote the dissemination and use of effective strategies for preventing type 2 diabetes;

• To assess applicant organizations’ compliance with the DPRP Standards, their progression from “Pending” and “Preliminary” to “Full” recognition status, and their need for technical assistance to help strengthen delivery of the program;

• To enhance public health intervention strategies at the organizational, state, regional, and/or national level;

• To help potential participants, health care providers, and payers identify CDC- recognized organizations, including their locations.

Pending Recognition:

Organizations applying for Pending recognition must submit an application for each delivery modality and agree to deliver a yearlong evidence-based program using a CDC-approved curriculum. They must also agree to submit evaluation data semi-annually to allow the DPRP to monitor fidelity of program delivery and program effectiveness, and to provide technical assistance.

Preliminary Recognition:

In keeping with CDC’s priority to advance health equity, organizations will be considered for immediate advancement to Preliminary recognition at the time of application approval if they are serving a population that resides in a county classified as having “high” vulnerability according to the CDC/ATSDR Social Vulnerability Index (SVI*). Organizations wishing to be considered under this provision will need to indicate their interest on the DPRP application and will be contacted by the National DPP Customer Service Center for further information about their capacity and experience serving populations in these counties. If organizations meet these additional requirements, immediate advancement to Preliminary recognition will allow them to skip the normal 12-18 month waiting period to apply for approval as an MDPP supplier and begin to bill CMS. Having access to Medicare reimbursement will provide additional financial support to help meet the needs of these participants.

If an organization has Preliminary, Full, or Full Plus recognition for one delivery mode and subsequently applies to deliver the National DPP LCP through an additional delivery mode, the DPRP will consider awarding Preliminary recognition to the new delivery mode pending a review.

Organizations will move into Preliminary recognition at the time of the Sequence 1 (6-month) or Sequence 2 (12-month) data submission if records indicate that at least 5 eligible participants have attended at least 8 sessions.

If options 1, 2, or 3 do not apply, organizations will move into Preliminary recognition when both of the following criteria have been met:

• The evaluation cohort includes at least 5 eligible participants whose cohorts began 12-18 months prior to the data submission month, and

• At least 30% of the eligible participants (Section A. of Attachment 3. Participant Eligibility) meet the definition of a completer.

Once an organization meets the requirements for Preliminary recognition, the organization may remain in Preliminary indefinitely if it continues to submit the required data every 6 months.

Full Recognition:

Organizations achieve Full recognition when they meet the following criteria:

• Requirements 1-4 for Pending recognition (submission of an application, use of a CDC-approved curriculum, agreement to offer the program for the required duration and intensity).

• Requirement 5*: Retaining participants to completer status.

• The evaluation cohort must include at least 5 eligible participants whose cohorts began 12-18 months prior to the data submission month.

• At least 30% of all eligible participants must meet the definition of a completer.

*Requirements 6 and 7 will only be calculated for an evaluation for Full recognition if requirement 5 is met.

• Requirement 6: Risk Reduction. Organizations must demonstrate that there has been a reduction in risk of developing type 2 diabetes among completers in the evaluation cohort by showing that at least 60% achieved at least one of the following outcomes:

• 5% weight loss 12 months after the cohort began. Weight loss is calculated using the first and last recorded weights during the Core and Core Maintenance phases.

• 4% weight loss and at least 8 sessions associated with an average of 150 minutes/week of physical activity. Weight loss is calculated using the first and last recorded weights during the Core and Core Maintenance phases.

• 4% weight loss and at least 17 sessions attended. Weight loss is calculated using the first and last recorded weights during the Core and Core Maintenance phases.

• 0.2% reduction in baseline A1C (recorded within one year of enrollment).

• Requirement 7: Eligibility. Organizations must show that at least 35% of completers in the evaluation cohort are eligible for the yearlong National DPP LCP based on either a blood test indicating prediabetes or a history of gestational diabetes mellitus (GDM).

Once an organization meets the requirements for Full recognition, the organization may remain in Full indefinitely if it continues to submit the required data every 6 months.

Full Plus Recognition:

Retention. Organizations achieve Full Plus recognition when they meet the following criteria in addition to requirements 1-7:

• Eligible participants in the evaluation cohort must have been retained at the following percentages:

• A minimum of 50% at the beginning of the 4th month since the cohorts’ first sessions.

• A minimum of 40% at the beginning of the 7th month since the cohorts’ first sessions.

• A minimum of 30% at the beginning of the 10th month since the cohorts’ first sessions.

A designation of Full Plus recognition will last 12 months. At that time, if the organization does not meet the requirements for Full Plus, it will be placed in Full recognition.

Application data: CDC uses the data elements from the DPRP application to communicate with the applicant organization. A limited amount of information about the applicant organization [organization name, organization code, telephone number, location, web address (if provided and approved), program delivery mode, organization class locations for mapping purposes, and level of recognition] is made publicly available on the National DPP web site or through other directories. This information helps consumers, health care providers, and payers such as CMS identify organizations that are delivering the National DPP LCP with fidelity to the evidence.

Evaluation data: The evaluation data elements provide the basis for the recognition process. Using the elements and objective criteria, CDC monitors the fidelity of program delivery and effectiveness and provides timely feedback and technical assistance. The evaluation data elements address both fidelity of program delivery and participant outcomes. However, CDC’s primary objective is to assess the effectiveness of organizations rather than the success or failure of the individual program participants. A secondary objective is to assist organizations in meeting requirements to secure reimbursement from CMS and other public and private payers.

CDC provides technical assistance to help organizations identify opportunities for improving program delivery and/or for providing additional support to participants. For example, technical assistance may include, but is not limited to, discussing optimal intervention strategies for each delivery mode and implementing strategies to encourage program participants to make and maintain behavioral changes. In 2018, CDC developed a National DPP Customer Service Center (CSC). Through this federal agency Gears of Government award-winning Center, CDC is able to provide a wide range of technical assistance to numerous partners. The CSC continues to provide this assistance to CDC-recognized organizations and to other key diabetes prevention stakeholders.

Without the ongoing collection of evaluation information, CDC could not verify program eligibility or effectiveness, and there would be no way to monitor and evaluate program quality on a national level. In addition, CMS would not be able to implement the MDPP Expanded Model, since CDC recognition is a requirement for organizations offering the MDPP to Medicare beneficiaries. CMS continues to depend on the DPRP to assure the quality of the National DPP LCP for Medicare beneficiaries ages 65+ who are at high risk for type 2 diabetes.^1b

Privacy Impact Assessment Information

Application data: Each organization seeking recognition must submit contact information, including the organization’s name, mailing address, telephone and fax numbers, and web url (if applicable); as well as the names, job titles, and e-mail addresses of employees designated to serve as the organization’s primary and secondary contacts and designated data preparer. Organizations must also submit training entity information to ensure adequate and proper training of Lifestyle Coaches. Although the application includes personnel-related personally identifiable information (PII) (e.g., names), the information is not considered personal or private in nature. CDC maintains the PII in password-protected files in a secure facility. A directory of recognized programs is publicly available. However, the directory lists only the name, address, telephone number, web address (if provided and approved), type of organization, and recognition status of each organization; it does not include the name of the organization’s contact person or any other person’s name.

Evaluation data: CDC analyzes the evaluation data submitted by organizations to objectively assess adherence to the DPRP Standards and recognition criteria. The method of determining prediabetes status is collected to assess compliance with program eligibility standards. Participant-level identification codes and session attendance elements (session date, session type, weight, physical activity minutes, and optional pre- and post-intervention A1Cs) are used to evaluate recognition criteria. The elements are aggregated across participants to indicate whether an organization met the required percentage of overall recognition outcome goals.

Collection of demographic information about program participants is necessary to ensure program effectiveness across sex/gender, ages (18+), socioeconomic status (SES) groups (measured by education level), racial/ethnic groups, disability status, social determinants of health variables, and zip code. Participant process and outcome data include site-specific information (organization code). The organizations generate, assign, and maintain a coded identification number for each participant. Only de-identified, coded, participant-level information is transmitted to CDC. CDC recognizes that some of the participant-specific information (state of residence, ethnicity, race, age, sex/gender, insurance status, method of determining prediabetes status, disability status) when coupled with other data (organization code) might be considered PII. However, CDC does not receive or store specific names of persons and will not attempt to identify individuals by data linkages involving demographic, geographic, or outcome information. CDC will also not contact individual participants or disclose any participant-level data.

As stated above, the required data elements are essential for monitoring the fidelity and effectiveness of the National DPP LCP; providing targeted technical assistance to the CDC-recognized organizations; assisting CMS with implementation of the MDPP Expanded Model; and helping consumers, health care providers, and public and private payers identify quality organizations.

We believe that the proposed procedures are appropriately scaled to ensure low likelihood of disclosure and low likelihood of harm that could result from inadvertent disclosure of individual participant information.

To elaborate, in the DPRP data system, participant-level evaluation data are linked to organization-level application data through the organization code, which is assigned to the organization by CDC at the time of acceptance into the program and subsequently appended to all participant-level records the organization sends to CDC. Hence, the only linkage of participant records within the DPRP data system is to the organization’s contact information (e.g., organization name, address, phone number, contact person). The organizations assign and maintain participant IDs, and CDC does not have access to the keys for these codes or to the applicants’ data systems.

No PII about participants—directly or indirectly identifiable—is transmitted to CDC. All identifiers (except the organization code, which is provided by CDC) are assigned and maintained by the applicant organization. Data are submitted in a precisely defined format. The DPRP data system incorporates standard procedures for checking the format and for validating the content of evaluation data submissions upon receipt. Evaluation data sent to CDC that does not conform to the specified format, or that includes any PII, is not accepted and is returned immediately and never stored by the DPRP.

CDC is concerned with national program, organizational, and aggregated cohort performance, not the performance of individual participants. CDC reports recognition status for each participating organization and may produce summary reports that include data on the performance of all or some recognized organizations but will not report on individual participant performance. CDC summary reports may link aggregate program data to geographic variables (e.g., state or county-level demographics, or zip code where individuals cannot be personally identified) or to organizations for the purpose of providing technical assistance, but we do not believe that such reports could be used to identify an individual participant.

In summary, we believe the risk for identification or disclosure of PII is very low for several reasons:

1. CDC does not accept PII about participants. This is ensured by requiring that evaluation data be submitted in a specific format and having procedures to check format and content before data are accepted.

2. IF PII is sent to CDC, CDC immediately returns, then destroys, any participant-level PII submitted by an organization.

3. The only direct linkage of participant-level data in the DPRP data system is to each organization’s contact information via the organization code.

4. CDC does not have access to the keys to any codes, other than the organization code, or to the applicant organizations’ data systems.

5. CDC does not attempt to identify individuals by data linkages involving demographic, geographic, or outcome information.

6. CDC does not report on the performance of individual participants and will not disclose any participant-level data.

CDC uses the data only as described and safeguards and secures the data to the full extent required by law. The DPRP Standards clearly assign the principal responsibility for maintaining participant privacy to the participating organizations.

3. Use of Improved Information Technology and Burden Reduction

CDC designed this information collection to minimize the burden to respondents and to the government, to maximize convenience and flexibility, and to ensure the quality and utility of the information collected. One hundred percent of the information submitted to the DPRP is submitted electronically, as specified in the DPRP Standards.

4. Efforts to Identify Duplication and Use of Similar Information

The National DPP, including the DPRP, is authorized under Sections 301(a) and 1703(a) of the Public Health Service Act (Attachment 1).

CDC originally examined credentialing, accreditation, or recognition of its National DPP program delivery organizations by the National Committee for Quality Assurance (NCQA), a not-for-profit organization dedicated to improving health care quality. NCQA does not have any efforts for specific monitoring of type 2 diabetes prevention programs. The closest is an accreditation for Wellness and Health Promotion Programs, focused on general risk reduction, primarily for programs offered by employers and health plans. This NCQA offering would not provide the data needed to monitor type 2 diabetes prevention programs.

Since no other federal agency or nonfederal organization monitors lifestyle change programs for the prevention of type 2 diabetes, and CMS now relies on the DPRP for data monitoring in order to implement and reimburse for the MDPP Expanded Model, the information collected by the DPRP is not available from other sources. CMS proposed the MDPP in Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh §424.59), authorizing CDC-recognized organizations to enroll as MDPP suppliers in order to bill CMS for these services since early 2018. This benefit specifies that only CDC-recognized organizations in good standing with the DPRP are eligible to be MDPP suppliers.^1b This benefit has been renewed under CMS RIN #0938-AT02. Thus, it is imperative that CDC continue the administration of the DPRP and the accompanying information collection.

5. Impact on Small Businesses or Other Small Entities

This data collection, while not specifically aimed at small business entities, does include organizations that are smaller businesses. Any organization—public, private, non-profit, government, academic, health care, etc.—can apply for CDC recognition if they have the capacity to offer the National DPP LCP. Thus far, approximately 25% of applicants are large business entities, and 75% are small business entities. Approximately 70% of applicants are from the private sector, and 30% are from the public sector. When a small business offering the National DPP LCP applies for CDC recognition through the DPRP, the small business is required to meet all the eligibility and evaluation requirements outlined in the DPRP Standards. CDC provides technical assistance on an as-needed basis. A small business may need, and receive, more technical assistance than a large business.

6. Consequences of Collecting the Data Less Frequently

The lifestyle change program is 12 months long with two required phases, a minimum of 16 weekly sessions in months 1-6 and a minimum of 6 monthly sessions in months 7-12. Organizations seeking recognition through the DPRP currently submit evaluation data to CDC every 6 months under the 2021 DPRP Standards and will continue to under this revision. CDC uses these data to monitor program effectiveness. This allows CDC to provide timely technical assistance to organizations having difficulty meeting minimum DPRP performance goals and gives organizations time to improve performance and achieve or maintain Preliminary or Full/Full Plus recognition. CDC will continue collecting data biannually and will continue to align with the CMS MDPP Expanded Model. Experience to date has demonstrated that splitting the annual data into two reporting periods permits more frequent organizational feedback and provides CMS critical information on program integrity which is required for payment.

Less frequent reporting would delay the provision of technical assistance and limit opportunities for organizations to implement corrective action. Ineffective programs have potential negative consequences, including but not limited to, inefficient use of health care dollars, harm to participants and the reputation of the National DPP, and reluctance of public and private payers to reimburse.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside of the

Agency (CDC National DPP’s Diabetes Prevention Recognition Program 2024 Standards and Operating Procedures):

A 60-day Federal Register Notice (60Day-24-0909) was published in the Federal Register on December 15, 2023, Docket No. CDC-2023-0096, Document Citation 2023-27550, pages 86901-86903 (3 pages). CDC received and responded to 19 sets of unique public comments that were related to this notice from both individuals and organizations outside of CDC. Commenter #3 had sent their comments twice, as had Commenter #1. Commenter #6 sent a supportive letter to the CDC agency director. Commenters #12 and #16 are identical with the addition of two signatories as an “update” and are listed in the table below as #12/16. CDC is not required to respond to questions or comments outside the scope of this ICR.

The table below summarizes the relevant comments answered and how CDC plans to address them:

Standards Area / Topic	Description	Comments	Response
A. Participant Eligibility	CDC recommended: “1. Participants who develop type 2 diabetes while in the program. These participants should be referred to their primary care providers for referrals to American Diabetes Association (ADA)-recognized or Association of Diabetes Care and Education Specialists (ADCES)-accredited diabetes self-management education and support (DSMES) services and other resources such as Medical Nutrition Therapy (MNT) as appropriate. 2. Participants who become pregnant while in the program. The National DPP LCP emphasizes weight loss and is not appropriate for women who are currently pregnant.”	Commenter #4: “We appreciate the clarity around participants whose eligibility changes during the program. Encouraging programs to refer participants to Diabetes Self-Management Education and Support (DSMES) programs that are ADA recognized or ADCES accredited is a useful way to support people who develop type 2 diabetes as well as allowing them to remain in the lifestyle change program to continue to receive support during their pregnancy. It is also helpful to have clear directives around what to do if a participant becomes pregnant during the program.”	CDC agrees with Commenter #4 and appreciates the feedback and support of this guidance to further enhance prevention, control, and treatment options for persons who develop type 2 diabetes or who become pregnant while in the lifestyle change program.
B. Safety of Participants and Data Privacy	CDC proposed: “Along with the physical safety of the participants, organizations should also be mindful of the need to ensure the privacy and confidentiality of participants’ data. It is the organization’s responsibility to be versed in and to comply with any federal, state, and/or local laws governing individual-level identifiable data, including those laws related to the Health Insurance Portability and Accountability Act (HIPAA), data collection, data storage, data use, and disclosure. Organizations should make clear to participants at the time of enrollment that their de-identified participant-level and session-level data will be shared with CDC.”	Commenter #4: “While [we] support the additional information that describes how the CDC plans to keep participant data safe, we would appreciate more specific direction from the agency on what organizations need to do to comply with this new guidance.”	CDC feels this guidance is thorough and has provided this guidance in past revisions of the DPRP Standards. This is not new; thus, CDC does not agree to revise this section.
D. Delivery Mode	CDC proposed the following five delivery modes: “1. In-person; 2. Distance learning (live); 3. In-person with a Distance Learning Component; 4. Online (non-live); and, 5. Combination with an Online Component that is non-live.”	Commenter #4: “We support the changes to delivery mode to include the following ways for participants to experience a DPP… [We] believe it is critical to meet participants where they are and given the expansion of telehealth modalities and other virtual learning opportunities in healthcare over the past four years, we think it is necessary for future programming and growth… This would not only create further alignment between the two programs, but it would increase the number of MDPP suppliers, increasing access to and utilization of the MDPP benefit by Medicare beneficiaries with prediabetes. Given the current rules with CMS and the Medicare DPP requirements, it is very helpful to have the addition of the in-person with a distance learning component modality to allow programs to have additional options for delivery.” Commenter #10: “Consider having three options only for organizational delivery mode….a. MDPP - CDC and CMS would collectively define this option. It would merge the proposed In-person and In-person with Distance Learning Components proposed in the 2024 standards. This way any organization in this category meeting the standards would be MDPP eligible, and over time, this org code could continue to reflect CMS’s evolving parameters for MDPP delivery. b. Online – CDC would continue to support this option until CMS allows online only providers as part of MDPP. c. Combination (any combination of delivery mode – in-person, distance learning, or online).” Commenters #10, #11, and #12/16: Recommend that this organizational level requirement be removed. Commenter #12: Recommends aligning delivery modes with MDPP. Commenter #17: “Suggests requiring one DPRP submission per location utilizing the organization code column to define which modality each participant is in, rather than submitting multiple DPRP reports.” Commenter #19: “The proposed change to delivery modes will create a financial and time barriers to programs… By increasing the delivery modality options, it is possible that an organization would have five organizational codes to track separately, would need to pay additional fees to a data tracking platform, and would have to submit data ten times annually. The change in delivery modes would be acceptable if an organization could track all data in a single csv by simply denoting the cohort delivery modality. This would eliminate time and financial barriers to programs.”	CDC agrees and appreciates the support. We continue to strive to align with the future of healthcare innovation and with the Medicare Diabetes Prevention Program. CDC does not agree to edit or remove delivery mode at the organizational level because this aligns with the current CMS MDPP rule and was jointly approved between CDC and CMS. Organizations wanting to consolidate delivery and data submission into a single orgcode will be able to do so. Organizations will also have the option of keeping delivery modes separate. Lastly, based on DPRP data, it is highly unlikely that one delivery organization would be using all 5 delivery modes.
F. Training	CDC proposed that MOU-holding training entities “have signed an MOU agreeing to train to a CDC-approved curriculum and to provide training nationally or regionally to organizations recognized by CDC. These entities further agree to provide quality training aligned with the DPRP Standards, which should help ensure competent Lifestyle Coaches. In addition to these training entities, formal training for Lifestyle Coaches may be provided by 1) a private organization with a national network of program sites whose Master Trainers were trained by an MOU-holding training entity, 2) a CDC-recognized virtual organization with national reach whose Master Trainers were trained by an MOU-holding training entity, or 3) a Master Trainer who has completed at least 12 hours of formal training as a Lifestyle Coach, successfully offered the National DPP LCP for at least two years, completed a Master Trainer program offered by an MOU-holding training entity, and has a current agreement with the training entity to serve as a Master Trainer. Advanced Coach Training can only be offered by an MOU-holding training entity.”	Commenter #14 and Commenter #18: “This section indicates that master trainers may provide initial coach training but may not provide the advanced coach training that is required annually. This presents a burden for sustainability (salaries/cost investments are cited) for organizations who have invested in a master trainer with the expectation that training for organizational coaches could then be able to be provided by such trainers.” And that the CDC should consider Master Trainers for the offering of Advance Coach Training.”	CDC does not agree to permit individual Master Trainers to develop and deliver Advanced Coach Training (ACT) content. All ACT is developed by either the CDC National DPP, itself, or by the MOU-holding training entities. This is for consistency of trainings/ messaging and for quality control purposes. MOU-holding training entities may have their own requirements and permissions for how they administer ACT, which may or may not allow Master Trainers to provide ACT. Master Trainers should consult the training entity with which they maintain their training agreement to determine whether provision of ACT is allowed.
H. Required Curriculum Content	CDC stated: “The National DPP LCP consists of a series of sessions where Lifestyle Coaches present information, facilitate interactive learning activities, provide outside-of-class activities, and offer feedback in stages to optimize behavior change. The program may be presented in-person or through an online or distance learning modality, or combination thereof.”	Commenter #4: “While [we] believe that the proposed changes to the curriculum for 2024 are acceptable in concept, as they make it easier for more programs to hit their recognition targets, it creates confusion for the programs for how to meet the actual standards. Programs that utilize ADA’s DPP Express electronic documentation and tracking tool, currently have the opportunity to see how their cohorts are progressing to meet the recognition requirements, providing a huge benefit to programs using the platform. For programs who are not using DPP Express, it is difficult to course-correct during the program, due to the length of time it takes to process data.”	CDC did not propose any changes to the use of CDC-approved curricula or how alternate curricula are approved. CDC continues to promote use of the evidence-based PreventT2 2021 and any other curriculum that has successfully undergone the CDC approval process. CDC is unsure how the quoted 2024 DPRP Standards section (i.e., Required Curriculum Content) impacts the DPP Express process. Data collection and burden is addressed later in this table.
I. Guidelines for Session Delivery- Extra and live Lifestyle Coach interaction and Reporting and recording considerations for online organizations	CDC proposed certain “Delivery requirements for online organizations: While CDC is supportive of online delivery of the LCP, there are some extra considerations necessary to allow the DPRP to maintain its quality assurance role when recognizing online delivery. This is especially important in instances where payers are reimbursing CDC-recognized organizations for the LCP as a health or wellness benefit. In particular, the DPRP needs to ensure that delivery of curriculum content is comparable to that of in-person programs.” CDC is requiring proactive outreach only for online programs: “Live Lifestyle Coach interaction is required and should be offered to each participant no less than once per week during the first six months of the program and once per month during the second six months. E-mails and text messages can count toward the requirement for live coach interaction as long as there is bi-directional communication (i.e., organizations may not simply send out an announcement via text or e-mail and count that as live coach interaction; the participant must have the ability to respond to and get support from the live coach).” CDC proposed that the “organization must collect each participant’s weekly physical activity minutes (0 if the participant did not report minutes).	Commenters #11 and #12/16: Both commenters “do not understand why the ‘extra considerations’ are being added, or if CDC deems them necessary, why they do not apply to all program suppliers equally.” And, “CDC does not cite evidence in the proposed standards that fully recognized, online National DPP LCPs are NOT delivering curriculum content that is comparable to that of in-person programs.” Commenters #11 and #12/16: Also stated that the Lifestyle Coach interaction statement (pg. 14) applies only to online organizations and should apply equality to all delivery modalities, as should the AI statement, and as should Knowledge Checks. Commenters #11 and #12/16: Proposed the following language for CDC to consider adapting in their 2024 Standards, “Programs must keep coaches apprised of participant engagement and lesson completion, whether online, in distance learning, or in person. Programs must remind participants to complete their tasks in a manner reasonably consistent with the modality of care. For example, an in-person program should remind participants at the next class or, if it has the technical capability, send between-session reminders electronically. A distance-learning or online program may send reminders automatically and electronically. Reminders, when sent automatically or sent manually, do not constitute substantive interaction between a coach and a member as otherwise specified in the Guidelines unless responded to substantively by the participant.” Commenters #11 and #12/16: “CDC proposes that Online Programs (only) must also be able to confirm accuracy of physical activity minutes that are self-reported CDC proposes that Online Programs (only) must also be able to confirm accuracy of activity minutes that are self-reported. Online National DPP LCP providers are interpreting this to mean that other non-online programs can record self-reported exercise minutes. If activity minutes are suspect when self-reported, they are suspect in all programs and any confirmation requirement should apply to all programs.“ Commenter #13: “Recommends that the CDC outline and/or provide additional guidance for how in-person programs should track session delivery within the DPRP (i.e., excel document, DPRP portal, email).” And, “We would like to encourage the CDC to consider adding additional language to the proposed changes to address health equity concerns that may arise, particularly for people with disabilities.” Commenter #14 and Commenter #18: “Requirements for coach interaction should be the same regardless of delivery type. the requirement to interact with participants no less than weekly for the first six months of the program is not in keeping with the requirements to conduct 16 weekly sessions within this 26-week period. This increases the requirement disproportionately for online programs to interact with each participant an additional 10 times without any opportunity for payment for these additional contacts…Additionally, there is not evidence to support this additional contact requirement. The Diabetes Prevention Program study did not require weekly contact throughout the first 6 months. It required contact at least 16 times in the first 24 weeks, consistent with the current proposed requirements for programs without online components.”	CDC does agree to move some of the extra considerations language that applies to all organizations under a general location. CDC reiterates that the Lifestyle Coach interaction language (pg. 14) is exactly the same as what was contained within the 2021 DPRP Standards. It does apply to all organizations. CDC does not agree to remove this statement. CDC contends that if a participant can actively engage in an online lifestyle change program remotely, even in a rural area, they should be able to similarly communicate with a Lifestyle Coach. Thus, changing communication/interaction requirements should not be necessary. CDC’s National DPP lifestyle change program is the evidence-based, translated, community-level public health intervention resulting, in part, from the DPP research trial and other follow-up efficacy studies (as cited in the accompanying Supporting Statement A. document in this OMB package). The OMB Paperwork Reduction Act process requires that the program be updated with modern evidence. To this end, CDC uses stakeholder feedback, literature reviews, evaluation studies from grantees, and its own DPRP data as evidence for updates. Thus, CDC does not agree to cite further evidence beyond the updated data and evidence used for this package. Our data indicate the need for consistent Lifestyle Coach interaction for program success. CDC will clarify the language in the DPRP Standards to the following: “However, live Lifestyle Coach interaction must be offered to each participant in conjunction with the module being delivered.”
J. Make-up Sessions	CDC stated: “Make-up sessions are not required but are highly encouraged to promote retention.” Part of the make-up session guidance included: “Participants should report the number of physical activity minutes they were planning to report on the day of the session that was missed. Physical activity minutes for a make-up session must reflect the number of minutes performed during the week leading up to the session that was missed. If this information is not available, the organization should record 0. Physical activity minutes for a make-up session must reflect the number of minutes performed during the week leading up to the session that was missed.”	Commenter #4: “The reporting of physical activity minutes during make-up sessions will be confusing to coaches. We recommend requiring coaches to document the actual number of minutes of physical activity that occurred.” Commenter #10: “We strongly urge CDC and CMS to align proposed changes to the DPRP with MDPP, for example, treatment of make-up sessions. CDC’s DPRP allows for one make-up session to occur on the same day as an attended session; however, MDPP does not allow this to occur and will not pay for a make-up session on the same day as an attended in-person session.” Commenter #12/16: “We recommend reverting to the 2021 language: "If a participant attends a make-up session for a session that has not yet been held, it is up to the discretion of the Lifestyle Coach as to which week the minutes should represent."	CDC will amend the guidance to state that, during make-up session coding, participants should always report the number of physical activity minutes performed since their last session attended. CDC will continue to engage in regular conversations with CMS about aligning the National DPP and MDPP wherever possible. CDC does not agree to allow the Lifestyle Coach to decide from which week PA should be reported. Participants should track and then report the total number of minutes of activity performed from the previous session to the session missed.
K. Requirements for Full Recognition- Number of eligible participants for evaluation	CDC proposed the following as Requirement 5 under Full Recognition: “2. Requirement 5: Retaining participants to completer status. a. The evaluation cohort must include at least 10 eligible participants whose cohorts began 12-18 months prior to the data submission month. b. At least 30% of all eligible participants meet the definition of a completer.”	Commenter #2: “The proposed Requirement 5: 10 eligible participants whose cohorts began 12-18 months prior to the data submission month, and 30% of eligible participants meet completer status change from 5 eligible participants in the 2021 Standards is a difficult barrier for smaller programs that start with <10 participants. We work with many community and religious-based National Diabetes Prevention Programs who often only have 5-6 participants and run 1-2 cohorts per year. This would make it difficult for these small providers to obtain Full Recognition. We submit that the number be kept at 5 eligible participants.” Commenters #7, #10, #12/16, #13, and #19 expressed the same concern regarding lowering the minimum number of eligible participants in an evaluation cohort.	CDC agrees to allow the minimum number of eligible participants in an evaluation cohort to be reduced to 5 from 10. However, we still maintain that a minimum of 30% of eligible participants must be retained to completer status in order to advance in recognition based on the results of the evaluation. We understand that enrolling 10 eligible participants in an evaluation cohort could be difficult for smaller organizations. Keeping the 30% retention threshold for evaluation purposes is important because CDC must consider a retention rate that is proportional and equitable across all delivery modalities. This is critical, since better retention generally results in better outcomes.
K. Requirements for Pending, Preliminary, Full, and Full Plus Recognition	CDC proposed allowing DSMES fast-tracking to preliminary for Medicare billing purposes. CDC also proposed in this section: “b. At least 30% of the eligible participants (Section A. Participant Eligibility) meet the definition of a completer.” CDC proposed “A designation of Full Plus recognition will last only until the next data submission.”	Commenter #4: “Appreciates the new option to fast-track an organization to preliminary recognition status for DSMES programs and organizations that are located within a county identified as having high vulnerability. This is a great way to increase the number of MDPP suppliers.” But, Commenter #4 further states that: “…requiring at least 30% of all eligible participants must meet the definition of a completer to achieve preliminary recognition if they are not a DSMES program or located within a county identified as high vulnerability. This could very well become a significant challenge to programs to achieve this recognition. While many other efforts have been created to make it easier to reach this recognition status, this is a requirement that will unfortunately, make it more difficult.” Commenter #9: “Asks that the CDC allow for Full Plus recognition to be measured over a 12-month span to allow organizations who may undergo staffing changes or other unexpected challenges to retain Full Plus recognition.” Commenter #10: Requests that Full Plus recognition, “remove this level completely or have it maintained for 2 or 3 years to address variability in semi-annual data submissions.” Commenter #10: The proposed 2024 standards indicate the DPRP will consider awarding Preliminary recognition to the new delivery mode pending a review.  What will this review include? CDC should provide clarity around what will be needed to ensure this is not subjective.” Also, “Must Requirement 5 be maintained at each data submission or does any data submissions suffice for indefinite preliminary recognition? Also, “Recommends CDC clarify what specifically needs to be included in the semi-annual data submissions. Must Requirement 6 and 7 be maintained at each data submission or does any data submissions suffice for indefinite full recognition?” Commenter #12/16: “We recommend that CDC either grant full plus recognition for an additional two years or eliminate it as a distinct recognition category.” Commenter #13: “Would like additional clarity on the changes made to the period an organization can remain in this status, which changed from 5 years to 6 months (pending data submission evaluation).”	CDC agrees to allow the minimum number of eligible participants to be 5, rather than 10. However, the organization must still retain at least 30% of these participants in order to be eligible to advance in recognition. CDC’s review for possible fast-tracking to Preliminary recognition will include questions that determine whether the organization has the capacity to enroll and deliver the LCP to highly vulnerable populations. Once organizations meet the requirements for Preliminary or Full, they no longer must meet those requirements in order to maintain that recognition status. CDC agrees to extend the expiration for Full Plus recognition beyond 6 months to 12 months.
K. Requirements for Fast-Tracking to Preliminary- Social Vulnerability Index (SVI)	CDC proposed that, “in keeping with CDC’s priority to advance health equity, organizations will be considered for immediate advancement to Preliminary recognition at the time of application approval if they are serving a population that resides in a county classified as having “high” vulnerability according to the CDC/ATSDR Social Vulnerability Index (SVI*). Organizations wishing to be considered under this provision will need to indicate their interest on the DPRP application and will be contacted by the National DPP Customer Service Center for further information about their capacity and experience serving populations in these counties. If organizations meet these additional requirements, immediate advancement to Preliminary recognition will allow them to forego the enrollment and retention requirements organizations need to demonstrate to apply for approval as an MDPP supplier and begin to bill CMS.”	Commenter #10: Asks “is this based on the organization’s zip code or the zip code where they are delivering services (if not where they are physically located)?  How will this be assessed or validated over time?  The proposed standards go on to indicate the DPP Customer Service Center will reach out to orgs for further information about their capacity and experience serving populations in these counties. How will this be assessed?” Recommends that “CDC should clarify what an organization needs to do or share what demonstrates “capacity” and “experience” serving the populations in the county.” Commenter #13: “Recommends that the CDC consider using other data sources, such as the Behavioral Risk Factor Surveillance System (BRFSS) and the Social Vulnerability Index (SVI). The BRFSS also captures disparities in diabetes data that may be missed by the SVI alone. State health departments have indicated that counties within their states may score lower on the SVI. At the same time, other data sources, such as BRFSS, show higher rates of disparities among priority groups.” Commenter #17: “We urge the CDC to clarify what specific Social Vulnerability ranking categories will qualify (e.g. “Very High” Relatively High”). [We] recommend that organizations who are current MDPP suppliers in pending status get fast-tracked to Preliminary if they are identified as having social vulnerability based on the Social Vulnerability Index.”	CDC agrees to offer training via a webinar on the use of SVI data, including how the Customer Service Center will reach out to organizations for further assessment. CDC does not agree to use BRSS data in lieu of, or with, SVI data. CDC states that, in order to apply to become an MDPP supplier, an organization must already have Preliminary recognition, not Pending. CDC has stated in the proposed 2024 DPRP Standards that a qualifying SVI ranking for fast-tracking to Preliminary recognition is, minimally, a ranking of High (which is 0.75-1).
M. Recognition Extensions and Exceptions	CDC stated: “CDC will grant extensions and exceptions to data submission requirements on a case-by-case basis due to extenuating circumstances including, but not limited to, natural disasters, public health emergencies, or unexpected staff losses. However, organizations must communicate these occurrences to CDC as soon as possible so that proper guidance can be given.”	Commenter #4: “We appreciate DPRP understanding the potential extenuating circumstances which may arise for participants and suppliers during the course of a 12-month program, and we welcome the flexibility for program suppliers who may need to change course, or submit data late depending on staffing changes, natural disasters, or the like.”	CDC agrees to remain flexible during such circumstances and thanks this commenter for their feedback.
III. Applying for Recognition	CDC proposed defining a Master Trainer on the Application data collection instrument as follows: “16. Lifestyle Coach Training Entity. Provide the primary training mechanism the applicant organization will use or has used to train their main Lifestyle Coaches. Choose from 1) a private organization with a national network of program sites whose Master Trainers were trained by an MOU-holding training entity; 2) a CDC-recognized virtual organization with national reach whose Master Trainers were trained by an MOU-holding training entity; or 3) a Master Trainer (has completed at least 12 hours of formal training as a Lifestyle Coach, successfully offered the National DPP LCP for at least two years, completed a Master Trainer program offered by an MOU-holding training entity, and has a current agreement with the training entity to serve as a Master Trainer).	Commenter #4: “Applying for Recognition. We would like to raise one concern about the requirements to become a Master Trainer. Requiring a coach to have two years of experience (versus one year) will reduce the number of people able to serve as master trainers, potentially causing hardship for programs due to the cost of training coaches. It is critical that we are not only encouraging as many participants to join in the program, but that we are making it accessible as possible to attract and maintain quality coaches who are key to increased retention in the program.”	CDC does not agree to change the two-year minimum coaching experience requirement for Master Trainers. Feedback from MOU-holding training entities and health and wellness coaching subject matter experts has suggested that one year of experience with one cohort does not provide the depth of knowledge and skills Master Trainers need to sufficiently train and provide ongoing support for Lifestyle Coaches. Two years or more appears to be the key to improved organizational outcomes. Additionally, the National DPP does not need as many Master Trainers as Lifestyle Coaches. This requirement is for Master Trainers only, and a minimum of two years’ experience is preferred.
IV. Submitting Evaluation Data to the DPRP- New social needs assessment variables	CDC proposed the following new social needs assessment variables: “5) Social Needs Assessment (new; optional- not tied to CDC recognition). This variable indicates whether the participant received an assessment for health-related social needs within the last year, either by the organization or another organization. Organizations are not required to conduct social needs assessments. 6) Social Needs Identification (new; optional- not tied to CDC recognition). This variable allows the organization to list up to 3 primary needs that were identified for the participant through the social needs assessment. Examples of response options are “Employment Assistance,” “Food and Nutrition Assistance,” or “Transportation.” If the response was “No” or “Unknown” to the previous question, or if no needs were identified, “Not applicable” should be entered. 7) Social Needs Action (new; optional- not tied to CDC recognition). This variable indicates whether the organization took action to meet one or more of the identified social needs for the participant. CDC does not require organizations to take action if unable to do so.”	Commenter #4: “Has concerns about the following requirements related to the social needs assessment for participants, and we strongly request that the CDC remove them. Requiring the Social Needs Assessment (SNA), Identification, and Action to be completed during the first session is not a realistic goal for any program. Programs that do implement these assessments, generally accomplish this over the first few sessions, as it is unrealistic to believe that a coach would be able to identify and act upon the needs of each of the 12 participants. It should be noted that many coaches still complete these SNAs on paper, which would make this process even more difficult to accomplish during the first session. Once the coach completes the SNA, they would then have to review all of the assessments and identify each of the participant’s needs, which would likely: (1) require individual discussions with each person about their needs, (2) require the coach to make referrals for each participant, potentially to internal and external support programs, and (3) ensure that the proper services are provided to each of these 12 people on the same day by both internal and external organizations. Further, providing a 50-character-only open text box for the coach to summarize each participant’s social needs and demographic information creates an additional burden for programs, as well as the CDC, as the data will not be consistent and difficult to evaluate. It is also difficult to only allow these assessments to happen once during the 12-month program as lifestyle and health changes may occur more than once.” Commenter #7: “Please clarify if these questions are to be asked in the beginning at enrollment and if so, are we requiring a healthcare professional… We are concerned about what follow-up is needed for SDOH needs identified.” Commenter #8: “Perhaps there is a way for suppliers to provide aggregate data related to Social Determinates of Health variables to limit the burden of accessing participant level data when our program would not be the ones actually doing SDOH screenings.” Commenter #11: “We strongly believe that, where healthcare programs ask for sensitive personal information, potential participants are hesitant to supply it. This in turn may cause potential participants to turn away from care. For this reason, we believe that social needs assessment data should not be required.” This commenter cites literature here. Commenter #10, #12/16 and #15: For both the SNA and Disabilities variables: “Given the sensitive nature of these questions, adding them will deter program enrollment… participants may experience survey fatigue or be turned off by the volume of questions… We believe that assessment on its own without action will be ineffective and that CDC should have suppliers collect this information only if the data will be acted upon.” Commenter #15: Stated the above and asked CDC to consider alternate means to collect these data. Including, “a survey of enrollees after they have attended several sessions, e.g. after they are engaged and feel comfortable with the program; or a random sample of enrollees AFTER enrollment.” Commenter #13: “Would encourage CDC to include training and skill-building resources” on collecting and reporting new social needs variables.” Commenter #17: “For Social Needs Identity, there should be a drop-down response for 5 CMS (employment, affordable and stable housing, healthy food, personal safety, transportation, and affordable utilities, Other) to eliminate data errors and standardize quality of the data. For Social Needs Action, it will certainly take longer than day of enrollment to find help for participants due to the complexity of social needs as well as the scarcity of resources. It will therefore not be possible to accurately respond to this question at intake and we recommend the CDC remove this question or provide additional time and a documentation space to report on this metric. [We] also recommend adding a third response to this question, “Refused”. In addition we ask the CDC to clarify what happens if needs had been identified and/or addressed at any time during the program--would the answers to the variables need to be changed (i.e. mid-program or end of program)?”	CDC, after hearing from key stakeholders, agrees to remove the Social Needs Assessment variables.
IV. Submitting Evaluation Data to the DPRP- New 6-point disabilities variables	CDC proposed the following new 6-point disabilities variables in the 2024 DPRP Standards asking if participants: “1. have difficulty hearing, 2. difficulty seeing, 3. have memory or concentration issues, 4. have difficulty walking or climbing stairs, 5. have difficulty dressing or bathing, or 6. have difficulty running errands: 20) Participant’s Disability Status (new). These variables refer to a six-part disability question to be asked only one time upon participant enrollment.”	Commenter #4: “Disability-Related Questions: [We] are unsure as to why these questions are being asked and how they will be used to help the participant, or the program, improve outcomes. Due to the personal nature of these questions, as well as the number of additional questions included here, we are concerned that requesting this information might actually deter individuals from participating in the program. It is also important for coaches to build trust with their participants at the outset and requiring completion of such a lengthy form significantly disrupts the relationship-building process. Further, it becomes even more cumbersome and risky to require suppliers to manage additional HIPAA-protected information. We encourage CDC to streamline some of these additional requirements on suppliers. We recommend that these questions be removed.” Commenter #8: “We feel that the proposed variables should be optional and not required reporting measures for all participants. We are concerned that in the short term, participants that identify themselves as having these variables would be encouraged not to join DPP as some of the reported variables are counter intuitive to program goals. This would limit access for these participants and DPRP would not get data on these participants.” Commenters #9, #10, and #11 echoed Commenter #8’s concerns. Commenter #10: “1. Given the complexity of assessing disability status, suggest CDC remove these proposed data elements from the 2024 proposed standards. 2. If collection of these data elements is required, CDC should add a “Not Reported” option in the Coding/valid values similar to the guidance provided for the Ethnicity and Race data elements.” Commenter #12/16: For both the SNA and Disabilities variables: “Given the sensitive nature of these questions, adding them will deter program enrollment… participants may experience survey fatigue or be turned off by the volume of questions… We believe that assessment on its own without action will be ineffective and that CDC should have suppliers collect this information only if the data will be acted upon.” Commenter #17: “Adding the additional 6 required intake questions proposed will add time to the intake process and would increase administrative burden. Please provide guidance on what accommodations would be required by the delivery organization to support equitable outcomes for all participants and what resources would be available from CDC to achieve these.”	CDC does not agree to remove the 6-point disabilities variables. However, we do agree to add a ‘Participant chose not to respond’ data variable option if participants cannot, or choose not to, respond. CDC is collecting this information to gain greater insight into the need for adapting the lifestyle change program to support persons with disabilities. CDC believes that organizations should be interested in knowing how their program delivery or materials could be adapted for their participants with disabilities. The CDC Office of Health Equity has identified persons with disabilities as a priority population. This is a goal area for CDC and its programs. CDC does contend that organizational processes should allow for HIPAA protection already and should be firmly in-place, as required for this program. In an effort to decrease the burden on organizations, CDC has proposed the option of submitting intake information on participants once via a separate CSV. In addition, we have included the new disability variables on the optional Participant Enrollment Form (Appendix D) to make data collection easier.
IV. Submitting Evaluation Data to the DPRP- New participant Zip Code	CDC proposed collecting the 5-digit zip code in which the participant resides.	Commenter #7: “Would suggest using 9-digit code to drill down to better demographics data for at risk or vulnerable populations.”	CDC does not agree to request a 9-digit zip code from participants, as we feel that most people do not know their 9-digit zip code. It would be the responsibility of the CDC-recognized organization to look up these codes for each participant, which would be an added burden. The use of the 9-digit code also raises privacy concerns, as it may drill down to a geographic location that could identify a participant’s address.
IV. Submitting Evaluation Data to the DPRP- New race/ethnicity variables added for Middle Eastern and North African participants, and New gender variable	CDC added a Middle Eastern or North African field to further capture participants’ self-identified race/ethnicity, and to align with new OMB requirements. CDC further added a free-text, write-in option.	Commenter #8: “We would caution adding a write-in option for race/ethnicity. Our experience is that the answers from a write-in option for this question have primarily been inappropriate. We recommend including an ‘Other’ option for those that do not fit the listed populations.” Commenter #11: “Gender Data…Suggest that any requirement from CDC makes clear that, where a program complies with other applicable law, the program also meets CDC requirements.” Commenter #17: “We ask the CDC to clarify how will write-in options be collected in a standard method to account for misspellings and other variables that free text would allow? Is the proposal to have a “write in” for both race and ethnicity?”	CDC does not agree to eliminate the write-in option and include an ‘Other’ option instead. This would not allow participants to sufficiently provide detailed information on their self-reported race and/or ethnicity, which is essential to collect in order to better understand the participant population and ensure the accessibility and cultural appropriateness of the program, in alignment with CDC’s goals of advancing health equity. The inclusion of a write-in option is consistent with revisions to the Office of Management and Budget Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity. Use of “Other” would create a heterogeneous category for which no meaningful or informative analyses or conclusions – and subsequent program guidance decisions – could be made. Any “inappropriate” submissions will not be added to the DPRP Portal or reported publicly. CDC feels the Safety of Participants and Data Privacy section of the proposed 2024 DPRP Standards makes it clear that CDC-recognized organizations should adhere to any State or Federal laws they fall under. CDC is providing the gender category in compliance with OMB specifications.
Appendix F. Guidance for Measuring/Recording Weight and Reporting Physical Activity Minutes	CDC provided guidance that “9. Weight should be recorded to the nearest tenth of a pound (for example: 184.6, 223.1).”	Commenter #11: “If the organization cannot confirm the accuracy of the outlier, it must be changed to the default entry of 999 and the session will not be counted as complete [or in the alternative “and the session will be counted as complete”].” Commenter #12/16: “We propose this edit to your sentence: “Each time a participant attends a session, his or her body weight should be measured and recorded to the nearest whole tenth of a pound if using a digital scale, or to the nearest pound if using an analog scale.”	CDC does not agree to this change. Sessions where a weight is not submitted are still considered completed sessions if the curriculum content has been delivered. CDC offers a default value for weight when the organization is not able to obtain it from the participant.
General comments- Data collection burden	CDC proposed the general burden hours of 1 hour for the Application data instrument and 2 hours (twice per year) for the Evaluation data instrument. CDC also proposed the new variables highlighted above.	Commenter #1 and #5 (same comments sent twice): “I am asking that the CDC please limit the amount of data organizations must obtain from participants to allow the most swift and least burdensome implementation of this program for both organizations and participants. Please do NOT enforce organizations to collect the proposed additional information.” Commenter #3 and Commenter #6 in stating support for Commenter #3: “General Comment. Collecting, entering, and submitting the current data elements already place a significant burden on suppliers, large and small. We are lucky to have an electronic health record, but every time there is a change to these data elements, we have to request an analyst who can update the participant questionnaire in our EHR and update the flowsheets/ reporting. Due to staffing issues and competing demands from other larger programs, the last update took 18 months to complete, which meant our program coordinator had to hand enter all of new data elements for three separate submissions. We were starting new groups every month, containing 8-10 people in each cohort, which meant a lot of time and burden for someone who was also working on several other projects. We are no longer able to offer as many classes because we don't have the administrative staff to support this type of work. This program is not reimbursed well enough to support the administrative requirements to maintain accreditation. There have been talks from leadership about discontinuing this program due to how expensive and resource-heavy it has become to facilitate. We should be collecting fewer data elements for an evidence-based program, not more. This is such a great program for participants. It has been life- changing for many, but the administration of it is becoming too burdensome.” Commenter #12/16: Lists 12 action steps, including additional literature reviews, surveys, data analyses, etc. before adding the SNA and disabilities variables. Commenter #17: “The additional questions proposed that will need to be placed on our existing registration form, plus the addition of the Diabetes Risk Test, will create a document that is rather lengthy for potential participants to complete. The proposed questions may also add additional reading level challenges for participants who are completing the form. We recommend the CDC decide on which questions are absolutely needed to maintain this program and eliminate other questions that propose an undo burden…We urge the CDC to offer additional supports to delivery organizations when proposing additional collection metrics and advocating for advocating for increased reimbursement rates for both public and private payers to help offset the increased administrative burden. Adding administrative burdens without resources is not sustainable in the long-term.”	CDC understands and respects the commenter’s concerns. While we do not agree to eliminate the data elements proposed, we do feel it is important to clarify and justify the data collection proposed within the 2024 DPRP Standards: Per Supporting Statement A, which accompanies the overall OMB package, CDC anticipates that, for most respondents, the majority of one-time application data elements will be a subset of the program data elements already collected and maintained at the organization level (including the organizational contacts). For MDPP suppliers, DPRP data elements are directly tied to CMS reimbursement. Thus, it is anticipated that respondents will be willing to collect and report such data. The new variables align with recommended CDC science, the Office of Health Equity, and with OMB requirements. Specific responses to race/ethnicity variables and disability variables are not used for CDC recognition purposes. If a participant does not respond to these questions, a CDC-recognized organization can use the ‘participant chose not to respond’ variable code accordingly. CDC is always available to provide technical assistance to any organization in need of data collection and reporting support. Please do not hesitate to contact the National DPP Customer Service Center at [email protected]. We can offer support on a case-by-case basis.
Miscellaneous comments- Session delivery time across delivery modalities and make-up sessions	CDC states, five times throughout the proposed 2024 Standards document that, “Each session must be of sufficient duration to convey the session content (approximately one hour).” Or that session delivery, or make-up sessions “should be approximately one hour in duration.”	Commenter #15: “Setting the length of time for each session is likely to lead consumers to either not enroll or drop out when they realize sessions are repetitive just to meet a random time requirement, it is not aligned with the need for these programs to effectively serve consumers within the time frames they have available, e.g. a 45 minute lunch hour for example. We urge CDC to limit curriculum standards to those that are evidence based.”	CDC does not agree to change the approximate length of session delivery time, as this has been the requirement since the first iteration of the Standards. This is not a new requirement. This is an evidence-based ‘dose response’ based on the original 2002 DPP trial and follow-up efficacy studies. It is also based in ongoing program and grantee evaluation. We do acknowledge that participants enrolled in online programs may not need the full hour to complete the module. However, the time it takes to go through the material, in addition to the associated coach interaction, should be approximately 1 hour.
Miscellaneous comments- Granting access to summary evaluation reports to Data Preparers	CDC proposes who/which roles will have access to evaluation reports in Table 1. System Permissions for Each Role in the DPRP Data Submission and Administration Portal. Data preparers do not currently have access to Evaluation Summary and Reports for Dissemination.	Commenter #10: Recommends granting “data preparers system permission for download of the Evaluation Summary & Reports for Dissemination for the organizations for which they are preparing data.”	CDC does not agree to allow data preparers access to evaluation reports, because some organizations use third party administrators to submit data on their behalf. We must consider that some organizations will not want an external party seeing their evaluation results. In addition, the Program Coordinator or Secondary Contact can always forward the report to additional parties.
Miscellaneous comments- General Health Equity concerns	CDC proposed new risk reduction markers for achieving Full recognition in an effort to further address health equity.	Commenter #10: “To prevent organizations from being dis-incented to serve low-income individuals or to include data only from specific participants in their data submissions, [we] urge CDC to regularly address health equity in its training and technical assistance,” and, “urge CDC to consider the socioeconomic status (SES) of program participants and how this may impact CDC recognition and DPP participant outcomes more generally, and risk adjust for these factors.” “In addition, we encourage CDC, when working with payors, including CMS, or organizations focused on business development, to incorporate the concept of risk adjustment to payments to ensure sufficient resources are available to reach and enroll participants who face additional challenges, such as the ones listed above, in the DPP.”	CDC does not agree to collect additional SES data. CDC researched requesting income data from participants for the 2018 and 2021 revisions of the DPRP Standards. Program specialists, researchers, DDT economists, and other key stakeholders were involved. A literature review was conducted as well. It was determined that persons participating in public health programs are less likely to feel comfortable reporting income as a measure of SES as opposed to education. Thus, the DPRP collects education attainment information from participants as a proxy for SES. As a public health agency, CDC does not have any authority to recommend payer policies. However, we will continue to publish findings based on analyses of DPRP data that address health disparities. CDC will also continue to provide guidance to CDC-recognized organizations on how to leverage new Medicare and Medicaid coverage provisions that help support participants with their health-related social needs.
Miscellaneous comments- Transition to the 2024 DPRP Standards	CDC routinely, with each iteration of the DPRP Standards, allows a transition period for data submission and hosts webinars to assist with learning the new Standards and transitioning to them.	Commenter #10: “How will data on inflight participants be assessed against the 2024 standards? In past transitions, CDC has, for a period of time, assessed inflight participants against both sets of standards. Is that how this transition will work? If so, we recommend CDC includes analysis on both standards (2021 and 2024) on the Evaluation Summary & Reports for Dissemination to help organizations see how their data holds up against both sets of standards. • While data systems are adapted to the new standards over the 6-month transition to the new standards, [our org] would like CDC to allow orgs to submit in either format (2021 standards or 2024 standards) during this window. • Will CDC allow organizations to enter default options or exempt organizations from providing new data elements on the participants that began prior to the start date of the 2024 standards or during the 6-month transition period? To account for the time needed for data system updates, organizations may need either default options or an exemption for these data elements – even after the new standards launch.” Commenter #17: “Asks the CDC to provide guidance on how data should be prepared and sent to DPRP for sites who have participants who started with the ’21 standards and participants who started with the ’24 standards.”	CDC does not agree to evaluate ongoing participants under both sets of Standards. Our system will not accommodate this request. We do agree to allow organizations to upload a file in the 2021 format for entering data into the conversion tool only. Once converted, organizations will need to download the new file and resubmit it in the 2024 format. The conversion tool will be active for 6 months. CDC does agree to allow organizations to enter default values (where applicable) for participants who came into the program before June 1, 2024, or before the time the new Standards go into effect.

9. Explanation of Any Payment or Gift to Respondents

No payments or gifts will be offered to organizations that seek CDC recognition through the DPRP.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

1. This submission has been reviewed by CDC’s Information Collection Review Office, as well as DDT’s program office, and both determined that the Privacy Act does not apply. Although the DPRP Application Form includes PII (the name and contact information of each organizational entity’s contact person and data preparer), this only provides information relating to their designated roles in the organization; personal information is not provided to CDC. The data submitted to CDC for evaluation purposes is identifiable by organizational entity. The participant-level evaluation data submitted to CDC does not include participant names, only participant codes (never linked to actual names). The organizational entity requesting CDC recognition through the DPRP assigns and maintains these participant codes.

2. Application form information and evaluation data are submitted to CDC via online forms. These transmission methods were reviewed and determined to be secure by CDC’s Information Systems Security Officer. Data are maintained on a password protected computer in secure CDC facilities and accessible only to DPRP staff (CDC personnel and onsite contractors) for approved analyses. CDC protects the data to the extent required by law. CDC does not collect, release, publish, or disclose PII relating to individual program participants. CDC publishes only aggregated data. At the discretion of DDT or National DPP leadership, aggregated data at the organizational, state, regional, or national level may be shared with external partners for the purpose of preparing reports or manuscripts or for providing targeted technical assistance.

3. Consent: Respondents are organizational entities, not individuals. Organizational consent is established by submission of the DPRP application form and evaluation data.

4. Nature of Response: Participation by organizations is strictly voluntary. Organizations may withdraw from the DPRP at any time by not transmitting evaluation data or for reasons specific to the organization. No additional withdrawal notification is required.

Data will be kept private to the extent allowed by law.

Privacy Impact Assessment

There are no changes to Privacy aspects of this package. (Att PN 0920 0909)

Overview of the Data Collection

Respondents are organizational entities that deliver the National DPP LCP and seek CDC recognition through the DPRP. Two types of information are being collected: application data and evaluation data. The currently approved online DPRP application form (Attachment 4A) is being revised and is located on the National DPP web site (Diabetes Prevention Recognition Program Application | CDC). The new application form (Attachment 4A) will replace the current form and may be submitted at any time beginning March 1, 2024. The information contained in the application is needed to communicate with the organization and provide technical assistance. Evaluation data are transmitted to the DPRP by organizations every 6 months in accordance with the DPRP Standards. These data are needed to assess recognition status according to objective criteria, assure fidelity to DPRP Standards, identify opportunities for quality improvement or technical assistance, and align with the MDPP Expanded Model to allow organizations to apply as MDPP suppliers and bill CMS for Medicare beneficiaries who participate in the program. To minimize the burden on organizations and ensure the quality and utility of the data, evaluation data are submitted to CDC using the DPRP’s interactive web application (Attachment 4A, Attachment 4B).

Information to Be Collected

A. Application data elements: Applicants for recognition are organizational entities, not individuals. The data elements collected on the DPRP application include some information in identifiable form (PII); however, the identifiable information is only that needed to enable communication with each organization’s designated contact person(s). The application form (Attachment 4A-screenshot) includes all of the following elements. There are no new data elements, but there are some updated descriptions/follow-up questions for some of the elements.

Below are the application data elements described in this revision of the DPRP Standards. New or revised elements for this fourth revision are marked accordingly:

1) Type of Application. Select Initial if this is the first application being submitted. Select Reapplying if this is a subsequent application due to previous withdrawal or loss of recognition. If an organization chooses to change their curriculum to another CDC-approved curriculum, a notification to CDC through the National DPP Customer Service Center at Home (cdc.gov) is required, and no further steps are needed involving the application until further notice from CDC.

2) Organization Code. This code is assigned by the DPRP. Organizations reapplying should enter the previously assigned organization code.

3) Organization Name. Upon application approval, the organization name will be published in the DPRP registry at: Diabetes Prevention Recognition Program Registry | CDC and in the CDC Find a Program locator at: Find a Program | Diabetes | CDC.

4) Organization Physical Address. Provide the main organization’s business office or headquarters address. Upon application approval, this will be published in the DPRP Registry and in the CDC Find a Program locator.

5) Organization Web Address or URL. Upon application approval, this will be published on the DPRP Registry and in the CDC Find a Program locator. All web addresses must link directly to a location where participants can find information about the organization’s CDC-recognized National DPP LCP and enroll in the program. CDC will not accept or host any other web addresses, including those that appear to endorse commercial products or services, diets, or dietary supplements in association with the National DPP LCP. Applications with web addresses promoting such products/services will be rejected.

6) Organization Phone Number. Provide the number that participants, payers, and others should call to obtain information about the program. Organizations should not provide a 1-800 number unless a live operator is available. Upon application approval, this phone number will be published in the DPRP Registry and in the CDC Find a Program locator.

7) Organization Type. Choose the option that best describes the organization type. This refers to an organization’s main headquarters location or main office: Local or Community YMCAs; Universities/Schools; State/Local Health Departments; Hospitals/Health Care Systems/Medical Groups/Physician Practices; Community-based Organizations; HRSA-funded Federally Qualified Health Centers (FQHCs), Community Health Centers, or Lookalikes; Pharmacies/Drug Stores/Compounding Pharmacies; Tribal Programs, Tribal Serving Organizations, Urban Indian Health Systems, Indian Health Service; Cooperative Extension Sites; Worksites/Employee Wellness Programs/Private Businesses; Senior/Aging/Elder Centers; Health Plans/Insurers; Faith-Based Organizations/Churches; ADA-recognized Diabetes Self-Management Education and Support (DSMES) Organizations/ADCES-accredited DSMES Organizations.

8) Delivery Mode (revised). An applicant organization can select one delivery mode for each application submitted [In-person, Distance Learning, In-person with a Distance Learning Component, Online, or Combination with an Online Component.]. Delivery modes will be published in the DPRP Registry and in the CDC Find a Program locator. For definitions, see Section D: Delivery Mode. Once a delivery mode has been selected, the application will populate with delivery mode-specific follow-up questions.

9) Program Coordinator Name. Provide the name of the individual who will be the applicant organization’s Program Coordinator. Provide a salutation [e.g., Mr., Mrs., Dr., Ms., Miss, other (please specify); last name; first name; and middle initial]. The Program Coordinator’s name will not be included in the DPRP Registry or the CDC Find a Program locator.

10) Program Coordinator Contact Information. Provide the phone number and email address of the organization’s Program Coordinator. DPRP staff will use this information to communicate with the organization. All DPRP-related documents, reports, and emails will go to the Program Coordinator. The Program Coordinator’s contact information will not be included in the DPRP registry or the CDC Find a Program locator.

11) Secondary Contact Name. Provide the name of the individual who will be the applicant organization’s Secondary Contact, if applicable. Provide a salutation [e.g., Mr., Mrs., Dr., Ms., Miss, other (please specify); last name; first name; and middle initial]. The Secondary Contact’s name will not be included in the DPRP registry or the CDC Find a Program locator.

12) Secondary Contact Information. Provide the phone number and email address of the organization’s Secondary Contact, if applicable. The Secondary Contact’s contact information will not be included in the DPRP registry or the CDC Find a Program locator.

13) Data Preparer Name. Provide the name of the individual who will be the organization’s Data Preparer. If a Data Preparer is not designated, the Program Coordinator or Secondary Contact may submit data for the organization. Provide a salutation [e.g., Mr., Mrs., Dr., Ms., Miss, other (please specify); last name; first name; middle initial; and affiliation). The Data Preparer’s name will not be included in the DPRP registry or the CDC Find a Program locator.

14) Data Preparer Contact Information. Provide the phone number and email address of the organization’s Data Preparer. DPRP staff will use this information to communicate with the organization about data submission issues, if required. The Data Preparer’s contact information will not be included in the DPRP registry or the CDC Find a Program locator.

15) Class Type. Select all applicable class types offered: public (open to anyone who qualifies for the National DPP LCP without further restrictions), employee (open only to employees of the CDC-recognized organization or the host organization), member-only (open only to member insureds; membership required) or other (write in target audience served, such as American Indian/Alaska Native persons, patients, clients, etc.). Organizations offering the program to the public are required to provide/update the physical addresses of their delivery sites in the manner that CDC specifies with their 6-month data submissions. Upon application approval, the class type will be published in the DPRP Registry. Additional information, such as public class information [addresses, if insurance is accepted (optional) or program costs (optional)], will be published in the CDC Find a Program locator. CDC-recognized organizations are expected to update their public class location information regularly. MDPP suppliers must report all active delivery locations in the DPRP Data Portal in the Class Information section.

16) Lifestyle Coach Training Entity. Provide the primary training mechanism the applicant organization will use or has used to train their main Lifestyle Coaches. Choose from 1) a private organization with a national network of program sites whose Master Trainers were trained by an MOU-holding training entity, 2) a CDC-recognized virtual organization with national reach whose Master Trainers were trained by an MOU-holding training entity, or 3) a Master Trainer (has completed at least 12 hours of formal training as a Lifestyle Coach, successfully offered the National DPP LCP for at least two years, completed a Master Trainer program offered by an MOU-holding training entity, and has a current agreement with the training entity to serve as a Master Trainer).

17) Curriculum. Select either a CDC-approved curriculum (one that CDC has either developed or previously approved for use by your or another organization) or ‘Other Curriculum’ if the applicant organization is submitting an alternate curriculum for review and approval. If selecting Other Curriculum, provide the completed yearlong curriculum with any supplemental materials, handouts, or web-based content together with the application.

18) Projected start date (new). Provide the projected first cohort start date, if available.

B. Evaluation data elements: Each CDC-recognized organization (Pending, Preliminary, or Full) transmits evaluation data (Attachment 4B) to CDC every 6 months, beginning 6 months from the organization’s effective date. Evaluation data are submitted to CDC via an online web application form. Data from all of the lifestyle change program sessions conducted by the organization during the preceding 6 months must be included in this transmission.

No PII is transmitted to CDC during evaluation data submissions. All identifiers (except the organization code that is provided by CDC) are assigned and maintained by the CDC-recognized organizations. Any MDPP-related PII is stored at the organization level only and not transmitted to CDC. MDPP suppliers will work directly with CMS to bill for qualifying Medicare participants based on any rule, law, or policy governing data storage and communication from CMS. All participants in CDC-recognized lifestyle change programs are 18 years of age or older.

Below are the evaluation data elements included as described in this revision of the DPRP Standards. New or revised elements for this fourth revision are marked accordingly:

1) Organization Code. The organization code will be assigned to the organization by the DPRP at the time of application approval. There will be one organization code per each delivery mode.

2) Participant ID. Participant IDs will be assigned by the organization to uniquely identify and track each enrolled participant. The Participant ID must be included on all session attendance records generated for individual participants. The Participant ID may not be based on a participant’s name, social security number, date of birth, or other PII and can never be reused.

3) Cohort ID. The Cohort ID will be assigned by the organization to uniquely identify and track a group or individual cohort. The Cohort ID must be included on all session attendance records generated for individual participants. The Cohort ID for an individual participant cohort (rather than a group participant cohort) must be equal to the participant ID. The Cohort ID may not be based on a participant’s name, social security number, or other PII. Cohort IDs should never be reused.

4) Coach ID. A Coach ID will be assigned by the organization to uniquely identify and track Lifestyle Coaches. The Coach ID must be included on all session attendance records generated for individual participants. The Coach ID may not be based on a coach’s name, social security number, or other PII. Lifestyle Coaches who deliver the MDPP should use their National Provider Identifier (NPI) as their Coach ID.

5) Enrollment Motivation. This variable identifies the main motivation which led the participant to enroll in the yearlong program.

6) Enrollment Source. This variable identifies whether a health care professional was the source which led the participant to enroll in the yearlong program.

7) Payer Type (revised). This variable identifies the main payment method the participant is using to cover the cost of their participation in the yearlong program.

8) Participant State. The state in which the participant resides. The two-letter postal abbreviation for the US state, territory, or freely associated state should be used. Organizations that deliver the LCP to US citizens residing outside of the United States, its territories, or freely associated states should default to the participant’s US state of residence or US Army Post Office (APO) address.

9) Participant Zip Code (new). The 5-digit zip code in which the participant resides.

10) Participant’s Age. Age should be recorded at enrollment.

11) Participant’s Ethnicity and Race (revised). Ethnicity and race should be recorded at enrollment. The participant should self-identify and choose one or more of the following: American Indian or Alaska Native, Asian or Asian American, Black or African American, Hispanic or Latino, Middle Eastern or North African, Native Hawaiian or Other Pacific Islander, and/or White. Multiple responses are allowed. This element requires responses for seven fields, and each field includes a response.

12) Participant’s Ethnicity and Race - Additional Information (revised). Participants may give additional information about the nationality, ethnic group, or culture with which they identify. Organizations should collect this additional information as a write-in option and refer to the Participant Intake Form.

13) Participant’s Sex. Sex should be recorded at enrollment. The participant should indicate the sex they were assigned at birth on their original birth certificate. The data record should indicate male or female.

14) Participant’s Gender (revised). Gender should be recorded upon enrollment. The participant should indicate how they describe themself. Multiple responses are allowed. The data record should indicate man; woman; transgender, non-binary, or another gender; or not reported.

15) Participant’s Height. Height should be recorded at enrollment. Height may be self-reported (i.e., it is not necessary to measure each participant’s height; the participant may simply be asked, “What is your height?” or “How tall are you?”). If the participant provides their height in feet and inches, please note that this must be converted to the nearest whole inch for submission.

16) Education. Education will identify the highest grade completed by the participant. This information should be recorded at enrollment.

17) Participant’s Disability Status (new- not tied to CDC recognition). These variables refer to a six-part disability question to be asked only one time upon participant enrollment. A ‘Participant chose not to respond’ variable option is available.

18) A1C Value. This optional data element is available only to participants who enter the program with a GLUCTEST value of 1 and an initial A1C value within the prediabetes range of 5.7% to 6.4%. The initial A1C value should be taken within a year before entering the program and reported within 14 days of the first session attended by the participant. A final A1C value must be the result of a test administered in months 9-12 and included with the participant’s completion records.

19) Participant’s Prediabetes Determination. Prediabetes determination should be recorded at

enrollment and included on all session attendance records generated for an individual participant. This indicates whether the participant’s prediabetes status was determined by a blood test, a previous diagnosis of GDM, or by screening positive on the ADA/CDC Prediabetes Risk Test (see guidance titled ADA/CDC Prediabetes Risk Test).

20) Delivery Mode. This variable identifies the delivery mode, as defined in the Applying for Recognition section, for the specific participant and session (i.e., in-person, online, distance learning). Please note that, since this is a session level variable, the combination mode does not apply.

21) Session Type. This variable identifies the session attended within months 1-6 (scheduled Core sessions) as “C”, Core Maintenance sessions attended within months 7-12 as “CM”, or Ongoing Maintenance sessions as “OM” in the second year (any sessions attended outside the yearlong National DPP LCP) for organizations that choose to offer Ongoing Maintenance sessions. Data submitted for Ongoing Maintenance sessions will not be evaluated for CDC recognition. Make-up sessions will be identified as “MU-C” if the participant attends the session in months 1-6. Make-up sessions will be identified as “MU-CM” if the participant attends the session in months 7-12. Make-up sessions will be identified as “MU-OM” if the participant is making up a session in the second year (post-yearlong National DPP LCP).

22) Session Date. Each time a participant attends a session, the actual date of the session should be recorded. The date should be recorded in mm/dd/yyyy format. A participant should not have more than one record (line of data) for any specific session date, with the following exception: One make-up session may be held on the same date as a regularly scheduled session for the convenience of the participant. For online sessions, organizations should record the date each session is completed.

23) Participant’s Weight. Each time a participant attends a session, his or her body weight should be measured and recorded to the nearest tenth of a pound. The weight should be included on the record for that participant and session. For online programs, organizations should record the weight associated with the session completion date. CDC will employ statistical methods to determine weight outliers. If the organization cannot confirm the accuracy of the outlier, it must be changed to the default entry of 999.

24) Participant’s Physical Activity Minutes. Participants are required to report the number of minutes of moderate or brisk physical activity completed since the previous session. The total number of minutes performed should be included on the record for that participant and session. If a participant reports doing no activity since the last session, or if they have not tracked their minutes, then zero (0) minutes should be recorded. Please note that participants should strive to achieve the weekly goal of 150 minutes, on average.

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

IRB Approval

The DPRP was initially reviewed by human subjects contacts in CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) in 2011, and the Center determined the DPRP’s function to be public health practice, with no research involving human subjects (Attachment 6). The HS Contact reviewed this project and nothing has changed since the original determination. Therefore, review by an Institutional Review Board is not required.

Justification for Sensitive Questions

Although all data submitted are de-identified, some data elements such as prediabetes status, weight, education, A1C values, , and attendance might be considered sensitive information. It is essential that this information be provided to the DPRP. Without this information, the DPRP cannot support CMS in implementing and evaluating the MDPP Expanded Model, monitor program delivery to ensure that quality programs are being delivered to individuals with prediabetes or at high risk for type 2 diabetes, or evaluate program effectiveness to ensure that participant cohorts are meeting attendance requirements and achieving weight loss outcomes proven to prevent or delay type 2 diabetes. In order to monitor program effectiveness and assure that CDC-recognized organizations are delivering science-based, effective programs to all eligible participants regardless of race/ethnicity, age, gender, sex, SES (i.e., education), and disability status, organizations transmit de-identified, coded information about participant demographics, prediabetes status, weight loss, A1C values, and session attendance to CDC.

It is important to emphasize that CDC does not collect or receive directly identifiable information about participants.

12. Estimates of Annualized Burden Hours and Costs

1. Burden Hours

Application Data (Attachment 4A). Respondents are organizational entities that seek CDC recognition through the DPRP. Each respondent will submit a brief one-time application form to the DPRP for each delivery mode (estimated burden of 1 hour per submission). The application form and instructions are posted on the National DPP web site, and the application must be completed online. There is no submission deadline, and respondents may apply whenever it is convenient for them to do so. For this three-year period, CDC is revising the total estimated annualized number of applicant organizations to 200, as the previous number was not realized during the three-year revision process in 2021. The distribution of those applicants is still predicted to be 70% (120) from the private sector and 30% (80) from the public sector, based on current DPRP data and projections. Table A.12-1. estimates the annualized burden to respondents by private and public entities by both application and evaluation burden. Trends indicate we will see a smaller number of organizations with capacity to enroll larger numbers of participants successfully.

Evaluation Data (Attachment 4B). Each respondent will submit evaluation data to the DPRP every 6 months (estimated burden of 2 hours per submission). The due dates for each organization’s submission will be determined by its effective date (the 1^st day of the month following DPRP approval of the application). The evaluation data are submitted to CDC via an online web application form in accordance with the DPRP Standards (4A). During the OMB approval period, the DPRP anticipates that 600 organizations (annualized to 200 per year) will apply for recognition, and that the number of organizations submitting data will increase from 1,700 by the end of the first year to 2,100 in the third year. The total estimated average annualized evaluation burden to respondents is 7,600 hours. This includes an estimate of the time needed to extract and compile the required data records and fields from an existing electronic database, review the data, create or enter a data file in the required format (i.e., an electronic CSV file), and submit the data file via the National DPP web site for automated upload into the DPRP Data Portal. Table A.12-1 provides a summary of the total annualized evaluation burden to respondents (in gray).

Table A.12-1. Estimated Annualized Burden to Respondents (public and private)

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Avg. Burden per Response	Total Burden
				(in hours)	(in hours)
Public sector organizations that deliver the National DPP LCP	DPRP Application Form	80	1	1	80
	DPRP Evaluation Data	740	2	2	2960
Private sector organizations that deliver the National DPP LCP	DPRP Application Form	120	1	1	120
	DPRP Evaluation Data	1160	2	2	4640
				Total	7,800

2. Cost to Respondents

We anticipate that respondents will use paid staff to provide the requested information to the DPRP, and we used two times the federal minimum wage as our basis for estimating the cost to respondents.

Table A.12-2. Estimated Annualized Cost to Respondents (public and private)

Type of Respondent	Form name	Number of respondents	Number of responses per respondent	Hourly wage rate	Total burden (in hours)	Total Cost
Public sector organizations that deliver the National DPP LCP	DPRP Application Form	80	1	$28.20	80	$2,256
	DPRP Evaluation Data	740	2	$28.20	2960	$83,472
Private sector organizations that deliver the National DPP LCP	DPRP Application Form	120	1	$28.20	120	$3,384
	DPRP Evaluation Data	1160	2	$28.20	4640	$130,848
	Total					$219,960

1. Source: National DPP Funding Opportunity Announcement, DP-12-1212, Grantee Evaluation, average Lifestyle Coach hourly salary, 2016.

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

We anticipate that, for most respondents, the majority of application data elements will be a subset of the program data elements already being collected and maintained at the organization level (including the organizational contacts listed once on the one-time application). It should be noted that the additional race/ethnicity variable categories, and the 6-point disability variables could cause minor data collection reprogramming, upfront. Importantly, these variables align with recommended CDC science and with OMB requirements. It is not anticipated that significant additional time and resources will be needed for data collection, since the DPRP Data Portal is being streamlined for ease-of-use. Since many DPRP data elements are directly tied to CMS reimbursement, it is anticipated that respondents will be willing to collect and report such data.

As a result of the new data elements, it is possible that some future applicant organizations and/or currently recognized organizations using third party administrators to assist with data collection may need to make modifications to their systems and may incur additional costs in doing so. CDC does offer an easy-to-use, no-cost comma separated variable spreadsheet that will link directly to the DPRP Data Portal for easy data upload and validation. Also, no-cost webinars and technical assistance on use of the Data Portal will be routinely offered in an effort to minimize data collection and reporting burden. Health care organizations that offer the program may also be able to report the optional A1C value, which will allow them multiple ways to successfully achieve CDC Full recognition. This will be seen as an advantage to such organizations, and not an additional burden, based on stakeholder feedback.

14. Annualized Cost to the Government

Labor Costs include personnel for oversight, communication, evaluation, development of the Information Collection Request for OMB, report writing, presentations, publications, and technical assistance; and contract labor for monitoring, data collection, analysis, evaluation, and assistance with report writing.

The total estimated annualized cost to the government is $2,554,530 as summarized in the table below.

Personnel Base salary Fringe Total cost

FTE* $337,738 $116,792 $454,530

Contract support** $2,100,000

TOTAL COSTS: $2,554,530

* FTE cost includes percentages of time for approximately 2 FTEs at 100% time and 1 FTE at 50% time.

**Contract support includes partial costs from 3 contracts supporting the DPRP – Peraton ($1,600,000), Cyberdata ($691,486), and Deloitte Consulting ($250,000).

15. Explanation of Program Changes or Adjustments

The estimated burden per response for each information collection is 1.0 hour for application completion (including reading the DPRP Standards). The actual completion of the automated, online application involves drop-down boxes and is not estimated to be time-consuming. The estimated information collection burden per response for each evaluation data submission is still 2.0 hours, as an automated data entry portal is now being provided for ease of data entry. A few changes are proposed for each information collection instrument (the DPRP Application Form and the DPRP Evaluation Data submission), as outlined in Attachment 5- Table of Changes. The proposed changes to the estimated number of respondents, the types of respondents, and the frequency of responses are described below.

In 2021, CDC estimated that 300 organizations per year would apply for CDC recognition through the DPRP. At that time, CDC estimated that 70% (210) of the applicants would be private sector organizations, and 30% (90) of the applicants would be from the public sector (state, local, or tribal government organizations). Each applicant organization would be required to submit a one-time DPRP application form, followed by biannual submissions of evaluation data.

For this three-year period, CDC is revising the total estimated annualized number of applicant organizations to 200, as the previous number was not realized during the three-year revision processes in 2018 and again in 2021. The 2021 estimates could not be met due to the COVID-19 public health emergency. The distribution of those applicants for the 2024 revision is still predicted to be 70% (120) from the private sector and 30% (80) from the public sector, based on current DPRP data and projections. Trends from the previous two revision years indicate we will see a smaller number of organizations with capacity to enroll larger numbers of participants successfully.

The DPRP application form will continue to be a one-time submission for each delivery mode. CDC is also increasing the estimated number of organizations submitting DPRP evaluation data from a little over 1,500 currently to 600 more in the upcoming three-year period (a rate of an additional 200 per year for three years). The revised estimate maintains the evaluation data burden hours of 2.0 hours biannually from the 2021 revision. New variables have been included, as outlined in Attachment 5- Table of Changes, but the updated automation of the DPRP Data Portal will result in organizations saving time when uploading and submitting data to CDC. CDC will continue to collect data every six months to allow organizations ample opportunity to advance to Preliminary recognition, which is required to apply to CMS to become an MDPP supplier. Data submission every six months also provides more frequent opportunities for organizations to review their own data, address areas of concern, receive technical assistance, and make early programmatic corrections to ensure success.

These changes result in a net increase of 724 annualized burden hours. The distribution of these changes is summarized in Table A.12-3. below.

Table A.12-3 Estimated Annual Data Collection Burden Hours by Respondent, 2021 to 2024

Type of Respondent and Form Name		2021* (Actual Hours)			2024			Change from 2021-2024
Type of Respondent	Form Name	Numberof Respondents	Number of Responses per Respondent	Total Burden Hours*	Number of Respondents	Number of Responses per Respondent	Total Burden Hours	Total Burden Hours
Public sector organizations that deliver the National DPP LCP	DPRP Application Form	90	1	90	80	1	80	-10
	DPRP Evaluation Data	290	2	1160	740	2	2960	1800
Private sector organizations that deliver the National DPP LCP	DPRP Application Form	210	1	210	120	1	120	-90
	DPRP Evaluation Data	1304	2	5216	1160	2	4640	-576
	Total			6,676			7,800	1124

*Actual 2021 burden hours; original 2021 estimated hours were 8,700 per year. We had over-estimated the possible burden in 2021 not realizing the impact of the public health emergency on our programs.

16. Plans for Tabulation and Publication and Project Time Schedule

Task Date

Application process (ongoing) ongoing since January 2012

Applicants transmit data (ongoing) ongoing since January 2012

Data analyses ongoing since July 2012

CDC recognition status renewed ongoing since January 2013

OMB approval of revision request April 30, 2024 (estimated)

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

The OMB expiration date will be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to this certification.

References

Current Diabetes/Prediabetes Statistics in Overview/Justification:

1a. Centers for Disease Control and Prevention. National Diabetes Statistics Report website.

https://www.cdc.gov/diabetes/data/statistics-report/index.html. Accessed 11/3/23.

Economic Costs of Diabetes:

1b. American Diabetes Association, Economic Costs of Diabetes in the U.S. in 2017,

Diabetes Care 2018 Mar. https://doi.org/10.2337/dci18-0007.

MDPP Report which the 2018 DPRP Standards helped support:

1c. Centers for Medicare and Medicaid. Medicare Diabetes Prevention Program (MDPP)

Expanded Model, 2017. Baltimore, MD: US Department of Health and Human Services; 2017. https://www.cms.gov/priorities/innovation/innovation-models/Medicare-diabetes-prevention-program.

Efficacy and Effectiveness Studies upon which the 2011 DPRP Standards were based:

2. Knowler, W.C., Barrett-Connor, E., Fowler, S.E., Hamman, R.F., Lachin, J.M., Walker, E.A., et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. New Engl J Med 2002; 346:393–403.

3. Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinology, 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0.

4. Lindstrom, J., Ilanne-Parikka, P., Peltonen, M., Aunola, S., Eriksson, J.G., Hemiö, K., et al. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: Follow-up of the Finnish Diabetes Prevention Study. Lancet 2006; 368:1673–79.

5. Li, G., Zhang, P., Wang, J., Gregg, E.W., Yang, W., Gong, Q., et al. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: A 20-year follow-up study. Lancet 2008; 371:1783–89.

6. Ackermann, R.T., Finch, E.A., Brizendine, E., Zhou, H., Marrero, D.G. Translating the Diabetes Prevention Program into the community: The DEPLOY pilot study. Am J Prev Med. 2008; 35(4):357–63.

7. Ackermann, R.T., Marrero, D.G. Adapting the diabetes prevention program lifestyle intervention for delivery in the community: The YMCA model. Diabetes Educ. 2007; 33:1–6.

8. Amundson, H.A., Butcher, M.K., Gohdes, D., Hall, T.O., Harwell, T.S., Helgerson, S.D., et al. Translating the diabetes prevention program into practice in the general community: Findings from the Montana Cardiovascular Disease and Diabetes Prevention Program. Diabetes Educ. 2009; 35:209. doi: 10.1177/0145721709333269.

9. Williamson, D.F., Marrero, D.G. Scaling up type 2 diabetes prevention programs for high risk persons: Progress and challenges in the United States (chapter). Diabetes prevention in practice. pp 69-81 Schwarz P, Reddy P, Greaves C, Dunbar J, Schwarz J, eds. World Congress on Prevention of Diabetes. Dresden, Germany 2010. TUMAINI Institute for Prevention Management. ISBN 978-3-00-03070765-2.

10. Abelson, R. An insurer’s new approach to diabetes. New York Times. April 13, 2010. http://www.nytimes.com/2010/04/14/health/14diabetes.html.

11. Tate, D.F., Jackvony, E.H., Wing, R.R. Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003;289(14):1833-1836.

Additional translational studies upon which the 2015 DPRP Standards were based:

12. Ackermann, R.T., Sandy, L.G., Beauregard, T., Coblitz, M., Norton, K.L., and Vojta, D. (2014), A randomized comparative effectiveness trial of using cable television to deliver diabetes prevention programming. Obesity. 22(7):1601-1607.

13. Sepah, C.S., Jiang, L., Peters, A.L. (2104). Translating the diabetes prevention program into an online social network: Validation against CDC standards. The Diabetes Educator. 40(4):435-443.

14. Marrero, D., Palmer, K., Rost, S., Frederick, A., Miller-Kovach, K., Saha, C. Using Weight Watchers approach to lifestyle modification to reduce risk for type 2 diabetes. [abstract] International Diabetes Federation. Melbourne, Australia 2013. http://clinicaltrials.gov/show/NCT02000024.

15. Ross, K., Kaufman, N.D. Automating coaching: Technology delivers proven weight loss intervention at affordable cost while minimizing personnel time. Presented at the Care Continuum Alliance conference, Oct. 2013.

Additional studies and evaluation research upon which the 2018 and current revision of the DPRP Standards are based:

Attrition/Retention:

16. Gray, L.J., et al. (2016). "Engagement, Retention, and Progression to Type 2 Diabetes: A

Retrospective Analysis of the Cluster-Randomised "Let's Prevent Diabetes" Trial." PLoS Med 13(7): e1002078.

Cost-effectiveness/Economic evaluation:

17. Alouki, K., et al. (2016). "Lifestyle Interventions to Prevent Type 2 Diabetes: A Systematic Review of Economic Evaluation Studies." Journal of Diabetes Research 2016.

17. Li, R., et al. (2015). "Economic Evaluation of Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among Persons at Increased Risk: A Systematic Review for the Community Preventive Services Task Force." Annals of Internal Medicine 163(6): 452-460.

Duration and intensity

17. Mudaliar, U., et al. (2016). "Cardiometabolic Risk Factor Changes Observed in Diabetes Prevention Programs in US Settings: A Systematic Review and Meta-analysis." PLoS Med 13(7): e1002095.

17. Aziz, Z., et al. (2015). "A systematic review of real-world diabetes prevention programs: learnings from the last 15 years." Implementation science: IS 10: 172.

17. Brokaw, S. M., et al. (2015). "Effectiveness of an Adapted Diabetes Prevention Program Lifestyle Intervention in Older and Younger Adults." J Am Geriatr Soc 63(6): 1067-1074.

17. Ackermann, R. T., et al. (2015). "A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes." American Journal of Public Health 105(11): 2328-2334.

Group size

17. Brokaw, S. M., et al. (2014). "Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups." Primary care diabetes 8(4): 295-300.

Evidence to support additional collection of education level

17. O'Brien, M. J., et al. (2015). "The comparative efficacy of lifestyle intervention and metformin by educational attainment in the Diabetes Prevention Program." Preventive Medicine 77: 125-130.

Physical activity

17. Eaglehouse, Y. L., et al. (2015). "Evaluation of physical activity reporting in community Diabetes Prevention Program lifestyle intervention efforts: A systematic review." Prev Med 77: 191-199.

Virtual programs

17. Michaelides, A., et al. (2016). "Weight loss efficacy of a novel mobile Diabetes Prevention Program delivery platform with human coaching." BMJ Open Diabetes Res Care 4(1): e000264.

17. Fischer, H. H., et al. (2016). "Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial." Diabetes Care 39(8): 1364-1370.

17. Sepah, S.C, Jiang L., & Peters, A.L. “Long-Term Outcomes of a Web-Based Diabetes Prevention Program: 2-Year Results of a Single-Arm Longitudinal Study.” Journal of Medical Internet Research 2015;17(4):e92; doi:10.2196/jmir.4052.

Weight loss achievement

17. DiBenedetto, J. C., et al. (2016). "Achievement of Weight Loss and Other Requirements of the Diabetes Prevention and Recognition Program: A National Diabetes Prevention Program Network Based on Nationally Certified Diabetes Self-management Education Programs." Diabetes Educ.

17. Franz, M. J., et al. (2015). "Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials." Journal of the Academy of Nutrition & Dietetics 115(9): 1447-1463.

31. Klem M.L., Wing R.R., McGuire M.T., Seagle H.M., Hill J.O. A descriptive study of individuals successful at long-term maintenance of substantial weight loss. Am J Clin Nutr. 1997 Aug;66(2):239-46. PubMed PMID: 9250100.

Gender differences

32. Caceres, B.A., Jackman. K.B., Edmondson, D., Bockting, W. O. “Assessing gender identity differences in cardiovascular disease in US adults: an analysis of data from the 2014–2017 BRFSS.” J Behav Med (2020) 43:329–338.

New A1C evidence (added based on 2021 public comments)

33. Toro-Ramos, T., Michaelides, A., Anton, M., Karim, Z., Kang-Oh, L., Argyrou, C., Loukaidou, E., Charitou, M., Sze, W., Miller, J. “Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial.” JMIR mHealth and uHealth (http://mhealth.jmir.org), 08.07.2020.

34. Daftarian, Z., Bowen, P. “Improving outcomes in patients with prediabetes through a lifestyle modification program.” Journal of the American Association of Nurse Practitioners: March 2020 - Volume 32 - Issue 3 - p 244-25.

New health equity (race/ethnicity and social determinants of health) evidence

35. National Association of Chronic Disease Directors. Content Updated: June 22, 2023. Available from: https://coveragetoolkit.org/health-equity-and-the-national-dpp/defining-health-equity/.

36. Office of Management and Budget. (1997a) Recommendation from the Interagency Committee for the Review of the Racial and Ethnic Standards to the Office of Management and Budget Concerning Changes to the Standards for Classification of Federal Data on Race and Ethnicity, Federal Register: 62: 36873-36946, July 9.

37. Office of Minority Health, Explanation of Data Standards for Race, Ethnicity, Sex, Primary Language, and Disability, https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.

38. Shin, Hyon B. and R. Kominski (2010). Language Use in the United States: 2007, American Community Survey Reports, ACS-12. U.S. Census Bureau, Washington, DC.

39. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Healthy People 2030. https://health.gov/healthypeople/priority-areas/social-determinants-health.

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