SS Part B (DPRP)_Final for ICRO_03-07-24_final

Information Collection Request

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

Revision

OMB No. 0920-0909

Supporting Statement: Part B

Program official/project officer: Stephanie Gruss, PhD, MSW

Centers for Disease Control and Prevention

National Diabetes Prevention Program

Atlanta, Georgia

April 17, 2024

TABLE OF CONTENTS

B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

B-1 Respondent Universe and Sampling Methods

B-2 Procedures for the Collection of Information

B-3 Methods to Maximize Response Rates and Deal With No Response

B-4 Tests of Procedures or Methods to Be Undertaken

B-5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or

Analyzing Data

REFERENCES IN SSA

ATTACHMENT

1 Authorizing Legislation PHSA

2A 60-Day Federal Register Notice

2B Summary of Public Comments (Placeholder)

3 DPRP Standards 2024

4A DPRP Application Form and Instructions (screenshot)

4B DPRP Evaluation Data Collection Form (screenshot)

5 Table of Changes

6 Human Subjects Research Determination

Section B. Collections of Information Employing Statistical Methods

Statistical methods are not used to select respondents. Respondents (organizational entities offering the National DPP lifestyle change program [LCP] and seeking CDC recognition through the DPRP) self-select by applying for recognition.

1. Respondent Universe and Sampling Methods

The potential respondent universe is any organizational entity in the United States, its territories, or military Army Post Office (APO) sites desiring CDC recognition of its type 2 diabetes prevention lifestyle change program. We anticipate 200 new applicant organizations per year with a one-hour each burden time, beginning with 1,500 current organizations already in our database; which averages to 1,900 total CDC-recognized organizations (annualized) that submit evaluation data during the 3-year OMB approval period (May 1, 2024 through April 30, 2027).

Calculating the Burden Hours for Submitting Process/Evaluation Data

OMB Year	Currently Recognized Programs	New Programs Recognized This Year	One-time Application for New Orgs	Total Recognized Programs	Burden Per Data Submission in hour	Submissions Per Year	Burden Per Year in hour
			(1 hours each)
Year 1	1500	200	1	1,700	2	2	6,800
Year 2	1700	200	1	1,900	2	2	7,600
Year 3	1900	200	1	2,100	2	2	8,400
Total for 3 years				5,700			22,800
Annualized Total				1,900			7,800

2. Procedures for the Collection of Information

For organizations applying on or after March 1, 2024 (pending OMB approval)

The DPRP administers the CDC DPRP Standards and Operating Procedures (DPRP Standards) (Attachment 3). Any organization with the capacity to deliver the National DPP LCP may apply for CDC recognition. Organizations seeking recognition must complete and submit an online application form (Attachment 4A), which includes organization-level information such as address, contacts, curriculum, and delivery mode. The DPRP application form is located on the National DPP website Diabetes Prevention Recognition Program Application | CDC and may be submitted at any time.

After submitting the application form, a confirmation web page is displayed and the applicant receives a confirmation e-mail. When the applicant indicates that a CDC-approved curriculum is being used, DPRP staff will notify the applicant by e-mail of the results of the CDC review within 15 working days. When the applicant indicates using an alternate curriculum, DPRP staff will review it along with the application. In this case, DPRP staff will notify the applicant by e-mail of the results of the CDC review within 4-6 weeks. When an organization’s application has been reviewed and approved, the DPRP will e-mail the organization’s Program Coordinator indicating that the organization has achieved pending recognition status. This e-mail will include the unique organization code assigned by the DPRP, the organization’s effective date (the first day of the month immediately following CDC approval of its application), the organization’s data submission timeline, and instructions for data submission. At the same time, the organization will be listed in the DPRP Registry on the CDC website and in a National DPP program locator application. This entire process takes approximately 15 working days.

When an application for recognition is approved, the organization will have pending recognition status and may begin offering classes on or after the application approval date. An organization is required to start offering classes no later than six months after its effective date.

Evaluation data are transmitted to the DPRP by the organization every 6 months in accordance with the DPRP Standards (Attachment 3). To minimize the burden on organizations and ensure data quality and utility, evaluation data transmission consists of either a single CSV data file (containing participant-level intake information and participant session-level information) or two CSV data files (one containing participant-level intake information and one containing participant session-level information) submitted via the DPRP Data Submission Portal (Attachment 4B). Detailed specifications for the evaluation data file are in the DPRP Standards Data Dictionary: Evaluation Data Elements (Attachment 3).

As with the 2021 DPRP Standards, the revised 2024 DPRP Standards require organizations to submit evaluation data to the DPRP every 6 months from the organizations’ effective dates (the first day of the month following the approval of an organization’s application). There must be at least one session record per participant in the organization’s submission at 6 months post-effective date and at least six months of participant data in the organization’s submission at 12 months post-effective date. Each data submission must include one record per participant for each session attended during the preceding 6 months. The first data submission (6 months post-effective date) must also include records for any sessions attended between the application approval date and the effective date. This will allow for timely data analysis and provide opportunities for the organization to receive interim feedback on its progress in meeting recognition requirements. Data may be submitted at any time during the submission due month. Organizations failing to submit complete and acceptable data in the month it is due or failing to report attendance in a 6-month period could lose recognition and face a 6-month wait before re-applying. CDC will send an email notice of loss of recognition only after organizations have not responded to multiple e-mail reminders and technical assistance offers.

Subsequent data submissions should not include participant session-level data previously submitted. After the first 6-month data submission, CDC will provide the organization with an interim Progress Report (PR). When an organization has submitted a full 12 months of complete program data, CDC will prepare the first Evaluation Report (ER) to assess whether the organization has met Preliminary, Full, or Full Plus recognition requirements. An organization can progress directly to Full or Full Plus recognition and bypass preliminary if all requirements for Full or Full Plus recognition are met. Either Preliminary, Full, or Full Plus recognition status will permit an organization to apply to become a Medicare Diabetes Prevention Program (MDPP) supplier. The evaluation will be based on data from participants who attended their first session at least one year but not more than 18 months before the submission due date.

The DPRP sends two data submission reminders to an organization’s contacts. The first is approximately one month prior to the data submission due month and the second is approximately 2 weeks after the data submission due month begins. If CDC does not receive the data submission after the multiple e-mail reminders and offers of technical assistance, the organization will lose recognition and will be removed from the DPRP Registry. 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.

For organizations approved prior to May 1, 2024 (pending OMB approval)

Organizations recognized prior to the implementation date of the 2024 DPRP Standards will be sent instructions, in advance of May 1, 2024, on how to make their first data submission under these new Standards.

Organizational evaluation for CDC recognition

An organization can be evaluated at the appropriate time for three types of CDC recognition described below- Preliminary, Full, or Full Plus. Organizations will be evaluated for Preliminary, Full, and Full Plus recognition only at the time of required data submissions. While organizations can be evaluated for early Preliminary recognition at the time of their 6- or 12-month data submission, to be eligible for an evaluation for Full or Full Plus recognition, organizations must have submitted data on at least one completed group or individual cohort. A group cohort is defined as multiple participants moving through the program at the same time. An individual cohort is defined as one participant moving through the program on their own timeline. Both group and individual cohorts are considered complete when 365 days have lapsed since the date of the first session of that cohort. Organizations can have multiple groups and/or individual cohorts running at the same time with different start dates.

Evaluations are performed on evaluation cohorts. An evaluation cohort is defined as all group and/or individual cohorts that hold their first session within the same 6-month sequence, at least one year but not more than 18 months before the first day of the current submission due month. This means that multiple groups and/or individual cohorts can be part of a single evaluation cohort.

If a new organization wants to be eligible for an evaluation at the time of its Sequence 2 (12-month) data submission, it will need to begin offering sessions immediately after approval of its application and before the effective date. This is the only way the organization will have a completed group or individual cohort required for an evaluation. Organizations that are not eligible for an evaluation at the time of their Sequence 2 (12 months) data submission will need to wait until their next required data submission at Sequence 3 (18 months).

While data must be submitted for all participants, evaluations are only performed on data from participants who achieve completer status. A participant is considered a completer if:

• they attended at least 8 sessions in months 1-6 and

• the time from the first session held for their cohort to the last session attended by the participant is at least 9 months.

Pending Recognition

To begin the recognition process, an organization submits an application to the DPRP for each delivery mode it plans to offer. An organization achieves Pending recognition when the DPRP determines the organization has met requirements 1-4 in the DPRP Standards (successful application submission, use of a CDC-approved LCP curriculum, agreement to provide a yearlong LCP, and agreement to provide the stated LCP intensity).

An organization with Pending recognition is required to make its first data submission 6 months after its effective date. An organization may remain in Pending recognition indefinitely if it continues to submit the required data every 6 months.

Preliminary Recognition

Organizations may achieve Preliminary recognition in several ways once requirements for Pending recognition are met:

1. 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): https://www.atsdr.cdc.gov/placeandhealth/svi/index.html.

2. 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.

3. 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.

4. If options 1, 2, or 3 do not apply, organizations will move into Preliminary recognition when both of the following criteria have been met (requirement 5):

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

   2. At least 30% of the eligible participants 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 will achieve Full recognition when they meet the following criteria:

1. The requirements for Pending recognition.

2. Requirement 5: Retaining participants to completer status.

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

3. At least 30% of all eligible participants 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.

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

   1. 5% weight loss 12 months after the cohort began or

   2. 4% weight loss and at least 8 sessions associated with an average of 150 minutes/week of physical activity

   3. 4% weight loss and at least 17 sessions attended

   4. 0.2% reduction in HbA1C

5. Requirement 7: 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.

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 4^th month since the cohorts’ first sessions.

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

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

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

3. Methods to Maximize Response Rates and Address Non Responses

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. All information submitted to the DPRP is submitted electronically, as specified in the DPRP Standards.

CDC provides regular training to organizations that have questions or may be encountering challenges in providing the required information within the required timeframes. Training includes monthly webinars to review the Standards and data submission requirements and resources on the National DPP Customer Service Center (CSC): https://nationaldppcsc.cdc.gov/s/. The DPRP also offers tailored technical assistance calls to organizations to help them achieve Preliminary or Full recognition. The frequency and nature of technical assistance efforts are based on demand, CDC staff resources, and emerging issues that are shared by multiple organizations. Concurrent with the release of the 2024 Standards, the DPRP will post quick, self-paced webinars on the National DPP CSC website. These will include, but are not limited to, an updated Welcome Kit, helpful hints for Lifestyle Coaches and organizations, and data submission assistance.

The online application form (Attachment 4A), the evaluation data elements (Attachment 4B), and the instructions for their transmission (Attachment 3) are posted on the National DPP website https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf. Potential applicants are encouraged to read and carefully review this information before applying for recognition. They are also strongly encouraged to complete the Organizational Capacity Assessment found in the Standards (Attachment 3) as Appendix A.

Participation by organizations is strictly voluntary. Organizations may withdraw from the DPRP at any time. In addition, an organization’s CDC-recognition may be revoked for not submitting evaluation data to the DPRP, but every effort will be made by CDC to work with organizations prior to revocation of recognition. Regardless of the circumstances of the withdrawal, once withdrawn, these organizations must wait 6 months prior to reapplying for CDC recognition.

4. Tests of Procedures or Methods to be Undertaken

Prior to receiving initial OMB approval in 2011, a DPRP workgroup comprised of internal and external stakeholders, including representatives from academic institutions and other organizations, met several times over the course of one year. During this time, the workgroup provided input on required data elements, on the frequency of data transmission to CDC, and on the application form and instructions. A hard copy of the DPRP application form was pilot tested with seven individuals (three CDC employees and four staff of potential applicant organizations).

During subsequent revisions (2015, 2018, 2021, and 2024), CDC continued to gather feedback through listening sessions with key National DPP stakeholders on the effectiveness and relevance of the Standards. Stakeholders included: state health departments; federal partners such as CMS; national organizations such as the American Medical Association and the American Diabetes Association; and a sample of currently recognized organizations based on size, ownership, and delivery mode. Recommendations from stakeholder listening sessions directly informed previous revisions and will inform this one. In addition, CDC has conducted updated DPRP data analyses on organizational performance trends, including organizations serving as MDPP suppliers.

Feedback was reviewed by National DPP staff and other CDC leaders in type 2 diabetes prevention. The DPRP Standards (Attachment 3), the online application form (Attachment 4A), and the evaluation data elements (Attachment 4B) were revised as deemed appropriate.

The MDPP Expanded Model was announced in early 2016, when the Secretary of Health and Human Services determined that the National DPP LCP met the statutory criteria for inclusion in Medicare’s expanded list of health care services for beneficiaries (https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/). This is the first time a preventive service model from the CMS Innovation Center has been expanded into Medicare. After extensive testing of this model in 17 sites across the US in 2014-2016, CMS implemented 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. The enrollment process began in April 2018. Only organizations in good standing with the DPRP are eligible to become MDPP suppliers. MDPP reimbursement continues to be dependent on organizations achieving either Preliminary or Full recognition status from the DPRP.

The current Standards revision will continue to align with the updated CMS MDPP rule (RIN 0938–AV07) that was finalized in 2023 and the initial rule that went into effect on January 1, 2018, and to account for new evidence in the type 2 diabetes prevention literature.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Staff in CDC’s Division of Diabetes Translation (DDT) (CDC personnel and contractors) have been consulted on the development and maintenance of the DPRP data collection processes and automated platforms, including the online application form, the online registry, and the web application [program] for data submission. All data management, analysis, and reporting are performed at CDC by DDT staff and on-site contractors. The individuals listed below were consulted on all statistical aspects of the DPRP. DDT staff will be responsible for DPRP data collection and data analysis.

Christopher Holliday, PhD MPH, MA, FACHE 

Director, Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Stephanie Gruss, PhD, MSW

Program Manager, Diabetes Prevention Recognition Program

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Elizabeth Ely, MS

Mathematical Statistician

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Shelly-Ann Bowen, PhD, MS(CT)

Epidemiologist

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

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