SS Part A_12 19 2014

SS Part A_12 19 2014.docx

CDC Diabetes Prevention Recognition Program (DPRP)

OMB: 0920-0909

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CDC Diabetes Prevention Recognition Program

Revision

OMB No. 0920-0909

Supporting Statement: Part A

Program official/project officer: Russell Sniegowski, MPH (NCCDPHP/DDT/OD)

Centers for Disease Control and Prevention

Division of Diabetes Translation

Telephone number: 770-488-5033

Fax number: 770-488-8634

Email address: [email protected]

September 11, 2014

Updated December 19, 2014

Table of Contents

Section A

A-1 Circumstances Making the Collection of Information Necessary

A-2 Purpose and Use of the Data

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 Assurance of Confidentiality Provided to Respondents

A-11 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

Attachments

1A Authorizing Legislation Public Law 111-148

1B Authorizing Legislation PHSA

2A Federal Register Notice

2B Summary of Public Comments

2B American Association of Diabetes Educators

2B America’s Health Insurance Plans

2B American Medical Association

2B Healthcare Leadership Council

2B San Juan Regional Medical Center

2B Weight Watchers International, Inc.

2B Wisconsin Division of Public Health

2B YMCA of the USA

3 DPRP Standards 2014

4A DPRP Application Form and Instructions (screenshot)

4B DPRP Homepage (screenshot)

4C DPRP Confirmation Page (screenshot)

4D DPRP Confirmation Email

4E DPRP Application Acceptance Email

4F DPRP Application Rejection Email

5A Data Dictionary: Evaluation Data Elements (updated 2014)

5B Data Dictionary: Evaluation Data Elements (previously approved by OMB 2011)

5C DPRP Data Web Application (screenshot)

5D(1) Data Reminder Email (4 weeks prior to due date)

5B(2) Data Reminder Email (2 weeks past due)

5D(3) Loss of Recognition Email (Failure to Send in any Data at 18 Months)

5D(4) Progress Report

5D(5) Evaluation report

5D(5) Evaluation Report (Determination of Full Recogniton)

5D(6) Loss of Recognition Email (Failure to Meet Standards)

5D(7) Notification of Achievement of Full Recognition

6 Overview of Changes

Overview

The Centers for Disease Control and Prevention (CDC) collects information needed to administer the Diabetes Prevention Recognition Program (DPRP) (OMB No. 0920-0909, exp. 11/30/2014). Through the DPRP, CDC recognizes organizations that successfully deliver an evidence-based lifestyle change program to participants who have pre-diabetes. The lifestyle program recommended by the DPRP is based on diabetes prevention strategies that were shown to be effective in a clinical setting, and translates these strategies to a 12-month educational and coaching curriculum delivered in a group or community setting. The DPRP Standards, initially approved in 2011, specified criteria for such programs and how organizations could attain recognition through the DPRP. Information submitted to CDC for DPRP recognition includes a one-time application form, followed by semi-annual transmission of evaluation data elements that allow CDC to assess the organization’s fidelity to DPRP program standards and the progress of program participants. Full recognition has been awarded to qualifying organizations when program participants achieved outcomes predicted by the original clinical studies.

This Revision request describes changes in the DPRP Standards and information collection that will allow CDC to recognize organizations that offer “virtual” lifestyle change programs, i.e., programs that employ Web-based tools and other distance learning technologies. It also outlines corresponding changes to the information collection plan that will allow CDC to identify virtual programs and ensure that uniform evaluation criteria are applied to both traditional and virtual programs. Additional changes are proposed to clarify forms/instructions, and to accommodate more user-friendly methods of transmitting required information to CDC. An overview of proposed changes to the DPRP Standards, the DPRP Application Form, and the DPRP Evaluation Data Elements is provided, along with revised versions of these materials.

This Revision request also describes changes that affect the annualized burden estimates. In the initial three-year approval period, CDC collected DPRP Evaluation Data Elements semi-annually. In the next approval period, organizations will submit this information once per year. Finally, CDC will increase the estimated number of organizations expected to apply for recognition through the DPRP. This adjustment reflects increased demand from organizations that offer virtual programs.There is a net increase in estimated annualized burden hours.

OMB approval is requested for three years.

Section A. Justification

1. Circumstances Making the Collection of Information Necessary

According to the CDC’s 2014 National Diabetes Statistics Report, 29.1 million people or 9.3% of the U.S. population have diabetes.¹ 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. In 2012, the direct and indirect cost of the management and treatment of diabetes and diabetes-related complications in the U. S. was estimated to be $245 billion. The percentage of Americans with diabetes has more than tripled in the past two decades, and an estimated 86 million Americans (ages 20 and over) have prediabetes, a condition in which blood sugar is elevated but not high enough for a diagnosis of diabetes. People with prediabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke. Without lifestyle changes to improve their health, 15% to 30% of people with prediabetes will develop type 2 diabetes within five years. 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.

Fortunately, research has shown that lifestyle intervention can prevent or delay diabetes in individuals at hight risk of the disease. In 2001, results from the Diabetes Prevention Program (DPP), an efficacy 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 Follow-up to the DPP and other international studies showed that results could be sustained for 10 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.^6-10 One study delivered the lifestyle program via the internet with and without behavioral e-counseling. ¹¹

CDC established the National Diabetes Prevention Program (NDPP), administered through the Division of Diabetes Translation (DDT), to make strategies for preventing type 2 diabetes broadly available to individuals at high risk of developing diabetes. Key features of interventions 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), attendance throughout the 12-month intervention (there is somewhat of a dose/response relationship between attendance and weight loss/maintaining weight loss although the exact “dose” has not been determined). The NDPP is authorized and funded in part through Section 399-V of P.L. 111-148, the Patient Protection and Affordable Care Act (Attachment 1A). The NDPP 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, based on the available scientific evidence, CDC established the Diabetes Prevention Recognition Program (DPRP) as one arm of the NDPP. The DPRP was created to recognize organizations that deliver effective evidence-base lifestyle change curricula via a 12-month in-person intervention, to individuals with pre-diabetes. Key objectives of the DPRP include:

Assure program quality, fidelity to scientific evidence, and broad use of effective type 2 diabetes prevention lifestyle interventions throughout the United States,
Monitor, evaluate, and provide technical assistance to entities that offer these programs to assist staff in effective program delivery and in problem-solving to achieve and maintain recognition status,
Develop and maintain a registry of organizations recognized for their ability to deliver effective type 2 diabetes prevention lifestyle interventions to people at high risk.

Criteria for achieving recognition are outlined in the CDC Diabetes Prevention and Recognition Program: Standards and Operating Procedures, referred to as DPRP Standards (Attachment 3) throughout this ICR. The DPRP Standards describe how an organization may apply for, earn, and maintain recognition. To maintain recognition, all programs, regardless of mode or method of delivery, must meet all of the requirements outlined in the standards. The requirements reflect the lifestyle program elements proven effective for the prevention of type 2 diabetes, including participant eligibility requirements, program intensity and duration, participant weight loss (at least 5% of body weight), documentation of physical activity minutes (with a goal of 150 minutes per week) and documentation of required attendance throughout the entire 12-month intervention. As authorized by the Public Health Service Act (Attachment 1B), CDC is currently approved to collect information from organizations seeking recognition through the DPRP (CDC Diabetes Recognition Prevention Program, OMB No. 0920-0909, exp. 11/30/2014). Two types of information are collected from applicant organizations: a one-time DPRP Application Form, followed by DPRP Evaluation Data Elements. The DPRP Application Form allows CDC to assess the applicant organization’s readiness to achieve recognition through the DPRP. Organizations that have the capacity to deliver a DPRP-approved lifestyle intervention and agree to the DPRP Standards proceed to “pending” recognition status. During the next one to two years, in which the organization’s DPRP recognition status remains “pending,” the organization submits semi-annual evaluation data to CDC for review. 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 programs that fully meet the requirements and participant outcomes described in the DPRP Standards within a specified time frame.

CDC seeks to extend OMB approval for DPRP data collection for three years, with changes. Importantly, the DPRP Standards are being revised to incorporate findings from studies which show that effective health education and coaching can be delivered through distance learning modes of program delivery. Initially, the DPRP did not recognize organizations that offered virtual programs because of the limited evidence of virtual program efficacy provided by a single study.¹¹ However, since the DPRP’s inception in 2011, additional translational research has shown that evidence-based curricula delivered outside of the typical classroom setting (e.g., virtual delivery) can produce results similar to those shown in early efficacy and effectiveness trials. ^12-15 As a result, CDC plans to allow organizations that deliver “virtual” programs (e.g., Web-based programs) to apply for and receive recognition through the DPRP if virtual program participants achieve outcomes that are comparable to outcomes achieved by participants who attend in-person education and coaching sessions. A number of changes to DPRP data collection are proposed to ensure that reporting and evaluation requirements are consistent for all DPRP applicants, regardless of mode of program delivery (traditional or virtual). Data items that are only applicable to in-person programs (e.g., in-person session ID) will be eliminated and one new data item will be added that allow CDC to describe the reach of virtual programs ( participant’s state of residence). This Revision request also describes a number of changes that are based on experience administering the DPRP (e.g., changes to clarify instructions for applicant organizations). Finally, a group of changes relate to burden estimates. The number of organizations applying for DPRP recognition will be adjusted to accommodate increased demand for DPRP services and recognition, but the frequency of reporting for DPRP Evaluation Data Elements will be reduced from semi-annual to annual. An overview of all changes is provided in Attachment 6. The overview clarifies how key changes in DPRP administration are reflected in the revised DPRP Standards (Attachment 3), the revised DPRP Application Form (Attachment 4A), and the revised DPRP Evaluation Data Elements (Attachment 5A).

The revised 2014 DPRP Standards and data collection requirements will be effective for all new applicants organizations immediately upon receipt of OMB approval of this Revision (estimated December 2014). CDC anticipates that some applicants will be in “pending” recognition status at this time. To provide for orderly transition from the initial 2011 DPRP Standards to the revised 2014 DPRP Standards, CDC will allow programs that initiated their applications under the 2011 DPRP Standards the option of submitting one additional Evaluation Data Elements report in the 2011 format. Thereafter, these programs will transition to the 2014 DPRP Standards. The transition plan will allow organizations to adapt their reporting systems without unduly interrupting progress toward achievement of DPRP recognition.

CDC anticipates that information collection will continue throughout the lifetime of DPRP. At this time CDC requests an additional three years of OMB approval to collect the information needed to administer the DPRP. However, ongoing discussions with recognized programs and potential applicants, along with results from ongoing studies, may necessitate additional changes to the DPRP Standards making another revision request possible before the end of the three-year period. For example, the CDC-preferred curriculum is currently being revised. The new curriculum will be identified more closely with the CDC and, although it will remain faithful to the science, should allow programs more flexibility in content and delivery.

Privacy Impact Assessment

Overview of the Data Collection

Respondents are organizational entities that deliver type 2 diabetes prevention lifestyle interventions and seek recognition through 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 DPRP Web site (www.cdc.gov/diabetes/prevention/recognition) (Attachment 4B), and may be submitted at any time. The information contained in the application is needed to communicate with the applicant organization and provide technical assistance. Evaluation data is transmitted to DPRP by the applicant organization every 12 months in accordance with DPRP Standards. These data are needed to assess recognition status according to objective criteria, assure fidelity to DPRP Standards, and identify opportunities for quality improvement or technical assistance. To minimize the burden on applicant organizations and ensure the quality and utility of the data, evaluation data are submitted to CDC using DPRP’s interactive web application (Attachment 5A, Attachment 5C).

Items of Information to Be Collected

Application data elements. Applicants for recognition through DPRP are organizational entities, not individuals. The data elements collected on the DPRP application include information in identifiable form (IIF), however, the identifiable information is only that needed to enable communication with the applicant entity’s designated contact person(s).

The application form (Attachment 4A) includes the following elements:

Type of Application (initial or reapplying)
Organization Code (unique identifier assigned by DPRP)
Organization Name, Organization Physical Address, Organization Web Address or URL, and Organization Phone Number (will be included in the DPRP registry and published on the DPRP Web site)
Contact Person Name, Contact Person Title, Contact Email Address, Contact Phone Number, Contact Fax Number, and Organization Mailing Address (will be used by DPRP staff to communicate with the applicant organization; no contact person information will be included in the registry)
New elements - (if applicable) Secondary Contact Person Name, Secondary Contract Person Title, Secondary Contact Email Address, Secondary Contact Phone Number, Secondary Contact Fax Number
New elements – (if applicable) Data Preparer Name, Data Preparer Title, Data Preparer Email Address, Data Preparer Phone Number, Data Preparer Fax Number (if applicable)
Curriculum - The CDC-preferred curriculum or other curriculum; if other curriculum is selected, the curriculum must be submitted with the application
New element – Intended Mode of Delivery (in-person only, virtual-only, other [specify]) (this is a new data element and will be used evaluate alternative modes of delivery and will be noted in the organization’s entry in the DPRP registry and published on the DPRP Web site)
Electronic signature asserting that the organization has read DPRP Standards and agrees to the recognition criteria

Evaluation data elements. Each DPRP recognized organization (pending or full) transmits evaluation data (Attachment 5A) to CDC every 12 months, beginning 12 months from the organization’s effective date. Evaluation data are submitted to CDC via an online web application form (Attachment 5C). Data from all of the lifestyle sessions conducted by the organization during the preceding 12 months must be included in this transmission.

No IIF about lifestyle program coaches or participants is transmitted to CDC. All identifiers (except the organization code that is provided by CDC) are assigned and maintained by the DPRP-recognized organization. All participants in DPRP-recognized lifestyle interventions are 18 years of age or older.

The evaluation data includes the following elements:

Organization Code (unique identifier assigned by DPRP)
Participant ID (assigned and maintained by the DPRP-recognized organization, used to uniquely identify and track participants across sessions; should not be based on social security number or other personally identifiable information)
Participant information recorded at program enrollment and used to establish eligibility: Participant’s Prediabetes Determination (used to assure that participants come from high risk groups in which diabetes prevention has been shown to be effective; the coding on this element has been simplified so that organizations no longer need to indicate the type of blood test performed), Participant’s Age (used to monitor program reach), Participant’s Height (used to determine body mass index for participant eligibility)
Participant information recorded at enrollment and used to provide technical assistance: Participant’s Ethnicity, Participant’s Race, Participant’s Sex (these four elements are used to monitor program reach and effectiveness across population groups)

Participant- and session-specific information used to evaluate program outcomes and provide technical assistance: Session Date (to monitor/evaluate the 12-month intervention), Participant’s State (new code) (to monitor program reach and enable reporting by state), Participant’s Weight (to determine if individual participants’ lose the 5-7% of body weight shown to prevent or delay diabetes), and Participant’s Physical Activity Minutes (to monitor programs to ensure recording of physical activity minutes and to determine if participants are achieveing the CDC-recommended 150 minutes of activity per week)

CDC uses evaluation data to assess the applicant organization’s progress toward meeting or maintaining DPRP recognition standards. Organizations may not achieve recognition, or lose recognition, if they do not:

meet the requirements for full recognition for two consecutive years;
submit complete and acceptable data within the month that it is due;
report attendance during any 12-month period.

Identification of Web Site(s) and Web Site Content Directed at Children Under 13 Years of Age

The online application form and instructions (Attachment 4A), and DPRP Standards (Attachment 3), which include complete specifications for the evaluation data elements and instructions for their transmission, are posted on the DPRP Web site (www.cdc.gov/diabetes/prevention/recognition) (Attachment 4B). There is no Web site content directed at children under 13 years old.

2. Purpose and Use of the Data

Information collected by CDC for DPRP administration is used

By the federal government to promote the dissemination and use of effective strategies for preventing diabetes
By CDC to assess applicant organizations’ compliance with DPRP Standards, their progression from “pending” recognition status to “full” recognition status, and to provide technical assistance that helps applicant organizations strengthen program delivery
By the public to identify organizations that have achieved full recognition or are in the process of seeking recognition.

The DPRP is a recognition program for lifestyle programs for the prevention of type 2 diabetes. The DPRP generates awareness of, and demand for, recognized diabetes prevention programs among people at high risk for developing type 2 diabetes, health care providers, and payers, including insurance providers. DPRP recognition of a lifestyle program is an assurance of program quality that encourages physicians and other health care providers to refer their patients with prediabetes to the recognized programs.

For an organization’s lifestyle program to receive pending recognition, the organization must agree to deliver an evidenced-based program using a DPRP-approved curriculum and submit evaluation data annually to allow the DPRP to monitor fidelity of program delivery and program effectiveness and to provide technical assistance. Full recognition is awarded after organizations meet all of the effectiveness criteria specified in the DPRP standards. Recongized programs continue to submit data annually thus allowing program effectiveness to be reassessed for as long as the organization participates in the recognition program. DPRP collects two types of data: 1) application data (contact information and curriculum to be used) and evalution data (to monitor program quality and effectiveness).

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, telephone number, location, Web address [ if provided], program delivery mode and level of recognition) is made publicly available on the DPRP Web site or through other directories. This information helps providers and consumers identify organizations recognized for delivering effective lifestyle interventions as well as entities that are working to achieve full recognition.

Evaluation data. The evaluation data elements are used to assess recognition status using objective criteria, monitor fidelity of program delivery and effectiveness, and provide timely feedback and technical assistance. The evaluation data elements include elements that are related to the fidelity of program delivery as well as participant outcomes. CDC’s objective is to assess the effectiveness of lifestyle intervention programs, not the success or failure of the individual programparticipants. CDC provides technical assistance to help applicant organizations identify opportunities for improving program delivery and/or areas where participants may need additional support. For example, technical assistance may encompass not only the modes and methods of delivery but strategies to engage and encourage program participants to make and maintain behavioral changes (thus enabling the organization to meet the DPRP requirements and the participants to prevent diabetes and continue to lead healthy lifestyles).

Without the ongoing collection of evaluation information, DPRP could not exist because CDC could not verify program eligibility or effectiveness and there would be no way to monitor and evaluate program quality on a national level.

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, as well as the name, job title, and e-mail address of an employee designated to serve as the organization’s primary contact person and, if applicable, a secondary contact person and designated data preparer. Although the application includes IIF, the information is not considered personal or private in nature. CDC maintains the IIF in password-protected files in a secure facility. A directory of recognized programs is publically available. However, the directory lists only the organization name, address, and telephone number (and Web address, if provided); 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 DPRP applicant organizations to objectively assess adherence to 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 and weight) are used to evaluate recognition criteria relating to attendance and weight loss (which are aggregated across participants to indicate whether or not the program met its percentage of overall weight loss goal). Collection of demographic information about program participants is necessary for analyses that ensure program effectiveness in both genders, across all ages (18+) and in all racial/ethnic groups. The participant process and outcome data includes site-specific information (organization code). The organizations generate, assign, and maintain a coded identification number for each participant, and only de-identified, coded, participant-level information is transmitted to CDC. However, CDC recognizes that some of the participant-specific information (state of residence, ethnicity, race, age, gender, method of determining prediabetes status) when coupled with other data (organization code) might be considered IIF. CDC does not and will not attempt to identify individuals by data linkages involving demographic, geographic, or outcome information, 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 type 2 diabetes lifestyle intervention programs and for providing targeted technical assistance.

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

To elaborate, in the DPRP data system, the participant-level evaluation data is linked to the 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 by the organization before sending to CDC. Hence, the only linkage of participant records within the DPRP data system is to the organization contact information (e.g., organization name, address, phone number, contact person). The DPRP applicant organizations assign and maintain the participant ID, and CDC does not have access to the keys for this code or to the applicants’ data systems.

No IIF (directly or indirectly identifiable) about participants is transmitted to CDC. All identifiers (except the organization code, which is provided by CDC) are assigned and maintained by the applicant organization. Data is submitted in a precisely defined format. The DPRP data system incorporates standard procedures for checking the format and content of evaluation data submissions upon receipt. Any evaluation data sent to CDC that does not conform to the specified format, or includes any IIF, is not accepted and is returned or destroyed immediately.

CDC is concerned with program 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, butwill not report on individual participant performance. CDC-produced summary reports may link aggregate program data to geographic area-level variables (e.g., state or county-level demographics) 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 is very low for several reasons:

CDC does not accept IIF 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.
The only direct linkage of participant-level data in the DPRP data system is to the organization contact information via the organization code.
CDC does not have access to the keys to any codes, other than the organization code, or to the applicant organizations’ data systems.
CDC does not attempt to identify individuals by data linkages involving demographic, geographic or outcome information.
CDC does not report on the performance of individual participants and will not disclose any participant-level data.

In addition, we would point out that CDC provides the critical assurance to participating organizations that CDC uses the data only as described and safeguards and secures the data to the full extent allowable by law. On the organization side, the DPRP Standards clearly assign the principal responsibility for maintaining participant privacy to the participating organization.

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 DPRP is submitted electronically, as specified in DPRP Standards.

4. Efforts to Identify Duplication and Use of Similar Information

Section 399V–3 of Public Law 111-148 (Attachment 1A), authorized CDC to establish a national diabetes prevention program for prevention of type 2 diabetes in high risk adults. As a part of this program, CDC was tasked “to determine eligibility of entities to deliver community-based type 2 diabetes prevention services” and to monitor, evaluate, and provide technical assistance to these entities.

CDC examined credentialing, accreditation, or recognition of programs 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 programs for the prevention of type 2 diabetes, the information needed to administer DPRP is not available from other sources.

5. Impact on Small Businesses or Other Small Entities

This data collection is not specifically aimed at small business entities. Thus far, approximately 25% of applicants are large entities and 75% are small entities. Approximately 60% of applicants are from the private sector and 40% are from the public sector. We anticipate that programmatic changes (e.g., participant eligibility via additional blood tests, virtual program delivery) will attract more large businesses and thus change the distribution among future participants. When a small business offering type 2 diabetes prevention programs applies for recognition through DPRP, the small business is required to meet all the eligibility and evaluation requirements outlined in 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.

The DPRP evaluation data elements are typically collected by organizations that deliver lifestyle interventions. Thus, the impact of DPRP data collection on respondents—including small businesses—is expected to be minimal.

6. Consequences of Collecting the Data Less Frequently

The lifestyle intervention is 12 months long (with two phases, months 1-6 and months 7-12). Organizations seeking recognition through DPRP submit evaluation data to CDC every 12 months. CDC uses these data to monitor program effectiveness. This allows CDC to provide timely technical assistance to programs having difficulty meeting minimum DPRP performance goals, thus giving programs time to improve performance and achieve or maintain full recognition.

Less frequent reporting would delay the provision of technical assistance and limit opportunities for applicant organizations to implement corrective action. Ineffective programs are an inefficient use of health care dollars, could potentially be harmful to the participants and the reputation of DPRP, and undermine efforts to encourage payers to reimburse the cost of lifestyle interventions.

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

A Notice was published in the Federal Register on April 11, 2014 (Attachment 2A). During the 60-day comment period, comments were received from eight organizations: the American Association of Diabetes Educators, America’s Health Insurance Plans, American Medical Association, Healthcare Leadership Council, San Juan Regional Medical Center, Weight Watchers International, Inc., Wisconsin Division of Public Health, and the Y-USA. The Y-USA provided extensive comments which included some topics also raised by one or more of the other responding organizations (e.g., virtual delivery). Thus, the comments from the Y-USA were chosen to represent comments from all eight organizations. The comments from the Y-USA, and CDC’s response, are included verbatim below. All comments were carefully considered and some resulted in changes or additions to the progam (e.g., the transition plan for existing organizations). For additional information on the public comments, as well as the complete comments/responses of all eight organizaitons, see Attachment 2B.

Note: (C) indicates the beginning of a comment, suggestion or request for clarification from the Y-USA; (R) indicates a response from CDC (CDC’s responses are indented).

From the outset of efforts to disseminate the YMCA’s DPP, the potential of formal CDC recognition has been one of the strongest motivators for YMCAs and their partners. Thus, we have been enthusiastically supportive of the creation of the DPRP, and have been glad to inform its development. Many Ys have applied for DPRP recognition under the DPRP, and many more will. It is our goal to have more than 300 YMCAs running the YMCA’s DPP, and seeking DPRP recognition, by 2017. Our goal has been and continues to be to leverage the DPRP as a means of documenting the quality of the YMCA’s DPP. By doing so, we aim to increase the number of insurance plans covering this intervention to reduce barriers to entry, control costs for participants, the long-term sustainability of the program, and the greatest possible benefit to society.

However, we have some significant concerns about the practical utility of the information being proposed to be collected through a revised set of standards for the DPRP. We also have concerns about the accuracy of the agency's estimate of the burden of the newly proposed requirements for the collection of information. We believe, and have data to demonstrate, that the proposed changes to the DPRP will potentially be counter-productive. This letter outlines all our concerns, which have been established after a thorough review of the DPRP data collection plans and instruments, and the generation of significant real-world experience in documenting the implementation of the YMCA’s DPP.

We believe that prior to adopting the proposed changes to the DPRP, current providers should be consulted and the proposed changes should be reviewed to:

A. Ensure the practical utility of the DPRP by holding program providers to clear, evidence-informed, and equitable standards regarding

1. the mode of DPP delivery,

2. risk assessment practices,

3. eligibility verification requirements,

4. reporting processes; and

B. Assess more accurately the additional time and costs that will be incurred by the majority of current successful DPP providers, who have made significant investments to conform to existing standards, and who will have to make changes to current operations, training practices, and technologies that currently allow for efficient and high-quality DPRP reporting.

Upon completion of the review of our concerns, we would hope that the proposed revisions to the DPRP reporting processes would be further amended to minimize the time and material costs associated with making changes to reporting systems, and to not put current providers at a financial and operational disadvantage when delivering recognition-worthy programs and reporting our successes.

(R) Regarding point A above, a notice of our intent to revise the DPRP Standards was published in the Federal Register on April 11, 2014. This notice outlined our proposed revisions and opened a 60-day public comment period. This 60-day comment period served as the DPRP’s official solicitation for comments on the DPRP Standards and during that period anyone wishing to do so, including the CDC-recognized organizations, could submit comments. Also, since the program’s inception in November 2011, any potential applicant or recognized organization could contact the DPRP with questions, concerns or suggestions to improve the program. The revisions to the standards were precipitated by feedback from recognized and/or partnering organizations, including the Y-USA.

Regarding point B above, to ensure the success of a national diabetes prevention program the reach of current prevention efforts must be expanded. After consultation with several national partners, the DPRP decided to allow programs more flexibility in the structure of the curriculum (e.g., the order in which sessions occur) and to allow virtual delivery of the lifestyle program. With these revisions, some data elements will no longer be meaningful for all organizations. To evaluate the national program, it is essential that the DPRP collect a uniform set of data elements from all participating organizations. Changes in the DPRP’s data elements were made to ensure the practical utility and comparability of the data. To lessen the burden associated with modifying the data, the DPRP kept changes to a minimum. Organizations may continue to collect all or part of the former dataset for internal use, but should send the DPRP only the required data fields. The DPRP added one new element, the participant’s state of residence. Virtual delivery makes this element essential for state or regional reporting purposes. We do not believe changing the dataset will be excessively burdensome for the majority of our recognized organizations. However, to help minimize the burden for all recognized organizations, the DPRP has developed a transition plan for organizations awarded pending or full recognized prior to 12/1/14 (pending OMB approval). The plan should help ease the transition to the new standards and data elements. Technical assistance will also be available.

A. Specific Concerns Regarding the Practical Utility of DPRP Data Requirements

(C) There are many changes being proposed to the DPRP which will have limited practical utility—and potentially even unhelpful effects—if greater clarity and consistency are not included in the revised standards. Areas of concern in this regard include:

1. In Section II. Standards and Requirements for Recognition, the subsection on Participant Eligibility includes (in item #2) a description of options for verifying eligibility of participants using values from screening tests. For DPP providers that offer in-person interventions, these values have been and will be required to be documented lab test values; but proposed changes would allow virtual providers to provide self-reported data from their participants. It is unclear and impractical that a difference should be allowed in the documentation practices for recording blood tests between in-person delivery and virtual delivery modes. A great deal of work is involved in documenting of blood screening test results, and for good reason. The evidence behind all DPP interventions is based on the effectiveness of these interventions on a group of individuals with a specific range of blood test values. The lack of a consistent standard in eligibility verification sets up a very real risk that the data submitted by providers offering different forms of DPPs will not be comparable, because the quality of self-reported data cannot reasonably be expected to be as valid or reliable as the quality of documented results. It is impractical and unequitable to hold in-person providers to a higher standard than virtual providers. At the very least, standards for documenting the eligibility of participants in recognizable programs should be consistent. Without consistency, the DPRP standards will produce data with less practical utility. Perhaps worse, the providers of the most proven and reliable form of the DPP (i.e., in-person) will essentially be subject to a “quality tax” by having to work harder to enroll participants than providers of less-proven modalities. If any inequalities are to be established by the DPRP, one would think that the efforts to prove the quality of less-proven modalities would have to reach a higher standard.

(R) Programs have always had the ability to accept participants who self-report that an acceptable blood test performed in the last year indicated prediabetes. We did not mean to imply that only virtual programs could accept participants based on a self-reported blood test and should have been clearer in addressing this standard. The text has been modified as follows:

“A minimum of 50% of a program’s participants must have had a recent (within the past year) blood test (blood test may be self-reported) or claim code . . .”

2. The same section and subsection referred to in the previous point includes new language regarding the utilization of claims-based coding data to identify potentially eligible participants (in bullet point #2) and new language regarding the use of claims-based risk tests (in bullet point #3). However, there are no concrete or detailed standards established for these tests and methods of eligibility verification. Additionally, there is not any language provided on how DPRP will track the use of these codes. This lack of clarity makes it difficult to determine what, if any, operational changes would be required by YMCAs that benefit from the use of a claims-based data mining system to establish eligibility. Further, the developers of any such methodology will have no clear understanding of whether the potentially eligible participants identified in future coding analysis systems would actually meet the eligibility criteria. Thus the data are likely of minimal practical utility and more thought and detail should be added to the proposed DPRP standards to ensure that innovations in data mining produce meaningful and actionable information for DPP providers and the CDC.

(R) The specific codes or risk tests will not be reported to, or tracked, by the DPRP. The data will be coded, as has the data for all previous eligibility criteria, to demonstrate eligibility by blood test, history of gestational diabetes (GDM) or risk test. This data will be analyzed to determine if an organization meets the DPRP eligibility requirement. Claims-based codes were added to provide recognized organizations an additional option through which high-risk individuals might be deemed eligible to participate. The use of claims-based codes is voluntary.

3. In the subsection titled Required Curriculum Content, the language around Intervention Intensity has changed substantially and has raised several concerns. This section under the current standards used to reflect the science behind the vast majority of DPP translations. The lifestyle intervention currently begins with an initial core phase during which a minimum of 16 one-hour, in-person, group-based sessions are offered to all participants over a period lasting at least 16 weeks and not more than 26 weeks. The proposed revisions now say the lifestyle intervention must begin with an initial six-month phase during which a minimum of 16 sessions are offered over a period lasting 16 weeks and not more than 26 weeks. Each session must be of sufficient duration to convey the session content – or approximately one hour in length. It is unclear how increasingly flexible standards will affect the utility of data collected on DPPs, but it is difficult to imagine that the utility of the data will be increased by allowing for more variability in the delivery of curriculum content.

(R) The requirements for recognition (e.g., percent weight loss, reporting of physical activity minutes, a minimum number of sessions attended during both the first and second six months of the program) have not changed. All recognized organizations submit the same data elements. To reach full recognition an organization, regardless of the mode of delivery or rigidness of program structure, must meet all of the minimum requirements in the DPRP Standards. Also, though reworded (e.g., by changing at least 16 to a minimum of 16), the requirement for a minimum number of sessions (16) to be delivered in no more than a set number of weeks (16-26) has not changed. The changes in this section, the addition of virtual delivery and the flexibility in duration of each session, are the direct result of feedback from partners and recognized organizations. Virtual delivery will expand the reach of the program. Sessions may still be one hour in length. However, flexibility in session duration will allow organizations to devote more or less time to curriculum areas based on participant need. Neither virtual delivery nor session duration affects the utility of the data as these are not included in the data analysis. As noted earlier, all recognized organizations submit the same data elements and must meet all of the minimum requirements to achieve recognition.

4. In Section II’s subsection on Additional Requirements for Full Recognition Status, the changes being proposed in point #5 are very significant. The practical utility of the data to be collected under this new approach must be questioned, because the standards have essentially changed to capture data on participants in ways that do not reflect well-established program delivery methods in previously approved curricula and the result will be that some providers will be reporting only core session data at the six-month point while others will be submitting data on both core and maintenance sessions. This will be problematic for data collection related to attendance, and will make analyses of potentially incomparable data less practically useful to the CDC, DPP providers, the public, etc.

(R) Although we no longer use the terms “core” and “post-core,” the required length of the two distinct parts of the lifestyle program, as specified in the 2014 DPRP Standards, has not changed. During the first six months of the program, a minimum of 16 sessions must be delivered over a period of not less than 16 weeks and not more than 26 weeks. During the second six months of the program, there must be a minimum of one session delivered in each of the six months (for a minimum of six sessions). Organizations wishing to provide more sessions during the second six months of the program may do so (and it may be wise to do so as participants may have difficulty transitioning to less frequent sessions). The frequency and timing of sessions delivered during phase one, which is an organizational choice, determines the length of time that programs use to deliver phase two. Programs choosing to complete the first phase of the program in 26 weeks, rather than in 16 weeks, could potentially move on to phase 2 of the lifestyle program later in time. However, no organization will have less than six months to complete the second half of the program. Participant engagement throughout the year-long program should be strongly encouraged.

5. The next item in this same subsection (i.e., #6) includes changes to the DPRP standards that have essentially reduced weight loss data reporting requirements. On one hand, this could be seen as an attempt to make an allowance for efficiencies in program delivery. However, the concern is that changing the standards (i.e., to allow for weight data to be captured in at least 80% attended classes for all people who attend at least four sessions) will in effect remove any requirement to collect weight loss data during the maintenance phase (now called Phase II) of program delivery. This new section should be tied to all weight data collected across the entire year of the intervention, but it’s not clearly called out by the revised requirements.

(R) Requirement 6 in the updated DPRP Standards states that “Documentation of body weights will be based on all participants who attended a minimum of four or more sessions. Body weight must have been recorded at 80% or more of all sessions attended.” Calculation of this measure will be based on all sessions attended by participants during the entire 12 months following their start dates.

6. Another item in this same subsection (#8) describes how weight loss data will be averaged across all participants attending a minimum of four sessions. In the existing standards, this requirement was specific to just core sessions but because of changes referenced above this will now include data on both core and maintenance sessions. There are purposefully designed differences in approved curricula between core and maintenance sessions. By removing the distinction between weight lost in core and maintenance phases the utility of the data reported to DPRP will likely be reduced as the effectiveness of distinct coaching strategies will not be discernable. Additional lack of clarity on how this standards will actually be applied comes from the relationship of an earlier standard (i.e., in #5, the average number of sessions attended must be a minimum of 9) to this standard. Why would DPRP anchor on that number for attendance but not for weight loss reporting? Consistency in the approach to data collection across attendance and weight loss data would likely increase the utility and efficiency of data reporting.

(R) Months 1-6 (first half of the intervention year) describes the timeframe during which “core” content is to be delivered in an intensive manner, with sessions offered approximately once per week. Months 7-12 (second half of the intervention year) describes the period during which participants are to be supported with monthly “post-core” or maintenance sessions to assist them in internalizing lessons learned so they can continue and maintain their lifestyle change beyond the end of the intervention. The change from “core” and “post-core” to first six months and second six months is largely semantic. By describing these phases in terms of time, DPRP will be able to accommodate minor, permissible variations in program delivery and still apply the evaluation criteria uniformly to all recognized organizations.

Session attendance is averaged over participants who attended a minimum of four sessions over the course of 12 months. Weight loss is also averaged over these same participants (those who attended a minimum of four sessions). Nine is the performance standard for average attendance in the first six months. Three is the performance standard for average attendance in the second six months. 5% is the performance standard for average weight loss, and is calculated at 6 and 12 months, with the first recorded weight as the baseline. We believe that these measures are consistent with one another, and also with the measures used in the 2011 version of the DPRP Standards.

To help organizations understand exactly how all performance measures will be calculated, we are providing a detailed example as an appendix to the 2014 DPRP Standards.

7. Changes to the very next bullet point (#9) have essentially just removed language around post core session attendance, and shifted to language describing session attendance for months 7-12 as Phase II. The metric for success is still the same (i.e., average number of sessions attended during months 7-12 must be 3 sessions attended). The anticipated result is a decrease in the time available for achieving success in this metric. This is probably an unintended consequence of trying to build more flexibility into the core session phase (i.e., Phase I). With an expected diminished rate of success in this aspect of DPP delivery, the utility of collecting data on this phase of the program under the proposed changes should be evaluated and explained.

(R) As stated above, although we no longer use the terms “core” and “post-core,” the required length of the two distinct parts of the lifestyle program, as specified in the 2014 DPRP Standards, has not changed. During the first six months of the program, a minimum of 16 sessions must be delivered over a period of not less than 16 weeks and not more than 26 weeks. During the second six months of the program, there must be a minimum of one session delivered in each of the six months (for a minimum of six sessions). Organizations wishing to provide more sessions during the second six months of the program may do so (and it may be wise to do so as participants may have difficulty transitioning to less frequent sessions). The frequency and timing of sessions delivered during phase one, which is an organizational choice, determines the length of time that programs use to deliver phase two. Programs choosing to complete the first phase of the program in 26 weeks, rather than in 16 weeks, could potentially move on to phase 2 of the lifestyle program later in time. However, no organization will have less than six months to complete the second half of the program. Participant engagement throughout the year-long program should be strongly encouraged.

8. In Section III, Applying for Recognition, point #14 states that organizations can now select various modes of delivery from all that apply. Options are in-person, virtual or “other”. It would be useful to define or clarify what is meant by “other”. Without greater clarity, this vague standard will reduce the value of collecting any data on the mode of delivery.

(R) Thank you for pointing out the need for additional clarification in this section. Organizations will now choose one of the following: 1) in-person only; 2) online/virtual only; 3) Other (hybrid/multiple modes) please specify __________.

9. In Section IV, Submitting Evaluation Data to DPRP, the subsection on Evaluation Data Elements includes a list of data elements that have been re-ordered from the previous version of DPRP standards. This seems to indicate that the packaging of data to CDC will now be required to be submitted in a revised format. If this is the intent of the CDC, then it would be beneficial to clarify this as an expected change.

(R) The data dictionary in the 2014 DPRP Standards includes changes to the variables and format of the data submission. Data must be submitted in the specified format. Variables (columns) in the data submission file should have the same names (column headings) as in the data dictionary. We have added a sentence to the data submission instructions to clarify. With the exception of “Participant State,” which is a new data element, the data elements required by the revised DPRP Standards are a subset of the previously required data. Thus, we do not anticipate that costs associated with re-ordering the variables will be prohibitive for the majority of the DPRP’s currently recognized organizations. The DPRP has developed a transition plan for organizations recognized prior to 12/1/14 (pending OMB approval). The plan should help ease the transition from the old (2011) standards to the new (2014) standards. Technical assistance will also be available.

10. In this same section and subsection, one of the points (#2) has been changed to “class code”. We think the existing “group code” field will map to this new field, but it has previously been allowable for participants to switch between groups if they must (e.g., when participants might start the year-long program in a community where they spend their winters, but end the program in a community where they live in the summer). It is unclear if CDC will allow more than one class code now per participant.

(R) After additional internal discussion, we decided not to change the Core Group Code to Class Code. The Core Group Code will be discontinued. For the purpose of data analysis to assess criteria for full recognition, each participant will be considered to be his/her own “class” and tracked via the organization-assigned participant ID. This will facilitate reporting for organizations where participants may move from one group to another.

11. CDC has also eliminated data that had to be reported on the “session type” (e.g., core vs. maintenance). We are concerned about this for many practical reasons mentioned above. With the transition to a system of recognition that is built on two 6 month phases, the concepts of ‘core’ and ‘maintenance’ which have proven useful and effective will be diminished in relevance to DPP providers and DPRP data will not distinctively discern the effectiveness of these independently valuable concepts.

(R) As under the 2011 standards, there are still two program phases. The curriculum topics and goals covered during the first six months (in at least 16 weeks but no more than 26 weeks) and the second six months of the program are exactly the same in the 2011 and 2014 standards. The goals in the first six months focus on moderate changes in both diet and physical activity to achieve modest weight loss in the range of 5% to 7% of baseline body weight. The second six months of the program focus on topics that reinforce and build on the content delivered during the first six months of the intervention, including topics that proved challenging for participants. Under the 2011 standards, program phases were defined by a session code number. Under the 2014 standards, program phases are defined by time (months 1-6 and months 7-12). We do not anticipate that this change will be problematic for the programs or for data analysis.

B. Specific Concerns Regarding Efforts Required for DPRP Data Submission

Y-USA has several concerns about the estimates of time (and other associated costs) related to the preparing and submission of DPRP data. In each of the sections referenced below, changes have been made to the DPRP standards which will result in the need for significant time and treasure to be spent adapting current systems and technology to the new requirements. Past experience has shown that these adjustments may take a year or more to complete, and require significant investment of resources. Disruption in data reporting for programs that are in the midst of program delivery will come with additional costs and challenges.

1. In section II’s subsection on Required Curriculum Content, changes to the way DPRP is recognizing the structure of any DPP (i.e., to Phase I and Phase II) will create a need for changes in the timing of reporting and our delivery cycle for the program, and there will be time and costs associated with adapting our reporting platform to these new requirements. Because Y-USA does not own this system, it is unclear what the exact costs or timeline for adjustments might be. We simply do not have knowledge of how other CDC partners, such as the Diabetes Prevention and Control Alliance, will adapt to these new requirements. As they are the owner of the reporting system used by all YMCA’s we cannot precisely define the change in time and effort required for reporting.

(R) The data collection, storage and submission process is potentially unique to each organization. The DPRP has no knowledge of, or control over, this process. Thus, we are unable to address your comments, numbered 1-6 and 8, regarding changes to specific data elements relative to the Y-USA. All recognized organizations will submit the same data elements. With the exception of “Participant State,” which is a new data element, the data elements required by the 2014 DPRP Standards are a subset of the previously required data. Thus, we do not anticipate that costs for adapting these processes, if necessary, will be prohibitive for the majority of the DPRP’s currently recognized organizations. The DPRP has developed a transition plan for organizations recognized prior to 12/1/14 (pending OMB approval). Under the plan, organizations will submit data one time per 12-month period and data due between 12/1/2014 and 11/30/15 may be submitted using either the 2011 or 2014 data elements. This additional time should help ease the transition from the 2011 standards to the 2014 standards. Technical assistance will also be available.

2. Point #4 in this section, discussed previously, includes language around Intervention Intensity. Changes in language related to the collection of weight loss data reporting requirements will result in the same types of increases in time and resources to rebuild our current reporting system.