CMS-10366 - Supporting Statement Part A [rev 05-21-2012]

Supporting Statement – Part A

Nursing Home Quality Improvement Questionnaire

CMS-10366. 0938-New

_Background

The Affordable Care Act (ACA) requires the Centers for Medicare & Medicaid Services (CMS) to establish standards, in the form of a new Federal regulation for a quality assurance and performance improvement (QAPI) program for nursing homes, and to develop tools and resources to assist nursing homes in meeting the new QAPI standards. As a result of this mandate, CMS has embarked on a multi- faceted program to provide technical assistance (TA) to nursing homes that seek to strengthen their current quality improvement systems.

To help ensure that this technical assistance is useful to nursing homes, Abt Associates, Inc. and the Colorado Foundation for Medical Care (CFMC) were contracted by CMS to collect information on QAPI programs and processes from a random sample of nursing home providers in the US via the Nursing Home Quality Improvement Questionnaire (Appendix A). The objective of the questionnaire is to collect standardized information on current quality improvement activities, challenges, and areas where technical assistance will benefit nursing homes.

The Questionnaire was designed around five key concepts that are found throughout effective quality systems, including:

1) Design and Scope;

2) Governance and Leadership;

3) Feedback, Data Systems, and Monitoring;

4) Performance Improvement Projects; and

5) Systematic Analysis and Systemic Action.

This data collection is planned to be administered in two waves approximately one and a half years apart, and each wave will include a sample of 4,200 randomly selected nursing homes, stratified by geographic location and size. The first wave of data collection is intended to establish a baseline of QAPI practices in nursing homes, and gather information on the challenges and barriers to implementing effective QAPI programs. The second wave of data collection is intended to assess the development of QAPI systems over time, and to determine what types of TA to make available to nursing homes in the future as well as the potential impact of TA in advancing QAPI in nursing homes.

Nursing home providers participating in the data collection effort will be given the option of completing an electronic questionnaire available via the internet or a hard copy questionnaire mailed directly to

their facility. The questionnaire is designed to take approximately 20 minutes to complete. Nursing homes participating in the data collection will not be identified by name or any other identifying information.

The questionnaire was pretested with a purposefully selected sample of nine nursing facilities in Colorado; participants were located in a geographically preferable region to avoid extensive travel. The nine facilities included in the pilot test were of varying size, profit status, and chain affiliation. The information obtained through the pretesting was used to revise and strengthen the

questionnaire and related data collection materials including the CMS invitation letter (Appendix

B) and information sheet (Appendix C).

The Nursing Home Quality Improvement Questionnaire was designed to be completed by nursing home administrators and their designees, although some sections of the questionnaire may necessitate assistance from other staff within the nursing home. The questionnaire is intended to be completely self-explanatory, although contact information for any needed assistance or questions is readily available. The questionnaire is intended to be appropriate for all types and sizes of nursing facilities.

Following each wave of data collection, Abt Associates staff will analyze the information collected and prepare a report on findings for CMS.

_{A. Justification}

_{1 . Need and Legal Basis}

The Affordable Care Act requires CMS to establish standards, in the form of a new regulation for QAPI programs, and to develop tools and resources to assist nursing homes in meeting the new QAPI standards. As a result of this mandate, CMS has embarked on a multi-faceted program to provide TA to nursing homes that seek to strengthen their current quality improvement systems. To help ensure that this TA is useful to nursing homes, Abt Associates, Inc. and CFMC will collect data, via the Nursing Home Quality Improvement Questionnaire on current quality improvement activities, challenges, and areas where TA will benefit nursing homes.

_{2. Information Users}

The information obtained via the Nursing Home Quality Improvement Questionnaire will be utilized by CMS staff in the Survey & Certification Group, Division of Nursing Homes, to identify areas for QAPI TA that will be useful to nursing facilities as they prepare to meet the new QAPI regulation that was mandated as part of the ACA. Specifically, the information collected through the use of the questionnaire will be used to establish a baseline of QAPI practices in nursing homes, gather information on the challenges and barriers to implementing effective QAPI

programs, assess the development of QAPI systems, determine what types of TA to make available to nursing homes, and assess the potential impact of TA in advancing QAPI in nursing homes

_{3. Use of Information Technology}

Nursing home providers participating in the data collection effort will be given the option of completing an electronic questionnaire available via the internet or a hard copy questionnaire mailed directly to their facility. Because some nursing home providers will prefer to complete the questionnaire electronically while others will prefer to complete a hard copy questionnaire, we are providing both options to sampled providers. We anticipate that between 25 and 50 percent of the sampled providers will complete the questionnaire electronically. After the internet site with the electronic questionnaire has been open for two weeks, a hard copy of the questionnaire will be mailed via US postal service to all sampled providers who did not respond to the questionnaire

electronically. Other data collection plan includes mailing of up to two hard copies of the questionnaire to non-respondents followed by reminder telephone calls, if necessary. The internet site with the electronic version of the questionnaire will remain open throughout the entire data collection period so that sampled providers can complete the electronic version of the questionnaire at any time or complete the hard copy version of the questionnaire and return it via US postal service to Abt Associates.

_{4. Duplication of Efforts}

The ACA mandate to CMS to establish QAPI standards and develop tools and resources to assist nursing homes in meeting these standards is a new mandate. As such, CMS has not previously collected information to either establish a baseline of QAPI practices in nursing homes or gather information on the challenges and barriers to implementing effective QAPI programs. In addition, the information necessary for CMS to determine the types of TA to make available to nursing homes to help them meet the requirements of the new QAPI regulation has not previously been collected. This information cannot be collected from any source other than from nursing home providers directly.

_{5. Small Businesses}

Some of the nursing facilities involved in this research may be considered to be small businesses. The questionnaire has been designed to minimize the burden to all participating nursing facilities regardless of size.

_{6. Less Frequent Collection}

To establish a baseline of QAPI implementation and then measure change over time, two data collections must be conducted. Therefore, we plan to conduct two waves of data collection, approximately one and a half years apart, which will provide a reasonable period of time to identify changes in QAPI program maturation from the first data collection to the second.

The first wave of data collection is planned for the early Summer of 2012, contingent upon OMB approval. This first wave of data collection is intended to take place just prior to the national roll-out of QAPI technical assistance, which we assume will occur by the end of Summer 2012/early Fall 2012. We recommend fielding the second wave of data collection approximately one year after the release of QAPI technical assistance (so likely 14-18 months after our first wave of data collection). Therefore, timing of the second wave of data collection is contingent on release of QAPI technical assistance nationally, however, we need to allow at least one year for nursing facilities to utilize the available technical assistance before starting the second wave of data collection. Our expectation is not that nursing homes will go from minimal to maximal QAPI implementation in one year. Rather, we believe QAPI implementation will be an iterative process for most nursing homes, and the two waves of data collection will allow CMS to gauge iterative improvement in QAPI implementation and assess the appropriateness and usefulness of the type and amount of technical assistance that has been made available to nursing homes.

_{7. Special Circumstances}

There are no special circumstances associated with this data collection.

_{8. Federal Register/Outside Consultation}

_{Federal Register}

The 60-day Federal Register notice published on November 18, 2011 (76 FR 71568). No comments were received.

Outside Consultation. As a precursor to the questionnaire, CFMC developed a comprehensive model of QAPI for CMS and convened a Technical Expert Panel meeting in October 2010 to thoroughly review the model and provide suggestions for revisions to the model. The 17 member TEP included representatives from aging services, quality improvement organizations, nursing home provider groups and researchers. During the QAPI TEP meeting, the TEP was informed that CMS was interested in implementing a national survey to obtain a baseline for QAPI practices in nursing homes. The TEP was asked for ideas about what to include in this kind of a survey. Several of the TEP referenced the 10 QAPI components presented during the TEP meeting and indicated that those components and their application in nursing homes, could serve as a basis for questions in the survey. The TEP also noted that the maturity assessment could be used to develop questions related to current QAPI implementation. Finally, the TEP suggested that focus groups could be used to test the survey before it is implemented in the field.

CFMC utilized the expertise of several TEP members in the development of the Nursing Home Quality Improvement Questionnaire. In addition, CFMC conducted a pre-test with nine nursing home providers to obtain their views on the availability of data, the frequency of planned data collection, the clarity of questionnaire instructions, and the data elements to be collected. The pre-test report was authored by CFMC, the Colorado Quality Improvement Organization, and is entitled Nursing Home Quality Improvement Questionnaire Pretest Report, dated September 8, 2011.

The following subcontractor staff also contributed to this project: Laura Palmer

^{Colorado Foundation for Medical Care}

Adrienne Mihelic, Ph.D.

Colorado Foundation for Medical Care

Allison Muma, MHA Abt Associates, Inc.

_{9. Payments/Gifts to Respondents}

No incentives or gifts will be offered to survey respondents.

_{10. Confidentiality}

Individuals will be assured of the confidentiality of their replies under Section 934(c) of the Public Health Service Act, 42 USC 299c-3(c). They will be told the purposes for which the information is being collected and that, in accordance with this statute, any identifiable information about them will not be used or disclosed for any other purpose.

Respondents will be informed in the introduction of the questionnaire that their answers will be anonymous and only aggregated information (not individual nursing facility information) will be sent to CMS. Participation will be entirely voluntary, and the study will conform to the requirements of the Privacy Act by omitting individuals’ names, addresses, telephone

numbers and other personal identifiers in the final data file.

The firm that will conduct the data collection, Abt Associates Inc., has conducted numerous projects and surveys involving both sensitive and non-sensitive information; consequently,

processes and procedures have been developed to maintain respondent confidentiality. All Abt Associates project staff will attest that no identification of respondents or their answers will be revealed to other persons who are not specifically involved with this project as an employee. All databases will be password protected, with only the data administrators having write authority over files. If electronic data transfer is necessary, the data will be transferred via diskette or CD-ROM to clients in an encrypted and password-protected format before shipping via a bonded courier.

Abt Associates emphasizes the importance of protecting the data while it is stored in their facilities. Abt Associates frequently maintains and manages large datasets, which frequently include highly sensitive information. In over a decade of conducting surveys on sensitive topics, Abt Associates has never suffered a breach of any respondent's privacy.

_{11. Sensitive Questions}

The data collection tool does not contain any questions concerning sexual behavior and attitudes, religious beliefs, or other matters that are commonly considered private.

_{12. Burden Estimates (Hours & Wages)}

Exhibit 1 shows the estimated annualized burden for the respondents’ time to participate in this project. The questionnaire will be completed by approximately 2,100 nursing home providers, in each wave of data collection. The questionnaire will require approximately 20 minutes (.33 hr) to complete. The total annual burden is estimated to be 693 hours.

_{Exhibit 1. Estimated annualized respondent burden hours}

Nursing Home Quality Improvement Questionnaire	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
Wave 1 (2012) data collection	2,100	1	.33 hr	693
Wave 2 (2013) data collection	2,100	1	.33 hr	693
Total	4,200	na	na	1,386

Exhibit 2 shows the estimated annualized cost burden associated with the respondents’ time to

participate in this project. The total annualized cost burden is estimated to be $29,300.

_{Exhibit 2. Estimated annualized cost burden}

Nursing Home Quality Improvement Questionnaire	Number of respondents	Total burden hours	Average hourly wage rate*	Total cost burden
Wave 1 (2012) data collection	2,100	693	$42.28	$29,300
Wave 2 (2013) data collection	2,100	693	$42.28	$29,300
Total	4,200	1,386	na	$58,600

*Based upon the mean of the average wages reflected in the National Compensation Survey (May 2010) U.S. Department of Labor, Bureau of Labor Statistics. Wage category used: Management occupations, medical and health services managers, United States.

_{13. Capital Costs}

There are no direct costs to respondents other than their time to participate in the study.

_{14. Cost to Federal Government}

Exhibit 3 shows the total and annualized costs to the government of the Nursing Home Quality Improvement Questionnaire. These costs include two waves of data collection. The project extends over three years, incorporating the development work through final reporting of results.

_{Exhibit 3. Total and annualized cost burden to the government}

Cost Component	Total Cost	Annualized Cost
Project Development	$110,000	$36,670
Data Collection Activities	$420,000	$140,000
Data Analysis	$110,000	$36,670
Reporting of results	$60,000	$20,000
TOTAL COSTS	$700,000	$233,340

_{15. Changes to Burden}

This is a new collection of information so there are no changes to the burden (hours and/or capital costs).

_{16. Publication/Tabulation Dates}

Once OMB clearance is received, we can begin programming the internet version of the survey and selecting the sample of 4,200 nursing home providers. We anticipate that the data collection period will be no more than ten weeks in duration, so that all data will be collected by early October 2012. Once the data collection period is closed, we will begin preparing the data for analysis and provide a draft report to CMS before the end of 2012. Data analysis

will center mainly on estimating various population parameters at each wave of data collection, and examining the difference in data between the two waves of data collection. Exhibit 4 shows the schedule for data collection activities.

_{Exhibit 4 - Schedule for Data Collection}

Task	Wave 1 (2012)	Wave 2 (2013)	Week of Field Period
Questionnaire development	March – October 2011	N/A	---
Questionnaire pretesting	August 2011	N/A	---
Questionnaire finalized	October 2011	N/A	---
OMB package submitted	November 2011	N/A	---
OMB approval received	June 1, 2012	N/A	---
Survey Sampling	June 4-15, 2012	October 2013	---
CMS Listserv “blast”	June 18, 2012	October 2013	1
CMS Invitation letter mailed via US postal service (to 4,200 sampled nursing homes)	June 20, 2012	October 2013	1
CMS Invitation letter placed in QIES mailboxes	June 21, 2012	November 2013	1
Internet site available	June 21,2012	November 2013	1
Reminder postcard mailed	June 28, 2012	November 2013	2
First hard copy questionnaire mailed to non-respondents	July 5, 2012	November 2013	3
Second hard copy questionnaire mailed to non- respondents	July 19, 2012	November 2013	5
Telephone reminders to non- Respondents	August 2, 2012	December 2013	7
Data collection closed	August 31, 2012	December 2013	11
Analyze data	September, 2012	January 2014	---
Draft data collection report to CMS	October 15, 2012	February 2014	---

_{17. Expiration Date}

CMS will display the expiration date for OMB approval on all of the data collection instruments.

_{18. Certification Statement}

This submission requires no exceptions to the Certificate for Paperwork Reduction Act (5

CFR 1320.9)

_{B: Collection of Information Employing Statistical Methods}

See Supporting Statement part B.

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