CMS-10393 11th_SOW_Supporting Statement_Part_A_ 02 15 2018

CMS 10393 Supporting Statement – Part A

Beneficiary and Family Centered Data Collection

1. Background

The Center for Medicare & Medicaid Services’ (CMS) Quality Improvement Organization (QIO) Program includes Beneficiary and Family Centered Care QIOs (BFCC QIOs) whose functions, as set forth in Section 1862(g) of the Social Security Act, are to improve the effectiveness, efficiency, economy, and quality of services delivered to Medicare beneficiaries. To accomplish these goals, the QIOs review health care services funded under Medicare to determine whether those services are reasonable, medically necessary, furnished in the appropriate setting, and meet professionally recognized standards of quality. The QIOs also review health care services where the beneficiary or a representative has complained about the quality of those services or is appealing alleged premature discharge.

Based on statutory language and CMS’ experience in administering the QIO Program, CMS has identified the following requirements for the Program:

• Improve quality of care for beneficiaries; and

• Protect beneficiaries by expeditiously addressing individual complaints, such as beneficiary complaints; provider-based notice appeals; Emergency Medical Treatment and Labor Act violations; and other related statutory QIO responsibilities.

As the QIO Program has evolved, CMS has aligned the QIO Statement of Work (SOW) with the recommendations put forth by the Institute of Medicine¹, principles set forth in the National Quality Strategy, and the CMS Quality Strategy. CMS has restructured the QIO program such that the BFCC QIO is solely focused on delivering beneficiary and family-centered care in an efficient and cost-effective manner.

To ensure the QIOs are effectively meeting their goals, CMS has historically collected patient experience information through a survey of beneficiaries who have interacted directly with a QIO representative. Through the collection of patient experience data, CMS:

• Assesses the degree to which the QIOs are achieving the above program requirements;

• Provides feedback to the QIOs to support them in improving the services they deliver to Medicare beneficiaries; and

• Measures the degree to which the QIOs are meeting their contractual obligations as laid out in their SOW.

The most recent version of this survey was approved by OMB in 2016 (control number 0938-1177). With the introduction of the revised instruments discussed below, the current survey is being retired.

CMS must continue to collect reliable and rich data on the experiences of Medicare beneficiaries. The nature of the data collected must evolve as QIO SOWs change so that CMS is adequately capturing how, when, and why QIOs are interacting with beneficiaries and beneficiary reports on their related experiences. Under the current 11^th QIO SOW, two organizations are providing services as BFCC QIOs across all of the United States. The QIO evaluation criteria have been revised to reflect this national regionalization and it is important for CMS to understand the impact on beneficiaries from this reorganization.

In alignment with CMS’ strategic goals to “Put Patients First”, they are committed to improving the CMS Customer Experience. One way to accomplish this is enhancing the Beneficiary Care Experience with the BFCC-QIO. As a result, CMS has incorporated Person and Family Engagement (PFE) activities (Figure 1) into the BFCC QIO 11SOW in support of the mission of the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS).

Figure 1 – BFCC PFE Program Model “Putting Patients First”

The existing data collection uses two variations of a survey to collect satisfaction data from two broad groups of beneficiaries who interact with QIOs. The revised data collection will use three variations of a survey to collect more targeted experience data from all beneficiaries who interact with the QIO, paying particular attention to the recent changes in QIO service delivery to “Put Patients First.” The revised instruments are intended to maximize utility of data, ensure data are valid and reliable, and minimize burden on Medicare beneficiaries, their families, and representatives.

The concepts from the existing data collection have been revised to ask about specific experiences while interacting with the QIOs instead of satisfaction with the QIO. This revision is aimed at collecting data that are more objective. Experience data will provide rigorous data to support QIO evaluation and on-going quality improvement. The included Survey Crosswalk lists the topics covered as well as the specific items addressing each topic in the existing data collection instrument as well as the proposed revised data collection instruments. A summary of overarching changes is as follows:

• Content from eight existing data collection items have been removed entirely. These items are not measuring areas where QIOs have substantial ability to impact change in the beneficiary experience. Removal of these items will remove all content in four topic areas: satisfaction with result; community coordination; receipt of forms/letters; and clarity of forms/letters.

• New content comprised of four items is being added to the revised data collection instruments. These items allow CMS to assess the efficacy of their increasingly patient-centered approach to supporting beneficiaries. This items specifically address: support completing forms/letters; and follow-up to immediate advocacy complaint resolution.

• Content in other topic areas are proposed to be slightly revised to reflect how QIOs deliver services under the most recent SOW. These items include content addressing: sample verification; mode of contact with QIO; responsiveness; communication; process rating; comments/feedback.

The data collection instruments prepared for the 11^th SOW rely on a combination of qualitative and quantitative strategies. Together, the data collection strategies will help CMS and the QIOs understand beneficiary experiences through all interactions with the QIO including initial contact, interim interactions, and case closure. Data collection instruments are tailored to reflect the steps in each type of process, as well as the average time it takes to complete each process. Draft data collection instruments are included with this submission.

The purpose and approach for each are summarized below.

• Experience Survey: The Experience Survey (Attachment A) will be administered via telephone and mail to beneficiaries/representatives after the complaint/appeal case has been closed. The goal of the experience survey is to assess beneficiary overall and specific experiences with the BFCC QIOs. The survey will take no more than 15 minutes for respondents to complete. General Survey instructions can be found in Attachment E. Mail-specific instructions can be found in Attachment G.

• The survey will be administered to all (census) beneficiaries/representatives who file a complaint and have it addressed through medical record review (n=4,900).

• The survey will be administered to all (census) beneficiaries/representatives who file a complaint and have it addressed through immediate advocacy (n=1,300).

• The survey will be administered to a sample of beneficiaries/representatives who file an appeal (n=8,800).

As described in Supporting Statement Part B, CMS intends to maintain a census of complaint cases including medical record review (annual n=4,900) and immediate advocacy (annual n=1,300) to ensure that sufficient data are collected to support analysis and reporting for each of the five Service Areas. A sample of appeals cases (annual n=8,800) will also be maintained to support analysis and reporting for the five Service Areas.

• Direct Follow-up: Direct Follow-up calls (Attachment B) will be made to a sample of beneficiaries/representatives who have contacted the BFCC QIO. This sample includes individuals who contacted the BFCC QIO help desk for any reason including those that did not result in the formal initiation of an appeal or complaint case. This data collection will provide information about beneficiary experiences with the QIOs that extend beyond processing of complaint and appeal cases. Administration time for Direct Follow-up is expected to last five minutes per respondent. Survey instructions can be found in Attachment F.

  • The survey will be administered to a sample of beneficiaries/representatives who contact the BFCC QIO help desk for any reason. (n=200).

• General Feedback Web Survey: All Beneficiaries/representatives who file a complaint or appeal will be given an opportunity to provide feedback about their experiences with the appeal/complaint process. A link to a General Feedback Web Survey (Attachment C) will be included with each case closure letter sent by the QIOs. We estimate that it will take no more than two minutes for respondents to complete the questions on the General Feedback Web survey. Survey instructions can be found in Attachment H.

  • The General Feedback Web Survey link will be sent to all (census) beneficiaries/ representatives who file a complaint or an appeal (n=150,200).

2. Justification

1. Need and Legal Basis

Section 1154 of the Social Security Act sets forth the functions of the Peer Review Organizations, including 1154 (a) (1) (B), determining whether the quality of health care services meets professionally recognized standards of health care. Relevant portions of this Act are included as Attachment D. The statutory authority for the QIO Program is found in Part B of Title XI of the Social Security Act as amended by the Peer Review Improvement Act of 1982 (P.L. 97-248, §§ 141-143, 96 Stat. 324). The Social Security Act established the Utilization and Quality Control Peer Review Organization Program, now known as the QIO Program. The Trade Adjustment Assistance Extension Act of 2011 (P.L. 112-40, § 261, 125 Stat. 401, included as Attachment D with pertinent sections highlighted) has since amended the provisions of the QIO program and requires QIOs to perform, subject to the terms of their contracts, activities that the Secretary of the Department of Health and Human Services (HHS) determines may be necessary for the purposes of improving the quality of care furnished to Medicare beneficiaries.

The BFCC ORC is responsible for providing oversight and review of QIO activities. The Beneficiary and Family Centered Data Collection activities undertaken by the BFCC ORC will be one of the central mechanisms that CMS will use to assess the degree to which the QIOs are successfully performing the functions set forth in the Act and improving the quality of care furnished to Medicare Beneficiaries. De-identified data and summary reports will be shared with CMS and the QIOs to support the program mandate. Data and summary reports will not be made publicly available as their purpose is to support program evaluation and internal quality improvement.

2. Information Users

The information obtained using the aforementioned data collection methods will assist CMS in:

1. Evaluating the success of each QIO in meeting its contractual requirements; and

2. Understanding the experience of Medicare beneficiaries and/or their representative with QIO contract mandated work.

Data from the existing CMS Medicare Beneficiary and Family Centered Satisfaction Survey are used to support immediate quality improvement initiatives and to refine QIO procedures for interacting with beneficiaries. Beneficiary experience data are also used as one component of QIO contract evaluation.

The revised data collection approaches will allow CMS to capture beneficiary experience with a greater range of QIO interactions and over a longer period of time. This additional information will help CMS and QIOs refine the approaches to handling beneficiary complaints and appeals and will support revisions to the future QIO scopes of work. Data also will continue to support QIO contract evaluation.

3. Use of Information Technology

Given that most Medicare beneficiaries are age 65 or older and the CMS records do not include email addresses for beneficiaries, the Experience Survey (Attachment A) and Direct Follow-up (Attachment B) initiatives will be conducted as telephone data collections. These information collections are not currently available electronically and do not require signatures from the respondents.

The General Feedback Web Survey will use Website/internet technology to collect information from Medicare beneficiaries electronically. The URL/Web address for the General Feedback Web Survey will be printed on all case closure/disposition letters mailed to beneficiaries/ representatives. We understand that recent literature suggests it is challenging to “drive” people to a Web site from a hard copy letter; however, CMS sees this initiative as an efficient means to promote patient-centeredness by offering every beneficiary/representative an opportunity to voice their experience.

4. Duplication of Efforts

This information collection does not duplicate any other effort and the information cannot be obtained from any other source.

5. Small Businesses

These requirements affect only individuals and households. Therefore, there is no economic impact on small businesses.

6. Less Frequent Collection

These information requirements are collected on an as-needed basis to support QIO contract evaluation during the current Scope of Work. Failure to collect this information would hinder quality improvement activities within the QIOs and would inhibit CMS’ ability to measure patient experience for QIO contract evaluation as indicated in the current QIO SOW.

7. Special Circumstances

There are no special circumstances associated with this collection.

8. Federal Register/Outside Consultation

The 60-day Federal Register notice was published on April 14, 2017 (82 FR 17997). There were no comments received. The 30-day notice published on June 30, 2017 (82 FR 29864)

To ensure that the data collected would be of greatest value to the organizations who are primarily tasked with using the information, CMS sought input from the BFCC QIOs, and the BFCC National Coordinating Center (NCC) who represent the QIOs as well as the Beneficiary and Family Advisory Council.

Exhibit 1: Survey development consultants

Organization	Name	Contact Information
Livanta (BFCC-QIO Areas 1 and 5)	Lance Coss	702-749-0601 [email protected]
KEPRO (BFCC-QIO Areas 2,3 & 4)	Gayle Smith	330-323-2188 [email protected]
	Rita Bowling	330-990-6865 [email protected]
	Cheryl Cook	844-455-8708 x 7201 [email protected]
KEPRO (BFCC-NCC )	Denise Mikin	216-503-5814 [email protected]

9. Payments/Gifts to Respondents

There are no payments or gifts associated with this collection.

10. Confidentiality

Data collected will be made available to CMS and the QIOs to support quality improvement efforts. While individual identifiers will not be linked to any survey data, it may be possible to identify respondents based on open-ended comments the respondents provide. Beneficiaries/ representatives will be told the purposes for which the information is collected. They will also be informed that directly identifiable information about them will not be reported or shared publicly, nor will their survey responses be shared with QIOs in any identifiable manner.

11. Sensitive Questions

There are no questions of sensitive nature in any of the data collection instruments.

12. Estimate of Annualized Burden Hours and Costs

Exhibit 2 shows the estimated annualized burden hours for respondents’ time to participate in the data collection initiatives. Exhibit 3 shows the estimated annualized cost burden for respondents’ time to participate in the data collection initiatives.

Exhibit 2: Estimated annual burden hours

Data Collection	Number of respondents	Number of responses per respondent	Hours per response	Burden hours
Experience Survey	9,750	1	0.25	2,438
Direct Follow-up	200	1	0.05	10
General Feedback Web Survey	15,020	1	0.03	451
Total burden hours				2,899

Exhibit 3: Estimated annualized cost burden

Data Collection	Number of respondents	Total burden hours	Average hourly wage rate2	Burden Cost
Experience Survey	9,750	2,438	$12.85	$31,328.30
Direct Follow-up	200	10	$12.85	$128.50
General Feedback Web Survey	15,020	451	$12.85	$5,795.35
Total	24,970	2,899		$37,252.15

13. Estimate of Annualized Capital and Maintenance Costs

There are no capital costs.

14. Estimate of Annualized Cost to the Government

The cost estimates for administering the Beneficiary and Family Centered Care, Oversight & Review Center, Beneficiary and Family Centered Data Collection are shown below. Annual cost estimates are presented in Exhibit 4 for each of the data collection initiatives.

Exhibit 4: Estimated annualized cost to the government

Data Collection	Year 1 (Option Year 2)	Year 2 (Option Year 3	Year 3 (Option Year 4)	Total
Experience Survey	$1,363,312.97	$1,411,028.92	$1,460,414.93	$4,234,756.82
Direct Follow-up	$83,729.70	$85,655.48	$87,625.56	$257,010.73
General Feedback Web Survey	$88,879.29	$90,923.51	$93,014.75	$272,817.56
Total	$1,535,921.96	$1,589,607.91	$1,641,055.24	$4,766,585.11

The annual cost is $1,588,862 ($4,766,585.11/3 years).

15. Changes in Burden

Given the significant restructuring of the QIO program in the most recent 11^th SOW, new instruments and methodologies are required to adequately collect the beneficiary experience data needed for QIO on-going improvement and contract evaluation. Specifically, the QIO structure has been changed from a state-based service model to a region-based service model where one QIO implements services across multiple states in a region with five regions comprising the entire nation. In the 10^th SOW 53 QIOs provided beneficiary protection services to Medicare beneficiaries across the nation whereas there are only two organizations providing services as BFCC QIOs across all five regions in the current 11^th SOW. The QIO evaluation criteria have been revised for the 11^th SOW to reflect this national regionalization and it is important for CMS to understand the impact on beneficiaries from this reorganization.

The revised data collection approach will increase the burden hours from 1,601 to 2,899. The burden from the previous package was not revised in ROCIS when the Supporting Statement was revised so ROCIS has 4,003 instead of 1,601.

16. Time Schedule, Publication and Analysis Plans

We anticipate that we would need four to eight weeks after receipt of OMB approval to prepare and begin the first round of data collection for the Experience Survey, the General Feedback Web Survey, and the Direct Follow-up.

Once data collection has been initiated, the BFCC ORC plans to conduct sampling, initial data collection, data cleaning, and delivery within a four to six-week period. This rapid cycle is important to provide CMS and QIOs with close to real time feedback from beneficiaries/ representatives. CMS and the QIOs will use on-line reporting dashboards to track progress and improvements to systems and processes over time.

17. OMB Expiration Date

CMS will display the expiration date on the web survey home page as well as any survey instruments mailed to beneficiaries. In keeping with the most recent OMB guidance, the statement below will be used. Estimated average time per response will be included for each of the three survey instruments. The PRA disclosure statement including average times are shown with the survey instruments in Attachments A, B, and C.

18. Certification Statement

There are no exceptions to the certification statement.

1 Medicare's Quality Improvement Organization Program: Maximizing Potential (Series: Pathways to Quality Health Care) (2006).

2 Based on Income and Assets of Medicare Beneficiaries, 2014 – 2030, published by the Kaiser Family Foundation Median annual income of $24,150. http://kff.org/medicare/issue-brief/income-and-assets-of-medicare-beneficiaries-2014-2030

CMS 10393 11^th SOW Supporting Statement Part A

4/4/2017 12