COMMUNITY-BASED CARE TRANSITIONS PROGRAM (CCTP) IMPLEMENTATION AND MONITORING
OMB CLEARANCE APPLICATION
CENTERS FOR MEDICARE &
MEDICAID SERVICES
June 1, 2012
Submitted by:
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Medicare Demonstrations Program
Rm. C4-17-26, 7500 Security Blvd.
Baltimore, MD 21244-1850
CONTENTS
A. JUSTIFICATION 1
1. Circumstances Making the Collection of Information Necessary 1
2. Purpose and Use of Information Collection 1
3. Use of Improved Information Technology and Burden Reduction 3
4. Efforts to Identify Duplication and Use of Similar Information 4
5. Impact on Small Businesses or Other Small Entities 4
6. Consequences of Collecting the Information Less Frequently 4
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 5
8. Comments in Response to the Federal Register Notice/Outside Consultation 5
9. Explanation of Any Payment/Gift to Respondents 6
10. Assurance of Confidentiality Provided to Respondents 6
11. Justification for Sensitive Questions 8
12. Estimates of Annualized Hour and Cost Burden 8
13. Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs 9
14. Annualized Cost to Federal Government 9
15. Explanation for Program Changes or Adjustments 10
16. Plans for Tabulation and Publication and Project Time Schedule 10
17. Reason(s) Display of OMB Expiration Date Is Inappropriate 10
18. Exceptions to Certification for Paperwork Reduction Act Submissions 10
REFERENCES 11
B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS 12
1. Respondent Universe and Sampling Methods 12
2. Procedures for the Collection of Information 12
3. Methods to Maximize Response Rates and Deal with Nonresponse 15
4. Tests of Procedures or Methods to Be Undertaken 16
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 17
REFERENCES 19
Contents (continued)
appendix a: section 3026 of the 2010 affordable care act A.3
appendix b: PATIENT experience survey items B.3
appendix c: 60-day federal register notice C.3
TABLES
A.1 CCTP Performance Measures 2
A.2 Estimated Annualized Burden Hours 8
A.3 Estimated Annualized Burden Costs 9
The Medicare Community-Based Care Transitions Program (CCTP), authorized by Section 3026 of the 2010 Affordable Care Act, is a major component of the Partnership for Patients initiative, one goal of which is to decrease preventable complications during transition from a care setting, such as a hospital, to home, community, or another care setting. Appendix A contains a copy of the relevant portion of the legislation.
The CCTP will provide funding to test models for improving care transitions from the hospital to the community for high-risk Medicare beneficiaries. The Centers for Medicare & Medicaid Services (CMS) initiated the CCTP in early 2011 and will operate the program for five years. Congress has authorized $500 million to cover the cost of the program. CMS expects that program agreements will be in place to authorize community-based organizations (CBOs), in partnership with acute care hospitals, to begin providing care transition services in November 2011 and, if successful, continue doing so for up to five years. The planned collection of a patient experience survey is part of the implementation and monitoring strategy that will review the performance of organizations contracted to provide transitional care services under the CCTP. This clearance package seeks approval for the three-month pilot test of the patient experience survey.
The goals for the CCTP are:
Reduce readmissions for high-risk beneficiaries
Improve transitions of beneficiaries from the inpatient hospital setting to home or other settings
Maintain or improve quality of care
Document measureable savings to the Medicare program
CMS
will monitor the extent to which the CCTP interventions are meeting
the project goals using four categories of performance measures: (1)
outcome measures, (2) process measures,
(3) adverse effect
measures, and (4) patient experience measures. The first three
measurement categories are based on Medicare claims data and the
submission of billing information from participating CBOs about what
services they are providing and to whom. The fourth category, patient
experience measures, will be based on survey data. Table A.1.
summarizes the planned performance measures and the data source for
each.
Table A.1. CCTP Performance Measures
Performance Measure |
Data Source |
I.
Outcome Measures (to be calculated at both the CBO and |
Administrative |
II.
Process Measures (to be calculated at both the CBO and hospital
|
Administrative |
III.
Adverse Effect Measures (to be calculated at both the CBO and
|
Administrative |
IV.
Patient Experience Measures (to be calculated at the CBO level |
Patient Experience Survey |
Measures of consumer activation and understanding and knowledge of aftercare plans are key monitoring metrics for the CCTP. The content of the patient experience survey will draw from three existing instruments: (1) five items from the Hospital Consumer Assessment of Healthcare Providers and Systems (H-CAHPS) Survey that assess the dissemination of information related to medicines and discharge plans for a recent hospital stay (see Agency for Healthcare Research and Quality); (2) the three-item Care Transitions Measure (CTM-3), which assesses patients’ understanding of the hospital discharge information (see National Quality Forum); and (3) the 13-item version of Hibbard’s Patient Activation Measure (PAM-13), which assesses patients’ perceptions of self-efficacy (knowledge, confidence, and skills) to manage their own health behaviors and health care following a hospital stay (Hibbard, et al. 2005). Appendix B contains the combined set of questions that will be asked (within four days of hospital discharge) of Medicare beneficiaries who are receiving care transition services from a CCTP-participating CBO. The PAM-13 items will be asked again of the same participants at the end of the care transition services (this could range from one week to three months, depending on the care transition model being used; see Boutwell, et al. [2009] for more information about program models). Once it is known what transition models the CBOs are using, it is possible that the activation measurement (PAM-13) will be irrelevant for participants of programs that offer only process-oriented services; participants in such programs will not be asked the second administration of PAM questions.
To help CBOs monitor their performance and identify and remediate barriers to intervention success, we will report response frequencies for each survey question from the H-CAHPS and CTM. In addition, for the CTM-3 and PAM-13 instruments, we will provide a summary score for each measure, and for the PAM-13 measure, we will provide scores that measure change in patient activation levels between the initiation and the conclusion of the care intervention. Data for these measures, in addition to other claims-based measures (see Table A.1), will be included in quarterly monitoring reports provided to CBOs and CMS, as well as to CMS’ CCTP technical assistance (TA) contractor (The Lewin Group) and evaluation contractor (to be determined).
Data collection of the patient experience survey will rely on a paper-and-pencil questionnaire administered by the CBOs’ care transition nurse, discharge advocate, intervention specialist, or other designated liaison who is providing care transition services to the participant. Development and use of information technology for data collection, such as a computer-assisted personal interviewing (CAPI) instrument, would not be cost-effective or feasible given that data collection will rely on administration by staff from up to 100 CBOs who may not have access to portable computers.
Data entry and submission of data will be done electronically. Based on CMS’ experience fielding questionnaires administered by lay interviewers for their Money Follows the Person (MFP) demonstration (Sloan and Irvin 2007), a standardized electronic database will be used to enter and transmit questionnaire response data. The CBOs will be given a run-time application (software like a Microsoft Access database) to input and store individual questionnaire responses; the data entry program will have a user-friendly, project-specific interface that replicates the hard copy of the survey to make data entry as easy and accurate as possible. At regular intervals (at least once per month), CBOs will submit their questionnaire responses to the contractor via CMS’ secure GENTRAN/TIBCO system. Each CBO will be provided with log in information and detailed training for submitting data via GENTRAN/TIBCO. At the analysis stage, the data will be moved from the GENTRAN/TIBCO mailbox to a secure server.
This information collection is associated with a new CMS initiative, does not duplicate any other effort, and will provide unique information unavailable from any other source. The information collected through the patient experience survey will provide a unique and important opportunity to monitor and assess the effectiveness of patient-centered care transition interventions implemented under the Partnership for Patients initiative.
The only small businesses affected by this effort will be CBOs who choose to participate as CCTP providers. The survey respondents are not small businesses or other small entities.
The patient experience survey will be administered one time in its entirety, and then a subset of questions will be administered a second time. All modules of the patient experience survey (21 items total) will be administered to all CCTP participants at the beginning of a treatment episode, within four days of discharge from the hospital. The PAM-13 module will be administered a second time at or near the end of services. The repeat administration of the PAM-13 is necessary to measure the change in participants’ knowledge, skill, and confidence for self-management of their health and health care following a hospital stay. This information is important for monitoring the performance of CBOs contracted to provide transitional care services. (As noted earlier, the second administration of the PAM-13 may be skipped for participants of programs that offer process-oriented services only, in which case the activation concept and measurement are not applicable.)
There are no special circumstances related to the proposed data collection.
The notice required by 5 CFR 1320.8 (d) was published in the Federal Register on July 22, 2011 (Volume 76, Number 141, pages 44009-44010). Appendix C contains a copy of the notice.
Public Comment and Responses. One public comment was received in response to the first Federal Register notice. The American Pharmacists Association submitted a two-page letter on September 20, 2011 in which they expressed support for the CCTP program and for the survey data collection that is part of the planned implementation and monitoring strategy. They noted that they would like to be included in the data collection:
Pharmacists serve an important role on the health care team during care transitions and as such APhA encourages CMS to include pharmacists in both the survey data and among the list of healthcare professionals to be checked off in the patient experience survey.
CMS has noted the support of the commenter. As for including pharmacists in the data collection, the respondents for this data collection are high-risk Medicare beneficiaries discharged from hospitals partnering with CBOs that are participants in the CCTP program. Health care professionals are not part of this data collection. As for the request to include pharmacists among the list of health care professionals, no such list is included in this questionnaire. As described earlier, the questionnaire for this data collection consists of questions that are used in other data collections and they do not include a list of health care professionals.
No payments will be made to CCTP participants for completion of the patient experience survey. CMS will require CBOs to collect and report patient experience survey data as a condition of their program award.
CMS, the CCTP implementation and monitoring contractor, and the CBOs will take several steps to assure respondents that the information they provide will be kept private to the extent allowed by law and will be used for implementation, monitoring, and evaluation purposes only. CBO staff responsible for administration of the patient experience survey will be trained on administration of the survey including processes for ensuring participant privacy. CBOs will be provided training and a written training manual that will be posted along with other training materials (such as training slides, frequently asked questions and answers, and question-by-question instructions for the survey) on a program website. There will also be monthly webinars for the first six months of the program (conditional on the initial demand and need for training), and then quarterly for new CBO staff or for individuals wishing to refresh their understanding of the data collection and privacy procedures. All CBO survey administrators will be required to attend at least one training within the first month of their organization’s receiving a CCTP award.
Respondents’ names will not be written on the patient experience questionnaire and participants will not be identified individually in any reports; the unit of data analysis is CBOs, and may possibly be divided further for each partnering hospital, depending on how many hospitals the CBO has as partners. Participants will be informed that their participation in the survey is voluntary and that they have the option to refuse to answer any question in the survey. Participants will also be told that neither their participation nor their responses will be shared with individuals outside the study team, nor will their responses affect the services they receive through their doctor or the care transition program.
Paper-and-pencil questionnaires completed by participants will be treated as sensitive documents at each stage of the process, from data collection by the CBOs to data entry by the CBOs to uploading on CMS’ secure system to downloading to the contractor’s secure server. The patient experience questionnaire will contain the participant’s Medicare beneficiary number to allow for the matching of survey data to Medicare claims data and information captured on the care transition list bills. Following the example of CMS’ MFP project, the CBOs will enter participant survey data, including the Medicare beneficiary number (the only identifying piece of data), into a database and will destroy the paper surveys within one year of data entry. CBOs will submit the survey data via the GENTRAN/TIBCO system, which requires the use of a log in process to maintain security. The contractor will move the survey data from the GENTRAN/TIBCO system to a secure server. The contractor, Mathematica Policy Research, protects its LAN with several security mechanisms available through the network operating system. Access to private information stored on LAN directories is restricted to authorized project staff by means of IDs and passwords. In addition, network servers containing private information are kept in a locked area. All contractor staff sign a confidentiality pledge as a term of employment; the confidentiality pledge requires that staff maintain the confidentiality of all information collected. Provision of data to CMS and other CCTP contractors will be done only in the secure CMS computing environment.
The patient experience survey does not contain sensitive questions. Participants will not be asked about their personal health. Questions assess participants’ experiences receiving information about medicines and discharge plans (H-CAHPS and CTM-3 items) and patients’ knowledge, confidence, and skills to manage their own health and health care following a hospital stay (PAM-13 items).
A three-month pilot test of the CCTP Patient Experience Survey will be conducted in order to test the data collection and feedback procedures. The pilot test will be conducted with two CBOs that have about the median number of hospital admissions eligible for CCTP services. If the pilot test is successful, we will plan for the full scale data collection after that.
Tables A.2 and A.3 present estimates of the three-month pilot test respondent burden for completing the patient experience survey. They show the expected number of respondents, the hours per response, and the pilot test hour and cost burden for the data collected. The patient experience survey is expected to take 15 minutes to complete (including both the initial full survey and terminal administration of the PAM-13 instrument). We expect the two participating CBOs to supply care transition services to an upper bound of about 1,900 participants during the pilot test.
Table A.2. Estimated Annualized Burden Hours
Forms |
Type of Respondent |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Hours per Response |
Total Burden Hours |
Patient Experience Survey (Initial Administration) |
CCTP participants |
1,900 |
1 |
10/60 |
317 |
PAM-13 (Terminal Administration) |
CCTP participants |
1,900 |
1 |
5/60 |
158 |
Total |
|
1,900 |
2 |
15/60 |
475 |
Data collection will begin as soon as OMB approval is given. Program agreements are in place, and CBOs began providing care transition services in February 2012 and, if successful, will continue doing so for up to five years.
The cost per participant survey was computed using a median hourly wage rate of $16.27: $16.27*0.25 = $4.07 per response.1
Table A.3. Estimated Annualized Burden Costs
Type of Respondent |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
CCTP Participants |
475 |
$16.27 |
$7,728 |
Full-scale data collection is anticipated to begin in the fall of 2012 after the pilot test field operations report has been submitted to and approved by OMB.
The patient experience survey is a one-time data collection effort for performance monitoring purposes. There are no direct costs to respondents other than their time to participate in the study.
The total value for the CCTP implementation and monitoring contract is $4,804,253 over five years. The annualized cost to the government is $960,850. These estimates are based on the contractor’s costs for supporting performance measurement data collection efforts, including labor and travel; other direct costs for computer, telephone, postage, reproduction, fax, and printing; and indirect costs for fringe benefits, general and administrative costs, and fees.
Data collection for the patient experience survey is new; therefore, there are no changes to burden.
Data collection for the patient experience survey will begin as soon as possible after the successful completion of the pilot test. It is anticipated that data collection will continue on a rolling basis for up to five years, based on performance of the CBOs. CBOs will submit patient experience survey data each month. CMS will receive data in two ways: (1) monthly data files containing survey data, Medicare claims data, and CBO billing information, which will serve as a key source of information for ongoing monitoring and evaluation of the programs; and (2) an aggregated quarterly performance report, including the patient experience survey data, to provide CMS and CBOs with information to measure and track progress toward meeting the program goals. The performance monitoring reports will also give CBOs an opportunity to measure changes in performance outcomes over time, as well as to identify and address potential shortcomings in advance of their two-year program renewal review by CMS. The reports will contain response frequencies for each survey question from the H-CAHPS and CTM as well as composite scores for the CTM-3 and PAM-13 items, and change scores for the PAM-13 measure from beginning to end of the intervention services, as appropriate.
The project also requires the contractor to deliver monthly update reports and a final contract completion report in July 2016.
The OMB expiration date will be displayed on the patient experience survey.
Data collection efforts for the patient experience survey will conform to all provisions of the Paperwork Reduction Act.
Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services. “CAHPS Hospital Survey (H-CAHPS).” Available at [https://www.cahps.ahrq.gov/content/products/HOSP/PROD_HOSP_Intro.asp]. Accessed June 18, 2011.
Boutwell, A., F. Griffin, S. Hwu, and D. Shannon. “Effective Interventions to Reduce Rehospitalizations: A Compendium of 15 Promising Interventions.” Cambridge, MA: Institute for Healthcare Improvement, 2009.
Bureau of Labor Statistics (BLS). “Occupational Employment Statistics: May 2010 National Occupational Employment and Wage Estimates.” 2011. Available at [http://www.bls.gov/oes/current/oes_nat.htm]. Accessed June 17, 2011.
Bureau of Labor Statistics (BLS). “Spotlight on Statistics: Older Workers.” July 2008. Available at [http://www.bls.gov/spotlight/2008/older_workers/data.htm#chart_02]. Accessed June 17, 2011.
Hibbard, Judith H., Eldon R. Mahoney, Jean Stockard, and Martin Tusler. “Development and Testing of a Short Form of the Patient Activation Measure.” Health Services Research, vol. 40, no. 6, Part I, December 2005, pp. 1918-1930.
The National Quality Forum. “Specifications for the Three-Item Care Transition Measure–CTM-3.” Available at [http://www.caretransitions.org/documents/CTM3Specs0807.pdf]. Accessed June 18, 2011.
Sloan, Matt, and Carol Irvin. “Money Follows the Person Quality of Life Survey.” Prepared for the Centers for Medicare & Medicaid Services. Washington, DC: Mathematica Policy Research, 2007.
1 The national hourly median wage according to the Bureau of Labor Statistics’ “Occupational Employment
Statistics: May 2010 National Occupational Employment and Wage Estimates” is $16.27 (BLS 2011). This burden estimate is high, since 2007 data from the Bureau of Labor Statistics show that only about 16 percent of the age 65 and over population (much of the Medicare population) is in the labor force (BLS 2008).
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| Author | Kari Beckmann |
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