OMB Control Number: 0938-1300
Supporting Statement – Part A
Currently 26 states are pursuing traditional Medicaid expansion as written under the Patient Protection and Affordable Care Act (ACA) of 2010. Six (6) states are expanding Medicaid by using an alternative to traditional Medicaid expansion (i.e., Section 1115 demonstration approvals). CMS anticipates that additional states may seek a Section 1115 demonstration for the new adult group, namelythose at or below 138% of the federal poverty level (FPL), under the ACA.
CMS approved the Healthy Indiana Program (HIP) 2.0 demonstration (hereinafter, “HIP 2.0 demonstration”) in January 2015. The demonstration expands Medicaid coverage under the ACA for individuals in Indiana. The objectives of the demonstration include: (1) promoting increased access to health care services; (2) encouraging health behaviors and appropriate care, including early intervention, prevention, and wellness; (3) increasing the quality of care and efficiency of the health care delivery system; and (4) promoting private market coverage and family coverage options through HIP Link to reduce network and provider fragmentation within families. The demonstration is authorized for three (3) years from February 1, 2015 through January 31, 2018. The non-emergency medical transportation waiver (NEMT) is due for renewal in the State of Indiana (hereinafter, “State” or “Indiana”). The NEMT benefit provides transportation for Medicaid beneficiaries who otherwise have no means of transportation to get to and from medical services. The HIP 2.0 demonstration provides authority for the State to not offer NEMT for the new adult group during the first year of the demonstration (except for pregnant women and individuals determined to be medically frail). The waiver of NEMT is authorized only through December 1, 2016). CMS may extend the State’s authority, subject to evaluation of the impact of this policy on access to care.
In 2014, CMS awarded cross-state federal evaluations covering four (4) 1115 demonstration types of high priority policy significance. This was the first federal evaluation in over ten (10) years. Subsequently, in late 2015, CMS awarded a federal evaluation of the HIP 2.0 demonstration. CMS expects that additional federal evaluations likely will be required for more states, and that the Indiana evaluation can serve as a model.
This request does not propose any new or revised information collection requirements or burden estimates outside of what is currently approved by OMB under the control number 0938-1300. We also request a waiver from displaying the expiration date, and provide a justification below in Item #17.
Approval of the survey (and associated focus groups, and informational interviews conducted during site visits and via phone) and is vital to adequately inform CMS decision making regarding Section 1115 Waivers, in particular the upcoming non-emergency medical transportation (NEMT) waiver due for renewal by December 1, 2016, in the State of Indiana (hereinafter, “State” or “Indiana”). The NEMT benefit provides transportation for Medicaid beneficiaries who otherwise have no means of transportation to get to and from medical services. The HIP demonstration provides authority for the State to not offer NEMT for the new adult group during the first year of the demonstration (except for pregnant women and individuals determined to be medically frail). CMS may extend the State’s authority, subject to evaluation of the impact of this policy on access to care.
CMS awarded a federal evaluation of the Indiana HIP 2.0 demonstration in late 2015.
In December 2015 CMS concluded work with the State on the State’s evaluation design and surveys. At that point, CMS made adjustments to the federal evaluation and developed a set of survey instruments that would minimize duplication between the State and federal evaluations and provide a robust approach to evaluating the HIP 2.0 demonstration. The new surveys were not available in time to avoid our emergency clearance request that was approved by OMB on March 21, 2016 for the testing/development and implementation of our survey and evaluation effort. This will enable CMS to meet its objective in time so that no harm is done to Medicaid beneficiaries. The regular PRA process could not be followed due to the need to meet important “hard” deadlines imposed by the waiver expiration timeline.
Conduct of the survey data collection and analysis is crucial to ensure enough time for CMS deliberation regarding the waiver prior to its December 1, 2016 expiration date. Another major activity in the first year will be an initial site visit to Indiana in the fall of 2016—to gather more in-depth information from a broader range of stakeholders and consumer advocates.
Additionally, focus groups and informational interviews with key stakeholders at the Indianapolis site will provide the qualitative context to understand the quantitative survey data being collected and the impact analyses being conducted as part of the evaluation, including informing decision-making around the NEMT waiver. Focus groups will enrich the evaluation by capturing the “voices” of adults affected by HIP 2.0, providing valuable details about their experiences and concerns, details that cannot be obtained in the beneficiary survey. The informational interviews will provide important insights into how major HIP 2.0 stakeholders perceive the operations and effectiveness of the program.
Under the emergency PRA approval process that led to the September 30, 2016 expiration date for this collection there were two public comment periods announced in the Federal Register. One was a week long period while the surveys were being tested, and the second was a 30 day-long PRA public comment period that covered the surveys, and focus group and informational interview guides. In addition, during the 30 day comment period, CMS held three conference calls with the State to obtain and consider the State’s oral comments. Following closure of the comment period, CMS again had a conference call with the State to discuss proposed edits in response to the oral and written comments provided by the State, which resulted in a second set of edits on the surveys. CMS also obtained comments from other entities, including extensive comments from NHELP. CMS addressed all of these comments and made revisions to accommodate the comments.
Because the existing approval will expire on September 30, 2016, a three-year extension is needed to continue data collection for the first wave of the beneficiary survey and the first site visit, focus groups, and informational interviews.
Information will be used by CMS to adequately inform CMS decision making regarding Section 1115 Waivers, in particular the upcoming NEMT waiver which is due for renewal by December 1, 2016. CMS and other stakeholders also will use the information as a point of comparison to states implementing similar demonstrations. Other states contemplating waivers may find the information helpful for their own decision-making processes.
The survey involves multi-mode data collection, consisting of: (1) paper self-administered questionnaire (SAQ) mailed by FedEx or Priority mail to beneficiaries, (2) phone follow-up to non-responders, and a (3) Web survey option. The SSS Team partner, Thoroughbred Research Group, will administer the survey and has several automated systems to help monitor all progress of survey administration incorporating mail, phone, and online survey modes. It is our experience that offering multiple modes of response is well-suited to gathering information on patient perceptions and helps to reduce burden on participants, foster compliance, enhance response rates, and accommodate beneficiary preferences. While we are aware that this population may have limited computer access, our proposed approach is based on past successful efforts that have achieved response rates of 30 percent and higher with Medicaid populations.
Survey information will be collected electronically by the system Survox Web Survey version 8.8.2. The information will be stored on the Thoroughbred Research Group secure servers and will then be uploaded via secure file transfer to the SSS Secure Data Center (SSS SDC). A link to the online survey is available for completion electronically. We expect approximately 10 percent of survey questionnaires to be completed online.
The survey data collection does not require a signature from the respondents.
For the focus groups, we will obtain written informed consent from participants after: (1) explaining to them the purpose of our study; (2) informing them that focus groups are confidential to the extent permitted by law, voluntary, and can be stopped at any time; (3) requesting their permission to take notes and audio record the focus group; and (4) soliciting and answering any questions they may have. A copy of the informed consent statement that participants will be asked to sign at the start of all focus groups is included with this package.
The focus group recruitment lists will be stored at the SSS Secure Data Center (SSS SDC) and will be sanitized from the system once the focus groups are completed. The security controls implemented at the SSS SDC are consistent with the recommendations from NIST and are compliant with a FISMA moderate security categorization. The data that resides at the SSS SDC, while at rest, are stored on encrypted drives that are dedicated to the project. Authorized users, such as the trained Briljent staff involved in recruitment, access the data via Citrix NetScaler using a FIPS 140-2 compliant encryption module. Authorized users are required to access the SSS SDC utilizing two-factor authentication which consists of a unique username and password combination in addition to a RSA SecurID token. Each user is allocated a virtual machine in the secure project environment. Once authenticated, users are permitted access to the environment and data files per role-based access controls using Windows Active Directory groups. In addition, there are protocols in place at the SSS SDC that further limit the access and sharing to authorized activities only. Printing capabilities within the SSS SDC have been removed; Internet access from within the SSS SDC is also denied.
Urban Institute researchers, part of the SSS team, will implement a number of safeguards to ensure the confidentiality of all communications between researchers and focus group participants. Urban Institute staff will save electronic audio recordings and focus group notes on a dedicated, segregated, password-protected partition on the Urban Institute secure server, which staff will access through PGP-encrypted computers. Access to these files will be restricted to researchers who have signed a staff pledge of confidentiality and have a need to access the data. All identifiers will be redacted in interview and focus group notes, and not mentioned in reports we write as part of this study. Recordings will be expunged once all focus group notes are cleaned and reviewed by research team members.
The project will adhere to the fundamental principles of research ethics to ensure that the security of the informational interviewee data collected are protected and maintained. Toward that end, we will use a digital audio recorder to create an audio recording of each interview (subject to consent of interviewee), and take notes on an encrypted, password-protected laptop during the interview. At the end of each day of interviewing, Urban staff will upload the audio recordings of their interviews onto the encrypted, password-protected laptops, and delete audio recordings from the digital recorder. Upon staff return to Urban’s offices, audio recordings and rough notes from interviews will be downloaded from secure laptops and saved to Urban’s private computer network drive, to a project folder only accessible by project staff with a need to use these data and who have signed a staff pledge of confidentiality. Files will then be deleted from laptops. All files kept private on the drive will be destroyed at the end of the project.
The federal evaluation of the HIP 2.0 demonstration, of which the federal survey, focus groups and informational interviews are major components, serves to complement rather than duplicate the State’s previous survey and evaluation. The federal survey will accomplish this by providing comparable but independent information on HIP 2.0 enrollees and disenrollees on their understanding, experience and satisfaction with aspects of HIP 2.0 that are priority for CMS. The federal evaluation will be conducted on a larger sample of beneficiaries and will allow greater precision in comparisons of key measures, and for two (2) different time points, than was possible with the State’s evaluation as CMS understands it. We will be conducting focus groups with HIP 2.0 enrollees and informational interviews with state officials, managed care organizations, consumer advocates, or employer or provider organizations.
This data collection effort should not have an impact on small businesses or other small entities.
A less frequent or delayed data collection would not serve the purposes of completion of the evaluation of the NEMT, due to expire December 2016, and other important waivers. It is crucial that the data collection be completed on time for this round, as we plan another round of survey, focus groups, and informational interviews to follow one year after this proposed data collection for comparisons over time. Reducing the frequency of this collection would potentially cause significant harm by depriving Medicaid beneficiaries affected by expiring waivers of medical services and needed care.
There are no special circumstances that would require an information collection to be conducted in a manner that requires respondents to:
Report information to the agency more often than quarterly;
Prepare a written response to a collection of information in fewer than 30 days after receipt of it;
Submit more than an original and two copies of any document;
Retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;
Collect data in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study,
Use a statistical data classification that has not been reviewed and approved by OMB;
Include a pledge of confidentiality that is not supported by authority established in statute or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
Submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
Federal Register (Seeking Extension: Survey Implementation, Focus Groups, and Informational Interviews)
Authorization for a three-year extension is being sought through the normal PRA process to continue the collection beyond the current expiration date, and will include a 60-day public comment period and a 30-day public comment period.
The public comments received will inform a revised PRA package submission that will include the second wave of the beneficiary survey and the second site visit (including focus groups and informational interviews).
Federal Register (Survey Implementation, Focus Groups, and Informational Interviews)
As indicated above, this emergency clearance process included a 30-day public comment period prior to the implementation phase of this effort. The 30-day notice was published in the Federal Register on May 4, 2016 (81 FR 26798) whereby comments were due by June 3, 2016.
Four sets of comments were received on June 3, 2016: from a public individual (Tracking No. 1k0-8pfw-q9kk), Planned Parenthood of Indiana and Kentucky (Tracking No. 1k0-8pzr-ebxr), the State of Indiana Office of the Governor (Tracking No.lk0-8pzv-eyos), and the NHeLP National Health Law Program (Tracking No. 1k0-8pzw-h74x ). A response to these comments is provided in the accompanying materials, and resulting revisions made to the instruments are detailed in the survey crosswalk. The comment letter is also attached.
Federal Register (Survey Testing)
A Federal Register notice published on March 29, 2016, which solicited public comment, set out pertinent PRA-related information including our request for emergency OMB processing for testing/developing the survey, and stated our intent to provide another public comment period related to the implementation of the evaluation.
One set of comments was received on April 8, 2016, from the NHeLP National Health Law Program (Tracking No. 1k08oyi2ji0). A response to these comments is provided in the accompanying materials, and resulting revisions made to the instruments are detailed in the survey crosswalk.1 The comment letter is also attached.
Outside Consultations
The State of Indiana also has been apprised of and engaged with this data collection effort, and will continue to be informed and engaged in its development.
Survey participants will be offered a $10 payment to cover any expenses such as transportation and childcare incurred as a result of taking time to participate in the data collection.
Focus group participants will each receive a $60 payment. Urban Institute staff will collect signed receipts from each focus group participant receiving a payment to defray any costs incurred in participation. Informational interview participants will not receive any payment for participation.
All information collected will be kept private to the extent allowable by law, and reported in the aggregate only.
The survey questions are not deemed to be of a sensitive nature.
12.1 Wage Estimates
Cost estimates per respondent are based on US Bureau of Labor Statistics May 2015 State Occupational Employment and Wage Estimates. Indiana (median overall hourly wage estimates for the State of Indiana (http://www.bls.gov/oes/current/oes_in.htm).
12.2 Burden Estimates
12.2.1 Burden Estimates: Beneficiaries Surveys
Surveys will be conducted with up to 5,182 respondents. Each survey is estimated to take an average of 15 minutes to complete based on our experience with testing the instruments and on previous experience with instruments of this length, and will only occur once per respondent.
Respondent |
No. of Respon-dents |
Frequency of Response |
Partici-pation Time |
Annual Hour Burden |
Wage Cost per Respon-dent |
Annual Cost (Labor) |
Respon-dents (HIP Enrollees and disen-rollees) |
5,182 |
1 time |
.25 hours |
1,296 hours |
$15.82/hr |
$20,503 |
Totals |
5,182 |
1 time |
.25 hours |
1,296 hours |
$15.82/hr |
$20,503 |
Survey Information Collection Instruments and Associated Materials
Enrollee Beneficiary Survey (web option screenshots)
Due to the numerous combinations possible for survey question number fifty-eight (58), we display one possible answer option as an example. Depending on the number of people they report in their family (survey question 58a), participants will be skipped to the appropriate income level choices in survey question fifty-eight (58). Please see the formatted paper version of the mail-in survey to see all possible answer options.
Disenrollee and Lockout Beneficiary Survey (web option screenshots)
Due to the numerous combinations possible for survey question number sixty-one (61), we display one possible answer option as an example. Depending on the number of people they report in their family (survey question 61a), participants will be skipped to the appropriate income level choices in survey question sixty-one (61). Please see the formatted paper version of the mail-in survey to see all possible answer options.
New Enrollee Beneficiary Survey (web option screenshots)
Due to the numerous combinations possible for survey question number thirty-one (31), we display one possible answer option as an example. Depending on the number of people they report in their family (survey question 31a), participants will be skipped to the appropriate income level choices in survey question thirty-one (31). Please see the formatted paper version of the mail-in survey to see all possible answer options.
Beneficiary Survey: Enrollees (paper)
Beneficiary Survey: Disenrollees & Lockouts (paper)
Beneficiary Survey: New Enrollee Survey (paper)
Survey Cover Letter
Survey Prenotification Letter
Survey Reminder
12.2.2 Burden Estimates: Focus Groups
Focus groups will last approximately 90 minutes each. We estimate each participant may spend up to 3 hours in total for participating in the recruitment call, receiving reminders, in commute to and from the focus group, and in the focus group itself. With 4 focus groups of up to 10 participants each, this results in 4 groups x 10 participants x 3 hours = 120 total burden hours involved with the focus groups.
Respondent |
No. of Respondents |
Frequency of Response |
Participation Time |
Annual Hour Burden |
Wage Cost per Respondent |
Annual Cost (Labor) |
Respondents (HIP Enrollees) |
40 |
1 time |
3 hours |
120 hours |
$15.82/hr |
$1,898 |
Totals |
40 |
1 time |
3 hours |
120 hours |
$15.82/hr |
$1,898 |
Focus Group Information Collection Instruments and Associated Materials
Telephone Recruitment Script
Participant Informed Consent Form
CORE Focus Group Moderator’s Guide
12.2.2 Burden Estimates: Informational Interviews
Respondent |
No. of Respondents |
Frequency of Response |
Participation Time |
Annual Hour Burden |
Wage Cost per Respondent |
Annual Cost (Labor) |
Respondents (stakeholders, etc. |
18 |
1 time |
1.5 hours |
27 hours |
$15.82/hr |
$427 |
Totals |
18 |
1 time |
1.5 hours |
27 hours |
$15.82/hr |
$427 |
Informational Interview Information Collection Instruments and Associated Materials
2016 Interview Guide
12.2 Burden Summary
Information Collection |
No. of Respondents |
Frequency of Response |
Participation Time |
Annual Hour Burden |
Wage Cost per Respondent |
Annual Cost (Labor) |
Beneficiaries Surveys |
5,182 |
1 time |
.25 hours |
1,296 hours |
$15.82/hr |
$20,503 |
Focus Groups |
40 |
1 time |
3 hours |
120 hours |
$15.82/hr |
$1,898 |
Informational Interviews |
18 |
1 time |
1.5 hours |
27 hours |
$15.82/hr |
$427 |
Totals |
5,240 |
1 time |
4.75 hours |
1,443 hours |
$15.82/hr |
$22,828 |
There will be no capital, operating, or maintenance costs to the respondents; this represents no change from the initial survey testing package.
No capital costs are expected.
Items 12, 13, & 14 |
Survey |
Focus Groups and Informational Interviews/Site Visit |
Total by Type |
Annual Hours and Wage Cost Burden |
$20,503 |
$2,325 |
$22,828 |
Capital Costs |
$0.00 |
$0.00 |
$0.00 |
Additional costs (contractor hours, operational expenses such as equipment, overhead, printing, and support staff, etc.) |
$269,735 |
$140,986 |
$410,721 |
Annualized Cost to the Government |
$290,238 |
$143,311 |
Grand Total (approximate): $433,549 |
The annualized cost to the federal government is approximately $433,549 (includes survey,and focus groups and informational interviews at site visit). This estimate includes contractor staff time, cost of printing, overhead, payments to respondents to cover expenses incurred to participate in data collection.
The survey instrument testing effort resulted in 15 participants with a total burden of 15 hours. For this proposed implementation information collection request, the target number of survey respondents is 5,182 with a total of 1,296 hours assuming a 15-minute average survey administration time. The additional burden of the focus groups (120 burden hours) and the informational interviews (27 burden hours) combined with the survey burden totals 1,443 hours per year.
The survey descriptive analyses will provide an in-depth profile of HIP 2.0, and will focus on the overall HIP 2.0 population and key subgroups of HIP Basic and HIP Plus eligible adults and enrollees. Indiana Medicaid administrative data, the beneficiary survey, and federal surveys will be used in these descriptive analyses.
Findings from the qualitative (focus groups and informational interviews) and quantitative components will feed into the evaluation’s Interim and Summative Evaluation Reports and Memos to be completed over the course of the project. Evaluation results will also be presented through a series of Webinars (up to 7) conducted in conjunction with the reports.
PUBLICATIONS |
DATES |
OMB PRA Emergency Clearance Package submitted - Main Study |
25-Apr-2016 |
Evaluation Design Report |
6-July-2016 |
Memo on Early Implementation and Consumer Experiences Based on First Site Visit/Focus Groups/Informational Interviews |
14-Oct-2016 |
Memo on Beneficiary Survey Instrument & Survey Methodology |
29-Apr-2016 |
Memo on 1st Wave (W1) of Beneficiary Survey - Descriptive Statistics & Population Comparisons |
14-Oct-2016 |
Memo on Identifying the Comparisons Groups for the Impact Analyses |
14-Oct-2016 |
Interim Report #1: |
31-Oct-2016 |
Webinar based on Interim Report #1 |
30-Nov-2016 |
Memo on Mature Program and Consumer Experiences Based on Second Site Visit/Focus Groups |
30-Oct-2017 |
Memo on 2nd Wave (W2) of Beneficiary Survey - Descriptive Statistics & Population Comparisons |
29-Dec-2017 |
Interim Report #2: |
30-Mar-2018 |
Webinar based on Interim Report #2 |
30-Apr-2018 |
Final Summative Report—Update & Synthesis of Findings in Interim Report #2 |
30-Nov-2018 |
Webinar based on Final Summative Report |
31-Dec-2018 |
Note: The dates in this table are subject to change since they depend on the beneficiary survey launch and site visit rescheduling. |
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We are actively pursuing authorization for a three-year extension through the normal PRA process to continue the data collection beyond the current expiration date. CMS is following the appropriate steps under the PRA to obtain authorization to continue with the fielding of the federal beneficiary surveys. The delay in fielding Wave 1 of the survey due to unanticipated and prolonged activities to complete the data use agreement between CMS contractors and the State has resulted in an emergency situation. CMS therefore would like to request a waiver from displaying the expiration date of “September 30, 2016.” We are requesting the waiver because we expect data collection to extend beyond the current emergency approval date as a result of further delays in finalizing a data use agreement and obtaining from the State the data needed to draw the survey sample. Displaying a date that is likely to change could result in undue use of time and government resources; should the expiration date change, all data collection materials would need to be revised (i.e., reprogrammed, reformatted, reprinted, and quality checked). The omission of the expiration date from the data collection instruments and materials would allow for the most efficient use of resources.
There are no exceptions to "Certification for Paperwork Reduction Act Submissions."
1 OMB granted emergency clearance approval to conduct survey testing and respondent debriefings on all three versions of the federal beneficiary survey instruments. The survey testing and respondent debriefings occurred from March 31, 2016 through April 8, 2016. A total of fifteen (15) interviews with HIP 2.0 enrollees and disenrollees were conducted in Fort Wayne and Indianapolis, Indiana. Respondent debriefings were recording, transcribed, and coded.
The majority of testing participants reported a positive experience in HIP 2.0, understood the purpose of the survey overall, and would participate in the actual survey if they were to receive it in the mail.
Several survey revisions were made based on common themes that emerged during the respondent debriefings. The HIP 2.0 Beneficiary Survey Crosswalk documents revisions made to the survey instruments that were tested. Most of the survey revisions were minor; revisions primarily were made to the “POWER account and monthly or annual contribution” survey section. The most prominent theme found in the testing results revolved around beneficiary confusion and/or misunderstanding of their POWER accounts (POWER accounts are special savings accounts called Personal Wellness and Responsibility accounts that all HIP beneficiaries possess). The majority of the revisions made in that particular survey section focus on improving the quality of the data collected by questions that measure beneficiary understanding and experience with regard to their POWER accounts.
As an example, when a testing respondent was asked about their POWER account and monthly contributions, one respondent stated: “I think I got that a little confused. I thought about one of my letters I got after I got my, um, mammogram. [….] And it was saying I had so much left in the power account. Well, I didn't put – I didn't contribute that.” Additionally, when asked if they had a POWER account: “I think I do. Pretty sure I do. They give me a card. So yeah, it says power account. -- So I'm guessing that's a yeah.”
To ensure and maintain a quality data collection, language was revised to reduce confusion among those who did not know if they had a POWER account. For example, we omitted references to “your” or “my POWER account” and stated them as “a/the POWER account.”
“Well a couple of the questions it really made me think and wonder about my plan and how I'm not that familiar with. I guess I need to be more familiar with HIP Indiana because there's things about it I guess I don't know. “
When asked about the overall purpose of the survey and any general comments after completing the debriefing, most participants found the survey relevant and the questions easy to comprehend.
“I understand most of it. Um, it was actually a learning tool [for the POWER account].”
“Um, no, not really. I mean, the, uh, some of the questions that I might have found a little difficult to answer really were on me. It's – it was whether I had fulfilled my part of the responsibility, and that is to understand my coverage.”
“Um, I thought it was pretty – honestly, I thought It was pretty easy. It was pretty self-explanatory the way you – the way it was written.”
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |