17 Extension - CMS-10615 - Supporting Statement A [rev 09-28-2016 by OSORA PRA]

Supporting Statement – Part A

Healthy Indiana Program (HIP) 2.0 Beneficiary Survey

CMS-10615, OMB 0938-1300

This request does not propose any new or revised information collection requirements or burden estimates outside of what is currently approved by OMB under control number 0938-1300. Rather, this requests seeks a three-year extension of the collection’s current expiration date of September 30, 2016. Authorization for the extension is being sought through the normal PRA process which will include the regular 60- and 30-day public comment periods.

Background

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.

A. Justification

1. Need and Legal Basis

The data collection under the OMB control number 0938-1300 includes the existing 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, namely March 29, 2016 (81 FR 17460) and May 4, 2016 (81 FR 26798). One was a week long period while the surveys were being tested, and the second was a 30-day- 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.

2. Information Users

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.

3. Use of Information Technology

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.

4. Duplication of Efforts

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.

5. Small Businesses

This data collection effort should not have an impact on small businesses or other small entities.

6. Less Frequent Collection

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.

7. Special Circumstances

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.

8. Federal Register/Outside Consultation

Federal Register

The 60-day notice published in the Federal Register on July 22, 2016 (81 FR 47807). No comments were received. Consequently, we are not making any changes from what is already approved by OMB. Nor are we making any changes based on internal agency review.

Public comments were intended to 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). In compliance with the PRA, this will be announced in an upcoming Federal Register notice whereby the public will have another opportunity to comment.

Outside Consultations

We are continuously engaging the state in activities to effectuate this data collection.

9. Payments to Respondents

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.

10. Confidentiality

All information collected will be kept private to the extent allowable by law, and reported in the aggregate only.

11. Sensitive Questions

The survey questions are not deemed to be of a sensitive nature.

12. Burden Estimates (Hours & Wages)

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 (While we are including a consent form as part of this information collection, we are not setting out such burden since the form does not meet the definition of a “information” under 5 CFR 1320.3(h)).

• CORE Focus Group Moderator’s Guide

12.2.3 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

12.3 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.

13. Capital Costs

No capital costs are expected.

14. Cost to Federal Government

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.

15. Changes to Burden

This request does not propose any new or revised information collection requirements or burden estimates outside of what is currently approved by OMB. Rather, this request seeks a three-year extension of the collection’s current expiration date of September 30, 2016.

16. Publication/Tabulation Dates

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
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: Initial Findings & Synthesis Based on First Site Visit/Focus Groups/Informational Interviews, Bene Survey, Administrative Data & Federal Surveys	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: Update of Findings & Synthesis Based on Second Site Visit/Focus Groups/Informational Interviews, Bene Survey, Administrative Data & Federal Surveys	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.

17. Expiration Date

The expiration date will be displayed.

18. Certification Statement

There are no exceptions to "Certification for Paperwork Reduction Act Submissions."

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