CMS-10615 - Supporting Statement A rev 04-17-18_OIRA pass CLEAN

Supporting Statement – Part A

Healthy Indiana Program (HIP) 2.0 Beneficiary Focus Groups

CMS-10615, OMB 0938-1300

This request revises the information collection requirements and burden estimates previously approved by OMB under control number 0938-1300.

Background

Currently 25 states are pursuing traditional Medicaid expansion as written under the Patient Protection and Affordable Care Act (ACA) of 2010. Eight (8) 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, namely those 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 and approved an amended extension of the demonstration in February 2018. 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.

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 a beneficiary survey and associated focus groups and informational interviews conducted during site visits and via phone. As described below, the beneficiary survey is no longer part of the study. The site visit and associated informational interviews and focus groups are vital to adequately inform CMS decision making regarding Section 1115 Waivers in the State of Indiana (hereinafter, “State” or “Indiana”).

In January 2015, Indiana received approval from the Centers for Medicare & Medicaid Services (CMS) to implement a new Section 1115 demonstration allowing for its Medicaid expansion under the Affordable Care Act (ACA)—the Healthy Indiana Plan (HIP) 2.0. Enrollment in HIP 2.0 began on February 1, 2015, and included some individuals who were previously eligible for Medicaid. As of June 2015, some 275,000 individuals were enrolled in HIP 2.0, including individuals who had previously been enrolled in Medicaid prior to HIP 2.0. Enrollment in HIP 2.0 was expected to eventually reach approximately 350,000 newly eligible beneficiaries.

The new demonstration built on Indiana’s existing Medicaid managed care program and its 2007 Section 1115 demonstration, HIP 1.0. HIP 2.0 is an innovative approach to Medicaid expansion, containing elements of personal responsibility through the use of monthly contributions, cost sharing, and strategies to promote healthy behaviors and a reliance on the private insurance market through Medicaid managed care plans and a premium assistance program. HIP 2.0 includes some provisions not included in earlier Medicaid expansions, such as (1) a high-deductible health plan (HDHP) paired with a Personal Wellness and Responsibility (POWER) account; (2) “lockouts” from re-enrolling in coverage for some newly eligible individuals who do not pay their monthly POWER account contributions within a grace period; (3) $25 copays under certain circumstances for non-emergent use of the emergency room (ER); and (4) optional POWER account contributions and enhanced benefits to newly eligible individuals with very low incomes. In addition, the HIP 2.0 demonstration includes a waiver of non-emergency medical transportation (NEMT) services.

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. At that point, CMS made adjustments to the federal evaluation that would minimize duplication between the State and federal evaluations and provide a robust approach to evaluating the HIP 2.0 demonstration.

There are three goals for the federal evaluation of Indiana’s Medicaid expansion waiver:

• Understand the design, implementation, and administrative costs of HIP 2.0;

• Estimate the impacts of the HIP 2.0 waiver; and

• Document beneficiary understanding of and experiences with HIP 2.0, including experiences with POWER accounts and enrollment and disenrollment.

In meeting these goals, the evaluation of Indiana’s Medicaid expansion waiver was to have three components:

• Qualitative analyses that included two rounds of site visits (Spring 2016 and Spring 2018), with four focus groups each round;

• Beneficiary Surveys and descriptive analyses based on Medicaid administrative data in 2016 and 2018; and

• Impact analyses using both Medicaid administrative data and federal survey data.

Prior to 2018, a Data Use Agreement between the CMS contractor – Social & Scientific Systems (SSS), Inc., and the State was not finalized. Medicaid administrative data needed to conduct the Beneficiary Surveys, descriptive analyses, and policy specific impact analyses were dropped from the evaluation since the Data Use agreement could not be completed within the timeframe for the contracted expenditure of funds. The eight focus groups were also pushed to 2018.

In the absence of the Beneficiary Surveys, the eight focus groups will be the source of information directly from Indiana residents on their experiences with HIP 2.0. The CMS evaluation will therefore significantly expand the focus group effort to include a larger number of groups than was originally proposed for 2018, allowing the evaluator to hear more voices from populations of interest across the state to fill part of the gap that arises from the loss of the Beneficiary Surveys. By expanding the number of focus groups for the 2018 site visit, the evaluation will still be able to obtain critical insights into how consumers experience HIP 2.0, whether they find care affordable and accessible, whether enrollment and renewal systems are convenient and efficient, and the extent to which insurance coverage is making a positive difference in their lives. Focus groups and informational interviews with key stakeholders at the Indianapolis site will provide the qualitative context to understand the impact analyses being conducted as part of the evaluation. The informational interviews will provide important insights into how major HIP 2.0 stakeholders perceive the operations and effectiveness of the program.

While the federal evaluation will address the three goals outlined above, it will provide a less rich understanding of the demonstration and of beneficiaries’ understanding and experiences with HIP 2.0 than had been planned. By limiting the case study and focus groups to 2018, the evaluation will obtain less reliable information on the design and implementation of the demonstration and on early experiences with POWER accounts, enrollment and disenrollment. By excluding the Beneficiary Surveys, the evaluation will obtain less in-depth and detailed information on consumer experiences, including the affordability of HELP and satisfaction with HELP. By removing the policy-specific impact analyses that would have relied on the administrative data, the evaluation will not be able to disentangle the impacts of key components of the HIP 2.0 waiver. The Evaluation Design Report was revised to reflect these changes and is available at Medicaid.Gov.¹

The impact evaluation will nonetheless provide a robust analysis, analyzing Indiana as compared to other expansion states and non-expansion states on measures of health insurance coverage, health care access and use (including preventive care), affordability, and health behaviors and health using the American Community Service (ACS) and Behavioral Risk Factor Surveillance System (BFRSS) data.  The SSS evaluation will rely on difference-in-differences models, with the comparison groups carefully structured to be similar to Indiana at baseline.  In addition, the SSS evaluation will compare its findings with other research and evaluations including: the federal multistate Medicaid expansion and healthy behaviors evaluation being conducted by Mathematica Policy Research, and Indiana’s own independent state evaluation. 

2. Information Users

Information will be used by CMS to adequately inform CMS decision making regarding Section 1115 Waivers. 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

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 focus groups and informational interviews are major components, serves to complement rather than duplicate the State’s previous survey and evaluation. The focus groups will accomplish this by providing rich, detailed 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 informational interviews with state officials, managed care organizations, consumer advocates, and employer or provider organizations, will also provide important contextual information for interpreting federal and state evaluation results.

5. Small Businesses

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

6. Less Frequent Collection

Focus group the informational interview data will be collected one time. A less frequent or delayed data collection would not serve the purposes of completion of the evaluation.

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

CMS submitted this request as a non-substantive change and therefore did not solicit public comments.

9. Payments to Respondents

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 interview and focus group 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 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. While the initial OMB approval included 4 focus groups, with the elimination of the beneficiary survey we are expanding the request to include up to 8 focus groups of up to 10 participants each. This results in 8 groups x 10 participants x 3 hours = 240 total burden hours involved with the focus groups.

Respondent Burden for 8 Focus Groups

Respondent	No. of Respondents	Frequency of Response	Participation Time	Annual Hour Burden	Wage Cost per Respondent	Annual Cost (Labor)
Respondents (HIP Enrollees)	80	1 time	3 hours	240 hours	$15.82/hr	$3,797
Totals	80	1 time	3 hours	240 hours	$15.82/hr	$3,797

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

12.2.2 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

Burden Summary – 8 Focus Groups and 18 Informational Interviews

Information Collection	No. of Respondents	Frequency of Response	Participation Time	Annual Hour Burden	Wage Cost per Respondent	Annual Cost (Labor)
Focus Groups	80	1 time	3 hours	240 hours	$15.82/hr	$3,797
Informational Interviews	18	1 time	1.5 hours	27 hours	$15.82/hr	$427
Totals	98	1 time	4.75 hours	267 hours	$15.82/hr	$4,224

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

Annualized Cost to Government – 8 Focus Groups and 18 Informational Interviews

Items 12, 13, & 14		Focus Groups and Informational Interviews/Site Visit	Total by Type
Annual Hours and Wage Cost Burden		$4,224	4,224
Capital Costs		$0.00
Additional costs (contractor hours, operational expenses such as equipment, overhead, printing, and support staff, etc.)		$242,000	242,000
Annualized Cost to the Government		$246,224	Grand Total (approximate): 246,224

The annualized cost to the federal government is approximately $246,224 for a site visit with 8 focus groups (includes 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 eliminates the survey from what is currently approved by OMB and 4 additional focus groups (going from up to 4 to up to 8 focus groups). The burden estimate for the survey when it was initially included as part of the PRA package included an annual hours and wage cost burden of $20,503, as well as additional costs in the form of contractor hours, operating expenses, printing and support staff of $269,735. When combined with the burden estimates for the 4 focus groups, we estimated an annualized cost to the Federal Government of approximately $440,000. With the elimination of the survey, and the subsequent increase in the number of focus groups, we now have a revised burden estimate with a revised annualized cost to the Federal Government of $246,224.

16. Publication/Tabulation Dates

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. Redacted transcripts from the focus groups are not included as a deliverable, nor will they be shared with the State.

PUBLICATIONS	DATES
Memo on Identifying the Comparisons Groups for the Impact Analyses	14-Oct-2016
Memo on Program Implementation and Consumer Experiences Based on Site Visit/Focus Groups/Informational Interviews	30-July-2018
Final Summative Report	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 site visit scheduling.

17. Expiration Date

The expiration date will be displayed.

18. Certification Statement

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

1 https://www.medicaid.gov/medicaid-chip-program-information/by-topics/waivers/1115/downloads/in/healthy-indiana-plan-2/in-healthy-indiana-plan-support-20-eval-dsgn-rpt-05222017.pdf

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