CMS-10635 - Supporting Statement A (OMB Passback 1)_rev_clean

Supporting Statement – Part A

Montana Health and Economic Livelihood Partnership (HELP)

Federal Evaluation

CMS-10635, OMB 0938-New

Background

Currently 31 states, including the District of Columbia, have adopted Medicaid expansion. Seven (7) 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 133% of the federal poverty level (FPL), under the Affordable Care Act (ACA).

CMS approved the Montana Health and Economic Livelihood Partnership (HELP) demonstration (hereinafter, “HELP demonstration”) in November 2015. The demonstration provides flexibility for the expanded Medicaid population under the Affordable Care Act for individuals in the state of Montana (hereinafter, “State” or “Montana”). Montana expects to achieve the following: (1) Premiums and copayment liability that will encourage HELP Program enrollees to be discerning health care purchasers, take personal responsibility for their health care decisions and develop health-conscious behaviors as consumers of health care services; (2) 12-month continuous eligibility to improve continuity of care. Additionally, Montana seeks to demonstrate the following over the life of the demonstration: (1) Premiums will not pose a barrier to accessing care for HELP Program beneficiaries; (2) HELP Program enrollees will exhibit health-conscious health care behaviors without harming beneficiary health; (3) 12-month continuous eligibility will promote continuity of coverage and reduce churning rates. The demonstration is authorized for five (5) years from January 1, 2016 through December 31, 2020. The demonstration includes the authority to charge premiums of 2 percent of household income to individuals in the new adult group with incomes between 50 and 133 percent of the FPL. The state will credit such individuals’ premium obligation towards copayments due. Non-payment of premiums may result in disenrollment for individuals with incomes above 100 percent of the FPL after notice and a grace period. Individuals at or below 100 percent who stop paying premiums will not be disenrolled.

In 2014, CMS awarded a cross-state federal evaluation covering four (4) 1115 demonstration types of high priority policy significance. This was the first federal evaluation in over ten (10) years. Subsequently, in early 2015, CMS awarded a federal evaluation of the Medicaid expansion demonstration (HIP 2.0) for the state of Indiana. Additionally, in early 2016, under the same contract CMS awarded a federal evaluation of the HELP demonstration. CMS expects that additional federal evaluations likely will be required for more states, and that both the Indiana and Montana evaluations can serve as a model.

A. Justification

1. Need and Legal Basis

Approval of the survey and associated focus groups, and informational interviews conducted during site visits and via phone, is vital to adequately inform CMS decision-making regarding Section 1115 Demonstrations. The HELP demonstration provides authority for the state to charge premiums of 2 percent of income to specific individuals in the new adult group with household incomes between 50 and 133 percent of the FPL, who are not medically frail or exempt under federal or state law. Additionally, the demonstration authorizes twelve months of continuous eligibility for all individuals who are eligible under the state plan in the new adult coverage group.

The federal evaluation of the Montana HELP demonstration includes two waves of the beneficiary survey, Wave 1 and Wave 2, to allow comparisons at two time points (approximately one year apart) in the demonstration. The SSS Team is requesting that approval for both survey waves and both site visits (including focus groups and informational interviews) be included in the same standard PRA package to increase project efficiency and to reduce burden on government resources. In order to allow for optimal comparisons between Wave 1 and Wave 2, the SSS Team is submitting the correct and final survey and does not anticipate making substantive changes to the survey instruments, sample respondents, data collection methods, response burden, or requirements between the two waves. Substantive changes to the survey instruments or the sample and data collection methods will pose challenges in comparing the experiences of respondents in the HELP program at two different points in time when it comes to the particular program elements that are being asked about in the survey. The Team recognizes, however, that several factors may impact the extent of changes to the survey, including: OMB feedback and the timing of approval, public comments and any additional comment period(s), and potential shifts in CMS priorities. If the Wave 2 survey requires significant revisions, a PRA Revision package will be submitted to OMB for approval.

2. Information Users

Information will be used by CMS to adequately inform CMS decision making regarding Section 1115 Demonstrations. CMS and other stakeholders also will use the information as a point of comparison to states implementing similar demonstrations. Other states contemplating demonstrations 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 Survey Operations Center and the Telephone Research Center will administer the survey and have 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 survey software packages DatStat and Blaise. The information will be stored in the SSS Secure Data Center (SSS SDC). A link to the online survey is available for electronic completion. 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 reside at the SSS SDC, while at rest, are stored on encrypted drives that are dedicated to the project. Authorized users, will 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.

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. SSS and Urban has quality control processes in place to ensure that the recordings of the interviews and focus groups will not include any identifiers. All identifiers will be redacted in interview and focus group notes, and not mentioned in reports we write as part of this study. At the end of each day of interviewing Urban staff will upload the audio recordings of their interviews onto the SSS SDC 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 Urban staff members who access such data will undergo the necessary training required to work in the SSS SDC.

4. Duplication of Efforts

Montana will not be conducting an independent evaluation of the HELP demonstration. CMS is allowing Montana to use the federal evaluation to meet the requirement for a state evaluation, thereby avoiding any duplication of efforts.

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 HELP demonstration, approved through December 31, 2020. It is crucial that the data collection be completed on time for both the first round and second round of surveys, focus groups, and informational interviews. The second round of data collection will occur approximately one year after the first round to allow for comparisons over time.

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

The 60-day notice published in the Federal Register on October 21, 2016 (81 FR 72806). While no comments were submitted via FDMS, the State of Montana submitted comments to the federal evaluation team regarding the federal evaluation design including comments on the beneficiary surveys, focus groups, and informational interviews.¹ Those comments were taken into consideration and materials were revised as appropriate. Moderate revisions made to the data collection instruments (i.e. beneficiary surveys, focus group moderator guide, and informational interview guide).

Changes in burden occurred due to an increase in the number of focus group participants, from 40 to 60 participants, and in the number of informational interviews, from 18 to 25 participants.

Beneficiary survey instrument testing occurred shortly after the 60-day public comment period closed. The testing only included 8 beneficiaries and took place in Billings, Montana. The survey testing consisted of respondent debriefings and resulted in minor survey revisions. A summary of the survey testing results follows:

Researchers conducted respondent debriefings with 8 beneficiaries. The 8 beneficiaries were current and previous enrollees in the Montana HELP plan. The respondent debriefings took place in-person in Billings, Montana over a two-day period (January 4, 2017 – January 5, 2017).

Overall, the respondent debriefings did not result in major survey questionnaire revisions. Given that nearly half of the survey questions were directly from or adapted from previously used and vetted beneficiary surveys, the survey team did not expect any major revisions. The respondent debriefings helped further validate clarity and beneficiary understanding of the survey question format, content, and definitions utilized.

While the testing did not reveal any challenging or confusing concepts within the survey questionnaire, a few testing participants indicated some confusion with the question structure asking whether they agreed, disagreed, or were not sure with some statements provided about the HELP plan. The question structure was updated to eliminate to more clearly ask respondents whether they think certain features or components (listed in the question) are part of HELP, not part of HELP, of if they are not sure.

9. ”Thank You” Gifts to Respondents

Survey participants will be offered a $10 Visa® gift card for their participation in the data collection. Based on past experience surveying Medicaid beneficiaries as well as the survey methods literature, we arrived at the $10 amount as the appropriate amount to provide potential survey respondents in order to thank them for their participation and incentivize them to respond to the survey(s).^{2 3 4} Focus group participants will each receive a $60 gift card as a “Thank You” and to defray any costs incurred in participation. The focus group amount is based on Urban Institute’s decades of experience successfully recruiting focus group participants, and recent experience with projects involving similar consumer populations. Urban Institute staff will collect signed receipts from each focus group participant receiving a payment. Informational interview participants will not receive a gift card 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

There are no sensitive questions associated with this collection. Specifically, the collection does not solicit questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

12. Burden Estimates (Hours & Wages)

12.1 Wage Estimates

For unemployed beneficiary participants, we use the minimum wage of $8.15/hour set forth by the State of Montana (2017. http://www.minimum-wage.org/states.asp?state=Montana), accounting for an estimated 1/3 of HELP eligibles (as a proxy measure) that are unemployed (http://dphhs.mt.gov/Portals/85/Documents/MedicaidExpansion/DPHHS%20HELP%20Act%20Progress%20Report%20LFC9_29_2016.pdf).

Wage burden estimates for employed beneficiaries are based on US Bureau of Labor Statistics. May 2016 State Occupational Employment and Wage Estimates. Montana (http://www.bls.gov/oes/current/oes_mt.htm). The following table presents the mean hourly wage, the cost of fringe benefits (calculated at 100 percent of salary), and the adjusted hourly wage.

Occupation Title	Occupation Code	Mean Hourly Wage ($/hr)	Fringe Benefit ($/hr)	Adjusted Hourly Wage ($/hr)
All Occupations*	00-0000	19.92	19.92	39.84
General and Operations Managers	11-1021	46.69	46.69	93.38

*Serves as a proxy for the average median hourly wage for all employed beneficiaries.

As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

12.2 Burden Estimates

12.2.1 Burden Estimates: Beneficiary Surveys

Two annual surveys (Wave 1 and Wave 2) will be conducted with approximately 1,400 respondents per year (Note: the respondent sample will include different individuals in Waves 1 and 2 so that no individual responds to the survey more than once). Each survey is estimated to take an average of 15 minutes to complete based on previous experience testing the questions in Indiana and on experience with similar instruments of this length.

The survey instrument testing conducted during the 60-day public comment period helped validate the 15-minute completion estimate for Montana. (Survey instrument testing took place with up to 8 beneficiaries only.)

Beneficiary Surveys

Respondent	No. of Respondents	Frequency of Response	Participation Time	Annual Hour Burden	Respondent Wage ($/hr)	Annual Labor Cost ($)
Respondents (HELP Enrollees and disenrollees)	Unemployed: 462/year; Employed: 938/year	1 time/year	.25 hours/year	115.5 hours; 234.5 hours	8.15; 39.84	941 9,343
Total	1,400/year	1 time/year	.25 hours/year	350 hours	8.15-39.84	10,284

Beneficiary Survey Information Collection Instructions and Associated Materials⁵

• Enrollee Beneficiary Survey (web option screenshots)

• Disenrollee and Lockout Beneficiary Survey (web option screenshots)

• Beneficiary Survey: Enrollees (paper - English)

• Beneficiary Survey: Disenrollees (paper - English)

• Beneficiary Survey: Enrollees (paper - Spanish)

• Beneficiary Survey: Disenrollees (paper - Spanish)

• Survey Cover Letter

• Survey Reminder Postcard

• Survey Thank You
  
  

12.2.2 Focus Group Information Collection Instruments and Associated Materials

Beneficiary Focus Groups

Respondent	No. of Respondents	Frequency of Response	Participation Time	Annual Hour Burden	Respondent Wage ($/hr)	Annual Labor Cost ($)
Respondents (Beneficiaries: Enrollees)	Unemployed: 24/year; Employed: 36/year	1 time/year	3 hours	72 hours; 108 hours	8.15 39.84	587; 4,303
Totals	60/year	1 time/year	3 hours	180 hours	8.15-39.84	4,890

• Telephone Recruitment Script

• Participant Informed Consent Form

• Core Focus Group Moderator’s Guide

12.2.3 Burden Estimates: Informational Interviews

Informational Interviews (Stakeholders, etc.)

Respondent	No. of Respondents	Frequency of Response	Participation Time	Annual Hour Burden	Respondent Wage ($/hr)	Annual Labor Cost ($)
Respondents (stakeholders, etc.	25/year	1 time/year	1.5 hours	37.5 hours	93.38	3,502
Totals	25/year	1 time/year	1.5 hours	37.5 hours	93.38	3,502

Informational Interview Information Collection Instruments and Associated Materials

• Interview Guide

12.3 Burden Summary

All Respondents

Information Collection	No. of Respondents	Frequency of Response	Participation Time	Annual Hour Burden	Wage Cost per Respondent	Annual Cost (Labor)
Beneficiaries Surveys	1,400	1 time	.25 hours	350 hours	$8.15-$39.84/hour	$10,284
Focus Groups	60	1 time	3 hours	180 hours	$8.15-$39.84/hour	$4,890
Informational Interviews	25	1 time	1.5 hours	37.5 hours	$93.38/hour	$3,502
Totals	1,485	1 time	4.75 hours	567.5 hours	$8.15/hour $39.84/hour $93.38/hour	$18,676

13. Capital Costs

There will be no capital, operating, or maintenance costs to the respondents.

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	$4,534.05	$3,663.06	$8,197.11
Capital Costs (Total)	$66,039.00	$0.00	$66,039.00
Additional costs (contractor hours, operational expenses such as equipment, overhead, printing, and support staff, etc.)	$205,305.00	$220,000.00	$425,305.00
Annualized Cost to the Government	$275,878.15	$223,663.06	Grand Total (approximate): $499,541.11

The annualized cost to the federal government is approximately $499,541. This figure includes costs of survey, focus groups and informational interview data collection, as well as capital costs, additional costs associated with data collection activities, and annual hours and wage cost burden estimates.

Capital Costs
Record storage	$19,400
Software	$46,639
Total Capital Costs	$66,039

The record storage capital costs include routine maintenance and storage costs for FISMA-moderate data backup/archival storage in the SSS Secure Data Center. The software capital costs include SAS and STATA licenses needed for analyses of data from all data collection activities.

15. Changes to Burden

Changes are not applicable. This is a new ICR.

16. Publication/Tabulation Dates

The survey descriptive analyses will provide an in-depth profile of HELP, and will focus on the overall HELP population and key subgroups. Montana 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 be incorporated into the evaluation’s Interim and Summative Evaluation Reports and Memos to be completed over the course of the project. Evaluation results also will be presented through a series of Webinars (up to 7) conducted in conjunction with the reports.

17. Expiration Date

CMS will display the expiration date.

18. Certification Statement

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

1 The federal evaluation team received the Montana comments from CMS on January 25, 2017.

2 Fredrickson, D. D., Jones, T. L., Molgaard, C. A., Carman, C. G., Schukman, J., Dismuke, S. E., & Ablah, E. (2005). Optimal design features for surveying low-income populations. Journal of Health Care for the Poor and Underserved, 16(4), 677–690

3 Beebe, T. J., Davern, M. E., McAlpine, D. D., Call, K. T., & Rockwood, T. H. (2005).

Increasing response rates in a survey of Medicaid enrollees: the effect of a prepaid monetary incentive and mixed modes (mail and telephone). Medical Care, 43(4), 411–414.

4 Singer E. “The Use and Effects of Incentives in Surveys,” prepared for presentation to the National Science Foundation, Washington DC, October 3-4, 2012.

5 Beneficiary survey screenshots are representative of all survey questions in the survey. The skip logic will be solely represented in the programming based on individual responses.

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