CMS-10521 - Supporting Statement A - CLEAN [rev by MBH on 11-14-2014]

Supporting Statement - Part A

Improving Quality of Care in Medicaid and CHIP through Increased Access to Preventive Services, State Survey

CMS-10521, OCN 0938-New

Background

The Centers for Medicare & Medicaid Services (CMS) requests approval to conduct a survey of Medicaid directors regarding coverage of and access to preventive services within their state's Medicaid program. This information will feed into a larger effort by CMS to focus on prevention within the Medicaid program.

The collection of this information is necessary to support the overall project goals of understanding states’ needs related to increasing utilization of preventive services by Medicaid and CHIP enrollees, and providing resources to states to help increase utilization of these services. The overall objective of the state survey is to collect information from each state Medicaid agency about their state’s coverage of preventive services, including each state’s efforts to educate Medicaid and Child Health Insurance Program (CHIP) enrollees about preventive services, to educate health care providers about the coverage of these services, and efforts to increase utilization of these benefits.

We feel that it is important to survey all state Medicaid agencies and not just collect information from a sample of states for several reasons. First, in order to be able to develop resources that will be useful to each state, and resources that can be adapted to each state’s needs, it is important that we receive information from as many states as possible. Second, because the total universe of respondents (i.e., states) is only 51, administering the survey to the full universe of possible respondents is only marginally more expensive than administering the survey to a sample. Third, it is anticipated that not all states will respond, so administering the survey to all states will result in a larger set of information.

The survey responses will be used by CMS and their contactors (Urban Institute, Health Management Associates, American Institutes for Research, and Weber Shandwick) to gain an understanding of states’ efforts to increase utilization of preventive services and to develop resources, including educational and outreach resources, to help states increase utilization of preventive services.

The overall objectives of this project are to support, track, and understand efforts to increase access to preventive health care services in Medicaid and CHIP, particularly the preventive services included in the initial core sets of health care quality measures for children and adults and those recommended by the U.S. Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (CDC’s ACIP). An additional purpose of the project is to utilize this information to develop resources to help states increase utilization of preventive services. Medicaid and CHIP beneficiaries tend to be poorer and have greater health needs than those with private insurance, and preventive services are critically important for early diagnosis of health problems and for promoting healthy behaviors that can reduce the risk of developing chronic conditions. Given the large number of vulnerable individuals covered by these programs, Medicaid and CHIP can play a major role in improving access to preventive services and high-quality care.

CMS contracted with Urban Institute (UI), and their partners Health Management Associates (HMA), American Institutes for Research (AIR), and Weber Shandwick to implement this project. The overall project has three broad initial areas of focus, with the ultimate goal of improving access to and the quality of preventive service delivery. First, the project will provide an environmental scan of states’ coverage of preventive services for adults and children in Medicaid and CHIP, assess the implementation and impacts of ACA Section 4106 in particular, and develop a plan for further study of CMS prevention efforts. Second, it will develop and disseminate resources for states to use in their efforts to increase public awareness of preventive health services available to Medicaid and CHIP beneficiaries. The project will also recommend strategies to improve use and reporting of prevention-focused quality measures and increase practices’ delivery of preventive services and quality of care for children.

The survey effort is one component of the overall project. It is designed to capture information from states about their experiences and efforts to increase utilization of these preventive services, and information that will help CMS develop additional resources to support increased utilization of preventive services. Specifically, the survey will gather information on challenges states face in improving access to and utilization of preventive services, current and past outreach and education efforts, resources that have been helpful in improving utilization of preventive services, and additional resources that would be helpful. Additionally, this survey is designed to gather information from states about their decision to either implement or not implement Section 4106 of the Affordable Care Act, which gives state Medicaid programs the option to receive an additional 1percent federal funding match if they add coverage without cost-sharing for all of the USPSTF-recommended and ACIP-recommended services for adult beneficiaries as part of standard Medicaid coverage.

This survey will also ask states to update information about coverage of preventive services that was collected in a previous survey effort by the Kaiser Commission on Medicaid and the Uninsured in 2013. States that did not respond to that survey effort will be asked to provide information about coverage of preventive services, rather than an update to existing data, because the comparative data are not available.

Surveys will be directed to each state’s Medicaid Director, with instructions for them to complete one survey per state. The survey will be completed and submitted electronically. We anticipate a response rate of 75 percent. This estimate is based on recent experience with a similar survey (referenced above) in which 41 of 51 (80%) of states responded. Because this survey is slightly longer, we adjusted the percentage down slightly.

The overall purpose of the data collection is to gather information to support development of resources for states to increase utilization of preventive services, and to assist CMS in their efforts to support increased utilization of preventive services.

Table 1 shows the types of information we will collect through survey and the justification for including each topic area.

Table 1: Survey Sections

Survey Section #	Domain	Specific area within domain
Section 1	Background Information	Background Information: Respondent name(s) and contact information
Section 2	Implementation of Section 4106	Implementation of Section 4106: Likelihood, reasons, timing, preparation, guidance, outreach, implementation, incentives
Section 3	Changes to Preventive Services Coverage	Changes to Preventive Services Coverage: preventive services table; compares prior to Section 4106 and current
Section 5	Other Initiatives to Increase Access to, and Utilization of, Preventive Health Care Services	Other initiatives in place to increase utilization of preventive services, including incentives for beneficiaries and providers, and any other state initiatives designed to increase utilization of preventive services
Section 6	Outreach and Awareness	Outreach and Awareness: State outreach efforts related to preventive services, perceived effectiveness of outreach services; resources that help with effectiveness, additional resources needed to make outreach more effective, messages that have been effective
Section 7	Support Needed	Other support needed: What other support do states need to be more effective at implementing Section 4106 or other preventive efforts?

A. Justification

1. Need and Legal Basis

One of the key areas of emphasis in the Affordable Care Act (ACA) is that of prevention. Because preventive services are optional services for adults in the Medicaid program, not all adults have access to all preventive services. In order to more effectively work with states to address preventive services and to encourage states to cover them, CMS needs a better understanding of both the current services that are covered in state Medicaid programs, what states are currently doing, and what kinds of outreach would be most effective. This survey will give CMS information on preventive services provided by states, including those covered under Section 4106 of the ACA, in order to inform future CMS guidance and technical assistance related to prevention. The survey will also provide states with valuable state-by-state comparison information. In addition, the survey is intended to assess whether the incentive included in Section 4106 of the ACA is enough to change state behavior.

2. Information Users

The project team will utilize results from the state survey to inform their efforts to develop resources for states to use in the future to improve utilization of preventive services. Policymakers at CMS will utilize this information to better understand the challenges that states face in improving utilization of preventive services, what their successes have been, and how CMS can support state efforts to improve utilization of preventive services in the future.

3. Use of Information Technology

In order to reduce burden, simple and easy to use information technology will be used. The survey will be administered electronically using the following process. Respondents will receive the survey electronically, as a Microsoft Word attachment, along with an email letter introducing the survey, and requesting that they complete the survey. A fillable Adobe PDF document has also been developed in the event that states would prefer to use that approach. Respondents will be given at least four weeks to complete the survey. Respondents can save the document electronically at any time to their desktop or hard drive. Once the survey is complete, respondents will return the completed document to HMA by email, or can print the document and return it via U.S. mail or other service.

4. Duplication of Efforts

The overall project is utilizing multiple methods to collect information and every effort has been made to ensure that data requested as part of this survey cannot be obtained via literature review, review of state websites, or other secondary sources. Any information that can be gathered via these means is not included in the survey.

5. Small Business

Not applicable. No small businesses or other small entities will serve as respondents for this survey.

6. Less Frequent Collection

N/A. This PRA package requests approval to conduct a single survey of state Medicaid Directors.

7. Special Circumstances

There are no special circumstances, as outlined in the Paperwork Reduction Act Submission general instructions, Section A7, associated with this information collection effort.

8. Federal Register/Outside Consultation

Federal Register

The 60-day Federal Register notice published on April 11, 2014 (79 FR 20211). One comment letter was received; our response has been added to this PRA package. While, the burden remains unchanged we added the following three questions in response to the comments. We do not believe that the added questions warrant any burden adjustments.

4. Does your state cover all FDA approved contraception methods? If not, please identify which methods are not covered.

5. Has your state experienced problems with ensuring access to all FDA approved methods for Medicaid clients who are part of health plans, such as use of a plan’s use of prior authorization, step therapy or other utilization management processes?

6. Do your state Medicaid program’s contracts with managed care plans explicitly require plans to limit the use of utilization control processes for contraceptive methods?

Outside Consultation

CMS contracted with Urban Institute (UI), and their partners Health Management Associates (HMA), American Institutes for Research (AIR), and Weber Shandwick to implement this project. The overall project has three broad initial areas of focus, with the ultimate goal of improving access to and the quality of preventive service delivery. First, the project will provide an environmental scan of states’ coverage of preventive services for adults and children in Medicaid and CHIP, assess the implementation and impacts of ACA Section 4106 in particular, and develop a plan for further study of CMS prevention efforts. Second, it will develop and disseminate resources for states to use in their efforts to increase public awareness of preventive health services available to Medicaid and CHIP beneficiaries. The project will also recommend strategies to improve use and reporting of prevention-focused quality measures and increase practices’ delivery of preventive services and quality of care for children

The survey results will be submitted to HMA, who will then review, clean, tabulate, and analyze the data to determine themes and other findings relevant to our research questions. Experienced senior data analysts at HMA will run basic descriptive analyses on quantitative aspects of the data using SPSS or Excel, and will generate charts, tables, and explanatory narrative that provide highlights of patterns and trends, variation in responses by type of respondent, or variation in responses by region.

For the open-ended or more qualitative aspects of the survey data, HMA analysts will enter responses into a data table and/or load them into NVivo and code the narrative to uncover themes and patterns in the data. Qualitative findings will be summarized by HMA analysts and a memo describing data collection methods, analytic methods, and findings will be generated for incorporation into the overall report. Urban Institute staff will provide input throughout this process and assist in these analyses as needed.

9. Payments/Gifts to Respondents

There will be no payment/gifts to respondents.

10. Confidentiality

As previously indicated, the survey administration will be conducted by HMA, and the survey administration process and instrument will undergo an Institutional Review Board (IRB) process before administration. The IRB review request will be for exempt status, per Title 45 Part 46 (CFR 46.101(b)) which states that:

“Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

1. Public benefit or service programs;

2. procedures for obtaining benefits or services under those programs;

3. possible changes in or alternatives to those programs or procedures; or

4. possible changes in methods or levels of payment for benefits or services under those programs.”

This survey meets the above criteria, so a request for exempt status will be requested of the Urban Institute’s IRB. The Urban Institute maintains an IRB to ensure that research practices and procedures effectively protect the rights and welfare of human subjects, consistent with the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46). The Urban Institute’s policy is that all research involving human subjects must adhere to the following principles, among others:

• Risks to human subjects from research must be reasonable in relation to anticipated benefits, and must be minimized to the extent possible;

• Human subjects must be fully and accurately informed of the nature of the research in which they will be involved, whether their participation is mandatory or voluntary, any consequences of non-participation, any risks associated with their participation, and how the research will be used;

• Adequate provision must be made to protect the privacy of human subjects and to maintain the confidentiality of data that are collected, where promised and as appropriate.

Because the information to be collected in this survey effort is not sensitive in nature, and because the information is essentially public information, no assurances of confidentiality will be made. However, in accordance with the above policies regarding human subjects protections, we will maintain the following procedures. First, before respondents participate in the survey, all respondents will be given a clear overview of the project and its goals. We will stress the voluntary nature of their participation and make clear to all parties that there are no negative consequences for them or for their state should they choose not to participate.

11. Sensitive Questions

No questions of a sensitive nature are included in the survey.

12. Burden Estimates (Hours & Wages)

The survey will be administered to every state and sent to one individual - the state Medicaid Director. It is anticipated that these Directors may ask their staff members and their state’s CHIP Director, to assist with the survey response. It is anticipated that the average time for each survey response will be 2.5 hours total. This estimate is based on piloting of the survey with a sample of four former state Medicaid Directors and high level Medicaid staff who were current HMA employees. This will result in an estimated response burden of 127.5 hours (see Table 2).

The cost estimate is based on estimated average hourly wages for State Medicaid Directors and their staff members (who are likely to complete a significant portion of the survey under the guidance of the State Medicaid Director). The following estimate is based on the following assumptions. The median annual salary of a state Medicaid Director is approximately $150,000, which is an hourly rate of $72. An estimated annual salary for a mid-level staff member who will be assisting with survey completion is $85,000, which is an hourly rate of $40. Assuming that the Medicaid Director spends .75 hours responding to the survey, and a mid-level staff member spends 1.75 hours responding to the survey, the total cost burden if all 51 states respond is $6,406.

Table 2: Survey Respondent Burden Estimate

Description	Number of Respondents	Estimated Hours per Response	Total Burden Hours	Total Burden Cost
Survey	51	2.5	127.5	$6,406

13. Capital Costs

There are no capital/start-up or ongoing operation/maintenance costs associated with this data collection.

14. Cost to Federal Government

The total cost to the government for this study, including but not limited to the data collection activities described in this submission, is $112,876 over a 24-month period (see Table 3). Included are costs associated with background research, development of the survey and database, information collection activities, and analysis. Federal full-time equivalent (FTE) costs are expected to be negligible. The administration of this survey is estimated to require less than 0.2% of a Project Officer’s time. This is based on the total annual work hours and is based on an estimate of the time that would be spent by CMS staff on the development of this survey.

Table 3. Estimated Total and Annualized Cost

Cost Component	Total Cost	Annualized Cost
Background research	$9,903	$4,951
Development of survey and database	$45,395	$22,698
Information collection activities	$36,598	$18,299
Analysis	$20,980	$10,490
Total	$112,876	$56,438

15. Changes to Burden

This is a new request for approval.

One comment letter was received during the 60-day comment period; our response has been added to this PRA package. While, the burden remains unchanged we added three questions in response to the comments. We do not believe that the added questions warrant any burden adjustments.

16. Publication/Tabulation Dates

The research team will analyze, integrate, and summarize data in interim and final reports to CMS, to be completed by March 20, 2015.

Assuming all approvals have been completed, the survey administration process would begin in mid- November 2014. To optimize state participation, we will send a personalized letter to each state Medicaid Director by email, including an explanation of the purpose of the survey and the manner in which findings will be used. This email will include a Microsoft Word attachment of the survey, including contact information for HMA staff in case the respondent has questions. We will monitor responses regularly and will send up to two follow-up emails to non-responders during the survey administration period. The HMA team will also be available to answer questions about the survey content or technical questions related to survey administration, and will respond to all telephone and email questions or comments. It is anticipated that the survey responses will be accepted until January 7, 2015. It is possible, based on the response rate and the outcomes of the reminder emails to respondents, that we will accept responses for a slightly longer period, if a state requests an extension to increase the response rate. Our experience with similar surveys indicates that this is likely the case, and we have planned for this contingency. On or near January 7, 2015, analyses will begin, with a report to the Urban Institute and CMS completed by March 20, 2015.

Table 3: Time Schedule

	Begin Date	End Date
Survey Administration and Analyses	Wed 11/19/14	Fri 3/20/15
Administer survey - TBD based on OMB approval	Wed 11/19/14	Wed 1/7/15
Introductory letter with request to complete survey sent, with survey	Wed 11/19/14
Email outreach to all recipients within one week of introductory letter and survey to answer questions and provide assistance in completing	Wed 11/19/14	Wed 11/26/14
Email reminders as needed	Wed 11/19/14	Wed 1/7/15
Phone calls as needed, to assist with completion and increase response rates	Wed 11/19/14	Wed 1/7/15
Conduct analyses and produce draft write up of findings	Mon 1/5/15	Mon 2/23/15
Team review of draft findings	Mon 2/23/15	Mon 3/9/15
Final draft of findings complete	Mon 3/9/15	Fri 3/20/15

17. Expiration Date

Not Applicable. HMA and Urban Institute will display the expiration date for OMB approval of the information collected on all instruments and correspondents with prospective respondents.

18. Certification Statement

This submission, describing data collection, requests no exceptions to the Certificate for Paperwork Reduction Act (5 CFR 1320.9).

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