CMS_10437_Supporting_Statement_A (30-day) - final

Supporting Statement – Part A

Supporting Statement For Paperwork Reduction Act Submissions

Generic Social Marketing & Consumer Testing Research (CMS-10437)

The purpose of this submission is to request a revision for our current Generic Social Marketing & Consumer Testing Research generic clearance. The current generic clearance covers a program of consumer research aimed at a broad audience of those affected by CMS programs including

Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace. This program extends strategic efforts to reach and tailor communications to beneficiaries, caregivers, providers, stakeholders, and any other audiences that are served by the Agency. This work will support the Agency in increasing satisfaction with our services, and its mission to improve the functioning of the health care system, improve patient care and outcomes, and reduce costs without sacrificing quality of care. The extension of this clearance will enable the Office of Communications to maintain a proactive process for rapid collection of data to inform development of communications around new and existing Agency initiatives, as well as providing rapid feedback on service delivery for continuous improvement of programs and communications aimed at diverse CMS target audiences.

Social marketing uses marketing principles to influence human behavior to improve health or benefit society. The research conducted under this clearance will use social marketing approaches to develop and refine methods for enhancing communication with CMS target audiences related to key Agency initiatives. To achieve the best results, it is necessary for CMS to regularly conduct consumer testing to develop and implement communication approaches that are crafted to meet the needs, values, motivations, and cognitive styles of its diverse audiences. This work must be done in a timely manner to inform rapidly developing communication needs, and an extension of this generic clearance will help the Office of Communications to continue to expedite a range of information collection efforts that will support and enhance communications with consumers and other stakeholders relating to existing or future services, initiatives, products, or communication materials.

Successful outreach and communication depends on a deep understanding of the target audience. CMS deploys a strategic approach to obtain a better understanding of the desired audiences with an aim toward improving and optimizing outreach and education strategies and materials. The strategy focuses on offering clear and readily available information for follow up and further enhancement of the process. Under this clearance, CMS proposes to continue to facilitate timely consumer research using a variety of methods including focus groups, usability studies, one-on- one or panel discussion groups, customer satisfaction surveys, post-transaction customer surveys, telephone surveys, online surveys, comment/complaint form analysis, and interactive consumer assessments of prototypes in development for consumer communication.

The extension of this generic clearance will allow for continued rapid response to inform CMS initiatives using a mixture of qualitative and quantitative consumer research strategies (including formative and developmental research studies as well as methodological tests) to improve communication with key CMS audiences. As new information resources and persuasive technologies are developed, they can be tested and evaluated for beneficiary response to the materials and delivery channels. Results will inform communication development and information architecture as well as allow for continuous quality improvement. The overall goal is to maximize the extent to which CMS target audiences have access to useful sources of CMS program information in a form that can help them make the most of their benefits and options.

Background

It is critical for CMS to research, collect data, and obtain feedback from the Agency’s varied target audiences. With the extension of this generic clearance, CMS will be able to continue to conduct social marketing research in a streamlined process, improving speed and efficiency of our work

while maximizing CMS’s ability to be effective in meeting the needs of the Agency, the general public, program beneficiaries, caregivers, providers, and other stakeholders.

All social marketing research under this clearance will include supporting documentation of the research topic and stated goals, method of data collection, categories of respondents, estimated “burden cap”, and plans on how the information will be utilized. Testing will be conducted to capture timely and useful information that can be applied to improve audience understanding and to effectively tailor outreach and education materials and strategies. The process will allow CMS to develop and refine methods for rapid and continuous enhancement of communication with CMS target audiences related to the Agency’s programs and initiatives.

All collection of information under this clearance will utilize resources to improve the integrity and quality of the information captured. The results will be compiled and disseminated so that future revisions can be guided by the needs and preferences of the target audience. We will use the findings to create the greatest possible public benefit.

1. Justification

1. Need and Legal Basis

This work is designed to allow CMS to develop and implement more effective outreach and education materials for those it serves. In an effort to facilitate timely and efficient compliance with the PRA, this extension will continue the expeditious process established through the original clearance which allows CMS to test and create information products and marketing campaigns which promote the goals of legislation related to health literacy, cultural sensitivity and effective use of program benefits. Without appropriate research, CMS will not be able to deliver health insurance benefits, options and related information in a way that will encourage appropriate consumer use in making informed choices as mandated in the legislation. There

are also less obvious costs associated with waste of communication resources and lost opportunities if messages and materials are not perceived as relevant, are not clearly understood, or do not lead to the appropriate consumer behavior. Untested messages can also have unintended consequences such as when untested content or materials lead to misunderstandings resulting in project failure or loss of program credibility.

In 2021, President Biden put The Executive Order on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government into place, with a goal of improving customer experience across providers of high impact services. Both Medicare and The Health Insurance Marketplace are considered high impact service providers. Research to provide recommendations for enhancing communication strategies and activities will be assist in driving Agency improvements.

The consumer research conducted under this generic clearance is also essential to achieving the mandates of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The law includes major changes to Medicare and CHIP, and effective outreach and education strategies will be required to inform CMS target audiences who will be impacted by these changes, especially beneficiaries, providers, and practice management staff. Consumer research can help develop and improve the strategies, content, and messaging used in these efforts. Policies related to this legislation continue to require clear communication and education activities that benefit from timely consumer research has been particularly useful:

1. Research conducted with healthcare professionals under GenIC #13 was instrumental in assisting the Agency with understanding the facilitators and barriers to adoption and implementation of the Quality Payment Program (MACRA, Sec. 101 and 102). Findings from the quantitative research helped us to understand characteristics associated with awareness, familiarity, and favorability of the program and program elements. Qualitative research enabled a deeper examination to support the development of targeted outreach and information to improve program awareness, and to support the development of targeted education and outreach strategies and materials.

2. Research conducted with healthcare professionals under GenIC #13 helped us to contextualize the way that healthcare professionals experience and manage administrative burden (MACRA, Sec. 106). Through this research, CMS explored the extent to which healthcare professionals perceive reporting requirements to be burdensome and whether they understand or appreciate the value of these efforts. This work was used to assist CMS in examining ways to reduce burden through process improvements, and to examine ways refine communications regarding reporting requirements that enhance communication about program benefits from an end-user point of view.

3. Research conducted with consumers under GenIC #1 examined the extent to which uninsured individuals understood and were able to effectively use quality ratings when making decisions about health insurance plans (MACRA Sec. 104). The results of this researched were used to assist in developing and refining quality information on HealthCare.gov to support consumer decision-making.

4. Research conducted with Medicare beneficiaries under GenIC #17 has enabled CMS to test educational information in the Medicare & You Handbook about, among other Agency

initiatives, the Social Security Number Removal Initiative (MACRA, Sec. 501) and the option to receive Medicare Summary Notices electronically (MACRA, Sec. 508). This research helped to refine the educational content, not only in the Handbook, but in other communication materials, to enhance comprehension and actionability of the information.

This work is also essential to the achieving the mandates of the Patient Protection and Affordable Care Act of 2010 (ACA) or the Healthcare Law that replaces it, and the American Rescue Plan Act of 2021 (ARPA). The ACA includes provisions to communicate health and health care information clearly; promote prevention; provide patient-centered care; assure equity and cultural competence; and deliver high-quality care. All of these general goals can be enhanced through timely consumer research. Timely research has enhanced CMS’s communication strategies and materials for continued research is needed on several specific topics mentioned in the legislation including:

1. Research conducted under GenICs #7, #11, and #23 has helped CMS to understand the barriers and facilitators to awareness and understanding of key aspects of the Health Insurance Marketplace and navigating and using information on HealthCare.gov. These studies have enabled us to enhance communication and outreach strategies and materials related to health insurance on the HealthCare.gov website (ACA, Sec. 1103) and the expansion of preventive benefits and how that impacts consumers (ACA, Sec. 4004). This research has assisted CMS in developing and continuously improving outreach and education information and web content to help uninsured individuals and individuals with health insurance through the Marketplace to make informed decisions that benefit their access to healthcare.

2. Research under GenIC #17 examined the comprehensibility of content related to closing the “doughnut hole” in Part D prescription drug coverage (ACA, Sec. 1003, RB 1101). In addition, research conducted under GenIC #11 has enabled us to explore how Medicare beneficiaries understand the drug pricing information on Medicare.gov and how they use that information to assist their decision-making around Part D and Medicare Advantage plan selections.

   • Accountable Care Organizations (ACA, Sec 3022, 2706, 2703)

   • Center for Innovation (ACA, Sec 3021)

   • Dual Eligible (ACA, Sec 2601, 2602)

   • Medicare Advantage Payment Reform (ACA, Sec 3001, 3209)

   • Public & Quality Reporting (ACA, Sec 10303, 10327, 10331, 2701, et al.)

   • Women’s Health Act (ACA, Sec, 2713(a)(4)

   • ARPA related tax credits for QHP enrollment (ARPA, Sec 9661)

The Inflation Reduction Act of 2022 provides meaningful financial relief for millions of people with Medicare by improving access to affordable treatments and strengthening the Medicare Program both now and long term. This Act includes provisions to increase accessibility and affordability of prescription drugs for Medicare beneficiaries, reduce the rate of growth in Medicare drug spending, and improve the financial sustainability of the Medicare

program. Consumer research can help develop and improve the strategies, content, and messaging used to provide outreach and education for these efforts. Some of the specific topics for which research can drive improvements in communication include:

• Sec 11102 Medicare Part D Rebate by Manufacturers

• Sec 11201 Part D Benefit Redesign

• Sec 11401 Coverage of Adult Vaccines Recommended by the Advisory Committee on Immunization Practices Under Medicare Part D

• Sec 11404 Expanding Eligibility for Low-Income Subsidies Under Part D of the Medicare Program

• Sec 11406 Appropriate Cost-Sharing for Covered Insulin Products Under Medicare Part D

The Plain Writing Act of 2010 mandated that all federal agencies use clear governmental communication that the public can understand and use. The purpose of the act is to effectively communicate with our target audience. Research conducted under this clearance is designed to ensure that communications coming from the Agency are comprehensible, usable, and appropriately targeted for CMS audiences. This is particularly important for developing effective communications about initiatives and Agency priorities such as Patients Over Paperwork, innovations such as alternative payment models, and the federal charge to increase customer satisfaction among High Impact Service Providers.

At the time of this submission, new initiatives and policies are being considered that will have impacts on CMS’ target audiences. Information about these new initiatives and policies will need to be communicated quickly and effectively to the people they impact. This extension will allow for continued rapid-cycle consumer research to shape those communication efforts and ensure that they are appropriately targeted to enable consumers to be aware and to understand what these changes mean for them.

2. Information Users

The Centers for Medicare and Medicaid Services will use this information for internal improvement projects that help to improve program operations. The research conducted under this package has not and will not be used for public reporting and data associated with projects conducted under this clearance will not be published. Some examples of how CMS has used research conducted under this generic package in the past include: continuous improvement of the Medicare & You Handbook based on qualitative materials testing with Medicare beneficiaries; development and improvement of outreach messages to motivate individuals with Medicare to review and compare plans, and uninsured individuals to go to HealthCare.gov to find health coverage; refinement and improvements to the HealthCare.gov, including the application, plan selection, and enrollment process through user testing of the website and web tools; improvements to the Medicare.gov through formative and usability

research with Medicare beneficiaries; and development of communications strategies about innovations and provider payment initiatives. .

The information collected will be useful and minimally burdensome for the public as required by the Paperwork Reduction Act.

3. Use of Information Technology

Measuring and helping to improve the effectiveness of CMS outreach, education, and communications efforts using information technology and emerging communication technology channels is a key part of our work and is reflected in assessments of overall perception of CMS brands and in consumer response to specific communication activities.

The research conducted under this clearance has leveraged, and will continue to leverage, information technology when possible, especially conducting online surveys. Additionally, the use of online or virtual techniques for qualitative data collection, including interviews and focus groups will be incorporated as appropriate to enhance the ability to reach broader participant segments.

4. Duplication of Efforts

This information collection does not duplicate any other effort, and the information cannot be obtained from any other source. The question bank is intentionally inclusive and broad to enable CMS to use the item bank for developing Gen ICs using the questions from the question bank while enabling flexibility that is needed to address the varying and evolving research needs of the Agency. Data collection instruments developed under this clearance will contain only items from the approved question bank.

5. Small Businesses

Programs that affect small business owners and employees of small businesses are included in the legislative mandate, so small businesses will be included in specific studies. We will be mindful of the need to minimize the burden on small businesses. For example, in our survey work with this target audience, brief online surveys will be preferred over telephone surveys. Online surveys can be taken when time permits at the leisure of the study participant. Similar accommodations to minimize burden will be made when other research methods are applied.

6. Less Frequent Collection

The information will be collected from a variety of sources. Collecting information will allow the Agency to stay aware of information needs. Less frequent collection will not support this initiative.

7. Special Circumstances

There are no special circumstances with this information collection package. Information collection will not be conducted in a manner:

• Requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it.

• Requiring respondents to submit more than an original and two copies of any document.

• Requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years.

• Requiring respondents to respond to sensitive questions or provide PII or PHI.

• Requiring the use of a statistical classification that has not been reviewed and approved by OMB.

• That includes a pledge of confidentiality which is not supported by authority established in statute or regulation, which 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.

• Requiring respondents to submit proprietary trade secrets, 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.

To ensure that minimal burden to research participants, information collection instruments developed under this package are designed to ensure that questions are tailored to ensure that the amount of time spent is sufficient to explore the topics at hand, and to minimize the amount of time required per participant. Surveys developed under this package average 10-15 minutes in length and do not exceed 20 minutes. Qualitative focus groups are two hours or less in length, averaging 90 minutes. In-depth interviews range in length from 45-60 minutes. All participants are informed of their right to refuse to respond to any questions and to end their participation at any time, without penalty.

8. Federal Register/Outside Consultation

The 60-day notice for this collection published April 26, 2024 (89 FR 32436). No comments were received.

The 30-day notice for this collection published July 20, 2024 (89 FR 61123).

9. Payments/Gifts to Respondents

Respondents are compensated for their participation in accordance to OMB Circular A-21, section C, and subsection 3 “Reasonable Costs”, which states: “A cost may be considered

reasonable if the nature of the goods or services acquired or applied, and the amount involved therefore, reflect the action that a prudent person would have taken under the circumstances prevailing at the time the decision to incur the cost was made.” The research in this package is marketing research, designed for fast turn-around to inform key Agency communication decisions. Providing incentives for participation in social research is not uncommon and is being used increasingly as one component of improving overall response rates and reducing non-response bias even in government-sponsored social research (see, e.g., Massey & Tourangeau, 2013; Singer & Ye, 2013; Abdelazeem et al, 2022). In the marketing research arena, providing participant incentives is a well-established and accepted standard practice in the healthcare industry. In our experience, in order to achieve a representative sample of required participants in a timely and cost-effective manner, projects must provide incentives at levels that attract, retain, and adequately compensate respondents for their time and effort.

This is especially true of populations that are hard to reach or hard to engage. The use of incentives to bolster participation applies to both quantitative and qualitative research.

Incentives improve the quality and efficiency of research in a number of ways, including reducing non-response bias, improving participation by those in hard-to-reach groups, and increasing the efficiency and cost-effectiveness of research (e.g., David & Ware, 2014; Singer & Ye, 2013; Stewart & Shamdasani, 2015).

References

Abdelazeem B, Abbas KS, Amin MA, El-Shahat NA, Malik B, Kalantary A, Eltobgy M. The effectiveness of incentives for research participation: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2022 Apr 22;17(4)

David MC and Ware RS (2014). Meta-analysis of randomized controlled trials supports the use of incentives for inducing response to electronic health surveys. J Clin Epidem, 67(11), 1210-1221.

Halpern SD, Chowdhury M, Bayes B, et al. Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials. JAMA Intern Med. 2021;181(11):1479–1488

Massey D and Tourangeau R (2013). New challenges to social measurement. Ann Am Acad Pol Soc Sci, 645(1): 6–22.

Singer E and Ye C (2013). The use and effects of incentives in surveys. Ann Am Acad Pol Soc Sci, 645(1): 112- 141.

Stewart DW and Shamdasani PN (2015). Focus Groups: Theory & Practice, 3rd Edition. Los Angeles: Sage.

10. Confidentiality

Assurance of confidentiality for Internet users responding to the survey tool will be made on the basis of the Privacy Act of 1974, as amended (45 CFR 5b).

User confidentiality will be assured by adherence to Section 903(d) of the Public Health Service Act (42 USC 299 a-1[c]) as follows:

• All information obtained will be reported in aggregate. No information will be published or released in other forms if the person who supplied the information or who is described in it is identifiable unless such person has consented (as determined under regulations of the Secretary) to its publication or release.

11. Sensitive Questions

There are no sensitive questions in this information collection request. The main issues addressed in this work deal with how individuals seek new information, how they use information, and how they make decisions about their health care and CMS program participation. These are typically not considered sensitive areas. However, there is no requirement to answer any question.

12. Burden Estimates (Hours & Wages)

The purpose of the project is to obtain feedback utilizing social marketing so beneficiaries can make better informed healthcare choices.

The process will employ a variety of methods. These methods will include qualitative consumer research (e.g., focus groups, one-time or panel discussion groups), one on one individual interviews, customer satisfaction surveys, post-transaction customer surveys, telephone surveys, online surveys, comment card and complaint form analysis, and usability studies.

Because the research conducted under this clearance may include a broad range of income situations, including retirees, individuals who are eligible for Medicaid or CHIP, uninsured individuals, Marketplace consumers, and professionals, the median wage for all occupation job code from the Bureau of Labor and Statistics was used to calculate the total cost estimate.¹ We are adjusting our hourly wage estimate 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.

An estimate of burden hours is shown in the Table below

Estimate of Burden Hours

1 https://www.bls.gov/oes/current/oes_nat.htm#00-0000

Type of Collection	No. of Respondents	Annual frequency per response	Hours per response	Total # of Respondents	Total hours	Total cost
Qualitative Studies (e.g., Focus Groups)	332	6	2 hours	1992	3984	$160,714.56
Individual Interviews	300	12	1 hour	3600	3600	$145,224.00
Usability testing	300	12	1 hour	3600	3600	$145,224.00
Misc. Consumer Satisfaction	2000	12	.25 hours	24000	6000	$242,040.00
Online or telephone Surveys	4800	6	.33 hours	28800	9504	$383,391.36
TOTAL	7732	48	4.58	61992	26688	$1,076,593.92

13. Capital Costs

There is no capital cost associated with this information collection request.

14. Cost to Federal Government

The estimated cost to the government for conducting the research covered in this request will be approximately $2,500,000 per year in contract costs including labor hours, materials and supplies, overhead, general and administrative costs, and fees.

15. Changes to Burden

The total number of burden hours (26,588) has been reduced by previously-approved GenIC’s, as follows:

GenIC	Burden Hours Deducted from Total
Online or telephone surveys	3,336
GenIC #3: Medicare Open Enrollment Survey	400*
GenIC #20 Medicare Online Qualitative Panel Monthly Survey	500
GenIC #23 Marketplace OE survey	1,200
GenIC #25 Medicare Savings Program and Extra Help Awareness Survey	333
GenIC #26 Nursing Home Career Outreach Tracker	333
GenIC #28 Health Insurance Literacy Survey	600
Qualitative Studies	3,750
GenIC #8: Qualitative Testing of Creative Materials	900
GenIC #13: Qualitative Research on Communications and Decision Support for Provider Initiatives	900
GenIC #16 Qualitative Testing of Creative Materials for Medicare	1,500
GenIC #27 Qualitative Testing of Message Concepts for Nursing Home Career Outreach	450
Individual Interviews	1,800
GenIC #7: Formative Research on Communications and Decision Support in Marketplace	900
GenIC #17 Formative Research and Materials Testing for Medicare	900
Usability Testing	200
GenIC #11: CMS Consumer Research on Websites and Tools	200**
Total Continuing GenIC Burden Hours	9,116
Total Remaining Burden Hours	17,472

* GenIC#3 contained data entry errors in the last approved submissions which created an incorrect burden total. The arithmetic was correct in the supporting statement; however, the data was incorrectly entered into ROCIS and requested 800 hours when it should have been 400 hours. The revised GenIC requests a total burden of 400 hours

400 hours = ((2000 respondents) x (1 response/respondent) x (0.2 hour/response)).

With this submission we are correcting the data entry issue for GenIC#3 and adjusting the burden accordingly.

**GenIC#11 contained data entry errors in the last approved submissions which created an incorrect burden total. The arithmetic was correct in the supporting statement; however, the data was incorrectly entered into ROCIS. The GenIC requests a total burden of 200 hours

200 hours = ((200 respondents) x (1 response/respondent) x (1 hour/response)).

With this submission we are correcting the data entry issue for GenIC#11 and adjusting the burden accordingly.

16. Publication/Tabulation Dates

Results from the analysis of these data will be presented in reports and briefings for senior CMS management involved in the development of CMS’s communication strategy. There are no publication dates.

17. Expiration Date

We have added the expiration date to the PRA Disclosure Statement for each instrument.

18. Certification Statement

The proposed data collection does not involve any exceptions to the certification statement identified in line 19 of OMB form 83-I.

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