CMS-P-0015A_0938-NEW_SSA_clean

The United States is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that was first detected in China and which has now been detected in more than 190 countries internationally, and all 50 States and the District of Columbia. The virus has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2”) and the disease it causes has been named “coronavirus disease 2019” (“COVID-19”).

On January 31, 2020, Health and Human Services Secretary, Alex M. Azar II, determined that a Public Health Emergency (PHE) exists for the United States to aid the nation’s healthcare community in responding to COVID-19 (hereafter referred to as the PHE for the COVID-19 pandemic); on April 21, 2020, Secretary Azar renewed, effective April 26, 2020, the determination that a PHE exists.

Older people and people of all ages with severe chronic medical conditions — like heart disease, lung disease and diabetes, for example — seem to be at higher risk of developing serious COVID-19 illness¹.

According to the Centers for Disease Control and Prevention (CDC), as of July 9, 2020, the pandemic has resulted in more than 3,047,671 confirmed human infections and more than 132,056 deaths in the United States². With the emergence of the COVID-19 pandemic in the U.S., CMS is uniquely positioned to collect timely and vital information on how the pandemic is impacting the Medicare population by utilizing the MCBS.

The Centers for Medicare and Medicaid Services (CMS) requests emergency approval of a new Information Collection Request (ICR) to conduct by telephone this fall the MCBS COVID-19 Rapid Response Supplement (hereafter referred to as the Fall COVID-19 Supplement). This is a short-term, urgent endeavor designed to minimize response burden and cost while addressing these emergent data needs. Given the rapidly changing dynamics of the pandemic for Medicare beneficiaries, there is an acute need for data that shed light on the situation as it is unfolding. We cannot reasonably comply with the normal clearance process due to the need to begin programming the survey no later than August 2020 in order to begin data collection no later than October 2020. Therefore, we request an emergency clearance.

The MCBS is a continuous, multi-purpose survey of a representative national sample of the Medicare population, including the population of beneficiaries aged 65 and over and beneficiaries aged 64 and below with eligible disabilities, residing in the United States; it is collected under 0938-0568, expiration 08/31/2022. In its rotating panel design, each sampled beneficiary is scientifically selected as part of a panel and is interviewed up to three times per year over a four year period. MCBS beneficiaries, by definition, are most at risk for underlying conditions that may lead to more severe COVID-19 complications. This new clearance requests approval to add the Fall COVID-19 Supplement to Fall 2020 Round 88 data collection.

The methods and instruments have been tested under CMS-10549 GenIC#7 MCBS COVID-19 Rapid Response Supplement Testing which was approved by OMB on May 7, 2020 under the MCBS Generic Clearance (0938-1275) and has informed this emergency clearance request. We refer to this test as the COVID-19 Supplement Test.

Attachment 1 includes a letter to OMB providing justification for this emergency request. The proposed community questions are shown in Attachment 2 (which includes a version showing changes from the COVID-19 Supplement Test as well as a clean version intended for fielding) and the proposed facility questions are in Attachment 3. Attachment 4 includes a crosswalk summarizing the changes from the COVID-19 Supplement Test to the Fall COVID-19 Supplement. An advance letter that will be sent to community respondents can be found in Attachment 5; this letter is the same letter OMB approved for use in the COVID-19 Supplement Test. The telephone contacting script which includes invitations to participate can be found in Attachment 6.

A2. Purpose and Use of Information Collection

CMS requests emergency OMB approval for the Fall COVID-19 Supplement to be administered by telephone during Fall 2020 Round 88. With the emergence of the COVID-19 pandemic in the U.S., CMS is uniquely positioned to quickly collect vital information on how the pandemic is impacting the Medicare population by utilizing the MCBS. MCBS beneficiaries, by definition, are most at risk for underlying conditions that may lead to more severe COVID-19 complications. By selecting MCBS respondents to participate in the Fall COVID-19 Supplement, we can reduce the burden of the questionnaire by only needing to ask questions directly related to the impact of the pandemic.

There are several purposes of this emergency information collection request.

First, due to the emergence of this public health emergency, the MCBS is especially well-suited to provide CMS critical data on measures of Medicare beneficiary availability regarding telehealth, deferred medical care, likelihood of taking a COVID-19 vaccine, social distancing and other important preventive health behaviors, along with updated information about COVID-19 testing and the results of those tests. Since the MCBS has a sample size sufficient for estimation, it provides a ready source to obtain high quality data.
Second, the COVID-19 Supplement Test demonstrated that beneficiaries were very cooperative and engaged in participating in the survey. Field interviewers conducting community interviews heard from numerous participants that the relevance of the topic was significant to them.
Third, as we noted in the Generic Clearance request for the COVID-19 Supplement Test, our intention was to test a series of questions in preparation for a Fall COVID-19 Supplement that will be administered to MCBS respondents. Testing the questions and methodology under the generic clearance provided meaningful information for the Fall COVID-19 Supplement. It demonstrated that the questions worked as intended and that the flow and administration by phone was smooth. The methods and questionnaires included in this submission are mostly the same as those used in the COVID-19 Supplement Test with two main differences: (1) some terminology and questions were changed to align with other Federal surveys or to meet additional needs of CMS and CDC collaborators and (2) some questions have been added for Facility administration. These two changes are discussed in greater detail below.
And fourth, this Fall COVID-19 Supplement extends research to date on CMS’ ability to conduct MCBS data collection over the phone in order to respond quickly to emerging health issues to fill data gaps and provide critical information for policy makers. MCBS is traditionally conducted as an in-person interview although telephone interviewing is permitted. Since late March 2020, MCBS interviews have pivoted to telephone collection in order to comply with restrictions related to the pandemic while continuing this important survey.

Field interviewers will telephone respondents from their home and will administer the Fall COVID-19 Supplement separate from the current MCBS Community questionnaire (again, the MCBS is fielded under 0938-0568). The MCBS uses slightly different questionnaires, depending on whether the sampled beneficiary lives in the community or in a facility. In addition to conducting community (e.g., household) interviews with beneficiaries, the MCBS follows beneficiaries into and out of long-term care facilities to maintain a comprehensive profile of their health care utilization and expenditures. Facility interviews are conducted with facility staff instead of the actual beneficiary. Thus, the Fall COVID-19 Supplement has two questionnaires – one administered to respondents living in the community (Attachment 2) and a second administered to facility staff who answer questions on behalf of the sampled beneficiary (Attachment 3). The Fall COVID-19 Supplement has also been approved by NORC’s Institutional Review Board.

The contacting script and questionnaire performed successfully during the COVID-19 Supplement Test.

For the Fall COVID-19 Supplement administered in community interviews, the questionnaire content will be specific to the impact of COVID-19 on the respondent’s life, such as availability of telehealth, deferred medical care, COVID-19 testing and health consequences, and the impact of the pandemic on their behavior and well-being. Working with the Centers for Disease Control and Prevention, questions about vaccine uptake or likelihood of getting a vaccine have also been added. Depending on whether a vaccine will be available prior to data collection, this short series will be revised to reflect the current situation and OMB will be notified via a non-substantive change request.

For the Fall COVID-19 Supplement administered in facility interviews, the questionnaire content includes several facility-level measures covering the following topics: suspension of health services; use of telemedicine; measures to prevent and control the spread of COVID-19 at the facility; changes in staffing and providers; and efforts to address mental health and loneliness among residents. These topics were requested by CMS’ Chief Medical Officer to assess key ways in which COVID-19 has impacted facilities that serve Medicare beneficiaries; this information is not available from other sources. There are also several beneficiary-level topics, similar to the community questionnaire: COVID-19 testing and treatment; services with additional provider types due to COVID-19 diagnosis; CDC COVID-19 vaccine items; and mental health (e.g., Patient Health Questionnaire or PHQ-9). The Fall COVID-19 Supplement will be administered as part of administering the Round 88 Facility instrument. As is always done on the MCBS, facility data collection is conducted with facility staff knowledgeable about the facility’s protocols and the beneficiary’s health status.

Attachment 4 contains a crosswalk showing the changes from the COVID-19 Supplement Test conducted under the generic clearance as compared with the proposed Fall COVID-19 Supplement. Questions proposed in this emergency clearance were cognitively tested with fewer than 10 respondents and performed well during testing.

A3. Use of Improved Information Technology and Burden Reduction

Due to the COVID-19 pandemic, MCBS Fall 2020 Round 88 interviews will be conducted by phone. Using the same methods and technology deployed for the COVID-19 Supplement Test conducted under the generic clearance, the Fall COVID-19 Supplement will also be administered during Round 88. The Fall COVID-19 Supplement for respondents living in the community will be programmed using Voxco, a software platform well-suited for computer assisted web interviewing (CAWI) surveys. It will be administered by trained field interviewers using the same interview equipment already in their possession for use on the MCBS – laptops, tablets, and telephone. Even though it is programmed for web administration, the questions will be asked by trained interviewers using the telephone. Key technology benefits of using Voxco includes programming that fully utilizes sophisticated logic checks, skip patterns, and text fills to ease question administration and reduce respondent burden by shortening the interview.

For Facility interviews, the current computer assisted personal interviewing (CAPI) instrument programmed in Blaise will be modified to incorporate the Fall COVID-19 Supplement. Field interviewers will administer the questions to facility staff by phone using their laptop.

A4. Efforts to Identify Duplication and Use of Similar Information

During the development of the Fall COVID-19 Supplement, a number of people inside and outside the Federal government were consulted. This consultation included issues of design, content, and statistical methodology and analysis with an emphasis on identifying data gaps and measures critical to understanding the impact of the pandemic. In addition, multiple surveys underway covering various dimensions of the COVID-19 pandemic were reviewed. Specifically, we have consulted with the National Center for Health Statistics to align some of the proposed questions with the RANDS During COVID-19 (0920-1298) and the National Health Interview Survey (0920-0214). We also reviewed the Census Bureau’s Household Pulse Survey (0607-1013) and the Data Foundation’s COVID Impact Survey (available at https://www.covid-impact.org/). We have determined that the proposed Fall COVID-19 Supplement does not duplicate these efforts, especially because the sample is targeted to Medicare beneficiaries who have participated in the MCBS. Linking the Fall COVID-19 Supplement to the richness of the MCBS data on health status, access to care, cost and utilization and other important measures is unique to this proposed collection and cannot be obtained from any other source.

A5. Impact on Small Businesses and Other Small Entities

Most of the data collected for the MCBS will be from individuals in households. However, the Fall COVID-19 Supplement will also include about 1,090 sample beneficiaries who are living in government- sponsored, non- profit, and for-profit institutions such as nursing and personal care homes. Some of these institutions likely qualify as small businesses. Facility staff provide responses on behalf of the sampled beneficiaries. The number of Fall COVID-19 Supplement questions proposed for the facility instrument was intentionally constrained to obtain only the required information with minimal respondent burden.

A6. Consequences of Collecting the Information Less Frequently

The Fall COVID-19 Supplement will only be administered once to existing MCBS respondents. Data collection for beneficiaries living in the community will occur in October 2020. Facility data collection will also begin in October 2020 and will end in December 2020.

A7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5

None of the special circumstances listed by OMB apply to the MCBS.

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agencies

Because this is a request for an emergency clearance, CMS published a 10-day Federal Register notice on July 21, 2020 (85 FR 44094). Three comments were received. Two of the comments noted the importance of adding or clarifying that telehealth includes audio-only telehealth. An instruction to the telehealth questions has been added to address this comment. A third comment noted inconsistent references to health care providers and requested that the Community and Facility COVID-19 items consistently use the phrase “doctor or other health professional.” This change has been made throughout both questionnaires. Within 30 days of approval, CMS intends to publish a 60 day notice providing further opportunity for public comment, followed by a 30 day notice, as required by the PRA. CMS also solicited input on the Fall COVID-19 Supplement from internal CMS data users, as well as the Centers for Disease Control and Prevention, National Center for Immunizations and Respiratory Diseases and National Center for Health Statistics.

A9. Explanation of Any Payment or Gift to Respondents

The MCBS does not provide payments or gifts as incentives to respond.

A10. Assurances of Confidentiality Provided to Respondents

On February 14, 2018, CMS published in the Federal Register a notice of a modified or altered System of Record (SOR) (System No. 09-70-0519). The notice was published in 83 Federal Register 6591.

The Community Advance Letter (Attachment 4) to the respondent includes the following statement regarding confidentiality of data:

Your participation in this special survey is your choice. Your Medicare benefits cannot be affected in any way by your decision to participate or the answers you provide, and your information will be kept private to the extent permitted by law, as prescribed by the Federal Privacy Act of 1974.

Interviewer training stresses the importance of maintaining confidentiality and project protocols are documented within the Field Interviewer manual. Field outreach and contacting procedures have been established to maintain and ensure confidentiality. These include the utilization of standard computer security procedures (dual authentication password protection) and prohibitions on submitting personally identifiable information through electronic mail submission.

For facility data collection, all materials will be provided as part of the full MCBS clearance (0938-0568). There are no changes to these materials due to the addition of the Fall COVID-19 Supplement.

As always, any MCBS data published will exclude information that might lead to the identification of specific individuals (e.g., ID number, claim numbers, and location codes). CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to the individual privacy or other personal or property rights of the individual.

All MCBS survey staff directly involved in MCBS data collection and/or analysis activities are required to sign a Non-Disclosure Agreement as well as a NORC confidentiality agreement.

A11. Justification for Sensitive Questions

CMS does not deem any content to be of a sensitive nature.

A12. Estimates of Annualized Burden Hours and Costs

To estimate the burden for the Fall COVID-19 Supplement, less than 10 cognitive interviews were conducted. In addition, the COVID-19 Supplement Test which was approved by OMB on May 7, 2020 under the MCBS Generic Clearance (0938-1275) has informed our estimates of burden and cost for Community interviews. The COVID-19 Supplement Test was launched June 10 and will end July 15. Because of the urgency of submitting this clearance, we cannot wait for the test to be completed before finalizing this request. However, we have sufficient preliminary data from the COVID-19 Supplement Test to inform the Fall COVID-19 Supplement.

In the first 20 days of administration (June 10—30), the COVID-19 Supplement Test took an average of 15 minutes, as predicted. Using the test instrument, a few new measures were added and a few measures were shortened, resulting in no net change to the survey’s length. Therefore, we estimate a burden of 15 minutes for each Fall COVID-19 Supplement Community interview.

For facility interviews, there are about 50 questions which took an average of 15 minutes to administer in cognitive tests. Therefore, we estimate a burden of 15 minutes for each Fall COVID-19 Supplement Facility interview.

Projects	Number of Participants	Number of Responses/ Participant	Average hours per response	Response Burden
MCBS COVID-19 Supplement - Community	10,446	1	0.25	2,611.5
MCBS COVID-19 Supplement -- Facility	1,090	1	0.25	272.5
Total Burden				2,884

In order to provide an estimate of the cost of participating in this survey, we must select an hourly rate to use which is then multiplied by the burden hours of the respondent. We selected the U.S. minimum wage ($7.25 for 2020³) and multiplied it to the Total Annual Hours for the Fall COVID-19 Supplement (2,884), for a Total Annual Cost Burden in terms of dollars of roughly $20,909.00.

A13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

We do not expect respondents to incur any costs other than that of their time to respond. All costs associated with this effort are reported in Items 12 and 14.

A14. Annualized Costs to the Federal Government

The estimated cost to the government for collecting these data are included in the annual NORC contract to conduct the MCBS. These costs include all labor hours, materials and supplies, reproduction, postage, telephone charges and indirect costs for a full year of MCBS data collection, data processing and data delivery plus the COVID-19 Supplement Test and the proposed Fall COVID-19 Supplement. The contract value for 2020 is $23,855,000.

CMS personnel involved in MCBS include approximately 12 FTEs at a cost of approximately. In addition, staff travel is budgeted for $8,000. The MCBS releases its documentation as downloadable files on its public website and also on CD Rom thus eliminating its printing budget. Thus, in-house CMS cost will be $1,472,160.

A15. Explanation for Burden Changes (Program Adjustments)

This is a new request. There are no changes or adjustments to an existing program.

A16. Plans for Tabulation and Publication and Project Time Schedule

The Fall COVID-19 Supplement will be in the field from October through December 2020. CMS plans to release preliminary weighted data in December 2020 from Community interviews completed in October. These data will also be included in the production of the 2019 MCBS Limited Data Sets which will be released in June 2021. The facility data will be released as part of the 2020 Survey File in June 2022. Additional tabular data is anticipated to be released in annual MCBS Chartbooks. In addition, MCBS Data User’s Guides and Methodology Reports will be updated to include pertinent information about the supplement. Access to disclosure protected data is also planned through a special stand-alone 2019 MCBS COVID PUF in order to provide the data in the most expeditious manner to data users both internal to and external to CMS.

A17. Display of OMB Expiration Date

The OMB expiration date will be displayed on the hardcopy respondent materials. It is also displayed on the MCBS website. Since the Fall COVID-19 Supplement is conducted by phone, there is no computer screen or hard copy questionnaire to display the OMB expiration date.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to this certification statement.

1 https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm

2 https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html

3 https://www.dol.gov/general/topic/wages/minimumwage

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	CMS-P-0015A (0938-NEW) Emergency Supporting Statement A
Subject	Emergency MCBS Supporting Statement A
File Modified	0000-00-00
File Created	2021-01-13