2021-16200. Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

DATES:

Comments on the collection(s) of information must be received by the OMB desk officer by August 30, 2021.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain . Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

1. Access CMS' website address at website address at: https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT:

William Parham at [phone].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: New Collection (Request for a new OMB control number); Title of Information Collection: Medicare Beneficiary Experiences with Care Survey (MBECS) System; Use: The MBECS system is designed to conduct population specific surveys that will be administered to the group of interest, fielded one time. This means that over the three-year period, two individual surveys will be administered. This will allow CMS OMH to respond quickly to the data needs of stakeholders with interests in these underrepresented groups. Data collected through the MBECS system will be used to better understand—and thus serve the needs of—Medicare beneficiaries in minority populations. The core questionnaire will collect information on communication with medical professionals, coordination of health care, experiences getting needed health care, experiences with personal doctors and specialists, and key demographics. Data will be compared to benchmarks from the FFS CAHPS, MA CAHPS, and NAM CAHPS surveys. The population-specific questionnaire module described and submitted via a specific collection request will collect information about issues most relevant for that particular group of interest.

The goal of this umbrella data collection effort is to gather data via separate surveys on a variety of minority Medicare beneficiaries' experiences. Topics and questions of interest may ask about beneficiaries' communication with medical professionals, coordination of health care, experiences getting needed health care, and experiences with personal doctors and specialists. CMS OMH will compare survey data to benchmarks from the general population of Medicare beneficiaries while controlling for population characteristics, as appropriate.

Survey respondents will have the opportunity to respond to an MBECS survey via a self-administered web-based survey (also called computer-assisted web interview or CAWI). CAWI technology minimizes respondent burden by (1) automatically providing text fills within questions and handling skip patterns based on responses to each question; (2) allowing respondents to complete the survey at a convenient time; (3) allowing respondents to stop and re-enter the survey if needed; and (4) capturing data in real-time, thereby eliminating the need for manual data entry. Form Number: CMS-10701 (OMB Control number: 0938-New); Frequency: Annually; Affected Public: Individuals and Households; Number of Respondents: 13,000; Total Annual Responses: 13,000; Total Annual Hours: 4,290 (For policy questions regarding this collection contact Luis Pons Perez at 410-786-8557).

2. Type of Information Collection Request: Extension of a currently approved information collection; Title of Information Collection: CLIA Collection of Information Requirements Related to SARS-CoV-2 Test Results Reporting; Use: In order to be in compliance with the new CLIA mandatory SARS-CoV-2 test results reporting requirements, laboratories will need to develop a mechanism to track, collect, and report test results as well as update policies and procedures. In addition, Accreditation Organizations (AOs) and Exempt States (ESs) will need to update laboratory standards to reflect the reporting requirements and update policies and procedures related to reporting laboratories that do not report test results as required.

The CDC has an information collection request (OMB Control Number 0920-1299) in order to collect laboratory data related to the COVID-19 Pandemic Response. The CMS package (ICR) is for laboratory implementation and CMS monitoring of compliance with the CMS-3401-IFC CLIA-certified laboratory reporting requirements.

The information collected by the Centers for Medicare and Medicaid Services (CMS) or its designee, such as a CMS agent or CMS approved laboratory accreditation organization, when conducting inspections will be used to determine a laboratory's compliance with the CLIA SARS-CoV-2 test result reporting requirements. During an on-site survey, the Condition-level laboratory requirement at 42 CFR 493.41and 493.1100(a) are assessed for compliance. The information is used by CMS in determining appropriate Civil Money Penalties (CMPs) when laboratories fail to report as required. Form Number: CMS-10757 (OMB control number: 0938-1391); Frequency: Daily; Affected Public: Private Sector Not-for-profit institutions and State, Local and Tribal Governments; Number of Respondents: 77,033; Total Annual Responses: 308,114; Total Annual Hours: 1,386,873 (For policy questions regarding this collection contact Sarah Bennett at 410-786-3354.)

Dated: July 26, 2021.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.