Centers for Medicare & Medicaid Services Seeks Public Comment on Info Collection: HIPAA Administrative Simplification Complaint Form

WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services's Centers for Medicare & Medicaid Services proposed a 60-day public comment period starting on Aug. 5, 2021, on an information collection entitled: "HIPAA Administrative Simplification Complaint Form".

A notice was published in the Federal Register by William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

SUPPLEMENTARY INFORMATION:

Contents

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

HIPAA Administrative Simplification (Non-Privacy/Security) Complaint FormCMS-10148

The Home Health Care CAHPS(R) Survey (HHCAHPS) Mode ExperimentCMS-10784

Under the 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 requires federal agencies to publish a 60-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.

Information Collection

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form; Use: The Secretary of Health and Human Services (HHS), hereafter known as "The Secretary," codified 45 CFR parts 160 and 164 Administrative Simplification provisions that apply to the enforcement of the Health Insurance Portability and Accountability Act of 1996 Public Law 104-191 (HIPAA). The provisions address rules relating to the investigation of non-compliance of the HIPAA Administrative Simplification code sets, unique identifiers, operating rules, and transactions. 45 CFR 160.306, Complaints to the Secretary, provides for investigations of covered entities by the Secretary. Further, it outlines the procedures and requirements for filing a complaint against a covered entity.

Anyone can file a complaint if he or she suspects a potential violation. Persons believing that a covered entity is not utilizing the adopted Administrative Simplification provisions of HIPAA are voluntarily requested to file a complaint with CMS via the Administrative Simplification Enforcement and Testing Tool (ASETT) online system, by mail, or by sending an email to the HIPAA mailbox at [email protected]. Information provided on the standard form will be used during the investigation process to validate non-compliance of HIPAA Administrative Simplification provisions.

This standard form collects identifying and contact information of the complainant, as well as the identifying and contact information of the filed against entity (FAE). This information enables CMS to respond to the complainant and gather more information if necessary, and to contact the FAE to discuss the complaint and CMS' findings. Form Number: CMS-10148 (OMB control number: 0938-0948); Frequency: Occasionally; Affected Public: Private sector, Business or Not-for-profit institutions, State, Local, or Tribal Governments, Federal Government, Not-for-profits institutions; Number of Respondents: 21; Total Annual Responses: 21; Total Annual Hours: 12. (For policy questions regarding this collection contact Kevin Stewart at 410-786-6149).

2. Type of Information Collection Request: New collection (Request for a new OMB control); Title of Information Collection: The Home Health Care CAHPS(R) Survey (HHCAHPS) Mode Experiment; Use: The reporting of quality data by HHAs is mandated by Section 1895(b)(3)(B)(v)(II) of the Social Security Act ("the Act"). This statute requires that "each home health agency shall submit to the Secretary such data that the Secretary determines are appropriate for the measurement of health care quality. Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this clause." HHCAHPS data are mandated in the Medicare regulations at 42 CFR 484.250(a), which requires HHAs to submit HHCAHPS data to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act. This collection of information is necessary to be able to test updates to the HHCAHPS survey and administration protocols.

CMS proposes to conduct a mode experiment with the main goal of testing the effects of a web-based mode on response rates and scores as an addition to the three currently approved modes (OMB Control Number: 0938-1370). The addition of a web mode will give HHAs an alternative or an addition to the use of mail and telephone modes. CMS is also interested in testing a revised, shorter version of the HHCAHPS survey, based on feedback from patients and stakeholders.

The data collected from the HHCAHPS Survey mode experiment will be used for the following purposes:

* Test the shortened survey instrument, including several new items;

* Compare survey responses across the four proposed modes to determine if adjustments are needed to ensure that data collection mode does not influence results; and

* Determine if and by how much patient characteristics affect the patients' rating of the care they receive and adjust results based on those factors.

The mode experiment is designed to examine the effects of the shortened survey on response rates and scores and to provide precise adjustment estimates for survey items and composites on the shortened survey instrument. Information from this mode experiment will help CMS determine whether an additional mode of administration (i.e., Web data collection) should be included and a shortened survey instrument should be used in the current national implementation of the HHCAHPS Survey. Form Number: CMS-10784 (OMB control number: 0938-New); Frequency: Annually; Affected Public: Individuals or Households; Number of Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours: 1,049. (For policy questions regarding this collection contact Lori E. Teichman at 410-786-6684).

Dated: August 2, 2021.

William N. Parham, III,

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

[FR Doc. 2021-16755 Filed 8-4-21; 8:45 am]

BILLING CODE 4120-01-P

* * *

Complete text: https://www.federalregister.gov/documents/2021/08/05/2021-16755/agency-information-collection-activities-proposed-collection-comment-request

TARGETED NEWS SERVICE (founded 2004) features non-partisan 'edited journalism' news briefs and information for news organizations, public policy groups and individuals; as well as 'gathered' public policy information, including news releases, reports, speeches. For more information contact MYRON STRUCK, editor, [email protected], Springfield, Virginia; 703/304-1897; https://targetednews.com