2023-25224. Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 must be received by January 16, 2024.

ADDRESSES:

When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: __, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.

FOR FURTHER INFORMATION CONTACT:

William N. Parham at (410) 786–4669.

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 ).

CMS–10662 Administrative Simplification HIPAA Compliance Review

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: Administrative Simplification HIPAA Compliance Review; Use: Section 1173 of the Social Security Act (the Act), 42 U.S.C. 1320d–2, and section 264 of HIPAA require the Secretary to adopt a number of national standards to facilitate the exchange of certain health information and to protect the privacy and security of such information.

The Secretary promulgated rules that relate to compliance with, and enforcement of, the HIPAA rules, which are codified at 45 CFR part 160, subparts C, D, and E and collectively referred to as the Enforcement Rule. The Secretary first issued an interim final rule promulgating the procedural requirements for imposition of civil money penalties on violations of the privacy standards on April 17, 2003, Civil Money Penalties: Procedures for Investigations, Imposition of Penalties (68 FR 18896). The Secretary subsequently proposed a rule on April 18, 2005, HIPAA Administrative Simplification: Enforcement; Proposed Rule (70 FR 20224), proposing the amendment of 45 CFR part 160, subparts A (General Provisions), C (Compliance and Enforcement), and E (Procedures for Hearing), and proposing a new subpart D (Imposition of Civil Money Penalties) that addressed the substantive issues related to the imposition of civil money penalties and proposing the above provisions be applied to all HIPAA rules.

The purpose of this collection is to retrieve information necessary to conduct a compliance review and carry out the authority delegated to CMS as described in CMS–0014–N (68 FR 60694). These forms will be submitted to the Centers for Medicare & Medicaid Services (CMS), National Standards Group, from entities covered by HIPAA Administrative Simplification regulations. This collection is not applicable to HIPAA Privacy and Security Rules. Form Number: CMS–10662 (OMB control number: 0938–1390); Frequency: Weekly; Affected Public: Private, State, Local, or Tribal Governments, Federal Government, Business or other for-profits, Not-for-profits institutions; Number of Respondents: 50; Total Annual Responses: 50; Total Annual Hours: 500. (For policy questions regarding this collection contact Kevin Stewart at (410) 786–6149.)

Dated: November 9, 2023.

William N. Parham, III,

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