29264 Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices 

TTY (local): (301) 427–1130; Email: 

pso@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background on Common Formats 

Development 

The Patient Safety and Quality 

Improvement Act of 2005 (Patient Safety 

Act), 42 U.S.C. 299b-21 to b-26, and the 

related Patient Safety and Quality 

Improvement Final Rule (Patient Safety 

Rule), 42 CFR part 3, published in the 

Federal Register on November 21, 2008, 

73 FR 70731–70814, provide for the 

formation of Patient Safety 

Organizations (PSOs), which collect, 

aggregate, and analyze confidential 

information regarding the quality and 

safety of health care delivery. The 

collection of patient safety work product 

allows for the aggregation of data that 

help to identify and address underlying 

causal factors of patient safety and 

quality issues. 

The Patient Safety Act provides for 

AHRQ to develop standardized 

reporting formats using common 

language and definitions (Common 

Formats) for reporting on health care 

quality and patient safety that will 

ensure that data collected by PSOs and 

other entities have comparable clinical 

meaning. The Common Formats 

facilitate aggregation of comparable data 

at local, PSO, regional and national 

levels. In addition, the Common 

Formats are intended to enhance the 

reporting of information that is 

standardized. 

Since February 2005, AHRQ has 

convened the Federal Patient Safety 

Work Group (PSWG) to assist AHRQ in 

developing and maintaining the 

Common Formats. The PSWG includes 

major health agencies within HHS as 

well as the Departments of Defense and 

Veterans Affairs. The PSWG helps 

assure the consistency of definitions/ 

formats with those of relevant 

government agencies. In addition, 

AHRQ has solicited comments from the 

private and public sectors, since 2008, 

regarding proposed versions of the 

Common Formats through a contract 

with the National Quality Forum (NQF), 

which is a non-profit organization 

focused on health care quality. After 

receiving comments, the NQF solicits 

review of the formats by its Common 

Formats Expert Panel. Subsequently, 

NQF provides this input to AHRQ who 

then uses it to refine the Common 

Formats before issuing a production 

version. 

AHRQ previously developed and 

maintains Common Formats for three 

settings of care—acute care hospitals, 

skilled nursing facilities, and 

community pharmacies—for use by 

healthcare providers and PSOs. AHRQlisted PSOs are required to collect 

patient safety work product in a 

standardized manner to the extent 

practical and appropriate, a requirement 

the PSO can meet by collecting such 

information using Common Formats. 

Additionally, health care providers and 

other organizations not working with an 

AHRQ-listed PSO can use the Common 

Formats in their work to improve 

quality and safety; however, they cannot 

benefit from the federal confidentiality 

and privilege protections of the Patient 

Safety Act. 

The CFER–DS is the first AHRQ 

Common Formats for Event Reporting 

that can be used across healthcare 

settings. It is designed to capture 

standardized, structured data to 

facilitate the reporting of diagnostic 

safety events for the purpose of learning 

about how to improve diagnostic safety 

and better support clinicians in the 

diagnostic process. 

The CFER–DS is not designed for 

frontline incident reporting. It is 

intended to facilitate the collection and 

organization of a basic set of meaningful 

data about diagnostic safety events that 

can be used, aggregated and analyzed 

for learning and improvement. Having a 

common frame of reference and 

standardized data elements is what 

makes shared learning possible at local, 

regional and national levels. Users 

decide if and how to integrate collection 

of specific data elements into their 

incident reporting systems and other 

existing work processes. 

AHRQ is specifically interested in 

receiving feedback in order to guide 

improvement of the CFER–DS V0.1. As 

with other Common Formats, the Event 

Description is available for public 

comment. Additionally, AHRQ is 

seeking feedback on a user guide and a 

form. Additional supporting 

documentation will be finalized and 

made available following AHRQ’s 

receipt of comment from the public and 

NQF’s Common Format Expert Panel. 

Information on how to comment is 

available at: http://

www.qualityforum.org/Project_Pages/ 

Common_Formats_for_Patient_Safety_

Data.aspx. 

Additional information about the 

AHRQ Common Formats can be 

obtained through AHRQ’s PSO website: 

https://pso.ahrq.gov/common-formats. 

Dated: May 25, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–11386 Filed 5–28–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–29, CMS–437 

and 10452] 

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 July 1, 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-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices 29265 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Verification of 

Clinic Data—Rural Health Clinic Form 

and Supporting Regulations; Use: The 

form is utilized as an application to be 

completed by suppliers of Rural Health 

Clinic (RHC) services requesting 

participation in the Medicare program. 

This form initiates the process of 

obtaining a decision as to whether the 

conditions for certification are met as a 

supplier of RHC services. It also 

promotes data reduction or introduction 

to and retrieval from the Automated 

Survey Process Environment (ASPEN) 

and related survey and certification 

databases by the CMS Regional Offices. 

Should any question arise regarding the 

structure of the organization, this 

information is readily available. Form 

Number: CMS–29 (OMB control number 

0938–0074); Frequency: Occasionally 

(initially and then every six years); 

Affected Public: Private Sector (Business 

or other for-profit and Not-for-profit 

institutions); Number of Respondents: 

1,887; Total Annual Responses: 5,661; 

Total Annual Hours: 1,269. (For policy 

questions regarding this collection 

contact Shonte Carter at 410–786–3532.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Psychiatric Unit 

Criteria Work Sheet; Use: Certain 

specialty hospitals and hospital 

specialty distinct-part units may be 

excluded from the Inpatient Medicare 

Prospective Payment System (IPPS) and 

be paid at a different rate. These 

specialty hospitals and distinct-part 

units of hospitals include Inpatient 

Rehabilitation Facilities (IRFs) units, 

Inpatient Rehabilitation Facilities (IRFs) 

hospitals and Inpatient Psychiatric 

Facilities (IPFs). 

CMS regulations at 42 CFR 412.20 

through 412.29 describe the criteria 

under which these specialty hospitals 

and specialty distinct-part hospital units 

are excluded from the IPPS. Form CMS– 

437 is used by Inpatient Psychiatric 

Facilities (IPFs) to attest to meeting the 

necessary requirements that make them 

exempt for receiving payment from 

Medicare under the IPPS. These IPFs 

must use CMS–437 to attest that they 

meet the requirements for IPPS exempt 

status prior to being placed into 

excluded status. The IPFs must re-attest 

to meeting the exclusion criteria 

annually. Form Number: CMS–437 

(OMB control number: 0938–0358); 

Frequency: Annually; Affected Public: 

Private sector—Business or other forprofits; Number of Respondents: 1,598; 

Total Annual Responses: 1,598; Total 

Annual Hours: 1,732. (For policy 

questions regarding this collection 

contact Caroline Gallaher at 410–786– 

8705.) 

3. Type of Information Collection 

Request: Extension of a previously 

approved collection; Title of 

Information Collection: CMS Identity 

Management (IDM) System; Use: HIPAA 

regulations require covered entities to 

verify the identity of the person 

requesting Personal Health Information 

(PHI) and the person’s authority to have 

access to that information. Per the 

HIPAA Security Rule, covered entities, 

regardless of their size, are required 

under Section 164.312(a)(2)(i) to ‘‘assign 

a unique name and/or number for 

identifying and tracking user identity.’’ 

A ‘user’ is defined in Section 164.304 as 

a ‘‘person or entity with authorized 

access’’. Accordingly, the Security Rule 

requires covered entities to assign a 

unique name and/or number to each 

employee or workforce member who 

uses a system that receives, maintains or 

transmits electronic PHI, so that system 

access and activity can be identified and 

tracked by user. This pertains to 

workforce members within health plans, 

group health plans, small or large 

provider offices, clearinghouses and 

beneficiaries. 

The information collected will be 

gathered and used solely by CMS, 

approved contractor(s), and state health 

insurance exchanges to prove the 

identity of an individual requesting 

electronic access to CMS protected 

information or services. Information 

confidentiality will conform to the 

Health Insurance Portability and 

Accountability Act (HIPAA) of 1996 and 

the Federal Information Security 

Management Act (FISMA) requirements. 

Respondents may also access CMS’ 

Terms of Service and Privacy Statement 

on the CMS Portal and IDM websites. 

CMS has moved from this centralized 

on premise model for enterprise identity 

management to a cloud-based solution, 

IDM, with multiple products providing 

specialized services: Okta Identity as a 

Service (IDaaS), which includes MultiFactor Authentication (MFA) services; 

Experian Remote Identity Proofing 

(RIDP) services; and Cloud Computing 

Services-Amazon Web Services/ 

Information Technology Operations 

(CCS–AWS/ITOps) Hub Hosting. In 

order to prove the identity of an 

individual requesting electronic access 

to CMS protected information or 

services, IDM (leveraging Experian 

Precise ID RIDP services) will collect a 

core set of attributes about that 

individual. Form Number: CMS–10452 

(OMB control number: 0938–1236); 

Frequency: Yearly; Affected Public: 

Individuals and Households; Number of 

Respondents: 560,000; Total Annual 

Responses: 560,000; Total Annual 

Hours: 186,667. (For policy questions 

regarding this collection contact 

Malachi Robinson at 410–786–1849). 

Dated: May 26, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–11491 Filed 5–28–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–179 and CMS– 

10775] 

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 


jbell on DSKJLSW7X2PROD with NOTICES