25642 Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3420–FN] 

Medicare and Medicaid Programs; 

Approval of Application by The Joint 

Commission (TJC) for Continued CMSApproval of its Hospital Accreditation 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve The Joint 

Commission for continued recognition 

as a national accrediting organization 

for hospitals that wish to participate in 

the Medicare or Medicaid programs. 

DATES: The decision announced in this 

final notice is effective July 15, 2022 

through July 15, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Caecilia Blondiaux, (410) 786–2190. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a hospital, provided 

certain requirements are met. Section 

1861(e) of the Social Security Act (the 

Act) establishes distinct criteria for 

facilities seeking designation as a 

hospital. Regulations concerning 

provider agreements are at 42 CFR part 

489 and those pertaining to activities 

relating to the survey and certification 

of facilities are at 42 CFR part 488. The 

regulations at 42 CFR part 482 specify 

the minimum conditions that a hospital 

must meet to participate in the Medicare 

program. 

Generally, to enter into an agreement, 

a hospital must first be certified by a 

state survey agency (SA) as complying 

with the conditions or requirements set 

forth in part 482 of our regulations. 

Thereafter, the hospital is subject to 

regular surveys by a SA to determine 

whether it continues to meet these 

requirements. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by a Centers for 

Medicare & Medicaid Services (CMS)- 

approved national accrediting 

organization (AO) that all applicable 

Medicare requirements are met or 

exceeded, we will deem those provider 

entities as having met such 

requirements. Accreditation by an AO is 

voluntary and is not required for 

Medicare participation. 

If an AO is recognized by the 

Secretary of the Department of Health 

and Human Services (the Secretary) as 

having standards for accreditation that 

meet or exceed Medicare requirements, 

any provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare requirements. A national AO 

applying for approval of its 

accreditation program under part 488, 

subpart A, must provide CMS with 

reasonable assurance that the AO 

requires the accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare requirements. 

Our regulations concerning the approval 

of AOs are set forth at §§ 488.4, 488.5 

and § 488.5(e)(2)(i). The regulations at 

§ 488.5(e)(2)(i) require AOs to reapply 

for continued approval of its 

accreditation program every 6 years or 

sooner, as determined by CMS. 

The Joint Commission’s (TJC’s) 

current term of approval for their 

hospital accreditation program expires 

July 15, 2022. 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On December 10, 2021, we published 

a proposed notice in the Federal 

Register (86 FR 70500), announcing 

TJC’s request for continued approval of 

its Medicare hospital accreditation 

program. In that proposed notice, we 

detailed our evaluation criteria. Under 

section 1865(a)(2) of the Act and in our 

regulations at § 488.5 and § 488.8(h), we 

conducted a review of TJC’s Medicare 

hospital accreditation application in 

accordance with the criteria specified by 

our regulations, which include, but are 

not limited to the following: 

• An administrative review of TJC’s: 

(1) Corporate policies; (2) financial and 

human resources available to 

accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its hospital surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited hospitals; and (5) survey 

review and decision-making process for 

accreditation. 

• A review of TJC’s survey processes 

to confirm that a provider or supplier, 

under TJC’s hospital deeming 

accreditation program, meets or exceeds 

the Medicare program requirements. 

• A documentation review of TJC’s 

survey process to do the following: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and TJC’s ability to provide continuing 

surveyor training. 

++ Compare TJC’s processes to those 

we require of state survey agencies, 

including periodic resurvey and the 

ability to investigate and respond 

appropriately to complaints against TJCaccredited hospitals. 

++ Evaluate TJC’s procedures for 

monitoring accredited hospitals it has 

found to be out of compliance with 

TJC’s program requirements. (This 

pertains only to monitoring procedures 

when TJC identifies non-compliance. If 

noncompliance is identified by a SA 

through a validation survey, the SA 

monitors corrections as specified at 

§ 488.9(c)). 

++ Assess TJC’s ability to report 

deficiencies to the surveyed hospitals 

and respond to the hospitals plan of 

correction in a timely manner. 

++ Establish TJC’s ability to provide 

CMS with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ Determine the adequacy of TJC’s 

staff and other resources. 

++ Confirm TJC’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm TJC’s policies with 

respect to surveys being unannounced. 

++ Confirm TJC’s policies and 

procedures to avoid conflicts of interest, 

including the appearance of conflicts of 

interest, involving individuals who 

conduct surveys or participate in 

accreditation decisions. 

++ Obtain TJC’s agreement to provide 

CMS with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require, including corrective 

action plans. 

IV. Analysis of and Responses to Public 

Comments on the Proposed Notice 

In accordance with section 

1865(a)(3)(A) of the Act, the December 

10, 2021 proposed notice also solicited 

public comments regarding whether 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices 25643 

1Administrative Memorandum 22–02–ALL 

(December 23, 2021). Transitioning Certification 

Functions for Changes of Ownership, 

Administrative Changes, and Initial Enrollment 

Performed by the CMS Survey and Operations 

Group https://www.cms.gov/files/document/admininfo-22-02-all.pdf. 

TJC’s requirements met or exceeded the 

Medicare conditions for participation 

(CoPs) for hospitals. We received one 

comment. 

The commenter inquired about CMS 

activities related to AO oversight. 

Specifically, the commenter stated that 

there continues to be discrepancies 

between AO and CMS standards and 

processes. The commenter stated it 

would be extremely helpful if the AOs 

and CMS could be consistent in 

interpretation and surveillance. 

CMS’ review requires AO standards to 

meet or exceed those of the Medicare 

CoPs and for AOs to have comparable 

survey processes. The December 2021 

proposed notice described CMS’ process 

and oversight activities in Section III. 

Evaluation of Deeming Authority 

Request, which highlighted the 

evaluation CMS conducts before 

granting deeming authority to an AO. In 

Section V. of this final notice, CMS is 

highlighting areas which were identified 

to have discrepancies or lack of clarity 

within TJC’s standards and survey 

processes. We note that TJC corrected 

these discrepancies before the renewing 

their deeming authority for CMSapproved hospital accreditation 

program. 

V. Provisions of the Final Notice 

A. Differences Between TJC’s Standards 

and Requirements for Accreditation and 

Medicare Conditions and Survey 

Requirements 

We compared TJC’s hospital 

accreditation requirements and survey 

process with the Medicare CoPs of parts 

482, and the survey and certification 

process requirements of parts 488 and 

489. Our review and evaluation of TJC’s 

hospital application, which were 

conducted as described in section III. of 

this final notice, yielded the following 

areas where, as of the date of this notice, 

TJC has completed revising its standards 

and certification processes in order to— 

• Meet the standard’s requirements of 

all of the following regulations: 

++ Section 482.12(c)(4)(i), to clarify 

that the governing body ensures that a 

doctor of medicine or osteopathy is 

responsible for the care of the patient. 

Specifically, that the applicability of the 

standard reflects both Medicare and 

Medicaid patients. 

++ Section 482.12(d)(3), to explicitly 

state that the facility’s overall 

institutional plan must provide for 

capital expenditures for at least a 3-year 

period. 

++ Section 482.12(d)(4), to provide 

specifics as outlined within the 

standards, to include specifics, such as 

that the facility’s overall institutional 

plan must include and identify in detail 

the objective of, and the anticipated 

sources of financing for, each 

anticipated capital expenditure in 

excess of $600,000 (or a lesser amount 

that is established, in accordance with 

section 1122(g)(1) of the Act, by the 

State in which the hospital is located). 

++ Sections 482.12(d)(4)(i) through 

482.12(d)(4)(iii), to provide specifics as 

outlined within the standard, to include 

acquisition of land; improvement of 

land, buildings, and equipment; or, the 

replacement, modernization, and 

expansion of buildings and equipment. 

++ Section 482.13(d)(2), to specify 

that the patient has the right to receive 

his or her medical records based on oral 

or written request and comparable 

language that that the hospital must not 

frustrate the legitimate efforts of 

individuals to gain access to their own 

medical records. 

++ Section 482.23(c)(6)(i)(A), to 

remove terminology of ‘‘independent’’ 

practitioners consistent with the 

regulation. 

++ Section 482.41(b)(5), to include 

language that requires the hospital fire 

control plan to contain provisions for 

cooperating with firefighting authorities. 

++ Section 482.41(d)(2), to include 

specifically, the requirement for 

supplies to be maintained to ensure and 

acceptable level of safety and quality. 

++ Section 482.41(d)(3), to provide 

clarifications that the physical 

environment must be based on the 

complexity of the facility and services 

offered. 

++ Section 482.41(e), to provide 

comparable standards which 

incorporate by reference the National 

Fire Protection Association (NFPA) 

standards. 

In addition to the standards review, 

CMS reviewed TJC’s comparable survey 

processes, which were conducted as 

described in section III. of this final 

notice, and yielded the following areas 

where, as of the date of this notice, TJC 

has completed revising its survey 

processes in order to demonstrate that it 

uses survey processes that are 

comparable to state survey agency 

processes by: 

++ Removing language suggesting a 

timeframe for completion of certain 

survey activities. In particular, revising 

the survey process to avoid imposing a 

time restriction, which could potentially 

suggest that a full assessment of all life 

safety and environment of care 

standards may not be conducted if 

timeframe exceeds. 

++ Revising TJC’s survey processes to 

include surveyor review to determine 

that a path of egress is well lit, 

including outside the building as 

required by NFPA 101–2012, 7.8.1.1. 

++ Developing survey procedures to 

incorporate that on any Medicare 

hospital survey, contracted patient care 

activities or patient services (such as 

dietary services, treatment services, and 

diagnostic services) located on hospital 

campuses or hospital provider-based 

locations should be surveyed as part of 

the hospital for compliance with the 

CoPs. 

++ Emphasizing in TJC’s policy and 

procedures that only CMS may approve 

temporary closures of deemed facilities. 

Specifically, TJC closely aligned their 

organizational policies with CMS’ 

guidance provided in Administrative 

Memorandum 22–02–ALL,1 which 

provided guidance related to temporary 

closures and cessation of business 

situations. 

++ Providing additional training to 

surveyors related the appropriate level 

of citations for Governing Body and 

Nursing Services when deficiencies are 

found in a hospital. 

++ Clarifying the complaint processes 

during the public health emergency and 

ensuring that all survey activities 

continue to be unannounced. 

B. Term of Approval 

Based on our review and observations 

described in section III. and section V. 

of this final notice, we approve TJC as 

a national accreditation organization for 

hospitals that request participation in 

the Medicare program. The decision 

announced in this final notice is 

effective July 15, 2022 through July 15, 

2025 (3 years). In accordance with 

§ 488.5(e)(2)(i) the term of the approval 

will not exceed 6 years. Due to travel 

restrictions and the reprioritization of 

survey activities brought on by the 2019 

Novel Coronavirus Disease (COVID–19) 

Public Health Emergency (PHE), CMS 

was unable to observe a hospital survey 

completed by TJC surveyors as part of 

the application review process, which is 

one component of the comparability 

evaluation. Therefore, we are providing 

TJC with a shorter period of approval. 

Based on our discussions with TJC and 

the information provided in its 

application, we are confident that TJC 

will continue to ensure that its deemed 

hospitals will continue to meet or 

exceed Medicare standards. While TJC 

has taken actions based on the findings 

annotated in section V.A., of this final 


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25644 Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices 

notice, (Differences Between TJC’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements) as authorized 

under § 488.8, we will continue ongoing 

review of TJC’s hospital survey. In 

keeping with CMS’s initiative to 

increase AO oversight broadly, and 

ensure that our requested revisions by 

TJC are completed, CMS expects more 

frequent review of TJC’s activities in the 

future. 

VI. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: April 27, 2022. 

Lynette Wilson, 

Federal Register Liaison, Center for Medicare 

& Medicaid Services. 

[FR Doc. 2022–09361 Filed 4–29–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–3427] 

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 June 1, 2022. 

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. 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: End Stage Renal 

Disease Application and Survey and 

Certification Report; Use: The Form 

CMS–3427 is required for each new 

ESRD facility seeking initial 

certification and for each existing 

facility seeking recertification, 

relocation, expansion/change of 

service(s), or change of ownership. The 

form is also used for information 

collection purposes related to a 

complaint survey of an ESRD facility. 

The Form CMS–3427 information is 

currently collected on paper as a 

manual option or may be completed in 

an online fillable format based on 

facility preference. This online form is 

a step in the direction towards 

electronic submission. Form Number: 

CMS–3427 (OMB control number: 

0938–0360); Frequency: Every three 

years; Affected Public: Private sector 

(Business or other for-profit and Not-for 

profit institutions); Number of 

Respondents: 7,883; Total Annual 

Responses: 2,601; Total Annual Hours: 

866. (For policy questions regarding this 

collection contact Jennifer Milby at 410– 

786–8828). 

Dated: April 27, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09388 Filed 4–29–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0354] 

Acrotech Biopharma LLC; Withdrawal 

of Approval of New Drug Application 

for MARQIBO (VinCRIStine Sulfate 

LIPOSOME Injection), 5 milligrams/5 

milliliters 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of new drug 

application (NDA) for MARQIBO 

(vinCRIStine sulfate LIPOSOME 

injection), 5 milligrams (mg)/5 

milliliters (mL), held by Acrotech 

Biopharma LLC (Acrotech), 29 

Princeton Hightstown Rd., East 

Windsor, NJ 08520. Acrotech has 

voluntarily requested that FDA 

withdraw approval of this application 


jspears on DSK121TN23PROD with NOTICES1