86654 Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Notices 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number 

of respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total 

cost 

burden 

Baseline Survey ............................................................................................... 3,450 1,150 $46.52 53,498 

Post-training Survey ........................................................................................ 3,450 1,150 46.52 53,498 

Follow-up Survey ............................................................................................. 3,450 1,150 46.52 53,498 

Total .......................................................................................................... 10,350 3,450 N/A 160,494 

* Based on the mean of the average wages for all health professionals (29–0000): Occupational Wages in the United States, May 2022, U.S. 

Department of Labor, Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm). 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: December 11, 2023. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2023–27465 Filed 12–13–23; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS 3444–FN] 

Medicare Program; Application by The 

Joint Commission (TJC) for Continued 

CMS Approval of Its Home Infusion 

Therapy (HIT) Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This final notice announces 

our decision to approve The Joint 

Commission (TJC) for continued 

recognition as a national accrediting 

organization that accredits suppliers of 

home infusion therapy (HIT) services 

that wish to participate in the Medicare 

or Medicaid programs. 

DATES: The approval announced in this 

final notice is effective December 15, 

2023 through December 15, 2029. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Freeland, (410) 786–4348. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Home infusion therapy (HIT) is a 

treatment option for Medicare 

beneficiaries with a wide range of acute 

and chronic conditions. Section 5012 of 

the 21st Century Cures Act (Pub. L. 114– 

255, enacted December 13, 2016) added 

section 1861(iii) to the Social Security 

Act (the Act), establishing a new 

Medicare benefit for HIT services. 

Section 1861(iii)(1) of the Act defines 

‘‘home infusion therapy’’ as professional 

services, including nursing services; 

training and education not otherwise 

covered under the Durable Medical 

Equipment (DME) benefit; remote 

monitoring; and other monitoring 

services. Home infusion therapy must 

be furnished by a qualified HIT supplier 

and furnished in the individual’s home. 

Sections 1861(iii)(A) and (B) require 

that the individual (patient) must: 

• Be under the care of an applicable 

provider (that is, physician, nurse 

practitioner, or physician assistant); and 

• Have a plan of care established and 

periodically reviewed by a physician in 

coordination with the furnishing of 

home infusion drugs under Part B, 

which prescribes the type, amount, and 

duration of infusion therapy services 

that are to be furnished. 

Section 1861(iii)(3)(D)(i)(III) of the Act 

requires that a qualified HIT supplier be 

accredited by an accrediting 

organization (AO) designated by the 

Secretary in accordance with section 

1834(u)(5) of the Act. 

Section 1834(u)(5)(A) of the Act 

identifies factors for designating HIT 

AOs and in reviewing and modifying 

the list of designated HIT AOs. These 

statutory factors are as follows: 

• The ability of the accrediting 

organization to conduct timely reviews 

of HIT accreditation applications. 

• The ability of the accrediting 

organization to take into account the 

capacities of HIT suppliers located in a 

rural area (as defined in section 

1886(d)(2)(D) of the Act). 

• Whether the accrediting 

organization has established reasonable 

fees to be charged to HIT suppliers 

applying for accreditation. 

• Such other factors as the Secretary 

determines appropriate. 

Section 1834(u)(5)(B) of the Act 

requires the Secretary to designate AOs 

to accredit HIT suppliers furnishing HIT 

not later than January 1, 2021. Section 

1861(iii)(3)(D)(i)(III) of the Act requires 

a ‘‘qualified home infusion therapy 

supplier’’ to be accredited by a CMSapproved AO, pursuant to section 

1834(u)(5) of the Act. 

The Joint Commission’s (TJC’s) 

current term of approval for their Home 

Infusion Therapy accreditation program 

expires December 15, 2023. 

II. Approval of Deeming Organization 

Section 1834(u)(5) of the Act and 

§ 488.1010 require that our findings 

concerning review and approval of a 

national accrediting organization’s 

requirements consider, among other 

factors, the applying accrediting 

organization’s requirements for 

accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide CMS with the 

necessary data. 

Our rules at 42 CFR 488.1020(a) 

require that we publish, after receipt of 

an organization’s complete application, 

a notice identifying the national 

accrediting body making the request, 


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Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Notices 86655 

describing the nature of the request, and 

providing at least a 30-day public 

comment period. Pursuant to our rules 

at 42 CFR 488.1010(d), we have 210 

days from the receipt of a complete 

application to publish notice of 

approval or denial of the application. 

III. Provisions of the Proposed Notice 

In the July 18, 2023 Federal Register 

(88 FR 45907), we published a proposed 

notice announcing The Joint 

Commission’s (TJC’s) request for 

continued recognition as a national 

accrediting organization providing 

home infusion therapy (HIT) services 

that wish to participate in the Medicare 

or Medicaid programs. In that proposed 

notice, we detailed our evaluation 

criteria. Under section 1834(u)(5) the 

Act and in our regulations at § 488.1010, 

we conducted a review of TJC’s 

Medicare HIT accreditation application 

in accordance with the criteria specified 

by our regulations, which included, but 

are not limited to the following: 

• An administrative review of TJC’s: 

++ Corporate policies; 

++ Financial and human resources 

available to accomplish the proposed 

surveys; 

++ Procedures for training, 

monitoring, and evaluation of its HIT 

surveyors; 

++ Ability to investigate and respond 

appropriately to complaints against 

accredited HITs; and 

++ Survey review and decisionmaking process for accreditation. 

• The equivalency of TJC’s standards 

for HIT as compared with CMS’ HIT 

conditions for certification. 

• TJC’s survey process to determine 

the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of TJC’s to 

CMS standards and processes, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

++ TJC’s processes and procedures 

for monitoring a HIT supplier found out 

of compliance with TJC’s program 

requirements. 

++ TJC’s capacity to report 

deficiencies to the surveyed HIT 

facilities and respond to the facility’s 

evidence of standards compliance in a 

timely manner. 

++ TJC’s capacity to provide CMS 

with electronic data and reports 

necessary for effective assessment and 

interpretation of the organization’s 

survey process. 

++ TJC’s capacity to adequately fund 

required surveys. 

++ TJC’s policies with respect to 

whether surveys are announced or 

unannounced, to ensure that surveys are 

unannounced, and 

++ 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 CMS may require (including 

corrective action plans or TJC’s 

evidence of standards compliance). 

• The adequacy of TJC’s staff and 

other resources, and its financial 

viability. 

• TJC’s agreement or policies for 

voluntary and involuntary termination 

of suppliers. 

• TJC’s agreement or policies for 

voluntary and involuntary termination 

of the HIT AO program. 

IV. Analysis of and Responses to Public 

Comments on the Proposed Notice 

In accordance with section 1834(u)(5) 

of the Act, the July 18, 2023, proposed 

notice also solicited public comments 

regarding whether TJC’s requirements 

met or exceeded the Medicare 

conditions for participation for HIT. We 

received one comment in response to 

our proposed notice. The comment and 

our response follows: 

Comment: The commenter believes 

that continued approval of home 

infusion therapy is one that greatly 

benefits those on Medicare and 

Medicaid. The commenter stated that it 

also provides many benefits to all 

including less travel, less staff needed, 

comfort of your home, and less exposure 

to others for the immune compromised. 

Response: We thank this commenter 

for their comment in support of the HIT 

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 HIT accreditation 

requirements and survey process with 

the Medicare CfCs of 42 CFR part 486, 

and the survey and certification process 

requirements of part 488. Our review 

and evaluation of TJC’s HIT 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 to meet the conditions at: 

• Section 486.520 (b), to address the 

requirement that the plan of care must 

be established by a physician 

prescribing the type, amount, and 

duration for HIT. 

• Section 486.520 (c), to address the 

requirement that the plan of care must 

be periodically reviewed by the 

physician. 

• Section 486.525 (a), to address the 

requirement that the HIT suppliers to be 

available 7 days a week, 24 hours a day. 

• Section 486.525 (a)(1), to address 

the requirement of all professional 

services, including nursing services, to 

be available to the home infusion 

patient. 

• Section 486.525 (a)(2), to address 

the requirement for patient education 

and training to be available for patients 

on a 7 day a week, 24 hour a day basis 

in accordance with the plan of care. 

• Section 486.525 (a)(3), to address 

the requirement of remote monitoring 

for the provision of HIT and home 

infusion drugs. 

B. Term of Approval 

Based on the review and observations 

described in section III. of this final 

notice, we have determined that TJC’s 

requirements for HITs meet or exceed 

our requirements. Therefore, we 

approve TJC as a national accreditation 

organization for HITs that request 

participation in the Medicare program, 

effective December 15, 2023 through 

December 15, 2029. 

VI. Collection of Information 

Requirements 

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. chapter 35). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Trenesha Fultz-Mimms, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Trenesha Fultz-Mimms, 

Federal Register Liaison,Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–27469 Filed 12–13–23; 8:45 am] 

BILLING CODE 4120–01–P 


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