Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76841 

notice also solicited public comments 

regarding whether NABP’s requirements 

met or exceeded the Medicare 

conditions for participation for HIT. No 

comments were received in response to 

our proposed notice. 

V. Provisions of the Final Notice 

A. Differences Between NABP’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements 

We compared NABP’s HIT 

accreditation requirements and survey 

process with the Medicare Conditions 

for Coverage of 42 CFR part 486, and the 

survey and certification process 

requirements of part 488. Our review 

and evaluation of NABP’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, 

NABP has completed revising its 

standards and certification processes to 

meet the conditions at §§ 486.500 to 

486.525. 

• Section 486.520(a), to address the 

requirement that all patients must be 

under the care of an applicable 

provider. 

• Section 486.520(b), to address the 

requirement that the plan of care must 

be established by a physician and that 

it prescribes the type, amount, and 

duration of the home infusion therapy 

services that are to be furnished. 

• Section 486.520(c), to address the 

requirement that the plan of care for 

each patient must be periodically 

reviewed by the physician. 

• Section 486.525(a), to address the 

requirement that the HIT supplier must 

provide the following services on a 7- 

day a week, 24 hour-a-day basis in 

accordance with the plan of care: 

++ Section 486.525(a)(1), to provide 

professional services, including nursing 

services. 

++ Section 486.525(a)(2), to address 

the requirement for patient training and 

education and not otherwise paid for as 

durable medical equipment. 

++ Section 486.525(a)(3), to address 

the requirement of remote monitoring 

services for the provision of HIT 

services and home infusion drugs. 

Section 486.525(b), to address the 

requirement that all home infusion 

therapy suppliers must provide HIT 

services in accordance with nationally 

recognized standards of practice, and in 

accordance with all applicable state and 

federal laws and regulations. 

B. Term of Approval 

Based on the review and observations 

described in section III. of this final 

notice, we have determined that NABP’s 

requirements for HIT meet or exceed our 

requirements. Therefore, we approve 

NABP as a national accreditation 

organization for HITs that request 

participation in the Medicare program, 

effective September 26, 2024 through 

September 26, 2030. 

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. 2024–21409 Filed 9–18–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3462–FN] 

Medicare Program; Application by The 

Compliance Team (TCT) 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: Final notice. 

SUMMARY: This final notice announces 

our decision to approve The 

Compliance Team (TCT) 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 September 28, 

2024, through September 28, 2030. 

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) of the Act 

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 for 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 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 current term of approval for The 

Compliance Team (TCT) HIT 


lotter on DSK11XQN23PROD with NOTICES1
76842 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

accreditation program expires 

September 28, 2024. 

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, 

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 April 29, 2024, Federal 

Register (89 FR 33354), we published a 

proposed notice announcing TCT’s 

request for continued recognition as a 

national accrediting organization for 

suppliers providing 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 TCT’s 

Medicare HIT accreditation application 

in accordance with the criteria specified 

by our regulations, which include, but 

are not limited to, the following: 

• An administrative review of TCT’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 TCT’s standards 

for HIT as compared with CMS’ HIT 

conditions for participation. 

• TCT’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 TCT’s to 

CMS’ standards and processes, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities; 

++ TCT’s processes and procedures 

for monitoring a HIT supplier found out 

of compliance with TCT’s program 

requirements; 

++ TCT’s capacity to report 

deficiencies to the surveyed HIT 

facilities and respond to the facility’s 

evidence of standards compliance in a 

timely manner; 

++ TCT’s capacity to provide CMS 

with electronic data and reports 

necessary for effective assessment and 

interpretation of the organization’s 

survey process; 

++ TCT’s capacity to adequately fund 

required surveys; 

++ TCT’s policies with respect to 

whether surveys are announced or 

unannounced, to ensure that surveys are 

unannounced; and 

++ TCT’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 TCT’s 

evidence of standards compliance). 

• The adequacy of TCT’s staff and 

other resources, and its financial 

viability. 

• TCT’s agreement or policies for 

voluntary and involuntary termination 

of suppliers. 

• TCT’s agreement or policies for 

voluntary and involuntary termination 

of the HIT AO program. 

• TCT’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. 

IV. Analysis of and Responses to Public 

Comments on the Proposed Notice 

In accordance with section 1834(u)(5) 

of the Act, the April 29, 2024, proposed 

notice also solicited public comments 

regarding whether TCT’s requirements 

met or exceeded the Medicare 

conditions for participation for HIT. No 

comments were received in response to 

our proposed notice. 

V. Provisions of the Final Notice 

A. Differences Between TCT’s Standards 

and Requirements for Accreditation and 

Medicare Conditions and Survey 

Requirements 

We compared TCT’s HIT accreditation 

requirements and survey process with 

the Medicare Conditions for Coverage of 

42 CFR part 486, and the survey and 

certification process requirements of 

part 488. Our review and evaluation of 

TCT’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, 

TCT has completed revising its 

standards and certification processes to 

meet the conditions at §§ 486.500 to 

486.525. 

• Section 486.520(a), to address the 

requirement of all patients must be 

under the care of an applicable 

provider. 

• Section 486.520(b), to address the 

requirement that the plan of care must 

be established by a physician and that 

it prescribes the type, amount, and 

duration of the home infusion therapy 

services that are to be furnished. 

• Section 486.520(c), to address the 

requirement that the plan of care for 

each patient must be periodically 

reviewed by the physician. 

• Section 486.525(a), to address the 

requirement that the HIT supplier must 

provide the following services on a 7- 

day a week, 24 hour-a-day basis in 

accordance with the plan of care: 

++ Section 486.525(a)(1), to provide 

professional services, including nursing 

services. 

++ Section 486.525(a)(2), to address 

the requirement for patient training and 

education and not otherwise paid for as 

durable medical equipment. 

++ Section 486.525(a)(3), to address 

the requirement of remote monitoring 

services for the provision of HIT 

services and home infusion drugs. 

• Section 486.525(b), to address the 

requirement that all home infusion 

therapy suppliers must provide HIT 

services in accordance with nationally 

recognized standards of practice, and in 

accordance with all applicable state and 

federal laws and regulations. 

B. Term of Approval 

Based on the review and observations 

described in section III. of this final 

notice, we have determined that TCT’s 

requirements for HIT meet or exceed our 

requirements. Therefore, we approve 

TCT as a national accreditation 

organization for HITs that request 

participation in the Medicare program, 

effective September 28, 2024 through 

September 28, 2030. 


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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76843 

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. 2024–21410 Filed 9–18–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–372(S) and 

CMS–R–284] 

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 October 21, 2024. 

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, 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/PRAListing 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Section 1915(c) 

Home and Community-Based Services 

Waivers and Supporting Regulations; 

Use: We use this report to compare 

actual data to the approved waiver 

estimates. In conjunction with the 

waiver compliance review reports, the 

information provided will be compared 

to that in the Medicaid Statistical 

Information System (MSIS) (CMS–R– 

284; OMB control number: 0938–0345) 

report and FFP claimed on a State’s 

Quarterly Expenditure Report (CMS–64; 

OMB control number: 0938–1265), to 

determine whether to continue the 

State’s home and community-based 

services waiver. States’ estimates of cost 

and utilization for renewal purposes are 

based upon the data compiled in the 

CMS–372(S) reports. Form Number: 

CMS–372(S) (OMB control number: 

0938–0272); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

47; Total Annual Responses: 259; Total 

Annual Hours: 11,396. (For policy 

questions regarding this collection 

contact George Failla at 410–786–7561.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Transformed— 

Medicaid Statistical Information System 

(T–MSIS); Use: The data reported in T– 

MSIS are used by Federal, State, and 

local officials, as well as by private 

researchers and corporations to monitor 

past and projected future trends in the 

Medicaid program. The data provide the 

only national level information 

available on enrollees, beneficiaries, and 

expenditures. It also provides the only 

national level information available on 

Medicaid utilization. The information is 

the basis for analyses and for cost 

savings estimates for the Department’s 

cost sharing legislative initiatives to 

Congress. The collected data are also 

crucial to our actuarial forecasts. Form 

Number: CMS–R–284 (OMB control 

number: 0938–0345); Frequency: 

Quarterly and monthly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 54; Total 

Annual Responses: 648; Total Annual 

Hours: 7,290. (For policy questions 

regarding this collection contact Connie 

Gibson at 410–786–0755.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–21444 Filed 9–18–24; 8:45 am] 

BILLING CODE 4120–01–P 


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