Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76839 

• Agenda item and application 

number; 

• Email address; 

• Any special assistance requests 

(will be considered if the registration is 

submitted by 5 p.m. ET, October 25, 

2024); 

• Whether the registrant is a primary 

speaker or a 5-minute speaker for an 

agenda item; and 

• Whether the primary speaker will 

use a PowerPoint presentation. 

B. Speakers and Attendees 

1. Primary Speakers 

Each applicant that submitted a 

HCPCS Level II code application that 

will be discussed at the virtual public 

meetings is permitted to designate a 

primary speaker. Fifteen minutes is the 

total time interval for a primary speaker 

per agenda item. Any unused time from 

the primary speaker will be forfeited 

and cannot be delegated to another 

speaker. The deadline for primary 

speakers to register and submit any 

supporting PowerPoint presentation is 5 

p.m. ET, October 25, 2024. CMS will 

accept PowerPoint presentations if those 

materials are emailed to HCPCS@

cms.hhs.gov by the stated deadline. Due 

to the timeframe needed for the 

planning and coordination of the 

HCPCS virtual public meetings, 

materials that are not submitted in 

accordance with this deadline cannot be 

accommodated. 

All PowerPoint presentation materials 

must not exceed 10 slides and should be 

in PowerPoint presentation format, not 

PDF. We will not play videos, 

transitions, or animations during the 

public meeting sessions and request that 

the speakers exclude these materials 

from their PowerPoint presentation and 

instead submit any relevant video or 

animation materials along with their 

written comments. We request that 

speakers ensure the presentation does 

not include any inappropriate content 

before submission. 

Every primary speaker must declare at 

the beginning of their presentation at 

the meeting, as well as in their written 

summary, whether they have any 

financial involvement with the 

manufacturer of the item that is the 

subject of the HCPCS Level II 

application that the primary speaker 

presented, or any competitors of that 

manufacturer with respect to the item. 

This includes any payment, salary, 

remuneration, or benefit provided to 

that speaker by the applicant. 

2. 5-Minute Speakers 

Any individual related to the public 

meeting agenda item, including but not 

limited to, an employee, interested 

parties, competitor, insurer, public 

consumer, etc., may register and speak 

as a 5-minute speaker. The deadline for 

registering to be a 5-minute speaker is 

5 p.m. ET, October 25, 2024. 

Every 5-minute speaker must declare 

at the beginning of their presentation at 

the meeting, as well as in their written 

summary, whether they have any 

financial involvement with the 

manufacturer of the item that is the 

subject of the HCPCS Level II code 

application or agenda item that the 5- 

minute speaker presented, or with any 

competitors of that manufacturer with 

respect to the item. This includes any 

payment, salary, remuneration, or 

benefit provided to that speaker by the 

applicant. We will not accept any other 

written materials, outside of the written 

comments, from a 5-minute speaker. 

3. All Other Attendees 

All individuals who plan to attend the 

virtual public meetings to listen and do 

not plan to speak, may access the virtual 

public meeting using the Zoom link 

posted on the HCPCS Level II website at 

https://www.cms.gov/medicare/codingbilling/healthcare-common-proceduresystem as well as the guidelines 

document. 

Individuals who require special 

assistance must register and request 

special assistance services by 5 p.m. ET, 

October 25, 2024. 

IV. Written Comments 

The primary and 5-minute speaker(s) 

must email a brief, written summary 

(one paragraph) of their comments and 

conclusions. Written comments from 

anyone, including the primary and 5- 

minute speaker(s), will only be accepted 

when emailed to: HCPCS@cms.hhs.gov 

before 5 p.m. ET on the date of the 

virtual public meeting at which the 

HCPCS Level II code application that is 

the subject of the comments is 

discussed. 

V. Additional Information 

The HCPCS section of the CMS 

website also includes details regarding 

the public meeting process for new 

revisions to the HCPCS Level II code set, 

including information on how to join 

the meeting remotely, and guidelines for 

an effective presentation. The HCPCS 

section of the CMS website also 

contains a document titled ‘‘Healthcare 

Common Procedure Coding System 

(HCPCS) Level II Coding Procedures 

(PDF),’’ which is a description of the 

HCPCS Level II coding process, 

including a detailed explanation of the 

procedures CMS uses to make HCPCS 

Level II coding determinations. 

When CMS refers to a HCPCS code or 

HCPCS Level II coding application 

above, CMS may also be referring to 

circumstances when a HCPCS code has 

already been issued, but a Medicare 

benefit category and/or payment has not 

been determined. CMS is working 

diligently to address Medicare benefit 

category and payment determinations 

for new items and services that may be 

DME, prosthetic devices, orthotics and 

prosthetics, therapeutic shoes and 

inserts, surgical dressings, or splints, 

casts, and other devices used for 

reductions of fractures and dislocations 

under Medicare Part B. Please check the 

CMS website listed above for the final 

agenda. 

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. 3501 et seq.). 

The Administrator of 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. 2024–21297 Filed 9–18–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3464–FN] 

Medicare Program; Application by the 

National Association of Boards of 

Pharmacy (NABP) 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 National 

Association of Boards of Pharmacy 

(NABP) for continued recognition as a 

national accrediting organization that 

accredits suppliers of home infusion 


lotter on DSK11XQN23PROD with NOTICES1
76840 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

therapy (HIT) services that wish to 

participate in the Medicare or Medicaid 

programs. 

DATES: The approval announced in this 

final notice is effective September 26, 

2024 through September 26, 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 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 current term of approval for the 

National Association of Boards of 

Pharmacy (NABP) HIT accreditation 

program expires September 26, 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 26, 2024 Federal Register 

(89 FR 32434), we published a proposed 

notice announcing NABP’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 NABP’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 

NABP’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 NABP’s 

standards for HIT as compared with 

CMS’ HIT conditions for participation. 

• NABP’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 NABP’s to 

CMS’ standards and processes, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities; 

++ NABP’s processes and procedures 

for monitoring a HIT supplier found out 

of compliance with NABP’s program 

requirements; 

++ NABP’s capacity to report 

deficiencies to the surveyed HIT 

facilities and respond to the facility’s 

evidence of standards compliance in a 

timely manner; 

++ NABP’s capacity to provide CMS 

with electronic data and reports 

necessary for effective assessment and 

interpretation of the organization’s 

survey process; 

++ NABP’s capacity to adequately 

fund required surveys; 

++ NABP’s policies with respect to 

whether surveys are announced or 

unannounced, to ensure that surveys are 

unannounced; and 

++ NABP’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 NABP’s 

evidence of standards compliance). 

• The adequacy of NABP’s staff and 

other resources, and its financial 

viability. 

• NABP’s agreement or policies for 

voluntary and involuntary termination 

of suppliers. 

• NABP’s agreement or policies for 

voluntary and involuntary termination 

of the HIT AO program. 

• NABP’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 26, 2024, proposed 


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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