Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 82377 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: https://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of organs to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover or procure organs in CMSdefined exclusive geographic service 

areas, pursuant to section 371(b)(1) of 

the Public Health Service Act (42 U.S.C. 

273(b)(1)) and our regulations at 42 CFR 

486.306. Once an OPO has been 

designated for an area, hospitals in that 

area that participate in Medicare and 

Medicaid are required to work with that 

OPO in providing organs for transplant, 

pursuant to section 1138(a)(1)(C) of the 

Social Security Act (the Act) and our 

regulations at 42 CFR 482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must establish 

protocols, which require the hospital to 

notify the designated OPO (for the 

service area in which it is located) of 

potential organ donors. Under section 

1138(a)(1)(C) of the Act, every hospital 

must have an agreement only with its 

designated OPO to identify potential 

donors. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

a waiver of the above requirements from 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one designated by CMS, if the 

hospital meets certain conditions 

specified in section 1138(a)(2)(A) of the 

Act. In addition, the Secretary may 

review additional criteria described in 

section 1138(a)(2)(B) of the Act to 

evaluate the hospital’s request for a 

waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to submit 

comments during the 60-day comment 

period beginning on the publication 

date in the Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

section 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information hospitals 

must provide in requesting a waiver. We 

indicated that upon receipt of a waiver 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the comments received. 

During the review process, we may 

consult on an as-needed basis with the 

Health Resources and Services 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by § 486.308(e), the 

following hospital has requested a 

waiver to enter into an agreement with 

a designated OPO other than the OPO 

designated for the service area in which 

the hospital is located: 

Renown South Meadows Medical 

Center, Reno, Nevada, is requesting a 

waiver to work with: 

Nevada Donor Network, Inc, 2055 E 

Sahara Ave., Las Vegas, NV 89104 

The Hospital’s Designated OPO is: 

Donor Network West, 12667 Alcosta 

Blvd. #500, San Ramon, CA 94583 

IV. 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.). 

V. Response to Comments 

We will consider all comments we 

receive by the date specified in the 

DATES section of this document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: November 17, 2023. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–25903 Filed 11–22–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS 3453–PN] 

Medicare Program; Application by the 

Accreditation Commission for Health 

Care (ACHC) 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 with request for 

comment. 


ddrumheller on DSK120RN23PROD with NOTICES1
82378 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 

SUMMARY: This notice acknowledges the 

receipt of an application from the 

Accreditation Commission for Health 

Care (ACHC) for continued approval by 

the Centers for Medicare & Medicaid 

Services (CMS) of ACHC’s national 

accrediting organization program for 

suppliers providing home infusion 

therapy (HIT) services and that wish to 

participate in the Medicare or Medicaid 

programs. The statute requires that 

within 60 days of receipt of an 

organization’s complete application, 

CMS will publish a notice that identifies 

the national accrediting body making 

the request, describes the nature of the 

request, and provides at least a 30-day 

public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, by 

December 26, 2023. 

ADDRESSES: In commenting, refer to file 

code CMS–3453–PN. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3453–PN, P.O. Box 8016, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3453–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Freeland, (410) 786–4348. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. We will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. We continue to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

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. HIT must be furnished by a 

qualified HIT supplier and furnished in 

the individual’s home. The individual 

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, that 

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 AOs and in 

reviewing and modifying the list of 

designated AOs. These statutory factors 

are as follows: 

• The ability of the organization to 

conduct timely reviews of accreditation 

applications. 

• The ability of the organization to 

take into account the capacities of 

suppliers located in a rural area (as 

defined in section 1886(d)(2)(D) of the 

Act). 

• Whether the organization has 

established reasonable fees to be 

charged to 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. 

On March 1, 2019, we published a 

solicitation notice entitled, ‘‘Medicare 

Program; Solicitation of Independent 

Accrediting Organizations to Participate 

in the Home Infusion Therapy Supplier 

Accreditation Program’’ (84 FR 7057). 

This notice informed national AOs that 

accredit HIT suppliers of an opportunity 

to submit applications to participate in 

the HIT supplier accreditation program. 

We stated that complete applications 

would be considered for the January 1, 

2021 designation deadline if received by 

February 1, 2020. Regulations for the 

approval and oversight of AOs for HIT 

organizations are located at 42 CFR part 

488, subpart L. The requirements for 

HIT suppliers are located at 42 CFR part 

486, subpart I. 

II. Approval of Deeming Organization 

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

regulations at 42 CFR 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 that identifies the national 

accrediting body making the request, 

describes the nature of the request, and 

provides 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. 

The purpose of this proposed notice 

is to inform the public of the CMS– 

3453–PN request for CMS’ continued 

recognition of its HIT accreditation 

program. This notice also solicits public 

comment on whether ACHC’s 

requirements meet or exceed the 

Medicare requirements of participation 

for HIT services. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 82379 

III. Evaluation of Deeming Authority 

Request 

In the November 25, 2019 Federal 

Register, we published ACHC’s initial 

application for recognition as an 

accreditation organization for HIT (84 

FR 64904). On April 24, 2020, we 

published notification of their approval 

as such an organization, effective April 

23, 2020 through April 23, 2024 (84 FR 

23046). ACHC has since submitted all 

the necessary materials to enable us to 

make a determination concerning its 

request for continued recognition of its 

HIT accreditation program. This 

application was determined to be 

complete on September 26, 2023. Under 

section 1834(u)(5) of the Act and 42 CFR 

488.1010 (Application and reapplication procedures for national 

home infusion therapy accrediting 

organizations), our review and 

evaluation of ACHC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of ACHC’s 

standards for HIT as compared with 

CMS’ HIT requirements for participation 

in the Medicare program. 

• ACHC’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 ACHC’s to 

CMS standards and processes, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

++ ACHC’s processes and procedures 

for monitoring a HIT supplier found out 

of compliance with ACHC’s program 

requirements. 

++ ACHC’s capacity to report 

deficiencies to the surveyed supplier 

and respond to the supplier’s plan of 

correction in a timely manner. 

++ ACHC’s capacity to provide CMS 

with electronic data and reports 

necessary for effective assessment and 

interpretation of the organization’s 

survey process. 

++ The adequacy of ACHC’s staff and 

other resources, and its financial 

viability. 

++ ACHC’s capacity to adequately 

fund required surveys. 

++ ACHC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ ACHC’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). 

++ ACHC’s agreement or policies for 

voluntary and involuntary termination 

of suppliers. 

++ ACHC agreement or policies for 

voluntary and involuntary termination 

of the HIT AO program. 

++ ACHC’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. 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.). 

V. Response to Comments 

Because of the large number of public 

comments, we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: November 17, 2023. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–25906 Filed 11–22–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: Document Identifiers: 

CMS–40B, CMS–10102, CMS–10866, and 

CMS–R–21] 

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 December 26, 2023. 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1