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
82380 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 

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: Application for 

Enrollment in Medicare Part B (Medical 

Insurance); Use: Medicare Part B is a 

voluntary program, financed from 

premium payments by enrollees, 

together with contributions from funds 

appropriated by the Federal 

government. The Social Security Act 

(the Act) at section 226(a) provides that 

individuals who are age 65 or older and 

eligible for, or entitled to, Social 

Security or Railroad Retirement Board 

(RRB) benefits shall be entitled to 

premium-free Part A upon filing an 

application for such benefits. Section 

1836 of the Act permits individuals 

with Medicare premium-free Part A to 

enroll in Part B. 

The CMS–40B provides the necessary 

information to determine eligibility and 

to process the beneficiary’s request for 

enrollment for Medicare Part B 

coverage. This form is only used for 

enrollment by beneficiaries who already 

have Part A, but not Part B. Form CMS– 

40B is completed by the person with 

Medicare or occasionally by an SSA 

representative using information 

provided by the Medicare enrollee 

during an in-person interview. The form 

is owned by CMS, but not completed by 

CMS staff. SSA processes Medicare 

enrollments on behalf of CMS. Form 

Number: CMS–40B (OMB control 

number: 0938–1230); Frequency: Once; 

Affected Public: Individuals or 

households; Number of Respondents: 

1,132,000; Number of Responses: 

1,132,000; Total Annual Hours: 192,440. 

(For policy questions regarding this 

collection, contact Candace Carter at 

410–786–8466.) 

2. Type of Information Collection 

Request: Extension without change of 

currently approved collection; Title of 

Information Collection: National 

Implementation of the Hospital 

Consumer Assessment of Healthcare 

Providers and Systems (HCAHPS) 

Survey; Use: The HCAHPS (Hospital 

Consumer Assessment of Healthcare 

Providers and Systems) Survey is the 

first national, standardized, publicly 

reported survey of patients’ perspectives 

of their hospital care. HCAHPS is a 29- 

item survey instrument and data 

collection methodology for measuring 

patients’ perceptions of their hospital 

experience. Since 2008, HCAHPS has 

allowed valid comparisons to be made 

across hospitals locally, regionally and 

nationally. 

Three broad goals have shaped 

HCAHPS. First, the standardized survey 

and implementation protocol produce 

data that allow objective and 

meaningful comparisons of hospitals on 

topics that are important to consumers. 

Second, public reporting of HCAHPS 

results creates new incentives for 

hospitals to improve quality of care. 

Third, public reporting enhances 

accountability in health care by 

increasing transparency of the quality of 

hospital care provided in return for the 

public investment. Form Number: CMS– 

10102 (OMB control number: 0938– 

0981); Frequency: Occasionally; 

Affected Public: Private Sector, Business 

or other for-profits, Not-for-profits 

institutions; Number of Respondents: 

2,304,450; Number of Responses: 

2,304,450; Total Annual Hours: 282,366. 

(For policy questions regarding this 

collection, contact William G. Lehrman 

at 410–786–1037.) 

3. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: CMS Health 

Equity Award—Call for Nominations; 

Use: CMS Office of Minority Health 

(OMH) is going to announce a call for 

nominations for the 2024 CMS Health 

Equity Award. This award will 

recognize organizations who 

demonstrate they have advanced health 

equity by designing, implementing, and 

operationalizing policies and programs 

that support health for all the people 

served by our programs, reducing 

avoidable differences in health 

outcomes experienced by people who 

are underserved, and provided the care 

and support that CMS enrollees need to 

thrive. 

The goals of the award are to 

encourage organizations to identify and 

address their health disparities, to 

disseminate best practices, and to show 

that progress is possible by having a 

results-oriented focus. By identifying 

organizations who are successfully 

closing gaps and reducing disparities, 

CMS can show our stakeholders how 

health equity work can be initiated, 

targeted, measured, and successfully 

reduce disparities among communities 

nationwide. 

CMS Representatives collect 

Company Name, Point of Contact 

Information (email, phone# & name) 

along with information from the 

organizations regarding their programs 

to improve the health quality, outcomes, 

and access to care for the communities 

that they serve. The CMS selection 

committee uses a scoring rubric to score 

the applicants on demonstrated 

measurable results in reducing a 

disparity in one or more of the CMS 

priority populations. Form Number: 

CMS–10866 (OMB control number: 

0938–NEW); Frequency: Annually; 

Affected Public: Federal Government, 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 50; Number of Responses: 

50; Total Annual Hours: 100. (For 

policy questions regarding this 

collection, contact Ashley PeddicordAustin at 410–786–0757.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Withholding 

Medicare Payments to Recover 

Medicaid Overpayments and 

Supporting Regulations in 42 CFR 

447.31; Use: Certain Medicaid providers 

that are subject to offsets for the 

collection of Medicaid overpayments 

may terminate or substantially reduce 

their participation in Medicaid, leaving 

the state Medicaid agency unable to 

recover the amounts due. Recovery 

procedures allow for determining the 

amount of overpayments and offsetting 

the overpayments by withholding the 

provider’s Medicare payments. To 

effectuate the withholding, the state 

agency must provide their respective 

CMS regional office with certain 

documentation that identifies the 

provider and the Medicaid overpayment 

amount. The agency must also 

demonstrate that the provider was 

notified of the overpayment and that 

demand for the overpayment was made. 

An opportunity to appeal the 

overpayment determination must be 

afforded to the provider by the Medicaid 

state agency. Lastly, Medicaid state 

agencies must notify CMS when to 

terminate the withholding; Form 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 82381 

Number: CMS–R–21 (OMB control 

number: 0938–0287); Frequency: 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 54; Total Annual 

Responses: 27; Total Annual Hours: 81. 

(For policy questions regarding this 

collection contact Stuart Goldstein at 

410–786–0694.) 

Dated: November 20, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–25976 Filed 11–22–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1816–NC] 

Medicare and Medicaid Programs; 

Announcement of Application From a 

Hospital Requesting Waiver for Organ 

Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: This notice acknowledges the 

receipt of an application from a hospital 

that has requested a waiver of statutory 

requirements that would otherwise 

require the hospital to enter into an 

agreement with its designated organ 

procurement organization (OPO). This 

notice requests comments from OPOs 

and the general public for our 

consideration in determining whether 

we should grant the requested waiver. 

DATES: Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, by January 23, 2024. 

ADDRESSES: In commenting, refer to file 

code CMS–1816–NC. 

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 https://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–1816–NC, P.O. Box 8010, 

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–1816–NC, 

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: 

Randy Throndset, (410) 786–0131. 

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: 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 


ddrumheller on DSK120RN23PROD with NOTICES1