Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 83947 

2024 for HOPDs and CY 2025 for ASCs. 

ASCs will continue with voluntary 

implementation of the OAS CAHPS 

Survey throughout CY 2024. 

HOPDs and ASCs contract with a 

CMS-approved, independent third-party 

survey vendor to implement the survey 

on their behalf and to submit the OAS 

CAHPS data to CMS. CMS publicly 

reports comparative results from OAS 

CAHPS after each facility has conducted 

data collection for 4 quarters. Data from 

OAS CAHPS enable consumers to make 

more informed decisions when choosing 

an outpatient surgery facility, aid 

facilities in their quality improvement 

efforts, and help CMS monitor the 

performance of outpatient surgery 

facilities. Considering the increasing 

Medicare expenditures for outpatient 

surgical services from HOPDs and ASCs, 

the implementation of OAS CAHPS 

provides CMS with much-needed 

statistically valid data from the patient 

perspective to inform quality 

improvement and comparative 

consumer information about specific 

facilities. The information collected in 

the OAS CAHPS survey will be used for 

the following purposes: 

• To provide a source of information 

from which patient experience of care 

measures can be publicly reported to 

beneficiaries to help them make 

informed decisions for outpatient 

surgery facility selection; 

• To aid facilities with their internal 

quality improvement efforts and 

external benchmarking with other 

facilities; and 

• To provide CMS with information 

for monitoring and public reporting 

purposes. 

Form Number: CMS–10500 (OMB 

control number: 0938–1240); Frequency: 

Once; Affected Public: Business or other 

for-profits and Not-for-profits 

institutions; Number of Respondents: 

2,534,643; Total Annual Responses: 

2,534,643; Total Annual Hours: 614,976. 

(For policy questions regarding this 

collection contact Memuna Ifedirah at 

410–786–6849). 

2. Type of Information Collection 

Request: Revision with change of the 

previously approved collection; Title of 

Information Collection: Collection of 

Encounter Data from MA Organizations, 

Section 1876 Cost HMOs/CMPs, MMPs, 

and PACE Organizations; Use: Section 

1853(a)(3)(B) of the Act directs CMS to 

require MA organizations and eligible 

organizations with risk-sharing 

contracts under 1876 to ‘‘submit data 

regarding inpatient hospital services ... 

and data regarding other services and 

other information as the Secretary 

deems necessary’’ in order to implement 

a methodology for ‘‘risk adjusting’’ 

payments made to MA organizations 

and other entities. Risk adjustments to 

enrollee monthly payments are made in 

order to take into account ‘‘variations in 

per capita costs based on [the] health 

status’’ of the Medicare beneficiaries 

enrolled in an MA plan. 

CMS uses encounter data to develop 

individual risk scores for risk adjusted 

payment to MA organizations, PACE 

organizations, and MMPs. Starting with 

Payment Year (PY) 2016, CMS began to 

blend risk scores calculated with Risk 

Adjustment Processing Data and 

Medicare Fee- For-Service (FFS) data 

with risk scores calculated with 

encounter data and FFS data, for risk 

scores calculated under both the CMS– 

HCC and the RxHCC models. In PY 

2022, we will move to calculating risk 

scores under both the CMS–HCC and 

the RxHCC models using 100 percent of 

the risk score calculated using 

encounter data and FFS data. 

All organizations required to submit 

encounter data use an electronic 

connection between the organization 

and CMS to submit encounter data and 

to receive information in return. CMS 

collects the data from MA organizations, 

1876 Cost Plans, MMPs and PACE 

organizations in the X12N 837 5010 

format for professional, DME, and 

institutional, and dental services or 

items provided to MA enrollees. Form 

Number: CMS–10340 (OMB control 

number: 0938–1152); Frequency: Daily; 

Affected Public: Private Sector, Business 

or other for-profits and Not-for-profits 

institutions; Number of Respondents: 

284; Total Annual Responses: 

1,467,645,179; Total Annual Hours: 

48,936,279. (For policy questions 

regarding this collection contact 

Raymond Mierwald at 410 446–5449). 

Dated: November 28, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–26449 Filed 11–30–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10525] 

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 January 2, 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 


lotter on DSK11XQN23PROD with NOTICES1
83948 Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Programs of AllInclusive Care for the Elderly (PACE) 

PACE Quality Data Monitoring and 

Reporting; Use: The Programs of AllInclusive Care for the Elderly (PACE) 

program is a unique model of managed 

care service delivery for the frail elderly, 

most of whom are dually-eligible for 

Medicare and Medicaid benefits. To be 

eligible to enroll in PACE, an individual 

must: be 55 or older, live in the service 

area of a PACE organization (PO), need 

a nursing home-level of care (as certified 

by the state in which he or she lives), 

and be able to live safely in the 

community with assistance from PACE. 

PACE organizations are responsible 

for providing all required Medicare and 

Medicaid covered services, and any 

other service that the interdisciplinary 

team (IDT) determines necessary to 

improve and maintain a participant’s 

overall health condition (42 CFR 

460.92). POs must also comply with the 

quality monitoring and reporting 

requirements outlined in §§ 460.140, 

460.200(b)(1), 460.200(c) and 460.202. 

POs are also required to report certain 

unusual incidents to other Federal and 

State agencies consistent with 

applicable statutory or regulatory 

requirements (see 42 CFR 460.136(a)(5)). 

Form Number: CMS–10525 (OMB 

control number: 0938–1264); Frequency: 

Occasion; Affected Public: Business or 

other for-profits, Not-for-profits 

institutions; Number of Respondents: 

152; Total Annual Responses: 1,279; 

Total Annual Hours: 1,471. (For policy 

questions regarding this collection 

contact Donna Williamson at 410 786 

4647.) 

Dated: November 28, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–26444 Filed 11–30–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1051] 

Modified Risk Tobacco Product 

Application: Renewal Applications for 

General Snus Smokeless Tobacco 

Products Submitted by Swedish Match 

U.S.A., Inc. 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity to provide 

public comment on modified risk 

tobacco product applications (MRTPAs). 

The applications are for renewal of 

existing modified risk tobacco product 

(MRTP) orders for General Snus 

smokeless tobacco products submitted 

by Swedish Match U.S.A., Inc. 

DATES: Electronic or written comments 

on the application may be submitted 

beginning December 1, 2023. FDA will 

establish a closing date for the comment 

period as described in section I. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–1051 for ‘‘Modified Risk 

Tobacco Product Applications: Renewal 

applications for General Snus smokeless 

tobacco products submitted by Swedish 

Match U.S.A., Inc.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read the background documents or 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 


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