26760 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 

beneficiary does not complete this 

additional information. 

With the long-term goal of collecting 

race and ethnicity data from all 

Medicare beneficiaries, CMS will focus 

initial efforts on beneficiaries who 

newly elect or change coverage in the 

Medicare Part C and D program. The 

detailed race and ethnicity categories 

collected through the demographic pilot 

on the enrollment form will be 

compliant with the 2011 HHS Data 

Collection Standards to provide 

granular information for plans and CMS 

to understand the diversity of the 

beneficiary population. The data will be 

used to: (1) Explore the response rate to 

race and ethnicity questions as a whole 

and how it intersects with beneficiary 

income and other demographics; (2) 

Conduct focus groups, to be approved in 

a separate PRA package, among nonresponders to the race and ethnicity 

questions to understand how people 

who elect to not respond to the race and 

ethnicity questions perceive the 

addition of those questions on the form; 

(32) Continue to test CMS’ race and 

ethnicity imputation models by adding 

additional race and ethnicity data to the 

data CMS already has; and (4) 

Determine the data necessary for 

sufficient samples sizes to conduct 

analyses of disaggregated race and 

ethnicity categories. As part of a broader 

health equity effort, CMS has interest in 

identifying patterns of differences across 

many key process and care outcomes by 

sociodemographic characteristics, 

including race and ethnicity. To best 

characterize these differences, selfreported and granular data are needed. 

Collecting these data will support efforts 

to continue to strengthen, for example, 

CMS OMH’s stratified reporting efforts, 

which currently do consider quality 

indicators by race and ethnicity, but at 

present these data are not granular and 

not self-reported. In addition, this data 

will allow us to validate imputation 

methods CMS currently uses for race 

and ethnicity, to ensure that we do not 

rely on methodologies that 

unintentionally create or exacerbate 

disparities. To assess readiness for 

analysis of collected data (particularly 

with regard to considering sample sizes, 

especially of small groups), continual 

assessment will be required— 

simultaneously as enrollment 

happens—because readiness will 

depend partly on distribution of 

responses to these items by enrollees. 

These categories are of great interest 

to CMS and will improve the accuracy 

of current data sets. We acknowledge 

that it may take several years of data 

collection to conduct other meaningful 

studies CMS intends to pursue that are 

not listed above. In addition to the 

aforementioned uses, CMS will 

ultimately use this information to: Track 

beneficiary enrollment, including 

tracking patterns in enrollment by race 

and ethnicity over time; to identify, 

monitor, and develop effective and 

efficient strategies and incentives to 

reduce and eliminate health and health 

care inequities; to validate existing race 

and ethnicity imputation methods; and 

to ensure that clinically appropriate and 

equitable care (in terms of payment, 

access, and quality) is consistently 

provided to all beneficiaries. Form 

Number: CMS–10718 (OMB control 

number: 0938–1378); Frequency: Yearly; 

Affected Public: State, Local, or Tribal 

Governments, Federal Government, 

Private Sector (Business or other forprofits and Not-for-profits); Number of 

Respondents: 80,539,628; Number of 

Responses: 80,539,628; Total Annual 

Hours: 8,567,975. (For questions 

regarding this collection contact Deme 

Umo at (410) 786–8854.) 

Dated: May 2, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09685 Filed 5–4–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–265–11, CMS– 

10544, CMS–10338, and CMS–10599] 

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 June 6, 2022. 

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, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Independent 

Renal Dialysis Facility Cost Report; Use: 

Under the authority of sections 1815(a) 


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Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 26761 

and 1833(e) of the Act, CMS requires 

that providers of services participating 

in the Medicare program submit 

information to determine costs for 

health care services rendered to 

Medicare beneficiaries. CMS requires 

that providers follow reasonable cost 

principles under 1861(v)(1)(A) of the 

Act when completing the Medicare cost 

report (MCR). Regulations at 42 CFR 

413.20 and 413.24 require that providers 

submit acceptable cost reports on an 

annual basis and maintain sufficient 

financial records and statistical data, 

capable of verification by qualified 

auditors. 

ESRD facilities participating in the 

Medicare program submit these cost 

reports annually to report cost and 

statistical data used by CMS to 

determine reasonable costs incurred for 

furnishing dialysis services to Medicare 

beneficiaries and to effect the year-end 

cost settlement for Medicare bad debts. 

Form Number: CMS–265–11 (OMB 

control number: 0938–0236); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profits, 

State, Local, or Tribal Governments); 

Number of Respondents: 7,492; Total 

Annual Responses: 7,492; Total Annual 

Hours: 494,472. (For questions regarding 

this collection contact Keplinger, Jill C. 

at 410–786–4550.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Good 

Cause Processes; Use: Section 

1851(g)(3)(B)(i) of the Act provides that 

MA organizations may terminate the 

enrollment of individuals who fail to 

pay basic and supplemental premiums 

after a grace period established by the 

plan. Section 1860D–1(b)(1)(B)(v) of the 

Act generally directs us to establish 

rules related to enrollment, 

disenrollment, and termination for Part 

D plan sponsors that are similar to those 

established for MA organizations under 

section 1851 of the Act. Consistent with 

these sections of the Act, subpart B in 

each of the Parts C and D regulations 

sets forth requirements with respect to 

involuntary disenrollment procedures at 

42 CFR 422.74 and 423.44, respectively. 

In addition, section 1876(c)(3)(B) 

establishes that individuals may be 

disenrolled from coverage as specified 

in regulations. Thus, current regulations 

at 42 CFR 417.460 specify that a cost 

plan, specifically a Health Maintenance 

Organization (HMO) or competitive 

medical plan (CMP), may disenroll a 

member who fails to pay premiums or 

other charges imposed by the plan for 

deductible and coinsurance amounts. 

These good cause provisions 

authorize CMS to reinstate a disenrolled 

individual’s enrollment without 

interruption in coverage if the nonpayment is due to circumstances that 

the individual could not reasonably 

foresee or could not control, such as an 

unexpected hospitalization. At its 

inception, the process of accepting, 

reviewing, and processing beneficiary 

requests for reinstatement for good 

cause was carried out exclusively by 

CMS. Form Number: CMS–10544 (OMB 

control number: 0938–1271); Frequency: 

Annually; Affected Public: Business or 

other for-profits State, Local, or Tribal 

Governments); Number of Respondents: 

312; Total Annual Responses: 41,289; 

Total Annual Hours: 27,499. (For 

questions regarding this collection 

contact Ronke Fabayo at (410) 786– 

4460.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Affordable Care 

Act Internal Claims and Appeals and 

External Review Procedures for Nongrandfathered Group Health Plans and 

Issuers and Individual Market Issuers; 

Use: The information collection 

requirements ensure that claimants 

receive adequate information regarding 

the plan’s claims procedures and the 

plan’s handling of specific benefit 

claims. Claimants need to understand 

plan procedures and plan decisions in 

order to appropriately request benefits 

and/or appeal benefit denials. The 

information collected in connection 

with the HHS-administered federal 

external review process is collected by 

HHS, and is used to provide claimants 

with an independent external review. 

Form Number: CMS–10338 (OMB 

control number: 0938–1099); Frequency: 

Occasionally; Affected Public: Private 

Sector (Business or other for-profit and 

Not-for-profit institutions); Number of 

Respondents: 497,262; Total Annual 

Responses: 517,014,153; Total Annual 

Hours: 1,198,692. (For policy questions 

regarding this collection contact Laura 

Byabazaire at 301–492–4128.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Review Choice 

Demonstration for Home Health 

Services; Use: Section 402(a)(1)(J) of the 

Social Security Amendments of 1967 

(42 U.S.C. 1395b–1(a)(1)(J)) authorizes 

the Secretary to ‘‘develop or 

demonstrate improved methods for the 

investigation and prosecution of fraud 

in the provision of care or services 

under the health programs established 

by the Social Security Act (the Act).’’ 

Pursuant to this authority, the CMS 

seeks to develop and implement a 

Medicare demonstration project, which 

CMS believes will help assist in 

developing improved procedures for the 

identification, investigation, and 

prosecution of Medicare fraud occurring 

among Home Health Agencies (HHA) 

providing services to Medicare 

beneficiaries. 

This revised demonstration helps 

assist in developing improved 

procedures for the identification, 

investigation, and prosecution of 

potential Medicare fraud. The 

demonstration helps make sure that 

payments for home health services are 

appropriate through either pre-claim or 

postpayment review, thereby working 

towards the prevention and 

identification of potential fraud, waste, 

and abuse; the protection of Medicare 

Trust Funds from improper payments; 

and the reduction of Medicare appeals. 

CMS has implemented the 

demonstration in Illinois, Ohio, North 

Carolina, Florida, and Texas with the 

option to expand to other states in the 

Palmetto/JM jurisdiction. Under this 

demonstration, CMS offers choices for 

providers to demonstrate their 

compliance with CMS’ home health 

policies. Providers in the demonstration 

states may participate in either 100 

percent pre-claim review or 100 percent 

post payment review. These providers 

will continue to be subject to a review 

method until the HHA reaches the target 

affirmation or claim approval rate. Once 

an HHA reaches the target pre-claim 

review affirmation or post-payment 

review claim approval rate, it may 

choose to be relieved from claim 

reviews, except for a spot check of their 

claims to ensure continued compliance. 

Providers who do not wish to 

participate in either 100 percent preclaim or post payment reviews have the 

option to furnish home health services 

and submit the associated claim for 

payment without undergoing such 

reviews; however, they will receive a 25 

percent payment reduction on all claims 

submitted for home health services and 

may be eligible for review by the 

Recovery Audit Contractors. 

The information required under this 

collection is required by Medicare 

contractors to determine proper 

payment or if there is a suspicion of 

fraud. Under the pre-claim review 

option, the HHA sends the pre-claim 

review request along with all required 

documentation to the Medicare 

contractor for review prior to submitting 

the final claim for payment. If a claim 

is submitted without a pre-claim review 

decision one file, the Medicare 

contractor will request the information 

from the HHA to determine if payment 

is appropriate. For the post payment 

review option, the Medicare contractor 


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26762 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 

will also request the information from 

the HHA provider who submitted the 

claim for payment from the Medicare 

program to determine if payment was 

appropriate. Form Number: CMS–10599 

(OMB control number: 0938–1311); 

Frequency: Frequently, until the HHA 

reaches the target affirmation or claim 

approval threshold and then 

occasionally; Affected Public: Private 

Sector (Business or other for-profits and 

Not-for-profits); Number of 

Respondents: 3,631; Number of 

Responses: 1,467,243; Total Annual 

Hours: 7,445,143. (For questions 

regarding this collection contact Jennifer 

McMullen (410)786–7635.) 

Dated: April 29, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09581 Filed 5–4–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity: National Medical Support 

Notice Part A (OMB No.: 0970–0222) 

AGENCY: Office of Child Support 

Enforcement, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Office of Child Support 

Enforcement (OCSE), Administration for 

Children and Families (ACF), is 

requesting a 3-year extension of the 

National Medical Support Notice 

(NMSN) Part A. This request includes 

minor revisions to the NMSN Part A 

form, revisions to and separation of the 

instructions into a stand-alone 

attachment, a Part A sample, and the 

addition of the State Medical Support 

Contacts and Program Requirements 

matrix. The current Office of 

Management and Budget (OMB) 

approval expires on October 31, 2022. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: Federal law requires that 

all child support orders under Title IV– 

D of the Social Security Act include 

medical coverage. The Child Support 

Performance and Incentive Act of 1998 

(CSPIA) requires enforcement of this 

provision; the NMSN Part A is the 

means to enforce health care orders. 

This information collection expedites 

requests for medical coverage between 

state child support enforcement 

agencies and employers. OCSE 

maintains Part A of the NMSN, which 

states initiate and send to a parent’s 

employer to complete. States must 

supply some sensitive information to 

the parent’s employer in order to enroll 

the child(ren) in the correct health 

coverage plan. This information 

includes names, dates of birth, Social 

Security numbers, and addresses. The 

employer retains the income 

withholding part of the form and 

withholds from the employee’s income 

any premium payments the health care 

plan may require. Then, the employer’s 

health care administrator enrolls the 

child(ren) in the health care plan. The 

Department of Labor (DOL) maintains 

Part B of the NMSN. This request 

includes minor revisions to the NMSN 

Part A form, revisions to and separation 

of the instructions into a stand-alone 

attachment, a Part A sample, and the 

addition of the State Medical Support 

Contacts and Program Requirements 

matrix. OCSE will also request from 

OMB that the NMSN Part A expiration 

date match the expiration date of the 

NMSN Part B, which will be submitted 

by DOL. 

Respondents: States and employers. 

ANNUAL BURDEN ESTIMATES

Information collections Respondent 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

National Medical Support Notice Part A and 

Instructions.

States ....................................

Employers .............................

54 

1,310,727 

90,194 

3.72 

.17 

.17 

827,981 

828,904 

State Medical Support Contacts and Program Requirements Matrix.States .................................... 54 1 1 54 

Estimated Total Annual Burden 

Hours: 1,656,939. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 45 U.S.C. 303.32; the 

Personal Responsibility and Work 

Opportunity Reconciliation Act of 1996, 

Public Law 104–193; CSPIA, Pub. L. 

105–200, Sec. 401(c); Sec. 609(a)(5)(C) 

of the Employee Retirement Income 

Security Act of 1974. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–09659 Filed 5–4–22; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0621] 

Advisory Committee; Anesthetic and 

Analgesic Drug Products Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 


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