Federal Register / Vol. 89, No. 26 / Wednesday, February 7, 2024 / Notices 8435 

The two laws implement various health 

insurance policies, including the 

essential health benefits (EHB). 

Beginning in 2014, all nongrandfathered health plans in the 

individual and small group market must 

cover EHB, as defined by the Secretary 

of Health and Human Services. 

In the final rule entitled HHS Notice 

of Benefit and Payment Parameters for 

2023 (2023 Payment Notice; CMS– 

9911–F),2 we repealed the ability for 

States to permit between category 

substitution of the EHBs at 45 CFR 

156.115. Thus, we revise this 

Supporting Statement to remove any 

burden associated with States opting to 

permit between category substitution of 

the EHBs and remove the form Essential 

Health Benefits (EHB) State Substitution 

Notification (Appendix F) from this 

collection. 

For annual reporting of state 

mandates, in the final rule entitled HHS 

Notice of Benefit and Payment 

Parameters for 2021 (2021 Payment 

Notice; CMS–9916–F),3 we finalized 

amendments to § 156.111(d) and adding 

new § 156.111(f) to require states to 

annually notify HHS in a format and 

manner specified by HHS, and by a date 

determined by HHS, of any staterequired benefits applicable to QHPs in 

the individual and/or small group 

market that are considered to be ‘‘in 

addition to EHB’’ in accordance with 

§ 155.170(a)(3). 

In the final rule entitled HHS Notice 

of Benefit and Payment Parameters for 

2023 (2023 Payment Notice; CMS– 

9911–F), we repealed the annual 

reporting requirement at § 156.111(d) 

and (f), including revising the section 

heading to § 156.111 to instead read, 

‘‘State selection of EHB benchmark plan 

for PYs beginning on or after January 1, 

2020.’’ Thus, we have revised this 

Supporting Statement to reflect that 

States are no longer required to annually 

notify HHS of any State-required 

benefits applicable to QHPs in the 

individual or small group market that 

are considered to be ‘‘in addition to 

EHB’’ or any benefits the State has 

identified as not in addition to EHB and 

not subject to defrayal. We also remove 

the forms State Annual Report on StateRequired Benefits (Appendix G) and 

State Certification of Annual Report on 

State-Required Benefits (Appendix H) 

from this collection. 

This information collection also 

previously included estimates for the 

burden on issuers to report their intent 

to offer SADPs. We no longer collect 

this information from issuers; we revise 

this Supporting Statement to remove the 

burden associated with this report. In 

this package, we make minimum 

required revisions to reflect only the 

regulatory changes that have occurred 

since it was last authorized in 2021. No 

comments were received in response to 

the 60-day FR Notice (September 27, 

2023 (88 FR 66452). Form Number: 

CMS–10448 (OMB control number: 

0938–1174); Frequency: Annually; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

10; Number of Responses: 10; Total 

Annual Hours: 470. (For questions 

regarding this collection, contact Ken 

Buerger at 410–786–1190). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–02445 Filed 2–6–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10711 and 

CMS–10725] 

Agency Information Collection 

Activities: Proposed Collection; 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

April 8, 2024. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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 N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10711 Prior Authorization 

Process and Requirements for Certain 

Hospital Outpatient Department 

(OPD) Services 

CMS–10725 Pharmacy Benefit 

Manager Transparency for Qualified 

Health Plans 

Under the 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 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 


khammond on DSKJM1Z7X2PROD with NOTICES
8436 Federal Register / Vol. 89, No. 26 / Wednesday, February 7, 2024 / Notices 

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. 

Information Collection 

1. Type of Information Collection 

Request: New collection of information; 

Title of Information Collection: Prior 

Authorization Process and 

Requirements for Certain Hospital 

Outpatient Department (OPD) Services; 

Use: Section 1833(t)(2)(F) of the Act 

authorizes CMS to develop a method for 

controlling unnecessary increases in the 

volume of covered OPD services. CMS 

believes the increases in volume 

associated with certain covered OPD 

services are unnecessary because the 

data show that the volume of utilization 

of these OPD service categories far 

exceeds what would be expected in 

light of the average rate-of-increase in 

the number of Medicare beneficiaries. 

Therefore, CMS is using the authority 

under section 1833(t)(2)(F) of the Act to 

require prior authorization for certain 

covered OPD services as a condition of 

Medicare payment. The reviews 

conducted under the program help to 

reduce unnecessary utilization and 

payments for these services. 

The information required for the prior 

authorization request includes all 

documentation necessary to show that 

the service meets applicable Medicare 

coverage, coding, and payment rules. 

Trained clinical reviewers at the 

Medicare Administrative Contractors 

(MACs) receive and review the 

information required for this collection. 

Review of that documentation is used to 

determine if the requested services are 

medically necessary and meet Medicare 

requirements to help reduce 

unnecessary increases for these services. 

Form Number: CMS–10711 (OMB 

Control Number: 0938–1368); 

Frequency: Occasionally; Affected 

Public: Business or other for-profits; 

Number of Respondents: 11,469; 

Number of Responses: 564,010; Annual 

Hours: 316,412. (For policy questions 

regarding this collection contact Yuliya 

Cook at Yuliya.Cook@cms.hhs.gov) 

2. Title of Information Collection: 

Pharmacy Benefit Manager 

Transparency for Qualified Health 

Plans; Type of Information Collection 

Request: Revision of a currently 

approved collection; Use: 

Implementation of section 1150A of the 

Social Security Act, as added by section 

6005 of the Patient Protection and 

Affordable Care Act (ACA), requires, 

among other entities, Qualified Health 

Plans (QHPs) and pharmacy benefit 

managers (PBMs) that serve QHP issuers 

to report information on prescription 

drug benefits to the U.S. Department of 

Health and Human Services (HHS). 

PBMs are third-party administrators of 

prescription programs for a variety of 

types of health plans, including QHPs. 

CMS finalized regulations for this 

reporting at 45 CFR 156.295 and 184.50. 

Under these requirements a QHP 

issuer is required to report issuer and 

plan level prescription drug data to 

CMS only when the QHP issuer does 

not contract with a PBM to administer 

the prescription drug benefit for their 

QHPs. Section 1150A(a)(1) of the Social 

Security Act authorizes CMS to collect 

the same prescription drug and rebate 

information from Prescription Drug Plan 

sponsors of a prescription drug plan and 

Medicare Advantage organizations 

offering a Medicare Advantage 

Prescription Drug Plan under part D of 

title XVIII. Since 2012, CMS has 

collected these data from Part D 

sponsors as part of the Medicare Part D 

Direct and Indirect Remuneration (DIR) 

reporting requirement, and detailed 

drug information for each National Drug 

Code (NDC) from the Prescription Drug 

Event (PDE) data that plans are required 

to submit. 

CMS is requesting to renew this 

collection of information in connection 

with submission from QHP issuers that 

do not contract with a PBM and PBMs 

(hereinafter referred to as ‘‘submitters’’). 

The information required from 

submitters and the process of 

submission has changed since the 

previous collection was approved in 

2021. The submitters are now required 

to complete a web form that reports the 

allocation methodology that is selected 

by the submitters to allocate data, where 

necessary. Submitters are required to 

maintain internal documentation of the 

allocation methodologies chosen, as 

CMS may need to follow up with the 

submitters to better understand the 

methodology. The burden estimates for 

the collection of information included 

in this package reflect the time and 

effort for submitters to provide 

prescription drug benefit information to 

CMS using the Health Information 

Oversight System (HIOS) module. Form 

Number: CMS–10725 (OMB control 

number: 0938–1394); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other For-Profits; 

Number of Respondents: 278; Number 

of Responses: 278; Total Annual Hours: 

1,285. (For questions regarding this 

collection, contact LeAnn Brodhead at 

(301) 492–4493.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–02444 Filed 2–6–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the 

cooperative agreement applications, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Clinical Trial 

Implementation Cooperative Agreement (U01 

Clinical Trial Required); NIAID SBIR Phase II 

Clinical Trial Implementation Cooperative 

Agreement (U44 Clinical Trial Required); 

Clinical Trial Planning Grants (R34 Clinical 

Trials) 

Date: February 29, 2024. 

Time: 9:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane Rockville, MD 

20892 (Video Assisted Meeting). 

Contact Person: Annie Walker-Abbey, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, MSC 9834, 

Rockville, MD 20852, 240–627–3390, 

aabbey@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 


khammond on DSKJM1Z7X2PROD with NOTICES