Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Notices 85539 

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–10912 Medicare Transaction 

Facilitator for 2026 and 2027 under 

Sections 11001 and 11002 of the 

Inflation Reduction Act (IRA) 

Information Collection Request 

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 

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 Collections 

1. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Medicare 

Transaction Facilitator for 2026 and 

2027 under Sections 11001 and 11002 of 

the Inflation Reduction Act (IRA) 

Information Collection Request; Use: 

Under the authority in sections 11001 

and 11002 of the Inflation Reduction 

Act of 2022 (Pub. L. 117–169), the 

Centers for Medicare & Medicaid 

Services (CMS) is implementing the 

Medicare Drug Price Negotiation 

Program, codified in sections 1191 

through 1198 of the Social Security Act 

(‘‘the Act’’). The Act establishes the 

Negotiation Program to negotiate 

maximum fair prices (‘‘MFPs’’), defined 

at 1191(c)(3) of the Act, for certain high 

expenditure, single source selected 

drugs covered under Medicare Part B 

and Part D (‘‘selected drugs’’). In 

accordance with section 1193(a) of the 

Act, any Primary Manufacturer of a 

selected drug that continues to 

participate in the Negotiation Program 

and reaches agreement upon an MFP 

must provide access to the MFP to MFPeligible individuals, defined in section 

1191(c)(2)(A) of the Act, and to 

pharmacies, mail order services, other 

dispensing entities, providers and 

suppliers with respect to such MFPeligible individuals who are dispensed 

that selected drug during a price 

applicability period. The purpose of this 

information collection request (ICR) is 

for CMS to collect information from 

manufacturers of drugs covered under 

Part D selected for negotiation under the 

Inflation Reduction Act for the initial 

price applicability years 2026 and 2027 

and the dispensing entities that 

dispense the selected drugs to MFPeligible individuals. To facilitate the 

effectuation of the MFP, CMS will 

engage a Medicare Transaction 

Facilitator (‘‘MTF’’). The MTF system 

will be composed of two modules: the 

MTF Data Module (MTF DM), and the 

MTF Payment Module (MTF PM). 

Medicare Transaction Facilitator Data 

Elements: The MTF system will be 

composed of two modules: the MTF 

Data Module (MTF DM), and the MTF 

Payment Module (MTF PM). Primary 

Manufacturers participating in the 

Negotiation Program are required to 

participate in the MTF DM. Further, 

CMS intends to propose in future 

rulemaking to require Part D plan 

sponsors to include in their pharmacy 

agreements provisions requiring 

dispensing entities to participate in the 

MTF DM for purposes of data exchange. 

As such, for the purposes of this ICR, 

CMS assumes full participation in the 

MTF DM by affected Primary 

Manufacturers and dispensing entities. 

Meanwhile, participation in the MTF 

PM, for use in passing through payment 

from the Primary Manufacturer to 

dispensing entities, will be optional for 

Primary Manufacturers; as a result, 

dispensing entities may receive fund 

transfers from the MTF PM, or via an 

alternative process established by a 

Primary Manufacturer. As discussed in 

section 40.4 of the Medicare Drug Price 

Negotiation Program: Final Guidance, 

Implementation of Sections 1191–1198 

of the Social Security Act for Initial 

Price Applicability Year 2027 and 

Manufacturer Effectuation of the 

Maximum Fair Price (MFP) in 2026 and 

2027 (‘‘final guidance’’), CMS will 

engage the MTF DM to facilitate the 

exchange of certain claim-level data 

elements and payment elements for 

selected drugs. The data exchange 

component of the MTF will involve 

both the transmission of certain claimlevel data elements to the Primary 

Manufacturer and receipt of claim-level 

payment elements from the Primary 

Manufacturer. Both Primary 

Manufacturers and dispensing entities 

will need to provide certain information 

at the onset of their enrollment in the 

MTF DM system to facilitate 

effectuation of the MFP via refunds from 

Primary Manufacturers. Both Primary 

Manufacturers and dispensing entities 

will be able to submit complaints and 

disputes through their participation in 

the MTF DM. Primary Manufacturers 

will also submit information to fulfill 

their requirement to provide an MFP 

Effectuation Plan and transmit recurring 

data submissions reflecting their 

payment elements, as described in the 

final guidance. Given these information 

collection requirements, this ICR 

includes the following forms: (A) Drug 

Price Negotiation Program MTF DM 

Dispensing Entity and Third-Party 

Support Enrollment Form; (B) Drug 

Price Negotiation Program MTF DM 

Primary Manufacturer Maximum Fair 

Price (MFP) Effectuation Plan Form; (C) 

Drug Price Negotiation Program MTF 

DM Primary Manufacturer Payment 

Elements Form; and (D) Drug Price 

Negotiation Program Complaint and 

Dispute Intake Form. Form Number: 

CMS–10912 (OMB control number: 

0938-New); Frequency: Once and Daily; 

Affected Public: Private sector, Business 

or other for-profit, and individuals; 

Number of Respondents: 85,853; Total 

Annual Responses: 93,120; Total 

Annual Hours: 821,560. (For policy 

questions regarding this collection 

contact Brennan Folsom at 667–414– 

0014.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25009 Filed 10–25–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10261] 

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 


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85540 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Notices 

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 November 27, 

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 

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 with change of a 

currently approved collection; Title of 

Information Collection: Part C Medicare 

Advantage Reporting Requirements; 

Use: The Centers for Medicare and 

Medicaid Services (CMS) established 

reporting requirements for Medicare 

Advantage Organizations (MAOs) under 

the authority described in 42 CFR 

422.516(a). Each MAO must have an 

effective procedure to develop, compile, 

evaluate, and report to CMS, to its 

enrollees, and to the general public at 

the times and in the manner that CMS 

requires. At the same time, each MAO 

must, in accordance with 42 CFR 

422.516(a), safeguard the confidentiality 

of the provider-patient relationship. 

Health plans can use this information 

to measure and benchmark their 

performance. CMS receives inquiries 

from the industry and other interested 

stakeholders about the beneficiary use 

of available benefits, including 

supplemental benefits, grievance and 

appeals rates, cost, and other factors 

pertaining to use of government funds, 

as well the performance of MA plans. 

Form Number: CMS–10261 (OMB 

control number: 0938–1054); Frequency: 

Yearly; Affected Public: Business or 

other for-profits; Number of 

Respondents: 783; Total Annual 

Responses: 7,830; Total Annual Hours: 

225,575. (For policy questions regarding 

this collection contact Lucia Patrone at 

410–786–8621 or Lucia.Patrone@

cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25015 Filed 10–25–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Request for Information: 

Administration for Children and 

Families Development of 

Interoperability Standards for Human 

Service Programs 

AGENCY: Office of the Chief Technology 

Officer, Administration of Children and 

Families, Department of Health and 

Human Services. 

ACTION: Request for information (RFI). 

SUMMARY: The Administration for 

Children and Families (ACF), in the 

U.S. Department of Health and Human 

Services (HHS), invites public 

comments to inform the use or adoption 

of interoperability standards for human 

services programs. ACF and state, local, 

and tribal governments all provide a 

number of health and human services 

programs for children, youth, families, 

communities, and individuals. ACF 

seeks public comment on the most 

effective approaches, technical 

standards, and technological tools that 

currently or could promote 

interoperability between health and 

human services programs. ACF 

collaborates with the Assistant Secretary 

for Technology Policy/Office of the 

National Coordinator for Health 

Information Technology (ASTP/ONC) as 

a critical steward and advisor for human 

services interoperability with 

responsibility for leading the 

development and harmonization of 

interoperability standards between 

health and human services in line with 

the HHS Data Strategy. The potential of 

interoperability across the full spectrum 

of health and human services is 

immense—it can enable efficient 

delivery of government services, 

enhance access to critical non-profit 

programs, and most importantly, 

improve overall individual and 

community outcomes. ACF has 

authority under the Title IV of the 

Social Security Act to designate use of 

interoperable data standards for several 

of its programs (e.g., Temporary 

Assistance for Needy Families (TANF), 

child support, child welfare, and foster 

care). The purpose of this RFI is to 

understand how ACF, in collaboration 

with ASTP/ONC, can better support 

interoperability between human 

services within and across states and 

local community resources, between 

states, and ACF. 

DATES: Comments are due within 60 

days of publication. 

ADDRESSES: Submit responses to 

DataRx@acf.hhs.gov, a federal mailbox 

allowing the public to submit comments 

on documents agencies have published 

in the Federal Register and are open for 

comment. Simply type ‘‘ACF-2024- 

Interoperability-RFI’’ in the Comment or 

Submission search box, click Go, and 

follow the instructions for submitting 

comments. 

Comments submitted in response to 

this notice are subject to the Freedom of 

Information Act and may be made 

available to the public. For this reason, 

please do not include any information 

of a confidential nature, such as 

sensitive personal information or 


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