[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37227-37228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10636, CMS-10874, and CMS-319]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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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 July 5, 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: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

[[Page 37228]]

    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/PRA-Listing

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--10636 Triennial Network Adequacy Review for Medicare Advantage 
Organizations and 1876 Cost Plans
CMS--10874 Part D Drug Management Program
CMS--319 State Medicaid Eligibility Quality Control Sample Selection 
Lists and Supporting Regulations

    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 Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Triennial Network 
Adequacy Review for Medicare Advantage Organizations and 1876 Cost 
Plans; Use: CMS regulations at 42 CFR 417.414, 417.416, 
422.112(a)(1)(i), and 422.114(a)(3)(ii) require that all Medicare 
Advantage organizations (MAOs) offering coordinated care plans, 
network-based private fee-for-service (PFFS) plans, and as well as 
section 1876 cost organizations, maintain a network of appropriate 
providers that is sufficient to provide adequate access to covered 
services to meet the needs of the population served. To enforce this 
requirement, CMS regulations at Sec.  422.116 outline network adequacy 
criteria which set forth the minimum number of providers and maximum 
travel time and distance from enrollees to providers, for required 
provider specialty types in each county in the United States and its 
territories. Organizations must be in compliance with the current CMS 
network adequacy criteria guidance, which is updated and published 
annually on CMS's website. This collection of information is essential 
to appropriate and timely compliance monitoring by CMS, in order to 
ensure that all active contracts offering network-based plans maintain 
an adequate network; Form Number: CMS-10636 (OMB control number: 0938-
1346); Frequency: Yearly; Affected Public: Private sector; Number of 
Respondents: 502; Number of Responses: 2,753; Total Annual Hours: 
27,470. (For policy questions regarding this collection contact Jackie 
Ford at 410-786-7767.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Part D 
Drug Management Program (DMP); Use: Section 1860D-4(c)(5)(A) of the 
Social Security Act requires that Part D sponsors have a DMP for 
beneficiaries at risk of abuse or misuse of frequently abused drugs 
(FADs). The information in this collection of information request is 
necessary for sponsor conformance with DMP requirements at Sec.  
423.153(f), including communicating with prescribers and pharmacies, 
informing beneficiaries that they have been identified as a PARB or 
ARB, and informing beneficiaries and CMS whether a beneficiary's access 
to FADs will be restricted to a selected prescriber and/or network 
pharmacy(ies) and/or through a beneficiary-specific point-of-sale claim 
edit. Part D sponsors will use the standardized and model documents to 
communicate with providers, enrollees, and other sponsors. 
Specifically, Part D sponsors may use the Model Part D Drug Management 
Program Prescriber Inquiry Letter to inform providers that their 
patient's pattern of use or history of use of FADs is potentially 
unsafe and has prompted a case management review under the plan's DMP. 
Part D sponsors must use the standardized Initial Notice and Second 
Notice, or Alternate Second Notice, to inform enrollees, following 
identification by CMS's OMS and subsequent case management, whether the 
beneficiaries have been identified as being potentially at risk or at 
risk for abuse or misuse of FADs. Part D sponsors may use the Model 
Part D Drug Management Program Sponsor Information Transfer Memorandum 
to communicate to a gaining sponsor the enrollee's history of misuse or 
abuse of FADs; Form Number: CMS-10874 (OMB control number: 0938-1465); 
Frequency: Yearly and once; Affected Public: Private sector; Number of 
Respondents: 319; Number of Responses: 62,248; Total Annual Hours: 
152,585. (For policy questions regarding this collection contact 
Valerie Yingling at 667-290-8657.)
    3. Type of Information Collection Request: Reinstatement with 
change to the previously approved information collection: Title of 
Information Collection: State Medicaid Eligibility Quality Control 
Sample Selection Lists and Supporting Regulations; Use: Title XIX and 
Title XXI State agencies are required to submit the MEQC pilot planning 
document in accordance with Sec.  431.814(b), and the MEQC case level 
and CAP reports based on pilot findings in accordance with Sec. Sec.  
431.816 and 431.820, respectively. The primary users of this 
information are State Medicaid (and where applicable CHIP) agencies and 
CMS. State agencies are expected to use the information collected for 
continuous quality improvement purposes. They will identify patterns of 
error in their eligibility processing operations and systems and take 
corrective actions to address issues and improve the eligibility 
determination process. CMS will use the data collected to identify and 
help those States that are most in need of technical assistance. CMS 
will also use the data set to identify potential weaknesses in Federal 
regulations. It will propose regulatory modifications designed to 
ensure that there are more effective quality controls in the 
eligibility determination process.; Form Number: CMS-319 (OMB control 
number: 0938-0147); Frequency: Occasionally; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 35; Number of 
Responses: 647; Total Annual Hours: 9,840. (For policy questions 
regarding this collection contact Camiel Rowe at 410-786-0069.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-09812 Filed 5-3-24; 8:45 am]
BILLING CODE 4120-01-P