[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54002-54004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14338]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-179, CMS-10536, CMS-R-153 and CMS-10326]


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 August 27, 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.
    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

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and associated materials (see ADDRESSES).

    CMS-179 Medicaid State Plan Base Plan Pages
    CMS-10536 Medicaid Eligibility and Enrollment (EE) Implementation 
Advanced Planning Document (IAPD) Template
    CMS-R-153 Medicaid Drug Use Review (DUR) Program
    CMS-10326 Electronic Submission of Medicare Graduate Medical 
Education (GME)

Affiliation Agreements

    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: Extension of a currently 
approved collection; Title of Information Collection: Medicaid State 
Plan Base Plan Pages; Use: State Medicaid agencies complete the plan 
pages while we review the information to determine if the state has met 
all of the requirements of the provisions the states choose to 
implement. If the requirements are met, we will approve the amendments 
to the state's Medicaid plan giving the state the authority to 
implement the flexibilities. For a state to receive Medicaid Title XIX 
funding, there must be an approved Title XIX state plan. Form Number: 
CMS-179 (OMB control number 0938-0193); Frequency: Occasionally; 
Affected Public: State, Local, and Tribal Governments; Number of 
Respondents: 56; Total Annual Responses: 1,120; Total Annual Hours: 
22,400. (For policy questions regarding this collection contact Gary 
Knight at 304-347-5723.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid 
Eligibility and Enrollment (EE) Implementation Advanced Planning 
Document (IAPD) Template; Use: To assess the appropriateness of states' 
requests for enhanced federal financial participation for expenditures 
related to Medicaid eligibility determination systems, we will review 
the submitted information and documentation to make an approval 
determination for the advanced planning document. Form Number: CMS-
10536 (OMB control number: 0938-1268); Frequency: Yearly, once, and 
occasionally; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 56; Total Annual Responses: 168; Total Annual 
Hours: 2,688. (For policy questions regarding this collection contact 
Loren Palestino at 410-786-8842.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug Use 
Review (DUR) Program; Use: States must provide for a review of drug 
therapy before each prescription is filled or delivered to a Medicaid 
patient. This review includes screening for potential drug therapy 
problems due to therapeutic duplication, drug-disease 
contraindications, drug-drug interactions, incorrect drug dosage or 
duration of drug treatment, drug-allergy interactions, and clinical 
abuse/misuse. Pharmacists must make a reasonable effort to obtain, 
record, and maintain Medicaid patient profiles. These profiles must 
reflect at least the patient's name, address, telephone number, date of 
birth/age, gender, history, e.g., allergies, drug reactions, list of 
medications, and pharmacist's comments relevant to the individual's 
drug therapy. The State must conduct retrospective drug use review 
which provides for the ongoing periodic examination of claims data and 
other records in order to identify patterns of fraud, abuse, 
inappropriate or medically unnecessary care. Patterns or trends of drug 
therapy problems are identified and reviewed to determine the need for 
intervention activity with pharmacists and/or physicians. States may 
conduct interventions via telephone, correspondence, or face-to-face 
contact. The states and managed care organizations (MCOs) are provided 
the reporting instrument (a survey) by CMS, and by responding to the 
survey, the states generate annual reports which are submitted to CMS 
for the purposes of monitoring compliance and evaluating the progress 
of states' DUR programs. The survey and the annual recordkeeping and 
reporting requirements under the pertinent regulations, are completed 
by pharmacists employed by, or contracted with the various state 
Medicaid programs and their MCOs. The annual reports submitted by 
states are reviewed and results are compiled by CMS in a format 
intended to provide information, comparisons and trends related to 
states' experiences with DUR. The states benefit from the information 
and may enhance their programs each year based on state reported 
innovative practices that are compiled by CMS from the annual reports. 
A comparison/summary of the data from the annual reports is published 
on Medicaid.gov annually, and serves as a resource for stakeholders, 
including but not limited to states, manufacturers, researchers, 
congress, CMS, the Office of Inspector General, non-governmental payers 
and clinicians on the topic of DUR in state Medicaid programs. Form 
Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: Yearly, 
quarterly, and occasionally; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 52; Total Annual Responses: 676; 
Total Annual Hours: 41,860. (For policy questions regarding this 
collection contact Mike Forman at 410-786-2666.)
    4. Type of Information Collection Request: Reinstatement without 
change of a currently approved collection; Title of Information 
Collection: Electronic Submission of Medicare Graduate Medical 
Education (GME) Affiliation Agreements; Use: Existing regulations at 
Sec.  413.75(b) permit hospitals that share residents to elect to form 
a Medicare GME affiliated group if they are in the same or contiguous 
urban or rural areas, if they are under common ownership, or if they 
are jointly listed as program sponsors or major participating 
institutions in the same program by the accrediting agency. The purpose 
of a Medicare GME affiliated group is to provide flexibility to 
hospitals in structuring rotations under an aggregate full time 
equivalent (FTE) resident cap when they share residents. The existing 
regulations at Sec.  413.79(f)(1) specify that each hospital in a 
Medicare GME affiliated group must submit a Medicare GME affiliation 
agreement (as defined under Sec.  413.75(b)) to the Medicare 
Administrative Contractor (MAC) servicing the hospital and send a copy 
to the Centers for Medicare and Medicaid Services' (CMS) Central 
Office, no later than July 1 of the residency program year during which 
the Medicare GME affiliation agreement will be in effect.
    CMS will use the information contained in electronic affiliation 
agreements as documentation of the existence of Medicare GME 
affiliations,

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and to verify that the affiliations being formed by teaching hospitals 
for the purposes of sharing their Medicare GME FTE cap slots are valid 
according to CMS regulations. CMS will also use these affiliation 
agreements as reference materials when potential issues involving 
specific affiliations arise. While we have used hard copies of 
affiliation agreements for those same purposes in the past, we 
implemented this electronic submission process in order to expedite and 
ease the process of retrieving, analyzing and evaluating affiliation 
agreements. Form Number: CMS-10326 (OMB control number: 0938-1111); 
Frequency: Annually; Affected Public: Private Sector, Business or other 
for profits, Not for profit institutions; Number of Respondents: 125; 
Total Annual Responses: 125; Total Annual Hours: 166. (For policy 
questions regarding this collection contact Shevi Marciano at 410-786-
2874.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-14338 Filed 6-27-24; 8:45 am]
BILLING CODE 4120-01-P