4120-01-U-P
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.
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 [INSERT DATE 60 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
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 web site by copying and
pasting the following web address into your web browser: https://www.cms.gov/Regulationsand-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-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, nongovernmental 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 § 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 § 413.79(f)(1) specify
that each hospital in a Medicare GME affiliated group must submit a Medicare GME affiliation
agreement (as defined under § 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, 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: 6/27/2024 8:45 am; Publication Date: 6/28/2024]