Agency Information Collection Activities: Proposed Collection; Comment Request
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Abstract
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.
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<title>Federal Register, Volume 89 Issue 127 (Tuesday, July 2, 2024)</title>
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[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54826-54827]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14581]
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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 September 3, 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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
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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 <a href="http://Medicaid.gov">Medicaid.gov</a> 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, 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. 2024-14581 Filed 7-1-24; 8:45 am]
BILLING CODE 4120-01-P
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