[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Notices]
[Pages 18022-18023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10398 #74 and #76]


Medicaid and Children's Health Insurance Program (CHIP) Generic 
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: On May 28, 2010, the Office of Management and Budget (OMB) 
issued Paperwork Reduction Act (PRA) guidance related to the 
``generic'' clearance process. Generally, this is an expedited process 
by which agencies may obtain OMB's approval of collection of 
information requests that are ``usually voluntary, low-burden, and 
uncontroversial collections,'' do not raise any substantive or policy 
issues, and do not require policy or methodological review. The process 
requires the submission of an overarching plan that defines the scope 
of the individual collections that would fall under its umbrella. On 
October 23, 2011, OMB approved our initial request to use the generic 
clearance process under control number 0938-1148 (CMS-10398). It was 
last approved on April 26, 2021, via the standard PRA process which 
included the publication of 60- and 30-day Federal Register notices. 
The scope of the April 2021 umbrella accounts for Medicaid and

[[Page 18023]]

CHIP State plan amendments, waivers, demonstrations, and reporting. 
This Federal Register notice seeks public comment on one or more of our 
collection of information requests that we believe are generic and fall 
within the scope of the umbrella. Interested persons are invited to 
submit 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 April 12, 2022.

ADDRESSES: When commenting, please reference the applicable form number 
(see below) and the OMB control number (0938-1148). 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: CMS-10398 (#__)/OMB 
control number: 0938-1148, 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, you may 
access CMS' website at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Following is a summary of the use and burden 
associated with the subject information collection(s). More detailed 
information can be found in the collection's supporting statement and 
associated materials (see ADDRESSES).

Generic Information Collections

    1. Title of Information Collection: Coverage of Routine Patient 
Cost for Items & Services in Qualifying Clinical Trials; Type of 
Information Collection Request: Revised; Use: Section 210 of the 
Consolidated Appropriations Act of 2021 amended section 1905(a) of the 
Social Security Act (the Act) to add a new mandatory benefit at 
1905(a)(30). The new benefit mandates coverage of routine patient 
services and costs furnished in connection with participation by 
Medicaid beneficiaries in qualifying clinical trials. Routine costs for 
services provided in connection with participation in a qualifying 
clinical trial generally include any item or service provided to the 
individual under the qualifying clinical trial, including any item or 
service provided to prevent, diagnose, monitor, or treat complications 
resulting from participation in the qualified clinical trial, to the 
extent that the provision of such items or services to the individual 
would otherwise be covered under the state plan or waiver.
    We propose that States and territories review the preprints 
completed for a Medicaid beneficiary to receive coverage of routine 
patient services and costs furnished in connection with participation 
in qualifying clinical trials. Completion of the preprint pages 
verifies in the Medicaid state plan that the mandatory clinical trials 
benefit is being furnished by a state. Completion of the preprint 
verifies that the requirements of a federally sponsored clinical trial 
is appropriate for the Medicaid beneficiary. Form Number: CMS-10398 
(#74) (OMB control number: 0938-1148); Frequency: Once and on occasion; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 56; Total Annual Responses: 66; Total Annual Hours: 61. 
(For policy questions regarding this collection contact Myla Adams at 
410-786-8107.)
    2. Title of Information Collection: Expressions of interest in the 
Improving Maternal Health by Reducing Low-Risk Cesarean Delivery 
Affinity Group; Type of Information Collection Request: New collection 
of information request; Use: State Medicaid and CHIP agencies are given 
the opportunity to submit the attached Expression of Interest Form 
regarding participation in the Improving Maternal Health by Reducing 
Low-Risk Cesarean Delivery Affinity Group. Information requested will 
be used to see if each state meets the criteria for participation in 
the Affinity Group. Criteria for affinity group participation include:
     Well-articulated goals for improving low-risk cesarean 
delivery rates,
     An understanding of the state's challenges and 
opportunities related to low-risk cesarean deliveries,
     Access to low-risk cesarean delivery data, including the 
ability to report the Core Set measure Low-Risk Cesarean Delivery 
(LRCD-CH),
     Identification of a well-rounded state team willing to 
work about 10 to 15 hours each month (depending on role, project, and 
team size) on the state quality improvement (QI) project, and
     Commitment to action, with support from Medicaid and/or 
CHIP leadership.
    Once participating in the Affinity Group, a states will meet 
monthly virtually for workshops and one-on-one state coaching calls, 
learning from QI advisors, subject matter experts, and peers in order 
to test, implement, and assess their data-driven QI change idea.
    Form Number: CMS-10398 (#76) (OMB control number: 0938-1148); 
Frequency: Once; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 20; Total Annual Responses: 20; Total Annual 
Hours: 140. (For policy questions regarding this collection contact 
Kristen Zycherman at 410-786-6974.)

    Dated: March 24, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-06593 Filed 3-28-22; 8:45 am]
BILLING CODE 4120-01-P