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.)

87 FR 18022