Department of Health and Human Services August 2, 2023 – Federal Register Recent Federal Regulation Documents
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Medicare Program; FY 2024 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. Additionally, this final rule rebases and revises the IPF market basket to reflect a 2021 base year. These changes will be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2023 through September 30, 2024 (FY 2024). In addition, this final rule discusses quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program with changes beginning with the FY 2025 payment determination through changes beginning with the FY 2028 payment determination.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2024 and Updates to the IRF Quality Reporting Program
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2024. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2024. It also rebases and revises the IRF market basket to reflect a 2021 base year. It also confirms when IRF units can become excluded and paid under the IRF PPS. This rule also includes updates for the IRF Quality Reporting Program (QRP).
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council
Notice is hereby given for the meeting on August 29, 2023, of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings . The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of April 25, 2023; planned CSAP activities and programming for Fiscal Year 2024; presentations on substance use prevention priorities; Council discussion and public comments.
Medicare Program; FY 2024 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice Quality Reporting Program Requirements, and Hospice Certifying Physician Provider Enrollment Requirements
This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2024. This rule discusses the comments received regarding information related to the provision of higher levels of hospice care; spending patterns for non-hospice services provided during the election of the hospice benefit; ownership transparency; equipping patients and caregivers with information to inform hospice selection; and ways to examine health equity under the hospice benefit. This rule also finalizes conforming regulations text changes related to the expiration of the COVID-19 public health emergency. In addition, this rule updates the Hospice Quality Reporting Program; discusses the Hospice Outcomes and Patient Evaluation tool; provides an update on Health Equity and future quality measures; and provides updates on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment. This rule also codifies hospice data submission thresholds and discusses updates to hospice survey and enforcement procedures. Additionally, the rule requires hospice certifying physicians to be Medicare-enrolled or to have validly opted-out.
Submission for Office of Management and Budget Review; Case Plan Requirement, Title IV-E of the Social Security Act
The Administration for Children and Families (ACF), is requesting a 3-year extension of the information collection Case Plan Requirement, Title IV-E of the Social Security Act, (Office of Management and Budget (OMB) #0970-0428, expiration September 30, 2023). There are no changes to the requirements, but burden estimates have been updated to reflect current numbers of children in foster care.
Scientific Advisory Committee on Alternative Toxicological Methods; Notice of Public Meeting; Request for Public Input
This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Interested individuals may attend the meeting in person or view the meeting webcast. Registration is required to attend in person and/or present oral comments. Written public comments will be accepted. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/32822.
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''
Agency Information Collection Activities; Proposed Collection; Comment Request; National Survey of Older Americans Act Participants [OMB 0985-0023]
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Proposed Extension without Change and the information collection requirements related to the National Survey of Older Americans Act Participants.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 059
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 059'' (Recognition List Number: 059), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submission for Office of Management and Budget Review; Administration for Children and Families Generic for Information Collections Related to Gatherings (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services intends to request approval from the Office of Management and Budget (OMB) for a generic clearance to request information from potential participants at ACF gatherings, such as meetings or conferences. The planning for these gatherings is most often on a quick timeline and the standard timeline to comply with a full request under the Paperwork Reduction Act (PRA) would inhibit the ability to collect information to inform these activities. Therefore, an umbrella generic is requested to allow for quick turnaround requests for similar information collections related to these activities.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is a notice of intent to award supplemental funding to the eight Minority Fellowship Program (MFP) recipients funded in FY 2018 under Notice of Funding Opportunity (NOFO) SM-18-002 and TI-18-013. This is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting supplements, which are consistent with the initial award, up to $1,776,319 for seven Minority Fellowship Program (MFP) recipients funded under NOFO SM-18-002, and up to $1,247,286 for one MFP recipient funded under TI-18-013, for a total of $13,662,335. These recipients have a project end date of September 29, 2023. The supplemental funding will extend the project period by one-year and the recipients will continue to enhance and increase the behavioral health workforce knowledge related to prevention, treatment, and recovery support for mental illness and substance use disorders among racial and ethnic minority populations by providing specialized training among the MFP professional organizations
Maternal and Child Health Workforce Development Center Program
HRSA will provide up to $825,000 in fiscal year 2023 supplemental funds to the current Maternal and Child Health (MCH) Workforce Development Center Program recipient for the period of September 1, 2023, to August 31, 2024. This funding will support coordinating fellowships for faculty at minority serving institutions (MSI) in MCH education, research, and practice. Faculty fellowships will contribute to building capacity and developing a diverse MCH workforce that is able to build and sustain academic-practice partnerships and support communities that are historically underserved.
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