Notice 22 Aug 2025 regulatory compliance, advisory committee, health care, chronic disease management, policy initiatives

🏥Nominations for Healthcare Advisory Committee and Business Impact

The Department of Health and Human Services announces its intent to establish the Healthcare Advisory Committee and invites nominations for the Committee.

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Rule 21 Aug 2025 compliance, health care, fda regulations, medical devices, gastrointestinal technology

⚙️FDA Classifies Laparoscopic Gastrointestinal Sizing Tool

The Food and Drug Administration (FDA, the Agency, or we) is classifying the laparoscopic gastrointestinal sizing tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the laparoscopic gastrointestinal sizing tool. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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Notice 14 Aug 2025 regulatory compliance, health care, grants, funding, hrsa, health centers

💰Health Center Performance Period Extension and Funding Overview

HRSA is extending health center grantees' performance periods to a total of 4 years. The change from a 3-year performance period to a 4-year performance period will provide current health centers additional time to serve their service area before they apply for a new award and will provide a funding amount consistent with what would have been made available through the Service Area Competition (SAC). The extended performance period supports HRSA's commitment to continuity in access to comprehensive primary care and will not impact HRSA's ability to ensure that health centers comply with Health Center Program requirements. This update will not change the statutory requirement that health centers that fail to comply with Health Center Program requirements will receive a 1-year performance period if a new project period is awarded.

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Rule 8 Aug 2025 fraud, gender-ideology, intergovernmental relations, health care, lawyers, compliance, department-of-defense, regulation, administrative practice and procedure, government employees, federal buildings and facilities, claims, courts

⚖️Department of Defense Rule Change on Gender Terminology in Litigation

In accordance with the Executive Order titled "Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government," this amendment rule removes text in this CFR part that promotes or otherwise inculcates gender ideology. This change is purely administrative.

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Notice 7 Aug 2025 compliance, 340b program, regulation, health resources and services administration, drug pricing, health care

💊Overview of 340B Drug Pricing Program Compliance Requirements

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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Notice 5 Aug 2025 nih, advisory council, regulations, diabetes, grants, health care

🏥Notice of National Diabetes Advisory Council Meeting 2025

This notice announces a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council, detailing the agenda, public access information, and the schedule for open and closed sessions. The meeting will cover council business, concept clearance, and review of grant applications, emphasizing the importance of participation for stakeholders in relevant health sectors.

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Proposed Rule 4 Aug 2025 veterans, administrative practice and procedure, veterans affairs, mental health programs, claims, health professions, health care, health facilities, government policy, health regulations, health records, medical research, medical devices, reproductive health, healthcare industry

⚕️VA Proposes Reinstatement of Abortion Exclusions in Medical Benefits

The Department of Veterans Affairs (VA) is proposing to reinstate the full exclusion on abortions and abortion counseling from the medical benefits package, which was removed in 2022. Before that time, this exclusion had been firmly in place since the medical benefits package was first established in 1999. VA is also proposing to reinstate the exclusions on abortion and abortion counseling for Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) that were removed in 2022. We take this action to ensure that VA provides only needed medical services to our nation's heroes and their families.

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Rule 4 Aug 2025 compliance, puerto rico, administrative practice and procedure, reporting and recordkeeping requirements, incorporation by reference, medicare, intergovernmental relations, penalties, health professions, health care, health facilities, health, medicaid, public health, laboratories, privacy, health records, health insurance, hospitals, computer technology, payment systems, health maintenance organizations (hmo), healthcare regulation, quality programs, hospital policy

🏥Medicare IPPS FY 2026 Regulations

This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy- related changes. We are also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, it finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.

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Rule 31 Jul 2025 regulatory compliance, veterans, administrative practice and procedure, financial assistance, reporting and recordkeeping requirements, employment, loan programs-education, colleges and universities, grant programs-education, vocational education, education, claims, health care, conflict of interests, civil rights, travel and transportation expenses, armed forces, grant programs-veterans, loan programs-veterans, manpower training programs, defense department, schools, training programs

🎓Update on 81-Month Rule for Dependents' Education Assistance

The Department of Veterans Affairs (VA) is issuing this final rule to update its regulation governing a beneficiary's receipt of education assistance from two or more programs. This action is necessary to implement a statutory amendment enacted in August 2012, which authorized an 81-month aggregate period for use of Survivors' and Dependents' Educational Assistance (Chapter 35) benefits in combination with other programs listed in the statute. This rulemaking amends the regulation to align it with the current statutory text.

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Rule 28 Jul 2025 healthcare, administrative practice and procedure, mental health programs, claims, health care, business impact, nih, fraud, health insurance, individuals with disabilities, clinical trials, infectious diseases, military personnel, covid-19, policy change, tricare, dof

🏥TRICARE Regulation Expands Coverage for Clinical Trials

The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.

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