This final rule implements the Global Benchmark for Efficient Drug Pricing Model (GLOBE Model), a new mandatory Medicare payment model under section 1115A of the Social Security Act. The GLOBE Model will test whether a payment model that uses an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable Medicare Part B drugs and biological products reduces costs for Original Medicare (OM) beneficiaries and the Medicare program while preserving quality of care. The term OM has the same meaning as Medicare fee-for-service and the traditional Medicare program.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF), System No. 09-80-0321, ORR Unaccompanied Children Bureau (UCB) Administrative Program Records. The system of records covers records about unaccompanied children, their intended sponsors, and members of the intended sponsors' households, used in administering ORR programs that provide for the children's care and placement. This modification includes changing the system of records name to "ORR Unaccompanied Alien Children Bureau (UACB) Administrative Program Records" and streamlining certain routine uses to enhance information sharing capabilities for child protection purposes while maintaining core privacy protections.

NIH seeks public input on its proposed NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants, including ways to promote and enable the research community to share summary level study results with clinical research participants.

This request for information (RFI) solicits input from interested parties for purposes of establishing standards for reasonable and relevant pharmacy contract terms and conditions under the Medicare prescription drug benefit. Section 6223(a) of the Consolidated Appropriations Act, 2026 (CAA, 2026) amends section 1860D- 4(b)(1)(A) of the Social Security Act (the Act) to require Part D plan sponsors to permit any pharmacy that meets standard contract terms and conditions under the plan to participate as a network pharmacy of the plan. Section 6223(a) of the CAA, 2026 further requires that, notwithstanding any other provision of law, for plan years beginning January 1, 2029, such standard contract terms and conditions offered by Part D plan sponsors must be reasonable and relevant according to standards established by the Secretary of the Department of Health and Human Services. Finally, section 6223(a) of the CAA, 2026 requires the Secretary to issue this RFI for purposes of establishing such standards.

The Centers for Disease Control and Prevention (CDC) seeks broad public input on how data intermediaries can be used to support secure, scalable, standards-based public health data exchange. CDC invites public comment to inform the evaluation and to explore how data intermediaries can advance broader goals to prevent disease, detect emerging threats, drive state-of-the-art solutions that empower communities, and strengthen public health systems for a safer, healthier nation.

This final rule requires that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18, and prohibits the use of Federal Medicaid dollars to fund sex-rejecting procedures for individuals under the age of 18. In addition, this final rule requires that a separate State Children's Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for sex-rejecting procedures for children under 19, and prohibits the use of Federal CHIP dollars to fund sex-rejecting procedures for individuals under the age of 19. For Medicaid and CHIP beneficiaries who are actively receiving cross-sex hormone therapy, State Medicaid and CHIP agencies may continue to claim Federal Financial Participation for those hormone therapy medications for a period of up to 6 months from the effective date of this final rule.

As the world's largest public funder of biomedical research, the National Institutes of Health (NIH) is committed to ensuring that gold-standard science is conducted under gold-standard biosafety conditions. To achieve this goal, NIH is proposing a new policy that modernizes and strengthens biosafety practices to ensure that oversight keeps pace with evolving risks. NIH is requesting public input on a new, comprehensive biosafety policy proposal that, when finalized, will replace the current NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (https://osp.od.nih.gov/wp-content/ uploads/NIH_Guidelines.pdf).

The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.

The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Digital Breast Tomosynthesis System," to identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.

This final rule will revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update 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); update and make changes to requirements for certain quality programs; and make other policy- related changes. ONC also adopts certain health information technology (health IT) standards and specifications on behalf of HHS.

The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public.

ANA is issuing final interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice relating to the following Fiscal Year (FY) 2026 Notices of Funding Opportunity (NOFOs): Economic Advancement Grants for Local Empowerment (EAGLE), AI3 Action Institute--Artificial Intelligence for American Indians (AI3 Action Institute), and the National Center for Native Training and Technical Assistance (NCNTTA).

Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking.

This proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2026 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the Medicare Promoting Interoperability Program.

On April 18, 2026, President Trump issued Executive Order (E.O.) 14401, "Accelerating Medical Treatments for Serious Mental Illness", acknowledging that individuals suffering from serious mental illness may not always respond to existing therapies. This request for information (RFI) solicits stakeholder feedback on training and care delivery models that could be used to ensure safe and effective delivery of potential future Food and Drug Administration (FDA)- approved psychedelic drugs, including drugs administered in ambulatory clinic settings, such as health centers and rural health clinics.

This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary's) receipt and review of Battelle Memorial Institute's 2025 Annual Activities Report to Congress. The Battelle Memorial Institute is the consensus-based entity (CBE) under a contract with the Secretary, as mandated by section 1890(b)(5) of the Social Security Act (the Act). The Secretary has reviewed CBE's 2025 Annual Report and is publishing the report in the Federal Register together with the Secretary's comments on the report not later than 6 months after receiving the report in accordance with section 1890(b)(5)(B) of the Act. This notice fulfills the statutory requirements. The Act requires the Secretary to review and publish the report; however, this statutory obligation does not constitute endorsement by the Secretary of the CBE's annual report or its specific recommendations.

This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.

This final rule removes duplicative and unnecessary sections from the Runaway and Homeless Youth Program regulations. These amendments will streamline the Runaway and Homeless Youth Program regulations to make them more accessible to the public.

The Centers for Medicare and Medicaid Services (CMS), Office of Health Technology and Products (OHTP), has been established. This new organizational component will provide enterprise leadership and oversight for CMS healthcare technology modernization, digital products, and transformation of platforms and services supporting Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and other CMS-administered programs, in close coordination with the CMS Chief Information Officer (CIO) and subject to CIO-led enterprise information technology (IT) governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, as well as CIO-led digital service delivery, customer experience, and public digital experience responsibilities under applicable law.