📄CMS Notice on Information Collection and Public Comment Opportunity
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send 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.
Learn More💊FDA Workshop on Advancing Development of Interchangeable Products
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs." The purpose of the public workshop is to address a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III) to hold a scientific workshop to discuss and identify future needs (e.g., guidance, research) that, when addressed, may help further advance the development of interchangeable biosimilar products.
Learn More📊VA Modifies System of Records Under Privacy Act of 1974
Pursuant to the Privacy Act of 1974, notice is hereby given that the VA is modifying the system of records titled, "Veteran, Patient, Employee, and Volunteer Research and Development Project Records-VA" (34VA10). This system of records is used to determine eligibility for research funding, to determine handling of intellectual properties, to manage proposed and/or approved research endeavors, and to evaluate the research and development program. This system may also be used for data analysis to address specific questions and gain generalizable knowledge and deepen understanding of a topic or issue.
Learn More📊VA Modifies National Patient Databases Impacting Healthcare Compliance
Pursuant to the Privacy Act of 1974, notice is hereby given that VA is modifying the system of records titled, "National Patient Databases-VA" (121VA10). VA provides health care services to many Veterans through VHA. During the course of providing health care, VHA collects medical and health information about Veterans under their care. This system is used for planning, distribution, and utilization of resources; monitoring the performance of VHA programs and Veteran population health; and statistical analysis of clinical and administrative support provided within VHA.
Learn More📋Notice of Modified System of Records for Non-VA Care Services
Pursuant to the Privacy Act of 1974, notice is hereby given that VA is modifying the system of records titled, "Non-VA Care (Fee) Records-VA" (23VA10NB3). This system is used to establish, determine, and monitor eligibility to receive VA benefits and for authorizing and paying Non- VA health care services furnished to veterans and beneficiaries.
Learn More🚫FDA Revokes Emergency Use Authorization for LumiraDx Device
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to LumiraDx UK Ltd. for the LumiraDx SARS CoV-2 RNA STAR Complete. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reason for revocation, is reprinted at the end of this document.
Learn More🎓Overview of Federal Immersive Learning Management Records-VA
Pursuant to the Privacy Act of 1974, notice is hereby given that the Department of Veterans Affairs (VA) is establishing a new system of records titled, Federal Immersive Learning Management Records-VA (217VA10). This system will allow for real-time collaboration, creation, and dissemination of simulation training content, scenarios, and simulation best practices, which will enable the delivery of high value care through better adoption of clinical simulation and all modalities training capabilities in the Veterans Health Administration (VHA).
Learn More⚖️Antitrust Notice
The notice outlines the legal implications of UnitedHealth's proposed acquisition of Amedisys, emphasizing concerns over reduced competition in home health and hospice services, potential civil penalties, and the necessity for divestitures. Stakeholders are invited to submit comments within a 60-day window, reflecting the ongoing regulatory scrutiny of the merger.
Learn More🏥HRSA Considers Duchenne Muscular Dystrophy for Newborn Screening Panel
HRSA is considering recommending to the Secretary the addition of Duchenne Muscular Dystrophy (DMD) to the Recommended Uniform Screening Panel (RUSP). HRSA is providing notice and requesting comments from the public on this potential recommendation. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants and children. Non- grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without cost-sharing (e.g., co-payment, co-insurance, etc.). HRSA is particularly interested in comments that address the potential benefit of early screening of DMD within the newborn period, the ability of state newborn screening programs to screen for DMD, and the availability of effective treatments for DMD. In deciding whether to provide recommendations to the Secretary supporting the addition of DMD to the RUSP, HRSA will consider public comments, including evidence-based reports, obtained through this notice.
Learn More💰Analysis of Medicare 2026 Payment Policies and Business Impact
This document corrects typographical and technical errors in the proposed rule that appeared in the July 16, 2025 Federal Register (90 FR 32352) titled "Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program" (hereinafter referred to as the CY 2026 PFS proposed rule), specifying proposed changes to the Medicare physician fee schedule (PFS) that is applicable for calendar year (CY) 2026, and other changes to Medicare Part B payment policies, as well as proposals regarding other Medicare payment policies.
Learn More