Notice 28 May 2025 compliance, regulation, education, health care, funding, hospitals, graduate medical education

💵HRSA's Information Collection Request on Graduate Medical Education

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 28 May 2025 regulatory compliance, cms, public comment, medicare, health care

🏥CMS Information Collection Notice and Comment Request Summary

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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

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Rule 27 May 2025 administrative practice and procedure, mental health programs, health care, federal agencies, health, cancer, government policy, workers' compensation, occupational safety and health, diseases, law enforcement officers, healthcare regulations, firefighters, volunteers, eligibility criteria, responders, lung diseases, wtc health program

🏥Expanded Eligibility for WTC Health Program Responders Announced

On September 11, 2024, CDC published in the Federal Register an interim final rule with request for comment to update existing regulations governing the WTC Health Program to align with statutory changes. The interim final rule expanded eligibility criteria for enrollment of new Pentagon and Shanksville responders, capped at 500 new members, and made various conforming amendments to the WTC Health Program regulations. In this final rule, CDC responds to public comment and finalizes the revisions to the regulation.

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Rule 9 May 2025 regulatory compliance, health care, fda, laboratories, medical devices, biotechnology, biologics

🧬FDA Classifies Medical Device for Microbial Nucleic Acids Detection

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens 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 device to detect and identify microbial nucleic acids by FISH in clinical specimens classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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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Rule 9 May 2025 compliance, regulation, health care, fda, laboratories, medical devices, biologics, microbial nucleic acids

🧪FDA Classifies Microbial Nucleic Acid Storage Devices

The Food and Drug Administration (FDA, Agency, or we) is classifying the microbial nucleic acid storage and stabilization device 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 microbial nucleic acid storage and stabilization device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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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Proposed Rule 30 Apr 2025 puerto rico, reporting and recordkeeping requirements, medicare, health care, health facilities, diseases, fiscal year 2026, quality reporting, skilled nursing facilities, payment system

🏥Proposed Payment Changes for Skilled Nursing Facilities in 2026

This proposed rule would change and update policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for FY 2026. This rulemaking also proposes to update the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.

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Proposed Rule 30 Apr 2025 compliance, puerto rico, healthcare, regulations, administrative practice and procedure, reporting and recordkeeping requirements, medicare, intergovernmental relations, penalties, health professions, health care, health facilities, medicaid, privacy, health records, health insurance, diseases, health maintenance organizations (hmo), quality programs, hospital payment

🏥Proposed Changes to Medicare Hospital Payment Systems for 2026

This proposed rule would 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.

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Notice 30 Apr 2025 compliance, health care, research, data collection, ahrq, hcup

📊AHRQ's Proposed Information Collection for HCUP Data Access

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the revision of the currently approved information collection project "Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP)," OMB # 0935-0206.

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Notice 28 Apr 2025 regulations, cms, medicare, health care, medicaid, accreditation, ambulatory surgical centers

🏥CMS Notice on DNV Healthcare's ASC Accreditation Application

This notice acknowledges the receipt of an application from DNV Healthcare Inc. for initial recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.

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Rule 15 Apr 2025 healthcare, administrative practice and procedure, reporting and recordkeeping requirements, business compliance, medicare, penalties, health care, health facilities, health, medicaid, civil rights, privacy, health records, health insurance, individuals with disabilities, aged, grant programs-health, sex discrimination, citizenship and naturalization, prescription drugs, regulation changes, health maintenance organizations (hmo), religious discrimination, cost-sharing

💊Key Medicare and Medicaid Regulatory Changes for 2026

This final rule revises the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Part C and D Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.

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