Federal Regulations

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens

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.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) 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 nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)'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.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System

The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole test system 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 voriconazole test system'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.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System

The Food and Drug Administration (FDA, Agency, or we) is classifying the breast milk macronutrients test system 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 breast milk macronutrients test system'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.

Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection

The Food and Drug Administration (FDA, Agency, or we) is classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection 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 cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection'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.

Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device

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.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections

The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections 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 measure non-microbial analytes to aid in the detection and identification of localized human infections' 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.

Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies

The Food and Drug Administration (FDA, Agency, or we) is classifying the DNA-based test to measure minimal residual disease in hematological malignancies 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 DNA-based test to measure minimal residual disease in hematological malignancies 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.

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2026. As required by statute, this proposed rule includes the proposed 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 2026. It also continues the second year of the 3-year phaseout of the rural adjustment, which began in FY 2025. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program (QRP).

Medicare Program; FY 2026 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes to revise the payment adjustment factors for teaching status and for IPFs located in rural areas. These proposed changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2025 through September 30, 2026. We are proposing to make changes to measures used in the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program, to update and codify the Extraordinary Circumstances Exception policy, and to solicit feedback through requests for information on future changes to the IPFQR Program.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes

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.

Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements

This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2026. This rule also proposes changes to the admission to hospice regulations and the hospice face-to-face attestation requirements under the certification of terminal illness regulations. This proposed rule also includes a technical correction to the regulatory text and provides updates to the Hospice Quality Reporting Program requirements. Finally, this proposed rule solicits comments regarding requests for information surrounding future measure concepts for Hospice Quality Reporting Program.

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 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.

Name Change From Office of Child Support Enforcement to Office of Child Support Services; Withdrawal

ACF published in the Federal Register on December 31, 2024, a direct final rule making technical updates throughout Title 45 Code of Federal Regulations (CFR) Chapter III. On February 27, 2025, ACF re- opened the comment period and delayed the effective date until April 28, 2025. The comment period closed March 31, 2025. ACF is withdrawing the direct final rule because the Agency received significant adverse comment.

Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly

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.

Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance; Clarification

The Department of Health and Human Services (HHS or the Department) is issuing this document to clarify the non-enforceability of certain language that was included in the preamble to--but not the regulatory text of--the May 9, 2024, final rule titled "Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance." Language in the preamble concerning gender dysphoria, which language is not included in the regulatory text, does not have the force or effect of law. Therefore, it cannot be enforced.

Nonprescription Drug Product With an Additional Condition for Nonprescription Use

In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.

Unaccompanied Children Program Foundational Rule; Update To Accord With Statutory Requirements

ORR is amending a regulation so that it comports with the express language of the governing legislation. That regulation relates to key aspects of the placement, care, and services provided to unaccompanied alien children (UACs) referred to ORR, pursuant to ORR's responsibilities for coordinating and implementing the care and placement of UACs who are in Federal custody by reason of their immigration status under the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA).

Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients

In the January 17, 2025, issue of the Federal Register, the Drug Enforcement Administration and the Department of Health and Human Services published two final rules related to the practice of telemedicine, titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients." These final rules were originally scheduled to become final on February 18, 2025. In accordance with the Presidential Memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the Drug Enforcement Administration and the Department of Health and Human Services delayed the effective dates of these two final rules to March 21, 2025, by issuing a final rule; delay of effective dates and request for comments in the February 19, 2025, issue of the Federal Register. The Drug Enforcement Administration received 32 comments in response to the request for public comments regarding the delayed effective date. Considering these comments, the Department of Justice wishes to further postpone the effective dates for the purpose of further reviewing any questions of fact, law, and policy that the rules may raise. Therefore, the Drug Enforcement Administration and the Department of Health and Human Services will delay the effective date of the two final rules titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients" to December 31, 2025.

Privacy Act; Implementation; Further Delay of Effective Date

On January 16, 2025, the Department of Health and Human Services published a final rule to make effective the exemptions that were previously proposed for a new Privacy Act system of records, "NIH Police Records," maintained by the National Institutes of Health (NIH), from certain requirements of the Act. That final rule was originally scheduled to take effect on February 18, 2025. Subsequently, the effective date was delayed until March 21, 2025, in response to the memorandum titled "Regulatory Freeze Pending Review," issued by the President on January 20, 2025. This notice further delays the effective date until May 5, 2025.

Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability

This proposed rule would revise standards relating to past-due premium payments; exclude Deferred Action for Childhood Arrivals recipients from the definition of "lawfully present"; the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; failure to file and reconcile; income eligibility verifications for premium tax credits and cost-sharing reductions; annual eligibility redetermination; the automatic reenrollment hierarchy; the annual open enrollment period; special enrollment periods; de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements and for income-based cost-sharing reduction plan variations; and the premium adjustment percentage methodology; and prohibit issuers of coverage subject to EHB requirements from providing coverage for sex-trait modification as an EHB.

Impossible Foods, Inc.; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to expand the safe use of soy leghemoglobin as a color additive to include use in plant-based meat, poultry, and fish analogue products (ground and whole cut).

Policy on Adhering to the Text of the Administrative Procedure Act

The Department of Health and Human Services' (the Department) Immediate Office of the Secretary is rescinding the policy on Public Participation in Rule Making (Richardson Waiver) and re-aligning the Department's rule-making procedures with the Administrative Procedure Act.

Name Change From Office of Child Support Enforcement to Office of Child Support Services; Reopening of Comment Period and Delaying Effective Date

The Department of Health and Human Services (HHS or Department) published a direct final rule entitled "Name Change From Office of Child Support Enforcement to Office of Child Support Services" in the Federal Register on December 31, 2024, which was to become effective March 3, 2025. HHS is reopening the public comment period and delaying the effective date for the purpose of reviewing any questions of fact, law, and policy that the rule may raise.

Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”

In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule entitled "Food Labeling: Nutrient Content Claims; Definition of Term `Healthy,' " is delayed until April 28, 2025.

Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients

In the January 17, 2025, issue of the Federal Register, the Drug Enforcement Administration and the Department of Health and Human Services published two final rules related to the practice of telemedicine, titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients." These final rules were scheduled to become final on February 18, 2025. In accordance with the Presidential Memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the Drug Enforcement Administration and the Department of Health and Human Services are delaying the effective dates of these two final rules to March 21, 2025, and are soliciting public comments specifically regarding this delayed effective date.

Privacy Act; Implementation

On January 16, 2025, the Department of Health and Human Services published a final rule to make effective the exemptions that were previously proposed for a new Privacy Act system of records, "NIH Police Records," maintained by the National Institutes of Health (NIH), from certain requirements of the Act. That final rule was originally scheduled to take effect on February 18, 2025. This document announces that the effective date is delayed until March 21, 2025, in response to the memorandum titled "Regulatory Freeze Pending Review," issued by the President on January 20, 2025.

Exchange Establishment Standards and Other Related Standards Under the Affordable Care Act

Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Delay of Effective Date

In accordance with the Presidential memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the effective date of the final rule titled "Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard" is delayed until April 14, 2025. That final rule adopted updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of HIPAA, which constitute modifications to the adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. It also adopted a modification to the standard for the Medicaid pharmacy subrogation transaction.