💰Proposed Medicare and Medicaid Payment Policies for CY 2026
This major 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 the Medicare Diabetes Prevention Program expanded 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, 2023 provisions; updates to the Medicare Promoting Interoperability Program.
Learn More💊FDA Patent Extension Review for TECELRA and Business Implications
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECELRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More📈Increase in Annual Limit for Prioritized Patent Examination Requests
The Leahy-Smith America Invents Act (AIA) includes provisions for prioritized examination of patent applications. Those provisions have been implemented by the United States Patent and Trademark Office (USPTO) in previous rulemakings. The AIA provides that the USPTO may not accept more than 10,000 requests for prioritization in any fiscal year (October 1 to September 30) until regulations setting another limit are prescribed. In 2019 and 2021, the USPTO published interim rules that expanded the limit on the number of requests to 12,000 and 15,000, respectively. The current final rule further expands the availability of prioritized examination by increasing the limit on the number of prioritized examination requests that may be accepted in a fiscal year to 20,000.
Learn More🏥Medicare and Medicaid Proposed Rule on Home Health Payment Updates
This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule proposes permanent and temporary behavior adjustments and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2026. Lastly, this proposed rule proposes policy changes to the face-to-face encounter policy. It also proposes changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it would update the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it proposes: a technical change to the HH conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.
Learn More🧪FDA Classifies Herpes Simplex Virus Assay as Class II Device
The Food and Drug Administration (FDA, the Agency, or we) is classifying the herpes simplex virus nucleic acid-based assay for central nervous system 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 classification of the herpes simplex virus nucleic acid-based assay for central nervous system infections. 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.
Learn More💊FDA Patent Extension Notice for COLUMVI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COLUMVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Notice for Oncologic Drugs Advisory Committee Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Learn More🦠FDA Classifies Antimicrobial Susceptibility Testing Device as Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing 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 cellular analysis system for multiplexed antimicrobial susceptibility testing'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.
Learn More⚗️FDA Classifies Clinical Mass Spectrometry Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying the clinical mass spectrometry microorganism identification and differentiation 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 clinical mass spectrometry microorganism identification and differentiation 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.
Learn More🦠FDA Classifies Fungal Nucleic Acid Detection Device to Class II
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify fungal nucleic acids directly in respiratory 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 fungal nucleic acids directly in respiratory 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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