💰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⚖️DEA Revocation
The Drug Enforcement Administration revokes the registration of Sasha Melissa Ikramelahai due to allegations of material falsification and lack of state authority to handle controlled substances in North Carolina. The case underscores the significance of regulatory compliance in the healthcare sector, emphasizing the severe consequences businesses face when failing to uphold licensure integrity.
Learn More🚫DEA Revocation Order
The Drug Enforcement Administration (DEA) issued a revocation order for Osric Malone Prioleau, N.P. due to his suspended nursing licenses in West Virginia. The order emphasizes the requirement for practitioners to maintain state licensure to dispense controlled substances, and outlines procedures for potential appeals within defined timelines.
Learn More⚖️DEA Revocation Order
The Drug Enforcement Administration (DEA) has issued an Order to Show Cause against Benson Sergiles, P.A., proposing to revoke its registration for handling controlled substances in Arizona due to a lack of state licensure. The decision underscores the necessity of maintaining valid state authority for healthcare practitioners to dispense controlled substances, highlighting regulatory compliance challenges within the healthcare sector.
Learn More🚑DEA Revokes Registration of Diana Clouthier
The Drug Enforcement Administration has revoked the registration of Diana Clouthier, N.P., due to her suspended licenses in Colorado, deeming her unable to handle controlled substances. This decision emphasizes the necessity of maintaining state licensing for healthcare practitioners to comply with federal regulations, highlighting potential risks for businesses operating in the healthcare field.
Learn More📄DOL Notice on Annual Reporting for Multiple Employer Welfare Arrangements
The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Learn More💊FDA Announces Regulatory Review Period for LAZCLUZE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAZCLUZE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
Learn More📋CMS Notice
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.
Learn More🚫DEA Revokes Registration for Arizona Physician Assistant
The Drug Enforcement Administration issued an Order to Show Cause to Elias Garcia Garcia, P.A., proposing the revocation of his registration due to lack of authority to handle controlled substances in Arizona. The registrant failed to request a hearing, leading to the admission of allegations and ultimately, the revocation of the DEA certificate.
Learn More🏥FDA Notice on Information Collection for Medical Device Programs
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements associated with the Q-Submission and Early Payor Feedback Request Programs for medical devices and Qualification of Medical Device Development Tools.
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