💊Revocation of DEA Registration for JYA LLC - Major Implications
The Department of Justice has revoked the DEA registration of JYA LLC d/b/a Webb's Square Pharmacy due to serious violations, including dispensing controlled substances without legitimate prescriptions. The agency determined that these actions posed an imminent danger to public health, resulting in immediate sanctions and the denial of future registration applications. The ruling underscores the critical importance of compliance in pharmacy practice.
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💊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🏥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.
Learn More🏥Medicare and Medicaid Home Health Payment System Updates
The Department of Health and Human Services has proposed updates to the Home Health Prospective Payment System (HH PPS), which includes rate adjustments and new requirements for quality reporting and value-based purchasing. Additional updates pertain to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program, influencing provider enrollment and compliance with new Medicare and Medicaid policies.
Learn More🏥Notice on Agency Information Collection and Public Comment Request
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🏥Notice of Special Medical Advisory Group Meeting by Veterans Affairs
The Department of Veterans Affairs announces a meeting of the Special Medical Advisory Group to discuss veterans’ healthcare strategies, including suicide prevention, homelessness solutions, and enhancements in patient care. The meeting, open for public attendance virtually, will allow time for public comments and insights on key healthcare issues facing veterans.
Learn More⚖️Revocation of DEA Registration and Business Compliance Implications
The Drug Enforcement Administration issued an Order to Show Cause against Dr. Hayriye Gok, proposing the revocation of her registration due to a suspended medical license in Pennsylvania. The document also lays out the procedural steps for enforcement and the consequences of defaulting on requests for hearings.
Learn More💊Medicare and Medicaid Updates for Home Health Payment Systems
This regulatory document addresses updates to the Medicare and Medicaid Programs, specifically focusing on the Home Health Prospective Payment System for 2026. It includes details on quality reporting requirements, value-based purchasing models, accreditation requirements for durable medical equipment, and other related policies essential for healthcare providers to understand for compliance and operational adjustments.
Learn More💊DEA Revokes Registration of Practitioner John Hanley, P.A.
The Drug Enforcement Administration has issued an Order to Show Cause proposing the revocation of John Hanley, P.A.'s registration, citing lack of authority to handle controlled substances in New Mexico due to the revocation of his physician assistant license. The Agency finds Registrant's default and confirms the necessity of state licensing for DEA registration, ruling the revocation effective immediately.
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