📊FDA Seeks Comments on Communications Testing for Medical Devices
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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the generic clearance for testing communications on medical devices and radiation-emitting products by FDA's Center for Devices and Radiological Health (CDRH). This generic ICR facilitates CDRH's efforts to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations.
Learn More🏥CDC Paperwork Reduction Act Review on Medical Tourism Surveillance
The CDC is seeking public comments on its information collection request regarding adverse health outcomes linked to medical tourism. This initiative aims to improve understanding and reporting of health complications among travelers receiving healthcare abroad, addressing vital public health concerns and enhancing surveillance systems in the U.S.
Learn More🩺Analysis of USMS Medical Forms Collection Initiative
The U.S. Marshals Service (USMS), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
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⚖️DEA Suspension of Registrant
The Drug Enforcement Administration's recent order revokes Scott Hansen's registration due to allegations of improper prescribing while his nursing license was suspended. The case highlights critical compliance issues regarding the authority of healthcare practitioners to prescribe controlled substances, emphasizing the importance of adherence to both federal and state regulations.
Learn More🏥FDA Seeks Nominations for Consumer Representatives on Advisory Committees
The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee selected without regard to race, color, national origin, religion, age, or sex.
Learn More💊FDA Proposes New Packaging Rules for Over-the-Counter Drugs
The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000037) entitled "Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the- Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms." This proposed order, if finalized, will require over-the- counter (OTC) monograph drugs in an orally disintegrating tablet (ODT) or film dosage form that are subject to specified OTC monographs to be packaged in single-unit or unit-dose containers.
Learn More⚖️Implications of DEA Registration Revocation for Medical Practitioners
The Drug Enforcement Administration (DEA) issued an order revoking the registration of Syed Warsi, M.D., due to the suspension of his medical license in Illinois. This decision, based on the authority of federal and state laws, emphasizes the critical need for practitioners to maintain valid licenses to handle controlled substances, impacting compliance within the healthcare sector.
Learn More⚖️DEA Revokes Registration of Victor Augusto Silva, M.D.
The Drug Enforcement Administration has revoked the registration of Dr. Victor Augusto Silva due to violations that allowed an unauthorized individual to prescribe controlled substances. This decision underscores the strict compliance required under federal and Florida laws regarding the use of DEA registrations and the serious implications of non-compliance for medical practitioners.
Learn More🚫DEA Revokes Registration for Doctor
The Drug Enforcement Administration (DEA) revoked the registration of Dr. Margaret Sprague, citing her lack of authority to prescribe controlled substances following the revocation of her California medical license. This decision emphasizes the critical link between state licensing and federal drug prescriptions, fundamentally impacting practitioners and healthcare businesses operating in compliance with federal regulations.
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