Search Results for agency_names:"Health and Human Services Department"

The Centers for Medicare & Medicaid Services (CMS) is announcing a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) scheduled for June 25, 2025. This meeting will focus on the best clinical endpoints to consider for devices that manage tremors in Parkinson's disease and essential tremor. Public comments and presentations are encouraged, and there are deadlines for speaker registration and submission of materials by May 21, 2025. The meeting seeks to involve various stakeholders and the public to ensure comprehensive discussion and recommendations to CMS.

The Food and Drug Administration (FDA) has issued an order permanently banning John Warrington Kosolcharoen from working with companies that have approved or pending drug product applications. This decision resulted from his felony conviction for fraudulently selling an unapproved stem cell product, ReGen, and making misleading claims about its safety and effectiveness. Mr. Kosolcharoen was given the chance to challenge the debarment but did not respond in the provided timeframe, leading to a waiver of his right to a hearing on the decision. During his debarment, any business that employs him for related services could also face penalties.

The Centers for Medicare & Medicaid Services (CMS) issued a final rule to establish a Medicare Coverage of Innovative Technology (MCIT) pathway, which provides faster access to new, FDA-designated breakthrough medical devices for Medicare beneficiaries. The rule allows up to four years of national Medicare coverage starting from the date of FDA market authorization, helping to ensure beneficiaries have timely access to cutting-edge treatments. Additionally, the rule defines "reasonable and necessary" criteria for determining Medicare coverage to ensure clarity and consistency with commercial insurers' practices. The MCIT pathway aims to encourage innovation while maintaining patient safety and evidence-based coverage decisions.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is proposing updates to their application plan for the Mental Health and Substance Use Block Grants for fiscal years 2026-2027. These changes aim to improve clarity, update terminology, and better integrate behavioral health with overall health care. SAMHSA is inviting public comments on whether these information collections are helpful and necessary, and how they might reduce the burden on respondents. The estimated time commitment for these processes is projected to remain the same.