Rules effective Jan. 1 for payment of hospital outpatient and physician services are released Nov. 1. In the outpatient 1rule, CMS moves ahead with a controversial "packaging" policy for seven new categories of services, making only minor modifications to its July proposal. The policy, the scope of which includes intra-operative services, image guidance, and diagnostic radiopharmaceuticals, is intended to combat rising outpatient costs and encourage hospitals to more prudently negotiate with manufacturers (2"The Gray Sheet" Sept. 24, 2007, p. 22). The 2008 physician fee 3schedule resembles the agency's July proposal, with no new big cuts for imaging (4"The Gray Sheet" July 9, 2007, p. 11)
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
