BeaconOne Healthcare Partners

The countdown is on - less than one month until #AHIP2025 in Baltimore! I am excited to attend the 2025 Medicare, Medicaid, Duals & Commercial Markets Forum, where industry leaders will dive into policy priorities, emerging challenges, and regulatory updates across different markets. A few sessions I’m particularly looking forward to: ? Eliminating Barriers to Deliver Personalized, Preventative Diabetes Care ? MA and Part D Compliance Audits: Best Practices & Lessons Learned ? Navigating the Future of Prior Authorization ? Tech Policy Landscape in 2025 & Beyond: Implications for Health Plans If you’re also attending, let’s connect! I’d love to grab a coffee before a session and go together. Send me a message and let me know which other sessions you’re excited about attending! #AHIP2025

We are excited to welcome Hannah Peric to our growing BeaconOne Boston team!

In August 2024, the National Institute for Health and Clinical Excellence (NICE), the Health Technology Assessment (HTA) body in the UK and influential in other markets around the world has published a position statement on the use of AI in HTA submissions.?The position statement considers the benefits and risks of AI and concludes that AI should only be used to support submissions where there is?clear rationale for doing?so. It states that submissions should not lead with AI if there are alternative sources of data. Overall NICE wants AI to augment rather?than?replace people. ? NICE is inviting organizations considering the use of AI in submissions to discuss the use of AI prior to making the submission and sets out clear rules as to how AI can be used.?The statement lists a number of AI methods and also guidelines and checklists that NICE would like to see used in AI-based submissions. The statement also draws attention to cybersecurity concerns and the expectation that submitting organizations will take all the appropriate steps to ensure data security. ? Overall, it?appears that NICE accepts that AI may augment a submission but that at least in the beginning the use of AI data will require careful justification. Access the link to read more detailed insights! https://lnkd.in/emwWWP-N #AI #MedTech #Marketaccess #HTA

BeaconOne Healthcare Partners' Thomas Goss is participating in this week's #THT2025 Conference in Boston. We continue to support access to innovative technologies that advance diagnosis and treatment of cardiovascular disease. #CardiacResearchFoundation #MarketAccess

In May 2024, the decades-long debate between the FDA and CLIA program over regulation of LDTs, seemingly came to an end with the publication of an FDA final rule, making it explicit that IVDs are classified as devices under the FD&C Act, including when the manufacturer of the IVD is a laboratory (i.e., LDT). This new rule formalized FDA’s oversight of LDTs, which have historically been regulated through CLIA under CMS. However, based on the AMP and ACLA lawsuits urging the courts to vacate the final rule, based on and claiming an overstep in FDA authority, the debate over regulatory control of LDTs is likely far from over. On January 23, the oral argument date for the lawsuits against the FDA was set for February 19, signaling the potential for a ruling prior to the Stage 1 May 6 implementation deadline, requiring LDT manufacturers to meet select MDR requirements. Access the link below for more insights! https://lnkd.in/ei_Kf8zC #IVDs #LDTs #FDA #Reimbursement #Diagnostics

On January 23, the oral argument date for the ACLA and AMP lawsuits against the FDA was set for February 19, signaling the potential for a ruling prior to the Stage 1 May 6 implementation deadline, requiring LDT manufacturers to meet select Medical Device Reporting (MDR) requirements. The AMP and ACLA lawsuits were filed in response to the FDA’s publication of the LDT final rule, which subjects laboratories that manufacture IVDs to comply with medical device regulations. The final rule, effective in July 2024, outlines a 4-year, 5-stage gradual enforcement of FDA oversight of LDTs. The lawsuits, although filed separately, were consolidated in US District Court Eastern Texas District of Texas in September 2024. Based on a request filed from AMP and ACLA, the February 19 oral arguments will be held jointly. For the latest global IVD policy, reimbursement, and market access news, subscribe to our newsletter https://beacononehcp.com/ #IVD #LDT #FDA #MarketAccess #Diagnostics #Reimbursement

As the calendar year draws to a close, we are reflecting on a year of milestones at BeaconOne Healthcare Partners and are even more excited for the new year as we continue to plan with clients to fuel their 2025 growth! Come meet the BeaconOne team at the Q1 Diagnostic Coverage and Reimbursement Conference in Boston next week or at JPM or CES in early 2025. #JPM2025, #CES2025, #reimbursement, #marketaccess, #medicaldevices, #IVD, #MedTech

As the calendar year draws to a close, we are reflecting on a year of milestones at BeaconOne Healthcare Partners and are even more excited for the new year as we continue to plan with clients to fuel their 2025 growth! Come meet the BeaconOne team at the Q1 Diagnostic Coverage and Reimbursement Conference in Boston next week or at JPM or CES in early 2025. #JPM2025, #CES2025, #reimbursement, #marketaccess, #medicaldevices, #IVD, #MedTech

BeaconOne will be attending CES in Las Vegas January 7-10th. Contact us if you will be there and want to discuss digital health commercial strategy and market access. #digitalhealth, #healthtech, #ces2025 #reimbursement #marketaccess

Join us! We continue to grow our Boston-based team and are now looking to add 2 Associates.?Please review the job posting on our website to learn more about our Company and the position.