Rubrum Advising

In the medical device industry, aligning clinical trials with market access objectives is paramount, particularly given the evidence standards of the Centers for Medicare & Medicaid Services, which require that products be deemed “reasonable and necessary.” Additionally, commercial payors must see that devices meet “medically necessary” criterion, further emphasizing the need for robust clinical evidence to support reimbursement decisions. At Rubrum Advising, we specialize in assisting our clients in the design of clinical trials that not only meet regulatory requirements but are also strategically aligned with market access goals. By prioritizing these objectives from the outset, we enable medical device companies to effectively demonstrate the value of their innovations and secure the reimbursement necessary for market success. At Rubrum, we also look to alternative forms of evidence generation, including real world evidence, to ensure patients have access to the highest quality data possible in a manner that is cost efficient and sustainable for medical device companies. Together, let us bridge the gap between clinical evidence and commercial viability. #MedicalDevices #MarketAccess #ClinicalTrials Rubrum Advising #HealthcareInnovation #Reimbursement #HealthEconomics #EvidenceBasedMedicine #Medicare #MedicallyNecessary #StrategicConsulting #DeviceDevelopment #HealthcareStrategy

We are thrilled to welcome Tamara Fuller Rook as our newest Principal at Rubrum Advising! With decades of experience in market access, health economics, and reimbursement policy within the medical device industry, Tamara is committed to enhancing patient access to life-changing technologies and will be a major asset to companies seeking counsel on their commercial strategy. Please reach out if you are looking for #marketaccess guidance from Tamara or any member of the team. ___________ Full announcement below: Ms. Rook is a distinguished leader in the medical device industry, known for her expertise in market access, health economics, and reimbursement policy. Throughout her career, she has focused on enhancing patient access to life-changing medical technologies by developing evidence generation plans and commercialization strategies that meet the requirements of both private and public payers, as well as health technology assessment organizations. With a proven track record in global market access and reimbursement strategy, she has held key leadership positions in neuromodulation and orthopedic medical device companies. Ms. Rook’s extensive domain knowledge includes offering strategic guidance to organizations, developing effective reimbursement strategies, and identifying payment policy opportunities to ensure innovative products reach patients in need. She excels in payer education strategies, leading to favorable coverage and reimbursement policies for new technologies, including implantable devices and digital technologies. Additionally, she has successfully recruited top talent to build high-performing Market Access teams focused on strategic and tactical efforts. Ms. Rook holds a BA in Public Policy from Texas State University and an MBA from the University of Houston. She also serves as a Committee Chair for the industry leadership group focused on advancing Health Economics and Patient Value (HEPV) with the Medical Device Innovation Consortium (MDIC). Tamara can be reached at tamararook@rubrumadvising.com if you would like to schedule an introductory consultation with her. Nancy Stade Kurt Herzer Matthew Fleisher J.D., M.P.H. Neha Prasad Samuel Yates, MHA Allison Goldring, MPH Eleanor Wolfe #healthcaremarketaccess #reimbursement #coverage #commericalpayor

In August, the Centers for Medicare & Medicaid Services released its long-awaited final guidance on the Transitioning Coverage of Emerging Technologies or #TCET, capping an eight-year journey from the first introduction of a breakthrough pathway for medical devices to receive transitional coverage. However, with only five medical device companies yearly qualifying for coverage as a breakthrough medical device, the limited scope of TCET leaves much to be desired. Join us at The Medtech Payment Summit on Sept. 18 for "What's Next: Will Congress Act on Payment Policy after TCET?" presented by Dr. Lee Fleisher of Rubrum Advising. An author of the original TCET, Dr. Fleisher will share insight on navigating the pathway and updates on this critical issue. Save with early-bird rates through Sept. 6: https://bit.ly/3xKyiRL #medtech #payment #reimbursment #breakthrough #earlybird #registernow #joinus

I am pleased to share that our latest article, “Ramifications of the Supreme Court’s Latest Term for Health Regulation,” has been published in JAMA. This work dives into the profound impacts of multiple recent Supreme Court rulings on health agencies, including Centers for Medicare & Medicaid Services and FDA, and policy-making beyond just the recent Loper-Bright decision. A huge thank you to my incredible co-authors, Anne Joseph O'Connell and Michelle Mello, whose expertise and collaboration were instrumental in bringing this article to life. It is always a privilege to work alongside such brilliant colleagues from Stanford Law School. University of Pennsylvania Carey Law School Bipartisan Policy Center The Regulatory Review #SupremeCourt. #healthpolicy #regulatorylaw Rubrum Advising