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Navigating the Inflation Reduction Act (IRA) with Former FDA Commissioner, Dr. Mark McClellan

Wednesday, 13 September 2023 20:40

Innopiphany specializes in consulting at every level of state and federal policy impact from product-specific evidence strategies and tactical responses to strategic pipeline direction and team education.

IRVINE, CA / ACCESSWIRE / September 14, 2023 / Innopiphany LLC., a life science consultancy, will be hosting a webinar on the IRA with former FDA commissioner, Mark McClellan. This 1-hour virtual event will address pressing questions regarding methodology and approach to evidence collection, anticipated future trajectories for CMS negotiations including bio-similar delay prevention, broad implications such as the overhaul of Medicare Part D, and CMS potentially adopting approaches akin to HTAs found in other nations. This is a unique opportunity to hear Dr. McClellan's views on this important topic and have your questions answered in a real-time Q&A.

The remote webinar will be held live on Sept 18, from 2:00 - 3:00 pm ET. Time permitting, our speakers will address questions raised by attendees. Register now to attend [REGISTRATION LINK]. The webinar will also be recorded and available on our website [WEBSITE] shortly after the event.

The IRA is one of the most consequential developments in US drug pricing history

The 2022 Inflation Reduction Act (IRA) heralds a groundbreaking shift in the landscape of US drug pricing, marking a historic milestone as CMS unveils its list of 10 drugs subject to price negotiations. Nobody yet can predict the full impact of this legislation, but the IRA is set to bring about monumental changes to the way drugs are priced and paid for by Medicare, with impacts that could echo across the nation not just in Medicare but for commercial insurance plans and state Medicaid.

The current legislation includes an amendment to the HHS "non-interference" clause, which allows CMS to negotiate drug prices for an escalating number of high-spend Part D and Part B medicines, reaching 60 drugs in 2029. Other new measures include a redesign of Medicare Part D contribution structures, inflation-based rebates from manufacturers, increasing fees for Medicare-qualifying biosimilars, and vaccine and insulin cost-sharing.

Products implicated in Medicare negotiations could face a 25% discount (for short-term monopolies) or a 60% discount (for long-term monopolies) off the non-federal average manufacturer price. This has sparked debates about the constitutionality of the act and the consequences of non-compliance amongst manufacturers.

Register for the webinar here [Register Here]

Meet Our Speakers:

Mark McClellan MD, Ph.D., served as the Food and Drug Administration commissioner of the FDA from 2002 to 2004, and the administrator of the Centers for Medicare and Medicaid from 2004 to 2006, where he developed and implemented major reforms in health policy, including the Medicare prescription drug benefit and Medicare and Medicaid payment reforms. He has also previously served as a member of the President's Council of Economic Advisers and senior director for health care policy at the White House, and as Deputy Assistant Secretary for Economic Policy at the Department of the Treasury. He is currently the Director of Robert J. Margolis Center and a Professor of Business, Medicine, and Policy at the Duke-Margolis Center for Health Policy. Dr. McClellan also chairs the National Academy of Medicine's Leadership Council for Value and Science-Driven Health Care, co-chairs the Guiding Committee of the Health Care Payment Learning and Action Network, and is a research associate at the National Bureau of Economic Research. He is a Senior Advisor on the faculty of the University of Texas Dell Medical School and an independent director on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ.

Lisa Kennedy, Ph.D., is the Cofounder and Chief Economist of Innopiphany, LLC., a woman-owned company operating in a federally designated historically economically underutilized zone (SBA Certified HUBZone). Innopiphany specializes in policy, value assessment, health economics, social determinants of health, clinical trial diversity, real-world data, AI, and machine learning. Dr. Kennedy has previously served as GM for the Lewin Group Europe as well as Chief Economist and Global Head of Marketing Operations for GE Healthcare. Dr. Kennedy has several peer-reviewed articles and has spoken internationally to NASA, the NHS, the EU, SXSW, FutureMed and the White House Office of Science and Technology Policy (OSTP), HIMSS, among others. She has been quoted by the Wall Street Journal and National Public Radio on future healthcare trends in consumer health and received the 1994 Russel Trust Award and the Gray Prize for research that changed WHO practice in the treatment of tuberculosis in Addis Ababa, Ethiopia.


Kyra Lee
[email protected]
+1 949-304-5052

SOURCE: Innopiphany, LLC

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