Trends, Events, and Developments (TEDs) in the Payer World – New Equity Measures, Change in FDA Leadership, Gene Therapy Reimbursement Challenges, and Medicare Advantage Enrollment Trends
Welcome to the End of Year Edition of the All Access Newsletter! I am Cynthia Miller, MD, MPH, FACP, Vice President, Access Experience Team, editor of the All Access Newsletter. This edition will shine a light on new equity measures, the recent change in FDA leadership, gene therapy reimbursement challenges, and Medicare enrollment trends and what these new events and challenges will mean for 2023. Our expert ex-payers will provide insights into these trends and developments and how they foresee them impacting the healthcare system, especially patients, health systems, and the pharmaceutical industry.
NCQA — New Equity Measures in HEDIS
Dan Danielson, MS, RPh, Senior Director, Access Experience Team
Dan discusses how NCQA is now stratifying HEDIS measures by race and ethnicity, the challenges associated with this new process, and how pharmaceutical companies can partner.
FDA Under New Leadership
Jennifer Williams, PharmD, BCOP, Vice President, Access Experience Team, PRECISIONvalue
Jenny then discusses Dr. Califf’s confirmation as FDA Commissioner. She reflects on how his new priorities around evidence generation may impact access to innovative therapies in the future.
The Future of Gene Therapy Reimbursement
Barbara Henry, RPh Senior Director
Barbara tackles the complex reimbursement of gene therapy. She discusses the multiple payment models and partnerships that assist plans in managing financial risk and tracking outcomes.
MA Plan Enrollment Trends
Janet Serluco, MS, Vice President, Access Experience Team, Oncology Lead
Finally, Janet dives into the rising enrollment in Medicare Advantage. She discusses the complexities around member satisfaction, healthcare savings, and pressures that pharmaceutical companies may see as a result.
We believe you will find these topics and their impact on market access insightful as you navigate the payer landscape. As always, please feel free to drop me a note and let me know if you have a topic suggestion for the payer team to address, and we’ll do our best to cover it in a future edition.
MD, MPH, FACP
VP, Medical Director
Access Experience Team
All Access is a bimonthly newsletter featuring key insights from our team of former payers intended specifically for market access leaders. It is published by PRECISIONvalue.
NCQA’s Healthcare Effectiveness Data and Information Set (HEDIS), beginning with the Measurement Year 2022 and ramping up through MY2024, will begin stratifying selected performance measures by race and ethnicity. The idea is that through HEDIS reporting, health plans will be able to identify and address inequities in healthcare and be held accountable for taking these actions.
In February 2022, Robert M. Califf was confirmed as the FDA Commissioner for the second time. A seasoned physician and leader who is late in his career, one can expect that his term will be impactful and influential. Advancements in medicine have required a faster approval process from the FDA while at the same time taxing payers financially and demanding robust evidence from manufacturers.
Gene therapies bring the prospect of cures once unimaginable. The potential is exciting, but we cannot assume today's healthcare system can accommodate the financial burden expected from the gene therapy pipeline. Innovative therapies come with high manufacturing and delivery costs and target low patient numbers leading to million-dollar price points.
On June 15, 2022, the Supreme Court of the United States (SCOTUS) ruled in favor of hospitals over Medicare regarding a 340B reimbursement policy instituted in 2018 and unanimously decided that the almost 30% in cuts to Medicare outpatient drug payments for hospitals participating in the 340B drug pricing program was unlawful.