A range of attendees, including state payers, drug manufacturers and covered entities, recently gathered in Chicago for the annual Medicaid Drug Rebate Program (MDRP) Summit to discuss the rapidly changing landscape around federal and state drug discount programs.
Change and uncertainty dominated discussions as experts from around the country shared insights and offered clarity on a blitz of new legislation and legal questions.
While topics ranged from the future of pharmaceutical innovation to how companies manage gross-to-net challenges, it was clear that three issues were top of mind for attendees:
- Understanding the impact of the recently passed Inflation Reduction Act (IRA) on the industry
- How to anticipate new challenges amid the continued growth of the 340B Drug Pricing Program
- What the Genesis Healthcare v. Becerra case could mean for the 340B program
Thought leaders from the health sector offered analysis and perspective on how to address these challenges and what to expect as the landscape evolves. Some experts, including Kalderos’ founder and chief strategy officer, Jeremy Docken, touted technology as a solution that could bolster collaboration among stakeholders as they navigate the ever-changing environment.
Understanding how the new law will shape the industry
It’s no surprise that the Inflation Reduction Act took center stage at MDRP; the legislation’s prescription drug provisions represent the most significant change to drug pricing since the Affordable Care Act in 2010. During the Congressional Insights Keynote, Anna Kaltenboeck, former senior health advisor for the U.S. Senate Finance Committee, discussed the law’s anticipated impact on the health sector, as well as the political motivations behind it.
Citing a Kaiser Family Foundation poll that found 1 in 4 Americans have trouble affording their prescription drugs, Kaltenboeck said, “The affordability component of this is really important from a political perspective.”
Other panels saw the passage of the IRA as a watershed moment for how the government will further shape the pharmaceutical space. One panel of attorneys emphasized that through the legislation, the government is entering the market in new ways, and questioned if implementing the IRA could hamper pharmaceutical innovation.
Face-to-face with significant change
“Whac-A-Mole on steroids” is how conference co-chair Odalys Caprisecca described the tumultuous future that pharmaceutical manufacturers and other stakeholders face.
While the IRA loomed large across MDRP’s three-day summit, there were also many reminders that much of the regulatory and market access landscape was changing. Caprisecca pointed out that it was imperative for attendees to read new statutes and, furthermore, read “between the lines” to get greater context on what is happening.
The continued growth of the 340B program and what it means for program participants stood out as multiple workshops focused on the program and the persistent challenge of duplicate discounts.
How a court ruling could transform the future of drug discount programs
Another issue that was top of mind during the summit was an ongoing legal battle in Genesis Healthcare v. Becerra, which centers on how a “patient” is defined in drug discount programs. The case’s outcome could have significant implications for stakeholders working in the 340B space.
In a deep-dive session, Docken of Kalderos and Trevor Wear, a partner at Sidley Austin, explored how a potential ruling may allow for a broader interpretation of 340B patients, opening the door for every stakeholder to create their own definition. In this world of ambiguous guidance, there is an increased risk of inadvertent diversion.
Docken said diversion could create a significant challenge for those working in the 340B program space, one that could supersede duplicate discounts in scale and complexity.
Turning to tech-enabled solutions
Though nearly all participants expressed concern about how these issues could play out, there was consensus that navigating these challenges will require subject matter expertise and tech-enabled solutions.
Christopher Schott, partner at Latham & Watkins, noted in the “Ask the Attorneys: What Keeps Them Up at Night?” panel that the right teams are a necessity for the road ahead. “This is why you need a group of experts, inside your company and with outside help, to be ready for this,” he said.
During the Genesis Healthcare v. Becerra session, Docken noted how Kalderos has sought to provide the technology that could ease friction among stakeholders. “We try to come up with solutions that are as compliant as possible and make as many people win as possible.”
While discussing the risks at hand, Docken showed optimism: “I’m going to hope that there are some collaborative approaches that could move the needle to provide the type of transparency needed to have manufacturers and covered entities work together on the risk of diversion.”
At Kalderos, we are monitoring these evolving issues. We will continue leveraging our technological solutions to facilitate greater collaboration and communication to make the process easier for all program stakeholders.