Last year, Florida passed one of the larger PBM and drug-pricing reform packages in recent memory. The legislation was a priority of Gov. Ron DeSantis and included anti-steering provisions, bans on spread pricing and clawbacks, and other licensing regulations. It also included reporting requirements for manufacturers to justify annual price increases and to give advance notice of price increases. One thing to watch moving forward is whether other states adopt this novel approach.
Prescription Drug Affordability Review Boards
A recent strategy by states to tackle rising drug costs involves the establishment of prescription drug affordability review boards (PDABs). These boards, usually instituted at the state level, serve as regulatory entities entrusted with evaluating the pricing of select prescription drugs. Their principal goal is to scrutinize whether the expenses linked to specific medications are rational and defensible, considering factors such as research and development, production and overall healthcare outcomes. Through comprehensive reviews, these boards aim to pinpoint instances of exorbitant pricing and introduce measures to mitigate such practices.
PDABs are relatively new, and Colorado is currently initiating its inaugural affordability review involving a few rheumatology drugs. However, the ongoing process has been characterized by a lack of clear definition, leading to concerns about transparency. If hasty evaluation of affordability leads to price caps being imposed without meticulous consideration, there is the potential for creating access challenges for patients who are stable on their medications. This approach may exacerbate existing inequities within the healthcare system. The ACR takes a nuanced stance on PDABs, neither endorsing nor opposing them, but rather offering insights to caution against unintended consequences. We will adjust that position if needed and will continue to closely monitor PDAB legislation and the PDAB process in states that establish them.
Other Issues to Watch
We are also monitoring utilization management issues once again. There has been quite a bit of success on these issues over the last five years and there are fewer remaining states to actively target for prior authorization and step therapy wins. We continue to closely monitor a few states where legislation could move this year, but this is a time of transition for utilization management issues. We are seeing the focus shift to new policy innovations, such as the prior authorization “gold card” legislation that has recently passed in Texas and Arkansas.
Artificial intelligence (AI) is another emerging topic of concern that we are closely monitoring. State regulators are becoming increasingly interested in AI and the potential for this innovative technology to be used in ways that could compromise patient safety and data security. We are monitoring these discussions and weighing in where appropriate. The ACR recently released its first ever AI position statement and will continue to build out that statement as AI and the issues around it evolves.
