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Experts share operational challenges and patient care implications of the Inflation Reduction Act's (IRA) drug pricing reforms.
In an interview with Pharmacy Times®, John Beardsley, senior vice president of corporate strategy at CoverMyMeds, and Fauzea Hussain, vice president of public policy at McKesson, explored the operational challenges pharmacies will face with the Inflation Reduction Act's (IRA) drug pricing reforms, focusing on managing 10 specific drugs with new pricing structures starting in 2026. They highlighted their presentation, “Beyond Drug Prices: The IRA's Potential Impact on Healthcare Access and Outcomes,” which they shared at Asembia's AXS25 Summit.
Beardsley and Hussain discussed the $2,000 out-of-pocket maximum and smoothing program, which will help patients on fixed incomes but create complexities for the health care supply chain. They highlighted potential unintended consequences, such as changes in formulary design and the uncertainty around how negotiated drug prices might impact patient access and pharmacy operations. Beardsley and Hussain also emphasized the importance of patient-centric approaches and the need for pharmacies to adapt to new data processes, payment flows, and regulatory requirements.
Pharmacy Times: What are the most significant operational changes you anticipate pharmacies will need to implement in response to the IRA's drug pricing reforms?
John Beardsley: Thanks for spending some time with us today. We appreciate the opportunity to talk with you about this. One of the biggest things that we think is going to affect pharmacies is just operational changes. There are going to be 10 drugs, starting January 1, 2026, that have a very different way of pricing, reimbursement, revenue, cycle, management, all of those things, and then 1000s of other drugs that they're dispensing. Managing the difference for those 10 versus the other 1000 is going to be a lot for them to think about.
Fauzea Hussain: I think you're right. Medicare has its own data processes and new data exchanges that pharmacies are going to have to navigate, including new payment flows from different sources that they are not normally used to. There are going to be a lot of issues around compliance and tracking on the ledger. If you've had a money-refunded charge, I think that's a lot for a pharmacy to balance. I think that will probably need specific technology and solutions outside of what CMS is offering for them to effectively navigate. You might see them running like 2 different systems, like those 10 drugs and then the rest of their portfolio.
Pharmacy Times: Beyond individual drug costs, how do you see the IRA influencing discussions around the overall cost of patient care and the role of social determinants of health?
Beardsley: There are already a number of conversations happening. You hear some of the PBMs coming out with their position on whether they're already effective at managing drug costs. But one of the things that's probably the biggest for people that maybe are on fixed income and things like that is the $2,000 maximum out-of-pocket and the concept of being able to enroll in a smoothing program throughout the year. Now, again, that's going to create complications for everyone else, operationally, in the supply chain, whether it's pharma, pharmacies, or payers, to implement the smoothing, but that's going to be helpful to those people that maybe are struggling with affordability. Within CoverMyMeds, we've done a lot of things to try to help with actionable insights that help with different parts of that view. The 2025 medication access report has some recommendations for pharmacies and payers and others for implementing that.
Hussain: I think you covered a lot of it. I think that if we think about the different components of the IRA, like the new Part D drug benefit, and then the negotiation program that you noted is going to go live in January, I think there are some unique considerations. I do think that the smoothing program is really important for patients. From an affordability perspective, I think it changes the conversation. Which are the meds you take when? When you know that you can maybe smooth it out and sort of front-load early in the year so that you can meet the deductible and then move into a more fixed, sort of predictable cost sharing for your drugs. I think that's going to be very helpful. This year, it's already in place, but I think as more pharmacists and patients get familiar with the benefits of the program, then I think it's going to become even more important for pharmacists to be able to navigate that new world. I think the other thing that's going to be really unique in the negotiation program, where we talk about affordability and accessibility for patients, is going to be maybe the realization that the negotiated drug is maybe not the cheapest drug for the patient, which is so counterintuitive. Or that the negotiated drug is not available at their preferred pharmacy because of the issues around the financial burdens and the administrative burdens of trying to comply with all of those new program regulations. I think there's going to be a lot of uncertainty in how we have those effective conversations.
Pharmacy Times: Considering the potential impacts on pharma, payers, pharmacies, providers, and patients, what are the key uncertainties and potential unintended consequences of the IRA that warrant close monitoring?
Beardsley: I think Fauzea actually covered a number of those just now. The idea is, what is the value of formulary and benefit design when you have 10 drugs that have a specific price, and do you still want to steer toward other drugs in that category that might be more efficacious but more expensive, or things like that? I think the effect of stock for pharmacies, the effective formulary for payers and PBMs, and just getting used to a different way of managing your budget as a human being who is part of the Medicare program, I think, are important. Again, you covered a lot there.
Hussain: I did. I'm always thinking about the patient. For me, it's always about the unintended consequence of the patient and making sure that they're actually seeing the benefit that was promised, that we're expecting them to receive. I think that is sometimes the biggest unintended consequence, that the best-laid plans, when you go to operationalize and see an industry respond, actually don't benefit the patient. I would say one of the biggest things to watch is what happens to benefit design and premiums moving forward. We already saw significant shifts this year with the new Part D benefit. To your point, add in now the negotiation program. How is that going to shift and change? I think there's a lot of uncertainty.