Another IRA Negotiation Round Void of the Appropriate Patient Feedback Solicitation
By John “CZ” Czwartacki, Founder & Chairman
Not even one year after the IRA’s drug pricing program implementation began, the Administration is already watering at the mouth thinking about the next round of “negotiations.” With no patience to see how the first cycle shakes out, they have put forth guidance they claim will improve upon last year’s program. I can save you the time of reviewing the 136-page document and provide the synopsis. It’s essentially copy and paste from the last round sans one discreet acknowledgment that they may have mishandled arguably one of the most critical elements of the initial implementation – seeking patient input.
As a patient and advocate for protecting access to innovative drugs, I was able to participate in the patient listening sessions that the Centers for Medicare and Medicaid (CMS) is alluding to and can attest that they felt like a dog and pony show. It was clear from the time they announced these sessions that the agency’s dedication and heart weren’t in it. To start, patients’ feedback should have been solicited before the law even made its way to President Biden’s desk (back in 2022). Patients should have been presented with the expert opinion that price controls within the IRA ran the risk of disincentivizing innovation, ultimately putting the development of cures and treatments further out of reach. Shouldn’t the stakeholders that a public policy would most impact have some say before it’s enacted?
That input wasn’t sought out till a year later, mind you, when the Administration had already announced that implementation was beginning with ten selected drugs. Stakeholders, including patients who took any of those medicines, were then allowed to apply to participate. The application and selection process were confusing, and paid little mind to patients who may not understand legal jargon or are easily scared off by warnings that their testimony would be recorded.
Asking for any patient, who suffers from conditions that some of us will never relate to, is a big ask, and it was frustrating to see a lack of empathy from a healthcare agency or acknowledgement of how difficult it is for patients to participate in such a public way. Speaking out about your illness is tough enough, but knowing that you’re not part of a conversation but instead only given three minutes to talk about how a drug treats your condition is outrageously intimidating. Most patients struggle to emphasize their own pain levels to a doctor, much less vouch for a drug on a public stage to demonstrate how their medication has eased their cancer’s unpleasant side effects.
Nonetheless, what should have been an open dialogue between patients, care providers, and healthcare stakeholders was instead organized as a one-way Zoom with a cold government bureaucrat cutting participants off when their three minutes were up. To make matters worse, there were no exceptions for overly strict rules nor humility concerning participants; many of whom, like me, face health conditions, such as trouble speaking and hand mobility, that pose challenges for operating or speaking on a Zoom challenging. CMS also didn’t provide any indications during the sessions that they heard us, explain how our data would be used, or even offer a reaction from the panel “listening.” I can only conclude that we were just all talking to a brick wall.
Ironically, for this upcoming round, CMS did say they are combining events for selected drugs that treat like conditions/diseases instead of hosting sessions for each of the 15 negotiated drugs. Or as I see it, they don’t want to spend the time hosting those sessions and instead prefer to knock them out one disease group at a time. So, let’s say 6 out of 15 drugs treat diabetes, then they can host those patients and say they did their due diligence for those drugs. Talk about trying to kill two birds with one stone!
CMS’s draft guidance for this next round of implementation is riddled with questions and no answers, signaling they heard enough complaints to know they can’t conduct this round of sessions the same way they did in 2023. Fortunately for us patients, a formal comment period through July is our opening to provide the feedback the agency needs to get these sessions right. Regardless of how dangerous the IRA is to innovation – and I’m not giving up on my fight to fix the wrongs of the IRA – it’s imperative that implementation doesn’t proceed without proper patient feedback and direction.