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The Medicare drug price “negotiation” process has entered its third year, with some evolution but continued complexity for patients and patient organizations.
This year, 15 drugs were selected for “negotiation,” covering Medicare Part D and, for the first time, Medicare Part B. The cycle also includes the first renegotiation of a previously selected drug. “Ensuring the patient voice is front and center in these ‘negotiations’ is vital,” explained Karin Hoelzer, Senior Director of Patient Advocacy as she kicked off the February Biotechnology Innovation Organization (BIO) Coffee Chat entitled “Putting Patients First – Incorporating Patient Perspectives in CMS drug price ‘negotiations.’”
The Centers for Medicare & Medicaid Services (CMS) will host patient-focused roundtables and Town Halls as part of the Medicare Drug Price Negotiation Program to gather input from patients, caregivers, clinicians, and advocacy organizations on their experiences with the selected drugs and related treatment alternatives. Patient groups have until March 1 to submit written responses and until March 6 to register for patient-focused roundtables scheduled for April 6–17 and Town Halls set for April 22 and 23. (Learn more and register on the CMS website.)
During the BIO February Coffee Chat webinar, patient advocates emphasized that the patient voice is vital to this process. But at the same time, engagement can be daunting for patient advocates and patient advocacy organizations navigating the structure and expectations of participation. They shared their experiences with prior rounds of negotiations and insights for organizations who want to participate this year.
The power of data and preparation
Mellanie True Hills, founder of StopAfib.org, began by sharing her organization’s experience and key learnings from participating in the first round of negotiations.
“We had three major steps when it came to preparing for these listening sessions: first to prepare, second to focus, and third to practice,” said Hills. “We surveyed our patient community and got hundreds and hundreds of responses. We recruited patients to speak, and then we armed them with the data from that survey.”
She went on to explain that because of the limited time each patient had to speak, a key part of their planning involved coordinating what data each person emphasized, and in what order.
“By dividing up the major points that came out of the survey, we were able to get 18 minutes total to get our points across,” said Hills. “We thoroughly prepared our responses and our sound bites to ensure that we got all of our points in.”
As Hills explained, engagement with CMS extended beyond these formal sessions. Participation in NHC meetings with CMS after the first round provided an opportunity for feedback on the process and discussion of improvements.
The bottom line: prepare! Hills explained that preparation—especially preparing clear, accessible messaging for CMS staff who may not be familiar with a specific condition—was absolutely critical.
The impact on patient communities
The first drugs negotiated had prices go into effect in January.
And for some atrial fibrillation patients, out-of-pocket costs have actually increased by approximately 30 percent as a result of the negotiations, said Hills. And while the $2,100 annual out-of-pocket cap for out-of-pocket costs in Medicare Part D and the Medicare Prescription Payment Plan (MPPP), which allows these costs to be spread over the plan year, help patients, many patients do not reach the cap, and many remain unaware of the MPPP.
As a result, some patients are experiencing less access rather than more, including higher out-of-pocket costs and narrower formularies.
“One misconception is that patients will benefit from these negotiations,” explained Hills. “The IRA‑negotiated price is what Medicare will pay—it’s not what patients will pay.”
She continued: “When the PBMs get finished playing their games, patients may actually pay more rather than less, since the PBMs are the ones that are in control of what we pay.”
How can CMS improve the negotiation process?
Advocates from the National Health Council (NHC), AiArthritis, Cancer Support Community (CSC), and others met with CMS after the last two rounds of negotiations to discuss the process and identify potential improvements.
Jennifer Dexter, Vice President of Policy for the National Health Council (NHC), discussed how NHC has worked with CMS and patient groups, including many non-members, to develop toolkits and resources as the process has evolved.
“It’s important to remember that the negotiation, patient engagement, public engagement events are not statutorily required,” said Dexter. “This is something that CMS has chosen to do based on input and desire … because patient groups were at the door, kind of banging to be let in.”
Tiffany Westrich-Robertson, CEO and founder of AiARTHRITIS and the Ensuring Access through Collaborative Health (EACH) and corresponding Patient Inclusion Council (PIC) coalition, described how these organizations have supported patient groups and patients in completing the Information Collection Request (ICR), preparing for negotiations, collecting data, and using all available strategies to get their voice heard and maximize the limited time patients have to convey their views to CMS—such as using the chat functions during roundtables to add additional information to the discussion.
“We are unique in that we also have the Patient Inclusion Council—so we have patients helping patients,” Westrich‑Robertson said. “We’re on standby. We do help with prep. It’s a very, very good service particularly for organizations that don’t have advocacy departments.”
And Westrich-Robertson and her team are supporting patients in countless ways throughout the process.
“CMS is going to email and say, ‘Guess what, you were selected,’” Westrich-Robertson explained. “Not everyone reads their emails. It goes to spam. This happens every year, and they only give you, what, like 72 hours or something like that to respond. So we’re literally sitting there going, ‘CMS emailed, CMS emailed’—sending DMs on Facebook, messaging, doing anything we can.”
The PIC recently hosted the first CMS-patient-facing webinar on Feb. 24, where CMS explained to patients what the negotiations were, followed by a conversation to help patients engage.
Daneen Sekoni, Vice President, Policy & Advocacy for the Cancer Support Community (CSC), also explained how CSC helped groups engage, including with their “Principles for Patient-Centered Engagement When Implementing the Medicare Drug Price Negotiation Program,” and by offering other key learnings from prior negotiations.
“A former official of the Medicare program shared with me that patient engagement in these listening sessions is so critically important because they have the data, but what they don’t have is the story behind the data,” said Sekoni. “And that’s what we’re doing—we’re bringing in the story behind the data.”
She added: “We really bring forward the lived experience of the patient. We really bring forward the lived experience of the caregiver when we have these conversations.”
Finally, Josie Cooper, Executive Director of Alliance for Patient Access (AfPA), discussed how AfPA has engaged in the process too, sharing what she and AfPA learned and how they are supporting the patient and healthcare provider community.
“When CMS sets a negotiated price that is well below that ASP‑plus‑six, healthcare providers might not actually recoup what they spent, and they could lose money on every patient they treat with a negotiated drug,” Cooper noted. And this, Cooper explained, could create a situation where patients lose access to their treatment not because the drug is unavailable, but simply because their provider cannot afford to administer it.
“While IRA negotiation obviously targets Medicare, there’s concern about potential spillover impact into the commercial insurance marketplace as well,” added Cooper. “A lot of commercial insurers use Medicare’s average sales price as a benchmark for reimbursement, and we’re concerned that reimbursement could get pulled down in commercial insurance too.”
What patient advocates need to know about this year’s negotiations
Panelists at the BIO event offered advice for patient groups and patients considering engaging in the negotiations this year.
A few tips:
- Don’t be afraid to ask for help.
- Elevate the stories of patients who cannot participate.
- Know that your voice matters.
Panelists indicated that the organizations represented are willing to assist others, regardless of disease area, membership, or prior experience working together. As groups and individuals prepare submissions and register for the upcoming engagement opportunities, the patient community is committed to helping each other navigate the process.
“Your voice matters,” asserted Sekoni. “We bring forward the lived experience of the patient and the caregiver. That’s what you bring to the conversation that no one else can bring.”
“I think the point I made earlier about kind of changing the culture at CMS is a really important part of it,” reminded Dexter. “We have to work together to make sure that they are taking into account patients’ input, that they are monitoring, watching for and minimizing ripple effects on cost or access, and that patients are listened to and engaged.”
“Sometimes we hear from advocates—whether it’s a patient, an advocacy group, or a physician—that ‘I’m not an expert in this.’ You don’t have to be an expert in everything. You’re an expert in the experience—in what this medication has meant for you as a patient or as a provider,” concluded Cooper.
