Rae Woods (00:05):
From Advisory Board, we are bringing you a Radio Advisory. My name is Rachel Woods, you can call me Rae. Look, so much has happened with vaccines and the health agencies in the last few days and weeks. So I'm recording this the morning of Wednesday, September 10th for a special Thursday release of Radio Advisory. My goal is to make sure you're up to speed on what we've seen so far, that you understand the decision points still to come and what you as health leaders can do in response. Allow me to start with the bottom line. It's no secret that HHS Secretary, RFK Jr., has strong opinions about vaccines and he has a history of spreading misinformation about science and medicine. Over the last few months, we've seen that rhetoric turn into action and change the way agencies like the CDC and FDA operate. This matters because the confusion and complexity around changing rules and differing positions will dampen vaccine access and coverage, which in turn will have very real consequences for patients and members and of course on healthcare business.

(01:11):
And it may do so at a critical time, right as we head into respiratory virus season. In the near term, expect more questions, expect higher volumes of respiratory illness, and expect an impact to public health. The reason we are so bullish about the impacts here is not because of rhetoric or talking points from the administration and the health secretary. It's because of the series of actions we've seen federal leaders take in succession and across a short period of time. So I want to remind you of all the things that have happened so far, and it's a lot, so bear with me. Back in June, the health secretary dismissed all 17 members of the CDC's Advisory Committee on Immunization Practices, the ACIP, replacing them with his own appointees. Now remember, the ACIP is the panel of experts that is responsible for vaccine recommendations and importantly, decides which vaccines must be covered by insurance under the Affordable Care Act.

(02:12):
The MAHA report released that same month and repeated in the report released this week, falsely claimed that children are over-medicated and subject to too many vaccines with unknown consequences that are pushed through due to "corporate capture over the scientific process". And two HHS leaders published an article in the New England Journal of Medicine in which they urge manufacturers to conduct placebo-controlled trials for new COVID-19 vaccines. And that's a significant departure from the standard practice because typically the FDA uses a strain change rule to update seasonal flu and COVID vaccines to target the latest strain, the latest mutation of the disease. And this predictable process allows manufacturers to quickly produce doses in time for flu season, and it avoids the ethical concern of withholding safe and effective products from a placebo group. The FDA also shifted its recommendation for COVID vaccines saying they are only appropriate for older adults and those with comorbid conditions that put them at a higher risk for severe outcomes.

(03:18):
And it appears that neither CDC nor ACIP was consulted with RFK acting unilaterally to institute new recommendations. And there's more. HHS also canceled a Moderna contract worth $700 million and HIV vaccine research funding through the NIH. Now, RFK Jr. has been outspoken about his suspicion of mRNA, and HHS alluded to unfounded safety concerns in their rationale for canceling the contract. And if I look at just those last two things together, it signals changes to the United States broader approach to vaccination, meaning it's not just COVID-19 vaccines. Not only do these moves undermine pandemic preparedness, they may also stall further research and investment in novel vaccines including mRNA technology.

(04:07):
Amidst these changes to vaccine funding, approval, regulation, HHS leadership ousted the director of the CDC, Dr. Susan Monarez, who signs off on and issues the ACIP's vaccine recommendations. At least four senior CDC leaders resigned in protest citing political interference in the agency's work, including around vaccine policy and the broader undermining of the agency's public health mission as the reason for their departure. And that brings us to the current moment. RFK Jr. defended these moves during a hearing where senators from both sides of the political aisle strongly criticized RFK Jr.'s actions. Senator Bill Cassidy, Chair of the Senate Health Committee called for the indefinite postponement of the ACIP meeting scheduled for September 18th. He went so far as to say that, "If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy." And then just hours before I set to record this, the Senate Health Committee announced it will hold a hearing with Dr. Monarez on September 17th, that's just the day before the ACIP is set to meet, where she will discuss her short tenure leading the agency, including the administration's public health policies and stance on vaccination.

(05:24):
Meanwhile, RFK Jr. named seven additional members to the ACIP and announced that HHS will collaborate with the White House to develop "a vaccine framework", which will include a vaccine injury research program. And those are just the actions within HHS, we're also tracking moves and reactions from other stakeholders. For example, the American Academy of Pediatrics responded to new FDA guidance with their own, continuing to recommend COVID-19 vaccination for all children six months and older, citing ongoing risks of hospitalization, death, and long-term complications. And we're seeing states take matters into their own hands. California, Oregon and Washington launched an alliance to give their own vaccine recommendations to their communities. The governor of Massachusetts is requiring insurers to cover vaccines recommended by the State Department of Public Health, frankly, regardless of how federal guidelines shake out. The state will also require retail pharmacies to schedule and give vaccines.

(06:25):
And there are of course moves in the opposite direction. The Surgeon General for the state of Florida announced that the state will work towards ending all vaccine mandates for Florida residents. Here's what's next, we're waiting for ACIP's formal recommendation whenever that comes. For now, it's unclear whether COVID shots will be covered by plans and employers at no cost as they have been up to this point. After all, plans are not required to cover the cost of vaccines that aren't recommended by the ACIP. Though for health plans, coverage decisions have long been baked into plans for this fall and winter season. But even if plans and employers cover the cost of vaccines, all the confusion, the chaos of these last few weeks coupled with rising distrust and misinformation are already likely to suppress uptake for seasonal shots.

(07:20):
Which brings me back to what you can do today. Remember, there are three things we expect to happen, more questions, a more extreme fall and winter season, and impact to public health. To address questions, have a single source of truth for your staff. Help them have complex conversations with patients and members, help them lead with evidence, but still hold space for the genuine concern and curiosity of the public. And make sure you're accounting for that time and those resources in workflows. To manage extreme seasonality, shore up capacity now. Get the right staff in place, meaning the people and the expertise to handle higher acuity patients. Get your throughput and length of stay as efficient as possible. In fact, we just re-released one of our top episodes of the year all about how leaders can address the three root causes of high hospital length of stay. I highly recommend going back and listening to that one.

(08:18):
And to combat eroding public health, I want to come back to a word of caution I've given before. Don't fall into the trap of merely raising the alarm. You have the power and the responsibility to systematically track the effects of policy changes on outcomes. And you can do that starting now. No one else is going to connect all of the dots between what happens in Washington and what happens to healthcare consumers. So you need to be tracking vaccination rates, ED volumes, length of stay, your workforce turnover and more, and track how all of those things are affecting the cost and quality of care. We can and we must work together to build a compelling, data-driven case that resonates with business leaders, with policymakers and with the public. And remember, as always, we're here to help.