As the world trudges toward the end of the pandemic’s second year — and the start of its third — healthcare policy mavens in Washington, DC, haven’t put COVID-19 on the back burner by any means. But the Biden administration’s fight against the pandemic has, in a sense, been superseded by the emergence of its sweeping social spending package framework.
So when one asks policy wonks about the landscape for the year ahead, one hears as much about Affordable Care Act marketplace subsidies as COVID-19. Indeed, with midterm elections looming, issues such as drug pricing are likely to remain top of mind well into 2022, according to Coalition for Healthcare Communication executive director Jon Bigelow.
“Healthcare will be a big part of this campaign, but no longer will it be about the Affordable Care Act,” he says. “It’s not going to be about Medicare For All either. That’s still a progressive dream, but it’s not in the cards for anytime in the near future. So it does really come back to issues like drug prices.”
Earlier in November, congressional Democrats settled on a drug pricing plan that made it into the $1.75 trillion social spending package after an earlier proposal was omitted entirely. The fact that pricing reform was rescued at the 11th hour signifies that the issue remains a priority for both the public and lawmakers, particularly when it comes to the reconciliation bill.
“Pharma’s arguments that drug reform will stop innovation have not been resonating with the public,” Bigelow acknowledges. “It’s the most visible cost issue to consumers and both parties want limits. This is something that unites everyone, from Donald Trump to Bernie Sanders.”
The latest legislative text on drug pricing reform highlights three core pieces, according to Ryan Urgo, managing director of the policy practice at healthcare consultancy Avalere. The first is that Medicare will be allowed to negotiate prices for Part B and D drugs in limited circumstances.
“This was portrayed in the media as a significantly watered-down version from broad, program-based negotiation,” Urgo said. “But I would not discount the importance and significance of setting a precedent for some negotiation on drugs that lack competition in the marketplace today. They’re doing this for the first time ever.”
There will also be inflation penalties on Part B and D drugs, which Urgo similarly considers a significant development.
Finally, the pricing package features Part D redesign, a long-sought goal of many policymakers on both sides of the aisle that would redistribute liability away from the federal government. The plan also includes an out-of-pocket cap on costs for senior citizens at $2,000 per year.
Of course, the legislation is subject to change — and there is still uncertainty over whether Build Back Better will clear the Senate after its passage by the House of Representatives on November 19. If the bill makes it through Congress, however, it will likely facilitate more pricing reform in 2022 and beyond.
“Without a doubt, this sets a precedent. Policymakers and progressives in particular will want to use this to build further,” Urgo notes. “This opens the door to broader change and that’s something that all stakeholders within the system really need to be thinking about, beyond the immediacy of what’s in this legislative text in particular.”
Bigelow agrees, adding, “I would not be surprised to see some efforts in the upcoming Congress to further extend the list of products that Medicare could negotiate with, measures to extend those savings into employer-based plans and other non-Medicare plans, and perhaps some other measures.”
Along those lines, Bigelow believes that, in 2022, the pharma industry will need to transition away from its stance as a firm opponent of pricing reform and into one that involves more compromise and negotiation.
“Pharma would do well to engage more actively with President Biden and Congress to try to reach some compromises, because this issue is not going away,” he says.
In a broader sense, the adjustments to ACA marketplace subsidies and drug pricing reform in the Build Back Better framework signal a trend toward value-based care, whether it’s through Medicare price negotiation or value-based purchasing. That shift may require healthcare marketers to adjust their approach to communications in 2022.
“The trend toward value is going to intensify the need to both have and communicate value,” explains Klick Health SVP of policy and advocacy David Bowen. “Those healthcare products and services that do bring value to patients will continue to thrive. From a marketing perspective, the takeaway is that it’s going to be increasingly important to not only make an emotionally compelling argument, but to make a quantitative argument as well.”
Bowen points to telehealth as another issue likely to blip on the policy radar during 2022. Telehealth may still be working through issues concerning poor patient experience and may well have plateaued since its explosion at the start of shutdown, but it’s not going anywhere. As a result, look for some policy movement around telehealth access and regulation.
“Pick your favorite metaphor: ‘the genie’s out of the bottle,’ ‘the horses are out of the barn,’” Bowen quips. “There’s now so much momentum behind the use of telehealth that, in general, the loosening of constraints will become permanent.”
Most of the policy tweaks will be designed to further enable telehealth use, Bowen predicts. “Patients have gotten used to it, providers have gotten comfortable with it and the idea of going back to the situation before just doesn’t seem realistic,” he continues. “Personally, I think it’s wonderful that we have new mechanisms to enable people to get better care, whether they’re in a remote area of Wyoming or an underserved area of Detroit or anywhere in between.”
As for the ongoing U.S. vaccination rollout, it was clearly the Biden administration’s main focus during 2021, and with good reason. While federal mandates have proven effective in boosting vaccination rates so far, a big part of the challenge lies ahead: maintaining a twin focus on vaccines and mandates as new variants emerge.
“I’m so optimistic and so pessimistic at the same time,” says Diana Silver, associate professor of public health policy at NYU School of Global Public Health. “Many of our institutions, like higher education and airlines, have rallied, and we’ve gotten portions of the economy that could put people at risk back into much safer environments. But we’re still going to be fighting those fights — because in some ways, these are blunt instruments. We don’t actually really know what we’re doing.”
President Biden’s sweeping vaccine mandates come with a January 4 deadline for businesses of more than 100 employees. The administration has taken a tough stance on the issue, with Surgeon General Dr. Vivek Murthy defending the mandates as “necessary” even amid legal challenges and a wave of resistance among Republican governors and attorneys general. How the Biden administration and the Occupational Safety and Health Administration address those legal challenges, despite the fact many of them likely won’t amount to much, will be an issue to watch during 2022.
Silver also advises monitoring the Biden administration’s long-term pandemic preparedness plans as well as its roadmap for when the pandemic inevitably turns into an endemic state. Both will be crucial, given the potential emergence of new variants and low public appetite for further lockdowns.
“Given that we have really big vaccine inequity across the globe, the likelihood that future variants make it to these shores is pretty high,” Silver says. “The question of whether Moderna and Pfizer are going to be good actors here, and make vaccines available for low-income countries to manufacture themselves, is an important one.”
She doesn’t believe vaccine donations are going to get us to that point. “We haven’t seen a real strategic plan to reach global vaccine equity with buy-in from the key stakeholders. And that is very concerning,” Silver adds.
Urgo echoes those concerns, noting that President Biden’s poll numbers suggest plenty of pandemic weariness. Action on the global front may help address some of the longer-term concerns.
“You will see a sense of urgency to improve vaccination rates throughout the population so they can get the Delta variant completely under control and minimize the risk of another vaccine-resistant strain developing,” he predicts. “There will also be a need to turn the corner on some of the safety measures that have been implemented over the last year in response to public frustration that, I think, is beginning to bleed out and be felt in a number of places.”
The pandemic has similarly taken a toll on the Centers for Disease Control and Prevention and the Food and Drug Administration. The messaging around COVID-19 has been especially muddled, with public health officials fumbling over how best to communicate the science around masking, booster shots and breakthrough infections. Public confidence in both agencies has sunk in the wake of those struggles.
The FDA will have a new leader in 2022: Former commissioner Dr. Robert Califf, who is expected to steer the agency in a different direction. During the FDA’s recent rough stretch, it has faced challenges beyond COVID-19. Politicians on both sides of the aisle wondered whether the agency’s traditional insulation from political influence has eroded, while numerous staffers flagged burnout and workload issues. The FDA’s decision to give its blessing to Biogen’s controversial Alzheimer’s drug Aduhelm prompted additional questions about accelerated approval pathways.
“All these things taken together have shaken confidence in the FDA. They need a strong leader who can start to right that ship and present clearer messaging to the public and to Capitol Hill,” Bigelow says.
It’s not all doom and gloom, though. Bowen characterizes the reconciliation bill as a far bigger deal, in terms of its impact on health equity, than most commentators have noted.
“If anything like what’s being considered on the House floor passes, it’s another huge move forward for healthcare,” he stresses. “Bringing the ability to receive regular coverage to more people, especially people who are in lower-income brackets, is a huge step forward, and it brings us closer to the idea that everyone in the United States will actually get healthcare.”
“This is a huge moment for healthcare,” he continues. “It’s been an incredibly important couple of weeks and months, and it will have a positive impact.”