On the health policy front, 2023 was considerably quieter than 2022. As the pandemic receded, most of the activity centered around a single question: “What’s next?”
That’s not to say the year was devoid of memorable policy-related moments. President Joe Biden officially declared the pandemic’s end in May. The Centers for Medicare and Medicaid Services chose the first 10 drugs for which Medicare would negotiate prices. Pharmacy benefit managers sat in the hot seat during multiple Congressional hearings about drug prices. And, after a long lag, Monica Bertagnolli was confirmed as the new National Institutes of Health director.
With the presidential election looming, we’re unlikely to see more action in 2024. It’s unlikely that any significant legislation, such as 2022’s Inflation Reduction Act, will make its way into law.
“Attempts to seriously change policy from both sides don’t have a chance of getting through in a Congress that is so closely divided,” notes Terry Haines, founder of healthcare consultancy Pangaea Policy. “What you end up with is a standstill on anything consequential.”
But according to health policy wonks, plenty of issues will remain on the policy periphery, with what Finn Partners senior partner for global public health Richard Hatzfeld calls “the recurring cast members of the typical health policy debate” discussed early and often. Those include abortion, drug pricing, mental health and pandemic preparedness and the usual crew.
But some new contenders could seize the spotlight in 2024. They include health misinformation, AI and the next steps of the Medicare negotiation program.
Matthew Fiedler, senior fellow at the Brookings Institution, shares Haines’ sentiment that major legislation isn’t likely to pass in 2024. His one possible exception: the ongoing implementation of the Medicare drug negotiation program.
“The negotiation process is going to continue to crank forward because there are statutory timelines that need to be met,” he explains. “That is probably something that the current administration is perfectly happy to be talking about in an election year.”
In August, the Biden administration identified the first 10 drugs that would be subject to price negotiations, a list including Eliquis, Jardiance and Xarelto. Shortly after, all pharma companies involved — including Merck, AstraZeneca, Johnson & Johnson and Novartis — agreed to play along. CMS will announce the new prices for those first 10 drugs by September 2024, with the prices set to go into effect in 2026.
Some of the legal fights launched by pharma companies contesting the validity of the program will continue, but most experts believe the IRA is here to stay. “It is not going away,” says Avalere Health president Sarah Alwardt. “Now that we’ve gotten past the shock phase of it, we’ll see what happens when this becomes part of life.”
As for cascading effects of the legislation, Alwardt believes companies might choose to abandon early pipeline assets set to enter a category that includes a negotiated drug. Similarly, she points to uncertainty on the payer front: “We don’t know how payers are going to respond to including the drugs that are negotiated, versus ones that are similar that could be rebated.
“It’s just the beginning of what we’re going to learn and what we’re going to need to do,” Alwardt adds. “It’s not a done issue at all. There’s way more to come.”
Nearly everyone agrees that abortion will remain a huge issue during the run-up to the presidential election. With both parties desperate to increase urgency in the electorate, Haines expects that Democrats “will hammer abortion as pretty much their only issue and frame themselves as rights defenders.”
Republicans may not have an effective counter. Since the overturning of Roe v. Wade, the abortion and reproductive rights landscape has become a patchwork of state regulations — and experts expect it to stay that way. “Efforts to turn abortion back to a federal issue don’t have a chance of happening,” Haines says.
What we can expect to emerge in 2024 are the longer-term health impacts of varying state regulations, according to Monique LaRocque Ashton, an EVP at Ogilvy Health and the newly elected mayor of Rockville, Maryland.
“A lot of states over the past year have either reaffirmed their commitment to supporting a full range of reproductive options or have gone in the opposite direction of being even more conservative,” she explains. “But no matter what your political stance is on this issue, it has ripple effects in other areas, such as where OBGYNs choose to practice …. Until there’s some big changes in the Supreme Court, you’re going to continue to see states play a major role.”
As for the smaller skirmishes around drug pricing, they will likely remain out of the election spotlight. But that doesn’t mean they won’t simmer in the background. Since taking the helm of the Senate Health, Education, Labor and Pensions (HELP) committee earlier this year, Sen. Bernie Sanders has vowed to pursue further drug pricing reform. Recent drug pricing efforts, many of which are bipartisan, include bills targeting PBMs, such as the Better Mental Health Care, Lower-Cost Drugs and Extenders Act.
Still, experts don’t believe any PBM- or drug-pricing-related legislation will make it through Congress anytime soon. “I don’t know if there would be enough support to do something in the next year, especially with the distraction of the election,” Alwardt says.
That doesn’t mean policymakers should neglect to consider crucial public-health concerns, Hatzfeld stresses, even as the nation’s pandemic fatigue has made lawmakers less inclined to solve still-unaddressed problems related to public health infrastructure.
“It’s human nature to subscribe to collective amnesia,” Hatzfeld shrugs. “We run the real risk of repeating a lot of the same mistakes.”
Hatzfeld pointed to a handful of public health bills, such as the President’s Emergency Plan for AIDS Relief (PEPFAR), that he hopes will make their way through Congressional gridlock. There’s also the PASTEUR Act, designed to encourage the development of antibiotics effective against resistant bacteria.
Finally, there’s the ongoing concern of stemming the tide of health-related misinformation, in the context of future pandemics or otherwise. “When we don’t have a way of managing misinformation, and especially misinformation that could actually be augmented by AI, we have a dangerous situation on our hands,” Hatzfeld continues. “From a federal and a health-policy standpoint, it is one of our biggest challenges.”
On the regulatory front, all eyes will be on AI, especially on how the federal government uses Biden’s recent executive order as a blueprint for specific rules around deployment of the technology.
“We’ve come into a world of generative AI and ChatGPT, which is coming to the forefront of popular culture and how we think about accessing and using large data sets,” Alwardt says. “This next stage is going to be how AI is used responsibly and what transparency will mean for AI.”
Biden’s executive order dictates that the Department of Health and Human Services and other federal agencies must develop responsible AI standards and monitor emerging AI tools in healthcare. However, Haines is skeptical that we’ll see significant movement anytime soon.
“It’s going to take a couple of years of grinding through the regulatory process before anybody actually sees anything on AI,” he says. “Until then, both domestically and internationally, it’s a free-for-all.”
All the same, Alwardt is looking forward to the beginning of those regulatory conversations.
“Figuring out how to regulate this transparently, in a way that respects privacy and in a way that’s beneficial, will be fun,” she says. “It will be an interesting year to watch.”
From the December 01, 2023 Issue of MM+M - Medical Marketing and Media
