The legislative, regulatory, and judicial outlook for health policy in 2022

The Biden administration's first year in office was unsurprisingly dominated by the Covid-19 pandemic. While Democrats in Congress were able to pass part one of President Biden’s infrastructure package, other health care priorities were largely sidelined. As we look to 2022, there are 10 key health care topics that are ripe for congressional or regulatory action. If and how Congress and the Biden administration move on those actions will have strategic implications for industry executives across the health care ecosystem.

Big moment #1: A new 'test to treat' model for Covid-19 antivirals offers much needed hope for vulnerable populations

The president was careful in his statements about Covid-19. On the one hand, Biden offered hope that after a long battle with the omicron variant, Covid-19 is "no longer in charge of our lives." But at the same time, the President underscored that living with Covid-19 doesn't mean we stop fighting. The biggest change in the Administration's Covid-19 strategy came when the President's announced a new 'test to treat' initiative where those who test positive for Covid-19 at a pharmacy can get immediate (and free) access to oral antiviral treatment. While the logistics of testing has been far from perfect—the promise of an immediate at-home treatment offers welcome relief for vulnerable populations who continue to live in fear of this virus.

We've written about what it will take to make Covid-19 antivirals 'game changers,' and a smooth sailing 'test to treat' program could actually meet many of the critical steps we outlined related to treatment distribution, accessibility, and patient support and navigation. While communicating this new model in Biden's speech put antivirals directly in the spotlight, continued public health messaging will be crucial. The 'test to treat' program should be commonplace knowledge if we want oral antivirals to make a large impact at the population wide level. Just because the option is available, it does not mean people will actually use it. We also know that people of color tend to show up when Covid-19 is at a later stage in progression, which is one factor for disparate outcomes. To ensure an equitable rollout of 'test to treat,' there needs to be a heightened focus around designing it for the communities hit hardest by Covid-19 with the least available resources. Community engagement is a necessary longitudinal imperative—working with community members rather than directing at them.

We are celebrating this massive step forward in the fight against Covid-19, and we hope its momentum will motivate all parts of the health care industry—providers, life sciences, payers, regulators, community organizations—to come together to help get these oral antivirals to patients in need.

Big moment #2: A direct aim at mental health—and the opportunity for rare bipartisan support

Biden went all in on mental health: "Let's get all Americans the mental health services they need…and full parity between mental and physical health care." To which I let out an audible "woah," since we have yet to see parity become a reality despite many years of effort.

President Biden put a spotlight on mental health. He highlighted the challenge of behavioral health in kids and the importance of schools as a place to uphold mental health—not to erode it. Mental health is a rare area of bipartisan support—and as we get closer and closer to midterms (and further from the chance of democratic leaning legislation) it is possible that we could see democrats and republicans unite around a chronically underfunded and undervalued gap in American health care.

What was left unsaid are the details of making this a reality and the ripple effects and unintended consequences of a renewed focus on mental health. Behavioral health remains the most used specialty of virtual care—and democratizing mental health is likely impossible without digital tools and the adequate reimbursement that providers demand.

But the more worrying ripple effect for me is what these well-intentioned efforts will mean for health equity. While virtual mental health must remain a priority, we cannot forget that the Americans who need the most behavioral health support may not have the broadband, tools, or skills that would connect them to a virtual tele behavioral health visit. I also wonder if the President's remarks truly mean mental health access for all—or if the comments are scoped to less acute behavioral health needs like relatively well-managed depression and anxiety. Among others, we need to ensure access to those struggling with severe mental illness and lacking access to key social determinants of health like stable housing and food security.

We've developed an equity impact assessment template to help identify and mitigate inequitable impacts of new initiatives. While this tool is not a substitute for meaningful input from marginalized communities, it can help get us closer to what we mean by mental health for all: Addressing the most vulnerable people with the greatest needs for intervention.

Big moment #3: A blink and you'll miss the promise for better nursing home care and reduced staffing shortages

If you walked away from your TV for a moment, it's likely that you missed the President's promise to improve nursing home care. In an effort to turn an entire domestic policy agenda into a 60-minute address—the final text only included three sentences on nursing homes. But those quick remarks represent a big commitment by HHS to improve safety and quality of nursing homes and to increase accountability for the quality of care they provide.

Here's the thing: The initiative to ensure adequate quality requires adequate staffing. A proposal that likely feels impossible for the post-acute facilities who are struggling with extraordinary rates of burnout, an increasingly traumatized workforce, turnover rates at or near 100%, and staff that are increasingly leaving the health care industry entirely.

The reality is that requiring adequate staffing levels won't address the root causes of problems many facilities face in finding and retaining staff. Facilities often struggle to pay staff comparable amounts to other settings due to the complexities of Medicare and Medicaid funding in post-acute and long-term care. And there is an unfortunate stigma many clinicians feel against working in the skilled nursing setting, which makes them less desirable employers in some potential employee's eyes than other health care jobs.

For more detail on what was discussed during the State of the Union, see below. I’ve included my parting thoughts at the end.

Parting thoughts

As big as the health care agenda may be, I hope you also see the line where policy stops and health leaders like you can and should step in. I'll be watching how the administration deals with implementation of new initiatives while keeping a close eye on any ripple effects or unintended consequences. My focus will also remain on cross industry leaders who will be responsible for mitigating major challenges moving forward.

After spending all night and morning thinking about the SOTU, I am ultimately feeling cautiously optimistic. We are far from perfect—it will take robust and collective action—but I think we can feel confident in the direction we are headed.

Andrew Mohama helped write and contribute to this article.

(Owens, Axios, 3/1; Thrush, New York Times, 3/1; Patteson, New York Post, 3/1; State of the Union remarks, 3/1)

The health care topics covered in the SOTU

In his speech, Biden noted his administration's upcoming health care priorities, including:

Covid-19 response

In the speech, Biden touted the progress the United States has made against Covid-19, saying the disease "need no longer control our lives."

"I know some are talking about 'living with Covid-19,'" Biden added. "Tonight, I say that we will never accept living with Covid-19. We will continue to combat the virus as we do other diseases. And because this is a virus that mutates and spreads, we will stay on guard."

Biden also noted that Pfizer will provide more pills of its Covid-19 antiviral Paxlovid, one of two antivirals authorized by FDA.

"We've ordered more pills than anyone in the world has. And Pfizer is working overtime to get us one million pills this month and more than double that next month," Biden said.

Biden also announced the launch of a "Test to Treat" initiative that will allow people who test positive for Covid-19 at a pharmacy to also receive antiviral pills "on the spot at no cost."

According to a White House official, the administration will launch "one-stop shops" for antivirals and Covid-19 testing this month, with hundreds of sites at places like CVS, Walgreens, and Kroger. Long-term care facilities will also receive antiviral pills, as part of the initiative.

To better prepare for new variants of the coronavirus, Biden announced that, if needed, the United States will "be able to deploy new vaccines within 100 days instead of many more months or years." He also called on Congress to provide funds for new stockpiles of tests, masks, and pills.

"I cannot promise a new variant won't come," Biden said. "But I can promise you we'll do everything within our power to be ready if it does."

Biden also said its time to "end the shutdown of schools and businesses," adding that Americans "can feel safe to begin to return to the office" and that children need to remain in school in person.

"[W]ith 75% of adult Americans fully vaccinated and hospitalizations down by 77%, most Americans can remove their masks, return to work, stay in the classroom, and move forward safely," Biden said.

Biden added that the United States "will continue vaccinating the world," noting the country has "sent 475 million vaccine doses to 112 countries, more than any other nation. And we won't stop."

Lowering drug costs

Biden also addressed the high prices of prescription drugs, with a specific focus on out-of-pocket insulin costs, saying the United States should "cap the cost of insulin at $35 a month so everyone can afford it."

Biden added that Medicare should be able to "negotiate lower prices for prescription drugs, like the [Department of Veterans Affairs] already does" and that the United States needs to "close the coverage gap" and make health care premium savings that were part of the American Rescue Plan permanent.

Improving nursing homes

Biden's speech also touched on his administration's plan to improve the quality of nursing homes in the United States.

"As Wall Street firms take over more nursing homes, quality in those homes has gone down and costs have gone up. That ends on my watch," Biden said. "Medicare is going to set higher standards for nursing homes and make sure your loved ones get the care they deserve and expect."

Addressing mental health

In his speech, Biden said all Americans should get access to "the mental health services they need. More people they can turn to for help, and full parity between physical and mental health care."

Biden specifically called for addressing mental health among children, "whose lives and education have been turned upside down," noting that the American Rescue Plan "gave schools money to hire teachers and help students make up for lost learning."

"Children were also struggling before the pandemic," Biden added. "Bullying, violence, trauma, and the harms of social media."

As a result, Biden said the United States should "hold social media platforms accountable for the national experiment they're conducting on our children for profit."

Making progress on cancer

Biden also said in his speech he wants to "end cancer as we know it," noting the disease is the number two cause of death in the United States, behind heart disease.

"Last month, I announced our plan to supercharge the Cancer Moonshot that President Obama asked me to lead six years ago," Biden said. "Our goal is to cut the cancer death rate by at least 50% over the next 25 years, turn more cancers from death sentences into treatable diseases."

Biden called on Congress to fund the Advance Research Projects Agency for Health as a way to reach that goal.