Each of these challenges is important because we all—in the government, in our hospitals, and elsewhere in American healthcare—share the same goal of better health for Americans. Better health is the ultimate goal of the vision the President set out for healthcare, and it’s what we’ve aimed to deliver every day at HHS.
Thank you, Tom [Nickels], for that introduction, and for inviting me to address all of you today.
I want to begin by thanking all of you for the remarkable work that America’s hospitals have done over the past year to respond to the COVID-19 pandemic. You have rapidly and creatively expanded capacity to care for COVID-19 patients, taking advantage of the historic regulatory flexibilities afforded by HHS and by states.
You’ve also now been working hard to administer vaccines to your workforces, and we appreciate those efforts. As you know, we have been in daily contact with states and other public health jurisdictions to coordinate vaccination, including the expansion of this work beyond hospitals, to places where Americans more often receive vaccines, like pharmacies. On Wednesday, we announced $3 billion in new CDC funding for jurisdictions, which they can use to leverage all the provider resources in their states to deliver the widest access to vaccines possible.
I want to offer a special note of gratitude for every worker on the frontlines in your hospitals, so many of whom have had so little time off from work this year. The work done in America’s hospitals this past year has been heroic, and it has saved countless lives.
While I look forward to providing an update on some COVID-19 matters later in our session, I want to focus my opening remarks on a number of the other public health challenges that we’ve prioritized under the Trump Administration.
One of the key ways we’ve picked priorities is looking at which challenges are impactable. Where do we have the tools to make progress, but there’s been a lack of federal focus, coordination, or commitment? What health challenges have been neglected for far too long?
Today, I’ll mention a few areas like that, where we’ve delivered results over the past few years: combating our country’s opioid crisis, other substance use disorders, and mental illness; addressing the rapid rise of youth e-cigarette use; ending the HIV epidemic in America; transforming kidney care; and American leadership in combating Ebola.
Our country’s opioid crisis was one of the very first priorities I identified upon taking office as Secretary. The number of Americans dying of opioid overdoses each year had been exploding since the 2000s, with drug overdoses becoming the most common accidental cause of death for the first time ever.
HHS had outlined some strategies for tackling this challenge under the previous administration, but it had not received real focus from the very top. Under President Trump, that changed—and we applied the very best science we had to the challenge.
In early 2017, under the Trump Administration, HHS released a five-point strategy for combating the opioid crisis: 1) better treatment, prevention, and recovery services; 2) better data; 3) better access to overdose-reversing drugs; 4) better pain management; and 5) better research.
In February 2018, I laid down a clear marker: We would let the science and evidence guide us in all of our work, including the opioid crisis. This administration viewed addiction as a medical challenge, not a moral failing. We knew that, in particular, medication-assisted treatment works in saving lives and supporting recovery from opioid use disorder. We knew stigma could be a barrier to MAT and to conquering addiction generally, and we would take that stigma head on.
I believe this mindset was not only the true, evidence-based view, but also an especially meaningful statement coming from a conservative administration and an absolutely vital step toward making real progress in this crisis.
We’ve put an unprecedented focus on expanding access to medication-assisted treatment. With the billions of dollars in State Opioid Response grants appropriated by Congress, we’ve required that states send these funds to treatment providers that make medication-assisted treatment an option. We’ve granted waivers to 31 states around Medicaid’s restrictions on paying for in-patient treatment for substance use disorders, and we’ve dramatically expanded the number of providers who are waivered to prescribe the necessary medications.
These efforts to expand treatment have had real results. The number of Americans receiving MAT has increased at least 38 percent since 2016, while prescriptions of two forms of MAT—buprenorphine and naltrexone—have risen 46 and 31 percent respectively. The number of patients receiving medication-assisted treatment at community health centers has risen 264 percent since 2016.
We’ve also substantially improved our data work. When I named Admiral Brett Giroir as senior advisor for the opioid crisis and mental health in 2018, he had his team go straight to work securing more timely data, allowing us to follow leading indicators of whether our policies were yielding results. CDC has made significant investments in states’ ability to rapidly report death data, and began publishing data with a much shorter lag, so that we can have a more up-to-date picture of national overdose trends.
In part thanks to SAMHSA and CDC work to equip those on the frontlines with training and access to overdose reversing drugs, we’ve seen prescribing of naloxone increase dramatically, by an incredible 502 percent since January 2017. We strongly encouraged Part D plans to include naloxone in a generic tier, which comes with very low out-of-pocket costs, and we anticipate that 99 percent of 2021 plans will cover a form of naloxone with low cost-sharing.
At the same time, we’ve seen the total number of opioids being prescribed decrease substantially, dropping 32 percent since January 2017. We’ve set records each year for prescription pills collected as part of the semiannual National Takeback Day, and we’ve taken steps in Medicare to cover more non-pharmacological alternatives and create safety alerts around potentially risky opioid use.
Finally, we’ve been expanding our knowledge base through research on new treatment and pain management options as well as on which policy interventions and approaches work best in tackling this crisis.
Early in my tenure, when I met with Sam Quinones, the author of Dreamland, which I’m sure many of you have read, he mentioned that he’s found reason for hope in places where all sectors of a community come together to combat the opioid crisis. That idea eventually fueled the HEALing Communities initiative, which invested more than $350 million in providing comprehensive support for communities across four states to try reducing overdose rates dramatically, an effort that is now in its second year. Two of these efforts are being led in part by AHA members, Boston Medical Center and the Ohio State University Medical Center.
We’ve also supported cutting-edge science on pain and addiction, and last September, NIH made 375 awards totaling nearly $1 billion through its HEAL Initiative, to expand the tools we have for managing pain, treating addiction, and promoting long-term recovery.
In 2018, we were incredibly heartened to see all of these efforts start to deliver results: That year, the number of Americans dying from drug overdoses dropped for the first time since the 1990s.
Tragically, that progress has not lasted. Overdose deaths began to rise again in 2019, likely due to the spread of fentanyl in western states and rising rates of overdoses involving stimulants. Death rates then rose quite dramatically in early 2020, during the COVID-19 pandemic.
But even before we saw numbers start to turn in the wrong direction, we had begun to take action. I secured flexibility from Congress so that states can use opioid grant funding to address stimulants as well, and we’ve slashed regulations during the pandemic so that Americans can continue receiving medication-assisted treatment safely, including via mail.
We also know that substance abuse so often intersects with mental illness—and serious mental illness especially is another neglected public health challenge.
In 2019, more than 13 million Americans lived with a serious mental illness, and we’ve seen significant increases in that number over the last several years, especially among younger Americans. The treatment they receive and the outcomes we see are completely unacceptable: By one estimate, about 10 times as many Americans with serious mental illness are in jail or prison as are receiving inpatient psychiatric treatment, and they are much more likely to die from suicide and experience homelessness.
This challenge had been neglected for too long. We needed to put much greater focus on getting Americans with serious mental illness effective, evidence-based treatment, and we need to combat any stigma around seeking that treatment. In early 2019, we released the first-ever guidance for state waivers from Medicaid’s bar on paying for inpatient mental health treatment—the same issue where we’ve granted waivers to address the opioid crisis. Now, we’ve approved waivers for four states that support community-based services and crisis stabilization services, as well as short-term stays in psychiatric hospitals and residential treatment settings.
We’ve also expanded funding for the proven strategies we have for outpatient treatment, including assisted outpatient treatment and assertive community treatment, and we’ve provided new educational resources for states to implement them.
We’ve also started to see some real progress on treatments for serious mental illness, where progress has been far too slow for decades. Last March, FDA approved the first new really innovative drug for major depression in decades, a nasal spray form of esketamine. Then, this year, the National Institutes of Health launched an Accelerating Medicines Partnership, or AMP, initiative for schizophrenia. These AMP initiatives are bold examples of public-private cooperation—a bit like Operation Warp Speed—where drug companies and publicly funded researchers work hand in hand to identify promising targets for drug development.
We will continue to face serious challenges around substance abuse and mental illness in the coming years, but I believe we have laid an incredibly strong foundation for progress, by putting science, evidence, and the role of effective treatment at the fore.
The final substance use issue I’ll mention is the incredibly rapid rise in youth use of e-cigarettes over the past decade. In 2013, FDA and CDC’s National Youth Tobacco Survey found that less than 5 percent of American high schoolers reported using e-cigarettes. By 2019, 30 percent of high schoolers were using them—a more rapid rise in use than we’d ever seen for any substance.
We knew from these surveys that youth were particularly using flavored e-cigarettes, with the exception of tobacco and menthol. After a variety of incremental steps, in September 2019, we announced that FDA planned to prioritize enforcement against illegally marketed e-cigs of all flavors besides tobacco and menthol, and companies soon pulled these kid-friendly products from the market.
While we have a long way to go, the results so far have been significant. According to the National Youth Tobacco Survey, the number of youth using any tobacco product dropped from 6.2 million in 2019 to about 4.5 million in 2020—down about 28 percent, a remarkable one-year drop.
By targeting those flavors most popular with children, we aimed to preserve the off-ramp from combustible cigarettes that these products might offer for adults, while trying to minimize the possibility that they can be an on-ramp to a lifetime of addiction for youth. While we undertake these efforts, FDA has also encouraged the development of more tools to help smokers quit. The agency has authorized the marketing of heat-not-burn products with information that could help addicted adult smokers completely transition away from combustible cigarettes and reduce their exposure to harmful chemicals.
As the market evolves, more efforts will no doubt be needed, but we have successfully slowed the explosion of youth e-cigarette use, helping to protect a generation from the risks of addiction.
The next health challenge I want to discuss is similar to the opioid crisis in that we had many of the tools we needed to defeat it, but there had been a lack of catalyzing leadership. Back in 2018, talking with colleagues like CDC Director Bob Redfield and Assistant Secretary for Health Brett Giroir, we realized that we had a unique opportunity in front of us: We had the right tools we needed to end the HIV epidemic in America, we had the right leaders committed to the effort, and we had the right data showing that this was a beatable challenge.
We made the case for this idea across the administration in 2018, and in his 2019 State of the Union, President Trump announced the launch of our effort to end the HIV epidemic in America within the decade. Later that year, we were pleased to see Congress respond to our request for funding for this effort, passing $267 million in first-year funding.
The plan we laid out requires executing on four strategies, which we have the tools to do today: diagnose all individuals with HIV soon after infection; treat people rapidly and effectively to achieve sustained viral suppression; prevent the spread of HIV through the use of PrEP and syringe services programs; and respond quickly to HIV outbreaks by getting prevention and treatment services to people who need them.
We know how to do all four of these things. We just needed a focused strategy to ensure they’re all happening and yielding results.
We knew focus would make a difference because more than half of new HIV diagnoses each year occur in just 48 counties, plus San Juan, Puerto Rico, and Washington, D.C. The plan identifies those jurisdictions, as well as seven states with disproportionate rural HIV burdens, as the place to start.
In mid 2019, we made the first grants to jumpstart activities in several pilot jurisdictions: Baltimore; Baton Rouge, Louisiana; DeKalb County, Georgia; and the Cherokee Nation. Then, in 2020, we awarded the first round of implementation funds to all of the key jurisdictions, and their plans have now been launched. Over the past couple of years, we also secured free access to PrEP medication for up to 200,000 uninsured Americans—a key part of slowing the virus’s transmission.
While the COVID-19 pandemic has been a challenge for our HIV efforts, we’ve responded by expanding the availability of at-home tests as well as mail-order treatment and prevention medications. We’ve also continued our work to deeply engage with people who live with the virus and the communities most at risk for it. That includes combating the stigma around HIV, which can intersect with the historic marginalization of communities who are affected by the virus, including African-Americans, Latinos, gay men, and American Indians and Alaska Natives. Work with these communities will continue to be a priority of our initiative over the next 10 years.
Another important area of public health focus is costly, noncommunicable chronic conditions, and there is no area where we have higher costs and worse results to show for it than kidney care.
The numbers are simply stunning: We spend almost 1 in 5 dollars in traditional Medicare, more than $114 billion a year, on patients who have kidney disease. Fifty percent of those who begin kidney dialysis die within five years.
Yet we do have better options: Home-based or peritoneal dialysis can be much more convenient than center-based dialysis, and transplants can be lifesaving. I know what these interventions can mean for kidney patients, because my late father benefited from both of them—and yet broken government payment models have disincentivized them for too long.
Over the last year and a half, we’ve changed that. We launched a voluntary value-based model to give providers real incentives to slow the progression of kidney disease and the onset of kidney failure. We also launched a mandatory model, enrolling about one-third of Medicare beneficiaries with ESRD, which pays their providers in ways that will encourage home dialysis and transplants.
We finalized a rule to transform how we hold accountable the organizations that procure organs, projected to result in tens of thousands of more transplants in the coming years, and we substantially expanded support for heroic living donors.
We launched an unprecedented national awareness campaign, with the American Society of Nephrology and the National Kidney Foundation, to raise awareness of chronic kidney disease. We increased the Medicare add-on payments for new technologies that can help kidney patients, and we launched a number of prize competitions through KidneyX, which have already brought dozens of innovators into the kidney space, with the eventual goal of developing an artificial kidney.
All told, this is more change in just the last couple of years for kidney care than the space has seen in the last couple of decades, and it will mean lives saved and better kidney health in the years to come.
I want to conclude by talking about how American leadership has been crucial on another infectious disease threat, Ebola, which has destabilized communities across Africa and cost thousands of lives in recent years. The 2014 Ebola outbreak in West Africa, the deadliest Ebola outbreak in history, was a serious wakeup call about our global preparedness. In its aftermath, we recognized that the international structure we had for responding to these outbreaks, including the World Health Organization, needed reforms, and needed to place its primary focus on infectious threats that can cross borders. We also needed further investments in all countries’ ability to respond to these threats on their own, and we needed better biomedical tools to respond to Ebola in particular. Those first two lessons, of course, have also been lessons from COVID-19.
In August 2018, an Ebola outbreak began in the eastern Democratic Republic of the Congo that presented a much different set of challenges from the West Africa outbreak. The outbreak was not far from the borders with Burundi, Rwanda, Uganda, Tanzania, and South Sudan—borders that, in some cases, see hundreds of thousands of travelers every day. Even more worryingly, the outbreak was occurring in one of the world’s most unstable conflict zones. There is almost no place on earth where it could be more challenging to respond to an infectious disease outbreak than the eastern DRC.
The DRC government, the World Health Organization, other international organizations and NGOs, and U.S. partners responded to the outbreak, but it continued to fester. Given its location so close to international borders, and in such an insecure area, there was real potential for the outbreak to spread widely and to take even more lives, in time, than the West Africa outbreak had.
The eastern DRC’s challenges required a more coordinated, cooperative response from all of the actors involved. The WHO’s efforts were not integrated with the DRC government’s, making it impossible to respond effectively in a place with so many security risks. In some cases, lack of coordination between the DRC government, WHO, and U.N. peacekeepers put medical responders in mortal danger. I pressed Director-General Tedros on this issue during meetings in May 2019, securing commitments from him for WHO to improve cooperation with the DRC.
Then, in September 2019, I traveled to the DRC, with CDC Director Bob Redfield and Dr. Tony Fauci, to learn about the outbreak and press for improved coordination. Working with our ambassador to the DRC, Mike Hammer, we met at length with the key DRC leaders, including President Tshisekedi, Minister of Health Longondo, and Professor Muyembe of their biomedical research institute. We also met with the key U.N. officials, including leadership from WHO and U.N. peacekeeping.
After our meetings, the DRC launched an Incident Management Structure, which they developed with CDC assistance, that finally provided better ways to work with WHO and other partners. Traveling there and communicating the U.S. commitment to strengthening the DRC’s health systems beyond Ebola was also crucial to building trust in communities that had been distrustful of the response—a problem called “Ebola Inc.”—and we were told that the commitments we made meaningfully boosted cooperation from the community.
HHS, along with longstanding partners in the DRC, also led the development of the vaccine and therapeutics responsible for ending this outbreak. Working with Merck, we helped develop a safe and highly effective vaccine, which became the first FDA-authorized Ebola vaccine ever, delivered to more than 200,000 people in the region. We also provided crucial assistance to clinical trials in the DRC for two therapeutics, which became the first-ever FDA-approved Ebola therapeutics.
The fact that we were able to conduct clinical trials in a place as challenging as the eastern DRC will, I think, go down as nothing short of a public health miracle. Without U.S. contributions—not just financial investments, but consultation from our security experts and commitment from our leaders and scientists—it would simply have been impossible to run these trials. Our role in the DRC response not only made it possible to end the outbreak there this past year, but also have the tools to respond much more effectively to the next outbreak, too.
The challenges I’ve described to you today are far from the only public health areas where we’ve taken new action and made real progress over the past several years. We’ve delivered new levels of commitment to combating antimicrobial resistance, through supporting new antibiotics and securing commitments from the private sector to improve stewardship. We’ve taken dozens of actions to improve the health of rural America, and laid out frameworks for more action on that issue and on reducing maternal mortality and morbidity. Through our efforts around value-based transformation, we’ve created a new set of incentives and opportunities for payers and providers to tackle social determinants of health.
We successfully quelled outbreaks of measles in 2019 that threatened the United States’ measles elimination status, tackling the serious challenge of vaccine hesitancy. We’ve seen remarkable process on a cure for sickle-cell disease, while also working to improve treatment for it in the United States and around the world. We helped respond to the health effects of the largest refugee crisis in the history of our hemisphere, caused by the failed government of Venezuela.
None of the battles I’ve described are fully won. Many of them have been made more difficult by the COVID-19 pandemic. But, over the past several years, we have made historic progress on many public health challenges that have not received the focus they deserved for too long. In the coming years, I believe federal leadership in these areas will continue to yield benefits—and we have laid a framework for how to use federal leadership to catalyze action on impactable, neglected challenges.
Each of these challenges is important because we all—in the government, in our hospitals, and elsewhere in American healthcare—share the same goal of better health for Americans.
Better health is the ultimate goal of the vision the President set out for healthcare, and it’s what we’ve aimed to deliver every day at HHS.
Thank you for your work with us toward that goal, and Tom, I’m now happy to take some questions.
