As part of the Biden administration’s plans to speed up COVID-19 vaccinations, they are looking to form a new partnership with community health centers, known for providing health care to some of the hardest-to-reach populations. The national strategy from the White House plans to use health centers as key distribution points for the vaccine as well as providers for managing the longer-term effects of COVID in their communities, such as symptoms of long COVID. It also aims to engage health centers in vaccine distribution to improve access to vaccines in communities of color, which, to date, appear to be receiving vaccinations at disproportionately low rates, although race/ethnicity data on vaccinations are still limited. Biden’s national strategy also proposes that health centers should be able to directly access vaccine supply and encourages states and jurisdictions to engage health centers in local vaccine distribution plans.

Community health centers are a national network of safety net primary care providers that served nearly 30 million patients in 2019 who are disproportionately low-income, persons of color, uninsured, or publicly insured – groups that have been especially hard hit by the pandemic. Health centers are already playing a significant role in state and local responses to the pandemic – for example, virtually all (99%) health centers are providing tests, and some are even utilizing mobile clinics to take testing and medical services into hard-to-reach communities, such as agricultural worker housing, meatpacking facilities, American Indian reservations, and homeless encampments. Once vaccinations are further scaled up, health centers will likely deploy mobile clinics, help staff mass vaccination sites, and provide onsite and pharmacy-based vaccinations as described in the Biden plan.

However, there are a number of potential issues that could keep health centers from vaccinating at full capacity.

In a weekly federal survey, health centers are reporting that the greatest challenges in deploying the vaccine are supply and staffing needed to administer the vaccine (Figure 1). While vaccine supply is expected to increase in the coming months as manufacturing increases and new vaccines become available, staffing issues may be difficult to solve. Health centers have historically faced staffing challenges, and although layoffs at health centers have been relatively limited during the pandemic, some health center staff are experiencing burnout and the ramifications of becoming infected with the coronavirus.

Even after vaccine supply challenges are addressed, ongoing financial pressures may hinder health centers’ vaccination efforts. Health centers are still recovering from steep declines in patient revenues during the pandemic while operating costs have increased due to purchasing testing supplies, personal protective equipment, and operating telehealth programs. It is also possible that delayed reimbursement for administering the COVID-19 vaccine could slow health centers’ vaccination capacity. For example, Medicare plans to reimburse health centers similarly to flu vaccinations (based on reasonable cost) and pay for COVID-19 vaccinations after a health center files an annual cost report at the end of their accounting year – which could take until 2022 in some cases. Although only 10% of patients were Medicare beneficiaries in 2019, the number of Medicare patients varies widely across communities and is generally higher in rural health centers (14% of patients compared to 8% in urban health centers in 2019). Overall, assisting with state vaccination efforts that currently target adults over age 65 means that health centers could serve more Medicare beneficiaries than normal, particularly if they are required by state and local partnerships to reach beyond their patient populations and vaccinate older residents in their communities. Biden’s plan calls for increased federal funding for health centers to support this expanded role, although it is unclear if that funding will pass in a narrowly divided Congress and, if so, how quickly health centers can access funds.

There are considerable challenges for health centers to carry out vaccinations at their fullest capacity. Biden’s proposal to give health centers direct access to vaccine supply and receive new federal funding could, if implemented, help address these significant barriers and promote more equitable access to vaccinations in the hardest-to-reach communities.

Key Points

• The Biden administration brings a starkly different vision for U.S. international engagement, including global health, compared to the “America First” foreign policy doctrine of its predecessor.
• At the top of the agenda is addressing COVID-19, re-engaging with the global community more broadly, and pursuing a stepped-up emphasis on global health security.
• The administration has already taken several actions including: releasing a National Strategy on COVID-19 and Pandemic Preparedness; issuing a National Security Memorandum and Executive Order on U.S. global leadership on COVID-19 and global health security; restoring funding for and membership in WHO; joining COVAX; and rescinding the Mexico City Policy. It has also proposed several other actions, including some that require Congressional support.
• Yet the extent to which the administration will seek to champion core global health programs beyond COVID-19 and preparedness remains unknown, as does the level of support from Congress, given the pressures of COVID-19 and economic strain at home. The stakes are even higher now, given the emergence of new COVID-19 variants and the slow roll-out of vaccines.
• Among the many key policy issues and outstanding questions ahead are the following:
  • How the U.S. will be received on the global stage;
  • How best to balance COVID-19 needs at home and abroad;
  • How robust will U.S. support for global COVID-19 vaccine access be;
  • Whether global health security will become a dominant frame for U.S. global health engagement;
  • How much room there will be to address the unfinished business of global health, including the effects of COVID-19 on core programs;
  • The balance between bilateral and multilateral U.S. health investments;
  • How the U.S. will approach WHO reform;
  • How far will the administration go in its support for global family planning and reproductive health and how will it withstand partisan push back in Congress; and
  • Whether the bipartisan consensus regarding global health funding can be maintained.

Introduction

On January 20, President Biden took the oath of office, in the midst of a pandemic that is raging out of control across the U.S. and throughout the world. Biden brings a starkly different vision for U.S. international engagement, including global health, compared to the “America First” foreign policy doctrine of his predecessor. At the top of the Biden administration’s agenda is addressing the COVID-19 pandemic at home and abroad, re-engaging with the global community more broadly, and pursuing a stepped-up emphasis on global health security. The administration has also signaled more general support for U.S. global health programs. In the first days of office, the Biden administration has already put into place policies, strategies, and staff with expertise in these areas and has indicated that more actions are to come. Some of the proposed actions can be taken via executive authority while others will require the cooperation and approval of Congress. While Congress has provided emergency support for global COVID-19 relief, including for health, and demonstrated some appetite for bolstering U.S. global health security, it is unclear how the new administration’s proposals will fare given broader partisan gridlock and the strains on the U.S. economy. In addition, the extent to which the Biden administration will seek to champion core U.S. global health programs, or change the broader U.S. global health architecture, beyond an expanded focus on global health security, remains unclear. It’s also possible that even maintaining support for the current U.S. global health portfolio could be difficult, given the extreme domestic pressures related to COVID-19. With this as the backdrop, we provide an overview of the Biden administration’s COVID-19 and global health actions to date, as well as likely ones on the horizon, and identify key policy issues and outstanding questions ahead. The stakes are particularly high, given the emergence of variants of SARS-CoV-2, the virus that causes COVID-19, that appear to spread more easily and the slow roll-out of vaccines.

The Biden Administration’s Global Health Agenda

Both on the campaign trail and during his first days of office, Biden has made it clear that he seeks to re-embrace international engagement, including on health, with COVID-19 as a top focus. Biden has made re-embracing the global community a key policy goal for his administration. This represents a major departure from the Trump administration’s posture, which saw the U.S. sit out the international response to COVID-19, withdraw from the Paris Climate Accord, and withhold funding for the World Health Organization (WHO), while initiating the process of withdrawing from WHO membership. By contrast, the Biden administration has critiqued this approach, stating that “America’s withdrawal from the international arena has impeded progress on a global COVID-19 response and left the United States more vulnerable to future pandemics. U.S. international engagement to combat COVID-19, promote health, and advance global health security will save lives, promote economic recovery, and build better resilience against future biological catastrophes.” The new administration has already taken several actions on this front, including issuing a National Strategy for the COVID-19 Response and Pandemic Preparedness; a National Security Memorandum on “United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness”; and an Executive Order on “Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security”. It has also proposed several other actions, some of which are dependent on Congressional support (see Table). Given the widespread nature and ever-evolving threat from COVID-19, including the rise of variants that may spread more easily, it appears likely that addressing the pandemic and its many effects will occupy much of the global health policy attention within the administration for the foreseeable future.

Among the new administration’s first actions was announcing that the U.S. would remain a WHO member and continue funding the organization. Just as the COVID-19 pandemic was devasting much of the world, including the U.S., Trump announced last April that he was putting a hold on U.S. funding to WHO, pending investigation of its COVID-19 response, and formally notified the United Nations in July of last year that the U.S. would withdraw from WHO membership (effective one-year later per U.S. law). Historically, the U.S. had been the largest funder of the WHO, providing $400 million to $500 million in funding to the organization each year, and had played a leadership role in the organization. Withholding funds and initiating a process to withdraw from the world’s international health organization had both practical and symbolic effects. Biden campaigned on retracting the Trump administration’s decision and restoring funding, actions taken on day one of the Biden administration. This included formal communication with the United Nations and WHO about the U.S. intent to remain a member of WHO and continue funding; a call by the Vice President to the WHO Director General; and, as specified in the National Security Memorandum on COVID-19 and global health security, intent to work with the WHO to strengthen and reform the organization to enhance its ability to respond to COVID-19, global health, and future pandemics, a goal shared by other Member States.

The administration also announced that the U.S. would support the Access to COVID-19 Tools (ACT) Accelerator and join the COVAX Facility and commit to multilateralism and the international COVID-19 response. These actions were announced on January 21, 2021, and directed by the President in the National Security Memorandum, as part of the new administration’s package of COVID-19 policies. By contrast, under the Trump administration, the U.S. had been one of the only countries not to formally participate in the ACT Accelerator or COVAX, or the broader international response. While Congress had provided emergency funding to Gavi in support of COVID-19 vaccine access in low- and middle- income countries, the absence of U.S. leadership in these initiatives under the Trump administration marked a break from how the U.S. responded to most other recent global health emergencies. The Biden administration also said it would develop a framework for donating surplus vaccines, once there is sufficient supply in the U.S., to countries in need, including through COVAX. The Trump administration had included similar language in a December 2020 Executive Order, which was largely focused on ensuring American access to vaccines. In addition, the Biden administration has said it would seek funding from Congress to strengthen and sustain other multilateral initiatives involved in addressing COVID-19, including the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi; and the Global Fund to Fight AIDS, TB and Malaria (Global Fund). Notably, the plan for a stepped-up U.S. international COVID-19 response explicitly includes an emphasis on “reducing racial and ethnic disparities and seeing to the needs of marginalized and indigenous communities, women and girls, and other groups.” Finally, the new administration announced it was re-entering the Paris Climate Agreement, as part of its major commitment to address climate change which it sees as a driver of health threats.

In addition, marking a significant break from the prior four years, the Biden administration has rescinded the Mexico City Policy and seek to restore funding for UNFPA, and has said it would recommit to addressing sexual and reproductive health and rights.  First announced in 1984 by the Reagan administration, the Mexico City Policy (called “Protecting Life in Global Health Assistance” by the Trump administration) has been rescinded and reinstated by subsequent administrations along party lines, having been in effect for 21 of the past 36 years. The policy requires foreign non-governmental organizations (NGOs) to certify that they will not “perform or actively promote abortion as a method of family planning” using funds from any source (including non-U.S. funds) as a condition of receiving U.S. government global family planning assistance and, under the Trump administration, most other U.S. global health assistance. This marked an unprecedented expansion of the policy. On January 28, President Biden issued a Presidential Memorandum announcing that he was rescinding the policy, effective immediately, and it would no longer be applied to existing awards or any future ones. In addition, the Memorandum also announced that the administration would take the necessary steps to restore funding to UNFPA. The Trump administration had withheld Congressionally-appropriated funding from UNFPA for four years, by invoking the Kemp-Kasten amendment. In rescinding the Mexico City Policy and moving to restore UNFPA funding, the Biden administration stated that it was U.S. policy “to support women’s and girls’ sexual and reproductive health and rights in the United States, as well as globally,” and also announced that it would withdraw from the Geneva Consensus Declaration, an October 2020 statement crafted and signed by the U.S. and 32 other countries, meant to enshrine the former administration’s values and principles related to women’s health, abortion in particular, and family, in the international sphere. Collectively, these actions signify a significant turn from the Trump administration’s approach which had sought to impose restrictions, limit funding, and alter international and bilateral agreements to reflect these views.

As part of his COVID-19 “American Rescue” plan, Biden has said he would seek $11 billion for global COVID-19 efforts. The American Rescue Plan includes $11 billion to support “the international health and humanitarian response; mitigate the pandemic’s devastating impact on global health, food security, and gender-based violence; support international efforts to develop and distribute medical countermeasures for COVID-19; and build the capacity required to fight COVID-19, its variants, and emerging biological threats.” To date, through prior COVID-19 relief bills, Congress has provided approximately $7.5 billion to overall global COVID-19 efforts. Of this, $5.2 billion has been allocated for global health, primarily for vaccine support ($4 billion); to date, no funding has been provided to address the primary or secondary impacts of the pandemic on existing global health programs. At this time. only limited detail on the administration’s $11 billion request is available and it is unclear if it will garner enough support from members of Congress.

The administration has also begun to institute a new structure for the White House and National Security Council (NSC) Staff, including re-establishing the NSC Directorate on Global Health Security and Biodefense. By all indications, Biden and his transition team see global health, especially as it relates to the pandemic, as an integral part of their foreign policy agenda. He re-established, via Executive Order, the NSC Directorate on Global Health Security and Biodefense (originally created during the Obama administration and charged with overseeing pandemic response but shuttered by the Trump administration in 2018), and named a COVID-19 Coordinator to oversee a whole of government approach to pandemic response. Further, Biden has already appointed or nominated advisors and key staff with experience in global health and infectious disease threats and/or a strong belief in the importance of international engagement, including his Chief of Staff (Ron Klain); Chief Medical Advisor (Tony Fauci); Secretary of State (Anthony Blinken); National Security Advisor (Jake Sullivan); NSC Senior Director for Global Health Security and Biodefense (Beth Cameron); CDC Director (Rochelle Walensky); USAID Administrator (Samantha Power); and the President’s Malaria Coordinator (Raj Panjabi). Biden will now look to nominate or appoint persons to fill other critical U.S. global health positions including the U.S. Global AIDS Coordinator, the Department of Health and Human Services’ Director of the Office of Global Affairs, and USAID’s Assistant Administrator for Global Health.

Indeed, scaling up the U.S. global health security effort and apparatus is shaping up to be a signature global health focus of the Biden agenda, one which already has some bipartisan support in Congress. In the administration’s National COVID-19 strategy and elsewhere, Biden and key staff have discussed the need for significant changes in the level and scope of U.S. support for global health security programs to reduce the chances of repeating our current pandemic crisis in the future. This includes the Executive Order on “Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security” and National Security Memorandum on “United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness. Global health security programs, which help countries build their capacities to prevent, detect, and respond to emerging disease outbreaks, have long been supported by the U.S. government and were maintained during the Trump administration, but have suffered from limited and sporadic funding and bouts of attention only during times of crisis. COVID-19 has precipitated urgent attention to this area that is likely to result in greatly expanded U.S. ambitions, with key Biden staff outlining such a vision for months and referencing public health as a permanent U.S. national security priority that will be an initial and major focus for the administration. There has also been some Congressional support for doing more, including a bipartisan proposal released last year from Senators Risch, Murphy, and Cardin to enhance strategic planning, strengthen interagency coordination, and grow U.S. diplomatic presence in global health security efforts.

The administration has expressed support for other core U.S. global health efforts, including PEPFAR, but it is not yet known how prominently they will figure into its agenda or how they will be connected to the broader global health security push; at the same time, there remains much unfinished business in improving the health of those in low-and middle-income countries. The U.S. is the largest funder of global health efforts in the world, operating programs in more than 70 countries; 80% of its funding is provided through bilateral programs and the remainder through multilateral efforts. These programs (including PEPFAR and the Global Fund) have not only been credited with saving millions of lives, they have been shown to contribute to global health security efforts, including during the 2014 Ebola outbreak in West Africa. Yet U.S. funding for global health has largely been stagnant for years, despite the unfinished business that remains (although Trump sought significant and unprecedented cuts each year in office, these were rejected time and again by Congress). Within the U.S. global health portfolio, PEPFAR represents the largest component, and one which has been credited with saving millions of lives. During his time as a Senator and Vice President, Biden supported U.S. global health programs broadly, including as a sponsor of PEPFAR’s first re-authorization and as recently as last month saying he would work to expand support for PEPFAR. As mentioned above, the administration has said it would seek more funding for the Global Fund and Gavi, given their direct role in responding to the pandemic, and seek to mitigate the secondary impacts of COVID-19 and strengthen bilateral U.S. programs in HIV, TB, malaria, and other health systems strengthening efforts. Biden’s strategy notes that in addition to the immediate response needs the pandemic is a moment the U.S. has an opportunity to “reset and drive action to advance the Sustainable Development Goals, make gains toward achieving Universal Health Coverage.”  But it is not yet clear if and to what extent the administration will seek to increase funding for, or make fundamental changes to, the core U.S. bilateral global health programs, or seek to shift the balance of its investments between bilateral and multilateral support to perhaps move toward these bolder, broader goals. Given that PEPFAR is largest component of the U.S. global health response and is primed for an update to its goals and direction, Biden’s choice to fill the U.S. Global AIDS Coordinator position and his first global health budget request will be especially significant and offer an indication of his vision for addressing HIV globally while also signaling his approach to broader U.S. global health engagement.

Key Questions Ahead

The global health agenda and overall approach to international engagement espoused by the Biden administration is a clear break from the four year “America First” approach under Trump. It also marks a potential departure from prior administrations, given its heavy focus on global health security in light of the devastation caused by the COVID-19 pandemic, a focus which could have lasting effects on the U.S. approach to global health. Whether or not Biden will be able to achieve the broad goals he has outlined is uncertain, and there are likely to be checks on his ambitions. It is also unclear how existing global health programs supported by the U.S. will figure into these plans. Among key questions to consider are the following:

1. How will the U.S. be received on the global stage? As the U.S. seeks to re-engage globally, how will the international community respond, especially given the changing and in some cases more prominent roles played by others, including China and the European Union? Is there a unique window of opportunity for the Biden administration to use its diplomatic power to rally countries and institutions in support of the global COVID-19 response, particularly around vaccines? Will vaccine aid become a new version of soft power? Or has the dynamic of U.S. leadership permanently shifted, given the retreat during the Trump years, and the ongoing challenges of battling COVID-19 at home? Will the circumstances of a post-COVID world require a new way for the U.S. to engage internationally on global health issues, or will relations revert back to the pre-COVID state of affairs?
2. How best to balance COVID-19 needs at home and abroad? Despite the fact that the COVID-19 pandemic has thrown into stark relief the interconnectedness of the world, the U.S. remains in the throes of a domestic health and economic crisis. There may emerge competition – for both resources and vaccine supply – between domestic and global needs. How much recognition will there be that U.S. safety is inextricably linked to success in addressing the global pandemic? Can a broader, global response be pursued by the Biden administration in this context? Will it face push back by Congress or a public that still awaits a return to some sense of normalcy?
3. How robustly will the administration support global COVID-19 vaccine access, including COVAX? Given that vaccinating as many people as possible around the world is the surest way to bring the pandemic under control, ensuring access to vaccines will be pivotal for U.S. progress on many domestic and international policy priorities. The U.S. has now stated an intention to join COVAX, but under what terms? Will it join as a self-financing country and purchase vaccines itself through this mechanism, and/or support the COVAX Advance Market Commitment in support of low- and middle- income country access? Exactly when and how will the U.S. government approach donating excess doses, through COVAX or otherwise? Given that successful vaccination programs rely not just on doses and supplies but also workers, PPE, and other capabilities, will support for delivery and health systems more broadly also be incorporated into the U.S. response?
4. Will global health security become a dominant frame for U.S. global health engagement going forward? U.S. global health programs address a broad array of health challenges – from HIV, to maternal and child mortality, to neglected tropical diseases and many more. Will contributions to preparedness and security become the overarching paradigm for thinking and talking about U.S. global health programs? If so, will this help to strengthen existing global health programs or create unintended consequences that could hinder their efforts? How might the U.S. define the focus and the scope of its health security approach? And, can the administration work with Congress to bring an end to the boom and bust cycles for global health security with longer-term commitments and predictable funding? Or, will this be once again forgotten when the world is able to move past COVID-19?
5. What about the unfinished business of global health? Is there room – beyond COVID-19 and global health security – to expand U.S. global health efforts and how aggressively will the new administration seek to do so? Given the enormity of COVID-19 it is understandable the Biden administration’s immediate focus is on the pandemic and global health security, but what will happen to the broader U.S. global health agenda? Will there be room to set ambitious new goals for core U.S. global health programs? Will the new administration double down in these core areas as part of a push to shore up global health security? With COVID-19 exposing the weaknesses of health systems and preparedness around the world, will there be a reexamination of the balance of U.S. global health support between vertical, disease-focused programs and broader, health systems strengthening? If so, what risks could this pose and how can the contribution of these programs to health systems strengthening and global health security be better measures, captured, and built upon? And, how can the new administration address the impacts of COVID-19 on existing U.S. supported health programs, as well as its secondary effects on the health and economies of low-and middle-income countries? To date, for example, none of the core U.S. global health programs (beyond global health security) have received any supplemental support to address the impacts of and setbacks due to COVID-19.
6. What is the right balance between bilateral and multilateral U.S. health investments, both for COVID-19 and global health more broadly? How should the administration’s $11 billion global COVID-19 relief request be channeled between its own programs and international response mechanisms? What about core U.S. global health investments, which have been impacted by COVID-19 but not yet received any emergency support? Are there ways to better coordinate between bilateral and multilateral health efforts, particularly PEPFAR and the Global Fund, to create greater impact? As the Global Fund and GAVI increasingly phase-down and end their support for middle income countries, what is the role of the U.S. government in helping to meet the needs of those living in these countries who continue to face access barriers and suffer adverse health outcomes? How will COVID-19 change these considerations?
7. What will be the administration’s approach to reforming WHO and other international institutions? 2021 will mark the beginning of a process to reckon with the weaknesses in international and domestic systems that were laid bare by the COVID-19 pandemic. How much will the administration push, for example, for significant change to multilateral institutions such as WHO or support attempts to revamp existing international health agreements such as the International Health Regulations? How will the tension between the U.S. and China, that played out so clearly in the pandemic, affect diplomacy around WHO reform?
8. How far will the administration go in its support for global family planning and reproductive health and how will it withstand partisan push back in Congress? How forceful will the new administration be on this front? Given that family planning and reproductive health is still likely be subject to fierce partisan battles in Congress, how will the new administration navigate and address these tensions? Can the U.S. move past the constant log-jam and ping pong nature of the Mexico City Policy?
9. Finally, how will the administration grapple with the reality of having only the slimmest of Democratic majorities in the Senate in seeking to achieve its COVID-19 and global health agenda? Undergirding much of a Biden agenda on COVID-19 and global health will be the need to maintain bipartisan, Congressional support. Will the bipartisan consensus that has characterized much of U.S. global health prevail, or will there be a turn toward austerity and pressure to cut foreign aid? Will exceptions be made for the global COVID-19 response? How can the Biden administration navigate support for global health across the aisle as it seeks an expansion domestic agenda? (as we’ve seen in the past during periods of economic distress and rising deficits)?

With the COVID-19 vaccination rollout still in its early stages, a KFF analysis finds that most older adults have not yet been vaccinated against the potentially deadly virus, as vaccine supplies remain limited and most states have only recently begun to make people 65 and older eligible.

Since January 12, the federal government has recommended that states expand vaccine eligibility to anyone 65 and older, beyond the initial higher-priority groups of health care workers and long-term care residents. Twenty-nine states plus DC have done so, according to KFF tracking.

Among the 15 states (including DC) that have expanded to vaccinate people 65 and older and are tracking vaccinations among this group, the share of people 65 and older who have gotten at least one dose ranges from 34 percent in West Virginia to 10 percent in Pennsylvania (though its data does not yet include Philadelphia County).

Among 13 states that report COVID-19 vaccinations for adults 60 and older, only 4 of which have expanded vaccinations to people 65 and older, the share of people 60 and older who have received at least one dose ranges from 37 percent in Alaska to 9 percent in Rhode Island.

The analysis is based on data retrieved as of February 4, 2021. As states grapple with limited vaccine supply, older adults have reportedly encountered a number of problems such as not knowing how to schedule appointments or where to get vaccinated, waiting in long lines, or arriving for an appointment to find vaccines no longer available.

Older adults are more vulnerable to serious illness from the novel coronavirus, and adults 65 and older have accounted for 75 percent or more of all COVID-19 deaths in every month since the escalation of the pandemic last spring.

The lack of consistent vaccination data across states makes it difficult to provide a clear picture of the rollout of vaccines to older adults overall and to certain high-risk populations, such as older adults in communities of color.

For more data and analyses, including our KFF’s COVID Vaccine Monitor and our state tracker of COVID-19 data and policy actions, visit kff.org.

As the country broadens COVID-19 vaccine distribution efforts, the latest research from the KFF COVID-19 Vaccine Monitor finds that side effects, including allergic reactions and long-term consequences, are the public’s top concern about getting vaccinated when asked to describe what worries them in their own words.

The latest report from the KFF COVID-19 Vaccine Monitor summarizes the public’s response to a series of open-ended questions aimed at better understanding people’s concerns around receiving a COVID-19 vaccine and the views of the messages and messengers that could affect their willingness to get one, and includes direct quotes from the more than 1,000 people interviewed.

The public’s responses suggest that hearing more information about the safety of the COVID-19 vaccines, and that they produce no, few or mild side effects, is likely to lead more people to be willing to get vaccinated.

When asked to name a person who could make them more likely to get vaccinated, the most common response was friends and family, highlighting how one’s social network may affect people’s decisions.

Available through the Monitor’s online dashboard, the report includes illustrative quotes from a diverse group of people across the country with varying levels of enthusiasm for getting vaccinated.

The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public’s attitudes and experiences with COVID-19 vaccinations. Using a combination of surveys and qualitative research, this project tracks the dynamic nature of public opinion as vaccine development and distribution unfold, including vaccine confidence and hesitancy, trusted messengers and messages, as well as the public’s experiences with vaccination.

Here’s our recap of the past week in the coronavirus pandemic from our tracking, policy analysis, polling, and journalism.

The COVID-19 Vaccine Monitor reports on how and where the public is getting its relevant information about the vaccine. There are differences in peoples’ enthusiasm for getting a vaccine based on their sources of vaccine information, with those most hesitant about vaccination being more likely to turn to social media for information. Available through the Vaccine Monitor’s new online dashboard, the analysis examines how vaccine information from cable networks including Fox, MSNBC and CNN, and social media platforms like Facebook and Twitter, affect hesitancy by age, race and ethnicity, and location (urban vs. suburban and rural communities).

KFF analysis of February 1 state-reported data on COVID-19 vaccinations, cases, and deaths by race/ethnicity indicate Black and Hispanic people continue to receive smaller shares of vaccinations compared to their shares of cases and deaths and compared to their proportions of the total population.

With the two COVID-19 vaccines authorized for use in the United States both being two-dose series, a new brief examines key issues related to multi-dose vaccination series generally as well as issues specific to COVID-19.

KHN’s coverage of the nation’s vaccination effort continues with a story on the divide between older Americans who have assistance from family and friends and/or have access to digital tools for scheduling vaccine appointments, and those with fewer social and technological resources. KHN is reporting from across the country with stories this week from Austin, Tampa, Philadelphia, rural California, Colorado, Michigan, and Montana.

Here are the latest coronavirus stats from KFF’s tracking resources:

Global Cases and Deaths: Total cases worldwide stand at nearly 105 million this week – with an increase of 3.4 million new confirmed cases in the past seven days. There were approximately 91,500 new confirmed deaths worldwide, bringing the total for confirmed deaths to nearly 2.3 million.

U.S. Cases and Deaths: Total confirmed cases in the U.S. approached 26.7 million this week. There was an increase of about 913,000 confirmed cases between Jan. 28 and Feb. 4. Approximately 22,700 confirmed deaths in the past week brought the total in the United States to 455,900.

State Social Distancing Actions (includes Washington D.C.) that went into effect this week:

Extensions: CO, GA, ID, NM, WI

Rollbacks: IL, ID, NE, NJ, RI, WA

The latest KFF COVID-19 resources:

• Latest Data on COVID-19 Vaccinations Race/Ethnicity (News Release, Issue Brief)
• KFF COVID-19 Vaccine Monitor: January 2021 – Recent Sources of Information (News Release, Report)
• What Does a Multi-Dose Series Mean for the COVID-19 Vaccination Effort? (Issue Brief)
• Updated: COVID-19 Coronavirus Tracker – Updated as of February 5 (Interactive)
• Updated: State Data and Policy Actions to Address Coronavirus (Interactive)
• Updated: Medicaid Emergency Authority Tracker: Approved State Actions to Address COVID-19 (Issue Brief)

The latest KHN COVID-19 stories:

• Older Adults Without Family or Friends Lag in Race to Get Vaccines (KHN, CNN)
• Head-Scratching Over Newsom’s Choice of Blue Shield to Lead Vaccination Push (KHN, Chico ER)
• 100 Million Covid Shots in 100 Days Doesn’t Get Us Back to Normal (KHN, PolitiFact)
• With Demand Far Exceeding Supply, It Matters That People Are Jumping the Vaccine Line (KHN, New York Times)
• In Austin, Some Try to Address Vaccine Inequity, but a Broad Plan Is Elusive (KHN)
• Dispelling Vaccine Misinformation and Myths in California’s Breadbasket (KHN, Spanish Version, Radio Biligue)
• Long-Haul Covid Cases Cast New Light on Chronic Fatigue Sufferers (KHN, San Diego Tribune)
• When Your Chance for a Covid Shot Comes, Don’t Worry About the Numbers (KHN)
• A Recipe for Trouble? Reversal of California Outdoor Dining Ban Has Heads Spinning (KHN)
• Lost on the Frontline: New this week (KHN, The Guardian)
• In Philadelphia, a Scandal Erupts Over Vaccination Startup Led by 22-Year-Old (KHN, NPR)
• How a Bounty of Vaccines Flooded a Small Hospital and Its Nearby College (KHN, Daily Beast)
• Tampa’s Mayor vs. a Covid-Era Super Bowl (KHN, USA Today)
• The State of Vaccine Supply: ‘Opaque.’ Unpredictable. ‘Hard to Pin Down.’ (KHN, Politifact)
• ‘Cruel’ Digital Race For Vaccines Leaves Many Seniors Behind (KHN, NPR)
• Hard Bargain: Biden and Congress Agree on Basic Relief, but Chasms Remain on Covid Plan (KHN)
• California’s Rural Counties Endure a Deadly Covid Winter (KHN)
• California’s Smallest County Makes Big Vaccination Gains (KHN, Los Angeles Times)
• Comparing Death Tolls From Covid to Past Wars Is Fraught (KHN, NPR)
• As Demand for Mental Health Care Spikes, Budget Ax Set to Strike (KHN)
• KHN’s ‘What the Health?’: Covid and Kids (KHN)
• Covid-Certified Businesses Try to Woo Leery Patrons (KHN, Fortune)
• Journalists Explore Inefficiency and Inequities of Vaccine Rollout (KHN)

Introduction

There are currently two COVID-19 vaccines authorized for use in the United States, both of which require a two-dose series (see Table 1). As efforts to promote equitable and rapid distribution and uptake of the vaccine in the U.S. intensify, one key challenge is ensuring people get both the first and second dose. In fact, in the COVID-19 vaccine playbook provided to states by the Centers for Disease Control and Prevention (CDC), the issue of second dose reminders was identified as a key area to be addressed.  In the context of routine immunization, multi-dose vaccine series are relatively common, but have also presented challenges for ensuring vaccine series completion where in many cases, there is a drop-off in uptake between the first and subsequent doses. Additionally, as COVID-19 vaccines have rolled out, there have been discussions about the appropriateness of flexibility in dosing schedules to accelerate first doses for more people; there is also a likelihood that a third vaccine from Johnson & Johnson, that uses only one dose, could be authorized soon. This issue brief examines key issues related to multi-dose vaccination series generally as well as issues specific to COVID-19.

How common are multi-dose vaccines?

Multi-dose vaccinations are very common. In fact, nearly all vaccines recommended for children and adolescents and many adult vaccinations, require a series of more than one dose (Table 2).

Why do some vaccinations require multi-dose series?

In some cases, multiple doses are necessary to achieve the highest possible levels of immunity, whereas in others, a second dose is administered because not all individuals respond sufficiently to a single dose. In addition, following the primary vaccination or vaccination series, certain vaccines require a booster for all people or certain groups of people after a period of time to improve waning immunity.

The number of doses in a vaccination series can be the same for everyone or differ based on risk group, age, and other factors. For instance, the human papillomavirus (HPV) vaccine is given in either two or three dose series, depending on age of initial vaccination.

The COVID-19 vaccines that have been authorized in the U.S. require a two-dose series to achieve highest levels of immunity. There is no recommendation for a booster shot at this time but Moderna, one of the manufacturers of an authorized vaccine states that while its vaccine is expected to be protective against COVID-19 variants, the company is exploring whether a booster can offer additional protection and Pfizer, the other manufacturer, has indicated that boosters are likely needed.

Is the annual flu shot an example of a multi-dose vaccination?

A vaccine with a multi-dose series differs from the annual flu shot. While flu shots are needed annually to maintain optimal levels of protection, the main reason subsequent shots are given is because the influenza vaccine is updated each year to account for virus mutations. The effectiveness of the influenza vaccine varies from year-to-year, often because there are differences between the strains targeted by the vaccine and the strains circulating and infecting people each year.

It is not yet known if COVID-19 vaccines will need to be updated annually (or at another interval), as we do with the flu shot, or if there will be a need for a booster shot later on. Given the rise of several viral variants in numerous countries around the world including the U.S., work has already begun on producing and setting up the regulatory approval pathways for a booster shot for some of the COVID-19 vaccines already authorized. For the time being, however, no additional doses beyond the first two are recommended at this time.

What do we know about uptake of multi-dose vaccinations?

In general, there is a decline in uptake between the first and subsequent doses of vaccines, especially for those provided to adolescents and adults. For example, the CDC recommends the multi-dose HPV vaccine at age 11 or 12, with two doses given six months apart. It is recommended that older teens and young adults, who initiate the series later, receive three doses. Multiple studies have shown that uptake of the HPV vaccines declines for 2^nd and 3^rd doses. For instance, a CDC analysis found that among adolescents 13-17 years old, 72% received ≥ 1 dose in 2019 but the series completion rate fell to 54%. In recognizing these challenges in part, researchers are studying the potential of a one-dose HPV vaccine, particularly for low and middle income countries, which have fewer financial resources for implementing vaccination programs and where cervical cancer prevalence is higher than the United States.

Qualitative research on HPV vaccination in the U.S. shows most parents who did not obtain their teen’s second or third dose intended to do so. Most said they did not because they were not reminded to come back for second doses by their providers, even though they expected a reminder. Parents also said that sometimes they forgot about the subsequent shot(s) or did not have time to return. This contributed to the drop off between first and subsequent vaccinations within a series.

There is also a drop off in acquisition of the booster for the MenACWY vaccine to prevent Meningitis, which has a long interval between doses. The first dose is recommended at age 11 or 12, while the booster is recommended at age 16. CDC analysis from 2019 shows that nearly nine in ten (89%) adolescents 13-17 had the initial dose of the MenACWY vaccine; however, among adolescents aged 17 years, just over half (54%) had received the booster dose.

A third example is Shingrix, the vaccine recommended for adults over 50 to prevent shingles. Shingrix is provided in two doses over the course of six months and offers some insight on multidose vaccines in adults. Recent KFF analysis found that one-quarter of Medicare beneficiaries (26%) who received an initial dose of Shingrix between January and June 2018 did not receive the second dose within the recommended timeframe.

Does uptake and completion of multi-dose vaccination series differ by race and ethnicity?

In several cases, racial and ethnic disparities are observed in multi-dose vaccine series completion. Series completion rates are lower among Hispanic adolescents compared to others for some vaccines, including MMR, Hepatitis B, and Varicella, though in other cases adolescents of color have completion rates comparable to White adolescents.

Looking to an adult vaccination, disparities are stark in Shingrix vaccine completion rates among Medicare beneficiaries. White beneficiaries saw higher completion rates (76%) than Hispanic (58%), American Indian/Alaska Native (61%), Black (61%), and Asian/Pacific Islander beneficiaries (69%).

Paying careful attention to these disparities in COVID-19 vaccine uptake and series completion will be critical, particularly as the pandemic has also taken a disproportionate toll on communities of color, including with higher death and case rates for certain groups. In addition, some people from immigrant communities, many of whom have been targeted in recent years by anti-immigration policies and discrimination, may be fearful about the vaccine monitoring process. This is especially relevant as vaccine providers will collect personal information to assist in efforts to get people to return for the second dose.

Indeed, initial data from state-reported vaccinations by race/ethnicity suggest emerging racial disparities in vaccination rates, with Black and Hispanic people receiving smaller shares of vaccinations than White people, despite accounting for disproportionate shares of cases and deaths. Notably, in their recently released COVID-19 Response Plan, the Biden Administration included protecting “those most at risk and advance equity, including across racial, ethnic and rural/urban lines” as one of the plan’s 7 goals.

What are possible unique challenges associated with a multi-dose COVID-19 vaccine?

The U.S. effort to distribute and administer the multi-dose COVID-19 vaccines has been met with unique challenges. Never before has such a large-scale vaccine rollout taken place with such urgency and aimed at so many people. Rollout has been hampered by a range of barriers, while some of these have to do with health care delivery in the U.S. (e.g. a fragmented health system, underfunded public health infrastructure, etc.) others that relate to the multidose nature of the currently authorized vaccine series and challenges are already surfacing.

Manufacturers and the FDA recommend the second dose is given either three or four weeks after the first, depending on which vaccine was administered.  (See Table 1). While a single dose offers some protection (see Table 1) it is below levels needed to achieve herd immunity and it is not known exactly how long protection lasts. Therefore, getting individuals to return for a second dose as soon as they are eligible will offer the best route to achieve the highest level of protection as quickly as possible.  However, as the initial distribution of COVID-19 vaccines has been going more slowly than originally intended, there have been discussions related to dosing and spacing from public health officials, researchers, clinicians, and advocates.

Challenges related to the COVID-19 vaccine include:

• Confusion around multiple vaccination options. Currently, the two authorized vaccines are made by different manufacturers and have different recommended timetables for second vaccination (See Table 1). The recommendation in the U.S. is to get a first and second dose vaccination from the same manufacturer, though CDC guidance now permits some flexibility in “exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available.” Differences in name and interval in the authorized vaccines complicate public health messaging and necessitates that some combination of individuals, providers, and localities/states keep track of who has had which vaccination and when. In addition, there could be a third COVID-19 vaccine from Johnson & Johnson authorized in the coming weeks requiring only a single dose, which would simplify the dosing schedule for recipients of that vaccine but would add further complexity to overall messaging about who should get which vaccine, and when.
• Key stakeholders have been grappling with how to improve timely access to the two doses. Questions have been raised about how to best accelerate rollout in the context of significant supply limitations and rising infections. Some have urged the use of all available vaccine for first doses while others would set aside a reserve to ensure second doses are completed at the recommended interval for all individuals. The Trump Administration initially held back significant supply to ensure second doses. However, due to the slow rollout and increasing spread in the US, many felt distribution needed to be sped up. The Biden Administration’s COVID-19 Plan pledges to “end the policy of holding back significant levels of doses, instead holding back a small reserve and monitoring supply to ensure that everyone receives the full regimen as recommended by the FDA.”.There have been separate questions about whether the interval between first and second doses can be longer than indicated in the EUA to speed up distribution of first doses to more people, as is the case in the UK and other countries.  U.S. officials have rejected this approach to date..In response to some of these discussions, FDA issued a statement emphasizing that the vaccines should be administered according to how they have been authorized and that changes to dosage or dosing schedule “not supported by adequate scientific evidence may ultimately be counterproductive to public health.”  Tony Fauci, Chief Medical Advisor to President Biden, has reiterated this sentiment in White House COVID-19 Response Team briefings..At the same time, recognizing the real world context in which the vaccine rollout is occurring, CDC guidance notes that while second doses “should be administered as close to the recommended interval as possible….if it is not feasible to adhere to the recommended interval, the second dose…may be scheduled for administration up to 6 weeks (42 days) after the first dose.”

• Unlike many vaccines, which are scheduled in conjunction with wellness visits, at this point, COVID-19 vaccinations are scheduled separately as unique events. This differs from many of the childhood/adolescent vaccinations that require a series of injections but are scheduled alongside office visits, raising additional concerns about people returning for second doses.
• Side effects may deter individuals from returning for a second dose. As with any vaccination, side effects occur for some individuals. CDC describes common COVID-19 vaccine side effects as pain and swelling in the arm of the injection site and fever, chills, tiredness, and headache, similar to what is described for the flu shot. While side effects appear to be more mild with the first dose in the series than the second, some people who experience COVID-19 vaccination side effects with the with first dose may be deterred from completing the series. Indeed, nationally representative polling has found that among those who are probably or definitely not planning to get a COVID-19 vaccine, 81% say worries about side effects are a reason for this position and 59% say it is a major reason.
• Underlying resource inequities may make it more difficult for some groups to receive the second dose. Access to resources including the internet, email, transportation, and having an existing relationship with a health care provider could all influence the ease of accessing and likelihood of receiving a second dose. People of color, low-income, and other underserved groups are less likely to have access to these resources that will play a key role in second dose reminders and access. To the extent that these unmet needs influence vaccine uptake and series completion, disparities in COVID-19 cases and deaths could widen.
• Additionally, we do not yet know how the pandemic will impact multi-dose vaccine series completion more generally. Vaccines are often provided as a part of routine care but the COVID-19 vaccine is being provided with great urgency in the midst of a pandemic. On the one hand, completing the vaccine series in midst of the pandemic could be more challenging for a range of reasons. On the other hand, people may be more aware of the need for two COVID-19 vaccine doses given extensive coverage in the media and elsewhere.

What do we know about effective messaging to boost vaccine uptake and ensure series completion?

Securing public trust and motivating large shares of the population to get vaccinated against COVID-19 is essential in curbing the epidemic, and ensuring that people return for their second dose will be critical to achieving the highest levels of efficacy. It will be important to engage in a range of activities to encourage individuals to get vaccinated. In addition to adopting clear and persuasive messaging to ensure sufficient vaccine uptake in the first places, public health stakeholders will also need to focus on vaccination series completion. Good intentions may not be enough. In fact, CDC’s interim playbook suggests a number of avenues that vaccine providers and recipients can use to encourage and facilitate uptake of second doses of COVID-19 vaccines:

• Schedule appointment for second dose at time of first dose
• Complete vaccination cards with accurate information, including the manufacturer, date of first dose, and date of appointment for second dose
• Advise vaccine recipients to keep and bring card to second appointment in case data systems are not operational
• Suggest that recipients take a picture of the card and enter second appointment into electronic calendar if they use one
• Maximize the capacity of Immunization information systems and electronic health record (EHR) systems to send reminders about second dose appointments. Given that some COVID vaccine providers will be new to vaccine administration and may not be familiar with immunization registries, it will be important to ensure that providers are trained and know how to use the information systems to issue reminders for second dose appointments.
• Consider automated phone calls, emails, and text messages to send reminders
• Use health plan claims data to monitor dosages and remind enrollees about second dose

A combination of approaches may be important because different strategies are likely to be more effective with different populations, particularly those groups with highest levels of vaccine hesitancy and government/medical mistrust as well as those with fewer resources. Research shows that seniors are less likely to have a smart phone or use a computer, so solely relying on this technology for second dose reminders may not be as effective in reaching this high priority population as it is for others. The same consideration will apply to other groups with limited access to technology. Provider recommendation for vaccines is also associated with increased vaccination rates , and this could be particularly important for targeting those who are who are most skeptical about vaccination, at greatest risk for infection and severe disease, which includes people of color and older adults.

Discussion

Widespread adoption of COVID-19 vaccines is a public health imperative. To date, the rollout has been challenging for many reasons and may be further complicated by the multi-dose nature of the two currently authorized COVID-19 vaccines. Past vaccine efforts for other multi-dose vaccines have shown that there is often a drop off between the first and subsequent doses. Additionally, in the context of COVID, so far there are varying dose schedules for the different products, and concerns about supply. Finally, COVID-19 vaccination is being rolled out in the midst of a global pandemic which is quite different than routine vaccination. While there are always challenges in implementing a new vaccination program, the combination of these factors may pose obstacles to completing a multi-dose COVID-19 vaccine series and will require focused efforts to overcome.

Introduction

In the closing days of 2020, Congress enacted and the President signed into law the No Surprises Act, providing new federal consumer protections against surprise medical bills.  The measure was included in omnibus legislation funding the federal government for fiscal year 2021 and providing stimulus relief for the COVID-19 pandemic.  Its enactment followed nearly two years of Congressional debate over competing approaches to the problem that, at times, appeared to be deadlocked.

The No Surprises Act contains key protections to hold consumers harmless from the cost of unanticipated out-of-network medical bills.  Surprise bills arise in in emergencies – when patients typically have little or no say in where they receive care.  They also arise in non-emergencies when patients at in-network hospitals or other facilities receive care from ancillary providers (such as anesthesiologists) who are not in-network and whom the patient did not choose.

Surprise bills lead the list of affordability concerns for many families; 2 in 3 adults say they worry about unexpected medical bills, more than the number worried about affording other health care or household expenses.  Surprise bills can number in the millions each year.  Among privately insured patients, an estimated 1 in 5 emergency claims and 1 in 6 in-network hospitalizations include at least one out-of-network bill.  A health plan that generally doesn’t cover out-of-network care, such as an HMO, might deny a surprise bill entirely.    Or plans might pay a portion of the bill, but leave the patient liable for balance billing – the difference between the undiscounted fee charged by the out-of-network provider and the amount reimbursed by the private health plan.¹    Balance billing on surprise medical bills can reach hundreds or even thousands of dollars.   Surprise medical bills are not a problem today under public programs – Medicare and Medicaid – that prohibit balance billing.

The new law takes effect for health plan years beginning on or after January 1, 2022 and it applies to nearly all private health plans offered by employers (including grandfathered group health plans and the Federal Employees Health Benefits Program), as well as non-group health insurance policies offered through and outside of the marketplace. The new law contains other related provisions, including a requirement for health plans to keep network provider directories up to date.  This brief summarizes key provisions of the No Surprises Act and issues that could arise during implementation.

Consumer Protections Under Federal Law

The law contains key provisions to protect consumers against the cost of surprise medical bills.

Health plans must cover surprise bills at in-network rates.  The law requires private health plans to cover surprise medical bills for emergency services, including air ambulance services, as well as out of network provider bills for services rendered at in-network hospitals and facilities.  An advisory committee will be appointed to recommend options for protecting patients against surprise ground ambulance bills.

The law requires surprise bills must be covered without prior authorization and in-network cost sharing must apply.  In-network cost sharing for surprise bills will be based on a “recognized amount,” which in most cases will be the median in-network payment amount under the plan for the same or similar services.

The law also requires that federal external appeal rights apply if consumers feel their health plan has not correctly identified and covered a surprise medical bill.  A 2011 federal regulation temporarily limited the scope of denied claims eligible for external appeal to those denied on the basis of medical necessity or similar clinical considerations, pending data on the volume of appeals requested; in 2015 this limited eligibility was made permanent.  Transparency data reported by federal marketplace health plans show consumers appeal less than 0.2% of denied claims, and seek external appeal even more rarely.

Balance billing is prohibited. Out-of-network providers for emergency services are not allowed to balance bill patients beyond the applicable in-network cost sharing amount for surprise bills.  This same requirement applies to out-of-network providers who render non-emergency services at an in-network hospital or other facility.  An exception applies for certain non-emergency services if providers gives prior written notice at least 72 hours in advance and obtain the patient’s written consent.  The notice must indicate the provider does not participate in-network, provide a good faith estimate of out-of-network charges, and include a list of other participating providers in the facility whom the patient could select.  This exception does not apply for ancillary services (such as anesthesia) or diagnostic services (such as radiology and lab) nor to other services or providers the Secretary may specify in regulation.

Out-of-network providers cannot send patients bills for excess charges. Importantly, the law specifies that providers “shall not bill, and shall not hold patients liable” for an amount that is more than the in-network cost sharing amount for such services.   The “shall not bill” language did not appear in earlier bill versions, and constitutes an additional element of consumer protection under the new law.  Essentially it puts the burden on out-of-network providers to determine a patient’s insurance status and the applicable in-network cost sharing for the surprise medical bill.  Absent the “shall not bill” language, nonparticipating providers might continue to bill patients for the full amount, and only later refund excess amounts when and if patients learn surprise billing protections apply.

Specific oversight and enforcement activities are required. With respect to private health plans, enforcement of the No Surprises Act generally follows the same rules that apply under the Affordable Care Act (ACA).  States may enforce federal requirements against health plans they regulate (non-group health plans and fully-insured employer-sponsored plans), with federal fallback enforcement required if it is determined that states are failing to substantially enforce.  The federal government has primary responsibility for oversight and enforcement with respect to self-insured group health plans, which today cover about half of all people with job-based coverage, and which states are preempted from regulating under the Employee Retirement and Income Security Act (ERISA).   The Secretaries of Labor and Treasury (which share enforcement over ERISA plans) must audit a sample of plans each year to ensure that plans are covering surprise bills and applying in-network cost sharing correctly. The Secretary must report annually to Congress on findings from the audit process.   In addition, by July 1, 2021, Secretaries from 3 federal departments (Health and Human Services, Labor, and Treasury) must establish a process for receiving complaints of violations of surprise bill protections by private health plans and issuers.

Enforcement with respect to health care providers and facilities also begins with the states. In cases where a state fails to substantially enforce the law’s provider requirements, the federal government will enforce. The Secretary of Health and Human Services must establish a complaints process for violations of surprise billing protections by health care providers and facilities.  Under federal enforcement, civil money penalties of up to $10,000 per violation can be applied to health care providers and facilities.

A number of states have enacted surprise medical bill protections for the plans they regulate.  State surprise medical bill laws are not preempted unless they prevent the application of federal law.

Resolving Payment Amount for Surprise Bills

As Congress debated this issue, there was general, bipartisan consensus about consumer protections, but significant disagreement about how to resolve the payment amount for surprise, out-of-network medical bills.  Some favored use of an independent dispute resolution process (IDR) to resolve every surprise bill and giving weight to the nonparticipating provider’s undiscounted charge.  The Congressional Budget Office (CBO) said such an approach would be inflationary, driving up health plan costs.  Others favored establishment of a benchmark payment, based on the health plan’s median in-network payment amount, to determine payment for most surprise medical bills. The CBO said this approach would tend to limit payment for surprise bills and significantly reduce health plan costs and the federal deficit.

The final compromise permits access to IDR for any surprise medical bill following a 30-day period when the plan and provider try to negotiate a payment amount.  The IDR process follows so-called baseball-style arbitration rules; each party submits a final offer, and within 30 days the IDR entity determines which offer is most reasonable.  The IDR decision is binding, and the losing party must pay the cost of the arbitration process. In making its determination, the IDR may consider a number factors, including the plan’s median in-network rate for the service; but it may not consider the undiscounted provider charge or the amount public programs (such as Medicare) would pay for the service. This approach is intended to minimize reliance on the IDR and encourage all parties to submit reasonable bids.  The CBO estimated the law will lower payments to some providers, resulting in a reduction of private health plan premiums between 0.5% and 1% on average, and – because the federal government subsidizes most private insurance directly or through tax preferences – reducing the federal deficit by $17 billion over 10 years.

Other Provisions

The law includes several other provisions to help consumers get information in advance about how their health plan will work in practice, and to promote transparency of medical care prices generally.

Health plans must provide an advanced explanation of benefits.  Also beginning in 2022, consumers can request advance information about how services will be covered before they are provided.  For scheduled services, consumers can submit requests and, generally within three business days, the health plan must provide written information including about whether the provider/facility participates in-network, and a good faith estimate of what the plan will pay and what patient cost liability may be.

Health plans must provide transitional continuity of coverage when a provider leaves the network.  The law requires health plans and issuers to notify enrollees when a provider/facility leaves the plan network while it is providing ongoing care.  In certain cases, health plans must also provide transitional coverage for up to 90 days or until treatment ends (whichever is earlier) at in-network rates.  The transitional coverage requirement applies to treatment for serious or complex health conditions, institutional or inpatient care, nonelective surgery, pregnancy, and care for patients with terminal illness.

Health plans must maintain accurate provider network directories.   Health plans and issuers must establish a verification process to update provider directory information at least every 90 days. They also must respond within 1 business day to requests from individuals about whether a provider or facility is in-network.  This information becomes binding.  Consumers who rely on incorrect information conveyed by plans or posted in directories are entitled to have services covered with in-network cost sharing applied.  Providers and facilities are also required to provide timely updates to health plans when the content of their directory information changes.

Health plans must disclose information about broker commissions. Individual health insurance plans, including short-term limited duration insurance, must disclose to enrollees the amount of direct and indirect compensation paid to brokers for that enrollment.  Plans must also report information on broker compensation annually to the Secretary.  This disclosure must be made before the individual finalizes plan selection.    Disclosure of broker and consultant commissions is also required for group health plans.

Implementation Issues

The first implementation deadline specified in the law is July 1, 2021.  By then, the federal government must publish regulations establishing the methodology used by group health plans and issuers to determine the in-network cost sharing amounts for surprise bills and the information that plans and issuers must share with non-participating providers and facilities.  In most cases the in-network cost sharing amount will be based on a health plan’s median in-network rate paid for a given service in 2019, with that amount (also called the “qualifying amount”) indexed for subsequent years. Regulations will also need to specify alternate methods for determining qualifying amounts for new plans and services with no established rates in 2019.

Also by July 1, 2021, HHS must have established a complaints process for consumers to report surprise medical bill problems. The law appropriates $500 million in funding for implementation.

It remains to be seen how new consumer protections will work in practice. The law establishes stiff penalties for violation of balance billing prohibitions, requires a consumer complaints process, and grants appeal rights to consumers whose health plans do not appropriately recognize and cover surprise medical bills.  Even so, experience shows consumers rarely avail themselves of complaints and appeals rights.  As noted above, in 2019 consumers appealed about 63,000 of the more than 40 million medical claims denied by federal marketplace insurers.  That year, the total number of complaints against health insurers compiled by the National Association of Insurance Commissioners (NAIC) was less than 40,000.  Federal implementation could specify a role for statewide consumer assistance programs (CAPs), established under the ACA, to help patients navigate new protections.  By law CAPs must help consumers resolve insurance problems and file appeals.  Health plans are also required already to include contact information for CAPs on all claims denial notices.  Forty CAPs were established in 2010 and provided individual assistance to 207,000 consumers in the first year; 36 CAPs are still in place.  Congress has not appropriated funding for CAPs since 2010, although it is possible that a portion of funds appropriated to implement the No Surprises Act could be used to support consumer assistance.

Implementation strategies could also consider ways to prevent violations in the first place.  It is common practice today for nonparticipating providers to bill patients directly and leave to them to work out claims submission and reimbursement with their insurer.  The No Surprises Act seems to put the burden on nonparticipating providers to deal directly with their patients’ health plans.  Regulations could clarify such a requirement, along with tools to carry it out.  Out-of-network providers will need to obtain permission – also called assignment of benefits – from patients in order to deal directly with their health plans, as state surprise billing laws generally require.

Implementers will need to establish and monitor IDR capacity in real time.  The law requires the federal government to ensure a sufficient number of independent dispute resolution entities (IDRE) are certified to ensure the timely and efficient provision of determinations. Potentially millions of surprise bills may arise each year and it is unclear how many of those might be resolved by the IDR process, vs. by health plan/provider negotiation and settlements.  Congress intended to incentivize health plans and providers to settle on their own, minimizing reliance on the IDR process.  The IDR process also requires a “cooling off” period; the party that initiates IDR cannot seek IDR again with the same party for the same service for 90 days.  How these incentives work in practice remains to be seen. The federal IDR system is similar to that established in New York, where 1,148 surprise medical bills were resolved by IDR in 2018, up from 149 cases in 2015 when the program opened.  The state system has jurisdiction over only a small portion of all surprise medical bills, as ERISA preempts state regulation of self-funded employer plans, which cover most privately insured individuals.²  Presumably, regulations will provide a way for the federal government to monitor sufficiency of IDR system capacity and make needed changes promptly.

Federal implementers will need to consider the number and type of IDR entities to engage.  State surprise medical bill resolution systems have followed different approaches to establish IDR capacity.  In New York, for example, the state contracts with several IDR entities, including independent review organizations (IROs) that also conduct independent claims review under the state’s external appeals law.  IROs contract with board certified physicians and other insurance contract experts to perform expert claims reviews.  Fees charged by IDRE organizations typically range from $300 to $600.  Other state surprise medical bill programs rely on individual mediators and arbitrators to provide IDR services.  The Texas Department of Insurance, for example, contracts with more than 200 individual attorneys to provide IDR services for surprise bills.  Their fixed fees per case range from $270 to $6,000.  In addition to IDR fees (which the losing party pays) the law requires the federal government to establish a federal administration fee for the program, another important implementation detail.

Implementation must also guard against conflict of interest in the IDR process.  The No Surprises Act prohibits IDREs from having “a material familial, financial, or professional relationship” with either party.  Conflicts may arise if IDR organizations also have contracts with employer health plans to conduct external appeals for denied claims.  Unlike state external review systems, where the state contracts with independent review organizations, federal guidelines require employer-sponsored plans to contract with at least three accredited IROs and rotate assignment of external appeals among them.

Substantial data collection and monitoring is required.  By law the IDR process must be transparent.  The Secretary is required to post online information quarterly on the number of surprise bills that go to the IDR process, the cost of the process, and amounts paid to each IDR entity.  In addition, for each surprise bill that goes to the IDR process, the Secretary must post information about the identity of the parties involved, the nature and geographic location of the service provided, the payment amounts offered by each party, which party prevailed, and the length of time involved in making the determination.

In addition, Congress required regular reporting on the impact of the new law on health care prices, provider participation in health plan networks, and other outcomes.  Congress is specifically interested in how the new law affects health care markets.  For example, if the new law results in payments for out-of-network claims that are “too high,” there could arise a disincentive for providers to participate in health plan networks.  By contrast, if it payments are too low, there could arise a disincentive for health plans to pay competitive rates to keep providers in network.  The law requires the Secretary of HHS, in consultation with the Attorney General and the Federal Trade Commission, to study and report annually to Congress on how the law affects competition in health care markets, as well as the laws impact on overall health costs and on access to health care services, especially in rural areas and other professional shortage areas. It also requires study and report by the Government Accountability Office (GAO) to collect data and report on the law’s impact on provider network participation rates and the adequacy of provider networks.  In addition, GAO is required to report on how the law impacts prices charged for health services and changes in patient out-of-pocket costs.

Beyond requirements in the No Surprises Act, the federal government has broad general authority to require reporting on surprise medical bill claims under ACA transparency data reporting provisions.  Use of this authority could help in tracking trends in surprise medical bills that do not use the IDR process.

1. The Affordable Care Act requires private health plans to cover out-of-network emergency services and to apply in-network cost sharing to such claims.  The Affordable Care Act also sets standards for a reasonable amount that plans must pay for out-of-network emergency services, but it does not prohibit balance billing by out-of-network emergency care providers. ↩︎
2. In addition, as of that year, New York’s surprise medical bill law did not apply to hospital charges for emergency services. ↩︎

Updated analysis of state-reported data as of February 1, 2021 on COVID-19 vaccinations, cases, and deaths by race/ethnicity is now available.

Based on nearly half of states reporting vaccination data by race/ethnicity, Black and Hispanic people continue to receive smaller shares of vaccinations compared to their shares of cases and deaths and compared to their proportions of the total population. In all 23 states reporting data, Black people account for a smaller share of vaccinations compared to their share of cases and smaller than (equal to in Vermont) their share of deaths. In 21 states reporting data on Hispanic people, the share of vaccinations among Hispanic people is smaller than their share of COVID-19 cases and also in their share of deaths with the exception of Missouri and Vermont.

Vaccination patterns may change as more data is available and more parts of the country gain greater access to vaccines. To date half of states are not yet reporting vaccinations by race/ethnicity. In 8 of the 23 reporting states, race/ethnicity is unknown for a quarter of vaccinations, including Texas and Virginia where over 40% of vaccinations have unknown race/ethnicity.

Beyond tracking data, KFF continues to produce analysis on racial equity in vaccination distribution and our news reporting at KHN also has shown that vaccination is lagging by various measures for people of color.