Ensuring racial and ethnic diversity in clinical trials for development of COVID-19 vaccines is particularly important since COVID-19 has taken a heavy disproportionate toll on people of color, and people of color, particularly Black adults, historically have had lower vaccination rates and express more concerns about getting a COVID-19 vaccine compared to their White counterparts. Diversity within clinical trials for a COVID-19 vaccine helps ensure safety and effectiveness across populations and may increase confidence in getting the vaccine among people of color. Historically, people of color have been underrepresented in clinical trials. There have been recent efforts to increase racial diversity within clinical trials and specific efforts to increase diversity within the trials associated with development of COVID-19 vaccines. With two COVID-19 vaccines now authorized in the U.S. (the Pfizer-BioNTech and Moderna vaccines), we review why racial diversity within COVID-19 vaccine clinical trials is important, discuss the barriers to participation in clinical trials among people of color, and examine the racial/ethnic composition of clinical trial participants for the Pfizer-BioNTech and Moderna vaccines.

Why is it important to have diversity within the COVID-19 vaccine trials?

Diverse racial/ethnic representation in COVID-19 vaccine trials is important because drugs and vaccines can differentially affect groups reflecting variation in underlying experiences and environmental exposure. Clinical trials are research studies that determine whether medical products like medicines, vaccines, or devices are safe and effective. It important for participants in clinical trials to represent the patients that will be using the medical products since responses may vary across patient groups. In general, to be representative, vaccine trials should enroll people of color in percentages similar to their representation in the population. However, since people of color have been disproportionately affected by COVID-19 pandemic, scientists, including Dr. Fauci, have indicated that the COVID-19 vaccine trials should overrepresent people of color compared to their population share.

Why are people of color underrepresented in clinical trials?

Access barriers, lack of information, and historic and ongoing racism and discrimination contribute to underrepresentation of people of color in clinical trials. People of color face an array of structural access-related barriers to participating in trials. For example, fewer clinical trials are available through under-resourced hospital systems where people of color are more likely to receive care, and people of color may be less likely to be eligible to participate in trials if being uninsured or having co-morbidities excludes individuals from participation. Other access challenges, such as prohibitive distance to trial sites for people with limited transportation options, limited flexibility in work and caregiving schedules, and lack of access to technology for monitoring that may be required as part of the trial also may increase barriers to participation among people of color. Beyond these challenges, lack of awareness and information may limit participation. For example, some research suggests that physicians are less likely to discuss clinical trials with patients of color. Further, enrollment efforts may not effectively reach people of color if they are not culturally appropriate and do not address differences in language and health literacy. Moreover, the medical system’s historic abuse and mistreatment of people of color, including but not limited to the infamous Tuskegee syphilis experiment, as well as ongoing racism and discrimination in health care today may contribute to less willingness among people of color to participate in clinical trials.

What steps are being taken to increase racial diversity within clinical trials?

There have been ongoing efforts to increase diversity in clinical trials broadly and specific to development of COVID-19 vaccines. The Federal Drug Administration (FDA) is engaged in a range of efforts to encourage greater diversity in clinical trials, including creating a public-facing education and outreach campaign and working with varied stakeholders. It also developed recommendations to industry and agency staff on how to collect race and ethnicity data in clinical trials. The National Institutes of Health (NIH) has longstanding guidelines on the inclusion of women and minorities as subjects in clinical research. In addition to these general guidelines, there have been specific efforts focused on COVID-19 vaccine trials. For example, in June 2020, the FDA offered nonbinding recommendations to the industry on development and licensure of COVID-19 vaccines that strongly encouraged the “enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities.” Both Pfizer and Moderna have said they worked to ensure that people of color were included in their trials, with Moderna even slowing down enrollment to try to enroll more racial and ethnic minorities. There have also been efforts on the community side. For example, historically Black colleges and universities are participating in COVID-19 vaccine trials and encouraging participation among their communities.

How diverse are participants in COVID-19 vaccine trials?

Pfizer-BioNTech and Moderna have reported the racial/ethnic composition of the participants in the late-stage clinical trials for their COVID-19 vaccines. Pfizer-BioNTech and Moderna provided demographic data for participants in their late-stage clinical trials, including racial/ethnic composition, as part of their emergency use authorization (EUAs) applications to the FDA. These data show, that, overall, people of color are underrepresented in these trials relative to their share of the total U.S. population (Table 1), with the largest disparity among the Black population. While the trials have not included the overrepresentation of people of color that some had suggested, as noted above, these trials have achieved greater diversity than many previous trials for other drugs. In both COVID-19 trials, the demographics of the placebo and vaccine groups are similar, as are the characteristics between all participants and the safety populations (the group of individuals receiving the vaccine and followed for safety). In addition, similar vaccine efficacy results were observed across racial and ethnic groups in both the Pfizer and Moderna trials.

What are implications of diversity in COVID-19 vaccine trials for vaccination efforts?

These data show that although people of color are underrepresented in the clinical trials for the two initial COVID-19 vaccines compared to their share of the population, the trials include people from diverse racial/ethnic backgrounds and are more diverse than some trials have historically been. The findings showing that vaccine safety and efficacy were similar for people of color and White participants could help increase confidence in willingness to get the vaccine, particularly among Black adults who are more likely than White adults to point to concerns about safety and side effects as major reasons for why they probably or definitely would not get the vaccine. As such, information on the diversity of participants in the clinical trials and the trials’ findings on safety and efficacy for people of color could be an important component of outreach and education campaigns and vaccination efforts that could help prevent disparities in vaccination.

A new KFF analysis finds donor government support for global family planning efforts totaled US$1.5 billion in 2019, matching the previous year’s record level and well above the US$1.1 billion in 2012 since the London Summit on Family Planning that created an international goal of increasing family planning services.

The funding helps to support a range of activities including contraceptives, information, education and communication activities; and capacity building and training in low- and middle- income countries. It reflects donor nation’s funding decisions prior to the global COVID-19 pandemic and does not reflect any changes in priorities sparked by that crisis.

Key findings include:

• Half of donors increased bilateral funding in 2019 (Australia, Canada, Norway, Sweden, and the U.K.) while the other half decreased funding (Denmark, France, Germany, the Netherlands, and the U.S.).
• Despite a decline by the U.S., it remains the largest bilateral donor to family planning, providing US$592.5 million or 39% of total funding from donor governments. The decline is largely due to timing and does not reflect the actual U.S, appropriations by Congress, which have remained steady.
• Funding for the multilateral United Nations Population Fund (UNFPA) remained steady in 2019, with Norway providing the largest contribution at US$62.0 million, followed by Sweden, Denmark, Germany, and the Netherland keeping the funding levels at US$367.6 million, similar to 2018 (US$374.1 million). The Trump administration withheld all U.S. support for UNFPA throughout its tenure.
• Future funding levels for family planning could depend on the fallout from the COVID-19 pandemic and the changing U.S. administration priorities. The incoming Biden administration has expressed support for global family planning efforts and may seek additional funding, though any funding request would need to be approved by Congress.

Results of this analysis are also included in the annual progress report from FP2020, The Arc of Progress,  a global partnership to monitor progress toward the 2012 London Summit on Family Planning goals to expand contraceptive access to an additional 120 million women and girls in low- and middle income countries by 2020.

The COVID-19 pandemic has resulted in administrative challenges for state Medicaid agencies from staff transitions to telework due to social distancing requirements, increased applications during the economic downturn, and the need to modify policies and procedures to facilitate access to coverage and care in response to the public health crisis. As a result, states have faced increased enrollment while having fewer staff and resources available for routine eligibility and enrollment processing. At the same time, Maintenance of Eligibility (MOE) provisions require states to keep beneficiaries enrolled until the end of the month when the COVID-19 public health emergency (PHE) ends and prohibit states from adopting more stringent eligibility criteria or increasing premiums, as conditions of receiving temporary increased federal Medicaid funding under the Families First Coronavirus Response Act. Consequently, states will need to address a backlog of Medicaid eligibility renewals and redeterminations as well as continue to process new applications after the PHE ends.

In addition, many states have adopted temporary policy changes through various Medicaid emergency authorities to expand eligibility and/or streamline enrollment processes to connect individuals to coverage more quickly during the pandemic. States also have used emergency authorities to adopt other policies such as relaxing cost sharing and prior authorization requirements, increasing provider payments, and adding new benefits. States will have to decide whether to continue these policy changes after the PHE ends. If states return to pre-PHE eligibility and enrollment rules, they will need to redetermine eligibility for impacted enrollees. They also will need to notify beneficiaries and providers about any payment or benefit changes.

On December 22, 2020, CMS released a state health official letter outlining how states are expected to unwind emergency authorities and resume normal eligibility and enrollment processing after the end of the PHE. The current PHE declaration expires on April 21, 2021, but the Biden Administration has indicated the PHE will likely remain in place throughout 2021 and that states will receive 60 days notice before the end of the PHE to prepare for the end of emergency authorities and the resumption of pre-PHE rules. The change in Presidential administration could have implications for state planning and decisions at the end of the PHE, as the Biden Administration could revise the December 2020 guidance as well as the Trump Administration’s interim final rule (IFR) governing the MOE provisions. Because the Trump Administration did not finalize the IFR following the end of the comment period in January, the Biden Administration will have the opportunity to review comments and could make modifications in response to comments before finalizing the rule. This brief highlights key issues from the new CMS guidance to states as issued in December 2020.

What actions does CMS expect states to take during the PHE?

CMS expects states to process applications, redeterminations and renewals to the extent possible during the PHE, even though they cannot terminate coverage for most enrollees due to the MOE. CMS emphasizes prioritizing actions to ensure that individuals can enroll in and retain coverage, such as determining eligibility for new applications, during the PHE.¹  Table 1 summarizes the circumstances that may result in state backlogs and the actions that CMS expects states to take during the PHE to address pending eligibility and enrollment actions. CMS also encourages states to conduct CHIP and Basic Health Plan (BHP) redeterminations and renewals during the PHE. Because the MOE does not apply to those programs, CMS notes that states can process CHIP and BHP actions now, which could allow them more time to focus on clearing Medicaid backlogs after the PHE and MOE conditions end.

To help ensure that future workloads are manageable, states can take action to evenly distribute renewals throughout the year. When completing renewals that were delayed during the PHE on an ex parte basis (using information available to the state and not requiring information from the individual), states have the option to retain the individual’s original eligibility period (effective when the renewal was due) instead of beginning a new eligibility period on the date the renewal actually is completed. This may help states distribute workloads in future years by staggering renewal dates but may also result in renewal periods for enrollees that are shorter than 12 months.

How quickly does CMS expect states to clear eligibility and enrollment backlogs after the PHE ends?

CMS expects states to complete all pending eligibility and enrollment actions and clear any backlogs within six months after the PHE ends. The guidance sets timelines for states to return to normal operations for eligibility determinations on new applications as well as eligibility verifications, redeterminations based on changes in circumstances, and renewals that are pending when the PHE ends (Figure 1). Initial milestones focus on processing applications, followed by completing pending verifications, redeterminations, and renewals.

States need to adopt a methodology for prioritizing which pending eligibility and enrollment actions to complete first, focused on individuals “most likely” to no longer be eligible (Table 2).²  States have discretion about whether to adopt one of CMS’s methodologies or to develop their own approach. The state’s methodology will be part of the operational plan that it must develop to set out how it will process pending actions within CMS-required timeframes after the PHE ends. CMS will not approve state operational plans but may request them from states that are not meeting the required timeframes. States must submit baseline data about pending eligibility and enrollment actions at the end of the PHE and submit updates quarterly thereafter to show progress toward the timeframes. If states meet these timeframes, CMS will not consider eligibility and enrollment actions delayed due to the PHE as untimely for Program Error Rate Measurement (PERM) purposes.³ 

The guidance reiterates existing policies states can adopt to streamline eligibility and enrollment processes and reduce administrative workload. For MAGI populations (whose eligibility is based solely on low income), these options include renewing coverage for 12 months when processing changes in circumstances and a data check shows continued eligibility, relying on income determinations made by SNAP or TANF, as well as Express Lane Eligibility and 12-month continuous enrollment for children. States can also streamline eligibility and renewal processes for non-MAGI enrollees (whose eligibility is based on old age or disability) by adopting 12 month renewal periods, using prepopulated renewal forms, offering renewal reconsideration periods, and modifying verification policies to accept self-attestation, among other policies.⁴ 

After the PHE ends, what do states need to do before terminating coverage?

States cannot terminate coverage until the end of the month in which the PHE ends, due to the MOE requirements. After the MOE and any temporary emergency authorities end, states must follow regular program rules that require sending 10 day advance notice and providing the opportunity for a fair hearing prior to terminating coverage. If states are ending emergency authorities and redetermining eligibility under more restrictive pre-PHE rules, states must provide enrollees with a reasonable timeframe, at least 30 days, to provide information to establish their continued eligibility.⁵  States also must ensure a smooth transition to other insurance affordability programs for those who lose Medicaid eligibility but may be eligible for Marketplace or other coverage.

After the PHE and MOE requirements end, states do not have to repeat redeterminations or renewals before terminating coverage for individuals who have been determined ineligible within six months of the date the state sends an advance notice of coverage termination. To adopt this option, states must inform the enrollee at the time of the ineligibility determination that coverage will end after the month in which PHE ends, and the state will redetermine their eligibility based on any changes in circumstances that they report prior to termination. The state then must send a second notice in advance of the termination date. In cases where the state requests information to establish continued eligibility, states must allow individuals to respond through the end of the PHE, regardless of when the request was sent. If an individual has not responded to a request that was sent within six months of the date on which the state intends to terminate coverage after the PHE ends, the state may send advance notice of termination without attempting a repeated verification or redetermination.

What do states need to do if they want to continue or end policies adopted through emergency authorities?

The various Medicaid emergency authorities adopted during the PHE will end automatically (when the PHE ends or on a specified end date), unless a state takes action to extend them. States are not subject to public notice requirements for returning to pre-PHE rules. However, CMS strongly encourages states to communicate about changes with providers, enrollees, and managed care plans. And, states must provide advance notice to enrollees of any actions that result in a loss of eligibility, a reduction in benefits, or an increase in cost-sharing; this includes changes due to ending an emergency authority that temporarily expanded eligibility or benefits. Although some states already have sent notices during the PHE informing enrollees of changes that will take effect after the PHE or MOE ends (such as increased cost-sharing), states must send a second advance notice at the end of the PHE prior to implementing these changes.⁶ 

CMS encourages states to consider whether some emergency authorities should end before the PHE ends. For example, many states paused Preadmission Screening and Resident Review (PASRR) assessments, which prevent unnecessary nursing facility stays and facilitate community transitions, for people with intellectual or developmental disabilities or mental illness entering nursing homes during the pandemic. Given PASRR’s role in preventing unnecessary institutionalization, CMS encourages states to re-start PASRR before the PHE ends.⁷ 

States may want to continue some policies adopted under emergency authorities after the PHE ends, though not all policies can be continued. For example, states can amend their state plans or HCBS waivers to continue service delivery via telehealth. States also can update their verification plans to continue streamlined eligibility and enrollment options. CMS specifically encourages states to identify any temporary authorities that increased access to HCBS and make these changes permanent. However, states that used Section 1135 waiver authority to relax provider screening requirements and/or temporarily enroll providers who participate in other state Medicaid programs or Medicare must return to regular program rules. States have six months from the end of the PHE to complete screenings of these provisional providers and to stop payments to any providers not fully enrolled.

CMS is also now allowing states to extend HCBS waiver emergency authorities adopted under Appendix K up to six months after the PHE ends. Appendix K allows states to make temporary changes to HCBS waivers in response to emergencies, such as modifying or expanding eligibility or benefits, modifying or suspending service planning and delivery requirements, and adopting policies to support providers. Appendix K approvals to date were scheduled to expire after one year, with the first expirations to occur in late January 2021. Given the pandemic’s longevity and uncertainty about how long the PHE ultimately will last, CMS is now allowing states to submit requests to extend existing Appendix K approvals up to six months after the PHE ends and will apply this end date to new Appendix K requests going forward.⁸  After six months post-PHE, states can continue many Appendix K policies by amending their HCBS waivers.⁹ 

1. CMS, State Health Official Letter #20-004, Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency at p. 26 (Dec. 22, 2020), https://www.medicaid.gov/federal-policy-guidance/downloads/sho20004.pdf; see also CMS, All-State Call, (Dec. 1, 2020), https://www.cms.gov/files/audio/covid19allstatecall12012020.mp3 . ↩︎
2. CMS, State Health Official Letter #20-004, Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency at p. 23-24 (Dec. 22, 2020), https://www.medicaid.gov/federal-policy-guidance/downloads/sho20004.pdf ↩︎
3. CMS will issue future guidance on how states are expected to resume regular program integrity operations. The guidance will account for changes that occurred due to state adoption of emergency authorities during the PHE. Id. at p. 35. ↩︎
4. Certain renewal rules that are required for MAGI enrollees are optional for non-MAGI enrollees. For more discussion, see KFF, Medicaid Maintenance of Eligibility (MOE) Requirements: Issues to Watch, (Dec. 17, 2020), https://modern.kff.org/medicaid/issue-brief/medicaid-maintenance-of-eligibility-moe-requirements-issues-to-watch/. ↩︎
5. CMS specifies an exception for enrollees in the COVID-19 uninsured testing group: states may send a notice at the time of initial enrollment informing enrollees that their coverage will end after the PHE. The state does not have to redetermine eligibility (unless the enrollee submits an application for full Medicaid benefits) but must send a 10-day advance notice prior to terminating coverage after the PHE and MOE end. CMS, COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and Children’s Health Insurance Program (CHIP) Agencies (last updated Jan. 6, 2021), https://www.medicaid.gov/state-resource-center/downloads/covid-19-faqs.pdf. ↩︎
6. States that used emergency authorities to extend the timeframe for individuals to request a fair hearing during the PHE must honor those timeframes after the PHE ends for notices that already have been sent, even if the state is reverting back to its former shorter timeframes after the PHE ends. CMS, State Health Official Letter #20-004, Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency at p. 17 (Dec. 22, 2020), https://www.medicaid.gov/federal-policy-guidance/downloads/sho20004.pdf. ↩︎
7. Id. at 5. ↩︎
8. All Appendix K authorities expire on the specified end date, except that individuals whose level of care renewals are extended for 12 months receive this full time period, regardless of the Appendix K end date. Id. at 17. ↩︎
9. Examples of Appendix K changes that can continue after the PHE ends include authorizing service delivery via telehealth, adding services like home-delivered meals, increasing payment rates, providing 30-day retainer payments, and including family caregivers as paid providers. Appendix K changes that cannot continue after the PHE ends include expanded timeframes for level of care re-evaluations, waivers of home and community-based settings and conflict of interest requirements, extensions of due dates for submitting data and reports to CMS, and changes approved under Section 1135 emergency authority such as extending timeframes for recertifying person-centered service plans and accepting verbal signatures for service plans. Id. at 7. ↩︎

Even before the COVID-19 pandemic began, signing up for health coverage and applying for financial assistance was often challenging.  A 2020 KFF survey found half (51%) of consumers who looked for coverage during the 2020 open enrollment encountered difficulties, and nearly 5 million consumers sought in-person help but couldn’t get it.  During the 2021 open enrollment, challenges compounded as consumers unfamiliar with the process needed to find replacement marketplace or Medicaid coverage for the first time, in-person assistance shifted to remote, and other pandemic-related complexities arose.  Last year, nearly all state based marketplaces (SBM) re-opened marketplace enrollment in response to the pandemic, and SBMs are beginning to announce COVID re-openings this year.  President Biden has said he favors providing a COVID-19 special enrollment period in the federal marketplace for people who are uninsured. (People who lose job-based insurance already qualify for a 60-day special enrollment period, but people who are already uninsured do not.)

Earlier this month, KFF convened a discussion with Navigators and other consumer assistance professionals from federal- and state-based marketplace states.¹   They offered observations about the 2021 Open Enrollment period, discussed general and pandemic-specific challenges facing consumers seeking coverage, and offered suggestions to improve enrollment outcomes. This brief summarizes those observations.

In addition, this brief reviews information about federal marketplace resources and spending priorities contained in Trump Administration budget documents.  Federal marketplace spending on consumer assistance, marketing, and other consumer assistance activities has declined during the Trump administration, even while revenue from user fees – which finance most of federal marketplace expenses – has held steady.  It appears that more than $1 billion in unspent federal user fee revenue has accumulated and could be used to invest in changes that would make it easier for consumers to enroll in health coverage.

Available Marketplace Revenue

Unspent marketplace user fee revenue has accumulated. The Trump Administration substantially reduced spending on key activities that support marketplace enrollment, including navigator consumer assistance, marketing and outreach, the HealthCare.gov marketplace website, and the federal marketplace call center.  At the same time, according to budget documents, the Administration did not spend all of the user fee revenue paid by marketplace health plans.  Unused funds appear to have accumulated to more than $1 billion over fiscal years 2018-2020.  Table 1 summarizes budget data from Fiscal Years 2013 and 2016, the first and last years of marketplace operations under the Obama Administration and from Fiscal Years 2017-2020 under the Trump Administration.

Spending cuts on consumer assistance and outreach activities, even as revenue held steady, contributed to the user fee carryover. Most spending for federal marketplace operations is for consumer information and outreach activities (navigator enrollment assistance, marketing and outreach, and the federal call center) and for information technology (HealthCare.gov).  Spending on these, as well as other eligibility and enrollment activities declined precipitously under the Trump administration and accounts for most of the reduction in overall spending for marketplace operations during that time.  Because of these spending reductions, marketplace expenses were cut below the level of user fee revenue collected.  From Trump Administration budget documents, it appears that for three years, FY 2018-2020, roughly $400 million per year in available user fee revenue was not spent, resulting in a cumulative carryover of revenue of more than $1.2 billion.²   Additional unused revenue likely accumulated during the current fiscal year, though that cannot be seen from budget documents released to date³ .  A final regulation issued by the Trump Administration in its closing days would reduce the federal marketplace user fee rate from 3% to 2.5% starting in 2022.  Unless changed by the new Administration, this reduction in the user fee rate would make it difficult for the federal marketplace to reverse cuts in spending on consumer information, outreach, and assistance activities.

Supporting Enrollment During the Pandemic

Following the close of the 2021 open enrollment period in, Navigators stressed the importance of reopening the federal marketplace for enrollment in 2021.  For the first time in several years, marketplace enrollment increased in a number of states.  Nevertheless, Navigators noted address unresolved problems that hindered access for some consumers during the regular open enrollment period.  They also pointed to the importance of making every effort to get people covered during the pandemic.  Navigators offered several recommendations for ensuring a successful COVID-19 special enrollment period.

Navigators urged that an emergency COVID enrollment period extend for longer than the 6-week federal open enrollment period that just concluded.  They noted that time will be needed not only to sign up new consumers, but to follow up with those who experienced difficulties during the regular open enrollment.  As the pandemic took off in March 2020, 11 of the 12 SBMs reopened marketplaces for enrollment, most – initially – for a period of 6 to 8 weeks.  As the year progressed, however, most SBMs extended the enrollment opportunity, some into the summer, and several to year end. (Table 2)

Navigators also stressed the importance of investing substantially in publicizing a COVID re-opening of marketplace enrollment.  As KFF Tracking Polls have found for years, most consumers are unaware of marketplace open enrollment deadlines. The KFF tracking poll for December 2020 found that fewer than 1 in 5 respondents knew the then-upcoming deadline to sign up for 2021 coverage through the marketplace.  Greater publicity will be required to inform people when and how to sign up for a special, COVID-related enrollment opportunity.  Navigators also suggested the federal government could spend more on marketing and advertising, funding that had been cut by 90% by the Trump administration. At the same time, SBM navigators urged that federal marketing efforts be carried out in consultation with SBMs, whose timing and other rules for COVID-19 enrollment periods may differ from those of the federal marketplace.

Navigators noted the importance of targeted outreach strategies to reach some consumers, including those who do not speak English, non-citizens, and those who have been uninsured for a longer period of time.  These groups are typically more difficult to reach and may be less aware of extended enrollment periods.  The 2020 KFF survey found that 71% of uninsured individuals did not even try to find coverage for 2020.  The perceived high cost, lack of awareness about subsidies, fear of how getting coverage subsidies could affect their immigration status, and other factors discourage millions of uninsured consumers from even looking into coverage options.  Outreach from trusted individuals and community based organizations could be undertaken to reach such consumers, particularly during a special enrollment period.

As part of any marketing efforts, federal Navigators advised against describing the reopening of marketplace enrollment as a COVID-19 special enrollment period or SEP, and instead recommended it be characterized as a new open enrollment period. They noted that the term SEP can be confusing to for consumers, who may not realize the “special” enrollment opportunity applies to them, or who may have had difficulty applying for SEPs in the past.  Navigators also pointed out that while the Trump Administration revised rules during the pandemic, giving consumers more time to apply for a SEP following coverage loss, consumers still had to provide documentation of that coverage loss before they could enroll using the COVID-SEP.

To be effective, federal Navigators indicated they will need additional resources to provide consumer assistance during a COVID enrollment period.  Current year funding awards to federal marketplace navigators ($10 million) are less than 10% of the amount the Obama Administration invested in enrollment assistance during the first open enrollment period ($108 million).  While a few federal navigator programs have been able to find supplemental funding resources from their states or foundations, others have had to substantially reduce capacity as a result of federal funding cuts.  For example one statewide program that used to employ 30 full time navigators now has 6.  In addition, most navigator programs now “front load” their annual award, using most resources during the 6-week open enrollment period, and maintaining only skeleton capacity to help consumers during the rest of the year. Currently operating federal navigator programs said, with enhanced funding, they could respond immediately if a COVID enrollment period is established, but they noted it will take time to ramp up the number of people they can help as they re-hire and train staff, and hoped decisions about the length of a federal COVID enrollment period would take that into account.

Addressing problems that arose during the 2021 open enrollment period

Navigators described several issues that surfaced during the most recent open enrollment period, some related to the economic upheaval caused by the coronavirus pandemic. These issues included difficulties in estimating income for the year due to job loss or receipt of unemployment benefits, receipt of failure to file notices due to IRS backlogs in processing income tax returns, and policies discouraging enrollment among eligible immigrants.  They suggested policy changes in conjunction with a COVID enrollment period anticipate and try to respond to problems that affected consumer’s ability to enroll during the last Open Enrollment.

Navigators reported an increase in consumers facing difficulties in estimating annual income this year because of job loss, reductions in hours, or because of receipt of unemployment benefits which varied in availability and amount during 2020.  Marketplace subsidies are based on a consumer’s estimated income for the coming calendar year and when consumers apply for subsidies, the marketplace conducts real-time verification of their income estimate, comparing it to their most recently filed federal tax return.  Pandemic-related job loss or reductions in hours after years of steady employment can lead to problems verifying income.  In these cases, consumers may receive a notice of data match inconsistency (DMI) that requests further documentation.  Although subsidies will be temporarily approved based on the consumer’s estimated income, they will be reduced or terminated 90 days later unless required DMI documentation is received and approved.  Navigators expressed concern that DMI-related subsidy terminations could start happening in February-March for consumers who cannot successfully complete the verification process.  Navigators also heard from clients who worried they may have to repay some or all of the premium tax credit that they received during the pandemic if they their income increases later in the year.  In response to these concerns, Navigators suggested the marketplace could target outreach and assistance to consumers who received DMI notices during open enrollment.  Additionally, the federal government could waive repayment of excess premium tax credits during the pandemic.

Because of backlogs at the Internal Revenue Service (IRS), Navigators also reported that some consumers who filed their income taxes nevertheless received failure to file notices, putting their current subsidies at risk.  Recipients of marketplace premium tax credits in a year are required to file a federal tax return for that year if they want to continue receiving subsidies in the subsequent year.  Because of the pandemic, the 2019 tax filing deadline was extended to July 2020 and the IRS experienced delays processing returns. As a result, some consumers were notified they were at risk of losing marketplace subsidies even though they had filed their income taxes as required. The notice did not clearly indicate what steps to take next, leaving many consumers unsure of how to address the issue.  Navigators said providing targeted outreach and assistance for consumers who received failure to file notices could help ensure they are covered and subsidies continue.

Navigators are concerned about actions that have discouraged enrollment by immigrants.  Navigators reported that a series of Trump Administration policy actions, including recent changes to the “public charge” policy, have instilled fear and deterred enrollment in public coverage among immigrants.  Although the public charge policy does not apply to marketplace subsidies, Navigators said this policy has suppressed enrollment in marketplace coverage and Medicaid.  The Biden Administration has vowed to rescind the public charge rule changes. Navigators also suggested targeted outreach to immigrants during a COVID enrollment period.

While the Medicaid maintenance of eligibility (MOE) requirements tied to enhanced federal Medicaid funding for states during the public health emergency (PHE) have helped consumers maintain Medicaid, Navigators worried about potential loss of coverage when the PHE ends. Under the MOE requirements, states must provide continuous coverage through the end of the month in which the PHE ends for people enrolled in Medicaid.  Navigators said this policy has enabled consumers to maintain their Medicaid coverage during the pandemic.  However, they expressed concern that when the PHE ends and Medicaid redeterminations resume, some consumers could lose their Medicaid and need help finding new coverage.  Consumers who lose Medicaid coverage mid-year are eligible for a 60-day special enrollment period (SEP) during which they can sign up for marketplace coverage, although Trump Administration policy changes made this process more difficult for consumers.  Navigators suggested the  marketplace could coordinate with state Medicaid programs as they resume redeterminations and refer people for enrollment assistance if they need to transition to new coverage.

Ongoing Challenges Hindering Marketplace Enrollment

Navigators raised other concerns – some of them longstanding – that could be addressed to support in-person enrollment assistance and make the enrollment process more efficient and easier for consumers. The federal marketplace could begin to invest in improvements using some carryover funding, although investments will likely be needed beyond the time of any COVID-enrollment period.

Beyond additional funding during an emergency COVID-related enrollment period, navigators spoke to the restoration of federal funding for consumer assistance. Federal navigators said increased funding is necessary to rebuild a diminished workforce.  They stressed it will take time to rebuild after years of funding cuts but agreed immediate improvements could be achieved.  Federal navigators also noted the importance of re-establishing navigator services that have been eliminated altogether under the Trump Administration.  Currently no navigator services are offered in two federal marketplace states (South Carolina and Utah), and none are offered in most of the counties of six other states (Texas, Michigan, Ohio, Illinois, Kansas and Nebraska).  The Trump Administration also eliminated the requirement to have at least two navigator programs serving each state; in 2016 there were 100 federal navigator grantees, today there are 30.  In addition, the requirement for federal navigators to maintain a physical presence in the state they serve was eliminated.  While much more help was provided remotely during the pandemic, a small number of current federal navigator grantees only maintain web and phone services in the states they serve.

Federal navigators expressed frustration with the quality of the assistance provided by the federal marketplace call center. Concerns about the effectiveness and reliability of help from the federal marketplace call center date back years.  In a 2015 KFF survey, most marketplace assisters said help from the call center was rarely or only sometimes effective.  Current federal navigators noted some call center staff lacked the training and experience to provide adequate assistance.  They also said that the call center lacks an effective system for escalating complex cases to more highly trained specialists.  By contrast, navigators in several SBM states reported more positive experiences with their call centers.  Several said SBM call centers make dedicated lines and specially trained staff available for Navigators.  In some SBMs, the call centers also directly refer consumers to navigators when those consumers are in need of in-person assistance.

Federal navigators also raised concerns about the federal marketplace website and offered ideas for improvement they felt would streamline the enrollment process. Some concerns related to the Find Local Help tool – the Trump Administration redesigned this tool to steer consumers to brokers instead of marketplace assisters.  The tool also no longer identifies navigator programs, but rather lists them among other volunteer assister programs that the marketplace does not fund.  Other concerns related to design of the online application.  For example, when consumers need to correct or update information in their online application, they cannot go directly to the specific screen, but must scroll through each application question in order.  Federal navigators also noted that the federal government’s training program does not include access to the online application, making it harder for them to learn the flow of questions and required information and to identify changes in the online application from one year to the next.  Navigators in SBM states had few complaints about their marketplace websites and felt they were well-designed and included needed functionality.  In particular, the New York marketplace has created a secure portal for certified navigators so they can access their clients’ online accounts, input information, review the application status, and handle other basic administrative tasks, such as password changes.  Federal navigators said having this type of portal on healthcare.gov would enable them to help consumers more efficiently and reduce reliance on the call center.

Navigators reported ongoing challenges with coordination between the marketplace and Medicaid.  While most SBM states have integrated marketplace websites that determine eligibility for marketplace coverage and Medicaid, the process for determining eligibility for Medicaid in FFM states is less streamlined. Eight states that use healthcare.gov have delegated authority to the federal marketplace to make eligibility determinations for the Medicaid programs. In the remaining states on the healthcare.gov platform, the marketplace makes an initial assessment of eligibility for Medicaid, then refers the applicant’s information to the state Medicaid agency to make a final eligibility determination. How well this handoff operates in practice can vary.  Delays in processing Medicaid applications in some states can mean that some consumers initially assessed as eligible for Medicaid but ultimately determined ineligible cannot complete their marketplace application during the open enrollment period and instead must apply for an SEP to finish the application and enroll. 

Navigators reported that some consumers who signed up during open enrollment are already experiencing post-enrollment problems, such as not receiving their first premium invoice, having claims denied, or trouble learning to use new coverage.  While Navigators provide some post-enrollment assistance, by law, they are required to refer such problems to statewide consumer assistance programs (CAPs), established under the ACA. The ACA provided an initial appropriation for CAPs, but Congress has not provided further appropriations, and CAP programs have received no federal funding since 2012.  Navigators urged that CAP funding should also be a priority.

Discussion

As he takes office, President Biden faces a daunting list of challenges as he endeavors to make progress on the health reform proposals he made during the campaign.  Some, such as proposals to expand ACA subsidies, will require an act of Congress.  Others, including re-opening enrollment in the federal marketplace, require only executive action.  To make the enrollment process simpler and enable more people to enroll, additional investments would also be needed.  Beyond just reversing Trump Administration cuts, there are opportunities to make the make the marketplace more responsive to consumer needs and to work with Navigators to identify and address problems as they emerge.  The availability of unspent, carryover user fee revenue could make possible immediate investments in marketing and outreach, support for enrollment assistance, and other improvements.

A reopened ACA enrollment period has the potential to get more people covered during a public health emergency and in the midst of massive economic dislocation. There are, however, challenges and trade-offs involved. Without any increase in federal subsidies, many people who are uninsured may still find coverage unaffordable. A new enrollment period could also provide an opportunity for people who have recently developed health conditions to sign up, which would provide them greater access to care but could also worsen the risk pool and lead to an increase in premiums. A concerted outreach effort could help get more people covered, including those who are currently healthy, thus improving the risk pool and reducing the number who are uninsured.

1. Participants in the discussion were from Arizona, Colorado, District of Columbia, Florida, Indiana, Maine, New York, Pennsylvania, Texas, Virginia, and Wisconsin. ↩︎
2. Data on user fee revenue was not published during the Obama Administration.  Disclosed detail on marketplace spending and revenue began in 2017, with inclusion of the Health Insurance Exchanges Transparency table in Trump Administration budget documents.    In addition to user fee revenue, a portion of marketplace operations expenses are financed through discretionary appropriations to the Centers for Medicare and Medicaid Services (CMS), recognizing that some activities also provide cross-cutting support to Medicare, Medicaid and CHIP. ↩︎
3. The Trump Administration’s FY 2021 budget justification shows proposed spending levels, which are not necessarily achieved, while budget documents show actual spending and revenue amounts for prior years. ↩︎

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

This week marked the one-year anniversary since the first patient with COVID-19 was hospitalized in the United States. At this point, coinciding with President Joe Biden’s inauguration and a new administration leading the federal response, the country has surpassed 24.6 million COVID-19 total cases and roughly 410,100 total deaths as of January 21.

On his first day in office, President Biden signed several executive orders including requiring masks and physical distancing in federal buildings and on other federal properties. On Thursday, the President signed an executive order mandating masks for interstate travel in the U.S. and released a national strategy responding to the pandemic. KHN outlines what President Biden promised during the presidential campaign and will be tracking the administration’s actions on health and COVID-19 related promises.

The latest COVID-19 Vaccine Monitor reports that half the public expect the vaccine rollout to get better under President Biden. The new report also highlights that a majority of the public, including prioritized groups like older adults and essential workers, say they don’t have enough information about where and when to receive a vaccine.

Meanwhile, an update to January 19 data on states’ COVID-19 vaccine priorities shows 12 states have moved to redefine their priority populations or open vaccine availability to people 65 and older, bringing the total number of states placing this population in the 1a or 1b category to 28. Six states moved those under age 65 with high risk medical conditions up in line as well.

A new analysis explores state-reported data on vaccination by race/ethnicity and will be regularly updated and available on KFF’s COVID-19 state data and policy tracker. While it is still early in the vaccine distribution timeline for the general public, the preliminary data provided by 16 states indicate Black and Hispanic people’s share of vaccinations is smaller than their share of cases and deaths in most of these reporting states. The data and our news reporting at KHN have also shown that vaccination is lagging by various measures for people of color.

Media reports indicate some health workers are opting not to be vaccinated, particularly among those working in long-term care facilities. A new data note examines the makeup (by race/ethnicity, income level, age, gender, education, and citizenship status) and health insurance coverage of the estimated 15.5 million health care workers with direct patient contact.

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

Global Cases and Deaths: Total cases worldwide stand at 97.5 million this week – with an increase of nearly 4.4 million new confirmed cases in the past seven days. There were approximately 95,400 new confirmed deaths worldwide, bringing the total for confirmed deaths to nearly 2.1 million.

U.S. Cases and Deaths: Total confirmed cases in the U.S. reached 24.6 million this week. There was an increase of about 1.3 million confirmed cases between Jan. 14 and Jan. 21. Approximately 21,400 confirmed deaths in the past week brought the total in the United States to 410,100.

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

Extensions: AL, ME, MD, MA, MI, NJ, OH, RI, UT, WI

Rollbacks: DC, IL, MA, MI, ND, VT

The latest KFF COVID-19 resources:

• The COVID-19 “Vaccination Line”: An Update on State Prioritization Plans (News Release, Issue Brief)
• We Need a Better Way Of Distributing the COVID-19 Vaccine. Here’s How To Do It. (Washington Post Op-Ed)
• The Challenge of Vaccine Hesitancy In Rural America (Full Column, Axios Column)
• Factors Associated With COVID-19 Cases and Deaths in Long-Term Care Facilities: Findings from a Literature Review (News Release, Issue Brief)
• Patterns in COVID-19 Cases and Deaths in Long-Term Care Facilities in 2020 (Issue Brief)
• January 14 Web Event: A Shot in the Arm For Long-Term Care Facilities? Early Lessons from the COVID-19 Vaccine Rollout to High Priority Populations (Archived Recording)
• Vaccine Hesitancy Among Hispanic Adults (News Release, Poll Finding)
• Immigrant Access to COVID-19 Vaccines: Key Issues to Consider (Issue Brief)
• Updated: COVID-19 Coronavirus Tracker – Updated as of January 15 (Interactive)
• Updated: State Data and Policy Actions to Address Coronavirus (Interactive)
• KFF COVID-19 Vaccine Monitor: January 2021 (News Release, Poll Finding)
• Early State Vaccination Data Raise Warning Flags for Racial Equity (News Release, Policy Watch)
• The COVID-19 Vaccine Priority Line Continues to Change as States Make Further Updates (Policy Watch Post)
• Key Characteristics of Health Care Workers and Implications for COVID-19 Vaccination (Issue Brief)
• Updated: Analysis of Recent National Trends in Medicaid and CHIP Enrollment (Issue Brief)
• Updated: COVID-19 Coronavirus Tracker – Updated as of January 21 (Interactive)
• Updated: State Data and Policy Actions to Address Coronavirus (Interactive)

The latest KHN COVID-19 stories:

• Black Americans Are Getting Vaccinated at Lower Rates Than White Americans (KHN, NBC News)
• On Trump’s Last Full Day, Nation Records 400,000 Covid Deaths (KHN, NPR)
• Patients Fend for Themselves to Access Highly Touted Covid Antibody Treatments (KHN)
• California Is Overriding Its Limits on Nurse Workloads as Covid Surges (KHN, NPR)
• Lost on the Frontline: New this week (KHN, The Guardian)
• Are Public Health Ads Worth the Price? Not if They’re All About Fear (KHN, Fortune)
• Biden’s Covid Challenge: 100 Million Vaccinations in the First 100 Days. It Won’t Be Easy. (KHN)
• Biden Terms Vaccine Rollout ‘A Dismal Failure’ as He Unveils Pandemic Response Plan (KHN)
• Biden Takes the Reins, Calls for a United Front Against Covid and Other Threats (KHN)
• Door to Door in Miami’s Little Havana to Build Trust in Testing, Vaccination (KHN, NPR)
• Covid Vaccine Rollout Leaves Most Older Adults Confused Where to Get Shots (KHN)
• Yurts, Igloos and Pop-Up Domes: How Safe Is ‘Outside’ Restaurant Dining This Winter? (KHN, NPR)

Section 1115 waiver activity has been a key area of interest in the final weeks of the Trump Administration. Section 1115 authority allows the HHS Secretary to waive certain provisions of federal law in state Medicaid programs to test policies that are likely to promote program objectives. These waivers generally reflect administration priorities, although the Secretary’s discretion is not unlimited. The incoming Biden Administration could rescind existing waiver guidance (such as guidance related to work requirements and capped financing) and/or issue new guidance. It could also review provisions in currently approved waivers and renewal requests and move to withdraw or not renew waivers that do not promote program objectives. Although CMS generally reserves the right to withdraw approved waiver and/or expenditure authorities at any time, precedent for withdrawing approved waivers is limited.

In its final days, the Trump Administration has approved controversial waivers that had been pending (most recently for Tennessee), extended other waivers more than a year before expiration, and took steps to try to prolong the process for withdrawing or amending approved waivers. This issue brief takes a closer look at this recent activity to understand implications for the Biden Administration.

Tennessee Approval

On January 8, 2021, CMS approved a waiver request from Tennessee that would transition nearly all of the state’s Medicaid program currently covered by its long-standing TennCare II waiver into a new TennCare III program. This waiver includes most TennCare enrollees, including children, parents, and pregnant women as well as many seniors and people with disabilities. This complex approval is particularly significant nationally due to provisions related to financing, drug coverage, and the duration of the waiver (Figure 1). These factors make Tennessee’s waiver a prime candidate for review by the Biden Administration.

Financing: The TennCare III waiver sets an aggregate cap on federal spending and provides an opportunity for the state to keep a portion of any federal savings (Figure 2). Both of these features differ from the way Medicaid financing works under current law where costs and savings are shared by the states and the federal government due to the formula that guarantees federal matching dollars at a rate set in statute without a pre-set limit. While Section 1115 waivers must be budget neutral to the federal government, that budget neutrality is typically determined on a per enrollee basis rather than an aggregate basis. In the past, capped demonstrations have been approved in Rhode Island, Vermont, and Virginia (for a limited population), but they are no longer in place in these states. CMS is explicit that its approval of Tennessee’s waiver is not a part of the Trump Administration’s Healthy Adult Opportunity (HAO) initiative, which allows for capped financing. The match rate is an area of Medicaid that may not be changed under Section 1115 waiver authority. Key financing elements of TennCare III include:

• Setting the Cap. The aggregate cap would be adjusted each year to reflect the expected growth in federal Medicaid spending in the President’s budget and adjusted for positive or negative changes in enrollment that are greater than one percentage point in magnitude.
• Spending Above the Cap. Typically, capped financing would pose fiscal risks to states and could lower a state’s effective match rate because any state spending above the cap would not receive federal matching funds, as is the case with capped financing for Puerto Rico and the other Territories. However, adjustments to Tennessee’s cap tied to the growth rate for Medicaid in the President’s budget (which has historically been higher than inflation and higher than the Tennessee’s historic growth) and to increased enrollment mitigate the risk of this capped financing model to Tennessee. If Tennessee’s expenditures do exceed the cap, the state may carry over savings accrued during the final five years of TennCare II to pay for certain expenditures. While Tennessee must submit an amendment to reduce the level of benefits or covered populations below what was in place at the end of 2020, the TennCare III approval does not prohibit such changes.
• Spending Below the Cap. If expenditures are below the cap in a given demonstration year, Tennessee may access up to 55% of the federal share of savings to reinvest in state health programs (including those not eligible for Medicaid funding) if the state meets certain quality metrics (to be determined by Tennessee and CMS in the coming months), in addition to retaining 100% of the savings the state would normally get under Medicaid matching formula. Under this provision, Tennessee could see a higher effective match rate than statutory levels since this opportunity for shared savings allows the state to receive additional federal Medicaid dollars without additional state spending. Prior CMS guidance related to the use of federal Medicaid funds for non-Medicaid state programs has been mixed. Guidance from 2017 noted that CMS would no longer allow federal matching funds for designated state health programs (DSHP); however, in its approval of TennCare III CMS explained that it would allow for federal funds for non-Medicaid state health programs in line with policy principles established in its Health Adult Opportunity (HAO) guidance.

Closed Formulary: Under federal rules, in exchange for significant rebates on prescription drugs, state Medicaid programs must cover nearly all drugs approved by the FDA, essentially requiring an “open formulary” (unlike private insurers, who can enter into negotiations with manufacturers about whether or not to include drugs on the insurers’ formularies). The TennCare III approval would allow Tennessee to instead cover the greater of either one drug per therapeutic class or the same number of drugs per class as a selected Essential Health Benefits benchmark plan in the Affordable Care Act exchange, with an exceptions process for coverage of non-formulary drugs. Tennessee could still collect statutory rebates for covered drugs. CMS previously rejected a similar proposal in Massachusetts.

10-Year Approval: In November 2017 guidance, CMS indicated it would consider approving “routine, successful, non-complex” Section 1115 extension requests for up to 10 years. Since then, CMS has approved 10-year waiver extensions for three non-family planning demonstrations (WI, ME, and IN). CMS approved TennCare III for 10 years even though it does not appear to meet the conditions in the 2017 guidance: it was approved as a new waiver (not an extension), received 6,186 comments (of which “the vast majority” opposed the waiver), and contains complex financing and provisions.

Other Key Waiver Issues to Watch

Other recent activity under the Trump Administration may hamper the Biden Administration’s efforts to review certain waivers.

Expedited and Early Approval of Waivers. On January 15, 2021 CMS approved a ten-year extension for the Texas Healthcare Transformation and Quality Improvement Program (THTQIP) waiver following a “fast track” extension process which allowed the state to waive public notice and comment requirements (citing the immediacy of the COVID-19 public health emergency). The THTQIP waiver had been set to expire on September 30, 2022. On the same day, CMS renewed Florida’s Managed Medical Assistance waiver (which had been set to expire in June 2022) through June 2030. These renewals include provisions that the Biden Administration may review, including uncompensated care pools which provide funding for people who could be covered through the Medicaid expansion. Early approvals of these requests under the Trump Administration may make it more difficult for the Biden Administration to modify or withdraw these provisions subsequently.

Process to Withdraw Waiver Authorities. Outgoing CMS Administrator Seema Verma has encouraged states to sign a “letter of agreement” that specifies that any future CMS determination suspending, terminating, or withdrawing a waiver must have an effective date no sooner than nine months after the initial determination. The letter also specifies timelines for hearings and a briefing schedule for states to challenge these determinations. These agreements could make it more difficult for the Biden Administration to amend or withdraw waivers that it determines to be inconsistent with Medicaid program objectives, depending upon how they are construed. Congressional Democrats have noted that these “letters of agreement” conflict with existing regulations that require CMS to establish such a process as part of each waiver’s terms and conditions and requested that CMS rescind them immediately.

Pending Litigation. The Supreme Court is reviewing appeals court decisions setting aside work requirement waivers in Arkansas and New Hampshire, with the opening briefs filed by the Trump Administration and states on January 19, 2021. Although the Biden Administration is likely to rescind guidance related to Medicaid work requirements and could move to withdraw other currently approved work requirement waivers, a Supreme Court ruling in favor of the HHS Secretary’s authority to approve work requirements could still leave these waivers open to future administrations.

A new Policy Watch, Early State Vaccination Data Raise Warning Flags for Racial Equity, explores the latest state-reported data on vaccination by race/ethnicity available on KFF’s COVID-19 state data and policy tracker.

As of January 19, 2021, 17 states were reporting some vaccination data by race/ethnicity, including 16 states reporting the distribution of vaccinations by race/ethnicity.

Black Americans’ share of vaccinations is smaller than their share of cases in 16 reporting states and smaller than their share of deaths in 15 of the states. The trend is similar for Hispanic Americans with them accounting for a smaller share of vaccinations compared to cases and deaths in most states reporting data.

White Americans’ share of vaccinations is larger than their share of cases in 13 of the 16 reporting states and larger than their share of deaths in 9 states.

Asian Americans are experiencing fewer and smaller gaps between their share of vaccinations and cases in reporting states. Data on Asians’ share of deaths is limited and data gaps also exist for American Indian and Alaska Native and Native Hawaiian and Other Pacific Islander people.

Vaccines are not yet broadly available and states are prioritizing specific groups before the general public, so vaccination patterns may change as more data is available. However, data and our news reporting at KHN have shown that vaccination is lagging by various measures for people of color. KFF will regularly update the data by race/ethnicity to track racial disparities in access and administration of COVID-19 vaccines.

Also available is a new data note examining the makeup (by race/ethnicity, income level, age, gender, education, and citizenship status) and health insurance coverage status of the estimated 15.5 million health care workers with direct patient contact. Health and long-term care workers were among the first groups prioritized for the COVID-19 vaccination based on federal guidelines, which states have tailored and implemented.

Some key findings in the data note include:

• Overall, 59% of health care workers are White and 41% are people of color (including 17% who are Black, 14% who are Hispanic, and 8% who are Asian). However, the majority (52%) of workers in long-term care settings are people of color (including 28% who are Black, 15% who are Hispanic, and 6% who are Asian) while 48% are White.
• A large majority (77%) of health care workers are women, and the number rises to 84% in long-term care settings.
• 17% of health care workers are low-income (household income less than 200% of the federal poverty level), with 5% having household income below the poverty level. One-third (33%) of workers in long-term care settings are low-income, including 11% who have household income below poverty.
• 14% of health workers in long-term care are uninsured and about one in five (21%) have Medicaid coverage. Overall, less than one in ten (7%) health care workers are uninsured.
• Eight in ten of health care workers have completed at least some college, while 4% have not completed high school. Among those working in long-term care, six in ten have completed some college, with 10% having less than a high school education.

Media reports indicate some health workers are opting not to be vaccinated, particularly among those working in long-term care facilities, and recent KFF COVID-19 Vaccine Monitor data show that roughly three in ten health care workers (29%) express hesitancy about getting a COVID-19 vaccine. A better understanding of the health care workforce in direct contact with patients can better inform educational efforts and messages about the vaccine to ensure equity in its distribution. Read Key Characteristics of Health Care Workers and Implications for COVID-19 Vaccination for the full findings and discussion.

Despite Optimism about COVID-19 Vaccines in the Future, Half Say They are Frustrated with the Current Situation and Nearly a Quarter are Angry

While older Americans are a high-priority group for getting a COVID-19 vaccine, the latest KFF COVID-19 Vaccine Monitor report finds that, among those who have not yet been vaccinated, most people ages 65 and older say they do not have enough information about when (58%) and where (59%) they will be able to get vaccinated.

Most essential workers, another high-priority group, say they have enough information about where to get a vaccine (55%) but do not have enough information about when they will be able to get vaccinated (55%). This includes some health care workers who have not yet gotten vaccinated and say they don’t have enough information about when they will be able to get vaccinated (21%).

“The Biden administration has been left with a huge challenge on vaccine administration. Most Americans don’t know when or where they can get a vaccine, including older Americans, who are already eligible to get a vaccine in a growing number of states,” KFF President and CEO Drew Altman said. “Understandably large numbers of people are frustrated, angry and confused.”

The findings highlight a key challenge facing public health authorities seeking to get their limited supplies of vaccine into the arms of priority populations. While the priorities differ across states, older Americans and at least some essential workers are high priorities for early phases of distribution across states.

Among the broader public, most who have not yet been vaccinated say they do not have enough information about when people like them will be able to get a vaccine (60%) or about where they can get a vaccine (55%).

Black and Hispanic adults, as well as low-income households, are among the groups least likely to say they have enough information. Within each group, at least two thirds say that they do not have enough information about when they can get vaccinated, and at least 6 in 10 say they don’t have enough information about where to get vaccinated.

Based on the latest Monitor survey fielded during the last days of the Trump administration, the Monitor report finds that about two thirds (65%) of the public rate the federal government’s distribution efforts so far as “fair” or “poor.”

There is a wide gap in how partisans grade the federal government’s performance. Republicans are more than twice as likely as Democrats to say the federal government is doing an “excellent” or “good” job (43% v. 17%), and Democrats are much more likely than Republicans to give negative marks (80% v. 46%). Independents fall in the middle with two-thirds giving the federal government negative marks.

Most Americans also rate their state government’s performance as only fair or poor (60%), though without a partisan divide, as majorities of Democrats, Republicans and independents hold this view.

About half (48%) of the public expects vaccine distribution to “get better” under President Biden’s administration, while most others expect the situation to “stay about the same” (36%). Relatively few (12%) expect distribution to “get worse.”

Democrats overwhelmingly expect improvements under President Biden (83%), as do a plurality of independents (45%). While few (12%) Republicans expect the situation to “get better” under President Biden, most (57%) expect it to stay about the same.

With millions of health care workers, long-term care residents and staff, and older adults across the country already getting vaccinated against COVID-19, most (66%) of the public say they feel “optimistic” that things will get better.

At the same time, half (50%) say they are “frustrated,” a third (33%) say they feel “confused,” and nearly a quarter (23%) say they are “angry,” highlighting the difficulties ahead as the vaccine rollout continues.

While optimism crosses party lines, more Democrats (61%) than Republicans (42%) or independents (48%) say they are frustrated, reflecting their higher levels of concerns about the pandemic. The groups most likely to express confusion about the current situation includes at least four in ten Black adults (46%), those under age 30 (40%), and those with annual incomes under $40,000 (42%).

Other findings include:

• Two thirds (65%) of the public, including most Democrats (70%), independents (64%), and Republicans (59%), are confident that vaccines are being distributed in a way that is fair, similar to the December KFF COVID-19 Vaccine Monitor which found 67% of adults were confident the vaccine would be distributed in a fair manner.
• While most Black adults express confidence that vaccines overall are being distributed fairly, half (52%) say they lack confidence that the needs of Black people are being taken into account. Among Hispanic adults, a significant minority (44%) lacks confidence that the needs of Hispanic people are being taken into account.

Next week, KFF will release new findings on people’s willingness to get a vaccine.

Designed and analyzed by public opinion researchers at KFF, the KFF Vaccine Monitor survey was conducted from Jan. 11-18 among a nationally representative random digit dial telephone sample of 1,563 adults, including oversamples of adults who are Black (310) or Hispanic (306). Interviews were conducted in English and Spanish by landline (287) and cell phone (1,276). The margin of sampling error is plus or minus 3 percentage points for the full sample. For results based on subgroups, the margin of sampling error may be higher.

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.