Nearly a third (31%) of the public says they want to “wait and see” how a COVID-19 vaccine works for others before they would get it, representing a critical group for efforts aimed at boosting vaccinations.

The latest analysis from the KFF COVID-19 Vaccine Monitor highlights how attitudes differ by partisan identification and race and ethnicity in ways that could affect what vaccination messages are most persuasive to subgroups. For example:

• Republicans and Republican-leaning independents in the “wait and see” group are more likely to believe that the threat posed by COVID-19 is exaggerated and that vaccination is a personal choice. Messages that focus on how getting vaccinated can protect people’s own health and the health of their families may resonate more with Republican audiences than those that emphasize the seriousness of the pandemic or the broader societal benefits.
• Black and Hispanic adults who want to “wait and see” are more likely than White adults to worry that someone in their family will get sick from COVID-19 and to express concern about serious side effects. About 3 in 10 also say they are “very concerned” that they could get COVID-19 from a vaccine, suggesting an opportunity to correct misperceptions about how the vaccine works among this group.

Available through the Monitor’s online dashboard, the new analysis also examines how different subgroups in the “wait and see” group respond to messages and information about vaccination and which sources of vaccine information they most trust.

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 unfolds, including vaccine confidence and hesitancy, trusted messengers and messages, as well as the public’s experiences with vaccination.

(This post was updated on February 19, 2021, to reflect recent CMS actions)

The Biden Administration has started the process to withdraw Medicaid work requirement waivers approved by the Trump Administration, as the March 29th Supreme Court oral argument date approaches. Before leaving office, the Trump Administration asked the Court to decide whether Medicaid work requirements are legal. A decision is expected by the end of the term in June – unless the Court agrees that the Biden Administration’s reversal makes the cases moot. The Supreme Court decided to hear the cases after the DC appeals court, in a unanimous opinion written by a judge appointed by President Reagan, affirmed that the HHS Secretary’s approval of Medicaid work requirements in Arkansas was unlawful because the Secretary failed to consider the impact on coverage. The DC appeals court subsequently ruled that its decision in the Arkansas case applied to a New Hampshire case challenging Medicaid work requirements and affirmed that the Secretary’s New Hampshire approval also was unlawful. In addition to work requirements, both cases challenge waivers of Medicaid’s 3-month retroactive coverage requirement. The Trump Administration also approved work requirement waivers in other states, but none is currently in effect, either due to litigation or the pandemic.

What Actions Has the Biden Administration Taken?

A January 28^th executive order from President Biden to “protect and strengthen Medicaid” set the stage for the Biden Administration’s recent actions. The executive order directed HHS to consider whether to suspend, revise, or rescind any policies or waivers that “may reduce coverage under or otherwise undermine Medicaid” as well as policies or practices that “may present unnecessary barriers” to people attempting to access Medicaid. On February 12^th, the Biden Administration sent letters notifying Arkansas, New Hampshire, and other states with approved work requirement waivers that CMS has “preliminarily determined” that work requirements do not further Medicaid program objectives. States have 30 days to provide additional information to CMS that they believe “may warrant not withdrawing” the work requirement authorities. The Biden Administration also removed from Medicaid.gov the Trump Administration guidance that invited states to apply for work requirement waivers.

In its letter to Arkansas, CMS cited data showing that over 18,000 people lost coverage while work reporting requirements were in place there. CMS noted that states cannot terminate coverage for failing to meet a work requirement while receiving the enhanced federal matching funds provided by the Families First Coronavirus Response Act in response to the public health emergency. CMS also said that the COVID-19 pandemic’s impact on enrollee health and the economy creates “serious concerns about testing policies that create a risk of a substantial loss of health care coverage in the near term.” Across states, other data show that most Medicaid adults were working prior to the coronavirus pandemic, albeit primarily in low-wage jobs in industries likely affected by the recent economic downturn. Among those not working, many face barriers such as caregiving responsibilities, illness or disability, and school attendance. Data in Arkansas revealed that issues related to disability and technology were major barriers for eligible people to maintain coverage and navigate work reporting and exemption rules.

What Happens Next in the Supreme Court?

The opening brief setting out HHS’s position in the Supreme Court cases was filed by the Trump Administration on January 19^th, the day before President Biden’s Inauguration. Arkansas and New Hampshire joined the Trump Administration in urging the Supreme Court to reverse the appeals court decisions. Seventeen states, led by Indiana, filed an amicus brief in support of work requirements, and Nebraska filed a separate amicus brief making a similar argument. The answering brief setting out the arguments of the Medicaid enrollees who challenged the Arkansas and New Hampshire approvals has been filed, and amicus briefs in support of the enrollees’ position are due on February 25^th. HHS’s reply brief is due shortly before the March 29^th argument date. Court observers and policymakers will be closely watching the Biden Administration’s subsequent actions now that the process to withdraw work requirement waivers has begun.

President Biden’s January 28th executive order to reopen enrollment in the federal ACA Marketplace from February 15 through May 15, combined with $50 million in federal spending on outreach and education about ACA coverage options, has the potential to reach millions of people who were uninsured prior to or have lost coverage during the pandemic. As of 2019, there were 29 million non-elderly uninsured people, and the majority (57%) were eligible for financial assistance through the ACA Marketplaces (33%) or Medicaid (25%). KFF estimates indicate that nearly nine million uninsured people could be eligible for free or subsidized Marketplace coverage during the new enrollment period. Importantly, these actions to facilitate enrollment in ACA Marketplace coverage will also likely lead eligible low-income people to enroll in Medicaid coverage.

Prior to the pandemic, 7.3 million uninsured people were eligible for Medicaid. Nearly two-thirds of these people are children (27%, or 2.0 million) or adults (38%, or 2.8 million) living in the 36 states in which the ACA Marketplace is federally-operated (FFM) or state-operated but the state uses the federal Healthcare.gov platform (SBM-FP) and will reopen for enrollment under the executive order (Figure 1). During 2020, all but one of the State-based Marketplace (SBM) states reopened Marketplace enrollment due to the pandemic. In response to the reopening of the federal Marketplace, 11 of the 15 SBM states have announced similar enrollment periods.

Under enrollment simplification processes established by the ACA, states must provide a single application for Medicaid, CHIP, and Marketplace coverage, thereby establishing a “no wrong door” application process for ACA coverage. This process means that the Marketplaces will screen or assess individuals’ eligibility for all health coverage programs, including Medicaid and CHIP, and individuals will be enrolled in or referred to the program for which they are eligible regardless of how they apply. Most states utilizing the FFM do not authorize the FFM to make final Medicaid eligibility determinations for most groups, but instead conduct full eligibility determinations for individuals after the FFM assesses them as eligible for Medicaid. The states that operate SBMs typically have a single integrated system through which individuals can apply for and renew Medicaid, CHIP and Marketplace coverage.

In recent Marketplace open enrollment periods, nearly a million people who applied for ACA coverage through the FFM have been assessed eligible for Medicaid, and millions more who apply through SBMs are determined eligible. During the 2020 Marketplace open enrollment period (which closed in December 2019), 836,451 people who applied for ACA coverage through the FFM, or 8% of all applicants, were assessed or determined eligible for Medicaid. The number was down slightly from the 952,049 during the 2019 open enrollment period and much lower than the 1.2 million assessed/determined eligible during the 2016 open enrollment period. Large reductions in funding for marketing, outreach, and in-person enrollment assistance have likely contributed to declines in Marketplace applications and enrollment since 2016. During the 2016 open enrollment period, the last year for which complete data on SBMs was reported, more than 4 million people who applied for coverage through the Marketplace were determined eligible for Medicaid, though that number includes some people who intended to apply for Medicaid and has likely declined in recent years as Marketplace applications and enrollment have stabilized.

Investments in outreach and advertising as well as enhanced funding for in-person assistance to support the new Marketplace enrollment period can also raise awareness of Medicaid and promote Medicaid enrollment. Findings from a consumer survey reveal most people are unaware of ACA-related coverage options, including whether their state has expanded Medicaid, and lack basic information on how to apply. And, many who do apply for Marketplace or Medicaid coverage face challenges with the application process. Expansive advertising campaigns coupled with targeted outreach strategies during the new enrollment period can educate consumers on the availability of both Marketplace and Medicaid coverage. In addition, supplemental funding for federal navigators would enable them to respond more quickly to provide in-person help to both Marketplace and Medicaid enrollees.

While much attention has been paid to the importance of expanding eligibility to the over 2 million people in the Medicaid coverage gap, who currently have no affordable coverage option, it may be possible to make gains in Medicaid coverage by reaching those who are eligible but not enrolled. Ongoing efforts to expand ACA Marketplace coverage may reach some of these individuals.

In recent years, federal and state policymakers have introduced several proposals to lower prescription drug costs in an attempt to respond to the public’s ongoing concerns about high and rising drug prices. As President Biden takes the reins in Washington DC, his administration inherits a handful of final rules advanced by the Trump Administration in its final months related to Medicare, importation, and 340B pricing for insulin and epinephrine. It also seems likely that lawmakers in the new 117^th Congress will push to enact some of the key drug pricing proposals related to Medicare and drug prices more generally that were voted on but not enacted into law in the previous session. In this brief, we provide a status update on these final rules and an overview of key Medicare-related drug pricing proposals supported by President Biden during the campaign that may return to the forefront of health policy discussions in the coming years.

Most Favored Nations Model

In November 2020, the Trump Administration issued an interim final rule implementing the Most Favored Nation (MFN) Model, which is designed to test an approach to lower Medicare Part B drug spending by pegging Medicare reimbursement to the lowest price paid by certain Organisation for Economic Co-operation and Development (OECD) member countries. While the model was slated to take effect on January 1, 2021, implementation has been temporarily blocked by several U.S. district courts,¹  including a preliminary injunction by the U.S. District Court for the Northern District of California based on its ruling that the Trump Administration failed to follow the standard notice and comment rulemaking procedures.² 

According to CMS’s Innovation Center, which was responsible for conducting the model, in light of the preliminary injunction, the MFN model will not be implemented without further rulemaking. This puts the fate of this model in the hands of the Biden Administration, which could choose to move forward with the same policy, but with a standard notice and comment period, modify the design of the model and issue a new proposed rule, or withdraw it. Alternatively, the Biden Administration could choose to work with Congress to adopt legislation to achieve similar goals.

The Biden campaign supported a proposal to use international reference prices in helping set prices for newly-launched specialty drugs. But the Most Favored Nation Model is a different approach to using international prices, in that it would use the lowest price in other selected countries as the amount of Medicare reimbursement for selected Part B drugs nationwide. (Drugs covered by Part B of Medicare include those administered by physicians.) The pharmaceutical industry and others have raised concerns about the potential for this approach to adversely affect patients’ access to medications and to lead to higher prices in other countries. Medicare’s actuaries estimated $85.5 billion in savings from the Trump Administration’s model over its seven-year span, while noting that a portion of savings from the model would be due to reductions in utilization of up to 19% from 2023 to 2027, assuming some beneficiaries would lose access to physician-administered medications.

Removing Safe Harbor for Medicare Drug Rebates

In November 2020, the Trump Administration issued a final rule to eliminate rebates negotiated between drug manufacturers and pharmacy benefit managers (PBMs) or health plan sponsors in Medicare Part D by removing the safe harbor protection currently extended to these rebate arrangements under the federal anti-kickback statute. The rule provides a new safe harbor for discounts passed directly from manufacturers to patients at the point of sale. These provisions are intended to reduce beneficiary out-of-pocket drug spending at the point of sale, increase price transparency, and create incentives for manufacturers to lower list prices.

Removing the safe harbor protection for rebates under Part D was slated to take effect on January 1, 2022. However, a federal district court recently issued a ruling on a lawsuit filed by the PBM industry, which challenged the legality of the rebate rule. The court ruling delayed implementation until January 1, 2023, pending HHS’s review of the rebate rule, and gave the Biden Administration until April 1, 2021 to decide whether or not to defend the rebate rule in court. The Biden Administration has also issued a final rule to delay the effective date of other provisions of the rebate rule that were slated to take effect on January 29, 2021 to March 22, 2021, as part of the Administration’s overall efforts to review new or pending rules issued by the Trump Administration in its final days and weeks. The Biden Administration’s rule also cites the pending litigation and the Administration’s need to evaluate its position on the case as further cause for the 60-day delay.

If the Biden Administration wished to change or undo the rule, it could choose not to defend the rule in the pending lawsuit. The Biden Administration could also undergo new rulemaking to modify or eliminate the rebate rule. This action could be proposed as part of an agreement to settle the lawsuit. New rulemaking also would be needed if the Administration wished to proceed with the rule in some form but the current rule ultimately is blocked by a final court order.

Alternatively, the rebate rule could be blocked through Congressional action, including use of the Congressional Review Act (CRA) to overturn the rule or other legislative action to block implementation of the rule. Using the CRA means HHS could not issue substantially similar regulation in the future, unless Congress authorized it through subsequent legislation. Blocking implementation of the rule through other legislation could offer Congress the opportunity to score savings that could be used for other purposes, based on CBO’s estimate of higher Medicare spending under the rule.

There is some disagreement as to whether and to what extent eliminating rebates in Part D would have the intended effects on out-of-pocket spending and list prices, or would instead result in both higher Part D premiums and higher out-of-pocket drug spending for beneficiaries and increased spending for the federal government. When the final rule was issued, the Secretary of HHS issued a statement that the rebate rule would not increase federal spending, premiums, or out-of-pocket costs. However, both the Congressional Budget Office (CBO) and Medicare’s actuaries estimated substantially higher Medicare spending over the next 10 years as a result of banning drug rebates – up to $170 billion higher, according to CBO, and up to $196 billion higher, according to the HHS Office of the Actuary (OACT). With the loss of rebate revenue, plans are expected to raise their premiums, leading to increased premium subsidies paid by the federal government, resulting in greater overall costs for the Medicare program as well as higher drug plan premiums paid by enrollees. Banning rebates in Part D would not necessarily lead manufacturers to lower list prices, particularly since rebates in the commercial market are still allowed. At the same time, a small group of beneficiaries who use drugs with significant manufacturer rebates could see a decline in their overall out-of-pocket spending, assuming manufacturers pass on price discounts at the point of sale.

Prescription Drug Importation

In Fall 2020, the Trump Administration issued a final rule and FDA guidance for industry creating two new pathways for the safe importation of drugs from Canada and other countries. The first pathway would authorize states, territories, and Indian tribes, and in certain future circumstances wholesalers and pharmacists, to implement time-limited importation programs for importation of prescription drugs from Canada only. The second pathway outlines how manufacturers can import and market FDA-approved drugs in the U.S. that were manufactured abroad and intended to be marketed and authorized for sale in a foreign country. The importation rule was effective November 30, 2020.

President Biden supported prescription drug importation during the campaign. While several states have pursued importation plans, it is unclear how much traction these plans will have moving forward or how far any entities will move down either of the Trump Administration’s pathways for drug importation. For example, while Florida has been at the forefront of this effort at the state level, the state struggled for a time before finding a vender to help implement its program, which limits eligible importers to wholesalers or pharmacists who dispense prescription drugs on behalf of public payers, including Medicaid, the Department of Corrections, and the Department for Children and Families. Colorado also recently initiated a bidding process for venders to help implement its state importation plan, but does not expect to begin importing drugs before mid-2022. Canada has said it will block exportation of certain medicines if they expect a shortage.

Moreover, the final rule authorizing states to create importation programs is the subject of a lawsuit filed by PhRMA and other parties challenging the rule based on safety and other concerns. As of this writing, the Biden Administration’s response to this complaint is still pending. But even if the rule withstands this legal challenge, it is likely to have a narrow impact. And because biologics are excluded from drugs that can be imported, importation plans will not help people struggling with the cost of certain types of drugs – in particular, insulin, which has been the subject of recent congressional investigations and is a frequently sought after medication from abroad.

340B Pricing on Insulin and Epinephrine

In December 2020, the Trump Administration issued a final rule requiring Federally Qualified Health Centers (FQHCs) that participate in the federal 340B drug pricing program to provide qualifying low- and moderate-income health center patients with insulin and injectable epinephrine at the 340B discounted prices. Under the 340B program, drug manufacturers agree to provide outpatient drugs to participating entities at discounted prices. The final rule makes federal grants to FQHCs conditional upon passing on these discounts. The Administration’s stated rationale for this rule was to address affordability concerns for these life-saving medications among low-income patients experiencing financial hardship as a result of the COVID-19 pandemic. However, stakeholders have raised concerns that the rule itself would be administratively burdensome for FQHCs, contribute to financial instability among health centers, and not result in lower drug prices. According to HHS, the rule is expected to have “minimal economic impact.”

While this rule was scheduled to take effect on January 22, 2021, the Biden Administration has delayed implementation until March 22, 2021. This delay gives the new Administration an opportunity to assess whether to move forward with the existing rule or take steps to withdraw it.

Medicare Part D Redesign

In recent years, a growing number of policymakers have expressed concern about the current design of the Part D benefit, which has no cap on out-of-pocket spending for Medicare Part D enrollees and places the burden of financial responsibility for the majority of catastrophic coverage costs on Medicare, not plan sponsors or pharmaceutical companies. During the campaign, President Biden supported adding a cap on out-of-pocket drug costs to Part D, and in the 116^th Congress, there was bipartisan support for proposals to modify the design of the Part D benefit, establish an out-of-pocket spending limit, and reallocate liability for catastrophic coverage costs among Medicare, plan sponsors, and drug manufacturers. This proposal was included in drug price legislation that passed the House of Representatives in December 2019 (H.R. 3), legislation that passed out of the Senate Finance Committee in the 116^th Congress, and a Trump Administration FY2020 budget proposal.

Adding an out-of-pocket spending limit in Part D would provide substantial savings for beneficiaries who have high drug costs, and protect against exposure to high drug costs for those who may need costly medications at some point in time. A hard cap on out-of-pocket drug spending without any other changes to the Part D benefit would increase Medicare spending by shifting costs incurred by Medicare beneficiaries to Medicare (and by extension, taxpayers), but this spending could be offset by reallocating liability for catastrophic coverage costs, reducing Medicare’s share of these costs and increasing the share paid by Part D plans and/or drug manufacturers, as was recommended by MedPAC and included in both the House-passed bill and Senate Finance proposal.

Drug Price Inflation Rebates

During the campaign, President Biden supported a proposal to limit drug price increases to no more than the inflation rate. In the 116^th Congress, lawmakers introduced proposals that would require drug manufacturers to pay a rebate to the federal government if their prices for drugs covered under Medicare Part B and Part D increased by more than the rate of inflation (with the potential to extend rebates to group coverage as well). This proposal was included in legislation passed by the House of Representatives (H.R. 3) and by the Senate Finance Committee, under the chairmanship of GOP Senator Chuck Grassley, though it was not brought up for a floor vote in the Republican-controlled Senate. The Trump Administration’s FY2020 budget included a related proposal that applied inflation rebates only to drugs covered under Part B. The Senate Finance Committee inflation rebate proposal was based on list prices, which do not include manufacturer rebates and discounts to plans (Wholesale Acquisition Cost), while the House proposal was based on Average Manufacturer Price, which may include some discounts to wholesalers but not rebates paid to plans and PBMs.

CBO estimated 10-year savings from the drug inflation rebate provisions amounting to $36 billion for H.R. 3 and $82 billion for the Senate Finance Committee legislation; 10-year savings would be lower under H.R. 3. because the inflation provision would not apply to drugs subject to the government negotiation process that would be established by that bill. KFF analysis indicates the potential for significant savings if drug manufactures limited price increases to the rate of inflation or paid a rebate to the federal government. Medicare beneficiaries could also benefit from such a policy because cost sharing under Part D often comes in the form of coinsurance (and always does in the case of Part B drugs), which is calculated as a percentage of the list price. The magnitude of actual changes in spending would depend on several factors, including the drugs to which the policy applies, the price measure used to compare against inflation, and the base year used for calculating rebates, as well as how drug companies respond. If drug manufacturers respond to the policy change by increasing launch prices for new drugs, some Medicare beneficiaries could face higher out-of-pocket costs for new drugs that come to market, with potential spillover effects on costs incurred by other payers as well.

Because this approach to lowering drug costs is supported by President Biden, and had some measure of bipartisan support in the previous Congress, it might have somewhat better prospects in the 117^th Congress with Democrats controlling both the House and the Senate, even with narrow majorities.

Medicare Drug Price Negotiation

During his campaign, President Biden expressed support for allowing the federal government to negotiate drug prices in Medicare Part D and for other payers, which is currently prohibited under the so-called “non-interference” clause. This proposal has strong bipartisan public support and was a key feature of H.R. 3, the drug price legislation passed by the House of Representatives in December 2019. (The Senate Finance Committee did not include a similar provision in its bipartisan drug price legislation.) Under H.R. 3, the HHS Secretary would be given authority to negotiate prices for between 50 and 250 drugs without market competition, with an upper limit based on prices in a set of foreign countries. The negotiated price would apply to both Medicare and commercial payers.

CBO estimated over $450 billion in 10-year (2020-2029) savings from the Medicare drug price negotiation provision in H.R. 3., including nearly $450 billion in savings to Medicare and $12 billion for private health insurance. A separate CBO estimate of the same Medicare drug price negotiation provision included in a separate House bill in the 116^th Congress (H.R. 1425, the Patient Protection and Affordable Care Enhancement Act) estimated higher 10-year savings of nearly $530 billion, mainly because the Secretary would negotiate prices for a somewhat larger set of drugs in year 2 of the negotiation program under H.R. 1425 than under the version of H.R. 3 that CBO scored (50 vs. 25 drugs).

While CBO expects that the lower drug prices resulting from allowing the federal government to negotiate drug prices would lead to lower beneficiary premiums and cost sharing, CBO also expects that this policy would lower revenues for drug manufacturers, lead to higher drug prices in other countries, and lead to a modest reduction in the number of drugs coming to market in the future, due to the loss in revenue for drug manufacturers. This proposal would require a change in the law, which could be challenging in the current legislative environment, given that drug price negotiation proposals have not garnered bipartisan support among lawmakers. Republican lawmakers historically have been opposed to this proposal, and it has also faced stiff opposition from the pharmaceutical industry.

Conclusion

Drug costs are likely to remain a significant concern for patients. A relatively narrow Democratic majority in the House and even narrower majority in the Senate could make major legislative action on this issue difficult in the upcoming Congressional session. And yet there may be room for proposals that have garnered bipartisan support, such as adding a cap on out-of-pocket spending under Part D and imposing limits on drug price increases. In addition, given concerns among some lawmakers about the rise in federal spending, lawmakers could look more favorably on proposals that lower federal Medicare spending, or potentially use these savings to fund other priorities. Support from President Biden might provide the momentum needed to get these proposals over the finish line.

Regardless of what happens in Congress, the door is open for executive action on drug prices from the Biden Administration, including the introduction of new drug pricing models through CMS’s Center for Medicare & Medicaid Innovation, though these efforts may be complicated by Trump Administration initiatives currently tied up in court. While prescription drug proposals are likely to take a back seat in the short term to addressing the COVID-19 pandemic and economic stimulus and recovery efforts, it seems reasonable to expect more executive action on drug prices, and for the Biden Administration to support whatever bipartisan legislative efforts emerge.

1. In another case, the U.S. District Court for the Southern District of New York temporarily prohibited the federal government from applying the rule to a single drug (EYLEA), manufactured by Regeneron Pharmaceuticals. ↩︎
2. The Northern District of California case has been stayed until April 23, 2021, at which point the parties will update the court on whether to continue the stay, allow the lawsuit to proceed, or dismiss the case. In another case, the U.S. District Court for the District of Maryland entered a temporary restraining order prohibiting implementation of the rule until January 20, 2021. The parties agreed to stay the Maryland litigation until a final rule based on the interim final rule is published, provided that the federal government does not seek to have the California court’s preliminary injunction overturned on appeal. If the federal government decides to rescind the interim final rule or otherwise decides not to proceed with it, the parties must notify the court. ↩︎

A new KFF analysis finds that across 46 PEPFAR countries and among six different indicators of progress, the majority (40) has met at least one target, 17 countries have met at least half of the targets, and one country has met five targets. No country has met all targets and six have not met any target.

The analysis is part of a dashboard that provides a detailed look at progress being made to address the HIV/AIDS epidemic in countries where PEPFAR operates and will be updated over time. It examines six different indicators of progress, including PEPFAR’s epidemic control target (the point at which the total number of new HIV infections falls below the total number of deaths from all causes among HIV-infected individuals), UNAIDS global “90-90-90” targets (90% of people living with HIV know their status, 90% of people who know their status are accessing treatment, and 90% of people on treatment have suppressed viral loads), and two other HIV incidence-based targets.

This dashboard pulls together the latest available country data to make it easier to assess where countries stand in their progress toward achieving global HIV/AIDS targets.

The dashboard also highlights the 13 high-burden countries targeted by PEPFAR and key trends over time. In the 13 high-burden countries targeted by PEPFAR, the analysis found that only a few have met global targets, but most countries have made improvements over time. While PEPFAR may be the largest donor government program in many countries, it does not work in isolation and numerous actors also contribute to the HIV/AIDS response.

This dashboard reflects all 46 countries’ progress prior to the COVID-19 pandemic, which could impact their progress in the fight against HIV/AIDS and PEPFAR’s response.

As the COVID-19 vaccination program has rolled out nationwide, state data has continued to document that racial and ethnic disparities continue to exist between coronavirus cases and deaths in communities of color and the rate at which Black and Hispanic adults are being vaccinated when compared to their White counterparts. Beyond the physical mechanics of distribution to communities of color, surveys suggest there also seems to be an information flow problem. In the January report from the KFF COVID-19 Vaccine Monitor, six in ten of those who have not yet been vaccinated against the coronavirus say they do not have enough information about when people like them will be able to. An additional majority (55%) of those who are not yet vaccinated say they don’t have enough information about where they will get a COVID-19 vaccine.

This lack of information is particularly disparate among Hispanic and Black adults when compared to White adults. About six in ten Black (62%) and Hispanic (63%) adults say they do not have enough information about where to get a COVID-19 vaccine, compared to about half of White adults who say they do not enough information (51%).

Source

KFF COVID-19 Vaccine Monitor: January 2021

Throughout the COVID-19 pandemic and resulting economic crisis, about 4 in 10 adults nationwide have reported symptoms of anxiety or depressive disorder – a four-fold increase from pre-pandemic levels.

Drawing on the latest national survey data, KFF polling and other research, an updated brief explores what’s known about the pandemic’s impact on people’s mental health and substance use and its implications for Americans’ well-being.

Among the key conclusions:

• Young adults have been especially hard hit. Those ages 18-24 are about twice as likely as all adults to report new or increased substance use (25% vs. 13%) or recent suicidal thoughts (26% vs. 11%).

• More women than men are facing mental health challenges. As in the past, during the pandemic, women have been more likely to report symptoms of anxiety and/or depressive disorder (47% vs. 38%).

• People experiencing job or income losses are at higher risk for mental health problems. Adults in households that experienced job losses or reduced incomes report higher rates of mental health symptoms than other households (53% vs. 32%). This is consistent with research around prior economic downturns.

• Essential workers face greater challenges than other workers. Essential workers, who work outside their homes where they could be exposed to COVID-19, are also more likely than non-essential workers to report symptoms of anxiety or depressive disorder (42% vs. 30%), increased or new substance use (25% vs. 11%), or recent suicidal thoughts (22% vs. 8%).

• Communities of color are disproportionately affected. Non-Hispanic Black adults (48%) and Hispanic or Latino adults (46%) are more likely to report symptoms of anxiety or depressive disorder than White adults (41%).

KFF also has compiled state-specific data on mental health and substance use on more than 20 indicators, with mental health state fact sheets available profiling each state.

What is it?

The “Ending the HIV Epidemic Initiative: A Plan for America” (EHE) is a federal effort to reduce new HIV infections in the United States by 75% in five years and by 90% in ten years and includes four “pillars”: diagnose, treat, prevent and respond (see below). It was launched by the Trump Administration in 2019, building on efforts made by the Obama Administration; President Biden has also expressed commitment to “ending the HIV/AIDS epidemic by 2025” and signaled that they will continue the initiative. However, it remains to be seen if the new administration will make changes to the EHE. In addition, because of the COVID-19 pandemic, HIV programs in general, and the EHE effort, have been slowed down.

Where are the targeted jurisdictions?

During “Phase 1,” the initiative runs from 2020-2025 and focuses efforts on the regions hardest hit by the HIV epidemic. Its reach extends to the 48 counties that had the highest number of HIV diagnoses between 2016 and 2017, as well as San Juan, Puerto Rico, and Washington D.C. It also focuses on seven states with a substantial rural burden. More than 50% of HIV diagnoses in the US occur in these 48 counties, D.C., and San Juan.

Phase II of the initiative is set to begin in 2026 during which EHE efforts will be more widely disseminated across the nation and Phase III will focus on providing care and treatment and intensive case management aimed at keeping the number of new HIV infections below 3,000 per year.

How is it Funded?

The commitment to “ending the HIV epidemic” has been accompanied by additional federal funding, including with reprogrammed FY 2019 funding and new Congressional appropriations in since FY 2020. Funding in FY 2019 consisted of a small number of grants reprogramed from the Secretary’s Minority AIDS Initiative (MAI) fund, totaling $35 million, to launch the initiative. The first influx of new funding, through congressional appropriations, was provided in FY 2020, totaling $266 million and that level has increased each year, now with the FY 2023 level totaling $573.25 million. (See Table 1)

Agency funding is distributed via grants to the targeted jurisdictions, as well as to support related efforts. For additional detail, see our EHE funding tracker.

It is important to note that while EHE funding represents a significant increase for certain agencies, it still accounts for a relatively small share of total federal HIV funding provided to state and local jurisdictions. For a fuller accounting of such funding, see our state HIV funding tracker.

What are the EHE goals? What is the plan to meet them? And can they be met?

The goal of the EHE is to reduce new HIV infections by 75% in five years and by 90% in ten years. If successful, it is estimated that this would avert an estimated 250,000 new infections.  

There are four “pillars” to the initiative that serve as a road map for achieving EHE goals:

• Diagnose: Currently, 14% of people in the United States with HIV are unaware of their infection and 40% of all new HIV infections result from someone who did not know they were HIV positive. This strategy pillar seeks to diagnose all people in the US as soon as possible after infection.
• Treat: HIV Treatment is important for optimal individual health outcomes and harnessing the benefits of “treatment as prevention”– that is when someone is virally suppressed, they cannot transmit HIV to others. This pillar aims to treat people with HIV rapidly after diagnosis to help achieve and maintain viral suppression.
• Prevent – While the rate of new HIV infections has slowed since its peak, progress has stagnated in recent years and racial disparities persist. The prevent pillar seeks to use proven prevention interventions to stop new HIV infections from occurring with a specific focus on bolstering PrEP uptake.
• Respond – The respond pillar is focused on rapidly responding to potential HIV outbreaks to disseminate prevention and treatment services as needed and in part relies on harnessing public health strategies, such as molecular surveillance.

The EHE goals are ambitious and the strategy to reach them is grounded in science, yet one model suggests that the goal of reducing new infections by 90% in ten years “is likely unachievable with the current intervention toolkit.” However, these researchers also note that while the goals may not be fully realized, HIV infections could be reduced by up to 67% with higher levels of engagement in care and increased PrEP uptake.

What is the process for determining local-level activities?

In Phase 1, the initiative focus is on areas where HIV transmission occurs most frequently or disproportionately. As such, HHS is working to provide these jurisdictions with “resources, expertise, and technology to develop and implement locally tailored EHE plans.” Locally-focused plans mean that jurisdictions can adjust their efforts to meet local cultural and epidemiological needs. For example, a jurisdiction hard hit by the opioid epidemic might make addressing this a central theme in their EHE plan, but such a focus might not be appropriate in all areas. However, because of the COVID-19 pandemic, the finalization of these plans was delayed.

How does the EHE fit within the larger policy environment?

The EHE initiative, while grounded in science and public health principles, does not take place in a vacuum. The Trump Administration backed a range of policies that limit health care access (e.g. work requirements in the Medicaid program, support for non-compliant health plans, efforts to repeal the ACA, etc.), remove protections for LGBT people and other minority groups (e.g. remove gender identity and sexual orientation protections from regulations implementing the ACA, implementation of the public charge rule, etc.), and could diminish EHE’s reach and success. The Biden Administration has opposed these policies and pledged to reverse them. While in some cases, executive actions mean these policies can be revered immediately, in others, reversing or rewriting policy can take several months or longer. In fact, President Biden issued an executive order on his first full week in office, aimed at strengthening the ACA, including by reviewing and potentially amending “policies or practices that may undermine protections for people with pre-existing conditions…” Additionally, on his first day in office, President Biden signed a separate executive order building on the Supreme Court’s Bostock v. Clayton County decision, directing federal agencies to include sexual orientation and gender identity in their definition of sex, as possible. These actions could broaden access to coverage, limit noncompliant plans, and renew and expand protections based on sexual orientation and gender identity in health care.

More broadly, our recent analysis explored a range of contextual and structural factors that could mitigate or facilitate EHE progress across the jurisdictions in four areas: policy and legal, socioeconomic, service availability, and overlapping. We find substantial regional differences that may ultimately indicate uneven EHE implementation and progress over time.

What is the relationship between the EHE, the National HIV/AIDS Strategy (NHAS), and the HIV National Strategic Plan?

The National HIV/AIDS Strategy (NHAS) was first introduced by the Obama Administration in 2010 marking the first time US government agencies came together to develop a coordinated approach to addressing the HIV epidemic. It was updated in 2015 and a again in 2020 in the final days of the Trump

Administration, this time rebranded as “The HIV National Strategic Plan”. Prior to his inauguration, on World AIDS Day 2020, then President-elect Biden stated he would “release a new comprehensive National Strategy on HIV/AIDS” but to date details have not been revealed.

Very similar to those outlined in NHAS, the HIV National Strategic Plan lays out four main goals to 1) prevent new HIV infections 2) Improve HIV-related health outcomes of people with HIV 3) Reduce HIV-related disparities and health inequities, and 4) Achieve integrated, coordinated efforts that address the HIV epidemic among all partners and stakeholders.

The Strategic Plan explains, that “The HIV Plan and the Ending the HIV Epidemic: A Plan for America (EHE) initiative are closely aligned and complementary, with EHE serving as a leading component…The EHE initiative is beginning in the jurisdictions now hardest hit by the epidemic. The HIV Plan covers the entire country, has a broader focus across federal departments and agencies beyond HHS and all sectors of society…”.

What might the future hold for the EHE?

There are substantial unknowns around whether the EHE goals can be met and how effective the initiative will be in the short and long term. It is also not clear whether or not the Biden administration will seek to make changes to this initiative but leadership has signaled it will continue. Some key questions include:

• Will the Biden administration continue with the EHE and if so, will it do so in its current form? While the approach of the EHE is grounded in science and has had the support of a range of stakeholders, the Biden administration may want to make their own mark on addressing HIV. They have committed to “building upon…shared achievements and to working with established and new partners to achieve our EHE goals.” The new administration would likely want to incorporate policies that they support and that could help achieve EHE goals that the previous administration opposed such as strengthen coverage opportunities under ACA and adopting protections for individuals based on sexual orientation and gender identity. Indeed, they have stated their approach will center on equity, which is a new take on how to meet the initiative’s goals.
• Will decisions made at local levels in Phase 1 jurisdictions result in different outcomes? As noted, there are underlying contextual and structural factors within each local jurisdictions that will facilitate or mitigate EHE success so disparate outcomes across the nation could occur.
• Will current levels of funding be maintained, expanded, or decreased? The ability to meet the goals of the EHE initiative depends on funding. Congressional allocations for EHE have not matched requests from federal agencies to date and are therefore not likely enough to meet the ambitious goals the EHE sets out. It is uncertain how EHE funding will play out in the current environment but the Biden campaign said they would seek additional funding.
• How might the COVID-19 pandemic and domestic response impact the ability to meet EHE goals? While efforts to roll out EHE have continued despite the COVID-19 pandemic, implementation delays have occurred and HIV providers have faced significant challenges, including in delivering HIV treatment and prevention services. In addition, many federal employees, local health department staff, and front-line workers focused on HIV have been redeployed as infectious disease specialists to address the emerging pandemic. In recognition of these challenges, Congress appropriated additional funding for the Ryan White HIV/AIDS Program and the Housing Opportunities for People with AIDS (HOPWA) program, to assist grantees in preparing for, preventing, and responding to the COVID-19 pandemic.