Travis Manint - Advocate and Consultant Travis Manint - Advocate and Consultant

MPOX and Beyond: Reforming Emergency Response

The MPOX—a smallpox-related virus outbreak of 2022 served as a painful reminder that the United States remains alarmingly unprepared for public health emergencies. In the early stages of the outbreak, CANN highlighted the need for swift action and equitable responses to mitigate its spread and impact. However, mirroring the challenges experienced during previous crises, the response to MPOX was plagued by familiar, deeply concerning failures – sluggish testing rollouts, inadequate communication, and a failure to prioritize the needs of the most vulnerable. A recent Government Accountability Office (GAO) report examining the U.S. Department of Health and Human Services (HHS) underscores these recurring failings, emphasizing systemic and persistent weaknesses continue to jeopardize the nation’s response capabilities. New data from the Centers for Disease Control and Prevention (CDC) indicates a troubling resurgence of MPOX cases, with this year's infection numbers already close to double those seen in 2022. If we fail to heed the lessons learned from the MPOX response and the countless warnings that emerged throughout past outbreaks, we risk even greater health inequities and unnecessary suffering in the next inevitable crisis.

GAO Report Highlights Recurring Crisis Weaknesses

GAO’s report on the MPOX response offers a damning indictment of the nation's emergency preparedness, concluding that "persistent gaps" continue to undermine effective responses to public health crises. Among the most critical failures exposed by the report were severe delays in scaling up testing capacity and a lack of clear and consistent communication from HHS. The report emphasizes that "delays in testing capacity...limited the ability to understand the scope of the outbreak," hindering efforts to target resources and protective measures effectively. Similarly, the absence of a cohesive HHS communication strategy led to confusion and mistrust, ultimately slowing the rollout of vaccines, treatments, and preventative information needed to contain the spread. GAO's Mary Denigan-Macauley underscored this reality on the GAO Podcast: "So communication is key. Who's being infected by this?... They also needed to make sure that they knew exactly how much of the vaccine was coming, because we don't have an unlimited supply…Some officials said CDC's risk communication at the beginning of the mpox outbreak did not clearly identify those who were most at-risk for mpox (men who have sex with men) and the most common mode of transmission (sexual contact).”

The GAO report goes beyond the specific issues surrounding the MPOX response to stress the recurring nature of these problems. Notably, HHS faced challenges with delays in testing capacity, communication hurdles, and a lack of interagency coordination – problems that directly mirror those seen in previous public health emergencies. The GAO criticizes the lack of a centralized, coordinated approach: "HHS–as the designated lead for the federal public health and medical response to emergencies—does not have a coordinated, department-wide after-action program to identify and resolve recurring emergency response challenges." This lack of a cohesive strategy and failure to learn from previous outbreaks has grave implications, with the GAO warning that it "may affect the department’s ability to respond to future emergencies that could be more infectious and lethal than mpox."

Community Impacts

The systemic failures highlighted in the GAO report weren't merely abstract concepts; their consequences were acutely felt within affected communities. The podcast analysis we conducted amplified concerns related to the very same issues raised by the GAO. Speakers emphasized how access barriers and limited testing, particularly within marginalized communities, exacerbated the spread of MPOX. Additionally, the lack of clear and inclusive messaging perpetuated harmful stigma, causing significant delays in people seeking testing or treatment.

Failures during the MPOX response didn't affect everyone equally. CDC’s data reveals significant disparities in MPOX case rates along the lines of race, ethnicity, and gender. Hispanic/Latinx and Black/African American people were disproportionately impacted. Underscoring the urgency of addressing this disparity, the CDC highlighted the reality that: as of April 2023, 78% of Black persons and 75% of non-Hispanic American Indian or Alaska Native (AI/AN) persons remained unvaccinated against MPOX. The CDC further states, "Achieving equitable progress in JYNNEOS vaccination coverage will require substantial decreases in shortfalls among Black and AI/AN persons." These disparities underscore the inequities at the heart of the U.S. healthcare system and crisis response mechanisms. The MPOX outbreak is merely a symptom of this larger systemic failure, demonstrating how pre-existing disparities create vulnerabilities that worsen the impact of any public health emergency.

The Need for Reform

The GAO analysis goes beyond identifying the problems to offering concrete recommendations. To prevent these same systemic failures from hindering future public health responses, the GAO calls for two key changes:

  • Coordinated After-Action Program: The creation of a department-wide after-action program within HHS that would systematically and centrally analyze the lessons learned from each crisis. This program would ensure a comprehensive and coordinated understanding of recurring problems, essential to developing effective solutions.

  • Stakeholder Involvement: The GAO emphasizes the importance of including "relevant external stakeholders", in these after-action reviews. This inclusion of community voices, public health experts, and other critical partners would bring diverse insights into the analysis, ensuring that solutions are comprehensive and address the on-the-ground needs that can often be missed in a purely bureaucratic approach.

Key Takeaway: The GAO's analysis highlights that the failures during the MPOX outbreak aren't isolated incidents but symptoms of systemic weaknesses within the nation's emergency preparedness systems. Unless these weaknesses are addressed with coordinated reform, the nation remains vulnerable to ineffective and inequitable responses to future health threats.

Case Surge: A Warning Sign

The specter of MPOX looms large once again. As of this writing, MPOX cases in the U.S. have nearly doubled compared to the same period last year. This surge, particularly in regions like New York City, DC/Virginia, California, and Florida, underscores the continued vulnerability to MPOX outbreaks and highlights the urgent need to address the root causes of the persistent failures observed during the 2022 outbreak. Complacency in the face of this surge poses a danger, especially given the devastating outbreak in the Democratic Republic of Congo (DRC).

The DRC is experiencing its largest ever MPOX outbreak, with about 400 suspected cases reported each week – the majority in children. This outbreak presents a "triple threat": a deadlier strain of the virus circulating with a fatality rate of nearly 1 in 10, alongside the virus' spread into new areas, new populations (including sex workers), and in new ways – including sexually – and evading diagnostic tests. This crisis emphasizes the need for global cooperation and proactive solutions to prevent the spread of deadlier strains and future outbreaks.

Beyond MPOX: Systemic Failures Demand Systemic Change

On the heels of the COVID-19 pandemic, the MPOX outbreak of 2022 was further evidence that recurring failures and persistent inequities within the U.S. healthcare system leave the nation dangerously unprepared for public health emergencies. The GAO's critical report highlights a chronic reliance on reactive crisis management and failures in coordination, directly contributing to the ineffective MPOX response. While containing MPOX remains important, the nation cannot afford to repeat the mistakes of the past. The GAO's call for a coordinated after-action program and stakeholder inclusion offers a starting point for the reforms needed to address these systemic weaknesses.

These recommendations aren't abstract ideals but a roadmap to protect public health, especially for the most vulnerable in our society. In order to effect change, policymakers, healthcare organizations, and all stakeholders must prioritize the following for effective crisis preparedness:

Recommendation 1: Proactive Preparedness

The GAO report highlights a chronic reliance on reactive crisis management, condemning the tendency to delay action until a health threat has escalated. To break this dangerous cycle, we must advocate for a shift towards data-driven early detection and proactive response planning. Investing in innovative surveillance and data systems is critical. As Mary Denigan-Macauley states, "It really wasn't until the White House stepped in and took control that... it became a better response from the federal government." We cannot afford to wait for the next crisis to strike before mobilizing the resources needed for timely intervention. And we can’t afford for agencies such as HHS to wait for the White House to react to a crisis. Policymakers should consider carefully how to equip agencies and subject matter experts to respond and act in the best interest of the nation and humanity when next public health crisis emerges.

Recommendation 2: Community-Centered Response

Public health experts and CDC data illuminate how failing to center the needs of marginalized communities can devastate crisis response efforts. Stigma, lack of culturally-competent communication, and inadequate access to testing and treatment all exacerbated the disparate impact of MPOX. Preparedness plans, communication strategies, and resource allocation must prioritize the specific needs of those historically underserved if we hope to prevent the repetition of such failures.

Recommendation 3: Tackling Systemic Inequities

The MPOX case, like so many public health crises, underscores that systemic inequities are at the root of health disparities. Policy changes are urgently needed to address structural barriers (lack of access, discrimination, etc.) that worsen the impact of outbreaks on vulnerable populations. While the specifics of these changes require development and debate, the World Health Organization emphasizes the importance of global collaboration, investment in health systems particularly in underserved regions, and addressing stigma to ensure an equitable and effective response to future outbreaks.

This focus requires investment, policy reform, and sustained advocacy to dismantle the chronic failures that turn each new health threat into a disproportionate crisis for marginalized communities.

*Editor’s Note: This blog uses the term MPOX to be consistent with CDC and GAO terminology, but CANN's earlier policy materials used the previous designation MPV.

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Jen Laws, President & CEO Jen Laws, President & CEO

A Patient’s Guide to 340B: Why Accountability Matters to You

***This is the third report in a six-part series to educate patients about the 340B Drug Pricing Program***

The word accountable is defined as “being required or expect to justify actions or decisions.” Accountability is often broadly discussed on a variety of levels about governmental and social issues, and the 340B Drug Pricing Program is certainly no exception. The 340B program exists to address the health care needs of a segment of society – social needs. As such, program accountability is of paramount importance since patient health depends on it.

Accountability in use of 340B dollars follows the benchmarks of transparency in reporting: federal grantees are required by contract to demonstrate patient benefit in use of program dollars and non-grantee covered entities are held to no such standard. Without fiscal transparency, non-grantee entities cannot be held accountable for their use of these revenues. The Health Resources Services Administration (HRSA) largely selects covered entities for audit based on a selection of “risk” characteristics. While some criticism of manufacturers is warranted in terms of accountability, manufacturers have only one statutory requirement. That requirement is to provide discounts or rebates on qualifying medications to covered entities. HRSA selects manufacturers for audit based on complaints from covered entities. Areas of complaint about manufacturers typically consist of overcharging a covered entity, not making a particular medication available, or not being transparent about the “ceiling price” of a drug.

To be fair, the statutory accountability requirements of 340B program are…limited and…vague. However, according to a 2020 report by the Government Accountability Office (GAO-20-108), the Health Resources and Services Administration (HRSA) severely lacks meaningful oversight, uniform assessment and request standards, and, as with many other reports, finds HRSA’s administration of the program to be largely inadequate.

As an example, GAO identified HRSA audits from 2017 and 2018 reviewed less than 10% of all non-governmental hospitals enrolled in the program. HRSA primarily relies upon hospitals to self-attest their eligibility. Of the selected hospitals participating in the GAO review, 18 submitted documents that would constitute a government contract – any description of a community program – and when HRSA found these instances, allowed the hospitals to avoid getting in trouble by acquiring contracts with retroactive applicability. All of that meaning, these hospitals in question did not experience any reprimand for failing to provide programming to low-income people but they got to enjoy the perks of unaccountable 340B dollars until they got caught. At the rate HRSA reviews these entities, it’s possible for a non-compliant or otherwise non-qualifying entity could go an entire decade soaking up dollars meant for patients in needs.

While HRSA’s annual 340B audits are primarily targeted toward covered entities, drug manufacturers are also audited to ensure they’re not charging covered entities more than they should be for 340B medications, to ensure drug manufacturers are not discriminating against covered entities, and make sure drug manufacturers are making sure their products are made available in compliance with the 340B program. Manufacturers represent about ten percent of annual audits, while covered entities represent about 90 percent and there are about 900 drug manufacturers participating in the program (dramatically less than covered entities). To be fair, GAO concluded HRSA also needed to provide clearer guidance to drug manufacturers regarding what qualifies as an acceptable distribution restriction due to anticipated or actual supply shortages and to provide specific guidance as to what constitutes “discrimination” of covered entity participants.

This issue of defining discrimination is developing and playing out in “real-time”. In May of 2021, HRSA announced notification letters sent to 6 manufacturers regarding their new policies requiring additional reporting from covered entities with contract pharmacies (as opposed to in-house pharmacies). HRSA’s interpretation of statutory language (“…shall…each covered entity…”) as non-discretionary on the part of manufacturers. In essence, if an entity is registered with HRSA for the program, a manufacturer is required by law to offer medications at ceiling price or below to that entity, regardless of any potential for a covered entity to use program dollars outside of the intent of the program. While skepticism of non-grantee use of these dollars may be warranted due to lack of transparency in use of these dollars, diversion, or duplicate discount concerns, given that federal grantees are already required to report use of these dollars to their federal funders, a more narrowly tailored policy directed exclusively at non-grantee covered entities would be more appropriate to address the interest needs of manufacturers, the public, and program stability. However, given HRSA’s interpretation of the statutory language, even such a proposal might run the risk of rubbing regulators wrong. At the time of this writing, at least one of the manufacturers has sued the Department of Health and Human Services to prevent any monetary penalties related to these letters from being imposed. A judge has dismissed the government’s opposition to the suit in June of 2021. And on September 22, 2021 HRSA issued letters to the manufacturers in question, stating the issue had been referred to the Office of the Inspector General.

Lack of transparency means less accountability. Patients are better served when 340B-related dollars remain within the same geographic area they were generated by the covered entities. After all, if serving low-income patients means serving community and getting usable revenue required to be used on low-income patients, those dollars should be put back into the same community in which they were generated, right? But covered entities with large networks and multiple covered entity sites aren’t required to show those revenues are reinvested in the same area they were generated. For instance, monies made off the health and illness of an Atlanta community should not be spent to buy up profit generating imaging machines in a well-to-do suburban area outside of Los Angeles. But, without both transparency and accountability, 340B dollars can easily become a slush fund of revenues for any industrious non-grantee covered entity.

Indeed, many large contract pharmacies offer software programs to covered entities as a measure of their own “transparency” with internal reporting but the real goal is to show the covered entities “here’s how you can make more 340B dollars” – but at a cost of providing the service and without uniform assessment metrics. That means the contract pharmacy can tilt the experience of a patient by applying pressure to the covered entities very subtly through software programs telling the provider, “You can make more money off this patient by prescribing…”. Advocates have very good reason to be suspicious of contract pharmacies associated with (or even owning) pharmacy benefit managers who, then, can very easily provide programming that targets their profits over ensuring rebate dollars make it back to a patient.

Statutory clarification could greatly benefit the intended purpose of the 340B program – ensuring low-income patients get the care they need by taking a few, simple steps, specifying reporting requirements that mirror existing transparency and accountability found among grantees. Additional oversight is needed in numerous areas, all designed to further benefit patient access to care and medications. Among them, non-grantee entities should be required to report how 340B dollars are being used, by which payer source a claim is generated, how much charity care a non-grantee entity provides, and how much revenue is generated from pharmacy sales (and how much is generated from 340B sales). Patients might not understand the nuances behind the program complexities, but they do understand when they cannot access the care they need and deserve. If the purpose of the 340B program is to expand access to care and medications, then why not go that extra mile?

Congress could go a great deal further to ensure these billions of dollars serve patients, rather than the interests of shareholders in private hospital systems or propping-up senior management compensation packages, or other non-medically-related expenses. Congress could also opt to provide for additional minimum requirements in order to qualify as a covered entity – especially with regard to private hospitals providing a certain percentage of charity care.  

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

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