Equitable and Data-Driven Viral Hepatitis Quality Measures
Viral hepatitis remains a significant public health threat in the United States, affecting approximately 3.3 million people with chronic hepatitis B and C infections. In 2021, there were 12,715 reported cases of chronic hepatitis B (HBV) and 117,105 reported cases of chronic hepatitis C (HCV). Despite the availability of effective treatments, these infections disproportionately impact marginalized communities, including people who inject drugs, those experiencing homelessness, and Black and Indigenous populations. This reality underscores the urgent need for a comprehensive and equitable approach to viral hepatitis care.
Recognizing this challenge, the U.S. Department of Health and Human Services’ (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has issued a call for public comment on proposed viral hepatitis quality measures for Medicaid. This initiative, aimed at supporting the nation's goal of eliminating viral hepatitis by 2030, focuses on a crucial measure: hepatitis C screening and treatment initiation.
OIDP's call for public comment presents a critical opportunity to advance health equity, strengthen data-driven decision-making, and foster collaboration to accelerate progress towards eliminating viral hepatitis as a public health threat. Engaging in this process is essential for ensuring that the final measures effectively address disparities, improve care, and ultimately save lives.
The Landscape of Disparities and the Need for Action
The urgency for action is amplified by the significant disparities that exist in HCV care. Research consistently demonstrates that Black, Indigenous, and people of color, as well as those with lower socioeconomic status, face significant barriers to timely diagnosis and treatment. A study of Medicare beneficiaries found that while disparities in Direct-Acting Antiviral (DAA) use between Black and White patients narrowed by 2016, socioeconomic disparities persisted, with those receiving a Part D low-income subsidy less likely to access these life-saving medications. As the researchers noted, "DAA use among Medicare patients remained far below the level needed to eradicate HCV. The black-white gap in HCV treatment was closed by 2016, but disparities by patient socioeconomic status remained."
These disparities are deeply intertwined with social determinants of health. Factors such as poverty, limited access to healthcare, inadequate transportation, and low health literacy create significant obstacles to receiving quality HCV-related care. As one study aptly pointed out, "A variety of elements contribute to lower quality of care in rural areas, including shortages of medical equipment and services, poor health literacy, lack of transportation, and travel time and long distances."
Quality measures offer a vital tool for dismantling these barriers and fostering health equity. By tracking screening rates, treatment initiation, and outcomes across different populations, quality measures can illuminate where disparities exist and guide targeted interventions. They provide a data-driven framework for holding healthcare systems accountable for providing equitable care and for measuring progress towards eliminating viral hepatitis.
Analyzing the Proposed Measures
At the heart of OIDP’s proposal lies the HCV screening and treatment initiation measure. This measure, designed to track the percentage of Medicaid beneficiaries who receive both timely screening and treatment for HCV, is structured with a clear numerator and denominator. The numerator encompasses those Medicaid members who are screened for HCV and, if diagnosed, initiate treatment within a specified timeframe. The denominator includes all adult Medicaid enrollees within a defined age range, excluding those with evidence of Medicare or third-party insurance coverage.
This measure, viewed through an equity lens, holds immense potential for dismantling the barriers that prevent marginalized communities from accessing life-saving HCV care. By promoting universal screening, the measure encourages a proactive approach to diagnosis, reaching people who might otherwise remain unaware of their infection until they experience serious complications. Furthermore, the focus on timely treatment initiation is crucial for addressing disparities in treatment access. By tracking this metric, healthcare systems can be held accountable for ensuring that all patients diagnosed with HCV receive prompt and effective treatment, regardless of their background or socioeconomic status.
The transcript from HHS’s Viral Hepatitis Quality Measures Technical Consultation Meeting provides compelling insights into how similar measures have been leveraged at the state level to advance health equity. Dr. Su Wang, a clinician and advocate deeply involved in hepatitis care, shared her perspective, stating, "We really believe, those of us who have been doing this clinical work and also advocacy work, that quality metrics can really help us achieve hepatitis elimination by 2030." This sentiment is echoed by the experiences of states like Michigan, which has implemented a suite of HCV quality measures, including those focused on screening during pregnancy and medication adherence. These measures have not only helped Michigan track progress towards elimination but have also provided valuable data for identifying and addressing disparities in care.
Data Considerations
The success of this measure hinges on the feasibility of data collection and the robustness of the data sources used. While claims data, readily available through Medicaid programs, offer a practical starting point for tracking screening and treatment initiation, this source has limitations. Claims data primarily capture billing codes, which may not fully reflect the nuances of clinical encounters or capture social determinants of health that influence care access.
Electronic Health Record (EHR) data, on the other hand, hold a wealth of clinical information that can provide a more comprehensive picture of patient care. As noted during the technical consultation meeting, "There's a lot more information, digitally available through EHRs, health information exchanges, etc. that are readily available and allows us to get closer to real-time measurement and response." Leveraging EHR data could enhance the measure's accuracy and timeliness, enabling more rapid identification of disparities and interventions. However, widespread use of EHR data for quality measurement faces challenges, including variations in EHR systems, interoperability issues, and privacy concerns.
Additionally, capturing the influence of social determinants of health requires going beyond traditional clinical data sources. Integrating data from community organizations, social service agencies, and patient surveys could provide valuable insights into the social and economic factors that shape health outcomes. This multifaceted data approach, while complex, is essential for developing a truly equitable and effective hepatitis C quality measure.
Collaborative Action
The successful implementation of the HCV quality measure demands a collaborative approach that transcends traditional silos and brings together a diverse array of stakeholders. Public health agencies, Medicaid programs, healthcare providers, community organizations, and, most importantly, patients themselves must be actively engaged in the process.
The transcript from the technical consultation meeting showcases inspiring examples of collaborative action from states at the forefront of viral hepatitis elimination efforts. In Pennsylvania, the Department of Human Services (DHS) and the Department of Health (DOH) forged a strong partnership to drive their elimination plan, recognizing the critical role of Medicaid in reaching those most impacted by HCV. As Lauren Orkis, HBV supervisor at the Pennsylvania DOH, emphasized, "Our Medicaid partners are absolutely critical in our elimination planning efforts, statewide. So we made the partnerships strong between DHS and DOH in Pennsylvania from the get-go as we got our elimination plan underway."
Similarly, Washington State's Bree Collaborative, a legislatively mandated group focused on quality improvement for Medicaid, exemplifies the power of multi-stakeholder engagement. This collaborative, which includes representatives from various sectors, has been instrumental in developing and recommending quality measures for a range of health issues, including HCV. By bringing diverse perspectives to the table, these collaborative models foster innovation, ensure buy-in from key stakeholders, and pave the way for effective implementation.
Conclusion
OIDP's call for public comment on proposed viral hepatitis quality measures presents a defining moment in the fight against this silent epidemic. By engaging in this process, we have the power to shape measures that not only track progress but also drive meaningful change, reduce disparities, and improve the lives of millions. Let us seize this opportunity to advocate for equity, data-driven decision-making, and collaborative action.
Submit your comments, raise your voice, and join the movement to eliminate viral hepatitis. Together, we can ensure that quality measures become powerful tools for achieving health equity and creating a future where viral hepatitis is no longer a threat to our communities. The path to elimination is within reach, and quality measures, shaped by our collective voice, can light the way.
Community Roundtable Defines the Shape of Public Health Advocacy Amid COVID-19
Last week, Community Access National Network (CANN) hosted its annual Community Roundtable event, like last year, focused on the impacts of COVID-19 on public health programs and patient advocacy around HIV, viral hepatitis, and substance use disorder. CANN’s President & CEO (your’s truly) was joined by Kaiser Family Foundation’s (KFF) Director of LGBTQ Policy, Lindsey Dawson, and Georgetown University’s Katie Keith. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmaceutical companies, and federally or state funded service providers. The virtual event was sponsored by ADAP Advocacy Association, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and ViiV Healthcare.
I welcomed attendees, noting my own professional admiration for both Lindsey and Katie, as experts leading in education on policy issues and data analysis around issues affecting communities highly impacted by HIV, viral hepatitis, and substance use disorder. Prior to co-presenters introducing themselves, audience members were reminded both KFF and Georgetown University are both non-partisan, education entities. The impetus and aims of this year’s event in including these astounding co-presenters was to help define the ecosystem of public health affecting programs particularly serving patient communities CANN serves.
Lindsey’s presentation offered a “potpourri” of relevant data regarding AIDS Drug Assistance Programs and Ryan White Funding stagnating, tele-PrEP, the federal Ending the HIV Epidemic (EHE) initiative, Medicaid programs, and LGBTQ people’s health outcomes (especially mental health) throughout the pandemic thus far. Reviewing previously published KFF data and briefs, Lindsey reminded attendees that federal appropriations for HIV programs have largely stagnated for more than a decade and, when adjusted for inflation, have fallen. Despite the federal EHE initiative, seeking to jump start the country’s stagnating HIV progress, does not meet the funding requests of advocates. Large doubt remains as to exactly how much can be done with how little has yet to be given. For good reason, the audience was asked to consider if the existing roadmap is the “right” roadmap and what EHE might need to look like in the coming years in order to meet the goals of the initiative. Lindsey reminded attendees that 36% of PLWH live in Medicaid non-expansion states, including Georgia (which just last week shut down a proposal to expand the state’s Medicaid program to PLWH under a waiver). Moving onto a particular point with regard to access to care, tele-PrEP program successes (and weaknesses) could be attributed to flexibilities which have been the direct result of early policy answers to COVID-19. These flexibilities are among policies patient and provider communities stand to lose when the public health emergency comes to an end, unless legislators take action. Wrapping up her presentation, Lindsey drew attention to the health outcomes affecting a highly impacted patient population, LGBTQ people. Data from KFF showed LGBTQ people were more likely have received a COVID-19 vaccination series, more likely to consider COVID-19 vaccination a duty to community and others in an effort to help keep healthy, and more likely to have experienced negative mental health outcomes as a result of the pandemic.
I followed Lindsey’s presentation discussing the landscape of patient advocacy in the age of COVID. Recognizing COVID-19, despite any sentiment of the public at large, is not “over”. Considerations regarding in-person attendance to events, meetings, and travel are still in flex. Also recognizing the political landscape has significantly soured relative to “public health” in general, even if not to HIV, viral hepatitis, and substance use programs specifically, and that dramatically impacts both court rulings and legislators’ willingness to consider the crucial role “legacy” public health programs play in maintaining the health of the nation. Cautioning against potential neglect, rather than support (so much for the “heroes” of the early epidemic), I reminded audiences of the power of in-person events and the need to weigh precautions and monitoring of COVID transmission metrics when planning in-person events, regardless of how big or small they may be. Further on, the presentation focused on the structure of effective advocacy via storytelling, personalizing experiences, providing supporting data to make those personal experiences tangible among a constituency, defining an “ask” by knowing the mechanisms of action (re: actionable policy), and readily recognizing the powers, humanity, and limits of an advocate’s audience.
The final presentations, provided by, Katie Keith, reviewed historical and anticipated policy changes, including those relative to the Affordable Care Act (ACA) – specifically, the family glitch and section 1557 – and those as a result of early COVID-19 legislation, much of which is quickly coming to the end of their legislatively defined program periods, either by specified date or by way of ending the federally declared public health emergency. Katie reviewed how the Biden administration approached some of these issues upon transition to power, having already met 8 of the policy requests of advocates, have yet to meet 4 of those requests, and at least 1 request was “in progress” with potential for administrative resolution any day now (section 1557 final rule re-write, specifically defining the edges of the ACA’s non-discrimination protections. Katie also briefly discussed how the Dobbs (abortion) ruling may impact domestic public health programs, urged attendees to watch Kelley v. Becerra, and urged advocates to closely watch the 2022 midterm elections as legislators have an unbridled ability to impact public health programs.
Panelists wrapped up by reminding attendees they and their organizations remain a readily available resource. The slide deck can be downloaded here.
Pediatric Hepatitis of Unknown Origin: Are Viruses to Blame?
Navigating new and especially concerning developments can be challenging in the day and age of the Internet being the foremost platform for receiving up to date information…and misinformation. Navigating emerging evidence and opinions, prioritizing what “voices” hold prominence in your own formation of ideas can be difficult. I need to emphasize, the most reliable sources of information are official sources, those associated with government and institutions of positive reputation. Even if you have personal distaste for the approach or conclusions of these entities or personalities, their base facts are indeed facts, not conflation or cherry picking. Internet literacy is a critical skill set in navigating the most expedient tool of information. These details are particularly important as medical personnel and public health professionals turn their eyes to the developing issue of pediatric patients presenting with acute hepatitis “of unknown origin”.
At the time of this writing, more than 300 cases had been identified across more than 20 countries and at least 5 children have died. None of the cases being investigated have uncovered typical hepatitis viruses. According to a Centers for Disease Control and Prevention (CDC) brief, many of the cases in the United States have found active adenovirus infections. The CDC’s brief also “ruled out” COVID-19 as a cause. In the United Kingdom however, about 20% have uncovered active SARS-CoV-2 (the virus that causes COVID-19) infections. Other potential causes are being investigated as public health officials at the WHO and across are requesting providers share case data with local health departments in order to aggregate sufficient information.
Using the official CDC Director’s Twitter account, Dr. Rachel Walensky shared recently issued guidance to providers. The responses from users claiming a variety of expertise expressed concern at the CDC’s declaration that COVID-19 is not a potential cause for these cases. For these users, and likely parents watching the issue hit various news outlets, the omission of a potential for post-COVID responses seems odd and without an explanation and clarity as to investigative processes taken, doesn’t do a whole lot for repairing already deeply damaged public trust. Indeed, all of the readily available links on the issue from the CDC’s website exclusively point toward adenovirus, undermining the nature of investigative efforts to explore multiple potential causes. In contrast, the UK’s governmental updates outline why the COVID vaccine has been ruled out: most children affected are too young to have received the shots (the CDC’s briefing does not include this statement). The United Kingdom Health Security Agency’s latest update on this issue can be found here.
Part of why COVID is suspected is because of some of the unique features of the virus. A growing body of evidence is finding “pieces” of SARS-CoV-2 in a variety of body tissue, not just the lungs or brain as has been readily covered in other reports. One of the most persistent theories being tossed around includes hepatitis (generally, inflammation of the liver) as an issue of “long COVID” or a type of “post-viral” syndrome as a result of COVID infection. Part of the reason for that leap is SARS-CoV-2 has a special propensity for causing cell-to-cell fusion, resulting in “giant” cells with multiple nuclei and allowing the virus to spread in a body in an unusual fashion, evading the immune system. An additional concern is the issue of SARS-CoV-2 “superantigens” or a pathogen that “hyper-stimulates” immune responses. In one theory, currently being investigated, the super-antigenic effects of a COVID infection are being looked at as to the potential causation of multisystem inflammatory syndrome in children (MIS-C). Indeed, the issue is of such concern researchers have submitted to the Lancet (a leading scientific journal regarding infectious disease) an article urging providers to appropriately test tissue samples beyond blood in order to rule out potential long-lasting but harder to detect impacts of a SARS-CoV-2 infection.
Regardless of particular cause, at this stage, parents concerned about their children’s health should be aware that acute hepatitis tends to present similarly to most gastrointestinal bugs; abdominal pain, fever, vomiting, and nausea are common. Jaundice of the skin and eyes and darkening of urine are very key indicators something severe is occurring and needs immediate medical attention. Parents should contact their child’s provider if their children are expressing concerning symptoms.
Community Roundtable Emphasizes Impacts of Covid-19
In late June, Community Access National Network hosted a virtual Community Roundtable on Covid-19’s Impacts on HIV, Viral Hepatitis, Sexually Transmitted Infections, and Substance Use Disorder. CANN’s policy consultant (yours truly) was joined by A. Toni Young, founder and executive director at Community Education Group, and Kenneth Westberry, senior manager of policy and government relations at the National Coalition of STD Directors, in discussing the wide-reaching impacts of the Covid-19 pandemic and subsequent public health emergency on the nation’s longest and most well-funded public health service providers…so far. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmseutical companies, and federally or state funded service providers from 20 states and the District of Columbia. The event was sponsored by ADAP Advocacy Association, ViiV Healthcare, Abbvie, Merck, and Janssen Pharmaceutical Companies of Johnson & Johnson.
Toni started off a whirl wind of information with making direct comparisons between the previous year’s overdose death rates and this year’s and emphasizing the plight of West Virginia by comparing the nation’s increases to the state’s. This opened the roundtable with a clear message that would ring through with every new data point: the pandemic’s impacts are not equal. Building upon the point made in a blog post earlier this year, Toni pointed to a stark decrease in HCV screening and, more pointedly, reviewed available data on HCV medication access – showing a decrease of 37-48% during the first few months of the public health emergency. She warned listeners not view initial lower incidence rates as optimistic, rather these findings should be viewed under a lens of a lack of access to screening and services. She further stressed the lack of SUD services accessed at the beginning of the pandemic resulting in alarming increases in injection drug use-related HIV diagnoses as a year over year trend with 2021 looking even more worrisome. Rounding out this segment of the roundtable, Toni cautioned attendees: we have good reason to believe screenings will not necessarily return to their pre-pandemic levels in a speedy fashion or without additional effort and funding.
I followed Toni’s dynamic presentation, picking up with the Centers for Disease Control and Prevention surveillance reports for 2015-2019 – reminding the audience federal level data often lags by two years and the CDC has already presented data for 2020 on fewer HIV tests being performed. This portion of the presentation highlighted disparities in HIV along geography, racial and ethnic lines, as well as sex assigned at birth. I needed to note: gender identity is not uniformly collected data in HIV surveillance. The CDC’s pre-exposure prophylaxis data was similarly…unfortunate. With right around 10% for Hispanic/Latino people identified as living at risk for HIV receiving PrEP services and medication in 2018 and just over 6% of African American/Black people living at risk for HIV receiving PrEP services and medication in the same year. Similarly, people assigned male at birth were more likely than people assigned female at birth to have access to PrEP. Looking to the pandemic, I cited two Kaiser Family Foundation reports one on the similar disparate impacts between HIV and Covid-19 among racial and ethnic communities compared to their white peers and the other on Covid-19’s impact on Ryan White service providers. The KFF reports showed service providers reporting an increase in patients without insurance or receiving Medicaid, some clinics reporting a decrease in patient retention and other reporting increases in patient retention, and clinics reporting a decrease in patient demand for HIV screenings and accessing PrEP services.
The final presenter, Kenneth Westberry, began by giving a brief overview of the state of STI’s as public programming: a steady increase year over year in reported STI incidence, a lack of significant funding increases in the last 15 years, and nearly 40% of clinics reporting a decrease in hours or closing entirely during the height of Covid-related restrictions. Of the particular burdens, Covid-19 brought state and local health departments, nearly 80% redeployed their staff from STI programming to Covid-19 programming, reducing capacity to manage STI caseloads, and facing an unprecedented lack of testing supplies as manufacturers also refocused on making Covid-19 tests. Kenneth then reviewed the findings of NCSD’s surveys seeking to evaluate the state of STI programs (phase I, phase II, and phase III) showing many health departments are still behind in terms of having enough staff to meet the needs of both Covid-19 as a public health emergency and regular STI programs.
Moving onto the nuts and bolts of the federal response to Covid-19, Kenneth highlighted the role of disease intervention specialists historically and in response to Covid-19, answering the “why” the Biden Administration’s change in stature toward the pandemic was critically necessary. Particularly, the American rescue Plan Act added $1.13 billion to expand and sustain current DIS and the President’s budget request includes an increase in funding for STI programs in addition to current spending levels.
The three panelists then spent a brief amount of time discussing the funding weaknesses exposed by Covid-19 diverting resources. In a particular “shot across the bow”, Toni stated “Health departments and appropriators have learned Ryan White dollars aren’t sacrosanct anymore. If the emergency is big enough, they can grab those monies,” urging advocates to keep on their toes and watch actions at the state and local as much as they do at the federal level. Each panelist also mentioned a need for greater collaboration between “silos” in order to reach the nation’s lofty public health goals with regard to HIV, HCV, STI’s, and SUD.
Panelists wrapped up by highlighting upcoming events for each organization, sharing resources, and once again thanking each other, attendees, and sponsors. The slide deck can be downloaded here.
Future events will be hosted to ensure we’re “tracking what’s on the ground” and connecting community partners with pertinent resources and information.