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.
Improvements to Public Health Guidelines, Despite Covid-19
2022 is off to a roaring Covid-19 start with both mainstream news and scientific outlets focusing on variant development, diversifying vaccines, and the impacts of the pandemic on various aspects of our lives. Last year, Community Access National Network opened our blog with discussing Covid-19’s Impact on HIV, HCV, and Substance Use Disorder and the theme crawled through our public policy discussions of the last year. While the topic is likely to set the frame for all variety of public health and policy throughout 2022, there is a necessity to discuss the developments in our space in spite of the distractions COVID has to offer.
Early 2021 found the Biden administration rescinding the “axe” the previous administration gave to the so-called “X” waiver, a requirement for providers to seek specified training in order to administer buprenorphine based medication assisted treatment for patients experiencing opioid use disorder. While providers and advocates hailed eliminating the X-waiver as a move toward advancing care, reports stated administration officials found problems with the rule as written, calling it “premature”. The Department of Health and Human Services (HHS) would later update treatment guidelines by way of formal notice posted to the federal register on April 28th, expanding eligibility of providers to administer the treatment when they “intend” to treat fewer than 30 patients a year. What enforcement looks like around the word “intent will be an area to watch as this area of public policy develops.
Later in the year, the Centers for Disease Control and Prevention (CDC) updated their Sexually Transmitted Infections Treatment Guidelines, the first overhaul since 2015. While the most significant updates to the guidelines are focused on the treatment of gonorrhea, an area of focus given the bacteria’s penchant for developing resistance to treatment, other highlights include aligning the guidelines with the CDCs 2020 recommendation for universal Hepatitis C screenings and adoption of the Advisory Committee on Immunization Practices (ACIP) recommendation for Human Papilloma Virus (HPV) “catch-up” vaccination schedules for people assigned male at birth. These and other additional updates were made, in part, because the CDC’s 2021 annual report found the United States facing the 6th consecutive year of STI increases.
Among ACIP’s many accomplishments in a year that found the panel meeting nearly twice as often as usual, a November meeting overshadowed by the endorsement of recommending Covid-19 vaccines for 5-11 year olds provided also found ACIP recommending universal adult Hepatitis B vaccination.
In a similar vein to the aforementioned updates (and with much rejoicing from advocates), the White House Office of National AIDS Policy “turned the lights back on” with the appointment of Harold Phillips as Director. Mr. Phillips provided an update to the National HIV/AIDS Strategy, announced in December with a focus on acknowledging structural barriers to achieving goals, including racism, stigma, and violence against transgender women. The plan, however, does not specifically outline ways to address these particularly challenging, systemic issues. President Biden also recognized World AIDS Day with a characteristically frank review of the history this country has with HIV and AIDS and the obstacles we still face in working to Ending the HIV Epidemic.
One of the last developments of 2021 included the CDC updating its clinical practice guidelines for pre-exposure prophylaxis for the prevention of HIV (PrEP). The update shifts language in such a way to encourage providers to more openly bring up the issue of PrEP with all patients rather than solely seeking to target “high-risk” populations. This move falls in-line with the efforts to reduce PrEP stigma among the broader public and, specifically, among providers. This was a particularly exciting development in light of the Food and Drug Administration’s (FDA) approval of cabotegravir (branded as Apretude) for PrEP. The long-acting injectable was first approved for the treatment of HIV in early 2021 and poses an extraordinary advancement in the potential for medication delivery mechanisms, improving adherence, and, ultimately, advancing efforts to End the Epidemic. Of note, pharmacy benefit managers, specifically CVS, anticipated this move as much as advocates and patients have. Despite a supposed commitment to investing in health equity with regard to HIV, CVS’ own “payor solutions” site boasts of the methods the entity will use seeking to delay or deny access to this and other innovative care under the need to “balance cost” with effective or curative treatments.
Looking into the new year, HHS’ annual policy report indicates the agency will seek to strengthen protections afforded to LGBTQ patients and more appropriately define discrimination in plan design, affecting patients living with HIV and HCV.
While these changes in direction and advancements in treatment are quite thrilling, advocates should be prepared to compete for space to be heard and anticipate familiar “foes” continuing to refuse to engage or finding ways to blockade access to care. Be they based in political ideal or industry priority or even from providers, patients and advocates would be better served when those who have traditionally disfavored advancing equity and access engaged in discussions on how to find the win-win for all parties. Community Access National Network remains committed to engaging stakeholders across interests in this space and looks forward to the good-faith efforts of those who seek to move these adversarial relationships to partnerships and even friendships.