Policy Analysis Paper – Hepatitis C policy National Policy

Policy Analysis Paper – Hepatitis C policy National Policy

Healthcare policies help establish guidelines that benefit the healthcare system in its entirety. These policies define care and care management aspects and caregivers’ and patients’ behavior toward health promotion and preservation (Kind et al., 2022). The Hepatitis C National Policy is an example of a federal-level policy that guides care management for the disease. This policy is part of the larger healthcare policy on Hepatitis spectrum diseases that provides a road-map towards eliminating these diseases as public health threats in the U.S. The goal of this policy is to prevent new viral hepatitis infection, improve healthcare outcomes for patients with hepatitis C infection, lessen disparities related to hepatitis C infection, improve surveillance of the disease, and achieve care coordination and the consumption of integrative technologies utilized in the management of the disease (Kind et al., 2022). This paper details an in-depth analysis of the Hepatitis C National Policy.

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Evolution and History

Hepatitis C is an infection of the liver caused by the hepatitis C virus. It remains a leading cause of morbidity and mortality, affecting over two million Americans. Comprehensive care for hepatitis C has traditionally focused on early detection of the disease, improvement of hepatitis C-related health outcomes, and elimination of perinatal transmission of hepatitis C.  Tenner et al. (2019) report that accurate diagnosis of the disease and aggressive pharmacotherapy with antiviral medications have considerably lowered morbidity and mortality from the virus. The year 2010 saw the conception of a federal hepatitis action plan according to the Institute of Medicine’s recommendation on the need to address hepatitis as a health concern in the U.S. This action plan was intended to guide all stakeholders in healthcare as well as state and local governments on aspects of managing the disease (HHS, 2021). This plan formed the basis for stakeholder collaboration and unilateralism in managing the common forms of hepatitis. In its lifetime and over ten years of existence, the hepatitis action plan has seen several iterations, with the first two directed toward national government partners and focused on fostering cross-agency collaboration in preventing and treating hepatitis infections. HHS (2021) notes that iterations of the Hepatitis C policy action plan have been informed by scientific research on aspects of the disease and integrate best practices effective in lessening disease severity and eliminating the causal factors for the disease.

The third and current iteration of the hepatitis action plan was directed to all stakeholders involved in hepatitis care. This is in recognition of the broad range of support and stakeholder commitment toward managing the disease and lowering its impact on community health (HHS, 2021). This current plan focuses on enhancing awareness of the disease and diagnostic innovation on the disease, treating the disease, lessening disparities on hepatitis, and encouraging a holistic approach to managing the disease (Kind et al., 2022). This current approach also expanded the metrics utilized in surveilling and tracking progress toward achieving the care goal for hepatitis C infections. This plan thus presents an integrative, comprehensive means of meeting the care goal of eliminating hepatitis as a public health concern in the U.S.

Societal Values, Priorities, and Ethical Concerns

Whereas societal values underpin the healthcare goals pursued by healthcare systems across the globe, ambiguity still exists on how societal values can be incorporated into policy decision-making processes (Vélez et al., 2020). However, policymaking processes increasingly recognize societal policies. Goal-related societal values that represent societal expectations of the healthcare systems, such as quality, universality, and equity, are often incorporated into policymaking processes. These values are integral to the right to health provision that underlines healthcare systems’ health promotion and preservation interventions. The Hepatitis C action plan embodies how the societal values of quality, universality, and equity apply in policymaking. This action plan considers these values and lays down a framework for addressing their provisions (HHS, 2021). Governance values such as accountability and transparency are also supported in the Hepatitis C National Policy. The plan calls for caregivers’ commitment to eliminating the public health threat posed by the virus (Vélez et al., 2020). This further highlights how the plan supports societal values.

The Hepatitis C National Policy is also driven by the presenting communities’ concerns about health. It supports specific community health concerns such as quality healthcare and societal well-being, meeting the specific needs of vulnerable community members, and the capacity to utilize available resources. The inception and establishment of the hepatitis C action plan and policy toward eliminating it stemmed from recognizing the health impact of hepatitis spectrum diseases (HHS, 2021). This supports the priority community need for wellness and access to healthcare. Additionally, the provisions of this plan that direct comprehensive care and innovative diagnostics attempt to improve the quality of care that communities can receive. Through the lessening disparities framework outlined by this policy act, the American healthcare system can lessen the traditional problems of access to care and health disparities in many American societies. These provisions further show the commitment of the policy toward addressing priority needs across American societies.

While healthcare policies are positive amends that governments make to combat poor clinical and health outcomes, specific ethical concerns may sometimes present during the formulation and implementation of these policies (Zadey et al., 2021). Ethics-driven policymaking considers the ethical concerns that may be apparent during the implementation of a healthcare policy (Zadey et al., 2021). The hepatitis healthcare policy draws a lot from the principlism concepts drawn from ethical care.

The inception and implementation of the Hepatitis C National Policy were cognizant of the principle of justice, which requires all fairness when distributing healthcare resources, and beneficence, which requires caregivers to promote the welfare of their patients. The beneficence provisions are best represented by the goal-driven approach that the policy has toward eliminating the threat posed by the hepatitis C virus. The preventive statement on the policy aims to increase awareness of hepatitis C and increase the capacity of healthcare systems, providers, and the public in its entirety to prevent and manage hepatitis C (HHS, 2021). These efforts lead to preserving community lives and ensuring that all community members maintain accountability by caring for themselves.

The traditional problem of healthcare inequities has long been a debate topic across American societies (Lavizzo-Mourey et al., 2021). Healthcare inequities hinder the effective management of infectious diseases and the distribution of community resources vital to promoting and preserving community lives. The national healthcare policy on hepatitis C is targeted at lessening health inequities. It identifies communities disproportionately impacted by the hepatitis virus, such as racial and ethnic minority groups, and proposes address measures against these problems. Some of the specific interventions proposed by this act include enhancing insurance coverage among these communities to enhance their access to care and eliminating logistical barriers to accessing healthcare, such as lack of transportation and availability of community resources vital in the comprehensive management of the disease (Lavizzo-Mourey et al., 2021). This policy provision also recognizes the significance of improving health outcomes for communities affected by health inequity by advocating for the need to address the social determinants of health. Supporting positive changes in individual behavior, creating awareness in communities of the disease to lessen stigma and discrimination, and improving the conditions individuals live in within their communities may significantly lower health inequities (Brown et al., 2019). This further shows the commitment of this policy to addressing potential health inequities.

Target Population

The target population of the Hepatitis C National Policy has shifted with each iteration, with the current iteration providing a broader scope of coverage to include all stakeholders involved in healthcare. This includes healthcare providers, whose roles are central to the management process, creating disease awareness, providing quality care for those affected, and tracking the disease (HHS, 2021). The communities are also part of the target population for this act. This act implores communities to embrace collective responsibility in the fight against the disease. In this regard, they are expected to adopt best practices in prevention, such as vaccination and maintaining hygiene (Fokuo et al., 2020). This act also targets healthcare agencies such as the CDC. They play a role in tracking the disease, surveilling it, and developing innovative diagnostics to help in the early identification of the disease (HHS, 2021). Healthcare administrators and governments also play a role in tracking, reporting, surveillance, and funding aspects of managing the disease, such as research. By synchronizing their roles and maintaining unity in purpose, all these stakeholders may make a difference in the pursuit of eliminating hepatitis C as a public health threat in the U.S.

The hepatitis C policy stresses the need to address social determinants of health in its pursuit to improve care for communities disproportionately affected by the hepatitis C virus (HHS, 2021). It emphasizes the significance of the physical environment in which people live, social support, and access to healthcare as important factors in the perpetuation of hepatitis C infection. Fostering quality relationships between community members and caregivers and improving the environment in which people work and live may enhance the health of these communities (HHS, 2021). This calls for intersectoral collaboration in integrating the provisions of the Hepatitis C National Policy and to guarantee that the act’s objectives are achieved.

Implementation

The national policy on hepatitis C was centered on the thematic issues of disease prevention, treatment, early detection through innovative diagnostics, and health disparities associated with the disease. The current iteration of the hepatitis C policy was released for implementation by all the involved stakeholders in 2021 (HHS, 2021). These include healthcare facilities, caregivers, communities, and federal agencies such as the CDC. This version presents a multi-pronged approach to its implementation. Healthcare systems across the country are expected to design a working mechanism to eliminate the disease (HHS, 2021). This may include but is not limited to establishing multidisciplinary clinical teams to handle cases of the disease and organizing community awareness programs to educate communities on the disease. Healthcare facilities across the country increasingly conform to these provisions, with many moving to design a working mechanism for managing the disease (Fokuo et al., 2020). Healthcare providers are also increasingly receiving hepatitis C virus-related training to expand their capacity and knowledge to handle these diseases (Fokuo et al., 2020). Other priority areas in the implementation of the provisions of this plan are strengthening the surveillance of the disease and improving testing for the disease.

So far, the involved stakeholders have implemented most of these provisions (HHS, 2021). Fokuo et al. (2020) note that caregivers across the country are better knowledgeable about the disease. There are also marked improvements in the available community resources, which are valuable in modulating the impact of the hepatitis C virus on communities (Fokuo et al., 2020). Healthcare facilities have also put much strain on disease screening and measures to prevent hepatitis C infection. While these provisions remain an imprint of the action plan against hepatitis C virus infection, they are also integral to ethical and sound healthcare practice. The need to improve the quality of care patients receive is part of the overall healthcare providers’ responsibilities and central to their professional standards of practice.

Federal policies have also been significant in overseeing the implementation of these provisions. The value-based systems under the Medicaid program that push for quality enhancement in care delivery and the Occupational Safety and Health Administration (OSHA) that pushes for a safe environment during care delivery are examples of federal policies that have perpetuated the provision of the federal policy on hepatitis. These policies have promoted the success of these provisions by ensuring that the involved stakeholders diligently execute their roles.

Cost-Benefit Analysis

Meeting the hepatitis health goals as defined in the hepatitis C action plan would have several beneficial consequences for communities and the government. However, implementation of the stated objectives fetches considerable healthcare costs. The WHO report reveals that the cost of implementing the objective of the integrated action plan against the disease is expected to eclipse 11 billion dollars per year (Tenner et al., 2019). Disease testing and treatment are the principal drivers of this high management cost of the disease (Tenner et al., 2019). In Tampa, FL, for instance, the cost of treating the disease ranges from 25,000 to 99,000 dollars, depending on the severity of the disease and the medication used (Klas, 2018). This is reflected in other areas within the vast state of Florida, with the average cost of treating the disease in the state using the Harvoni regimen being approximately 94,000 dollars (Brandy, 2018). While the cost of managing the disease varies across states, the average cost of treating hepatitis C virus infection in the U.S. could be more than 140,000 dollars based on the pharmacotherapeutic agents used (Brandy, 2018).

Various community resources are available for use by the population affected by the disease. The hepatitis prevention program in Florida is an example of a community resource that has been able to link patients with the disease to care. Other similar and notable resources include the American Liver Foundation (ALF) and the Hepatitis Resource Center. Despite their significance in improving care to the affected patients, they have not succeeded in keeping the cost of treating the disease low.

The proposed benefits of implementing the provisions of the hepatitis C virus action plan justify the cost. Full implementation of the policy action plan provisions will significantly reduce the morbidity and mortality associated with hepatitis C virus infection. Tatar et al. (2020) report that therapy that results in partial or full cure of hepatitis C virus infections yields up to 17.50 quality-adjusted life years. Additionally, research findings reveal that a partial cure in patients with mild to moderate disease may result in cost savings of up to 20,180 dollars per patient in savings, while a full cure may result in cost savings of more than 47,000 dollars (Mattingly et al., 2020). Other findings also point to the cost-effectiveness of implementing the provisions of the plan. Screening for hepatitis C virus increased the quality-adjusted life years by up to 0.23 with a cost-effective ratio of 45,465 dollars per quality-adjusted life year (Tatar et al., 2020). This further reveals the benefits of implementing these plans.

Findings on the cost of treating hepatitis C virus infection are consensual on the high cost of treating the disease. The high cost of medications makes the overall management of the disease high. These findings are also consensual on the cost-effectiveness of managing the disease. Disease screening to enable early disease detection and pharmacotherapy using medications have been weighted as effective therapeutic modalities against the disease. These interventions considerably improve the quality-adjusted life years for patients diagnosed with hepatitis C viral infections. Additionally, the overall cost-effectiveness of these interventions is high. The benefits of implementing the provisions of the hepatitis C virus policy provisions thus justify the cost. This warrants the adoption of the policy provisions in mainstream care operationalization.

Role and Impact on Healthcare and Healthcare Providers

The Hepatitis C National Policy significantly impacts care operationalizations and overall care delivery. Notably, this policy casts the burden of eliminating the disease on the healthcare system, providers, and communities. Healthcare systems are expected to design mechanisms for eliminating this virus. As such, this may require them to change aspects of their operationalizations. This includes ensuring that they improve disease testing and care processes, participate in disease tracking, reporting, and surveillance, and foster collaborations with other stakeholders involved in this fight. While some of these roles are intrinsic to the overall healthcare roles, they may sometimes fetch considerable financial and human resource considerations. However, the pursuit of safe communities warrants them to undertake such investments.

Healthcare providers also play a vital role in this regard. As educators and advocates for healthy communities, they are required to be involved in educational programs that create awareness within communities. The provisions of this policy also have an impact on the framework of delivering care. This policy requires providers to obtain hepatitis C virus-related knowledge to enhance their capacity and knowledge to handle this disease. Additionally, they are required to provide quality care to all patients presenting with the disease. These provisions, in general, call for better accountability among healthcare providers and the healthcare systems in which they work.

Evaluation

Throughout its lifetime, the act has seen several changes in healthcare approaches to managing the disease. The consequence of implementing this policy at local, state, and federal levels has been evident across healthcare systems. Marked progress has been made as far as the policy goals are concerned. To begin with, a working mechanism for eliminating the disease has been established across care systems in the country. This has helped coordinate hepatitis disease management and has enhanced the adoption of various innovations and technologies applicable to managing the disease. Healthcare facilities capable of handling the disease have also been designated across most localities in the country (Cox et al., 2020). This has improved the overall quality of care for patients with the disease. The percentage of blood screened for the disease has also increased.

Despite marked improvement in the diagnosis and management fronts of this action plan, morbidity and mortality rates from the disease continue to rise. The public knowledge of hepatitis C virus infection is still low. Early diagnosis of the disease is also still challenging due to the high cost of diagnosing the disease and inadequate surveillance of the disease (Cox et al., 2020). These challenges presented hurdles to the comprehensive management of the disease.

The policy has, in part, met its goals of preventing new infections, increasing awareness of the disease, and eliminating it. Specific areas that have seen marked progress include safe injection at care institutions, increased numbers of hospitals performing PCR hepatitis C virus screening, a percentage of people receiving care for the disease, and an increase in the number of caregivers receiving hepatitis C virus-related training. This shows greater accountability in eliminating this problem among the involved stakeholders. Progress reports on various policy provisions, such as the number of people screened for the disease and those started on therapy, will be valuable in determining its effectiveness.

Conclusion

Healthcare policies maintain significance in defining aspects of care delivery. The Hepatitis C National Policy is an example of healthcare policies that guide care delivery. This policy has seen several iterations throughout its lifetime, with aspects of care updated to address current needs. This policy maintains significance in defining hepatitis C care and recommends aspects of this disease’s management, such as prevention and quality treatment. So far, this policy has been able to meet some of its goals, warranting further implementation of this policy’s provisions.

References

Brandy, H. (2018). Drug pricing & challenges to hepatitis C treatment access. Journal of health & biomedical law. https://pubmed.ncbi.nlm.nih.gov/30258323.

Brown, A. F., Ma, G. X., Miranda, J., Eng, E., Castille, D., Brockie, T., Jones, P., Airhihenbuwa, C. O., Farhat, T., Zhu, L., & Trinh-Shevrin, C. (2019). Structural interventions to reduce and eliminate health disparities. American Journal of Public Health, 109(S1). https://doi.org/10.2105/ajph.2018.304844.

Cox, A. L., El-Sayed, M. H., Kao, J.-H., Lazarus, J. V., Lemoine, M., Lok, A. S., & Zoulim, F. (2020). Progress towards elimination goals for viral hepatitis. Nature Reviews Gastroenterology & Hepatology, 17(9), 533–542. https://doi.org/10.1038/s41575-020-0332-6.

Fokuo, J. K., Masson, C. L., Anderson, A., Powell, J., Bush, D., Ricco, M., Zevin, B., Ayala, C., & Khalili, M. (2020). Recommendations for implementing hepatitis C virus care in homeless shelters: The stakeholder perspective. Hepatology Communications, 4(5), 646–656. https://doi.org/10.1002/hep4.1492

HHS. (2021, July 9). Viral hepatitis national strategic plan. HHS.gov. Retrieved February 19, 2023, from https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/index.html

Kind, J., Maeschli, B., & Bruggmann, P. (2022). How to set the agenda for hepatitis C: A theory-driven policy analysis. Health Research Policy and Systems, 20(1). https://doi.org/10.1186/s12961-022-00824-3

Klas, M. E. (2018). Florida let hepatitis C go untreated in prisons. Now, it may cost taxpayers millions. Tampa Bay Times. Retrieved February 21, 2023, from https://www.tampabay.com/florida-politics/buzz/2017/11/20/florida-let-hepatitis-c-go-untreated-in-prisons-now-it-may-cost-taxpayers-millions/

Lavizzo-Mourey, R. J., Besser, R. E., & Williams, D. R. (2021). Understanding and mitigating health inequities — past, current, and Future Directions. New England Journal of Medicine, 384(18), 1681–1684. https://doi.org/10.1056/nejmp2008628

Mattingly, T. J., Love, B. L., & Khokhar, B. (2020). Real-world cost-of-illness evidence in hepatitis C virus: A systematic review. PharmacoEconomics, 38(9), 927–939. https://doi.org/10.1007/s40273-020-00933-3

Tatar, M., Keeshin, S. W., Mailliard, M., & Wilson, F. A. (2020). Cost-effectiveness of universal and targeted hepatitis C virus screening in the United States. JAMA Network Open, 3(9). https://doi.org/10.1001/jamanetworkopen.2020.15756.

Tenner, L., Melhado, T. V., Bobadilla, R., Turner, B. J., & Morgan, R. (2019). The cost of cure: Barriers to access for hepatitis C virus treatment in South Texas. Journal of Oncology Practice, 15(2), 61–63. https://doi.org/10.1200/jop.18.00525.

Vélez, C. M., Wilson, M. G., Lavis, J. N., Abelson, J., & Florez, I. D. (2020). A framework for explaining the role of values in health policy decision-making in Latin America: A critical interpretive synthesis. Health Research Policy and Systems, 18(1). https://doi.org/10.1186/s12961-020-00584-y.

Zadey, S., Dharmadhikari, S., & Mukuntharaj, P. (2021). Ethics-driven policy framework for implementation of movement restrictions in pandemics. BMJ Global Health, 6(6). https://doi.org/10.1136/bmjgh-2021-005202.

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