December 3, 2020
David Kim, M.D.
Office of Infectious Disease and HIV/AIDS Policy
Department of Health and Human Services200 Independence Ave. SW
Washington, DC 20201
RE: Request for Information (RFI): Vaccines National Strategic Plan Draft Available for Public Comment
Dear Dr. Kim,
As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Office of Infectious Disease and HIV/AIDS Policy (OIDP) Request for Information (RFI) on the Vaccines National Strategic Plan (VNSP) draft. This updated plan presents a series of goals, objectives, and recommended vaccine strategies across the lifespan that will guide priority actions for the period 2021–2025 and set important markers around the swiftly changing vaccine landscape.
AVAC consists of over 60 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations.
We appreciate the broad focus of the VNSP on the entire vaccine enterprise, including HHS’ move to adopt vaccine strategies across the lifespan. The development of the VNSP comes at a critical time as our nation plans for the upcoming allocation, distribution, and administration of forthcoming COVID-19 vaccines, which will be judged by how well it ensures equitable access for all. We expect this vaccination program will be the greatest public health effort of our generation. While this effort will present significant challenges, it also brings a new opportunity to build upon the strength of existing immunization program infrastructure in the United States.
Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases each year. Adult coverage lagged behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.1 Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of information about recommended vaccines, financial hurdles, and technological and logistical obstacles. We see opportunity in the NVSP to lay the foundation for improved access to and utilization of vaccines, especially through the reduction in technological, logistical, geographic, socio-economic, and financial barriers to the full complement of ACIP-recommended adult immunizations. Again, thank you for the opportunity to share responses to the questions laid out in the RFI around the federal governments’ efforts to strengthen and improve the nation’s response to vaccine preventative disease and strategies to address infectious disease through vaccination.
- DO THE DRAFT VACCINE PLAN’S GOALS, OBJECTIVES, AND STRATEGIES APPROPRIATELY ADDRESS THE VACCINE LANDSCAPE?
Importantly, the plan focuses on five key areas that, together, can go a long way to improve immunization rates across the lifespan: 1. Foster innovation in vaccine development and related technologies. 2. Maintain the highest possible levels of vaccine safety. 3. Increase knowledge of and confidence in routinely recommended vaccines. 4. Increase access to and use of all routinely recommended vaccines. 5. Protect the health of the American public by supporting global immunization efforts. Complimenting these five goals are a set of targeted objectives and strategies that will benchmark and guide progress.
Our comments focus primarily on goals 3 and 4, which fall most centrally as part of the work of our coalition. AVAC member organizations support improving access to and utilization of vaccines by reducing technological, logistical, geographic, socio-economic, and financial barriers to the full complement of ACIP-recommended adult immunizations. As you work to finalize the plan, we encourage OIDP to prioritize the goals and objectives set forth in the plan. AVAC intends to prioritize certain goals and objectives that we have highlighted below as areas of common interest.
Goal 3: Increase knowledge of and confidence in routinely recommended vaccines.
Increasing knowledge of and confidence in recommended vaccines will help to increase community demand for immunizations, and will be key to achieving NVSP success. The third goal highlights an important aspect where greater attention and concerted effort is desperately needed in the adult populations. Education and awareness of the importance of immunizations should be closely linked with efforts to improve access. While significant progress has been made towards providing accurate, timely, and transparent information about immunizations and recommended vaccines through varied communications and partnership efforts, additional tools are needed to disseminate vaccine information—including publication of evidence-based recommendations, use of mass media and new media, provider education and training, and support of non-federal stakeholder partners. These tools are essential to educating and increasing community demand for adult immunizations. We commend the recognition of investment needed to build our efforts to provide public health partners, healthcare providers, policy makers, and other stakeholders the tools necessary to work together to improve awareness and confidence. We recommend that the third and fourth goals of the NVSP be viewed and pursued in tandem.
We appreciate that Objective 3.1 seeks to counter vaccine mis- and disinformation and increase public support for the individual and societal benefits of vaccination. We will need to rely on using effective communication strategies to build understanding and support for the individual and societal benefits of vaccination. There is growing concern that the spread of mis– and disinformation is eroding vaccine confidence and leading to lower vaccination coverage rates across the life course. The federal government, working with immunization partners and trusted community leaders and organizations, must continue to be proactive, clear, consistent, and highly visible in their communications to keep the public informed of vaccine development, safety processes, and approval and recommendation criteria.
With regard to forthcoming Covid-19 vaccines, this will be especially important as we will need to ensure that information about the vaccine, the principles and process for distribution, and information about priority populations reach the public in a clear, understandable, and transparent way. Trusted community leaders and partners (3.1.3) are critical for ensuring that information reaches communities with low immunization rates, and can help bridge the gap in keeping the public informed on the importance of vaccines. Information on vaccines will go a long way in making the case that vaccines save lives. It is especially important to have data on the direct and indirect costs and benefits of vaccinations in the adult population (3.1.5).
Objective 3.2 Increase provider capacity to promote knowledge of the benefits of immunization and increased vaccine acceptance by the public will be most impactful if barriers to access have been effectively addressed. In addition to the ability to leverage direct lines of communication to their patients, HCPs are trusted sources of information on how beneficiaries can safely receive preventative care. It is important to continuously educate and inform healthcare professionals (HCPs) on the latest vaccine information, to ensure they have confidence themselves and are able to make a strong recommendation to patients (3.2.1). Special attention should be paid to establishing vaccination training for providers that build vaccination as part of preventive care and help to build confidence in vaccination as a societal norm (3.2.2). Vaccine outreach and communication to HCPs should also encourage providers to raise awareness among patients regarding the need to receive all ACIP-recommended vaccinations across the life course and locations where vaccines may be available to them (3.2.3).
Objective 3.3 Ensure key decision- and policy-makers receive accurate and timely information on vaccines and strategies to promote vaccine uptake should prioritize stakeholder, cross-agency, and intra-agency collaboration to inform vaccine policy development overall (3.2.2). These relationships will go a long way towards demonstrating that the federal government is prioritizing all aspects of immunization policy. There is also a great need for key decision–makers to have information on vaccine benefits and risks; economics; and public knowledge, attitudes, and benefits.
Efforts to advance Objective 3.4 Reduce disparities and inequities in vaccine confidence and acceptance will require a multifaceted approach but is vital to achieving the goals of the NVSP. By developing a better understanding of these differences, we can work collaboratively to tailor messages and strategies to address the specific issues and concerns within a community. The federal government, working with immunization partners and trusted community leaders and organizations, must be proactive, clear, consistent, and highly visible in their communications to keep the public informed of recommended vaccines, safety processes, and approval and recommendation criteria. Gaps exists in the lines of communications between vaccine program managers, third party payers, and key decision– and policy–makers (3.4.1). The communications should be localized and flexible in its ability to reach different racial and ethnic communities and communities who have limited English proficiency, in order to build trust and acceptance (3.4.2). Special attention must be paid to advancing strategic, evidence-based metrics that measure whether activities are culturally appropriate and reflect the health literacy, language proficiency, and functional and access needs of specific target populations (3.4.3). We know that the best messengers to communities experiencing health disparities are the organizations and partners they already trust. Therefore, vaccination campaigns must be able to extend to areas where people are least likely to be reached by traditional health care infrastructure and where there are known pockets of vaccine hesitancy. It is vital that targeted resources are dedicated on an ongoing basis to enable local leaders to test and tailor proactive messages, while countering mis-and disinformation as well as anti-vaccination sentiments that may infiltrate communities (3.4.4).
Goal 4. Increase access to and use of all routinely recommended vaccines.
National immunization campaigns to protect the population against vaccine-preventable diseases have the ability to make a difference, but Goal 3 will be most impactful if and only if barriers to access have been effectively addressed, such as laid out in Objective 4. The fourth goal of the NVSP to improve access to and use of all recommended vaccines is critically important and is a core tenet for AVAC. The six objectives specified within this goal each include aspects that we support overall.
We agree with Objective 4.1 Increase the availability of vaccines in a variety of settings. Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of information about recommended vaccines, financial hurdles, as well as technological and logistical obstacles. A concerted approach to adult immunization with clear benchmarks and expectations of success is absolutely essential to increase vaccine utilization and coverage targets. The immediate needs are around increased coverage and utilization of adult immunizations; greater IT capabilities; better quality measurement and tracking; and increased coverage and utilization of adult immunizations.
We support (4.1.1) regarding the importance of removing patient barriers to accessing vaccines, incentivizing vaccination across the immunization neighborhood, as well as new strategies for offering vaccinations. Federally supported supplemental vaccination sites may be especially beneficial in high risk communities and should promote new strategies for mass vaccination, such as drive-thru clinics and clinics in nontraditional locations that are easy to access and are safe for vaccinators and the public. It is important to recognize the need to scale-up implementation of evidence-based systems-level strategies that increase vaccine uptake (e.g. centralized reminder-recall system, standing orders) as laid out (4.1.2).
Together with Objective 3.4, Objective 4.2 Reduce disparities and inequities in access to and use of routinely recommended vaccines across the lifespan must work to ensure vaccines reach vulnerable and underrepresented populations. We know that health inequity limits access to health care resources needed in many communities, including in Black, Hispanic or Latinx, American Indian, Alaska Native, Asian American, and Native Hawaiian and Pacific Islander populations. This has long held true for vaccination rates, especially for those living in rural areas, below the poverty line, and in communities of color. Recently, these are the same populations that have experienced greater loss during the COVID-19 pandemic, including greater risk of COVID-19 infection and death. We fully agree with the need to support continued research on race and ethnicity, age, social, economic, cultural, and other factors that contribute to disparities in vaccination rates, and develop targeted interventions to address them (4.2.1). Special attention should be paid to establishing vaccination as a routine part of preventive care. Building confidence in vaccination as a societal norm should build in strong support from state and local health departments’ efforts to study local immunization disparities and strengthen their community engagement efforts (4.2.2)
AVAC shares the view that advancements in immunization information Objective 4.3 Strengthen data infrastructure, including Immunization Information Systems have the potential to vastly improve monitoring of vaccine preventable disease rates and vaccine coverage data in real time, as well as to facilitate the exchange of data that can improve the quality of preventive care among targeted adult populations and patient outcomes. The ongoing COVID-19 pandemic brought to light gaps in the immunization infrastructure, especially around Immunization Information Systems (IIS), which can provide timely and accurate vaccination data, and must be used to support any mass immunization efforts around COVID-19. Accountability measures, such as those laid out in Objective 4, should be highlighted to expand the incorporation of vaccinations and the use of IIS into quality improvement programs.
IIS must be enhanced to meet new and changing data standards and access to IIS must be expanded to more providers and settings across the health care system (4.3.1). Currently, some IIS face challenges and policy barriers that limit their ability to maximize their use. To be optimally effective, IIS should encompass all vaccinations received during each person’s lifetime, contain a person’s consolidated immunization history, and fully meet the standards recommended by the CDC and American Immunization Registry Association (AIRA) to support clinicians in efforts such as administering multidose vaccines. There must also be coordination, interoperability, and bidirectional communication between the IIS and electronic health records, electronic case reporting, and health information exchange networks, including any new technologies created around Covid-19 distribution (4.3.2). The NVSP should prioritize the completeness of, and communication between, IIS and EHRs to monitor vaccine coverage and efforts to support the adoption of interoperable health information technology and EHRs for immunization. Investments are needed to increase data analytics capacity to conduct disease surveillance and increase enrollment of adult health care providers in immunization information systems (4.3.3). Likewise, additional resources for training, technical assistance, and incentives to improve IIS are necessary to increase reporting capabilities by adult vaccine providers (4.3.4).
We strongly agree with Objective 4.4 Reduce financial and systems barriers for providers to facilitate delivery of routinely recommended vaccines. AVAC has long advocated for the prioritization of efforts to reduce financial barriers to vaccination. There must be adequate Medicaid and Medicare reimbursement to cover the cost of vaccine administration counseling. Inadequate reimbursement discourages healthcare providers, such as physicians, nurses, pharmacists, and others, from proactively offering immunizations, and results in missed immunization opportunities and declines in immunization rates. (4.4.1). Reducing financial barriers that prevent adults from receiving recommended immunizations and hinder the ability of providers to stock and supply vaccines will also help create equity in access (4.4.2). We wholeheartedly agree that the financial barriers to all ACIP recommended vaccines must be eliminated for individuals covered by Medicaid and Medicare to improve the underlying health of the communities (4.4.3), but would urge the plan to go further to incorporate elimination of financial barriers for all recommended vaccines in all federal programming. AVAC supports strengthening and the establishment of additional federal benchmarks and measures to encourage health plans to track, report, and achieve increased adult immunization rates (4.4.4). Finally, we agree that eliminating regulatory and payment barriers to innovative services, such as the use of mobile vans and telehealth for vaccine counseling, should be emphasized and prioritized (4.4.5).
As part of public health preparedness, we need to eliminate financial barriers for access to vaccines such as Objective 4.5 Reduce financial and systems barriers for the public to facilitate access to routinely recommended vaccines. Older adults are at particular risk for serious illness and those 50 and older, particularly with multiple comorbidities, are at higher risk of dying as a result of a vaccine preventable condition. Fixing structural inequities by removing co-pays, cost sharing, and other financial barriers by health care plans for all routinely recommended vaccines in vaccine coverage (4.5.1) will provide a clear and direct financial and health benefit and will help to improve our national preparedness. As included in the NVSP, the federal government should continue to encourage and promote adequate payments for vaccines and vaccinations by public and private health plans to incentivize providers to vaccinate, thereby promoting access (4.5.2). There should also be a baseline of consistent and reliable access to immunizations for the uninsured, and reliable Medicaid coverage of vaccines made available to adult populations across all states. Currently, access to vaccines under Medicaid varies, depending on where you live and your Medicaid eligibility status. Medicaid enrollees who are covered through Medicaid expansion programs are guaranteed access to all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) with no cost sharing requirements. By contrast, not all vaccines recommended for adults are covered by traditional Medicaid programs, and those that are covered may have cost sharing requirements that put access to the vaccine out of reach (4.5.3).
We strongly believe in Objective 4.6 Promote public-private partnerships to increase the capacity of the health system to deliver vaccines for routine use and protection during outbreaks as a means to achieve all of the elements of the NVSP. As such, in order to successfully execute strategies 4.6.1-4.6.3, there is a need for infrastructure investments aimed at strengthening, enhancing, and expanding the ability of public health officials, primary care physicians, nurses, pharmacists, and other health care providers practicing at the top of their license in the community to meet vaccine demand, especially in light of forthcoming COVID-19 vaccines and the need to reach populations who are currently under-vaccinated. A strong immunization infrastructure will be essential for routine vaccine use and during public health emergencies.
- II.ARE THERE ANY CRITICAL GAPS IN THE VACCINE PLAN’S GOALS, OBJECTIVES, AND STRATEGIES? PLEASE IDENTIFY:
AVAC applauds the progress that has been made over the last decade but more must be done to improve access and utilization. We believe there is opportunity to continue to build on the framework laid in the NVSP to ensure it remains a dynamic, current, and useful document. While we believe the general framework laid out in the goals is comprehensive, we see opportunity to strengthen a variety of strategies under the various objectives.
Recommended Additional Strategies for Goal 3
- AVAC sees the importance of the proposed goals and objectives. However, we would like to highlight the need to enhance partnerships for communications efforts as especially important. As a coalition representing providers, public health groups, vaccine makers, pharmacies, and consumers, we share the NVSPs goals of reducing barriers and improving access. Tremendous work is taking place across the country to identify the barriers and challenges around adult vaccines. The NVSP should further prioritize collaborations with community stakeholders to disseminate information, and to learn from current outreach and practices. We recommend doing so by creating strategy 3.3.3.
- Similarly, this strategy should build out support for the development of immunization champions within health systems and provider practices. Provider groups such as AMGA/ACP/AAFP have all demonstrated ability to improve immunization rates and activities through building internal champions and training programs that having someone who is responsible and accountable for vaccinating. We recommend building this type of provider training in the plan 3.3.4.
- There is also a great need for key decision–makers to have information on vaccine benefits and risks; economics; and public knowledge, attitudes, and benefits. We recommend incorporating this as part of 3.3.2 or creating a new strategy 3.3.5.
Recommended Additional Strategies for Goal 4.
- We recommend including long term care facilities, nursing homes, and other congregate living settings as part of this list. 4.1.1. Remove barriers to and incentivize vaccination in non-health care settings, including workplaces, places of worship, community centers, and pharmacies, as well as in specialty health care settings (e.g., cancer treatment centers). As part of 4.1.1, we also recommend the need for federally supported supplemental vaccination sites in high risk communities to vaccinate for Covid-19. These could promote new strategies for mass vaccination, such as drive-thru clinics and clinics in nontraditional locations (such as transit hubs) that are easy to access and are safe for vaccinators and the public. Services should also be provided over extended hours, such as nights and weekends, to allow individuals who may not be able to seek immunizations during traditional work hours to access these services when it is most convenient for them.
- Section 4.4.3 should include language stronger than “encouraging” state changes. The NVSP could call for specific actions, such as recommending the Center for Medicaid at CMS issue guidance to state Medicaid directors encouraging states to assess current vaccine coverage under their respective plan review provider reimbursement rates for the cost of the vaccine as well as its administration, with the goal of identifying deficiencies and developing plans to close insurance coverage and reimbursement gaps that hinder access to vaccines for Medicaid populations relative to other coverage groups. We should be encouraging states to seek plan amendments to support this work as well as leverage contractual agreements with Medicaid managed care plans to improve access to this important preventive service. Greater leadership and direction at the federal policy level could go a long way to facilitate equal access to vaccines through Medicaid.
- Section 4.4.4 promotes the use of vaccination as a quality measure in value-based payment models, however, this section should specifically call out the two recently developed measures, the Adult Immunization Status and the Maternal Immunization Status measure. We recommend 4.4.4 specifically mention the need for a strategy on how the two developmental measures around the adult immunization status and the life course IIS that were included in Healthy People 2030 will be implemented over the next five years. Additionally, Table 1, indicators and targets should include specific timelines and metrics for implementation of these two developmental measures. Further efforts to promote the use of ACIP-recommended adult immunizations quality measures and benchmarks under Medicare, Medicaid, and private insurance would go a long way to help drive utilization and improve patient access to these effective, life-saving, and low-cost services. This should include broad utilization of the adult immunization status measure and the maternal immunization status measure.
- As part of strengthening infrastructure needs, the plan should include incorporate needs around recruiting and training the necessary workforce in certain public health settings 4.6.4.
- Do any of the Vaccine Plan’s goals, objectives and strategies cause concern? If so, please specify the goal, objective or strategy, and describe the concern regarding it.
No.
Thank you again for this opportunity to offer our responses regarding the goals, objectives, and strategies around the NSVP. Please contact the AVAC Coalition Managers Abby Bownas (abownas@nvgllc.com) or Lisa Foster (lfoster@nvgllc.com) if you would like more information about our views, or the work of AVAC.
Sincerely,
Alliance for Aging Research
American Immunization Registry Association (AIRA)
American Lung Association
American Public Health Association
Biotechnology Innovation Organization (BIO)
Emily Stillman Foundation
Families Fighting Flu
GSK
Hep B United
Hepatitis B Foundation
Infectious Diseases Society of America
Kimberly Coffey Foundation
March of Dimes
Medicago
Meningitis B Action Project
Moderna
National Association of Nutrition and Aging Services Programs (NANASP)
National Foundation for Infectious Diseases
National Viral Hepatitis Roundtable
STChealth
The AIDS Institute
The Gerontological Society of America
Trust for America’s Health
WomenHeart: The National Coalition for Women with Heart Disease