October 24, 2019

Tammy R. Beckham, DVM, PhD
Director, Office of Infectious Disease and HIV/AIDS Policy
Department of Health and Human Services (HHS)
200 Independence Ave. SW
Washington, DC 20201

RE: Request for Information (RFI) from Non-Federal Stakeholders: Developing the 2020 National Vaccine Plan

Dear Dr. Beckham,

On behalf of the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Office of Infectious Disease and HIV/AIDS Policy’s (OIDP) Request for Information (RFI) from Non-Federal Stakeholders regarding development of the 2020 National Vaccine Plan.

AVAC consists of over 55 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 and utilization of adult immunizations.

We appreciate HHS’ intention to develop a new National Vaccine Plan that will adopt vaccine strategies across the lifespan and guide priority actions for the period 2020–2025. The development of the 2020 NVP comes at a critical time. Vaccine confidence and hesitancy issues remain a challenge across all sectors of the health care system and our government. Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases each year. Adult coverage lags behind current Healthy People targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV. Additionally, 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.

With a strong existing complement of adult vaccines and an exciting pipeline of new vaccines on the horizon, we see great opportunity in the 2020 NVP to lay the foundation for improved access and utilization of adult vaccines 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 recommendations around the federal government’s efforts to strengthen and improve the nation’s response to vaccine preventative disease and strategies to address infectious disease through vaccination.

1. Priorities for the 2020 National Vaccine Plan during 2020–2025. What do you recommend as the top priorities for vaccines and immunizations in the United States? Why are these priorities most important to you?

We encourage the 2020 NVP to prioritize goals, objectives and strategies that will result in: 1) Increased coverage, access, and sustained utilization of immunizations across the life course; 2) Strengthened immunization infrastructure, specifically immunization information system capabilities and broad access; and 3) Improved quality measurement tools to track immunization progress and identify gap areas of immunization coverage.

To increase vaccine coverage, access, and utilization, we recommend strategies that include:

a. Alleviating financial barriers that create disincentives for patients to receive and providers to offer vaccines. Vaccines should be equally accessible among all insured populations. The NVP should assess the financial barriers that prevent adults, particularly those with public insurance coverage, from receiving recommended immunizations from providers able to administer the vaccines. The plan should also acknowledge the real or perceived challenges/disincentives/barriers around adequate reimbursement and support the incorporation of workflow strategies and the National Vaccine Advisory Committee (NVAC) Standards for Adult Immunization Practice, to assess, recommend, administer or refer and document the vaccines the patient may (or may not) have received during the encounter with the healthcare provider, whether that be in a medical office, pharmacy or other setting. Adequate reimbursement in the 2020 NVP will help bring greater consistency across providers and reduce the financial burden on providers across the immunization neighborhood and encourage the availability of recommended vaccines for adults.

b. Increasing education activities and resources for immunization across the life course. Greater attention and effort are needed to drive meaningful improvements in immunization rates among the adult population. The NVP should emphasize the importance of consistent education and encouragement of individuals to be aware of and receive recommended immunizations across the life course. This communication should be strategic, evidence-based, and culturally appropriate and should reflect the health literacy, language proficiency, and functional and access needs of specific target populations. Particular attention should be paid to the development of vaccine champions within different racial and ethnic groups who can best deliver pro-vaccine messages to adults.

Providers play an essential role in providing education and counseling to patients and must have the tools and resources to do this job effectively in the course of providing care to patients. Immunization champion programs have demonstrated success at improving immunization coverage rates within provider practices. Adequate reimbursement for the time spent on vaccine counseling should be accounted for to ensure services provided by clinicians are appropriately reimbursed in accordance with the work performed rather than the clinician’s occupation. There is an additionally important role for community-based organizations in providing education.

c. Generating evidence about the health and economic impact of immunization across the life course. In order to reinforce the case for vaccines across the life course, the NVP should prioritize economic data gathering and analysis, including an assessment of the burden of vaccine preventable disease and the direct and indirect costs that can be averted through increased use of vaccines.

Strengthen and enhance the stability and sustainability of immunization infrastructure.

a. Supporting Immunization Infrastructure. Our nation’s immunization infrastructure serves as the backbone for surveillance, reporting, and response activities for a wide variety of stakeholders across the health care system. However, the cost of these vital functions, including vaccine purchase, storage and handling, safety, provider and community education and outreach, immunization information systems (IIS) or registries, disease surveillance, and outbreak response, rely on the limited budgets of state and local public health programs.

In particular, widespread implementation of health information technology (HIT), IIS, and electronic health record (EHR) systems have the potential to improve monitoring of vaccine preventable disease and vaccine coverage rates in real time at a population level and better address gaps in vaccination coverage as well as to facilitate the exchange of data that can improve coordination and the quality and patient outcomes of preventive care among targeted adult populations. Greater utilization of and interoperability between EHRs and IIS systems, among all health care providers across all sites of care for vaccine administration are integral for improving and maintaining increases in immunization rates, and is the first step in identifying gaps where efforts and resources should be directed.

b. Encourage broad adoption of immunization quality measures and quality improvement activities. Strong and robust immunization infrastructure is critical to quality measurement program efforts to promote quality improvement, adherence and consistent utilization of recommended adult vaccines. AVAC recommends the NVP strongly encourage the widespread adoption of quality measurement tools, including the Adult Immunization Status (AIS), End-Stage Renal Disease (ESRD), and maternal composite measures. Adoption of composite measures that can be electronically reported will provide a sound, reliable and comprehensive means to assess the receipt of routinely recommended adult immunizations while reducing the administrative reporting burden on providers.

c. Increase the recognition of the societal value of vaccination.
The societal value of vaccination needs to be adequately recognized by all stakeholders in order maximize the benefits of vaccination across the life course. To ensure the appreciation and recognition of value and its link to affordability, the societal value of vaccination should be considered during the prioritization of preventative health services, during funding decisions for vaccination programs, as well as during the purchasing and reimbursement process.

Furthermore, recognizing the value of innovation is especially important for vaccines, where the development process is faced with a series of challenges that other pharmaceuticals do not have. Due to increased costs of goods and high post-approval costs to meet increasing quality standards, product complexity makes the investment greater for new vaccine products to come to market. A policy environment that supports the value of innovation, both for breakthrough discoveries and incremental innovation, leads to the research and development of new vaccines, improvements in pipeline products, and other discoveries that support the vaccine ecosystem to reduce vaccine-preventable diseases across the life course. The 2020 NVP should focus on promoting the societal value of vaccination, including the value of innovation, as appropriate throughout the Plan.

2. What changes should be made to the 2010 National Vaccine Plan to make it more current and useful? This could include changes to the goals, objectives, strategies, activities, indicators, and other areas of the plan. Which components of the 2010 National Vaccine Plan worked well and should be maintained?

The vaccine ecosystem has undergone significant changes since the introduction and implementation of the 2010 NVP. Over the last decade, advancements in technology, policy, and infrastructure have strengthened the immunization landscape. For example, the adult vaccine platform has broadened, and the pipeline continues to expand, permitting future protection against a wide array of vaccine-preventable diseases. The 2020 NVP is an opportunity to continue to build on the framework laid out in the 2010 NVP and make it more current, useful, and strengthen several areas. Given the nature of AVAC’s work, we encourage OIDP to maintain many of the strategies encompassed in 2010 NVP Goals 3 and 4 and we recommend inclusion of new goals and objectives that focus specifically on increasing access, promoting the societal value of vaccination, and increasing vaccine confidence.

2010 NVPO Goal 3: Support Communications to Enhance Vaccine Decision-Making

Goal 3 of the 2010 NVP is more imperative now than ever before. A concerted and sustained approach to communication to providers across the health care system, patients and family members across the life course, and the public generally is central to the success of all aspects of the NVP.

The 2020 NVP should further strengthen the workflow under Goal 3. 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. Efforts to build and enhance collaborations and partnerships for communication efforts, particularly with state and local partners, should remain a high priority (3.2). Strategies must not just rely on external campaigns but should prioritize stakeholder (3.2.1), cross-agency, and intra-agency collaboration (3.2.2). The 2020 NVP should continue to prioritize collaborations with stakeholders (3.2.3) to disseminate information, and to learn from current practices on an ongoing basis, not just when an outbreak occurs. The 2020 NVP should re-emphasize the core elements of the “immunization neighborhood” and the value of optimizing the knowledge, skills, access and public trust of the various players in the neighborhood.

Meaningful improvements in vaccine access, utilization, and coverage rates can only be achieved with a strong foundation that incorporates the latest research and communication strategies. Tools to disseminate vaccine information—including publication of evidence-based recommendations, use of mass and social media, provider education and training, and support of non-federal stakeholder partners—are proven ways to educate and drive adult immunization demand. Public and private payers have an important role to play in communication efforts through resources such as the Medicare Handbook and Medicare Learning Network (MLN) publications. Additionally, reminder messages (postcard/text/email) to patients are reliable methods to communicate immunization information to providers and patients, and their utilization should be encouraged.

The 2020 NVP should put greater emphasis on initiatives aimed at boosting immunization rates for minority, at-risk, and vulnerable populations across the life course (3.4). Communication and engagement should be strategic, evidence-based, culturally appropriate and reflect the health literacy, language proficiency, and functional and access needs of specific target populations. Special attention should be paid to communicating the risk and cost of vaccine preventable diseases with the goal of establishing vaccination as a routine part of preventive care and building confidence in vaccination as a societal norm (3.4).

The NVP should prioritize improving the lines of communication between state and local vaccine program managers, third party payers, large health systems, and key decision and policy makers (3.5). Ensuring that policy makers at all levels of government have current information on vaccine benefits and risks- personally and at a community-level, and in terms of healthcare and economics, as well as an understanding of public knowledge and attitudes towards vaccination will help to better inform the policymaking process (3.5). It is especially important for key decision makers to have data on the direct and indirect costs and benefits of vaccinations across the life course (3.5.3).

2010 NVP Goal 4: Ensure a Stable Supply of, Access to, and Better Use of Recommended Vaccines in the United States

Significant progress has been made to ensure the supply and delivery of vaccines over the last decade. The 2020 NVP should prioritize objectives to improve access to and utilization of immunization across the life course. While tremendous progress has been made in access to childhood immunization, adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers. There also often is a lack of understanding about recommended vaccines, financial hurdles, as well as technological and logistical obstacles.

Disparities in vaccine insurance coverage remain, and with an increasingly complex Advisory Committee on Immunization Practices (ACIP) recommendations, providers and patients continue to confront insurance coverage and implementation challenges. The challenges facing the vaccine ecosystem today are vastly different from those faced in 2010, and the 2020 NVP should be revised to reflect the challenges that continue to contribute to access barriers and a lack of recognition of the societal value of vaccination.

AVAC supports considering many of the priorities outlined in detail in our response to question 1, and we will also summarize them here. Gaps to improving access and utilization of adult vaccines include the following areas:

1. Enhancements in health information technology (4.4) that will provide widespread and seamless interoperability between IIS and EHRs, among all health care providers across all sites of care for vaccine administration, are needed to create a comprehensive immunization record for individuals across the life course and ease the burden of provider reporting. Timely, complete and accurate information can inform decision-making at the point of clinical care.

2. Streamlining and adoption of immunization composite quality reporting measures will standardize these metrics, which are increasingly important to benchmark progress and outcomes in preventive health services (4.6). Integration of validated adult immunizations quality measures by Medicare, Medicaid, and private insurance will drive utilization and improve patient access.

3. Alleviating financial barriers that prevent adults from receiving recommended immunizations will improve access and reduce barriers that hinder the ability of providers to carry and administer vaccines (4.3). Adequate reimbursement for the time spent on vaccine counseling should be accounted for to ensure services provided by clinicians are appropriately reimbursed in accordance with the work performed rather than the clinician’s occupation. In addition, barriers to access based on the type of practitioner/practice should be eliminated to allow enhanced access that meets the needs of patients.

3. What are the goals, objectives, and strategies for each of your top priority areas? Are there any goals in the current strategy that should be discarded or revised? Which ones and why?

AVAC sees the value of carrying over many of the 2010 NVP goals, objectives and strategies to the proposed 2020 plan. While good progress has been made over the past decade, there is still room for improvement within many of the existing goals.

Streamlining and assigning specific actions and benchmarks to stakeholders in the immunization neighborhood could help to improve the actionability and accountability of the Plan in the implementation phase. As this process moves forward, we would encourage the inclusion of strategies that are targeted across the life course and identification of specific strategies that will potentially benefit the various Plan stakeholders seeking to make progress toward the various goals and objectives. We would additionally encourage the plan to include strategies to address growing vaccine hesitancy in the community to increase vaccine confidence and build a resilient ecosystem. Our previous RFI responses outlined in this letter provide some specific examples.

Increased partnerships for communications efforts will be especially important. As a coalition representing providers, public health groups, vaccine innovators and manufacturers, pharmacy, and consumers, we share the NVP’s goals of reducing barriers and improving access to immunization. Tremendous work is taking place across the country to identify the barriers and challenges around adult vaccines. The NVP should prioritize collaborations with stakeholders to disseminate information, and to learn from current outreach and practices.

The NVP should prioritize efforts to reduce financial barriers to vaccination. This includes efforts to ensure that out-of-pocket costs do not represent a significant barrier to adults and providers across all sites of care for vaccine administration are adequately compensated for the purchase and administration of ACIP-recommended vaccines.

A strong immunization infrastructure, including robustly supported and comprehensive IIS that have the capacity to deliver accurate and timely immunization coverage information on routinely administered vaccines, easily transmit immunization encounters, and facilitate quality measure reporting should be the backbone of the goals outlined in the 2020 NVP. The NVP should prioritize the completeness of and communication between IIS and EHR, among all health care providers across all sites of care for vaccine administration, to monitor vaccine coverage and efforts to support the adoption of interoperable HIT and EHRs for immunization. For example, HHS should aggregate data from MA prescription drug plans (MA-PD) and Part D plan sponsors through EHRs to better monitor, measure and attribute the impact different providers, including pharmacists, have on vaccination rates of Medicare beneficiaries.

AVAC is committed to improving our nation’s immunization infrastructure and would encourage increased and predictable discretionary funding through the Centers for Disease Control and Prevention (CDC) for state and local immunization programs administered by public health departments. In addition, AVAC would encourage, broader investment from federal stakeholders within and outside of HHS that rely upon these services and systems, including the Centers Medicare and Medicaid Services (CMS), the Departments of Defense (DOD) and Veterans Affairs (VA), among others.

There should also be close collaboration and coordination across federal agencies on efforts where there are implications in terms of disease outbreaks and vaccinations. For instance, the nationwide opioid epidemic has resulted in a concurrent rise the number of cases of Hepatitis A and B. Response efforts have severely strained federal, state and local resources and budgets. Improved collaboration and coordination across the viral hepatitis and immunization divisions will help to address some of this burden and improve response efforts aimed at addressing, mitigating, and containing these outbreaks.

Similarly, as our health system increasingly turns to the use of quality reporting and improvement tools in clinical practice, immunization should be prominently featured across these programs. Efforts to strengthen and support the dissemination and adoption of federal benchmarks and measures to encourage improved monitoring and reporting on immunization activities will help drive increased adult immunization rates and should also be considered a core strategy. Measures that consider the application of adult immunization standards across all health care providers in different health care settings should be highlighted as a means to expand the consistent availability of immunizations as well as the use of IIS and quality improvement programs.

4. What indicators can be used to measure your top priorities and goals? Are there any indicators in the 2010 National Vaccine Plan or the National Adult Immunization Plan that should continue to be used? If so, which ones, and why?

A focused, concerted approach to life-course immunization will need clear benchmarks and expectations of success. We recommend the NVP include an implementation plan that will show how goals, objectives, and strategies will be met as well as who will be responsible for working together on the different activities for implementation.

The NVP should drive government resource allocation in terms of federal dollars, time and resources. Immunizations must be a national effort that involves multiple federal partners. The plan should incorporate plans to coordinate with other Federal partners, including HHS, CDC, CMS, ACL, HRSA, IHS, VA, and DOD, to inform vaccine policy implementation. The NVP should outline a structure for interagency cooperation to ensure that the implementation of vaccine efforts are integrated, comprehensive, efficient and effective.

The elements of the NVP should be harmonized with other federal government objectives. However, the proposed Healthy People 2030 objectives significantly reduced the number of objectives related to immunization. The NVP is an appropriate vehicle for more specific objectives than those that are ultimately included in Healthy People 2030 because it is a vaccination-specific document. We also encourage the NVP to prioritize surveillance data, among all health care providers across all sites of care for vaccine administration, to more accurately evaluate coverage gaps and disparities, particularly among minority and vulnerable populations. Understanding these gaps is essential to improving the impact of adult immunization efforts and expanding coverage. Another example would be to set forth specific strategies around immunization quality that correspond with CMS quality roadmap goals and objectives.

We also encourage the NVP to prioritize timely surveillance data to more accurately evaluate coverage gaps and disparities, particularly among minority and vulnerable populations. This is essential to implementing evidence-based policies and strategies aimed at improving the impact and effectiveness of immunization efforts to increase and expand coverage.

Access to a real-time immunization dashboard could serve to highlight immunization champions as well as identify current and emerging coverage gaps in immunization in particular areas or among specific age groups or other subpopulations. This knowledge would inform policies and help to effectively target activities and resources to where they are needed most.

When possible, immunization data should also tie in to related surveillance systems. For example, there has been a rise in hepatitis with the increase in opioid use, and this data should be cross referenced.

5. Identify which stakeholders you believe should have responsibility for enacting the objectives and strategies listed in the 2020 National Vaccine Plan, as well as for any new objectives and strategies you suggest. Specifically identify roles that you or your organization might have in the 2020 National Vaccine Plan.

Successful implementation of the NVP will rest in large part on our shared commitment to several principles: educating all adults about the incredible benefits vaccines provide; making ACIP recommended vaccines available to everyone across the life-course, from all backgrounds; and simplifying the delivery process.

We agree with the Stakeholder Engagement Diagram as set forth in the National Vaccine Plan Development 2020 recommendations from NVAC in September 2019. HHS, and in particular OIDP, has a long history of working with federal and non-federal partners to devise the NVP and strategies towards implementation.

The NVP should consider new partners, including more focus with larger health systems, medical groups, Community Health Centers and community pharmacies. External service providers for older adults, senior centers, pharmacies and employers all have role in enacting the strategies of the plan.

Stakeholder partners will continue to play an essential role in helping bring the NVP to fruition. These are the values on which AVAC was founded and they will inspire us to help make implementation of this plan a success. With many stakeholders standing ready to help, implementation of strategies should be targeted to various groups -for example public health, industry or specific provider groups.

AVAC recommends that the members of the National Vaccine Advisory Committee be tasked with responsibilities around enacting objectives and strategies. Workgroups could be created based on what is recommended in the plan across the lifespan to help oversee the various issues.

The various federal and non-federal partners should be tasked with specific goals and priorities within the NVP. This way, we can come at the solutions from different angles at the same time.

Finally, consumer to consumer resources, education and information sharing should also be made available to help empower groups to help with fortification of advocates and to help information flow more smoothly in positive direction. A bold NVP can serve as an opportunity to galvanize stakeholders, supporters, and consumers.

Again, thank you for the opportunity to comment. We stand ready to work with OIDP and other federal and nonfederal stakeholders toward common goals and objectives that will strengthen and enhance access to and utilization of immunization across the life course in 2020 and beyond. Please reach out to AVAC Managers Abby Bownas (abownas@nvgllc.com) or Lisa Foster (lfoster@nvgllc.com) for additional information.

Sincerely,

Alliance for Aging Research
American Immunization Registry Association
American Pharmacists Association
American Public Health Association
Biotechnology Innovation Organization (BIO)
Families Fighting Flu
GSK
Hep B United
Hepatitis B Foundation
Infectious Diseases Society of America
National Association of County and City Health Officials
National Association of Nutrition and Aging Services Programs (NANASP)
National Black Nurses Association
National Consumers League
National Hispanic Medical Association
National Viral Hepatitis Roundtable
Novavax
Seqirus
The Gerontological Society of America
Trust for America’s Health
Vaccinate Your Family