AVAC Commends Introduction of the Protecting Seniors Act

Members of the Adult Vaccine Access Coalition (AVAC) wrote to Reps. Shalala, Buchson, Kuster, and Roe, commending them for introducing the Protecting Seniors Through Immunization Act of 2019. The Protecting Seniors Act would eliminate out-of-pocket costs for immunization in Medicare Part D.

November 13, 2019

Dear Representatives Shalala, Buchson, Kuster, and Roe,

As members of the Adult Vaccine Access Coalition (AVAC), we would like to take this opportunity to commend you for introducing the Protecting Seniors Through Immunization Act of 2019.

AVAC consists of more than fifty organizational leaders in health and public health who are committed to raising awareness of the importance of adult immunization with the ultimate goal of addressing barriers to adult immunization. Our mission is informed by scientific and empirical evidence that shows immunization improves health and protects lives against a variety of debilitating and potentially deadly conditions, saving costs to the healthcare system and to society as a whole. AVAC priorities and objectives are driven by a consensus process with the goal of enabling a range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations. A top priority for AVAC is to achieve increased adult immunization rates through improving education and awareness of recommended vaccines and addressing challenges to access.

Immunizations are a cornerstone of our nation’s disease prevention efforts and have a demonstrated track record of success as a cost-effective means of reducing disease burden and saving lives among pediatric populations. The CDC estimates that over 20 years, childhood immunizations prevent 732,000 deaths and 21 million hospitalizations. The HHS Strategic Plan FY2018–2022, acknowledges that “infectious diseases are a major health and economic burden for the United States, and makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.” Yet, despite the well-known benefits of immunization, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lags behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV. Millions more adults suffer from vaccine-preventable diseases, causing them to miss work and leaving some unable to care for those who depend on them.

Adults seeking access to and coverage for vaccines encounter a confusing health care  system that presents multiple barriers, including lack of awareness and information about recommended vaccines, financial hurdles including high cost sharing, as well as technological and logistical obstacles. The Protecting Seniors Through Immunization Act of 2019 addresses these critical issues. The legislation will help inform more beneficiaries about Medicare coverage for vaccines. Often, Medicare beneficiaries do not realize that coverage for immunizations is divided between Medicare Part B and Medicare Part D. While vaccines under Medicare Part B are available to beneficiaries with no cost sharing or deductibles, beneficiaries face varied cost-sharing requirements under Medicare Part D plans. The bill brings parity between out-pocket costs between Medicare Part B and Medicare Part D.

The future holds great promise for new immunizations, specifically for older adults, but the benefits of immunization cannot be realized if patients do not access the services. Reducing the number of missed immunization opportunities for Medicare beneficiaries is an important step in improving health and reducing the burden of vaccine-preventable illness among this population. AVAC members are pleased to offer our support for this important legislation and stand ready to work with you toward equitable access and parity of coverage for all ACIP- recommended vaccines for the Medicare population.

Sincerely,

American Association of Occupational Health Nurses (AAOHN)

Alliance for Aging Research

American College of Preventive Medicine (ACPM)

American Immunization Registry Association (AIRA)

American Pharmacists Association (APhA)

American Public Health Association (APHA)

Association of Asian Pacific Community Health Organizations (AAPCHO)

Association of Immunization Managers (AIM)

Association for Professionals in Infection Control and Epidemiology (APIC)

Asian & Pacific Islander American Health Forum (APIAHF)

Biotechnology Innovation Organization (BIO)

Dynavax

Families Fighting Flu

GSK

Hep B United

Hepatitis B  Foundation

Immunization Action Coalition (IAC)

Infectious Diseases Society of America (IDSA)

Medicago

Merck

National Association of Chain Drug Stores (NACDS)

National Association of County and City Health Officials (NACCHO)

National Association of Nutrition and Aging Services Programs (NANASP)

National Consumers League

National Council of Asian Pacific Islander Physicians (NCAPIP)

National Foundation for Infectious Diseases (NFID)

National Hispanic Medical Association (NHMA)

National Viral Hepatitis Roundtable (NVHR)

Novavax

Pfizer

Sanofi

Scientific Technologies Corporation (STC)

Takeda

The Gerontological Society of America (GSA)

Trust for America’s Health

Vaccinate Your Family

AVAC Makes Recommendations for the Development of the 2020 National Vaccine Plan

AVAC responded to questions posed by Dr. Tammy Beckham, Director of the Office of Infectious Disease and HIV/AIDS Policy at HHS, as they start to develop the 2020 National Vaccine Plan (NVP). AVAC sees 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.

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

AVAC Offers Comments on Proposed Changes to the Hospital Outpatient Payment System

AVAC expressed deep concern that the hospital outpatient and ambulatory surgical center quality reporting programs no longer includes adult immunization quality measures and urged that CMS consider including the Adult Immunization Status measure in the final rule.

September 27, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1717-P
P.O. Box 8013
Baltimore, MD 21244-1850

RE: CMS-1717-P Medicare Program: Proposed Changes to Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs proposed rule. AVAC remains deeply concerned that the hospital outpatient and ambulatory surgical center quality reporting programs no longer include adult immunization quality measures and would urge inclusion of the Adult Immunization Status measure in the final rule.

AVAC consists of 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.

Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.5,6 One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of adult immunization status that will result in increased adult immunization rates.

Adult Immunization Status (AIS) Measure
AVAC has been disappointed over the last few years to see several important immunization measures for influenza and pneumococcal removed from quality reporting programs under the rule. AVAC strongly urges CMS to prioritize prevention quality measurement by including the Adult Immunization Status (AIS) measure in the final rule. The AIS has also been proposed for adoption under the MIPS/MSSP as well as a number of primary and specialty areas in the CY2020 Physician Fee Schedule rule.

The AIS measure is a composite of several age-recommended vaccines for adults, comprising influenza, pneumococcal, zoster, and Tdap vaccines. Adoption of the composite measure would provide a sound, reliable and comprehensive means to assesses the receipt of routinely recommended adult immunizations. The AIS will reduce the reporting burden on providers while also incentivizing them to follow the National Vaccine Advisory Committee (NVAC) Practice Standards for Adult Immunization Practice2 to assess, recommend, administer or refer and document the vaccines the patient may (or may not) have received during the visit.

Monitoring immunization status and reporting of offered and administered immunizations to patients are critical preventive service benchmarks that help to ensure immunizations remain a priority under new payment models and in the forefront of clinical care standards. Reducing the number of missed immunization opportunities, particularly among Medicare beneficiaries, is critical to improving health and reducing the burden of vaccine preventable disease.

Opportunities to assess the immunization status of Medicare beneficiaries should be done by the range of clinicians who care for them, including primary care and specialty providers. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong provider recommendation have been found to improve the likelihood of a patient being immunized.

In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines.3 The report highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Department of Health and Human Services (HHS) recognizes that immunization is an important tool to keep people healthy and reduce avoidable health care costs. In its Strategic Plan FY 2018 –2022, HHS acknowledges that “infectious diseases are a major health and economic burden for the United States.” Additionally, strategic objective 2.1 makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.”

AVAC believes that adult immunization quality measurement also meets the three core strategies underlying the movement toward a truly patient-centered health care delivery system by: 1) Improving the way clinicians are paid to incentivize quality and value of care over simply quantity of services; 2) improving the way care is delivered by providing clinical practice support, data and feedback reports to guide improvement and better decision-making and; 3) making data more available in real-time at the point of contact and enabling the use of certified Electronic Health Record (EHR) technology and other data sources to support care delivery.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
Biotechnology Innovation Organization
Dynavax Technologies Corporation
Families Fighting Flu
GSK
Immunization Action Coalition
Infectious Disease Society of America
Medicago
National Consumers League
Novavax
Sanofi
The Gerontological Society of America
Trust for America’s Health

AVAC Comments on the CMS’s Proposed Changes to the Physician Fee Schedule

AVAC expressed support for the inclusion of the Adult Immunization Status (AIS) measure in both the MIPS and MSSP and additional specialty sets but expressed concern for the proposed 15 percent reduction in practice expense relative value units for Vaccine Administration. If the proposed reduction is allowed to take effect, providers will face a 44 percent reduction in vaccine administration since 2017.

September 27, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1693-P
P.O. Box 8016
Baltimore, MD 21244-8016

RE: CMS-1715-P Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc.

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc.

Specifically, AVAC:
• Strongly supports the inclusion of the Adult Immunization Status (AIS) measure in both the MIPS and MSSP and additional specialty sets.
• Opposes the proposed 15 percent reduction in practice expense relative value units for Vaccine Administration. If the proposed reduction is allowed to take effect, providers will face a 44 percent reduction in vaccine administration since 2017.

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.

Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV. One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of adult immunization status that will result in increased adult immunization rates.

Adult Immunization Status Measure
We appreciate that the proposed rule contains a number of important provisions aimed at the transition from volume-to-value based payment policy. Specifically, the proposed rule includes elements pertaining to the operation of the Medicare Shared Savings Program (MSSP) as well as the Merit-based Incentive Payment System (MIPS) that offer important opportunities to encourage access to and utilization of recommended adult immunizations to priority populations within the Medicare program.

AVAC strongly supports the inclusion of the Adult Immunization Status measure in both the MIPS and MSSP and encourages CMS to maintain the measure in the final rule. The AIS measure is a composite of several age-recommended vaccines for adults, comprising influenza, pneumococcal, zoster, and Tdap vaccines. Adoption of the composite measure will provide a sound, reliable and comprehensive means to assesses the receipt of routinely recommended adult immunizations. The AIS will reduce the reporting burden on providers while also incentivizing them to follow the National Vaccine Advisory Committee (NVAC) Practice Standards for Adult Immunization Practice1 to assess, recommend, administer or refer and document the vaccines the patient may (or may not) have received during the office visit.

In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. The report highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Adult Immunization Status quality measurement is a valuable addition because it meets the three core strategies underlying the movement toward a truly patient-centered health care delivery system by: 1) Improving the way clinicians are paid to incentivize quality and value of care over simply quantity of services; 2) improving the way care is delivered by providing clinical practice support, data and feedback reports to guide improvement and better decision-making and; 3) making data more available in real-time at the point of contact and enabling the use of certified Electronic Health Record (EHR) technology and other data sources to support care delivery.

ACO-47
AVAC commends CMS for including Adult Immunization Status (ACO-47) under the AIM: Better Health for Populations under the MSSP beginning in 2020, for phase in as a pay-for-performance measure starting in performance year 2022. Its’ inclusion presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC appreciates CMS’ recognition of the need to engage in a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries.

Monitoring immunization status and reporting of offered and administered immunizations to patients are critical preventive service benchmarks that help to ensure immunizations remain a priority under new payment models and in the forefront of clinical care standards. Reducing the number of missed immunization opportunities, particularly among Medicare beneficiaries, is critical to improving health and reducing the burden of vaccine preventable disease.

CY2020 MIPS Specialty Measure Sets (Appendix 1)
Opportunities to assess the immunization status of Medicare beneficiaries should be done by the range of clinicians who care for them, including primary care and specialty providers. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong provider recommendation have been found to improve the likelihood of a patient being immunized.

AVAC is pleased the proposed rule takes steps to adopt past AVAC recommendations to the agency to broadly incorporate the Adult Immunization Status measure through the following specialty sets.
✓ Allergy/Immunology
✓ Family Medicine
✓ Internal Medicine
✓ Otolaryngology
✓ Preventive Medicine
✓ Nephrology
✓ General Surgery
✓ Oncology
✓ Infectious Disease
✓ Rheumatology
✓ Geriatrics
✓ Skilled Nursing Facility
✓ Endocrinology

Cardiology
We encourage CMS to consider also adding the Adult Immunization Status measure into the Cardiology specialty measure set given the vital importance of vaccines in preserving and protecting the health and well-being of patients with cardiovascular conditions, such as heart disease.

Obstetrics/Gynecology
AVAC notes the inclusion of the Adult Immunization Status measure under the Obstetrics/Gynecology specialty measure set. We would encourage CMS to also consider adopting the Prenatal Immunization Status measure, which was created specifically for maternal populations and better reflects the Advisory Committee on Immunization Practices (ACIP) recommendations for pregnant women, specifically Tdap and influenza.

Like the AIS, the Prenatal Immunization Status measure will help to address substantial disparities in prenatal immunization rates. Immunizing mothers during their third trimester protects 9 in 10 babies from pertussis infections serious enough to need treatment in a hospital. Getting a flu shot reduces a pregnant woman’s risk of hospitalization by 40% and helps protect the newborn before he/she is old enough to be vaccinated.

Reduction in Practice Expense Relative Value Units for Vaccine Administration
Immunizations are an important public health imperative and ensuring that immunization providers are properly reimbursed is key to fostering a sustained environment of timely immunization. Vaccine administration by health care providers in their office, at the point of care, is an opportunity that needs to be maintained and encouraged. Studies show that inadequate reimbursement for vaccination administration result in missed immunization opportunities and declines in immunization rates.

AVAC is deeply concerned with the proposed 15% reduction in the reimbursement rate for CPT codes for vaccine administration (90471-90474) in 2020. In 2013, Medicare providers received $25.86 for vaccine administration whereas under the proposed rule, providers would only receive $14.42 beginning in 2020. Between 2017 and 2020, providers are facing up to a 44 percent reduction in reimbursement at a time when practice expense costs have been increasing, not decreasing.

In previous and current proposed reductions, CMS utilizes the AMA’s RUC recommendations, which are based on a determination that less resources are needed to furnish services associated with CPT 96372, as reflected in the reduction in Practice Expense (PE) inputs. None of the immunization administration codes were used as a reference or comparison in the AMA’s revaluation of 96372.

While overhead costs are considered in the calculation of the PE PVU component of CPT 90471-90474, this calculation is inappropriately applied to immunization administration, as it underestimates the provider burden associated with vaccinating adult patients. Thus, CMS’ reduction in the payment rate results in a misevaluation of the CPT code and a subsequent underpayment for immunization services. CMS’ payment rates for immunization administration should reflect this distinction.

Specifically, provider offices must manage vaccine ordering and inventory, ancillary supplies directly related to the administration of vaccines, such as syringes and gloves as well as indirect overhead costs associated with reporting and other administrative requirements specific to immunizations. Providers also must effectively an influx of patient visits solely for immunization during certain times of year (particularly during back to school and flu season, October-March).

A recent study in the journal Vaccines notes, “A number of studies have documented that physician practices feel they face financial challenges in providing adult vaccination, such as inadequate reimbursement, delays in receiving reimbursement, uncertainty in forecasting vaccine needs, and substantial expenses in acquiring and maintaining vaccine stock.” These factors have driven many providers to consider discontinuing or limiting vaccine services to patients.

AVAC is deeply concerned that the continued erosion in vaccine administration reimbursement will only exacerbate this alarming trend and further erode adult immunization coverage rates. Missed opportunities to immunize the Medicare population will result in increased burdens of vaccine preventable diseases and additional costs to health systems. These payment reductions also have the potential to have spillover effects on commercial coverage of vaccines, strain critical public health infrastructure and set our nation back in terms of achieving Healthy People goals to further increase vaccination rates for adults.

The proposed reduction also runs counter to the Administration’s ongoing efforts to improve access to vaccination. On September 19, the President issued an Executive Order to modernize and improve influenza vaccination to promote national security and public health. Section 2 of the EO states, “This is a public health and national security priority, as influenza has the potential to significantly harm the United States and our interests, including through large-scale illness and death, disruption to military operations, and damage the economy.”8 Similarly, the HHS’ Strategic Plan FY2018–2022, acknowledged that “infectious diseases are a major health and economic burden for the United States.” Objective 2.1 of the Strategic Plan makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.9”

Given the current gaps in immunization access for older adults as well as the potential negative long-term impact on providers’ ability to offer recommended immunizations to Medicare patients, AVAC strongly urges CMS to abandon this proposed reduction in vaccine administration reimbursement. AVAC encourages the agency to consider decoupling the practice expense RVU for vaccine administration from therapeutic injection and come up with a more accurate formula for calculating vaccine administration costs.

We appreciate this opportunity to share our perspective on the proposed rule and are grateful for your work to update and streamline the quality measurement tools available to providers. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
American Immunization Registry Association (AIRA)
American Pharmacists Association
Asian Pacific Islander American Health Forum
Association of Immunization Managers
BIO
Dynavax
Families Fighting Flu
GSK
Hepatitis B Foundation
Hep B United
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition
Immunization Coalition of Washington DC
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
National Consumers League
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association
Novavax
Pfizer
Sanofi
Seqirus
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health
Vaccinate Your Family

AVAC Sends Comments to CMS on the Medicare Program End Stage Renal Disease Prospective Payment System (ESRD PPS) and Quality Incentive Program Proposed Rule

AVAC expressed concern that the ESRD PPS no longer includes immunization quality measures for health care professionals or the patients they serve. AVAC also encouraged CMS to consider the inclusion of the Composite ESRD Immunization measure for ACIP-recommended vaccines (influenza, pneumococcal and hepatitis B) under the ESRD Quality Incentive Program (ESRD QIP) in the final rule. This new composite measure would promote higher quality and more efficient health care for vulnerable ESRD patients who are at increased risk of vaccine preventable illness.

September 27, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1713-P
P.O. Box 8010,
Baltimore, MD 21244-8010

RE: CMS-1713-P Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program End Stage Renal Disease Prospective Payment System (ESRD PPS) and Quality Incentive Program proposed rule. AVAC remains deeply concerned that the ESRD PPS no longer includes immunization quality measures for health care professionals or the patients they serve. Our coalition strongly encourages CMS to consider the inclusion of the Composite ESRD Immunization measure for ACIP-recommended vaccines (influenza, pneumococcal and hepatitis B) under the ESRD Quality Incentive Program (ESRD QIP) in the final rule. This new composite measure would promote higher quality and more efficient health care for vulnerable ESRD patients who are at increased risk of vaccine preventable illness.

AVAC consists of 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.

Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.5,6 One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates.

In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. The report highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Department of Health and Human Services (HHS) recognizes that immunization is an important tool to keep people healthy and reduce avoidable health care costs. In its Strategic Plan FY 2018 –2022, HHS acknowledges that “infectious diseases are a major health and economic burden for the United States.” Additionally, strategic objective 2.1 makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.” Unfortunately, access to vaccines is not equal across a person’s lifespan.

Composite ESRD Vaccination Measure
The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group spearheaded the development and testing of a new composite measure for end-stage renal disease patients covering influenza, pneumococcal and hepatitis B vaccines. A review of CMS fee-for-service claims data warrants the use of such a measure as current vaccination rates for the ESRD population fall well below recommended targets.

Research has shown that kidney care centers with vaccination protocols have demonstrated reduced infection rates and resulted in decreased morbidity and mortality. Vaccines, including hepatitis B and pneumococcal conjugate and pneumococcal polysaccharide, are specifically recommended for dialysis or CKD patients. However, like with other adult populations, vaccines are underutilized in CKD patients, who could benefit greatly from improved access to immunization services.

A composite measure for ACIP-recommended vaccines for ESRD patients would be of great benefit to the ESRD QIP now and in the future. The ESRD QIP presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries that preserves health and avoids unnecessary health expenditures due to vaccine preventable illness. AVAC strongly believes the ESRD QIP should include a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of patients living with kidney disease. An ESRD composite measure would provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP).

We look forward to working with CMS to ensure meaningful measures that reflect priority health care services, such as immunization, that will streamline and reduce the reporting burden on providers, provide an accurate representation of ESRD facility performance in the least burdensome manner possible and provide meaningful data to the Medicare program on access to this important preventive service.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
Asian & Pacific Islander American Health Forum (APIAHF)
Association of Immunization Managers
Biotechnology Innovation Organization
Families Fighting Flu
GSK
Immunization Action Coalition (IAC)
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
Novavax
Sanofi
Seqirus
The Gerontological Society of America
Trust for America’s Health

AVAC Comments on the Medicare Program Hospital Inpatient Prospective Payment Proposed Rule for FY 2020

AVAC commented on CMS’s Hospital Inpatient Prospective Payment proposed rule, expressing support for the adoption of streamlined adult immunization composite measure; the idea of future stratification of Hospital IQR Program data by race, ethnicity, geographic area, sex, and disability on Hospital Compare, as well as on potential future hospital quality measures that incorporate health equity; and the proposal to maintain the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431). AVAC is committed to advocating for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates.

June 24, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services Attention: CMS-11716-P
P.O. Box 8013
Baltimore, MD 21244-1850

RE: CMS–1716–P Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Hospital Inpatient Prospective Payment proposed rule for Fiscal Year 2020.

AVAC consists of over 50 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.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. Immunization quality measures are a crucial tool for health care quality improvement and have demonstrated effectiveness in increasing immunization rates.

Opportunities to assess the immunization status of Medicare beneficiaries for should be done by the range of clinicians who care for them, including primary care and specialty providers. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong provider recommendation have been found to improve the likelihood of a patient being immunized. Published literature indicates that integrating immunization assessment and additional providers offering these critical preventive services will result in greater opportunities for immunization. The National Vaccine Advisory Committee’s (NVAC) Adult Immunization Standards call for all providers caring for adult patients to assess, recommend, vaccinate or refer, and document vaccinations.

Influenza Quality Measures.

The Department of Health and Human Services Strategic Plan FY 2018 –2022, the Department of Health and Human Services encourages the use of age appropriate vaccines to minimize the burden of vaccine-preventable diseases across the life span. Unfortunately, access to vaccines is not equal across a person’s lifespan. Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lags behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.

Preventing transmission of influenza and other infectious agents within inpatient hospital settings requires a multi-faceted approach since the spread of influenza can occur among patients, Health Care Professionals (HCP), and visitors. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to the annual influenza vaccine.

The Advisory Committee on Immunization Practices (ACIP) recommends an annual influenza vaccination for all people age 6 months or older. Each year, influenza causes approximately 200,000 hospitalizations and an average of 36,000 deaths in the United States each year. A Centers for Disease Control and Prevention (CDC) review of deaths associated with seasonal influenza between 1976 and 2007 found that 90 percent were among adults age 65 and older. According to a study in the Journal of Primary Prevention, this costs the United States about $8.3 billion or 54 percent of the total annual cost to treat vaccine- preventable diseases among US adults 65 and over. Influenza immunization measures help increase access and utilization of this important vaccine by patients and health care providers alike.

Hospital Inpatient Quality Reporting (IQR)/ PPS-exempt Cancer Hospital Quality Reporting Program/Long-term Care Hospitals Quality Reporting Program (LTCHQRP).

We support the proposal to maintain the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431). This measure plays a critical role in the CMS Quality Strategy as well as the National Quality Strategy in terms of influenza immunization efforts. Ensuring healthcare personnel vaccination adherence against influenza has been shown to improve patient safety and reduce disease transmission, which is essential for immunocompromised patients in the cancer hospital setting.

Empowering patients and caregivers with the ability to assess cancer hospitals based on this measure could ultimately result in improved outcomes for patients through lower complications. Data transparency of reported measures is an important tool for patients and families seeking to evaluate LTCH settings and an essential component in the identification and management of influenza outbreaks. We support public reporting LTCH QRP data on a CMS website, such as Hospital Compare and support the inclusion of the two above measures in this effort. Tracking vaccine status among health care workers has the ability to increase vaccination rates and reduce absenteeism among healthcare personnel.

Last year’s rule discussed CMS efforts to identify standardized patient assessment data that could be incorporated into assessment instruments across post-acute care settings. Streamlining adult immunization quality measures across health care settings remains an AVAC priority and supports this effort. Greater consistency in quality measurement tools will facilitate data exchange across health care providers as well as improve care coordination and ultimately patient outcomes. In that vein, preventing transmission of influenza virus within healthcare settings requires a multi-faceted, cross-cutting approach.

Social Risk Factors. AVAC coalition members are working on projects that seek to identify and enhance our understanding of coverage gaps and are developing pilot programs to test targeted solutions where these disparities currently exist. The proposed rule indicates that CMS continues to work with the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering and Medicine on accounting for social risk factors in the Hospital IQR Program. We support the idea of future stratification of Hospital IQR Program data by race, ethnicity, geographic area, sex, and disability on Hospital Compare, as well as on potential future hospital quality measures that incorporate health equity. Additionally, we recommend that the data also be stratified by primary language. Together, this type of data will enable more accurate evaluation in coverage gaps and disparities, particularly among minority and vulnerable populations, and are essential to improving the impact of adult immunization efforts and expanding coverage.

New Measures. Lastly, AVAC supports the adoption of streamlined adult immunization composite measure to the QRPs outlined in this rulemaking. The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have been instrumental in spearheading the development and testing of a new adult immunization composite measure (influenza, Td/Tdap, zoster and pneumococcal), along with measures for maternal immunization and end-stage renal disease patients. AVAC strongly supports the addition of an adult immunization measure that incorporates ACIP-recommended vaccines and we look forward to working with your office to support their widespread adoption. Adult composite measures provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP). AVAC appreciates the work of NCQA, PQA and others to develop and test reliable measurement tools that will streamline the patchwork of existing adult immunization measures, reduce the reporting burden on providers, and provide meaningful data to the Medicare program on access to this important preventive service.

In the Value and Imperative of Quality Measures for Adult Vaccines, renowned vaccine experts explain how quality measures that capture and create incentives for appropriate adult vaccinations can prevent illness and death, reduce caregiving demands, save unnecessary healthcare spending, and set the foundation for healthy aging. There is evidence that a composite measure of the adult immunization schedule, such as those demonstrated by the Northwest Tribal Epidemiology Center and by the National Nursing Home Quality Care Collaborative, can improve patient health outcomes. Such a measure would put vaccination coverage rates into a larger context and encourage a more systematic approach for all vaccines.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
Asian & Pacific Islander American Health Forum
Biotechnology Innovation Organization (BIO)
Families Fighting Flu
GSK
Immunization Action Coalition
Infectious Diseases Society of America
Medicago
National Association of County and City Health Officials
National Hispanic Medical Association
Novavax
Pfizer
Pharmaceutical Research and Manufacturers of America (PhRMA)
Sanofi
Seqirus
STC Health
The Gerontological Society of America
Trust for America’s Health
Vaccinate Your Family

AVAC Submits Comments on the 2020 Medicare Advantage and Part D Advance Notice and Draft Call Letter

AVAC appreciates the opportunity to comment on the CMS 2020 Medicare Advantage and Part D Advance Notice and Draft Call Letter. AVAC was encouraged that the call letter prioritizes improved access to and utilization of adult immunization services for beneficiaries in Medicare Advantage and Prescription Drug Plans (PDP). AVAC also made other recommendations that CMS should consider.

March 1, 2019

Seema Verma Administrator
Centers for Medicare and Medicaid Services 7500 Security Boulevard
Baltimore, MD 21244

RE: 2020 Medicare Advantage and Part D Advance Notice and Draft Call Letter (CMS-2017- 0163)

Dear Administrator Verma:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) 2020 Medicare Advantage and Part D Advance Notice and Draft Call Letter.

We are encouraged that the call letter prioritizes improved access to and utilization of adult immunization services for beneficiaries in Medicare Advantage and Prescription Drug Plans (PDP), including:

  • Inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier or to place vaccines on a formulary tier with low cost-sharing. We strongly urge maintaining this language in the final letter.
  • Maintaining a Star Ratings Influenza Measure. We also suggest the addition of an adult immunization composite measure on the display page and for Star Ratings.

In the final Call Letter, we also ask CMS to consider:

  • Adoption of the Adult Immunization Status Composite Measure on the Star Ratings Display Page.
  • Increased application of MTM programs for the purpose of improving immunization rates among Medicare beneficiaries, particularly those with chronic conditions.

AVAC consists of more than fifty organizational leaders in health and public health who are committed to raising awareness of the importance of adult immunization with the ultimate goal of addressing barriers to adult immunization. Our mission is informed by scientific and empirical evidence that shows immunization improves health and protects lives against a variety of debilitating and potentially deadly conditions, saving costs to the healthcare system and to society as a whole. AVAC priorities and objectives are driven by a consensus process with the goal of enabling a range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations.

Immunizations are a cornerstone of our nation’s disease prevention efforts and have a demonstrated track record of success as a cost-effective means of reducing disease burden and saving lives among pediatric populations. The CDC estimates that over 20 years, childhood immunizations prevent 732,000 deaths and 21 million hospitalizations.1 In the draft Strategic Plan FY 2018 –2022, the Department of Health and Human Services encourages the use of age appropriate vaccines to minimize the burden of vaccine-preventable diseases across the life span.2 Unfortunately, access to vaccines is not equal across a person’s lifespan.

Despite the well-known benefits of immunization, more than 50,000 adults die from vaccine- preventable diseases while adult coverage lags behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV. Millions more adults suffer from vaccine-preventable diseases, causing them to miss work and leaving some unable to care for those who depend on them.

Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of awareness and information about recommended vaccines, financial hurdles including high cost sharing, as well as technological and logistical obstacles. Socioeconomic and linguistic barriers further challenge the ability of diverse and medically underserved communities from accessing needed immunizations.

AVAC wishes to offer the following comments with the strong hope that CMS will maintain these important immunization provisions in the final call letter:

Improving Access to Part D Vaccines (page 179)

AVAC greatly appreciates the inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing, and strongly urge maintaining it in the final letter.

According to the Center for Disease Control and Prevention’s (CDC) Surveillance of Vaccination Coverage Among Adults in the United States, National Health Interview Survey, 2016, vaccination rates remain low for tetanus and diphtheria (Td) and tetanus and diphtheria with acellular pertussis (Tdap) for adults age 65 and older, at 58% and 20% respectively. While the Healthy People 2020 herpes zoster target vaccination rate has been achieved, approximately 70% of adults for whom the vaccine is recommended remain unprotected. In a 2010 Government Accountability Office (GAO) Survey of State Health Insurance Assistance Programs (SHIPs), 40% of SHIPs reported difficulty affording the cost-sharing as a barrier to beneficiaries accessing herpes zoster vaccine. A 2018 study of Tdap and herpes zoster vaccine claims in Part D demonstrated that higher out-of-pocket cost-sharing was associated with higher rates of cancelled vaccination claims, suggesting vaccination was abandoned. In this study, cost-sharing of $51 or greater was associated with a 2 to 2.7-times greater rate of cancelled vaccination claims compared with $0 cost-sharing. In an effort to improve access to these and other Part D vaccines, we continue to encourage Part D sponsors to either offer a $0 vaccine tier, or to place vaccines on a formulary tier with low cost- sharing.

A growing body of research illustrates the direct and indirect cost attributable to vaccine- preventable disease. A study published in The Journal of Primary Prevention found the estimated annual cost of just four major vaccine-preventable diseases among US adults 65 years and older was more than $15 billion in 2013. Medical costs related to vaccine- preventable diseases (VPD) in older adults are expected to grow substantially in the coming years; one study forecasts U.S. medical costs for Americans ≥65 in the Medicare population to be $4.74 billion by 2030 for just one VPD.

Financial barriers stand out as one of the most impactful and avoidable barriers to adult immunization. Studies have shown that the variable cost sharing requirements currently imposed on the majority of Part D vaccines discourage immunization among elderly, disabled and chronically ill populations who account for a disproportionate percentage of the morbidity and mortality from vaccine-preventable conditions.

  • A 2017 report by Avalere Health found between 47 and 72 percent of the 24 million Medicare beneficiaries with Part D coverage had some level of cost sharing for vaccines, ranging from $35 to $70 in 2015. Another study found that only 4 percent or less of Medicare Part D enrollees had access to vaccines with no cost sharing.
  • A study evaluating the relationship between vaccine co-pays for Part D beneficiaries and Tdap and Zoster vaccination claims in their doctor’s office showed that, compared with no co-pay, beneficiaries who had to pay a co-pay amount of $26–50, $51–75 or $76–100, respectively, are 1.39, 1.66 or 2.07 times as likely to cancel their zoster vaccination.3
  • A 2015 report by the Alliance for Aging Research on vaccination rates among older adults found that cost sharing for vaccines under Part D varies depending on a beneficiary’s prescription drug plan or Medicare Advantage plan formulary offerings.

Addressing cost sharing requirements currently imposed on the majority of Part D vaccines will greatly improve beneficiary access, utilization and health outcomes among at-risk elderly, disabled and chronically ill populations who account for a disproportionate percentage of the morbidity and mortality from vaccine preventable conditions. The Call Letter language sends an important signal to Medicare Advantage and Prescription Drug Plans that access to Part D vaccines should be a high priority as they develop formulary and cost sharing tiers.

Incentivize Immunization Through Adoption of Evidence Based Measures (page 114)

We greatly appreciate that the annual influenza (flu) vaccine has been maintained as a candidate for the Star Ratings Categorical Adjustment Index (CAI). Influenza is a serious disease that can lead to hospitalization and sometimes even death. Millions of people get the flu every year, hundreds of thousands of people are hospitalized and thousands or tens of thousands of people die from flu-related causes every year. Flu accounts for an estimated 8.95 billion, or 65% of the annual economic burden of adult vaccine-preventable diseases.

According to the Centers for Disease Control and Prevention (CDC), a 6.2 percent reduction in the adult immunization rate for flu during the 2017-18 influenza season was a contributing factor in the record number of deaths. Vaccination has been shown to have many benefits including reducing the risk of flu illnesses, hospitalizations and even the risk of flu-related death.

Quality measurement, particularly when tied to reporting and payment, serve as a mechanism to incentivize plans, providers, health systems, and other stakeholders to improve immunization rates. By strengthening and enhancing the development and implementation of adult immunization quality measures, CMS will help to reduce barriers to adult immunization by creating incentives for offering vaccines.

While we are encouraged by the inclusion of the flu measure again this year, we would note the CY2019 call letter requested comments on inclusion of a pneumococcal measure as a potential new measure under Part C for the 2020 plan year. We are disappointed the measure has not been included in the draft call letter. Further, we ask that CMS consider the inclusion of the Adult Immunization Status Composite Measure, which includes four specific vaccines in one (influenza; tetanus, diphtheria, and pertussis (Tdap) or tetanus and diphtheria (Td) booster; herpes zoster; and pneumococcal). The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC), in collaboration with the National Adult Immunization and Influenza Summit spearheaded the development of the composite. The immunization composite measure provides a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP).

NCQA added the adult composite measure to their 2019 Healthcare Effectiveness Data Information Set (HEDIS) using the Electronic Clinical Data System (ECDS) reporting domain.

Measures in the HEDIS ECDS domain are calculated using electronic data from administrative claims, electronic medical records, case management systems and registries. Prior to HEDIS, the composite was piloted by the Indian Health Service. The FY19 Call letter “Potential New Measures for 2020 and Beyond (page 150-151)” laid the groundwork for adoption of this important measure. AVAC supports an adult immunization composite measure and asks that CMS include an Adult Immunization Composite Measure on the Star Ratings Display Page.

The addition of the adult composite measure would provide the foundation for Medicare quality reporting programs and reflects both the National Quality Strategy (NQS) “triple aim” of better care, affordable care, and healthy people/communities which serves as an overarching framework for guiding and aligning public and private efforts to improve quality healthcare, as well as the National Prevention Strategy (NPS) framework for improving quality of life through greater emphasis on prevention and wellness. In addition, the composite will help to streamline the patchwork of existing adult immunization measures and help to reduce the reporting burden on providers.

Medication Therapy Management Program (page 146)

AVAC also appreciates language in the call letter encouraging utilization of the Medication Therapy Management (MTM) Program as part of innovations in health care design. Medicare beneficiaries account for a large portion of total prescription drug expenditures and individuals with chronic conditions such as diabetes, heart and lung disease account for a disproportionate share of Part D spending. MTM programs have been shown to be effective in improving medication adherence, health outcomes and reducing adverse drug events. Enhanced MTM programs offer an additional opportunity for PDPs to innovate prescription drug delivery services with the goal of improving health care quality while lowering costs.

MTM and enhanced MTM programs offer an important, yet underutilized, means to routinely assess the immunization status of eligible beneficiaries and provide counseling as well as administer recommended vaccinations (when permitted by state law). AVAC urges CMS to include language in the CY2020 call letter directing PDP and MA plans to encourage increased application of MTM programs for the purpose of improving immunization rates among Medicare beneficiaries, particularly those with chronic conditions.

Thank you for the opportunity to offer our perspective on the 2020 Medicare Advantage and Part D Advance Notice and Draft Call Letter. We hope CMS will maintain strong language in the final letter encouraging Part D plans to include vaccines in the $0 vaccine tier or low-cost sharing tier in the final letter, language supporting the inclusion of the adult immunization composite, and the addition of language encouraging greater utilization of MTM programs to improve access to immunization services. We greatly appreciate CMS’ efforts to balance plans’ fiduciary responsibilities and beneficiary access to important preventive health services.

Please contact an AVAC manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to discuss our comments or adult immunization access and coverage.

Sincerely,

Alliance for Aging Research
American College of Preventive Medicine
American Immunization Registry Association (AIRA)
Asian & Pacific Islander American Health Forum (APIAHF) American Pharmacists Association
Association of Asian Pacific Community Health Organizations
Association of Immunization Managers (AIM)
Biotechnology Innovation Organization (BIO)
Dynavax
Families Fighting Flu GSK
Hep B United
Hepatitis B Foundation
Immunization Action Coalition (IAC)
Medicago
National Association of Chain Drug Stores (NACDS)
National Association of City and County Health Officials (NACCHO)
National Black Nurses Association National Consumers League
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association
Novavax Pfizer
Pharmacy Quality Alliance
Sanofi
Scientific Technologies Corp Seqirus
The Gerontological Society of America
Trust for America’s Health (TFAH) Vaccinate your Family
Walgreens

 

CC: Demetrios Kouzoukas, Principal Deputy Administrator and Director, Center for Medicare

 

1 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6316a4.htm

2 HHS Strategic Plan, FY 2018 –2022, Draft, September 2017, page 51

3 Akinbosoye OE et al. Factors Associated with Zostavax Abandonment. AJPB. 2016;8(4):84-89.

AVAC Provides Comments on Immunization and Infectious Disease (IID) objectives for Healthy People (HP) 2030

AVAC provided comments on the Advisory Committee on National Health and Disease Prevention proposed Immunization and Infectious Disease (IID) objectives for Healthy People (HP) 2030. AVAC expressed disappoint that the proposed 2030 IID objectives deviated greatly from AVAC’s previous recommendations and deep concern that the proposed 2030 objectives will significantly minimize and weaken immunization related activities over the coming decade.

January 17, 2019

Don Wright, MD, MPH, FAAFP
Deputy Assistant Secretary for Health
Office of Disease Prevention and Health Promotion
Department of Health and Human Services
Tower Building 1101 Wootton Parkway, Suite LL100
Rockville, MD 20852

Re: Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for Healthy People 2030

Dear Dr. Wright:

The Adult Vaccine Access Coalition (AVAC) greatly appreciates the opportunity to provide our comments on the Secretary’s Advisory Committee on National Health and Disease Prevention proposed Immunization and Infectious Disease (IID) objectives for Healthy People (HP) 2030.

AVAC consists of over 50 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 demonstrated benefits of adult immunization as a preventive measure that protects lives and avoids costly health care expenditures. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system.

Over the past several decades, Healthy People immunization and infectious disease objectives have been a core benchmark for national efforts to improve and maintain immunization coverage across the lifespan. These federal objectives help to guide the actions of public and private stakeholders across the national, state and local landscapes who are committed to improving the health and wellbeing of our nation and provide a foundation for measuring progress.

We appreciated previous opportunities to offer comments to the Healthy People 2030 Framework and through the open comment period. We were grateful to have had the chance to meet with officials within the HHS Office of Disease Prevention and Health Promotion to learn more about the HP2030 process. At that time, AVAC shared recommendations, including our interest in the development of a Lifespan Immunization Objective as a Leading Health Indicator (LHI); strengthening and maintaining existing adult immunization measures (influenza, pneumococcal, shingles); incorporating the Adult Immunization Composite Measure in HP 2030 Objectives; broadening the Hepatitis B vaccine coverage measure to the full population (2020 objective only addresses coverage among health care personnel); encouraging the inclusion of lifespan immunization records in a fully operational, population-based immunization information system (IIS); and increasing the focus on addressing disparities in adult immunization rates.

We are disappointed that the proposed 2030 IID objectives deviated greatly from AVAC’s previous recommendations and are deeply concerned that the proposed 2030 objectives will significantly minimize and weaken immunization related activities over the coming decade. These proposed objectives fail to reflect the HHS Strategic Plan FY2018–2022, which acknowledges that “infectious diseases are a major health and economic burden for the United States.” Objective 2.1 of the Strategic Plan makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.”2 Yet, despite the availability of vaccines that protect adults against 14 different diseases, in addition to the well-known benefits of immunizations, more than 50,000 adults die from vaccine preventable conditions each year.

We wish to offer the following recommendations to the proposed Healthy People 2030 IID objectives so that they remain an important and meaningful benchmark in improving and maintaining immunization coverage across the lifespan:

We encourage the Committee to emphasize immunizations across the lifespan. We appreciate that the Committee maintained a lifespan seasonal influenza vaccination objective (IID-2030-13) that streamlines multiple age cohort objectives from Healthy People 2020. Coverage against seasonal influenza is an urgent public health priority. According to the Centers for Disease Control and Prevention, a 6.2 percent reduction in the adult immunization rate for flu during the 2017-18 influenza season was a contributing factor in the record number of deaths. The flu accounts for an estimated 8.95 billion, or 65% of the annual economic burden of adult vaccine-preventable diseases. The Healthy People 2020 target 70 percent vaccination rate is an appropriate and achievable goal for Healthy People 2030. We strongly urge the Committee to take a similar, consistent approach with regard to other ACIP- recommended vaccines. We understand and appreciate that a core aspect of the Healthy People 2030 process is to significantly reduce the number of objectives and to focus on objectives that can be reasonably and effectively measured and maintained. Federal leadership in immunization objectives to protect against vaccine preventable conditions across the lifespan can be effectively monitored through existing data sources and would yield important benefits across the health care system.

We ask that the Committee incorporate the new adult immunization composite measure (influenza, Td/Tdap, zoster and pneumococcal) as a Healthy People 2030 objective. The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit have developed and tested a new composite measure for adult immunization which includes flu, Tdap, shingles, and pneumonia vaccines. It has been successfully utilized in the Indian Health Service program and is now being initially rolled out in HEDIS 2019.

Having a composite objective as part of HP2030 would put vaccination coverage rates into a larger context and encourage a more consistent approach for all vaccines. The composite is very much in line with the Healthy People 2030 plan to set national goals and measurable objectives to guide evidence-based policies, programs and other actions to improve health and well-being. An adult immunization composite objective would provide a single focal point to promote adherence to the adult immunization clinical standards of care. The addition of an adult composite would be complementary to similar composite objectives included for children and adolescent immunization status as part of Healthy People 2020, and would provide an efficient and robust means to monitor immunization coverage among specific populations at the national level.

At the same time, adopting the adult composite would align HP2030 objectives with external health care quality measurements tools, which in turn would help to streamline the patchwork of existing adult immunization measures, reduce the reporting burden, and provide a meaningful national picture of access to this important preventive service. An adult immunization composite objective would provide a clear national target for patients and providers on this important population health imperative.

AVAC advocates for the Committee to include a Hepatitis B vaccine coverage objective (proposed objective IID-2030-02). AVAC is deeply concerned about the recent rise in acute hepatitis B (HBV) infection rates in many parts of the U.S. as a result of the ongoing opioid crisis, with rates increasing by 100% to over 400% in some states. It is estimated that up to 2.2 million Americans are living with HBV. Chronic Hepatitis B increases the odds of liver cancer 50 to 100 times, and 1 in 4 individuals with chronic HBV will develop cirrhosis, liver failure and/or liver cancer. Despite the availability of current HBV vaccines to protect against this devastating condition and prevent its spread, there are up to 70,000 new infections each year. This number is exacerbated by the ongoing opioid epidemic affecting primarily young adults.

National survey data indicate only a quarter of adults age 19 and older are fully immunized, as adults aged approximately 25 years and older were not routinely vaccinated against hepatitis B at birth in the U.S. Recent studies also suggest that hepatitis B vaccine coverage is low among people with diabetes, HIV-infected individuals, hepatitis C-infected individuals, and individuals with chronic liver disease and chronic kidney disease, who are all at significantly increased risk of acquiring hepatitis B infection without completed immunization. The March 2017 report of the National Academy of Sciences, A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report, recommended a series of actions across five areas that will help bring the elimination of viral hepatitis by 2030. The report found that a 50 percent reduction in mortality from chronic hepatitis B would result in 60,000 fewer deaths. The report also noted that hepatitis elimination requires coordinated action from federal and state agencies involved in this effort. Healthy People 2020 included a developmental objective to increase hepatitis B vaccine coverage among high-risk populations. Unfortunately, there is no Hepatitis B immunization objective as part of the HP2030.

AVAC urges the Committee to restore an immunization information system reporting objective (IID-20) and would encourage it be expanded to include reporting of immunization records across the lifespan (childhood/adolescent/adult). With the growing importance of health information technology, Immunization Information Systems (IIS) are an essential part of immunization infrastructure. IIS are confidential systems that allow real-time access to comprehensive, consolidated immunization records for individuals. Improving IIS and integrating them into the healthcare system is critical to expanding access to and utilization of immunizations and, in turn, will lead to a healthier future. IIS can be used by providers to help determine which recommended vaccines may be appropriate for a patient. IIS can also provide aggregate data on immunizations coverage (and gaps). This information is valuable for surveillance and program operations and guiding public health action. IIS serve as a vital link to responding to a vaccine-preventable disease outbreak or community or public health emergency.

Every state has an IIS, and although many people associate IIS with keeping track of childhood immunizations, at least 42 states maintain immunization records across patients’ full lifespans. Despite the benefits of IIS, several factors inhibit the use of IIS for adults, including: wide variations in use and capabilities for registries to accept adult immunization records, depending on the state, and the need for opt-in approval to roll childhood data into adult immunization registries; limited staff time and resources; the need for additional education and awareness; costs associated with EHR modifications; and technical interface challenges between a provider EHR and IIS. The fact that adults receive vaccinations in a variety of different settings (clinical practices, pharmacies, employer-sponsored health clinics, etc.) poses an additional challenge and supports IIS’ value to coordination of care. HP2020 included childhood (target 95 percent under age 6) and adolescent (80 percent between ages 11 and 18 with at least 2 records) immunization reporting objectives. AVAC recommends one lifespan IIS objective that would elevate immunization record capture into an IIS to be more of a national priority.

AVAC urges the Committee to increase the focus on addressing disparities in adult immunization rates. AVAC appreciates and supports the Advisory Committee’s commitment to better identify and target disparities in HP2030 objectives. Disparities persist in immunizations, with generally lower immunization coverage in certain racial and ethnic groups. AVAC coalition members are working on projects that seek to identify and enhance our understanding of coverage gaps and are developing pilot programs to test targeted solutions where these disparities currently exist. As such, AVAC supports the idea of stratification of Heathy People 2030 objective data by race, ethnicity, geographic area, sex, and disability as well as potential objectives to incorporate health equity. Maintaining a focus on addressing disparities will enable more accurate evaluation in coverage gaps and disparities, particularly among minority and vulnerable populations, and are essential to improving the impact of adult immunization efforts and expanding coverage.

AVAC urges the Committee to elevate infectious disease and immunization as a leading health indicator for (LHI) HP2030. The disparate nature of our health care system leads to a range of challenges and barriers to access across payers, providers and patients. The 2016 Department of Health and Human Services’ National Vaccine Program Office National Adult Immunization Plan, cites the following barriers to adult immunization: lack of information about recommended vaccines; financial hurdles; technological, logistical, linguistic and socioeconomic obstacles. Such barriers could be overcome by communicating immunization as a high-priority health issue. A strong emphasis on immunizing the American public would support healthy aging and would help to lessen the impact of vaccine preventable conditions and their complications, particularly among at risk populations such as the elderly, persons with chronic illness and pregnant women. At the same time, it would make economic sense by reducing avoidable health care costs, such as hospitalizations and other expensive medical interventions.

In addition to the above priorities, we wish to record our support for the following childhood and maternal IID Healthy People 2030 objectives.

  1. Expand the pregnancy immunization developmental measure (IID-2030-D01) to include all ACIP-recommended vaccines. We strongly encourage the Committee expand the parameters of the objective so it can reflect current maternal immunization composite that includes influenza. Beyond influenza, there is a strong indication that important vaccines, such as RSV and Streptococcal B, may become available and recommended for pregnant women in the coming decade. A composite objective that reflects ACIP-recommended vaccines would enable those new vaccines to be monitored.
  2. Including an objective to measure the number of adolescents who have received all ACIP-recommended vaccines by age 13. We commend the Committee’s inclusion of the objective IID-2030-12: Increase the percentage of adolescents aged 13 through 15 years who receive recommended doses of human papillomavirus (HPV) vaccine. Despite the disease prevalence, vaccination rates remain low so it is extremely important that HP 2030 encourage HPV vaccination. However, there are no proposed objectives related to receipt of other adolescent vaccines. HP2030 should seek to improve vaccination rates for adolescents, just as it does for young children, as both age cohorts are vulnerable to dangerous diseases that can be prevented by recommended vaccines. Given the very different vaccination rates between HPV and other immunizations recommended for adolescents, we believe a composite measure is very important for ensuring our children remain protected from tetanus, diphtheria, pertussis and meningococcal disease.
  3. Adding an objective to measure the number of children who have received all ACIP-recommended vaccines by age 6. We believe this measure is distinct from the currently proposed IID-2030-11, which would identify the number of children who have received no vaccines by age 2. Many children who are not fully immunized have missed only some vaccines, not all. By focusing on children who are simply missing some vaccine by age 6, we can better identify whether ongoing access issues or mistaken beliefs are affecting immunization levels.

Thank you again for this opportunity to offer our thoughts and recommendations on the proposed HP2030 objectives. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
American College of Preventive Medicine
American Immunization Registry Association
American Pharmacists Association
Asian & Pacific Islander American Health Forum (APIAHF)
Association of Asian Pacific Community Health Organizations (AAPCHO)
Biotechnology Innovation Organization (BIO)
Dynavax
Families Fighting Flu
GSK
Hep B United
Hepatitis B Foundation
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition (IAC)
Immunize Nevada
Medicago
National Association of County and City Health Officials (NACCHO)
National Association of Chain Drug Stores (NACDS)
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association (NHMA)
Novavax
Sanofi
Scientific Technologies Corporation
Seqirus
Takeda Vaccines
The Gerontological Society of America
Trust for America’s Health
University of Pennsylvania
Vaccinate Your Family
Walgreens

AVAC Responds to CMS’s Proposed Rule on the Physician Fee Schedule, Medicare Shared Savings Program, and Other Programs

AVAC is concerned about the proposed reduction in vaccine administration reimbursement outlined in the rule. AVAC is also concerned about the proposed removal and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s) but greatly appreciate the addition of zoster, pneumococcal and influenza measures in several Alternative Payment Models (APMs) as well as a number of specialty provider measure sets.

September 10, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1693-P
P.O. Box 8016
Baltimore, MD 21244-8016

RE: CMS-1693-P Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other  Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Reporting Program; and Medicaid Promoting Interoperability Program

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Reporting Program; and Medicaid Promoting Interoperability Program. As discussed further in our letter, AVAC is concerned about the proposed reduction in vaccine administration reimbursement outlined in the rule. We are also concerned about the proposed removal and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s) but greatly appreciate the addition of zoster, pneumococcal and influenza measures in several Alternative Payment Models (APMs) as well as a number of specialty provider measure sets.

AVAC consists of over 50 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.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines.1 The report highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Department of Health and Human Services (HHS) recognizes that immunization is an important tool to keep people healthy and reduce avoidable health care costs. In its Strategic Plan FY 2018 –2022, HHS acknowledges that “infectious diseases are a major health and economic burden for the United States.2” Additionally, strategic objective 2.1 makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.”2 Unfortunately, access to vaccines is not equal across a person’s lifespan. Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.

AVAC believes that adult immunization quality measurement meets the three core strategies underlying the movement toward a truly patient-centered health care delivery system by: 1) Improving the way clinicians are paid to incentivize quality and value of care over simply quantity of services; 2) improving the way care is delivered by providing clinical practice support, data and feedback reports to guide improvement and better decision-making and; 3) making data more available in real-time at the point of contact and enabling the use of certified Electronic Health Record (EHR) technology and other data sources to support care delivery.

The main purpose of the proposed rule is to update payment policies under the physician fee schedule as well as make other changes under Medicare Part B policy. In that context, the proposed rule contains a number of important provisions aimed at the transition from volume-to-value based payment policy. Specifically, the proposed rule includes elements pertaining to the operation of the Medicare Shared Savings Program (MSSP) as well as the Merit-based Incentive Payment System (MIPS). These two programs offer important opportunities to encourage access to and utilization of recommended adult immunizations to priority populations within the Medicare program.

p. 35707 Reduction in Practice Expense Relative Value Units for Vaccine Administration

AVAC is deeply concerned with the proposed reduction in reimbursement rates for CPT codes for vaccine administration due to current gaps in immunization access as well as the potential negative long-term impact on providers’ ability to offer recommended immunizations to Medicare patients.

Immunizations are an important public health imperative and ensuring that immunization providers are properly reimbursed is key to fostering a sustained environment of timely immunization. Vaccine administration by health care providers in their office, at the point of care, is an opportunity that needs to be maintained and encouraged. Studies show that inadequate reimbursement for vaccination administration result in missed immunization opportunities3 and declines in immunization rates. Given HHS’s Healthy People 2020 goals and the gaps in care that current exist in adult vaccination, any reimbursement reductions at the physician/provider level could widen those care gaps and have unnecessary population health consequences.

AVAC urges CMS to maintain CPT codes for vaccine administration at rates that properly reimburse for the cost of the service and will continue to encourage providers to offer Medicare beneficiaries recommended immunizations at the clinical point of care.

p. 35935 Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) – Comprehensive ESRD Care

AVAC is pleased the merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) for comprehensive ESRD Care in the proposed rule includes the following adult immunization measures:

➢ Influenza Immunization for the ESRD Population
➢ Pneumococcal Vaccination Status (NQF #0043)

p. 35939 Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) – Comprehensive Primary Care Plus (CPC+) Model

AVAC is pleased the Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) for the Comprehensive Primary Care Plus (CPC+) Model in the proposed rule includes the following adult immunization measures:

➢ Preventive Care and Screening: Influenza Immunization (NQF#0041)
➢ Pneumococcal Vaccination Status for Older Adults (NCQA measure)

p. 35945 Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) – Maryland Total Cost of Care Model

AVAC is pleased the Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) for the Maryland Total Cost of Care Model includes the following adult immunization measures:

➢ Preventive Care and Screening: Influenza Immunization (NQF#0041)
➢ Pneumococcal Vaccination Status for Older Adults (NCQA measure)

P. 35878 Medicare Shared Savings Program (MSSP)

The Medicare Shared Savings Program (MSSP) presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC believes the CMS should engage in a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries.

AVAC commends CMS for maintaining Influenza Vaccination (ACO #14) under the AIM: Better Health for Populations category but are deeply concerned by the proposed removal of and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s).

Monitoring immunization status and reporting of offered and administered immunizations to patients are critical preventive service benchmarks that help to ensure immunizations remain a priority under new payment models and in the forefront of clinical care standards. Reducing the number of missed immunization opportunities, particularly among Medicare beneficiaries, is critical to improving health and reducing the burden of vaccine preventable disease.

The Annual Influenza Vaccination (ACO #14) and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) represent important baseline measures in determining access to influenza and pneumococcal vaccinations and ascertaining where gaps in access to these services may persist.

These two vaccine preventable conditions exact a heavy toll on adults in terms of health and productivity costs and both measures should remain in the MSSP. According to the Centers for Disease Control and Prevention (CDC), an estimated 900,000 Americans get pneumococcal pneumonia each year, resulting in as many as 400,000 hospitalizations and more than 53,000 deaths. Despite the fact that most pneumococcal pneumonia deaths each year are adults, pneumococcal vaccination rates remain inadequate, with only 63 percent of adults over the age of 64 and 22 percent of high-risk adults being vaccinated.4 By contrast, a recent CDC study of flu-associated deaths prevented over a nine-year period from 2005-2006 through 2013-2014 found that nearly 89 percent were in people 65 years of age and older.

However, AVAC also remains concerned that current and new Medicare payment models could threaten access to critical prevention services such as immunization as providers are under increased financial pressure to provide cost efficient care, particularly to medically complex and chronically ill Medicare beneficiaries. AVAC would encourage CMS to closely monitor the potential impact of payment models such as the MSSP on access to critical preventive services, such as immunization. AVAC would like to work with CMS to explore the different payment model programs underway and lift up best practices that expand and improve access to immunization services as well as other lifesaving prevention interventions.

p. 35964 Social Risk Factors

AVAC coalition members are working on projects that seek to identify and enhance our understanding of coverage gaps and are developing pilot programs to test targeted solutions where these disparities currently exist. The proposed rule indicates that CMS is currently reviewing reports by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering and Medicine on accounting for social risk factors in the Hospital IQR Program. We support the idea of future stratification of IFR QRP data by race, ethnicity, geographic area, sex, and disability on Hospital Compare, as well as on potential future hospital quality measures that incorporate health equity. Additionally, we recommend that the data also be stratified by primary language. Together, this type of data will enable more accurate evaluation in coverage gaps and disparities, particularly among minority and vulnerable populations, and are essential to improving the impact of adult immunization efforts and expanding coverage.

p. 36092 CY2019 MIPS Specialty Measure Sets (Appendix 1)

Opportunities to assess the immunization status of Medicare beneficiaries for should be done by the range of clinicians who care for them, including primary care and specialty providers. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong provider recommendation have been found to improve the likelihood of a patient being immunized. Published literature indicates that integrating immunization assessment and additional providers offering these critical preventive services will result in greater opportunities for immunization. The National Vaccine Advisory Committee’s (NVAC) Adult Immunization Standards call for all providers caring for adult patients to assess, recommend, vaccinate or refer, and document vaccinations.6 AVAC greatly appreciates that the proposed rule addressed past concerns that have been raised about the limited number of specialty sets that included adult immunization quality measures. Specifically, the inclusion of Preventive Care and Screening: Influenza Immunization (NQF #0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043) into a number of primary care and specialty quality measure sets reflects an important advancement that will help ensure better access to immunization services across Medicare providers.

Prioritizing quality measures around immunizations will help close existing measure gaps, improve upon immunization rates and health outcomes for the millions of Medicare beneficiaries. The National Quality Forum (NQF) in its August 2014 report “Priority Setting for Healthcare Performance Measurement: Addressing Performance Measures Gaps for Adult Immunizations”, highlighted ten age specific and composite measure gap priorities that should be addressed.

The proposed rule also seeks to adopt 10 new quality measures into the MIPs program for 2021 payment. AVAC is pleased that one of the new measures is for Zoster (Shingles) Vaccination.

This non-NQF endorsed measure is already in use by the Home Health Value-Based Purchasing Program. AVAC supports broader adoption of a herpes zoster measure across specialty sets to reduce the number of missed immunization opportunities for this debilitating condition. According to the CDC, 27.9 percent of adults age 60 and older reported receiving the herpes zoster vaccine.8 The health and economic burden associated with shingles and its complications are significant. As cited by the CDC, in 2007, the Agency for Healthcare Research and Quality (AHRQ) estimated the average cost of shingles and its complications to be $566 million a year while another study estimated the overall cost could be as high as $1.7 billion a year.

AVAC supports a meaningful core quality measure sets for widespread use to both inform clinical decision making at the point of care and improve quality in the provider setting. CMS has made the alignment of quality measures with the National Quality Strategy (NQS), the CMS Strategic Plan, and other CMS quality reporting and value-based purchasing programs a priority. AVAC fully supports the alignment of reporting mechanisms and believes doing so will strengthen and enhance the development and implementation of adult immunization quality measures.

AVAC was encouraged that the following specialty sets include the following immunization process quality measures for the 2021 payment year:
Family Medicine. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents (NQF # 1407)
Internal Medicine. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
Obstetrics/Gynecology. Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043)
Otolaryngology. Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043)
Pediatrics. Preventive Care and Screening: Influenza Immunization (NQF# 0041); Childhood Immunization Status (NQF #0038); and Immunizations for Adolescents (NQF # 1407)
Preventive Medicine. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
Nephrology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
Oncology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
✓ Infectious Disease. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
Rheumatology. Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043)
Geriatrics. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents (NQF # 1407)
Skilled Nursing Facility. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041)

AVAC was, however, disappointed that the final rule did not include adult immunization quality measures in a few key specialty areas who care for chronically ill patients at-risk of serious complications from vaccine preventable illness. The Advisory Committee on Immunization Practices (ACIP) includes age-based, as well as condition-specific recommendations for adult vaccination. For pregnant women, ACIP recommends a Tdap vaccination. We are pleased that efforts to develop a composite Tdap/influenza measure for pregnant women has completed testing and is now under review by the National Committee for Quality Assurance (NCQA). AVAC looks forward to further dialogue your agency on this topic as it moves forward.

In addition, patients living with chronic conditions such as heart disease and diabetes are at a significantly higher risk of complications and death from influenza and pneumonia. The CDC has reported that in 2013 only 21.2% of adults in this group had received a pneumococcal vaccination, and this number has remained unchanged for at least a decade.10 Individuals with diabetes are at increased risk for hepatitis B infection. As such, the ACIP recommends hepatitis B vaccination for all patients with diabetes age 6011 and under as well as other at-risk patients, such as those living with HIV/AIDS and chronic kidney disease.

We strongly encourage CMS to add the following immunization quality measures into these specialty measure sets:

Endocrinology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043).

Cardiology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043).

General Surgery. Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043).

Skilled Nursing Facility. Pneumonia Vaccination Status for Older Adults (NQF# 0043)

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
American Immunization Registry Association (AIRA)
American Pharmacists Association
Asian Pacific Islander American Health Forum
BIO
Dynavax
Every Child By Two (ECBT)
Families Fighting Flu
GSK
Hepatitis B Foundation
Hep B United
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition
Immunization Coalition of Washington DC
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
National Foundation for Infectious Diseases (NFID)
Novavax
Pfizer
Sanofi
Seqirus
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health

AVAC Expresses Concerns About CMS’s Medicare Program End Stage Renal Disease Prospective Payment System and Quality Incentive Program Proposed Rule

AVAC wrote to CMS because of concerns that the Medicare Program End Stage Renal Disease Prospective Payment System and Quality Incentive Program proposed rule seeks to remove the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) from the ESRD Quality Incentive Program (QIP) for PY2021.

September 10, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1691-P
P.O. Box 8010,
Baltimore, MD 21244-8010

RE: CMS-1691-P Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program End Stage Renal Disease Prospective Payment System and Quality Incentive Program proposed rule. We are deeply concerned the proposed rule seeks to remove the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) from the ESRD Quality Incentive Program (QIP) for PY2021. We also urge CMS to include a new composite measure for ACIP-recommended vaccines (influenza, pneumococcal and hepatitis B) in the ESRD Quality Incentive Program (ESRD QIP) to promote higher quality and more efficient health care for vulnerable ESRD patients at increased risk of vaccine preventable illness.

AVAC consist s of over 50 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.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage measures for adult vaccines.1 The report highlight s the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Department of Health and Human Services (HHS) recognizes that immunization is an important tool to keep people healthy and reduce avoidable health care costs. In its Strategic Plan FY 2018 –2022, HHS acknowledges that “infectious diseases are a major health and  economic burden for the United States.2” Additionally, strategic objective 2.1 makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.” Unfortunately, access to vaccines is not equal across a person’s lifespan. Despite the well known benefits of immunizations, more than 50,000 adult s die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.

(p. 34339) Proposed Removal of the Healthcare Personnel Influenza Vaccination Reporting Measure From the ESRD QIP Measure Set

The proposed rule indicates that CMS originally adopted the Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) in CY2015 because “we recognize that influenza immunization is an important public health issue and that vaccinating healthcare personnel against influenza can help to protect healthcare personnel and their patient s (79 FR 66206 through 66208)”. According to the Centers for Disease Control and Prevention (CDC), individuals with chronic kidney disease have a higher incidence or severity of some vaccine-preventable diseases due to altered immunocompetence3. In fact, infectious disease is the second most common cause of death in late-stage Chronic Kidney Disease (CKD) patients.

The Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) was adopted in the FY 2015 IPF PPS final rule, “due to public health concerns regarding influenza virus infection among the IPF population” and the measure addressed this concern “by assessing influenza vaccination in the IPF among healthcare personnel (HCP), who can serve as vectors for influenza transmission.”

However, CMS analysis of CY 2016 data in the proposed rule indicates, “ESRD facility performance on the measure was consistently high; 98 percent of ESRD facilities received the highest possible score on the measure (10 points) and the remaining 2 percent received no score on the measure because they did not report the required data. This finding indicates that influenza vaccination of healthcare personnel in ESRD facilities is a widespread practice and that there is little room for improvement on this measure.”

AVAC strongly disagrees with this contention. Removal of the Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) from the ESRD QIP will send the impression to ESRD facilities that preventive health care services such as immunization are no longer a priority, despite the serious economic and health consequences of influenza outbreaks in this population. The fact that the analysis of the measure for CY 2016 indicates that nearly every ESRD facility received the highest possible score is a clear indicator of the success of the measure. Sustained widespread utilization of the influenza vaccine among healthcare personnel and the adoption of an adult immunization composite metric for ESRD patients should be an utmost priority for ESRD patients since, “these patient s represent a high-risk group for developing infectious diseases.”

The proposal to remove this measure is also inconsistent with CMS’ own position and argument s with respect to this same measure in the inpatient hospital quality reporting program. The Hospital Inpatient Prospective Payment System proposed rule (CMS-1694-P) states with respect to the Influenza Vaccination Coverage Among Healthcare Personnel (HCP) measure (NQF #0431), it “promotes improved health out comes among beneficiaries because: (1) health care personnel that have received the influenza vaccination are less likely to transmit  influenza to patients under their care; and (2) vaccination of health care personnel reduces the probability that hospitals may experience staffing shortages as a result of illness that would impact ability to provide adequate patient care. Thus, we believe the cost s associated with reporting this chart-abstracted measure outweighs the associated benefit s of keeping it in the Hospital IQR Program.”

A recent commentary, Influenza in long-term care facilities notes, “a study of health care workers (HCW)s in an acute hospital during a mild epidemic season, found that 23% had serological evidence of new influenza infection during the season, implying a potential transmission risk to patient s as between 28% and 59% of infected workers had subclinical infections and continued to work.” For ESRD patients with, “[c]o-morbidities such as diabetes mellitus and the inherent process of dialysis, where patients are frequently exposed to multiple pathogenic agents and potential cross-contamination from dialysis equipment in the health care environment, add to the susceptibility of t his population.”

AVAC strongly believes removal of this measure from the ESRD QIP would create greater inconsistency across quality reporting programs, add to provider reporting confusion and ultimately leave an extremely vulnerable population of Medicare beneficiaries more susceptible to vaccine preventable illness.

Composite ESRD Vaccination Measure
The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevent ion (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have spearheaded the development and test ing of a new composite measure for end-stage renal disease patient s covering influenza, pneumococcal and hepatitis B vaccines. A review of CMS fee-for-service claims data warrant s the use of such a measures as current vaccination rates for the ESRD population fall well below recommended targets.

Research has shown that kidney care centers with vaccination protocols have demonstrated reduced infection rates and resulted in decreased morbidity and mortality7. Vaccines, including hepatitis B and pneumococcal conjugate and pneumococcal polysaccharide, are specifically recommended for dialysis or CKD patients. However, like with other adult populations, vaccines are underutilized in CKD patients, who could benefit greatly from improved access to immunization services.8

This work provides an important foundation for a composite measure for ACIP-recommended vaccines for ESRD patients and would be of great benefit to the ESRD QIP now in the future. The ESRD Quality Incentive Program (ESRD QIP) presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC strongly believes the ESRD QIP should include a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of patients living with kidney disease. An ESRD composite measure would provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Commit tee on Immunization Practices (ACIP).

We look forward to working with CMS to ensure meaningful measures that reflect priority health care services, such as immunization, that also will streamline and reduce the report ing burden on providers, provide an accurate representation of ESRD facility performance in the least burdensome manner possible and provide meaningful data to the Medicare program on access to this important preventive service.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,
Alliance for Aging Research
Asian & Pacific Islander American Health Forum (APIAHF)
BIO
Families Fight ing Flu
GSK
Immunization Action Coalition (IAC)
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
Sanofi
Seqirus
The Gerontological Society of America