December 16, 2019

The Honorable Diana DeGette
US House of Representatives
2111 Rayburn House Office Building
Washington, DC 20515

The Honorable Fred Upton
US House of Representatives
2183 Rayburn House Office Building
Washington, DC 20515

Dear Representatives DeGette and Upton,

The Adult Vaccine Access Coalition (AVAC) appreciates the opportunity to provide feedback that will help shape and inform the development of “Cures 2.0.”

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 to and utilization of adult immunizations.

We appreciate your interest in modernizing and improving the capabilities of the health care system in order to deliver current and future cures to patients in need. Immunizations are a highly cost-effective form of preventive medicine that help save lives by protecting the health and wellbeing of individuals and families in communities nationwide. 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 21st Century Cures Act recognized the value of innovation for a wide array of medical products, including vaccines. Vaccines are unique in that the development process includes additional thresholds for approval that other pharmaceuticals do not have. Manufacturing costs and additional post-approval requirements necessary to meet quality standards, and product complexity in general, makes the investment in new vaccine candidate products an especially challenging endeavor. A policy environment that supports the value of innovation leads to the research and development of new vaccines. This in turn will provide improvements in existing products, breakthroughs in vaccine platform technologies, and other important discoveries that support the vaccine ecosystem
and help in the fight to reduce vaccine-preventable diseases across the lifecourse.

The work around Cures 2.0 comes at a critical time for vaccines. 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, and technological and logistical obstacles.

With the existing portfolio of lifesaving adult vaccines and an exciting pipeline of new vaccines for a range of unmet needs on the horizon, we see great opportunity in Cures 2.0 to lay the foundation for improved access to and utilization of adult vaccines through the reduction in technological, logistical, geographic, socioeconomic, and financial barriers to the full complement of ACIP-recommended adult immunizations. The below comments further outline our interest in policy that will result in: 1) Increased coverage, access, and sustained utilization of immunizations across the life course; 2) Strengthened digital health technology, specifically immunization information system capabilities; and 3) Improved education and health literacy to close gaps in immunization coverage.

Increased coverage, access, and sustained utilization of immunizations across the life course

Significant progress has been made to ensure the supply and delivery of vaccines over the last decade. However, there is a great need to improve access to and utilization of immunization across the life course. Vaccine innovations are especially important to maintaining health in adults 65 and older. Immunizations help ensure a more active aging population and reduce the risk of disability and loss of independence as a result of vaccine preventable illness. Immunizations provide especially high-value among patients with chronic conditions, such as diabetes or heart disease, who are at higher risk of adverse health consequences as a result of vaccine preventable disease. Cures 2.0 should support eliminating out-of-pocket costs around Medicare Part D vaccines so that vaccines can be equally accessible among all insured populations.

The U.S. spends about $26.5 billion annually treating four major vaccine-preventable diseases among U.S. adults (flu, pneumococcal, shingles, pertussis). Vaccines covered under Medicare Part D—such as Tdap and shingles—typically require out-of-pocket costs for patients ranging from $0 to $160. When patients are faced with an additional expense on top of regular medication costs, they will typically forgo the immunization which results in lower vaccine uptake and therefore affects vaccine coverage rates. By contrast, vaccines covered under Medicare Part B—such as flu and pneumococcal—require no out of pocket costs from patients, leading to higher vaccination rates.

Specifically, we recommend that Cures 2.0 align Part D coverage of vaccines with Medicare Part B and private insurance vaccine coverage in terms of patient co-pays, use of deductibles and coinsurance, coverage limits, and annual out-of-pocket spending thresholds.1 By investing in this cost-effective prevention intervention, rather than paying for the consequences of vaccine preventable disease, we can cultivate more active and healthier aging populations, reduce the risk of vaccine preventable disability, loss of mobility, and independence, and protect patients with chronic conditions. 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. These efforts will not only enhance the quality of life for beneficiaries but will also align incentives across providers and payers to encourage improved access to immunization services under the Medicare program and provide certainty to manufacturers that revolutionary preventive vaccine products will be accessible to 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 and delayed reimbursement for vaccination administration results in missed immunization opportunities and declines in immunization rates.6 Cures 2.0 has an opportunity to ensure that vaccine administration costs under Medicare are properly coded and providers are adequately reimbursed for the additional time and resources it takes to offer immunization services to this important population.

Since 2009, Medicare codes for vaccine administration have been consistently mis-valued due to the fact that the codes are calculated based off of practice expense inputs for therapeutic injections. The consequence has been a reduction in reimbursement at a time when practice expense costs for vaccines have been increasing, not decreasing. 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 respond to an influx of patient visits solely for immunization during certain times of year.

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.”7 These factors have driven many providers to consider discontinuing or limiting vaccine services to patients.

Cures 2.0 should address this underpayment for immunization services by directing CMS to come up with a more accurate formula for calculating vaccine administration costs that does not rely on practice expense codes for therapeutic injections.

Strengthened digital technology, specifically Immunization Information Systems (IIS)

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. The widespread implementation of Health Information Technology (HIT), Immunization Information Systems (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, address gaps in vaccination coverage, and facilitate the exchange of data that can improve care coordination and quality and patient outcomes. Cures 2.0 should strengthen and support the capacity of IIS to deliver accurate and timely immunization coverage information across the country and across the life course.

Immunizations are an extremely important prevention tool, and as such, are recommended for virtually every American. However, the lack of timely and complete vaccine record information hinders immunization uptake. There are notable variations in use and capabilities of immunization systems. IIS’ are primarily supported through federal grants to state and local health departments to operate and manage. This framework has resulted in a patchwork of systems that vary depending on the state: states often have limited staff and resources to adequately maintain them, perform technical upgrades, or conduct necessary outreach and education to onboard providers and teach them have to use the system. There are also challenges and added costs associated with enabling interoperability between state and local IIS systems and EHR systems of large provider and health systems. Another complication specific to adults stems from the fact that adults receive vaccinations in a variety of different health care settings (clinical practices, pharmacies, employer-sponsored health clinics, etc.).

As comprehensive, confidential, population-based systems, IIS have great potential to be used by providers to determine an individual’s immunization status as well as document immunization doses administered to a patient. They provide state and local public health agencies aggregate data on immunization coverage rates for disease surveillance and program operations and can be essential to guiding public health action in both routine immunization activities and disease outbreak response efforts. IIS can enable communication with providers across a variety of health care settings, identifying variations in immunization access and utilization and aiding in the development and implementation of targeted outreach and response strategies.

Under the current system of immunization record-keeping, verifying an individual’s vaccine history and determining recommended immunizations can be a complex and time-consuming endeavor. Immunization information systems generally lack the ability to rapidly and securely query records across state systems or even from one system to another in a single state. These variations challenge large provider health organizations and partners who work across states and need access and the ability to report records into to multiple IIS.

The need for timely and secure access to immunization record data only becomes more acute when an outbreak or a pandemic occurs. An IIS is a critical tool to mitigate the impact. For example, between April and August 2017, Minnesota had 75 confirmed cases of measles and several thousand more exposures, including 8,500 exposures in child care and school settings. During the outbreak, the Minnesota Department of Health officials were able to leverage their IIS, MIIC, to determine immunity status for children in a child care center. As a result of utilizing MIIC during the outbreak, 92% fewer resources were used. MIIC saved both time (1,147 hours) and money ($30,021.92). Additionally, the Tennessee immunization program led the state’s strong response to the 2009 influenza pandemic—all of the routine work and relationships were translated into vaccine distribution to more than 1,500 clinics and pharmacies to vaccinate adults and children. Their communication and collaboration with partners led to broad-based, swift access to vaccines for both the public and healthcare personnel.

The next serious influenza pandemic is not a question of if, but when. It could require two doses of vaccine per person, making it more challenging to control and more dangerous to our health and the economy. Critical advances in the interoperability between IIS and electronic health records allow us to use these tools to protect our population more efficiently but these electronic infrastructure investments must be sustained. Improved immunization information systems will allow for real-time identification of pockets of need, will empower providers with information on a patient’s vaccine history as well as provide recommendations on what vaccines that person might need based on their age and health status, and will ultimately provide better protection of the nation’s overall health and wellbeing while strengthening our ability to prepare for and more swiftly respond in public health emergencies.

Improved education and health literacy to close gap areas of immunization coverage.

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. Policy is needed to drive meaningful improvements in immunization rates among the adult population. Cures 2.0 should emphasize the importance of consistent education and encouragement of individuals to be aware of and receive recommended immunizations across the life course.

Communication should be strategic, evidence-based, and culturally appropriate and should reflect the health literacy, language proficiency, and 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 important preventive health and immunization messages to adults. There is an additionally important role for community-based organizations in providing education. Providing meaningful information that clearly communicates the risks and costs of vaccine preventable disease will go a long way toward establishing vaccination as a routine part of preventive care and building confidence in vaccination as a societal norm.

Again, thank you for the opportunity to share recommendations on how Cures 2.0 can help to strengthen and improve the nation’s response to vaccine preventative disease and strategies to address infectious disease through vaccination. 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
BIO
GSK
Hepatitis B Foundation
Hep B United
Immunization Action Coalition (IAC)
National Association of County and City Health Officials
National Association of Nutrition and Aging Services Programs (NANASP)
National Consumers League
Seqirus USA, Inc.
The Gerontological Society of America
Trust for America’s Health

1 Protecting Seniors through Immunization Act (H.R. 5076)