Ensuring Equitable Access To COVID-19 Vaccines In The US: Current System Challenges And Opportunities.

There has been a worldwide effort to accelerate the development of safe and effective vaccines for severe acute respiratory syndrome coronavirus-2. When vaccines become licensed and available broadly to the public, the final hurdle is equitable distribution and access for all who are recommended for vaccination. Frameworks and existing systems for allocation, distribution, vaccination, and monitoring for safety and effectiveness are assets of the current immunization delivery system that should be leveraged to ensure the equitable distribution and broad uptake of licensed vaccines. The system should be strengthened to address gaps in access to immunization services and to modernize the public health infrastructure. We offer five recommendations as guideposts to ensure that policies and practices at the federal, state, local, and tribal levels support equity, transparency, accountability, availability, and access to coronavirus disease 2019 vaccines.

Characteristics of vaccinating providers reported through Medicare claims in office-based settings: Volume of influenza and pneumococcal vaccinations.

Vaccination coverage among older adults is low in the United States. A recommendation from a provider is a strong predictor of vaccine receipt. Using Medicare Fee-For-Service data (2015-2017) this study characterized providers by the number of influenza and pneumococcal vaccines administered in physician offices, age, gender, and professional specialty to determine the volume of vaccines provided by individual providers and characteristics of these providers. Half of all vaccinations were provided by 10% of providers. The mean age of 224,483 and 165,710 unique influenza and pneumococcal providers respectively was 49 years (SD: 12 years) with males and females equally distributed. The highest vaccinating quartile of providers tended to be older, more likely male and more likely general physicians. Those who administered a high volume of one vaccine were likely to administer a high volume of the other. Providers administering vaccines in office-based settings can do more to increase vaccination coverage rates.

The pharmacist and pharmacy have evolved to become more than the corner drugstore: a win for vaccinations and public health.

Perhaps under acknowledged in the adult immunization delivery system are pharmacists. Depending on the state, pharmacists can assess and administer vaccines to patients under vaccination protocols, standing orders or with a physician's prescription for vaccination. As most individuals live within miles of a community pharmacy that offer accessibility, broad operating hours, and lack of visit fees or few requirements for appointments, the role of the local community pharmacy and pharmacists has evolved. Many pharmacies have embraced immunizations as a service offering seasonal influenza and often a range of Advisory Committee on Immunization Practices-recommended vaccines across the lifespan. Pharmacists are moving away from strictly product distribution to supporting public health and prevention, experiencing tremendous growth and expansion of services across the public health and primary care spectrum. Pharmacies are using vaccination services as a strategy to transform and advance community pharmacy, shaping a model that provides greater convenience and access to vaccines and other preventive services benefiting population and public health while seeking to optimize health outcomes and control health-care costs.

Patient characteristics of Medicare beneficiaries who report not getting influenza and pneumococcal vaccinations, 2001-2013.

Background: Despite long standing recommendations of pneumococcal and influenza vaccination for adults age 65 years and older and wide-spread availability to vaccination services, vaccination coverage in the United states is low. We sought to explore reasons patients reportedly did not receive these vaccines.Methods: We used publicly available data from the Medicare Current Beneficiary Survey, a continuous panel survey of a representative sample of the Medicare population, as well as Medicare enrollment data. We explored questions pertaining to influenza and pneumococcal vaccination status, self-reported reasons for being unvaccinated and patient perspectives toward health care utilization.Results: The majority of the respondents who did not receive vaccines for influenza or pneumococcal disease reported that they did not know it was needed or that their doctor did not recommend it. Respondents who were not vaccinated against influenza reported concerns about side effects. Coverage for both vaccines was lower among respondents in the Southeast region and among those who are dual-eligible or less engaged in healthcare utilization. Little difference was observed by gender, urban status, or Part C enrollment for influenza respondents. Higher pneumococcal vaccine coverage was found among females as well as those living in urban settings or enrolled in Medicare Part C.Conclusions: Implementation of the national guidelines calling for all health care professions - whether they provide vaccinations or not - to take steps to help ensure adults are fully immunized is critical. Tailored communication to beneficiaries that addresses the importance of both vaccines as well as key barriers, like side effects, is also needed.

Analysis of the profitability of adult vaccination in 13 private provider practices in the United States.

Vaccination coverage among adults remains low in the United States. Understanding the barriers to provision of adult vaccination is an important step to increasing vaccination coverage and improving public health. To better understand financial factors that may affect practice decisions about adult vaccination, this study sought to understand how costs compared with payments for adult vaccinations in a sample of U.S. physician practices. We recruited a convenience sample of 19 practices in nine states in 2017. We conducted a time-motion study to assess the time costs of vaccination activities and conducted a survey of practice managers to assess materials, management, and dose costs and payments for vaccination. We received complete cost and payment data from 13 of the 19 practices. We calculated annual income from vaccination services by comparing estimated costs with payments received for vaccine doses and vaccine administration. Median annual total income from vaccination services was $90,343 at family medicine practices (range: $3968-$249,628), $28,267 at internal medicine practices (-$32,659-$141,034) and $2886 at obstetrics and gynecology practices (-$73,451-$23,820). Adult vaccination was profitable at the median of our sample, but there is wide variation in profitability due to differences in costs and payment rates across practices. This study provides evidence on the financial viability of adult vaccination and supports actions for improving financial viability. These results can help inform practices' decisions whether to provide adult vaccines and contribute to keeping adults up-to-date with the recommended vaccination schedule.

Vaccination among Medicare-fee-for service beneficiaries: Characteristics and predictors of vaccine receipt, 2014-2017.

BACKGROUND: Vaccination coverage rates for older adults are low. To better understand utilization of Medicare vaccination benefits we examined a retrospective cohort of more than 26 million Medicare fee-for-service beneficiaries age 65 years and older from 2014 to 2017. METHODS: Multivariate logistic regression was used to obtain marginal effects (ME) describing the association between patient-level characteristics and the likelihood of vaccination. Vaccines routinely recommended by the Advisory Committee on Immunization Practices-seasonal influenza, 23-valent pneumococcal polysaccharide, 13-valent pneumococcal conjugate, and herpes zoster vaccines-were examined. Variables considered include demographics (e.g., age, sex, race), use of preventive services, frailty indicators, and co-morbidities. RESULTS: The mean beneficiary age (SD) for each vaccine examined-seasonal influenza (2016-2017), pneumococcal, and herpes zoster-was 75.0 (7.9) years, 74.5 (7.5) years, 74.5 (7.4) years respectively; and 43.7%, 43.2%, and 39.5% were males respectively. Adjusted marginal effects showed that Black beneficiaries were less likely to receive any of the three vaccines compared to White beneficiaries, while North American Native beneficiaries were most likely to receive a pneumococcal vaccine. Trends by race and sex were similar across all ages. Beneficiaries utilizing preventive services, particularly cardiovascular disease screening (ME of 13.8%, 15.6% and 1.5% for influenza, pneumococcal and herpes zoster vaccine respectively), other vaccinations, and the Medicare Annual Wellness Visit (ME of 9.8%, 15.3% and 0.4% respectively) were predictors of vaccination for all three vaccines. For herpes zoster vaccines, beneficiaries in rural settings (ME of 1.0%) and those who are dual-eligible for Medicare and Medicaid insurance (ME of 1.7%) were more likely to receive herpes zoster vaccine than beneficiaries in urban settings and those not dual-eligible, respectively. CONCLUSION: Medicare beneficiaries of certain demographic with selected comorbid conditions are less likely to receive routinely-recommended vaccines. Strategies and interventions can target such sub-populations of Medicare beneficiaries by optimizing the utilization of preventive services.

Influenza vaccination coverage estimates in the fee-for service Medicare beneficiary population 2006 - 2016: Using population-based administrative data to support a geographic based near real-time tool.

Older adults are at great risk of developing serious complications from seasonal influenza. We explore vaccination coverage estimates in the Medicare population through the use of administrative claims data and describe a tool designed to help shape outreach efforts and inform strategies to help raise influenza vaccination rates. This interactive mapping tool uses claims data to compare vaccination levels between geographic (i.e., state, county, zip code) and demographic (i.e., race, age) groups at different points in a season. Trends can also be compared across seasons. Utilization of this tool can assist key actors interested in prevention - medical groups, health plans, hospitals, and state and local public health authorities - in supporting strategies for reaching pools of unvaccinated beneficiaries where general national population estimates of coverage are less informative. Implementing evidence-based tools can be used to address persistent racial and ethnic disparities and prevent a substantial number of influenza cases and hospitalizations.

Driving immunization through the Medicare Annual Wellness Visit: A growing opportunity.

INTRODUCTION: The Annual Wellness Visit (AWV) is a Medicare benefit designed to help prevent disease and disability based on individualized health and risk factors. METHODS: This study analyzes Medicare Part B fee-for-service claims from 2011 to 2016 to assess AWV and seasonal influenza and pneumococcal conjugate vaccinations utilization over time. RESULTS: Utilization of the AWV has increased from 8% of Medicare beneficiaries in 2011 to 19% in 2015. In each year, influenza and PCV13 vaccination rates are higher among those who utilize the benefit. More than one-third (33%) of patients who had an AWV in 2015 received a PCV13 vaccination in that same year, compared to 14% of those who did not. Similarly, the seasonal influenza vaccination rate was 64% among those with an AWV and 44% among those without. CONCLUSION: The AWV demonstrates promise for improving immunization rates among Medicare beneficiaries particularly at the point of care.

Beneficiary characteristics and vaccinations in the end-stage renal disease Medicare beneficiary population, an analysis of claims data 2006-2015.

BACKGROUND: The Advisory Committee on Immunization Practices (ACIP) routinely recommends three vaccines - influenza, hepatitis B, and pneumococcal vaccines - for End-Stage Renal Disease (ESRD) dialysis patients. METHODS: We sought to assess vaccination coverage among fee-for-service (FFS) Medicare beneficiaries with ESRD who received Part B dialysis services at any point from January 1, 2006 through December 31, 2015 (through June 30, 2016 for influenza). To assess influenza vaccination rates in a given influenza season, we restricted the population to beneficiaries who were continuously enrolled in Medicare Parts A and B throughout all twelve months of that season. To assess hepatitis B and pneumococcal vaccine coverage following dialysis initiation, we developed a Kaplan-Meier curve for all patients who began dialysis between 2006 and 2015. RESULTS: For influenza vaccination, we identified an average of approximately 325,000 ESRD dialysis beneficiaries enrolled through each influenza season from 2006-2015. Seasonal influenza vaccination rates steadily increased during the 10-year period, from 52% in 2006-2007 to 71% in 2015-2016. The greatest increases in influenza vaccination appear in non-white beneficiaries with overall utilization in non-whites higher than in whites (p < .001). For the hepatitis B and pneumococcal vaccinations, we identified over 350,000 ESRD dialysis beneficiaries who began dialysis over the 10-year study window. The probability of receiving a hepatitis B vaccine within the first three years of entering into the ESRD program was higher (77%) than the probability of receiving any pneumococcal vaccine (53%). 45% of ESRD patients completed at least one dose of the two hepatitis B series (three-dose or four-dose) at any time during the study period. CONCLUSIONS: Opportunities exist at regional and facility levels to improve vaccination coverage. Compliance to ACIP recommendations may directly affect risk for ESRD dialysis patients for complications from diseases that can be mitigated by vaccination.

Using campaigns to improve perceptions of the value of adult vaccination in the United States: Health communication considerations and insights.

Vaccines have much relevance and promise for improving adult health in the United States, but to date, overall use and uptake remain far below desired levels. Many adults have not received recommended vaccinations and many healthcare providers do not strongly and actively encourage their use with patients. This has led some public health and medical experts to conclude that adult vaccines are severely undervalued by the U.S. public and healthcare providers and to call for campaigns and communication-based efforts to foster increased appreciation, and in turn, higher adult immunization rates. A narrative integrative review that draws upon the vaccine valuation and health communication literatures is used to develop a framework to guide campaign and communication-based efforts to improve public, provider, and policymakers' assessment of the value of adult vaccination. The review does this by: (1) distinguishing social psychological value from economic value; (2) identifying the implications of social psychological value considerations for adult vaccination-related communication campaigns; and (3) using five core health communication considerations to illustrate how social psychological notions of value can be integrated into campaigns or communication that are intended to improve adult vaccination value perceptions and assessments, and in turn, motivate greater support for and uptake of recommended adult vaccines.

Vaccine purchasing groups in the United States: An overview of their policies and practices.

BACKGROUND: Vaccine purchasing groups (VPGs) may help reduce the upfront cost of vaccines. The objective of this study was to describe key business practices of VPGs in the United States. METHODS: Semi-structured, qualitative telephone interviews were conducted with representatives from 11 VPGs, based on a sampling frame of 53 VPGs. Interviews were transcribed and summarized by topic. RESULTS: Characteristics of the 11 VPGs interviewed reflect the broader VPG population: 64% national vs 36% regional; 8% charge a membership fee; membership ranging from 40 to over 300,000 sites. VPGs establish agreements with vaccine manufacturers, typically with either GlaxoSmithKline or Merck and Sanofi Pasteur; 1 VPG reported a single-product (Trumenba) agreement with Pfizer. VPG agreements specify "product loyalty" benchmarks (proportion of that manufacturer's product line) that the VPG and its members must meet to receive discounted vaccine pricing. The amount of discount is considered proprietary. Practices may actively participate with only one VPG; the member discount is automatically applied by the manufacturer at the time of ordering. Vaccine manufacturers monitor sales data to ensure compliance with product loyalty terms; practices that do not meet benchmarks may be removed from the VPG. VPGs are paid administration fees by the manufacturers. VPGs use these fees to cover their operating expenses and often rebate a portion of these fees back to their members. All 11 VPGs offer additional services to members, ranging from immunization-focused education and technical assistance to discounts on a broad range of medical and business supplies. CONCLUSIONS: VPGs can facilitate access to reduced purchase prices for most vaccines routinely recommended in the United States. Data on the magnitude of the price reductions were not publicly available. VPG members must balance loyalty-based price reductions against considerations of having a wider choice of vaccine products.

Country Ownership And Gavi Transition: Comprehensive Approaches To Supporting New Vaccine Introduction.

Since the mid-2000s low- and lower-middle-income countries have been focusing on developing and using evidence for immunization policy making, with an increasing emphasis on cost-effectiveness analysis, program costing, and financial flows-particularly for the introduction of newer, more expensive vaccines. While this is critical to informing decisions, countries still need to increase national immunization investment and explore innovative approaches to augment financing of immunization programs. The need for increased financing is especially strong in countries transitioning from support by Gavi, the Vaccine Alliance. With increased fiscal space to finance health and immunization programs as a result of improved economic performance, low- and lower-middle-income countries can reach the health status enjoyed by wealthier nations within a generation. However, new strategies and approaches related to domestic resources for immunization programs are needed to achieve this goal. Governments will need to increase their investments and modify existing external immunization financing arrangements if country ownership of immunization programs and the full promise of new vaccines are to be realized.

Applying lessons learned from the USAID family planning graduation experience to the GAVI graduation process.

As low income countries experience economic transition, characterized by rapid economic growth and increased government spending potential in health, they have increased fiscal space to support and sustain more of their own health programmes, decreasing need for donor development assistance. Phase out of external funds should be systematic and efforts towards this end should concentrate on government commitments towards country ownership and self-sustainability. The 2006 US Agency for International Development (USAID) family planning (FP) graduation strategy is one such example of a systematic phase-out approach. Triggers for graduation were based on pre-determined criteria and programme indicators. In 2011 the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunizations) which primarily supports financing of new vaccines, established a graduation policy process. Countries whose gross national income per capita exceeds $1570 incrementally increase their co-financing of new vaccines over a 5-year period until they are no longer eligible to apply for new GAVI funding, although previously awarded support will continue. This article compares and contrasts the USAID and GAVI processes to apply lessons learned from the USAID FP graduation experience to the GAVI process. The findings of the review are 3-fold: (1) FP graduation plans served an important purpose by focusing on strategic needs across six graduation plan foci, facilitating graduation with pre-determined financial and technical benchmarks, (2) USAID sought to assure contraceptive security prior to graduation, phasing out of contraceptive donations first before phasing out from technical assistance in other programme areas and (3) USAID sought to sustain political support to assure financing of products and programmes continue after graduation. Improving sustainability more broadly beyond vaccine financing provides a more comprehensive approach to graduation. The USAID FP experience provides a window into understanding one approach to graduation from donor assistance. The process itself-involving transparent country-level partners well in advance of graduation-appears a valuable lesson towards success.

How might immunization rates change if cost sharing is eliminated?

OBJECTIVES: There is a debate regarding the effect of cost sharing on immunization, particularly as the Affordable Care Act will eliminate cost sharing for recommended vaccines. This study estimates changes in immunization rates and spending associated with extending first-dollar coverage to privately insured children for four childhood vaccines. METHODS: We used the 2008 National Immunization Survey and peer-reviewed literature to generate estimates of immunization status for each vaccine by age group and insurance type. We used the Truven Health Analytics 2006 MarketScan Commercial Claims and Encounters Database of line-item medical claims to estimate changes in immunization rates that would result from eliminating cost sharing, and we used the Kaiser Family Foundation/Health Research and Educational Trust Employer Health Benefits Survey to determine the prevalence of coverage for patients with first-dollar coverage, patients who face office visit cost sharing, and patients who face cost sharing for all vaccine cost components. We assumed that once cost sharing is removed, coverage rates in plans that impose cost sharing will rise to the level of plans that do not. RESULTS: We estimate that immunization rates would increase modestly and result in additional direct spending of $26.0 million to insurers/employers. Further, these payers would have an additional $11.0 million in spending associated with eliminating cost sharing for children already receiving immunizations. CONCLUSIONS: The effects of eliminating cost sharing for vaccines vary by vaccine. Overall, immunization rates will rise modestly given high insurance coverage for vaccinations, and these increases would be more substantial for those currently facing cost sharing. However, in addition to the removal of cost sharing for immunizations, these findings suggest other strategies to consider to further increase immunization rates.

The first national adult immunization summit 2012: implementing change through action.

To address lagging vaccine coverage among adults in the United States, over 150 organizations representing a wide range of immunization partners convened in Atlanta, GA from May 15-16, 2012 for the inaugural National Adult Immunization Summit. The meeting called for solution-oriented discussion toward improving current immunization levels, implementing the 2011 National Vaccine Advisory Committee adult immunization recommendations, and capitalizing on new opportunities to improve coverage. Provisions in the federal health reform law that increase access to preventive services, including immunizations, and the increasing numbers of complementary vaccine providers such as pharmacists, create new opportunities to increase access for immunization services and improve coverage for adults. The Summit organized around five focal areas: empowering providers, quality and performance measures, increasing access and collaboration, educating patients, and informing decision-makers. These focal areas formed the basis of working groups, charged to coordinate efforts by the participating organizations to address gaps in the current immunization system. Summit participants identified priority themes to address as tasks during the coming year, including better communicating the value of immunizations to increase demand for immunizations, creating a central repository of resources for providers, patients, and others interested in improving adult immunization levels, examining performance and quality measures and evaluating means to use such measures to motivate vaccine providers, increasing engagement with employer and employee groups to increase awareness and demand for vaccinations, improving the use of immunization information systems and electronic health reports, decreasing barriers to all vaccine providers including pharmacists and community vaccinators, decreasing the complexity of the adult vaccine schedule where possible, engaging adult immunization champions and leaders in key sectors, including adult healthcare provider groups, and encouraging more integration of immunization services with other preventive services.

Financial impact to providers using pediatric combination vaccines.

OBJECTIVE: To understand the financial impact to providers for using a combination vaccine (Pediarix [GlaxoSmithKline Biologicals, King of Prussia, PA]) versus its equivalent component vaccines for children aged 1 year or younger. METHODS: Using a subscription remittance billing service offered to private-practice office-based physicians, we analyzed charge and payment information submitted by providers to insurance payers from June 2007 through July 2009. We analyzed provider and payer characteristics, payer comments, and the ratio of vaccine product to immunization administration (IA) codes and computed total charges and payments to providers for both arms of the study. RESULTS: Most providers in our data set were pediatricians (74%), and most payers were commercial (75%), primarily managed care. The ratio of the number of vaccine products to the number of IAs was 1:1 in the majority of the claims. Twenty percent of claims were paid with no adjustment by the payer, whereas 76% of the claims were adjusted for charges that exceeded the contract arrangement or the fee schedule. Providers received $23 less from commercial payers and $13 less from Medicaid for the use of Pediarix compared with the equivalent component vaccines. The mean commercial payment was greater for age-specific Current Procedural Terminology IA codes 90465 and 90466 than for non-age-specific codes 90471 and 90472, whereas the reverse was true for Medicaid. CONCLUSIONS: Providers who administer vaccines to children face a reduction in payment when choosing to provide combination vaccines. The new IA codes should be monitored for correction of financial barriers to the use of combination vaccines.

Policy implications of first-dollar coverage: a qualitative examination from the payer perspective.

OBJECTIVES: Immunization against potentially life-threatening illnesses for children and adults has proved to be one of the great public health successes of the 20th century and is extremely cost-effective. The Patient Protection and Affordable Care Act includes a number of provisions to increase coverage and access to immunizations for the consumer, including a provision for health plans to cover all Advisory Committee on Immunization Practices-recommended vaccines at first dollar, or without cost sharing. In this study, we examined payers' perspectives on first-dollar coverage of vaccines and strategies to improve vaccination rates. METHODS: This was a qualitative study, using a literature review and semistructured expert interviews with payers. RESULTS: Four key themes emerged, including (1) the cost implications of the first-dollar change; (2) the importance of examining barriers to children, adolescents, and adults separately to focus interventions more strategically; (3) the importance of provider knowledge and education in increasing immunization; and (4) the effect of first-dollar coverage on those who decline vaccination for personal reasons. CONCLUSIONS: We determined that, while reducing financial barriers through first-dollar coverage is an important first step to increasing immunization rates, there are structural and cultural barriers that also will require collaborative, strategic work among all vaccine stakeholders.