AVAC Advises CMS on Response to the COVID-19 Pandemic

AVAC submitted comments to CMS  on Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. The comments focused on the provisions aimed at ensuring every American has timely access to a COVID–19 vaccine without any out-of-pocket expenses, no matter their source of coverage, or whether they are covered at all. 

January 4, 2021 

Centers for Medicare & Medicaid Services 

Department of Health and Human Services 

Attention: CMS-9912-IFC 

P.O. Box 8016, 

Baltimore, MD 21244-8016 comports 

RE: RIN 0938-AU35: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency CMS-9912-IFC 

To Whom It May Concern: 

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. Our comments focus on the provisions aimed at ensuring every American has timely access to a COVID–19 vaccine without any out-of-pocket expenses, no matter their source of coverage, or whether they are covered at all. 

Specifically, AVAC: 

  • Supports the Centers for Medicare and Medicaid Services (CMS) interpretation that safe and effective COVID-19 vaccines that have been authorized by the Food and Drug Administration (FDA) during a public health emergency (PHE) should be made available to Medicare beneficiaries without deductibles or coinsurance. 
  • Urges CMS to value CPT codes for COVID-19 vaccine administration that reflect the relative value of the additional practice expenses specific to COVID-19 vaccines. 
  • Strongly urges CMS to use its authority to immediately increase vaccine administration reimbursement rates for routine Part B vaccines (influenza, pneumococcal, and hepatitis B for those at-risk). 
  • Urges CMS to allow providers to submit COVID-19 vaccine administration claims for Medicare Advantage beneficiaries to the plans instead of requiring submission to MACs. 
  • Recommends that CMS provide clear guidance that states must cover COVID-19 vaccines without cost sharing for all Medicaid beneficiaries, regardless of their benefit or waiver category, and regardless of whether the vaccine was authorized under an EUA or received full FDA approval. 
  • Encourages CMS to work with HRSA to streamline and expedite the reimbursement process for Provider Relief Funds to ensure that uninsured populations have timely and equitable access to COVID-19 vaccines. 

AVAC consists of sixty 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. 

II. Provisions of the Interim Final Rule—Department of Health and Human Services 

A. Medicare Coding and Payment for COVID–19 Vaccine 

The IFC provides a detailed explanation as to why it is imperative for Medicare beneficiaries to have access to a COVID-19 vaccine without cost sharing. It is consistent with the intent of Congress in the CARES Act and it comports with FDA authority and guidance around the use of a vaccine that is found to be safe and effective during a public health emergency (PHE) period. 

Specifically, the IFR states, “That is, even though section 3713 of the CARES Act refers to a COVID–19 vaccine ‘‘licensed under section 351 of the PHS Act,’’ CMS could consider any vaccine for which FDA issued an EUA during the PHE, when furnished consistent with terms of the EUA, to be eligible for Medicare coverage and payment. We consider our interpretation of section 3713(d) of the CARES Act to be consistent with Congress’ intent to provide for Medicare coverage without deductible or coinsurance of any COVID–19 vaccine (and its administration) that FDA has authorized to be introduced into interstate commerce, which would be the case both for a vaccine for which emergency use is authorized under section 564 of the FD&C Act and for a vaccine that is licensed under section 351 of the PHS Act. Our interpretation also would be consistent with Congress’ general intent in the CARES Act and other recent legislation to provide for rapid coverage of COVID–19 vaccines.” AVAC strongly supports this interpretation and urges CMS to communicate instructions to Medicare providers and suppliers in order to ensure timely beneficiary access to COVID–19 vaccines. 

Our coalition also strongly supports the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations in determining priority groups and phases for vaccine distribution and providing additional guidance to immunizing providers during this process. 

4. Implementation and Methods of Coding and Payment for COVID–19 Vaccine and Administration 

The IFR also addresses provider reimbursement rates for the cost of a COVID-19 vaccine and its administration. AVAC urges CMS to value CPT codes for administration that reflect the relative value of the additional practice expenses specific to COVID-19 vaccine administration. These new vaccines have varying storage, handling, and administration requirements that make them more expensive than routine immunizations, such as flu and pneumococcal. COVID-19 vaccines will also require that more time and resources are dedicated to patient and caregiver counseling and education. Adequate reimbursement that reflects these additional costs is essential to ensuring widespread access to COVID-19 vaccines across the immunization neighborhood. It is likely that current Medicare rates for vaccine administration will not sufficiently account for the resources required to successfully implement COVID-19 vaccination efforts in the provider setting. 

AVAC is also concerned that immunizations received by Medicare Advantage beneficiaries will not be reported back to the plans due to the fact that providers are directed to submit claims for COVID-19 vaccines directly to the MAC. Requiring providers to report immunizations to the regional MAC not only presents an additional burden on the provider but also could result in gaps in data in terms of the patient health record. Medicare Advantage plans would not have access to claims data that they would process under ordinary circumstances, such as what vaccine the patient received and when. This data is important not only for ensuring beneficiary adherence to vaccine schedule completion (through the use of reminders and other direct beneficiary outreach) but can also be extremely valuable for vaccine safety monitoring. AVAC urges CMS to maintain the current provider claims process for vaccine administration for Medicare Advantage plan beneficiaries and to have the MA plans and the MACs manage the Medicare fee-for-service payment process on the back end. Doing so will ensure that plans have access to important patient data and that providers will be relieved of an additional burden that will complicate billing and timely reimbursement for Medicare Advantage beneficiaries. 

AVAC also encourages CMS to take corrective action on disparities in vaccine administration rates for routinely recommended vaccines, such as influenza, pneumococcal, and hepatitis B (for at risk patients) through the IFR. Over the past several years, AVAC has noted the decline in Medicare Part B vaccine administration rates, commenting on the 2019 and 2020 proposed physician fee schedule (PFS) rules and during a telephone conference with members of the HAPG on May 26, 2020. The 2019 final PFS rule stated, “We recognize that it is in the public interest to ensure appropriate payments to physicians and other practitioners for provision of the immunization administration services that are used to deliver vaccines and plan to review the valuations for these services to ensure appropriate payment.” However, the final 2020 PFS rule abandoned a proposal to decouple the practice expense RVU for vaccine administration from therapeutic injection (96372) to crosswalk the valuation of vaccine administration CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein). It is important that providers are adequately compensated for their efforts to implement vaccination strategies to immunize patients safely during this pandemic and that will remain as providers work to restore immunization coverage rates for other routinely recommended vaccines to pre-pandemic levels, or better. AVAC urges CMS to use existing emergency authority under the PHE to immediately increase the values of HCPCS codes G0008, G0009, and G0010. The pandemic has placed a significant financial burden on many immunizing providers and we cannot afford to undermine their ability to offer access to immunization services, especially the COVID-19 vaccine. Patients rely on their health care providers for advice and their trusted voices and leadership in this effort will be essential. 

B. COVID–19 Vaccine Coverage for Medicaid, CHIP, and BHP Beneficiaries 

The IFR also notes that states receiving a temporary 6.2 percent increase in the Federal Medical Assistance Percentage (FMAP) rate are required to cover COVID–19 testing services and treatments, including the vaccines and the administration, for Medicaid enrollees without cost sharing. The IFR also indicates that states must compensate Medicaid providers with a vaccine administration fee or reimbursement for a provider visit. According to the Families First COVID Relief Act (FFCRA), the increase, and the requirements associated with it, is available through the end of the quarter in which the PHE for COVID–19 ends. 

We regret that the IFR does not apply to all Medicaid beneficiaries. Specifically, “CMS has not interpreted section 6008(b)(4) of the FFCRA to require that state Medicaid programs cover the services described in that provision for individuals whose Medicaid eligibility is limited by statute to only a narrow range of benefits that would not otherwise include these services. FFCRA section 6008(b)(4) did not amend the varying benefits packages that are required for different Medicaid eligibility groups under section 1902(a)(10) of the Act.” We are concerned that these patients will not have access to the COVID-19 vaccine and believe that it was Congress’ intent to guarantee that all Medicaid beneficiaries have access. AVAC strongly recommends that CMS correct this interpretation and provide clear guidance that states must cover COVID-19 vaccines without cost sharing for all Medicaid beneficiaries, regardless of their benefit or waiver category, and regardless of whether the vaccine was authorized under an EUA or received full FDA approval. 

Lastly, we appreciate that Provider Relief Funds have been made available to compensate providers for COVID-19 vaccine administration costs for uninsured populations. However, we would note that, to date, providers have found the process for seeking reimbursement for other COVID related diagnostic and treatment services to be slow and burdensome. AVAC urges CMS to work with HRSA to streamline and expedite this program so uninsured populations, many of whom are at higher risk of COVID-19 disease, complications, and death, have timely and equitable access to the vaccine. 

Now more than ever, immunizations are a public health imperative and ensuring that immunization providers are properly reimbursed is key to fostering a sustained environment of timely immunization now and in the future. Vaccine administration by health care providers at the point of care is an opportunity that needs to be maintained and encouraged during the COVID-19 pandemic and beyond. It is imperative that we work across all segments of government and the health care system to build and support a better system for immunization services that is not only safe and effective but is also accessible and equitable for everyone. 

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 Academy of Family Physicians 

Asian & Pacific Islander American Health Forum 

Association of Asian Pacific Community Health Organizations (AAPCHO) 

Association of Immunization Managers 

Biotechnology Innovation Organization (BIO) 

Families Fighting Flu 

Hep B United 

Hepatitis B Foundation 

Immunization Action Coalition 

Infectious Diseases Society of America 

Kimberly Coffey Foundation 

Moderna 

National Association of Nutrition and Aging Services Programs 

National Consumers League 

National Viral Hepatitis Roundtable 

Novavax, Inc 

STChealth 

The AIDS Institute 

Trust for America’s Health 

Vaccinate Your Family 

AVAC Responds to Request for Information on the Vaccines National Strategic Plan Draft

AVAC responded to the Office of Infectious Disease and HIV/AIDS Policy (OIDP) Request for Information (RFI) on the Vaccines National Strategic Plan (VNSP) draft. The updated plan presents a series of goals, objectives, and recommended vaccine strategies across the lifespan that will guide priority actions for the period 2021–2025 and set important markers around the swiftly changing vaccine landscape.   

December 3, 2020  

David Kim, M.D.  

Office of Infectious Disease and HIV/AIDS Policy   

Department of Health and Human Services200 Independence Ave. SW 

Washington, DC  20201 

 RE: Request for Information (RFI): Vaccines National Strategic Plan Draft Available for Public Comment  

Dear Dr. Kim, 

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Office of Infectious Disease and HIV/AIDS Policy (OIDP) Request for Information (RFI) on the Vaccines National Strategic Plan (VNSP) draft. This updated plan presents a series of goals, objectives, and recommended vaccine strategies across the lifespan that will guide priority actions for the period 2021–2025 and set important markers around the swiftly changing vaccine landscape.   

AVAC consists of over 60 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization.  AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system.  Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations.   

We appreciate the broad focus of the VNSP on the entire vaccine enterprise, including HHS’ move to adopt vaccine strategies across the lifespan.  The development of the VNSP comes at a critical time as our nation plans for the upcoming allocation, distribution, and administration of forthcoming COVID-19 vaccines, which will be judged by how well it ensures equitable access for all.  We expect this vaccination program will be the greatest public health effort of our generation. While this effort will present significant challenges, it also brings a new opportunity to build upon the strength of existing immunization program infrastructure in the United States. 

Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases each year.  Adult coverage lagged behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.1 Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of information about recommended vaccines, financial hurdles, and technological and logistical obstacles.  We see opportunity in the NVSP to lay the foundation for improved access to and utilization of vaccines, especially through the reduction in technological, logistical, geographic, socio-economic, and financial barriers to the full complement of ACIP-recommended adult immunizations.  Again, thank you for the opportunity to share responses to the questions laid out in the RFI around the federal governments’ efforts to strengthen and improve the nation’s response to vaccine preventative disease and strategies to address infectious disease through vaccination. 

  1. DO THE DRAFT VACCINE PLAN’S GOALS, OBJECTIVES, AND STRATEGIES APPROPRIATELY ADDRESS THE VACCINE LANDSCAPE?  

Importantly, the plan focuses on five key areas that, together, can go a long way to improve immunization rates across the lifespan: 1. Foster innovation in vaccine development and related technologies. 2. Maintain the highest possible levels of vaccine safety. 3. Increase knowledge of and confidence in routinely recommended vaccines. 4. Increase access to and use of all routinely recommended vaccines. 5. Protect the health of the American public by supporting global immunization effortsComplimenting these five goals are a set of targeted objectives and strategies that will benchmark and guide progress. 

Our comments focus primarily on goals 3 and 4, which fall most centrally as part of the work of our coalition AVAC member organizations support improving access to and utilization of vaccines by reducing technological, logistical, geographic, socio-economic, and financial barriers to the full complement of ACIP-recommended adult immunizations. As you work to finalize the plan, we encourage OIDP to prioritize the goals and objectives set forth in the plan. AVAC intends to prioritize certain goals and objectives that we have highlighted below as areas of common interest. 

Goal 3: Increase knowledge of and confidence in routinely recommended vaccines. 

Increasing knowledge of and confidence in recommended vaccines will help to increase community demand for immunizations, and will be key to achieving NVSP success. The third goal highlights an important aspect where greater attention and concerted effort is desperately needed in the adult populations. Education and awareness of the importance of immunizations should be closely linked with efforts to improve access. While significant progress has been made towards providing accurate, timely, and transparent information about immunizations and recommended vaccines through varied communications and partnership efforts, additional tools are needed to disseminate vaccine information—including publication of evidence-based recommendations, use of mass media and new media, provider education and training, and support of non-federal stakeholder partners.  These tools are essential to educating and increasing community demand for adult immunizations.  We commend the recognition of investment needed to build our efforts to provide public health partners, healthcare providers, policy makers, and other stakeholders the tools necessary to work together to improve awareness and confidence.  We recommend that the third and fourth goals of the NVSP be viewed and pursued in tandem. 

We appreciate that Objective 3.1 seeks to counter vaccine mis- and disinformation and increase public support for the individual and societal benefits of vaccination. We will need to rely on using effective communication strategies to build understanding and support for the individual and societal benefits of vaccinationThere is growing concern that the spread of mis and disinformation is eroding vaccine confidence and leading to lower vaccination coverage rates across the life course. The federal government, working with immunization partners and trusted community leaders and organizations, must continue to be proactive, clear, consistent, and highly visible in their communications to keep the public informed of vaccine development, safety processes, and approval and recommendation criteria.   

With regard to forthcoming Covid-19 vaccines, this will be especially important as we will need to ensure that information about the vaccine, the principles and process for distribution, and information about priority populations reach the public in a clear, understandable, and transparent way.  Trusted community leaders and partners (3.1.3) are critical for ensuring that information reaches communities with low immunization rates, and can help bridge the gap in keeping the public informed on the importance of vaccines.  Information on vaccines will go a long way in making the case that vaccines save lives.  It is especially important to have data on the direct and indirect costs and benefits of vaccinations in the adult population (3.1.5).   

Objective 3.2 Increase provider capacity to promote knowledge of the benefits of immunization and increased vaccine acceptance by the public will be most impactful if barriers to access have been effectively addressed.  In addition to the ability to leverage direct lines of communication to their patients, HCPs are trusted sources of information on how beneficiaries can safely receive preventative care. It is important to continuously educate and inform healthcare professionals (HCPs) on the latest vaccine information, to ensure they have confidence themselves and are able to make a strong recommendation to patients (3.2.1).  Special attention should be paid to establishing vaccination training for providers that build vaccination as part of preventive care and help to build confidence in vaccination as a societal norm (3.2.2).  Vaccine outreach and communication to HCPs should also encourage providers to raise awareness among patients regarding the need to receive all ACIP-recommended vaccinations across the life course and locations where vaccines may be available to them (3.2.3).    

Objective 3.3 Ensure key decision- and policy-makers receive accurate and timely information on vaccines and strategies to promote vaccine uptake should prioritize stakeholder, cross-agency, and intra-agency collaboration to inform vaccine policy development overall (3.2.2). These relationships will go a long way towards demonstrating that the federal government is prioritizing all aspects of immunization policy. There is also a great need for key decisionmakers to have information on vaccine benefits and risks; economics; and public knowledge, attitudes, and benefits.   

Efforts to advance Objective 3.4 Reduce disparities and inequities in vaccine confidence and acceptance will require a multifaceted approach but is vital to achieving the goals of the NVSP By developing a better understanding of these differences, we can work collaboratively to tailor messages and strategies to address the specific issues and concerns within a community. The federal government, working with immunization partners and trusted community leaders and organizations, must be proactive, clear, consistent, and highly visible in their communications to keep the public informed of recommended vaccines, safety processes, and approval and recommendation criteria.  Gaps exists in the lines of communications between vaccine program managers, third party payers, and key decision and policymakers (3.4.1).  The communications should be localized and flexible in its ability to reach different racial and ethnic communities and communities who have limited English proficiency, in order to build trust and acceptance (3.4.2). Special attention must be paid to advancing strategic, evidence-based metrics that measure whether activities are culturally appropriate and reflect the health literacy, language proficiency, and functional and access needs of specific target populations (3.4.3).  We know that the best messengers to communities experiencing health disparities are the organizations and partners they already trust.  Therefore, vaccination campaigns must be able to extend to areas where people are least likely to be reached by traditional health care infrastructure and where there are known pockets of vaccine hesitancy. It is vital that targeted resources are dedicated on an ongoing basis to enable local leaders to test and tailor proactive messages, while countering mis-and disinformation as well as anti-vaccination sentiments that may infiltrate communities (3.4.4).   

Goal 4. Increase access to and use of all routinely recommended vaccines. 

National immunization campaigns to protect the population against vaccine-preventable diseases have the ability to make a difference, but Goal 3 will be most impactful if and only if barriers to access have been effectively addressed, such as laid out in Objective 4.  The fourth goal of the NVSP to improve access to and use of all recommended vaccines is critically important and is a core tenet for AVAC. The six objectives specified within this goal each include aspects that we support overall.   

We agree with Objective 4.1 Increase the availability of vaccines in a variety of settings.  Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of information about recommended vaccines, financial hurdles, as well as technological and logistical obstacles.  A concerted approach to adult immunization with clear benchmarks and expectations of success is absolutely essential to increase vaccine utilization and coverage targets. The immediate needs are around increased coverage and utilization of adult immunizations; greater IT capabilities; better quality measurement and tracking; and increased coverage and utilization of adult immunizations.  

Wsupport (4.1.1) regarding the importance of removing patient barriers to accessing vaccines, incentivizing vaccination across the immunization neighborhood, as well as new strategies for offering vaccinations. Federally supported supplemental vaccination sites may be especially beneficial in high risk communities and should promote new strategies for mass vaccination, such as drive-thru clinics and clinics in nontraditional locations that are easy to access and are safe for vaccinators and the public.  It is important to recognize the need to scale-up implementation of evidence-based systems-level strategies that increase vaccine uptake (e.g. centralized reminder-recall system, standing orders) as laid out (4.1.2).    

Together with Objective 3.4, Objective 4.2 Reduce disparities and inequities in access to and use of routinely recommended vaccines across the lifespan must work to ensure vaccines reach vulnerable and underrepresented populations.  We know that health inequity limits access to health care resources needed in many communities, including in Black, Hispanic or Latinx, American Indian, Alaska Native, Asian American, and Native Hawaiian and Pacific Islander populations. This has long held true for vaccination rates, especially for those living in rural areas, below the poverty line, and in communities of color. Recently, these are the same populations that have experienced greater loss during the COVID-19 pandemic, including greater risk of COVID-19 infection and death.  We fully agree with the need to support continued research on race and ethnicity, age, social, economic, cultural, and other factors that contribute to disparities in vaccination rates, and develop targeted interventions to address them (4.2.1).  Special attention should be paid to establishing vaccination as a routine part of preventive care.  Building confidence in vaccination as a societal norm should build in strong support from state and local health departments’ efforts to study local immunization disparities and strengthen their community engagement efforts (4.2.2)  

AVAC shares the view that advancements in immunization information Objective 4.3 Strengthen data infrastructure, including Immunization Information Systems have the potential to vastly improve monitoring of vaccine preventable disease rates and vaccine coverage data in real time, as well as to facilitate the exchange of data that can improve the quality of preventive care among targeted adult populations and patient outcomes. The ongoing COVID-19 pandemic brought to light gaps in the immunization infrastructure, especially around Immunization Information Systems (IIS), which can provide timely and accurate vaccination data, and must be used to support any mass immunization efforts around COVID-19.  Accountability measures, such as those laid out in Objective 4, should be highlighted to expand the incorporation of vaccinations and the use of IIS into quality improvement programs.   

IIS must be enhanced to meet new and changing data standards and access to IIS must be expanded to more providers and settings across the health care system (4.3.1)Currently, some IIS face challenges and policy barriers that limit their ability to maximize their use. To be optimally effective, IIS should encompass all vaccinations received during each person’s lifetime, contain a person’s consolidated immunization history, and fully meet the standards recommended by the CDC and American Immunization Registry Association (AIRA) to support clinicians in efforts such as administering multidose vaccines. There must also be coordination, interoperability, and bidirectional communication between the IIS and electronic health records, electronic case reporting, and health information exchange networks, including any new technologies created around Covid-19 distribution (4.3.2). The NVSP should prioritize the completeness of, and communication between, IIS and EHRs to monitor vaccine coverage and efforts to support the adoption of interoperable health information technology and EHRs for immunization.  Investments are needed to increase data analytics capacity to conduct disease surveillance and increase enrollment of adult health care providers in immunization information systems (4.3.3).  Likewise, additional resources for training, technical assistance, and incentives to improve IIS are necessary to increase reporting capabilities by adult vaccine providers (4.3.4).   

We strongly agree with Objective 4.4 Reduce financial and systems barriers for providers to facilitate delivery of routinely recommended vaccines.  AVAC has long advocated for the prioritization of efforts to reduce financial barriers to vaccinationThere must be adequate Medicaid and Medicare reimbursement to cover the cost of vaccine administration counseling.  Inadequate reimbursement discourages healthcare providers, such as physicians, nurses, pharmacists, and others, from proactively offering immunizations, and results in missed immunization opportunities and declines in immunization rates. (4.4.1).  Reducing financial barriers that prevent adults from receiving recommended immunizations and hinder the ability of providers to stock and supply vaccines will also help create equity in access (4.4.2).  We wholeheartedly agree that the financial barriers to all ACIP recommended vaccines must be eliminated for individuals covered by Medicaid and Medicare to improve the underlying health of the communities (4.4.3)but would urge the plan to go further to incorporate elimination of financial barriers for all recommended vaccines in all federal programming. AVAC supports strengthening and the establishment of additional federal benchmarks and measures to encourage health plans to track, report, and achieve increased adult immunization rates (4.4.4). Finally, we agree that eliminating regulatory and payment barriers to innovative services, such as the use of mobile vans and telehealth for vaccine counseling, should be emphasized and prioritized (4.4.5).   

As part of public health preparedness, we need to eliminate financial barriers for access to vaccines such as Objective 4.5 Reduce financial and systems barriers for the public to facilitate access to routinely recommended vaccines.  Older adults are at particular risk for serious illness and those 50 and older, particularly with multiple comorbidities, are at higher risk of dying as a result of a vaccine preventable condition Fixing structural inequities by removing co-pays, cost sharing, and other financial barriers by health care plans for all routinely recommended vaccines in vaccine coverage (4.5.1) will provide a clear and direct financial and health benefit and will help to improve our national preparedness.  As included in the NVSP, the federal government should continue to encourage and promote adequate payments for vaccines and vaccinations by public and private health plans to incentivize providers to vaccinate, thereby promoting access (4.5.2). There should also be a baseline of consistent and reliable access to immunizations for the uninsured, and reliable Medicaid coverage of vaccines made available to adult populations across all states.  Currently, access to vaccines under Medicaid varies, depending on where you live and your Medicaid eligibility status. Medicaid enrollees who are covered through Medicaid expansion programs are guaranteed access to all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) with no cost sharing requirements. By contrast, not all vaccines recommended for adults are covered by traditional Medicaid programs, and those that are covered may have cost sharing requirements that put access to the vaccine out of reach (4.5.3).   

We strongly believe in Objective 4.6 Promote public-private partnerships to increase the capacity of the health system to deliver vaccines for routine use and protection during outbreaks as a means to achieve all of the elements of the NVSP.  As such, in order to successfully execute strategies 4.6.1-4.6.3, there is a need for infrastructure investments aimed at strengthening, enhancing, and expanding the ability of public health officials, primary care physicians, nurses, pharmacists, and other health care providers practicing at the top of their license in the community to meet vaccine demand, especially in light of  forthcoming COVID-19 vaccines and the need to reach populations who are currently under-vaccinated. A strong immunization infrastructure will be essential for routine vaccine use and during public health emergencies.   

  1. II.ARE THERE ANY CRITICAL GAPS IN THE VACCINE PLAN’S GOALS, OBJECTIVES, AND STRATEGIES?  PLEASE IDENTIFY: 

AVAC applauds the progress that has been made over the last decade but more must be done to improve access and utilization.  We believe there is opportunity to continue to build on the framework laid in the NVSP to ensure it remains a dynamic, current, and useful document.  While we believe the general framework laid out in the goals is comprehensive, we see opportunity to strengthen a variety of strategies under the various objectives 

Recommended Additional Strategies for Goal  

  • AVAC sees the importance of the proposed goals and objectives. However, we would like to highlight the need to enhance partnerships for communications efforts as especially important.  As a coalition representing providers, public health groups, vaccine makers, pharmacies, and consumers, we share the NVSPs goals of reducing barriers and improving access.  Tremendous work is taking place across the country to identify the barriers and challenges around adult vaccines.  The NVSP should further prioritize collaborations with community stakeholders to disseminate information, and to learn from current outreach and practices.  We recommend doing so by creating strategy 3.3.3.   
  • Similarly, this strategy should build out support for the development of immunization champions within health systems and provider practices.  Provider groups such as AMGA/ACP/AAFP have all demonstrated ability to improve immunization rates and activities through building internal champions and training programs that having someone who is responsible and accountable for vaccinating. We recommend building this type of provider training in the plan 3.3.4.  
  • There is also a great need for key decisionmakers to have information on vaccine benefits and risks; economics; and public knowledge, attitudes, and benefits.  We recommend incorporating this as part of 3.3.2 or creating a new strategy 3.3.5.   

Recommended Additional Strategies for Goal 4.  

  • We recommend including long term care facilitiesnursing homes, and other congregate living settings as part of this list.  4.1.1. Remove barriers to and incentivize vaccination in non-health care settings, including workplaces, places of worship, community centers, and pharmacies, as well as in specialty health care settings (e.g., cancer treatment centers).  As part of 4.1.1, we also recommend the need for federally supported supplemental vaccination sites in high risk communities to vaccinate for Covid-19.  These could promote new strategies for mass vaccination, such as drive-thru clinics and clinics in nontraditional locations (such as transit hubs) that are easy to access and are safe for vaccinators and the public.  Services should also be provided over extended hours, such as nights and weekends, to allow individuals who may not be able to seek immunizations during traditional work hours to access these services when it is most convenient for them.  
  • Section 4.4.3 should include language stronger than “encouraging state changes. The NVSP could call for specific actions, such as recommending the Center for Medicaid at CMS issue guidance to state Medicaid directors encouraging states to assess current vaccine coverage under their respective plan review provider reimbursement rates for the cost of the vaccine as well as its administration, with the goal of identifying deficiencies and developing plans to close insurance coverage and reimbursement gaps that hinder access to vaccines for Medicaid populations relative to other coverage groupsWe should be encouraging states to seek plan amendments to support this work as well as leverage contractual agreements with Medicaid managed care plans to improve access to this important preventive service. Greater leadership and direction at the federal policy level could go a long way to facilitate equal access to vaccines through Medicaid.   
  • Section 4.4.4 promotes the use of vaccination as a quality measure in value-based payment models, however, this section should specifically call out the two recently developed measures, the Adult Immunization Status and the Maternal Immunization Status measure.  We recommend 4.4.4 specifically mention the need for a strategy on how the two developmental measures around the adult immunization status and the life course IIS that were included in Healthy People 2030 will be implemented over the next five years.  Additionally, Table 1, indicators and targets should include specific timelines and metrics for implementation of these two developmental measures. Further efforts to promote the use of ACIP-recommended adult immunizations quality measures and benchmarks under Medicare, Medicaid, and private insurance would go a long way to help drive utilization and improve patient access to these effective, life-saving, and low-cost services. This should include broad utilization of the adult immunization status measure and the maternal immunization status measure.    
  • As part of strengthening infrastructure needs, the plan should include incorporate needs around recruiting and training the necessary workforce in certain public health settings 4.6.4.   
  1. Do any of the Vaccine Plan’s goals, objectives and strategies cause concern? If so, please specify the goal, objective or strategy, and describe the concern regarding it.

No.  

Thank you again for this opportunity to offer our responses regarding the goals, objectives, and strategies around the NSVP. Please contact the AVAC Coalition Managers Abby Bownas (abownas@nvgllc.comor Lisa Foster (lfoster@nvgllc.com) if you would like more information about our views, or the work of AVAC. 

Sincerely, 

Alliance for Aging Research  

American Immunization Registry Association (AIRA) 

American Lung Association 

American Public Health Association 

Biotechnology Innovation Organization (BIO) 

Emily Stillman Foundation 

Families Fighting Flu 

GSK 

Hep B United 

Hepatitis B Foundation  

Infectious Diseases Society of America 

Kimberly Coffey Foundation 

March of Dimes 

Medicago 

Meningitis B Action Project 

Moderna 

National Association of Nutrition and Aging Services Programs (NANASP) 

National Foundation for Infectious Diseases 

National Viral Hepatitis Roundtable 

STChealth  

The AIDS Institute 

The Gerontological Society of America 

Trust for America’s Health 

WomenHeart: The National Coalition for Women with Heart Disease 

AVAC Strongly Supports the Helping Adults Protect Immunity (HAPI) Act

AVAC wrote a letter to Senator Sherrod Brown and Representative Darren Soto, thanking them for their leadership on the Helping Adults Protect Immunity (HAPI) Act. Currently, access to vaccines under Medicaid varies, depending on where live and your Medicaid eligibility status. The HAPI Act seeks to ensure that all Medicaid enrollees have access to vaccines and do not face insurmountable financial hurdles when a recommended vaccine provides a clear and direct health benefit.

November 10, 2020

Dear Senator Sherrod Brown and Representative Darren Soto,

We write to express our strong support for the Helping Adults Protect Immunity (HAPI) Act. We appreciate your bi-cameral leadership to strengthen access to immunizations under Medicaid.

Medicaid, along with the Children’s Health Insurance Program (CHIP) is a federal-state insurance partnership that provides coverage to over 70 million low income children and adults. Medicaid covers low-income older adults, persons with disabilities and chronic conditions, and pregnant women. Many of these same populations have been hit hard by the COVID-19 pandemic. These high-risk health groups are also extremely vulnerable to serious adverse health consequences of other vaccine preventable illnesses. Hospitalizations, increased morbidity and mortality, loss of independence, the ability to engage in activities of daily living and reduced quality of life are but a few of the devastating, but avoidable, direct and indirect costs. Vaccine preventable conditions add over $8.3 billion to the health care system overall, according to a 2016 study of just four vaccine preventable conditions (influenza, pneumococcal disease, herpes zoster and pertussis)1.

The HAPI Act seeks to provide a baseline of consistent and reliable Medicaid coverage across the country. Currently, access to vaccines under Medicaid varies, depending on where live and your Medicaid eligibility status. Medicaid enrollees who are covered through Medicaid expansion programs are guaranteed access to all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) with no cost sharing requirements. By contrast, not all vaccines recommended for adults are covered by traditional Medicaid programs and those that are covered may have cost sharing requirements that put access to the vaccine out of reach. The HAPI Act seeks to ensure that all Medicaid enrollees have access to this important preventive health service and do not face insurmountable financial hurdles when a recommended vaccine provides a clear and direct health benefit.

Again, thank you for leadership on the HAPI Act. Members of AVAC stand ready to work with you on this, and other important policy solutions to strengthen and expand coverage for recommended vaccines to those who most need it.

Sincerely,

Alliance for Aging Research

American Immunization Registry Association

American Lung Association

Association for Professionals in Infection Control and Epidemiology

Emily Stillman Foundation

Families Fighting Flu

Hep B United

Hepatitis B Foundation

Infectious Diseases Society of America

Kimberly Coffey Foundation

Medicago

National Association of Nutrition and Aging Services Programs (NANASP)

National Black Nurses Association

National Viral Hepatitis Roundtable

STChealth

The AIDS Institute

The Gerontological Society of America

Trust for America’s Health

Vaccinate Your Family

WomenHeart: The National Coalition for Women with Heart Disease

AVAC Joins Stakeholders in Letter to Congress About Preparing for COVID-19 Vaccine

AVAC joined a diverse group of stakeholders in a letter to Congressional leadership, making recommendations for preparing for the allocation, distribution, and administration of new COVID-19 pandemic vaccines. Recommendations included making investments in immunization infrastructure, funding communication efforts that will help increase public confidence in a COVID-19 vaccine, and funding CDC campaigns that will be essential for the distribution of a COVID-19 vaccine.

October 22, 2020

Dear Majority Leader McConnell, Speaker Pelosi, and Minority Leaders Schumer and McCarthy:

As the nation continues to struggle with the COVID-19 pandemic, it is imperative that the federal government, in coordination with state, local, tribal, and territorial governments, as well as public health, primary care physicians, pharmacists, and other health care providers on the front lines, prepare for the allocation, distribution, and administration of new COVID-19 pandemic vaccines.

While continued emphasis on testing and contact tracing are essential, we believe that deployment of a safe and effective COVID-19 vaccine is the ultimate key to fully re-opening the American economy. We expect this vaccination program will be the greatest public health effort of our generation, and we greatly appreciate your leadership now to prepare the nation for this response.

As part of Operation Warp Speed, the government has been laying the groundwork for months to distribute and administer a safe and effective COVID-19 vaccine as soon as it meets FDA’s gold standard. The plan relies on the strength of existing public health preparedness and response and immunization program infrastructure in the United States. While our immunization infrastructure is built on a solid foundation, gaps in capacity and capability across public health and health care systems must be addressed to ensure that our nation is prepared to succeed in a timely, comprehensive, and equitable vaccination campaign.

Infrastructure investments must be made today to further strengthen, enhance, and scale up the ability of public health, primary care physicians, pharmacists, and other health care providers in the community who provide immunizations to meet demand for a future COVID-19 vaccine. This important work requires resources for planning, prioritization, expanding the public health workforce, and close collaboration between public health and existing primary care physicians, pharmacists, and other health care providers within the immunization neighborhood.

Concurrently, electronic health record vendors and immunization information systems (IIS) must have the resources necessary to quickly update and prepare these essential data reporting systems. Other essential factors that must be supported are onboarding and orientation of new primary care physicians, pharmacists, and other health care providers to administer and report vaccines in settings, such as long-term care facilities, as needed and to supplement immunization providers.

It is critical there be a heightened focus on addressing vaccination hesitancy concerns and increasing public confidence in the safety and efficacy of vaccines as a potentially lifesaving medical countermeasure. Funding for beneficiary engagement and patient and provider communications will be needed to build our ongoing education and outreach efforts around the new COVID-19 vaccine, as well as promote the need to continue the stay up to date with immunizations recommended by the Advisory Committee on Immunization Practices (ACIP), including vaccinations for flu, pneumococcal disease, shingles, and hepatitis.

Support for public health, primary care physicians, pharmacists, and other health care providers in the community is needed now to implement plans for managing the volume of procurement, storage, and distribution of ancillary supplies that will be needed for a successful pandemic vaccination effort, such as personal protective equipment (PPE), syringes, and alcohol wipes. One can expect that there will be an unprecedented demand for vaccine across the country and across all segments of the population, and there will be intense pressure on already fragile and overworked health care and public health systems.

In order to support the multitude of activities now underway to achieve a successful COVID-19 vaccination campaign, our organizations urge Congress to provide over $8 billion in funding for CDC-wide activities, prioritizing the following:

$3 billion in funding to administer the COVID-19 vaccine through the governmental public health system, primary care physicians, pharmacists and other health care provider workforce.

$1.2 billion for cold chain supply

$1 billion for State and Local vaccination infrastructure

$1 billion to stand up additional vaccination sites

$700 million for the national immunization survey

$500 million for immunization information systems (IIS) data modernization.

$500 million for Emergency Use Authorization regulation and oversight

$500 million for targeting hard to reach populations

Additionally, we urge an additional $500 million for the current flu season underway and ask for an enhanced Medicaid Federal Medical Assistance Percentages (FMAP) for vaccine counseling and administration.

We appreciate your thoughtful consideration of these recommendations and look forward to working with you to prepare the nation for the next phase in this fight against the COVID-19 pandemic.

Sincerely,

Adult Vaccine Access Coalition (AVAC)

Alliance for Aging Research

American Academy of Family Physicians

American College of Preventive Medicine

American Immunization Registry Association

American Lung Association

American Society for Microbiology

Association of Immunization Managers (AIM)

American Pharmacists Association

American Public Health Association

American Society for Microbiology

Asian & Pacific Islander American Health Forum

Association for Professionals in Infection Control and Epidemiology

Association of Asian Pacific Community Health Organizations (AAPCHO)

Association of Immunization Managers

Association of Maternal & Child Health Programs

Association of State and Territorial Health Officials

Biotechnology Innovation Organization (BIO)

Families Fighting Flu

GSK

Hep B United

Hepatitis B Foundation

Immunization Action Coalition

Infectious Diseases Society of America

Lupus and Allied Diseases Association, Inc.

March of Dimes

Medicago

National Association of County and City Health Officials

National Foundation for Infectious Diseases (NFID)

National Minority Quality Forum

National Viral Hepatitis Roundtable

Novavax

Sepsis Alliance

Seqirus USA, Inc.

Society for Maternal-Fetal Medicine

STChealth LLC

The Gerontological Society of America

Trust For America’s Health

Vaccinate Your Family

AVAC Leads Stakeholder Letter on Equitable COVID Vaccine Distribution

As our nation plans for the upcoming allocation, distribution, and administration of a new COVID-19 pandemic vaccine, AVAC has brought together leading partner organizations and allies to emphasize the importance of ensuring equitable access to a future COVID-19 vaccine for all.

 

The over 70 organizations signing on to this letter offer several principles and policy recommendations to facilitate the equitable allocation, distribution, access, and utilization of a COVID-19 vaccine, including:

  1. Provide full transparency at every stage of the process to foster public confidence and maximize vaccine acceptance and use, especially among communities that have been the hardest hit by, and are most susceptible to severe illness as a result of, COVID-19.
  2. Ensure information, resources, and vaccines reach and are utilized by at-risk and underrepresented populations.
  3. Support essential immunization infrastructure and the community-based immunization providers.

Dear Secretary Azar, ADM Giroir, Director Redfield, Commissioner Hahn, and Chief Advisor Slaoui: 

 As the nation plans for the upcoming allocation, distribution, and administration of a new COVID-19 pandemic vaccine, we write to emphasize that the success of that plan will be judged by how well it ensures equitable access for all. While continued efforts on testing and contact tracing are essential, we believe that deployment of a safe and effective COVID-19 vaccine is key to fully re-opening the American economy and to ensuring safe workplaces, schools, and communities. We expect this vaccination program will be the greatest public health effort of our generation and we greatly appreciate your leadership now to prepare the nation for this response.  

The Adult Vaccine Access Coalition (AVAC) works to address rural, socio-economic, and racial disparities, and to increase immunization access among at-risk populations, persons with chronic illness, and maternal populations. It is with this in mind that members of AVAC join with stakeholder partners and allies to share several principles and policy recommendations to facilitate the equitable allocation, distribution, access, and utilization of a COVID-19 vaccine.  

We strongly encourage transparency at every point of the planning, approval, allocation, and distribution process, as we believe it is the key to ensuring vaccine confidence and utilization, especially for high risk groups. AVAC appreciates that federal, state, and local governments have been laying the groundwork for months to distribute and administer a safe and effective COVID-19 vaccine. These plans rely on the strength of existing public health preparedness and response efforts and the immunization program infrastructure in the United States. Therefore, investments in communication efforts and immunization infrastructure must be increased. 

To ensure equitable allocation, distribution, access, and utilization of forthcoming COVID-19 vaccines, we recommend the following actions be taken:  

  1. Provide full transparency at every stage of the process to foster public confidence and maximize vaccine acceptance and use, especially among communities that have been the hardest hit by, and are most susceptible to severe illness as a result of, COVID-19.  
  1. Ensure information, resources, and vaccines reach and are utilized by at-risk and underrepresented populations.  
  1. Support essential immunization infrastructure and the community-based immunization providers. 

Providing full transparency in order to foster public confidence and maximize vaccine use, especially among communities that have been the hardest hit by, and are most susceptible to, COVID-19.   

Much work is being done now to develop and get COVID-19 vaccine candidates to market. We share the sense of urgency the pandemic presents and believe an Emergency Use Authorization (EUA) sought by innovators can be in the public’s interest. However, introduction of new COVID-19 vaccines under an EUA or full licensure must be supported by evidence. Expert scientists from the FDA should take a prominent role in communicating that the FDA gold standards for safety and effectiveness have been met. Clear and consistent communication of evidence-based information on COVID-19 vaccine authorizations and approvals will be vital to public acceptance and willingness to receive a vaccine, particularly during the early phases of a pandemic vaccination effort.    

We specifically appreciate FDA’s October issuance of Guidance for Industry on Emergency Use Authorization for Vaccine to Prevent COVID-19. The guidance, recognizing the potential for rapid and widespread administration of a vaccine authorized under an EUA to millions of individuals, calls for two months of monitoring safety data before submission for approval to the FDA.1 Importantly, the guidance also reaffirms the commitment from FDA Commissioner Hahn at the September 23 Senate Health, Education, Labor and Pensions (HELP) Committee hearing to hold not only a general meeting of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), but to also convene additional VRBPAC open session meetings to review safety and effectiveness data for each vaccine candidate seeking an EUA.2 We believe the transparency that will be facilitated by VRBPAC open sessions is extremely beneficial for building confidence in vaccines authorized under an EUA. 

Once a vaccine is authorized or approved by FDA, it will be essential for the Advisory Committee on Immunization Practices (ACIP) to quickly meet and make strong and clear recommendations for the providers who will administer COVID-19 vaccines. These recommendations should include recommendation on a vaccine dosing schedule, including which populations should receive the vaccine first, and during what phase of the vaccine distribution process other populations should begin to receive the vaccine. Conflicting messages and intentional misinformation efforts around the COVID-19 vaccine can be combated by elevating the longstanding role of the ACIP as the vaccine policy recommending body for the US and by clearly communicating its transparent and rigorous thorough vetting process with the public.   

We appreciate that guidance and numerous planning documents are underway to inform prioritization of populations to receive vaccine in the short and long term, especially the National Academies of Science and Engineering Medicine’s, “A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus.” The ACIP should take these recommendations into account, while continuing to review the research data, and make recommendations on who should receive specific COVID-19 vaccines. We support the work ACIP has done to date, including putting forth three criteria for the prioritization process: that it be ethically principled; evidence based; and transparent. We recommend further consideration on how the ethics and equity framework can be better incorporated into the ACIP evidence-to-recommendation process, along with clear definitions of who is included, so these recommendations can be implemented consistently and without controversy.  

Additionally, all COVID-19 vaccines, regardless of whether authorized through an EUA or licensed through a BLA, should be continuously monitored for safety and efficacy through existing vaccine safety and reporting systems, including the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), Clinical Immunization Safety Assessment Project (CISA), and the Post-Licensure Rapid Immunization Safety Monitoring. Robust monitoring of COVID-19 vaccines post approval and communication of potential adverse events will be imperative to sustaining confidence and public trust during all phases of the pandemic vaccination effort.   

Ensuring vaccines reach vulnerable and underrepresented populations.  

We know that health inequity limits access to health care resources needed in many communities, including in Black, Hispanic or Latinx, American Indian, Alaska Native, Asian American and Native Hawaiian and Pacific Islander populations. This has long held true for vaccination rates, especially for those living in rural areas, below the poverty line, and in communities of color. These are the same populations that have experienced greater loss during the COVID-19 pandemic, including greater risk of COVID-19 infection and death. While vaccination planning to date addresses allocation, distribution, and administration, broad public confidence in a safe and effective vaccine is also a critical factor to combatting harmful health disparities. The Federal Government, working with immunization partners and trusted community leaders and organizations, must be proactive, clear, consistent, and highly visible in their communications to keep the public informed of vaccine development, safety processes, and approval and recommendation criteria.   

Special consideration must be given to the protection of people who are most vulnerable from COVID-19.  It is vital that those most at risk for complications and death are able and willing to receive the vaccine no matter their insurance status, immigration status, language ability, cultural awareness, chronic health conditions, ability to access care during regular business hours, transportation issues, and more.  

Accordingly, we hope you will consider the following recommendations:  

  • Information about the new vaccine, the principles and process for allocation, phases of distribution, and priority populations must reach public health officials so they can plan accordingly to respond to the specific needs of their community. Guidance must be clear, understandable, and open for review, while also providing consistency between federal strategies and mass vaccination campaigns.  
  • A strategy to simultaneously educate and inform healthcare professionals (HCPs) to ensure they have confidence in receiving the vaccine and are able to make a strong recommendation to patients. In addition to the ability to leverage direct lines of communication to their patients, HCPs are trusted sources of information on how beneficiaries can safely receive preventative care during the COVID-19 pandemic. Training plans should be made available to all types of immunization providers throughout the country. Vaccine outreach and communication to HCPs should also encourage providers to raise awareness among patients regarding the need to receive all ACIP-recommended vaccinations and the alternative vaccination locations that may be available to them. Our country and public health infrastructure cannot afford to follow a pandemic with an increase in cases or large outbreaks of other vaccine preventable diseases.  
  • Trusted community leaders and partners should also receive proactive, clear, and consistent updates with regard to planning, allocation, and distribution efforts. Their support is critical for ensuring that information reaches the communities that have been hardest hit by COVID-19, including essential workers who are disproportionally from communities of color3, and keeping the public informed of vaccine development, safety processes, and approval and recommendation criteria.   
  • The communications plan should be localized and flexible in its ability to reach different racial and ethnic communities and communities who have limited English proficiency, in order to build trust and acceptance. Vaccination campaigns must be able to extend to areas where people are least likely to be reached by traditional health care infrastructure and where there are known pockets of vaccine hesitancy. Community level grants should be made available to help support this work. Targeted resources will enable local leaders to test and tailor proactive messageswhile countering anti-vaccination sentiments. We know that the best messengers to communities experiencing health disparities are the organizations and partners they already trust.   

Supporting essential immunization infrastructure and modernizing immunization information systems (IIS) to ensure equitable distribution of a vaccine to all Americans.   

Adequate resources for distribution, tracking, and monitoring will be needed to successfully implement plans to vaccinate all Americans, especially those communities at greatest risk of COVID-19 complications and death. Infrastructure investments must go towards strengthening, enhancing, and expanding the ability of public health officials, primary care physicians, nurses, pharmacists, and other health care providers practicing at the top of their license in the community to meet demand for a future COVID-19 vaccine and also reach populations who are currently under-vaccinated. This important work will require the full strength of partnerships within the immunization neighborhood working together. We believe at least $8.4 billion in funding should be directed to support this effort.  

  • Funding for immunization infrastructure should include specific resources for recruiting and training the necessary additional workforce for state, local, Tribal, and territorial health departments; primary care settings; and pharmacies—with special focus on reaching communities of color and other vulnerable populations.   
  • Additional resources will be necessary to set-up federally supported supplemental vaccination sites in high risk communities and promote new strategies for mass vaccination, such as drive-thru clinics and clinics in nontraditional locations that are easy to access and are safe for vaccinators and the public.  
  • Immunization Information Systems (IIS), which can provide timely and accurate vaccination data, should be used to support any mass immunization efforts around COVID-19. IIS must be enhanced to meet new and changing data standards and access to IIS must be expanded to more providers and settings across the health care system. The interim playbook4 recommends that, within 24 hours of administering a dose of COVID-19 vaccine and adjuvant (if applicable), the information should be recorded in the vaccine recipient’s record and should be reported to the relevant state, local, or territorial public health authority. However, some IIS face challenges and policy barriers that limit their ability to maximize their use. To be optimally effective, IIS should encompass all vaccinations received during each person’s lifetime, contain a person’s consolidated immunization history, and fully meet the standards recommended by the CDC and American Immunization Registry Association (AIRA) to support clinicians in efforts such as administering a second dose of the appropriate vaccine product to a patient who has received an initial dose. There must also be coordination, interoperability, and bidirectional communication between the IIS and any new technologies such as the Vaccine Administration Management System (VAMS). 
  • There must be adequate Medicaid and Medicare reimbursement to cover the cost of vaccine administration counseling, and eventually the cost of the vaccine.  Inadequate reimbursement discourages authorized healthcare providers, such as physicians, nurses, pharmacists and others, from proactively offering immunizations, and results in missed immunization opportunities and declines in immunization rates. Adequate reimbursement will be essential for any vaccine approved under the regular approval process, or authorized under Emergency Use Authorization (EUA).    
  • Providers should be appropriately compensated for ancillary supplies. Public health officials, primary care physicians, nurses, pharmacists, and other health care providers in the community will need to manage the volume of procurement, storage, and distribution of ancillary supplies that will be required for a successful pandemic vaccination effort, such as personal protective equipment (PPE), syringes, and alcohol wipes.  
  • Providers should be compensated for virtual or in-person conversations about the importance and safety of vaccines. These will help build confidence in not only a future COVID-19 vaccine but all recommended vaccines. During the initial role out, grants should be made available to urban and rural providers, including FQHCs and rural community health centers, that may need additional financial assistance in order to successfully run COVID-19 vaccine clinics.   
  • Financial barriers to all ACIP recommended vaccines must be eliminated for individuals covered by Medicaid and Medicare to improve the underlying health of the communities most at risk for COVID-19.   

Now is the time to redouble our efforts to eliminate the underlying vaccination disparities that have been prevalent in our health care system for too long. Again, thank you for the opportunity to share our perspective on principles, priorities, and recommendations to ensure equitable allocation, distribution, and access to the COVID-19 vaccine. Our organizations are available to answer your questions at your earliest convenience. Please reach out to AVAC Managers Abby Bownas, (abownas@nvgllc.com) or Lisa Foster (lfoster@nvgllc.com).  

Sincerely, 

Aging Life Care Association 

Alliance for Aging Research  

American Academy of Family Physicians 

American Geriatrics Society 

American Heart Association 

American Immunization Registry Association 

American Lung Association 

American Public Health Association  

American Society on Aging 

American Society of Consultant Pharmacists 

American Society for Microbiology  

Asian & Pacific Islander American Health Forum 

Association of Asian Pacific Community Health Organizations (AAPCHO)  

Association of Black Cardiologists 

Association of Immunization Managers (AIM) 

Association of Maternal & Child Health Programs  

Association for Professionals in Infection Control and Epidemiology 

Association of State and Territorial Health Officials 

Arthritis Foundation 

BIO 

California Primary Care Association 

Caregiver Action Network  

Dynavax 

Emily Stillman Foundation   

Families Fighting Flu  

GSK 

HealthyWomen  

Heart Valve Voice US  

Hep B United   

Hepatitis B Foundation  

Immunization Action Coalition  

Immunize Nevada  

Indivisible Northern Nevada  

Infectious Diseases Society of America   

Johnson & Johnson  

Justice in Aging 

March of Dimes  

Medicago  

National Adult Day Services Association (NADSA)  

National Association of County and City Health Officials 

National Association of Nutrition and Aging Services Programs  

National Association of Pediatric Nurse Practitioners 

NASTAD 

National Black Nurses Association 

National Consumers league 

National Council on Aging 

National Foundation for Infectious Diseases 

National Indian Council on Aging 

National Minority Quality Forum  

National Urban League 

National Viral Hepatitis Roundtable  

Nevada Academy of Family Physicians  

Nevada Public Health Association  

OCHIN 

Planned Parenthood Federation of America   

Sanofi 

Seqirus  

Service Employees International Union  

STChealth LLC  

The AIDS Institute   

The Gerontological Society of America 

The Kimberly Coffey Foundation  

The Mended Hearts  

The National Black Nurses Association 

The National Consumer Voice for Quality Long-Term Care 

The Preventive Cardiovascular Nurses Association 

Trust For America’s Health  

U.S. Pharmacopeia 

Vaccinate Your Family 

Vivent Health 

WomenHeart: The National Coalition for Women with Heart Disease 

 

AVAC Comments on CMS Physician Fee Schedule

AVAC members offered comments 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. AVAC supports the proposed increase in practice expense relative value units for Vaccine Administration; the inclusion of recommended immunizations in the written screening schedule developed for beneficiaries through the Annual Wellness Visit (AWV); the establishment of a new alternative reporting measure: Health Information Exchange (HIE) Bi-Directional Exchange; and maintaining adult immunization quality measures throughout specialty measure sets.

October 5, 2020

Centers for Medicare & Medicaid Services

Department of Health and Human Services

Attention: CMS-1734-P

P.O. Box 8016

Baltimore, MD 21244-8016

RE: CMS-1734-P Medicare Program: CY 2021 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 proposed increase in practice expense relative value units for Vaccine Administration and urges the Centers for Medicare and Medicaid Services (CMS) to implement the increase prior to the January 1, 2021 effective date for the PFS rule.
  • Supports the inclusion of recommended immunizations in the written screening schedule developed for beneficiaries through the Annual Wellness Visit (AWV) as well as information about vaccines designed for older adults.
  • Supports the engagement in bi-directional exchange on immunization data through Health Information Exchange (HIE) through the establishment of a new alternative reporting measure: Health Information Exchange (HIE) Bi-Directional Exchange.
  • Support maintaining adult immunization quality measures throughout specialty measure sets (Appendix 1, Table B)

AVAC consists of sixty 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 lags behind federal 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.

Proposed Increase in Vaccine Administration Rates

AVAC is grateful for CMS’ ongoing work to restore vaccine administration rates. As you may recall from our comments to the 2020 proposed rule, we raised concern about the proposed 15% reduction in the reimbursement rate for CPT codes for vaccine administration (90471-90474). If the proposed reductions had taken effect, they would have resulted in a cumulative 44 percent reduction in reimbursement over a three-year period.

Thankfully, the Administration acted to stop the proposed reduction in the final rule, stating, “We recognize that it is in the public interest to ensure appropriate payments to physicians and other practitioners for provision of the immunization administration services that are used to deliver vaccines and plan to review the valuations for these services to ensure appropriate payment.”

CMS has demonstrated its’ commitment to ensuring that providers receive adequate reimbursement for the costs associated with vaccine administration. Specifically, the 2021 proposed rule seeks to crosswalk the valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein).

We appreciate that CMS has agreed to move forward with a proposal that would decouple the practice expense RVU for vaccine administration from therapeutic injection (96372), which caused the decline in rates over the past several years. We share CMS’ view that that the crosswalk with CPT code 36000 “is the most accurate valuation of these services and will also serve to ensure the appropriate relative resources involved in furnishing all of these services is reflected in the payment for these critical immunization and vaccination services in the context of the health needs of Medicare beneficiaries.”

AVAC shares the agency’s desire to promote beneficiary access to vaccines in the context of the COVID-19 Public Health Emergency, and greatly appreciates that action is being taken to address stakeholder concerns regarding past reductions in payment rates for vaccine administration services.

As you know, there has been a significant reduction in routine immunizations across the life course due to COVID. While practices are starting to rebound in terms of patient visits, they have not been fully rebounding in terms immunization delivery.

CMS recognizes that adequate reimbursement for providers is critical now as we enter the 2020-21 influenza season and will be even much more so when vaccines for COVID-19 become available in the coming months. Restoring vaccine administration rates is vital to effective and sustainable vaccine delivery and Medicare providers are an integral part of that effort. In that vein, we would urge CMS to use its available authority to make this proposed change in vaccine administration valuation effective prior to January 1, 2021. Timely and appropriate payment for immunization administration that reflects resource cost is critical in maintaining high immunization rates in the United States, as well as having the capacity to respond quickly to vaccinate against preventable disease outbreaks which could create an unnecessary burden on the healthcare systems straining under the COVID-19 epidemic. It is imperative that providers are adequately compensated for efforts being undertaken now to implement vaccination strategies to immunize patients safely so we can avoid further declines in the immunization opportunities for patients most vulnerable to vaccine preventable illness.

Looking ahead, we urge CMS to consider innovative approaches to provide the financial support necessary to address the varied infrastructure needs that future COVID vaccines might require. While vaccine administration costs tend to be fairly consistent, specialized transportation, storage and handling for different COVID-19 vaccines could be complex and costly to providers depending on their location among other factors. AVAC encourages CMS to explore how variable infrastructure costs might be addressed separately from vaccine administration fees as new COVID-19 vaccine become available.

Annual Wellness Visit (AWV) written screening schedule beneficiaries (p. 412)

As the 2021 rule points out, the Annual Wellness Visit (AWV) is a wellness visit that focuses on identification of certain risk factors, personalized health advice, and referral for additional preventive services and lifestyle interventions. In terms of immunization, providers need to have up to date information about routinely assessing the vaccine needs of their patients, strongly recommending needed vaccines, and either vaccinating or referring patients to others who administer vaccinations. Educating adults and their caregivers on their immunization need, particularly those vaccines designed for older adults, have an impact beyond this population – helping to protect children and increasing access to people over the age of 65 or Medicare beneficiaries. The AWV is an important opportunity for providers to educate and encourage patients to receive recommended vaccines and make a patient-centered plan for doing so. AVAC appreciates that the proposed rule includes coding and regulatory additions that will strengthen provider engagement with patients through the AWV and encourages CMS to maintain those additions in the final rule.

MIPS Alternative Measure: Health Information Exchange (HIE) Bi-Directional Exchange (p. 678)

AVAC supports the engagement in bi-directional exchange on immunization data through Health Information Exchange (HIE) and appreciates that the 2021 proposed rule proposes the establishment of a new alternative reporting measure: Health Information Exchange (HIE) Bi-Directional Exchange. The proposed rule points out that there are several benefits to this bidirectional exchange of data. Specifically, the proposed rule notes, “Healthcare quality and public health outcomes have been shown in multiple studies to experience a beneficial effect from health information exchanges with improved medication reconciliation, improved immunization and health record completeness, and improved population level immunization rates. Another study has shown that if every clinician who submits claims under Medicare Part B were connected to an HIE, Medicare would have saved $63 million annually for each therapeutic procedure performed at a physician’s office due to the reduction in duplicate procedures, while other research has shown a decrease in emergency department utilization and improved care process when using an HIE research has shown a decrease in emergency department utilization and improved care process when using an HIE.”

Providers are being called upon to assess and counsel adult patients on recommended immunizations based on their age and health status with the goal of administering needed vaccines or referring patients to other immunization providers. Having access to a patient’s immunization record through bidirectional data exchange is a vital element in clinical decision support and having the ability to report and record data to public health authorities is important for population health as well as surveillance efforts to identify gaps in immunization coverage. Bidirectional exchange of immunization data is vitally important and we hope that the addition of this new measure will help further strengthen and enhance these efforts. AVAC urges CMS to include this new alternative measure in the final rule.

CY2020 MIPS Specialty Measure Sets (Appendix 1, Table B)

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 appreciates that MIPS specialty sets include immunization measures in the 2021 proposed rule and urges CMS to maintain those measures in the final rule.

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.1

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 for Professionals in Infection Control and Epidemiology

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

Janssen Pharmaceuticals

Medicago

Merck

National Association of County and City Health Officials

National Black Nurses Association

National Consumers League

National Foundation for Infectious Diseases

National Hispanic Medical Association

Novavax

Pfizer

Sanofi

Seqirus

STChealth

The Gerontological Society of America

Trust for America’s Health

Vaccinate Your Family

Vaxcare

Sources
https://www.aafp.org/dam/AAFP/documents/patient_care/nrn/loskutova-missed-opportunities.pdf

AVAC Comments on the CY 2021 Home Health Proposed Rule

AVAC submitted comments to CMS on the CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements proposed rule. AVAC appreciated that the proposed rule maintains Influenza Immunization Received for the Current Flu Season among the 20 measures currently adopted for the 2022 Home Health Quality Reporting Program (HHQRP).

August 24, 2020

Centers for Medicare & Medicaid Services

Department of Health and Human Services

Attention: CMS-1730-PP.O. Box 8013,

Baltimore, MD 21244-8013

RE: CMS-1730-P Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements proposed rule.

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. 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.

Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended health care interventions, including adult vaccines. Vaccines play a vital role in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. 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 across the lifecourse, especially given the current COVID-19 pandemic and upcoming flu season this fall. Unfortunately, access to vaccines is not equal across a person’s lifespan.

Despite the well-known benefits of immunizations, adults routinely die from vaccine-preventable diseases and adult coverage has lagged behind federal targets for most commonly recommended vaccines for a number of years: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV. Now more than ever before, Home Health Agencies (HHAs) are essential community providers for older adults and disabled patients and have an increasingly important role to play in improving vaccine access and utilization. Home health visits provide a unique opportunity to assess the patient in their home environment and employ a multidisciplinary approach to patient care. Incorporating vaccine assessment and administration during a home health episode optimizes patient care by removing a significant barrier to access, transportation for homebound patients. Studies have shown that multidisciplinary healthcare providers can have a significant impact on vaccine administration rates in a home setting1. 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.2

Our coalition firmly believes that adult immunization quality measurement is central to ensuring continued focus on this high value prevention intervention. Even circumstances where HHA patients are offered a recommended vaccine but decline or patients who are ineligible to receive a vaccine due to contraindications present important learning opportunities.

Quality Measures Currently Adopted for the CY 2022 HH QRP

 We appreciate that the proposed rule maintains Influenza Immunization Received for the Current Flu Season among the 20 measures currently adopted for the 2022 Home Health Quality Reporting Program (HHQRP). This measure will be especially important for the upcoming flu season as well as next year’s flu season to emphasize that beneficiary immunization status with respect to influenza remains a core prevention priority for CMS.

In ordinary times, influenza represents a serious risk to the health and overall wellbeing of older adults, particularly among those beneficiaries with disabilities and chronic conditions. A 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. Each year, influenza causes approximately 200,000 hospitalizations and an average of 36,000 deaths in the United States alone. Achieving the highest possible influenza vaccination rate for the 2020-21 and 2021-22 flu seasons is going to be extremely important as scarce health care resources need to be preserved for the fight against COVID-19.

Influenza immunization measures help increase access and utilization of this important vaccine by patients and health care providers alike and AVAC urges CMS to maintain the influenza measure in the final rule.

Immunizations beyond influenza also provide especially high value among patients with chronic conditions, such as diabetes or chronic heart disease, who are at higher risk of adverse health consequences resulting from vaccine-preventable diseases.3 The Centers for Disease Control and Prevention (CDC) estimates 900,000 Americans get pneumococcal pneumonia each year, resulting in as many as 400,000 hospitalizations and more than 53,000 deaths. Among adults age 65 and older, the annual cost of pneumococcal disease is over $3 billion dollars. 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.

In the future, AVAC believes the HH QRP should include a focused, concerted effort to improve access and utilization of all Advisory Committee on Immunization Practices (ACIP) recommended adult immunizations as a means of improving the overall health of Medicare beneficiaries receiving home health services.

We look forward to working with CMS to ensure meaningful measures that reflect priority health care services, such as immunization, that also provide an accurate representation of HHA performance in the least burdensome manner possible can be included in the home health value-based and quality reporting programs in future comment cycles. The National Committee on Quality Assurance (NCQA) has spearheaded the testing of a new composite measure for adult immunization, along with measures for maternal immunization and end-stage renal disease patients. The adult immunization composite measure incorporates multiple ACIP-recommended vaccines and we look forward to working with CMS to support the widespread adoption of the measure. An adult composite measure would provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the ACIP. AVAC strongly supports 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.

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)

Every Child by Two

Families Fighting Flu

Gerontological Society of America

GSK

Immunization Action Coalition

Medicago

National Association of Nutrition and Aging Services Programs (NANASP)

National Foundation for Infectious Diseases (NFID)

National Hispanic Medical Association (NHMA)

National Viral Hepatitis Roundtable

Novavax

Sanofi

Seqirus

STChealth

 

Sources:

  1. https://www.jscimedcentral.com/FamilyMedicine/familymedicine-3-1074.pdf
  2. http://www.publichealthreports.org/issueopen.cfm?articleID=3145
  3. http://www.cdc.gov/Mmwr/preview/mmwrhtml/mm6404a6.htm

AVAC Sends CMS Recommendations Around Improving Adult Immunization

AVAC wrote a letter offering recommendations for CMS that will help to strengthen, enhance, and expand access and utilization of essential immunization services during and beyond the COVID-19 pandemic.

Memo

To:  Seema Verma, Administrator for the Center for Medicare at the Centers for Medicare and Medicaid Services

From: Adult Vaccine Access Coalition (Abby Bownas / Lisa Foster, AVAC Managers)

CC: Brady Brookes; Demetrios Kouzoukas; Kimberly Brandt; and Jeffrey Kelman

Date: 7/29/2020

Re: Recommendations to CMS around improving Adult Immunizations

Incentivize beneficiary uptake of recommended routine immunizations through first dollar coverage of vaccines under Medicare Part D and Medicaid;On behalf of members of the Adult Vaccine Access Coalition (AVAC), we write to offer several recommendations for the Centers for Medicare and Medicaid Services (CMS) that will help to strengthen, enhance, and expand access and utilization of essential immunization services during and beyond the COVID-19 pandemic, including:

  • Alleviate provider burdens to offering immunizations through enhanced and timely reimbursement for vaccine administration;
  • Expand opportunities and give health care providers greater flexibility to provide necessary counseling and education to patients and caregivers;
  • Develop an immunization communication & outreach

About AVAC

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. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Incentivize beneficiary uptake of recommended routine immunizations through first dollar coverage of vaccines under Medicare Part D and Medicaid. 

Eliminate Cost Sharing Under Part D

Immunization coverage for Medicare beneficiaries is segmented between Medicare Part  B,  which covers vaccinations against influenza, pneumococcal  and  hepatitis  B  for  at-risk  patients  and Medicare Part D, which covers all other commercially available vaccines when deemed medically necessary to prevent illness. While beneficiaries receive Part B-covered vaccines with no cost sharing, they often encounter copays or cost sharing requirements for Part D vaccines. Studies have shown that the cost sharing requirements on Part D vaccines discourage immunization uptake among older people, people with disabilities, and chronically ill populations.1

We encourage CMS to work with Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost sharing. Now is the time to empower Medicare beneficiaries with the tools they need to stay healthy during the pandemic and beyond. Immunizations are one of the most effective and efficient forms of prevention that we know save lives and billions in avoidable health care costs.

Provide Uniform Access in Medicaid

We also encourage CMS to issue guidance to states to provide uniform access to vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for all Medicaid populations with no cost sharing. Low-income and minority Medicaid and Medicaid Managed Care beneficiaries have unequal access to vaccines compared to those with commercial insurance coverage. Medicaid enrollees also experience higher rates of chronic conditions, such as heart and lung diseases, and diabetes, which increase their risk of serious and adverse health consequences from vaccine preventable illness.

Alleviate provider burdens to offering immunizations through enhanced and timely reimbursement for vaccine administration

Increasing Reimbursement for G Codes

Ensuring that clinicians are properly reimbursed is another key to fostering a sustained environment for high-value immunizations. Inadequate reimbursement for vaccination administration discourages providers from proactively offering immunizations, and results in missed immunization opportunities and declines in immunization rates.2 Administering routine or pandemic vaccines comes with a number of important responsibilities for providers, including staff training, ordering and tracking vaccine inventory and ancillary supplies for vaccine administration, proper handling, storage and reporting for each vaccine administered, as well as counseling and educating patients and caregivers. A new vaccine for COVID-19 will require all of these activities on a potentially unprecedented scale all while having to implement new safety measures while vaccinating.

In order to incentivize primary care practices to start immunizing again, CMS should increase reimbursement for G codes (including G0008, G0009, G0010) for the 2020 flu vaccine season. Due to COVID-19, there has been a drop in routine immunizations across the life course.3 While practices are starting to rebound in terms of patient visits, they are not rebounding in immunization delivery. There is a concern for the upcoming influenza season that if people served by Medicare continue using the telehealth services and mail order pharmacy that were expanded to protect them from COVID-19, there will be decreases in the immunization opportunities for patients most vulnerable to vaccine preventable illness.

With the flu vaccine season starting in about 2 months, better payment incentives can be a noteworthy solution in order to drive provider behavior and thereby reduce the risk of patients missing flu vaccine in a year when it may never be more important. Likewise, pneumococcal numbers are down significantly, leaving people over the age of 65 at risk for secondary bacterial pneumonia with flu or a COVID primary infection. Reimbursement for G codes have been reduced over several years and the unintended consequences are now visible. Restoring payment for G codes to 2017 levels may drive better vaccine delivery and reduce the burden of vaccine preventable diseases across the population.

DeCouple Practice Expenses for Vaccine Administration from Therapeutic Injection

AVAC is grateful that the Administration acted to stop a proposed 15 percent reduction in payment for CPT codes for vaccine administration (90471-90474) in the CY2020 physician fee schedule (PFS) rule, which stated, “We recognize that it is in the public interest to ensure appropriate payments to physicians and other practitioners for provision of the immunization administration services that are used to deliver vaccines and plan to review the valuations for these services to ensure appropriate payment.” We appreciated the intervention of the HAPG when AVAC brought to their attention that some MACs had in fact implemented the reduction in vaccine administration codes from the proposed rule. We urge CMS to ensure that all MACs are consistently applying the higher reimbursement rate for 2020 in accordance with the final rule and to retrospectively reimburse providers who may have received a lower rate as a result of this error.

Looking to the CY2021 proposed PFS rule, we strongly urge CMS to decouple the practice expense   RVU for vaccine administration from therapeutic injection (96372) and instead utilize the RUC- recommended direct PE inputs. These direct PE inputs were reviewed in October 2009 for practice expense RVUs for CPT immunization administration codes 90471, 90473, and 90460 and would provide relief from automatic reductions in vaccine administration practice expense RVUs at a time when the costs associated with maintaining a vaccine program are rising.

Require Medicaid managed care plans to offer formulary adoption for all U.S. influenza vaccines.

With the overwhelming number of influenza doses purchased by providers and the Centers for Disease Control and Prevention (CDC), it is critical that providers are able to bill and receive reimbursement for the vaccine product as well as the administration fee for Medicaid eligible patients. We urge CMS to direct State Medicaid fee-for-service and Medicaid managed care plans to adopt all CPT codes for influenza vaccines on all plan formularies to assure reimbursement for the product and the administration service. This guidance should include the following influenza CPT codes: (ccIIV4) 90674 and 90756; (RIV4) 90682; (LAIV4) 90672; (IIV4) 90685 – 90688.

Expand opportunities and give health care providers greater flexibility to provide necessary counseling and education to patients and caregivers;

E/M Coding for Telehealth that Considers Immunization Assessments

We appreciate CMS recent ruling on E/M coding that will enable primary care providers to conduct patient immunization status assessments and counseling, particularly for complex patients with    chronic conditions. We encourage CMS to consider allowing the use and billing for telehealth services to do E/M for vaccines remotely.

Enhanced Reimbursement for Immunization During the Public Health Emergency

We urge CMS to announce an enhanced fee for vaccine administration to ensure providers are able to offer immunization services to Medicare beneficiaries in environments that are safe for all. Provider offices are expanding outreach efforts to counsel on the need for influenza vaccine during the pandemic and the practices that the providers are instituting to make patients feel the office is a  safe place to seek immunization. These efforts are critical to maintain the immunization rates achieved in previous years. Additionally, providers are working to include innovative options such as drive-by or drive-through vaccinations or offering vaccinations in a patient’s home. We also encourage CMS to extend this enhanced fee to immunizers who roster bill for vaccines. In-office and alternative immunization approaches will come with added costs, such as increased staff costs for patient scheduling and communication, reconfiguration of practice sites to accommodate immunization-only hours and immunization-only areas, increased reliance of mobile technology to record vaccine information in the patient medical record and with the public health immunization program, and additional equipment will be necessary for proper storage and handling of vaccine supply being administered in home or community-based settings.

Provide an enhanced Medicaid FMAP for vaccine counseling and administration.

Providing an enhanced payment for providers who care for underserved populations will also enable them to improve and expand immunization programs within their practices through the adoption of interoperable and bidirectional immunization reporting capabilities. These additional resources will be essential to ensure that providers are able to effectively offer this lifesaving preventive service through this critical safety net program. We further recommend that CMS issue guidance to state Medicaid plans targeted at eliminating racial, socio economic and geographic disparities around vaccination.

Develop an immunization communication & outreach strategy.

Beneficiary Outreach

Due in large part to the magnitude of this effort, CMS should engage in a timely, comprehensive, and equitable vaccination campaign. Such a campaign should be broad based and focused on reminding patients of the importance of asking providers about all recommended vaccines for Medicare, including Part B vaccines (influenza, pneumonia, and Hepatitis), as well as Part D vaccines (tetanus, diphtheria, pertussis, zoster (shingles)). Activities could include:

  • Updates to various agency websites, including gov, Centers for Disease Control and Prevention flu and pneumococcal vaccine-specific websites, the Social Security Administration, Medicare Administrative Contractors (MACs);
  • Social Media Campaign for beneficiaries and loved ones;
  • Email messages from CMS or the Social Security Administration directly to Medicare beneficiaries;
  • Special notices about these new programs and their importance via US Mail;
  • Special notices available at places frequented by Medicare beneficiaries even during the COVID-19 pandemic, such as grocery stores and pharmacies;
  • Colorful informational inserts in Medicare Summary Notices that Medicare beneficiaries routinely receive from CMS; and
  • Public Service Announcements, including television commercials by personalities widely recognized by senior

Provider Outreach

A strategy should also engage healthcare professionals (HCPs) urging that providers make a strong recommendation to vaccinate for all ACIP recommended immunizations. In addition to the ability to leverage direct lines of communication to their patients, HCPs are viewed as trusted sources regarding how beneficiaries may safely receive preventative care during the COVID-19 national outbreak. Outreach to HCPs should encourage providers to raise the awareness of their patients regarding the need to receive all ACIP recommended vaccinations and the alternative vaccination options that may be available to them. Providing these communications through HCPs will give older adults and their caregivers the confidence to receive their recommended vaccinations and feel safe in receiving vaccinations in their chosen location this year and moving forward. Such engagement might include:

  • MLN Matters notifications encouraging providers to forward specific communications regarding available alternative vaccination options to their patients; and
  • Introduction by CMS of a Merit-based Incentive Payment System (“MIPS”) practice improvement measure based on enhanced provider communication to patients regarding the special need for vaccine awareness, including available alternative vaccination

As part of all of CMS educational efforts, the Center should proactively work to address disparities in vaccine coverage and help build confidence in and demand for immunization services. This should include the development of culturally-appropriate immunization materials for Medicaid providers.

Again, thank you for the opportunity to share our perspective with respect to issues that are having an acute impact on Medicare and Medicaid Immunization issues. Now more than ever before we must effectively utilize the proven health care interventions of immunizations to help older adults and individuals with chronic conditions to remain healthy. Members of our coalition would be interested in setting up time to further discuss our recommendations with you at your earliest convenience. Abby Bownas, AVAC Manager, will follow up with your staff to schedule a discussion.

Sources:

  1. http://go.avalere.com/acton/attachment/12909/f-0297/1/-/-/-/-/20160217_Medicare%20Vaccines%20Coverage%20Paper.pdf; http://www.jmcp.org/doi/10.18553/jmcp.2015.21.s4.1; http://www.jmcp.org/doi/pdf/10.18553/jmcp.2016.22.4.S1
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594851/
  3. https://www.cdc.gov/mmwr/volumes/69/wr/mm6919e2.htm?s_cid=mm6919e2_w

AVAC Makes Recommendations to 2021 Physician Fee Schedule

AVAC wrote to CMS to offer several recommendations in advance of the Centers for Medicare and Medicaid Services (CMS) 2021 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.

May 19, 2020

Demetrios Kouzoukas

Principal Deputy Administrator for Medicare and Director Centers for Medicare & Medicaid Services

7500 Security Boulevard

Baltimore, MD 21244

RE: Adult Vaccine Access Coalition (AVAC) Recommendations for the FY2021  Proposed Rule 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.

Dear Principal Deputy Administrator for Medicare and Director Kouzoukas:

On behalf of members of the Adult Vaccine Access Coalition (AVAC), we write to  offer several recommendations in advance of the Centers for Medicare and Medicaid Services (CMS) 2021 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.

AVAC recommendations:

  • CMS should immediately issue guidance to Medicare Administrative Contractors (MACs) to clarify that CY20 payment amounts for HCPCS immunization administration codes G0008-G0010 should be equal to, and not lower than, the applicable CY 2019 payment amounts, consistent with the policy you established in the final CY 2020 Physician Fee Schedule regulation.
  • CMS should use the upcoming rulemaking cycle to propose adoption of the RUC-recommended practice expense RVUs for CPT immunization administration codes 90471, 90473, and 90460.
  • CMS should reaffirm E/M coding that enables primary care providers to conduct patient immunization status assessments and counseling, particularly for complex patients with chronic conditions.
  • During this COVID-19 emergency and the upcoming flu season, CMS should announce an enhanced fee for vaccine administration to ensure providers are able to serve Medicare beneficiaries safely.

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.

Immunizations are an important public health imperative and ensuring that clinicians are properly reimbursed is key to fostering a sustained environment for this high-value preventive service. Vaccine administration by health care providers at the point of care is an opportunity that needs to encouraged. Studies show that inadequate reimbursement for vaccination administration results in missed immunization opportunities and declines in immunization rates.

AVAC is grateful that the Administration acted to stop  a  proposed  15  percent reduction in payment for CPT codes for vaccine administration (90471-90474) in the CY2020 physician fee schedule (PFS) rule, which stated, “We recognize that it is in the public interest to ensure appropriate payments to physicians and other  practitioners for provision of the immunization administration services that are used to deliver vaccines and plan to review the valuations for these services to ensure appropriate payment.”

However, it has come to our attention that some MACs have implemented the 15 percent reduction in the vaccine administration rate for CY20 while others have maintained the CY19 rate in accordance with the final rule. We are concerned that vaccine administration rates remain at risk of further erosion at a time when we need all clinicians to be practicing at the top of their licensure with respect to immunizing. AVAC strongly encourages CMS to take immediate action to address this ambiguity.

Specifically, CMS must instruct all MACs to maintain the CY19 payment rates as CMS intended and any MAC that implemented the CY20 proposed rate should retroactively implement that higher rate and cover any difference in payment to providers that may have occurred as a result of this error.

As we anticipate a vaccine to prevent COVID-19 in the coming months, it is absolutely imperative that Medicare providers are appropriately reimbursed for vaccine services. During routine immunization activities, providers have a number of important responsibilities, including staff training, ordering and tracking vaccine inventory and ancillary supplies for vaccine administration, proper handling, storage and reporting for each vaccine administered, as well as counseling and educating patients and caregivers. A new vaccine for COVID-19 will require all of these activities on a potentially unprecedented scale.

Vaccine administration fees are a key component for maintaining the personnel and resources needed to carry out immunizations. There is a concern for the upcoming influenza season that the people served by Medicare will continue using the telehealth services and mail order pharmacy that were expanded to protect them from COVID-19. Continued use of these services decreases the immunization opportunities for the most vulnerable patients.

To incentivize the implementation of innovative immunization services during this COVID-19 emergency, healthcare providers should be assured that their additional costs will be compensated. We urge CMS to announce an enhanced fee for vaccine administration to ensure providers are able to offer immunization services to Medicare beneficiaries in environments that are safe for all. This could include innovative options such as drive-by or drive-through vaccinations.

Now more than ever before we  must  effectively  utilize  proven  health  care interventions such as immunization that help older adults and individuals with chronic conditions, such as diabetes and heart and lung diseases, to remain healthy. Studies have shown that vaccine preventable  illness  drives  increased morbidity  and  mortality in these vulnerable populations. Immediate action by CMS is needed to address the discrepancy in the CY20 vaccine administration  rate. Moreover,  the  2021  proposed PFS rule should decouple the practice expense RVU for vaccine administration from therapeutic injection (96372) and instead utilize the  RUC-recommended  direct  PE inputs that were reviewed in October 2009 to publish practice expense RVUs for CPT immunization administration codes 90471, 90473, and 90460. We also encourage CMS to preserve E/M codes that reflect the importance of  primary  care  providers  in assessing and counseling medically complex patients on recommended immunization services. Undervaluing the role of primary care undermines the ability of providers to offer this important preventive service to their patients, which threatens their overall health and wellbeing.

We appreciate this opportunity to share our perspective with respect to issues that are having an acute impact on Medicare providers. AVAC members are available to further discuss our comments with you. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research

American College of Physicians

American Immunization Registry Association (AIRA)

American Pharmacists Association

Asian Pacific Islander American Health Forum

Association of Asian Pacific Community Health Organizations (AAPCHO)

Association of Immunization Managers

Association of State and Territorial Health Officials

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

STCHealth

Takeda Vaccines, Inc.

The Gerontological Society of America

Trust for America’s Health

Vaccinate Your Family

 

Cc: Hospital and Ambulatory Policy Group (HAPG) Ann Marshall

Emily Yoder Liane Grayson

Christiane LaBonte

AVAC Sends Recommendations on Immunization Infrastructure During COVID Pandemic

AVAC sent a letter to Congress to share ideas to help strengthen and enhance immunization infrastructure in the context of COVID-19 public health response efforts.

Adult Vaccine Access Coalition’s Recommendations to Strengthen Immunization Infrastructure for COVID-19 Response

The Adult Vaccine Access Coalition (AVAC) would like to take this opportunity to share ideas to help strengthen and enhance immunization infrastructure in the context of COVID-19 public health response efforts. The CARES Act provided an infusion of resources to help address immediate resource needs. However, as stakeholders across industry, academia, and government search for a COVID-19 vaccine to  protect the public, policymakers and the health care system must take steps now to prepare to distribute a new vaccine once it becomes available. These recommendations have been developed and reviewed by AVAC members and   reflect policies that are going to help providers on the ground prepare for a forthcoming COVID-19 vaccine as well as effectively manage ongoing routine vaccination efforts, including the upcoming annual flu season.

AVAC urges Congress to authorize and provide funding for these efforts under the leadership of Department of Health and Human Services, through the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), the Administration for Community Living (ACL), the Office of the National Coordinator (ONC). HHS should establish an interagency task force to coordinate with the Department of Defense, the Department of Veteran’s Affairs and the Department of Justice Bureau of Prisons, along with health care stakeholders, including public health organizations, health care provider organizations (physicians/pharmacists/nurses) and immunization information system and electronic health record experts to prepare our immunization infrastructure in the following ways:

1) Follow the H1N1 playbook and leverage learnings from the H1N1 experience:

In 2009, the country faced an influenza pandemic with novel influenza A (H1N1). The federal government financed the development of a vaccine and provided the vaccine free of charge to Americans.1 The vaccine was distributed through existing centralized vaccine ordering and distribution systems.2 States allocated vaccines to providers who agreed to prioritize specific populations for the vaccination as instructed by states based on Advisory Committee on Immunization Practices (ACIP) guidance. Funding to prepare for and carry out mass vaccination with H1N1 vaccine was provided by Congress through CDC to state and local public health agencies through the Public Health Emergency Response program.

2) Begin planning for vaccine distribution now through existing public health immunization infrastructure.

Governors and COVID-19 state and local operational and planning teams should include immunization, emergency  preparedness, housing, aging and justice program leadership, provider organizations and health systems. They should work from pandemic influenza vaccine distribution plans, and address before vaccine supply becomes available any existing regulatory barriers      to provider and patient access to the novel coronavirus vaccine. Plans should also account for resource needs for the provision of routine immunization efforts and annual flu vaccine efforts. During H1N1, vaccine supply shipments began as soon   as the vaccine was available but it will take weeks or possibly months to have sufficient supplies of a COVID-19 vaccine distributed around the country for all who require it. Vaccine supply distribution must be prioritized based on ACIP guidelines and address potential socio-economic or ethnic access

3) Assess and provide resources necessary for Immunization Information Systems (IIS) enhancements for accelerated and expanded provider registration, vaccine distribution, vaccine accountability, dose administered reporting, patient recall if a second dose is needed, and adverse event tracking. Areas of focus in preparation for a new COVID-19 vaccine will include:

Governmental level proposals:

  • Provide guidance on relaxing data restrictions and consent requirements that hinder timely reporting of evidence of immunity (through approved serological testing confirmation or history of disease from a positive lab test result) or record of immunization by state/local/tribal/territorial entities for COVID-19. Similar actions were taken during the H1N1 influenza pandemic in 3
  • Implement CDC’s HL7 reporting standards and coding4 for recording and exchanging immunizations and include in IIS standards the ability to collect and store evidence of immunity and lab results
  • Assess and address IIS infrastructure needs and resources necessary through a landscape analysis of current capabilities and functionality to establish standards-based interoperable data exchange connections to aid communication between state/local/tribal/territorial IIS systems, immunization providers and health systems, and the CDC.5
  • Develop process for rapid post-marketing surveillance (e.g. rapid cycle analysis and prospective EHR analysis from public and private health insurers to look at prespecified adverse events) and an effective means of regularly communicating results to the Establish an interagency HHS task force to provide updates to the National Vaccine Advisory Committee (NVAC).

Provider level proposals:

  • Recruit and register willing providers (organized based on populations and geographic areas they serve) to provide and report
  • Provide incentives and support  to  smaller  providers  (physician offices/community health centers/community pharmacies) to participate in pandemic vaccination and adopt IT  systems  necessary  to  enable  timely reporting of COVID-19 immunity or vaccine administration to IIS through a    certified electronic medical record or pharmacy record/documentation
  • Provide vaccine and vaccine supply ordering capacity to providers and approval through state allocation
  • Track vaccine uptake in priority groups and report doses administered in real time.
  • Account for vaccine use and replenish
  • Document vaccine and adjuvant (if needed) by lot number or another unique identifier and capacity to conduct patient reminder recalls if two doses are needed.
  • Enable secure consumer access to personal immunization records (through printing or other means) to enable individuals to provide documentation and share information with a person’s medical home if a vaccine is administered elsewhere (e.g. vaccination clinic).

4)    Assess and provide for additional staffing needed to onboard providers and assure orderly vaccine distribution that is consistent and targeted to priority populations.

  • Providers who serve all populations, but especially those prioritized for vaccine or at high risk for serious SARS-CoV-2 disease outcomes, need to be identified and enrolled as vaccinators and staffing plans must be developed for mass vaccination clinics. During the 2009 H1N1 pandemic, states enrolled approximately 3 times the number of providers for the vaccination
  • Develop COVID-19 vaccine allocation plan to assure that initial vaccine supplies are effectively prioritized and equitably distributed across providers and geographic areas to meet patient and community access
  • Ensure adequate staffing to maintain routine vaccination activities, particularly related to influenza, contain ongoing regional outbreaks of vaccine-preventable diseases (measles, hepatitis, pertussis) and support immunization efforts across the lifespan. Many states have been forced to suspend surveillance and outbreak response activities around hepatitis A and hepatitis B as a result of the coronavirus outbreak. Explore feasibility (based on the availability of financial resources, vaccine supplies and staffing) of providing multiple vaccines in one visit (e.g. COVID and flu) based on ACIP

5)     Scale up outreach and communication.

  • Develop plans for educating Americans about the COVID-19 vaccine and inform consumers how to access vaccine when one becomes
  • Train and/or recertify providers on vaccine storage and handling, administering, IIS reporting as well as capability to provide information and ongoing communication and guidance relative to vaccine orders and supplies.
  • Continue messaging on the importance of routine preventive health and standards of immunization care in order to address gaps in vaccine confidence and trust in

6)    Prepare and implement policies needed for large scale vaccination. Elements that need to be addressed include:

  • Prioritization plan and funding for federal government purchase and equitable distribution of
  • Memorandum of Understanding agreements with pharmacy providers (corporations, pharmacy networks, health systems, etc.) and licensing accommodations for providers enlisted to participate, such as healthcare professional students, dentists
  • Guidance to allow the greatest number of vaccinators possible, including authority for pharmacists, as well as other diverse healthcare specialists and providers, such as endocrinologists, cardiologists,
  • Assessment of pandemic vaccination plans to accommodate local factors and overcome challenges (Locations such as community health centers, senior centers, schools, hospitals, pharmacies, drive through clinics, meal delivery ; staffing; vaccine transport; data collection; scheduling, security, etc.)
  • Scale the ability of IIS to safely and confidentially exchange data across jurisdictions and have this data available to clinicians to ensure coverage of all segments of the
  • Establish linkages between IIS and Vaccine Adverse Event Reporting System (VAERS) to monitor vaccine outcomes and document and investigate potential vaccine adverse

We appreciate this opportunity and hope this information is helpful as Congress and the Administration continues to work to respond to the many facets of the ongoing COVID-19 pandemic. If you have any questions or would like to discuss any of the ideas provided in additional detail, please contact AVAC Managers Abby Bownas (abownas@nvgllc.com) or Lisa Foster (lfoster@nvgllc.com).

Sources:

1 https://www.gao.gov/new.items/d11632.pdf

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/SCLetter-10- 06-Influenza.pdf

3 https://wwwnc.cdc.gov/eid/article/20/4/13-1114_article

4 https://www.cdc.gov/vaccines/programs/iis/technical-guidance/hl7.html

5 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6788900/