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 tracingm 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/

AVAC Letter to Senate Finance Committee on Solutions to Improve Maternal Health

AVAC appreciated the opportunity to respond to the Senate Finance Committee’s request for evidence-based proposals to improve maternal health. Low maternal immunization rates are one of the many factors contributing to poor maternal health outcomes in the United States. AVAC made several recommendations including reducing financial barriers for pregnant women; addressing provider issues around billing, coding, and low rates of reimbursement; strengthening education and encouragement so that women are aware of and receive recommended immunizations during each pregnancy; and improving data collection and reporting through a widespread implementation of interoperable health information technology (HIT), Immunization Information Systems (IIS), and electronic health record (EHR) systems.

The Adult Vaccine Access Coalition (AVAC) appreciated the opportunity to respond to the Senate Finance Committee’s request for evidence-based proposals to improve maternal health. Low maternal immunization rates are one of the many factors contributing to poor maternal health outcomes in the United States. AVAC made several recommendations including reducing financial barriers for pregnant women; addressing provider issues around billing, coding, and low rates of reimbursement; strengthening education and encouragement so that women are aware of and receive recommended immunizations during each pregnancy; and improving data collection and reporting through a widespread implementation of interoperable health information technology (HIT), Immunization Information Systems (IIS), and electronic health record (EHR) systems.

Read the full letter below and here

MEMO

Date: April 3, 2020
To: Senate Finance Committee Chairman Grassley & Ranking Member Wyden
From: Adult Vaccine Access Coalition (AVAC)

Re: Maternal Health Bill and Immunizations

The Adult Vaccine Access Coalition (AVAC) appreciates the opportunity to respond to the Committee’s request for evidence-based proposals to improve maternal health.

AVAC consists of over 55 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations.

We appreciate your interest in modernizing and improving the capabilities of the maternal health care. Low maternal immunization rates are one of the many factors contributing to poor maternal health outcomes in the United States. A recent report by the Centers for Disease Control and Prevention’s (CDC) National Vital Statistics Reports found that the number of women dying each year during pregnancy or childbirth has remained steady. Significant disparities emerged however when these figures were reviewed by age and race, with the rate of maternal death being three times higher among black women as compared to white and Hispanic women. Similar patterns can be seen with respect to maternal immunization rates.

The Advisory Committee on Immunization Practices (ACIP) has issued recommendations on the importance of maternal immunization. Since 2004, ACIP has recommended that all pregnant women receive the influenza vaccine and has made a similar recommendation for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine since 2012. A study of insurance claims from public and commercial payers in the American Journal of Preventive Medicine1 found maternal immunization rates increased across regions of the country and payers over the period from 2010 to 2017. However, the report noted significant variability depending on age, race, region and number of obstetric visits during a pregnancy, among other factors. A 2018 survey by the Centers for Disease Control and Prevention (CDC) found that, “many pregnant women are unvaccinated, and they and their babies continue to be vulnerable to influenza and pertussis infection and potentially serious complications including hospitalization and death.”2 Over the survey period (October 2017-March 2018), and 49.1 percent of women reported receiving the influenza vaccine, while 54.4 percent reported receiving Tdap. These rates, however, are notably lower for minority women.3

The work around maternal health comes a critical time for vaccines. Vaccine confidence and hesitancy issues remain a challenge, including among pregnant women. Despite the well-known benefits of immunizations, more than 50,000 adults die in the United States from vaccine-preventable diseases each year. Adult coverage lags behind current federal targets for recommended vaccines during pregnancy. Additionally, pregnant women seeking access to and coverage for vaccines encounter multiple barriers, including lack of information about recommended vaccines, financial hurdles, and technological and logistical obstacles. In addition, there are several new vaccines in the research pipeline for life threatening conditions that could provide important health benefits to pregnant women and their children.

Seeking to better understand some of the ongoing challenges and barriers to successful maternal immunization, the National Vaccine Advisory Committee (NVAC) convened a working group to review the current state of maternal immunizations, identify existing best practices as well as programmatic gaps in this field of preventive medicine. In 2015, NVAC issued a report highlighting the range of patient and provider challenges as well as offering recommendations.4

As immunizations are a highly cost-effective form of preventive medicine that help save lives by protecting the health and wellbeing of individuals and families in communities nationwide, it is in our nation’s interest to improve immunization coverage rates as a means to improve maternal health outcomes. We greatly appreciate the Committee’s consideration of the following recommendations as you work to develop maternal health legislation.

I. Coverage and standards of care to improve maternal health.

Vaccines should be equally accessible for pregnant women among all insured populations. Financial barriers can prevent pregnant women, particularly those with public insurance coverage5, from receiving recommended immunizations during the time of pregnancy. Concurrently, provider issues around billing, coding, and low rates of reimbursement can discourage providers from stocking vaccines and recommending them to obstetric patients. We urge the Committee to consider the following provisions around coverage and access:

  • Improve Provider Billing for Maternal Immunization Services. Direct HHS ASH, in coordination with CMS, HRSA and payers to develop a workplan and proposed budget to improve upon current process issues related to billing, coding and payment for maternal immunizations, including a review of challenges around vaccine purchase, storage and handling.
  • Vaccine Counseling and Administration Reimbursement. Develop payment mechanisms for CMS/HRSA to reimburse for the costs associated with counseling a patient and vaccine administration.
  • Eliminate Cost Sharing Barriers for Maternal Immunization. Require state Medicaid plans that offer immunization coverage to do so with no cost sharing for pregnant/postpartum women.

II. Addressing disparities and disparate outcomes.

There is a need to strengthen the appreciation and recognition of the value of immunization during pregnancy and beyond. Greater attention and effort are needed to drive meaningful improvements in immunization rates among the maternal population. Consistent education and encouragement can be strengthened so that women are aware of and receive recommended immunizations during each pregnancy. This communication should be strategic, evidence-based, and culturally appropriate and should reflect the health literacy, language. At the same time, providers play an essential role in providing education and counseling to patients and must have the tools and resources to do this job effectively in the course of providing care to patients.

Lack of a strong provider recommendation of immunization during pregnancy results in missed opportunities to protect pregnant women and from conferring immunity protection to their newborns as well. We recommend the following provisions around education and outreach:

  • Maternal Immunization Education Materials. HHS ASH, CMS and CDC to work with federal and state partners, public health, medical professional and minority health organizations to develop and distribute communication strategies and educational materials to aid health care providers in effectively communicating the risks and benefits of maternal immunization and childhood immunization.
  • Communication Campaign. Coordinate the dissemination of a comprehensive toolkit and other resources aimed at improving obstetrical provider immunization office workflow and administration (ie. business practice and billing support, adoption of NVAC adult standards of care, utilization of AFIX).
  • Data collection and effective evaluation to improve outcomes and quality. Improvements in maternal immunization are needed and can help to improve outcomes and quality of care for pregnant and post-partum women. We strongly recommend:
    • Incentivize Widespread Adoption of Maternal Composite Measure. Encourage the widespread adoption of the
      National Committee for Quality Assurance (NCQA) prenatal immunization composite measure (influenza and
      Tdap)6 across federally-funded health care providers and programs (ie. CHC, FQHCs, RHCs and Medicaid
      providers).
    • Establish initial incentives for federally-funded providers who implement the maternal composite measure
      and additional rewards for demonstrating ongoing improvements in maternal immunization rates among their
      patients.

III. Improve data collection and reporting on maternal immunization.

Widespread implementation of interoperable health information technology (HIT), Immunization Information Systems (IIS), and electronic health record (EHR) systems have the potential to improve monitoring of vaccine preventable disease and vaccine coverage rates in real time at a population level and better address gaps in vaccination coverage among pregnant women, as well as to facilitate the exchange of data that can improve coordination and the quality and patient outcomes of preventive care. AcademyHealth, the National Academy for State Health Policy (NASHP) and the Colorado Children’s Immunization Coalition (CCIC) through formation of a Community of Practice (CoP) sought to study and improve immunization rates for pregnant women and children on Medicaid. This collaboration comprised of five states’ Medicaid, and public health agency immunization programs in a shared commitment to leveraging data through IIS to identify gap areas of coverage and monitor improvements in immunization rates.7 At the same time, economic data gathering and analysis, including an assessment of the burden of vaccine preventable disease during pregnancy and the direct and indirect costs that can be averted through increased use of vaccines for the maternal population would go a long way in making the case for increased immunization. We recommend the following provisions to strengthen data and reporting:

  • Strengthen IIS Interoperability and Reporting. Authorize HHS grants in coordination with CMS, CDC, and ONC, to enhance uptake, use, and interoperability of state and local IIS with provider health record systems to improve the bidirectional exchange of maternal immunization data among providers, IIS, and public health authorities.
  • Medicaid Data Report. Study looking at coverage and access to immunization services for pregnant and postpartum women who do not have another source of coverage.

Again, thank you for the opportunity to share these recommendations and look forward to working with the Committee to improve maternal health outcomes in this country. If you have any questions or would like to discuss these recommendations further, please contact AVAC Managers Abby Bownas (abownas@nvgllc.com) or Lisa Foster (lfoster@nvgllc.com) for additional information.

  1. https://www.ajpmonline.org/article/S0749-3797(19)30207-7/fulltext
  2. https://www.cdc.gov/mmwr/volumes/67/wr/mm6738a3.htm?s_cid=mm6738a3_w
  3. https://www.cdc.gov/grand-rounds/pp/2019/20190918-maternal-vaccination.pdf (slides 14 and 15)
  4. https://www.hhs.gov/sites/default/files/nvpo/nvac/reports/nvac_reducing_patient_barriers_maternal_immunizations.pdf
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4720160/
  6. https://www.ncqa.org/wp-content/uploads/2019/02/NCQA-AIS-PRS-Webinar-Slides-Feb-2019.pdf (slides 18-26)
  7. https://www.academyhealth.org/blog/2019-04/community-practice-tackles-barriers-increase-immunization-rates

Over 100 Stakeholders Join AVAC in Supporting the Protecting Seniors Act

Over 100 organizations joined AVAC in offering their strong support for the Protecting Seniors Through Immunization Act (H.R. 5076/S. 1872). They sent this letter to Congress, urging them to include this important legislation in an upcoming pandemic response package.

April 1, 2020

The Honorable Mitch McConnell Majority Leader
U.S. Senate Washington, D.C. 20510

The Honorable Nancy Pelosi Speaker
U.S. House of Representatives Washington, DC 20515

The Honorable Charles Schumer Minority Leader
U.S. Senate Washington, D.C. 20510

The Honorable Kevin McCarthy Minority Leader
U.S. House of Representatives Washington, DC 20515

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

We, the undersigned organizations that care about healthy aging, write to offer our strong support for the Protecting Seniors Through Immunization Act (H.R. 5076/S. 1872), and urge Congress to include this important legislation in an upcoming pandemic response package. This bipartisan legislation, which was introduced by Representatives Shalala, Bouchon, Kuster and Roe, would address a long-standing structural inequity that hinders immunization opportunities for Medicare beneficiaries, a cost-effective means of reducing disease burden and saving lives.

The Protecting Seniors Through Immunization Act will address the out-of-pocket payment required of Medicare beneficiaries, many of whom are on fixed incomes. Copayments apply to vaccines covered under Medicare Part D (tetanus-diphtheria-acellular pertussis (Tdap) and varicella zoster (shingles)) but not vaccines under Part B (flu, pneumococcal), which are available with no cost to the beneficiary. The bill will also improve education and access to recommended vaccines for Medicare beneficiaries, with the goal of helping to increase vaccination rates.

This legislation is especially important in the wake of coronavirus public health crisis. As part of our public health preparedness we need to fix Medicare Part D. Older adults are at particular risk for serious illness and those 50 and older, particularly with multiple comorbidities, are at higher risk of dying if infected. Fixing structural inequities in vaccine coverage now through passage of the Protecting Seniors Through Immunization Act will provide a clear and direct financial and health benefit for people age 65 and over and will help to improve our national preparedness among the Medicare population.

Thank you for your leadership in swiftly addressing the serious health and economic challenges facing our nation during this uncertain time. We stand ready to work with you toward to improve vaccine access to a future COVID-19 vaccine as well as all recommended vaccines for the Medicare population.

Sincerely,

Advanced Practice Nursing

African American Health Alliance

Alliance for Aging Research

Alliance for Immunizations in Michigan (AIM)

American Academy of Physician Assistants (AAPA)

American Autoimmune Related Diseases Association

American Behcet’s Disease Association

American College of Preventive Medicine

American Immunization Registry

Association American Kidney Fund

American Lung Association

American Society of Consultant Pharmacists (ASCP)

American Society on Aging

AOHP

Arthur Caplan, PhD, NYU Langone Health

Asian & Pacific Islander American Health Forum

Association for Professionals in Infection Control and Epidemiology

Association of Asian Pacific Community Health Organizations

Association of Immunization Managers

Black Women’s Health Imperative

Blank Children’s Hospital

California Immunization Coalition

Caregiver Action Network

Children’s Hospital of Philadelphia

COPD Foundation

Dane County Immunization Coalition

Dba Avalon Health Care Center

Families Fighting Flu

Forward Pharmacy

Forward Pharmacy of Columbus

Freddi Segal, GIDAN, Member of AAPA, GSA, and AGS

Geriatric Medicine Physician Assistants

Harris Teeter Pharmacy

Harvard University

HealthHIV

Healthy Solutions, Inc.

HealthyWomen

Hep B United

Hepatitis B Foundation

Idaho Immunization Coalition

Immune Deficiency Foundation

Immunization Action Coalition

Immunize Colorado

Immunize Nevada

ImmunizeOhio

ImmunizeTN

Indiana Immunization Coalition

Infectious Disease Epidemiologist

Infectious Diseases Society of America

Institute for Public Health Innovation

Justice in Aging

Keck School of Medicine

Kelsey-Seybold Clinic

Lupus and Allied Diseases Association, inc.

Men’s Health Network

National Association of County and City Health Officials

National Association of Hispanic Nurses
National Association of Nutrition and Aging Services Programs (NANASP)

National Black Nurses Association

National Caucus and Center on Black Aging

National Consumers League

National Council on Aging

National Foundation for Infectious Diseases (NFID)

National Grange

National Hispanic Council on Aging (NHCOA)

National Hispanic Medical Association

National Organization for Rare Disorders

National Urban League

National Viral Hepatitis Roundtable

North Carolina Immunization Coalition

Patient Access Network (PAN) Foundation

Pennsylvania Immunization Coalition

Retiresafe

Sioux Falls Area Immunization Coalition

STChealth LLC

The Arizona Partnership for Immunization

The Gerontological Society of America

The Immunization Partnership

Trust for America’s Health

Tulsa Area Immunization Coalition

University of Arkansas for Medical Sciences

University of Iowa College of Public Health

University of Pennsylvania

University of Wisconsin School of Medicine & Public Health

UPH-Meriter Mckee Clinic Pediatrics

Utah Adult Immunization Coalition

Vaccinate Your Family

Vaccine Ambassadors

Virginia Barrette

Walmart

WV Immunization Network, a program of The Center for Rural Health Development, Inc.

WomenHeart: The National Coalition for Women with Heart Disease

cc:
Chairman Grassley, Senate Finance Committee Ranking Member Wyden, Senate Finance Committee
Chairman Pallone, House Energy & Commerce Committee Ranking Member Walden, House Energy & Commerce Committee Chairman Neal, House Ways & Means Committee
Ranking Member Brady, House Ways & Means Committee

AVAC Submits Comments on Medicare Part D Proposed Rule

AVAC offered comments on Part II of the Advance Notice of Methodological Changes for Calendar Year (CY) 2021 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies.

March 6, 2020

 

Seema Verma

Administrator

Centers for Medicare and Medicaid Services

7500 Security Boulevard

Baltimore, MD 21244

 

RE: Advance Notice of Methodological Changes for Calendar Year (CY) 2021 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part II

Dear Administrator Verma:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on Part II of the Advance Notice of Methodological Changes for Calendar Year (CY) 2021 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies.  Specifically:

  • AVAC urges CMS to strongly encourage Part D plan sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing and to strongly urge maintaining it in the final letter. Studies have shown a direct correlation between high cost sharing and increased abandonment rates of vaccines.  Removing financial barriers will greatly improve beneficiary access, utilization and health outcomes.
  • AVAC recommends that CMS encourage Part D plan sponsors to waive or eliminate the 25 percent cost sharing for vaccine administration fees for beneficiaries in the coverage gap. This additional cost burden is a significant deterrent and presents a burdensome financial challenge for beneficiaries who are already facing increased drug costs.
  • AVAC strongly supports the inclusion of the annual flu vaccine Star Ratings Improvement measure and encourages CMS to consider the future addition of the adult immunization status (AIS) composite measure on the display page and for Star Ratings. This HEDIS measure provides a comprehensive means to assess the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP).  AVAC appreciates the work of NCQA, PQA and others to develop and test reliable measurement tools that will streamline the patchwork of existing adult immunization measures, has to potential to reduce the reporting burden on providers, and provides meaningful data to the Medicare program on access to this important preventive service.

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

Immunizations are a cornerstone of our nation’s disease prevention efforts and have a demonstrated track record of success as a cost-effective means of reducing disease burden and saving lives among pediatric populations. The CDC estimates that over 20 years, childhood immunizations prevent 732,000 deaths and 21 million hospitalizations.[1]

In the Strategic Plan FY 2018 –2022, the Department of Health and Human Services commits to “support access to preventive services including immunization and screenings, especially for high-risk, high-need populations.”[2] Unfortunately, access to vaccines is not equal across a person’s lifecourse. Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while millions more suffer the immediate and longer-term negative health impacts of vaccine-preventable diseases.  Despite relatively consistently high rates of childhood immunization, adult coverage rates lag behind Healthy People goals for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.

Adults in need of this important preventive service encounter a range of potential challenges, including lack of awareness and information about recommended vaccines, financial hurdles, including high cost sharing, as well as technological and logistical obstacles.  Socioeconomic and linguistic barriers further challenge the ability of diverse and medically underserved communities from accessing needed immunizations.

A growing body of research illustrates the direct and indirect cost attributable to vaccine preventable disease. A study published in The Journal of Primary Prevention found the estimated annual cost of just four major vaccine-preventable diseases among US adults 65 years and older was more than $15 billion in 2013.[3]  Medical costs related to vaccine-preventable diseases (VPD) in older adults are expected to grow substantially in the coming years; one study forecasts U.S. medical costs for Americans ≥65 in the Medicare population to be $4.74 billion by 2030 for just one VPD.[4]

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, Part D vaccines are typically subject to cost sharing requirements.

Previous CMS Part D call letters prioritized and encouraged improved access to and utilization of adult immunization services for beneficiaries in Medicare Advantage and Prescription Drug Plans (PDP).  As such, AVAC wishes to offer the following comments:

Section F. Dispensing Feeds and Vaccine Administration Fees for Applicable Drugs in the Coverage Gap. (page 50-51)

AVAC greatly appreciated the inclusion of language in past Medicare Part D call letters that strongly encouraged Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing.  While not mandatory, this language sent an important signal to Medicare Advantage and Prescription Drug Plans that access to Part D vaccines should be a high priority as they develop formulary and cost sharing tiers.

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

  • A February 2018 Manatt study found that only 4 percent or less of Medicare Part D enrollees had access to vaccines with no cost sharing.[5] The variable cost sharing requirements currently imposed on the majority of Part D vaccines discourage immunization among elderly, disabled and chronically ill populations who account for a disproportionate percentage of the morbidity and mortality from vaccine preventable conditions.
  • A 2017 report by Avalere Health found between 47 and 72 percent of the 24 million Medicare beneficiaries with Part D coverage had some level of cost sharing for vaccines, ranging from $35 to $70 in 2015. Another study found that only 4 percent or less of Medicare Part D enrollees had access to vaccines with no cost sharing.
  • A study evaluating the relationship between vaccine co-pays for Part D beneficiaries and Zoster vaccination claims showed that out-of-pocket cost (OOP) remained the most significant predictor of abandonment. The odds of abandonment were 1.66 times higher for patients with OOP in the $15-$34 range compared with those with OOP ≤$14.99, odds were much higher—at 5.53 times—for those with OOP in the $105-$174.99 range.[6]
  • A 2015 report by the Alliance for Aging Research on vaccination rates among older adults found that cost sharing for vaccines under Part D varies depending on a beneficiary’s prescription drug plan or Medicare Advantage plan formulary offerings.[7]

Another study found that patient out-of-pocket (OOP) cost is one of the most significant predictors of vaccine abandonment, after adjusting for other factors.[8] Removing financial barriers would greatly improve beneficiary access, utilization and health outcomes among at-risk elderly and chronically ill populations who account for a disproportionate percentage of the morbidity and mortality from vaccine preventable conditions.

AVAC recommends that CMS encourage Part D plan sponsors to waive or eliminate the 25 percent cost sharing for vaccine administration fees for beneficiaries in coverage gap. This additional cost burden is a significant deterrent and presents a burdensome financial challenge for beneficiaries who are already facing increased drug costs.

Table 1: 2021 Star Ratings Improvement Measures (p. 59-60)

AVAC is grateful that the advance notice has maintained the annual influenza (flu) vaccine in the Star Ratings Improvement Measures for 2021. Influenza is a serious disease that can lead to hospitalization and sometimes even death. Millions of people get the flu every year, hundreds of thousands of people are hospitalized and thousands or tens of thousands of people die from flu-related causes every year. Flu accounts for an estimated 8.95 billion, or 65% of the annual economic burden of adult vaccine-preventable diseases. According to the Centers for Disease Control and Prevention (CDC), a 6.2 percent reduction in the adult immunization rate for flu during the 2017-18 influenza season was a contributing factor in the record number of deaths. Vaccination has been shown to have many benefits including reducing the risk of flu illnesses, hospitalizations and even the risk of flu-related death.

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

AVAC also strongly supports and urges CMS to seriously consider the future addition of an adult immunization status (AIS) composite measure on the display page and as a Star Ratings measure.  NCQA added the adult composite measure to their 2019 Healthcare Effectiveness Data Information Set (HEDIS), using the Electronic Clinical Data System (ECDS) reporting domain. Measures in the HEDIS ECDS domain are calculated using electronic data from administrative claims, electronic medical records, case management systems and registries. Prior to HEDIS, the composite was piloted by the Indian Health Service. This HEDIS measure provides a comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP).  AVAC appreciates the work of NCQA, PQA and others to develop and test reliable measurement tools that will streamline the patchwork of existing adult immunization measures, have the potential to reduce the reporting burden on providers, and provide meaningful data to the Medicare program on access to this important preventive service.

In the Value and Imperative of Quality Measures for Adult Vaccines[9], renowned vaccine experts explain how quality measures that capture and create incentives for appropriate adult vaccinations can prevent illness and death, reduce caregiving demands, save unnecessary healthcare spending, and set the foundation for healthy aging. There is evidence that a composite measure of the adult patient cohort’s vaccination schedule–such as those demonstrated by the Northwest Tribal Epidemiology Center[10] and by the National Nursing Home Quality Care Collaborative–can improve outcomes. Such a measure would put vaccination coverage rates into a larger context and encourage a more systematic approach for all vaccines.

Thank you for the opportunity to offer our perspective on the 2021 Medicare Advantage and Part D Advance Notice. We look forward to working with you to further strengthen CMS’ commitment to proven preventive health measures and in support of efforts that will help Part D plan sponsors balance fiduciary responsibilities and beneficiary access to important recommended immunizations that protect and preserve health and quality of life.

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

Sincerely,

Alliance for Aging Research

American College of Preventive Medicine

American Immunization Registry Association (AIRA)

Asian & Pacific Islander American Health Forum (APIAHF)

American Pharmacists Association

Association of Asian Pacific Community Health Organizations

Association of Immunization Managers (AIM)

Biotechnology Innovation Organization (BIO)

Dynavax

Families Fighting Flu

GSK

Hep B United

Hepatitis B Foundation

Immunization Action Coalition (IAC)

Medicago

National Association of City and County Health Officials (NACCHO)

National Black Nurses Association

National Consumers League (NCL)

National Foundation for Infectious Diseases (NFID)

National Hispanic Medical Association

National Viral Hepatitis Roundtable

Novavax

Pfizer

Pharmacy Quality Alliance

Sanofi

Scientific Technologies Corp

Seqirus

The Gerontological Society of America

Trust for America’s Health (TFAH)

Vaccinate your Family

 

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

 

Sources:

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

[2] https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html

[3] https://www.ncbi.nlm.nih.gov/pubmed/26032932

[4]   Varghese L et al. The temporal impact of aging on the burden of herpes zoster. BMC Geriatrics (2017) 17:30.

[5] https://www.manatt.com/getattachment/495e2566-3821-4037-bf16-9b207bd968ff/attachment.aspx

[6] https://www.pharmacytimes.com/publications/ajpb/2016/AJPB_JulyAugust2016/factors-associated-with-zostavax-abandonment

[7]  https://www.agingresearch.org/document/our-best-shot-the-importance-of-vaccines-for-older-adults-quick-guide-take-home-for-participants/

[8]   Varghese L et al. The temporal impact of aging on the burden of herpes zoster. BMC Geriatrics (2017) 17:30.

[9] https://adultvaccinesnow.org/wp-content/uploads/2016/07/AVN-White-Paper-FINAL.pdf

[10] https://www.hhs.gov/sites/default/files/tab_10.05_weiser_adult_iz_composite-measures.pdf