Letters Archive - Page 7 of 12 - Adult Vaccine Access Coalition

AVAC Urges Full Funding of Immunization-related Activities at HHS

AVAC wrote to the Labor, Health and Human Services (LHHS), and Education Appropriations Subcommittee Chairman Tom Cole and Ranking Member Rosa DeLauro to ask for full funding of immunization-related activities at the Department of Health and Human Services for FY 2019.

Letters to Congress

Appropriations/Funding for Immunization

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March 15, 2018
The Honorable Tom Cole
Chairman
House Labor, Health and Human Services,
Education, and Related Agencies
Subcommittee
2358B Rayburn House Office Building
Washington, DC 20515

The Honorable Rosa DeLauro
Ranking Member
House Labor, Health and Human Services,
Education, and Related Agencies
Subcommittee
2413 Rayburn House Office Building
Washington, DC 20515

Dear Chairmen Cole and Ranking Member DeLauro,

As members of the Adult Vaccine Access Coalition (AVAC), we write to ask for full funding of immunization-related activities at the Department of Health and Human Services as part of the fiscal year (FY) 2019 Labor, Health and Human Services (LHHS), and Education Appropriations bill.

Immunizations are a sound investment because they 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. Vaccines not only help protect the immunized person but they can also help protect those around them who may not be able to be immunized because they are too young to be vaccinated themselves or suffer from a health condition that prevents them from being immunized.

We ask the Committee to strongly support the following programs in the FY19 LHHS bill:

➢ $650 million for the National Immunization Program at the Centers for Disease Control and Prevention (CDC). The immunization program at CDC provides funding to state and local health departments to carry out a variety of activities vital to the prevention, detection and mitigation of vaccine-preventable conditions. These essential grants are utilized not only for the purchase of vaccines for children, adolescents and adults, but also to support a number of other important activities, including: surveillance, safety and effectiveness studies, education and outreach, implementation of evidence-based community interventions to increase immunization coverage among underserved and high-risk populations, and vaccine-preventable disease outbreak response. At a time when disease outbreaks—from measles in Minnesota to Zika in Miami—are on the rise, these resources are vital to communities across the country, many of whom rely solely on these funds to support their immunization activities. Over the past several years, immunization infrastructure financing has grown more complex, with around 50 percent of immunization funding coming from the Prevention and Public Health Fund.

➢ $6.4 million for the National Vaccine Program Office (NVPO). NVPO plays an essential role in coordinating immunization activities among the various federal agencies. These dollars will also help ensure robust implementation of the National Adult Immunization Plan (NAIP). This comprehensive plan lays out overarching goals along with a series of tangible objectives aimed at raising adult immunization rates in line with federal targets. The NAIP also contains specific milestones intended to monitor progress on improving adult immunization.

Now more than ever, we must fully fund immunization programs to prevent and mitigate disease outbreaks. We look forward to working with your office as the FY19 appropriations process gets underway. For further information, please contact the AVAC managers at 202-540-1070 or info@adultvaccinesnow.org.

Sincerely,
Alliance for Aging Research
American College of Preventive Medicine
American Immunization Registry Association
American Public Health Association
Asian & Pacific Islander American Health Forum
Association of Immunization Managers
Association of Occupational Health Nurses
Association of State and Territorial Health Officials
Biotechnology Innovation Organization
Dynavax
Every Child By Two
Families Fighting Flu
GSK
Hep B United
Hepatitis B Foundation
Immunization Action Coalition
Immunization Coalition of Washington, DC
Infectious Diseases Society of America
March of Dimes
Medicago
National Association of City and County Health Officials
National Foundation for Infectious Diseases
National Hispanic Medical Association
National Viral Hepatitis Roundtable
Novavax
Pfizer
Sanofi
Scientific Technologies Corporation
Seqirus
Takeda Vaccines
The Gerontological Society of America
Trust for America’s Health

AVAC Comments on the 2019 Part D Advance Notice and Draft Call Letter

AVAC wrote to CMS to comment on their 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter. AVAC appreciated the inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing and strongly urge maintaining it in the final letter. AVAC also expressed strong support for the future addition of an adult immunization composite measure on the display page and for Star Ratings.

Letters to Administration

Quality Measures Reducing Financial Barriers

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March 5, 2018

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

RE: 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter (CMS-2017-0163)

Dear Administrator Verma:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter. Specifically:

AVAC greatly appreciates the inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing and strongly urge maintaining it in the final letter. 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 strongly supports the future addition of an adult immunization composite measure on the display page and for Star Ratings. This HEDIS measure would build off the current pneumococcal measure and provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP). AVAC appreciates the work of NCQA, PQA and others to develop and test reliable measurement tools that will streamline the patchwork of existing adult immunization measures, reduce the reporting burden on providers and provide meaningful data to the Medicare program on access to this important preventive service.

AVAC consists of more than fifty organizational leaders in health and public health who are committed to raising awareness of the importance of adult immunization with the ultimate goal of addressing barriers to adult immunization. Our mission is informed by scientific and empirical evidence that shows immunization improves health and protecting 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.

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

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

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.

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.

According to a February 2018 Manatt study, only 4 percent or less of Medicare Part D enrollees had access to vaccines with no cost sharing. 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 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. Similarly, 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.

The FY2019 draft call letter prioritizes and encourages 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 with the strong hope that CMS will maintain these important immunization provisions in the final call letter:

Potential New Measures for 2020 and Beyond (page 150-151)

Adult Immunization Measure (Part C). For HEDIS 2018, NCQA added the Pneumococcal Vaccination Coverage for Older Adults measure to the 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. For HEDIS 2019, NCQA will build off the pneumococcal measure and evaluate the relevance, scientific soundness, and feasibility of a composite measure for HEDIS that 151 assesses the receipt of routine adult vaccinations. The measure developer is focusing on four specific vaccines: influenza vaccine; tetanus, diphtheria, and pertussis (Tdap) or tetanus and diphtheria (Td) booster vaccine; herpes zoster vaccine; and pneumococcal vaccine. If approved, the new measure would be included in HEDIS 2019. CMS would welcome feedback on the feasibility, value of, and burden/reduction in burden of this change in data source. Depending on results of implementation, CMS will determine the use of this new composite measure for the display page and Star Ratings for the future.

AVAC strongly supports the future addition of an adult immunization composite measure on the display page and a Star Ratings measure. This HEDIS measure would build off the pneumococcal measure and provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP). AVAC appreciates the work of NCQA, PQA and others to develop and test reliable measurement tools that will streamline the patchwork of existing adult immunization measures, reduce the reporting burden on providers, and provide meaningful data to the Medicare program on access to this important preventive service.

In the Value and Imperative of Quality Measures for Adult Vaccines8, 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 Center9 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.

Improving Access to Part D Vaccines (page 199)
According to the Center for Disease Control and Prevention’s (CDC) Surveillance of Vaccination Coverage among Adult Populations — United States, 2015, vaccination rates remain low for tetanus and diphtheria with acellular pertussis (Tdap). While the Healthy People 2020 herpes zoster target vaccination rate has been achieved, approximately 70% of adults for whom the vaccine is recommended remain unprotected. In an effort to improve access to these and other Part D vaccines, we encourage Part D sponsors to either offer a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing.

AVAC greatly appreciates the inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing and strongly urge maintaining it in the final letter. While not mandatory, this language sends an important signal to Medicare Advantage and Prescription Drug Plans that access to Part D vaccines should be a high priority as they develop formulary and cost sharing tiers.

Studies have shown a direct correlation between high cost sharing and increased abandonment rates of vaccines. A study evaluating the relationship between vaccine co-pays for Part D beneficiaries and Tdap and Zoster vaccination claims in their doctor’s office showed that, compared with no co-pay, beneficiaries who had to pay a co-pay amount of $26–50, $51–75 or $76–100, respectively, are 1.39, 1.66 or 2.07 times as likely to cancel their zoster vaccination.

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.Removing financial barriers will 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.

Thank you for the opportunity to offer our perspective on the 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter. We hope CMS will maintain strong language in the final letter encouraging Part D plans to include vaccines in the $0 vaccine tier or low-cost sharing tier in the final letter and language supporting efforts to develop and implement a composite quality measure for adult immunizations. We greatly appreciate CMS’ efforts to balance plans’ fiduciary responsibilities and beneficiary access to this important preventive health service.

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)
Association of Immunization Managers (AIM)
Biotechnology Innovation Organization (BIO)
Dynavax
GSK
Hep B United
Hepatitis B Foundation
Immunization Action Coalition (IAC)
Medicago
National Association of Chain Drug Stores (NACDS)
National Association of City and County Health Officials (NACCHO)
National Black Nurses Association
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association
Novavax
Pfizer
Pharmacy Quality Alliance
PhRMA
Sanofi
The Gerontological Society of America
Trust for America’s Health (TFAH)

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

AVAC Offered Recommendations to CMS on Measure Sets for 2019 MIPS

AVAC valued the opportunity to offer our perspective on the current specialty measure sets as well as potential new MIPS measures being considered for implementation. As the Medicare program transitions from a volume-based physician payment model to a system that rewards value, it is important that proven prevention interventions such as immunizations are represented.

Letters to Administration

Quality Measures

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February 9, 2018

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-5522-P
P.O. Box 8013
Baltimore, MD 21244-8013

RE: Stakeholder Recommendations for Potential Consideration of New Specialty Measure Sets and/or Revisions to the Existing Specialty Measure Sets for the 2019 Program Year of Meritbased Incentive Payment System (MIPS)

Dear Administrator Verma:

AVAC appreciates the opportunity to offer comments in response to the Potential Consideration of New Specialty Measure Sets and/or Revisions to the Existing Specialty Measure Sets for the 2019 Program Year of Merit-based Incentive Payment System (MIPS). As a stakeholder interested in advancing physician payment models that encourage access to essential preventive services such as immunization, we are grateful to CMS for its continued work and stakeholder engagement in this area.

AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to 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 mission is informed by scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against debilitating and potentially deadly conditions, and avoiding unnecessary costs to the healthcare system and to society.

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 to and utilization of adult immunizations. A top priority for AVAC is to achieve increased adult immunization rates through federal benchmarks and performance measures that encourage utilization of recommended vaccines.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines are underutilized in the adult population and lag behind Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, human papillomavirus vaccine (HPV)). Disparities are even greater among at-risk populations, including seniors and people with chronic illness, many of the same vulnerable populations Medicare covers across the country.

AVAC values the opportunity to offer our perspective on the current specialty measure sets as well as potential new MIPS measures being considered for implementation. As the Medicare program transitions from a volume-based physician payment model to a system that rewards value, it is important that proven prevention interventions such as immunizations are represented. Our coalition firmly believes that adult immunization quality measurement is central to ensuring continued focus on this core prevention intervention. AVAC shares your goal of building, strengthening and advancing a new generation of process and outcome measures, as outlined in the CMS Quality Strategy. We are also committed to ensuring this new generation of adult immunization measures bring increased value without adding burden on providers.

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

CY2018 MIPS Specialty Measure Sets
Opportunities to assess the immunization status of Medicare beneficiaries for should be done by the range of clinicians who care for them, including primary care and specialty providers. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong provider recommendation have been found to improve the likelihood of a patient being immunized. Published literature indicates that integrating immunization assessment and additional providers offering these critical preventive services will result in greater opportunities for immunization. The National Vaccine Advisory Committee’s (NVAC) Adult Immunization Standards call for all providers caring for adult patients to assess, recommend, vaccinate or refer, and document vaccinations.

The 2018 Quality Payment Program added immunization quality measures to several specialty measure sets. AVAC was encouraged that the following specialty sets included the following immunization process quality measures in the final rule:

✓ Allergy/Immunology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults
✓ Family Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults and NQF # 1407 Immunizations for Adolescents
✓ Infectious Disease. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults and NQF # 1407 Immunizations for Adolescents
✓ Nephrology. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults
✓ Obstetrics/Gynecology. NQF# 0041 Preventive Care and Screening: Influenza Immunization.
✓ Otolaryngology. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults
✓ Pediatrics. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF #0038 Childhood Immunization Status and NQF # 1407 Immunizations for Adolescents
✓ Preventive Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults
✓ Rheumatology. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults

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

In addition, patients living with chronic conditions such as heart disease and diabetes are at a significantly higher risk of complications and death from influenza and pneumonia. The CDC has reported that in 2013 only 21.2% of adults in this group had received a pneumococcal vaccination, and this number has been essentially unchanged for at least a decade. Individuals with diabetes are at increased risk for hepatitis B infection. As such, the ACIP recommends hepatitis B vaccination for all patients with diabetes age 606 and under as well as other at-risk patients, such as those living with HIV/AIDS and chronic kidney disease.

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

➢ Internal Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ Endocrinology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ Cardiology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ General Surgery. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ Oncology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.

MIPS Measures under Consideration
AVAC is pleased to have the opportunity to offer comments on potential measures to be included in specialty measure sets. In terms of adult immunization, the Measures under Consideration (MUC) includes the following measure for herpes zoster (shingles) immunization, “The percentage of patients 60 years of age and older who have a Varicella Zoster (shingles) vaccination.” The absence of zoster vaccination measures was identified by the National Quality Forum as a significant gap in performance measurement and the development of a measure had been identified as a priority.

AVAC urges CMS to consider incorporating this important measure under the following specialty sets: Cardiology, Family Medicine, Infectious Disease, Internal Medicine, Nephrology, Oncology, Preventive Medicine.

Presently, a Herpes Zoster (Shingles) vaccination process measure is only being utilized in the home health value-based payment program – Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination? AVAC supports broader adoption of a herpes zoster measure across specialty sets to reduce the number of missed immunization opportunities for this debilitating condition.

According to the CDC, 27.9 percent of adults age 60 and older reported receiving the herpes zoster vaccine. The health and economic burden associated with shingles and its complications are significant for patients as well as the health care system. In 2007, the Agency for Healthcare Research and Quality (AHRQ) estimated the average cost of shingles and its complications to be $566 million a year while another study estimated the overall cost could be as high as $1.7 billion a year.

Immunizations have demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and improving overall health in a cost-efficient manner. Reducing the number of missed immunization opportunities is imperative to improving health and reducing the burden of vaccine preventable illness among Medicare beneficiaries. AVAC looks forward to working with CMS to ensure that adult immunization quality measures remain an integral component of the Quality Payment Program and in keeping current clinical guidelines in the coming years.

Thank you for this opportunity to offer our perspective on this proposed rule. Please contact the 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)
Asian Pacific Islander American Health Forum
BIO
Dynavax
Every Child By Two (ECBT)
Families Fighting Flu
GSK
Hepatitis B Foundation
Hep B United
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition
Immunization Coalition of Washington DC
National Association of County and City Health Officials (NACCHO)
National Foundation for Infectious Diseases (NFID)
Novavax
Sanofi
Sequirus
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health

AVAC Responds to CMS’s Request For Information on CMMI’s Future Initiatives

CMMI is uniquely situated to test out innovative models relating to adult immunization that can address challenges around adult immunization, and would improve access and utilization of recommended vaccines for the Medicare population. AVAC offered several demonstration project proposals related to adult immunization that would fit under current or potential models proposed.

Letters to Administration

Quality Measures Reducing Financial Barriers

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RE: Centers for Medicare & Medicaid Services: Innovation Center New Direction Request for Information

To Whom it may Concern:

As members of the Adult Vaccine Access Coalition (AVAC), we value the opportunity to comment on the Centers for Medicare and Medicaid Services: Innovation Center New Direction Request for Information (RFI), one that promotes patient-centered care and tests reforms that empower Medicare beneficiaries, brings greater transparency and competition to drive quality, reduce costs and improve outcomes.

CMMI is uniquely situated to test out innovative models relating to adult immunization that can address challenges around adult immunization, and would improve access and utilization of recommended vaccines for the Medicare population. Our comments offer several demonstration project proposals related to adult immunization that would fit under current or potential models proposed:

➢ Alternative Provider Billing Systems Under Medicare Part D
➢ Strengthen and enhance vaccine access through the Initial Preventive Physical Examination (IPPE) and the Annual Wellness Visit (AWV)
➢ No cost sharing vaccine tier in Medicare Advantage plans offering Part D coverage
➢ No cost sharing vaccine tier under Prescription Drug Plans (PDPs)

AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to adult immunization and to raising awareness of and engaging in advocacy on the importance of adult immunization. Our mission is informed by scientific and empirical evidence that shows immunization improves health, protect lives against a variety of debilitating and potentially deadly conditions, and save 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 stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations. Our coalition advocates for policies that will reduce barriers to immunization and for common sense measures that will improve the ability of providers and patients to make informed decisions at the point of care.

Background
Immunizations are a proven intervention that is effective at preserving health and reducing avoidable health care costs such as hospitalizations and other expensive medical interventions that result from vaccine preventable illness1. Over 20 years, vaccines will prevent 732,000 deaths and 21 million hospitalizations. Despite Advisory Committee on Immunization Practices (ACIP) recommendations, which include 13 different vaccines for adults, vaccines have been consistently underutilized in the adult population and lag behind the Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap (tetanus, diphtheria, pertussis), hepatitis B, herpes zoster, HPV).

Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems that cause them to miss work and leave them unable to care for those who depend on them.3 A growing body of research illustrates the direct and indirect cost attributable to vaccine preventable disease. One study published in The Journal of Primary Prevention found the estimated annual cost of just four major vaccine-preventable diseases among US adults was $26.5 billion annually, $15 billion of which was attributed to those 65 years and older.

While immunizations are essential to protecting health across the lifespan, it is especially important to immunize older adults, who are at increased risk for vaccine-preventable conditions as a result of waning immunity and increased likelihood of co-morbid, chronic conditions, and who are more likely to develop complications. Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of awareness and information about recommended vaccines, financial hurdles, including high cost sharing, as well as technological and logistical obstacles. Socioeconomic and linguistic barriers further challenge the ability of diverse and medically underserved communities from accessing needed immunizations.

Recognizing the challenges, barriers, and opportunities around adult vaccination, the National Vaccine Program Office within the Department of Health and Human Services issued the National Adult Immunization Plan (NAIP) in 2016.5 The NAIP and its accompanying implementation guide set out four core goals along with a series of objectives and strategies what steps the range of federal and nonfederal stakeholders need to undertake to help drive adult immunization rates.

Guiding Principles
The RFI sets forth six guiding principles that support the overarching goals and objectives of the demonstration project proposals presented in this letter. AVAC supports these guiding principles in that context. The guiding principles are as follows:

1. Choice and competition in the market – Promote competition based on quality, outcomes, and costs.

2. Provider Choice and Incentives – Focus voluntary models that reduce burdensome requirements and unnecessary regulations, allow physicians and other providers to focus on providing high-quality healthcare to their patients, and give beneficiaries and healthcare providers the tools and information they need to make decisions that work best for them.

3. Patient-centered care – Empower beneficiaries, their families, and caregivers to take ownership of their health and ensure that they have the flexibility and information to make choices as they seek care.

4. Benefit design and price transparency – Use data-driven insights to ensure cost-effective care that also leads to improvements in beneficiary outcomes.

5. Transparent model design and evaluation – Draw on partnerships and collaborations with public stakeholders and harness ideas from a broad range of organizations and individuals across the country.

6. Small Scale Testing– Test smaller models that may be scaled if they meet the requirements for expansion under 1115 A(c) of the ACA. Focus on payment interventions rather than on specific devices or equipment.

Demonstration Project Proposals

AVAC proposes four pilot project models for CMMI consideration. These models focus on barriers to adult immunization for the Medicare population and present an important opportunity to test data driven approaches to improving access and utilization of recommended adult vaccines. Specifically, the models touch upon provider challenges to offering the broad range of vaccinations in the office setting as well as financial barriers for Medicare beneficiaries seeking access to vaccines through the Part D benefit.

While each represents a different approach and intervention, all share the goal of strengthening and enhancing access and utilization of adult immunizations that serve to protect health and prevent or mitigate serious illness. Additionally, each model seeks to improve transparency, beneficiary choice and competition in the market through patient centered initiatives that will ultimately improve care and drive down health care costs over the longer term.

Alternative Provider Billing Systems Under Medicare Part D

Test the integration and utilization of billing systems that enable providers in the clinical setting to review a patient’s Part D vaccine coverage and to directly bill Part D plans for the cost and administration of covered vaccines . Study the impact on vaccination rates and potential savings to the Medicare program through the reduction in avoidable downstream healthcare costs. This pilot could fall under the prescription drug model focus area described in the RFI.

Whereas Medicare Part B covers vaccines for several serious vaccine-preventable diseases, including influenza, pneumonia, and Hepatitis B for at-risk patients with zero cost sharing; a growing number of other vaccines are covered under the Medicare Part D program.

Should a provider wish to offer and administer Part D covered vaccines to beneficiaries, they encounter a difficult and time consuming process since they do not have access to the same systems that pharmacies utilize to process claims for Part D covered prescriptions.6 First, it can be challenging for Part B providers to assess a beneficiary’s Part D eligibility, coverage and cost sharing requirements. Providers who choose to offer Part D vaccines in their office must also find a mechanism by which to submit claims for vaccine services. This can include billing the patient for the total upfront cost of the vaccine; enrolling in a commercially available out-of-network billing system for Part D vaccine claims (such as TransactRX); or obtaining an out-of-network authorization for coverage from the Part D plan, then submitting the out-of-network claim on the patient’s behalf and agreeing to accept the Part D payment on a patient-by-patient basis. For physicians who choose to stock vaccines in their offices, these options are not only complex but also create a great deal of financial uncertainty around reimbursement. As a result, many providers opt to not offer Part D vaccines, resulting in missed immunization opportunities during office visits. The current billing system severely hinders opportunities to fully immunize Medicare beneficiaries in a medical setting and hampers efforts to improve immunization rates for the 65 and over population.

The study would determine the effectiveness of billing mechanisms that enable Part B Medicare providers to assess beneficiary Part D coverage as well as bill Part D plans directly for vaccines administered in their office. The main objectives of this study would be to reduce administrative burdens on providers by improving their ability to search Part D plan eligibility and coverage data and to facilitate electronic claims submission for vaccines and their administration Additional element of this study would include data reporting to state or local immunization information systems (IIS) in order to measure changes in immunization rates among the study group as well as a review of overall health claims to determine downstream savings to the Medicare program.

Strengthen and enhance vaccine access through the Initial Preventive Physical Examination (IPPE) and the Annual Wellness Visit (AWV)

Explore the impact of strengthening and enhancing the role of immunization assessment and counseling at the IPPE and the AWV on Medicare beneficiary immunization coverage rates. The objectives of this pilot would be to improve patient care and enhance reporting of administered vaccinations with goal of bolstering immunization rates for beneficiaries while reducing downstream health expenditures for the Medicare program. This pilot could be incorporated as an element of the Comprehensive Primary Care Plus project or the Transforming Clinical Practice Initiative under the Primary Care Transformation category presently ongoing at CMMI.

The IPPE, or “Welcome to Medicare” visit, along with the AWV, represent important opportunities to assess the overall health status of a new Medicare beneficiary entering the program as well as monitor and assess their health on an ongoing basis. Since 2011, the number of Medicare beneficiaries utilizing the AWV has grown steadily from 8 percent in 2011 to 19 percent in 2015.7 While an assessment of immunization status is a core element of the IPPE, confusion around which vaccines covered through Medicare Part B and Medicare Part D can result in a weak or perhaps no provider recommendation to receive certain vaccines.

The pilot would explore the impact of the HHS National Vaccine Advisory Committee (NVAC) Standards for Adult Immunization Practice for ACIP recommended vaccines on provider interactions with Medicare beneficiaries during the IPPE and the AWV. The adult standards call for providers to assess the immunization status of the patient; strongly recommend needed vaccines based on the age and health status of the beneficiary; administer or refer the patient to a vaccine provider and document to the state or local immunization registry. Consistent application of these standards during the IPPE and AWV would improve the efficiency and effectiveness of these interactions between providers and Medicare beneficiaries, resulting in a reduced number of missed immunization opportunities, improved immunization coverage rates, patient health outcomes and lower downstream costs to Medicare program.

No cost sharing vaccine tier in Medicare Advantage plans offering Part D coverage

Analyze the impact of offering Part D vaccines with no cost sharing to beneficiaries in Medicare Advantage plans. A growing number of Medicare beneficiaries are enrolling in Medicare Advantage plans options. Today, one in three Medicare beneficiaries, a total of 19 million people, is enrolled in a Medicare Advantage plan. Since MA plans include both the medical and pharmacy spending, they can be leveraged to assess how vaccination uptake impacts downstream medical spending within one plan. Primary goals of this study would be to examine the impact of cost sharing upon vaccination rates and explore reductions in avoidable hospitalizations and other healthcare costs. This pilot would fall under the Medicare Advantage (MA) Innovation Models testing area focus of the RFI.

A number of studies indicate that financial barriers to Part D vaccines are a significant impediment to beneficiary access to some immunization services. The vaccines covered through Part B do not have any beneficiary cost sharing requirements. In comparison, cost sharing is allowed for vaccines covered under the Part D program. 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.9 Similarly, a 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.

No cost sharing vaccine tier under stand-alone Prescription Drug Plans (PDPs)

Similar to the above pilot, CMS could evaluate vaccine utilization rates in a stand-alone Part D plan where beneficiaries have zero-dollar cost sharing for all ACIP-recommended vaccines not covered under Part B. The project could also assess varying tiers of cost sharing (i.e. no cost vaccine tier compared to a range of cost sharing regimens) to better identify the cost threshold for vaccine uptake. In addition, this model would improve competition and price transparency for vaccine coverage under Part D plans. This pilot could be a prescription drug model focus area for CMMI.

A study in the August 2016 Journal of American Pharmacy Benefits found a correlation between increases in cost sharing and increased vaccine abandonment at the pharmacy. During the study period, a total of 172,977 fills for Zostavax were initiated, and a total of 67,369 were abandoned for an overall abandonment rate was 38.9%. While the abandonment rate varied by patient demographics and health plan factors, patient out-of-pocket cost (OOP) remained the most significant predictor of abandonment, after adjusting for other factors. For patients with $15-$34 copays, the odds of abandonment were 1.66 percent compared to those with costs of $14.99 and below. Patients with cost sharing ranging from $105-$174.99 were 5.53 times more likely to abandon the vaccine.

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. Removing this financial barrier could have a significant impact on improving beneficiary access to and utilization of vaccines and will also help drive reductions in hospitalizations and avoidable medical expenditures in other parts of the Medicare program. Addressing this barrier will be even more important as new vaccines for a growing variety of infectious and devastating conditions enter the market in the future.

Immunization has demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and has been proven to improve overall health in a cost-efficient manner. Reducing the number of missed immunization opportunities for Medicare beneficiaries is an important step to improving health and reducing the burden of vaccine-preventable illness among this rapidly growing segment of our population.

Thank you for this opportunity to offer our perspective on this important topic. We look forward to working with CMMI moving forward to increase access and utilization of adult vaccines. Please contact Lisa Foster, AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org to schedule a chance to further discuss our comments in response to this RFI. To learn more about the work of AVAC, visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
Asian Pacific Islander American Health Forum (APIAHF)
GSK
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition (IAC)
Medicago
National Association of County and City Health Officials (NACCHO)
National Foundation for Infectious Disease (NFID)
National Hispanic Medical Association
Novavax
Pfizer
Sanofi
Seqirus
The Gerontological Society of America (GSA)
Trust for America’s Health (TFAH)

AVAC Endorses Shingles Prevention Act

AVAC wrote a letter to Senator Hirono, Senator Capito, Representative Bucshon, and Representative Green expressing support for their new legislation: The Shingles Prevention Act. The Shingles Prevention Act addresses two critical issues impeding Medicare beneficiary access to the Herpes Zoster vaccine: awareness and cost sharing. AVAC urges support of this legislation.

Letters to Congress

Reducing Financial Barriers

Download

November 8, 2017

The Honorable Mazie Hirono
United States Senate
330 Hart Senate Office Building
Washington, D.C. 20510

The Honorable Shelley Moore Capito
United States Senate
172 Russell Senate Office Building
Washington, D.C. 20510

The Honorable Larry Bucshon
House of Representatives
1005 House Office Building
Washington, D.C. 20515

The Honorable Gene Green
House of Representatives
2470 House Office Building
Washington, D.C. 20515

Dear Senator Hirono, Senator Capito, Representative Bucshon and Representative Green:

As members of the Adult Vaccine Access Coalition (AVAC), we would like to take this opportunity to commend you for introducing the Shingles Prevention Act.

AVAC includes more than fifty organizational leaders in health and public health who are committed to overcoming the barriers to adult immunization and to raising awareness of and engaging in advocacy on the importance of adult immunization. Our mission is informed by a growing body of scientific and empirical evidence that shows that immunization improves health, protects lives against a variety of debilitating and potentially deadly conditions, and saves costs to the healthcare system and to society as a whole. Immunization has demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and has been proven to improve overall health in a costefficient manner. A top priority for AVAC is to achieve increased adult immunization rates through improving education and awareness of recommended vaccines and addressing challenges to access.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines have been consistently underutilized in the adult population and lag behind the Healthy People 2020 goals for recommended vaccines (influenza, pneumococcal, Adult Tetanus, Diphtheria, Pertussis [Tdap], shingles, Human Papillomavirus [HPV], hepatitis B vaccine). Disparities are even greater for at-risk populations, including seniors and people with chronic illnesses.

The Shingles Prevention Act addresses two critical issues impeding Medicare beneficiary access to the Herpes Zoster vaccine: awareness and cost sharing. Medicare beneficiaries often do not realize that coverage for immunizations is divided between Medicare Part B and Medicare Part D. While vaccines under Medicare Part B are available to beneficiaries with no cost sharing or deductibles, beneficiaries face varied cost-sharing requirements for the shingles vaccine under Medicare Part D plans. Your bipartisan legislation would help inform beneficiaries about Medicare coverage for vaccines and would eliminate out-of-pocket costs that significantly hinder access to immunization services under Medicare Part D.

Medicare beneficiaries deserve the same access to protection provided by immunizations as those with commercial coverage currently receive, yet variable cost sharing for vaccines across Medicare programs greatly hinders beneficiary access. Reducing the number of missed immunization opportunities for Medicare beneficiaries is an important step in improving health and reducing the burden of vaccine-preventable illness among this population. It also helps provide protection across the lifespan.

Thank you for your commitment to ensuring that Medicare beneficiaries are aware of the full range of recommended immunizations and to removing financial barriers to access. AVAC members are pleased to offer our support for this important legislation and look forward to working with you toward equitable access and parity of coverage for all ACIP-recommended vaccines for the Medicare population. We look forward to working with you to strengthen and enhance Medicare beneficiary access to this critical preventive service. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org or visit www.adultvaccinesnow.org if you wish to learn more about the work of AVAC.

Sincerely,
Alliance for Aging Research
American Association of Occupational Health Nurses (AAOHN)
American College of Preventive Medicine (ACPM)
American Pharmacists Association (APhA)
Asian & Pacific Islander American Health Forum (APIAHF)
Biotechnology Innovation Organization (BIO)
Dynavax
Every Child By Two (ECBT)
GSK
Hep B United
Hepatitis B Foundation
Immunization Action Coalition (IAC)
Infectious Diseases Society of America (IDSA)
Merck
National Association of Chain Drug Stores (NACDS)
National Association of County and City Health Officials (NACCHO)
National Council of Asian Pacific Islander Physicians (NCAPIP)
National Hispanic Medical Association (NHMA)
National Viral Hepatitis Roundtable (NVHR)
Pfizer
Sanofi
Scientific Technologies Corporation (STC)
Takeda Vaccines, Inc.
The Gerontological Society of America (GSA)

AVAC Asks that Adult Immunization Goals and Objects Remain in HealthyPeople 2030

AVAC offered comments in response to the Healthy People 2030 Framework. AVAC urges the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention to ensure that adult immunization goals and objectives remain an integral part of the Immunization and Infectious Diseases Topic Area for Healthy People 2030.

Letters to Administration

Quality Measures

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September 29, 2017

To Whom It May Concern:

AVAC appreciates the opportunity to offer comments in response to the Healthy People 2030 Framework. As a stakeholder coalition interested in improving the health and wellbeing of adults through better access to immunization services, we value the work of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention on an approach to the development and implementation of objectives for Healthy People 2030.

AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to adult immunization. AVAC works toward regulatory and legislative solutions that will strengthen and enhance access to adult immunization across the healthcare system. Our mission is informed by scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against a variety of debilitating and potentially deadly conditions, and saving costs to the healthcare system and to society. A top priority for AVAC is to achieve increased adult immunization rates by encouraging compliance with federal benchmarks and performance measures that encourage utilization of recommended vaccines.

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. Since the Healthy People initiative began in 1979, there has been tremendous progress with respect to improved childhood immunization rates – one of the greatest public health achievements of the 20th century. Vaccine programs have contributed to the elimination of polio in the US and have dramatically reduced the spread of many more crippling and potentially life-threatening diseases such as diphtheria, tetanus, measles, mumps, and rubella. Vaccines also prevent the spread of common infectious and potentially fatal diseases such as chickenpox, influenza, hepatitis A, hepatitis B, meningococcal disease, pneumococcal disease, and whooping cough (pertussis). Vaccines not only help protect the immunized person but also those around them who may not be able to be immunized because they are too young to be vaccinated themselves or suffer from a health condition that prevents them from being immunized. These persons are protected indirectly because they are not exposed to the infectious agent. When immunity levels in the population are high, the infectious agents do not circulate, which is known as herd immunity. Maintaining herd immunity is essential to protecting and preserving the health and wellbeing of individuals and entire communities from vaccine preventable conditions.

Despite the demonstrated benefits of vaccination and the tremendous success in achieving and maintaining high immunization coverage rates for children, every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines are underutilized in the adult population for the most commonly recommended vaccines (influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, human papillomavirus (HPV,)and meningococcal vaccines). Disparities are even greater among at-risk populations, including seniors and people with chronic illness, as well as racial and ethnic underserved populations.

Background

Healthy People goals and objectives are an essential tool in guiding the actions of the wide range of stakeholders who are committed to improving the health and wellbeing of our nation. AVAC is grateful that Healthy People 2020 included several objectives aimed at reducing or eliminating instances of vaccine-preventable diseases in adult populations. While the Healthy People 2020 Midcourse review indicates progress in several areas, including a decline in the incidence of pneumococcal infections and an increase in the percentage of adults vaccinated against influenza and herpes zoster, other indicators reveal that there is more work to be done as we look ahead to the next decade.

Vision

With the aging of the U.S. population, the impact of vaccine preventable conditions and their complications in adults is only expected to grow, with significant implications for the economy and society. With Americans age 85 and older representing the fastest growing segment of the elderly population, it is imperative that as a nation we remain focused on improving adult vaccination rates. Adult immunization is a core preventive health intervention that supports healthy aging and helps to avoid the costly effects of vaccine preventable illness. As such, AVAC urges the Committee to ensure that adult immunization goals and objectives remain an integral part of the Immunization and Infectious Diseases Topic Area for Healthy People 2030.

The 2016 Department of Health and Human Services’ National Vaccine Program Office National Adult Immunization Plan, cites a number of barriers to adult immunization, including lack of information about recommended vaccines, financial hurdles, as well as technological and logistical obstacles. The Healthy People 2020 goals and objectives for adult immunization provided an important benchmark and framework for measuring the progress of federal coordinated efforts to improve adult vaccines.

Foundational Principles

Another area where Healthy People 2030 plays an extremely important role in improving the health and well-being of all Americans is the focus on “eliminating health disparities, achieving health equity and attaining health literacy”. AVAC supports this effort and strongly believes that reducing disparities in adult immunization rates is central to our work to increase access and to improve utilization of this proven disease prevention intervention. Annual adult vaccine coverage reports consistently show disparities in immunization rates depending on race or ethnicity. Access to regular sources of health care, linguistic, and cultural barriers are often obstacles for medically underserved populations. National goals and objectives centered on reducing these barriers will go a long way toward improving the health and well-being of our nation.

In closing, AVAC strongly encourages the Advisory Committee to update and maintain objectives centered on advancing adult immunization coverage rates in the Healthy People 2030 framework. For decades, Healthy People has set the standard at the national, state, and local levels as we strive to improve health and well-being across all stages of life and among all segments of our great nation. Immunization has demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and has been proven to improve overall health in a cost-efficient manner. Improving immunization opportunities across the lifespan should remain a foundational element in the overall effort to improve health and reduce the burden of disease for the United States.

Thank you for this opportunity to offer our perspective on this important framework. Please contact the 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,
American Academy of Family Physicians
Asian & Pacific Islander American Health Forum
Every Child By Two
Families Fighting Flu
GSK
Immunization Coalition of Washington, DC
Medicago
National Association of Chain Drug Stores
National Association of County and City Health Officials
National Foundation for Infectious Diseases
National Viral Hepatitis Roundtable
Sanofi
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health

AVAC Sends CMS Comments in Response to their Proposed Home Health Rule

The Home Health Value-Based Purchasing Model (HHVBP) presents an important opportunity to promote higher quality and more efficient healthcare for Medicare beneficiaries. AVAC firmly believes that adult immunization quality measurement is central to ensuring continued focus on this core prevention intervention. Read more to see AVAC’s comments on aspects of the proposed rule relevant to the provision of immunizations.

Letters to Administration

Quality Measures

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September 25, 2017

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1672-P
P.O. Box 8016
Baltimore, MD 21244-8016

RE: Medicare and Medicaid Programs: CY 2018 Home Health Prospective Payment System Rate Update and Proposed CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements

To Whom It May Concern:

AVAC appreciates the opportunity to offer comments in response to the CY 2018 Home Health Prospective Payment System Rate Update and Proposed CY2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. As a stakeholder coalition interested in advancing payment models that encourage access to immunization, we are grateful to the Centers for Medicare and Medicaid Services (CMS) for its work in this area.

AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to adult immunization. AVAC works toward regulatory and legislative solutions that will strengthen and enhance access to adult immunization across the healthcare system. Our mission is informed by scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against a variety of debilitating and potentially deadly conditions, and saving costs to the healthcare system and to society. A top priority for AVAC is to achieve increased adult immunization rates through federal benchmarks and performance measures that encourage utilization of recommended vaccines.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems1. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines are underutilized in the adult population and lag behind the Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, and human papillomavirus (HPV)). Disparities are even greater among at-risk populations, including seniors and people with chronic illness, many of the same vulnerable populations Medicare covers across the country.

Home Health Agencies (HHAs) are essential community providers for frail elderly and disabled patients and have an 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 setting.

The Home Health Value-Based Purchasing Model (HHVBP) presents an important opportunity to promote higher quality and more efficient healthcare for Medicare beneficiaries. AVAC values the opportunity to offer our comments on aspects of the proposed rule relevant to the provision of immunizations. Our coalition firmly believes that adult immunization quality measurement is central to ensuring continued focus on this core prevention intervention. We look forward to working with you to improve upon existing adult immunization quality measures and to advance new measures for current vaccines and future vaccines in the pipeline. AVAC shares your goal of building, strengthening and advancing a new generation of process and outcome measures, as outlined in the CMS Quality Strategy. We are also committed to ensuring this new generation of adult immunization measures strikes the right balance in terms of not adding a burden on providers while enhancing the integrity and societal value of quality measurement.

AVAC believes the home health proposed rule should include a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries receiving home health services. Last summer, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines.4 The report highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging.

p. 35335 Measure Set for the HHVBP Model Beginning in Performance Year 3

The proposed rule maintains several immunization measures in the Home Health Value-Based Purchasing (HHVBP) program and well as the Home Health Quality Reporting program. These process measures are important tools to incentivize and encourage adult immunization in the home health setting. Specifically, AVAC commends CMS for maintaining the following measures (see Table 43) among the Population/Community Health measures for the HHVBP Performance Year 3 and urges CMS to maintain them in the final rule.

➢ Influenza Immunization Received for Current Flu Season (NQF#0522)
➢ Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431) and
➢ Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?

The proposed rule also maintains Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525), however, it is worth noting that this measure no longer reflects current recommendations of the Advisory Committee on Immunization Practices (ACIP). AVAC strongly encourages CMS to replace this outdated measure in the final rule. Other CMS quality programs have implemented Pneumonia Vaccination Status for Older Adults (NQF#0043), as it better reflects the current Advisory Committee for Immunization Practice (ACIP) recommendation for PCV13 and PPSV23 vaccination in adults age 65 and older as well as at-risk adults 19-64 years old. The health and economic burden of pneumococcal disease, particularly among elderly and high-risk adult populations, is significant.

According to the Centers for Disease Control and Prevention (CDC), an estimated 900,000 Americans get pneumococcal pneumonia each year, resulting in as many as 400,000 hospitalizations and more than 53,000 deaths. It is estimated that 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.

By contrast, AVAC appreciates that the HHVBP maintains Influenza Immunization Received for Current Flu Season (NQF#0522) along with Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431). Protecting frail elderly, disabled and chronically ill Medicare beneficiaries against influenza is extremely important. A recent CDC study of flu-associated deaths prevented over a nine-year period from 2005-2006 through 2013-2014 found that nearly 89 percent were in people 65 years of age and older.

Leading medical and health professional associations support influenza vaccination policies for healthcare professionals to help protect patients. The Advisory Committee on Immunization Practices (ACIP) recommends that all healthcare personnel (HCP) be vaccinated annually against influenza. Vaccination of HCP has been associated with reduced rates of work absenteeism and with fewer deaths among nursing home patients and elderly hospitalized patients. Although annual vaccination is recommended for all HCP and is a high priority for reducing morbidity associated with influenza in healthcare settings, national survey data have demonstrated that vaccination coverage levels are approximately 70%, falling short of recommendations under Health People 2020 to increase the number of HCPs receiving an annual influenza vaccination to the target rate of 90%. Healthcare personnel are the first line of defense when it comes to preventing illness and preserving health. Quality measurement reflecting this priority is essential to promoting and advancing prevention in the home health settings.

Additionally, we greatly appreciate that the HHVBP model includes Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?, as the HHVBP is the only value-based payment program within CMS to recognize the value and importance of a herpes zoster (shingles) vaccination measure. AVAC encourages other CMS programs to follow the lead of HHVBP and include a quality measure assessing whether or not a Medicare beneficiary has received a herpes zoster vaccination.

According to the CDC, 27.9 percent of adults age 60 and older reported receiving the herpes zoster vaccine.10 The health and economic burden associated with shingles and its complications are significant for patients as well as the health care system. In 2007, the Agency for Healthcare Research and Quality (AHRQ) estimated the average cost of shingles and its complications to be $566 million a year while another study estimated the overall cost could be as high as $1.7 billion a year.

The disease also takes a toll on the health and quality of life of those who have been afflicted. Postherpetic neuralgia (PHN) is the most common complication; however, other lingering and potentially severe complications and pain can impact an individual for months. AVAC urges CMS to maintain the herpes zoster vaccination process measure in the final rule. We hope that other value-based purchasing and quality reporting programs will also consider this measure in the future, particularly since the absence of zoster vaccination measures has been identified by the National Quality Forum as a significant gap in performance measurement and the development of a measure has been identified as a priority.

P. 35345 Measures Currently Adopted for the Home Health Quality Reporting Program (HHQRP)
The Home Health Quality Reporting Program (HHQRP) also includes immunization measures among the 23 quality measures presented in Table 47. The measures are:

➢ Influenza Immunization Received for Current Flu Season (NQF#0522)
➢ Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525)

While we support maintaining the influenza measure (NQF#0522), we would again urge CMS to replace the pneumococcal measure (NQF#0525) with Pneumonia Vaccination Status for Older Adults (NQF#0043) in the final rule. Together, these measures would represent an important baseline for access to influenza and pneumococcal vaccination services.

Lastly, the FY17 proposed rule included under the Table 33, HHQRP measures for future consideration, the Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay). The proposed measure would fall under the NQS Patient and Caregiver Centered Care category. Given the importance of the annual flu vaccine, we believe this measure presents an important opportunity to help improve overall immunization rates.

AVAC also urges CMS to consider adult immunization quality measures that reflect the recommendations of the Advisory Committee on Immunization Practices (ACIP) adult immunization quality measures, as well as measures that reflect provider assessment of a patient’s immunization status, as part of HHQRP future measure selection and development. Assessment should be done by all health care providers to ensure that all beneficiaries are counseled and have the opportunity to receive the recommended immunizations, based on their age and health status. Published literature indicates that integrating immunization screening and additional providers offering these critical preventive services will result in greater opportunities for immunization. The National Vaccine Advisory Committee’s (NVAC) Adult Immunization Standards call for all providers caring for adult patients to assess, recommend, vaccinate or refer, and document vaccinations. Together, these efforts help to reduce d immunization opportunities among home health patients and result in improved health and reduced disease burden among this frail and vulnerable population.

Sincerely,
Alliance for Aging Research
American College of Preventive Medicine
Asian & Pacific Islander American Health Forum (APIAHF)
Every Child by Two
GSK
Immunization Action Coalition
Immunization Coalition of Washington, DC
National Association of County and City Health Officials (NACCHO)
Novavax

AVAC Comments on CMS’s Outpatient Prospective Payment Proposed Rule

AVAC offered comments on CMS’s Medicare Program Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs proposed rule. AVAC supports the proposal to continue to pay separately for Medicare Part B vaccine administration services. AVAC appreciates that both the Hospital OQR and ASCQR programs maintain Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431) among the core measure sets. AVAC believes the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical Center Quality Reporting (ASCQR) should also include a focused, concerted effort to improve access to and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries. AVAC also encourages CMS to consider including influenza and pneumococcal immunization measures in the OQR and ASCQR programs and eventually incorporate measures that address all ACIP-recommended vaccines for adults.

Letters to Administration

Supporting Providers

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September 11, 2017

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1678-P
P.O. Box 8013
Baltimore, MD 21244-1850

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs

To Whom It May Concern:

As members of the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs proposed rule.

AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to adult immunization and to raising awareness of and engaging in advocacy on the importance of adult immunization. Our mission is informed by scientific and empirical evidence that shows immunization improves health, protect lives against a variety of debilitating and potentially deadly conditions, and save 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 stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations. A top priority for AVAC is to achieve increased adult immunization rates through federal benchmarks and performance measures that encourage utilization of recommended vaccines.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems. Despite Advisory Committee on Immunization Practices (ACIP) recommendations, vaccines have been consistently underutilized in the adult population and lag behind the Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap (tetanus, diphtheria, pertussis), hepatitis B, herpes zoster, HPV). Disparities are even greater for at-risk populations, including seniors and people with chronic illnesses.

We note that the proposed rule includes changes intended to make Outpatient Prospective Payment System (OPPS) payments for all services more consistent with those of a prospective payment system and less like those of a per-service fee schedule. Within that overarching goal, we appreciate CMS’ acknowledgment that preventive services are different from other Medicare Part B drugs, and as such, are excluded from the majority of the proposed changes to packaging and other policies. AVAC supports the proposal to continue to pay separately for Medicare Part B vaccine administration services.

It is important to understand the unique and relatively complex nature of immunization services for clinicians. Many providers struggle with storage, inventory, and payment hurdles for vaccines. Managing all of these aspects under a capitated arrangement can actually result in declines in vaccine utilization. The unique cost and management challenges associated with vaccines in the provider office should be considered and not serve a disincentive for providers, particularly those serving low-income/minority populations. Standardizing the offering of vaccines has been shown to reduce differences in vaccination rates. Adequate provider payment rates support an important foundation of prevention through immunization.

Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs

The proposed rule includes Hospital OQR program measures sets previously adopted for CY 2020 payment determination as well as a table summarizing proposed and previously adopted measures for CY 2020 and beyond. Similarly, the proposed rule also includes measure sets previously finalized for the ASCQR for CY 2020 payment determination as well as measure sets previously finalized and proposed for CY 2021 and subsequent years’ payment determination. AVAC appreciates that both the Hospital OQR and ASCQR programs maintain Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431) among the core measure sets. Leading medical and health professional associations support influenza vaccination policies for healthcare professionals to help protect patients. AVAC strongly supports maintaining this measure in the Hospital OQR and ASCQR programs in the final rule.

The Advisory Committee on Immunization Practices (ACIP) recommends that all healthcare personnel (HCP) be vaccinated annually against influenza. Vaccination of HCP has been associated with reduced rates of work absenteeism and with fewer deaths among nursing home patients and elderly hospitalized patients. Although annual vaccination is recommended for all HCP and is a high priority for reducing morbidity associated with influenza in healthcare settings, national survey data have demonstrated that vaccination coverage levels are only approximately 70%, falling short of recommendations under Health People 2020 to increase the number of HCPs receiving an annual influenza vaccination to the target rate of 90%.

Healthcare personnel are the first line of defense when it comes to preventing illness and preserving health. Quality measurement reflecting this priority is essential to promoting and advancing prevention in the outpatient and ambulatory surgical healthcare settings and should remain a priority within these programs.

The Medicare Program Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs present an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC believes the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical Center Quality Reporting (ASCQR) should also include a focused, concerted effort to improve access to and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries. Last year, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. The paper highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging.

AVAC also encourages CMS to consider including influenza and pneumococcal immunization measures in the OQR and ASCQR programs and eventually incorporate measures that address all ACIP-recommended vaccines for adults. The health and economic burden of pneumococcal disease, particularly among elderly and high-risk adult populations, is significant. Yet, 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.

Future Measure Topics

AVAC appreciates the opportunity to respond to the request for comment on possible measure topics for future consideration in the Hospital OQR program. As the proposed rule notes, CMS programs are moving toward greater use of outcome measures and away from clinical process measures. Prioritizing quality measures around immunization in the Hospital OQR Program would help close existing measure gaps, improve upon immunization rates and health outcomes for the millions of Medicare beneficiaries seeking care in the outpatient hospital setting.

The proposed rule also notes intent to develop a quality measure set for the ASCQR Program that focuses on the following NQS and CMS Quality Strategy measure domains: Make care safer by reducing harm caused in the delivery of care; strengthen person and family engagement as partners in their care; promote effective communication and coordination of care; promote effective prevention and treatment of chronic disease; work with communities to promote best practices of healthy living; and make care affordable.

AVAC strongly urges CMS to consider including a core set of adult immunization quality measures that reflect the recommendations of the Advisory Committee on Immunization Practices (ACIP) adult immunization quality measures, as well as measures that reflect provider assessment of a patient’s immunization status, as part of CMS’ future measure selection and development process for the Hospital OQR and ASCQR Programs. Screening should be done by primary care, as well as specialty providers to ensure that everyone is counseled and has the opportunity to receive the appropriate immunizations, based on their age and health status. Published literature indicates that integrating immunization screening and additional providers offering these critical preventive services will result in greater opportunities for immunization. The National Vaccine Advisory Committee’s (NVAC) Adult Immunization Standards call for all providers caring for adult patients to assess, recommend, vaccinate or refer, and document vaccinations.

AVAC firmly believes that adult immunization quality measurement is central to ensuring continued focus on this core prevention intervention. We look forward to working with you toward improving upon adult immunization quality measures in both the Hospital OQR and ASCQR. AVAC shares your goal of building, strengthening and advancing a new generation of measures, as outlined in the CMS Quality Strategy. We are also committed to ensuring this new generation of adult immunization measures strikes the right balance in terms of the burden on providers while ensuring the integrity and societal value of quality measurement.

Immunization has demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and has been proven to improve overall health in a cost-efficient manner. Reducing the number of missed immunization opportunities for Medicare beneficiaries through outpatient and ambulatory surgical settings is an important step to improving health and reducing the burden of vaccine-preventable illness among this population.

Thank you for this opportunity to offer our perspective on this important proposed rule. Please contact the 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
BIO
Dynavax Technologies Corporation
Families Fighting Flu
GSK
Immunization Action Coalition
Medicago
Novavax
Sanofi
The Gerontological Society of America

AVAC Sends CMS Comments on the CY 2018 Physician Fee Schedule

AVAC wrote to CMS with comments on proposed changes to the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program. AVAC encouraged CMS to consider including a core set of adult immunization quality measures that reflect the full spectrum of recommendations of the Advisory Committee on Immunization Practices (ACIP) into the MSSP in future rule-making. AVAC also encouraged CMS to closely monitor the potential impact of payment models such as the MSSP on access to critical preventive services, such as immunization. AVAC asked that CMS consider for next year’s rule making, a modifier or other change for the time and effort required for counseling on vaccinations.

Letters to Administration

Quality Measures Supporting Providers

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September 11, 2017

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1676-P
P.O. Box 8016
Baltimore, MD 21244-8013

RE: Medicare Program: Revisions to Payment Policies Under Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program

Dear Administrator Verma:

AVAC appreciates the opportunity to offer comments in response to the Medicare Program: Revisions to Payment Policies Under Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program proposed rule.

As a stakeholder interested in advancing payment models that encourage access to essential preventive services such as immunization, we are grateful to CMS for its work in this area. AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to 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 mission is informed by scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against a variety of debilitating and potentially deadly conditions, and saving costs to the healthcare system and to society.

AVAC priorities and objectives are driven by a consensus process with the goal of enabling stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations. A top priority for AVAC is to achieve increased adult immunization rates through federal benchmarks and performance measures that encourage utilization of recommended vaccines.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems1. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines are underutilized in the adult population and lag behind Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, human papillomavirus vaccine (HPV)). Disparities are even greater among at-risk populations, including seniors and people with chronic illness, many of the same vulnerable populations Medicare covers across the country.

AVAC values the opportunity to offer our perspective on aspects of the proposed rule that are relevant to the provision of immunizations. Our coalition firmly believes that adult immunization quality measurement is central to ensuring continued focus on this core prevention intervention. AVAC shares your goal of building, strengthening and advancing a new generation of process and outcome measures, as outlined in the CMS Quality Strategy. We are also committed to ensuring this new generation of adult immunization measures bring increased value without adding burden on providers. We look forward to working with you toward improving upon existing adult immunization quality measures.

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

P. 34104 Medicare Shared Savings Program (MSSP)

The Medicare Shared Savings Program (MSSP) presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC believes the CMS should engage in a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries. Last year, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. The paper highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging.

AVAC commends CMS for maintaining the modified Annual Influenza Vaccination (ACO #14) and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s). These measures were included under the AIM: Better Health for Populations category. Monitoring immunization status and reporting of offered and administered immunizations to patients are critical preventive service benchmarks that help to ensure immunizations remain a priority under new payment models and in the forefront of clinical care standards. Reducing the number of missed immunization opportunities, particularly among Medicare beneficiaries, is critical to improving health and reducing the burden of vaccine preventable disease.

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

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

While influenza and pneumococcal represent a significant proportion of the disease burden from vaccine-preventable illness, there are also several other important immunizations recommended to individuals of Medicare age. AVAC encourages CMS to consider including a core set of adult immunization quality measures that reflect the full spectrum of recommendations of the Advisory Committee on Immunization Practices (ACIP) into the MSSP in future rulemaking. Prioritizing quality measures around immunizations would help close existing measure gaps, improve upon immunization rates and health outcomes for the millions of Medicare beneficiaries. The National Quality Forum (NQF) in its August 2014 report “Priority Setting for Healthcare Performance Measurement: Addressing Performance Measures Gaps for Adult Immunizations”, highlighted ten age specific and composite measure gap priorities that should be addressed.

For instance, AVAC would encourage CMS to consider including “Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?” as an MSSP measure in the final rule. This non-NQF endorsed measure is used under the Home Health Value-Based Purchasing Program. According to the CDC, 27.9 percent of adults age 60 and older reported receiving the herpes zoster vaccine.6 The health and economic burden associated with shingles and its complications are significant. As cited by the CDC, in 2007, the Agency for Healthcare Research and Quality (AHRQ) estimated the average cost of shingles and its complications to be $566 million a year while another study estimated the overall cost could be as high as $1.7 billion a year.

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

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

Additionally, as providers are under increased financial and time pressure in providing care, AVAC asks that CMS consider for next year’s rule making, a modifier or other change for the time and effort required for counseling on vaccinations. Low health literacy and cognitive issues for seniors can make education on immunizations a challenging and time-consuming effort for physicians. We believe that explicit recognition of the time and effort will create a tighter alignment between payment and the quality measure incentives for immunizations, as well as potentially reduce physician frustration with the increased demands of measurement in a value based system.

p. 34191 Medicare Diabetes Prevention Program Expanded Model (MDPP)

Lastly, under the proposed expansion of the diabetes prevention program, AVAC would strongly urge CMS to include provider assessment of vaccine status along with beneficiary education on the ACIP-recommended immunizations among the list of services for patients eligible to participate in the MDPP. Individuals with diabetes and multiple chronic conditions are at significantly higher risk of complications and death from vaccine preventable conditions such as influenza and pneumonia.

According to the American Diabetes Association, people with diabetes are three times more likely to die with flu and pneumonia, yet only a third of people with diabetes receive a pneumococcal vaccination and only 50% of people with diabetes receive an influenza vaccinatation. Provider assessment and education about the benefits and risks of immunization and awareness of which vaccines are specifically recommended for individuals with diabetes will help to reduce the number of missed immunization opportunities, improve overall health and reduce the incidence and burden of vaccine preventable disease for patients at high risk of serious and life-threatening complications.
Immunizations have demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and improving overall health in a cost-efficient manner. Reducing the number of missed immunization opportunities is imperative to improving health and reducing the burden of vaccine preventable illness among Medicare beneficiaries. AVAC looks forward to working with CMS to ensure that adult immunization quality measures incentivize improved access to and utilization of adult vaccines without imposing an additional burden on providers.

Sincerely,

BIO
Dynavax Technologies Corporation
GSK
Immunization Action Coalition
Medicago
National Association of Chain Drug Stores
Novavax
Pfizer
Sanofi
The Gerontological Society of America

AVAC Offers Comments on CMS’s Updates to the Quality Payment Program

AVAC wrote to CMS to offer comments in response to the Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. AVAC was encouraged to see that the following specialty sets include immunization related process quality measures. AVAC also urged CMS to look broadly across payment systems under its purview and incorporate a broad array of relevant adult immunization quality measures from other clinical settings. AVAC expressed disappointment that the proposed rule did not include quality measures aimed at patients at greater risk of serious complications from vaccine preventable illness.

Letters to Administration

Quality Measures

Download

August 21, 2017

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-5522-P
P.O. Box 8013 Baltimore, MD 21244-8013

RE: Medicare Program: CY 2018 Updates to the Quality Payment Program

Dear Administrator Verma:

AVAC appreciates the opportunity to offer comments in response to the Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. As a stakeholder interested in advancing new physician payment models that encourage access to essential preventive services such as immunization, we are grateful to CMS for its work in this area. AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to 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 mission is informed by scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against a variety of debilitating and potentially deadly conditions, and saving costs to the healthcare system and to society.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems1. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines are underutilized in the adult population and lag behind Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, human papillomavirus vaccine (HPV)). Disparities are even greater among at-risk populations, including seniors and people with chronic illness, many of the same vulnerable populations Medicare covers across the country.

The proposed rule seeks to advance payment and policy changes to the Quality Payment Program established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The law represented a significant step in the transition from a volume-based physician payment model to a system that rewards value.

For 2019, the proposed rule calls for the quality performance category to account for 60 percent of a clinician’s composite performance score (CPS), thereby representing a significant portion of their ultimate payment under MIPS. The measures ultimately selected under the quality performance category will have major implications in terms of clinicians’ delivery of care. AVAC appreciates that the 2018 proposed rule maintains important adult immunization measures such as NQF# 0041/110 – Preventive Care and Screening: Influenza Immunization and NQF# 0043/111- Pneumococcal Vaccination Status along with childhood and adolescent immunization measures. The proposed rule also removes cross cutting measures from most of the specialty sets but also seeks comment on ways to incorporate cross-cutting measures into MIPS in the future. With that in mind, AVAC would like to offer the following comments:

Cross-cutting Measures

Cross-cutting measures help focus our efforts on population health improvement. As recognized in Healthy People 2020, prevention of infectious disease through immunization is a key factor in improving the health of our nation. AVAC urges CMS to consider adding the following measures to the list of cross-cutting measures in the future.

➢ Preventive Care and Screening: Influenza Immunization (NQF# 0041/110) — Community/Population Health. Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization.

➢ Pneumococcal Vaccination Status (NQF# 0043/111) — Community/Population Health. Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine.

Prior to finalization, the 2017 rule eliminated immunization-related cross-cutting measures for influenza and pneumonia. AVAC believes that all Medicare providers, regardless of whether their scope of practice is focused on primary care or specialty care, should be incentivized to offer immunization services while providing care to patients. The influenza vaccine presents an annual opportunity for a beneficiaries’ main provider, which in the case of chronically ill patient, could be a specialist such as an endocrinologist, a cardiologist or another type of clinician, to review their immunization status and ensure they have access to ACIP-recommended vaccines.

Screening should be done by primary care, as well as specialty providers to ensure that everyone is counseled and has the opportunity to receive the appropriate immunizations, based on their age and health status. Published literature indicates that integrating immunization screening and additional providers offering these critical preventive services will result in greater opportunities for immunization.3. 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.

Advancing Care Information Performance Category (p. 30015)

One quarter (25 percent) of the MIPS final score is based on performance in the advancing care information (ACI) category, which consists of a base score, performance score and potential bonus points for reporting certain measures and activities. The FY18 proposed rule modifies the reporting standard for meeting the Immunization Registry Reporting Measure requirement to accommodate eligible clinicians in parts of the country where immunization registries are not available. While we do not oppose this modification, we believe it is vitally important that the Centers for Medicare and Medicaid Services (CMS) work to support expanded access and reporting to immunization registries across the country. According to the Centers for Disease Control and Prevention (CDC), Immunization Information Systems (IIS), or immunization registries, currently operate in all 50 states, 5 cities, the District of Columbia (D.C.) and 8 territories. While every state in the US presently operates an immunization registry, not all systems are equal, or can connect with all providers in a community. Limited resources and staffing as well as legal and policy barriers hinder the ability of all eligible clinicians in a community to report data to their state or local immunization registry. AVAC urges CMS to work with CDC and its IIS grantees to drive a higher level of interoperability and address legal and policy barriers that prevent Medicare clinicians from reporting data to immunization registries as required under Meaningful Use as well as the Advancing Care Information Performance category. The goal should be for Immunization Registry Reporting to eventually become a required reporting measure under MIPS.

Although immunizations are often administered in a clinical setting, a patient’s lifetime immunization record will span decades, and the consolidation of records as individuals move among health care providers is a unique public health function. It is this consolidated record that drives the accurate forecast of immunizations due, and past due, at the point of care. For this reason, seamless multidirectional interoperability between certified electronic health record technology (CEHRT) and public health in general, and IIS is essential to ensure the provision of appropriate clinical services, and a precursor for accurate measurement of quality care. It is also imperative that all immunization providers, including pharmacists, are able to exchange of relevant clinical information under Certified Electronic Health Record Technology (CEHRT), to ensure CMS and eligible clinicians are able to maximize the benefits of coordinated, team-based care.

Additionally, we recommend that the ACI incentivize and encourage the following:
• Sending reminders to patients using certified EHRs;
• Sending educational information to patients using EHRs;
• Implementing clinical decision support (CDS) tools to identify patients requiring vaccines;
• EHR generated lists of patients requiring immunizations;
• Use of ePrescribing technology to implement electronic, two-way communication between the vaccine-recommending clinician’s chart and that of the vaccinating provider, accomplishing health information exchange (HIE) and the exchange of and access to data between immunization providers within the immunization neighborhood.

These EHR functionalities will strongly promote immunization and assist busy clinicians in assessing, recommending, providing/referring for, and documenting immunizations –the four call-to-actions in the revised Standards for Adult Immunization Practice. Incorporating these functions will facilitate the implementation of technology that exists today but is not fully utilized—and stands as a barrier to increased adult immunization— including IIS reporting and two-way exchange of data between referring clinicians and vaccinating providers in complementary settings, such as pharmacies, hospitals, and health departments.

Moreover, the proposed rule differentiates the Immunization Registry Reporting Measure between active engagement under Stage 2 and Stage 3 reporting. AVAC appreciates that the proposed rule strongly encourages the reporting of immunization data and continues to advance efforts to provide for multidirectional data exchange. Immunization forecasts and patient histories are important tools that strengthen and enhance the ability of clinicians to educate patients and improve clinical decision making at the point of care. Also, ensuring that all immunization providers, including pharmacists, are able to report administered vaccines through an EHR would help to provide a comprehensive database from which to measure patient immunization status.

Lastly, vaccine management in private and public health care settings is an additional area where greater reporting and interoperability would be of benefit. EHR-IIS interoperability is essential to stronger and more efficient vaccine supply management through providing vaccine ordering, inventory, and accountability functions in clinical care settings, both during routine provision of immunizations and in cases of disease outbreaks.

MIPS APM List Comprehensive ESRD care (p. 30093)

AVAC is pleased that two Alternative Payment Model programs included influenza and pneumococcal immunization measures. Influenza and pneumonia are particularly dangerous for persons who are immunocompromised or who suffer from chronic conditions. Preventive measures such as immunizations can help to prevent costly hospitalizations, serious complications and even early mortality. Effective immunization programs can also help to prevent the transmission of deadly and debilitating infectious conditions among medically fragile populations within a community. The specific measures are listed below for the ESRD Care APM list as well as the Comprehensive Primary Care Plus (CPC+) Model APM list.

➢ Influenza Immunization for the ESRD Population (NQF# 0041/110). Community/Population Health. Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization.

➢ Pneumococcal Vaccination Status (NQF# 0043/111).
Community/Population Health. Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine.

MIPS APM List Comprehensive Primary Care Plus (CPC+)

➢ Preventive Care and Screening: Influenza Immunization (NQF# 0041/110). Community/Population Health. Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization.
➢ Pneumonia Vaccination Status for Older Adults. (NQF#0043/111). Community/Population Health. Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine.

MIPS Specialty Measure Sets (p. 30271)

The 2018 Quality Payment Program proposed rule added immunization quality measures to several specialty measure sets. AVAC is encouraged to see that the following specialty sets include immunization related process quality measures:

➢ Allergy/Immunology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults
➢ Family Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults and NQF # 1407 Immunizations for Adolescents
➢ Infectious Disease. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults and NQF # 1407 Immunizations for Adolescents
➢ Nephrology. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults
➢ Obstetrics/Gynecology. NQF# 0041 Preventive Care and Screening: Influenza Immunization.
➢ Otolaryngology. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults
➢ Pediatrics. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF #0038 Childhood Immunization Status and NQF # 1407 Immunizations for Adolescents
➢ Preventive Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults
➢ Rheumatology. NQF# 0041 Preventive Care and Screening: Influenza Immunization, NQF# 0043 Pneumonia Vaccination Status for Older Adults

AVAC was, however, disappointed that the proposed rule did not include quality measures aimed at patients at greater risk of serious complications from vaccine preventable illness. The ACIP includes age-based, as well as condition-specific recommendations for adult vaccination. For instance, patients living with chronic conditions such as heart disease and diabetes are at a significantly higher risk of complications and death from influenza and pneumonia. The CDC has reported that in 2013 only 21.2% of adults in this group had received a pneumococcal vaccination, and this number has been essentially unchanged for at least a decade.

Additionally, individuals with diabetes are at increased risk for hepatitis B infection. As such, the ACIP recommends hepatitis B vaccination for all patients with diabetes age 607 and under as well as other at-risk patients, such as those living with HIV/AIDS and chronic kidney disease. We strongly encourage CMS to add the following immunization quality measures into these specialty measure sets:

➢ Internal Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ Endocrinology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ Cardiology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
➢ Hemotology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.

General Surgery. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.The proposed rule notes that Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use measures from other CMS payment systems, such as measures for inpatient hospitals, for purposes of the quality and resource use performance categories. AVAC also appreciates that the 2018 proposed rule encourages the submission of potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. AVAC urges CMS to look broadly across payment systems under its purview and incorporate a broad array of relevant adult immunization quality measures from other clinical settings, such as the Herpes Zoster (Shingles) vaccination process measure being utilized in the home health value-based payment program – Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?

Considerations for Social Risk (p. 30134)

AVAC appreciates that the CMS continues to study and work with stakeholders to develop and utilize measures that appropriately account for risk factors such as socioeconomic and demographic characteristics, ethnicity and individual health status. We would also urge CMS to carefully consider the overall impact of the resource use measure on immunization services. We understand CMS plans to continue its review of recommendations from the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) on the issue of social risk factors. While disparities in childhood immunization rates by race/ethnicity have largely disappeared, disparities in immunization coverage rates along racial and ethnic lines continue to persist across the range of recommended adult immunizations.

The proposed rule seeks comment on the most appropriate social risk factors for stratifying measure scores and/or potential risk adjustment of a measure. The proposed rule notes that social risk factors include, but are not limited to the following: Dual eligibility/low-income subsidy; race and ethnicity; and geographic area of residence. Annual surveillance reports on vaccination coverage among adult populations stratify vaccination coverage by race/ethnicity. The 2015 Surveillance report found that “racial/ethnic differences in vaccination coverage persisted for all seven vaccines” and “Blacks, Hispanics and Asians had lower vaccination coverage than that of whites for all of the vaccines routinely recommended for adults, with just a few exceptions.”AVAC would urge CMS to consider including race/ethnicity in social risk factors for stratifying measure scores and/or potential risk adjustment of a particular measure.

AVAC would also urge CMS to consider an adjustment for socioeconomic status to ensure that clinicians who care for a disproportionate number of low-income beneficiaries are not inadvertently disadvantaged under the resource use calculation relative to their counterparts. It is important to understand the unique and relatively complex nature of immunization services for clinicians. Many providers struggle with storage, inventory, and payment hurdles for vaccines. Managing all of these aspects under a capitated arrangement can actually result in declines in vaccine utilization. It is vitally important that unique cost and management challenges are accounted for in quality measure reporting and do not create a disincentive for providers serving low-income/minority populations to offer important preventive services such as recommended immunizations. Standardizing the offering of vaccines has been shown to reduce differences in vaccination rates.

Immunizations have demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and improving overall health in a cost-efficient manner. Reducing the number of missed immunization opportunities is imperative to improving health and reducing the burden of vaccine preventable illness among Medicare beneficiaries. AVAC looks forward to working with CMS to ensure that adult immunization quality measures remain an integral component of the Quality Payment Program and are a focus of Alternative Payment Models (APMs) in the coming years as well.

Sincerely,

Alliance for Aging Research
American Immunization Registry Association (AIRA)
Asian Pacific Islander American Health Forum
BIO
Dynavax
Every Child By Two (ECBT)
GSK
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition
Immunization Coalition of Washington DC
National Association of County and City Health Officials (NACCHO)
Novavax
Sanofi
Sequirus
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health