AVAC Comments on the CY 2019 Medicare Program Home Health Prospective Payment System Update Proposed Rule

AVAC wrote to CMS to express concern that the CY 2019 Medicare Program Home Health Prospective Payment System Update proposed rule seeks to remove two important adult immunization measures from the Home Health Value Based Purchasing (HHVBP) Model beginning in performance year 4: Influenza Immunization Received for Current Flu Season (NQF#0522) and Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525).

August 31, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1689-P
P.O. Box 8013,
Baltimore, MD 21244-8013

RE: CMS-1689-P Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the CY 2019 Medicare Program Home Health Prospective Payment System Update proposed rule. We are deeply concerned the proposed rule seeks to remove two important adult immunization measures from the Home Health Value Based Purchasing (HHVBP) Model beginning in performance year 4: Influenza Immunization Received for Current Flu Season (NQF#0522) and Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525).

AVAC consists of over 50 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. 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. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Department of Health and Human Services (HHS) recognizes that immunization is an important tool to keep people healthy and reduce avoidable health care costs. In its Strategic Plan FY 2018 –2022, HHS acknowledges that “infectious diseases are a major health and economic burden for the United States.2” Additionally, strategic objective 2.1 makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.”2 Unfortunately, access to vaccines is not equal across a person’s lifespan. Despite the wellknown benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.

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 setting3. 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.

IV. Home Health Value-Based Purchasing (HHVBP) Model (p. 32426)
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. As such, we are strongly opposed to the proposal to remove the following OASIS-based process measures from the HHVBP for PY4 and subsequent performance years,

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

The proposed rule indicates that the Influenza Immunization Received for Current Flu Season (NQF#0522) is being considered for removal because the measure does not exclude HHA patients who were offered the vaccine but declined it and patients who were ineligible to receive it due to contraindications and as a result, may not fully capture Home Health Agency’s (HHA’s) true performance. However, it is important to note that the measure does include an exclusion in the denominator to account for “Episodes in which the patient does not meet the CDC guidelines for influenza vaccine.”

The proposed rule also seeks to remove the Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525) measure on the basis that it does not fully reflect the current ACIP guidelines. We acknowledge that the measure does not reflect current clinical practice standards, we would urge CMS to consider using an alternative pneumococcal measure Pneumonia Vaccination Status for Older Adults (NQF#0043). Other CMS quality programs have implemented this measure 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.

We believe that simply removing these measures in response to concerns will send the wrong message to HHAs that beneficiary immunization status is no longer a priority for CMS, despite the serious economic and health consequences of influenza and pneumococcal, particularly among the frail elderly.

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. Each year, influenza causes approximately 200,000 hospitalizations and an average of 36,000 deaths in the United States alone. Influenza immunization measures help increase access and utilization of this important vaccine by patients and health care providers alike. Immunizations provide especially high value among patients with chronic conditions, such as diabetes or chronic heart disease, who are at higher risk of adverse health consequences resulting from vaccine-preventable diseases.

Similarly, the Centers for Disease Control and Prevention (CDC) estimates 900,000 Americans get pneumococcal pneumonia each year, resulting in as many as 400,000 hospitalizations and more than 53,000 deaths. Among adults age 65 and older, the annual cost of pneumococcal disease is over $3 billion dollars. Despite the fact that most pneumococcal pneumonia deaths each year are adults, pneumococcal vaccination rates remain inadequate, with only 63 percent of adults over the age of 64 and 22 percent of high risk adults being vaccinated.

By contrast, AVAC appreciates that the HHVBP maintains the following measures:

➢ Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431)
➢ Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?

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%.10 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.

We also greatly appreciate that the HHVBP model maintains the Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination? Measure, as it is the only value-based payment program within CMS to recognize the value and importance of a herpes zoster (shingles) vaccination measure. 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.

According to the CDC, 27.9 percent of adults age 60 and older reported receiving the herpes zoster vaccine.12 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. AVAC urges CMS to maintain the influenza for health care personnel and the herpes zoster vaccination process measures in the HHVBP final rule.

V. Proposed Updates to the Home Health Quality Reporting Program (HHQRP) (p.32443)

AVAC is concerned by the proposed removal of the Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525) from the HHQRP beginning in 2021.We acknowledge that the measure does not reflect current clinical practice standards as noted in the proposed rule but we would urge CMS to consider using an alternative pneumococcal measure Pneumonia Vaccination Status for Older Adults (NQF#0043). Other CMS quality programs have implemented this measure 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.

We appreciate the HHQRP maintains the Influenza Immunization Received for Current Flu Season (NQF#0522) among the HHQRP quality measures presented in Table 54 for CY2020 and urge CMS to maintain the measure in the final rule.

Future Rulemaking

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. We look forward to working with CMS to ensure meaningful measures that reflect priority health care services, such as immunization, that also provide an accurate representation of HHA performance in the least burdensome manner possible can be included in the HHVBP and HHQRP in this comment cycle and future comment cycles.

The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have been spearheading the development and testing of a new composite measure for adult immunization, along with measures for maternal immunization and endstage renal disease patients. AVAC strongly supports an adult immunization composite measure that incorporates multiple ACIP-recommended vaccines and we look forward to working with CMS to support their widespread adoption. An adult composite measure would 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 strongly supports ongoing efforts 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.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,
Alliance for Aging Research
Biotechnology Innovation Organization (BIO)
Every Child by Two
Families Fighting Flu
Gerontological Society of America
GSK
Immunization Action Coalition
Immunization Coalition of Washington, DC
Medicago
National Hispanic Medical Association (NHMA)
Novavax
Sanofi
Seqirus

AVAC Submitted Comments to CMS on the Medicare Program Hospital Inpatient Psychiatric Facilities Prospective Payment proposed rule for FY 2019

AVAC wrote to CMS to ask that they maintain the various quality reporting requirements in Medicare in FY 2019. One of AVAC’s key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. Immunization quality measures are a crucial tool for health care quality improvement and have demonstrated effectiveness in increasing immunization rates.

June 26, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1690-P
P.O. Box 8010
Baltimore, MD 21244-1810

RE: CMS-1690-P Medicare Program; FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Hospital Inpatient Psychiatric Facilities Prospective Payment proposed rule for Fiscal Year 2019.

AVAC consists of over 50 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. Immunization quality measures are a crucial tool for health care quality improvement and have demonstrated effectiveness in increasing immunization rates.

The Advisory Committee on Immunization Practices (ACIP) recommends an annual influenza vaccination for all people age 6 months or older. Each year, influenza causes approximately 200,000 hospitalizations and an average of 36,000 deaths in the
United States each year.1 A Centers for Disease Control and Prevention (CDC) review of deaths associated with seasonal influenza between 1976 and 2007 found that 90 percent were among adults age 65 and older.2 According to a study in the Journal of Primary Prevention, this costs the United States about $8.3 billion or 54 percent of the total annual cost to treat vaccine-preventable diseases among US adults 65 and over. Influenza immunization measures help increase access and utilization of this important vaccine by patients and health care providers alike.

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.4 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.5

Preventing transmission of influenza and other infectious agents within inpatient psychiatric hospital settings requires a multi-faceted approach since the spread of influenza can occur among patients, Health Care Professionals (HCP), and visitors. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to the annual influenza vaccine.

The proposed rule would maintain Influenza Immunization IMM-2 (NQF #1659) for the FY2020 payment year, we are deeply concerned that the proposed rule seeks to remove Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) from the Inpatient Psychiatric Facilities (IPF) Quality Reporting Program prescribed in the rule. AVAC strongly urges CMS to maintain both measures in the FY 2020 payment reporting year for the reasons outlined in this letter.

Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program.
The proposed rule would make several changes to the IPFQR Program, including removal of the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) measure on the basis that the costs associated with this measure outweigh the benefit of its continued use in the program (Factor 8).

The proposed rule indicates that CMS originally adopted the Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) because “we recognize that influenza immunization is an important public health issue, especially for vulnerable patients who may have limited access to the healthcare system, such as patients in IPFs.” Indeed, persons with mental illness often have lower rates of influenza vaccination as compared to the general population. Many of these patients may also suffer comorbid conditions that make them even more susceptible to the adverse health effects of vaccine-preventable conditions such as influenza.

The Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) was adopted in the FY 2015 IPF PPS final rule, “due to public health concerns regarding influenza virus infection among the IPF population” and the measure addressed this concern “by assessing influenza vaccination in the IPF among healthcare personnel (HCP), who can serve as vectors for influenza transmission.” A recent commentary, Influenza in long-term care facilities notes, “a study of health care workers (HCW)s in an acute hospital during a mild epidemic season, found that 23% had serological evidence of new influenza infection during the season, implying a potential transmission risk to patients as between 28% and 59% of infected workers had subclinical infections and continued to work.”

The proposal to remove this measure is inconsistent with CMS’ own position and arguments with respect to this same measure in the inpatient hospital quality reporting program. The Hospital Inpatient Prospective Payment System proposed rule (CMS-1694-P) states with respect to the Influenza Vaccination Coverage Among Healthcare Personnel (HCP) measure (NQF #0431), it “promotes improved health outcomes among beneficiaries because: (1) health care personnel that have received the influenza vaccination are less likely to transmit influenza to patients under their care; and (2) vaccination of health care personnel reduces the probability that hospitals may experience staffing shortages as a result of illness that would impact ability to provide adequate patient care. Thus, we believe the costs associated with reporting this chart-abstracted measure outweighs the associated benefits of keeping it in the Hospital IQR Program.”

AVAC strongly believes removal of this measure from the IPFQR program would create greater inconsistency across inpatient quality reporting programs, add to provider reporting confusion and ultimately leave an extremely vulnerable population of Medicare beneficiaries more susceptible to vaccine preventable illness.

We strongly urge CMS to maintain the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) and support the proposal to maintain the Chart-Abstracted Clinical Process of Care Measure Influenza Immunization IMM-2 (NQF #1659) as part of the program for FY 2020 payment determination and subsequent years as well. These measures play a critical role in the CMS Quality Strategy as well as the National Quality Strategy in terms of influenza immunization efforts.

Influenza Quality Measures.
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 span7. 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. Adult coverage lags behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV.

Social Risk Factors. AVAC coalition members are working on projects that seek to identify and enhance our understanding of coverage gaps and are developing pilot programs to test targeted solutions where these disparities currently exist. The proposed rule indicates that CMS continues to work with the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering and Medicine on accounting for social risk factors in the Hospital IQR Program. We support the idea of future stratification of IPF QR Program data by race, ethnicity, geographic area, sex, and disability on Hospital Compare, as well as on potential future hospital quality measures that incorporate health equity. Additionally, we recommend that the data also be stratified by primary language. Together, this type of data will enable more accurate evaluation in coverage gaps and disparities, particularly among minority and vulnerable populations, and are essential to improving the impact of adult immunization efforts and expanding coverage.

New Measures. Lastly, AVAC strongly supports the future adoption of adult immunization measures to the IPF QRP in this rulemaking. The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have been instrumental in spearheading the development and testing of a new composite measure for adult immunization, along with measures for maternal immunization and end-stage renal disease patients. AVAC strongly supports an adult immunization measures that incorporate ACIP-recommended vaccines and we look forward to working with CMS to support their widespread adoption. An adult composite measure would 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 The National Committee for Quality Assurance (NCQA), Pharmacy Quality Alliance (PQA, Inc.) 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 Vaccines, 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 immunization schedule, such as those demonstrated by the Northwest Tribal Epidemiology Center11 and by the National Nursing Home Quality Care Collaborative, can improve patient health outcomes. Such a measure would put vaccination coverage rates into a larger context and encourage a more systematic approach for all vaccines.

In the meantime, the continued lack of pneumococcal quality measures in Medicare inpatient quality reporting programs is a missed opportunity to improve health and reduce unnecessary federal expenditures on treatment and hospitalizations as a result of this vaccine-preventable disease. Pneumonia is responsible for over a million hospitalizations and 50,000 deaths each year in the United States. Vaccines are an effective intervention against the high cost of medical care and rates of preventable death associated with this disease, particularly among medically vulnerable populations and the elderly. That is why the 2014 ACIP recommendations call for adults aged 65 years or older and individuals with underlying immunocompromising health conditions between 19 and 64 years of age to receive both PCV13 and PPSV23. ACIP also recommends PPSV23 for adults 19 through 64 years of age with underlying chronic health conditions like diabetes, heart disease, liver disease or lung disease (including people who smoke or have asthma). We strongly encourage CMS to prioritize inclusion of the Pneumococcal Vaccination for Older Adults in the IPF QRP and across the other inpatient hospital quality reporting programs.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,
Asian & Pacific Islander American Health Forum
Biotechnology Innovation Organization (BIO)
Every Child By Two
Gerontological Society of America
GSK
Immunization Action Coalition
National Association of County and City Health Officials
National Hispanic Medical Association
Novavax
Pfizer
Sanofi
Seqirus
Trust for America’s Health

AVAC Offers Thoughts on Medicare Program Inpatient Rehabilitation Facility Prospective Payment proposed rule for Fiscal Year 2019

AVAC expressed support that the proposed rule would maintain the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) for the FY2020 payment year, but concern that the proposed rule seeks to remove the Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF #0680) from the Inpatient Rehabilitation Facility Quality Reporting Program for fiscal year 2021. AVAC outlined reasons to maintain both measures in their letter to CMS.

June 26,2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1688-P
P.O. Box 8016
Baltimore, MD 21244-8016

RE: CMS–1694–P Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Inpatient Rehabilitation Facility Prospective Payment proposed rule for Fiscal Year 2019.

AVAC consists of over 50 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. Immunization quality measures are a crucial tool for health care quality improvement and have demonstrated effectiveness in increasing immunization rates.

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.1 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 proposed rule would maintain the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) for the FY2020 payment year, but we are deeply concerned that the proposed rule seeks to remove the Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF #0680) from the Inpatient Rehabilitation Facility Quality Reporting Program for fiscal year 2021. AVAC strongly urges CMS to maintain both for the reasons outlined in this letter.

IRF Quality Reporting Program (IRF QRP).

The proposed rule would remove two measures from the IRF QR Program, including the Influenza Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF #0680) measure on the basis that “measure performance among IRFs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.” (Factor 1) The measure was adopted in the FY 2014 IRF PPS final rule because many patients receiving care in the IRF setting are 65 years and older and considered to be the target population for the influenza vaccination.

Specifically, the CMS analysis revealed that for the 2015-2016 and the 2016-2017 influenza seasons, nearly every IRF patient was assessed and more than 75 percent of IRFs (n = 836) were vaccinating IRF patients who had not already received a flu vaccination. Additionally, over the last two influenza seasons, the number of IRFs who achieved a perfect score (100 percent) on this measure has grown substantially, increasing by approximately 50 percent from 146 IRFs (12.9 percent) in the 2015-2016 influenza season to 210 IRFs (18.8 percent) in the 2016-2017 influenza season. The mean performance score for this measure was between 91.04 and 93.88 percent over the last two influenza seasons. The proposed rule states, “proximity of these mean rates to the maximum score of 100 percent suggests a potential ceiling effect and a lack of variation that restricts distinction between facilities. Given that performance among IRFs has remained so high and that no meaningful distinction in performance can be made across the majority of IRFs, we are proposing the removal of this measure.”

AVAC strongly disagrees with this contention. Removal of the Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF #0680) of from the IRF QR Program will send the impression to rehabilitation hospitals that preventive health care services such as immunization are no longer a priority, despite the serious economic and health consequences of influenza outbreaks in the inpatient setting. The fact that the analysis of the measure for the last two influenza seasons indicates that nearly every IRF assessed and vaccinated patients is a clear indicator of the success of the measure. Sustained widespread assessment and documentation of influenza vaccination and the adoption of a composite metric reflecting the array of vaccines recommended by the ACIP should remain an utmost priority for patients in IRF settings since individuals residing in long-term care facilities “present a population very susceptible to the acquisition and spread of infectious diseases and for whom the consequences may be serious.”

AVAC strongly believes removal of the measure from the IPFQR program would create greater inconsistency across inpatient quality reporting programs, add to provider reporting confusion and ultimately leave an extremely vulnerable population of Medicare beneficiaries more susceptible to vaccine-preventable illness. These measures play a critical role in the CMS Quality Strategy as well as the National Quality Strategy in terms of influenza immunization efforts.

Influenza Quality Measures.
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.4 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.

Preventing transmission of influenza and other infectious agents within inpatient hospital settings requires a multi-faceted approach since the spread of influenza can occur among patients, Health Care Professionals (HCP), and visitors. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of the annual influenza vaccine.

The Advisory Committee on Immunization Practices (ACIP) recommends an annual influenza vaccination for all people age 6 months or older. Each year, influenza causes approximately 200,000 hospitalizations and an average of 36,000 deaths in the United States alone. A Centers for Disease Control and Prevention (CDC) review of deaths associated with seasonal influenza between 1976 and 2007 found that 90 percent were among adults age 65 and older. According to a study in the Journal of Primary Prevention, this costs the United States about $8.3 billion or 54 percent of the total annual cost to treat vaccine-preventable diseases among US adults 65 and over. Influenza immunization measures help increase access and utilization of this important vaccine by patients and health care providers alike.

In addition, data transparency of reported measures is an important tool for patients and families seeking to evaluate post-acute care settings and an essential component in the identification and management of influenza outbreaks. Tracking vaccine status among health care workers has the ability to increase vaccination rates and reduce absenteeism among healthcare personnel. We support public reporting IRF QRP data on a CMS website, such as IRF Compare and support maintaining the two above measures in this campaign. The 2014 National Healthcare Quality and Disparities Report by the Agency for Health Care Research and Quality (AHRQ) found that publicly-reported CMS measures were much more feasible than measures reported by other sources to stimulate high levels of performance.

Social Risk Factors. AVAC coalition members are working on projects that seek to identify and enhance our understanding of coverage gaps and are developing pilot programs to test targeted solutions where these disparities currently exist. The proposed rule indicates that CMS is currently reviewing reports by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering and Medicine on accounting for social risk factors in the Hospital IQR Program. We support the idea of future stratification of IFR QRP data by race, ethnicity, geographic area, sex, and disability on Hospital Compare, as well as on potential future hospital quality measures that incorporate health equity. Additionally, we recommend that the data also be stratified by primary language. Together, this type of data will enable more accurate evaluation in coverage gaps and disparities, particularly among minority and vulnerable populations, and are essential to improving the impact of adult immunization efforts and expanding coverage.

New Measures. AVAC believes the IRF QRP should include a focused, concerted approach to adult immunizations as a means of improving the overall health of patients in post-acute care facilities. The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have been instrumental in spearheading the development and testing of a new composite measure for adult immunization, along with measures for maternal immunization and end-stage renal disease patients. AVAC strongly supports an adult immunization measures that incorporate ACIP-recommended vaccines and we look forward to working with CMS to support their widespread adoption. AVAC strongly supports the future adoption of an adult immunization composite measure that would provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP). We encourage CMS to consider future adoption in the IRF QRP of adult immunization measures that reflects ACIP recommended vaccines. We value your request for comment on potential new quality measures under consideration for future inclusion in the IRF Quality Reporting Program. AVAC appreciates the work of The National Committee for Quality Assurance (NCQA), Pharmacy Quality Alliance (PQA, Inc.), 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 Vaccines, 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 immunization schedule, such as those demonstrated by the Northwest Tribal Epidemiology Center12 and by the National Nursing Home Quality Care Collaborative, can improve patient health outcomes. Such a measure would put vaccination coverage rates into a larger context and encourage a more systematic approach for all vaccines.

In the meantime, the current lack of pneumococcal quality measures in Medicare inpatient hospital quality reporting programs is a missed opportunity to improve health and reduce unnecessary federal expenditures on treatment and hospitalizations as a result of this vaccine-preventable disease. Vaccines are an effective intervention against the high cost of medical care and rates of preventable death associated with this disease, particularly among medically vulnerable populations and the elderly. That is why the 2014 ACIP recommendations call for adults aged 65 years or older and individuals with underlying immunocompromising health conditions between 19 and 64 years of age to receive both PCV13 and PPSV23. ACIP also recommends PPSV23 for adults 19 through 64 years of age with underlying chronic health conditions like diabetes, heart disease, liver disease or lung disease (including people who smoke or have asthma). We strongly encourage CMS to prioritize adding the NCQA Pneumococcal Vaccination Coverage for Older Adults measure pneumococcal immunization measurement back into the IRF quality reporting program and across the other inpatient hospital quality reporting programs.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Asian & Pacific Islander American Health Forum
Biotechnology Innovation Organization (BIO)
Every Child By Two
Gerontological Society of America
GSK
Immunization Action Coalition
Medicago
National Association of County and City Health Officials
National Hispanic Medical Association
Novavax
Pfizer
Sanofi
Seqirus
Trust for America’s Health

AVAC Comments on CMS’s Medicare Program Hospital Inpatient Prospective Payment proposed rule for FY 2019

AVAC wrote to CMS with concerns that the proposed rule seeks to remove key benchmarks for influenza immunization from quality reporting programs prescribed in the rule. One of AVAC’s key priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. Immunization quality measures are a crucial tool for health care quality improvement and have demonstrated effectiveness in increasing immunization rates.

June 25, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1694-P
P.O. Box 8011
Baltimore, MD 21244-1850

RE: CMS–1694–P Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Hospital Inpatient Prospective Payment proposed rule for Fiscal Year 2019.

AVAC consists of over 50 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations.

One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of immunization status that will result in increased adult immunization rates. Immunization quality measures are a crucial tool for health care quality improvement and have demonstrated effectiveness in increasing immunization rates.

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.1 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.

That is why we are deeply concerned that the proposed rule seeks to remove key benchmarks for influenza immunization from quality reporting programs prescribed in the rule. Specifically, the proposed rule calls for the removal of the following measures from quality reporting programs.

• Influenza Immunization measure (NQF #1659) (IMM-2) from the Hospital Inpatient Quality Reporting (IQR) Program.
• Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF #0680) from the Long-Term Care Hospital QRP.

Influenza Quality Measures. 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.2 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.

Preventing transmission of influenza and other infectious agents within inpatient hospital settings requires a multi-faceted approach since the spread of influenza can occur among patients, Health Care Professionals (HCP), and visitors. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to the annual influenza vaccine.

The Advisory Committee on Immunization Practices (ACIP) recommends an annual influenza vaccination for all people age 6 months or older. Each year, influenza causes approximately 200,000 hospitalizations and an average of 36,000 deaths in the United States each year. A Centers for Disease Control and Prevention (CDC) review of deaths associated with seasonal influenza between 1976 and 2007 found that 90 percent were among adults age 65 and older.3 According to a study in the Journal of Primary Prevention, this costs the United States about $8.3 billion or 54 percent of the total annual cost to treat vaccine-preventable diseases among US adults 65 and over.4 Influenza immunization measures help increase access and utilization of this important vaccine by patients and health care providers alike.

Hospital Inpatient Quality Reporting (IQR). We urge CMS to maintain the Chart-Abstracted Clinical Process of Care Measure Influenza Immunization IMM-2 (NQF #1659) along with the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431). These measures play a critical role in the CMS Quality Strategy as well as the National Quality Strategy in terms of influenza immunization efforts.

The proposed rule would remove (NQF#1659) (IMM-2) beginning with the CY 2019 reporting period on the basis that hospital performance on IMM-2 is statistically “topped-out” (Removal Factor 1), meaning there is “statistically indistinguishable performance at the 75th and 90th percentile and the measure’s truncated coefficient of variation is less than or equal to 0.10” and the costs associated with the measure outweigh the benefits (Removal Factor 8).

The proposed rule states, “[o]ur topped-out analysis shows that administration of the influenza vaccination to admitted patients is widely in practice and there is little room for improvement. We believe that hospitals will continue this practice even after the measure is removed; thus, utility in the program is limited.” AVAC strongly disagrees with this contention. Removal of IMM-2 from the IQR program will send the impression to hospitals that preventive health care services such as immunization are no longer a priority, despite the serious economic and health consequences of influenza outbreaks in the inpatient setting.

The proposed rule also indicates that “the costs associated with a measure outweigh the benefit of its continued use in the program” based on the information collection burden associated with manual chart abstraction, and it does not directly measure patient outcomes. The preamble of the proposed rule says, “one of the goals of the Meaningful Measures Initiative is to reduce costs associated with payment policy, quality measures, documentation requirements, conditions of participation, and health information technology. The proposed rule estimates that the cumulative savings of removing IMM-2 as well as two other measures would be approximately “$38.3 million across all 3,300 IPPS hospitals participating in the Hospital IQR Program for CY2019 reporting period/FY2021 payment determination.”

Another goal of the Meaningful Measures Initiative is to utilize measures that are “outcome-based where possible.” IMM-2 is a process measure that tracks patients assessed and given an influenza vaccination with their consent but does not directly measure patient outcomes.” This point of view does not take into account the fact that unlike other clinical interventions, preventive health services, such an influenza vaccination, cannot be measured in terms of outcomes since the outcome is the absence or the reduction in severity of a disease.

Removal of IMM-2 is also inconsistent with CMS’ own position and arguments with respect to this same measure in the inpatient psychiatric facility quality reporting program. The Hospital Inpatient Psychiatric Facilities Prospective Payment System proposed rule (CMS-1690-P) states with respect to the Influenza Immunization IMM-2 (NQF #1659), “the measure set remains responsive to the public health concern of influenza infection.”

PPS-exempt Cancer Hospital Quality Reporting Program (PCHQR). We support the proposal to maintain Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) as part of the program for the FY 2020 payment determination and subsequent years but would urge CMS to not defer public display of the measure till calendar year 2019. Ensuring healthcare personnel vaccination adherence against influenza has been shown to improve patient safety and reduce disease transmission, which is essential for immunocompromised patients in the cancer hospital setting. Empowering patients and caregivers with the ability to assess cancer hospitals based on this measure could ultimately result in improved outcomes for patients through lower complications.

Long-term Care Hospitals Quality Reporting Program (LTCHQRP). We are deeply concerned by the proposal to remove the Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF #0680) beginning with the FY 2021 LTCH QRP on the grounds that the costs associated with a measure outweigh the benefit of its continued use in the program. The measure was adopted in the FY2013 LTCH QRP to act as “a safeguard for patients who did not receive vaccinations prior to admission to an LTCH, since many patients receiving care in the LTCH setting are older adults, those 65 years and older, considered to be the target population for the influenza vaccination.” The fact that the analysis of the measure for the 2016-2017 influenza season indicates that nearly every patient was assessed by the LTCH upon admission is a clear indicator of the success of the measure. Continued widespread assessment and documentation of influenza vaccination and the adoption of a composite metric reflecting the array of vaccines recommended by the ACIP should remain an utmost priority for patients in LTCH settings since individuals residing in long-term care facilities “present a population very susceptible to the acquisition and spread of infectious diseases and for whom the consequences may be serious.”

The proposed rule notes that stakeholders have argued that the data collection associated with this measure is administratively costly and burdensome for LTCHs, and that the process of assessing whether vaccination is needed is often a duplicative process for patients who were already screened during their proximal stay at an acute care facility. The proposed rule contends that removing the measure would “reduce provider reporting costs and burden by eliminating duplicative patient assessments across healthcare settings, minimizing data collection and reporting, and avoiding potentially confusing public reporting of other influenza-related quality measures.” However, the proposed rule also seeks to remove Influenza Immunization measure (NQF #1659) (IMM-2) from the Hospital Inpatient Quality Reporting (IQR) Program. In other words, the proposed rule would go from an alleged over-reporting of a patient’s influenza vaccination status to absolutely no assessment or reporting in either the acute of LTC hospital settings. We strongly believe such a change will have a drastic negative impact in terms of future hospital influenza outbreaks. AVAC believes this approach is shortsighted and will result in increased costs to the health care system over the long-term.

We appreciate that the proposed rule maintains Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431) quality measures in the LTCH QRP for FY 2020. Data transparency of reported measures is an important tool for patients and families seeking to evaluate LTCH settings and an essential component in the identification and management of influenza outbreaks. We support public reporting LTCH QRP data on a CMS website, such as Hospital Compare and support the inclusion of the two above measures in this effort. Tracking vaccine status among health care workers has the ability to increase vaccination rates and reduce absenteeism among healthcare personnel.

Last year’s rule discussed CMS efforts to identify standardized patient assessment data that could be incorporated into assessment instruments across post-acute care settings. Streamlining adult immunization quality measures across health care settings remains an AVAC priority and supports this effort. Greater consistency in quality measurement tools will facilitate data exchange across health care providers as well as improve care coordination and ultimately patient outcomes. In that vein, preventing transmission of influenza virus within healthcare settings requires a multi-faceted, cross-cutting approach.

Social Risk Factors. AVAC coalition members are working on projects that seek to identify and enhance our understanding of coverage gaps and are developing pilot programs to test targeted solutions where these disparities currently exist. The proposed rule indicates that CMS continues to work with the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering and Medicine on accounting for social risk factors in the Hospital IQR Program. We support the idea of future stratification of Hospital IQR Program data by race, ethnicity, geographic area, sex, and disability on Hospital Compare, as well as on potential future hospital quality measures that incorporate health equity. Additionally, we recommend that the data also be stratified by primary language. Together, this type of data will enable more accurate evaluation in coverage gaps and disparities, particularly among minority and vulnerable populations, and are essential to improving the impact of adult immunization efforts and expanding coverage.

New Measures. Lastly, AVAC strongly supports the future adoption of streamlined adult immunization measures to the QRPs outlined in this rulemaking. The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevention (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have been instrumental in spearheading the development and testing of a new composite measure for adult immunization, along with measures for maternal immunization and end-stage renal disease patients. AVAC strongly supports an adult immunization measures that incorporate ACIP-recommended vaccines and we look forward to working with your office to support their widespread adoption. Adult composite measures 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 Vaccines, 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 immunization schedule, such as those demonstrated by the Northwest Tribal Epidemiology Center and by the National Nursing Home Quality Care Collaborative, can improve patient health outcomes. Such a measure would put vaccination coverage rates into a larger context and encourage a more systematic approach for all vaccines.

In the meantime, the continued lack of pneumococcal quality measures in Medicare inpatient hospital quality reporting programs is a missed opportunity to improve health and reduce unnecessary federal expenditures on treatment and hospitalizations as a result of this vaccine-preventable disease. Pneumonia is responsible for over a million hospitalizations and 50,000 deaths each year in the United States. Vaccines are an effective intervention against the high cost of medical care and rates of preventable death associated with this disease, particularly among medically vulnerable populations and the elderly. That is why the 2014 ACIP recommendations call for adults aged 65 years or older and individuals with underlying immunocompromising health conditions between 19 and 64 years of age to receive both PCV13 and PPSV23. ACIP also recommends PPSV23 for adults 19 through 64 years of age with underlying chronic health conditions like diabetes, heart disease, liver disease or lung disease (including people who smoke or have asthma). We strongly encourage CMS to prioritize inclusion of the Pneumococcal Vaccination for Older Adults in the Hospital IQR program and across the other inpatient hospital quality reporting programs.

We appreciate this opportunity to share our perspective on this proposed rule. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
Asian & Pacific Islander American Health Forum
Biotechnology Innovation Organization (BIO)
Every Child By Two
GSK
Immunization Action Coalition
Infectious Diseases Society of America
Medicago
National Association of County and City Health Officials
National Hispanic Medical Association
Novavax
Pfizer
Pharmaceutical Research and Manufacturers of America (PhRMA)
Sanofi
Seqirus
Trust for America’s Health

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.

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.

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.

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.

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. We hope that CMS will explore including a herpes zoster measure in other value-based purchasing and quality reporting programs in the future, particularly since there new ACIP recommendations.

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.

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.

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.

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