Archives: Letters

September 27, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1713-P
P.O. Box 8010,
Baltimore, MD 21244-8010

RE: CMS-1713-P Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program End Stage Renal Disease Prospective Payment System (ESRD PPS) and Quality Incentive Program proposed rule. AVAC remains deeply concerned that the ESRD PPS no longer includes immunization quality measures for health care professionals or the patients they serve. Our coalition strongly encourages CMS to consider the inclusion of the Composite ESRD Immunization measure for ACIP-recommended vaccines (influenza, pneumococcal and hepatitis B) under the ESRD Quality Incentive Program (ESRD QIP) in the final rule. This new composite measure would promote higher quality and more efficient health care for vulnerable ESRD patients who are at increased risk of vaccine preventable illness.

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

Despite the well-known 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.5,6 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.” 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.” Unfortunately, access to vaccines is not equal across a person’s lifespan.

Composite ESRD Vaccination Measure
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 spearheaded the development and testing of a new composite measure for end-stage renal disease patients covering influenza, pneumococcal and hepatitis B vaccines. A review of CMS fee-for-service claims data warrants the use of such a measure as current vaccination rates for the ESRD population fall well below recommended targets.

Research has shown that kidney care centers with vaccination protocols have demonstrated reduced infection rates and resulted in decreased morbidity and mortality. Vaccines, including hepatitis B and pneumococcal conjugate and pneumococcal polysaccharide, are specifically recommended for dialysis or CKD patients. However, like with other adult populations, vaccines are underutilized in CKD patients, who could benefit greatly from improved access to immunization services.

A composite measure for ACIP-recommended vaccines for ESRD patients would be of great benefit to the ESRD QIP now and in the future. The ESRD QIP presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries that preserves health and avoids unnecessary health expenditures due to vaccine preventable illness. AVAC strongly believes the ESRD QIP should include a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of patients living with kidney disease. An ESRD 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).

We look forward to working with CMS to ensure meaningful measures that reflect priority health care services, such as immunization, that will streamline and reduce the reporting burden on providers, provide an accurate representation of ESRD facility performance in the least burdensome manner possible and provide meaningful data to the Medicare program on access to this important preventive service.

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

Sincerely,

Alliance for Aging Research
Asian & Pacific Islander American Health Forum (APIAHF)
Association of Immunization Managers
Biotechnology Innovation Organization
Families Fighting Flu
GSK
Immunization Action Coalition (IAC)
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
Novavax
Sanofi
Seqirus
The Gerontological Society of America
Trust for America’s Health

June 24, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services Attention: CMS-11716-P
P.O. Box 8013
Baltimore, MD 21244-1850

RE: CMS–1716–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 2020.

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. 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.

Influenza Quality Measures.

The Department of Health and Human Services 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.

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. 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.

Hospital Inpatient Quality Reporting (IQR)/ PPS-exempt Cancer Hospital Quality Reporting Program/Long-term Care Hospitals Quality Reporting Program (LTCHQRP).

We support the proposal to maintain the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431). This measure plays a critical role in the CMS Quality Strategy as well as the National Quality Strategy in terms of influenza immunization efforts. 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. 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 supports the adoption of streamlined adult immunization composite measure 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 adult immunization composite measure (influenza, Td/Tdap, zoster and pneumococcal), along with measures for maternal immunization and end-stage renal disease patients. AVAC strongly supports the addition of an adult immunization measure that incorporates 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.

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)
Families Fighting Flu
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
STC Health
The Gerontological Society of America
Trust for America’s Health
Vaccinate Your Family

January 17, 2019

Don Wright, MD, MPH, FAAFP
Deputy Assistant Secretary for Health
Office of Disease Prevention and Health Promotion
Department of Health and Human Services
Tower Building 1101 Wootton Parkway, Suite LL100
Rockville, MD 20852

Re: Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for Healthy People 2030

Dear Dr. Wright:

The Adult Vaccine Access Coalition (AVAC) greatly appreciates the opportunity to provide our comments on the Secretary’s Advisory Committee on National Health and Disease Prevention proposed Immunization and Infectious Disease (IID) objectives for Healthy People (HP) 2030.

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 demonstrated benefits of adult immunization as a preventive measure that protects lives and avoids costly health care expenditures. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system.

Over the past several decades, Healthy People immunization and infectious disease objectives have been a core benchmark for national efforts to improve and maintain immunization coverage across the lifespan. These federal objectives help to guide the actions of public and private stakeholders across the national, state and local landscapes who are committed to improving the health and wellbeing of our nation and provide a foundation for measuring progress.

We appreciated previous opportunities to offer comments to the Healthy People 2030 Framework and through the open comment period. We were grateful to have had the chance to meet with officials within the HHS Office of Disease Prevention and Health Promotion to learn more about the HP2030 process. At that time, AVAC shared recommendations, including our interest in the development of a Lifespan Immunization Objective as a Leading Health Indicator (LHI); strengthening and maintaining existing adult immunization measures (influenza, pneumococcal, shingles); incorporating the Adult Immunization Composite Measure in HP 2030 Objectives; broadening the Hepatitis B vaccine coverage measure to the full population (2020 objective only addresses coverage among health care personnel); encouraging the inclusion of lifespan immunization records in a fully operational, population-based immunization information system (IIS); and increasing the focus on addressing disparities in adult immunization rates.

We are disappointed that the proposed 2030 IID objectives deviated greatly from AVAC’s previous recommendations and are deeply concerned that the proposed 2030 objectives will significantly minimize and weaken immunization related activities over the coming decade. These proposed objectives fail to reflect the HHS Strategic Plan FY2018–2022, which acknowledges that “infectious diseases are a major health and economic burden for the United States.” Objective 2.1 of the Strategic Plan makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.”2 Yet, despite the availability of vaccines that protect adults against 14 different diseases, in addition to the well-known benefits of immunizations, more than 50,000 adults die from vaccine preventable conditions each year.

We wish to offer the following recommendations to the proposed Healthy People 2030 IID objectives so that they remain an important and meaningful benchmark in improving and maintaining immunization coverage across the lifespan:

We encourage the Committee to emphasize immunizations across the lifespan. We appreciate that the Committee maintained a lifespan seasonal influenza vaccination objective (IID-2030-13) that streamlines multiple age cohort objectives from Healthy People 2020. Coverage against seasonal influenza is an urgent public health priority. According to the Centers for Disease Control and Prevention, a 6.2 percent reduction in the adult immunization rate for flu during the 2017-18 influenza season was a contributing factor in the record number of deaths. The flu accounts for an estimated 8.95 billion, or 65% of the annual economic burden of adult vaccine-preventable diseases. The Healthy People 2020 target 70 percent vaccination rate is an appropriate and achievable goal for Healthy People 2030. We strongly urge the Committee to take a similar, consistent approach with regard to other ACIP- recommended vaccines. We understand and appreciate that a core aspect of the Healthy People 2030 process is to significantly reduce the number of objectives and to focus on objectives that can be reasonably and effectively measured and maintained. Federal leadership in immunization objectives to protect against vaccine preventable conditions across the lifespan can be effectively monitored through existing data sources and would yield important benefits across the health care system.

We ask that the Committee incorporate the new adult immunization composite measure (influenza, Td/Tdap, zoster and pneumococcal) as a Healthy People 2030 objective. 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 have developed and tested a new composite measure for adult immunization which includes flu, Tdap, shingles, and pneumonia vaccines. It has been successfully utilized in the Indian Health Service program and is now being initially rolled out in HEDIS 2019.

Having a composite objective as part of HP2030 would put vaccination coverage rates into a larger context and encourage a more consistent approach for all vaccines. The composite is very much in line with the Healthy People 2030 plan to set national goals and measurable objectives to guide evidence-based policies, programs and other actions to improve health and well-being. An adult immunization composite objective would provide a single focal point to promote adherence to the adult immunization clinical standards of care. The addition of an adult composite would be complementary to similar composite objectives included for children and adolescent immunization status as part of Healthy People 2020, and would provide an efficient and robust means to monitor immunization coverage among specific populations at the national level.

At the same time, adopting the adult composite would align HP2030 objectives with external health care quality measurements tools, which in turn would help to streamline the patchwork of existing adult immunization measures, reduce the reporting burden, and provide a meaningful national picture of access to this important preventive service. An adult immunization composite objective would provide a clear national target for patients and providers on this important population health imperative.

AVAC advocates for the Committee to include a Hepatitis B vaccine coverage objective (proposed objective IID-2030-02). AVAC is deeply concerned about the recent rise in acute hepatitis B (HBV) infection rates in many parts of the U.S. as a result of the ongoing opioid crisis, with rates increasing by 100% to over 400% in some states. It is estimated that up to 2.2 million Americans are living with HBV. Chronic Hepatitis B increases the odds of liver cancer 50 to 100 times, and 1 in 4 individuals with chronic HBV will develop cirrhosis, liver failure and/or liver cancer. Despite the availability of current HBV vaccines to protect against this devastating condition and prevent its spread, there are up to 70,000 new infections each year. This number is exacerbated by the ongoing opioid epidemic affecting primarily young adults.

National survey data indicate only a quarter of adults age 19 and older are fully immunized, as adults aged approximately 25 years and older were not routinely vaccinated against hepatitis B at birth in the U.S. Recent studies also suggest that hepatitis B vaccine coverage is low among people with diabetes, HIV-infected individuals, hepatitis C-infected individuals, and individuals with chronic liver disease and chronic kidney disease, who are all at significantly increased risk of acquiring hepatitis B infection without completed immunization. The March 2017 report of the National Academy of Sciences, A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report, recommended a series of actions across five areas that will help bring the elimination of viral hepatitis by 2030. The report found that a 50 percent reduction in mortality from chronic hepatitis B would result in 60,000 fewer deaths. The report also noted that hepatitis elimination requires coordinated action from federal and state agencies involved in this effort. Healthy People 2020 included a developmental objective to increase hepatitis B vaccine coverage among high-risk populations. Unfortunately, there is no Hepatitis B immunization objective as part of the HP2030.

AVAC urges the Committee to restore an immunization information system reporting objective (IID-20) and would encourage it be expanded to include reporting of immunization records across the lifespan (childhood/adolescent/adult). With the growing importance of health information technology, Immunization Information Systems (IIS) are an essential part of immunization infrastructure. IIS are confidential systems that allow real-time access to comprehensive, consolidated immunization records for individuals. Improving IIS and integrating them into the healthcare system is critical to expanding access to and utilization of immunizations and, in turn, will lead to a healthier future. IIS can be used by providers to help determine which recommended vaccines may be appropriate for a patient. IIS can also provide aggregate data on immunizations coverage (and gaps). This information is valuable for surveillance and program operations and guiding public health action. IIS serve as a vital link to responding to a vaccine-preventable disease outbreak or community or public health emergency.

Every state has an IIS, and although many people associate IIS with keeping track of childhood immunizations, at least 42 states maintain immunization records across patients’ full lifespans. Despite the benefits of IIS, several factors inhibit the use of IIS for adults, including: wide variations in use and capabilities for registries to accept adult immunization records, depending on the state, and the need for opt-in approval to roll childhood data into adult immunization registries; limited staff time and resources; the need for additional education and awareness; costs associated with EHR modifications; and technical interface challenges between a provider EHR and IIS. The fact that adults receive vaccinations in a variety of different settings (clinical practices, pharmacies, employer-sponsored health clinics, etc.) poses an additional challenge and supports IIS’ value to coordination of care. HP2020 included childhood (target 95 percent under age 6) and adolescent (80 percent between ages 11 and 18 with at least 2 records) immunization reporting objectives. AVAC recommends one lifespan IIS objective that would elevate immunization record capture into an IIS to be more of a national priority.

AVAC urges the Committee to increase the focus on addressing disparities in adult immunization rates. AVAC appreciates and supports the Advisory Committee’s commitment to better identify and target disparities in HP2030 objectives. Disparities persist in immunizations, with generally lower immunization coverage in certain racial and ethnic groups. 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. As such, AVAC supports the idea of stratification of Heathy People 2030 objective data by race, ethnicity, geographic area, sex, and disability as well as potential objectives to incorporate health equity. Maintaining a focus on addressing disparities 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.

AVAC urges the Committee to elevate infectious disease and immunization as a leading health indicator for (LHI) HP2030. The disparate nature of our health care system leads to a range of challenges and barriers to access across payers, providers and patients. The 2016 Department of Health and Human Services’ National Vaccine Program Office National Adult Immunization Plan, cites the following barriers to adult immunization: lack of information about recommended vaccines; financial hurdles; technological, logistical, linguistic and socioeconomic obstacles. Such barriers could be overcome by communicating immunization as a high-priority health issue. A strong emphasis on immunizing the American public would support healthy aging and would help to lessen the impact of vaccine preventable conditions and their complications, particularly among at risk populations such as the elderly, persons with chronic illness and pregnant women. At the same time, it would make economic sense by reducing avoidable health care costs, such as hospitalizations and other expensive medical interventions.

In addition to the above priorities, we wish to record our support for the following childhood and maternal IID Healthy People 2030 objectives.

1. Expand the pregnancy immunization developmental measure (IID-2030-D01) to include all ACIP-recommended vaccines. We strongly encourage the Committee expand the parameters of the objective so it can reflect current maternal immunization composite that includes influenza. Beyond influenza, there is a strong indication that important vaccines, such as RSV and Streptococcal B, may become available and recommended for pregnant women in the coming decade. A composite objective that reflects ACIP-recommended vaccines would enable those new vaccines to be monitored.
2. Including an objective to measure the number of adolescents who have received all ACIP-recommended vaccines by age 13. We commend the Committee’s inclusion of the objective IID-2030-12: Increase the percentage of adolescents aged 13 through 15 years who receive recommended doses of human papillomavirus (HPV) vaccine. Despite the disease prevalence, vaccination rates remain low so it is extremely important that HP 2030 encourage HPV vaccination. However, there are no proposed objectives related to receipt of other adolescent vaccines. HP2030 should seek to improve vaccination rates for adolescents, just as it does for young children, as both age cohorts are vulnerable to dangerous diseases that can be prevented by recommended vaccines. Given the very different vaccination rates between HPV and other immunizations recommended for adolescents, we believe a composite measure is very important for ensuring our children remain protected from tetanus, diphtheria, pertussis and meningococcal disease.
3. Adding an objective to measure the number of children who have received all ACIP-recommended vaccines by age 6. We believe this measure is distinct from the currently proposed IID-2030-11, which would identify the number of children who have received no vaccines by age 2. Many children who are not fully immunized have missed only some vaccines, not all. By focusing on children who are simply missing some vaccine by age 6, we can better identify whether ongoing access issues or mistaken beliefs are affecting immunization levels.

Thank you again for this opportunity to offer our thoughts and recommendations on the proposed HP2030 objectives. Please contact an AVAC Coalition Manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to further discuss our comments. To learn more about the work of AVAC visit www.adultvaccinesnow.org.

Sincerely,

Alliance for Aging Research
American College of Preventive Medicine
American Immunization Registry Association
American Pharmacists Association
Asian & Pacific Islander American Health Forum (APIAHF)
Association of Asian Pacific Community Health Organizations (AAPCHO)
Biotechnology Innovation Organization (BIO)
Dynavax
Families Fighting Flu
GSK
Hep B United
Hepatitis B Foundation
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition (IAC)
Immunize Nevada
Medicago
National Association of County and City Health Officials (NACCHO)
National Association of Chain Drug Stores (NACDS)
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association (NHMA)
Novavax
Sanofi
Scientific Technologies Corporation
Seqirus
Takeda Vaccines
The Gerontological Society of America
Trust for America’s Health
University of Pennsylvania
Vaccinate Your Family
Walgreens

September 10, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1693-P
P.O. Box 8016
Baltimore, MD 21244-8016

RE: CMS-1693-P Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other  Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Reporting Program; and Medicaid Promoting Interoperability Program

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Reporting Program; and Medicaid Promoting Interoperability Program. As discussed further in our letter, AVAC is concerned about the proposed reduction in vaccine administration reimbursement outlined in the rule. We are also concerned about the proposed removal and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s) but greatly appreciate the addition of zoster, pneumococcal and influenza measures in several Alternative Payment Models (APMs) as well as a number of specialty provider measure sets.

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.1 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 well-known 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.

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.

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

p. 35707 Reduction in Practice Expense Relative Value Units for Vaccine Administration

AVAC is deeply concerned with the proposed reduction in reimbursement rates for CPT codes for vaccine administration due to current gaps in immunization access as well as the potential negative long-term impact on providers’ ability to offer recommended immunizations to Medicare patients.

Immunizations are an important public health imperative and ensuring that immunization providers are properly reimbursed is key to fostering a sustained environment of timely immunization. Vaccine administration by health care providers in their office, at the point of care, is an opportunity that needs to be maintained and encouraged. Studies show that inadequate reimbursement for vaccination administration result in missed immunization opportunities3 and declines in immunization rates. Given HHS’s Healthy People 2020 goals and the gaps in care that current exist in adult vaccination, any reimbursement reductions at the physician/provider level could widen those care gaps and have unnecessary population health consequences.

AVAC urges CMS to maintain CPT codes for vaccine administration at rates that properly reimburse for the cost of the service and will continue to encourage providers to offer Medicare beneficiaries recommended immunizations at the clinical point of care.

p. 35935 Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) – Comprehensive ESRD Care

AVAC is pleased the merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) for comprehensive ESRD Care in the proposed rule includes the following adult immunization measures:

➢ Influenza Immunization for the ESRD Population
➢ Pneumococcal Vaccination Status (NQF #0043)

p. 35939 Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) – Comprehensive Primary Care Plus (CPC+) Model

AVAC is pleased the Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) for the Comprehensive Primary Care Plus (CPC+) Model in the proposed rule includes the following adult immunization measures:

➢ Preventive Care and Screening: Influenza Immunization (NQF#0041)
➢ Pneumococcal Vaccination Status for Older Adults (NCQA measure)

p. 35945 Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) – Maryland Total Cost of Care Model

AVAC is pleased the Merit-based Incentive Payment System (MIPS) Alternative Payment Model (APM) for the Maryland Total Cost of Care Model includes the following adult immunization measures:

➢ Preventive Care and Screening: Influenza Immunization (NQF#0041)
➢ Pneumococcal Vaccination Status for Older Adults (NCQA measure)

P. 35878 Medicare Shared Savings Program (MSSP)

The Medicare Shared Savings Program (MSSP) presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC believes the CMS should engage in a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of Medicare beneficiaries.

AVAC commends CMS for maintaining Influenza Vaccination (ACO #14) under the AIM: Better Health for Populations category but are deeply concerned by the proposed removal of and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s).

Monitoring immunization status and reporting of offered and administered immunizations to patients are critical preventive service benchmarks that help to ensure immunizations remain a priority under new payment models and in the forefront of clinical care standards. Reducing the number of missed immunization opportunities, particularly among Medicare beneficiaries, is critical to improving health and reducing the burden of vaccine preventable disease.

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

These two vaccine preventable conditions exact a heavy toll on adults in terms of health and productivity costs and both measures should remain in the MSSP. According to the Centers for Disease Control and Prevention (CDC), an estimated 900,000 Americans get pneumococcal pneumonia each year, resulting in as many as 400,000 hospitalizations and more than 53,000 deaths. Despite the fact that most pneumococcal pneumonia deaths each year are adults, pneumococcal vaccination rates remain inadequate, with only 63 percent of adults over the age of 64 and 22 percent of high-risk adults being vaccinated.4 By contrast, a recent CDC study of flu-associated deaths prevented over a nine-year period from 2005-2006 through 2013-2014 found that nearly 89 percent were in people 65 years of age and older.

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

p. 35964 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.

p. 36092 CY2019 MIPS Specialty Measure Sets (Appendix 1)

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.6 AVAC greatly appreciates that the proposed rule addressed past concerns that have been raised about the limited number of specialty sets that included adult immunization quality measures. Specifically, the inclusion of Preventive Care and Screening: Influenza Immunization (NQF #0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043) into a number of primary care and specialty quality measure sets reflects an important advancement that will help ensure better access to immunization services across Medicare providers.

Prioritizing quality measures around immunizations will help close existing measure gaps, improve upon immunization rates and health outcomes for the millions of Medicare beneficiaries. The National Quality Forum (NQF) in its August 2014 report “Priority Setting for Healthcare Performance Measurement: Addressing Performance Measures Gaps for Adult Immunizations”, highlighted ten age specific and composite measure gap priorities that should be addressed.

The proposed rule also seeks to adopt 10 new quality measures into the MIPs program for 2021 payment. AVAC is pleased that one of the new measures is for Zoster (Shingles) Vaccination.

This non-NQF endorsed measure is already in use by the Home Health Value-Based Purchasing Program. 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.8 The health and economic burden associated with shingles and its complications are significant. As cited by the CDC, in 2007, the Agency for Healthcare Research and Quality (AHRQ) estimated the average cost of shingles and its complications to be $566 million a year while another study estimated the overall cost could be as high as $1.7 billion a year.

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

AVAC was encouraged that the following specialty sets include the following immunization process quality measures for the 2021 payment year:
✓ Family Medicine. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents (NQF # 1407)
✓ Internal Medicine. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
✓ Obstetrics/Gynecology. Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043)
✓ Otolaryngology. Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043)
✓ Pediatrics. Preventive Care and Screening: Influenza Immunization (NQF# 0041); Childhood Immunization Status (NQF #0038); and Immunizations for Adolescents (NQF # 1407)
✓ Preventive Medicine. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
✓ Nephrology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
✓ Oncology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
✓ Infectious Disease. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents
✓ Rheumatology. Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043)
✓ Geriatrics. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041); Pneumonia Vaccination Status for Older Adults (NQF# 0043); and Immunizations for Adolescents (NQF # 1407)
✓ Skilled Nursing Facility. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041)

AVAC was, however, disappointed that the final rule did not include adult immunization quality measures in a few key specialty areas who care for chronically ill patients at-risk of serious complications from vaccine preventable illness. The Advisory Committee on Immunization Practices (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 remained unchanged for at least a decade.10 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 6011 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:

Endocrinology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043).

Cardiology. Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043).

General Surgery. Preventive Care and Screening: Influenza Immunization (NQF# 0041) and Pneumonia Vaccination Status for Older Adults (NQF# 0043).

Skilled Nursing Facility. Pneumonia Vaccination Status for Older Adults (NQF# 0043)

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
American Immunization Registry Association (AIRA)
American Pharmacists Association
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
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
National Foundation for Infectious Diseases (NFID)
Novavax
Pfizer
Sanofi
Seqirus
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health

September 10, 2018

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1691-P
P.O. Box 8010,
Baltimore, MD 21244-8010

RE: CMS-1691-P Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program End Stage Renal Disease Prospective Payment System and Quality Incentive Program proposed rule. We are deeply concerned the proposed rule seeks to remove the Influenza Vaccination Coverage Among Healthcare Personnel (NQF#0431) from the ESRD Quality Incentive Program (QIP) for PY2021. We also urge CMS to include a new composite measure for ACIP-recommended vaccines (influenza, pneumococcal and hepatitis B) in the ESRD Quality Incentive Program (ESRD QIP) to promote higher quality and more efficient health care for vulnerable ESRD patients at increased risk of vaccine preventable illness.

AVAC consist s 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 measures for adult vaccines.1 The report highlight s 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.” Unfortunately, access to vaccines is not equal across a person’s lifespan. Despite the well known benefits of immunizations, more than 50,000 adult s 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.

(p. 34339) Proposed Removal of the Healthcare Personnel Influenza Vaccination Reporting Measure From the ESRD QIP Measure Set

The proposed rule indicates that CMS originally adopted the Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) in CY2015 because “we recognize that influenza immunization is an important public health issue and that vaccinating healthcare personnel against influenza can help to protect healthcare personnel and their patient s (79 FR 66206 through 66208)”. According to the Centers for Disease Control and Prevention (CDC), individuals with chronic kidney disease have a higher incidence or severity of some vaccine-preventable diseases due to altered immunocompetence3. In fact, infectious disease is the second most common cause of death in late-stage Chronic Kidney Disease (CKD) patients.

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.”

However, CMS analysis of CY 2016 data in the proposed rule indicates, “ESRD facility performance on the measure was consistently high; 98 percent of ESRD facilities received the highest possible score on the measure (10 points) and the remaining 2 percent received no score on the measure because they did not report the required data. This finding indicates that influenza vaccination of healthcare personnel in ESRD facilities is a widespread practice and that there is little room for improvement on this measure.”

AVAC strongly disagrees with this contention. Removal of the Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431) from the ESRD QIP will send the impression to ESRD facilities that preventive health care services such as immunization are no longer a priority, despite the serious economic and health consequences of influenza outbreaks in this population. The fact that the analysis of the measure for CY 2016 indicates that nearly every ESRD facility received the highest possible score is a clear indicator of the success of the measure. Sustained widespread utilization of the influenza vaccine among healthcare personnel and the adoption of an adult immunization composite metric for ESRD patients should be an utmost priority for ESRD patients since, “these patient s represent a high-risk group for developing infectious diseases.”

The proposal to remove this measure is also inconsistent with CMS’ own position and argument s 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 out comes 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 cost s associated with reporting this chart-abstracted measure outweighs the associated benefit s of keeping it in the Hospital IQR Program.”

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 patient s as between 28% and 59% of infected workers had subclinical infections and continued to work.” For ESRD patients with, “[c]o-morbidities such as diabetes mellitus and the inherent process of dialysis, where patients are frequently exposed to multiple pathogenic agents and potential cross-contamination from dialysis equipment in the health care environment, add to the susceptibility of t his population.”

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

Composite ESRD Vaccination Measure
The HHS National Vaccine Program Office (NVPO) and the Centers for Disease Control and Prevent ion (CDC) in collaboration with the National Adult Immunization and Influenza Summit Quality Working group have spearheaded the development and test ing of a new composite measure for end-stage renal disease patient s covering influenza, pneumococcal and hepatitis B vaccines. A review of CMS fee-for-service claims data warrant s the use of such a measures as current vaccination rates for the ESRD population fall well below recommended targets.

Research has shown that kidney care centers with vaccination protocols have demonstrated reduced infection rates and resulted in decreased morbidity and mortality7. Vaccines, including hepatitis B and pneumococcal conjugate and pneumococcal polysaccharide, are specifically recommended for dialysis or CKD patients. However, like with other adult populations, vaccines are underutilized in CKD patients, who could benefit greatly from improved access to immunization services.8

This work provides an important foundation for a composite measure for ACIP-recommended vaccines for ESRD patients and would be of great benefit to the ESRD QIP now in the future. The ESRD Quality Incentive Program (ESRD QIP) presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC strongly believes the ESRD QIP should include a focused, concerted effort to improve access and utilization of adult immunizations as a means of improving the overall health of patients living with kidney disease. An ESRD composite measure would provide a sound, reliable and comprehensive means to assesses the receipt of routine adult vaccinations recommended by the Advisory Commit tee on Immunization Practices (ACIP).

We look forward to working with CMS to ensure meaningful measures that reflect priority health care services, such as immunization, that also will streamline and reduce the report ing burden on providers, provide an accurate representation of ESRD facility performance in the least burdensome manner possible and provide meaningful data to the Medicare program on access to this important preventive service.

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

Sincerely,
Alliance for Aging Research
Asian & Pacific Islander American Health Forum (APIAHF)
BIO
Families Fight ing Flu
GSK
Immunization Action Coalition (IAC)
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
Sanofi
Seqirus
The Gerontological Society of America

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

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

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

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