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 overreporting 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