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