August 23, 2016

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1651-P
P.O. Box 8010
Baltimore, MD 21244-8010

To Whom It May Concern:

As members of the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program End Stage Renal Disease (ESRD) prospective payment proposed rule.

AVAC includes more than fifty organizational leaders in health and public health who are committed to overcoming the barriers to adult immunization and to raising awareness of and engaging in advocacy on the importance of adult immunization. Our mission is informed by a growing body of scientific and empirical evidence that shows that immunization improves health, protect lives against a variety of debilitating and potentially deadly conditions, and save costs to the healthcare system and to society as a whole. A top priority for AVAC is to achieve increased adult immunization rates through federal benchmarks and measures that encourage tracking and reporting of recommended vaccines.

Vaccines protect us from a variety of common diseases that can be serious and even deadly. Every year, more than 50,000 adults die from vaccine preventable diseases and thousands more suffer serious health problems. Despite Advisory Committee on Immunization Practices (ACIP) recommendations, vaccines have been consistently underutilized in the adult population and lag far behind the 2

Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap (tetanus, diphtheria, pertussis), hepatitis B, herpes zoster, HPV). Disparities are even greater for at-risk populations, including  seniors and people with chronic illnesses- many of the same vulnerable populations residing in skilled nursing facilities across the country.

According to the Centers for Disease Control and Prevention (CDC), individuals with chronic kidney disease have higher incidence or severity of some vaccinepreventable diseases due to altered immunocompetence1. In fact, infectious disease is the second most common cause of death in late stage Chronic Kidney Disease (CKD) patients. Research has shown that kidney care centers with vaccination protocols have demonstrated reduced infection rates and resulted in decreased morbidity and mortality2. 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.3 Moreover, the National Adult and Influenza Immunization Summit (NAIIS) Quality Work Group has a subgroup dedicated to the development and testing of an ESRD composite measure covering influenza, pneumoccal and hepatitis B vaccines. We believe this work provides an important foundation that will eventually allow for a comprehensive composite measure for all ACIP-recommended vaccines for ESRD patients and will be of great benefit to the ESRD QIP program 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 believes the SNF 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. Earlier this summer AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines.4 The paper highlights the role of vaccine quality measures in preventing illness and death, reducing caregiving demands, avoiding unnecessary healthcare spending, and setting the foundation for healthy aging. Moreover, the National Adult and Influenza Immunization Summit (NAIIS) Quality Work Group5 has a subgroup dedicated to the development and testing of an ESRD composite measure covering influenza, pneumococcal, and hepatitis B vaccines. We believe this work will be of great benefit to the ESRD QIP program in the future.

AVAC appreciates the opportunity to respond to the request for comment on the proposal that would allow for ESRD facilities to administer vaccines to beneficiaries with Acute Kidney Injury (AKI). Specifically, ESRD facilities would be enabled to “furnish vaccines to beneficiaries with AKI and bill Medicare in accordance with billing requirements in Pub. 100–04, Chapter 18 Preventive and Screening Services, section 10.2”.6 This section of the Medicare claims processing manual sets forth billing requirements for influenza, pneumococcal and hepatitis B vaccination. These vaccines are recommended by the Advisory Committee on Immunization Practices (ACIP) for patients with kidney disease since they are particularly vulnerable to serious and potentially life-threatening complications from these vaccine-preventable conditions. Encouraging ESRD facilities to offer and administer vaccines to AKI patients is important to reducing the number of missed immunization opportunities and improving vaccine coverage rates for this population. We strongly support this proposal and urge CMS to maintain it in the final rule.

The proposed rule would also maintain the National Healthcare Safety Network (NHSN) Healthcare Provider Influenza Vaccination reporting measure (79 FR 66209). AVAC supports maintaining this measure into PY 2020. We would note, however, that Table 11 in the proposed rule indicates there is no minimum data reporting requirement for the measure. HHS urges healthcare facilities to work toward the goal of 90 percent influenza vaccination coverage for healthcare personnel. We would urge CMS to consider including a baseline reporting threshold for ESRD facilities similar to what is required for inpatient rehab hospitals and other healthcare facilities.

Section IV of the proposed rule recommends a series of quality improvement initiatives for the ESRD program. Included is a proposal in PY 2019 to adopt a patient-level influenza immunization reporting measure that could be used to calculate a future clinical measure based on either ‘‘ESRD Vaccination—Full Season Influenza Vaccination’’ (MAP #XDEFM) or NQF #0226: ‘‘Influenza 5 http://www.izsummitpartners.org/naiis-workgroups/quality-and-performance-measures/ 6 https://www.gpo.gov/fdsys/pkg/FR-2016-06-30/pdf/2016-15188.pdf (p. 42822) 4 Immunization  in the ESRD Population (Facility Level).’’ AVAC supports this step and urges CMS to consider including reporting measures for pneumococcal
and hepatitis B vaccination and urges CMS to move swiftly to include patientlevel reporting for influenza and other ACIP-recommended vaccines into the ESRD QIP.

Immunization has demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and has been proven to improve overall health in a cost efficient manner. Reducing the number of missed immunization opportunities is critical to improving health and reducing the burden of vaccine-preventable illness among the ESRD population.

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

Sincerely,
Alliance for Aging Research
American Association of Occupational Health Nurses (AAOHN)
American College of Preventive Medicine
Asian & Pacific Islander American Health Forum (APIAHF)
Dynavax Technologies
Immunization Action Coalition (IAC)
Medicago
National Association of County and City Health Officials (NACCHO)
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association
National Viral Hepatitis Roundtable
Takeda Vaccines
The Gerontological Society of America
Trust for America’s Health