To Whom It May Concern:

As members of the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs 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 behind the 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.

The Medicare Program Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs present an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC believes the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical Center Quality Reporting (ASCQR) 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. Earlier this summer AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines.1 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.

The proposed rule includes Hospital OQR program measures sets previously adopted for CY 2019 payment determination as well as a table summarizing proposed and previously adopted measures for CY 2020 and beyond. The proposed rule also includes measure sets previously finalized for the ASCQR for CY 2019 payment determination as well as measure sets previously finalized and proposed for CY 2020 and subsequent years’ payment determination. AVAC appreciates that both the Hospital OQR and ASCQR programs maintain Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431) among the core measure sets. Leading medical and health professional associations support influenza vaccination policies for healthcare professionals to help protect patients.2 AVAC strongly supports maintaining these measures in the final rule.

The Advisory Committee on Immunization Practices (ACIP) recommends that all healthcare personnel (HCP) be vaccinated annually against influenza.3 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 only approximately 70%4, 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%.5

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 outpatient and ambulatory surgical healthcare settings and should remain a priority within these programs.

AVAC also encourages CMS to consider including influenza immunization and pneumococcal immunization measures in the OQR and ASCQR programs and eventually incorporate measures that address all ACIP-recommended vaccines for adults. CMS’ Physician Quality Reporting System (PQRS) presently includes measures for both influenza and pneumococcal. The health and economic burden of influenza and pneumococcal disease, particularly among elderly and high risk adult populations, is significant. Pneumococcal vaccination rates remain inadequate, with only 61.3 percent of adults over the age of 64 and 20.3 percent of high risk adults being vaccinated in 2014, declining slightly from the previous year.6

Other federal agencies have demonstrated success in using quality measurement to increase vaccine coverage rates. For instance, beginning in 1995, the Veterans Health Administration (VHA) increased influenza vaccination rates from 27 percent to 70 percent, and pneumococcal vaccination rates rose from 28 percent to 85 percent, among eligible adults. The VHA was also able to demonstrate a significant reduction in hospitalizations attributable to pneumococcal disease. Pneumonia hospitalization rates decreased by 50 percent, and it is estimated that the VHA saved $117 for each vaccine administered.7

AVAC also appreciates the opportunity to respond to the request for comment on possible measure topics for future consideration in the Hospital OQR program. As the proposed rule notes, CMS programs are moving toward greater use of outcome measures and away from clinical process measures. We strongly urge CMS to consider including a core set of adult immunization quality measures that reflect the recommendations of the Advisory Committee on Immunization Practices (ACIP) into the Hospital OQR Program in the future. Prioritizing quality measures around immunizations in the Hospital OQR Program would help close existing measure gaps, improve upon immunization rates and health outcomes for the millions of Medicare beneficiaries seeking care in the outpatient hospital setting. As CMS moves from clinical process measures to outcome measures AVAC would also encourage CMS to closely monitor the potential impact of this shift on access to critical preventive services, such as immunization.

The proposed rule also notes intent to develop a comprehensive set of quality measures to be available for widespread use for making informed decisions and quality improvement in the ASC setting. AVAC was disappointed that the proposed rule did not include a more robust adult immunization measure set, such as measures for pneumococcal and influenza vaccination, in light of the significant risk and burden pneumonia presents to chronically ill and medically vulnerable Medicare beneficiaries. AVAC urges CMS to consider including adult immunization quality measures as part of CMS’ future measure selection and development process for the ASCQR. CMS states that future quality measures will be aligned with the National Quality Strategy (NQS), the CMS Strategic Plan, and other CMS quality reporting and value-based purchasing programs. 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 firmly believes that adult immunization quality measurement is central to ensuring continued focus on this core prevention intervention. We look forward to working with you toward improving upon adult immunization quality measures in both the Hospital OQR and ASCQR and to advance new measures for current vaccines and vaccines in the pipeline. AVAC shares your goal of building, strengthening and advancing a new generation of measures, as outlined in the CMS Quality Strategy. We are also committed to ensuring this new generation of adult immunization measures strikes the right balance in terms of the burden on providers while ensuring the integrity and societal value of quality measurement.

AVAC would also like to comment on proposed changes to the Medicare Electronic Health Record (EHR) Incentive Program that was finalized in October 2015. The proposed rule states several reasons for the proposed changes, including to better align with the new standards set forth in the MACRA/MIPS proposed rule, to better enable hospitals and CAHs seeking to attest under the EHR program for the first time in 2017, and to reduce the burden on hospitals and CAHs under the EHR program so they can focus on providing quality patient care, updating and optimizing CEHRT functionalities to meet the requirements of the EHR Incentive Program and prepare for Stage 3 of meaningful use. AVAC is concerned with the proposed changes to Objective 4, Public Health and Clinical Data Registry Reporting.

Specifically, the proposed rule would reduce the reporting threshold for Objective 4 from the current Stage 3 as finalized in October 2015 to a modified Stage 2 threshold for hospitals and CAHs attesting under the Medicare EHR Incentive program. The requirement would be any combination of three measures from any combination of six measures in alignment with Modified Stage 2 requirements. The six reporting measures are Immunization Registry Reporting Measure, Syndromic Surveillance Reporting Measure, Electronic Case Reporting Measure, Public Health Registry Reporting Measure, Clinical Data Registry Reporting Measure, Electronic Reportable Laboratory Result Reporting Measure.

The reason for the proposed change in this reporting standard is that hospitals and hospital associations have difficulty finding registries and determining whether or not they are able to accept data in the standard required to successfully attest. In addition, some hospitals have indicated additional technologies are sometimes required to transmit data, which presents an additional burden and administrative cost.

The proposed rule contends that “reducing the reporting requirements to any combination of three measures would still add value while minimizing the administrative burden”8. AVAC is deeply concerned that reducing the reporting threshold for Objective 4 from the current Stage 3 to a modified Stage 2 will weaken incentives for eligible professionals under the proposed MACRA rule to report and receive immunization registry data and decelerate efforts to align data reporting standards and improve interoperability between immunization registries and EHR systems. AVAC would urge CMS to seriously reconsider the proposed reduction in the reporting threshold for Objective 4 to the modified Stage 2 standard in the final rule. We would strongly encourage CMS to work with the Centers for Disease Control and Prevention (CDC), EHR vendors, hospitals, the American Immunization Registry Association (AIRA) and other public health organizations, to find ways to streamline data standards and improve interoperability consistently across immunization registry programs, hospitals and EHR systems.

Immunization has demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and has been proven to improve overall health in a cost efficient manner. Reducing the number of missed immunization opportunities for Medicare beneficiaries through outpatient and ambulatory surgical settings is an important step to improving health and reducing the burden of vaccine-preventable illness among this population. It also helps provide protection across the lifespan.

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
BIO
Dynavax Technologies
Every Child By Two
Merck
Novavax
Pfizer
Sanofi
The Gerontological Society of America