September 11, 2017

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1676-P
P.O. Box 8016
Baltimore, MD 21244-8013

RE: Medicare Program: Revisions to Payment Policies Under Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program

Dear Administrator Verma:

AVAC appreciates the opportunity to offer comments in response to the Medicare Program: Revisions to Payment Policies Under Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program proposed rule.

As a stakeholder interested in advancing payment models that encourage access to essential preventive services such as immunization, we are grateful to CMS for its work in this area. AVAC includes more than fifty organizational leaders in health and public health who are committed to addressing barriers to 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 mission is informed by scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against a variety of debilitating and potentially deadly conditions, and saving costs to the healthcare system and to society.

AVAC priorities and objectives are driven by a consensus process with the goal of enabling stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations. A top priority for AVAC is to achieve increased adult immunization rates through federal benchmarks and performance measures that encourage utilization 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 problems1. Despite Advisory Committee for Immunization Practices (ACIP) recommendations, vaccines are underutilized in the adult population and lag behind Healthy People 2020 goals for the most commonly recommended vaccines (influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, human papillomavirus vaccine (HPV)). Disparities are even greater among at-risk populations, including seniors and people with chronic illness, many of the same vulnerable populations Medicare covers across the country.

AVAC values the opportunity to offer our perspective on aspects of the proposed rule that are 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. AVAC shares your goal of building, strengthening and advancing a new generation of process and outcome measures, as outlined in the CMS Quality Strategy. We are also committed to ensuring this new generation of adult immunization measures bring increased value without adding burden on providers. We look forward to working with you toward improving upon existing adult immunization quality measures.

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 important provisions guiding eligibility and services provided under the Medicare Diabetes Prevention Program expanded model. These two programs offer important opportunities to encourage access to and utilization of recommended adult immunizations to priority populations within the Medicare program.

P. 34104 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. Last year, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. 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.

AVAC commends CMS for maintaining the modified Annual Influenza Vaccination (ACO #14) and the Pneumonia Vaccination Status for Older Adults measure (ACO #15) in the Medicare Shared Savings Program (MSSP’s). These measures were included under the AIM: Better Health for Populations category. 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. 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. 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.

While influenza and pneumococcal represent a significant proportion of the disease burden from vaccine-preventable illness, there are also several other important immunizations recommended to individuals of Medicare age. AVAC encourages CMS to consider including a core set of adult immunization quality measures that reflect the full spectrum of recommendations of the Advisory Committee on Immunization Practices (ACIP) into the MSSP in future rulemaking. Prioritizing quality measures around immunizations would 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.

For instance, AVAC would encourage CMS to consider including “Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?” as an MSSP measure in the final rule. This non-NQF endorsed measure is used under the Home Health Value-Based Purchasing Program. According to the CDC, 27.9 percent of adults age 60 and older reported receiving the herpes zoster vaccine.6 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.

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.

Additionally, as providers are under increased financial and time pressure in providing care, AVAC asks that CMS consider for next year’s rule making, a modifier or other change for the time and effort required for counseling on vaccinations. Low health literacy and cognitive issues for seniors can make education on immunizations a challenging and time-consuming effort for physicians. We believe that explicit recognition of the time and effort will create a tighter alignment between payment and the quality measure incentives for immunizations, as well as potentially reduce physician frustration with the increased demands of measurement in a value based system.

p. 34191 Medicare Diabetes Prevention Program Expanded Model (MDPP)

Lastly, under the proposed expansion of the diabetes prevention program, AVAC would strongly urge CMS to include provider assessment of vaccine status along with beneficiary education on the ACIP-recommended immunizations among the list of services for patients eligible to participate in the MDPP. Individuals with diabetes and multiple chronic conditions are at significantly higher risk of complications and death from vaccine preventable conditions such as influenza and pneumonia.

According to the American Diabetes Association, people with diabetes are three times more likely to die with flu and pneumonia, yet only a third of people with diabetes receive a pneumococcal vaccination and only 50% of people with diabetes receive an influenza vaccinatation. Provider assessment and education about the benefits and risks of immunization and awareness of which vaccines are specifically recommended for individuals with diabetes will help to reduce the number of missed immunization opportunities, improve overall health and reduce the incidence and burden of vaccine preventable disease for patients at high risk of serious and life-threatening complications.
Immunizations have demonstrated “effective prevention” in reducing rates of morbidity and mortality from a growing number of preventable conditions and improving overall health in a cost-efficient manner. Reducing the number of missed immunization opportunities is imperative to improving health and reducing the burden of vaccine preventable illness among Medicare beneficiaries. AVAC looks forward to working with CMS to ensure that adult immunization quality measures incentivize improved access to and utilization of adult vaccines without imposing an additional burden on providers.

Thank you for this opportunity to offer our perspective on this 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,

BIO
Dynavax Technologies Corporation
GSK
Immunization Action Coalition
Medicago
National Association of Chain Drug Stores
Novavax
Pfizer
Sanofi
The Gerontological Society of America