March 5, 2018

Seema Verma
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter (CMS-2017-0163)

Dear Administrator Verma:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter. Specifically:

• AVAC greatly appreciates the inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing and strongly urge maintaining it in the final letter. Studies have shown a direct correlation between high cost sharing and increased abandonment rates of vaccines. Removing financial barriers will greatly improve beneficiary access, utilization and health outcomes.

• AVAC strongly supports the future addition of an adult immunization composite measure on the display page and for Star Ratings. This HEDIS measure would build off the current pneumococcal measure and 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.

AVAC consists of more than fifty organizational leaders in health and public health who are committed to raising awareness of the importance of adult immunization with the ultimate goal of addressing barriers to adult immunization. Our mission is informed by scientific and empirical evidence that shows immunization improves health and protecting lives against a variety of debilitating and potentially deadly conditions, saving costs to the healthcare system and to society as a whole. AVAC 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.

Immunizations are a cornerstone of our nation’s disease prevention efforts and have a demonstrated track record of success as a cost-effective means of reducing disease burden and saving lives among pediatric populations. The CDC estimates that over 20 years, childhood immunizations prevent 732,000 deaths and 21 million hospitalizations.

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. 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. Millions more adults suffer from vaccine-preventable diseases, causing them to miss work and leaving some unable to care for those who depend on them.

Adults seeking access to and coverage for vaccines encounter a confusing health care system that presents multiple barriers, including lack of awareness and information about recommended vaccines, financial hurdles, including high cost sharing, as well as technological and logistical obstacles. Socioeconomic and linguistic barriers further challenge the ability of diverse and medically underserved communities from accessing needed immunizations.

A growing body of research illustrates the direct and indirect cost attributable to vaccine preventable disease. A study published in The Journal of Primary Prevention found the estimated annual cost of just four major vaccine-preventable diseases among US adults 65 years and older was more than $15 billion in 2013.3 Medical costs related to vaccine-preventable diseases (VPD) in older adults are expected to grow substantially in the coming years; one study forecasts U.S. medical costs for Americans ≥65 in the Medicare population to be $4.74 billion by 2030 for just one VPD.

Immunization coverage for Medicare beneficiaries is segmented between Medicare Part B, which covers vaccinations against influenza, pneumococcal and hepatitis B for at-risk patients and Medicare Part D, which covers all other commercially available vaccines when deemed medically necessary to prevent illness. While beneficiaries receive Part B-covered vaccines with no cost sharing, Part D vaccines are typically subject to cost sharing requirements.

According to a February 2018 Manatt study, only 4 percent or less of Medicare Part D enrollees had access to vaccines with no cost sharing. The variable cost sharing requirements currently imposed on the majority of Part D vaccines discourage immunization among elderly, disabled and chronically ill populations who account for a disproportionate percentage of the morbidity and mortality from vaccine preventable conditions. A 2015 report by the Alliance for Aging Research on vaccination rates among older adults found that cost sharing for vaccines under Part D varies depending on a beneficiary’s prescription drug plan or Medicare Advantage plan formulary offerings. Similarly, a 2017 report by Avalere Health found between 47 and 72 percent of the 24 million Medicare beneficiaries with Part D coverage had some level of cost sharing for vaccines, ranging from $35 to $70 in 2015.

The FY2019 draft call letter prioritizes and encourages improved access to and utilization of adult immunization services for beneficiaries in Medicare Advantage and Prescription Drug Plans (PDP). As such, AVAC wishes to offer the following comments with the strong hope that CMS will maintain these important immunization provisions in the final call letter:

Potential New Measures for 2020 and Beyond (page 150-151)

Adult Immunization Measure (Part C). For HEDIS 2018, NCQA added the Pneumococcal Vaccination Coverage for Older Adults measure to the ECDS reporting domain. Measures in the HEDIS ECDS domain are calculated using electronic data from administrative claims, electronic medical records, case management systems and registries. For HEDIS 2019, NCQA will build off the pneumococcal measure and evaluate the relevance, scientific soundness, and feasibility of a composite measure for HEDIS that 151 assesses the receipt of routine adult vaccinations. The measure developer is focusing on four specific vaccines: influenza vaccine; tetanus, diphtheria, and pertussis (Tdap) or tetanus and diphtheria (Td) booster vaccine; herpes zoster vaccine; and pneumococcal vaccine. If approved, the new measure would be included in HEDIS 2019. CMS would welcome feedback on the feasibility, value of, and burden/reduction in burden of this change in data source. Depending on results of implementation, CMS will determine the use of this new composite measure for the display page and Star Ratings for the future.

AVAC strongly supports the future addition of an adult immunization composite measure on the display page and a Star Ratings measure. This HEDIS measure would build off the pneumococcal measure and 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 Vaccines8, 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 patient cohort’s vaccination schedule–such as those demonstrated by the Northwest Tribal Epidemiology Center9 and by the National Nursing Home Quality Care Collaborative–can improve outcomes. Such a measure would put vaccination coverage rates into a larger context and encourage a more systematic approach for all vaccines.

Improving Access to Part D Vaccines (page 199)
According to the Center for Disease Control and Prevention’s (CDC) Surveillance of Vaccination Coverage among Adult Populations — United States, 2015, vaccination rates remain low for tetanus and diphtheria with acellular pertussis (Tdap). While the Healthy People 2020 herpes zoster target vaccination rate has been achieved, approximately 70% of adults for whom the vaccine is recommended remain unprotected. In an effort to improve access to these and other Part D vaccines, we encourage Part D sponsors to either offer a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing.

AVAC greatly appreciates the inclusion of language encouraging Part D sponsors to offer either a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing and strongly urge maintaining it in the final letter. While not mandatory, this language sends an important signal to Medicare Advantage and Prescription Drug Plans that access to Part D vaccines should be a high priority as they develop formulary and cost sharing tiers.

Studies have shown a direct correlation between high cost sharing and increased abandonment rates of vaccines. A study evaluating the relationship between vaccine co-pays for Part D beneficiaries and Tdap and Zoster vaccination claims in their doctor’s office showed that, compared with no co-pay, beneficiaries who had to pay a co-pay amount of $26–50, $51–75 or $76–100, respectively, are 1.39, 1.66 or 2.07 times as likely to cancel their zoster vaccination.

Another study found that patient out-of-pocket (OOP) cost is one of the most significant predictors of vaccine abandonment, after adjusting for other factors.Removing financial barriers will greatly improve beneficiary access, utilization and health outcomes among at-risk elderly and chronically ill populations who account for a disproportionate percentage of the morbidity and mortality from vaccine preventable conditions.

Thank you for the opportunity to offer our perspective on the 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter. We hope CMS will maintain strong language in the final letter encouraging Part D plans to include vaccines in the $0 vaccine tier or low-cost sharing tier in the final letter and language supporting efforts to develop and implement a composite quality measure for adult immunizations. We greatly appreciate CMS’ efforts to balance plans’ fiduciary responsibilities and beneficiary access to this important preventive health service.

Please contact an AVAC manager at (202) 540-1070 or info@adultvaccinesnow.org if you wish to discuss our comments or adult immunization access and coverage.

Sincerely,

Alliance for Aging Research
American College of Preventive Medicine
American Immunization Registry Association (AIRA)
Asian & Pacific Islander American Health Forum (APIAHF)
Association of Immunization Managers (AIM)
Biotechnology Innovation Organization (BIO)
Dynavax
GSK
Hep B United
Hepatitis B Foundation
Immunization Action Coalition (IAC)
Medicago
National Association of Chain Drug Stores (NACDS)
National Association of City and County Health Officials (NACCHO)
National Black Nurses Association
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association
Novavax
Pfizer
Pharmacy Quality Alliance
PhRMA
Sanofi
The Gerontological Society of America
Trust for America’s Health (TFAH)

CC: Demetrios Kouzoukas, Principal Deputy Administrator and Director, Center for Medicare