To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) 2018 Medicare Advantage and Part D Advance Notice and Final Call Letter. Specifically:

• Pneumococcal Vaccination Status for Older Adults (p. 98): AVAC encourages CMS to continue to work with NCQA, PQA and other relevant quality measure stakeholders to update, refine and streamline pneumococcal vaccination-related quality measurement for both Medicare Part C and Part D, ensuring it calls out both pneumococcal vaccines per the ACIP recommendation
• $0 Vaccine tier (p. 152): AVAC encourages CMS to incentivize plans to utilize the $0 vaccine tier through the inclusion of immunization benchmarks in the Star Ratings Program

2017 Transformation Ideas (Attachment I, p.8) We also greatly appreciate the opportunity to offer ideas for “regulatory, sub-regulatory, policy, practice and procedural changes” that we believe will improve the transparency and efficiency of the MA and Part D program and improve beneficiary access to recommended immunizations.

• Facilitate the integration and greater utilization of billing systems that will enable providers in the medical setting to review a patient’s Part D vaccine coverage as well as enable those providers to directly bill Part D plans for vaccine services
• Clarify the distinction in vaccine coverage between Parts B and D in the Medicare Handbook, including an explanation of current ACIP-recommendations for older adults, an explanation of which vaccines are covered under each program and a description of how and where a beneficiary can obtain access to vaccine services
• Revise provider guidelines and explanatory documents to include a discussion of all ACIP-recommended vaccines for persons over the age of 65 and with certain chronic conditions under the IPPE.
• Work with NQF to conduct an assessment of adult immunization quality measures utilized across health care settings, and develop an action plan to streamline, update and fill gaps in adult immunization quality measurement for recommended vaccines
• Collaborate with NCQA, PQA and other relevant quality measures stakeholders to develop composite measures for adult immunization status that addresses known measurement gaps.
• Work with EHR and technology vendors to improve and widely disseminate a web-based system to enable providers to more easily and efficiently verify patient Part D coverage and also allow providers to direct bill Medicare Part D plans for covered vaccine services.

AVAC consists of over 50 organizational leaders in health and public health that are committed to addressing 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. 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 and utilization of adult immunizations.

Our coalition advocates for policies that will reduce barriers to immunization and for common sense measures that will improve the ability of providers and patients to make informed decisions at the point of care.

Pneumococcal Vaccination Status for Older Adults (p. 98)

AVAC appreciates that the final call letter maintains a change in the wording of the Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey measure, “Pneumococcal Vaccination Status for Older Adults”. This patient-based survey measure assesses the percentage of Medicare members 65 years of age and older who have ever received a pneumococcal vaccination. We appreciate that CMS is working with the National Committee for Quality Assurance (NCQA) on alternate, non-survey based methods to assess pneumococcal vaccination status and adherence, including claims, case management systems, medical records, registries and electronic health records. We encourage CMS to utilize all available sources (e.g., SNOMED-CT) to provide a comprehensive assessment of pneumococcal coverage rates among this population.

$0 Vaccine tier (p. 152)

AVAC is disappointed that the final 2018 letter does not include language encouraging Part D plans to offer vaccines in the $0 vaccine tier. Instead, the final letter only makes a brief reference to the vaccine tier in a footnote. Since 2012, the CMS call letter has included language similar to the following, “We encourage Part D sponsors to consider offering $0 or low cost-sharing for vaccines to promote this important benefit.”1 While adoption of the $0 vaccine tier is voluntary, we believe this language demonstrates that CMS views access to preventive services such as immunizations as a priority for Medicare beneficiaries.

We appreciate the opportunity to share a few ideas that AVAC believes will help to close immunization coverage gaps for senior populations and improve adult immunization rates overall.

2017 Transformation Ideas

Part C & D Beneficiary Immunization Access Star Rating

Over the past several years, CMS has been deeply involved in the development and implementation of tools designed to measure beneficiary experience and outcomes, as well as quality of care and delivery across plans, providers and health care settings. As the May 2016 Blueprint for the CMS Measures Management System notes, these efforts are having a meaningful Impact. “For the first time in many years, we are seeing improvements at the national level on a number of critically important metrics such as hospital readmission rates, CLABSI, Surgical Site infections, early elective deliveries and ventilator associated pneumonia. We have also seen a sustained decrease in total Medicare per capita costs. In the Medicare Advantage programs, plans are rated by stars to reflect the quality of the services they offer, and beneficiaries are increasingly choosing plans that have higher star ratings.”2

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. Yet, despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases. Adult coverage lags behind Healthy People 2020 targets for many commonly recommended vaccines, including, influenza, pneumococcal, tetanus, hepatitis B, and HPV. Millions more adults are sickened by vaccine-preventable illness, causing them to miss work and leaving some unable to care for those who depend on them.

A growing body of research illustrates the direct and indirect cost attributable to vaccine-preventable disease. For instance, 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

Immunization coverage for Medicare beneficiaries is segmented between Medicare Part B, which covers vaccinations against influenza and pneumococcal, as well as tetanus and hepatitis B for at-risk patients and Medicare Part D, which covers all other commercially available vaccines when deemed reasonable and necessary to prevent illness.4 While beneficiaries receive Part B-covered vaccines with no cost sharing, Part D vaccines are typically subject to cost sharing requirements. Beneficiary cost sharing under Medicare Part D is a barrier to access that hinders public health and provider efforts to improve immunization rates among elderly and disabled Medicare populations.

A number of studies indicate that financial barriers to Part D vaccines are a significant impediment to beneficiary access to some immunization services. 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.5 Similarly, a 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. 6 The report also found that approximately 12 percent of enrollees in Medicare Advantage Prescription Drug (MA-PD) plans had access to these vaccines in 2015 at zero cost sharing and no standalone Part D plans covered any of these vaccines with zero cost sharing. In 2015, only 81 of 1,945 MA plans offer a special vaccine tier to beneficiaries.

A study in the August 2016 Journal of American Pharmacy Benefits found a correlation between increases in cost sharing and increased vaccine abandonment at the pharmacy. During the study period, a total of 172,977 fills for Zostavax were initiated, and a total of 67,369 were abandoned for an overall abandonment rate was 38.9%. While the abandonment rate varied by patient demographics and health plan factors, patient out-of-pocket cost (OOP) remained the most significant predictor of abandonment, after adjusting for other factors. For patients with $15-$34 copays, the odds of abandonment were 1.66 percent compared to those with costs of $14.99 and below. Patients with cost sharing ranging from $105-$174.99 were 5.53 times more likely to abandon the vaccine.7

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. Removing this financial barrier could have a significant impact on improving beneficiary access to and utilization of vaccines and will also help drive reductions in hospitalizations and avoidable medical expenditures in other parts of the Medicare program. Addressing this barrier will be even more important as new vaccines for a growing variety of infectious and devastating conditions enter the market in the future.

AVAC urges CMS to consider the following regulatory actions:

• Develop Star Ratings Measure for C and D plans to indicate whether or not beneficiaries are able to access Part D vaccines with no cost sharing. We believe the inclusion of such a measure would drive Part D plan sponsors to integrate the $0 vaccine tier into plan design and benefits packages.
• As further incentive, we would urge CMS to consider allowing Part D plan sponsors to count spending on beneficiary education campaigns and other efforts to promote access to ACIP recommended vaccines toward medical loss ratio (MLR) totals, when those plans transition vaccines from higher cost sharing tiers to the $0 cost sharing tier option.

Adult Immunization Quality Measures

In addition to a Star Ratings measure, AVAC also urges CMS to explore quality measures being utilized to monitor clinical processes and outcomes for a multitude of conditions and across a variety of health care settings. Immunization measures for influenza and pneumococcal in particular help ensure that healthcare providers routinely discuss and offer recommended vaccines to their patients, which can lead to higher vaccine uptake and better health outcomes.

The Department of Veteran’s Affairs has successfully utilized measurement benchmarks to drive improved influenza and pneumococcal immunization rates while also reducing pneumonia hospitalizations.8 This was clearly shown following the introduction of performance measures for influenza and pneumococcal vaccinations in the Veterans Health Administration (VHA) in 1995. Between 1995 and 2003, among eligible adults, influenza vaccination rates increased from 27 percent to 70 percent, and pneumococcal vaccination rates rose from 28 percent to 85 percent, with limited variability in performance between networks; pneumonia hospitalization rates decreased by 50 percent.

An Indian Health Service pilot study is also showing similar success through the development and implementation of age-based adult immunization composite measures aimed at capturing rates for multiple vaccines.9 For IHS patients 65 and over, the composite included Tdap/Td, Zoster, Pneumococcal polysaccharide-23 (PPSV-23) and pneumococcal conjugate (PCV-13). The pilot showed for this population that rates improved significantly, rising from a baseline of 11 percent to 26 percent, over the few months of the study. Some individual vaccines showed even more dramatic improvement. For instance, Zoster rates rose from 13 percent to 34 percent during the study period. IHS is presently working to transition from the current GPRA measure that accounts for only PPSV 23 and the influenza vaccine to this adult composite measure.

AVAC encourages CMS to take the following policy actions:

• Work with NQF to conduct an assessment of adult immunization quality measures currently utilized across health care settings (physicians, hospitals, outpatient facilities, etc.) and develop a detailed action plan to streamline immunization measures, refine and harmonize existing measures to reflect ACIP recommendations and fill existing gaps in adult immunization quality measurement for recommended vaccines (based on age and chronic condition).10 AVAC believes this undertaking would yield tremendous benefit in terms of eliminating outdated and duplicative measures while also bringing greater efficiency and effectiveness to efforts to improve adult immunization rates of all ACIP-recommended vaccines.
• Work with NQF, NQCA, PQA and other stakeholders to develop adult immunization status composite measures that reflect ACIP-recommended immunizations, based on age and health status (e.g., diabetes composite measure). Such measures will help ensure that elderly, disabled and chronically ill Medicare beneficiaries receive ACIP-recommended vaccinations. Composite measures for adult vaccines would be less burdensome for providers and would also offer more detailed, meaningful and valuable data for facilities and for CMS on vaccine improvement efforts.

Facilitate provider billing of Part D plans

While physicians have the ability to bill Medicare for the cost and administration of vaccines under Part B, these same providers often are not able to directly bill Part D plans for vaccines covered under that program. Should a provider wish to offer and administer Part D covered vaccines to beneficiaries, they encounter a complicated and cumbersome array of options for doing so.11 Those physicians who do offer Part D vaccines in their offices must bill the patient for the total upfront cost of the vaccine; enroll in a commercially available out-of-network billing system for Part D vaccine claims; or obtain an out-of-network authorization for coverage from the Part D plan, submit the out-of-network claim on the patient’s behalf and agree to accept the Part D payment on a patient-by-patient basis. For physicians who choose to stock vaccines in their offices, these options are not only complex but also create a great deal of financial uncertainty around reimbursement. As a result, many physicians opt to not offer Part D vaccines, resulting in missed immunization opportunities during office visits. The current system severely hinders opportunities to fully immunize Medicare beneficiaries in a medical setting and hampers efforts to improve immunization rates for the 65 and over population.

AVAC encourages CMS to take the following administrative action:

• Work with EHR and technology vendors to improve and widely disseminate a web-based system to enable providers to more easily and efficiently verify patient Part D coverage and also allow providers to direct bill Medicare Part D plans for vaccines for covered vaccine services, allowing them to submit electronic claims directly to Part D plans.

Clarifications to the Medicare Handbook and Welcome to Medicare Visit

The Advisory Committee on Immunization Practices (ACIP) recommends up to 13 vaccines for adults 65 and older and adults with chronic illness. The Medicare and You Handbook12 presently divides the discussion of vaccines by individual shot and does not provide guidance on which vaccines beneficiaries should seek based on their age and health status. Moreover, the Initial Preventive Physical Examination (IPPE) or Welcome to Medicare Visit, also takes a fragmented approach to a beneficiaries’ immunization status.13 AVAC believes that the IPPE presents an important opportunity for a provider to review a new Medicare beneficiary’s complete immunization history and status. Limiting the discussion to only vaccines covered under Part B is a missed opportunity to educate beneficiaries about the fully complement of ACIP-recommended vaccines for individuals age 65 and over.

AVAC urges CMS to consider the following policy administrative actions:

• Clarify the Medicare Handbook discussion of vaccines. Specifically, provide an explanation of vaccine coverage between Parts B and D, include an explanation of current ACIP-recommendations for older adults, an explanation of which vaccines are covered under each program (and possible cost sharing requirements) and a description of how and where a beneficiary can obtain access to vaccine services. AVAC believes a clear and comprehensive presentation of information on vaccine coverage under Medicare, benefits and risks of immunization, which vaccines are recommended and how you can find a qualified health care provider would greatly improve Medicare beneficiary understanding and willingness to seek this important preventive service.
• Revise provider guidelines and explanatory documents to include a discussion of all ACIP-recommended vaccines for persons over the age of 65 and with certain chronic conditions under the IPPE.

Thank you for the opportunity to offer our perspective and ideas for improvements to the Medicare Part D program. We look forward to working with you to ensure that properly designed and executed adult immunization incentives and benchmarks will drive improvements in beneficiary health outcomes while resulting in lower overall cost to the Medicare program. AVAC also stands ready to assist you in any effort to clarify language in provider and beneficiary guidebooks and documents around the topic of adult immunization. We share CMS’ desire for greater transparency and efficiency through administrative changes and improvements to the program.

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 issues.

Sincerely,

Alliance for Aging Research
Asian & Pacific Islander American Health Forum (APIAHF)
BIO
Infectious Diseases Society of America (IDSA)
Medicago
National Association of Chain Drug Stores (NACDS)
National Association of City and County Health Officials (NACCHO)
Novavax
Pfizer
Pharmacy Quality Alliance (PQA)
Sanofi
The Gerontological Society of America (GSA)
Trust for America’s Health (TFAH)