Archives: Letters

December 19, 2016
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-5517-FC
P.O. Box 8013
Baltimore, MD 21244-8013

RE: Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models

To Whom It May Concern:

AVAC would like to take this opportunity to offer comments to the final rule Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.

AVAC consists of over 50 organizational leaders in health and public health who are committed to addressing the range of barriers to adult immunization and to raising awareness of its importance. 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 a growing body of 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 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. 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 for 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, 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. The MACRA rule represents a significant step in the transition of Medicare physician payments away from a volume-based model to a system that incentivizes and rewards value. Measuring provider performance and basing payment on a series of metrics is a complicated process that requires a thorough and highly deliberative process. AVAC appreciates the opportunity to share our thoughts on the final rule put forth by CMS in this area.

The rule establishes the Merit-Based Incentive Payment System (MIPS) by consolidating three existing quality and performance measure programs – Physician Quality Reporting System (PQRS), the Physician Value-based Modifier (VM) and the Medicare Electronic Health Record (EHR) Incentive Program. The rule also lays out incentives and requirements for participation in alternative payment models (APMs). Within MIPS, the rule outlines measures, activities, reporting and data submission standards across the four new performance categories that together will comprise the MIPS composite performance score.

AVAC values the opportunity to offer our comments on elements of each performance category relevant to adult immunization. Our coalition firmly believes that adult immunization performance and quality measurement is central to ensuring continued focus on this core prevention intervention. We look forward to working with you toward improving upon existing adult immunization quality measures. AVAC shares CMS’ 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 a new generation of adult immunization measures strikes the right balance between the integrity and societal value of measure without adding to the burden on providers to report.

The final rule seeks to lay the foundation 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 EHR technology and other data sources to support care delivery. AVAC is concerned that the final rule does not adequately prioritize adult immunization quality measurement, and in fact, weakens several provisions that were included in the proposed rule.

The proposed rule called for the new quality performance category to reflect many of the attributes of the PQRS program while also providing some flexibility. For 2019, the quality performance category would account for 50 percent of a clinician’s composite performance score (CPS), thereby representing a significant portion of their ultimate payment under MIPS. The measures ultimately selected under the quality performance category will have major implications in terms of clinicians’ delivery of care. Unlike the proposed rule, the final rule does not finalize the cross-cutting measure set. However, the final rule maintains the position that several cross-cutting measures that were available under PQRS for 2016 will not be available in 2017, including PQRS #110 (Preventive Care and Screening: Influenza Immunization), PQRS #111 (Pneumonia Vaccination Status for Older Adults) and PQRS #240 (Childhood Immunization Status).

AVAC is deeply concerned eliminating of these foundational cross-cutting measures in 2017 will result in fewer providers being incentivized to review a patient’s immunization status and thus result in missed immunization opportunities and a greater likelihood of illness and complications from vaccine preventable conditions such as influenza and pneumonia. A recent Health Affairs study estimates the economic burden attributable to vaccine-preventable diseases among US adults to be approximately $9 billion (2015)1. The study, which examines ten vaccines recommended for adults 19+, also finds that unvaccinated individuals are responsible for almost 80 percent ($7.1 billion) of the financial burden. Additional research has shown that a physician recommendation is a strong driver of patients getting immunized and the National Vaccine Advisory Committee (NVAC) adult standards encourage efforts to increase provider engagement on the subject of immunization2. Removing cross-cutting measures that encourage that dialogue between providers and patients around the importance of immunization could result in fewer Medicare beneficiaries being immunized. AVAC encourages CMS to consider these measures in the cross-cutting category in future rulemaking.

It is imperative that patients have access to ACIP-recommended vaccines through their main provider, which in the case of chronically ill beneficiaries, could be a specialist such as an endocrinologist, a cardiologist or another member of the patient’s healthcare team. CMS’ rationale for eliminating some of the cross-cutting measures, “the reporting MIPS eligible clinician may not actually be providing the care, but are just reporting another MIPS eligible clinician’s performance result” is not relevant to immunization status measures as they are an important first step to ascertaining whether or not a patient is up-to-date on their immunizations based on their age and health status. Screenings ensure that each individual is counseled and has the opportunity to receive the appropriate immunizations.

Advancing Care Information (ACI)
The proposed rule and the final rule transition the Meaningful Use of certified EHR technology to the new Advancing Care Information (ACI) performance category. The rule provides flexibility to allow clinicians who are at different stages of Meaningful Use to participate in the new ACI performance category while recognizing that not all providers are able to meet the goals of Stage 3 Meaningful Use at this time.

Immunization Information System (IIS) reporting has long been encouraged through the Meaningful Use program and has resulted in more providers seeking to report patient immunization data to state and jurisdictional registry programs. Immunizations are often administered in a clinical setting but a patient’s lifetime immunization record will span decades across different providers, facilities, and geographic locations. Ensuring an individual’s immunization record is accurate and complete over the course of a lifetime is a uniquely public health function. It is this consolidated record that drives the accurate forecast of immunizations due, and past due, at the point of care. For this reason, seamless multidirectional interoperability between CEHRT and Public Health in general, and IIS in particular, is essential to ensure the provision of appropriate clinical services, and a precursor for accurate measurement of quality care.

Under the proposed rule, a MIPS eligible clinician would only need to complete submission on the Immunization Registry Reporting measure to earn the full base score points. AVAC was deeply disappointed to learn that CMS amended the Immunization Registry Reporting so that it is no longer required as part of the base score in the final rule. Instead, MIPS eligible clinicians can earn 10 percent in the performance score for reporting this measure. Our coalition believes that the ACI category would serve as a strong incentive for the continued participation of clinicians in state and jurisdictional IIS’ and removing this requirement in the final rule, “in our effort to reduce the number of required measures in the base score and simplify reporting requirements”3 weakens this incentive for providers to report and will result in fewer adult immunization encounters being submitted to IIS’. We strongly urge CMS to go back to the original base score IIS reporting provision that was specified in the proposed rule and request an explanation for why the proposal was amended in the final rule.

Furthermore, we urge CMS to consider utilizing the ACI performance category to incentivize and encourage the following: sending reminders to patients using certified EHRs; sending educational information to patients using EHRs; implementing clinical decision support (CDS) tools to identify patients requiring vaccines; EHR generation of patient lists requiring immunizations; use of ePrescribing technology to implement electronic, two-way communication between the vaccine-recommending clinician’s chart and that of the vaccinating provider, accomplishing health information exchange (HIE) and the exchange and access to data between immunization providers within the immunization neighborhood. All of these EHR functionalities will strongly promote immunization and assist busy clinicians in assessing, recommending, providing/ referring for, and documenting immunizations –the four call-to-actions in the revised Standards for Adult Immunization Practice4. Incorporating these functions will facilitate the implementation of technology that exists today but is not fully utilized—and stands as a barrier to increased adult immunization— including IIS reporting and two-way exchange of data between referring clinicians and vaccinating providers in complementary settings, such as pharmacies, hospitals, and health departments.

Lastly, an additional area where greater reporting and interoperability would be of benefit is in support of vaccine management in private and public health care settings. EHR-IIS interoperability is essential to stronger and more efficient vaccine supply management through providing vaccine ordering, inventory, and accountability functions in clinical care settings, both during routine provision of immunizations and in cases of disease outbreaks.

Individual Quality Measures
The final rule (Table A) maintains a majority of PQRS measures for the first year of MIPS, including several important, immunization-related process measures. All of the immunization measures fall under the Community/Population Health domain of the National Quality Strategy.

– NQF #0041 PQRS #110 Preventive Care and Screening: Influenza Immunization. Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization.
– NQF #0043/PQRS #111 Pneumonia Vaccination Status for Older Adults. Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine.
– NQF #1407/PQRS #394 Immunizations for Adolescents. The percentage of adolescents 13 years of age who had the recommended immunizations by their 13th birthday.

In terms of these individual measures, AVAC would strongly recommend that they be characterized as high priority and core measures. Prioritizing these measures will expand the number of clinicians utilizing them and help to drive increased adult immunization rates. We also recommend that CMS work to broaden the scope of the adult immunization measures included under the individual measures category, to include other ACIP-recommended vaccines, such as Tdap and Zoster, as well as immunization measures for special populations at greater risk of vaccine preventable disease (e.g., people with diabetes, high-risk populations over 50).

Going forward, AVAC encourages CMS to streamline the quality measure development process for new vaccines to ensure more timely alignment with FDA approval and ACIP recommendations. Reducing delays in the adoption of accurate measures will result in improved uptake and utilization of adult vaccines across healthcare settings.

Specialty Quality Measures
The final rule maintains a number of adult immunization-related quality measures under various specialty measure sets. AVAC was grateful that CMS added NQF#0041 Preventive Care and Screening: Influenza Immunization was added into specialty measure sets for “General Practice/Family Medicine” as well as “Internal Medicine and Obstetrics/Gynecology”; NQF#1407 Immunizations for Adolescents was included in the Pediatrics specialty measure set.
 Allergy/Immunology/Rheumatology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults
 General Practice/Family Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF # 1407 Immunizations for Adolescents
 Internal Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization
 Obstetrics/Gynecology. NQF# 0041 Preventive Care and Screening: Influenza Immunization
 Pediatrics. NQF# 0041 Preventive Care and Screening: Influenza Immunization; NQF #0038 Childhood Immunization Status and NQF # 1407 Immunizations for Adolescents
 Preventive Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults

By contrast, AVAC was disappointed that CMS did not include NQF# 0043 Pneumonia Vaccination Status for Older Adults more broadly in the specialty measure sets. The Advisory Committee on Immunization Practices (ACIP) recommends routine use of a series of pneumococcal vaccinations for adults over the age of 65, including both the 23-valent pneumococcal polysaccharide vaccine (PPV23) and 13-valent pneumococcal conjugate vaccine. Healthy People 2020 set a goal to achieve at least 90 percent coverage for PPV among individuals 65 and older, but the current immunization rate for this population is estimated to be around 64 percent according to the CDC.

AVAC applauds CMS’ inclusion of the pneumococcal immunization measure in the “Preventive Medicine” specialty measure set. We appreciate CMS’ recognition of the value of pneumococcal vaccination as a preventive measure. It is concerning, however, that the pneumococcal immunization measure was not likewise included in the “General Practice/Family Practice” and “Internal Medicine” sets, unlike other vaccines. Our hope is that this was simply an oversight on the part of CMS and not a deliberate exclusion. General and family practitioners as well as internists are important community immunizers and can undoubtedly move pneumococcal immunization towards its Healthy People 2020 goal. We request that CMS reconsider this exclusion and incorporate the pneumococcal vaccination in the “General Practice/Family Practice” and “Internal Medicine Set.”

AVAC was disappointed that CMS went ahead with its proposal to remove NQF#0399 Hepatitis C: Hepatitis A Vaccination in the final rule. In light of the significant health and economic burden hepatitis C represents for the estimated 3.2 million Americans living with chronic hepatitis infection, proposing to remove a measure helps to protect the health of these patients from other vaccine preventable conditions seems like a step in the wrong direction. We disagree with the rule’s assessment that the “measure is considered low-bar and not robust enough to stand alone.”

AVAC was also disappointed that the rule did not prioritize adult immunization quality measures for chronically ill patients at greater risk of serious complications from vaccine preventable illness. The ACIP includes age-based as well as condition-specific recommendations for adult vaccination. For instance, patients living with chronic illnesses such as heart disease and diabetes are at a significantly higher risk of complications and death from influenza and pneumonia. The CDC has reported that in 2013 only 21.2% of adults in this group had received a pneumococcal vaccination, and this number has been essentially unchanged for at least a decade.5 Additionally, individuals with diabetes are at increased risk for hepatitis B infection. As such, the ACIP recommends hepatitis B vaccination for all patients with diabetes age 604 and under as well as other at risk patients, such as those living with HIV/AIDS and chronic kidney disease. We strongly encourage CMS to add this measure into the individual and specialty measure sets.

AVAC would also urge CMS to, at a minimum, include the following measures under the following specialty measure sets in future rulemaking:
 Endocrinology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.
 Cardiology. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.

The proposed rule notes that Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use measures from other CMS payment systems, such as measures for inpatient hospitals, for purposes of the quality and resource use performance categories. AVAC urges CMS to look broadly across payment systems under its purview and incorporate a broad array of relevant adult immunization quality measures from other clinical settings, such as the Herpes Zoster (Shingles) vaccination process measure being advanced under the home health value-based payment program – Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?

Aligned incentives and policy should encourage provider collaboration, coordination and communication – all tenets of the immunization neighborhood. 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 remain an integral component of the new MIPS and are a focus of certain Alternative Payment Models (APMs) in the coming years as well.

Thank you for this opportunity to offer our perspective on this rule being considered. 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,
American College of Preventive Medicine (ACPM)
American Pharmacists Association
Asian & Pacific Islander American Health Forum (APIAHF)
BIO
Dynavax Technologies
GSK
Immunization Action Coalition (IAC)
Merck
National Association of Chain Drug Stores (NACDS)
National Association of County and City Health Officials (NACCHO)
National Hispanic Medical Association (NHMA)
Novavax
Sanofi
Takeda Pharmaceuticals
The Gerontological Society of America
Trust for America’s Health

The Adult Vaccine Access Coalition (AVAC) consists of over 50 organizational leaders in health and public health who are committed to tackling the range of barriers to adult immunization and to raising awareness of its importance. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system.

As you know, every year, more than 50,000 American adults become seriously ill or lose their life as a result of a vaccine-preventable condition. Vaccine-preventable diseases cost the U.S. billions each year. As the U.S. population ages at an unprecedented rate, with 78 million Baby Boomers becoming seniors, improving rates of adult vaccination is a national imperative. Higher vaccination rates among adults reduce clinic visits, hospitalizations, and the incidence of long-term disability. Nevertheless, adult vaccination rates remain below national goals.

We appreciate the NVAC session today on the important issue of quality measurement. AVAC strongly supports building, strengthening and advancing a new generation of process and outcome quality measures to enable providers and health plans to track, report, and ultimately achieve increased adult immunization rates. We are committed to ensuring that adult immunization measures strike the right balance in terms of the burden on providers while ensuring the integrity and societal value of quality measurement.

Quality reporting measures are an increasingly important tool to track progress and desired outcomes in terms of preventive services benchmarks. Monitoring and reporting of offered and administered immunizations helps to ensure that the growing number ACIP-recommended immunizations for adults remain a priority and in the forefront of clinical care standards. In addition, reducing the number of missed immunization opportunities is imperative to improving health and reducing the burden of vaccine preventable disease. Developing, testing, and integrating ACIP-recommended adult immunizations as quality measures and incentive benchmarks under Medicare, Medicaid, and private insurance would help drive utilization and improve patient access to these low-cost preventive services.

Recently, representatives from AVAC and renowned vaccine experts partnered on a white paper entitled The Value and Imperative of Quality Measures for Adult Vaccinesi. The paper highlights how vaccine quality measures can prevent illness and death, reduce caregiving demands, save unnecessary healthcare spending, and set the foundation for healthy aging. We have a few copies here and you can also find the report on our website – www.adultvaccinesnow.org.

As heard at the February NVAC meeting, there has been some amazing work out of the Indian Health Service around Immunization Composite Measures. The adult immunization schedule is complex, and composite measures offer an efficient and effective way to enhance measurement of adult vaccines without further burdening providers. Additionally, as you heard today, the Pharmacy Quality Alliance (PQA) and other organizations are developing immunization quality metrics to identify and address gaps in adult immunization, including PQAs work to improve reporting to immunization registries. We hope to see this work continue and supported by NVAC.

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. Again, thank you for the opportunity to provide comments today.

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1654-P
P.O. Box 8013
Baltimore, MD 21244-8013

Re: Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model

To Whom It May Concern:

As members of the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Medicare Program Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.

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 2 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 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. 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.

AVAC commends CMS for maintaining the 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) are important baselines for measuring access to influenza and pneumococcal vaccination services. 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 61.3 percent of adults over the age of 64 and 20.3 percent of high risk adults being vaccinated in 2014, a slight decrease from the previous year.2 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.

AVAC encourages CMS to advance adult immunization quality measurement through the MSSP by working with relevant stakeholders and quality measure organizations to develop an updated pneumococcal immunization measure that reflects the current Advisory Committee for Immunization Practice (ACIP) recommendation for PCV13 and PPSV23 vaccination in adults age 65 and older as well as at risk adults 19-64 years old. The Health and Well-Being Committee for the National Quality Forum (NQF) proposed standards specifications for pneumococcal measures in order to better align measures across healthcare settings and to bring measures in accordance with ACIP recommendations.3

AVAC would further urge 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.4

The proposed rule notes that the “principal goal in selecting quality measures for ACOs has been to identify measures of success in the delivery of high-quality health care at the individual and population levels with a focus on outcomes.” The proposed rule further states that “the statute does not limit us to using endorsed measures in the Shared Savings Program.”5 As such, CMS has previously exercised discretion in including certain measures believed to be high impact but that are not currently endorsed. We would encourage CMS to consider including non-NQF endorsed adult immunization measures into the MSSP.

Specifically, 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 presently being 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.7

AVAC supports a meaningful core quality measure set for current vaccines and the development of measures for vaccines in the pipeline 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 new and evolving 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 new 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.

Lastly, under the proposed expansion of the diabetes prevention program, AVAC would strongly encourage CMS to include provider and beneficiary education on the ACIP-recommended vaccines for patients with or at risk of diabetes. 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. We believe 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 who are high risk of serious and life threatening complications.

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. Increasing immunization coverage rates among the Medicare population 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
American Association of Occupational Health Nurses (AAOHN)
BIO
Dynavax Technologies
Every Child By Two
Merck
Novavax
Pfizer
The Gerontological Society of America
Sanofi
National Association of Chain Drug Stores

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

August 26, 2016
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1648-P
P.O. Box 80136
Baltimore, MD 21244-8016

RE: Medicare and Medicaid Programs: CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements

To Whom It May Concern:

AVAC appreciates the opportunity to offer comments in response to the Medicare and Medicaid Programs: CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing (HHVBP) Model; and Home Health Quality Reporting Requirements. As a stakeholder coalition interested in advancing new payment models that encourage access to immunization, we are grateful to Centers for Medicare and Medicaid Services (CMS) for its work in this area.

AVAC consists of over 50 organizational leaders in health and public health who are committed to overcoming the barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC promotes solutions that will strengthen and enhance access to adult immunization across the healthcare system. Our mission is informed by a growing body of scientific and empirical evidence that shows that immunizations improve health, protect lives against a variety of debilitating and potentially deadly conditions, and avoid 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 all 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 for Immunization Practices (ACIP) recommendations, vaccines have been consistently underutilized in the adult population and lag behind the Healthy People 2020 goals for influenza, pneumococcal, Tdap, hepatitis B, herpes zoster, and human papillomavirus (HPV) vaccines. 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.

Home Health Agencies (HHAs) are instrumental community providers for elderly and frail patients and have an important role to play in improving vaccine access and utilization. Home health visits provide a unique opportunity to assess the patient in their home environment and employ a multidisciplinary approach to patient care. Incorporating vaccine assessment and administration during a home health episode optimizes patient care through removal of access barriers, including transportation for homebound patients. Studies have shown that multidisciplinary healthcare providers can have a significant impact on vaccine administration rates in a home visit format. 1

The HHVBP presents an important opportunity to promote higher quality and more efficient healthcare for Medicare beneficiaries. AVAC values the opportunity to offer our comments on aspects of the proposed rule 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. We look forward to working with you to improve upon existing adult immunization quality measures and to advance new measures for current vaccines and future vaccines in the pipeline. 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 strikes the right balance in terms of the burden on providers while ensuring the integrity and societal value of quality measurement.

AVAC believes the home health proposed rule 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 receiving home health services. Earlier this summer, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines.2 The report 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 rule proposes to remove several measures, as described in Figure 4a of the CY 2016 HH PPS final rule, from the set of applicable measures, including “Influenza Vaccine Data Collection Period: Does this episode of care include any dates on or between October 1 and March 31?”; and “Reason Pneumococcal Vaccine Not Received”. The proposed rule indicates the reason for proposing to remove the influenza measure is because the data element (OASIS item M1041) is used to calculate another HHVBP measure “Influenza Immunization Received for Current Flu Season” which is proposed to be maintained in CY 2017. The proposed rule would require HHAs to report this measure annually instead of quarterly.

The proposed rule would also remove the “Reason Pneumococcal Vaccine Not Received” measure because the data are already reported as an element of the patient record for clinical decision making and inform agency policy. Additionally, the reason for the removal of individuals for whom the vaccine is not appropriate is already included in the numerator of the “Pneumococcal Polysaccharide Vaccine Ever Received”, an existing measure in the HHVBP Model. Since the influenza and pneumococcal measures are captured elsewhere through the HHVBP, AVAC is comfortable with the proposed adjustment of the 2 measures described in Figure 4 a in this context. It will be essential for home health providers to understand these adjustments which may help improve vaccine reporting.

AVAC commends CMS for maintaining under Table 31 the Influenza Immunization Received for Current Flu Season (NQF#0522) among the Population/Community Health measures for the HHVBP. The proposed rule also maintains a Pneumococcal Polysaccharide Vaccine Ever Received (NQF#0525) but would note this measure no longer reflects current recommendations of the Advisory Committee on Immunization Practices (ACIP). We urge CMS to consider including an alternative measure, Pneumonia Vaccination Status for Older Adults (NQF#0043) in the final rule. Together, these measures would represent an important baseline for access to influenza and pneumococcal vaccination services and are being utilized effectively in other settings under the Medicare program. We believe they would greatly enhance the ability of home health providers to monitor immunization status and report offered and administered influenza and pneumococcal immunizations to beneficiaries. Reducing the number of missed immunization opportunities among patients in the home health setting is critical to improving health and reducing the burden of vaccine preventable disease.

Looking ahead, the NQF report “Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Adult Immunizations”3 noted that 60 measures have been developed to address pneumococcal immunization and that to reduce the burden and improve the value of measurement, measures should be harmonized and consolidated and “at a minimum, all measures should be up to date with current ACIP/CDC recommendations.” To that end, through its Health and Well-Being Standing Committee, NQF has proposed and approved standard specifications for pneumococcal vaccination to enable measure stewards for the existing measures (CMS and NCQA) to assess, and presumably modify, measures based on the revised standardized specifications.4 We encourage CMS to work with relevant stakeholders and quality measure organizations such as NQF to develop an updated pneumococcal immunization measure that reflects the current Advisory Committee for Immunization Practice (ACIP) recommendation for PCV13 and PPSV23 vaccination in adults age 65 and older as well as at-risk adults 19-64 years old for inclusion in the HHVBP.

AVAC is pleased that CMS is proposing to maintain two other immunization process measures in the HHVBP, “Influenza Vaccination Coverage among Healthcare Personnel” (NQF #0431) and “Herpes Zoster (Shingles) Vaccination: Has the Patient Ever Received the Shingles Vaccination?”. NQF#0431 is utilized effectively in a number of other healthcare settings. Moreover, leading medical and health professional associations support influenza vaccination policies for healthcare professionals to help protect patients.5 Healthcare personnel are the first line of defense when it comes to preventing illness and preserving health. Measurement tools reflecting this priority are essential to promoting health and advancing prevention in the home health setting and AVAC strongly supports the inclusion of this measure in the final rule.

We greatly appreciate that Table 31 in the proposed rule also makes herpes zoster vaccination a priority for the HHVBP. Only 28 percent of adults age 60 and older reported receiving the herpes zoster vaccine.6 Yet, the health and economic burden associated with shingles and its complications are significant. 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.7

Postherpetic neuralgia (PHN) is a common complication; however, other lingering and potentially severe complications and pain can have a lasting impact on an individual. AVAC urges CMS to maintain the herpes zoster vaccination process measure in the final rule. We hope that other value-based purchasing and quality reporting programs will also consider this measure in the future, particularly since the absence of zoster vaccination measures has been identified by the National Quality Forum as a significant gap in performance measurement and the development of a measure has
been identified as a priority.8

Lastly, AVAC supports under Table 33, Home Health Quality Reporting Program measures for future consideration, the proposed addition under health and well-being, the Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay). The proposed measure would fall under the NQS Patient and Caregiver Centered Care category.

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 not only among Medicare beneficiaries but also helps provide protection to grandchildren and great-grandchildren who might be too young to be immunized as well. AVAC looks forward to working with CMS to ensure that adult immunization quality measures remain an integral component of the new HHVBP and HH QRP.

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,

Alliance for Aging Research
American College of Preventive Medicine
Asian & Pacific Islander American Health Forum (APIAHF)
Every Child By Two (ECBT)
GlaxoSmithKline
Immunization Action Coalition (IAC)
National Association of County and City Health Officials (NACCHO)
Medicago
Merck
Novavax
The Gerontological Society of America
Trust for America’s Health