June 27, 2016

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-5517-P
P.O. Box 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 appreciates the opportunity to offer comments in response to the 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. As a stakeholder interested in advancing new physician payment models that encourage access to essential preventive services such as immunization, we are grateful to CMS for its work in this area.

AVAC consists of 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. 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 far 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. The stated goal of the proposed rule is to, “…improve physician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in alternative payment models.”1

The proposed rule seeks to establish the Merit-Based Incentive Payment System (MIPS), 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 — and establish incentives for participation in certain alternative payment models (APMs). Within MIPS, the proposed 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 aspects of each performance category relevant to the provision of immunizations as well as our view on other related aspects of the proposed rule. 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 toward improving upon existing adult immunization quality measures. 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 that adult immunization quality measurement and the three core strategies underlying the foundation for progress toward a truly patient-centered health care delivery system in the proposed rule can also help drive improved adult immunization coverage rates 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.

Quality

The proposed rule calls 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. The proposed rule specifies that from the list of possible measures, clinicians must report on a minimum of six measures, including one cross-cutting measure and an outcome measure (or another priority measure such as appropriate use, patient safety, efficiency, patient experience or care coordination if an outcome measure is not available). Clinicians may choose from the individual or specialty-specific measure sets outlined in the proposed rule. With that in mind, AVAC would like to offer the following comments:

Cross-cutting Measures

“Cross-cutting measures help focus our efforts on population health improvement.” As recognized in Healthy People 2020, prevention of infectious disease through immunization is a key factor in improving the health of our nation.

The proposed rule recommends that the following immunization-related cross-cutting measures not continue for 2017: PQRS #110 (Preventive Care and Screening: Influenza Immunization), PQRS #111 (Pneumonia Vaccination Status for Older Adults) and PQRS #240 (Childhood Immunization Status). AVAC has deep concerns with this proposal and its potential impact on the provision of and access to immunization services for Medicare beneficiaries.

It is imperative that elderly and disabled 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. The rationale applied to eliminate 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” does not apply to either of these vaccine measures as the first step is to screen for immunization.

Screening should be done by the main providers to ensure that each individual is counseled and has the opportunity to receive the appropriate immunizations. Removing PQRS #110 and PQRS #111 as cross-cutting measures would significantly reduce the likelihood that eligible professionals in a variety of care settings will be incentivized to offer immunization services in the course of providing care to patients. Published literature indicates that fewer providers offering these critical prevention services will result in more ‘missed opportunities’ for immunization and a greater likelihood of illness and complications from vaccine preventable conditions such as influenza and pneumonia. The National Vaccine Advisory Committee’s (NVAC) Adult Immunization Standards call for all providers caring for adult patients to assess, recommend, vaccinate or refer, and document vaccinations.2

Individual Quality Measures AVAC appreciates that the proposed rule maintains a majority of PQRS measures for the first year of MIPS, including several important, immunization-related process measures. All of these 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 the aforementioned individual measures, AVAC would strongly recommend that NQF #0041 and #0043 be characterized as high priority and core measures. Prioritizing these measures will expand the number of clinicians utilizing them and produce increased adult immunization rates in the U.S. We also recommend that CMS work to broaden the scope of the adult immunization measures included under quality performance 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).

We encourage 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.

AVAC is concerned that the following measure is proposed to be removed:

Hepatitis C: Hepatitis A Vaccination. Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who have received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A. In light of the health and economic burden hepatitis C represents for millions of Americans, proposing to remove a measure that would help protect the health of these patients from other vaccine preventable conditions seems like a step in the wrong direction. We disagree with the proposed rule’s assessment that the “measure is considered low-bar and not robust enough to stand alone.”

The proposed rule offers a number of quality measures under specialty measure sets. AVAC is encouraged to see that the following specialty sets include immunization related process quality measures:

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 # 1407 Immunizations for Adolescents

Pediatrics. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF #0038 Childhood Immunization Status

Preventive Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults

AVAC was, however, disappointed that the proposed rule did not include quality measures aimed at patients at greater risk of serious complications from vaccine preventable illness. In particular, please note that 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.3

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:

Internal Medicine. NQF# 0041 Preventive Care and Screening: Influenza Immunization and NQF# 0043 Pneumonia Vaccination Status for Older Adults.

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.

Obstetrics/Gynecology. NQF# 0041 Preventive Care and Screening: Influenza Immunization.

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?

AVAC appreciates that eligible clinicians have the ability to submit quality performance data through a variety of means, including claims, QCDR, a qualified registry, EHR, or automatically through administrative claims.

Innovation Center Quality Measure Review Process

AVAC is pleased that the proposed rule seeks to establish an Innovation Center quality measure review process for those measures that are not NQF-endorsed or included on the final MIPS measure list to assess if the quality measures have an evidence-based focus, and are reliable and valid. We would encourage CMS to consider prioritizing a broader set of recommended immunization measures as part of the Innovation Center’s quality measure review process. We ask that CMS work with relevant stakeholders to develop, test, and integrate additional ACIP-recommended adult immunizations into quality measure and incentive benchmarks under MIPS.

Moving forward, AVAC believes that important work is currently underway to develop and test comprehensive, composite measures for adults5 that could bring greater flexibility and more complete information regarding the immunization status of an adult as ACIP-recommendations evolve and change, similar to what pediatric and family providers currently use to measure childhood immunization status.

AVAC encourages CMS to prioritize the development of adult immunization quality measures and include them in future updates. The National Quality Forum in their August 2014 report, “Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Adult Immunizations”6 identifies several age specific and composite measure sets for adult immunization that would help address current gaps in immunization and reduce the number of missed opportunities to vaccinate patients with the greatest need. Moreover, a number of promising new vaccines in late stage development have great potential to save lives and reduce healthcare costs. Yet, delays in the development and implementation of quality measures can have a detrimental impact on immunization rates. Therefore, we would encourage CMS to streamline the quality measure development process once a vaccine for the Medicare population receives both FDA approval and a recommendation by the ACIP.

Clinical Practice Improvement Activity (CPIA)

AVAC supports the goal of the Clinical Practice Improvement Activity (CPIA performance category to, “use a patient-centered approach to program development that leads to better, smarter and healthier care.”7 A number of adult immunization performance improvement activities are evidence-based, are feasible to implement, are linked to continuous improvement over time, result in improved health outcomes, are linked to population health management, align with the requirements of a patient-centered medical home, and can promote health equity. While the CPIA performance category only accounts for 15 percent of the composite performance score, it is an important new element that will drive improvements in care over the long-term. AVAC encourages CMS to consider and prioritize CPIAs that will lead to improved adult immunization rates and overall health outcomes, and will encourage provider alignment with the NVAC Adult Immunization Standards.

Advancing Care Information (ACI)

The proposed rule seeks to transition the meaningful use of certified EHR technology to the new advancing care information performance category. The proposed rule provides accommodations to ensure that clinicians who are at different stages of meaningful use are able to participate in the advancing care information performance category while also recognizing that not all providers in all states have the ability to report immunization record data to an Immunization Information System (IIS). Although immunizations are often administered in a clinical setting, a patient’s lifetime immunization record will span decades, and the consolidation of records as individuals move among health care providers 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.

In terms of immunization, AVAC was pleased to note that the advancing care information category incentivizes the continued participation of clinicians in state and local immunization information systems. Specifically, to earn the full base score points, a MIPS eligible clinician would only need to complete submission on the Immunization Registry Reporting measure of this objective. Completing any additional measures under this objective would earn one additional bonus point in the advancing care information performance category score.

In addition to reporting to state Immunization Information Systems (IIS), we urge that the ACI 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 Practice8. 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.

Moreover, the proposed rule differentiates the Immunization Registry Reporting Measure between active engagement under Stage 2 and Stage 3 reporting. AVAC appreciates that the proposed rule strongly encourages the reporting of immunization data and continues to advance efforts to provide for multidirectional data exchange. Immunization forecasts and patient histories are important tools that strengthen and enhance the ability of clinicians to educate patients and improve clinical decision making at the point of care.

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.

Resource Use

The proposed rule would continue two measures currently employed under the value-based modifier – total per capita costs for all attributed beneficiaries and Medicare Spending per Beneficiary.

While AVAC appreciates that the measures account for risk factors such as socioeconomic and demographic characteristics, ethnicity and individual health status, we would also urge CMS to carefully consider the overall impact of the resource use measure on immunization services. We understand CMS plans to review recommendations from the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) on the issue of risk adjustment for socioeconomic status to ensure that clinicians who care for a disproportionate number of low-income beneficiaries are not inadvertently disadvantaged under the resource use calculation relative to their counterparts. It is also important to understand the unique and relatively complex nature of immunization services for clinicians. Many struggle with storage, inventory, and payment hurdles for vaccines. Managing all of these aspects under a capitated arrangement can actually result in declines in vaccine utilization.

The proposed rule indicates that in measuring resource use, “the Secretary shall use the per patient total allowed charges for all services under Medicare Part A and B but also provides discretion to also include Part D, as appropriate.” AVAC strongly believes that patients should be able to receive all recommended vaccines in their preferred healthcare setting. Our coalition urges CMS to improve billing systems for providers administering Part D vaccines. However, should Part D become part of the resource use performance component, we urge you to exclude Part D vaccine costs so as not to disincentivize clinicians who wish to offer the full complement of ACIP recommended vaccines to patients. In addition, providers should be incentivized to collaborate with other healthcare providers who can efficiently provide immunization services, increase patient access and achieve patient completion of vaccination series. In regards to immunizations, 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)
Biotechnology Innovation Organization (BIO)
Dynavax
GSK
Hep B United
Hepatitis B Foundation
Immunization Action Coalition (IAC)
Infectious Diseases Society of America (IDSA)
Merck
National Association of County and City Health Officials (NACCHO)
National Association of Chain Drug Stores (NACDS)
National Foundation for Infectious Diseases
Novavax
Pfizer
Sanofi
Takeda Pharmaceuticals
The Gerontological Society of America
Trust for America’s Health