AVAC Responds to CMS’s Final Rule on 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 offered comments to the final rule CMS published on the 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 was 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.

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.

American College of Preventive Medicine (ACPM)
American Pharmacists Association
Asian & Pacific Islander American Health Forum (APIAHF)
Dynavax Technologies
Immunization Action Coalition (IAC)
National Association of Chain Drug Stores (NACDS)
National Association of County and City Health Officials (NACCHO)
National Hispanic Medical Association (NHMA)
Takeda Pharmaceuticals
The Gerontological Society of America
Trust for America’s Health