September 27, 2019

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1693-P
P.O. Box 8016
Baltimore, MD 21244-8016

RE: CMS-1715-P Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc.

To Whom It May Concern:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc.

Specifically, AVAC:
• Strongly supports the inclusion of the Adult Immunization Status (AIS) measure in both the MIPS and MSSP and additional specialty sets.
• Opposes the proposed 15 percent reduction in practice expense relative value units for Vaccine Administration. If the proposed reduction is allowed to take effect, providers will face a 44 percent reduction in vaccine administration since 2017.

AVAC consists of over 55 organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our 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.

Despite the well-known benefits of immunizations, more than 50,000 adults die from vaccine-preventable diseases while adult coverage lag behind Healthy People 2020 targets for most commonly recommended vaccines: influenza, pneumococcal, tetanus, hepatitis B, herpes zoster, and HPV. One of our key coalition priorities is to advocate for federal benchmarks and quality measures to encourage improved tracking and reporting of adult immunization status that will result in increased adult immunization rates.

Adult Immunization Status Measure
We appreciate that the proposed rule contains a number of important provisions aimed at the transition from volume-to-value based payment policy. Specifically, the proposed rule includes elements pertaining to the operation of the Medicare Shared Savings Program (MSSP) as well as the Merit-based Incentive Payment System (MIPS) that offer important opportunities to encourage access to and utilization of recommended adult immunizations to priority populations within the Medicare program.

AVAC strongly supports the inclusion of the Adult Immunization Status measure in both the MIPS and MSSP and encourages CMS to maintain the measure in the final rule. The AIS measure is a composite of several age-recommended vaccines for adults, comprising influenza, pneumococcal, zoster, and Tdap vaccines. Adoption of the composite measure will provide a sound, reliable and comprehensive means to assesses the receipt of routinely recommended adult immunizations. The AIS will reduce the reporting burden on providers while also incentivizing them to follow the National Vaccine Advisory Committee (NVAC) Practice Standards for Adult Immunization Practice1 to assess, recommend, administer or refer and document the vaccines the patient may (or may not) have received during the office visit.

In 2016, AVAC released a White Paper outlining the value and imperative of quality measures for adult vaccines. 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. Quality measurement programs through Medicare play a critical role in promoting improved quality and encouraging adherence to and consistent utilization of recommended adult vaccines.

The Adult Immunization Status quality measurement is a valuable addition because it meets the three core strategies underlying the movement 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 Electronic Health Record (EHR) technology and other data sources to support care delivery.

ACO-47
AVAC commends CMS for including Adult Immunization Status (ACO-47) under the AIM: Better Health for Populations under the MSSP beginning in 2020, for phase in as a pay-for-performance measure starting in performance year 2022. Its’ inclusion presents an important opportunity to promote higher quality and more efficient health care for Medicare beneficiaries. AVAC appreciates CMS’ recognition of the need to 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.

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.

CY2020 MIPS Specialty Measure Sets (Appendix 1)
Opportunities to assess the immunization status of Medicare beneficiaries should be done by the range of clinicians who care for them, including primary care and specialty providers. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong provider recommendation have been found to improve the likelihood of a patient being immunized.

AVAC is pleased the proposed rule takes steps to adopt past AVAC recommendations to the agency to broadly incorporate the Adult Immunization Status measure through the following specialty sets.
✓ Allergy/Immunology
✓ Family Medicine
✓ Internal Medicine
✓ Otolaryngology
✓ Preventive Medicine
✓ Nephrology
✓ General Surgery
✓ Oncology
✓ Infectious Disease
✓ Rheumatology
✓ Geriatrics
✓ Skilled Nursing Facility
✓ Endocrinology

Cardiology
We encourage CMS to consider also adding the Adult Immunization Status measure into the Cardiology specialty measure set given the vital importance of vaccines in preserving and protecting the health and well-being of patients with cardiovascular conditions, such as heart disease.

Obstetrics/Gynecology
AVAC notes the inclusion of the Adult Immunization Status measure under the Obstetrics/Gynecology specialty measure set. We would encourage CMS to also consider adopting the Prenatal Immunization Status measure, which was created specifically for maternal populations and better reflects the Advisory Committee on Immunization Practices (ACIP) recommendations for pregnant women, specifically Tdap and influenza.

Like the AIS, the Prenatal Immunization Status measure will help to address substantial disparities in prenatal immunization rates. Immunizing mothers during their third trimester protects 9 in 10 babies from pertussis infections serious enough to need treatment in a hospital. Getting a flu shot reduces a pregnant woman’s risk of hospitalization by 40% and helps protect the newborn before he/she is old enough to be vaccinated.

Reduction in Practice Expense Relative Value Units for Vaccine Administration
Immunizations are an important public health imperative and ensuring that immunization providers are properly reimbursed is key to fostering a sustained environment of timely immunization. Vaccine administration by health care providers in their office, at the point of care, is an opportunity that needs to be maintained and encouraged. Studies show that inadequate reimbursement for vaccination administration result in missed immunization opportunities and declines in immunization rates.

AVAC is deeply concerned with the proposed 15% reduction in the reimbursement rate for CPT codes for vaccine administration (90471-90474) in 2020. In 2013, Medicare providers received $25.86 for vaccine administration whereas under the proposed rule, providers would only receive $14.42 beginning in 2020. Between 2017 and 2020, providers are facing up to a 44 percent reduction in reimbursement at a time when practice expense costs have been increasing, not decreasing.

In previous and current proposed reductions, CMS utilizes the AMA’s RUC recommendations, which are based on a determination that less resources are needed to furnish services associated with CPT 96372, as reflected in the reduction in Practice Expense (PE) inputs. None of the immunization administration codes were used as a reference or comparison in the AMA’s revaluation of 96372.

While overhead costs are considered in the calculation of the PE PVU component of CPT 90471-90474, this calculation is inappropriately applied to immunization administration, as it underestimates the provider burden associated with vaccinating adult patients. Thus, CMS’ reduction in the payment rate results in a misvaluation of the CPT code and a subsequent underpayment for immunization services. CMS’ payment rates for immunization administration should reflect this distinction.

Specifically, provider offices must manage vaccine ordering and inventory, ancillary supplies directly related to the administration of vaccines, such as syringes and gloves as well as indirect overhead costs associated with reporting and other administrative requirements specific to immunizations. Providers also must effectively an influx of patient visits solely for immunization during certain times of year (particularly during back to school and flu season, October-March).

A recent study in the journal Vaccines notes, “A number of studies have documented that physician practices feel they face financial challenges in providing adult vaccination, such as inadequate reimbursement, delays in receiving reimbursement, uncertainty in forecasting vaccine needs, and substantial expenses in acquiring and maintaining vaccine stock.” These factors have driven many providers to consider discontinuing or limiting vaccine services to patients.

AVAC is deeply concerned that the continued erosion in vaccine administration reimbursement will only exacerbate this alarming trend and further erode adult immunization coverage rates. Missed opportunities to immunize the Medicare population will result in increased burdens of vaccine preventable diseases and additional costs to health systems. These payment reductions also have the potential to have spillover effects on commercial coverage of vaccines, strain critical public health infrastructure and set our nation back in terms of achieving Healthy People goals to further increase vaccination rates for adults.

The proposed reduction also runs counter to the Administration’s ongoing efforts to improve access to vaccination. On September 19, the President issued an Executive Order to modernize and improve influenza vaccination to promote national security and public health. Section 2 of the EO states, “This is a public health and national security priority, as influenza has the potential to significantly harm the United States and our interests, including through large-scale illness and death, disruption to military operations, and damage the economy.”8 Similarly, the HHS’ Strategic Plan FY2018–2022, acknowledged that “infectious diseases are a major health and economic burden for the United States.” Objective 2.1 of the Strategic Plan makes a commitment to “support access to preventive services including immunizations and screenings, especially for high-risk, high-need populations.9”

Given the current gaps in immunization access for older adults as well as the potential negative long-term impact on providers’ ability to offer recommended immunizations to Medicare patients, AVAC strongly urges CMS to abandon this proposed reduction in vaccine administration reimbursement. AVAC encourages the agency to consider decoupling the practice expense RVU for vaccine administration from therapeutic injection and come up with a more accurate formula for calculating vaccine administration costs.

We appreciate this opportunity to share our perspective on the proposed rule and are grateful for your work to update and streamline the quality measurement tools available to providers. Please contact an 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 Immunization Registry Association (AIRA)
American Pharmacists Association
Asian Pacific Islander American Health Forum
Association of Immunization Managers
BIO
Dynavax
Families Fighting Flu
GSK
Hepatitis B Foundation
Hep B United
Infectious Diseases Society of America (IDSA)
Immunization Action Coalition
Immunization Coalition of Washington DC
Medicago
Merck
National Association of County and City Health Officials (NACCHO)
National Black Nurses Association
National Consumers League
National Foundation for Infectious Diseases (NFID)
National Hispanic Medical Association
Novavax
Pfizer
Sanofi
Seqirus
Takeda Vaccines, Inc.
The Gerontological Society of America
Trust for America’s Health
Vaccinate Your Family