GlaxoSmithKline Issues Public Comment on OMB Notice

WASHINGTON, July 10 -- Margaret Nowak Mann, vice president for public policy at GlaxoSmithKline, Brentford, United Kingdom, has issued a public comment on the Office of Management and Budget notice entitled "Methods and Leading Practices for Advancing Equity and Support for Underserved Communities through Government". The comment was written and posted on July 6, 2021:

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GlaxoSmithKline (GSK) is pleased to submit comments on the above-referenced request for information regarding advancing equity. GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines, vaccines and consumer health products that are used by millions of people in the US and around the world.

GSK has a broad portfolio of medicines in respiratory, HIV, immuno-inflammation and oncology. We are strengthening our research and development (R&D) pipeline through a focus on immunology, human genetics and advanced technologies to help us deliver transformational new medicines for patients. Our vaccines business has a portfolio of more than 20 vaccines to help protect people from a range of diseases throughout their lives.

ViiV Healthcare (ViiV), an affiliate that focuses on human immunodeficiency virus (HIV), is a global specialist company in HIV that we majority own, with Pfizer and Shionogi as shareholders. ViiV is the only independent, global specialist company devoted exclusively to delivering advancements in human immunodeficiency virus (HIV) treatment and prevention to support the needs of people living with HIV (PLWH). From its inception in 2009, ViiV has had a singular focus to improve the health and quality of life of people affected by this disease and has worked to address significant gaps and unmet needs in HIV care.

Everything we do at GSK supports our purpose, to help people do more, feel better, and live longer. While our medicines, vaccines and consumer healthcare products improve quality of life for patients around the world, there are still millions of people living with unmet healthcare needs. We believe one of the biggest areas where we can help advance equity and support underserved communities is by increasing access to healthcare for people of color and vulnerable populations.

GSK is dedicated to working with policymakers and the federal government to advance solutions that eliminate health disparities. We believe that "health equity is achieved when every person has the opportunity to attain his or her full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances."/1

Our approach to philanthropy in the US centers on addressing inequality in the communities where we live and work. Whether focused on improving Science, Technology, Engineering, and Mathematics (STEM) education, social determinants of health, or disaster preparedness, we have intentionally designed our giving programs to address inequity with the voice of the community as our guide.

We note the broad range of topics for which the Office of Management and Budget (OMB) has invited comment, but respectfully limit our comments to three areas of utmost importance to GSK and the patients we serve: 1) Equity Assessments and Strategies; 2) Barrier and Burden Reduction; and 3) Stakeholder and Community Engagement. GSK hopes that, by providing comments here, we can all help reach a better outcome for patients.

1. Equity Assessments and Strategies. Approaches and methods for holistic and program- or policy-specific assessments of equity for public sector entities, including but not limited to the development of public policy strategies that advance equity and the use of data to inform equitable public policy strategies.

GSK recommends OMB consider revising their current race and ethnicity standards in order to collect more appropriate data that reflects underserved individuals and communities. OMB's race and ethnicity standards are used across many organizations. For example, National Committee for Quality Assurance (NCQA) now require health plans to stratify select Healthcare Effectiveness Data and Information Set (HEDIS) measures based on OMB's race and ethnicity standards. During NCQA's public comment period and during the question-and-answer portion of the Future of HEDIS - Health Equity webinar held on June 22, 2021, some stakeholders noted that OMB's race and ethnicity standards do not account for the Middle Eastern/North African population, as well as other ethnicities besides Hispanic/Latino.

There are many challenges associated with collecting accurate data on race and ethnicity. As highlighted in the Institute of Medicine's report, Race, Ethnicity, and Language Data Standardization for Health Care Quality Improvement, lack of standardized race and ethnicity categories is a barrier to collection and utilization of this data. Discrepancies in race and ethnicity data may limit the ability to measure disparities in care. The current OMB standards lack the granularity that is meaningful for patients. Therefore, OMB should consider revising their race and ethnicity standards as data standardization efforts evolve and organizations bring equity and inclusivity to the forefront of their priorities.

GSK suggests that OMB work with Centers for Medicare & Medicaid Services (CMS) to foster improved demographic data collection within its quality reporting programs. In order to have a comprehensive assessment of health equity, quality measures that are used in CMS programs should be stratified by social factors, such as socioeconomic status. Persons with low socioeconomic status (SES) are more likely to be Medicaid recipients or uninsured, have poor health outcomes, and seek health care less often. Following the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014, CMS commissioned NCQA to explore the effects of SES on select HEDIS Medicare measures. As a result, HEDIS currently requires a SES stratification for four HEDIS measures. GSK recommends that CMS further align with NCQA by expanding stratified reporting to SES. Additionally, this type of reporting will give OMB more insights into health equity for program and policy-specific assessments.

GSK encourages OMB to further work with CMS to develop quality measures in order to assess health equity within quality and pay-for-performance programs. Incorporating and implementing measures within quality-reporting programs will help CMS and OMB identify gaps and opportunities to improve health equity among patients.

National Quality Forum (NQF) has developed roadmaps for "disparities-sensitive" measures that should be considered for future measure development efforts.

GSK recommends OMB coordinate and align their equity efforts with other federal agencies, including the National Institute on Minority Health and Health Disparities (NIMHD). By working with other agencies, OMB can expand research linked to place-based initiatives around how social and economic conditions are connected to health outcomes. This would help OMB tackle the first step in addressing the request laid out by President Biden - to explore more equitable allocation and distribution of resources to underserved populations. President Biden's executive order on Advancing Equity also calls for federal agencies to engage with grassroots organizations at the local level./2

GSK recommends that OMB coordinate with community-based and civil rights organizations to achieve equity in underserved populations.

GSK recommends that OMB develop a scoring system to measure health equity, just as the Congressional Budget Office (CBO) scores bills with impact on the federal budget, as recently proposed and outlined by the Brookings Institute. The OMB should work with researchers and other stakeholders to establish methods to measure and evaluate policy outputs as they relate to racial economic inclusion, civic engagement, and social equity. Policymakers at local, state, and federal levels could adopt this method to assess policy proposals' impacts on racial inclusion.

GSK recommends and encourages efforts to address health disparities and inequities in terms of both sexual orientation and gender identity (SOGI) and also racial, cultural and linguistic assessments and interventions. Lack of publicly available comparable data on the individuals and populations served by public programs is a key perpetuator of health disparities. We encourage efforts to address health disparities and inequities in terms of both sexual orientation and gender identity (SOGI) and also racial, cultural and linguistic assessments and interventions. We encourage all federal health programs to collect this data and also make it public, and comparable across states, regions, programs, payers, providers etc.

GSK recommends the collection of outcomes data in health programs related to diseases and conditions with high rates of disparity of impact. HIV continues to have a disproportionate impact on certain populations, particularly racial and ethnic minorities and gay and bisexual men. The "HIV Viral Load Suppression (VLS)" quality measure demonstrates that a patient has reached the goal of HIV treatment, which is viral suppression. However, few states report statewide VLS rates in their Medicaid programs, or require plan level reporting in Medicaid managed care, despite the fact that Medicaid is the largest source of coverage for people with HIV. Because of this, VLS rates are not currently included on the CMS Medicaid Scorecard, and so it is difficult to track or compare disparities in HIV care across state Medicaid programs. Use of the VLS metric would help OMB track treatment progress across geographies and populations and identify areas where more attention, education and care are needed.

GSK recommends OMB, in developing its goals and strategies around health equity, review and model elements of the Ryan White HIV/AIDS Program (RWHAP), that have proven to be effective in supporting optimal patient care, addressing health disparities and driving treatment success in HIV for over 30 years. In 2018, 87.1 percent of RWHAP clients were reported to be virally suppressed, far exceeding the national viral suppression average of 62.7 percent at the time. Nearly three-quarters of RWHAP clients are from racial/ethnic minority populations. The RWHAP rigorously collects data on the populations the program serves and measures the outcomes of program grantees at every level. The success of specific RWHAP could help to inform models of data collection as a basis for measuring health equity in program service delivery and outcomes.

GSK recommends OMB work with the US Department of Health and Human Services (HHS) to review and model the success of COVID-19 immunization efforts when considering how to develop programs to address vaccination disparities. To date, the US has immunized over 165 million adults with at least a single dose of a COVID-19 vaccine- an astonishing achievement in six months. This extraordinary campaign has been largely facilitated by the removal of known barriers to optimize access for Americans including: eliminating out-of-pocket (OOP) costs, focusing attention on health equity to meet people where they are, and launching a nationwide educational initiative. These lessons learned can be applied to closing disparities in immunization rates for all recommended vaccines, especially among adults.

GSK encourages OMB to adopt use of real time public health data collection across the federal government. GSK believes that the COVID-19 pandemic has demonstrated the need and value of real time collection of information on adult, child, and adolescent immunizations. Current efforts to collect information by state helps inform policy and identify inequities. However, states vary in the manner of data submissions and the information collected. More should be done to standardize information collection and broaden collection of these data. State adult immunization reporting systems are not standardized or consistently used. A federal immunization reporting system or set of standards could support better understanding of access to and use of preventive services.

GSK encourages OMB to recommend cross-government use and availability of internal equity data and studies. Studies by internal offices/agencies at HHS, such as the Office of the Assistant Secretary of Planning and Evaluation (ASPE) can be used to support Department-wide initiatives to increase equitable access to and uptake of preventive services, such as immunizations. For example, recent detailed work on vaccine hesitancy by ASPE can help identify segments of the population that may be underserved with regard to vaccines.

GSK recommends that OMB provide training, on best practices for health equity data collection, at the state and local level and for partners. Federal agencies, such as HHS, could provide trainings and support for best practices among states and partners to improve data collection and reporting efforts related to preventive and public health services, including immunizations.

2. Barrier and Burden Reduction. Approaches and methods for assessing and remedying barriers, burden, and inequities in public service delivery and access.

GSK recommends OMB support policies that improve continuous coverage and access to health care. GSK believes more must be done to ensure that health equity is being addressed first and foremost by ensuring coverage is widely available and accessible and that those that are eligible for Federal health programs are enrolled and remain enrolled. This will improve access to preventive services and care. Further, enrollment processes should be straightforward and culturally appropriate to support continuous coverage. Assistance should be available to support redeterminations and reenrollment in federal and state programs like Medicaid as well as coverage available through the Health Insurance Marketplaces.

GSK recommends OMB support policies that ensure access to preventive health services. Health policies should increase the availability of preventive services in minority and underserved populations, including access to life-saving immunizations for those that are uninsured.

GSK encourages OMB to consider removing barriers across the federal government that prevent health equity. Policies should focus on consideration and removal of known barriers to care and services for Americans, including eliminating out-of-pocket (OOP) costs, ensuring provider/service access in underserved communities, and using data to better evaluate the impact of policy on specific population groups.

GSK recommends OMB use and strengthen current population health measures (Healthy People 2030) to advance health equity. HHS has a strong platform of readily available metrics on health care access and issues in the objectives and data collection for Healthy People 2030. The information is also intended to measure health disparities in objective performance. GSK believes more can be done to highlight and refer to performance on these measures in establishing policies across HHS. Additionally, the data used to support these measures (some of which are based on self-reported survey data) can be improved to be more real-time and up-to-date using electronic health systems and reporting and/or private and public partnerships in collecting and analyzing data.

3. Stakeholder and Community Engagement. Approaches and methods for accessible and meaningful agency engagement with underserved communities.

GSK recommends OMB support multi-sector Public-Private Stakeholder Collaborations. GSK believes that collaboration between government groups at all levels (federal, state, and local), stakeholders (including patient groups, advocates, and faith-based organizations), and representatives from industry, payers, public health and provider communities are needed to strengthen and inform community engagement. This will also help to ensure issues are identified earlier, that there is baseline understanding on issues among groups and to provide and share lessons and experiences.

GSK encourages OMB to seek input from a diverse range of patient groups and communities when developing health communication materials. Communication materials regarding public health, health care coverage, and treatment access should be reviewed by a diverse set of communities so that benchmarks can be set, and information can be tracked across stakeholders to improve communication targeted to specific population segments.

GSK recommends OMB, in developing its goals and strategies around health equity, review and model elements of the Ryan White HIV/AIDS Program (RWHAP) on community engagement, oversight, and accountability. Nearly three-quarters of RWHAP clients are from racial/ethnic minority populations. RWHAP Part A grants are overseen by Planning Councils that set HIV-related service priorities and allocates funds on the basis of the size, demographics, and needs of people with HIV. Planning Council membership must reflect the demographics of the local epidemic and include members with specific expertise in the populations the program serves. The success of the RWHAP in addressing the health need of populations disproportionately impacted by HIV should serve as a model for other federal programs in increasing community engagement and input for federal programs.

4. General Comments

GSK encourages OMB, in developing its goals and strategies around health equity, not to reinvent the wheel, but rather to review and model elements of federal programs that already demonstrate success and excellence in this area. The RWHAP also includes the Minority AIDS Initiative (MAI) which was established by Congress to improve access to HIV care and health outcomes for disproportionately affected minority populations, including black populations. The MAI provides grants to improve access and reduce disparities in HIV/AIDS health outcomes through outreach and education services, support services to minority populations, training for minority providers in underserved communities, and early interventions. The success of specific RWHAP interventions could help to inform the efforts to address racial disparities in federal grant programs through community input, and rigorous measurement and accountability.

GSK appreciates the opportunity to comment on the OMB Request for Information on Advancing Equity. We hope that OMB finds these comments helpful. Please do not hesitate to contact me at (202) 715-1048 and/or at margaret.n.mann@gsk.com if you have any questions.

Respectfully submitted,

Margaret Nowak Mann

VP, Public Policy

GlaxoSmithKline

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Footnotes:

1/ The Centers for Disease Control and Prevention. "Health Equity." (March 2020). Accessible at: https://www.cdc.gov/chronicdisease/healthequity/index.htm

2/ The White House "Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government." (January 2021). Accessible at: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/

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The notice can be viewed at: https://www.regulations.gov/document/OMB-2021-0005-0001

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