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New Offices Of Minority Health At FDA And CMS: Will They Help Eliminate Disparities In Health?



June 19th, 2014

Given the rocky roll-out of healthcare.gov, the end of the open enrollment period brought surprising good news: over eight million Americans signed up for coverage through the new Health Insurance Marketplaces. Three million previously uninsured young adults are now covered through their parents’ policies and six million more are enrolled in Medicaid and the Children’s Health Insurance Program.

Minorities are disproportionately more likely to be uninsured, and continued expansions in coverage will help significantly to close gaps in care. However, the impact of the Affordable Care Act (ACA) will not be limited to coverage. A number of provisions to address disparities were included in the ACA, relating to community health, workforce, and data collection. In addition, the ACA authorized new offices of minority health to lead and coordinate federal and national efforts to improve health and reduce disparities.

Several operating divisions at the U.S. Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality, had existing offices dedicated to improving the health of vulnerable populations. However, this was not the case for the Food and Drug Administration (FDA) or the Centers for Medicare & Medicaid Services (CMS).

Given the powerful scope and authorities of these two agencies, the minority health community had advocated for offices of minority health at these agencies for many years but without success. The passage of the ACA proved to be an opportune time for accomplishing this feat.  Five years later, the new Offices of Minority Health (OMHs) have permanent directors in place as well as staff and budgets and have begun to influence agency policy and programs. The early actions of these OMHs merit greater scrutiny as they foreshadow what can be expected in the months ahead.

The CMS Office of Minority Health 

Housed within the CMS Administrator’s office, the Centers for Medicare & Medicaid Services Office of Minority Health (CMS OMH) is directed by Dr. Cara James, former director of the Disparities Policy Project at Kaiser Family Foundation. The CMS OMH is responsible for “providing leadership, vision and direction to address HHS and CMS Strategic Plan goals and objectives related to improving minority health and eliminating health disparities.” CMS has requested $6 million in funding for minority health initiatives for 2015.

One of the CMS OMH’s earliest efforts focused on supporting outreach and enrollment, particularly for individuals who were potentially eligible for coverage through the Health Insurance Marketplaces. Preliminary analyses of enrollees in the Marketplaces indicate that minority enrollment has lagged behind enrollment of non-minority populations. Available data demonstrate the enrollment pool is comprised of only 10.7 percent Latinos, 16.7 percent African Americans and 7.9 percent Asians.

While many minority uninsured reside in non-Medicaid expansion states, thus limiting coverage opportunities, available data signal that before the next open enrollment in November, ongoing efforts are needed to enroll as many eligible, minority individuals as possible. That said, the CMS OMH has moved ahead and expanded its efforts to address other access and health care quality concerns for the newest enrollees as well as current Medicare and Medicaid beneficiaries.

As recently announced on June 16,  the CMS OMH has formally launched the national initiative “From Coverage to Care (C2C)” to assist newly insured individuals across the nation. These resources include a thoughtful set of discussion guides for community partners that outline the “roadmap” to better care and health, explaining the basics of health insurance, such as the meaning of “deductibles,” “coinsurance” and “network.”

Further, they include practical information on how to obtain care and navigate the health care system. For example, sections cover how to find a doctor, make an appointment, and prepare for the actual visit. Finally, the materials provide preventive health recommendations and links to federal and national websites for additional information. Importantly, the CMS OMH dedicates considerable focus on how community-based organizations can strengthen their capacity and relationships with newly insured populations, which implicitly acknowledges the value of these groups for health reform implementation and federal expectation that these partnerships will continue.

A second area of focus for the CMS OMH is improving CMS’ data on race, ethnicity, and primary language, by working across the agency to implement the enhanced data collection standards, as prescribed by Section 4302 of the ACA. CMS incorporated many of the enhanced standards in the streamlined application for the Marketplace as well as the Medicare Health Outcomes Survey and Transformed Medicaid Statistical Information System. Finally, CMS’ Justification of Estimates for the Appropriation Committee for fiscal year 2015 includes mention of other minority health activities focused on provision of more culturally and linguistically appropriate services for CMS beneficiaries and addressing diabetes related disparities. Both of these issues have been long-standing priorities for CMS, and the CMS OMH can be expected to build upon and expand existing efforts in these areas.

The FDA Office of Minority Health

Directed by former FDA official Dr. Jonca Bull, the FDA Office of Minority Health (FDA OMH) is housed within the Office of the Commissioner and is the principal advisor on minority health and health disparities. The office is responsible for coordinating efforts throughout the FDA and has focused its efforts on three key areas: communicating and disseminating agency information to vulnerable populations; increasing participation of diverse health professionals in FDA activities to strengthen its capacity to address health disparities; and advocating for meaningful participation of minorities in clinical trials as well as the analysis of subpopulation data.

Regarding the first two goals, the FDA OMH is partnering with external advocacy groups to educate patients/consumers on both the benefits and potential harms of medical products. One such partnership has been formed with the American Diabetes Association to help individuals with diabetes, a chronic condition which disproportionately affects minority populations. To improve FDA communication with patients, FDA OMH is supporting research in health literacy and has solicited public comment in this area. Finally, the FDA OMH seeks to increase participation of minority health professionals and scien­tists in FDA decision-making to ensure expert input and guidance on diversity matters. As one concrete example, the FDA OMH will assist the agency’s recruitment for advisory committees to ensure a diverse pool of candidates.

The FDA OMH’s third goal to diversify clinical trial participation and analyze sub-population data has attracted considerable attention. Race and ethnicity can be important considerations for choosing drug regimens, as evidenced by numerous studies finding variations in effectiveness of certain medications in minority groups as well as risks of adverse drug reactions. Identification of these differences, achieved through careful examination of data from clinical trials and post-approval studies, is critically important for patient safety.

Unfortunately, various factors, both historic and practical, have led to minority and low-income individuals being less likely to enroll in clinical trials. The FDA OMH is collaborating with advocacy groups and minority health professionals to strengthen outreach efforts to potential participants. However, the FDA OMH has signaled that it may use its regulatory powers to move this issue forward more forcefully.

On April 1, the FDA OMH hosted a public hearing on the challenges of collecting and analyzing information on demographic subgroups in clinical trials for FDA-regulated medical products. The office formally solicited public comments to gather ideas and viewpoints from stakeholder groups, including academia, industry, health care professionals, and patient advocates.

Additionally, the FDA OMH is sponsoring a newly established regulatory science research program on minority health through FDA’s two Centers of Excellence in Reg­ulatory Science and Innovation. Collectively, the findings from these initiatives will inform development of an FDA action plan to improve the collection and analysis of data on the sex, race, ethnicity, and age of clinical trial participants in applications submitted for FDA review and approval.

Congress also has become more engaged in the issue of clinical trial homogeneity – on April 30, a bipartisan group of 15 Senators wrote to the FDA calling for an increase in the number of women and minorities participating in clinical trials. A separate group of U.S. Members of Congress requested that the Government Accountability Office report on the National Institutes of Health’s efforts to include more women in federally funded clinical trials. This political pressure combined with the FDA OMH’s policy imperative could lead to a meaningful shift in how and the extent to which clinical research acknowledges and addresses the health status of disparate populations.

Moving Forward

The leadership of both the CMS OMH and the FDA OMH have proven their ability to be forward-leaning; however, immediate priorities are readily identifiable and must be addressed. The CMS OMH must redouble its efforts to reach minorities, particularly Latinos, which will be no easy feat. Latino enrollment has been stymied by an uneasy relationship between the Latino community and the Administration, due in part to their mistrust fueled by the Administration’s aggressive stance on deportation. At the same time, the CMS OMH must push forward with helping the newly insured obtain care, engaging aggressively in other CMS quality initiatives, and weighing in on thorny policy issues, such as risk adjustment for vulnerable populations.

Similarly, the FDA OMH will be challenged to implement its three core priorities, particularly diversifying clinical trials, which will require thinking about new ways to tackle old problems. Beyond the core priorities, the FDA OMH will need to advise on other matters which may have diversity considerations, including modernization of clinical trial design, personalized medicine and genomics, and acceptance of foreign data, amongst other issues.

As agency OMHs move to comply with Congress’ directives, it must be noted that the ACA also included provisions relating to the HHS OMH. The ACA required the HHS OMH, which leads HHS disparity initiatives and coordinates agency OMH efforts, to transition from the Office of the Assistant Secretary of Health to become its own independent office, reporting directly to the Secretary of HHS. Although HHS appears to have complied with the rule of the law, the practical implications remain unclear. Questions regarding the office’s autonomy during the budget process, grant-making functions, and staffing have not been fully answered.

The new regulatory Offices of Minority Health will be powerful leaders for advancing minority health, given the new authorities and resources at their disposal. Both the CMS OMH and the FDA OMH already have demonstrated their potential with early actions. The timing could not be more propitious — the national debate over issues related to coverage, quality, and prevention have helped to draw significant attention to the presence of, and underlying factors for, disparities in health and health care. For successful and sustainable effort, the OMHs must be adequately funded, integrated into agency fabric and function, and supported at the highest levels by the Administration and Congress.

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