April 04, 2023
7:44 pm
The Report of the Secretary’s Task Force on Black and Minority Health was released in 1985, serving as a catalyst for the U.S. Department of Health and Human Services (HHS) to begin addressing health disparities, and Congress to form the Office of Minority Health within HHS the following year. Today, much of the progress in this arena is taking place in the private sector. The healthcare industry is taking steps to achieve health equity with considerable vigor and with some lessons learned under its belt. The Healthcare Leadership Council (HLC), representing all health industry sectors, released a report in January 2023 with ZS, entitled, “Addressing Health Equity: Practical Solutions to Address Variations in Care,” identifying multiple structural barriers in both the private and public sectors that contribute to existing health disparities. The report was followed by a release stating HLC members’ commitment to shared principles aimed at eliminating health disparities. HLC also recently hosted a webinar, “Breaking Down Barriers to Achieve the Highest Level of Health,” in which representatives from its member companies discussed current strategies and overarching philosophies. The panel was made up of three participants:
- Joneigh Khaldun, MD, Chief Health Equity Officer, CVS Health
- Josette Gbemudu, Executive Director, Health Equity and Social Determinants of Health, Merck
- Keith Dawson, Principal Science Leader, Global Health Equity and Population Science, Genentech
Dr. Khaldun opened by describing CVS’s enterprise-wide health equity strategy, highlighting the need to empower all employees by educating them about systemic inequities and providing tailored training for cultural competency. Dr. Khaldun also talked about measuring what matters to uncover inequities and utilizing these insights to design programs and policies to address them effectively. Examples of specific programs included CVS’s Community Equity Alliance, which aligns academic, community and healthcare partners to expand and integrate community health workers into care teams, and its workforce innovation training centers, which support job training needs across the country. Dr. Khaldun noted that disparities took centuries to develop, and that health equity is a journey that will not be achieved by one initiative in a short period of time.
Josette Gbemudu echoed Dr. Khaldun in that there must be internal integration of health equity across an entire business and not just through one initiative. She pointed to Merck’s $650 million commitment to improving maternal health globally and how it is using the learnings to embed health equity into its core business functions. Citing numerous statistics to show the broad range of disparities, Josette shared that Merck is not just focused on addressing social determinants of health barriers such as food insecurity, health literacy and health access, but it is dedicated to strengthening the entire health ecosystem. Merck Foundation launched a $20 million initiative to advance equity in U.S. cancer care. Josette emphasized that many communities have historically been unable to access screenings, which leads to later diagnoses and poorer outcomes. The alliance is utilizing a collaborative approach to build community partnerships in order to address barriers to care.
Keith Dawson discussed Genentech’s efforts to develop solutions that will broaden inclusion of historically underrepresented groups in clinical research so that all patients can realize the full benefits of personalized healthcare. He stressed that clinical research is not benefiting all groups equally, that genomic data is not diverse enough and that Blacks and Hispanics are not informed about clinical trial opportunities. The diversity of patients enrolled in clinical studies is highly correlated with site personnel diversity, he pointed out. Keith stated that Genentech prioritizes fostering belonging and cultivating an environment where all are included. The Advancing Inclusive Research Site Alliance Partnership was created to develop an ecosystem based on trust and meeting patients where they are. This alliance uses an external council of advisors and patient and provider partnerships to provide educational tools to improve awareness of clinical trials. It also distributes grants to external organizations striving to address inclusive research, equity in care and workforce diversity.
January 24, 2023
2:01 pm
Cancer is one of the leading causes of death across the globe and affects the lives of millions every year in the United States. As advances have been made in screening, diagnosing and therapeutics, providers have been able to utilize new technologies and precision medicine to achieve improved outcomes. The Healthcare Leadership Council hosted a webinar to highlight the commitment to medical research and discovery and the most recent accomplishments of some of its member companies. The webinar, “What’s New in Cancer Innovation?”, included three panelists:
- Dr. Qasim Ahmad, Head of US Oncology Medical Affairs, Novartis
- Dr. Harlan Levine, President, Health Innovation and Policy, City of Hope
- Victoria Raymond, Senior Director of Medical Affairs, Guardant Health
Ms. Raymond described Guardant’s focus on blood-based diagnostics as a less invasive way to screen for specific cancers. This method of screening can assist in early detection as well as ensuring appropriate therapy selection. Dr. Ahmad concurred that there has been a shift from making the patient fit the treatment, to making the treatment fit the patient. He presented Novartis’s strategy to harness the power of targeted therapy, immunotherapy, cell and gene therapy, and radioligand therapy to attack cancer using multiple approaches and provide the best outcomes for patients at every stage of the disease.
Dr. Levine noted that the rate of change in oncology exceeds the ability for most oncologists to keep up with the advances in each subtype of cancer or surgical technique. He stated that while with precision medicine and genomics we are able to identify tumor types and DNA signals, we still address value-based oncology with tools that were developed decades ago as though cancer is a single specialty with only a handful of chemotherapy agents. Reliance on these generic tools will limit the benefit of emerging technology and propagate disparities.
The discussion underscored the lack of diversity across clinical trial sites, doctors, study investigators and trial participants. A map was provided as a visual to portray how one’s survival is directly impacted by one’s zip code. The need to innovate the system so that it is accessible and equitable is vital to improving cancer care. The panelists acknowledged efforts to increase diversity in clinical trials and addressing barriers that hinder trial participation and access to treatment. Educating the public on opportunities is just one piece of the puzzle. Finding easier ways for people to follow through with what they know they need to do is the next challenge.
Finally, the Inflation Reduction Act (IRA) was raised as a hindrance to cancer research, which require long-term commitments and significant investments. There is a need for broader understanding of the investment required to subsidize clinical trials for cell-based therapies and the potential impact of the IRA in discouraging that investment. Policy measures that result in reduced research and fewer trials, ultimately limiting access to new therapies, is harmful to patients and society as a whole.
July 20, 2022
3:31 pm
This is a guest post by John Lumpkin, M.D., President of the Blue Cross and Blue Shield of North Carolina Foundation and Vice President, Drivers of Health.
Blue Cross and Blue Shield of North Carolina (Blue Cross NC) has been committed to engagement with the communities we serve for nearly a century. This work is not about writing checks or “giving back.” Instead, we think of our community support as “investing in.” In recent years, we have thought strategically about how to expand and maximize the impact of these efforts.
Good health happens where people live, work and play. We know that food, healthy housing, companionship, transportation and other resources play a far more significant role in a person’s health and well-being than what happens during those few hours per year spent in a provider’s office. And yet, not everyone has equal access to these resources. Putting people in contact with the resources they need for health and well-being is the right thing to do … it’s also the logical thing to do from a business perspective. Making these investments helps prevent, correct or manage trouble spots before they escalate into complex, expensive and painful health issues.
This investment mindset is apparent in the language we use to describe this work. Blue Cross NC made the conscious choice to abandon the common industry terminology, “social determinants of health,” in favor of “drivers of health.” We have argued for this change in part because we recognize the importance of giving agency to individuals and communities. No one’s well-being is pre-determined. With strong commitment and strategic thinking, individuals, communities and the health care industry can knock down barriers to good health.
But smart investment needs to be informed by data and guided by rigorous reasoning. Neither of these is necessarily easy to come by at this historical moment. Our industry is only just starting to acknowledge the important role a drivers of health strategy can play improving health outcomes and promoting health equity. Insurers don’t yet have the solid knowledge base to help them develop and implement the programs that will have the most impact.
The Blue Cross and Blue Shield of North Carolina Foundation was established in 2000 to improve the health and well-being of communities across the state. Further, Blue Cross NC’s Community and Diversity Engagement team offers additional widescale support for nonprofit organizations and health entities committed to connecting communities with the resources they need. To go further in addressing drivers of health through business practices and to close the knowledge gap, Blue Cross NC formally established its Drivers of Health Strategy team in 2019. The Drivers of Health Strategy team has a focus to implement innovative intervention models, measure their long-term impact and share these findings to promote informed and systemic change across our lines of business and across the industry.
Since 2020, the Drivers of Health Strategy team has launched four test and learn models, focused on food security, social isolation and transportation. More are on the way. We launched these pilots with the understanding that we couldn’t predict which would have the most significant impact. Our goal is to gather quantifiable evidence of long-term health impacts, overall member experience and savings from preventable medical expenses. Data from these models will start to roll in this year. In addition to testing these models internally, Blue Cross NC is collaborating with UNC Health Alliance and the Sheps Center at UNC-Chapel Hill to conduct a clinical research study to establish sustainable best practices for helping individuals improve health through nutritious food. Which is more effective, food vouchers or delivery? Does health coaching improve the efficacy of food interventions? What is the optimum length for a food intervention program?
In essence, our Drivers of Health Strategy team functions as a research, development, and implementation group to help Blue Cross NC identify viable drivers of health programs that will improve outcomes for our members, make the company more competitive and attract new members. Our findings will help guide evidence-based product decisions. And, as we share our insights externally, we will help build the evidence base other insurers will need to make informed decisions about their own products and programs.
This investment-minded approach is guided by a fundamental recognition that drivers of health impact us all, not just those who face barriers to vital resources. Greater access to these resources will help prevent, reverse or better manage chronic disease. A healthier population will reduce the strain on our health system and reliance on emergency department visits. Ultimately, this proactive approach will lower health care costs for everyone.
As an industry, we are at a critical time. Making a concerted effort to move toward a more comprehensive, data-driven approach to addressing drivers of health needs will lead to more sustainable models with greater reach and a measurable impact on individual, family and community health.
June 01, 2022
2:19 pm
Across the healthcare industry work is taking place to address health disparities. The Healthcare Leadership Council (HLC) has delved specifically into social determinants of health, broadband access, disparities in care delivery, vaccine acceptance, behavioral health, and workforce and clinical trial diversity. Amgen, an HLC member, is a leader in improving clinical trial diversity as a means to ensure better outcomes for those of diverse racial and ethnic backgrounds. This recent post below lays out the company’s comprehensive strategy, strengthened by collaboration, to address systemic issues which affect participation in research.
Improving Diversity in Our Clinical Trials for Long-term Health Equity
Darryl Sleep, Amgen’s senior vice president and Global Medical and Chief Medical Officer
Last April, Amgen stood with PhRMA as the first-ever industry-wide Principles on Clinical Trials Diversity officially took effect. The goals of these Principles are to expand participation among diverse patient populations by increasing understanding and awareness about clinical trials and improving access. Since then, we’ve already seen two very significant positive outcomes. First, improving diversity and representation in clinical trials has evolved from a niche issue into a core industry commitment. Second is the development of enthusiastic, industry-wide initiatives to improve how sponsors approach and improve diversity and representation in clinical trials. We are sharing best practices and de-identified aggregated clinical trial data to continue advancing this work via our cross-industry collaborations and partnerships. In this purpose, there is no holding back; we are all dedicated to making long-overdue changes that will result in diversity and representation in clinical trials becoming a reality and not just an ideal.
Clinical trials are a critical part of the long and careful process of developing new medicines. This research is complex and multidisciplinary and there isn’t a single accelerator that can be used to address the systemic issues that deter people from participating. Instead, we need a range of different levers to update decades-old processes and create new best practices.
I want to use the one-year anniversary of the PhRMA Principles to share some highlights about the data-driven efforts we’ve taken at Amgen to lead the way in breaking down barriers and help us find new medicines supported by clinical trials that are representative of all patients who suffer from serious illnesses.
We have a dedicated team
While the push for more diversity and inclusion in clinical trials is not new to Amgen, we accelerated our efforts in 2020 with the formation of RISE (Representation in ClInical ReSEarch), a team dedicated to addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors. We have significant momentum with our goals as programs and teams across Amgen, including RISE, Global Medical, Advocacy, Compliance, and Global Development, trial execution and data & analytics teams work together to create greater equity through diversity and proportional representation in clinical trials.
Ongoing learning to gain understanding and insights
Communication and information-sharing are fundamental to driving change. The output from our Health Equity Summit: Disrupting Health Disparities through Partnership and multiple Community Advisory Boards focused on direct insights from Black, Indigenous and People of Color (BIPOC) which provided information on barriers, strategies, and tactics that can apply across communities. We are using these insights to directly inform the design and implementation of a long-term, study-agnostic community engagement plan – a critical step in building sustainable, trusted relationships. Additionally, our patient-focused advisory councils with representation of racial and ethnic minorities will inform our clinical trial design and execution.
Building foundational capabilities
Logistical and financial barriers, gaps in awareness, and lack of trust all impact participation in clinical trials. We are partnering with organizations and diverse suppliers to thoughtfully build our enrollment support capabilities, including providing transportation, and other potential support capabilities, as well as finding optimal ways to support staff at clinical trial sites. Taking a holistic approach to tackling these industry-wide issues will help us move the needle.
New partnerships and collaborations
Collaborative partnerships play a significant role in advancing understanding of the science and our ability to positively engage patient communities in clinical trials. Toward that end, we are engaged in a number of efforts including:
- A pilot program of the American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials, including navigators to help patients address logistical and financial challenges to enrolling and completing those clinical trials.
- The CEO Roundtable on Cancer’s Going for Gold initiative, in partnership with Historically Black Colleges and Universities (HBCUs) and Hispanic Serving Institutions (HSIs), that focuses on equitable cancer care.
- A collaboration with The Digital Medicine Society (DiMe) to drive inclusion in digital clinical trials by providing the tools and framework necessary to successfully engage underrepresented populations during the planning process for clinical trials that include a technology device for participation.
- Creation of the HBCU BioTech Fellowship program, a professional development program that will prepare and empower 50 students (and soon-to-be graduates) from Historically Black Colleges and Universities for careers at Amgen.
Measuring progress in our own trials
We have undertaken important steps including a baseline study that will help us measure progress for trials currently underway as well as for new trials on the horizon. Additionally, we have a number of tools in development to help us measure and evaluate best practices for improvement in enrollment of participants from diverse racial and ethnic backgrounds.
Recognizing differences in disease incidence, exposure and response to medicines
We have long been committed to unlocking the potential of biology for all patients suffering from serious illnesses using advanced human genetics to unravel the complexities of disease. Accordingly, we are using data on human diversity in our own labs and with research partners. Together, we will better understand incidence of obesity, cardiovascular disease from risk factors such as elevated Lp(a), inflammatory diseases such as atopic dermatitis and lupus, and multiple cancers in diverse populations.
In addition, we are seeking to understand and actively address the social determinants of health (SDOH) that contribute to wide health disparities and inequities that impact disease burden and access to healthcare.
Reaching the finish line will allow us to get new medicines faster to patients who need them. It will also help doctors assure their patients that the medication they’re being prescribed was studied in people like them, with results that indicate they are likely to benefit. We’re not there yet, but we’re taking informed steps with care, with the scientific expertise for which we are known, and with humility. Every day, we dedicate ourselves to serving patients by transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. As we work to fulfill our own values and PhRMA’s Principles, we’ll get closer to serving all patients, beginning with clinical trials that include people of all races and ethnicities who will benefit.
For more information, please visit Clinical Trial Diversity & Representation.
May 25, 2022
10:31 am
Recently, Health Affairs Forefront, published a post by Dan L. Crippen, former director of the Congressional Budget Office and currently a Healthcare Leaddership Council consultant, that should be a catalyst for discussion on a critical element of the Center for Medicare and Medicaid Innovation’s future direction.
In his post, Dr. Crippen enters the debate over whether models being tested by CMMI should have mandatory or voluntary participation on the part of healthcare providers. Some have argued that demonstration projects have floundered under voluntary participation because providers have brought in cohorts of comparatively healthy patients not reflective of the Medicare beneficiary population at large. He points to several examples, though, to make the case that voluntary participation did not result in adverse selection and that a more weighty problem plaguing CMMI demonstration projects has been the lack of timely data flowing to model participants.
The Crippen post is below and at the link above, which will take readers to the Health Affairs Forefront site.
***
The tenth anniversary of the Center for Medicare and Medicaid Innovation (the Innovation Center) was in 2020. This anniversary was accompanied by several retrospectives of the results of the Innovation Center’s first decade of operation. Unfortunately, most of the analysts, including those from the Centers for Medicare and Medicaid Services (CMS), reached similar conclusions: that the demonstrations deployed by the Innovation Center neither saved much money nor greatly improved quality, the two primary objectives set out for the Innovation Center in the Affordable Care Act.
Past and present Innovation Center directors concluded that the primary reason for the demonstrations’ failure to achieve the objectives was selection bias by the providers who had volunteered to participate in the various models. The claim is that the providers brought with them a cohort of healthier-than-average patients, making it easy to show savings relative to the benchmark. Relative to providers with sicker patient populations, these providers were more motivated to participate in the demonstrations due to the potential opportunity to earn a bonus from the Innovation Center if they spent less than the Innovations Center’s benchmarks.
Some of the demonstrations included an alignment algorithm for assigning patients to providers within an accountable care organization (ACO), at least one of which assigned patients depending upon their previous use of participating providers in the ACO. In some demonstrations, there was considerable turnover in both the beneficiaries and providers, which theoretically allowed ACOs the opportunity to alter their risk pool by selecting or changing providers (or other aspects of the model) to create a patient population with certain characteristics or health care needs. The former and current directors concluded that only mandatory participation by providers would overcome this perceived selection bias.
However, before seeking a solution to this problem, the question of whether selection by voluntary providers contributed to the disappointing results of the demonstrations should be explored. This article summarizes a multitude of analyses surrounding the reasons the demonstrations show little savings or quality improvement. The analyses indicate that the failure was not due to voluntary, as opposed to mandatory, participation by providers. The article then suggests several ways that any future selection challenges could be addressed, should they occur, without requiring mandatory participation.
The Evidence On Selection Related To Voluntary Participation
As described below, outside observers, papers published by think tanks, academic research, contractors hired by the Innovation Center to provide an independent evaluation of the demonstrations, as well as reports by the Innovation Center itself neither found the existence of selection bias nor recommended mandatory participation. These experts offered many suggestions on how the Innovation Center could achieve its stated objectives, but mandatory participation was not among them.
The ACO model is one of the Innovation Center’s longest running demonstrations, albeit in different forms over time, which attempts to measure cost-effectiveness and quality of treatment. It is the early experience of this model that most proponents of mandatory participation cite as proof of selection bias, primarily because so many providers dropped out at the beginning of the demonstration. Only 123 (36 percent) of the 339 ACOs entering the program between 2012 and 2014 were still participating in 2020.
There were several reasons for the attrition, much of which occurred early in the program. Many of the provider groups were small and ill-equipped to provide the complex reporting and data required by the Innovation Center. The participants did not understand the convoluted requirements before they enrolled, and only thereafter realized they were very unlikely to achieve savings, and therefore the bonuses offered by the Innovation Center. Moreover, participants did not have the processes, experience, or capital to ultimately assume the downside risk required later in the demonstration. In accordance with the rules of the program, they were allowed to drop out and did so.
An outside evaluator concluded: “Pioneer ACO stakeholders also noted that the relationship between the ACOs’ activities and their financial results were not well understood or articulated and that they struggled to firmly understand the Pioneer model rules such as the beneficiary alignment algorithm and financial benchmark calculations…[which] raises the question of whether the alignment algorithm may de-align or not align beneficiaries who are less healthy.”
Other credible sources determined that voluntary participation did not result in adverse selection. For example:
- One analysis concluded: “We also find no evidence that ACOs systematically manipulated provider composition or billing to earn bonuses…. Robustness checks revealed no evidence of residual risk selection…. Careful examination of selection issues revealed that these findings were not driven by nonrandom participation.”
- A study published by the Brookings Schaffer Center concluded: “Evidence suggests that there was minimal systematic patient-level risk selection by ACOs in the first three years of the Medicare Shared Savings Program (MSSP).”
- An internal CMS evaluation noted: “It does not appear that participants are selecting healthier patients.”
- The Innovation Center engaged outside experts to evaluate the operation of each demonstration, several of whom included explicit conclusions about selection bias. One expert concluded: “This finding suggests that AIM [AIM Investment Model] ACO participant changes over time did not result in selection of certain types of beneficiaries, on average.”
No evaluator of the many demonstrations suggested that that mandatory participation was necessary to produce better results. In one demonstration, the third-party reviewer concluded that the results of the mandatory model were no better than voluntary models. One study directly compared results for mandatory verses voluntary participation and concluded: “spending changes did not differ between the voluntary and mandatory hospitals. This result does not support the concept that organizations perform better when self-selecting into programs.”
If Not Selection, Then What?
While adverse selection did not distort model results, studies did show that there was a myriad of other factors that plagued the initial demonstrations and persisted throughout much of the first decade. A common complaint by providers was a lack of timely data from the Department of Health and Human Services on demonstration operation and performance. One CMS internal evaluator lamented that the inability of CMS technology systems to perform basic tasks for value-based care, including providing performance data to participants, was a key contributor to the reasons providers dropped out.
Additionally, in a 2020 Medicare Payment Advisory Commission meeting, commissioners expressed the view that the multiplicity and overlap of demonstrations made it difficult for participants to sort out the effects of one demonstration from the other. This burden of sorting through the complex requirements for providing data and reports, and inconsistent reporting specifications between the demonstrations, caused many smaller participants to quickly drop out of the demonstrations.
The benchmark calculations, which were intended to measure providers’ effects on costs, were too narrowly drawn and created disincentives that increased over time. The use of historical performance for providers could lock in original calculations of savings/costs. Savings by providers with high-cost patients resulted in lower future benchmarks, which made it more difficult to continue to achieve savings, reducing the incentive to do so.
Many of the shortcomings of previous demonstrations were recognized by the Innovation Center in its assessment of the first decade. The review included a number of suggestions, including health equity a centerpiece of every model; reducing the number, complexity, and redundancy of the many models; re-evaluating how the Innovation Center designs financial incentives to ensure meaningful provider participation (presumably including mandatory participation given the director’s previous comments); better enabling participants to handle down-side risk by providing the tools to participate; reducing the complexity of establishing benchmarks; and expanding the definition of success to include lasting transformation and a broad array of quality investments, rather than focusing on each model’s cost and quality.
Looking Ahead
Despite evidence to the contrary, the Innovation Center has not publicly dropped its position that adverse selection is a problem and that the solution is to require mandatory participation by providers.
Even if selection remains a concern for the Innovation Center, there are ways to detect and correct for selection. One alternative is the expanded use of risk adjusters to assess each participant’s risk before, during, and after the demonstration. Risk adjustment, which is typically used to establish initial payment rates, can also be used to evaluate the risk pools of participants at the end of demonstrations, with payments and shared savings adjusted accordingly.
If benchmarks remain the comparator, risk adjustment will become more important, especially as applied to high- and low-cost beneficiaries as benchmarks converge over time. Risk adjustment is and will continue to be an imperfect process but can be improved by better data, improved statistical techniques, and perhaps, artificial intelligence.
Evidence from many different sources shows that adverse selection has not heretofore been an issue and is not a cause of the failures of past Innovation Center demonstrations in meeting the objectives of savings and quality. Other factors in the operation of the demonstrations are much more likely to explain the results. If selection should ever become an issue, there are ways to adjust models other than forcing providers to participate.
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