The Utilization of Race-Based Clinical Algorithms to Make Healthcare Decisions

Do race-based clinical algorithms undermine health equity? In 2023, PlusInc published a blog entitled “Diversity in Clinical Trials Still Lags,” which focused on the various issues related to a lack of gender, racial, and ethnic diversity in clinical and medical device trials, highlighting one particularly galling disparity that was of major importance during the COVID-19 global pandemic:

“A retrospective cohort study released in the Journal of the American Medical Association Internal Medicine found that compared to white patients, “…Asian, Black, and Hispanic patients had a higher adjusted time-weighted average pulse oximetry reading and were administered significantly less supplemental oxygen for a given hemoglobin oxygen saturation compared with white patients” (Gottlieb, et al., 2022).”

 The 2023 blog post focused on how that lack of inclusion of women and racial and ethnic minorities in clinical and medical device trials can result in the development of vaccines, medications, and devices that inadvertently presuppose that the patient being treated is White, potentially resulting in worse diagnostic and health outcomes for Black, Indigenous, and other People of Color (BIPOC). This blog focuses on another aspect of healthcare that may be resulting in significant diagnostic and health outcomes: race-based clinical algorithms.

This year, a recent article published as part of STAT’s “Embedded Bias” series shed light on another issue that is both deeply embedded in clinical practice and is potentially exacerbating negative health outcomes among minority populations: the use of race-based clinical algorithms to determine care pathways.

In their article, Katie Palmer and Usha Lee McFarling found that clinical algorithms—a series of questions or steps, in some cases a flow-chart, ostensibly designed to assist providers with making medical decisions about a patient—continue to use outdated and biologically unsupported assumptions based upon race (Palmer & McFarling, 2024).

One such assumption inaccurately estimated a higher level of kidney function in Black patients than for non-Black patients with otherwise identical patient-specific variables. This Estimated Glomerular Filtration Rate (eGFR) value measures how quickly a person’s kidneys remove creatinine from the blood, and the inclusion of race as a factor in that measurement has resulted in Black patients being diagnosed with kidney failure at much later stages in the disease compared to non-Black patients causing them to miss out on years of vital dialysis treatment, exacerbating co-morbid conditions, and delaying their placement on kidney transplant lists (United Network for Organ Sharing, 2023). And this race-based algorithm has been in place since 1999 (National Institutes of Health, 2021).

The use of a race coefficient in this coefficient for the eGFR test traces back to a 1998 study that showed that Black patients had higher serum creatinine levels, on average, than White patients, but didn’t examine why some groups may have higher levels compared to others. These higher creatinine levels were associated with better kidney function in Black patients than was actually the case, and researchers found that, when using the 2009 CKD-EPI eGFR formula, all Black patients automatically received a 16% higher score in their eGFR test results because of this flawed, race-based assumption. To put this into greater perspective, Black patients have a higher rate of chronic kidney disease than their white counterparts, being more than three times as likely to develop kidney failure (Nicholas, 2022).

Thankfully for Black patients, the Board of Directors of the Organ Procurement and Transplantation Network (OPTN) unanimously approved a process to backdate the waiting times of Black kidney transplant candidates who were disadvantages by the previous use of the race-based eGFR calculation, the use of which has been prohibited since July 27th, 2022 (OPTN, 2023).

Other race-based algorithms, however, are more firmly entrenched. As Palmer and McFarling found, the American healthcare system is both unaccustomed, and often hostile, to reassess, replace, and discontinue long-held assumptions, beliefs, and practices when it comes to patient care (Palmer & McFarling, 2024). This is in part because the American healthcare system is neither centralized, nor designed to quickly adapt to changes due to being a for-profit model designed to maximize profits at both the provider and payor levels while minimizing expenditures on patient care by payors, and in part because clinicians simply don’t want to admit being wrong.

The disjointed and disconnected nature of the healthcare system—by which we mean the decentralized nature of a system that spans well over 3,000 miles from the furthest Eastern point to the furthest Western point of the United States—makes implementing changes to clinical algorithms on a broad scale incredibly difficult. While some providers living in urban and suburban areas may be quicker to adopt new algorithms that remove race-based assumptions from their calculations, others will be slower to adapt. A good way to think of it is to look at the adoption of broadband (and even fiberoptic) Internet service: while large cities were quick to transition from dial-up Internet services using telephone wires to broadband services using coaxial and ethernet cables, it took smaller cities, suburbs, and rural areas considerably longer to make this transition. For some, even basic broadband and Wi-Fi services that many of us take for granted simple don’t exist in parts of the United States. The same is true for changes in healthcare standards.

In addition to the slow adoption of and resistance to replacing race-based algorithms, there is little appetite for enforcing such changes. While a new rule that will prohibit discrimination through the use of patient care decision support tools is set to go into effect in May 2025, the U.S. Department of Health and Human Services constructed the rule in such a way as to support voluntary compliance, rather than mandated and enforced compliance (Palmer & McFarling, 2024). Moreover, as we’ve seen with other aspects of healthcare provision, DHS has consistently been hesitant to enforce compliance with its rules, either through sanctions, fines, or civil or criminal charges. Because physicians are licensed by different administrative and governmental bodies, there is no centralized control over who can and cannot practice medicine in the United States, meaning that physicians who fail to adhere to basic standards of care and continue to use tools that result in discriminatory and race-based diagnoses and treatments face limited scrutiny or consequences for failing to comport with new standards.

Sadly, these kinds of changes take far too long to take hold in the American healthcare system. But, theycanhappen. The COVID-19 pandemic demonstrated how quickly a system can adapt if sufficient technical assistance, supportive, and financial resources are provided to ensure that new protocols are adopted. The reality, however, is that we need to move faster to ensure that non-White patients are not being inadvertently harmed because our healthcare system is stuck in an inertial state where doing “what we’ve always done” is easier—and let’s face it, cheaper—than identifying, diagnosing, and fixing the problems that exist

Health Disparities in Jefferson County

PlusInc and AIDS Alabama are working to address health disparities in Jefferson County in Alabama. Like many communities in Alabama, Birmingham’s greater metropolitan area has many health conditions afflicting its residents. Our collaborative effort pays particular interest to numerous health disparities, among them HIV/AIDS, Mental Health Services, and Substance Use Disorder. AIDS Alabama is a 501(c)(3) non-profit organization that provides housing, health care services, health insurance premium assistance and support groups designed to empower community members living with HIV/AIDS. AIDS Alabama also offers comprehensive Prevention Programs which provide HIV testing and STI testing and treatment, counseling and outreach to at-risk communities.

-> Learn more about health disparities in Jefferson County

Due to the incidence rate being so low for some of these health conditions in Jefferson Counties, county data are not broken down into demographic categories in order to protect the identities of patients. Nonetheless, it does provide a glimpse into what is happening in Alabama’s North Central region. To achieve greater health equity, our healthcare infrastructure needs to identify the health disparities that exist in the United States, and how they can vary from one health condition or another.

The Slow Walking of Diversity in Clinical Trials

A recent article in STAT led with the following alarming headline:

“[National Institutes of Health] wanted to make cancer research more diverse. The effort turned out to be a costly failure.”

This headline encapsulates one of the primary arguments many pharmaceutical companies make behind closed doors—that the cost of ensuring diversity in clinical trials is higher than any potential rewards. At least, it is how this issue is perceived in some circles.

So, what made this effort from the National Institutes of Health (NIH) a ‘costly failure’? According to the spokesperson quoted in the article, it came down to two factors:

1.     The National Cancer Institute’s (NCI’s) Center for Cancer Research (CCR) experienced a 45% increase in travel costs, and;

2.     The program did not result in an increase in the diversity of enrollees.

What apparently made the pilot program too costly was the increased expense of providing potential patients, and in some cases, their caregivers, with funds to cover first-visit travel expenses to determine their eligibility for NCI cancer trials.

Prior to this pilot program, patients and caregivers were required to pay for travel, food, lodging, childcare, and missed work expenses out of pocket, which researchers believed would discourage lower-income patients from volunteering for trials. The thinking was that, because the populations that are disproportionately impacted by cancer health outcomes were more likely to be Black, Indigenous, and other People of Color (BIPOC) who are more likely to have lower incomes.

The NCI CCR pilot program came on the heels of a late-2022 law passed by Congress, the Food and Drug Omnibus Reform Act of 2022 (FDORA), which required pharmaceutical and medical device companies to deliver their plans for diversifying clinical trials to the U.S. Food and Drug Administration (FDA) by the end of March 2025.

This is where the issue of cost again comes into play:

Pharmaceutical and medical device companies essentially operate on a cycle that revolves around developing new products, updating existing products, and either limiting or increasing the supplies of existing and newer products on the market to ensure profitability. In order to maintain profitability, this cycle must be perpetuated to ensure that consumers, including both patients and providers, remain customers by bringing new or improved products to the market on a regular basis. This requires making products as quickly and as efficiently as possible to both control costs and increase profit margins.

The trial phases of these products can play a vital role in determining that profitability. In 2023, a pharmaceutical executive posed this question about new HIV drugs: “Are you comfortable with adding another three to five years of product development to ensure that the trials have the requisite diversity?”

When new requirements demanding diversity in clinical trials go into effect, there are significant concerns that the FDA will be heavy-handed in enforcing compliance with FDORA regulatory requirements:

“Bethany Hills, a partner at DLA Piper who represents drugmakers, said it will be difficult for FDA to strike a balance that enables researchers to notice when a drug doesn’t work for one group of people without delaying its availability to those for whom it does work” (Wilkerson, 2023).

Part of the issue is that the FDA has not yet released those regulatory requirements, so these industries aren’t even sure with what they’ll be required to comply. While the FDA is very likely to focus heavily on racial and ethnic diversity requirements, additional demographic categories may be considered, such as age, sex, and income (though the latter is less likely).

The other part of the issue is the perception that, again according to Hill, “There’s just certain populations where it’s going to be really hard to reach them.”

There are common arguments made by these industries: that it’s just too hard to make clinical trials diverse because it will take too long, because minority patients are less likely to participate, and because fewer minority patients will qualify, so they expend more resources trying to recruit diverse patient populations.

There are some data to back up these assertions:

According to October 2023 research released by Research America:

• Black (69%), Asian (62%), and Hispanic patients (70%) are less likely to report that they’ve heard about a clinical trial opportunity;

• While 67% of all patients surveyed reported “very or somewhat positive” feelings about clinical trials, just 57% of Black and 61% of Asian Americans responded in that manner;

• Black and Asian Americans were less likely to respond that they agreed or strongly agreed that “people like me benefit from clinical research and its findings,” and;

• Black Americans were less likely to agree that clinical trials were conducted ethically or that it was conducted fairly (Research America, 2023).

In addition to those findings, research from the BECOME Research Project found that, while interest and willingness to participate in clinical trials was high among Black Women, healthcare providers were unlikely to initiate discussions about clinical trials with them (Felder, 2022).

Making the matter more complex for industry manufacturers is that a majority of Americans (43%) believe that “…the FDA should act more slowly in order to reduce risk, even if it means patients may wait for treatments,” and 48% of Black patients responded in that manner (Research America, 2023).

This seems to answer the question that was posed in 2023: yes—Americans would be okay with adding three to five years to make sure that a drug works for every patient population.

These sentiments are not, of course, universal. Patients living with conditions for which there are a variety of existing medications that are relatively easily tolerated are more likely to respond that they’re willing to wait, while patients living with rare conditions for which there are few existing treatments or treatments that are hard to tolerate are more likely to respond that the FDA should speed up the process, even if it means accepting more risk.

As with patient sentiments being diverse, so too are existing pharmaceutical company commitments to ensure patient diversity in clinical trials. Rather than slow walking the march to diversity or making promises but providing little evidence of those promises’ fruition, Gilead Sciences (one of PlusInc’s corporate sponsors) has actively been recruiting diverse patient populations. According to a recent stakeholder announcement:

“The Phase 2 studies, PURPOSE 3 (HPTN-102, NCT06101329) and PURPOSE 4 (HPTN-103, NCT06101342), are part of Gilead's PURPOSE program. The PURPOSE program, which also includes two ongoing Phase 3 clinical trials, is assessing the potential of twice-yearly subcutaneous injections of lenacapavir to help a diverse range of people around the world who could benefit from HIV-1 pre-exposure prophylaxis (PrEP). PURPOSE 3/HPTN-102 is enrolling cisgender women in the U.S. who are disproportionately affected by HIV, with a focus on Black women and other women of color. PURPOSE 4/HPTN-103 is enrolling people in the U.S. who inject drugs.”

Gilead Sciences is no stranger to challenges when it comes to a lack of diversity in clinical trials for HIV prevention. In 2019, Gilead’s oral regimen for the prevention of HIV, Descovy (emtricitabine/tenofovir alafenamide) received FDA approval for use in HIV-1 Pre-Exposure Prophylaxis (PrEP) treatment in patients “…excluding those who have receptive vaginal sex” (FDA, 2019).

At the time, Gilead claimed that it would have required “…too many resources” to enroll a sufficient number of cisgender women into the trial and closely monitor their adherence to the daily pill regimen (Blackstock, 2019). Since then, Gilead has made significant strides to change its paradigm after the Descovy incident, which is laudable considering that many other companies continue to slow walk diversity efforts.

PlusInc will continue to monitor diversity issues in the clinical trial space.

Examining Disparities in Maternal Health

Maternal Health refers to a pregnant woman’s health and wellbeing before, during, and after pregnancy and encompasses aspects of physical, mental, emotional, and social health. Maternal health also includes the absence of maternal morbidity (health conditions that complicate pregnancy and childbirth or that have a negative impact on a person’s health and wellbeing), severe maternal morbidity (outcomes of labor and birth that result in significant negative short- or long-term consequences to a woman's health), and maternal mortality (the death of a woman directly related to complications of pregnancy, birth, or within 12 months of giving birth).

The disparities related to maternal health and mortality are likely related to patients’ ability (or inability) to access maternal care services. According to the March of Dimes, 1,117 counties in the United States (35.57%) lack access to any maternal care services, including hospitals and birth centers offering obstetric care or obstetric providers (OBs, OB/GYNs, or Certified Nurse Midwife [CNM]) per 10,000 birthday), and another 373 counties (11.88%) have low access to maternity care services (Figure 1; Bignance et al., 2022).

Figure 1 - America’s Maternity Care Deserts

Note - Data from Bignance et al., 2022. Dashboard available at: https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/march-of-dimes-maternity-care-deserts-dashboard.html

The United States has the worst maternal mortality rate out of any high-income country (Gunja, Gumas, & Williams, 2022). While maternal mortality rates in the United States have seen significant annual increases across all racial groups since 2018, when 658 women died at a rate of 17.4 deaths (per 100k live births), and peaking in 2021, when 1,205 women died at a rate of 32.9 (per 100k live births; Hoyert, 2023), recent data indicate that 817 women died in 2023, at a rate of 22.3. Maternal mortality rates decreased significantly among Black, White, and Hispanic Women, and decreased marginally for Asian Women (Hoyert, 2024). These decreases were seen across all age groups, as well.

Despite these decreases, Black Women continue to bear a disproportionate burden compared to their peers with a maternal mortality rate of 49.5 (per 100k live births) in 2022, compared to White Women (19.0), Hispanic Women (16.9), and Asian Women (13.2).

Older women continued to have the highest rates of maternal mortality, at 87.1, compared to 21.1 in women aged 25-39 and 14.4 in women younger than 25.

As we noted in 2023’s Disparities Statement, little research has been conducted to examine the correlational or causal relationship between income levels and maternal mortality. Somewhat paradoxically, women with higher incomes may be at risk of experiencing complications or mortality during pregnancy. This appears to be because women with higher levels of income are more likely than those with lower incomes to wait to attempt pregnancies until later in life, which increases the risk of complications and mortality, and are more likely to have multiple birth pregnancies, which may be the result of fertilization treatments used to get pregnant. Women with lower incomes are more likely to become pregnant much earlier in life, which may mean they have fewer complications and lower rates of infant or mother mortality.

What can be observed, however, is that Black families, regardless of their income levels, have worse infant and maternal health outcomes than the very poorest White families (Kennedy-Moulton et al., 2022).

Women living in the American South (i.e., Alabama, Arkansas, Kentucky, Louisiana, Mississippi, and Tennessee) experienced the highest rates of maternal mortality from 2018-2020, with Arkansas having the highest rate at 40.4, compared to the national rate of 20.4 (Figure 2; KFF, n.d.). However, data were suppressed for 20 states and the District of Columbia, painting an uneven picture of maternal mortality rates across the U.S.

Figure 2 - Maternal Mortality Rates by State, 2018-2020

Note - Data from KFF, n.d.

Considerations and Discussion: The Potential Impacts of the Dobbs Decision on Maternal Health Outcomes

While maternal mortality rates saw significant decreases from 2021 to 2022, it is unknown whether or not this decline will become a continuing trend, particularly due to the recent overturning of Roe v. Wade by the Supreme Court in 2022 in their Dobbs v. Jackson Women’s Health Organizations ruling. Since that time, several states have moved to severely limit or eliminate access to abortion services and medications. This has already resulted in obstetricians leaving those states, further worsening a field already beleaguered by a limited number of physicians and too many patients per physician (Weiner, 2023).

A qualitative study published in JAMA Network Open surveyed 54 OB-GYNs practicing under abortion bans in 13 states about their perceptions on the impacts on the OB-GYN field and patient outcomes (Sabbath, McKetchnie, Arora, & Buchbinder, 2024). Physicians raised concerns that these laws may result in delayed medically necessary care until patients were at risk of death or permanent impairment in order to comply with state laws. They were also concerned about what types of counseling they could provide without running afoul of those laws, and about their inability to provide care under the statutes without the risk of losing their licenses. 6 of surveyed OB-GYNs indicated that they had already relocated their practices out of their respective states and reopened in states with stronger abortion protections, while another 29 reported wanting to leave the state but being unable to do so due to personal ties. The OB-GYNs surveyed also reported that these laws were likely to make recruiting new physicians or students more difficult.

A prime example of this is the state of Idaho, where 21 of Idaho’s 44 counties (47.73%) are designated as Maternal Care Deserts (Bignance, et al., 2022). Since the passage of a near-total abortion ban in August 2022, the number of obstetricians decreased from 227 in 2022 to 176 in 2023 (Associated Press, 2024). In addition, three facilities in Idaho have closed their maternity services since August 2022—Bonner General Hospital (Campoamor, 2023), Valor Health Hospital (Tabachnick, 2023), and West Valley Medical Center (Moseley-Morris, 2024).

These closures and the loss of maternal health providers are not isolated to Idaho, nor does it appear that the issues of critical understaffing and new blood entering the field in states with abortion restrictions or bans will be abating any time soon. Moreover, because we are only two years past the Dobbs decision, it is difficult to definitively quantify how these state-level bans will impact maternal health outcomes.

Because many of the states who have already passed or are rushing to pass abortion restrictions are located in states where the majority of counties already have low- to no-access to maternal care services, these restrictions may make accessing maternal care even more difficult, should physicians continue to leave without applicants willing to risk their licenses by practices in legislatively hostile states. This may further exacerbate maternal mortality rates, particularly among Black Women living in Southern states.

PlusInc will continue to monitor disparities in maternal health outcomes.

COST CONTAINMENT vs. CARE EQUALITY: How Health Disparities Among Chronic Health Conditions & Rare Diseases are Fueled by Payor-Driven Barriers

By: Brandon M. Macsata and Marcus J. Hopkins

Despite being among the wealthiest and most educated societies, health disparities in the United States are a consistent risk among specific population groups.[1] Black and brown Americans don’t enjoy the same access to care as their white counterparts; women experience more years of poor health than men;[2] age impacts health outcomes,[3] as do gender identity,[4] sexual orientation,[5] and geographic location.[6] The humanistic and environmental factors driving health disparities are only made more complex by the fragmented healthcare delivery system, which is known for payors, including public and private health insurers, putting up barriers between patients, their providers, and the treatments and medications they need.

Aside from institutional bias (i.e., racism, agism, and other stigmatizing attitudes toward specific barriers and  characteristics), emerging provider deserts where patients live without access to hospitals, primary care physicians, and pharmacies,[7] as well as the lack of affordable food, housing, and transportation, there is a direct correlation between health insurance coverage and health disparities in this country.[8] According to the Centers for Disease Control & Prevention (CDC), “Insurance coverage is strongly related to better health outcomes. Substantial disparities in uninsured rates were observed among all the demographic and socioeconomic groups.” In 2022, approximately 7.9 percent of the population was uninsured, down by 0.4 percentage points from 2021.[9] Health insurance coverage in and of itself, however, doesn’t necessarily result in equitable access to healthcare services or equitable health outcomes because often it is an insurance policy’s benefit and payment parameters that open the door to such disparities.

The so-called “cost containment tools” utilized by health insurance companies and pharmacy benefit managers (PBMs) are hurting patients.[10] Notably, they are driving and exacerbating health disparities. Some of the most common payor-driven barriers encountered by patients include prior authorization (PA), step therapy, copay accumulators, health insurance plan design, and an emerging one: prescription drug affordability boards (PDABs). This article highlights why these cost-containment strategies are problematic for patient access, affordability, and equity.

Prior Authorization (PA) requirements are widely recognized as the Payor’s Boogeyman because they create overly burdensome, layered processes for patients to obtain approval for provider-prescribed care. These processes often result in lengthy delays that increase the likelihood that patients will abandon their care or treatment plans rather than fight the system. Numerous associations representing varied interests within the healthcare sector have correctly labeled PAs as fueling health disparities with disproportionate impacts on poor and minority populations.

The American Medical Association (AMA) has been an outspoken critic of the practice, calling it a “nightmare” for disrupting patient care. Their latest AMA prior-authorization physician survey found the PA process led to delays in care over ninety percent (90%)  of the time, leading Heather McComas, PharmD, Director of the AMA’s administrative simplification initiatives to argue: “Our physicians are saying that prior-authorization care delays actually hurt patients: 80% of physicians reported that prior authorization can lead to patients completely abandoning a prescribed or ordered course of care. Most alarming, one-third of physicians reported that prior authorization has led to a serious adverse event for a patient in their care. And a serious adverse event is something like hospitalization, permanent impairment or even death.”[11] 

Patients who fall within the lower socioeconomic status of our society are less likely to have the education or financial means to remedy the negative impacts caused by the delays in care and treatment. It creates additional hardship on communities of color, rural communities, and immigrant populations where English is probably a second language. The American Academy of Family Physicians (AAFP) made this very argument in a recent letter:

“Evidence indicates that prior authorization requirements may be discriminatory and worsen health disparities, as documented in a study examining access to treatment for HIV pre-exposure prophylaxis and a white paper which examined the disproportionate impact of prior authorization requirements on cardiovascular care for Black and other patients of color. We are concerned that prior authorization requirements can worsen health disparities and create barriers to care for medically underserved patients, patients of color, LGBTQ+ patients, patients in rural areas, and those at risk for poor health outcomes. Federal oversight and action is needed to address the negative impacts prior authorizations are having on patients and physicians.”[12]

Concerns over disparities in cardiovascular care caused by prior authorization was raised by the Association of Black Cardiologists (ABC), which issued a comprehensive white paper in 2019, Identifying How Prior Authorization Impacts Treatment of Underserved and Minority Patients. The white paper “…hypothesized that lower resource levels at cardiology practices with a majority of patients from underserved and minority populations may pose a unique barrier to responding to PA needs for these patients, further fostering existing treatment disparities.”[13] 

ABC found that, when asked, physicians agree 'very much' that PA contributes to delays in care (61%), higher patient confusion (50%), increased medication discontinuation (45%), reduction in medication adherence (32%), and worse outcomes (16%). In terms of time devoted to PA, about half of physicians (47%) note the staff spends five hours or more per week, and a third (32%) say their staff spends seven or more hours a week. This time also includes appeals, since about sixty percent of physicians (61%) submit an appeal if a PA is rejected. The burden on practice staff is considered high or extremely high by a majority of physicians (57%).[14]  

Not surprisingly, most of ABC’s member cardiologists were unable to name a single positive impact of PA for their underserved and minority patients. 

There is also evidence that Step Therapy and the nonmedical switching of prescription medications are yet another “cost containment” strategy employed by health insurance companies and other payors exacerbate health disparities in the United States. Commonly called “fail-first” policies, step therapy can result in additional visits to the doctor, which disproportionately affects rural communities. Step therapy also means providers have less time to spend with patients, again disproportionately impacting rural communities.

According to a position paper published by the American College of Physicians (ACP), Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety, “Step therapy, nonmedical drug switching, and other cost-curbing formulary designs can also undermine the medical expertise of physicians and fail to adequately account for the individual characteristics and needs of patients, including comorbid conditions, concurrent medications, and demographic factors, all of which can impact a medication’s effectiveness and side effects.”[15]

As an example, ACP cited patients with rheumatoid arthritis who experienced adverse health events because of step therapy requirements or nonmedical drug switching. Despite being switched to a lower-cost medication, these patients experienced a 126.2% increase in yearly medical payments ($6,254 to $14,127).[16] Rheumatoid arthritis disproportionately impacts women and African Americans who have educational attainment levels less than high school and low family incomes, thus offering a clear indication of how these payor-drive cost containment strategies can impact patients living with certain chronic health conditions.

"Insurance-mandated step therapy exacerbates several factors that contribute to health disparities,” says Sarah Buchanan, Co-Chair of the Safe Step Act Ad Hoc Coalition and Senior Federal Government Relations Director at the National Psoriasis Foundation. Many patients and providers don't have the time or resources to pursue step therapy exceptions because the process can be challenging and uncertain. As a result, individuals who find it difficult to access health care—for example, because they live far from a provider with the resources to engage insurers, they don't trust the health system, or they don't speak English well—can lose confidence in their providers and decide not to pursue appropriate care. By the time family members step in, or the patients themselves decide to return for medical care, it is often too late to prevent permanent damage. That is why patient advocacy groups across the country are working to pass step therapy exception laws in states and in Congress. These laws would ensure that health plans offer a reasonable and expedient step therapy exceptions process that is accessible to both the patients and providers. Buchanan further stated:

“By creating a clear exceptions process and carving out circumstances when a patient should be granted an exception, we hope to empower patients and providers to pursue coverage for the right treatment sooner, and ultimately to avoid the severe or irreversible health outcomes that are occurring because of insurance barriers.”

With respect to the intersection between Copay Accumulators and health disparities, a dynamic assessment yields more troubling data. Copay accumulators (also known as “copay maximizers” or “accumulator adjustment schemes”) are a policy implemented by a commercial health insurance company or Pharmacy Benefit Manager (PBM) that prevent copay assistance coupons from being utilized toward insurance deductibles or out-of-pocket maximums (OPMs). These policies can be present in both insurance coverage purchased from the health insurance marketplace and in employer-sponsored plans, although employers are able to negotiate with insurance companies or offer at least one option that does not include an accumulator policy.[17]

Copay accumulator policies can have devastating financial consequences for patients whose insurance coverage includes them. When copay assistance is not counted toward a patient’s deductible and out-of-pocket maximum, they end up spending more money out-of-pocket even though the insurance companies still get paid by both the patient and the drug manufacturer (Figure 1). This is particularly true for patients who are enrolled in High-Deductible Health Plans (HDHPs) for whom “cost-sharing” is already higher.

Figure 1 - Example of How Copay Accumulator Programs Negatively Impact Patients

Note: Retrieved from The AIDS Institute, 2024[18]

To understand how accumulator programs can contribute to disparities in access to care, it’s important to first establish who is eligible for, likely to utilize, or already accessing copay assistance programs. Most copay assistance programs offered by both drug manufacturers and private organizations require patients to be:

1. Enrolled in commercial insurance plans.

2. To be uninsured.

3. To have incomes that fall within the maximum income requirements set by each issuer.

A 2022 survey from the American Cancer Society found that 83% of patients who applied to copay assistance programs and were accepted said that the copay assistance coupons enabled them to access the medications they would otherwise be unable to afford. It also found that 27% of assistance recipients reported that those coupons were not counted toward their deductibles or OPMs due to a copay accumulator policy.[19]

The utilization rates of copay assistance coupons are largely tied to the types of disease those drugs are designed to treat. Manufacturers, really, only offer assistance programs for medications that treat conditions that are expensive to treat, such as HIV, cancer, and Rheumatoid Arthritis (RA). Black Americans are likelier to develop or be living with each of the conditions, compared to their White peers, and yet, White Americans are likelier to be aware of and utilize copay assistance programs than minority patients.[20]

Research published in the Journal of Managed Care & Specialty Pharmacy found that copay assistance programs have the potential to narrow health outcome disparities in Black and Hispanic patients by increasing medication adherence and decreasing treatment abandonment because of being unable to afford medications. However, increasing awareness and utilization of copay assistance programs will require concerted efforts on behalf of manufacturers, providers, and other people within the healthcare infrastructure.[21]

These data means that, because minority patients are more likely to being living with expensive-to-treat illnesses, and more likely to earn less than their White peers,[22] they are more likely to both need copay assistance and, if they are commercially insured, likely to be negatively impacted by copay accumulator programs.

Health Insurance Plan Design is also a significant driver of disparate health outcomes, particularly amongst lower-income and minority patients because it impacts the ability to access and afford either public or commercial health insurance. But, beyond just its accessibility and affordability lies another factor that is often overlooked: health insurance plan and benefits design.

When a patient selects health insurance coverage through an employer, the health insurance marketplace, or some other source, they are often provided with a variety of options or plans that ostensibly allow them to select the plan that best suits their needs. But several questions should be considered:

1. Will this plan cover my current provider or providers local to me?

2. Will this plan cover the medications I currently use?

3. Will my insurance be accepted at the pharmacy of my choosing?

4. Will I be able to afford the premiums, deductible, co-insurance, copays, and out-of-pocket maximums?

The answers to these questions may not always result in a patient finding an insurance plan that suits their needs. This is where the concept of “health insurance plan and benefits design” comes into play.

Plan design includes (but is not limited to):

• What services are covered;

• Which providers and hospitals are included, and;

• Out-of-pocket costs[23]

In order for health insurers to remain profitable, they design plans using a system of constraints and incentives applied to both healthcare providers and patients. The first level applies those constraints and incentives to providers, such as by requiring them to submit prior authorization requests before treating patients with high-dollar procedures and medications. The second level is applied to patients in the form of cost-sharing (i.e., deductibles, copays, co-insurance, and out-of-pocket maximums).[24]

Another aspect of plan design that supports this profitability model involves selecting in-network providers and hospitals. In order for an insurance plan to be useable for patients, they need to able to access in-network providers that are relatively local to them. For those who live in rural, geographically isolated, or underserved parts of the country, this can mean that, while services are technically covered, the healthcare providers and services required to treat chronic illnesses, such as cancers, non-infectious diseases, and infectious diseases may be out of reach for many poor or minority patients.

The reality is that virtually every cost, regardless of how nominal payors may consider them to be, can serve as a barrier to accessing care and treatment. Insurance companies and other payors often fail to consider the reality that even a $5.00 copay may result in a patient deciding between buying medications and paying rent or utility bills…and patients will usually choose the latter over medication.[25] Moreover, they often don’t consider the costs of transportation to or from providers to access even basic healthcare services when determining cost-sharing levels for services.

These plan design issues often contribute to and exacerbate existing health disparities in lower-income and minority communities. For example, both the lack of insurance and the inability to afford the cost-sharing associated with seeking services and treatment can increase rates of late-stage breast and cervical cancer detection and decrease survivability. In Alabama’s Black Belt—17 counties in which Black Americans make up at least 50% of the population that lack access to social and medical services, whose economies depend primarily upon agriculture, and have per capita incomes around $13,000 per year—only 4 had at least one obstetrician-gynecologist as of 2018.[26] This means that Black people living in those counties are less likely to be able to get to, access, or afford screening services on a regular basis that might identify cancers earlier in their progression and increase survivability among Black people. When examining data from 2009-2018, Black women were more likely to be diagnosed with and die from both breast and cervical cancer than their White peers.35 While this disparity cannot entirely be blamed upon plan design, insurers can subsidize preventive and routine screenings to reduce some of the costs associated with seeking these services.

Another way that insurers could mitigate some of these costs is to provide either reimbursement for and subsidize (in whole or in part) transportation to and from healthcare providers in these types of areas. This is something that often exists in public insurance coverage but is infrequently found in commercial coverage. This generally involves patients submitting receipts for fuel and mileage for reimbursement or scheduling subsidized transportation services to and from certain types of services through a 3rd-Party company that is contracted by their state’s Medicaid agency to help patients access care.

A new and yet alarmingly troubling trend at the state level are the emergence of so-called Prescription Drug Affordability Boards, or PDABs. “Affordability” is a nuanced term with these little understood government-sanctioned price control entities.

A National Minority Quality Forum’s webinar focused its attention on the escalating prevalence of state prescription drug affordability boards and their intersection with efforts to embed health equity as a tenant of the American health system. The reality is that PDABs can enable or hinder equitable access to efficacious therapies.[27]

According to Jen Laws, President & CEO of the Community Access National Network (CANN)—a transgender man living with HIV in the American South—PDABs, on the surface, are supposed to make prescription drugs more affordable, but the application in how these entities move forward doesn’t necessarily address the issues of access, especially for marginalized communities. The rate-setting mechanism utilized by PDABs hasn’t demonstrated an ability to translate into better access, better health equity on marginalized community access to care, or even better network availability around access to care.

In a recent blog post, CANN argued:

“It’s no secret that the high cost of healthcare is a significant concern for most Americans. The total national health expenditure in 2021 increased by 2.7% from the previous year to 4.3 trillion dollars which was 18.3% of the gross domestic product. The federal government held the majority of the spending burden at 34%, with individual households a close second at 27%.A cornerstone component of medical treatment is the access to prescription drugs. In 2019 in the U.S., the government and private insurers spent twice as much on prescription drugs as in other comparatively wealthy countries. Despite catchy phrases that poll well, and “simple” solutions by politicians that promise to fix the problem—such as Prescription Drug Advisory Boards (also known as Drug Pricing Advisory Boards)—it is mindful to remember one thing: if it sounds good to be true, then it probably isn’t true.”[28]

In Colorado, CANN has sounded the alarm on how that state’s price control board could further fuel health disparities among marginalized populations living with cancer, HIV, and Hepatitis C (HCV). According to the CDC, there are 24,280 Coloradoans living with cancer, 13,442 Coloradoans living with HIV, and 1,840 Coloradoans living with HCV.[29]

Why are these figures relevant to health disparities?

Local data for all cancer sites (meaning all types of cancer in sites throughout the body) indicate that cancer rates are highest amongst people aged 50 and older, with rates in the thousands (per 100,000 residents) once Coloradans turn 65. The most reliable predictor of cancer diagnoses is age. As the body ages, cells become damaged and degrade both through normal aging and through external factors, such as exposure to certain chemicals, including those in cigarettes, the excessive consumption of alcohol, or too much ultraviolet radiation from the sun. In addition to age-related rates, American Indians and Alaska Natives in Colorado have a rate of 1,349.4 (per 100k)—a significantly higher rate than members of other races.[30]This aligns with national risk evaluations. According to the Roswell Park Comprehensive Cancer Center, based in Buffalo, NY, Native Americans, despite regional and tribal differences, have overall higher-than-average rates of most cancers and have the lowest cancer survival rates in the United States. This may be attributed to several disparities faced by Native Americans and Alaska Natives, including:[31]

• Native Americans communities tend to have higher rates of poverty and lower levels of education and educational attainment than other communities.

• Native Americans also have the highest rates of cigarette smoking in the U.S., are 10 times more likely to die of alcohol-related reasons, and twice as likely to die from a drug overdose than other U.S. residents.

• Native Americans are more likely to suffer from obesity than other races, with obesity rates varying widely by tribe and geographic location.

• The diets of Alaska Natives tend to include foods that are high in salty, preserved fish and low in fresh fruits and vegetables.

• Native American and Alaska Native communities are disproportionately impacted by environmental pollutants caused by the agricultural, drilling, and mining industries.

Compounding these environmental risks is the fact that healthcare services, along with other necessities, including electricity, phone service, sewage and water treatment, and internet access, are harder to access in indigenous communities. What healthcare services do exist are chronically underfunded, under-resourced, and understaffed.

With respect to HIV, Black residents of Colorado are disproportionately impacted, with a diagnosis rate of 34.2 (per 100k) compared to just 5.5 in White Coloradans, and a prevalence rate of 1,029.0, compared to 215.6 in Whites. Indigenous and Hispanic persons are also disproportionately impacted, with infection rates of 18.5 and 12.8, respectively, and prevalence rates of 267.8 and 332.9, respectively.[32] Again, these disparities are doubly felt because accessing and affording medications to treat HIV is likely to be difficult for these communities due to higher levels of poverty and lower levels of education and educational attainment. Hispanic populations also face additional race-related stigma, with many members of the community fearing interactions with public health officials from fear of being accused of being in the country illegally.

Finally, Viral Hepatitis (including Acute and Chronic Hepatitis B and Hepatitis C) statistics are less clear. With acute cases of both HBV and HCV, the state of Colorado's county and state departments of health have never fully recovered or staff their departments to address hepatitis-related case investigations. As a result, the last year for reliable data is 2019. The diagnoses of chronic HBV and HCV, however, are much easier to determine, as they are reported directly from physicians and do not require confirmatory testing, making 2021 the most reliable year for information. Men and persons aged 20-39 are disproportionately impacted by Acute HCV, with men accounting for 68.6% of new diagnoses and persons aged 20-39 accounting for 60.8% of diagnoses. Women are more likely to be diagnosed with Acute HBV, representing 52.2% of cases, and most cases are diagnosed in persons aged 20-59, with persons aged 20-39 accounting for 43.5% and those aged 40-59 accounting for 47.8% of new Acute HBV diagnoses. White Coloradans account for much of both acute HCV and HBV diagnoses. As it relates to chronic HCV and HBV, Men are disproportionately impacted by both diseases, accounting for 69.5% of Chronic HCV and 55.6% of Chronic HBV cases. Again, persons aged 20-59 account for most chronic diagnoses, with persons aged 20-39 accounting for 44.7% of chronic HCV and 40.6% of chronic HBV diagnoses, and persons aged 40-59 accounting for 31.2% of Chronic HCV and 39.3% of Chronic HBV diagnoses. No racial demographic data are available for Chronic HCV, and many new diagnoses for Chronic HBV are in patients whose race was reported as "Unknown," indicating that reporting on race is incomplete.[33]

CANN isn’t alone in its concern over the unintended consequences of PDABs, in general, but also specifically on driving health disparities. The Global Coalition on Aging (GCA) contends that such price controls will have an adverse impact on patient outcomes through the lens of an aging population.

In a recent letter to the Colorado PDAB, GCA wrote:

“Many diseases that once burdened aging populations have evolved into manageable chronic conditions due to modern, safer, and more effective treatments, allowing many aging patients to live longer, healthier lives. However, while there have been significant strides to discover new treatments in recent decades, there remains a vast unmet patient need for new solutions to complex, age-related health challenges, including Alzheimer’s disease, HIV, heart disease, cancer, bone health, and more.”[34]

The potential impact on patients with chronic health conditions and rare diseases by these government-sanctioned boards is cause for alarm. According to Linda Goler Blount, President & CEO of the Black Women’s Health Imperative, African Americans, and Latinos die disproportionately from rare diseases. In fact, during a speech at The National Press Club, Blount highlighted that “Blacks have higher death rates than whites for 12 of the 15 leading causes of death in the United States, and almost are rare diseases,” that “Black women also have 42% higher breast cancer mortality rates,” and “Latinos have higher death rates than whites for diabetes, hypertension, liver cirrhosis and homicide.”[35]

The Rare Access Action Project (RAAP) has echoed some of these very same concerns. Michael Eging, who leads RAAP, contends:

“PDABs will continue to increase health disparities as rare patients are increasingly treated under a center of excellence model. These patients often travel out of state for their care, see specialists at centers of excellence, and are prescribed, and even receive their therapies (whether through infusion or prescription outpatient) from sources located outside their state. Creating upper payment limits will put those delivery systems at risk; and patients will find a growing patchwork of access as those providers cut back on services and fulfillment of prescription therapies. Already some institutions require patients to “brown bag” or supply the therapy rather than the center of excellence take the risk for payment. Rare patients in Medicaid will find this particularly acute as they will be the most vulnerable to limitations on access without recourse. And of those patients, children from low-income minority families will be impacted by the reductions in access.”[36]

There are varied social and health indicators related to the growing trend of health disparities and inequities in the United States. These disparities can be examined by race and ethnicity, gender, sexual orientation and gender identity, disability status, and geographic location. Of equal importance is a better understanding of the drivers behind these health disparities and inequities, including the access to care and payment reimbursement policies pushed by health insurance companies, pharmacy benefits managers, and other payors. There is clear evidence to suggest these policies are a key driver behind the inequities that exist by gender, geography, socioeconomic status, race and ethnicity, and other areas.

To download a copy of this white paper, click here.

[1] National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Community-Based Solutions to Promote Health Equity in the United States; Baciu A, Negussie Y, Geller A, et al., editors. Communities in Action: Pathways to Health Equity. Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The State of Health Disparities in the United States. Available from: https://www.ncbi.nlm.nih.gov/books/NBK425844/

[2] AXA; Bogataj, Marie. 2019, Jun 16. Women vs. men: is there a health equality gap? Available from https://www.axa.com/en/news/women-vs-men-is-there-a-health-equality-gap

[3] U.S. Department of Health and Human Services; Office of Disease Prevention and Health Promotion; 2023, Sep 14. Social Determinants of Health and Older Adults. Available from https://health.gov/our-work/national-health-initiatives/healthy-aging/social-determinants-health-and-older-adults

[4] Lee Robertson, Ellesse-Roselee Akré, and Gilbert Gonzales.Mental Health Disparities at the Intersections of Gender Identity, Race, and Ethnicity.LGBT Health.Dec 2021.526-535. Available from: http://doi.org/10.1089/lgbt.2020.0429

[5] Hafeez H, Zeshan M, Tahir MA, Jahan N, Naveed S. Health Care Disparities Among Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review. Cureus. 2017 Apr 20;9(4):e1184. doi: 10.7759/cureus.1184. PMID: 28638747; PMCID: PMC5478215. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/

[6] Institute of Medicine (US) Roundtable on Health Disparities. Challenges and Successes in Reducing Health Disparities: Workshop Summary. Washington (DC): National Academies Press (US); 2008. 2, The Impact of Geography on Health Disparities in the United States: Different Perspectives. Available from: https://www.ncbi.nlm.nih.gov/books/NBK215365/

[7] Horowitz, Brian T; 2022, Jun 2. What Are Medical Deserts, and How Can Technology Alleviate Them? HealthTech. Available from: https://healthtechmagazine.net/article/2022/06/what-are-medical-deserts-perfcon#:~:text=Areas%20without%20access%20to%20hospitals%2C%20primary%20care%20physicians%2C,research%20at%20GoodRx%2C%20a%20consumer-focused%20digital%20healthcare%20platform.

[8] U.S. Department of Health & Human Services; Centers for Disease Control & Prevention; Morbidity and Mortality Weekly Report; 2011, Jan 25. Fact Sheet: Health Disparities in Health Insurance Coverage. Available from https://www.cdc.gov/minorityhealth/chdir/2011/factsheets/insurance.pdf#:~:text=Insurance%20coverage%20is%20strongly%20related%20to%20better%20health,with%20a%20higher%20percentage%20of%20males%20being%20uninsured

[9] United States Census Bureau; 2023, Sep 12. Health Insurance Coverage in the United States: 2022. Available from: https://www.census.gov/content/dam/Census/newsroom/press-kits/2023/iphi/20230912-iphi-slides-health-insurance.pdf#:~:text=The%20uninsured%20rate%20decreased%20by%200.4%20percentage%20points,In%202022%2C%20the%20uninsured%20rate%20was%207.9%20percent

[10] American Medical Association; 2023, May 12. How prior authorization disrupts patient care, Part I. Available from: https://www.ama-assn.org/practice-management/prior-authorization/how-prior-authorization-disrupts-patient-care-part-i#:~:text=Our%20physicians%20are%20saying%20that%20prior%20authorization%20care,that%20prior%20authorization%20leads%20to%20negative%20clinical%20outcomes

[11] Robeznieks, Andis; 2023, May 3. Once just a burden, prior authorization has become a nightmare. American Medical Association. Available from: https://www.ama-assn.org/practice-management/prior-authorization/once-just-burden-prior-authorization-has-become-nightmare

[12] American Academy of Family Physicians; (2022, Mar 22). RIN 0955-AA04; Request for Information: Electronic Prior Authorization Standards, Implementation Specifications, and Certification Criteria. Available from: https://www.aafp.org/dam/AAFP/documents/advocacy/health_it/ehr/LT-HHS-ONC-ElectronicPriorAuthorization-032222.pdf

[13] Association of Black Cardiologists; (Winter 2019). Identifying How Prior Authorization Impacts Treatment of Underserved and Minority Patients. Available from: http://abcardio.org/wp-content/uploads/2019/03/AB-20190227-PA-White-Paper-Survey-Results-final.pdf

[14] Association of Black Cardiologists; (Winter 2019). Identifying How Prior Authorization Impacts Treatment of Underserved and Minority Patients. Available from: http://abcardio.org/wp-content/uploads/2019/03/AB-20190227-PA-White-Paper-Survey-Results-final.pdf

[15] American College of Physicians; (2020). Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety. Available from: https://assets.acponline.org/acp_policy/policies/step_therapy_nonmedical_switching_prescription_drugs_policy_2020.pdf

[16] American College of Physicians; (2020). Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety. Available from: https://assets.acponline.org/acp_policy/policies/step_therapy_nonmedical_switching_prescription_drugs_policy_2020.pdf

[17] Aimed Alliance. (2020). Copay accumulator programs: What employers need to know. Washington, DC. https://aimedalliance.org/wp-content/uploads/2020/07/CopayAccumulators_FactSheet.pdf

[18] The AIDS Institute. (2024). Unchecked: Copay accumulator adjustment policies in 2024. Washington, DC. https://aidsinstitute.net/documents/TAI-2024-Report-2.27.pdf

[19] American Cancer Society. (2022, May). Survivor views – copay assistance: May 2022 survey findings summary. Washington, DC: American Cancer Society: Cancer Action Network. https://www.fightcancer.org/sites/default/files/national_documents/survivorviews-copayassist_0.pdf

[20] Institute for Patient Access. (2022, December). Health disparities & medication access. https://instituteforpatientaccess.org/wp-content/uploads/2022/12/IfPA_HealthDisparitiesReport_Dec-2022.pdf

[21] Wong, W. B., Donahue, A., Thiesen, J., & Yeaw, J. (2023, January 24). Copay assistance use and prescription abandonment across race, ethnicity, or household income levels for select rheumatoid arthritis and oral oncolytic medicines. Journal of Managed Care & Specialty Pharmacy, 29(3), 229-334. https://doi.org/10.18553/jmcp.2023.22288

[22] Office of Federal Contract Compliance Programs. (n.d.). Earnings disparities by race and ethnicity. Washington, DC: United States Department of Labor: Office of Federal Contract Compliance Programs: About Us: Data and Results: Earnings Disparities. https://www.dol.gov/agencies/ofccp/about/data/earnings/race-and-ethnicity

[23] Baicker, K. (2021). Rethinking health insurance design. JAMA Health Forum, 2(5), e211440. https://doi.org/10.1001/jamahealthforum.2021.1440

[24] Prager, E. (2023, November 03). Smarter health insurance plan design. Rochester, NY: University of Rochester: Simon Business School: Simon Blog: Dean’s Corner. https://simon.rochester.edu/blog/deans-corner/smarter-health-insurance-plan-design

[25] Schilling, B. (n.d.). Hitting the copay sweet spot. New York, NY: The Commonwealth Fund: Areas of Focus: Improving Health Care Quality. https://www.commonwealthfund.org/publications/newsletter-article/hitting-copay-sweet-spot

[26] Brady, K. C., Stephens, C. P., Sudan, S. K., Singh, A. P., Dasgupta, S., & Singh, S. (2022, December). Breast and cervical cancer disparities in Alabama: Current scenario, ongoing efforts to reduce the disparity gaps, and what more we could be doing. Cancer Health Disparities, 6, e1-e10. https://pubmed.ncbi.nlm.nih.gov/36777282

[27] National Minority Quality Forum; (2024, February 2). State Prescription Drug Affordability Boards & Health Equity. Retrieved online at https://www.youtube.com/watch?v=ZC_XSrWP9eE

[28] Simons, Ranier; (2023, July 10). Prescription Drug Advisory Boards: What They Are and Why They Matter to Patients. Community Access National Network. Retrieved online at https://www.hiv-hcv-watch.com/blog/pdab-2023-1

[29] Community Access National Network; (2023, November 20). Prescription Drug Advisory Boards: Where They Are and How to Influence Them. Retrieved online at https://www.tiicann.org/pdf-docs/2023_CANN_PDAB_Project_Infographic_3_11-20-23.pdf

[30] Colorado Department of Public Health & Environment; (2024). Colorado Health Information Dataset (CoHID), Cancer Cases, Counts. Retrieved online at https://cohealthviz.dphe.state.co.us/t/HealthInformaticsPublic/views/COHIDCancerIncidenceRates/CancerIncidences?iframeSizedToWindow=true&%3Aembed=y&%3AshowAppBanner=false&%3Adisplay_count=no&%3AshowVizHome=no

[31] Haring, Rodney C.; (2018, April 30). Native American Cancer Risks. Roswell Park. Retrieved online at https://www.roswellpark.org/cancertalk/201804/native-american-cancer-risks

[32] Centers for Disease Control & Prevention; (2024, February 9). Social Determinant of Health Data. U.S. Department of Health & Human Services (HHS). Retrieved online at https://www.cdc.gov/nchhstp/atlas/index.htm 

[33] Colorado Department of Public Health & Environment; (March 2023). Viral Hepatitis Surveillance in

Colorado - 2021 Annual Report. Retrieved online at https://drive.google.com/file/d/1FnoK1zBcwOoVttylxe5C_k-HxmeOt8GK/view

[34] Global Coalition on Aging; (2023, September 12). Colorado PDAB Must Be Accountable in Drug Affordability Reviews & Ensure Patient Access. Retrieved online at https://www.linkedin.com/posts/global-coalition-on-aging_gcoa-letter-of-concer-to-colorado-pdab-activity-7107343258887806976-LwZI/ 

[35] Clark, Sydney; (2021, September 21). African Americans underrepresented in research and clinical trials; 

Historical discrimination, malpractice and lingering mistrust block the path to significant diversity in rare disease research. National Press Foundation. Retrieved online at https://nationalpress.org/topic/diversity-elusive-in-rare-disease-research/

[36] National Organization for Rare Disorders (NORD) [Internet]. NORD (National Organization for Rare Disorders). [cited 2017 Apr 19]. https://rarediseases.org/

Examining Disparities in Perinatal HIV Transmission

The transmission of HIV from a pregnant woman to a child is referred to as “perinatal transmission,” but can also be referred to as “vertical transmission” or “mother-to-child transmission.” This mode of transmission can occur during the pregnancy gestation period, during delivery of a child, or through breastfeeding. Without treatment, 25-30% of babies born to a person living with HIV are likely to contract the virus (Minnesota Department of Health, 2022).

Pregnant women can drastically reduce the risk of transmitting HIV to their children by taking antiretroviral (ARV) medications to treat their HIV and achieving viral suppression—when the number of replicating copies of the HIV virus drops below 200 copies per milliliter of blood (Centers for Disease Control and Prevention, 2023c)—during pregnancy and after their children have been delivered. The use of ARV treatments has reduced the rate of perinatal HIV transmission to 1% of less in the United States and Europe (HIV Info, 2023).

Pregnant women living with HIV who have high viral loads—more than 1,000 replicating copies of HIV per milliliter of blood—or those with an unknown viral load can also reduce the risk of perinatal HIV transmission by scheduling a Cesarean delivery (or, “c-section”; HIV Info, 2023)

After birth, babies born to women living with HIV should receive ARV medications to reduce the risk of perinatal transmission. This type of treatment is based upon numerous factors which can be found at the following link: Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. 

Perinatal Transmission by the Numbers:

Overall
When examining the data for perinatal transmission, the incidence is both rare and has been decreasing over time (Table 1), with just 99 cases identified in 2021, the most recent year for reliable reporting (CDC, 2023a). Still, within the overall reporting, we see that a disparity exists: people over the aged 13 or older who were assigned Female as their sex at birth represent 49 (49.5%) of the 99 identified cases—greater than the number of adolescents aged younger than 13, for whom there were 39 identified cases. 2021 marked the first year that this has occurred since 2017 (CDC, 2023a).

Disparities Based on Race
When looking at 2021 data, one disparity becomes glaringly obvious: Black Americans are exponentially more likely than any other racial category to be diagnosed with HIV as a result of perinatal transmission. Among Males aged ≥13 years at the time of diagnosis, Black Males accounted for 8 of the 11 cases identified (72.7%). Among Females aged ≥13 years, Black Females accounted for 35 of the 49 cases identified (71.4%). Among Children aged <13 years, Black Children accounted for 26 of the 39 cases identified (66.7%).

Among Males, the only other racial category in which perinatal transmission was identified in 2021 was in Hispanic Males. Among both Females and Children, transmission occurred in other races, but Hispanic persons still had the second-highest number of transmissions in both categories (Table 2).

Considerations and Discussion: Racial Disparities in HIV Prevention and Treatment
That Black Americans (and Hispanic Americans) are disproportionately impacted by perinatal transmission of HIV is really unsurprising given that Black and Hispanic Americans account for the majority of all new HIV diagnoses, regardless of mode of transmission, with Black Americans accounting for 14,555 of the 35,769 (40.7%) new cases of HIV identified in 2021, and Hispanic Americans accounting for 10,070 (28.2%). Black Americans have a rate of HIV transmission that is exponentially higher than any other racial category, at 34.8 diagnoses per 100,000 Black persons, followed by Hispanic Americans at 16.1 (per 100k).

Data released in 2023 by AIDSVu—the interactive mapping tool that visualizes the impact of the HIV epidemic on communities across the United States (Sullivan et al., 2020)—found that Black and Hispanic Americans accounted for just 14% and 17% of Pre-Exposure Prophylaxis (PrEP) users in 2022, respectively . Additionally, Females accounted for just 8% of PrEP users (AIDSVu, 2023). These utilization data align with what we’re seeing in terms of both overall and perinatal transmission rates—the people most impacted are the least likely to have access to or use PrEP as a preventative tool against HIV transmission.

When it comes to viral suppression, Americans “enjoy” appallingly low rates of viral suppression compared to economically comparable countries, such as the United Kingdom, France, and Australia. In the United States, just 65.9% of Americans living with HIV/AIDS who were engaged in HIV treatment in 2021 were virally suppressed (CDC, 2023b), compared to 89% in the United Kingdom in 2019 (National AIDS Trust, 2022), 90% in France (KPMG, 2019), and 98% in Australia (UNAIDS, 2023). The primary difference between the United States and other members of the Organization for Economic Co-operation and Development (OECD) member states is that we are the only nation that fails to provide universal healthcare as a human right, relying instead on a profit-driven system of private insurance that is highly inefficient, greatly inequitable, and unaffordable for a majority of Americans.

When looking at the racial breakdowns of viral suppression fo HIV in the United States, 61.6% of Black Americans living with HIV/AIDS in 2021 were virally suppressed, compared to 64.3% of Hispanic Americans, and 71.7% of White Americans. The only racial group that surpassed White Americans in terms of viral suppression were Multiracial Americans, at 73.5%. Only Asian Americans (69.9%), White Americans, and Multiracial Americans had suppression rates higher than the national average of 65.9% (CDC, 2023b).

Recommendations and Potential Solutions
It is clear that, while rates of perinatal transmission have declined since 2017, there are still disparities to conquer, particularly among Black Americans and persons who are Female at birth. Significant efforts must be made to increase testing and diagnosis not just in pregnant women, but for the general population, as a whole. This cannot occur without significant pushes by federal, state, and local health agencies and legislative bodies to routinize HIV testing as a part of regular healthcare visits for all patients, regardless of age, race, and sex/gender. Many different types of stakeholders will need to come to various tables to make the routinization of HIV testing and diagnosis a reality, including:

• Stakeholders with educational expertise, such as epidemiologists, scientists, and public health professionals;

• Stakeholders with practical experience, such as infectious disease specialists, primary care physicians, and nurses;

• Stakeholders with lived experience, such as Persons Living with HIV/AIDS (PLWHA), persons in high risk categories for HIV transmission, and patients outside of those high risk categories who recognize the need for this kind of routine health intervention;

• Stakeholders who serve as payors of healthcare services and treatments, including public healthcare systems, like Medicaid, Medicare, and the Department of Veterans Affairs, and private insurers, and;

• Stakeholders who develop and manufacture the supplies necessary to test and diagnose HIV in a variety of healthcare settings, as well as those who develop and manufacture the medications needed to prevent and treat HIV.

Bringing these stakeholder groups to these tables will allow for the development of reasonable and patient-centric policies and implementation timelines around the delivery and reimbursement of HIV testing as a part of routine healthcare services across numerous healthcare settings and by a broad range of healthcare providers.

The two key policies that need to be in place to make routinization of HIV testing and linkage to care a reality are payment/reimbursement and enforcement mechanisms. We need to develop clear policies that outline who will pay for and reimburse these expanded HIV testing services and how state and federal governments will enforce these requirements. As we have seen with epidemiological reporting requirements, simply requiring things to happen doesn’t actually mean that they will or that the rollouts of those policies will be successful without these mechanisms in place.

While the routinizing of HIV testing in the general population is vital to reducing HIV transmission and increasing prevention and treatment access, concerted efforts must be made to increase and improve access to regular testing of pregnant people for HIV, Viral Hepatitis, and other STIs.

On the treatment side of preventing perinatal transmission, it is clear that barriers exist that prevent certain patient populations from either accessing or affording HIV treatment. These barriers may include (but are not limited to:

• Transportation barriers (e.g., lack of access to a personal vehicle or public transportation);

• Geographic barriers (e.g., distance to treatment, geographic isolation, or terrain barriers that prevent easy transportation);

• Access barriers (e.g., a lack of access to pharmacies or trusted medication providers);

• Housing barriers (e.g., a lack of stable housing or a lack of any housing);

• Financial barriers (e.g., the inability to afford medications or competing financial obligations that require patients to choose between paying one bill to the exclusion of purchasing medications), and;

• Stigma-based barriers (e.g., fears of being discriminated against or facing hostile or poor treatment from medical providers or pharmacists when seeking services).

Another potential barrier to accessing and utilizing HIV treatment is the lack of treatment options that suit the needs of pregnant women. The vast majority of PLWHA who receive treatment currently take daily oral single-pill regimens. However, a newer treatment option exists—Long-Acting Injectables (LAIs) that are delivered on either a monthly or bi-monthly (every other month) basis. Few public data are available, however, about utilization rates of these LAI regimens.

Preliminary data from a short survey of PLWHA conducted by ADAP Advocacy in 2023-2024 found that 54.7% of Black respondents would prefer to receive treatment using either a provider-administered or self-administered LAI regimen, compared to 45.3% who prefer daily pill-based regimens. While self-administered LAI treatment options are not currently available, these preliminary findings indicate that patients are clamoring for treatment options that better fit their lives and lifestyles.

Another barrier exists, however, that may prevent patients from accessing LAIs as a treatment regimen: requirements by the U.S. Food and Drug Administration that patients demonstrate both treatment adherence and a record of viral suppression before beginning treatment with an LAI.

While the statistics about viral suppression indicate that 65.9% of patients who are being treated for their HIV, those data only account for patients who are engaged in care. When looking at the estimated 1.2 million Americans living with HIV/AIDS, research indicates that just 56.8% of PLWHA have achieved viral suppression, meaning that more than 2 out of every 5 PLWHA (43.2%) would be ineligible to even begin an LAI regimen (Pinto et al., 2023). This barrier to accessing LAIs essentially means that they are currently unavailable for use as first-line treatment options.

Despite this current barrier, many advocates are working behind the scenes to change both payor and drug indication policies to make LAIs the first-line treatment options for patient populations that have been deemed “Hard-to-Reach; Hard-to-Treat,” including persons who use or inject drugs, person experiencing homelessness, and persons who live in rural areas. The lack of self-administered delivery also serves as a barrier, particularly for patients living in rural and remote areas.

While the promise of LAIs as a first-line treatment option, additional research indicates that patients would prefer long-term oral pill-based regimens over injectable medications (Graham et al., 2023). While these treatment options are currently unavailable, the desire of patients to have treatment options that are easier to take and require less time and ef

PlusInc is dedicated to research, highlighting, and developing solutions to address disparities in healthcare, and we will continue to examine the perinatal transmission of HIV.

RSV Surveillance After the Pandemic and the Growing Risks to Life in Appalachia

Respiratory Syncytial (sin-SISH-uhl) Virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the United States.

In 2022, PlusInc published summaries highlighting the disparities in the incidence and mortality rates of RSV between various regions, states, and populations. In 2024, PlusInc, in collaboration with the Appalachian Learning Initiative (APPLI, pronounced like “apply”), will be focusing on highlighting the risks that RSV poses in the 13 states, 423 counties, and 8 independent Virginia cities that make up the Appalachian Region.

In our 2022 report, we highlighted the following trends:

• The incidence of RSV in the 2020-2021 RSV season—which generally runs from early August through late July—saw record low rates of antigen test detections and polymerase chain reaction (PCR) test detections for RSV in every U.S. Census Region except for South, which includes the following states: Alabama, Arkansas, Delaware, the District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Virginia, and West Virginia. This historically low level of infections was likely the result of COVID-19-related pandemic shutdowns and the proliferation of public masking and social distancing policies.

  • The Midwest Region, which typically has the highest rates of detection out of any region, saw just 610.0 antigen test detections and 5,142.0 PCR detections.

  • By comparison, the South saw 3,220.0 antigen detections and 14,148.2 PCR detections during the same period.

    • This is likely due to the fact that many states in the Southern region began attempting to “return to normal” in 2021, after the first year of COVID-19-related shutdowns. These decisions to “normalize” were made in large part because of public and political outcries against what some believed to be “government overreach,” and were accompanied by legislative changes in many Southern states that highly limited the legal ability of state and local departments of health to enact public health protocols in response to disease outbreaks.

• The 2021-2022 season saw a resurgence of RSV across every region, with a total of 10169.1 antigen detections and 42,880.7 PCR detections, with the Midwest leading the nation with 42,880.7 PCR detections and the Northeast with the fewest, at 13,353.7.

  • The likely reason behind this increase was, again, a return to normal daily interactions and a move away from pandemic protocols.

After that initial disparities report, PlusInc continued to gather data about the disease and the following trends have occurred:

• The 2022-2023 season saw an explosion of new RSV detections across the United States, with a total of 14,129.1 antigen detections and 203,193.9 PCR detections, with the Midwest again leading the nation with 73,559.9 PCR detections, followed by the West with 67,286.2. The number of detections in the South continued to climb in that season with 36,023.3 PCR detections.

• In the 2023-2024, to date, the nation has seen 10,603.5 antigen detections and 148,382.1 PCR detections, with the Midwest again leading the nation at 48,710.6. This year, however, the South has already surpassed the 2022-2023 season, with 38,095.4 PCR detections, while both the Midwest and West regions are unlikely to reach the same levels as the year before (Centers for Disease Control and Prevention, 2024a)

So—why are these data from the South so concerning?

10 of Appalachia’s 13 states—Alabama, Georgia, Kentucky, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia—are located in this region (Figure 1).

Figure 1 – United States Census Regions

Notes: Retrieved from the Centers for Disease Control and Prevention (CDC), 2023. (https://www.cdc.gov/surveillance/nrevss/downloads/us-census-regional.pdf)

When breaking down surveillance into the 13 states, we gathered data for the 2021-2022, 2022-2023, and 2023-2024 RSV seasons. The findings are troubling for a number of reasons:

• As is the case with all diseases, the states with the higher populations are going to have higher incidence numbers both because there are more people and because there are larger population centers with tighter population density.

• Georgia, North Carolina, and Tennessee are seeing incredibly concerning trends:

  • Georgia saw a 14% increase in PCR detections from the 2021-2022 season to the 2022–2023 season, and has seen a 45.4% increase in PCR detections this season, to date, above the previous season.

  • North Carolina saw a 279.4% increase in PCR detections from the 2021-2022 season to the 2022-2023 season, and has seen another 23.8% increase in PCR detections this season, to date, above the previous season.

  • While the overall incidence of RSV detections is traditionally low in Tennessee, the state still saw a 47.6% increase from the 2021-2022 season to the 2022-2023 season, and has seen another 54.5% increase in the current season.

However…the more concerning issue with the state of Tennessee lies a bit deeper and actually extends to the state of Alabama, as well:

An unusual trend has occurred in the current RSV season, where antigen tests in both Alabama and Tennessee are showing significantly higher detection levels than PCR detections for the same period of time. Normally, the antigen detections are lower than the PCR detections because PCR testing is more definitive. Essentially, the antigen tests can only determine if you have an active virus in the body and cannot detect small amounts of the virus or asymptomatic cases as accurately as PCR testing.

When we see a trend of antigen testing results being much higher than PCR testing results, it can mean a couple of things:

1. Finalized testing data may not be finalized for those periods. This may occur early in the report stages when the individual clinics and state agencies have either not received all of the data, there are duplicate data, or other issues with the data exist, or;

2. A more concerning issue exists where patients are testing positive for RSV using rapid test but are not following up those rapid tests with definitive PCR testing. This may be the result of lacking access to facilities that provide that testing, being unable to afford additional testing, being afraid or hesitant to follow up with confirmatory testing, or simply choosing not to proceed with additional testing for whatever reason.

Another dangerous trend is emerging in West Virginia:

When looking at the 2021-2022 RSV season, infections coincided with the start of the first full year of in-person school attendance during the second year of the COVID-19 pandemic, and essentially ending shortly after the New Year going into 2022. In the 2022-2023 season, infections didn’t really start to get going until late September, again trailing off after the New Year going into 2023.

In the 2023-2024 season, however, RSV got a very late start, with infection rates not really spiking until early-November, and continuing to stay high throughout January. Across the state of West Virginia, anecdotal reports of respiratory illnesses are showing up all over social media and in school district Facebook pages. And, while the state may not have already surpassed the numbers from 2022-2023, many residents are concerned about that possibility, particularly in a state where vaccine uptake rates across all disease states are starting to see sharp declines (CDC, 2024b).

Aside from these trends, another risk is posed, particularly in Central Appalachian counties located in Kentucky, North Carolina, Tennessee, Virginia, and West Virginia: the terrible ravages that have resulted from drug addiction.

Since the mid-2000s, the rates of drug addiction and overdose deaths as a result of drug use have increased nationwide, and few regions have been more impacted than Central Appalachia. While finalized drug overdose data for 2022 have not yet been released by the CDC, West Virginia, Tennessee, and Kentucky occupied the first, third, and fifth spots for the highest rates of overdose deaths per 100,000 residents in 2021, at 90.9, 56.6, and 55.6, respectively. Unfortunately, due to changes in the CDC drug overdose reporting systems, access to previous surveillance reports and dashboards appears to have disappeared in the process of transitioning to the new systems. However, state-level reporting outside of the CDC appears to remain unchanged, which allows us to access older records.

Because these states and counties have experienced high rates of overdose deaths, as well as non-fatal overdoses and drug charge-related incarceration, the impacts of drug addiction tend to stretch far beyond the individual living with substance use issues. According to a 2020 interview with Katrina Harmon, Executive Director of the West Virginia Child Care Association, over 90% of children currently in West Virginia’s foster care system are there due to drug-related issues. However, the foster system isn’t the first choice for the Department of Child Protective Services; CPS always tries placing a child whose life has been upended by drug-related issues with a family member. This has led to a broad increase in intergenerational households, with children being raised by grandparents and great-grandparents, all of whom are particularly susceptible to RSV. These circumstances mean that children who attend school and pick up colds, flus, RSV, and other respiratory ailments then bring those illnesses home to their loved ones, which can result in entire families being all but incapacitated by disease with normally high survival rates.

These concerns are further complicated by growing reports, both scientific and anecdotal, about growing vaccine hesitancy and distrust of healthcare providers, particularly in Southern, Appalachian, and largely rural states (Vestal, 2023). While child-age vaccination rates decreased during the pandemic shutdowns and reduction of healthcare services provision, these rates have not returned to their pre-pandemic rates.

After vaccine requirements were legally instituted by federal and state governments for COVID-19, many states have begun to reexamine their own general vaccination requirements for children prior to attending schools. Prior to the pandemic, relatively few state-level bills related to vaccines were introduced. With the release of the vaccine in 2021, several states began enacting legislation preventing COVID-19 vaccine requirements, specifically, but also began looking at the possibilities of either eliminating or expanding exemptions to existing routine immunization requirements for students (Roth, 2023).

As the RSV continues, we will continue to monitor national, regional, and state-level surveillance as we work to raise attention about.

Health Disparities in Cabell & Kanawha Counties

PlusInc and the Appalachian Learning Initiative (APPLI) are working to address health disparities in Cabell and Kanawha Counties in West Virigia. Like many communities in West Virginia, both Cabell and Kanawha Counties have many health conditions afflicting its residents. Our collaborative effort pays particular interest to numerous health disparities, among them Hepatitis B, Hepatitis C, Mental Health Services, Substance Use Disorder and HIV/AIDSs. APPLI is a 501(c)(3) non-profit organization that focuses on conducting research regarding, reporting on, advocating for, and building technological solutions to address issues related to adult literacy, adult numeracy, health literacy, and access to public services in the 13-state, 423-county Appalachian Region.

-> Learn more about health disparities in Cabell County

-> Learn more about health disparities in Kanawha County

Due to the incidence rate being so low for some of these health conditions in Cabell and Kanawha Counties, county data are not broken down into demographic categories in order to protect the identities of patients. Nonetheless, it does provide a glimpse into what is happening in the Central Appalachia part of the Southern Valley, West Virginia. To achieve greater health equity, our healthcare infrastructure needs to identify the health disparities that exist in the United States, and how they can vary from one health condition or another.

More Equitable Practices Promised for Pharmaceutical Clinical Trials

In Diversity in Clinical Trials Still Lags, we discussed some of the ways in which the medical manufacturing and trial processes have failed to be inclusive of non-White patients. From drug trials to the development of diagnostic devices, companies have systemically failed to include Black, Indigenous, and other People of Color (BIPOC) patients in their testing, trials, and product development phases, which either leads to or further exacerbates existing healthcare inequities. As a follow-up to that piece, we decided to look at some of the ways in which pharmaceutical companies have promised to address issues related to the lack of diversity in the medical community and in the drug and device development processes.

One of the first things we discovered is that virtually every pharmaceutical company has made some sort of statement about increasing diversity or addressing a lack of diversity in their processes. While there wasn’t really any set “start date” to this process, these statements generally started arising around the late-2010s/early-2020s and have focused on a relatively broad spectrum of ideas and issues.

In a recent BlackDoctor.org Facebook Live panel discussion, Dr. Ted W. Love, Chair of the Biotechnology Innovation Organization (BIO – the world’s largest advocacy organization that advocates on behalf of the biotechnical industry) said, “We are losing a lot of opportunity by having clinical trials underrepresent certain groups. We don’t get the science from studying those populations—and sometimes the science could be different, and we don’t know until we study it.”

This position is one of the primary reasons why patients, providers, and advocates alike have been calling for increased diversity in clinical trials and medical device development. Right now, “…we don’t know what we don’t know,” and that leaves us with a largely and unacceptably imperfect system where medications are optimized to treat primarily White European patients when White Europeans are not, in fact, either the largest patient population or, in many cases, the patients facing the highest risks of transmission, complications, or misdiagnoses.

Dr. Love continued by saying that “…many physicians…have a negative view of even recruiting people of color in their clinical trials,” and so those patients are simply not asked to participate. In J.P. Carroll’s latest piece in Bio.News, he explains the pitfalls of failing to include a diverse patient population as a matter of practicality. When we have diverse populations in clinical trials, we get better treatment options, or we discover that some treatment options work well in certain populations but not in others, which leads us to develop treatment options that do work in the “other” patients.

Genentech, a San Francisco-based biotechnology company that works to develop and discover medicines for people with serious and life-threatening diseases, tells us that they (and we) need to “Ask Bigger Questions,” and tries to shift the narrative away from the important, yet simplistic questions we tend to ask, and toward broader questions that underpin these issues. For example, instead of asking, “Why are clinical trials so slow,” Genentech asks, “Why are clinical trials 85% White;” instead of asking, “How can we improve cancer care,” Genentech asks, “Can we improve people care?”

Genentech’s mission with this campaign is to work on addressing the underlying issues of systemic racism, a lack of direct and effective outreach into minority communities when seeking clinical trial patients, and other pressing concerns that have plagued the healthcare field since its inception.

We know that Genentech actively seeks to partner with minority-owned and -led Community-Based and Faith-Based Organizations (CBOs and FBOs, respectively) in order to better reach potential patients where they may be unable to do so on their own. Their work in the cancer space related to improving access to and utilization of genetic and genomic testing among BIPOC patients has been excellent and they have actively supported and empowered the voices of incredible organizations and advocates, such as Touch4Life and its Founder and President, Laura Crandon. Touch4Life is a Black-owned, -led, and -operated organization that focuses on increasing breast health IQ in BIPOC communities where rates and health outcomes for breast and other cancers are far worse than for their White peers. Genentech’s support of Touch4Life and Miss Crandon has allowed her organization to reach over 5,000 people in need of information and support where the existing medical and care communities have failed to have a presence.

So, we know that Genentech is, for all intents and purposes, keeping its promises. But, what about other companies?

Merck published a blog in December 2022 that laid out very specific steps they plan to take to address diversity issues in clinical trials, including:

• Implemented a new process that requires diversity plans (actionable steps) across all late-stage clinical trials.

• Prioritized selection of U.S. sites in diverse communities by using census data.

• Developed various partnerships with community organizations, colleges and universities, and professional organizations to expand outreach to people from different genders, races, ethnicities, and sexual orientations. Examples of the organizations with whom Merck is collaborating are:

  • Greenphire to help reduce financial and travel barriers for clinical trial participants globally.

  • BlackDoctor.org on its Clinical Trial Resource Center, which is an online repository of information regarding clinical trials specifically for the Black community.

  • A network of Diversity Sites in the US, including HBCUs via the Beacon of Hope, which is an initiative created by Novartis and the Novartis U.S. Foundation to create greater diversity, equity, and inclusion across the research and development ecosystem. Merck operates clinical trials through four Historically Black Medical School clinical trial Centers of Excellence as part of the initiative.

  • Association of Clinical Research Professionals (ACRP) to provide access to training for clinical research sites located in historically underrepresented communities and for community college and high school students in these communities interested in the clinical research profession (Merck, 2023, Public Statement Correspondence).

• Formed a community advisory panel this year to offer insights on overcoming research trust, trial barriers , informed consent, recruitment, and retention strategies.

• Invested in training and tools for researchers, our teams, clinicians, and others at clinical trial sites to address the need for broader clinical trial access (Merck, 2022).

These action items appear to be working, according to Merck:

Our approach is working. In 2022, approximately 50% of our clinical trial patients were from diverse backgrounds – both in the U.S. and globally.

But we need to do more. Our diversity & inclusion in clinical trials team is focused on increasing access to clinical trials in the U.S. and will expand those efforts globally (Merck, 2022).

So, Merck has demonstrated that they are going to hold themselves accountable for their promises. Another excellent start. And yet…

As we conducted outreach during the information-gathering period of writing this blog (a process that began in late May and continued through July), we found that few companies were willing to answer questions about their initiatives or provide updates on any progress they’ve made toward achieving their stated goals and commitments. Even when we made it clear that the purpose of this article was the highlight the good work being done by pharmaceutical companies, we were met with a dearth of willingness to respond to our inquiries.

That is not to say that we received no responses; rather, we found that companies tended to be reluctant to speak about their outcomes. While they provided no reasons why, we have come to believe that this may be a way to avoid being lured into speaking with a writer only to have their words twisted to portray the company or its efforts in a negative light. And, frankly, they have good reason to be concerned on that front:

All too often, we see healthcare non-profits lambasting pharmaceutical companies for their lack of diversity and inclusion efforts. No effort is ever good enough, diverse enough, or listens to the “right” people, and any efforts to engage the “right” people are often met with either skepticism or outright hostility. We see this in the HIV space, the Harm Reduction space, and other public health spaces. It seems to be a self-defeating exercise where we demand more inclusion and a seat at the table, but refuse to sit at the table with the people from whom we demanded a seat.

During our information-gathering process, we did receive a statement from the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group that represents pharmaceutical companies in the United States:

Equitable Breakthroughs in Medicine Development is a comprehensive effort to increase diversity in clinical trials and address systemic barriers to participation by communities of color. This effort seeks to help underrepresented patients be more involved in the research and development of potential life-saving medicines. Funded by a grant from PhRMA, Equitable Breakthroughs in Medicine Development works to bring together diverse communities, patients, providers, health partners, community organizations and academic institutions, along with the support of the pharmaceutical industry, to pilot a network of sustainable, connected, community-based clinical trial sites.

Both PhRMA and individual companies have efforts underway that highlight how a community-based infrastructure is critical to help enhance participation of diverse populations in clinical trials. These collective efforts take time and ongoing resources to create a sustainable approach towards tackling the systemic barriers that often stand in the way of people participating in clinical trials, particularly people from underrepresented populations in underserved communities (PhRMA, 2023, Public Statement).

This is, to some degree, part of the problem:

There are a lot of promises being made, but not a lot of transparency in the processes being used to achieve the stated goals or about the progress companies have made.

At a recent gathering in Nashville, Tennessee, a person from a pharmaceutical company not listed above posed the following question when discussing diversity in clinical trials:

“Do you want clinical trials to be fast, or are you okay with them taking three to five years?”

To that question, there seems to be only one acceptable response:

“I want medications that are proven effective for people from every racial demographic, and if a drug doesn’t work as well in Black people, I want us to find or develop one that does.”

Diversity in Clinical Trials Still Lags

In addition to age, sex, diet, underlying disease, and the concomitant use of other medications, race and genetic factors may play pivotal parts in the variability of subjects' responses to a medication. Regrettably, minority groups are underrepresented in most clinical trials. Often, there are insufficient data to assess the effectiveness or safety of new drugs in members of minority groups, especially Blacks. Concern about this issue led the National Institutes of Health and the Food and Drug Administration to establish guidelines encouraging the inclusion of more women and minority groups in clinical trials. However, it is uncertain whether these guidelines are being implemented and whether the participation of minority groups in clinical trials has increased (King, 2002).

This opening paragraph from a 2002 editorial in the New England Journal of Medicine raised the alarms over the lack of sexual, gender, and racial diversity in clinical trials and the lagging effort being put into correcting the issue over two decades ago. Regrettably, women and minority groups are still vastly underrepresented in most clinical trials in 2023—a scourge that plagues clinical testing and trials across virtually every segment of the medical industry.

A prime example of this lack of diversity exists in the world of HIV prevention:

In 2019, Gilead Sciences announced that they had received approval from the U.S. Food and Drug Administration (FDA) to prescribe Descovy (emtricitabine/tenofovir alafenamide, FTC/TAF) for use as part of a Pre-Exposure Prophylaxis (PrEP) regimen to prevent the transmission of HIV…except for use in people assigned female at birth (Gilead Sciences, 2019).

The primary advantages of using TAF in a PrEP regimen over the previously approved Truvada (tenofovir disoproxil fumarate, TDF) are that TAF is simply a better, safer drug. TAF is absorbed more quickly than TDF and produces higher levels of the active drug in cells, meaning it can be given in smaller doses, leading to lower levels of exposure to the kidneys and less bone density loss—some of the biggest concerns related to the use of TDF as PrEP which led to higher rates of drug discontinuation (Hill, et al., 2018).

And yet, despite the fact that roughly 19% of new HIV diagnoses occurred in women in 2019 (Centers for Disease Control and Prevention, 2022), Gilead Sciences fundamentally failed to successfully include women in their clinical trials to ensure that the drug was effective in “…individuals at risk from receptive vaginal sex” (Gilead Sciences). This resulted in Descovy receiving a black box warning—the strictest labeling requirement that the FDA can mandate for prescription drugs that highlights serious and sometimes life-threatening adverse drug reactions—which essentially precluded over half of the U.S. population from being prescribed the drug.

This lack of diversity isn’t unique to the field of HIV; it extends to every aspect of the medical field, from vaccines to therapeutic drugs to medical devices. This lack of inclusion of essentially anyone other than young and middle-aged men of European descent in testing and trials has created a landscape where commonly used and relied upon vaccines, therapies, and medical devices are administered to patients without any real knowledge of whether or not they are as effective—or even effectively at all—across patient demographic populations.

Another example resides in a widely accepted piece of standard medical equipment: the pulse oximeter. This easy-to-use device measures the saturation of oxygen in the blood by using a cold light source that shines a light through the fingertip, analyzes the light from the light source that passes through the finger, and determines the percentage of oxygen in the red blood cell. Unfortunately, it works poorly on people with non-white skin:

A retrospective cohort study released in the Journal of the American Medical Association Internal Medicine found that compared to white patients, “…Asian, Black, and Hispanic patients had a higher adjusted time-weighted average pulse oximetry reading and were administered significantly less supplemental oxygen for a given hemoglobin oxygen saturation compared with white patients” (Gottlieb, et al., 2022).

To put that in lay terms, non-white patients had higher readings from pulse oximeter devices than white patients because of the way that light penetrates skin tissue, and as a result, received less supplemental oxygen than white patients.

This disparity was particularly important to consider during the height of the Coronavirus 2019 (COVID-19) global pandemic when Black, Hispanic, and American Indian patients were much more likely to contract, experience worse symptoms of, be hospitalized for, and die from COVID than White patients (Tai, et al., 2022). As a respiratory disease, COVID-19 required patients to be placed on respirators in an effort to sustain and save lives, and there were (and still are) serious concerns that relying upon pulse oximetry readings resulted in minority patients receiving inadequate levels of supplement oxygen compared to white patients.

Continuing on the topic of COVID-19, minority patients were overwhelmingly underrepresented in both the Pfizer BioNTech and Moderna mRNA vaccine studies:

Across the three Pfizer trials, over 80% of participants across every age group (12-15 years, 16-25 years, and 18+ years) were white, while Black patients represented only 3-9% of participants, Asians 1-8%, American Indians/Alaska Natives (AI/AN) 0-6%, and Hispanics 3-20%.

Across the four Moderna trials, over 79% of participants across every age group were white, while Black patients represented 0-10%, Asians 1-5%, AI/AN 0-2%, and Hispanics 0-18% (Khalil, et al., 2022).

Khalil, et al., found that this lack of diversity essentially mirrors similar vaccine trials during the development of the H1N1 vaccine in 2009. After the H1N1 pandemic, much handwringing occurred across the U.S. medical establishment over the low uptake of vaccination among minority populations, particularly Black and Hispanic people. Little attention was paid at the time, though, to the vast disparity in H1N1 vaccine trials, in which 91% of participants were white (Khalil, et al.). The majority of studies published about this lack of diversity were not published until 2021 and 2022…in the wake of the COVID-19 vaccine trials.

So, how do we fix what is clearly a broken system? The answers seem simple:

As referenced in the opening paragraph of this piece, federal guidance has been in place since the 1990s “encouraging” increased recruiting of diverse patient populations, and those guidelines have been updated since that time.

• Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (FDA, 2020)

• Minority Health and Health Disparities Strategic Plan 2021–2025 (National Institutes of Health, 2021).

But time is money in the pharmaceutical and medical device industries, and most companies are simply either unwilling to invest the time, effort, and resources to recruit significantly diverse patient populations when it’s far more profitable and expedient to work with an easily accessible and willing white population that is perceived to be more compliant with the requirements of trials (and this, also, is a biased belief).

The truth is that many companies too often fall back on the beliefs that there are too many cultural barriers to overcome in order to recruit Black, Hispanic, and AI/AN patients for clinical and device trials, that it’s too costly to actively try to overcome those barriers, and that the patients are “difficult to deal with” during the process. These biases persist despite many of the scientists, themselves, involved in these trials being from racially and ethnically diverse backgrounds. Why invest these resources when you can bring a vaccine, drug, or device to market with FDA approval much faster by using the “reliable” population?

The reason they must invest is that the consequences of their failure to diversify result in the loss of human lives. When these companies fail to live up to their duty to fully test their products, minority populations pay the price. If they are not going to willingly do so, then the FDA needs to step in and institute minimum participation requirements in order to receive approval, even if that means the upheaval of existing “norms” around the approvals process.

New Faces Join Efforts to Address Health Disparities

Five amazing, dynamic, and extremely well-intentioned professionals have committed themselves to promoting health equity by joining the PlusInc Board of Directors. By lending their expertise and experience to our leadership, PlusInc has taken a giant step forward in our efforts to address health disparities.

In late 2022, PlusInc seated a trio of fabulous women — Kassy Perry, Laura Friedman, Meg Cooksey — from three very different lines of work. Kassy Perry is a force all her own. A shrewd strategic thinker with uncommon creativity, Kassy is also a smart tactician. She presently serves as the President & CEO of Perry Communications Group, , which she founded in 1996. Laura Friedman is currently a Senior Vice President, Communications and People Strategy Lead for Markets Technology at Citigroup. Prior to joining Citi, she previously served as the Associate Director of Communications at Workforce Opportunity Services (WOS), as well as the Communications and Programs Manager at Hearing Health Foundation (HHF). Mary M. “Meg” Cooksey, RN-BC, currently serves as Nurse Manager for the Division of Infectious Diseases at MedStar Georgetown University. Meg is Board-Certified in Ambulatory Care Nursing and has a special interest in ensuring equity in access to vaccines for underserved populations.

In early 2023, PlusInc seated a dynamic duo: Glen Pietrandoni and Vanessa Lathan. Glen Pietrandoni, R.Ph., AAHIVP is chief advocacy officer at Avita Care Solutions, passionate healthcare advocate, and internationally respected HIV and LGBTQ+ activist. Glen is deeply engaged in Avita's mission to advocate for health equity and the 340B Drug Pricing program. Vanessa Lathan, MPH, BSW is an HBCU-educated, unapologetic Black and communities of color-focused change agent driven to dismantle oppressive and systemic racism policies within sexual and reproductive health. Vanessa is a Senior Program Manager for the Southern HIV Impact Fund program at AIDS United.

These new faces join long-time board members, Andrew Richter and Michelle Anderson, as well as 2021-seated board members, Michael Pickering, and Jonathan J. Pena, MSW, LCSW-A. Check out our phenomenal leadership team here!

Health Disparities Portfolio Expanded to Include More Chronic Health Conditions

In 2022, PlusInc launched its national campaign to raise awareness about health disparities among marginalized communities in the United States. Health Equity can only be achieved by addressing and changing the systemic institutional and societal barriers that result in health disparities. Initially, our health disparities portfolio focused on COVID-19, Escherichia coli Pyomyositis (ExPEC), HIV/AIDS, Mental Health, Respiratory Syncytial Virus (RSV), Substance Use Disorder (opioids, stimulants), and Viral Hepatitis (HBV, HCV). Next year, we will expand our reach into seven additional chronic health conditions to complement the work we’re already doing.

In 2023, PlusInc’s expanded health disparities portfolio will include:

1. Behavioral Health

2. Cancer - Colon

3. Cancer - Melanoma

4. Cardiovascular Disease

5. Maternal Health & Mortality

6. Respiratory - Asthma

7. Respiratory - Chronic Obstructive Pulmonary Disease (COPD)

The additions represent a broad array of the health issues long plaguing marginalized communities in the United States, as well as others emerging as incident rates increase and more data becomes available on them. For example, we have known for quite some time that poor maternal health outcomes disproportionately impact communities of color. According to the U.S. Centers for Disease Control & Prevention (CDC), black mothers are three times more likely than white mothers to die from maternal health complications, and many of them avoidable with better care. Additionally, a federal study on maternal deaths yielded a very troubling statistic: most (like, 90%) maternal deaths among Indigenous mothers were preventable. More troubling is pregnant mothers are now being threatened by a new trend in the United States, namely maternity care ‘deserts’ are on the rise.

But there are other deserts impacting quality healthcare. There are significant care gaps in behavioral health. Fortunately, there is a new behavioral health data mapping tool, which could remedy the problem. Change won’t happen unless such tools are accompanied by heightened awareness, additional resources, and better community outreach. PlusInc exists to help in this effort.

Moving forward into next year, PlusInc will build upon our momentum we started this year by not only taking a deeper dive into the health disparities surrounding these chronic health conditions, but also evaluating how they’re impacting local communities.

Health Disparities in Merced & Stanislaus Counties

PlusInc and Legacy Health Endowment are working to address health disparities in Merced and Stanislaus Counties in California. Like many communities in California, both Merced and Stanislaus Counties have many health conditions afflicting its residents. Our collaborative effort pays particular interest in how COVID-19, Hepatitis B, Hepatitis C, Mental Health Services, Substance Use Disorder and HIV/AIDS are impacting our local communities. Legacy Health Endowment provides funding and technical support to create healthcare solutions and facilitate improved wellness within Stanislaus and Merced Counties.

-> Learn more about health disparities in Merced County

-> Learn more about health disparities in Stanislaus County

Due to the incidence rate being so low for some of these health conditions in Merced and Stanislaus Counties, county data are not broken down into demographic categories in order to protect the identities of patients. Nonetheless, it does provide a glimpse into what is happening in the northern San Joaquin Valley section of the Central Valley, California. To achieve greater health equity, our healthcare infrastructure needs to identify the health disparities that exist in the United States, and how they can vary from one health condition or another.

Patients Have a Stake in Health Equity, too

In recent years, “health equity” terminology has become increasingly used in the national conversation about healthcare in the United States. Health equity is often used interchangeably with another term, health disparities, although each one has its own unique meaning. According to the U.S. Centers for Disease Control & Prevention (CDC), “Health equity is when everyone has the opportunity to be as healthy as possible. Health disparities are differences in health outcomes and their causes among groups of people. Many health disparities are related to social determinants of health, the conditions in which people are born, grow, live, work and age.” (CDC, 2020) To achieve greater health equity, our healthcare infrastructure needs to identify the health disparities that exist in the United States, and how they can vary from one health condition or another.

In 2016, a multimodal survey of mayors and health commissioners was conducted by Jonathan Purtle, et al. and it yielded some interesting findings. First of all, less than half of the mayors and health commissioners contacted took the time to complete the survey — which in and of itself, is a sad indictment on how those officials prioritize public health in their respective jurisdictions. That aside, Purtle reported, “Forty-two percent of mayors and 61.1% of health commissioners strongly agreed that health disparities existed in their cities. Thirty percent of mayors and 8.0% of health commissioners believed that city policies could have little or no impact on disparities.” Not surprisingly in today’s political climate, ideology is strongly associated with opinions about disparities. (Purtle, 2018)

Maybe part of the problem is the terminology, health equity and health disparities, is not defined explicitly. Nearly a decade ago, Paula Braveman, MD, MPH warned, “Ambiguity in the definitions of these terms could lead to misdirection of resources.” Dr. Braveman outlined the why explicit definitions are needed, because “not all health differences are health disparities” (Brakeman, 2014).

Health disparities exist, as defined by Dr. Bravemen through a social justice lense, and they are getting worse. Whereas numerous organizations committed to health equity exist, none approach health disparities specific to health conditions from the patient perspective. This is why PlusInc exists.