This article was written by Prashasti Bhatnagar, JD/MPH candidate at Georgetown University Law Center/Johns Hopkins Bloomberg School of Public Health.
Hepatitis C is one of the most common blood-borne infections in the United States; about 3.5 million persons are estimated to be chronically infected with hepatitis C virus (HCV) infections in the nation. Health disparities are evident within the HCV epidemic as well, wherein the LGBT community—specifically gays, bisexuals, and men who have sex with men—are at a greater risk of being infected with HCV. Accordingly, the Department of Health and Human Services (HHS) has taken important initiatives such as the National Viral Hepatitis Action Plan 2017-2020 (“Action Plan”) to prevent new viral hepatitis infections, reduce deaths and improve the health of people living with viral hepatitis, reduce viral hepatitis health disparities, and coordinate, monitor, and report on the implementation of viral hepatitis activities. In fact, based on these goals, some states have taken unprecedented efforts to eliminate HCV infections by removing restrictions from Medicaid, which provides health insurance coverage to many HCV patients and, thus expand coverage to treatment for HCV patients. Additionally, as emphasized by the Action Plan, states have issued comprehensive elimination efforts that seek to focus on “priority populations,” who are at the most risk for HCV. Despite these important efforts, vulnerable populations such as LGBT persons and immigrants who bear the burden of the disease are left behind; many immigrants are not “qualified” to participate in Medicaid, and LGBT and immigrant populations are not identified as “priority populations” for HCV elimination purposes. In order to successfully eliminate HCV, it is important to center elimination efforts around populations such as LGBT persons and immigrants. Accordingly, this post will (1) advocate for expanding and removing restrictions from Medicaid in order to increase access to HCV treatment for patients, and (2) emphasize the role of community health centers in HCV elimination efforts as they serve as important safety-net for populations excluded from Medicaid.
EXPANDING MEDICAID & REMOVING RESTRICTIONS IS NECESSARY TO EXPAND TREATMENT EFFORTS FOR ELIMINATING HCV
Medicaid and Medicare, created out of the Social Security Amendments Act in 1965, are important programs that have played significant roles in improving access to health care for some of the most vulnerable communities. Specifically, Medicaid is a means-tested public program—eligibility for the program is linked to individual or family income. While benefits of Medicaid beneficiaries vary between states and by program, in general, Medicaid covers the following services: doctor visits, inpatient and outpatient hospital services, some mental health services, family planning services and supplies, long-term care facility services, home health care, emergency services, transportation to medical services, laboratory and X-ray services, and Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services for children and adults under the age of 21 years. As of January 2020, Medicaid is the nation’s largest insurer, responsible for providing low- or no-cost health coverage to nearly 70 million people including many individuals who are LGBT; overall, one in five Americans receive health insurance coverage through Medicaid in any given year. This importance of Medicaid services was further amplified through the signing of the Affordable Care Act (ACA) in 2010; under the ACA, state Medicaid programs had the option to expand their programs. As of April 2020, 37 states (including District of Columbia) have expanded their Medicaid programs to cover all individuals with incomes up to 138 percent of the federal poverty line. With this expansion, beneficiaries are entitled to ten essential health benefit categories as covered services: ambulatory patient services, emergency services, hospitalization, maternity and newborn care, mental health and substance use disorder services, prescription drugs, rehabilitative and habilitative services and devices, laboratory services, preventive and wellness services, and chronic disease management, and pediatric services.
Expanded Medicaid services are especially critical for LGBT people because of the high prevalence of poverty and uninsurance in LGBT communities. Research estimates that about one in five gay and bisexual men, and one in four lesbian and bisexual women are living in poverty. In general, LGBT people collectively have a poverty rate of 21.6 percent, in comparison to the rate of 15.7 percent for cisgender straight people. Among LGBT people, transgender people have especially high rates of poverty—29.4%; in fact, transgender people are four times more likely than the general population to be living below the poverty line. Lesbian (17.9 percent) and straight (17.8 percent) cisgender women have higher poverty rates than gay (12.1 percent) and straight (13.4 percent) cisgender men. Bisexual cisgender women (29.4 percent) and men (19.5 percent) report higher poverty rates than cisgender straight women and men, respectively. Additionally, 60 percent of people within the LGBT community report incomes in the Medicaid expansion range—up to 138 percent of the federal poverty line. LGBT persons are also more likely to be uninsured than their peers; one in three (34 percent) of LGBT adults ages 18 to 64 with incomes less than 400 percent of the FPL were uninsured before ACA’s expansion.
It is undisputed that negative social determinants of health such as poverty and uninsurance lead to chronic illness, thereby exacerbating existing health disparities among marginalized populations. Despite research underscoring the importance of Medicaid services especially for LGBT populations, Medicaid continues to place discriminatory restrictions on HCV treatment, which further limit access for HCV patients. For instance, several Medicaid state programs require patients to reach a certain stage of liver disease in order to be eligible for HCV treatment, bar patients with a history of alcohol or substance use, or limit the number of specialists who can prescribe a cure. About twelve states cover treatment only for people with advanced liver fibrosis, twenty states require at least six months of abstinence from drug or alcohol use, and nine states limit prescription of cure to a liver disease specialist. These restrictions are especially burdensome for LGBT populations—as discussed above, LGBT people are more likely to rely on Medicaid for their health insurance coverage. Moreover, negative social determinants of health leave LGBT populations vulnerable to a higher risk of getting infected with HCV, and high rates of alcoholism and substance abuse. In addition to having a disparate impact on LGBT individuals, these restrictions have no basis in medically accepted standard of care, or medical evidence. HCV guidelines recommend treatment for all patients with chronic HCV infection regardless of liver disease stage; research suggests that people on opioid substitution therapy and active drug users can successfully complete HCV treatment; and, primary care physicians and nurse practitioners can successfully provide hepatitis C treatment. Based on these obvious discrepancies, some states have aptly removed all restrictions from their Medicaid program in order to increase access to HCV treatments. Additionally, states are engaging in innovative payment models to make treatment accessible and affordable. For instance, states like Louisiana and Washington have rolled out a “Netflix model” for payment that will allow them to cover HCV treatments at no cost for beneficiaries. Under this model, the state is set to pay an annual fee for access to an unlimited supply of the company’s genetic hepatitis C medication over a period of five years.
Therefore, eliminating restrictions on Medicaid for HCV treatments, in addition to expanding coverage will increase access for LGBT patients, who bear the burden of the disease.
COMMUNITY HEALTH CLINICS CAN PLAY AN IMPORTANT ROLE IN PROVIDING TREATMENT TO HCV PATIENTS WHO ARE NOT ELIGIBLE FOR MEDICAID THROUGH THE 340B PROGRAM
Even though expanding Medicaid in addition to lifting restrictions on HCV treatments is critical for increasing access to HCV treatment and elimination, especially for LGBT people, it still leaves behind vulnerable populations such as immigrants. This is because, in general, lawfully present immigrants must have a “qualified” immigration status in order to be eligible for Medicaid; immigrants must wait for five years after obtaining their qualified status before they can be Medicaid-eligible. The 1996 welfare laws define who is considered to be a qualified immigrant—this exhaustive list includes: lawful permanent residents; refugees, people granted asylum or withholding of deportation/removal, and conditional entrants; people granted parole by the Department of Homeland Security for a period of at least one year; Cuban and Haitian entrants; certain abused immigrants, their children, and/or their parents; and certain survivors of trafficking. All other immigrants, including undocumented immigrants are “not qualified” and thus, barred from participating in Medicaid. It is estimated that at least 267,000 undocumented immigrants identify as LGBT.
Accordingly, immigrants like many other marginalized communities who lack insurance turn to community health centers (CHCs) for their care, who act as safety-nets for such populations. Federally-funded CHCs serve a large and diverse patient population—more than 25.9 million children and adults (one in twelve people) in over 10,400 urban and rural locations. Because of their positionality in medically underserved communities, over nine in ten CHC patients reported an income at or below 200% of the federal poverty level, and nearly six in ten CHC patients were from racial or ethnic minority groups. CHCs provide a range of services to meet their patients’ needs such as primary health care, specialty care, behavioral health, outreach and community services, patient support services, among other services.
CHCs are also eligible to participate in the 340B Drug Pricing Program (“340B Program”), which allows them to reduce the price of outpatient pharmaceuticals for patients, and consequently, expand health services to the patients and communities they serve. The 340B Program rises out of Section 340B of the Public Health Service Act; under this Act, pharmaceutical manufacturers participating in Medicaid are required to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients. Other than CHCs, health care organizations such as children’s hospitals, hemophilia treatment centers, critical access hospitals (CAHs), sole community hospitals (SCHs), rural referral centers (RRCs), and public and nonprofit disproportionate share hospitals (DSH) that serve low-income and indigent populations are also eligible to participate in the 340B Program.
The 340B Program can play a unique role in addressing HCV infections; 340B entities such as CHCs and hospitals are able to provide liver assessments and education, chronic liver and biliary disease management, liver medication management, and disease treatment through the discounted pricing and saving. Some research has indicated that 340B program savings can be used to increase access for HCV medications. For instance, Boston Medical Center, which is the largest safety-net hospital in New England, used their $40 million savings gained through the 340B program to establish a primary-care based multidisciplinary HCV treatment program. Through these 340B savings, BMC saved $930 per patient and successfully achieved the gold standard for HCV care, that is, 97 percent of patients showed no signs of HCV in their blood three months after completing treatment. The 340B program savings were critical in the operation of this HCV program; researchers estimated that without these discounts, BMC’s HCV treatment program would have produced a net loss of $370 per patient, thereby making it impossible for the program to last. Similarly, New York Department of Health established a HCV Treatment Network pursuant to their goal of elimination HCV through Project INSPIRE NYC, wherein they used the 340B Program to increase access to HCV drugs. At Mount Sinai and Montefiore hospitals, HCV drugs were purchased at 340B prices, and the savings were applied to providing additional resources for providing care to patients.
Therefore, based on these successful treatment models, CHCs can invest their 340B Program savings into creating a modified HCV treatment program to increase access to HCV treatment for marginalized communities.
All of these elimination plans whether national or state-led fail to identify key vulnerable populations such as LGBT persons and immigrants in the “priority populations” despite the prevalence of HCV infections within these communities. In order to successfully eliminate HCV, it is important to center elimination efforts around populations who bear the burden of the disease. This includes expanding and removing restrictions from Medicaid in order to increase access to HCV treatment for patients, and exploring the role of community health centers in HCV elimination efforts as they serve as important safety-net for populations excluded from Medicaid.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.