Thursday, October 31, 2024

Putting Politics Ahead of Public Health is Spelling Trouble for Tennessee

By: Ranier Simons, ADAP Blog Guest Contributor

In 2023, Tennessee Governor Bill Lee, rejected nine million dollars in federal HIV funding from the Centers for Disease Control & Prevention (CDC). This meant that the pass-through grant contracts associated with the Integrated HIV Programs for Health Departments to Support Ending the Epidemic in the United States CDC-RFA-PS20-2010 grant and the Tennessee Integrated HIV Surveillance and Prevention Programs for Health Departments CDC-RFA-PS18-1802 grant ended in May of 2023.[1] The decision meant a significant cut in funding for HIV prevention, education, and treatment for public health centers and many community-based organizations. The adverse effects of the decision are materializing, and experts continue to sound the alarm about how devastating the outcomes will impact the state.

Memphis ranked #2 in the nation for new HIV cases
Photo Source: The Tennessee Conservative

The governor stated he refused the funds to decrease dependence on federal funds and be more independent as a state. He also expressed that the move was to make it easier for organizations and public health departments to access funding without having to deal with bureaucratic red tape.[2] However, analysis shows that the decision was politically motivated. Lee is on public record expressing disapproval of two organizations that were HIV grant recipients, Planned Parenthood and a task force on transgender health issues.[3] Refusing CDC funding means that the state is no longer required to distribute funding based on science, evidence-based data, and research. The goal of the state was to replace the CDC funds with state funding.

In response to Tennessee’s refusal of funding, the CDC decided to try and circumvent the legislature. It decided to directly provide four million dollars in funding to United Way of Greater Nashville.[4] This would allow United Way to distribute funds to nonprofit organizations, such as Planned Parenthood, to continue their HIV prevention efforts. However, four million dollars is only half of the nine million dollars refused.

When the state government replaced the lost CDC funding with state funding, it was mainly local health departments that were guaranteed funding to make up for the cuts.[4] This meant the state health departments could make decisions concerning funding distribution that did not require alignment with CDC requirements. This was eventually followed by an announcement to reallocate funding away from the most at-risk priority communities, such as men who have sex with men, to new groups. The new groups are first responders, pregnant women, and survivors of sex trafficking. Studies are showing that this will result in unnecessary deaths and poor health outcomes because this group is not where the need resides.

Clinical Infectious Diseases
Photo Source: Clinical Infectious Diseases

A study published in July of this year in the journal Clinical Infectious Diseases spells out the negative ramifications of Tennessee’s state resource allocation. Men who have sex with men, transgender women, and heterosexual Black women are the evidenced-based identified priority demographic most affected by HIV in Tennessee.[5] The study projected conservative estimates the Tennessee decision would mean 166 preventable HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. The study’s more pessimistic or worst-case scenario projections were 1359 preventable HIV transmissions, 712 additional deaths, and 2,778 life-years lost over 10 years.[5] 

Comparatively, this means the reallocation in funding would be prohibitively damaging to the original priority group with negligible benefit for the new priority pivot. “Under Reallocation, MSM would comprise most of the HIV transmissions (77%), followed by TGW (8.6%) and HSBW (6.8%). First responders would contribute 0.5%, pregnant people 0.2%, and SST 6.9% to the total HIV transmissions over 10 years.”[5] The newly suggested priority populations only comprise %1 of all Tennesseans living with HIV compared to the CDC-defined priority populations, which comprise %99 percent.[6]

Funding losses have already begun to negatively affect agencies serving vulnerable populations. Before the change, CDC grant money provided stability for HIV programming for five years at a time. The new state-provided funds happen on a one-year cycle. The one-year budget rides on the auspices of the state legislature, which votes on it each year.[7] Reduced funding means loss of staff for many organizations. According to Amna Osman, CEO of Nashville CARES, “There’s no sustainable grant funding to support these positions…Employees really want some stability.”[7]

Moreover, the new funding plan routes money mainly to metro state health departments and groups associated with them. This translates into a drastic cut to resources for those in rural areas in addition to groups who, under the new reallocation priorities, would not be able to garner funding from the state. 

Nashville CARES mobile HIV testing van
Photo Source: The New York Times

The motivation behind the original CDC funding was to concentrate efforts on HIV prevention, education, and treatment for those most in need in Tennessee. Prevention requires testing, surveillance, access to PrEP, and more. Before the funding reallocation, a third of those most in need of PrEP did not know where they could access it. Now, issues of access have worsened. Osman states she has heard from community members who say, “Well, I’m hearing there’s no dollars for prevention education for HIV. Then, that means ‘I think there’s no money for me to get a service,”[7] Memphis, Tennessee is second in the nation regarding the rate of new HIV cases. Over 7,500 people in Shelby County alone are living with HIV or AIDS.[8] That number is second only to Miami, Florida.[8]

HIV prevention and testing is not just about HIV. Testing involves STI testing. STI testing benefits the entire community as a public health safeguard as well as a tool in the fight to prevent HIV transmission. People living with HIV do not live in a vacuum, nor do those living with STIs. Effectively focusing funding and infrastructure on the populations that science and health professionals have identified as significantly at risk is the only way to reverse the tide in all of Tennessee’s communities. Only time will tell if voting and continued public and professional outcry, in combination with pressure from the medical community, will result in the legislature changing its course.

[1] Talley, P. (2023, January 17). Dear Colleagues Letter. Retrieved from https://wpln.org/wp-content/uploads/sites/7/2023/01/Notification-HIV-Funding-Changes.pdf

[2] Stillman, J. (2023, April 22). Tennessee Rejected HIV Funds From Feds, But The State Was Just Outsmarted. Retrieved from https://www.hivplusmag.com/politics/tennessee-rejected-hiv-funds-from-feds-but-the-state-was-just-outsmarted

[3] Cha, A., Nirallil, F. (2023, Januery 26). HIV at center of latest culture war after Tennessee rejects federal funds. Retrieved from https://www.washingtonpost.com/health/2023/01/26/tennessee-federal-hiv-funding/

[4] Watts, M. (2023, April 17). Federal HIV funding rerouted to nonprofits, bypasses Tennessee health department entirely. Retrieved from https://www.tennessean.com/story/news/local/2023/04/17/hiv-federal-funds-will-reroute-to-tennessee-nonprofits-state-cut-out/70116510007/

[5] Borre, E. D., Ahonkhai, A. A., Chi, K. K., Osman, A., Thayer, K., Person, A. K., Weddle, A., Flanagan, C. F., Pettit, A. C., Closs, D., Cotton, M., Agwu, A. L., Cespedes, M. S., Ciaranello, A. L., Gonsalves, G., Hyle, E. P., Paltiel, A. D., Freedberg, K. A., & Neilan, A. M. (2024). Projecting the potential clinical and economic impact of human immunodeficiency virus prevention resource reallocation in Tennessee. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae243

[6] Ridings, M. (2024, July 11). Study Finds That Tennessee’s Shift in HIV Prevention Funding Will Lead to Poorer Health Outcomes for its Residents. Retrieved from https://www.massgeneral.org/news/press-release/tennessee-shift-in-hiv-policy-will-lead-to-poorer-outcomes

[7] Sweeney, C. (2024, October 22). Tennessee replaced its federal HIV funding with state money. Public health experts say the change is causing damage. Retrieved from https://www.wkms.org/health/2024-10-22/tennessee-replaced-its-federal-hiv-funding-with-state-money-public-health-experts-say-the-change-is-causing-damage

[8] Paul, A. (2024, August 13). Memphis ranks second in the nation in highest number of new HIV cases. Retrieved from https://wreg.com/news/memphis-ranks-second-in-the-nation-in-highest-number-of-new-hiv-cases/l

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Thursday, October 24, 2024

Kidney Transplants Between Donors and Recipients with HIV is Safe; Study

By: Ranier Simons, ADAP Blog Guest Contributor

Every eight minutes, a person is added to the U.S. organ transplant waiting list.[1] Although names are added and removed daily, as of October 21st, there are 104,360 candidates on the list.[2] Daily, around seventeen people die waiting for an organ.[1] The organ transplantation landscape for people who are HIV-positive is more dire because they face a higher likelihood of dying while on the waitlist in addition to lesser access to transplants than those living without HIV.[3] This is why the resulting conclusion of a study published last week in The New England Journal of Medicine is promising news. The study data proved that kidney transplantation between donors and recipients with HIV is safe.[4]

Cartoon hands holding organs
Photo Source: The Bioethics Project

Prior to 2013, using organs from HIV-positive donors was prohibited, even If the recipient was also living with HIV. In November of 2013, the HIV Organ Policy Equity Act (HOPE Act) was passed. Its implementation began in November of 2015.[5] The HOPE Act allowed the utilization of organs from HIV-positive donors for transplantation into HIV-positive recipients for research purposes. The goal was to gather data on the safety, efficacy, and feasibility of those transplants. These types of transplants are only allowed at approved facilities observing specific research protocols developed by the National Institutes of Health (NIH).[5] The guidelines specify clinical and safety guidelines as well as study team experience and facility prerequisites.[5] The initial 2015 policy permitted kidney and liver transplants, and in 2020, it was updated to allow the utilization of all organs.

As of November 2022, 358 organs have been successfully transplanted under the HOPE Act. The organs were retrieved from a mixture of live and deceased donors. The recent study published in The New England Journal of Medicine, led by Dr. Christine Durand, is significant because it is the first of its kind to statistically prove that kidney transplantation from HIV-positive donors to HIV-positive recipients is non-inferior to transplantation from donors without HIV.[4] A non-inferior study aims to prove that one treatment is just as good as another and is not worse than what it is being compared to by a pre-determined amount. 

The study is an observational study of 198 candidates where 99 people received a kidney from an HIV-positive donor and 99 received one from a donor without HIV.[4] Its purpose was to measure the non-inferiority of the transplants as well as the risks of HIV breakthrough infection, HIV superinfection, and post-transplantation complications.[4] The primary outcome measure was a safety event defined as a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment, or opportunistic infection.[4] The primary outcome is the one investigators of a study consider the most important to measure. The adjusted hazard ratio for the composite primary outcome was 1.00.[4] The adjusted hazard ratio is a measure of the frequency of an event occurrence in one group compared to another. An adjusted hazard ratio of 1.00 means that occurrences or risks are the same. 

Other secondary outcomes were also similar. Regardless of the HIV status of the donor, overall survival at one year was 94% vs. 95%, survival at 3 years was 85% vs. 87%, and survival without graft loss after one year was 93% vs. 90%.[4] HIV breakthrough infection was higher among the recipients of organs from HIV-positive donors. However, that outcome was attributed to medication non-adherence and was corrected with proper medication administration. The reversion from undetectable status was not enduring. 

Additionally, organ rejection rates are lower with more modern HIV antiretroviral medications. They have fewer adverse interactions with transplantation-required immunosuppressive drugs than older HIV medications. Previous positive outcomes from studies in South Africa were the evidence used to support the idea of kidney transplantation between HIV-positive donors and recipients as a viable option. HIV-positive patients on dialysis have a higher risk of death and less access to kidney transplantation. Due to health conditions, HIV-positive patients waiting for kidneys have lower odds of remaining active on the waiting list as well as a lower likelihood of living donor kidney transplantation.[6]

The Durand study supports expanding the availability of these types of transplants. Dr. Durand states, “allowing transplant centers to do these transplants as clinical care, outside of HOPE Act studies, will broaden the impact of this life-saving therapy.”[7] Presently, there are about 30 centers that allow HOPE Act transplants compared to a total of over 250 transplant centers nationwide.[7] Furthermore, a 2023 study showed that the wait time for an HIV-positive kidney was 10.8 months compared to 60.8 months for a non-HOPE Act transplant.[8]

Back-to-back HIV organ donor graphic
Photo Source: Clinical Advisor

Based on research such as this study, the Biden Administration proposed a new rule in September 2024, entitled: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act.[9] The proposed rule, if approved, will expand the number of centers eligible to offer transplantation between HIV-positive donors and recipients. It removes the clinical research and institutional review board requirements currently under the HOPE Act, specifically for kidney and liver transplants.[9] This is because those two organs are the only two with an abundance of data supporting their usage. The NIH also plans to put together a group to study the criteria for other organs under the HOPE Act with the goal of strengthening data on the utilization of other organs besides kidneys and livers. HHS stated in their press release that “HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV.”[9]

People living with HIV/AIDS face multiple barriers to achieving health equity. In synergy with evidence-based policy responses such as the Biden-Harris proposed rule change, studies such as these are steps towards judicious improvements of the status quo. Increasing the availability of organs from HIV-positive donors not only increases the available organ pool for HIV-positive candidates but potentially increases the availability of organs for transplant candidates without HIV from donors who are not HIV-positive.

[1] Health Resources and Services Administration. (2024, October). Organ Donation Statistics. Retrieved from https://www.organdonor.gov/learn/organ-donation-statistics 

[2] Organ Procurement and Transplantation Network. (2024, October 21). National Data. Retrieved from https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/#

[3] National Institutes of Health. (2024, October 16). Kidney transplantation between donors and recipients with HIV is safe. Retrieved from https://www.nih.gov/news-events/news-releases/kidney-transplantation-between-donors-recipients-hiv-safe#:~:text=Kidney%20transplants%20offer%20a%20survival,transplants%20than%20people%20without%20HIV.

[4] Durand, C. M., Massie, A., Florman, S., Liang, T., Rana, M. M., Friedman-Moraco, R., Gilbert, A., Stock, P., Mehta, S. A., Mehta, S., Stosor, V., Pereira, M. R., Morris, M. I., Hand, J., Aslam, S., Malinis, M., Haidar, G., Small, C. B., Santos, C. A. Q., … Segev, D. L. (2024). Safety of kidney transplantation from donors with HIV. New England Journal of Medicine, 391(15), 1390–1401. https://doi.org/10.1056/nejmoa2403733

[5] Organ Procurement and Transplantation Network. (2020, April). HOPE Act. Retrieved from https://optn.transplant.hrsa.gov/professionals/by-topic/hope-act/

[6] Locke, J. E., Mehta, S., Sawinski, D., Gustafson, S., Shelton, B. A., Reed, R. D., MacLennan, P., Bolch, C., Durand, C., Massie, A., Mannon, R. B., Gaston, R., Saag, M., Overton, T., & Segev, D. L. (2017). Access to Kidney Transplantation among HIV-Infected Waitlist Candidates. Clinical Journal of the American Society of Nephrology: CJASN, 12(3), 467–475. https://doi.org/10.2215/CJN.07460716

[7] Melville, N. (2024, October 17). HIV-Positive Donors Safe for Kidney Transplants. Retrieved from https://www.medscape.com/viewarticle/hiv-positive-donors-safe-kidney-transplants-2024a1000izf?form=fpf

[8] Motter, J. D., Hussain, S., Brown, D. M., Florman, S., Rana, M. M., Friedman-Moraco, R., Gilbert, A. J., Stock, P., Mehta, S., Mehta, S. A., Stosor, V., Elias, N., Pereira, M. R., Haidar, G., Malinis, M., Morris, M. I., Hand, J., Aslam, S., Schaenman, J. M., . . . Durand, C. M. (2023). Wait time advantage for transplant candidates with HIV who accept kidneys from donors with HIV under the HOPE Act. Transplantation. https://doi.org/10.1097/tp.0000000000004857

[9] U.S. Department of Health and Human Services. (2024, September 12). Biden-Harris Administration Issues Proposed Rule to Expand Access to Life-Saving Organs for People with HIV. Retrieved from https://www.hhs.gov/about/news/2024/09/12/biden-harris-administration-issues-proposed-rule-expand-access-life-saving-organs-people-hiv.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, October 17, 2024

Biden Sides with Insurers, Shifting More Costs to Patients

By: Ranier Simons, ADAP Blog Guest Contributor

The high cost of healthcare is the product of a complex, fragmented financing system. The machinations of multiple public and private payors coupled with the advent of middlemen, such as pharmacy benefit managers, in the healthcare expenditure landscape often hinder the development of common sense solutions. This is especially true in the present discourse surrounding 340B Drug Pricing Program, Prescription Drug Affordability Boards (PDABs), and Alternative Funding Programs, which are all intertwined around 'controlling' prescription drug costs. At the center of the medical, fiscal maelstrom is the patient. Rising medical debt has a crushing impact on many aspects of patients’ lives and healthcare outcomes. Potential solutions come and go. Unfortunately, one remedy to alleviate patient costs recently failed. The Biden Administration fell short of instituting promised regulations surrounding patient protections against insurers abusing copay assistance programs.[1]

CMS Proposed Rule
Photo Source: Lifepoint Health

The 2026 Notice of Benefit and Payment Parameters (NBPP) proposed rule was posted to the Federal Register on October 10th.[1] This rule addresses many things, including the operations of insurance plans. The executive summary states explicitly, “Our goal with these proposed requirements is providing quality, affordable coverage to consumers while minimizing administrative burden and ensuring program integrity. The changes proposed in this rule are also intended to help advance health equity, mitigate health disparities, and alleviate discrimination.”[1] However, the proposed rule lacks promised provisions that would have closed essential health benefits loopholes and shielded patients from adverse cost-sharing activities by insurers. In the NBPP, insurers won and patients lost.

This is a fight that many advocates felt had already been won, thanks to the combined efforts of the HIV+Hepatitis Policy Institute, Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition. In September of 2023, a federal court struck down a previous federal rule issued under the Trump Administration that allowed insurance companies to use copay accumulators and maximizers, which allowed them to take advantage of manufacturer copay assistance programs to the detriment of patients.[2] This ruling meant that insurers had to follow previous 2020 federal guidelines that prohibited the usage of copay accumulator practices except with regard to brand name drugs that have generic equivalents if allowed by state law.[3]

The court remanded authority back to the U.S. Department of Health & Human Services (HHS), meaning the federal government needed to issue new regulations. The government previously in November 2023 stated in a brief that it would issue new rules directly addressing the prohibition of copay accumulator practices.[4] Yet, it has not, and the 2026 NBPP does not do that. As of January 2024, 19 states have passed legislation that bans or restricts accumulators in individual or small-group health plans.[5] That leaves patients in many states unprotected without federal regulation that explicitly bans copay accumulator practices. Without protection, patients are still victim to insurers using copay accumulators, maximizers, and even alternative funding programs.

The 2026 NBPP also does not include a provision to close an essential health benefits loophole insurers, and PBMs are taking advantage of it. Essential health benefits (EHB) are categories of services the Affordable Care Act (ACA) states insurance plans must cover.[6] One of those categories is prescription drugs. The ACA provides cost-sharing limits on EHBs. What is happening is that PBMs are investigating which drugs have high-cost thresholds or those for which manufacturer copay assistance programs are available. They subsequently identify those drugs as ‘non-essential health benefit’ drugs, removing their shield of protection. That designation enables them to siphon all of the manufacturer copay assistance funds to themselves without applying it to patients' deductibles and other cost-sharing. A 2025 NBPP rule closed this loophole for individual and small group markets but is still open for large group and self-funded plans. The 2026 NBPP does not bring the federal government’s promise to close the loophole to fruition.

Patient at Rx Counter unable to pay for her medications
Photo Source: Chronic Disease Coalition

Copay accumulators, maximizers, and alternative funding programs increase patients’ financial burden while lowering costs and increasing profits for insurance plan sponsors and other vendors. Copay accumulators accept manufacturer copay assistance funds up to the limits of patients’ insurance deductibles while not counting it towards patients’ out-of-pocket contributions towards their deductible.[5] Adam J. Fein, Ph.D. with the Drug Channels Institute, summarized, "Benefit designs have been shifting drug costs to patients, some of whom are now responsible for a much greater share of their prescription costs. These out-of-pocket expenses can be quite high, especially for more expensive specialty drugs when patients face coinsurance amounts and payment in the deductible coverage phase."[5] Thus, patients still have to meet their out-of-pocket contributions even after they have already been met by the copay assistance program. The insurance plan is effectively being paid twice, known as ‘double dipping.’

Copay maximizers are more nefarious because they drain a disproportionate share of manufacturer assistance funding.[5] Here, the plans set a patient’s out-of-pocket obligation to match the maximum value of support the copay assistance program provides. Thus, even if a deductible is $5,000, a patient’s out-of-pocket obligation could be set to $20,000 if that was the maximum use case of a particular copay assistance program. Patients incur very low out-of-pocket costs, but funding that could be stretched to help more patients is drained into industry coffers.

Alternative funding programs are the newest development in violating patient protections. Here, plans eliminate coverage entirely for specialty or costly drugs, thus leaving patients with the plans effectively uninsured.[5] Then, the patients are made to apply for patient assistance programs, which pay the entire list price for the drug. Patients incur minimal costs. However, plan sponsors and other vendors are paid the entire list cost value, which reduces their plan expenses but is a significant and improper financial depletion of assistance funds.[5] Additionally, there are delays involved in patients applying for these programs, and some are denied. Delays and denials are unnecessary barriers to patient access to medication that should be essential health benefits.

Medical debt
Photo Source: First Federal Credit Control

Since the EHB loophole remains open for large group and self-funded plans, masses of patients are left unprotected. It is not enough for the federal government to acknowledge a problem. Effective remedy requires acknowledgment of a problem, specific delineation of a solution, followed by enforcement of the solution. It is likely this loophole will only exacerbate the growing problem with medical debt.

Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, encapsulates the situation perfectly, stating, “Every day these rules are delayed is another day that insurers and PBMs are pocketing billions of dollars meant for patients who are struggling to afford their drugs. Coming from an administration that prides itself on supporting patients and lowering their prescription drug costs, this is a huge disappointment. While they have gone on record that they will issue these rules, the clock is ticking, and there isn’t much time left.”[7]

[1] National Archives and Records Administration. (2024, October 10). Proposed Rule: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program. Retrieved from https://www.federalregister.gov/documents/2024/10/10/2024-23103/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2026-and

[2] United States District Court. (2023, September 29). Memorandum Opinion. Retrieved from https://hivhep.org/wp-content/uploads/2023/09/HIV-Hepatitis-Policy-Institute-v.-HHS-DDC-opinion.pdf

[3] HIV+Hepatitis Policy Institute. (2023, October 2). Court Strikes Down HHS Rule that Allowed Insurers to Not Count Copay Assistance. Retrieved from https://hivhep.org/wp-content/uploads/2023/10/copay-accumulator-court-decision-press-release-10.2.23.pdf

[4] United States District Court. (2023, November 27). Defendant's Conditional Motion to Clarify Scope of Court's Order. Retrieved from https://hivhep.org/wp-content/uploads/2023/11/govt-clarification-request.pdf

[5] Fein, A. (2024, February 14). Copay Accumulator and Maximizer Update: Adoption Expands as Legal Barriers Grow. Retrieved from https://www.drugchannels.net/2024/02/copay-accumulator-and-maximizer-update.html

[6] HealthCare.Gov. (2024). Essential Health Benefits. Retrieved from https://www.healthcare.gov/glossary/essential-health-benefits/#:~:text=A%20set%20of%2010%20categories,offers%20when%20you%20compare%20plans

[7] HIV+Hepatitis Policy Institute. (2024, October 4). Biden-Harris Administration Sides with Insurers & Fails to Take Steps to Lower Patient Costs for Prescription Drugs. Retrieved from https://hivhep.org/press-releases/biden-harris-administration-sides-with-insurers-fails-to-take-steps-to-lower-patient-costs-for-prescription-drugs/

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Thursday, October 10, 2024

Are Nonprofit Hospitals' Community Benefit Tax Breaks Truly Serving Communities in Need?

By: Ranier Simons, ADAP Blog Guest Contributor

Nonprofit hospitals are supposed to be primarily focused on the communities they serve. They exist, in theory, to provide quality, equitable access to care for all, regardless of the ability to pay. The mission should be community service and improving the healthcare outcomes and well-being of their communities. Unlike for-profit hospitals, which concentrate on generating profits for private shareholders or owners, nonprofit hospitals are mandated to use their profits to invest in the community. Unfortunately, data shows that many nonprofit hospitals are not fiscally operating to properly benefit their communities despite the significant tax exemptions they are afforded, referred to as community benefits. In fact, some nonprofit hospital systems are exploiting their tax incentives and adding to patient and community medical debt. As such, many stakeholders and policymakers are increasingly scrutinizing nonprofit hospitals' tax-exempt status.

Cash on a table with medical symbol paper weight on it
Photo Source: Third Way

Over half of the hospitals in the United State are designated by the Internal Revenue Service (IRS) as nonprofit.[1] According to the American Hospital Association (AHA), there are approximately 6,120 hospitals in the United States, with 2,987 of them categorized as nongovernment not-for-profit community hospitals.[2] The nonprofit designation means the entities are tax-exempt from most federal, state, and local taxes. A recent study conducted by researchers at Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Carey Business School, and Texas Christian University found that in 2021, nonprofit hospitals received $37.1 billion in tax benefits.[3] Over the next decade, estimates indicate that the federal revenue lost from nonprofit tax breaks will be approximately $260 billion.[1] The significant tax deductions should spawn considerable community benefits. Nevertheless, the reality paints a different picture.

In turn, for the designation as a charitable non-hospital, these entities are required to use the funding generated from the tax breaks to provide for the needs of the patients served. This help is referred to as community benefit obligations. These obligations can be fulfilled with endeavors such as health education programs, community health improvement initiatives, charity care, and financial assistance programs.[1] Unfortunately, data shows that many nonprofit hospitals are not adequately fulfilling their community benefit requirements and, in some cases, operate like for-profit institutions. In some cases, they even fall short of the level of community benefit given by for-profit institutions. 

One of the most quantifiable and identifiable metrics of community benefit is charity care. Charity care is defined as providing free or significantly discounted medical care for patients who cannot afford it. Many patients who face medical affordability challenges are significantly impacted by emergency room or inpatient hospitalization expenses.[4] Both uninsured/underinsured and insured patients present a need for charity care. 

There is a growing chorus amongst stakeholders invested in improving public health calling for reforms to the lucrative 340B Drug Pricing Program, which was initially designed to "stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services." According to a recent report by IQVIA, the 340B Program ballooned to $124B in 2023, yet another report found 85% of disproportionate share hospitals (DSH) earn more in 340B profit than they spend on charity care. The special interests fighting 340B reform claim clear guidelines already exist for community benefit requirements. 

The IRS first issued guidance for hospitals designated as 501(c)(3) nonprofit entities regarding the specific charity care requirement in 1956.[1] This was before Medicare and Medicaid when there was a dire need for a means to help those in need. It directly specified that nonprofit hospitals could not deny care to those who couldn’t pay if they wanted to maintain their nonprofit status. After the advent of Medicare and Medicaid, the IRS pivoted to the community benefits standard concept of required activity in 1969.[5] This broader definition is part of the present dilemma with qualifying the community help nonprofit hospitals provide.

Whether specifically charity care or community benefit, data shows that most nonprofit hospitals are not adequately utilizing their savings from tax-exempt status to reinvest in the community. According to a March 2024 policy brief issued by the nonpartisan Lown Institute, in 2021, “about 80% of [nonprofit] hospitals spent less on meaningful community investment compared to the value of their tax breaks.”[6] For charity care specifically, in 2018, Johns Hopkins University research data showed that overall, nonprofit hospitals provided charity care valued at only 2.3% of their total operating expenses compared to the valuation of their tax exemption, which was 4.3% of total operating expenses.[7] A 2023 United States Senate HELP Committee report indicated similarly trending 2021 data. The report examined 16 major nonprofit hospital chains, all of which had more than $3 billion in annual revenue. Twelve of the 16 allotted less than two percent of their total revenue to charity care, with six of those twelve allotting less than one percent.[8]

In contrast to most nonprofit hospitals with poor levels of tax break investment, the Lown Institute identified a few positive anomalies for the 2021 fiscal year. Data was taken from information on IRS Form 990. Ten hospitals and ten hospital systems were identified as having community investments that exceeded their tax breaks.[9] The analysis was based on metrics deemed to have a “direct and meaningful impact on community health.”[9] These metrics included financial assistance, community health improvement services, cash and in-kind contributions, community-building activities, and subsidized health services.[9] 

Lakeland (Fla.) Regional Medical Center and Summit Healthcare Regional Medical Center (Show Low, Ariz.) topped the hospital list with high community investment spending at $194 million and $159 million, respectively.[9] Hackensack Meridian Health (Edison, N.J.) and Nebraska Medicine (Omaha) topped the health system list at $358 million and $119 million, respectively.[9] It is unusual for nonprofit entities to have community investments that exceed their tax exemptions. Usually, for-profit entities would have more of an incentive to have high levels of charity expenditures as for-profit entities can write them off to lower their tax burden, unlike nonprofits.

Photo Source: Health Affairs

The actions of nonprofit hospitals that do not adequately satisfy their charity care and community benefit are damaging in multiple ways. Some of the bad actors have low levels of revenue spent on charity care yet aggressively pursue bills of patients who cannot afford their needed care. Nonprofit hospitals have sold patient debts to for-profit collection agencies, garnished wages, put liens on property, and even denied non-emergent care to low-income individuals with insurmountable medical debt.[10] This is in bad faith and not in the community's best interests when there is ample revenue from the tax-exemption profit that can and should be used for charity care. Data shows that many low-income patients who are victims of aggressive debt collection practices are eligible for free and discounted care. Despite the protections put in place by the Affordable Care Act (ACA), many nonprofit hospitals make it difficult for patients to find out they are eligible for charity care, in addition to making the process challenging to navigate.[8]

Some nonprofit hospitals operate more like for-profit entities, especially regarding acquisition. Nonprofit hospitals have merged, acquired for-profit hospitals and insurers, and even opened for-profit businesses in other countries.[11] Several nonprofit hospitals with low percentages of revenue spent on charity care also have high CEO compensation. For example, in 2021, Allina Health System in Minneapolis, Minnesota, paid its CEO a salary equal to 21% of the total charity care provided by the entire hospital system.[8] New York Presbyterian Hospital paid its CEO $10.9 million while only allotting $68.5 million in charity care when the total 2021 hospital system revenue was almost $10 billion.[8]

Reform is needed to ensure nonprofit hospitals operate in the manner for which they were intended. Reforms suggested by the Committee for a Responsible Federal Budget include transparency and refining reporting, clearly delineating what community benefit means, and setting minimum community benefit spending levels.[8] The form entities use to report their community benefit activities is IRS Form 990 Schedule H. That form needs to be revised to require nonprofit hospitals to give significantly more details of categories and amounts of community benefit spending.[8] Moreover, rules should be updated to require reporting at the facility level, not the health system parent organization level.[8]

Community benefit should be more explicitly defined. Currently, it is too nebulous and includes metrics that are hard to measure and do not necessarily provide direct community or patient benefit.[8] Things like physician education and Medicaid shortfall should no longer be considered. Most importantly, things like Medicaid shortfall expenditures are already offset by funding, such as disproportionate share hospital payments.[8]

Federally, Congress should consider setting minimum levels of community benefit spending. Some states have already instituted this. Texas, for example, has stringent state laws around nonprofit hospitals. If an entity is not designated as a Medicaid Disproportionate Share Hospital (DSH), it can fulfill the required charity care levels by: providing charity care and community benefit equaling at least five percent of the entity or system’s net patient revenue with four percent of that being charity care and government-sponsored indigent care, provide charity care that exceeds the amount of funding generated by tax-exempt status, or prove that charity care is being given at proportionate levels corresponding to the community needs and entity’s ability.[12]

Investigation: Many U.S. hospitals sue patients for debts or threaten their credit
Photo Source: NPR

As a part of the continuing examination of the burden of medical debt, this week, ADAP Advocacy launched an online survey to collect data on patient perspectives and experiences with medical debt. It is available nationwide for anyone in the United States to participate. It is also anonymous with the option of providing personal information if you wish to be contacted for additional follow-up.

The ADAP Advocacy-sponsored Ryan White Grantee 340B Patient Advisory Committee commissioned the study to support patient-centered reform. Many hospitals, as recipients of drug rebates under the 340B Drug Pricing Program, are notoriously bad actors. Data from the survey will add color to patients’ lived experiences with medical debt’s whole-person effect on their lives.

Medical debt continues to adversely affect patients' healthcare outcomes and cause stresses on other aspects of daily living. Nonprofit hospitals are supposed to operate in a manner that benefits anyone who needs care regardless of the financial means to pay for it; however, that is not the status quo. Reform is necessary since data shows many nonprofit hospitals are focused on generating profits instead of providing robust investment into their communities.

Senator Bernie Sanders succinctly described the dire situation when he expressed, “At a time when 85 million Americans are uninsured or underinsured, over 500,000 people go bankrupt because of medically-related debt, and over 60,000 Americans die each year because they cannot afford to go to a doctor when they need to, nonprofit hospitals should be providing more charity care to those who desperately need it, not less….And if they refuse to do so, they should lose their tax-exempt status.”

Read our related blog, In the United State, is Medical Debt is Truly Hospital Debt?

[1] Committee for a Responsible Federal Budget. (2024, June 12). The Federal Tax Benefits for Nonprofit Hospitals. Retrieved from https://www.crfb.org/papers/federal-tax-benefits-nonprofit-hospitals

[2] American Hospital Association. (2024, January). Fast facts on U.S. Hospitals. Retrieved from https://www.aha.org/statistics/fast-facts-us-hospitals

[3] Johns Hopkins Bloomberg School of Public Health. (2024, September 26). U.S. Nonprofit Hospitals Received More than $37 Billion in Total Tax Benefits in 2021. Retrieved from https://publichealth.jhu.edu/2024/us-nonprofit-hospitals-received-more-than-37-billion-in-total-tax-benefits-in-2021

[4] Levinson, Z., Hulver, S., Neuman, T. (2022, November 3). Hospital Charity Care: How It Works and Why It Matters. Retrieved from https://www.kff.org/health-costs/issue-brief/hospital-charity-care-how-it-works-and-why-it-matters/

[5] Bai, G., Letchuman, S., & Hyman, D. A. (2023). Do nonprofit hospitals deserve their tax exemption? New England Journal of Medicine, 389(3), 196–197. https://doi.org/10.1056/nejmp2303245

[6] Lown Institute. (2024, March). Hospital Community Benefit Spending: Improving transparency and accountability around standards for tax-exempt hospitals. Retrieved from https://lownhospitalsindex.org/wp-content/uploads/2024/03/lown-institute-fair-share-policy-brief-20240321.pdf

[7] Zare, H., Eisenberg, M. D., & Anderson, G. (2021). Comparing the value of community benefit and Tax‐Exemption in nonprofit hospitals. Health Services Research, 57(2), 270–284. https://doi.org/10.1111/1475-6773.13668

[8] United States Senate HELP Committee. (2023, October 10). Executive Charity Major Nonprofit Hospitals Take Advantage of Tax Breaks and Prioritize CEO Pay Over Helping Patients Afford Medical Care. Retrieved from https://www.sanders.senate.gov/wp-content/uploads/Executive-Charity-HELP-Committee-Majority-Staff-Report-Final.pdf

[9] Gooch, K. (2024, March 26). 20 hospitals, systems where charity care exceeds tax breaks. Retrieved from https://www.beckershospitalreview.com/finance/20-hospitals-systems-where-charity-care-exceeds-tax-breaks.html?oly_enc_id=8229J1560589D4S

[10] Thompson, I. (2023, September 5). Nonprofit Hospitals Pursue Aggressive Medical Debt Collection. Retrieved from https://nonprofitquarterly.org/nonprofit-hospitals-pursue-aggressive-medical-debt-collection/

[11] Rosenthal, E. (2024, July 22). Why many nonprofit (wink, wink) hospitals are rolling in money. Retrieved from https://www.washingtonpost.com/opinions/2024/07/22/nonprofit-hospital-health-care-industry/

[12] Texas Hospital Association. (2024, September). Charity Care and Community Benefit in Texas: Frequently Asked Questions. Retrieved from https://www.tha.org/wp-content/uploads/2024/09/Charity-care-FAQ-September-2024-FINAL.pdf

[13] Muoio, D. (2023, October 11). Sanders: Nonprofit hospitals 'should lose their tax-exempt status' if they 'refuse' to increase charity care. Retrieved from https://www.fiercehealthcare.com/providers/sen-sanders-nonprofit-hospitals-should-lose-their-tax-exempt-status-if-they-refuse

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Thursday, October 3, 2024

In the United State, is Medical Debt is Truly Hospital Debt?

By: Ranier Simons, ADAP Blog Guest Contributor

Medical debt continues to be a crippling financial burden to many Americans, with most of the debt being owed to hospitals in the United States. Approximately 100 million adults have medical debt ranging from $500 to over $5,000.[1] Despite changes credit reporting agencies made in 2022, 15 million Americans still have more than $49 billion in unpaid medical collections on their credit reports.[2] Medical debt is a financial hindrance to many aspects of people’s lives and can even result in poor healthcare outcomes and denial of care. The evolution of medical debt relief efforts continues to move forward on the federal and state levels in hopes of unsaddling Americans of debt that they had no choice in incurring.

Past Due Notice for Medical Bill
Photo Source: Rhode Island Currant | Getty Images

In response to a 2022 report conducted by the Consumer Financial Protection Bureau (CFPB), three nationwide credit reporting bureaus - Equifax, Experian, and TransUnion – voluntarily made changes to reduce the number of reported medical bills in collections. They increased the time span that trigger reporting of medical bills in collections from 180 days to one year, stopped reporting and removed bills less than $500, and stopped reporting bills that were previously bad debt in collections but had been paid, thus resolved.[2] Despite these actions, 15 million Americans are still plagued with unpaid medical collections on their credit reporting.

In an attempt to further help Americans, CFPB proposed new rules in June 2024 that would be significant if finalized. The rules would eliminate the special medical debt exception, establish guardrails for credit reporting companies, and ban repossession of medical devices.[3] The CFPBs intent is “to end the senseless practice of weaponizing the credit reporting system to coerce patients into paying medical bills that they do not owe.”[3] These rules would help close existing loopholes that leave medical debt accessible to creditors. Additionally, since much of the collection activity reported is inaccurate, it would prevent predatory collections on false claims. Most of the people who have medical collections on their reports do not have any history of other types of credit problems.[4] It is unfair for creditors to block people from the things that they need when the CFPB found that a medical bill on a credit file is not a good indicator of the likelihood a person will repay a loan.[3]

The Urban Institute has done a great deal of work aggregating medical debt data. They created an interactive mapping tool, which shows the geography of debt in America and the debt differences that can reinforce the wealth gap between white communities and communities of color. Nationwide, roughly five percent of Americans have unpaid medical debt based on their credit reports.[5] However, the South and people of color carry a disproportionate amount of that debt. For example, in North Carolina, 8.5% of the population has medical debt in collections compared to 5% nationally. In terms of demographic distinction, 10.5% of communities of color in North Carolina have bad medical debt in contrast to 7.8% of white communities.[5]

North Carolina Governor Roy Cooper
Photo Source: Carolina Journal

Following the trajectory of other states, the administration of Governor Roy Cooper in North Carolina created a plan to alleviate medical debt in the state. With the federal government's support, Governor Cooper created the model for a plan that would link Medicaid expansion dollars to patient debt. Medicaid expansion provides billions in funding for hospitals through state-directed payments that states use to pay hospitals to care for low-income patients.[6] Governor Cooper created a plan that penalizes hospitals, reducing the Medicaid expansion funds they would receive if they do not agree to his debt-relief plan. 

Hospitals would have to expand financial aid criteria to allow more patients to qualify for aid to stave off a future of debt, in addition to eliminating old debts of low-income patients.[6] Eliminating debt would occur via debt buy-back in the manner non-profits such as Undue Medical Debt have succeeded.[6] In essence, bad debt is purchased at extreme discounts and then written off. By agreeing to the plan, hospitals would gain almost twice as much funding as they would if they did not. Atrium Health would receive roughly $1.7 billion by participating, compared to $900 million if they did not.[6] Atrium Health has been historically very aggressive with debt collection efforts against patients. In agreement with Cooper’s plan, Atrium Health announced it would nullify all existing judgments and liens against patients for unpaid bills, some going back as far as twenty years.[7]

Numerous reports have showcased how some large hospital systems have practiced aggressive collection and billing activity against vulnerable low-income patients in conflict with their fiduciary requirements to exercise charity care and institute patient financial assistance. Most of the medical debt is specifically hospital debt.[8] According to a report published by the Robert Wood Johnson Foundation, nearly 75% of adults with medical debt owe some or all of it to hospitals.

Chart Showing Source of Past-Due Medical Debt Among Adults Ages 18 to 64, Overall and by Family Income, June 2022
Photo Source: Urban Institute | RWJF

Brenda Miller with the Lown Institute previously argued in a blog, "Hospitals have the choice to offer robust financial assistance, set reasonable prices, not sue patients, and pay their fair share in community benefits if they are nonprofit. By adjusting their policies, hospitals have the power to alleviate the long-term financial suffering caused by our broken healthcare system."[9]

As a part of the continuing examination of the burden of medical debt, this week, ADAP Advocacy launched an online survey to collect data on patient perspectives and experiences with medical debt. It is available nationwide for anyone in the United States to participate. It is also anonymous with the option of providing personal information if you wish to be contacted for additional follow-up.

The ADAP Advocacy-sponsored Ryan White Grantee 340B Patient Advisory Committee commissioned the study to support patient-centered reform. Many hospitals, as recipients of drug rebates under the 340B Drug Pricing Program, are notoriously bad actors. Data from the survey will add color to patients’ lived experiences with medical debt’s whole-person effect on their lives.

Many types of consumer spending are voluntary. Most medical spending is not. When one’s health and well-being are threatened, potential financial ruin should not add stress to decisions nor influence them. Capitalism-driven financial toxicity has no place in healthcare. Hospitals should be institutions of optimal healing for all. As Jen Laws (he/him/his), CEO of Community Access National Network, points out, “...equity-minded persons and entities prioritizing impact over intent is a very real thing.”[10]

Read our related blog, Are Nonprofit Hospitals' Community Benefit Tax Breaks Truly Serving Communities in Need?

[1] Vankar, P. (2024, January 31). Medical debt in the U.S. - Statistics & Facts. Retrieved from https://www.statista.com/topics/8219/medical-debt-in-the-us/#topicOverview

[2] Consumer Financial Protection Bureau. (2024, April 29). CFPB Finds 15 Million Americans Have Medical Bills on Their Credit Reports. Retrieved from  https://www.consumerfinance.gov/about-us/newsroom/cfpb-finds-15-million-americans-have-medical-bills-on-their-credit-reports/

[3] Consumer Financial Protection Bureau. (2024, June 11). CFPB Proposes to Ban Medical Bills from Credit Reports. Retrieved from https://www.consumerfinance.gov/about-us/newsroom/cfpb-proposes-to-ban-medical-bills-from-credit-reports/

[4] Pollitz, K. (2015, Jan 8). Medical Debt Among Insured Consumers: The Role of Cost Sharing, Transparency, and Consumer Assistance. Retrieved from https://www.kff.org/health-costs/perspective/medical-debt-among-insured-consumers-the-role-of-cost-sharing-transparency-and-consumer-assistance/

[5] Urban Institute. (2024, July 10). The Changing Medical Debt Landscape in the United States. Retrieved from https://apps.urban.org/features/medical-debt-over-time/

[6] Levey, N., Alexander, A. (2024, September 23). How North Carolina Made Its Hospitals Do Something About Medical Debt. Retrieved from https://kffhealthnews.org/news/article/north-carolina-hospitals-medical-debt/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9_BieSj5YKhMJyyO8tuHpBuD1MMqvTUIH1qbLMpxBqXd2wLyVlWUhNZuMd1TjH99Epf8GJEgAie1fXAtiopyrJGRkkQg&_hsmi=325818163&utm_content=325818163&utm_source=hs_email

[7] Crouch, M., Ledger, C. (2024, September 20). Atrium Health cancels thousands of past medical debt judgments

[8] Karpman, Michal. (March 2023). MOST ADULTS W ITH PAST-DUE ME DICAL DE BT OWE MONEY TO HOSP ITAL. Robert Wood Johnson Foundation. Retrieved from https://www.rwjf.org/en/insights/our-research/2023/03/most-adults-with-past-due-medical-debt-owe-money-to-hospitals.html

[9] Miller, Brenda. (2023, March 28). Are Hospitals Driving Medical Debt? The Lown Institute. Retrieved from https://lowninstitute.org/are-hospitals-driving-medical-debt/

[10] Laws, J. (2023, June 19). The Necessity of Patient-Centered 340B Reform. Retrieved from https://www.hiv-hcv-watch.com/blog/june-19-23

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Thursday, September 26, 2024

Injectable PrEP a Game Changer for HIV Prevention, But is it Accessible?

By: Ranier Simons, ADAP Blog Guest Contributor

Benjamin Franklin is credited with the phrase ‘an ounce of prevention is worth a pound of cure.’ In other words, it is better to prevent something than to deal with the consequences or attempt to fix the damage after the fact. This sentiment can be applied to many aspects of the human condition, including public health, in general, and specifically HIV/AIDS. That is why developments in Pre-Exposure Prophylaxis (PrEP) are so valuable. Recently, researchers reported a new milestone in clinical trials involving the long-acting injectable antiretroviral lenacapavir as an option for PrEP. It could be a game-changer for HIV prevention, if potential patients can access it.

Long-Acting Injectables
Photo Source: European AIDS Treatment Group

The FDA approved Gilead Science’s lenacapavir, under the brand name Sunlenca, in December 2022 as an HIV treatment for adults with limited treatment options because of things such as multi-drug resistance.[1] Sunlenca is administered as a twice-yearly injection that is given in conjunction with combinations of other HIV antiretrovirals. Gilead has continued developing additional utilizations of lenacapavir, with clinical trials exploring its efficacy as a pre-exposure prophylaxis option. This month, Gilead released interim results from one of those studies that are so promising it will begin to start seeking global regulatory approval towards the end of the year.[2]

The recent successful clinical trial results came from the Phase III PURPOSE 2 study. This study involved 2,180 subjects who were cisgender men, transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth.[2] The study compared twice-yearly injections of lenacapavir to taking a once-daily Truvada pill. There were only two cases of HIV infection among the 2,180 subjects, meaning 99.9% of those in the lenacapavir arm did not acquire HIV. The comparative arm consisted of 1,087 people who take a daily Truvada pill. That group contained nine subjects who contracted HIV.[3] The study proved that twice-yearly lenacapavir performed better than the current standard form of PrEP in daily Truvada. Compared to Truvada, researchers reported that lenacapavir reduced the likelihood of contracting HIV by 96% as compared to no intervention.[3]

PURPOSE STUDY silhouette graphic
Photo Source: Amfar

These findings support lenacapavir’s effectiveness, as proven by Gilead’s Phase III PURPOSE 1 Study. The PURPOSE 1 clinical trial involved over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda.[4] This trial also compared twice-yearly injected lenacapavir to daily oral Truvada (emitricitabine/ tenofovir disoproxil fumarate) or daily oral Descovy (emitricitabine/tenofovir alafenamide). The efficacy of lenacapavir was 100%, with none of those receiving lenacapavir contracting HIV. Conversely, 16 of the 1,068 women who took Truvada and 39 of the 2,136 women who received Descovy contracted HIV.[4]

Long-acting injectables for PrEP create a prevention option offering more ease of use than daily pills, thus increasing uptake and consistency.[5] Studies have shown that some people have adherence challenges regarding taking daily medication. For some, keeping up with a daily regimen is too psychologically or logistically taxing. For others, like some of the women in countries in Africa, having their medication discovered could pose personal safety issues. Moreover, various access challenges, including transportation, have an affect on successfully utilizing daily treatments for PrEP. A twice-yearly injection helps maintain privacy, reducing stigma, and requires less of a burden on the frequency of physical access to clinics. Moreover, it is easier to get patient buy-in on a twice-yearly injection compared to adherence to a daily treatment to prevent a disease they do not have.

Lenacapavir as PrEP would also be an injectable PrEP alternative to Apretude (cabotegravir). Presently, cabotegravir is an FDA-approved long-acting injectable for PrEP that is administered bi-monthly. However, in the two years since its approval in the U.S., there have only been about 11,000 prescriptions given compared to the roughly 382,000 annual users of oral PrEP.[6] That is only about 1.4% of PrEP users. Additionally, lenacapavir is administered subcutaneously in the abdominal area, unlike cabotegravir, which is a deep intra-muscular injection. A subcutaneous injection may be more appealing to some than a deep intra-muscular injection. Furthermore, a subcutaneous injection could mean easier access for administration since it requires less expertise than a deep intra-muscular injection.

Rx pill bottle with $100 bills rolled-up inside it
Photo Source: Daily Caring

The innovation of long-acting injectable PrEP is lost if those who are most in need cannot access it. Thus, financial innovation needs to occur as well. Long-acting injectable PrEP will most likely cost significantly more than the current generic version of Truvada as daily PrEP in pill form, which can be obtained for about $20 a month.[3] Insurers will need to be convinced of the benefits of covering twice-yearly injectable lenacapavir. Most importantly, Medicaid, which provides care for over 40% of adults under the age of 65 living with HIV, will need to effectively cover long-acting injectable PrEP.[7] Data shows that PrEP uptake is lower among those on Medicaid compared to people with private insurance, with privately insured people initiating PrEP at a seven times higher rate.[7]

The O’Neill Institute for National and Global Health Law released a publication suggesting how Medicaid can ensure coverage for long-acting injectables. The two overarching ideas are that the federal government facilitates support for long-acting integration and states modify practices to effect widespread long-acting injectable access.[8] On the federal level, the institute suggests that the Centers for Medicare and Medicaid Services (CMS) issue guidance on Medicaid’s role in supporting PrEP uptake and update their 2016 Informational Bulletin on HIV Prevention and Care Delivery to include all currently available HIV therapies and services. Additionally, they point out there is no senior administrator in CMS with HIV expertise focused on coordinating HIV policy with Medicare and Medicaid regarding the National HIV/AIDS Strategy. Thus, they should appoint an official to handle that task.[8] On a state level, they suggest that states should examine their Medicaid managed care contract standards to ensure all covered HIV medications are available across all health plans.[8]

Ongoing inquiries provide data showing that patients have favorable inclinations toward long-acting injectables, especially once they become fully aware of what is available. One source of this data is a project executed by ADAP Advocacy entitled ‘HIV LONG-ACTING INJECTABLES: Patient Access Considerations for Injectable HIV Therapies & Injectable HIV Pre-Exposure Prophylaxis’. The project consisted of a quantitative survey, a qualitative focus group, and an analysis of data among those who were HIV-positive in terms of long-acting injectables for treatment and those who were HIV-negative regarding long-acting injectables for prevention.

HIV LONG-ACTING INJECTABLES

The sample population focused on long-acting injectables for prevention included participants from 35 states, the District of Columbia and Puerto Rico.[9] Of these respondents, the majority reported that they would prefer provider or self-administered long-acting injectable PrEP as opposed to daily oral pills.[9] There was a mixture of awareness of the specific medication, Apretude. However, upon being made aware of it, those who were already aware and those newly aware were mostly open to learning more about using it or would strongly consider switching from a pill-based regimen.[9] A frequent concern was being unsure if they would be able to afford it or worried if their insurance would cover it.[9]

The PURPOSE 1 and 2 clinical trials and ongoing data indicate the promise of effective prevention that long-acting injectables can bring. Future results from PURPOSE 3, 4, and 5 will continue to strengthen proof of efficacy among even more diverse groups. It is imperative that education, policy, funding, and infrastructure be created and maintained to ensure access to those who are most in need of and desire to utilize not only long-acting injectable PrEP, but long-acting HIV treatment of all forms.

[1]  Mahobe, R. (2022, December 22). U.S. FDA approves Gilead's long-acting HIV drug Sunlenca. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-gileads-long-acting-hiv-drug-sunlenca-2022-12-22/#:~:text=By%20Raghav%20Mahobe,Licensing%20Rights%20%2C%20opens%20new%20tab 

[2] Manalac, T. (2024, September 13). Gilead touts 96% HIV risk reduction with twice-Yearly PrEP, eyes regulatory filings. Retrieved from https://www.biospace.com/drug-development/gilead-touts-96-hiv-risk-reduction-with-twice-yearly-prep-eyes-regulatory-filings

[3] Mundell, E. (2024, September 13). Twice-yearly injection cuts HIV risk by 96%, but will cost cut access? Retrieved from https://medicalxpress.com/news/2024-09-yearly-hiv-access.html#google_vignette

[4] Foster, Robin. (2024, June 24). Twice-a-year injection gives women full protection against HIV, trial finds. Retrieved from https://www.healthday.com/health-news/infectious-disease/twice-a-year-injection-gives-women-full-protection-against-hiv-trial-finds

[5] Edwards, G. G., Miyashita-Ochoa, A., Castillo, E. G., Goodman-Meza, D., Kalofonos, I., Landovitz, R. J., Leibowitz, A. A., Pulsipher, C., El Sayed, E., Shoptaw, S., Shover, C. L., Tabajonda, M., Yang, Y. S., & Harawa, N. T. (2023). Long-Acting Injectable Therapy for People with HIV: Looking Ahead with Lessons from Psychiatry and Addiction Medicine. AIDS and Behavior, 27(1), 10–24. https://doi.org/10.1007/s10461-022-03817-z

[6] Cairns, G. (2024, March 29). Why is the roll-out of injectable PrEP taking so long?. Retrieved from https://www.aidsmap.com/news/mar-2024/why-roll-out-injectable-prep-taking-so-long

[7] Wirth, D., Crowley, J. (2024, Sept 19). Medicaid must prepare to cover twice-yearly HIV prevention injection. Retrieved from https://www.statnews.com/2024/09/19/medicaid-prep-long-lasting-twice-yearly-prep-hiv-injection-cms/

[8] O'Neill Institute. (2024, July). Medicaid Leadership Must Ensure Access to Longer-Acting HIV Products. Retrieved from https://oneill.law.georgetown.edu/wp-content/uploads/2024/07/ONL_BIIB_Medicaid_Leadership_P5.pdf

[9] ADAP Advocacy. (2024, June). Patient access considerations for  Injectable HIV Therapies  & Injectable HIV Pre-exposure prophylaxis. Retrieved from https://www.adapadvocacy.org/pdf-docs/2024_ADAP_Project_Long_Acting_Injectables_Final_Report_06-25-24.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Wednesday, September 18, 2024

HRSA Issues Numerous Guidance Letters Offering Patient Assistance

By: Ranier Simons, ADAP Blog Guest Contributor

The clients who qualify for and receive assistance through the Ryan White HIV/AIDS Program (RWHAP) are often representative of vulnerable populations. Providing a comprehensive means of providing HIV medications, healthcare, and related-services requires a whole-person approach. As such, Health Resources & Services Administration (HRSA) continues to evaluate and update its RWHAP endeavors to meet client needs. Systematic barriers exist that all to often challenge RWHAP clients’ ability to receive appropriate and consistent care. Recently, HRSA issued numerous guidance letters addressing those barriers.

HRSA

HRSA has created patient assistance initiatives to enable a more seamless delivery service system aimed at addressing various socio-economic and systemic structural needs. Two of the program letters HRSA released in June 2024 address services for people living with HIV/AIDS (PLWHA) who have been involved in the criminal justice system, and those who are affected by housing insecurity.

PLWHA, who have been involved with the criminal justice system face barriers to access to care, among many other things. A person having legal involvement is defined as anyone who is engaged at any point along the continuum of the legal system as a defendant, including arrest, incarceration, and community supervision.[1] The HRSA HIV/AIDS Bureau (HAB) released guidance emphasizing how RWHAP funds may be used to support this demographic. RWHAP funds can be used to assist PLWHA who have been incarcerated or who are incarcerated and have an expectation of eligibility for RWHAP services upon release.[1] One effective means of support is assistance with the expungement of criminal records.

Incarcerated male standing with look for reflection on his face
Photo Source: ADAP Advocacy | iStock Images

A criminal history is an obstacle to a person obtaining employment, housing, and education and subsequently affects access to healthcare. Expungement of criminal records improves the chances of successful reintegration into the community, reduces stigma, and protects privacy.[2] HRSA recognizes the importance of decreasing disparities to improve health outcomes for PLWHA. The expungement of criminal records facilitates obtaining gainful employment and securing housing, both of which translate into improving healthcare access. HRSA’s guidance informs providers that according to HRSA/HAB Policy Clarification Notice (PCN) #18-02, using RWHAP funds to help pay for expungement falls under the purview of allowable legal services because it is a matter “related to or arising from [an individual’s] HIV.”[1] Stipulations require any RWHAP recipients offering expungement services to research local laws, partner with legal counsel to create policies to determine how the services will be enacted, and ensure they are available to all eligible clients who seek help.[1]

In a related vein, in April 2024, HRSA announced new funding to support healthcare services for people transitioning out of incarceration. It earmarked $51 million to create funding opportunities for HRSA-funded health centers to develop innovative ways to give healthcare services to people in the 90-day period before their incarceration release.[3] Many people who are incarcerated have mental health conditions, substance abuse challenges, and chronic disease conditions such as HIV. The funding will enable HRSA-funded centers to provide care that ensures the continuity of medical services. This population needs case management services to help navigate things such as reinstating insurance eligibility, continuing access to medications and mental health counseling, reducing drug overdose risk, and even addressing housing and food insecurity.[3]

Quality Housing and HIV

Regarding housing assistance, HRSA also released guidance educating providers, Policy Clarification Notice (PCN) #16-02, on an additional pathway RWHAP funds can be used to assist with housing instability. HRSA listened to clients who explained that statutory stipulations against using RWHAP funds to help pay housing security deposits for clients were a roadblock to helping them access stable and permanent housing.[4] As a result, HRSA/HAB issued guidance explaining that RWHAP funds can be used to pay for housing security deposits only if procedures are in place to ensure the security deposit is returned to the RWHAP service provider and not the RWHAP client.[4] It is not mandatory for RWHAP funds to be used for this purpose. Other funding sources, such as Ending the HIV Epidemic (EHE) funds, income generated from 340B program proceeds, and non-RWHAP grant awards, can also be used to help pay for housing security deposits.[4] This guidance is simply education on the existence of the option if needed.

HRSA has additional endeavors targeting the housing needs of PLWHA in the RWHAP. One of these is the SURE Housing initiative. SURE stands for Supporting Replication of Housing Interventions in the Ryan White HIV/AIDS Program. It is a program funded from 2022 through 2026 through HRSA’s RWHAP Part F Special Projects of National Significance Program.[5] Under this initiative, ten implementation sites are funded to create replicable effective interventions for rapid re-housing and housing stability for PLWHA who fall into one of three categories: those who have been involved with the legal system, those who identify as LGBTQ+, and young adults aged 18-24.[5]

With these guidance letters, HRSA/HAB has demonstrated its commitment to fostering an effective system, offering continuity of care and services for ADAP and RWHAP clients. HRSA continues to evaluate and modify current RWHAP offerings, communicate with recipients to investigate needs of new offerings, and examine how changing policy and legal landscapes affect funding rules and statutes. Housing instability and incarceration continue to complicate the lives of many PLWHA. It is imperative that government funding continues and scales with changing needs to ensure that no one falls through the cracks.

[1] HRSA HIV/AIDS Bureau. (2024, June 6). Ryan White Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hrsa-hab-expungement-program-letter.pdf

[2] Hamann, K., Riley, P., Bismuth, C. (2024, January 22).The evolving landscape of sealing and expungement statutes. Retrieved from https://www.americanbar.org/groups/criminal_justice/publications/criminal-justice-magazine/2024/winter/evolving-landscape-sealing-expungement-statutes/

[3] U.S. Department of Health and Human Services. (2024, April 10). Press Release: During Second Chance Month, HRSA Takes Policy Action, Releases First-Ever Funding Opportunity for Health Centers to Support Transitions in Care for People Leaving Incarceration. Retrieved from https://www.hhs.gov/about/news/2024/04/10/health-centers-to-support-transitions-in-care-for-people-leaving-incarceration.html

[4] HRSA HIV/AIDS Bureau. (2024, June 26). Ryan White Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hrsa-hab-security-deposit-program-letter.pdf

[5] Target HIV. (2024). SURE Housing Initiative. Retrieved from https://targethiv.org/spns/SUREHousing

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.