Who Holds the Cards in America’s Medical Debt Crisis?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

An updated Urban Institute report found that more than 1 in 4 adults (26.6%) reported owing medical debt, including more than 1 in 7 (15.4%) with past-due medical bills or bills they can't pay. Karpman also found that more than half (52.1%) of medical debt was owed to hospitals, though many respondents also held debt for specialist services (41.5%), dental care (37.6%), and general doctor visits (33.5%) (Karpman, 2026).

Source: Grammarist

These findings echo ADAP Advocacy’s 2025 research, which found that 74% of respondents held medical debt, 39% of whom owed debt to hospitals. ADAP Advocacy’s research went a step further: we asked whether hospitals made patients aware of financial assistance available to help them afford their services. The overwhelming majority of respondents (87.5%) said they either had not been informed or did not remember being informed by a hospital employee that their healthcare services might be eligible for the hospital’s charity care program (Macsata et al., 2025).

One of the only available metrics by which 340B Drug Pricing Program-eligible hospitals can be measured is how much they spend on “charity care”—the provision of healthcare services at cost. Recent research by the policy think tank Pioneer Institute found that 340B hospitals spent just 2.16% of operating expenses on charity care, compared with 2.82% at non-340B hospitals (Popovian et al., 2026).

The American Hospital Association (AHA) responded to these findings with their standard talking points, as 340B hospitals have long argued, that charity care is not the only metric by which they should be measured when serving patients and communities (Hughes, 2026).

Source: Urban Institute

This statement, however, should be met with significant skepticism.

In addition to arguing that charity care is a poor metric for assessing community benefit, 340B hospitals have also fought vehemently against any efforts to reform the 340B program that require them to be transparent about how the program's revenues are used.

In fact, hospitals appear to believe that any sort of transparency will lead to institutional anaphylaxis. To date, more than half of American hospitals (51%) are out of compliance with a 2019 law requiring all hospitals to establish, update, and make public a list of all standard charges for all items and services (Pifer Parduhn, 2026; Hospital Price Transparency, 2026).

The reality appears to be that hospitals are doing everything in their collective power to avoid making public any information that would hold them accountable. This makes sense when we consider that, although they’re listed as non-profit companies, hospitals are in the business of making profits. Transparency requirements, whether related to pricing or expenditures, would open them to scrutiny and uncomfortable questions about cost and corner-cutting, service reductions, and executive compensation.

And truly, so long as the penalties remain civil monetary penalties (e.g., fines)—particularly if those penalties are as low as $300 per day (with $5,500/day being the maximum) for noncompliance with the price listings (Hospital Price Transparency, 2026)—nothing will change. Until the penalties for noncompliance include severe financial penalties and/or the revocation of eligibility for 340B.

Moreover, medical debt is unlikely to go away and is highly likely to spiral out of control.

Source: The Commonwealth Fund

For patients who purchase health insurance plans through the Affordable Care Act marketplace, insurers are proposing a median 15% premium increase for 2027 after raising premiums by more than 20% in 2026 (Pogue et al., 2026). In addition, the Trump Administration’s affinity for economic tariffs may be contributing to price increases, particularly at hospitals that spend 10.5% of their annual budgets on imported medical supplies and pharmaceutical products (Hider et al., 2026).

Here is where 340B revenues can, and should, go: helping eligible patients defray out-of-pocket medical expenses. In this way, 340B can be the glue holding our healthcare system together. One of the greatest barriers to using the program this way is the opacity of how 340B revenues are used. As the debate over the 340B Program continues, maybe the time has come to shift the program's paradigm to a "money follows the person" framework, modeled after Medicaid's Money Follows the Person (MFP) demonstration. The medical debt crisis...hospital debt crisis... will not go away on its own.

Learn more about ADAP Advocacy’s proposals for common-sense 340B reforms in our recent white paper:

340B PROGRAM: The Glue That Should Hold Our Healthcare System Together

Disclaimer: All funders of the ADAP Advocacy Association are publicly listed on our website. 

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

References:

[1] Hider, A. M., O’Connell, D., & Berlin, N. L. (2025, September 18). Tariffs: Added Strain On The US Health Care System. Health Affairs: Forefront. https://www.healthaffairs.org/content/forefront/tariffs-added-strain-us-health-care-system

[2] Hospital Price Transparency, 45 C.F.R. pt. 180 (2026). https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-E/part-180

[3] Hughes, J. (2026, September 25). 340B hospitals lag behind peers in charity care spending: report. Newton, MA: Healthcare Dive: News: Dive Brief. https://www.healthcaredive.com/news/340b-hospitals-lag-behind-peers-in-charity-care-spending-report/831394/

[4] Karpman, M. (2026, October 06). More than One-Quarter of US Adults Had Medical Debt in 2025. Washington, DC: The Urban Institute: Research. https://www.urban.org/research/publication/more-one-quarter-us-adults-had-medical-debt-2025

[5] Macsata, B. M., Laws, J., Hopkins, M. J. & Sosa, J. (2025, April). Patient Medical Debt: Findings from Quantitative Patient Survey in the United States. Washington, DC: ADAP Advocacy. https://www.adapadvocacy.org/s/2025_ADAP_Project_RW_340B_Asset_17_Medical_Debt_Survey_Report_04-23-25-gfhj.pdf

[6] Macsata, B. M., Anthony, G., Hopkins, M. J., & Sosa, J. (2026, June). 340B Program: The Glue That Should Hold Our Healthcare System Together. Washington, DC: ADAP Advocacy. https://www.adapadvocacy.org/s/2026_ADAP_Project_RW_340B_Asset_32_340B_Glue_Should_Hold_Healthcare_Together_061526.pdf

[7] Pifer Parduhn, R. (2026, September 11). More than half of hospitals still not fully compliant with price transparency rules: report. Newton, MA: Healthcare Dive: News: Dive Brief. https://www.healthcaredive.com/news/hospital-compliance-price-transparency-regulations-pra-report/830087/

[8] Pogue, S., Knapp, A., & Giovanelli, J. (2026, October 08). More ACA Premium Spikes to Come in 2027 Amid Federal Policy Changes. New York, NY: The Commonwealth Fund: Blog. https://www.commonwealthfund.org/blog/2026/more-aca-premium-spikes-come-2027-amid-federal-policy-changes

[9] Popovian, R., Sydor, A. M., Czubaruk, K., Walker, M., & Smith, W. (2026, September 24). The 340B Accountability Gap: Charity Care, Uncompensated Care, and Medicaid Patient Volume Among 340B and Non-340B Hospitals: What the Data Mean for 340B Accountability and Reform. Boston, MA: The Pioneer Institute: Pioneer Health. https://pioneerinstitute.org/wp-content/uploads/2026/09/2026-09-08-Cancer-Care-340B-Paper.pdf

What’s Affordable, Anyway?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

New polling data from the Kaiser Family Foundation (KFF) found that the cost of living—particularly healthcare and gasoline costs—is at the top of Americans’ minds as the U.S. heads into the 2026 mid-term elections. KFF found that, when asked if they were worried about being able to afford different basic needs, 60% of respondents indicated that healthcare costs, including the costs of health insurance and out-of-pocket expenses, such as office visits and prescription drugs, were of most concern, followed by 59% of respondents indicating that gasoline and transportation costs were top of mind (Schumacher et al., 2026).

Source: Gallup

This raises a key question with which few are willing to grapple:

How are we defining “affordable”?

In the strictest sense, “affordable” means something is priced low enough to be easily paid for or purchased.

But this raises another important question:

Affordable for whom?

According to Donald J. Trump, “The word ‘affordability’ is a Democrat scam” (Revell, 2025). He’s also called the concept of affordability a “fake narrative,” a “hoax,” and a “con job” (Green, 2025).

None of this is surprising, as the president has never had to “afford” anything in his entire life; nor, apparently, have any key members of his administration, including Trump Secretary of the Treasury, Scott Bessent, who claimed that Americans should be worried about affordability because, “…the Biden Administration destroyed affordability” (Wang & Farrow, 2026).

This has been the refrain of Republicans at both the state and federal levels since time immemorial: when costs increase during a Republican administration, it is always the fault of Democratic policies and politicians, regardless of how long Republicans have been in power and irrespective of objective reality.

But let us not lay the blame of unaffordability directly at the feet of just Republicans. Democrats have regularly abused the word “affordable,” with the naming of the Affordable Care Act (ACA) serving as one of the primary examples of how simply slapping the word “affordable” on something does not make it affordable. Despite its promises to control healthcare cost growth, national healthcare expenditures (in 2024 U.S. dollars) have soared from $3.83 trillion in 2014, when much of the ACA took effect, to $5.28 trillion in 2024 (Rakshit et al., 2026).

The issue with affordability is that it is largely subjective: when you’re poor, virtually nothing is “affordable” unless it’s free; when you’re wealthy and don’t have to worry about choosing food or healthcare, your concept of affordability skews toward your own experiences.

And maybe this is the crux of the issue: the people who set the policies that affect prices—from filing fees to taxes to tariffs to rates for goods and services—live in a bubble where “affordability” is largely an afterthought.

Source: Institute for New Economic Thinking

Despite consistent promises made by every presidential administration since the 1970s’ stagflation crisis to make life more affordable for Americans, nothing seems to change, in no small part because the private entities that set prices for food, healthcare services, and medications are often the largest donors to American politicians. When it comes time to craft meaningful legislative and administrative solutions to actually make life affordable, those donors expect obeisance from the officials they’ve purchased.

When it comes to healthcare costs, the same truths come into sharper focus. Few other industries are so regularly and publicly asked to substantiate the costs of their services to the American public—or Congress—than actors in the healthcare space. Health insurers, pharmaceutical manufacturers, and hospital industry representatives are often required to show up and justify why costs are so high, but little decisive action to reduce costs for consumers is ever taken; instead, we get political theater, even when both political teams come out swinging against the healthcare industry, and no real changes.

Why is that?

The simplest explanation is that nobody wants to truly upset the two proverbial apple carts:

The first apple cart holds the industries that provide healthcare services to Americans. In 2024, healthcare expenditures in the U.S. accounted for 18% of economic spending as a percentage of Gross Domestic Product (GDP), and that number is expected to grow to 21% by 2034 (Peter G. Peterson Foundation, 2026). Moreover, the U.S. healthcare system depends heavily on various funding mechanisms, such as the 340B Drug Pricing Program, for survival, meaning that trying to solve the healthcare affordability crisis by addressing just one aspect of healthcare services could cause another to collapse.

For example, 340B-eligible hospitals argue that if they are forced to demonstrate they are using 340B revenues appropriately, they will have to close locations. Why? Because that level of transparency would cost them their eligibility.

But this isn’t just the argument made by hospitals. Virtually any policy that is designed to lower costs for consumers is met with thinly veiled threats by healthcare industry players:

The most common refrain we hear from pharmaceutical partners is that any price controls introduced in the U.S. will force them to slow innovation, slow or halt drug development, or simply take products off the market. Health insurers echo this refrain, arguing that any attempt to force them to lower premiums and deductibles will force them to close operations and leave people without health insurance coverage.

This makes the first apple cart particularly pernicious: healthcare industries are more than willing to threaten service reductions or closures when their profits are threatened.

The second apple cart holds the donors that can make or break political campaigns.

Source: Politico

It’s hard to demand substantive changes from those who have paid their way into office, or who have used their position to enhance their personal wealth. When industries are allowed to bankroll politicians—actions that have been deemed “protected speech” by the U.S. Supreme Court—it’s not surprising that they then expect those politicians to fall in line when it comes to advancing their interests over the interests of everyday Americans. As a result, we get regulatory frameworks without teeth; healthcare laws that don’t actually control healthcare costs; endless Congressional investigations and hearings that provide excellent soundbites, but don’t go anywhere in terms of legislation and policymaking.

The hard truth for many to swallow is that making healthcare affordable means making it affordable for everyone, whether healthcare industry players like it or not. This means regulations and eligibility requirements that have teeth; it means making it more expensive for companies to fall out of compliance than to comply; it means revoking eligibility for federal programs, subsidies, and pricing agreements if providers are regularly non-compliant.

But this is not a conversation that many are willing to have, because in America, the Almighty Dollar is King. And so long as profits are high and shareholders are happy, we plebeians can go kick rocks!

Disclaimer: All funders of the ADAP Advocacy Association are publicly listed on our website. 

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

References:

[1] Green, E. L. (2025, December 02). Trump Calls Affordability a ‘Con Job’ as His Edge on the Economy Slips. New York, NY: The New York Times: US: Politics. https://www.nytimes.com/2025/12/02/us/politics/trump-affordability-economy-messaging.html

[2] Peter G. Peterson Foundation. (2026, August 11). Chart Pack: Healthcare. New York, NY: Peter G. Peterson Foundation. https://www.pgpf.org/article/chart-pack-healthcare/

[3] Rakshit, S., Winger, A., Cotter, L., McGough, M., Wager, E., & Cox, C. (2026, January 22). How has U.S. spending on healthcare changed over time? San Francisco, CA: Peterson-KFF Health System Tracker: Health Spending. https://www.healthsystemtracker.org/chart-collection/u-s-spending-healthcare-changed-time/

[4] Revell, E. (2025, December 02). Trump calls affordability 'a Democrat scam' as inflation concerns persist nationwide. New York, NY: Fox Business: Politics. https://www.foxbusiness.com/politics/trump-calls-affordability-a-democrat-scam-inflation-concerns-persist-nationwide

[5] Schumacher, S., Valdes, I., Mulugeta, M., Kearney, A., Kirzinger, A., & Hamel, L. (2026, October 06). KFF Health Tracking Poll: Health Care Issues in the Lead-Up to the 2026 Midterm Election. San Francisco, CA: KFF: Public Opinion. https://www.kff.org/public-opinion/kff-health-tracking-poll-health-care-issues-in-the-lead-up-to-the-2026-midterm-election/

[6] Wang, S. & Farrow, F. (2026, January 28). Bessent says Americans 'should be worried about affordability,' but blames Biden for cost issues. New York, NY: ABC News: Politics. https://abcnews.com/Politics/bessent-americans-worried-affordability-blames-biden-cost-issues/story?id=129636939

Harvard Pilgrim Health Care Offered Discriminatory Plans to People Living with HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Discrimination is nothing new for people living with HIV/AIDS (PLWHAs), as it impacts multiple facets of their daily lives. Aside from HIV-related discrimination in employment, housing, healthcare, and criminal justice, an often-overlooked area is insurance. Discriminatory plan design refers to the barriers health insurance companies impose on PLWHAs thereby limiting access to care and treatment for years, advocacy groups have battled insurers with public scrutiny and, in some cases, litigation (Andrews, 2016.) Despite some coverage improvements, complaints and lawsuits continue as insurers maintain practices in non-compliance with federal law. 

Photo Source: AIDS Foundation of Chicago

One recent large plan instance of discriminatory coverage involved Harvard Pilgrim Health Care (HPHC). In November of 2024, the HIV+Hepatitis Policy Institute filed discrimination complaints against HPHC because their Core 4-Tier and Core 5-Tier plans in Maine, New Hampshire, and Rhode Island contained inadequate coverage of HIV antiretrovirals in violation of the ACA. In solidarity of the cause, several other groups sent a letter to the insurer. A few of the groups included were the Federal AIDS Policy Partnership (FAPP), HealthHIV, NASTAD, and AIDS Alabama (HIV+HEP, 2024).

The U.S. Department of Health and Human Services (HHS) guidelines recommend four preferred treatment regimens as initial HIV antiretroviral therapy: Biktarvy, Dovato, Symtuza, or a combination of Tivicay with either Truvada or Descovy (“Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV,” n.d.). The plans only covered Dovato or Tivicay + Truvada. Biktarvy is a single-pill regiment prescribed to over 49% of PLWH and should be covered (HIV+HEP, 2024). Dovato was covered but is not appropriate for PLWH with high viral loads or HIV that is resistant to lamivudine or dolutegravir. The plans excluded Symtuza, even though it is the only recommended treatment for PLWH who have taken long-acting injectable PrEP (cabotegravir) and have possible HIV resistance to Integrase strand transfer inhibitors (INSTI) (HIV+HEP, 2024). There are other clinical situations where HHS guidelines recommend Delstrigo, Odefsey, Triumeq, and a combination of Prezcobix and Epzicom as initial regimen alternative therapies. The plans covered only Odefsy and Triumeq (HIV+HEP, 2024).

When patients lose access to covered medications, they not only experience lapses in treatment but sometimes must change to treatments that are not the best for them. Sometimes, even alternative therapies still result in a financial burden or non-adherence due to treatment. If a patient is moved from a single-pill regimen to a multi-pill treatment, they are likely to have issues staying consistent with their treatment plan (HIV+HEP, 2024). Lack of coverage on one plan may also force a patient to choose a different one that may cover their needed medication but has adverse financial effects.

Photo Source: HIV + HEP Policy Institute

As a result of advocacy bringing public awareness directed at state policy leadership and insurance carriers, HPHC reversed its problematic coverage decisions and updated the Maine, New Hampshire, and Rhode Island formularies at the end of December. For 2025, they now cover eight complete initial HIV treatment regimens: Biktarvy, Dovato, Symtuza, Tivicay (in combination with Truvada or Descovy), Delstrigo, Odefsey, Triumeq, and Prezcobix (in combination with abacavir and lamivudine) (HPHC, 2025). While this is progress, the medications are located on the highest drug tiers of the formularies. This may render the formularies clinically effective, but they are still cost-prohibitive. Drugs on the highest formularies have the highest cost-sharing for patients, requiring them to pay significant percentages of the drug's prices as co-insurance. A high financial burden is still a barrier to access and effective care. 

As Tim Horn, Director of Medication Access with NASTAD, points out, “Relegating virtually all branded antiretrovirals to the highest cost-sharing tiers has been associated with co-insurance that typically exceeds 25% of the retail cost of the prescribed antiretroviral drug product(s), which can be considerable costs, certainly for plan beneficiaries but also for safety net programs like state ADAPs.” Director Horn also adds, “ADAP-funded insurance programs providing premium and cost-sharing support for people living with HIV are likely important factors in these carriers' decisions to ultimately engage in discriminatory formulary design practices. Of course, it is vitally important that ADAPs are able to provide premium and cost-sharing support for their clients and, likely, a significant proportion of otherwise uninsured people living with HIV in these states.”

Insurance companies do not want ADAPs to utilize their plans because they are a built-in permanent population of covered lives requiring expensive medication. Director Horn further explains, “Carriers, particularly those operating in states where few other carriers or Marketplace plans, likely consider ADAPs making their plans affordable for people living with HIV as a risk to their bottom lines. The result, as we saw with the initial Harvard Pilgrim Health decision to remove a huge swath of important antiretroviral drugs from its core formularies in three states, can be profoundly cynical and discriminatory practices that can have serious repercussions for both people living with HIV and the vitally important, yet fiscally constrained, HIV programs, such as state ADAPs.”

According to Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, more vigorous enforcement would be a solution to discriminatory plan design. For example, in Texas, the Affordable Care Act guidelines are not enforced by the state insurance regulator but are enforced by the federal government. Moreover, the federal government constructs templates delineating ACA appropriate coverage guidelines for insurance plans to follow. Schmid explains that the templates in use are outdated, thus not reflecting current best practices. Hence, the federal government is not effectively engaging in enforcement. 

Unfortunately, advocacy groups and public outcry are how most insurance companies’ discriminatory plan malfeasance comes to light. Currently, many other grievances are being elevated and watched. Two, in particular, involve Medica and Community Health Choice Texas. HIV + HEP Policy Institute filed complaints against Medica in Minnesota and Iowa for inadequate recommended coverage in addition to placing all HIV antiretrovirals on their highest tiers. Their filing in Texas against Community Health Choice was also regarding inadequate HIV drug coverage regarding treatment guidelines (Burke, 2024).

The vigilance of advocacy groups, patients, and other entities is the only robust tool against discriminatory plan design. Until more effective federal and state enforcement occurs, there will not be any consistent ethical and legal behavior in the industry. The law, regulations, guidance, and implementation all must be aligned. As Schmid states, “Insurers will try to get away with as much as they can until they are caught.”

Patients living with HIV experiencing similar health plan discriminatory design are encouraged to alert the HIV + HEP Policy Institute at https://hivhep.org/contact/.

[1] Andrews, M. (2016, October 18). 7 Insurers Alleged To Use Skimpy Drug Coverage To Discourage HIV Patients. Retrieved from https://kffhealthnews.org/news/7-insurers-alleged-to-use-skimpy-drug-coverage-to-discourage-hiv-patients/

[2] Burke, J. (2024, December 17). Press Release. Retrieved fromhttps://hivhep.org/wp-content/uploads/2024/12/hiv-discrimination-complaints-maine-harvard-pilgrim-12.17.24.pdf

[3] Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. (n.d.). In Centers for Disease Control and Prevention, U.S. Food and Drug Administration, Health Resource and Services Administration, & National Institutes of Health, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/tables-adult-adolescent-arv.pdf

[4] Harvard Pilgrim Health Care. (2025, January 2). Press Release. Retrieved from https://www.harvardpilgrim.org/public/news-detail?nt=HPH_News_C&nid=1471978029629

[5] HIV + HEP Policy Institute. (2024, November 8). Substandard & Discriminatory HIV Medication Coverage & Plan Design by Harvard Pilgrim Health Care. Retrieved from https://hivhep.org/wp-content/uploads/2024/11/maine-harvard-pilgrim-HIV-complaint-11.8.24.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. 

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]

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.

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.

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.   

Provider ‘Smash and Grab’ Tactics Fueling Medical Debt, Hurting Patients

By: Ranier Simons, ADAP Blog Guest Contributor

In the United States, healthcare is one universal expense incurred by everyone, regardless of their station in life. Approximately 100 million people in this country, including 41% of adults, have some sort of medical debt.[1] Some people can manage it, but many struggle. As a result of medical debt, people have had to cut spending on food and necessities, deplete savings, delay purchasing a home, work multiple jobs, or even declare bankruptcy.[1]

Photo Source: iStock (purchased)

Most of the medical debt is actually hospital debt, and that debt is owed to large hospitals, not small private practices. In the United States, there are two different types of hospitals: for-profit and nonprofit. There are 5,139 community hospitals, with 1,228 being for-profit, 951 being state and local government-run hospitals, and 2,960 being non-governmental nonprofit health facilities.[2] For-profit hospitals are business-oriented and owned by investors and shareholders; thus, they are focused on making money for their stakeholders. Nonprofit hospitals are not beholden to any shareholders or investors. In theory, their profits are to be reinvested into the hospitals for their operations. Additionally, nonprofit hospitals are tax-exempt and required to provide more community health services and serve patients regardless of whether they can afford care. Unfortunately, some nonprofit hospitals are the worst offenders when it comes to saddling patients with debt.

Nonprofit hospitals do not pay any federal and state income, property, or sales taxes and receive other tax breaks.[2] In 2020, the nation’s nonprofit hospitals received an estimated $28 billion in tax benefits, accounting for 44% of their net income.[3] In return for the tax benefits, the federal government requires nonprofit hospitals to provide community benefits such as charity care. Charity care is providing services to low-income people for free or at significantly reduced rates.[3] The Affordable Care Act (ACA) also mandates that they must maintain a transparent and available financial assistance program and refrain from taking “extraordinary collection actions” against patients eligible for charity care.[4] The reality of some of the largest nonprofit hospitals is a travesty of the concept of charity care.

Photo Source: National Nurses United

Some nonprofit hospitals aggressively pursue patients over their bills. They garnish paychecks and sell patient accounts to collection agencies (debt buyers) that harass and intimidate. Lawsuits are filed against patients for outstanding balances. Some of them are filed against people who qualify for charity care. These lawsuits attach legal fees and late payment interest, multiplying the original outstanding debt amounts. Moreover, some hospitals pursue family members for a patient’s medical debts and even place property liens on patients’ homes. Many do not find out about property liens until a relative has passed. Property liens lower the value of homes and adversely affect the transference of intergenerational wealth.

Federal tax law mandates that nonprofit hospitals spend some of their revenues as community benefit and defines the kind of spending that qualifies but does not stipulate the amount. Charity care is just one of the defined categories of spend. In 2020, nonprofit hospitals had approximately $28 billion in tax exemptions but provided only $16 billion in free or discounted services through charity care.[5] 

U.S. Senator Bernie Sanders, chair of the Senate Committee on Health, Education, Labor & Pensions (HELP), filed a congressional report on nonprofit hospitals and their tax exemptions. The committee examined 16 of the largest nonprofit health systems in the U.S., finding that they spent less than 60% of the estimated value of their tax breaks on charity care.[6] The 16 hospital chains examined took in more than 3$ billion in annual revenue. Twelve of the 16 chains dedicated less than two percent of their total revenue to charity care, with 6 of those 12 having less than 1% of their total revenue dedicated to charity care.[3] Between 2012 and 2019, nonprofit hospitals increased their average operating profit by more than 36% and almost doubled their cash reserves. In the same timeframe, charity care spending dropped from only $6.7 million to $6.4 million.[3] Ironically, in 2021, of the 16 nonprofit hospital chains in the report, the average CEO compensation was $8 million, with a collective total of more than $140 million.[3]

Photo Source: WRAL

Editor's Note: ADAP Advocacy recently called into question 340B Drug Discount Program practices with an examination focused on growing 340B revenues, increasing executive compensation, declining charity care, and the exploding medical debt.

Sen. Sanders feels that Congress should specifically define the level of charity care and financial assistance required of nonprofit hospitals. One suggestion is that tax breaks be limited to the amount of charity care provided. Additionally, Sanders feels that hospital financial assistance programs should have defined standards. For example, some of the hospitals do not transparently explain, advertise, or actively facilitate entering qualified patients into the programs. Instead, some hospital systems, such as Atrium in North Carolina, steer patients towards loans to pay their outstanding bills that sometimes have interest rates as high as 13%.[7]

Hospital groups pushed back against the analyses by Sen. Sanders, but they also tend to oppose any accountability or transparency reforms.. The American Hospital Association states that nonprofit hospitals' community benefit is comprehensive and encompasses more than just charity care. It says that community benefit includes research, medical innovation, absorbing underpayments from Medicaid, health education, and housing assistance.[6,8] That sentiment is misleading and flawed. For example, a good deal of research is funded by taxpayers’ dollars.

Jen Laws, President & CEO of the Community Access National Network (CANN), isn't buying the AHA's argument. According to Laws, financial assistance and community benefit are different line items on the Internal Revenue Service's Form 990 for a reason. In fact, CANN has been quite vocal on the need for reforms to programs designed to help indigent patients, yet are falling short of that intended goal.

According to Laws, community assumption is a "good faith" definition, but loopholes surrounding hospital-related nonprofit status tax rules inevitably can lead to bad faith in this space, or even abuse. He believes the overwhelming body of evidence surrounding the decline in hospital charity care is in direct opposition of the IRS' intention, namely providing a benefit to needy persons, families, and communities.

Laws said, "For example, our government, namely the IRS, hasn't updated 'community benefit' rules in decades and many no longer apply, like having an open Emergency Room. This gets to the core of CANN's position - honesty is not part of that muddy language. And we need to be frank about that lack of honesty."

It is crucial that community benefit standards are revamped with a focus on charity care that directly benefits those in need. In some states, the difference between the amount of funds spent on charity care and the total tax exemptions the nonprofit hospitals receive is greater than the recorded debts listed on patients' credit reports.[3] Change must come so that needy patients' lives are no longer ruined by being sued by hospitals for outstanding balances as low as $500 or less that they can’t afford to pay.

[1] Levey,N. (2022, June 16). 100 Million people in America are saddled with health care debt. Retrieved from https://kffhealthnews.org/news/article/diagnosis-debt-investigation-100-million-americans-hidden-medical-debt/

[2] Modi, J. (2023, March 21). Nonprofit vs. for-profit hospitals: what’s the difference? Retrieved from https://www.buzzrx.com/blog/nonprofit-vs-for-profit-hospitals-whats-the-difference

[3] United States Senate Health, Education, Labor, and Pensions Committee. (2023, October 10). Mahority Staff Report: 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

[4] 26 U.S.C 501(r)(4), (6); Internal Revenue Serv, Billing and Collections – Section 501(r)(6) (Jul. 13, 2023), https://www.irs.gov/charities-non-profits/billing-and-collections-section-501r6. 

[5] Miller, A., Hawryluk,M. (2023, July 11). As Nonprofit hospitals reap big tax breaks, states scrutinize their required charity spending. Retrieved from https://kffhealthnews.org/news/article/nonprofit-hospitals-tax-breaks-community-benefit/

[6] Wilkerson,J. (2023, October 10). Bernie Sanders bashes nonprofit hospitals over their tax breaks. Retrieved from https://www.statnews.com/2023/10/10/bernie-sanders-nonprofit-hospitals/

[7] Levey,N. (2023, August 16). North Carolina hospitals have sued thousands of their patients, a new report finds. Retrieved from https://kffhealthnews.org/news/article/north-carolina-hospitals-patient-debt-lawsuits/

[8] American Hospital Association. (2023, October). Tax-exempt hospitals provided nearly $130 billion in total benefits to their communities. Retrieved from https://www.aha.org/system/files/media/file/2023/10/Results-from-2020-Tax-Exempt-Hospitals-Schedule-H-Community-Benefit-Reports.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.   

Did South Carolina Just Weaken Patient Choice Protections for Specialty Drugs?

By: Ranier Simons, ADAP Blog Guest Contributor

An undeniable fact with largely universal consensus is that the United States needs healthcare reform. Healthcare reform is an overhauling of the healthcare system to achieve what the Institute for Healthcare Improvement describes as the Triple Aim: “improving the patient experience of care (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of health care.”[1] The Affordable Care Act (ACA) is the most recent attempt to reach the Triple Aim by increasing insurance access, mandating levels of quality, and trying to make healthcare more affordable. The challenge of healthcare reform is that healthcare is a system. By definition, a system has moving components that not only move independently but also are interdependent upon other parts of the system. Regarding healthcare, the moving parts of the system are smaller systems. South Carolina recently attempted to make some positive changes to the healthcare infrastructure in that state, though it is unclear if all the changes will actually benefit patients.

Photo Source: Greenville Legal

It is important to remember that regulation is one tool used to attempt the improvement of the many U.S. healthcare system components. Through legislative regulation, lawmakers try to create frameworks to optimize how various healthcare system component’s function. A significant component of healthcare is prescription medication. Pharmacies, pharmacy benefit managers (PBMs), and insurance plans are several players in the prescription medication system. Presently, the costs and availability of drugs are primarily controlled by PBMs. Insurance companies employ pharmacy benefit managers who control which drugs appear on plan formularies, negotiate the prices insurance plans pay for prescriptions, decide which pharmacies can participate in a plan’s network, and more.[3,5]

While many components within the U.S. healthcare system operate under detailed and enforced regulation, PBMs do not. They are largely unregulated. To maximize their profits, they participate in multiple practices that create challenges for insurance plans, pharmacies, and ultimately patients, driving up costs and creating inefficiencies in patient care.[3,5] South Carolina has been working through legislation to curtail and regulate the activity of PBMs - including Senate Bill 520 (SB520), part of the Pharmacy Audit Protection Act - which was recently passed by the state legislature.[2]

One of many excessive practices by PBMs to drive profit is pharmacy audit. A pharmacist with over 30 years experience providing care to patients living with HIV/AIDS summarized, “Pharmacists are constantly being audited by strong-arm PBMs. They often go after the high-cost drugs and deny claims for minor infractions. It’s a bullying tactic.” SB520 aims to protect pharmacies from unjust audits by PBMs. The bill defines explicitly the structure of what entity can be designated a PBM; it explains what PBMs operationally can and cannot do, defines the rights of pharmacies in general and in the face of a PBM audit, gives patients freedom of choice in utilizing in-network pharmacies, and much more. PBMs use numerous abusive audit practices to drive profit, including audit fees, denying claims for minor clerical errors forcing pharmacies to pay back money for drugs they were reimbursed, and making it difficult for pharmacies to re-bill PBMs after winning audit appeals.

Photo Source: Framework LTC

The bill is essentially a step in the right direction. However, multiple payers lobbied to add verbiage potentially adversely affecting HIV patients and others. Section 38-71-2245, subsection (A) states: “A pharmacy benefits manager may neither limit an insured from selecting an in-network pharmacy or pharmacist of the insured's choice nor deny the right of a pharmacy or pharmacist to participate in a network if the pharmacy or pharmacist meets the requirements for network participation set forth by the pharmacy benefits manager, and the pharmacy or pharmacist agrees to the contract terms, conditions, and rates of reimbursements.”[2]  This section protects patient choice of pharmacists. 

Payers asked for the following verbiage added to the section: 

“Notwithstanding subsection (A), a pharmacy benefits manager may, for specialized delivery drugs, specify requirements for network participation that: (1) directly relate to the ability of the pharmacy or pharmacist to store, handle, or deliver a prescription drug in a manner that ensures the quality, integrity, or safety of the drug, its delivery, or its use; or  (2) relate to quality metrics that affect a pharmacy's or pharmacist's ability to participate, provided that the pharmacy benefits manager applies such terms equally to all network participants. (C) For prescription drugs that qualify as a high-cost prescription drug, subsection (A) of this section does not apply to a pharmacy benefits manager. A high-cost prescription drug is defined as a prescription drug whose current or prior year's annual average wholesale price exceeded 300 percent of the Federal Poverty Level for a single-member household. (D) A pharmacy benefits manager must provide notification of any changes to all applicable specialized delivery drug lists and high-cost prescription drug lists and must make such lists available on a website and upon request to participating pharmacies. A pharmacy may appeal a classification determination to the Department of Insurance.”[2]

The verbiage states that patient choice protections do not apply to specialty or high-cost prescription drugs. In section 38-71-2200, the bill defines specialized delivery drugs as “a prescription drug that meets a majority of the following criteria, as set forth by the manufacturer, FDA, or other applicable law or regulatory body and: (a) requires special handling or storage; (b) requires complex and extended patient education or counseling; (c) requires intensive monitoring; (d) requires clinical oversight; or (e) requires product support services; and the drug is used to treat chronic and complex, or rare medical conditions  (i) that can be progressive; or (ii) that can be debilitating or fatal if left untreated or under-treated.”[2]

Given the broad definition of specialty and high-cost prescription drugs, the bill allows PBMs to manipulate how HIV antiretrovirals and related treatments are filled. The pharmacist consulted on this issue also explains, "It’s a way for PBMs to mandate that these prescriptions need to be filled from their central mail pharmacies. Since most HIV ARVs are oral and do not require special handling, access has commonly been allowed at retail. The high cost is what’s driving this change. Also, most independent pharmacies don’t mind not having to fill these drugs because of the high cost. For HIV-focused pharmacies, these prescriptions and patients will no longer have access to trained pharmacists and relationships with providers… will all go to mail and automation.” 

He further explains that: “In exchange for fewer audits on specialty drugs, since the retail pharmacies won't be filling them anymore, the managed care organizations will allow more access to more regular prescriptions at retail pharmacies, a move that a lot of non-specialty pharmacies like because it allows them to serve more patients. They’re trading away HIV patients for more ‘non-specialty’ patients.”

Photo Source: SNF Solutions

The bill's definition of “specialized delivery” drugs affects other types of drugs as well. Using the example of antibiotics for a UTI for an elderly person, Jen Laws, President & CEO of Community Access National Network (CANN), explains: “Under the requirements set forth, most antibiotics lose efficacy when exposed to high heat, might require education as to contraindications for patients with other co-occurring conditions, will require monitoring for clearance of infection, and these types of infections can be progressive or debilitating in elderly patients. And while this is an extreme example, it is possible under the bill as written. Given payer willingness to abuse carve-outs and loopholes in laws, it's egregious to define ‘specialty’ so broadly, especially as medicine becomes more and more personalized.”

Increased financial burden on HIV patients and providers is another bill outcome. ARVs are not always defined as specialty drugs on formularies, and thus, many times, they are on lower tiers of formularies that only require cost-sharing of fixed lower copays. Since the bill allows PBMs to define all ARVs as specialty drugs, they can move them to higher formulary tiers, which have much higher cost-sharing practices, such as significantly higher copays and coinsurance. This creates a significantly increased out-of-pocket financial burden on patients and covered entities that are covering the 340B patient copay cost.  

Compounding the increased financial burden is the usage of copay accumulators. Patients in the past who used manufacturer copay assistance programs could apply the copay card payments to their insurance deductible and out-of-pocket costs. Presently, many insurers use copay accumulators, which allow the copay assistance programs to pay the copays but do not allow the payments to count towards deductibles or out-of-pocket expense limits. Thus, the insurance companies are essentially being paid twice by requiring the insured to still must pay their deductibles and out-of-pocket limits after exhausting copay assistance cards. Additionally, patients are in danger of being unable to afford their medication since they would be responsible for paying the full price of their medications after the copay assistance was exhausted up until the limits of completely paying their deductibles.[4]

This bill is an example of the challenges of healthcare reform. It is easy for well-intentioned legislation to be tainted by opposing interests. It is imperative to be vigilant about whom we select as legislative representation and stay informed about legislation being written that affects our daily lives.

[1] Institute for Healthcare Improvement. (2023). The IHI Triple Aim. Retrieved from https://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx

[2] South Carolina State House. (2023). S0520. Retrieved from https://www.scstatehouse.gov/sess125_2023-2024/bills/520.htm

[3] Royce, T., Schenkel, C., Kirkwood, K., Levit, L., Levit, K., Kircher, S. (2020). Impact of pharmacy benefit managers on oncology practices and patients. JCO Oncology Practice 16(5) 276-284. DOI: 10.1200/JOP.19.00606

[4] National Conference of State Legislatures. (2023, February 23). Copayment Adjustment Programs. Retrieved from https://www.ncsl.org/health/copayment-adjustment-programs#:~:text=When%20a%20patient's%20health%20plan,out%2Dof%2Dpocket%20maximums

[5] Healthcare Value Hub. (2018, January). Pharmacy benefit managers: Can they return to their client-centered origins? Retrieved from https://www.healthcarevaluehub.org/advocate-resources/publications/pharmacy-benefit-managers-can-they-return-their-client-centered-origins

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.  

Affordable Care Act Marketplace Plans & Drug Benefit Design

By: Ranier Simons, ADAP Blog Guest Contributor

Healthcare insurance policy and finance are not abstract entities relegated to the arenas of political debate and Wall Street discourse. The convoluted machinations of how money flows in healthcare insurance finance affect the bank account of anyone who has ever been prescribed a prescription drug. People living with HIV are very aware of the importance of understanding how insurance operates regarding paying for expensive antiretroviral medications that cost thousands of dollars per month. 

Photo Source: Sciworthy

When choosing insurance plans, one of the most important aspects people living with HIV/AIDS (PLWHA) consider is how or if a particular plan covers their anti-retroviral (ARV) therapy. AIDS Drug Assistance Programs (ADAP) also pay close attention to drug coverage and drug pricing, given that they help provide medications to those who are uninsured as well as those who are underinsured. The Affordable Care Act (ACA) has enabled many PLWHA to access lifesaving medicines. However, the drug benefit design of many qualified health plans (QHP) participating in the ACA Marketplaces can hinder expeditious access to efficacious drugs.

A recent study examined how insurance benefit design affects antiretroviral access. The study focused on the changes in insurance coverage of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Triumeq (dolutegravir/abacavir/lamivudine). These two drugs are first-line single-tablet regimens that have proven to be very effective. The U.S. Food & Drug Administration (FDA) approved Triumeq in 2014 and Biktarvy in 2018. Current treatment guidelines suggest that PLWHA start ART as soon as possible upon diagnosis, same day if possible. However, the study showed that access to novel treatments, such as Triumeq and Biktarvy, is slowed by delayed QHP coverage and benefit design.[1]

Photo Source: Rohan Khazanchi, MD, MPH | Twitter

The study assessed individual and small-group QHPs’ responses to the two new regimens. For the years 2018-2020, researchers examined coverage, cost sharing, specialty tiering, prior authorization (PA), and out-of-pocket (OOP) costs for Triumeq and Biktarvy nationally under QHP’s. Coverage refers to if a plan does or does not offer a drug in its formulary. Cost sharing refers to copays and coinsurance for drugs. A copay is a set fee patients pay for a prescription, whereas coinsurance is a percentage of a drug’s wholesale cost. Specialty tiering is the designation insurance drug formularies give to medications based on their costs. The higher the tier, the more of the costs are passed onto the consumer. More expensive drugs, such as ART, are in the higher tiers. Prior authorization is the bureaucratic process requiring healthcare providers to get pre-approval from a health plan before a drug is prescribed for the patient to qualify for payment coverage.

For 2018, 2019, and 2020, respectively, the study identified 19,533, 17,007, and 21,547 QHPs.[1] Overall, in 2018, 93% of the QHPs covered Triumeq, but only 60% covered Biktarvy. Triumeq coverage increased to 97% in 2019 and decreased to 91% in 2020. Biktarvy coverage decreased to 59% in 2019 but sharply increased to 86% in 2020. Concerning coinsurance, over the entire study period, a higher percentage of QHP’s required coinsurance for Biktarvy than Triumeq. The study also explicitly assessed coverage comparisons in EHE (Ending the HIV Epidemic Initiative) Phase I priority jurisdictions. Overall, across all three years studied, in both EHE and non-EHE jurisdictions, more QHPs covered Triumeq than Biktarvy. Interestingly, Biktarvy QHP coverage in 2020 was higher in EHE jurisdictions (90%) compared to non-EHE jurisdictions (85%). Biktarvy coverage in EHE jurisdictions increased from 74% in 2018 to 90% in 2020 due to increased coverage with coinsurance and copays. The study also found differences in prior authorization requirements. The prevalence of PA requirements for Triumeq was very low (2%, 2%, and 1% for 2018, 2019, and 2020, respectively).[1] PA prevalence was higher for Biktarvy, with 5% in 2018 and 8% in 2019. In 2020 all QHP had eliminated Biktarvy PAs except for 18 plans in Washington State.

Photo Source: HIVinfo

A multi-center, phase 3, double-blind, randomized control clinical trial of treatment naïve PLWHA showed that Biktarvy had the efficacy of viral suppression equal to Triumeq.[2,3] Additionally, it showed that Biktarvy had no evidence of treatment-emergent resistance and was better tolerated gastrointestinal due to its formulation and smaller pill size. Moreover, Biktarvy does not contain abacavir and thus does not require HLA-B*5701 testing making it a good candidate for same-day ARV initiation.[1] 

Evidence-based data showed Biktarvy to be a better candidate for first-line drug treatment for many than Triumeq. Yet, as stated previously, QHPs lagged in coverage of Biktarvy compared to Triumeq, even in EHE priority-1 jurisdictions. There were higher OOP costs given that more QHP’s required coinsurance for Biktarvy, and PA requirements were also initially more frequent for Biktarvy.

The critical takeaway from the study is that QHPs can slow the adoption of new HIV single-pill regimens by non-coverage decisions and other hurdles that limit access.[1] This does not stop at single-pill regimens. Ongoing HIV research continues to produce novel and innovative treatments such as Cabenuva and Sunlenca. Insurance companies base their coverage decisions mainly on the costs of the medications. Strident efforts are needed to create regulations to lower drug pricing. Additionally, cost-sharing measures need to evolve, such as basing patient coinsurance on post-PBM discounted drug prices instead of pre-discounted prices.[1] 

Increasing the pricing of novel and effective medication challenges ADAP’s ability to continue to help people. Additionally, prohibitive OOP costs for patients discourage medication adherence and treatment initiation. Many structural barriers to HIV treatment equality exist. Runaway pharmaceutical pricing and insurance drug coverage that is not scientifically evidence-based should not be amidst those barriers.

[1] Khazanchi, R., Powers, S., Killelea, A. et al. Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018–2020. J of Pharm Policy and Pract 16, 57 (2023). https://doi.org/10.1186/s40545-023-00559-8

[2] Acosta RK, Willkom M, Martin R, et al. Resistance analysis of Bictegravir–Emtricitabine–Tenofovir Alafenamide in HIV-1 treatment-naive patients through 48 weeks. Antimicrob Agents Chemother. 2019;63(5):e02533-18. https://doi.org/10.1128/AAC.02533-18

[3] Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019;33(5):825–32. https://doi.org/10.1097/QAD.0000000000002124

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.