Closing the EHB Loophole: Louisiana Leads, But National Action is Needed

"Jason," a Utah AIDS Foundation client, confronted a brutal truth in the wake of his HIV diagnosis: a healthcare system more interested in profits than patients. Faced with a staggering $3,200 co-pay for his HIV medication—well beyond his financial reach—Jason's plight was exacerbated by his insurance company's implementation of a co-pay accumulator policy. This policy effectively nullified the assistance he once relied on, leaving him stranded without his medication for months. "I felt scared and discouraged when I was told I have a $3,200 co-pay to pick up my HIV meds. I don’t even make that much money each month," Jason shared, his voice a stark indictment of a system failing its most vulnerable. His story, spotlighted by The Utah All Copays Count Coalition, underscores a pervasive issue: patients across the nation are cornered into impossible choices between health and financial ruin, casualties of an insurance industry's practices that blatantly prioritize margins over meaningful care.

Understanding the Problem

Jason's heartbreaking story sheds light on interconnected issues fueling the healthcare affordability crisis: co-pay accumulators and the Essential Health Benefits (EHB) loophole. These tactics have a devastating effect on patient well-being, so let's break them down:

Co-pay Accumulators: A Profit-Driven Scheme at the Expense of Patients

These programs allow insurers to take the value of manufacturer-provided coupons or patient assistance and apply it towards an annual deductible, but not towards a patient's out-of-pocket maximum. This means even with generous assistance, patients can face thousands of dollars in additional costs, forcing them to ration medication or abandon treatment altogether. The numbers reveal the widespread impact:

• The AIDS Institute reports that co-pay accumulator adjustment programs (CAAPs) are present in a shocking 66% of individual Affordable Care Act (ACA) marketplace plans nationwide, with some states showing 75-100% of available plans utilizing these tactics.

Co-pay Maximizers: A Further Threat to Affordability

Insurers are increasingly employing an even more severe tactic known as 'co-pay maximizers'. These programs set a patient's co-pay to the full amount of available assistance, even if it's intended to cover an entire year's medication cost. Unlike accumulators, which prevent assistance from counting towards the out-of-pocket maximum, maximizers essentially 'use up' all available assistance in a single payment. This leaves patients facing the full, often unaffordable, cost of medication for the rest of the year. The combined use of maximizers and accumulators is becoming increasingly common, leaving patients with limited options and magnifying the financial burden of life-saving treatments. A staggering 72% of commercially insured beneficiaries in the United States were enrolled in plans with co-pay maximizers as of 2023, according to a Drug Channels analysis.

This highlights the alarming prevalence of these practices and the immense pressure they place on patients struggling to manage chronic conditions.

The Essential Health Benefits (EHB) Loophole: Insurers Exploit Gaps in Coverage

Under the ACA, states have flexibility in selecting the 'essential' healthcare services that insurers must cover. Some insurers manipulate this system by classifying necessary medications (especially for chronic conditions) as 'non-essential'. This lets them continue using co-pay accumulators and maximizers on these medications, further undermining patient affordability.

• Centers for Medicate & Medicaid Services’ (CMS) data reveals that in many states, critical treatments for chronic disease management are not guaranteed coverage under 'essential' benefits. This means patients could be subject to accumulators and maximizers indefinitely, locked in a cycle of escalating costs even when reaching their out-of-pocket maximums.

The takeaway is clear: these practices prioritize the shareholder profits of insurance companies over the health and well-being of patients, especially those battling chronic and complex conditions.

Federal Action – Progress and Pitfalls

The CMS Notice of Benefit and Payment Parameters for 2025 signals a notable yet incomplete step towards remedying the healthcare affordability crisis. It attempts to close the Essential Health Benefits loophole starting in 2027 by mandating routine, non-pediatric dental coverage as an essential benefit. While seemingly tangential, this amendment serves as a precursor to addressing broader coverage issues, demonstrating the potential to mitigate part of the financial burdens that patients like Jason face. However, it underscores a significant gap in the rule's scope—its silence on co-pay accumulators and maximizers.

Limitations of the CMS Rule Change

The rule change’s failure to directly address co-pay accumulators and maximizers leaves a significant gap in patient protection. These payor-driven barriers systematically undermine patient affordability and access, especially for those managing chronic conditions. The absence of direct action against these schemes allows insurers to deploy cost-containment strategies that, while ostensibly designed to control expenditures, place the financial burden squarely on patients.

This oversight perpetuates financial hardship and deepens healthcare disparities. Accumulator and maximizer practices disproportionately affect marginalized populations, highlighting the limitations of regulatory changes that fail to comprehensively address the complex dynamics of healthcare affordability and access.

Without targeted measures to dismantle these financial mechanisms, efforts to expand coverage and close loopholes may achieve only superficial improvements. A significant portion of the population, particularly those managing chronic diseases, will continue to face insurmountable financial barriers to accessing essential treatments. This situation underscores the need for a more holistic approach to healthcare reform—one that confronts the financial mechanisms impairing patient care and seeks to eliminate systemic practices that prioritize profit over patient well-being.

Court Challenges: A Victory Shadowed by Continued Uncertainty

The battle against co-pay accumulators achieved a notable legal milestone when a federal court ruled these practices violated the Affordable Care Act's mandates. Despite this victory, the landscape remains fraught with ambiguity, largely due to the federal government's tepid response. The government’s retraction of its appeal in 2022, while upholding the court's decision, did not establish a nationwide prohibition on co-pay accumulators, leaving insurers in a legal gray area.

The HIV+Hepatitis Policy Institute has spotlighted the risk posed by the federal government's refusal to enforce the court's ruling against co-pay accumulators, shifting focus instead to addressing insurers' classification of certain drugs as “non-essential health benefits.” While the final 2025 Notice of Benefits and Payment Parameters rule curbs the classification of covered drugs beyond state benchmarks as non-essential, the government's inaction on co-pay accumulators marks a troubling disconnect between legal victories and their practical implementation.

This gap between legal wins and real-world application emphasizes the need for interventions at the state level. Louisiana's SB 210 emerges as a key measure, proposing tangible solutions to bridge the gap left by federal inaction and protect patients from the financial burdens imposed by insurers' exploitative tactics.

State Solutions: Louisiana as a Model

Louisiana's Legislative Response with SB 210

In an assertive move to safeguard healthcare affordability and accessibility, Senator Bob Owen's SB 210 targets the mechanisms of co-pay accumulators and the Essential Health Benefits (EHB) loophole. The legislation mandates comprehensive coverage under EHBs and holistic accumulator protections, ensuring all cost-sharing payments contribute towards the ACA's out-of-pocket maximums.

This legislative approach not only challenges the status quo but also highlights Louisiana's proactive stance in addressing healthcare disparities. By mandating that insurers recognize all federally designated EHB services and medications as essential, SB 210 directly confronts insurers' manipulative practices, ensuring patients receive the comprehensive coverage promised under the ACA.

Addressing the ‘Endless Deductible’

In a letter to the Louisiana State Senate Insurance Committee, CANN President and CEO Jen Laws warns that without robust protections like SB 210, insurers can impose what patients call "the endless deductible." This term illustrates the loophole that allows insurers to employ exploitative accounting practices, negating the ACA's intent to cap patient spending on healthcare. SB 210's provisions aim to close this loophole, ensuring patients are not burdened with exorbitant costs for essential treatments, thus preserving the ACA's core promise of affordable care.

In his letter, Laws reveals that Louisiana's health plan benchmarks do not guarantee coverage for essential cancer treatments such as radiation or chemotherapy, underlining the significance of SB 210. By ensuring that expenditures for such critical treatments are counted towards patients' out-of-pocket maximums, the bill offers a lifeline to those facing the daunting financial implications of treating life-threatening conditions. This measure is pivotal in bridging the gap left by the current healthcare system's shortcomings, providing patients with much-needed financial relief and access to life-saving treatments.

A Blueprint for National Reform

Louisiana's initiative serves as a compelling model for tackling the challenges posed by ambiguous EHB classifications, federal inaction, and exploitative co-pay practices. SB 210's success could inspire a wave of legislative efforts across the United States, advocating for a healthcare system that prioritizes patient well-being over payor profits. This approach highlights the potential for state-level innovations to influence national healthcare policy, paving the way for reforms that ensure healthcare accessibility and affordability for all, especially those living with chronic and life-threatening conditions.

Call to Action

The legislative changes proposed in Louisiana represent a critical juncture in the fight for healthcare affordability and access. To realize the full potential of these reforms, a concerted effort is needed from key stakeholders across the healthcare ecosystem:

For U.S. Policymakers:

Legislators at both state and federal levels must embrace proactive strategies to close the EHB loophole and regulate co-pay accumulator and maximizer use. Crafting and enacting policies that guarantee comprehensive coverage of essential health benefits and ensure all forms of patient assistance contribute towards out-of-pocket maximums are essential steps toward protecting patients from undue financial strain. Supporting state-level initiatives like Louisiana's SB 210 can serve as a foundation for broader national reforms, underscoring the importance of legislative action in safeguarding patient interests.

Healthcare Providers:

Medical professionals and healthcare institutions play a crucial role in advocating for their patients' rights and navigating the evolving insurance landscape. By staying informed about the implications of insurance policies on treatment access and affordability, healthcare providers can better support their patients in accessing the care they need. Engaging in policy discussions and supporting legislative efforts to address the EHB loophole and co-pay accumulator issue are necessary contributions to the broader push for healthcare reform.

Community Advocates and Patients:

The voices of patient advocacy groups and people affected by the healthcare system's complexities are instrumental in driving change. By raising awareness about the challenges posed by the EHB loophole and co-pay accumulators, mobilizing communities to demand reform, and sharing personal stories, advocates can influence policy decisions and encourage insurers to prioritize patient needs. Engaging in public discussions and advocating for policies that protect patients from harmful insurance practices are critical steps in building a more equitable healthcare system.

Actionable Next Steps:

• Reach out to state and federal representatives to express support for policies that ensure comprehensive coverage of essential health benefits and address the challenges posed by co-pay accumulators.

• Educate oneself and others about the impact of the EHB loophole and co-pay accumulators on healthcare affordability and access, leveraging resources and information provided by reputable patient advocacy organizations.

By uniting in the pursuit of meaningful healthcare reform, stakeholders across the spectrum can contribute to a future where healthcare accessibility and affordability are realities for all, especially for those facing chronic and life-threatening conditions. The journey toward closing the EHB loophole and eliminating unfair insurance practices demands collective action and unwavering commitment to patient well-being. Let's join forces to advocate for a healthcare system that truly serves the needs of its patients, ensuring equitable access to essential treatments and protections against financial hardship.

The Growing Burden of Medical Debt for Insured Americans

Health insurance, designed as a financial safeguard against illness and chronic conditions, presents a paradox in America: many insured individuals are burdened by substantial medical debt. This contradiction highlights systemic flaws in our healthcare system, where high out-of-pocket costs, aggressive debt collection by hospitals, and policy gaps create a crisis impacting financial stability, equitable healthcare access, economic mobility, and both financial and health disparities.

The Rising Tide of Medical Debt Among the Insured

Penelope Wingard's experience, a 58-year-old black woman from Charlotte, North Carolina, starkly illustrates the human cost of medical debt for the insured. After her breast cancer treatment in 2014, she faced a new challenge: escalating medical bills. Despite Medicaid coverage during treatment, she found herself uninsured and overwhelmed by costs for follow-up care. "My hair hadn’t even grown back from chemo, and I couldn’t see my oncologist," she recalls, underscoring the immediate financial burden of her illness.

Her financial woes deepened with subsequent medical issues, including an aneurysm and vision problems, leading to tens of thousands of dollars in debt. "It’s like you’re being punished for being sick," Wingard's experience reflects a broader trend affecting many insured Americans - not just the uninsured.

This trend is echoed in recent reporting by The Guardian, showing most hospital debt in the U.S. now involves insured patients, rather than uninsured patients, often due to high deductibles and unexpected out-of-pocket costs. The Kaiser Family Foundation’s 2023 Employer Health Benefits Survey further highlights it, noting a rise in high-deductible health plans, which, despite lower premiums, can lead to significant financial strain during medical emergencies. This change also represents employers selecting benefit designs that shift costs to employees or, more directly, a lower overall value of compensation packages.

Wingard's ordeal and these findings paint a concerning picture of U.S. healthcare, where insurance all too frequently fails to provide adequate financial protection, underscoring the need for a critical reevaluation of insurance structures and policies.

The Role of Hospitals and Aggressive Collection Practices

The medical debt crisis in the U.S. is worsened by many hospital systems, particularly so-called nonprofit hospitals, adopting aggressive debt collection tactics. A Nonprofit Quarterly article highlights that these hospitals, despite tax exemptions, often pursue lawsuits, wage garnishments, and home liens, exacerbating patients' financial woes.

The Human Rights Watch report, "In Sheep’s Clothing," reveals that about 60% of U.S. community hospitals are tax-exempt nonprofits, yet they spend significantly less on charity care than they receive in tax benefits, raising questions about their commitment to community service.

Additionally, the decline in charity care, vital for both uninsured and insured patients facing high out-of-pocket costs, is alarming. Hospitals' aggressive pursuit of unpaid bills, including legal actions and debt sales, seemingly contradicts their community-serving role and intensifies the medical debt crisis.

In response, legislative measures like New York State's Fair Medical Debt Reporting Act are emerging. This law, preventing hospitals from reporting unpaid medical debts to credit agencies, marks progress towards protecting patients and signals a shift towards more ethical debt management practices in healthcare.

Policy Gaps and the Need for Reform

The Affordable Care Act (ACA) and Medicaid Expansion stand as monumental efforts to increase coverage. Yet, the persistence of medical debt among the insured underscores a critical disconnect between policy intentions and real-world outcomes.

The ACA and Medicaid Expansion: Coverage vs. Cost

While the ACA and Medicaid Expansion have expanded healthcare access, they often fail to protect individuals from medical debt due to rising out-of-pocket costs. The Peterson-KFF Health System Tracker Brief indicates that the ACA’s maximum out-of-pocket limit is increasing faster than wages, burdening insured individuals with escalating healthcare expenses.

High-deductible health plans (HDHPs) exacerbate this affordability crisis. These plans, with lower premiums but higher initial costs, are increasingly common. The Kaiser Family Foundation’s 2023 Employer Health Benefits Survey shows a rise in HDHP enrollment, leading to significant debt for families as they pay more out-of-pocket before insurance coverage starts.

Coverage limitations under the ACA also contribute to this issue. Essential health benefits vary by state and plan, often leaving gaps in coverage for critical services like mental health or certain prescriptions. This variability, coupled with high deductibles, results in insured individuals facing substantial medical debt, contradicting the purpose of insurance.

Addressing this requires reevaluating health insurance structures and regulatory frameworks to balance affordable premiums with comprehensive, consistent coverage, reducing the risk of overwhelming medical debt for insured individuals.

Commonwealth Fund's 2023 Health Care Affordability Survey: Key Insights

The Commonwealth Fund's 2023 Health Care Affordability Survey reveals more than statistics; it highlights the real struggles of Americans with healthcare costs. The survey underscores the healthcare affordability crisis, showing that insurance doesn't always shield from financial burdens.

A major finding is the impact of high deductibles and copayments, which consume a significant part of many people's incomes, forcing tough choices like delaying medical care or incurring debt. Particularly affected are lower-income families, those with chronic conditions, and older adults, who often face a cycle of debt and deferred care, worsening health disparities.

The survey also points to a trend of underinsurance, especially in employer-sponsored plans with high deductibles, leaving many at financial risk. These insights call for urgent policy reforms to make healthcare truly affordable, focusing on reducing out-of-pocket costs, restructuring insurance plans, and enhancing subsidies for those in need.

State-Level Initiatives: Pioneering Change

States are at the forefront of combating medical debt with innovative solutions. The Commonwealth Fund State Protections report highlights diverse strategies to mitigate medical debt's impact.

Key initiatives include laws to limit aggressive hospital debt collection practices, crucial for protecting vulnerable groups like low-income families and those with chronic conditions. Some states have set legal boundaries on pursuing unpaid medical bills and capped interest rates on medical debt.

Expanding eligibility for charity care and financial assistance is another significant move. This broadening ensures more people, particularly those with limited resources, can access medical care without the fear of crippling debt, thereby improving community health outcomes.

States are also focusing on enhancing transparency in medical billing and insurance coverage, ensuring patients have clear information about service costs and their financial obligations. This clarity is essential for informed healthcare decisions and avoiding unexpected bills.

Furthermore, states are strengthening consumer protection laws to defend against unfair medical billing practices, holding providers and insurers accountable for billing errors and offering patients better dispute resolution options.

These state-level actions, varying in scope but united in purpose, demonstrate encouraging progress toward a more equitable healthcare system. They address not only the symptoms of medical debt but also several of the root causes, paving the way for broader healthcare reforms. These initiatives, alongside federal efforts, are shaping a future where healthcare affordability is accessible to all, not a privilege for a few. State governments' role in this fight is pivotal, with their policies and programs serving as models for national reform and effective strategies to alleviate medical debt.

Federal Actions: A Unified Approach with Enhanced Consumer Protection

Federally, initiatives like the White House Convening on Medical Debt and the Consumer Financial Protection Bureau's (CFPB) plan are key in combating medical debt. These efforts merge federal oversight with state innovation, addressing medical debt's complexities.

The White House Convening united federal and state policymakers, healthcare experts, and advocates to strategize on reducing medical debt and improving healthcare policies. This meeting was pivotal for sharing insights and identifying best practices for nationwide implementation, recognizing medical debt as a multifaceted issue.

Additionally, the CFPB's plan, noted in a National Consumer Law Center (NCLC) announcement, marks a significant move towards consumer protection. It proposes prohibiting medical debts from being reported on credit reports, a major relief for those burdened by medical debt. This initiative is widely supported by consumer groups and reflects an understanding of the disproportionate impact of medical debt on financial stability.

The collaboration of federal agencies like the Department of Health and Human Services, the CFPB, and the Centers for Medicare & Medicaid Services is crucial in formulating effective healthcare policies. Their joint efforts are expected to lead to comprehensive strategies that significantly alleviate the burden of medical debt.

This federal approach, emphasizing interagency cooperation and stakeholder engagement, is helping to create policies and practices that effectively reduce medical debt, integrating federal oversight with state-level innovation and consumer protection measures like the CFPB's plan. This integrated strategy is essential for relieving American families of medical debt and advancing towards a more equitable healthcare system.

The Blind Spot: Medical Credit Cards

Despite the good intentions of these proposals, a “blind spot” persists and more and more hospital systems are taking advantage of it by pressuring patients to agree to take on “medical credit” debt, prior to providing services - even in emergency departments. The most popular of these programs is known as “Care Credit” and the American public assumed some $23 billion in medical credit card debt across- more than 11 million users from 2018 through 2020. Unlike traditional medical debt, these medical credit programs accrue interest and do not qualify for financial assistance or charity care. They result in as much if not more damage to patient-consumer credit reports as traditional medical debt.

Once primarily limited to dental costs, which are not a required covered benefit for adults, the company that owns Care Credit says it believes patients typically generate this debt through “elective procedures”. However, patients urged to accept credit based medical debt in an emergency room or when facing cancer care or even in seeking dental care for an infected tooth may not feel these procedures are “elective” and the financial institution is not necessarily going to operate with the same definitions the general public would. Indeed, it does not serve Synchony’s interests to do so. In fact, Synchrony partners with multiple provider associations and as of 2023 with at least 17 hospital systems or about 300 hospitals but, when interviewed, refused to provide details because those agreements likely include “sponsorships” or what would otherwise be called a kick back scheme. That scheme structure is very likely prohibited by federal law protecting patients of public health programs like Medicare from providers and their affiliates that would take advantage of needy or elderly patients.

Once assumed as a means of paying for medical care, medical credit card debt reports just like traditional credit card debt and patient-consumers are no longer protected from those specific protections policymakers are considering now.

Conclusion and Call to Action

It's evident that this crisis is not just financial but a moral and systemic failure. The experiences of individuals like Penelope Wingard and findings from the Commonwealth Fund's 2023 Health Care Affordability Survey underscore the need for compassionate healthcare reform.

Policymakers, healthcare providers, patient advocates, and citizens must unite to address this crisis's root causes and reshape our healthcare system.

For Policymakers:

• Implement policies that go beyond expanding coverage to ensure affordability and accessibility.

• Reassess high-deductible health plans and their impact on families.

• Mandate comprehensive coverage in health plans, including closing the essential benefits loophole and ensuring network parity for services like mental health and chronic disease management.

• Enforce regulations ensuring hospitals commit to community-serving mandates, particularly in providing sufficient levels of charity care to justify nonprofit status. This can be implemented on both the state and federal levels.

For Healthcare Providers and Institutions:

• Prioritize ethical patient care over financial gains.

• Establish transparent billing practices and expand charity care programs.

• Collaborate with community organizations to identify and support vulnerable patients.

• Train staff in empathy and patient advocacy, focusing on the human aspect of healthcare.

For Patient Advocates and Community Members:

• Support legislation that protects patients from aggressive debt collection and unfair billing.

• Educate communities about their rights and resources regarding medical debt.

• Partner with local health systems to develop patient-centered care models.

For All Stakeholders:

• Collaborate to create a healthcare system that balances efficiency with empathy, justice, and accessibility.

• Strive to make medical debt a rarity, ensuring healthcare access for all, regardless of insurance status.

• Remember the human element in healthcare.

We possess the knowledge and resources to drive change. Let's collectively push for policies that safeguard the vulnerable and work towards a healthcare system where access is a right, not a privilege. The time to act is now and it is past time that our state and federal policymakers evaluate their allegiance to hospitals systems abusing government programs, the dollars that support those programs, and the patients those dollars are meant to benefit.

Jen’s Half Cents: Attacks on Abortion and Trans Care are Attacks on Medication Access

Coming into HIV advocacy, I was quickly introduced to this idea that access to life saving and life improving medications is a human right, best public health practice, and a public policy goal, something all stakeholders, public and private, held “on high” and were working toward. Everywhere I turned, “we must ensure access to life saving and quality of life improving medications”. I mean everywhere. This mantra was hammered home to me because antiretrovirals are medications that both save lives and improve the quality of life for people living with HIV and, thanks to the advent of pre-exposure prophylaxis (PrEP), people at risk for acquiring HIV. It is often the firm position of HIV advocates that restricting access to these medications is threat to life and quality of life and any such restrictions are an assault upon our lives. We fight day in and day out for programs and policies that safeguard access to care (medication and services). Every advancement is a fight and we have to muster up the same, very old arguments about the value of a patient’s life always being greater than the dollar sign attached to a medication.

That core piece is access to medication.

As the previous presidential administration issued rules that restricted international funding for those entities providing abortion services or referrals, I got antsy. Increasingly nervous and frustrated. In 2019, quite predictably, advocates confirmed those rules found impact primarily by reducing international aid to HIV services. Those rules also included one that required international partners to pledge to “denounce” sex work, a rule the Supreme Court upheld. Similarly, a whole slate of domestic policy moves sought to limit access to non-discrimination protections provided to people who sought or had an abortion and those who provided or referred a patient to abortion services. Those same rules sought to exempt transgender people and our care from non-discrimination protections. Of an important note: most abortions in the United States are medication abortions, not surgical.

If you’re new to these issues, let me help some. One of the first and most prominent methods of gender affirming medical care is by accessing medications falling under an umbrella of “hormone replacement therapy”, almost all of those medications are approved by the Food and Drug Administration and none of them have a specific indication to include gender affirmation (even cisgender folks – here’s looking at every old, cis guy who uses testosterone to feel young again). However, because medical experts generally agree these medications meet the needs of patients experiencing a wide variety of conditions, these medications are typically able to be written “off-label” or outside of their FDA approved indication. After years of advocacy and some last-minute push from the Obama administration regarding the Affordable Care Act’s Section 1557 (the non-discrimination provision of the law) , most private payers began covering some very basic transition-related hormone therapies (they were covering cisgender men seeking testosterone and other medications related to sexual performance for decades prior). The same rule prohibited covered entities from discriminating against people who had abortions, wanted abortions, or performed abortions. But Reed O’Connor, a long-time villain in the fight to defend the ACA, said “no” on the last day of 2016 and the guys who left the White House in 2021 agreed with him.

So here we are with this groundwork, this public health understanding that when people need care, they need as comprehensive care as they can get – as close to “one-stop-shop” as possible. And that’s true especially for people and communities experiencing the greatest disparities in health outcomes. Well-known among HIV advocates are the disproportionate number of women of color and transgender people living with and being diagnosed with HIV. The one thing all of these people, these patients need is medication access.

I need to not mince words, access to abortion is absolutely an issue of life improving care for someone who isn’t ready or doesn’t want a child. Adoption is not an option for a person who does not wish to complete a pregnancy and forcing them to do so by criminalization or by way of policy is state-sponsored seizure of that person’s body. Forcing a trans person (youth or adult) by criminalization or by way of policy is state-sanctioned violence. Denying people access to the medications that help them maintain their lives and the lives they wish to live is, at its core, an egregious attack on medication access.

Indeed, the next process-driven attack on the ACA is being pursued by plaintiffs that claim “moral injury”, if they should have to cover PrEP or contraception – issues of medication access. Kelly v. Beccera is, once again, in front of our previously mentioned judge, Reed O’Connor. We already know how this is gonna go. Meanwhile, we’re waiting on SCOTUS to decide the fate of Roe v. Wade (and possibly Casey), states are in the middle of a fight to beat everyone else to the punch. From proposing legislation that would criminalize access to abortion pills, to passing laws that criminalize providing gender affirming care to people under the age of 18, to passing laws that protect a person’s right to abortion and several states proposing bills that would protect families seeking safe-haven in order to provide children with gender affirming care, the landscape of US health care is becoming very fractured and much like some horror story of a wild west shoot out. Take a moment to ask if a state passes a law designed similar to Texas’ S.B. 8, wherein a private actor may sue a person for seeking or performing an abortion, that person runs to a state protecting those rights – or a parent ensuring their child is getting gender affirming care – exactly where does that fall? That’s not conjecture – how many families do you personally know who can afford the legal fight over jurisdiction?

Sure, we know where the executive branch of the federal government is gonna fall on this, at least until early 2025. But what then? Hope for the best?

HIV service providers need to get good with identifying quality lawyers and establishing relationships with their local or state queer and abortion advocacy organizations. And HIV advocacy needs to leverage our power to assist and uplift, not usurp, this issue. At the core of our work, we’ve maintained access to life saving and life improving medication is a must. We must not fail that mission now.

CMS Sides with the Devil: Insurers’ Co-Pay Accumulators Remain…for Now

The Affordable Care Act (ACA) was revolutionary in how prescriptive statutory language was in ensuring health insurers (payers) covered costs associated with pre-existing conditions, if they accepted even a penny of federal funding. The trade off was a simple theory: “cover more people and their entire health and we’ll make sure you’re still profitable”. There were hundreds of pages of caveats, definitions, incentives for public programs, pharmaceutical research, and regulatory authority passed to state and federal agencies. Everyone got a piece of the pie to the end benefit of Americans for whom health care had been out of reach for the majority of their lives. We would be healthier together by simply providing people the care we need and reducing overall costs. However, as these things go, payers are creative and pay their lawyers handsomely to find ways around that basic agreement. As payers fight to “contain costs”, co-pay accumulator programs are one of the most disingenuous methods to limit consumer access to quality care and pad payers profit margins.

From issues of discriminatory plan design, or making consumers pay the highest cost-sharing for medications which are only used to treat certain conditions like HIV, to limiting provider networks in such a way that a patient requiring a surgery or emergency care results in surprise bills to toxic practices known as “utilization management” (including, but not limited to, abusive prior authorizations and step therapy, also known as “fail first”), payers have paid their lawyers quite well to find loopholes or design new problems in order to maintain their profits. The ACA’s medical loss ratio (MLR) rule, also known as 80-20/85-15 rule (in general requiring 80% or 85% of a plans premiums to actually be used on costs of care or pay back to balance to consumers) has resulted in a startling 2 billion dollars to be paid back to consumers in 2019 alone. But the rule doesn’t necessarily count other income payers can produce by way of cost-sharing or deductible payments, co-pays (a fixed price typically paid after deductibles are met for care and medications), and – now, more commonly – “co-insurance” (a percentage price typically paid after deductibles are met for care and medications) as part of that rule. The result is consumers and those who would like to see us get the quality, individualized care we need are being put on the hook for payers’ greed.

Patient advocacy often has interesting bedfellows. And at the intersection of our care interests and that of industry, pharmaceutical manufacturers have found what can arguably described as a somewhat socialist model by way of patient assistance programs, often enacted as co-pay card or discount programs aimed at directly benefiting patients by taking care of the patients’ share of a medication’s cost. These programs are quite frequently limited by income or if a person is insured. The idea being to make sure the most costly medications make their way into the hands of the people who need them most and can least afford them. In this, our interests as patients absolutely converge with that of manufacturers. We want quality therapies made available to us. However, when a medication “goes generic”, often these programs are no longer available as a less costly, generic medication is preferred by the payer unless a patient fails that particular medication (see: step therapy, “fail-first”). The problem is generic medications are not held to extraordinarily strict requirements for Food and Drug Administration (FDA) approval that brand name medications are held to. Indeed, earlier this year, Vice offered a fantastic explanation of the problem with preferencing generic medications by payers (both public and private) is harmful to patients and why our generics “approval” process is a threat to the health and safety of patients. It’s no wonder, with the lax oversight of generic medications and the offer of payment assistance from manufacturers that patients would want access brand name and newer medications on the market.

One of the most amazing benefits of patient assistance programs is, in theory, because they’re meant to cover the patient’s cost-sharing obligations, these out-of-pocket (OOP) costs should apply to the patient’s deductible and OOP maximums and reduce the cost burden to patients for future care throughout the plan year. Right?

Wrong.

Payers have near uniformly adopted a practice known as “accumulator adjustment programs”, or co-pay accumulators, in which a payer basically says to a patient and a manufacturer “all for me, none for thee”, taking the entirety of the benefit offered by a patient assistance program and not crediting the patient with those funds received against the patient’s deductible, co-pay or co-insurance, or out-of-pocket maximums. To boot, manufacturers have zero control over this practice and often don’t know when it’s happening until a patient complains about the experience. Payers justify this move as “cost-containment” and disincentivizing patients from seeking more costly medications – which translates to newer, more effective, safer medications (go back to the problem with generic approvals above).

So far, the Centers for Medicare and Medicaid Services (CMS), the primary authority in which payment rules are issued from the federal government to payers, have generally made extraordinary effort to ensure protect the interests of patients and those who align with our interest. In the instance of CMS’s newest rebate rule, CMS chose to side with payers for some inexplicable reason. The rule states pharmaceutical manufacturers, not payers, would have to count these direct-to-consumer assistance programs among “best price” calculations, which govern Medicaid rebate price setting or what the government pays for a medication, if a patient didn’t receive 100% of the benefit of the assistance program. Previous rules on what to consider in calculating “best price” were generally limited to prices negotiated within industry movers inside the supply chain, not that of end users. The theory goes like this: “if ultimately this assistance program is paying an insurer’s bottom line and not helping patients, then it should be considered a price you (manufacturers’) negotiated. You were planning for that in setting your prices anyways, right?” Pop quiz answer: wonky negotiations with payers is not what manufacturers were planning on in designing income limited, only-accessible-by-consumers-asking for-it assistance programs. The solution CMS offered was for manufacturers to ensure patients received the intended benefit by requiring patients to pay for a medication up front and then ask for reimbursement – a process that only makes medication access and affordability infinitely more complicated and burdensome for patients.

In the end, CMS decided that in response to an excessively abusive payer practice that disadvantages patients, the answer was to create further barriers to accessing care for patients rather than to reduce them.

Let’s make this real and “back of the envelope” this practice in terms of realized patient experiences:

Monthly Income: $2,583 (based on average US income in 2019 provided by the Census Bureau)
Monthly premium: $304 (lowest cost local silver deductible is $3,400, OOP maximum is $8550, co-insurance is 20-40%)

Absent a public payer intervention, co-pay accumulators might allow a patient assistance program to cover the estimated $600 per month co-insurance would demand for a certain medication, however, I’m not likely to meet my deductible or maximum OOP for the year at all. With local rent costing about $1000 per month, a car payment and car insurance in order to work (there’s no meaningful public transit in the vast majority of the country), food costs, utilities, etc. Even with federal subsidies provided via the health care market place, every month, I’m in the negative. Which means I can’t afford to see my doctor or get my quarterly labs, which means I can’t get my medication in the first place.

However, without the application of a co-pay accumulator, accessing just 3 month’s worth of a patient assistance program would meet my deductible and maximum OOP costs for the year. I don’t have to worry about at least $200 per month in medical costs. And one less financial strain is off my shoulders.

For the vast majority of us, our medications are not a luxury item. They’re not something we can afford to pay for up front and mail-in a rebate request and wait months for. In doing so, CMS not only suggests an increase to the paperwork burden on patients and manufacturers alike, CMS also seeks to increase barriers to accessing life saving medications to begin with.

All to the benefit (read: profit) of payers. So it’s no wonder the trade organizations, Pharmaceutical Research & Manufacturers of America (PhRMA) chose to initiate a lawsuit to halt the implementation of CMS’s backwards and punitive rule.

While patient advocates may spar readily about the role of industry among advocates, we should also recognize actions that align with our own interests on their face. Yes, PhRMA may be leading up this suit - and CMS should listen to the needs of patients, reverse course, and voluntarily pull this rule.

What a Narrowly Divided Senate Means for Health Policy

On January 5th, Reverend Raphael Warnock and Jon Ossoff defeated Senators Kelly Loeffler and David Perdue in the Georgia Senate run-off elections, respectively. Democrats narrowly winning both Georgia Senate seats also means Democrats have narrowly won the Senate, dividing seats 50-50 between members who caucus with Democrats and Republicans with Vice President-elect Harris empowered to cast any tie-breaking votes and handing the incoming Biden administration a unified government.

While those with lofty ambitions on policy and legislative issues are cheering, there’s good reason to consider the need for moderating what can be expected from the 117th Congress: Democrats aren’t always on agreement on major issues like direct payment amounts as part of COVID relief or Medicare For All. The Biden administration will likely need to rely heavily on the regulatory powers allowed to federal agencies – which makes the prospective appointment of Xavier Becerra to lead Health and Human Services make more sense than it perhaps did on the surface. After all, who appoints an attorney to lead a health care agency?

The Trump administration made dramatic regulatory moves with regard to health care, targeting non-discrimination rules in health care, the Affordable Care Act including attempting to get the legislation declared unconstitutional by the Supreme Court, drug pricing, and championed legislative changes eliminating individual mandate penalty. While a judge has already temporarily blocked Trumps’ effort to tie drug prices to that of other nations’ prices and the Supreme Court has given the green light to recently-revived Food and Drug Administration rules on abortion pill access, these issues are regulatory in nature. The Biden administration could simply choose not to defend these moves in court change these regulations. While state push back is likely, a lack of Congressional challenge against these moves may help smooth the way for institutional changes.

It’s largely expected that among Biden’s first moves regarding health care will include expanding COVID relief measures and vaccine distribution plans, rescind the Mexico City policy (also known as the “Global Gag Rule”), “expand[ing] access to high-quality health care for Lesbian, Gay, Biden, Transgender, and Queer+ individuals” (or moving quickly to rescind the “Provider Conscience” rule), and reversing the 23% rate cut to 340B entities. With the help of a unified House and Senate, among Biden’s first accomplishments may be a legislative “fix” to the Affordable Care Act challenge awaiting ruling from the Supreme Court. Other campaign promises from Biden include seeking legislation to end HIV criminalization and increasing research into harm reduction models, expanding syringe services programs, and substance treatment funding – an issue Biden has evolved on and largely due to bearing witness and supporting his son through.

Other moves to watch for:

Strengthening the Affordable Care Act:
                - A regulatory move recalculating and increasing subsidies for Marketplace plans
                - Restoring Marketplace Navigator funding
                - Returning the open enrollment period to 90 days
                - Rescinding a proposed rule on 1332 waivers allowing states to opt-out of the Marketplace
                - Changes to regulations regarding short-term policies and association health plans (including reduced allowable coverage periods and requiring coverage of pre-existing conditions, including pregnancies, HIV, HCV, and transgender identity among others)
                - Reduce documentation burden for subsidies and Special Enrollment Periods
                - Expand the definition of qualifying life events and rules regarding special enrollment periods
                - Enforce mental health and substance abuse coverage parity
Strengthening Medicaid:
                - Rescind, reject, and stop defending 1115 waivers seeking work requirements
                - Encourage 1115 waivers to include the impacts of increasing coverage
                - Revise increased eligibility verification for Medicaid
                - Encourage policies regarding presumptive eligibility outside of hospitalization and emergency situations
                - Review and revise reimbursement schedules for Rural Hospitals
LGBTQ Health Equity:
                - Issue guidance and seek funding to address mental health services and support staff in schools
                - Reinstitute and/or strengthen Obama era guidance regarding transgender students and Title IX protections
                - Revise and strengthen Affordable Care Act, Section 1557 non-discrimination rules protecting women, Lesbian, Gay, Bisexual, Transgender, and Queer people, and people living with pre-existing conditions like HIV or HCV (in which the Trump administration would allow payers and providers to refuse care
                - Rescind the Trump era ban on transgender people serving in the military
                - Reverse or rescind Trump era “religious conscience” applying to civil rights laws – use regulatory power to include Lesbian, Gay, Bisexual, Transgender, and Queer people in civil rights protections in health, housing, and labor
                - Expanding data collection policies to include sexual and gender identities

While some may view the heads of regulation making agencies as “unelected officials”, in many ways, who we elect to be the executive is very much choosing who leads the agencies that impact our lives on a daily basis. There is much work to do for the Biden administration on the regulatory front and unified, carefully crafted legislation speaking to these issues may well help cement these changes beyond political party ping pong.