Healthcare in the Lame Duck
Lawmakers have returned to Washington for what many observers predict will be a subdued lame duck session. With former President Donald Trump set to return to the White House in January 2025 and Republicans poised to control both chambers of Congress in the new session, the current Democratic-led Congress faces tough decisions about which healthcare priorities can realistically advance before the year ends. Given these shifting dynamics and a continuing resolution set to expire on December 20th, many healthcare stakeholders are closely watching to see if a handful of critical policies—ranging from Medicare telehealth extensions to community health center funding—will receive even short-term relief.
Multiple programs tied to patient access and affordability are slated to expire on December 31, 2024. These include expanded Medicare telehealth flexibilities, community health center (CHC) funding, and measures preventing Medicaid Disproportionate Share Hospital (DSH) payment reductions. Efforts to stabilize Medicare physician payments, address pharmacy benefit manager (PBM) practices, and implement site-neutral payment reforms are also on the table. However, the political uncertainty, combined with constrained legislative days and an incoming administration that may set different healthcare priorities, create a complex landscape for deciding which items are addressed before the new year.
The Broader Political Context
The upcoming change in leadership is already influencing legislative calculations. Republicans, who will soon have unified control in 2025, may choose to defer major reforms or costly extensions until they can shape policy more extensively under the incoming Trump Administration. Analysts suggest that lawmakers will likely focus on minimal, must-pass measures to keep essential programs afloat while leaving more sweeping changes to the next Congress.
Several sources point to a “lamer-than-usual” lame duck session, with meaningful healthcare legislation potentially limited to urgent deadlines. The December 20th government funding cutoff provides a possible vehicle for limited healthcare fixes. Short-term extensions—buying mere months, rather than years—are a likely reality. During this time, people living with chronic conditions, those receiving services at safety-net providers, and people living in rural areas risk seeing uncertainty in care continuity if Congress cannot secure even interim solutions.
The incoming administration’s planned appointments to health agencies and global health leadership changes could realign federal priorities. While the previous administration’s approach emphasized a strong response to public health emergencies, the incoming leadership has signaled greater skepticism toward traditional vaccine policies and may focus less on infectious disease prevention, shifting attention toward other areas of healthcare. As a result, the current Congress may feel pressure to secure patient protections now, anticipating policy moves in 2025 that could reduce certain resources or alter public health strategies.
Must-Pass Healthcare Extensions: Preserving Patient Access Before 2025
Medicare Telehealth Flexibilities
One of the most urgent healthcare priorities involves extending Medicare telehealth flexibilities set to expire on December 31st. Initially expanded during the COVID-19 public health emergency, these provisions have allowed Medicare beneficiaries—including those in rural and underserved communities—to receive certain types of care without the geographic and site restrictions that once applied. The expansion has played a significant role in maintaining continuity of care, especially for behavioral health and chronic disease management services. A House Energy & Commerce Committee proposal would extend these provisions for two years, enabling policymakers to gather more data on telehealth’s cost and quality impact.
A permanent expansion faces a cost barrier. While telehealth enjoys bipartisan support, the price tag remains a challenge to achieving a long-term fix. Thus, a short-term extension appears the most likely outcome. If Congress allows the telehealth provisions to lapse, people who have integrated virtual visits into their healthcare routines—particularly for managing conditions such as HIV—might lose access to services they have come to rely on. This would create new hurdles for maintaining adherence to treatment regimens and managing ongoing care.
Medicare Physician Payment Stabilization
Another pressing issue involves Medicare physician payment rates. Under the current trajectory, doctors face a 2.83% pay cut in 2025—a continuation of multiple consecutive years of reimbursement reductions. Physician groups and bipartisan coalitions in Congress support a Medicare payment stabilization bill that would offset these reductions. Yet cost considerations and the search for budgetary offsets loom large.
Some policymakers view site-neutral payment reforms—discussed later—as a potential “pay-for” to fund these physician payment patches. The prospect of linking physician payment relief with spending cuts elsewhere may shape what Congress accomplishes now. Without a temporary fix, physicians in rural and lower-resource areas might limit the number of Medicare beneficiaries they see, potentially shrinking access to care just as winter months and other public health challenges approach.
Community Health Centers and Safety-Net Providers
CHCs, serving roughly 31 million people, face potential disruptions if their funding authorization expires at year’s end. According to George Washington University research, CHCs often operate on thin margins and rely heavily on federal support. Any gap in funding could mean reduced primary care services, delayed hiring or retention of medical staff, and less capacity to serve people who rely on these centers as their primary healthcare access point.
Medicaid DSH payments, which help hospitals serving people with lower incomes and those living in poverty, also face cuts. Without legislative action, an $8 billion reduction in DSH payments could take effect. Advocacy groups and hospital associations warn that this could erode crucial parts of the healthcare safety net, limiting services at facilities that care for populations disproportionately affected by chronic conditions and economic instability.
The lame duck session provides a narrow window to secure short-term extensions, preserving CHC and Medicaid DSH programs into early 2025. Lawmakers must balance competing priorities, including the need for cost offsets, making it uncertain whether robust, multi-year reauthorizations are possible. With Republicans waiting to implement their policy vision next year, the likely outcome may be modest stopgaps rather than a long-term solution.
Uncertainty for Other Key Programs: Ryan White and PEPFAR
Beyond the well-known year-end deadlines, advocates are also paying attention to larger federal programs that were previously reauthorized but now continue largely through appropriations. The Ryan White HIV/AIDS Program and the President’s Emergency Plan for AIDS Relief (PEPFAR) have historically enjoyed bipartisan support, delivering life-saving care, treatment, and prevention services for people living with HIV in the U.S. and abroad. However, as the next Congress and Administration look to reduce spending, longstanding programs that rely on continued federal investment but lack recent formal reauthorization could come under scrutiny.
Advocates fear that with a new majority eager to trim budgets and revisit healthcare spending priorities, both Ryan White and PEPFAR could face more critical examination. While no immediate action on these programs is expected in the lame duck session, their future stability may depend on how the incoming leadership chooses to address them in the months ahead. This uncertainty raises concerns in public health communities that rely on these programs to maintain progress in HIV prevention, treatment retention, and global health collaborations.
PBM Reform and Drug Pricing: A Fleeting Opportunity?
Pharmacy Benefit Managers have drawn increasing scrutiny from Congress for pricing practices that, according to some analyses, drive up medication costs and limit access to necessary prescriptions. There has been a rare display of bipartisan interest in addressing PBM transparency. The House-passed Lower Costs, More Transparency Act—referenced by Mercer—offers a framework for imposing new reporting requirements on PBMs and prohibiting certain practices like spread pricing in Medicaid.
Recent Federal Trade Commission (FTC) actions against the largest PBMs underscore these concerns. The FTC’s administrative complaint alleges that PBM rebating structures inflate medication costs, impairing access to more affordable alternatives. Policymakers, patient advocates, and public health officials have pointed out that PBM practices may particularly affect people living with HIV and other chronic conditions, who depend on stable access to medications. Restrictions like mandatory mail-order pharmacy rules can disrupt continuity of care, especially for those who require regular medication management.
Still, significant PBM reforms may not pass during the lame duck session. Republicans may prefer to tackle drug pricing and PBM oversight under their upcoming majority, potentially shaping legislation more to their liking. If any PBM-related measures pass now, they will likely serve as incremental changes or as offsets for other healthcare priorities rather than representing the comprehensive reform that some lawmakers and patient advocates seek.
Site-Neutral Payment Reforms: A Budgetary Lever
One of the most closely watched and potentially transformative policy changes up for discussion involves site-neutral payment reforms. Current Medicare regulations often allow higher reimbursements for services delivered at off-campus hospital outpatient departments compared to physician offices or ambulatory surgical centers. Hospitals justify these higher rates based on overhead and regulatory requirements, but policymakers, backed by advisors like the Medicare Payment Advisory Commission (MedPAC), have increasingly called for aligning payments across settings to reduce unnecessary spending.
According to Modern Healthcare reporting, robust site-neutral legislation could save over $100 billion over ten years. This makes the policy attractive as a funding mechanism—lawmakers can use those savings to pay for other priorities like extending telehealth, stabilizing Medicare physician payments, or preserving safety-net funding.
In previous Congresses, only modest site-neutral measures advanced. However, the political environment has changed. Analysts note that with a unified Republican government in 2025, policymakers may be more inclined to pass significant site-neutral reforms to secure long-term savings. During the lame duck session, a narrow measure included in the bipartisan Lower Costs, More Transparency Act—requiring site-neutral payments for certain drug administration services—could move forward as a pay-for. This smaller step might pave the way for broader reforms next year.
Hospitals, supported by the American Hospital Association, strongly oppose site-neutral policies, arguing these cuts would limit their ability to provide comprehensive services. Some advocates worry that reducing hospital outpatient department payments could disproportionately affect rural and underserved areas, threatening access to care if hospitals respond by consolidating or reducing less profitable services. Congress must weigh these concerns against the promise of substantial cost savings. Whether any notable site-neutral measures pass now or wait until next year remains uncertain.
The Upcoming Administration: Implications for Public Health Priorities
By early 2025, incoming administration appointees will shape federal healthcare priorities. As PBS NewsHour reports, the Administration’s picks signal possible skepticism toward established vaccine policies and a shift in public health approach, potentially reducing the emphasis on infectious disease prevention that guided previous eras. Meanwhile, experts warn that changes could weaken U.S. influence on global health initiatives.
This shifting focus could impact ongoing campaigns to address HIV and other chronic or communicable conditions. Without consistent federal direction and robust support, gains made under established programs may not be sustained. Advocates hope that at least some lame duck extensions can preserve the foundation of existing programs—like telehealth and CHCs—helping insulate vulnerable communities from policy swings that may come with new leadership.
Programs like Ryan White and PEPFAR, which have maintained strong bipartisan support in the past, could face new scrutiny in an environment where budget discipline and re-examining unreauthorized programs take center stage, potentially embroiling these critical pillars of HIV care and prevention in broader spending debates.
Navigating Short-Term Extensions and Long-Term Implications
Analysts predict a restrained legislative approach during the lame duck, with lawmakers likely settling for short-term solutions to avert immediate disruptions rather than enacting comprehensive reforms. This approach may feel unsatisfying to those seeking lasting certainty, but it can prevent sudden gaps in coverage and services while buying time to reassess priorities in 2025.
For example, a brief funding extension for CHCs or a short-term continuation of telehealth flexibilities could prevent abrupt care disruptions. Telehealth has already proven critical for expanding access to behavioral health services, and federal agencies have now taken further steps to preserve this access. The U.S. Drug Enforcement Administration (DEA) and U.S. Department of Health and Human Services (HHS) recently extended telemedicine flexibilities for prescribing Schedule II-V controlled substances through the end of 2025. This marks the third extension of pandemic-era policies that allow practitioners to prescribe controlled medications—such as suboxone (used in opioid use disorder treatment)—via telemedicine without an in-person evaluation. Retaining these flexibilities, even if temporary, helps sustain harm reduction efforts and essential treatment access for those managing substance use disorders.
A modest Medicare physician payment patch could also preserve provider participation while deeper structural reforms are debated. On the revenue side, modest site-neutral tweaks may generate savings to fund these stopgaps without forcing lawmakers to finalize wide-ranging changes immediately.
Meanwhile, Democrats have floated extending Affordable Care Act subsidies in a potential year-end health deal that also includes telehealth extensions and incremental improvements in physician reimbursements. Such proposals face uncertainty as Republicans prepare to take full control in 2025, but even short-term deals could maintain coverage gains and service expansions that benefit people managing chronic conditions and those relying on affordable insurance options.
Given the incoming administration’s focus on spending and efficiency, it may be prudent for stakeholders to identify areas where reducing waste, redundancy, or abuse is possible—particularly within large, long-standing programs. Offering proactive solutions aligned with fiscal priorities, while demonstrating that essential services remain intact, could help preserve support for programs like Ryan White. This approach allows advocates to show policymakers that sustained funding can go hand-in-hand with accountability and cost-effectiveness, paving the way for more secure, long-term access to critical healthcare services.
Actions for Advocates and Public Health Officials
Engage Legislators Before December 20th:
With deadlines looming, advocates can communicate the importance of even short-term extensions for telehealth, CHC funding, and Medicare physician payment stabilization. Stressing the immediate impact of allowing these programs to expire can help secure stopgap measures.
Highlight Evidence and Outcomes:
Data-driven arguments can persuade legislators that certain policies merit continued investment. For example, demonstrating that telehealth has improved access in rural areas or that CHCs reduce costly emergency department visits can make a compelling case for sustained support.
Prepare for 2025 Debates:
The new Congress will likely reassess programs ranging from telehealth expansions to broader HIV initiatives like Ryan White and PEPFAR. Advocates should cultivate coalitions and gather patient stories now, ensuring they can respond effectively to future proposals that may challenge established healthcare priorities. By proactively preparing data and first-person accounts, stakeholders can better influence upcoming debates.
Monitor Agency Leadership and Policy Shifts:
Staying informed about new federal health agency leaders and their public statements helps anticipate changes in priorities. Understanding where the Administration might diverge from past practice can help advocates and providers design strategies to maintain access and care quality—even if federal emphasis shifts away from certain public health initiatives.
Conclusion
December 2024 places the U.S. healthcare landscape at a turning point. The lame duck session unfolds under a cloud of political transition, with an incoming administration and unified Republican control set to reshape policy debates. Lawmakers face a stacked agenda of expiring programs and urgent healthcare needs but may opt only for minimal extensions that maintain the status quo for now.
Decisions made in these final weeks of 2024—from temporary telehealth fixes to short-term CHC funding—will determine how seamlessly care continues into the new year. As Congress weighs sites of service, physician reimbursements, PBM practices, and the future of critical programs like Ryan White and PEPFAR, advocates must remain engaged. The approaching shift in power and priorities adds urgency to even the smallest policy wins now, as they may offer a critical foundation to protect patient access and maintain progress on significant public health initiatives in a potentially more challenging political climate.
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.
Eye on 2024: Federal Action on PBMs, 340B, and Telehealth
2024 stands as a pivotal year in federal healthcare policy, potentially overshadowed by a highly contentious and partisan political landscape during an election year. The backdrop includes ongoing budget fights, looming cuts threatening vital healthcare programs, and a shifting balance of power in Congress thanks to at least one member being removed from office and a couple of high-profile resignations, further complicating the path to meaningful bipartisan legislation. Amidst this chaos, key focus areas such as reforms related to Pharmacy Benefit Managers (PBMs) and the 340B Drug Pricing Program, as well as telehealth expansion are at the forefront of potentially significant policy shifts, all while renewed attacks on the Affordable Care Act (ACA) add to the uncertainty of healthcare reform in an election year.
Pharmacy Benefit Managers: Pushing for Transparency and Market Reform
PBMs have come under increasing scrutiny in the U.S. healthcare system, particularly regarding their role in prescription drug pricing. Dominated by just three key players, PBMs face criticism for opaque pricing models and practices that may contribute to rising drug costs. The Lower Costs More Transparency Act of 2023 represents a bipartisan effort to enhance transparency in PBM operations, requiring detailed disclosure of pricing and costs. The future of this legislation depends on whether the Senate will adopt the House version or introduce its own bill, with several Senate committees recently advancing similar proposals.
Experts, including those from the Brookings Institution, caution that while increased transparency is a positive step, it may only modestly impact overall drug costs. The effectiveness of these reforms hinges on addressing the complex relationships among PBMs, drug manufacturers, insurers, and healthcare providers.
The current PBM model, often criticized for incentivizing high drug list prices through 'spread pricing,' is under review. Proposed reforms, like those in the Pharmacy Benefit Manager Reform Act, aim to eliminate spread pricing and ensure that rebates and savings directly benefit plan sponsors and patients.
Additionally, the PBM market's consolidation and “vertical integration” (or self-dealing by another name) raises concerns about market power and its influence on drug pricing. With a few firms controlling a significant market share, PBMs' market power could lead to disproportionate profits, underscoring the need for regulatory measures to ensure fair pricing and competition.
As the healthcare community navigates these reforms, the focus remains on ensuring that changes in PBM operations directly benefit patients, especially those in underserved communities disproportionately affected by high drug costs.
340B Program: Addressing Challenges for Future Reforms
The 340B Drug Pricing Program, essential for providing discounted drugs to healthcare providers serving underserved communities, is at a critical juncture. Facing legal challenges and calls for reform, 340B is under scrutiny, particularly regarding its operational complexities and the definition of a 340B-eligible patient. This definition, crucial in determining who accesses discounted drugs, has been a point of contention, with legal interpretations suggesting a need for broader inclusivity, as noted in Bloomberg Law's analysis.
Advocates, including those supporting people living with HIV, recognize the program's significant impact but seek more direct patient benefits, a sentiment echoed in CANN's blog. The current model's effectiveness in providing direct patient benefits, such as reduced drug prices, is being questioned.
Efforts for greater transparency and accountability are intensifying, with state-level initiatives aiming to ensure that program savings directly benefit patients, especially those with financial barriers to medication access, as highlighted in Avalere's insights. State authority to regulate 340B, however, is still in question as Arkansas and Louisiana face lawsuits around recently passed legislation.
Amidst these challenges, 340B's commitment to aiding underserved communities remains paramount. Collaborative efforts among lawmakers, healthcare providers, and patient advocacy groups are crucial to reform the program, ensuring it continues to provide equitable access to care and addresses key issues like medical debt.
Telehealth: A Defining Year in 2024
2024 is set to be a defining year for telehealth, a sector transformed by the COVID-19 pandemic. This year will witness crucial legislative decisions that could shape the future of access to telehealth services.
At the forefront are policy decisions regarding Medicare reimbursement flexibilities for telehealth, as noted in Modern Healthcare's article. Set to expire in 2024, these flexibilities are vital for the continued viability of telehealth, particularly benefiting small practices and those in rural or underserved areas.
Another key development is the anticipated update to remote prescribing rules for controlled substances. The decisions made will crucially balance the need for accessible care with the regulation of controlled substances, impacting how telehealth can be used for medication prescribing.
As 2024 unfolds, the healthcare community faces the challenge of navigating these legislative and policy changes to maximize the benefits of telehealth in patient care and access.
Budget Battles: Critical Healthcare Advocacy Amid Congressional Challenges
The intense budget battles in Congress, underscored by proposed cuts in the House L-HHS Appropriations Bill (H.R. 5894), are central to healthcare advocacy. These cuts, amounting to $767 million, pose a significant threat to essential HIV/AIDS programs, risking the reversal of years of progress in treatment and care. These programs are not just healthcare initiatives; they are vital lifelines providing necessary medications and support to individuals living with HIV.
The Coalition on Human Needs has expressed grave concerns about potential severe cuts to non-defense discretionary appropriations (NDD) for fiscal year 2024, which could drastically impact a range of vital services. In their sign-on letter to Congressional leaders, they warn that these cuts, potentially up to 9% according to the Center on Budget and Policy Priorities, would significantly harm programs essential for public health, education, environmental protection, and more, affecting diverse communities across America. The Coalition advocates for completing the FY24 appropriations process with a bipartisan approach, emphasizing the need to protect these crucial investments that support the nation's most vulnerable populations and uphold the commitment to public health and welfare.
Any major legislative changes will be at the mercy of presidential election year politics, and the congressional balance of power will only make it harder. Issues like PBM reform, or 340B reform, and Telehealth expansion will probably receive a lot of attention via hearings and news clippings, but legislative action remains in doubt.
Covid-19: How Far We’ve Come & How Far We Have to Go
Unraveling a tangle of yarn can be maddening. Pull here, threads get tighter. Pull there, you’ve created another knot. Now, imagine having to weave with the same tangle – “undo” a well-organized mess and make it something functional, beautiful even. The fragile public health system in United States during the Covid-19 pandemic is much like that tangled yarn.
This dual task is very much an oversimplified explanation of where the American health care landscape exists in this moment. Like most collective traumas, this stage isn’t the “undoing” stage, it’s the stop the damage stage. In writing the first blog of the year, tracking site Worldometers reported 20 million confirmed COVID-19 cases in the United states and about 345,000 COVID-19 deaths. As of the time of this writing, the same site is reporting more than 30 million confirmed COVID-19 cases in the US and about 550,000 COVID-19 deaths. Daily case counts continue to remain high at around 50 thousand confirmed cases a day and around 1,100 deaths per day on average. While the introduction of 3 vaccine products has brought hope and another tool to our COVID toolkit, and daily new cases and deaths are far below their height, the pandemic still rages on.
Which is…concerning for the entirety of the health care spectrum and especially so for those spaces that have been historically underserved or needing additional protection or funding. From the Centers for Disease Control report at the Conference on Retroviruses and Opportunistic Infections (CROI) the United States performed at least 700,000 fewer HIV screenings and 5,000 fewer new diagnoses in the first 6 months of the pandemic (compared to the same time in 2019) to the extraordinary implications of COVID among vulnerable populations to Senators Grassley and Klobuchar introducing legislation to allow drug importation (despite very clear warnings about why this is not a great idea) to the Biden Administration issuing a formal disapproval of Medicaid work requirements, to say information is coming at “break neck speed” may well be as much of an understatement as a tangled ball of yarn.
With an emerging “surveillance gap” for both HIV and HCV, a startling HIV outbreak in West Virginia, overdoses increasing as a result of COVID, some of greatest tools gained in combating this pandemic, even those advocated for by the CDC, have already started to go away as states begin to “open up”. Indeed, Congress has already begun taking up old questions regarding telehealth restrictions and payment systems designs, this time with an eye for permanency.
While President Joseph R. Biden’s American Rescue Plan, recently passed by Congress and signed into law, offers a great deal of funding to address the needs of certain entities and programs to tackle COVID and even offers the most meaningful adjustments to the Affordable Care Act by expanding subsidies, the existing needs of the health care ecosystem have largely been neglected for the last year. Well…far longer…but I digress. Like any trauma, our need to strengthen patient protections and access, incentivize quality of care over quantity of services, and meaningfully reduce health disparities have been the ends of thread tightening around the knot of COVID. This pandemic did not create these disparities and the needs outlined above – but not having a plan for a pandemic, not addressing structural inequities and these burning policy needs with the urgency they so deserve absolutely made us more vulnerable to the most devastating impacts of any pandemic.
This isn’t “the end”, certainly. For advocates, this has always been our “normal”. We need those who have hung on our every word and insight through this emergency to stay at the table – we’re not done yet. Everything you were outraged by (and may still be enraged by thanks to vaccine access scarcity) remains and will continue to loom just over our shoulders, waiting to be exploited by an opportunistic disaster.
Indeed, the ghost of Scott County may well continue to haunt us for some time to come. This is, after all, a very big ball of very tangled yarn.