RFK Jr.’s Administration for a Healthy America is Not Healthy
RFK Jr.’s paradigm for reimagining the pathway to improve population health in the United States includes the creation of what he calls the Administration for a Healthy America (AHA). He has issued a mandate to solve chronic disease issues that he views as essential. Implementation of the AHA would consolidate many existing agencies and lines of funding to increase efficiency. However, there is no benefit to consolidation if it means stripping away resources, including finances and personnel, without fiscal reinvestment and infrastructure replacement.
The AHA absorbs multiple entities under one umbrella. Agencies such as the Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA), the Office of the Assistant Secretary for Health (OASH), and the National Institute of Environmental Health Sciences (NIEHS) would cease to exist and their functions would be absorbed into the new AHA entity. While there is some benefit to government reorganization and streamlining of funding and communication silos, the pathway set by AHA appears to eliminate the benefits of the current entities in favor of a nebulous description of chronic disease prevention.
RFK Jr. champions the fight against the causes of chronic disease across the nation. However, the specifics of his foci do not logically follow data. Approximately six out of 10 Americans live with one chronic disease, while four in ten have two or more. While extolling the virtues of eradicating chronic disease, actions by the U.S. Department of Health & Human Services (HHS)would abolish the Centers for Disease Control & Prevention’s (CDC) National Center for Chronic Disease Prevention and Health Promotion in its present form. In budget documents, AHA is referred to as “the primary federal agency committed to transforming the health of all Americans by addressing the root causes of chronic disease, promoting preventive care, advancing mental health and substance use services, and increasing access to a healthy environment and foods.” Yet the priorities of what are being viewed as pertinent chronic disease issues are what concern many stakeholders.
Kennedy continues to push the narrative that too much money and focus is spent on infectious disease inquiry at the expense of chronic diseases. However, the data show that this is not true. Receiving $8.1 billion, infectious diseases landed at ninth on the list of NIH-funded research subjects in 2024. Comparatively, brain disorders received $8.1 billion, and Cancer received almost the same as the entirety of infectious diseases. One cannot reallocate a resource focus from infectious disease to chronic disease because it is not a matter of one being more important than the other.
Infectious diseases and chronic diseases are inextricably linked to each other. Limiting infectious disease research would exacerbate chronic disease states, as communicable diseases play a crucial role in their development. For example, ongoing research suggests infections from things like herpes, syphilis, and pneumonia contribute to the development of neurological issues like Alzheimer’s. Moreover, HIV research has been integral in the advancement of treatments and understanding of chronic diseases. HIV research has led to a deeper understanding of the immune system. Knowledge concerning how the body identifies and targets infected cells is derived from HIV research. Lentiviruses function in a similar way to HIV, which led scientists to use lentiviruses in gene therapy to treat maladies such as blood cancers. The infectious Epstein-Barr virus has been associated with lymphoma, lupus, and multiple sclerosis.
Dismantling the current infrastructure to consolidate and reform under the AHA umbrella may be a setback because knowledgeable staff with valuable expertise and networks have already been laid off through reductions in force (RIFs). Recreating effective teams does not happen overnight and cannot be reconstituted with RFK Jr’s proposed reductions in funding. Additionally, chronic disease research, assessment, and prevention require analysis of data acquired through proper surveillance. Jerome Adams, surgeon general during Trump’s first administration, is quoted as stating, “Surveillance capabilities are crucial for identifying emerging health issues, directing resources efficiently, and evaluating the effectiveness of existing policies…Without robust data and surveillance systems, we cannot accurately assess whether we are truly making America healthier.”
The AHA agenda aims to investigate the “true” root causes of chronic diseases. However, a dearth of quality research already exists. Additionally, factors like obesity and environmental exposure have been proven to be causal factors of chronic disease. However, those issues have etiologies related to conditions such as socioeconomic status. Unfortunately, JFK Jr and the Trump Administration have described research in health disparities and health equity as lacking scientific merit and purpose. This is unfortunate when research of this nature is effective. A study that investigated disproportionate levels of mortality from COVID-19 among minorities resulted in improved efforts that led to a reduction of the racial gaps in vaccination rates, saving lives.
RFK Jr. has done nothing to generate trust in his vision or demonstrate the ability to make sound public health decisions. He recently released a health commission report on children’s chronic issues that was touted as gold-standard science. Instead, experts have proven many of the studies referenced in the report were mischaracterized, were of dubious merit, some having touted messaging that has already been debunked by evidence-based science, and seven studies referenced were fraudulent, having been complete fabrications. This behavior is further complicated by Kennedy's description of established peer-reviewed medical journals, such as The Lancet and the New England Journal, as corrupt. As an alternative, he expressed the possibility of creating government-run journals.
Divesting from infectious disease control and prevention will assuredly increase our chronic illness burden. Focusing efforts on chronic disease topics that are not significant factors in the most pressing public health needs diverts discourse and resources from issues that truly matter, ultimately harming the population. As JFK Jr.’s budgetary plans continue to develop, it is imperative to continually ask questions that shine a light on the opaque nature of his messaging and desired implementation.
Equal Health Policy is Queer Liberation
The month of June is recognized globally as Pride Month for the LGBTQ+ community. Set in motion at Stonewall and in my home of Kansas City where organizers of the movement met in 1966. It is a time to recognize those who have come before us, the progress we have made, and the continued commitment to live and love freely, authentically, and visibility.
The fight for equality has never been without its legislative setbacks, The Defense of Marriage Act, Don’t Ask, Don't Tell, and California’s Proposition 8. In recent years, a disturbing trend has emerged across the United States and beyond: a wave of legislation that directly targets the LGBTQ+ community—particularly transgender individuals—under the guise of public health, education, or religious freedom. While often framed as matters of morality or parental rights, these laws have very real and dangerous consequences for the health and well-being of our communities. The political weaponization of identity not only marginalizes communities but creates systemic barriers to healthcare access, exacerbating existing disparities such as houselessness, substance misuse, and mental health.
“In an era where queer lives are being legislated out of public existence and public health is being gutted for political theater, allyship means more than rainbow logos—it means resistance. It means leveraging your voice, your access, and your platforms to push back loudly, not later.” - Travis Manint, Director of Communication Community Access National Network
The Legislative Landscape: An Escalating Crisis
From bills banning gender-affirming care for youth, anti-DEI initiatives, and restricting LGBTQ-inclusive education, to efforts allowing providers to deny care based on religious beliefs, the legal attacks on LGBTQ health are mounting. In 2024 alone, hundreds of anti-LGBTQ bills were introduced across state legislatures—many of them passing into law.
Additionally, the suggestion of any cuts to HIV funding, including prevention, takes many back to times in our history when the Regan administration turned their backs on our community, and allowed an entire generation to be wiped out, citing moral panic as a reason to deny federal funding.
These measures are not benign. When transgender youth are denied access to hormone therapy or counseling, their mental health suffers, and a community more likely to consider suicide When schools are forbidden from discussing LGBTQ topics, students lose access to information that affirms their identities. And when healthcare providers can legally refuse to treat LGBTQ patients, trust in the healthcare system erodes. Each policy sends the wrong message: you do not belong, and you are not safe here.
The Health Consequences of Discrimination
LGBTQ youth experience houselessness at a rate far higher than their peers, with some studies indicating they are 120% more likely to experience it. While only 7% of the overall youth population identifies as LGBTQ, they comprise up to 40% of homeless youth. This disparity is particularly pronounced for transgender and nonbinary youth, with some research suggesting they experience houselessness at even higher rates. Houselessness is not limited to LGBTQIA+ youth, Sexual minority adults are twice as likely as the general population to have experienced homelessness in their lifetime.
Substance misuse is highly prevalent among LGBTQ+ persons, data on the rates of substance abuse in gay and transgender populations are sparse, it is estimated that between 20 percent to 30 percent of gay and transgender people abuse substances, compared to about 9 percent of the general population, yet affirming treatment centers for our community continue to be scarce. In 2021, over half of LGBTQ youth (56%) used alcohol in the last year, including 47% of LGBTQ youth under the age of 21. Over one in three LGBTQ youth (34%) used marijuana in the last year, including 29% of LGBTQ youth under the age of 21. One in 10 (11%) LGBTQ youth reported having used a prescription drug that was not prescribed to them in the last year, and this rate was the same for those under and over the age of 21. The stress that comes from daily battles with discrimination and stigma is a principle driver of these higher rates of substance use, as gay and transgender people turn to tobacco, alcohol, and other substances as a way to cope with these challenges.
Research has consistently shown that LGBTQ individuals face disproportionately high rates of mental health conditions, substance use, and chronic illness—not because of their identities, but because of the stigma and discrimination they face. According to the CDC, LGBTQ youth are more than four times as likely to attempt suicide compared to their non-LGBTQ peers. Transgender individuals face elevated risks of depression, anxiety, and suicidal ideation, especially when denied gender-affirming care. According to the Trevor Project 39% of LGBTQ+ young people seriously considered attempting suicide in the past year — including 46% of transgender and nonbinary young people.
Policy plays a pivotal role in either perpetuating or addressing these health disparities. Restrictive laws not only block access to care but foster environments of fear, alienation, and trauma. Conversely, affirming policies—such as nondiscrimination protections, inclusive data collection, and funding for LGBTQ+-specific services—create pathways to health equity.
LGBTQ+ Health Must Be a Policy Priority
Healthcare policy should be a tool for protection, not persecution. We must hold legislators accountable when they propose or support bills that endanger LGBTQ+ lives under the guise of “protecting children” or “religious liberty.” At the same time, we must uplift and support policies that affirm identity, improve access, and invest in LGBTQ+ health. Prioritizing LGBTQ+ health is not a matter of inclusion—it’s a matter of survival. Our laws should reflect the values of dignity, equity, and compassion.
In an environment where our very existence is being attacked in legislative sessions, it is time we draw from our history, become voices, not victims, and for our allies to stay engaged. It is our turn to make history, demanding better of our lawmakers. Because at the end of the day affirming, culturally competent, equitable LGBTQ+ healthcare is Queer liberation.
Strengthening Caregiving Infrastructure is Fundamental to a Healthy American Society
John’s Hopkins defines a caregiver as a person who tends to the needs or concerns of a person with short- or long-term limitations due to illness, injury, or disability. On June 24, 2025, PBS will air a documentary on the multifaceted landscape of caregiving executive produced by Bradley Cooper and narrated by Uzo Aduba. The documentary explores the history of various aspects of caregiving in the United States, with a focus on the lived experiences of care providers, particularly family caregivers who provide care in the home. The documentary is timely, given how caregiver support could be affected by the present-day potential changes to Medicaid and other healthcare funding changes. The caregiving continuum spans from birth to the end of life, yet the caregiving infrastructure in the United States is insufficient.
Caregiving in the United States is both paid and unpaid, provided by professionals and laypeople. Caregiving encompasses a wide range of services, including daycare, preschools, in-home care, nursing homes, and more. Notably, according to 2020 data from AARP, around 53 million Americans give unpaid care in the home. This level of effort is by necessity, not by choice. Paying for private care services is prohibitively expensive, and loved ones prefer those in need to be in the surroundings of their own homes, living through long-term health challenges, as opposed to institutions. Home surroundings are especially desired regarding end-of-life issues.
The current U.S. healthcare infrastructure is not sufficient to meet the needs of caregivers and those they care for. Nursing homes are where some individuals with long-term significant care needs find themselves because they don’t have any family to take care of them or their family is ill-equipped to meet their needs. While Medicaid will pay 100 percent of the costs of nursing homes, the logistics of the coverage is problematic.
Medicaid coverage of nursing home care requires specific financial and health conditional requirements. In general, the financial eligibility criteria mean that a person in need must have very little in assets. If a patient does not qualify for Medicaid financially, they essentially have to spend down all their assets until they reach the required level of poverty. Additionally, in some states, the state will go after possession of a patient’s home if there is a home in their name at the end of their life. It’s referred to as Medicaid estate recovery, where a lien is placed on the home to recover some of the funds spent on long-term institutional care.
This is damaging, as it undermines the home's ability to remain in the family as a means of generational wealth. Moreover, if relatives are living in the house, they lose their place of domicile. Medicare, on the other hand, does not pay for any long-term care, such as nursing homes. Medicare will only pay for short-term care, documented medically necessary care in skilled nursing facilities such as rehabilitation homes after someone has been inpatient in a hospital. Patients who have significant care needs but do not require a level of care demanding enough to meet Medicaid criteria or do not qualify for Medicaid financially have to be cared for at home.
Having been a multi-year primary caregiver of my mother, who dealt with multiple healthcare issues, I understand first-hand the demands of being an at-home caregiver. I was not trained to be a caregiver. I was unaware of resources available to help me care for her, nor were hospitals or outpatient clinics any significant help in navigating her increasing needs from year to year. When it got to the point where she couldn’t walk, feed herself, get out of bed to relieve herself, bathe, or groom, the responsibility fell upon me as her only child.
I had to navigate taking care of all of her physical and medical needs while trying to financially support myself and attempt to flesh out a modicum of normalcy in my life. Although I was fortunate to work from home, it was challenging to balance my demanding data analysis position with her care needs. It was painful to hear her calling out for me while I was in the middle of a meeting or presentation, whether those I was interfacing with could hear her or not. I was not concerned if someone heard her faintly from down the hall during virtual meetings. It was painful because I always let her know when I had meetings scheduled so I could take care of her needs preemptively before the events. Thus, hearing her call out for me meant that it was a serious, urgent need, knowing that she always felt like she was being a burden and tried not to disturb me unless she urgently needed to.
Her financial situation did not qualify her for Medicaid, especially given her retirement and social security benefits. She had Medicare, which was partially paid for through her employer as part of her retirement benefits. While Medicare paid for her medications, it did not cover care needs related to day-to-day living. Medicare would not pay for a nurse or trained care individual to come in daily or several times a week to give her a proper bath once she could no longer bathe herself, thoroughly make sure her private areas were cleaned adequately after bodily functions, make sure all her bodily skin folds were powdered and dressed, and so much more. For example, I knew that any time she relieved herself of solid waste while bedridden, that meant one to two hours of time it would take me to properly get her taken care of as she couldn’t help me move her body to tend to her needs.
After I talked in depth with her primary care doctor, Medicare agreed to pay for a basic home hospital bed that allowed me to raise her up to make her comfortable and raise her legs when necessary. Medicare paid for a lower extremity lymphedema pump air compression recovery boot system for her swollen legs that sometimes developed sores, which I had to dress and clean. She was overweight, in addition to being unable to mobilize herself. Thus, after petitioning a doctor who attended to her after one of many inpatient stays, Medicare paid to rent a Hoyer lift so that I was able to lift her to change the bed or help put her on stretchers at times I had to call EMS. Although Medicare paid for renting these items after many rounds of begging and discussions, they would not pay for someone to come in and help me utilize the tools.
I had to learn how to use them on my own. The only time Medicare paid for anyone to come into the home was when some of her leg wounds and bed sores exacerbated to the point of justifying once-a-week home health visits to take care of them. Most importantly, those visits were only temporary. Once they had healed to the point where she was evaluated as not requiring weekly paid care, the visits stopped. I had to learn the involved processes from the home health nurses and how to administer care on my own. They would even order extra supplies to send to our home so that Medicare would cover them, rather than my mother and I having to buy them ourselves.
The aforementioned is only a small part of the realities of being an at-home caregiver. However, it is a window into the kind of support that caregivers and patients need. There need to be payment innovations that provide funding for things like home care beyond temporary skilled nursing needs. When patients with significant needs are discharged back into their homes after inpatient stays, there needs to be robust networks of after-discharge support that include inquiring about the needs of caregivers and those they care for.
Chronic condition care often requires numerous durable medical goods and disposable medical products that Medicare and private insurance do not cover. A system that helped caregivers with some of the financial burden of those needs would prevent families from financial ruin. For example, since my mother was bedridden, she obtained a device called a Pure Wick system that was a means to relieve urination without the complications of skin breakdown from wetting adult diapers. We had to pay out of pocket for the single-use catheters used for the device, which cost $150 per month in addition to all of the other many care products used on a daily basis.
There are many reasons why people end up in a long-term home care situation. There needs to be infrastructure in place at the local level to fill the gaps and meet needs financially, emotionally, and physically. Presently, a company like Trualta has the right idea. It is an online platform that provides caregivers with access to various training, support, and a way to interact with other caregivers.
However, vast improvements in government infrastructure are needed to effectively remedy home health care needs. The current potential detrimental changes to Medicaid and Medicare present an exacerbation of the status quo instead of a solution. Only 10 states have any means of compensation for family caregivers, and just 13 have paid family and medical leave. Caregiving is not a private issue to be lived through in darkness and silence. Ensuring a robust and stable caregiving continuum from birth until the end of life is the only way to ensure an economically stable and medically healthy society.
CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing
The Centers for Medicare and Medicaid Services (CMS) released its draft guidance for the Medicare Drug Price Negotiation Program in May 2025, offering operational improvements like using Wholesale Acquisition Cost (WAC) for standardized refund calculations. Yet beneath these technical refinements lies a critical policy failure: CMS's refusal to mandate federal claims modifiers for affected transactions and contradictory programs. This decision creates a regulatory vacuum that enables systematic duplicate discounts worth billions annually while sidelining patient experiences.
By abdicating responsibility for duplicate discount prevention and suggesting retrospective payment models that could strain smaller entities, CMS has created an environment where unscrupulous actors can exploit loopholes as state laws increasingly block the transparency mechanisms needed for program integrity. The contrast is stark—CMS requires mandatory "TB" modifiers for Part B inflation rebates but makes them voluntary for Maximum Fair Price (MFP) effectuation, creating an inconsistent regulatory framework that undermines program integrity.
"CMS had an easy answer right in front of them," says Jen Laws, CEO of the Community Access National Network (CANN). "Claims modifiers are an already existing tool within the scope of Medicare claims and instead agency officials opted to offer more than 220 pages worth of justifying why they won't mandate the information and not one page was dedicated to appreciating how such a fragmented approach might harm patients. The only mention we got was off handed references about maybe listening to patient advocacy organizations - which didn't go so well for us during the initial listening sessions of drug selection. Honestly, it's all entirely baffling."
The Mechanics of Duplicate Discounts and Why Modifiers Matter
Without clear claims identification, the same drug unit may receive multiple discounts—340B pricing plus Medicare rebates or Medicaid rebates—creating billions in inappropriate financial flows. Federal law (42 USC 256b(a)(5)(A)(i)) explicitly prohibits duplicate discounts between 340B and Medicaid rebates on the same drug unit, yet enforcement remains weak. While this might seem fine, no specified benefit is required to flow to patients and these factors incentivize ever increasing, uncontrolled costs within the healthcare ecosystem.
The scope of this problem is staggering. IQVIA estimates $20-25 billion in duplicate discounts annually across the industry. A Government Accountability Office (GAO) audit found that 25% of audited 340B programs had duplicate discount errors, with 264 of 429 cases caused by inaccuracies in the Medicaid Exclusion File system (MEF) itself. For context, some states seeking to prohibit claims modifier requirements cite use of the MEF—these inaccuracies and resulting duplicate discounts highlight the flaws of this approach.
The exploitation extends beyond duplicate discounts. Contract pharmacy fees extract over $1 billion annually from the 340B ecosystem, with CVS's third-party administrator (TPA) operation alone collecting over $350 million in fees over a few years according to Senate HELP Committee inquiry.
"Statutorily prohibited duplicate discounts are one of the many ways the 340B program is exploited as a profit-making tool by large hospital systems and for-profit contract pharmacies," explains Kalvin Pugh, State 340B Policy Director at CANN. "A simple claims modifier would ensure that this guidance prevented continued abuse and taken a step forward in much-needed accountability."
Despite misleading statements to the contrary, claims modifiers do not risk patient privacy. Claims modifiers function as digital markers using de-identified information to tag individual claims as 340B, similar to Medicare claims, enabling automated systems to exclude them from other rebate calculations. Without this technical infrastructure, PBMs can attempt "illicit rebate grabs" on 340B drugs, and covered entities can divert Medicaid rebates that should be reinvested in state programs directly to their own entities. These exploitations drive up the overall cost of medication and care for patients, either directly by profiteering off of patients and not passing on those discounts or by way of increased private insurance premiums as justified by increased billing across the healthcare ecosystem.
State Medicaid Programs Bear the Cost of Federal Inaction
The absence of mandatory claims modifiers enables duplicate discounts that drain state Medicaid rebate programs of billions annually, forcing difficult choices between expanding access and protecting limited state resources. While the pending Reconciliation Bill making its way through the Senate includes provisions to prohibit 340B spread pricing in Medicaid programs—as was seen in the December 2024 Continuing Resolution prior to it being gutted—efficient and effective compliance requires a claims modifier.
A Health Management Associates study found that 9 states position that manufacturers should seek recoupment from providers rather than reducing state rebate payments. The Texas experience illustrates the real-world consequences—when the Texas Legislature considered legislation that would have expanded 340B contract pharmacy use without oversight or revenue-sharing requirements, the fiscal note projected the state's HIV Medication Program would become 'insolvent by 2027' with an estimated $72 million shortfall over a multiyear period. This demonstrates how policy changes affecting 340B identification can directly threaten state programs serving vulnerable populations, while some states implemented comprehensive carve-out policies removing all 340B drugs from managed care to avoid such complications entirely.
"State programs will lose out on numerous rebates by offering the option to use the often lower 340B discount instead of the Medicaid price," Pugh explains. "This will strain state resources and put vulnerable impoverished communities at risk of losing access to lifesaving healthcare and medications."
In non-fee-for-service states, choosing the 340B rate over the Medicaid rate diverts rebate value away from Medicaid program reinvestment, effectively divesting from state programs that serve vulnerable populations. This interaction between 340B and Medicaid creates perverse incentives that undermine both programs' effectiveness.
CMS's Abdication of Responsibility Creates a Regulatory Vacuum
By declaring it "will not, at this time, assume responsibility for deduplicating discounts", CMS has created a regulatory vacuum that enables bad actors while burdening manufacturers and providers with piecemeal solutions.
The consequences of this abdication are far-reaching. At least 12 states have enacted laws restricting 340B claims modifier requirements or data sharing. CMS provides limited oversight of state Medicaid duplicate discount prevention efforts, leaving this responsibility to states, which are not always sufficiently funded or staffed to meet this responsibility. The Indiana situation exemplifies this chaos—former state officials filed a "whistleblower" lawsuit alleging "tens, likely hundreds" of millions of dollars of Medicaid fraud by hospital systems and managed care entities (PBMs by any other name), partly due to inadequate state oversight.
According to insights from interviews with former and current Medicaid directors and pharmaceutical policy experts in 14 states, the Health Resources and Services Administration (HRSA) has been faulted with inconsistent and weak enforcement of 340B duplicate discounts due to lack of data transparency. The GAO review found that only 4 of 13 covered entities had accurate descriptions of state Medicaid policies.
"While CMS might be about to assume some of HRSA's responsibilities with regard to 340B, it seems the agency is prepared to repeat HRSA's abdication of responsibility," Laws notes. "The IRA's interaction with 340B under this draft guidance systematizes the absolute headache covered entities, manufacturers, and patients already have with one program and just...duplicates it."
Retrospective Payment Models Threaten Safety-Net Provider Viability
The shift from prospective 340B discounts to retrospective payment models could create existential cash flow threats for smaller safety-net providers who lack working capital to absorb payment delays. While the draft guidance offers a rubric for manufacturers to assess entity financial sustainability and requires manufacturers to enact individualized action plans, this approach is clumsy and not foolproof, nor does the guidance suggest how smaller entities might efficiently comply with a patchwork of manufacturer assessment tools.
The financial reality for true safety-net providers is bleak. Nearly 45% of rural hospitals operate with negative margins, making 340B savings vital for maintaining operations. 93% of rural hospitals report relying on 340B savings to help keep their doors open. However, rural hospitals average only $2.2 million in annual 340B savings, compared to $11.8 million for all hospitals. Compliance costs range from $100,000 to $200,000 annually, regardless of hospital size, posing a significant burden on these facilities.
The timing requirements compound these challenges. The 14-day MFP payment window plus manufacturer 45-day lookback requirements create complex compliance deadlines that smaller entities may struggle to meet.
CMS also fails to contemplate the natural and expected outcome of confusing and potentially conflicting billing for patients. People already face challenges determining actual payments due when engaging in critical care for chronic and complex health conditions. Bills may come slow or arrive with differing amounts due based upon claims adjudication. A complex retrospective payment process as suggested by CMS will only further exacerbate this issue.
Technical Infrastructure: Why Modifiers Are the Solution
Claims modifiers represent proven, existing technical infrastructure that could solve the identification problem with minimal additional burden on providers already using similar systems. Think of claims modifiers as digital tags—simple two-digit codes that healthcare providers already add to insurance claims to provide additional information about services without changing the fundamental billing process. The "TB" modifier became the universal 340B identifier for all covered entities when billing Medicare Part B starting January 1, 2025.
The key point is that this infrastructure already exists for Medicare—extending similar requirements to the Medicare Drug Price Negotiation Program would simply apply proven technology consistently across federal programs rather than creating new systems. Furthermore, False Claims Act liability creates potential fines up to $10,000 per incorrect Medicare entry, ensuring accuracy and proper use of these digital markers.
The Path Forward Requires Federal Leadership
The public comment period for CMS's draft guidance closes on June 26, 2025, representing a critical opportunity for stakeholders to advocate for mandatory modifiers.
"We had some high hopes for a more thoughtful and, frankly, direct approach to our already fractured healthcare system with this guidance," Laws reflects. "The draft, as it is, is a mess. Mandating a claims modifier is a direct and elegant answer that would require far less wasted ink. Despite this Administration's claims to the contrary, here we are watching draft guidance unfold that will perpetuate a system prone to fraud and abuse. And patients? Our experiences in the middle of all of this? We're an afterthought. It's just completely unacceptable. The only way systems meet patient needs is by starting with us. This is not that and CANN is prepared to be loud and clear about that fact."
A mandatory federal claims modifier can provide the systematic solution needed to protect safety-net providers and ensure program integrity. Technical fixes aren't enough—comprehensive policy reform is needed. The stakes are too high, and the patients we serve deserve better than regulatory half-measures that enable exploitation while threatening the safety net they depend on for survival.