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The 340B Hospital Markup Program

340B medicine markups are a goldmine for big hospital systems. You pay the price.

Big, non-profit hospitals and clinics abuse a little-known federal program to generate billions in profits on medicines. Nonprofit hospitals and clinics can purchase medicines for as little as a penny and then mark them up by thousands of dollars. The 340B program is a hidden tax for patients, employers and taxpayers.

There are no rules on how hospitals use program profits. Click here to watch more.

https://www.youtube.com/embed/3Vxb4Al1VKs

No one's checking how hospitals use 340B program profits.

340B hospitals and clinics generate billions from exploiting the 340B program, and there are no guardrails on how they use program profits. Hospitals can spend on luxury perks like stadium naming rights, movies studios and Michelin-star chefs while engaging in aggressive debt collection practices. Hospitals get rich while patients, taxpayers and employers pay more.

This government program was created in 1992 to help patients access more affordable medicines. Today, the 340B program has become less about patients and more about boosting the bottom lines of hospitals and for-profit pharmacies.

It’s a hidden tax on patients, employers and taxpayers.

Without oversight, 340B has strayed far from its safety net purpose to a profit engine for hospitals, PBMs, private equity firms and big chain pharmacies. These entities exploit loopholes to maximize profits, while patients, taxpayers and employers bear the hidden costs.

If the money isn’t benefiting patients, then where is it going?

Profits from 340B markups now account for nearly $65 billion and the program continues to grow unchecked. Worse, hospitals can charge full price to vulnerable patients, burying them in medical debt if they can’t pay.

When hospitals have free rein to markup medicines, everyone pays the price. It’s time for transparency and accountability to stop this greedy behavior.

Where is 340B?

340B hospitals and their many contract pharmacies are found in every state. How much charitable care are 340B hospitals in your state providing as compared to the national average? Are 340B hospitals in your state contracting with local pharmacies, or are they profiting from contracts with pharmacies nationwide? Select a state to access state-specific data on 340B.

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340B

Download the fact sheet on the 340B program in

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles New York 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles California 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Texas 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Alabama 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Alaska 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Arizona 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Arkansas 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Colorado 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Connecticut 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Delaware 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Florida 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Georgia 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Hawaii 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Illinois 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Indiana 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Iowa 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Kansas 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Kentucky 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Louisiana 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Maine 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Maryland 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Massachusetts 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Michigan 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Minnesota 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Mississippi 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Missouri 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Montana 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Nebraska 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Nevada 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles New Hampshire 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles New Jersey 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles New Mexico 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles North Carolina 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles North Dakota 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Ohio 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Oklahoma 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Oregon 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Pennsylvania 2026.pdf

https://cdn.aglty.io/phrma/fact-sheets/340b/2025/Fact Sheet - 340B State Profiles Rhode Island.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles South Carolina 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles South Dakota 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Tennessee 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Utah 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Vermont 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Washington 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Wisconsin 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Wyoming 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles West Virginia 2026.pdf

https://cdn.aglty.io/phrma/Fact Sheet - 340B State Profiles Virginia 2026.pdf

How did 340B become a giveaway for PBMs, private equity and other for-profits?

Hospitals that participate in the 340B program contract with pharmacies to dispense the program’s drug prescriptions. Today there are over 33,000 distinct pharmacies participating in the program, known as contract pharmacies. While one might expect to find 340B contract pharmacies located in medically underserved neighborhoods to help vulnerable patients access medicines, that isn’t the case. Studies have found the exponential growth in contract pharmacies from 2011 to 2019 was concentrated in affluent communities, and not in lower-income areas with high unmet need.

Because of consolidation in the supply chain, PBMs now own the majority of pharmacies nationwide and make the largest share of their profits (55%) from their pharmacy business. They use the 340B program to drive that profit. There are more than more than 94,000 contracts contracts between a 340B provider and a pharmacy with financial ties to one of the three largest PBMs — CVS Health, Express Scripts and OptumRx. 50 cents of each $1 in profits contract pharmacies receive through the 340B program go to just four PBM and pharmacy companies.

These for-profit entities and their affiliates have found their way into the 340B program to capture profits that could otherwise have been used to lower drug costs for low-income and vulnerable patients.

PBM Profit Engine

Areas for 340B Reform

What’s the Solution?

The 340B program lacks guardrails for how 340B profits can be used or oversight to where the money is going. This enables large, wealthy hospitals and chain pharmacies to exploit the program for profit, often at the expense of patients.

An analysis published in the New England Journal of Medicine found no evidence hospitals invest their 340B profits into safety-net care. Similarly, a study published in the Journal of the American Medical Association concluded: “Nonetheless, our work adds to a growing body of evidence questioning the degree to which 340B program growth serves vulnerable communities.”

If the money isn’t going to help patients, where is it going?

Here are some ways Congress can fix 340B.

Areas for 340B Reform

Ensure Benefits Reach Low-income Patients

All hospitals in the program and their contract pharmacies should be required to pass through 340B discounts to reduce the cost of medicines for low-income and vulnerable patients. Further, Congress needs to clarify in the law who is an eligible “patient” to help ensure the benefits of 340B are reaching those patients. There are currently zero patient protections and zero requirements for how hospitals use 340B discounts to help patients afford their medicines, enabling large hospital systems, chain pharmacies and pharmacy benefit managers (PBMs) to generate massive profits without commensurate growth in access and affordability for patients most in need.

Confirm True Safety-net Participation

Many hospital participants are not located in medically underserved communities, provide very little charity care and, alarmingly, engage in aggressive debt collection practices aimed at patients who are least able to afford care. This program isn’t working for patients. Congress needs to ensure that only true safety-net entities are participating in 340B and require 340B hospitals to provide meaningful levels of charity care to uninsured, low-income and other vulnerable patients.

Strengthen Accountability Measures

Congress must implement stronger, common-sense accountability measures for the program. This includes creating a neutral, third-party clearinghouse for claims-level data will help ensure 340B discounts are being properly claimed by hospitals and clinics, and that all participants are complying with key program safeguards. Congress should also clarify that 340B is a federal program governed by the federal government exclusively.

Related Resources

New report sheds light on payment flows in the pharmaceutical supply chain, including the role of 340B and vertical integration

A new report explains the flow of dollars through the pharmaceutical supply chain for commercially insured patients taking retail medicines and details how transactions between stakeholders affect patient costs at the pharmacy counter. The report also highlights how the 340B hospital markup program and increased consolidation and vertical integration among supply chain entities raises the cost of medicines for patients and employers.

The path a medicine takes from the biopharmaceutical manufacturer to the patient involves a complex supply chain, including wholesalers, pharmacy benefit managers (PBMs), insurers, and pharmacies.

pharmaceutical supply chain: key stakeholders

The report provides three hypothetical examples to illustrate how payments flow through the supply chain when a patient is purchasing a medicine in their deductible, with a copay or at a 340B contract pharmacy.

Middlemen pocket savings meant for patients.

Manufacturers provide billions in rebates and discounts to PBMs and insurers, which can lower a medicine’s average net price by 50% or more. However, PBMs and insurers rarely pass these savings to patients at the pharmacy counter, often leaving patients to pay more than their insurer or PBM. Rebates and discounts are often tied to the list price of medicines, which experts have noted may incentivize PBMs and insurers to favor drugs with higher list prices over lower cost alternatives. At the same time, insurers shift costs onto patients through high deductibles and coinsurance, which are also often based on the list prices.

Here is an example of what happens when a patient fills a prescription and has not yet met their deductible:

  • Jane takes a blood pressure medicine with a $100 list price. Because Jane hasn’t met her deductible, her insurer does not cover any costs for this prescription. Her PBM, however, still receives a rebate from the manufacturer, and shares a portion with the insurer. The PBM and insurer earn $10.65 and $23.10, respectively, from rebates and fees, while Jane pays $101.10 – a higher price than any stakeholder in the supply chain.

Here is an example of what happens when a patient fills a prescription and has met their deductible but has a required copayment:

  • Erik takes a blood pressure medicine with a $100 list price and has met his deductible. He pays a $40 copayment. The insurer/ plan sponsor spends $38 after accounting for the rebates and fees they receive. Ultimately, Erik pays more for his medicine than his insurer and PBM.

Big, tax-exempt hospitals and clinics abuse the 340B program by marking up medicines.

The 340B hospital markup program allows big, tax-exempt hospitals and clinics to purchase medicines at a low cost, sometimes as low as a penny, and then significantly mark up the price. When the medicines are dispensed at a contract pharmacy, patients, insurers, and employers pay the full marked-up price which is a hidden tax on medicines.

Here is an example of what happens when a patient fills a 340B eligible prescription at a 340B contract pharmacy:

  • Scott takes a blood pressure medicine with a $100 list price and fills it at a 340B contract pharmacy. The 340B hospital buys the medicine for $28, dispenses it through its contract pharmacy and receives $100.85 in return. The patient pays $40 in cost sharing and gets no benefit from the 340B discounted price. That means the hospital paid less than the patient while profiting $57.60 and earning twice as much as the manufacturer.

Vertical integration and consolidation put profits before patients.

The increase of vertical integration and consolidation among insurers, PBMs, pharmacies and providers has enabled these organizations to profit from nearly every transaction in the pharmaceutical supply chain through fees, spread pricing, and opaque practices. In fact, half of every dollar spent on medicines goes to middlemen and others that do not make the medicine, highlighting a growing problem that spending on medicines is increasingly being used to subsidize many parts of the health care system, often at the expense of patients.

Middlemen control what patients pay at the pharmacy counter, as well as which medicines patients can get and where they can get them. Vertical integration also financially incentivizes PBMs to steer patients towards the pharmacies they own.

To treat the problem, we must diagnose it correctly first. For policymakers to address rising health care costs, they must address where half of prescription drug spending is going – to entities that do not make medicines.

View the full report here and patient examples here.

Rachel Weissman

February 13, 2025

Follow the Dollar report preview

340B spending is exploding, forcing prices up for patients, employers and government programs

Year after year, the 340B program continues to balloon at a rate unseen in any other part of health care. 340B hospitals and grantees purchased more than $66 billion of medicines at discounted 340B prices according to new figures from HRSA – a nearly 24% increase compared to 2022 purchases. For comparison, total net spending by insurers and patients on all medicines increased only 5.6%, on average, over the past five years. And net prices for medicines are generally flat or falling. 

There is scant evidence that these reduced prices are reaching all of us who utilize hospital services, much less the vulnerable patients this program was designed to help. Instead, evidence suggests many 340B hospitals pocket the revenue they generated from the program and use it to expand their reach into wealthier areas, fund building upgrades, pay executive bonuses, and even cover the salary of football coaches. This constitutes a “hidden tax” that is borne by all of us – taxpayers, employers, and most importantly, the vulnerable patients that the program is supposed to help. Here’s what this looks like:

  • Higher costs for employers. An IQVIA analysis found that 340B increases self-insured employers’ drug costs by more than 4%, resulting in about $5 billion in lost revenue per year. The analysis was conducted before this latest government data release, and it’s likely that the cost to employers is growing as fast as the 340B program.
  • Higher costs for states and taxpayers. There is also evidence that 340B is harming Medicaid budgets, too. One analysis found that as 340B providers proliferated, Medicaid spending rose. The more 340B sites that opened, the more Medicaid spending increased, straining state budgets.
  • Higher costs for everyone. Because 340B hospitals are at a competitive advantage relative to non-340B hospitals, the program incentivizes hospitals and health systems to gobble up independent physician practices and convert them into outpatient departments of 340B hospitals, fundamentally distorting local health care markets. This drives increased prices as competition diminishes and care shifts from physician offices to higher cost hospital settings, helping to explain the impact on Medicaid and other health care spending. 

Considering all these facts, it begs the question – if the savings aren’t making their way to patients, where is all this money going? Here’s how it works:

  • 340B hospitals and grantees purchase medicines at prices that are, on average, 57% below the list price, but can be as low as a penny. They often turn around and charge patients, employers, and taxpayers full price. Reports show they even assign medical debt to patients based on the marked-up price.
  • According to IQVIA, 340B sales to hospitals and grantees increased more than three times faster than non-340B sales between 2018 and 2023 when measured at the estimated list price (129.4% vs. 41.4%, respectively).  

Given the negative repercussions across the system, policymakers are starting to take notice and have proposed comprehensive reforms to the 340B program. It’s time for 340B to get back on track and working for those it was originally intended to serve - vulnerable patients and communities. 

Drew Voytal

November 13, 2024

"340B spending is exploding, forcing prices up for patients, employers and government programs"

NYT exposes hospitals, middlemen make millions off a hospital markup program

A ground-breaking New York Times investigation reveals how a for-profit federal contractor helps hospitals abuse the 340B program to charge huge markups on medicines. 340B has become a tool for profit, benefiting large hospital systems and private corporations far more than the patients it was designed to serve. Here is what the New York Times uncovered:

340B hospital markups drive billions in profit for hospitals, middlemen.

Virginia King, a cancer patient from Santa Fe, NM, received a cancer medicine whose price was drastically marked up by the hospital. The hospital paid only $2,700 for the drug through the 340B program yet billed her insurance $22,700.

“She had unknowingly sought care from a hospital that participates in a federal program allowing it to buy drugs at a steep discount and charge patients and insurers a higher amount, keeping the difference.”

The hospital didn’t stop there. They sent Virginia to debt collection for an additional $2,500 – “more than half my take-home salary for a month” she told the Times.

340B abuse is a hidden tax on employers, patients and taxpayers.

340B, which began as a small program to help safety-net providers expand care for needy patients, has seen explosive growth with little evidence of patient benefit.

“Now, more than half of nonprofit hospitals in the United States take part. While some providers say it has helped keep their doors open, others — especially large nonprofit health systems — have been accused of maximizing payouts and swallowing the profits.”

“The program’s escalation has driven up health care costs for employers, patients and taxpayers, studies show.”

Loopholes to maximize profits.

Apexus, the for-profit company chosen by the federal government to help administer the 340B program, “has worked behind the scenes to supercharge the program.” More medicines to mark up means more profit for hospitals, middlemen --such as Apexus-- and other actors taking advantage of the program.

“...Apexus is allowed to collect a fee for almost every drug sold under the program, giving the company an incentive to help hospitals and clinics capture as many prescriptions as possible …”

“The numbers and the growth were staggering…We all bear the cost.”

No guardrails or oversight gives bad actors free rein.

There is a severe lack of transparency and oversight of the 340B program, with the New York Times noting that there are few rules to ensure patients are benefitting from the program. “Although the money is supposed to encourage care for impoverished patients, there are few rules to enforce that.

“Patients rarely know they are part of this system. Their prescriptions can be counted as 340B when they get outpatient treatment at a hospital or clinic that qualifies for the program, regardless of the patients’ own income or insurance status. The provider can continue to make money off the patients’ future outpatient prescriptions, even if they get them somewhere else.”

This investigation from the New York Times is yet one more clear piece of evidence that the 340B Hospital Markup Program is deeply broken and in desperate need of reform.

Policymakers need to put forth comprehensive reforms to hold 340B hospitals and middlemen accountable for their greedy behavior.

Drew Voytal

January 15, 2025

woman reviewing prescription bottle

New study: Entities that don’t make medicines get half of what is spent on those medicines

Half of every dollar spent on brand medicines goes to entities that play no role in the research, development, or manufacturing of those medicines, according to a new analysis by Berkeley Research Group (BRG).

The report’s findings highlight a growing problem: spending on medicines is padding the profits of middlemen and subsidizing many parts of the health care system, often at the expense of patients.

So, where exactly is the money going? It’s going to middlemen like PBMs and insurers who are aggressively consolidating their control over health care; mandatory government fees and rebates; hospitals, clinics and for-profit pharmacies in the 340B markup program; and patient assistance programs designed to help patients in a commercial insurance market that increasingly covers less while charging patients more.

WHERE'S THE DRUG DOLLAR GOING?

 

selected teaser image

PBMs, insurers, Group Purchasing Organizations (GPOs) and others in the supply chain retained the largest share of spending among non-manufacturers. In 2023, $170 billion in rebates, discounts, fees and other payments from biopharmaceutical companies went to these middlemen. While this represents 25% of all brand spending, middlemen can take up to 80% or more on some medicines. These payments lower the cost of medicines for insurers and PBMs, yet patients are often forced to pay their out-of-pocket costs based on the full undiscounted price, leading patients to pay more than they should for their medicines.

 

selected teaser image

340B providers and for-profit companies now get 18 times more of the drug dollar than they did a decade ago while patients, taxpayers and employers are saddled with a hidden tax that inflates their costs. The largest share of 340B costs is driven by hospital markups—where big tax-exempt hospitals markup drugs up to 7x or more.

 

selected teaser image

Biopharmaceutical companies paid $79 billion in rebates, discounts, and fees to government programs, including Medicaid and Medicare Part D. The Inflation Reduction Act (IRA) will further increase the amount of spending going to the government, eroding the investment in future research and development.

 

selected teaser image

As insurers force commercially covered patients to pay higher out-of-pocket costs, biopharmaceutical manufacturers provide billions in assistance to help them afford their medicines. This assistance represented nearly $23 billion in spending. Unfortunately, it’s not all getting to patients. In fact, insurers and PBMs kept nearly $5 billion of cost-sharing assistance for themselves through abusive copay accumulator and maximizer programs.



WHAT’S DRIVING DRUG SPENDING GROWTH?

 

Growth in Spending on Brand Medicines (2022-2023)

selected teaser image

 

From 2022 to 2023, spending on medicines increased $39 billion. The rebates, fees and other payments middlemen siphon out of the system was the single largest driver of this growth in spending. The second largest contributor was the growth 340B hospital markups and 340B provider and pharmacy profit on prescription drugs. These costs continue to increase because there’s no oversight or transparency. Worse, the money isn’t going to help low-income and uninsured patients.

As policymakers continue to look for ways to address rising health care costs and spending on medicines, the report’s findings are essential to help diagnose the right problems and pinpoint meaningful solutions. That starts with common sense reforms that put an end to insurer and PBM abuses, fix the IRA, reform the 340B markup program and ensure patient assistance goes to patients, not middlemen.

Elizabeth Carpenter

January 7, 2025

New study: Entities that don’t make medicines get half of what is spent on those medicines

New 340B report from Minnesota exposes steep hospital markups on medicines, patient benefits remain unclear

Large hospitals and clinics in Minnesota reported marking up the prices of medicines by at least a total of $630 million in 2023, though the actual amount may be much higher. A new 340B transparency report from the Minnesota Department of Health reveals stark inequities in how Minnesota hospitals, health care providers, and ultimately patients benefit from the thirty-year-old 340B program. Designed to support eligible safety-net providers that serve large vulnerable populations, the report shows 340B in Minnesota instead disproportionately benefits large hospital systems and for-profit middlemen, like contract pharmacies and third-party administrators, raising serious concerns about whether vulnerable patients are ultimately benefiting.

Key findings from the report show that just a small fraction of participating Minnesota hospitals generate the most profits from the program. However, according to charity care data that hospitals report to the federal government, many of these same hospitals fail to provide charity care or community benefits proportional to their financial gains from these markups. The Minnesota report also sheds new light on how for-profit middlemen have made millions of dollars off of this important safety net program.

The report is a step in the right direction toward much-needed transparency by bringing to light important details of the 340B program. However, serious questions remain.

  • What are these tax-exempt hospitals doing with the $630 million in 340B profit they made from their medicine markups? Charity care data provided to the federal government by many of the hospitals in the report show these profits are not helping low-income and uninsured patients afford the care they need. 
  • Why are large hospitals and for-profit entities reaping hundreds of millions of dollars in profit from 340B, while some safety net clinics operated their 340B programs at a loss? 13% of participants (primarily large hospitals) generated $500 million of the $630 million in reported 340B profits. The program was created to help vulnerable patients, not maximize profits for large hospitals, pharmacy chains and PBMs. 
  • Why are these for-profit entities making so much money off of this safety-net program? Partial reporting shows for-profit contract pharmacies and third-party administrators generated at least $120 million in fees from the program in 2023, representing approximately $16 out of every $100 in 340B profits.
  • If this report “substantially underestimates” hospital profits from 340B markups, how much larger could the problem actually be? Most hospitals and clinics did not report data on provider-administered drugs, which includes many cancer medicines, and account for about 80% of 340B spending.

Laudably, the findings suggest a small fraction of clinics serving vulnerable patients do pass 340B discounts directly to them. Conversely, the report also shows that the program, as implemented, mostly benefits large institutions and for-profit middlemen with no evidence these entities use 340B-generated profits to support underserved patients. Minnesota hospitals, and indeed hospitals around the country, must answer these tough questions. Policymakers must demand greater transparency and accountability from hospitals to ensure 340B funds are used as intended. Mandating reporting on 340B profits, tailoring use of contract pharmacies to ensure access for vulnerable patients and rebalancing the program to support true safety-net providers and the vulnerable patients they serve are critical steps to reform 340B at the federal level.

Without clear accountability, the program risks perpetuating inequities and further undermining its original purpose.

Drew Voytal

November 27, 2024

concerned patient

PhRMA urges HRSA not to impede new 340B pricing approaches to improve transparency and integrity

In a letter submitted to the Health Resources and Services Administration (HRSA) last week, PhRMA expressed serious concerns regarding the agency’s recent public statements about use of rebates to offer 340B ceiling prices to covered entities. PhRMA’s letter detailed persistent abuses and instances of some covered entities breaking the law in the 340B drug pricing program — and how the 340B statute contemplates manufacturers implementing alternative approaches to providing 340B prices that increase transparency and improve program integrity. Our letter to HRSA outlines the following:

As the 340B program continues to balloon in size, the Department of Health and Human Services (HHS) has not taken necessary action to prevent statutory 340B/Medicaid duplicate discount violations.

  • 340B is the second largest federal prescription drug program, behind only Medicare Part D. Nearly 60% of all hospitals participate in 340B. The program’s unrestrained growth has exacerbated program integrity challenges, and HRSA’s oversight has not kept pace. For example, HRSA has failed to ensure that manufacturers have access to even basic information about their medicines on which 340B pricing is requested. Covered entities have also resisted this transparency, including efforts to require covered entities to report how much money they are making from the program.

  • Government watchdogs like the Government Accountability Office and HHS Office of Inspector General have repeatedly highlighted the pervasive issue of 340B/Medicaid “duplicate discount” violations. This is when covered entities, such as hospitals, purchase a drug at the discounted 340B price while the drug also generates a Medicaid rebate. Duplicate discounts are an absolute prohibition under the law, but the issue has gone largely unaddressed. Worse, new requirements under the Inflation Reduction Act (IRA) would actually increase duplicate discount risks.

  • HRSA’s own covered entity audits suggest a concerning trend of non-compliance. However, when audits find program violations, they almost never result in penalties. It has also become more common for covered entities to try to thwart manufacturer audits by refusing to cooperate or even suing HRSA to try to stop the audits. Covered entities’ resistance to transparency on the front end while simultaneously resisting audits to remedy non-compliance on the back end highlights the need for a new approach.

Manufacturers want to make sure the requirements in the 340B law are met, and rebates are a common-sense approach used in numerous other federal health care programs.

  • When the 340B program was first created in 1992, U.S. health care looked very different than it does today. 340B must be modernized to reflect the realities of our current health system. To that end, manufacturers are working to address long-standing program violations and bring 340B in line with new policies like the IRA.

  • One possible approach is implementing a rebate model, which would provide manufacturers with information about 340B purchases before providing discounted pricing, thereby preventing program violations in the first place. Rebates are a common form of discount used in many other federal health care programs and would help improve integrity and transparency in 340B.

  • Rebates are explicitly mentioned in the 340B statute as a possible mechanism for offering reduced pricing to covered entities. Given the well-documented history of program violations, it would be wrong for HRSA to reject a rebate model without considering the increased transparency and program integrity improvements such a model could offer.

The profits covered entities generate through the 340B program should be used to help low-income, uninsured and other vulnerable patient populations access affordable medicines. Instead, the inadequacy of procedures to prevent duplicate discounts, along with other abuses in the system are enabling large, for-profit corporations to line their own pockets, raising costs for patients, employers and the government. It’s past time to get 340B back on track and working for patients.

Read the full letter.  

Drew Voytal

October 18, 2024

PhRMA urges HRSA not to impede new 340B pricing approaches to improve transparency and integrity

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