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Some of the most consequential changes for 340B this year came not from Washington D.C., but from statehouses across the country. We speak with Tom O’Donnell, senior vice president of government relations at 340B Health, to recap some of the biggest changes on the state legislative level throughout this year and to preview what might come from the states in 2026.

Seven States Enact New Reporting Laws

This year, Colorado, Hawaii, Idaho, Indiana, Ohio, Rhode Island, and Vermont have added new 340B reporting laws, increasing the list of states with such mandates to 10. O’Donnell says the first reporting requirements that Minnesota enacted in 2023 have influenced newer requirements in the other states. He notes hospitals’ continuing concerns about the burdens and possible repercussions of focusing on several specific types of reporting data, including breakdowns by payer type and most frequently used drugs.

Hybrid Bills Combine Protections With Reporting Mandates

Five states that passed new 340B laws in 2025 did so with a twist. Colorado, Hawaii, Maine, Rhode Island, and Vermont passed combination bills with both contract pharmacy protections with new reporting mandates. O’Donnell says he’s also concerned that statehouses are shoehorning in amendments to original statutes to ramp up concerning reporting requirements.

Model Legislation Could Mean More Debate in 2026

While Minnesota has served as a reference for reporting mandates for other states, model legislation from the American Legislative Exchange Council (ALEC) has created more opportunities for state legislators to push proposals that would limit or scrutinize 340B. O’Donnell says this reflects part of the latest efforts from drugmakers to take their 340B priorities to sympathetic lawmakers at the state level, and it underscores the importance of informing and supporting hospitals on how to push back against these bills.

Resources:

1. HRSA Approves Novartis’s 340B Rebate Pilot Proposal
2. State Policy & Advocacy Communications Resource Center

In this special mini-episode, we invite listeners to help shape the future of the show and enter a drawing for a $100 gift card by participating in our first-ever listener survey. 

Since launching in May 2020, 340B Insight has released more than 125 episodes featuring conversations with hospital and health system leaders, policy experts, and operations specialists from across the country. Their insights have helped listeners stay informed on the latest developments in 340B and bring practical lessons back to their own organizations.

As we plan the next phase of the podcast, we want to hear directly from our listeners. The brief survey asks what draws you to the show, the topics and guests you’ve found most valuable, and what you’d like us to explore in future episodes. Your input will help ensure the podcast continues to reflect the needs and interests of the 340B community.

The survey takes only a few minutes to complete. You may submit your responses anonymously, or you can share your contact information to be entered into a drawing for a $100 gift card. Take the survey by visiting 340bpodcast.org/survey. Thank you for listening and sharing your thoughts!

340B Insight wants to make our podcast the best it can be. To help us succeed, we’d like to hear your thoughts. Please take just a few minutes to complete our listener survey, and we will enter you in a drawing to win a $100 gift card! To participate, please go to 340bpodcast.org/survey.

The large and growing field of specialty pharmacy means new opportunities and challenges for ensuring patients receive the specialty drugs they need and stay on the therapies that might save their lives. St. Luke’s Health System, based in Boise, Idaho, has approached this mission by embedding clinical pharmacists in the specialty pharmacy space and using 340B as a critical tool. We speak with Josh Weber, senior director of ambulatory retail and specialty pharmacy services at St. Luke’s, to learn more.

How Clinical Pharmacists Can Be a “Value Multiplier”

Embedding clinical pharmacists in their specialty pharmacies improves operations in myriad ways. These pharmacists can take the burden off other providers by meeting with patients to go over their drug regimens, coordinating care, and running split-fill programs to reduce waste. At St. Luke’s, the approach has improved patient adherence to medications and reduced the time between the specialty prescription and the patient having the medication in hand to less than 48 hours – far quicker than the industry standard.

340B Savings Are Key to the Investment

Weber says cost savings from 340B are critical in calculating how they embed resources into specialty pharmacy, noting that improving adherence and retention can increase 340B savings exponentially. These savings then can enable health systems such as St. Luke’s to reinvest in their internal specialty pharmacies, provide more patient cost assistance and unreimbursed care, and ultimately shield themselves from headwinds such as drugmaker contract pharmacy restrictions.

Embedding Pharmacists Depends on Hospital-Specific Factors

For hospitals considering following the lead of St. Luke’s Health System, Weber said a variety of factors such as patient volume, payer mix, and drug spend can call for a variety of service models and investment strategies. Harnessing data such as heat maps showing where patients are and which clinics they visit can inform how best to embed pharmacists and ultimately improve specialty pharmacy care for patients.

Resources:

1. Drugmakers Release 340B Rebate Pilot Program Descriptions
2. HRSA 340B Rebate Model Pilot Program
3. Beacon Rebate Model Resources

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Between new developments on a rebate pilot program, discussions of possible cuts to Medicare payment for 340B drugs, and new action in states nationwide, this fall has been a jam-packed season for 340B. We sit down with 340B Health President and CEO Maureen Testoni to break down the latest.

Questions Remain About January’s 340B Rebate Pilot 

After the Health Resources & Services Administration (HRSA) released 340B rebate pilot program guidance over the summer, all nine manufacturers of the 10 drugs subject to Medicare price caps applied to HRSA to implement rebates for the drugs starting in January. Testoni says we expect to find out which plans are approved in early November, as drugmakers need to give eight weeks of notice so covered entities can prepare for the change. Testoni says questions remain about the rebate pilot, but information that the drugmakers’ rebate vendor has released so far provides enough detail for hospitals to start preparing for both rebates and price caps.

Potential Medicare Cuts Expected To Target 340B Hospitals

Earlier this year, the Trump administration released an executive order directing the Centers for Medicare & Medicaid Services (CMS) to survey hospitals on drug acquisition costs with the goal of using the results to set payment rates for Medicare Part B drugs starting in 2027. Testoni says she is concerned the proposed survey will lead to CMS targeting only 340B drugs for cuts that could bring payment rates down to actual acquisition costs, which would be a steeper cut than what the agency imposed during the first Trump administration.

States Keep Moving on Contract Pharmacy Protections, 340B Mandates

Nearly 20 states have contract pharmacy protection laws in place and a small number of drugmakers have sued to block all these statutes. But Testoni says so far, courts have denied those requests and the laws have stayed in effect despite significant opposition advocacy by drugmakers. An increasing number of states also have enacted laws requiring 340B hospitals to report substantial data on their 340B costs and savings, and some are looking to limit how hospitals can use those savings.

Resources:

1. Senate Hearing Features Both Bipartisan Support for 340B and Calls for Reforms
2. Read Our Comments on CBO’s 340B Growth Report
3. Review Our 340B Rebate Pilot and IRA Resources
4. Beacon Shares New Details on 340B Rebate Pilot Implementation

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About two years ago, Indiana University Health implemented a 340B-funded comprehensive medication review clinic after pharmacy staff noticed patients at their hospitals were not filling maintenance prescriptions due to high cost. Although patient assistance was available, there was not a systematic approach to connecting qualifying patients with the financial help and education they needed, and the health system started the clinic to fill that gap. IU Health Regional Pharmacy Manager of Ambulatory Services Carrie Krekeler discusses how the clinic came about and how it works to improve patient health outcomes.

Improved Drug Affordability and Patient Education

When a prescription goes through IU Health’s comprehensive medication review clinic, pharmacists and other staff will prioritize finding financial assistance for eligible individuals and teaching patients important information about taking their medications. Krekeler says clinic staff will look for discounts for all medications a patient is on and see what a patient’s insurance will cover, if there are copays, and if prior authorization is needed. Staff then will connect patients to coupon cards, manufacturer assistance programs, or 340B-funded assistance through IU Health.

Demonstrated Results

In the two years since the clinic launched, Krekeler says its success has prompted IU Health to reinvest more 340B dollars to expand its reach. Patients with heart failure and diabetes who have gone through the clinic have seen significant improvements in their key health metrics. The clinic helps patients better maintain their health and stay out of the hospital.

Understanding 340B Is Vital for Such Programs

Krekeler says IU Health was able to launch its clinic after adapting a similar initiative that UC Davis had implemented. The key to getting the IU Health clinic off the ground was obtaining buy-in from executives who understood 340B and finance and were able to see the long-term benefit in investing 340B dollars in this area.

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340B savings do not just enable hospitals to provide more care, they also help hospitals pioneer innovative approaches to bringing care directly to patients. For West Virginia University Medicine, which serves a high population of Medicare and Medicaid patients, one of these 340B-funded innovations came from recognizing a need to increase cancer screening rates. WVU Medicine 340B Enterprise Director Karen Famoso tells us how the system’s mobile cancer screening initiative came about.

The Barriers to Cancer Screening

WVU Medicine identified that some of the biggest social determinants of health for its West Virginia patients were relatively unique to the areas it serves. The rural state has significant travel barriers, small population areas, and high poverty rates, a combination that leaves thousands of patients without easy access to a source of primary care.

Mobile Screenings Look for Breast, Lung Cancers

Today, WVU Medicine operates two types of mobile cancer projects: Bonnie’s Bus and LUCAS. The former launched in 2009 and is a mobile mammography unit named after a patient who died because she had limited access to breast cancer screenings. Her family donated funding to the hospital to support this effort. More than a decade later, WVU Medicine introduced the mobile lung screening program LUCAS. That initiative provides low-dose CT scans to patients meeting the screening guideline using a nearly 70,000-pound tractor trailer.

340B Is Key To Sustaining Mobile Screening Efforts

Famoso says WVU Medicine funds its mobile cancer screening programs through grants and donations, but that is not enough to cover the full cost. That is where 340B savings can help cover the operating loss, which was almost $400,000 last year. Without those 340B savings, the health system’s financial situation would not allow investments in mission-focused programs such as Bonnie’s Bus and LUCAS.

Resources

1. Lung Cancer Screening on Wheels
2. HRSA Reviewing Rebate Pilot Proposals and Comments
3. Second Federal Appeals Court Upholds State Contract Pharmacy Law

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One important but understated aspect of 340B compliance is the importance of training new and existing team members on how the program works. But what does effective training look like? Pooja Shah, the system pharmacy manager of 340B programs at University of North Carolina Health, walks us through the key elements of an effective and engaging 340B education strategy.

Setting a Baseline of 340B Knowledge

UNC Health utilizes a two-pronged strategy to 340B education for its team: didactic and interactive approaches. The didactic approach involves creating three online, standardized learning modules to educate those who are new to 340B or who interact with it indirectly as well as those who are more involved in day-to-day 340B operations. The interactive approach involves an educational and decision-making structure designed to adapt to new 340B developments in real time. 

Compliance Meetings Facilitate Discussion

UNC Health uses entity-level and system-level oversight committees to discuss key 340B compliance issues and relevant metrics. Shah says these meetings offer ways to inform senior leadership about key 340B changes and keep other stakeholders, such as hospital compliance and legal credentialing professionals, in the loop.

340B Education Is Best When Nimble

As hospitals evaluate their 340B education efforts, Shah says it’s important they explore existing resources but also work with stakeholders to discuss what would best serve them when learning about 340B. Hospitals also can change existing governance structures to incorporate 340B discussions. Shah says the ability to stay nimble and be able to quickly identify and assemble key players in the 340B space is key to keeping teams informed amid times of change.

Resources

1. Read Our Appeals Court Brief Opposing 340B Rebate Schemes

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Mid-August to mid-September marks the time every year when hospitals need to recertify for 340B. Failure to recertify in time could cost a hospital its ability to participate in 340B. 340B Health Senior Manager of Policy and Compliance Rebecca Swartz joins us to walk listeners through the process.

Why recertification is “exceptionally important”

Swartz says annual recertification is not just important, it’s also one of the central tenets of 340B compliance. All hospital types except critical access hospitals need to make sure they’re meeting the minimum disproportionate share percentage threshold. Hospitals also need to affirm that they are non-profit facilities and that all their registered parent and child sites continue to have reimbursable outpatient costs and charges on their Medicare cost reports.

The cost of losing eligibility is high

Failure to recertify 340B eligibility in a timely manner can lock hospitals out of their access to 340B pricing for a year or more. That could deprive a hospital of crucial resources to provide the care and support its patients need.

Tips for a smooth recertification

Swartz says a key to making the process go smoothly is to start early and make sure hospital officials have the necessary worksheets and other documentation before the recertification process begins. Authorized officials and primary contacts should be on the lookout for returned tasks from HRSA and other messages to ensure their recertification process is complete. Taking screenshots of each step of the process also can help identify and fix discrepancies that might arise.

Resources

1. Annual Hospital Recertification Began August 11
2. 340B Health Webinars
3. HRSA Announces 340B Rebate Pilot Program for up to 10 Drugs in 2026 
4. 340B Health Responds To HRSA 340B Rebate Pilot Program

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Patients with behavioral health and substance use disorders often struggle with accessing and staying on the daily oral medications they need to keep their disorders controlled. That’s why SSM Health uses some of its 340B savings to run long-acting injectable (LAI) clinics in the St. Louis area to help these patients achieve better health. We speak with SSM Health Vice President of Pharmacy Financial Operations Michelle Schmitt to learn how much of a role 340B plays in that patient care mission.

LAI clinics offer comprehensive services

SSM Health’s three LAI clinics offer injections for patients with conditions such as bipolar disorder, schizophrenia, and alcohol and opioid use disorders that might last as long as three to six months. Clinic visits also give the patients access to a full team of pharmacists, psychiatrists, nurses, therapists, and others to help them navigate treatment and stay healthy.

340B funds are key to patient access

Because behavioral health is often a subsidized service, 340B savings are crucial to the operations of the clinics. They also enable SSM Health to offer financial assistance to patients living up to 400% of the poverty level so they can afford the treatments they need to stay on the road to recovery.

Cuts to 340B would be detrimental to patients

Schmitt says losing access to 340B pricing could mean a 60-70% price increase in the cost of LAI drugs, which would threaten the viability of the clinics and the financial assistance that many patients rely on to access their treatments. She says these clinics are a great example of how 340B is about much more than just price discounts; it provides resources for health systems to meet unique community health needs and serve patients where they are.

Resources

1. Federal Legislation Would Ban Harmful Drug Company Restrictions on 340B

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About three years after being signed into law, one provision of the Inflation Reduction Act (IRA) that is of particular importance to 340B hospitals is about to take effect: Medicare price caps. Jan. 1, 2026, marks the date that the first 10 Medicare drugs will be subject to a maximum fair price (MFP). Meetali Desai, director of pharmacy business services at UMass Memorial Medical Center, joins us to explain how this will affect 340B hospitals and health centers such as hers.

The Good and Bad News for Covered Entities

The good news, Desai says, is that there is potential for the 340B ceiling prices to go down for certain medications. This is because the MFP will become the new “best” price in the formula for calculating 340B prices. However, because the law will cap reimbursement rates to MFP when Medicare patients receive those drugs, 340B hospitals will see their 340B savings amounts go down for those dispenses.

Updated Calculator Can Help Hospitals Gauge Potential Impact

340B Health recently updated its calculator for hospitals to use to estimate the effects of MFP pricing based on the newest data. This new calculator allows users to project what the potential impact from the IRA could be on a hospital, including if drugmakers decide to lower their list prices significantly to avoid IRA inflation penalties. This drop in prices of Medicare drugs could result in 340B hospitals seeing higher ceiling prices and reduced savings.

Reduced Savings Could Impact Patient Care

Desai says Medicare price caps, combined with other financial pressures on hospitals, could mean some rough times ahead for hospitals that care for a large proportion of low-income patients. She encourages 340B teams to share their results from the IRA calculator with their senior leadership and with 340B Health as the hospital community prepares for the impact of these caps.

Resources

1. Use Our IRA Calculator and Share How Your 340B Savings Will Change
2. Read Our Analysis: Second Federal Court Affirms HRSA's Authority Over 340B Rebates