340B Insight

340B Health

340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.

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September 14 · 19 min
Pharmacy Technicians and 340B Go Hand in Hand
The popular belief that pharmacy technicians are solely focused on dispensing drugs is a common misconception, especially when these techs are working for 340B hospitals. We speak about the increasingly important role pharmacy techs are playing in the 340B world with Dartmouth Health Senior 340B Analyst Kayla Ciampi. Getting Into the 340B World After having limited experiences with 340B earlier in her career, Ciampi said things became “340B on steroids” once she moved to Dartmouth Health. Now much of her day-to-day responsibilities revolve around 340B purchasing and compliance issues, involving significant amount of time working with Excel, third-party administrators, and 340B claims auditing. She said what keeps her coming back are the challenges she tackles and the satisfaction she gets from finding solutions after hours of research. The Changing 340B Roles of Pharmacy Techs Ciampi says pharmacy techs are working hard figuring out when to purchase drugs on 340B accounts, ordering for contract pharmacies, and keeping track of increasing drugmakers restrictions. Techs are doing much of the analytical work behind the scenes to make sure 340B claims are eligible, making them a key part of the compliance infrastructure at hospitals. Advice for Other Techs As the 340B world picks up speed, Ciampi said being a pharmacy tech in that field can feel like being on a fast-moving freight train and trying to see what’s happening outside. Because of how rapidly that landscape is changing, she says attention to detail, a willingness to adapt, and a desire to learn are the keys to 340B success for techs. Resources 340B Health Urges CMS To Abandon Proposed Medicare Cuts to 340B Hospitals
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August 31 · 20 min
How Hospitals Can Wrangle 340B Data
A key dimension to navigating 340B involves data, because the way hospitals and their pharmacies crunch numbers can be key to avoiding compliance issues and finding new opportunities to improve savings and patient access to care. Saint Francis Health System’s 340B Program Manager Ted Houston tells us how his health system is getting the most value out of all the data. Compliance and Savings Opportunities Houston says his health system has put in a lot of work with its enterprise and data analytics team to align what the electronic health record system is exporting to what drug companies are demanding in order to improve compliance. But he said improving reports also led to additional savings for his system, as some claims were miscategorized within third-party administrator systems. Data Consolidation, Better Workflows Houston said health systems can improve their data monitoring by reducing individual data sources — for example, by using a standardized data extract from a third-party administrator and using tools to scan for certain types of claims. Saint Francis found success with improving oncology medication workflows, finding tens of thousands of dollars’ worth of eligible savings on certain oncology medicines. Investing in Better Data Quality, Not Volume To improve data collection, Houston said self-education — both about different analytical resources and what use cases would have the biggest impact — is critical to optimizing data. Those tools may cost money, but it is important to concisely communicate the value proposition for compliance or savings when investing in new tools to improve how hospitals gather and process data. Resources: Episode 140: What Illinois 340B Advocates Did To Succeed on 340B Protections Illinois Governor Signs 340B Contract Pharmacy Protections as Drugmakers File Lawsuits
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August 10 · 19 min
The Time Is Here for 340B Recertification
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 Associate Director 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 nonprofit 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 (AOs) and primary contacts (PCs) should be on the lookout for returned tasks from the Health Resources & Services Administration (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 Hospital Recertification Begins Aug. 10, Prepare Now! 340B Health Registration and Recertification Resource Page 340B Health Webinars
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July 27 · 18 min
Why Your Hospital Might Consider Opening a Retail Pharmacy
With hospitals facing increasing drug company restrictions on access to 340B savings and other challenges, some might be considering opening their own retail pharmacies to serve their patients. We speak with Sherstin Willyerd, director of pharmacy operations at Montgomery County Memorial Hospital in Iowa, to learn about how her hospital went this route and what others want to consider before doing the same. Buying Existing Pharmacies Can Be a Solution Willyerd said her hospital was able to purchase two independent pharmacies whose owners were retiring, providing an existing dispensing infrastructure and patient base from which to start. While the hospital still has some contract pharmacy partnerships, the in-house locations can serve patients and generate 340B savings that are less prone to drugmaker restrictions. A Retail Pharmacy Can Give Better Insight into Patient Struggles Operating a retail pharmacy allowed Willyerd’s hospital to see more clearly which patients were struggling with prescription drug costs and medication adherence and to provide more assistance to them. She noted that capturing more 340B savings makes it easier to pass along more discounts to patients who otherwise would not be able to afford their drugs. An Independent Insurance Plan Means Even More Assistance Montgomery County Memorial Hospital also partnered with a pharmacy benefit manager (PBM) to create a primary and secondary prescription drug insurance plan that it offers to certain patients with low incomes and hospital employees. Willyerd noted that this plan can mean hundreds of dollars in savings per month for uninsured patients and those whose coverage comes with high cost sharing. Resources: HRSA Releases 340B Purchase Data for 2025
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July 13 · 21 min
What Illinois 340B Advocates Did To Succeed on 340B Protections
After years of lobbying and advocacy work by 340B covered entities, the Illinois state legislature approved major 340B legislation earlier this year that protects 340B contract pharmacy access and prohibits drugmaker claims on data demands. Thomas Yu, system director of ambulatory pharmacy services at Sinai Chicago, discusses the campaign that made this legislative victory possible and what covered entities in other states can learn from this success. Joint Events Showed Unity Among Safety-Net Providers Yu says two “340B Saves Lives” days of action in Chicago helped drive support for the legislative effort. Under the leadership of an association representing community health centers, the events brought together covered entities, patients, lawmakers, and others to show a united front on the issue of protecting 340B. The Story of 340B Resonated With Lawmakers, Not Numbers Alone Yu reiterates that statistics and data can be helpful in making the case for 340B but that the story of 340B is what can swing votes. Focusing on community impact and how covered entities use their savings to benefit patients was much more effective at imparting the importance of legislation to protect access to those savings. Illinois Legislation Was a Compromise The legislation package in Illinois contains 340B reporting requirements for covered entities in the state. Yu argues that this compromise was necessary as the contract pharmacy and claims data provisions would have been a “nonstarter” without that addition. However, because the numbers go to the state for a one-time report and because drugmakers also must report data, he says the overall legislative package still makes for a big win for covered entities and patients in the state. Resources Illinois Legislature Delivers Contract Pharmacy Victory for 340B Hospitals Proposed Medicare Pay Cut for 340B Drugs Would Be Much Deeper Than 2018-2022 Reductions
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June 29 · 19 min
How Courts Are Shaping the Future of 340B
With scores of pending lawsuits involving drugmaker and covered entity challenges of how federal and state governments regulate 340B, the courts have become an important arena in the national 340B debate. 340B Health’s Vice President of Legal and Policy Amanda Nagrotsky unpacks some of the cases and what they might mean for 340B’s future. Courts Wrestle With Issues of Federal and State Authority Drug companies have filed about 80 lawsuits challenging state contract pharmacy protection laws. Nagrotsky says drugmakers are arguing these state laws conflict with federal oversight, but most courts so far have ruled that contract pharmacy protection laws fall within a state’s ability to regulate drug distribution and delivery. A recent decision from a federal judge in Mississippi was a major win for covered entities because it completely dismissed a drugmaker’s challenge to the state’s law rather than just ruling on whether to pause enforcement of the law. AbbVie Challenges 340B Patient Definition Drugmaker AbbVie is suing the Health Resources & Services Administration (HRSA) directly, arguing that the definition of whom the agency considers a 340B-eligible patient is too broad. AbbVie’s own, narrower patient definition would require drug companies to discount far fewer drugs and thus would limit hospital access to 340B savings significantly. The government is asking the court to dismiss the lawsuit on procedural grounds, and 340B Health along with two member hospitals are asking the court to allow them to intervene as defendants and provide additional arguments for why it should throw out the case. Uncertainty Remains Despite GPO, Child Site Rulings Federal district court decisions found that HRSA failed to explain why it adopted a 2013 policy barring certain 340B hospitals’ use of group purchasing organizations (GPOs) to make initial purchases for their virtual inventory systems and a 1994 policy establishing registration prerequisites for new 340B hospital outpatient facilities. Although the government opted against appealing the ruling striking down the GPO policy, the underlying prohibition remains in effect, leaving hospitals in limbo as to how HRSA will interpret the law. The government has appealed the child site ruling, and a final decision on that case will have a major impact on how quickly hospitals can use 340B drugs at new child sites.
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May 26 · 21 min
How To Calculate How the IRA Will Affect 340B in 2027
Hospitals already have felt some of the effects of the Inflation Reduction Act on 340B savings, but with the IRA set to expand to more drugs in 2027, hospitals also are starting to project how it might affect their bottom lines next year. 340B Vice President of Pharmacy Services and Education Steven Miller joins us to explain how hospitals can be making those projections now. The IRA Will Expand to Another 15 Drugs Next year, an additional 15 drugs will be subject to Medicare price caps under Medicare Part D on top of the 10 drugs that saw caps this year. Steve says this will cut into 340B savings and overall margins even more — with some 340B discounts possibly dropping to their statutory minimums. These reductions also will translate to commercial and cash-pay dispenses, changing the overall financial outlook for hospitals. Hospitals Cannot Rely on Current 340B Savings Levels for 2027 Steve says the 2027 changes are key for future budgeting. If hospitals do not adjust how they are budgeting for 340B drugs subject to Medicare price caps, they are likely to be short on their budget projections. He strongly recommends 340B teams have important conversations with finance teams now about how the IRA will affect their hospital or health system next year. Hospitals Can Be Planning Now For the rest of 2026, Steve recommends hospitals monitor list pricing and 340B ceiling pricing regularly and to increase monitoring of purchases overall, given how drugmaker pricing behavior affects future 340B prices and savings. As the IRA continues to broaden over the next several years, including to Medicare Part B dispenses, he also recommends hospitals consider securing funding or support from other areas for any 340B-funded services that might see negative IRA impacts. Resources: Prepare Your Leadership for 340B Changes From 2027 Medicare Drug Price Caps
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May 11 · 15 min
How To Navigate a Drug Company’s Good-Faith Inquiry
Drug companies often initiate good-faith inquiries of covered entities (CEs) to learn more about certain purchase patterns or volumes, but how should hospitals navigate these requests? Bibi Wishart, director of pharmacy at Atrium Health, describes what she’s learned being on the receiving end of these inquiries. Why Do Good-Faith Inquiries Happen? Bibi says the recent rise in good-faith inquiries is tied in part to drug companies gaining access to more varied data sources and expressing a goal of ensuring the information they collect is in line with what they are expecting. She says a variety of different factors could trigger this type of inquiry, including new providers purchasing certain drugs, concerns about duplicate discounts, or confusion around whether a drug is being used in an inpatient or outpatient setting. Hospitals are very complicated, so responding to an inquiry often can be more about educating drug companies about how hospitals dispense drugs. How Should a Hospital Respond? If her hospital receives a communication from a drug company through its authorized official and primary contact, Bibi says she prefers to respond within one or two business days just to confirm she has received the inquiry. She says that while it may take several days or weeks to respond with the requested data, that initial response establishes a cooperative tone and ultimately might prevent escalation to a formal audit process. That also gives the 340B team time to pull in the correct departments and hospital data to provide a full response. Ways To Prevent the Need for Inquiries Due to the sheer complexity of dispensing drugs — including reconciling data feeds from third-party administrators, vendors, and electronic medical records — regular internal audits are one of the best ways to identify discrepancies before drugmakers launch inquiries about them. Bibi recommends using internal auditing to catch these issues and having clear procedures in place for how to resolve any potential errors.
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April 13 · 22 min
The Rebate Debate and Other “Fast and Furious” 340B Developments
340B lately has had a news cycle that seems to change by the hour, and 340B Health President and CEO Maureen Testoni joins us to break down some of the biggest news happening in Washington, D.C., and in courthouses around the country. HRSA Seeks Feedback on Reviving Rebates After courts halted the rebate pilot that was set to go into effect in January, Maureen notes that the Health Resources & Services Administration is seeking more information on a possible revival of its rebate plans. Hospitals are responding with their objections, as are lawmakers on Capitol Hill. Nearly 100 members of the House of Representatives wrote a letter to the committee in charge of funding HRSA urging it to block federal spending for any HRSA rebate model. Huge Rulings on the GPO Prohibition, Child Site Registration The past several months have seen big 340B rulings from federal courts. One decision vacated HRSA guidance that had blocked certain 340B hospitals’ use of GPOs for their initial drug inventory, finding that HRSA failed to properly explain the reasons for that restriction. The other decision found that HRSA similarly failed to explain a rationale for restricting 340B eligibility for child sites for up to 23 months after the sites come online. Maureen notes that HRSA could appeal the rulings or seek to issue new guidance. Federal Government Weighs in on State Contract Pharmacy Lawsuits For the first time, the federal government has filed briefs in support of drug companies in several lawsuits over state contract pharmacy protection laws. In these briefs, Maureen says the government effectively is telling judges it does not believe states have the right to protect contract pharmacy because federal 340B law preempts such actions. With the federal government weighing in on the matter and a recent split among appeals courts over the issue of preemption, it is possible this issue might be appealed at some point to the U.S. Supreme Court. Resources Use Our Letter Template Today To Oppose Development of a New 340B Rebate Program Nearly 100 Members of Congress Urge Funding Block for 340B Rebate Model Please Help Advocate for Enforcement Actions Against Drugmakers’ In-House Claims Data Demands Federal Court Vacates HRSA’s 2013 GPO Prohibition Policy Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful Federal Government Backs Drug Companies in Litigation Over State Contract Pharmacy Laws Appeals Court Blocks West Virginia 340B Contract Pharmacy Law, Creating Potential Split with Other Circuits 340B Health Impact Profile Guidebook and Template
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March 30 · 18 min
How To Improve 340B Inventory Management
One of the most important responsibilities hospitals have in maintaining 340B compliance is effective and accurate inventory management, but how do hospitals juggle data from multiple systems and minimize discrepancies? Christina Carrizales Cortez, associate director of 340B compliance for UI Health in Chicago, outlines some of the common inventory issues she encounters and explains how her team works to prevent and fix discrepancies. 340B Discrepancies Can Come From a Variety of Sources Christina says that because 340B compliance relies on monitoring and analyzing a multitude of data feeds, inventory discrepancies can come in multiple forms. A wholesaler might lack an electronic interface — meaning items must be manually entered and verified by the hospital team. Accounts might not have up-to-date inventory locations and addresses. Test claims, a practice by which pharmacies ascertain the cost to a patient of certain drugs, can lead to discrepancies if they do not end up dispensing those drugs. Understanding Systems Can Be Key to Reducing Discrepancies Christina says that the terminology and quirks of 340B can introduce confusion. One remedy, she says, is to explain 340B better so non-340B staff can understand it. Breaking down the basics of 340B and explaining its intricacies can go a long way in rooting out common pain points. Other Tips for Reducing Discrepancies Christina finds that comprehensive monthly reviews are an excellent way to find mismatches, as are instituting different checkpoints in the review process. Analyzing data points such as timestamps can reveal patterns for hospitals. Mapping out all vendors and routinely auditing split-billing software can help ensure better compliance as well. Resources Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful
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March 9 · 22 min
Lessons From a Pro in Advocating Effectively for 340B
As state legislatures shape up to be the primary battlegrounds for 340B in 2026, Memorial Healthcare Associate Vice President of Advocacy and Government Relations Ben Frederick joins us to share what he’s learned about advocating for 340B. Early Involvement “Crucial” as Focus Shifts to States Ben notes that as states started becoming the primary venues for debating 340B legislation, lobbying efforts from both hospitals and pharmaceutical companies began increasing. This snowballed into deeper conversations — and misleading narratives — about the intent of 340B. Those conversations underscored the importance of hospitals lobbying early and frequently with key stakeholders to help set the record straight about 340B. 340B as Key to Hospital Resiliency For Ben, one of the biggest points he comes back to is the importance of the flexibility of 340B savings. With safety-net hospitals operating on thin margins, the ability to access 340B and the freedom to use savings where the community needs them most is essential not just for serving patients but in many cases for keeping the lights on in the first place. Know Your “Why” for Supporting 340B When illustrating the importance of 340B, Ben told us about his “why” for 340B: When his father received a terminal cancer diagnosis, it was 340B funding that enabled his local hospital to invest in the top-notch cancer treatments and palliative care he received. That is how his father was able to receive his treatments five minutes from home instead of 45 minutes away. Those resources afforded Ben’s family a “dignity of local access” that 340B can provide patients in hospitals nationwide. Resources HRSA Considering Broader 340B Rebate Model Than Withdrawn Pilot 340B Health Impact Profile Guidebook and Template
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February 23 · 22 min
What Happens After a State Enacts Contract Pharmacy Protections?
Some of the biggest recent policy developments for 340B hospitals are when states enact legislation to protect access to 340B pricing through contract pharmacies. Olivia Little, 340B director at Johnson County Hospital in Tecumseh, Neb., was closely involved with a coalition of providers that was able to get such a bill passed through the state’s legislature and signed into law by the governor. But she describes why getting the law enacted wasn’t the end of the story. A Wide Range of Responses Little says once her state’s contract pharmacy protection law went into effect, she began receiving notices about 340B pricing being restored from some drug companies. But not all drugmakers restored previous pricing levels right away in Nebraska — some took months, and some have not yet done so despite the law going into effect nearly a year ago. The wide range of ways in which companies responded to the new law created difficult choices for hospitals between risking a potential compliance issue or leaving some 340B savings on the table. Having a Game Plan Little says her advice to other health systems in states with new contract pharmacy protections would be to have a plan in place for what happens when the law goes into effect. Implementing these protections can raise questions about issue such as backdating, inventory, and retesting claims for 340B status. The complex tracking of multiple drugmaker policies in response to the Nebraska law resulted in her needing to closely document communications with drug companies and their vendors. The Need To Be Persistent Little also stressed that getting pharmacy protections to pass through her state legislature and get to the governor’s desk took years of effort, advocacy, and redrafting to ensure success. Between media appearances and advocating in the statehouse and on social media, Little says this success ultimately came down to the core message: 340B is good for patients, hospitals, and communities. Resources: HRSA Gives Short Window for Stakeholder Input on Reviving 340B Rebate Model
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February 9 · 13 min
Answering More of Your Top 340B Questions
For the third year in a row, we consulted 340B Health’s experts on our staff to answer our listeners’ most pressing 340B questions. As 2026 gets underway, we answer your questions about the CMS drug acquisition cost survey, what states are doing on 340B this year, and more. Some of the topics we cover: CMS Drug Acquisition Cost Survey Not Mandatory Earlier this year, the Center for Medicare & Medicaid Services (CMS) launched a new survey focusing on hospitals’ outpatient drug acquisition costs, which could lead to Medicare Part B payment cuts for 340B drugs. Some hospitals recently saw materials suggesting they are required to complete the survey. Amanda Nagrotsky, vice president of legal and policy for 340B Health, notes that a CMS rule states there are no penalties under the Medicare statute for hospitals that choose not to respond. 340B Health and other groups sent a joint letter asking for the language to be corrected, citing the confusion it has caused. State Legislatures Are Becoming Major Battlegrounds for 2026 Just over one month into 2026, statehouses are already shaping up to be one of the biggest venues to debate various aspects of the 340B. Two broad categories of bills are emerging: legislation protecting access to 340B pricing — including protections for contract pharmacy arrangements — and state-level reporting mandates. 340B Health Senior Vice President of Government Relations Tom O’Donnell says the proposed reporting mandates mirror other states’ recently enacted requirements, and he argues they can be misleading, burdensome, or modeled on frameworks promoted by large drug companies. Medicare Announces More Drug Price Caps for 2028 Medicare is phasing in maximum fair pricing – or MFP – for high-spending drugs over several years. CMS recently announced the next group of 15 drugs that will be subject to these types of price caps in 2028, adding to the 2026 and 2027 drug lists. Starting in 2028, these price caps will apply to both Medicare Part D and Part B drugs, including those purchased through Medicare Advantage. 340B Health Senior Manager of Pharmacy Services Gilda Yeboah says this means hospitals will see reduced 340B savings on certain drugs as Medicare prices move closer to existing 340B ceiling prices. Yeboah says the issue is complex and evolving, and 340B Health is working to share concerns about MFP implementation with federal agencies. Resources 340B Health and Allies Urge CMS Contractor To Correct Statement Suggesting Hospitals Must Respond to OPPS Drug Cost Survey States Introduce New 340B Legislation in 2026 Sessions Maine Federal Court Rejects Drug Company Challenge to State 340B Contract Pharmacy Law Medicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings Starting in 2028 Manufacturer Notices to Covered Entities HRSA Releases 340B Purchase Data for 2024 FY 2025 Manufacturer Audit Results
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January 26 · 18 min
Why 340B Rebates Are Off — For Now
January was set to be the first month of a new 340B rebate pilot program, marking a seismic shift in how the drug discount program functions. But a flurry of court activity just before and after the new year put a sudden pause on the rebate program and left the future of the rebate pilot in question. Amanda Nagrotsky, vice president of legal and policy with 340B Health, joins the show to fill us in on the latest. HRSA Pauses Rebate Implementation After Court Ruling In late December, a federal court in Maine issued a ruling that temporarily blocks the Health Resources & Services Administration (HRSA) from moving forward with the 340B rebate pilot. HRSA then announced it was pausing the pilot and instructed drug companies to continue providing 340B pricing through the traditional upfront discount model. Nagrotsky says the judge found that hospitals had demonstrated a high likelihood of irreversible harm if rebates went forward. Government Appeals, Then Reconsiders Immediately after the ruling, HRSA unsuccessfully argued to the Maine court and an appeals court that the agency still should be able to implement the 340B rebate pilot program while it appealed the initial ruling. After the courts denied that request, the government agreed to voluntarily dismiss its appeal and said it would reconsider its rebate program approvals. Nagrotsky stresses that it is unclear what this means. It could mean the government might overhaul or scrap the rebate program, or it might issue revised approval notices to better explain the rebates’ purpose and address concerns of potential harm to 340B hospitals. Medicare Maximum Fair Price Provisions Still Take Effect Despite the legal questions surrounding the 340B rebate pilot program, new Medicare maximum fair price (MFP) provisions did take effect at the beginning of January for the drugs that would have been subject to the rebates. Nagrotsky says that while 340B still can be used for these drugs, covered entities are not entitled to MFP refunds from drug companies in those scenarios. She recommends hospitals closely track expected MFP rebates to identify any missing refunds for claims that did not use 340B drugs. Resources Dismissal of Appeal Sets Stage for HRSA Reconsideration of 340B Rebates
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Dec 22, 2025 · 18 min
2025: The Year Rebates Took Shape
With monumental movement on 340B rebates, changes in Medicare and Medicaid payments, and evolving audit priorities, 2025 has been a transformative year in the world of 340B. We sit down with 340B Health Senior Manager of Policy and Compliance Rebecca Swartz to chronicle some of the biggest developments of such an eventful year and forecast what to expect in 2026. Rebates Take Shape Swartz says 2025 will go down as the year that a rebate model shifted from a hypothetical approach pushed by drugmakers into a fully developed model with implementation criteria. The Health Resources & Services Administration (HRSA) approved plans for 340B rebate models set to take effect in January for nine of 10 drugs subject to the 2026 Medicare maximum fair prices. Rebates for the remaining drug on that list will kick in April 1. Swartz discusses how hospitals should prepare for this pilot program, which is set to upend decades of established 340B operations and impose intense financial and logistical burdens on safety-net hospitals nationwide. Medicaid, IRA Changes Set To Impact 340B Hospitals This year also saw massive changes to Medicaid funding as well as Medicare pay changes under the implementation of the Inflation Reduction Act (IRA). Swartz says these developments are projected to shrink safety-net hospital margins even further. Renewed congressional focus is putting 340B in a high-profile spot, with potentially significant implications for the program and hospitals in the coming months. 2026 Tips for Hospitals Swartz says she’s identified two areas as more of a focus for HRSA audits this year: expanded scrutiny of offsite and on-site trial balances and the ways covered entities list shipping addresses. To prepare for possible shakeups in 2026, she recommends that covered entities begin and maintain cross-functional planning across departments and closely monitor denials, delays, and other costs from new rebate programs in addition to monitoring wholesale acquisition cost (WAC) changes and contract pharmacy developments. Resources 340B Health Year-in-Review Webinar: 2025 Highlights and What’s on the Horizon
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Dec 9, 2025 · 18 min
States Expand 340B Reporting Requirements
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: HRSA Approves Novartis’s 340B Rebate Pilot Proposal State Policy & Advocacy Communications Resource Center
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Nov 24, 2025 · 3 min
Special Mini-Episode: Listener Survey
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!
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Nov 10, 2025 · 23 min
How To Embed Clinical Pharmacists in Specialty Pharmacy
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: Drugmakers Release 340B Rebate Pilot Program Descriptions HRSA 340B Rebate Model Pilot Program Beacon Rebate Model Resources
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Oct 27, 2025 · 23 min
340B Rebates in 2026, Medicare Cuts in 2027?
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: Senate Hearing Features Both Bipartisan Support for 340B and Calls for Reforms Read Our Comments on CBO’s 340B Growth Report Review Our 340B Rebate Pilot and IRA Resources Beacon Shares New Details on 340B Rebate Pilot Implementation
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Oct 13, 2025 · 17 min
Using 340B for Comprehensive Medication Review
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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