340B Insight

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.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 SourcesChristina 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 DiscrepanciesChristina 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 DiscrepanciesChristina 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.ResourcesFederal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful

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.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 StatesBen 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 ResiliencyFor 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 340BWhen 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.ResourcesHRSA Considering Broader 340B Rebate Model Than Withdrawn Pilot340B Health Impact Profile Guidebook and Template

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.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 ResponsesLittle 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 PlanLittle 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 PersistentLittle 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

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.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 MandatoryEarlier 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 2026Just 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 2028Medicare 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.Resources340B Health and Allies Urge CMS Contractor To Correct Statement Suggesting Hospitals Must Respond to OPPS Drug Cost SurveyStates Introduce New 340B Legislation in 2026 SessionsMaine Federal Court Rejects Drug Company Challenge to State 340B Contract Pharmacy LawMedicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings Starting in 2028Manufacturer Notices to Covered EntitiesHRSA Releases 340B Purchase Data for 2024FY 2025 Manufacturer Audit Results

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.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 RulingIn 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 ReconsidersImmediately 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 EffectDespite 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.ResourcesDismissal of Appeal Sets Stage for HRSA Reconsideration of 340B Rebates

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.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 ShapeSwartz 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 HospitalsThis 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 HospitalsSwartz 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.Resources340B Health Year-in-Review Webinar: 2025 Highlights and What’s on the Horizon

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.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 LawsThis 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 MandatesFive 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 2026While 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 ProposalState 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 InvestmentWeber 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 FactorsFor 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 DescriptionsHRSA 340B Rebate Model Pilot ProgramBeacon Rebate Model Resources

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.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 HospitalsEarlier 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 MandatesNearly 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 ReformsRead Our Comments on CBO’s 340B Growth ReportReview Our 340B Rebate Pilot and IRA ResourcesBeacon Shares New Details on 340B Rebate Pilot Implementation

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.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 EducationWhen 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 ResultsIn 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 ProgramsKrekeler 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.

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.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 ScreeningWVU 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 CancersToday, 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 EffortsFamoso 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.ResourcesLung Cancer Screening on WheelsHRSA Reviewing Rebate Pilot Proposals and CommentsSecond Federal Appeals Court Upholds State Contract Pharmacy Law

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.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 KnowledgeUNC 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 DiscussionUNC 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 NimbleAs 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.ResourcesRead Our Appeals Court Brief Opposing 340B Rebate Schemes

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.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 highFailure 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 recertificationSwartz 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.ResourcesAnnual Hospital Recertification Began August 11340B Health WebinarsHRSA Announces 340B Rebate Pilot Program for up to 10 Drugs in 2026 340B Health Responds To HRSA 340B Rebate Pilot Program

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.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 servicesSSM 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 accessBecause 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 patientsSchmitt 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.ResourcesFederal Legislation Would Ban Harmful Drug Company Restrictions on 340B

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.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 EntitiesThe 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 Impact340B 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 CareDesai 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.ResourcesUse Our IRA Calculator and Share How Your 340B Savings Will ChangeRead Our Analysis: Second Federal Court Affirms HRSA's Authority Over 340B Rebates

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.Health systems eligible for 340B savings must strike a balance by staying compliant with purchasing rules while also maximizing the amount of eligible savings they can obtain to invest in patient care. Angela Campitelli, the director of the pharmacy 340B program at MetroHealth System in Cleveland, explains how a hospital system such as hers implements a purchasing strategy that achieves that balance.Following rules for 340B purchasesDisproportionate share (DSH) hospitals, children’s hospitals, and cancer hospitals are subject to a group purchasing organization (GPO) prohibition that bars them from buying covered outpatient drugs on GPO accounts. That requires maintaining a purchasing system that involves buying drugs at wholesale acquisition cost (WAC) for neutral inventory and then replenishing at 340B, WAC, or GPO pricing depending on how the drug is used.How the cycle can break downPurchasing drugs outside of the outlined processes could cause violations of the GPO prohibition or other 340B rules, which could lead to sanctions that might include losing eligibility for 340B. That is why health systems such as MetroHealth use staff education, regular auditing, and other safeguards to ensure they are purchasing and replenishing drugs on the correct accounts.Investments in the strategyCampitelli recommends 340B hospital teams bring their senior leadership on board to invest in auditing and other resources to ensure a strong purchasing strategy. Such investments will help avoid potential rule violations while ensuring that hospitals are not walking away from 340B savings to which they are entitled.Resources340B Health Appeals Rebate Ruling; Federal Court Agrees to Fast-Track Drugmaker Appeals

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.After months of litigation in a federal district court, a key decision recently came out in the legal fight over 340B drug rebates. 340B Health Vice President of Legal and Policy Amanda Nagrotsky updates us on the development.Court deals a blow to drugmakersD.C. district court judge Dabney Friedrich ruled on May 15 that manufacturers cannot unilaterally implement rebate models for 340B, agreeing with the Health Resources & Services Administration (HRSA) that the agency effectively has preapproval authority over rebates. In her decision, the judge cited early results from a 340B Health survey finding that shifting 340B to a rebate model would divert significant hospital resources from patient care. Drugmakers have already appealed the ruling.Some bright spots for drugmakers in this decisionAlthough the decision largely went against pharmaceutical companies, the judge ruled that the 340B statute does not categorically prohibit rebates, leaving the door open for government approvals of rebates. The judge also agreed with drugmakers’ assertions that HRSA should consider how rebate models could improve 340B compliance and how requiring the sharing of data through rebates could aid in drug company audits of covered entities.Will HRSA stop all rebates from proceeding?Despite this decision, the legal fight over rebates isn’t over yet. The judge found that, for three of the manufacturers in these cases, HRSA has yet to issue final decisions with respect to their proposed rebate models. In the case of Sanofi, the judge found that HRSA failed to adequately explain the legal basis for rejecting the drugmaker’s rebate model, and she directed the agency to reconsider its decision and explain whether and how it would violate the 340B statute. HRSA sent rebate guidance to the White House for approval earlier this month, though as of recording this episode it was not known what that guidance would say.ResourcesRead Our Analysis of the First Federal Court Decision on Rebates340B Health Continues Court Fight Against Rebates

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.More than a third of patients released from the hospital never fill their discharge prescriptions, but “meds-to-beds” programs can help improve that statistic. That is the approach Renown Health in Reno, Nev., took with the help of its 340B savings. Renown Vice President of Pharmacy Services Adam Porath joins us to describe how this meds-to-beds program improves patient care.Hospital readmissions down, patient convenience upRenown Health’s 340B-funded program offers medication to patients who are being discharged from the hospital, either through bedside delivery, pneumatic tube, or a unique discharge lounge. The effort began as a pilot for Medicaid patients in 2016, and it demonstrated patients in the program were 25% less likely to be readmitted to the hospital once discharged. These health improvements plus the added convenience of medication access for patients convinced the system to expand the program.340B pricing to patients who cannot payPorath says Renown Health refers patients who cannot afford discharge medications to its social services team, which can authorize providing the drugs to those patients at the 340B-discounted rate. The team also will work with patients to see if they qualify for coverage such as Medicaid or other programs to reduce their out-of-pocket costs. Porath said Renown’s meds-to-beds program provides drugs free of charge to about 30 patients per month.The keys to successRenown Health’s meds-to-beds program has been a success, with more than 80% of eligible patients participating as of the end of 2024. The hospital expanded the services to all patients and started operating it 24/7 in April 2024. Porath said the keys to success include regular reporting to stakeholders and innovations to handle a large volume of patients discharging at once. Such changes allow all parties to stay in the loop with the development of the program and to celebrate successes as they occur.ResourcesRead Our Analysis of the First Federal Court Decision on RebatesSecond Federal Judge Allows 340B Health, Member Hospitals To Intervene in Rebate Lawsuit

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.Big potential changes to how 340B operates plus heightened interest in both new protections and new restrictions for covered entities means there is much to keep track of in the 340B world. 340B Health CEO Maureen Testoni joins us to make sense of recent developments in the nation’s courts and beyond.Rebates Get Their Day in Court340B Health, two member hospitals, and the government met drug companies in court in late April to challenge drugmaker attempts to replace 340B discounts with rebates. Testoni says the judge cited potentially devastating consequences to hospitals if rebates proceeded but also had probing questions for the government on how it is working to address drugmaker compliance concerns. The Dept. of Health and Human Services is set to release guidance by early June on the rebate issue, and the court’s decision could come out soon.The White House Proposes 340B Big Oversight Shift A leaked copy of the Trump administration’s latest budget proposal includes a plan to move the Office of Pharmacy Affairs (OPA) from the Health Resources & Services Administration to the Centers for Medicare & Medicaid Services. Testoni says the oversight shift is concerning because of a stark difference between the purpose of 340B and the operations of Medicare and Medicaid. CMS also imposed years of Medicare payment cuts to 340B hospitals that the U.S. Supreme Court eventually overturned.340B Protections, Mandates Take Center StageStates continue enacting laws to protect hospital access to 340B pricing, but they also are moving forward with reporting mandates and proposals to define how hospitals should use their savings. Testoni said reporting and use-of-savings mandates lead to misdirected views on the purpose of 340B, which goes far beyond direct patient care and cost assistance. On Capitol Hill, a report from a long-running investigation of 340B recently came out, contributing to the debate over possible new restrictions.ResourcesFederal Government Signals Upcoming Guidance on 340B Rebate Models Amid Legal ChallengesBrief Your Leaders on White House Plans for Major 340B ChangesNebraska Is 12th State To Enact Contract Pharmacy ProtectionsIndiana Becomes Fifth State To Mandate 340B Reports From HospitalsKey Senator Concludes 340B Investigation, Calls for Major ReformsNew 340B Health Research340B Impact Profiles