340B Insight

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

1. Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful

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

1. HRSA Considering Broader 340B Rebate Model Than Withdrawn Pilot
2. 340B Health Impact Profile Guidebook and Template

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:

1. HRSA Gives Short Window for Stakeholder Input on Reviving 340B Rebate Model

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

1. 340B Health and Allies Urge CMS Contractor To Correct Statement Suggesting Hospitals Must Respond to OPPS Drug Cost Survey
2. States Introduce New 340B Legislation in 2026 Sessions
3. Maine Federal Court Rejects Drug Company Challenge to State 340B Contract Pharmacy Law
4. Medicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings Starting in 2028
5. Manufacturer Notices to Covered Entities
6. HRSA Releases 340B Purchase Data for 2024
7. FY 2025 Manufacturer Audit Results

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

1. Dismissal of Appeal Sets Stage for HRSA Reconsideration of 340B Rebates

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

1. 340B Health Year-in-Review Webinar: 2025 Highlights and What’s on the Horizon

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!

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

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