340B Insight

Lessons From a Pro in Advocating Effectively for 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.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access” that 340B can provide patients in hospitals nationwide.ResourcesHRSA Considering Broader 340B Rebate Model Than Withdrawn Pilot340B Health Impact Profile Guidebook and Template

What Happens After a State Enacts Contract Pharmacy Protections?

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

Answering More of Your Top 340B Questions

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

Why 340B Rebates Are Off — For Now

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

2025: The Year Rebates Took Shape

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