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.

  1. 1 DAY AGO

    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 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 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

    14 min
  2. 26 JAN

    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 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

    19 min
  3. 22/12/2025

    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 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

    18 min
  4. 09/12/2025

    States Expand 340B Reporting Requirements

    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 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 ProposalState Policy & Advocacy Communications Resource Center

    19 min
  5. 10/11/2025

    How To Embed Clinical Pharmacists in Specialty Pharmacy

    340B Insight wants to make our podcast the best it can be. To help us succeed, we’d like to hear your thoughts. Please take just a few minutes to complete our listener survey, and we will enter you in a drawing to win a $100 gift card! To participate, please go to 340bpodcast.org/survey. The large and growing field of specialty pharmacy means new opportunities and challenges for ensuring patients receive the specialty drugs they need and stay on the therapies that might save their lives. St. Luke’s Health System, based in Boise, Idaho, has approached this mission by embedding clinical pharmacists in the specialty pharmacy space and using 340B as a critical tool. We speak with Josh Weber, senior director of ambulatory retail and specialty pharmacy services at St. Luke’s, to learn more. How Clinical Pharmacists Can Be a “Value Multiplier” Embedding clinical pharmacists in their specialty pharmacies improves operations in myriad ways. These pharmacists can take the burden off other providers by meeting with patients to go over their drug regimens, coordinating care, and running split-fill programs to reduce waste. At St. Luke’s, the approach has improved patient adherence to medications and reduced the time between the specialty prescription and the patient having the medication in hand to less than 48 hours – far quicker than the industry standard. 340B Savings Are Key to the Investment Weber says cost savings from 340B are critical in calculating how they embed resources into specialty pharmacy, noting that improving adherence and retention can increase 340B savings exponentially. These savings then can enable health systems such as St. Luke’s to reinvest in their internal specialty pharmacies, provide more patient cost assistance and unreimbursed care, and ultimately shield themselves from headwinds such as drugmaker contract pharmacy restrictions. Embedding Pharmacists Depends on Hospital-Specific Factors For hospitals considering following the lead of St. Luke’s Health System, Weber said a variety of factors such as patient volume, payer mix, and drug spend can call for a variety of service models and investment strategies. Harnessing data such as heat maps showing where patients are and which clinics they visit can inform how best to embed pharmacists and ultimately improve specialty pharmacy care for patients. Resources: Drugmakers Release 340B Rebate Pilot Program DescriptionsHRSA 340B Rebate Model Pilot ProgramBeacon Rebate Model Resources

    24 min
  6. 27/10/2025

    340B Rebates in 2026, Medicare Cuts in 2027?

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

    24 min
  7. 13/10/2025

    Using 340B for Comprehensive Medication Review

    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 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.

    17 min

About

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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