340B Insight

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!

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 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

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

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

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

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

Health Resources & Services Administration (HRSA) audits of hospitals play a key role in ensuring compliance with 340B rules and regulations. In this episode, Dave Lacknauth, executive director of pharmacy services at Broward Health in Fort. Lauderdale, Fla., joins us to discuss the importance of taking a proactive, comprehensive approach to audit readiness with the goal of ensuring clean audit results. Compliance protects 340B accessBeing prepared for HRSA audits serves a crucial function that ultimately benefits the patients whom hospitals serve, Lacknauth explains. Maintaining the integrity of 340B means protecting access to 340B savings that hospitals can invest in crucial care for community members that need it. Continuous audit readinessLacknauth discusses how Broward Health maintains audit readiness by conducting internal audits, bringing in external consultants, and identifying areas of opportunity for improvement. A robust system of internal reviews means that when HRSA comes knocking, Broward Health is already prepared. This was evident after a recent audit of one of the system’s hospitals that resulted in zero recommendations for improvement.Organization, resources, transparency are keyPreparing for audits requires a health system to invest time and resources, but Lacknauth stresses that these investments pay off. Engaging a comprehensive team from various departments in the audit readiness process allows for a health system to have the appropriate level of responsiveness and transparency during a HRSA audit.Resources:Nebraska Is 12th State To Enact Contract Pharmacy ProtectionsIdaho Becomes Fourth State To Mandate 340B Reports From Hospitals