In this episode, 340B Report Associate Editors and Senior Writers Shannon Young and Will Newton and National Correspondent Luke Zarzecki break down the latest in 340B news, including the wave of identical responses to the Health Resources and Services Administration's (HRSA) 340B rebate request for information (RFI), the Trump Administration's renewed proposal to shift oversight of the 340B program to another federal agency and key legal developments with major 340B implications.

Key Topics Covered:

Duplicate 340B Rebate RFI Responses

Will breaks down early stakeholder responses to the HRSA's 340B rebate RFI, which the agency issued just days after withdrawing its previous 340B rebate pilot. He notes that more than half of the initial responses were identical submissions closely mirroring a template from Patients Rising, a patient group that lists more than a dozen large drugmakers among its corporate sponsors. Will notes that hours after 340B Report broke news on the submissions, Patients Rising said it was ending work with the third-party firm it hired for RFI outreach.

Trump's New Budget and Tariffs

Shannon discusses the Trump administration's proposed fiscal year (FY) 2027 Health and Human Services Department budget and what it means for the 340B program. She notes that the HHS spending proposal revives previous plans to restructure HRSA and move the 340B program to the Centers for Medicare and Medicaid Services, as well as calls for a major increase in 340B funding. Luke offers insights into how Congress could approach FY 27 funding legislation—including an effort to attach language barring a 340B rebate model. Luke also breaks down the White House's latest plans to implement tariffs on pharmaceutical products.

Key Legal Developments

Shannon discusses the implications of a recent Washington, D.C. federal district court ruling that struck down a 2013 HRSA policy that restricts how certain 340B hospitals can purchase initial drug inventory. Will breaks down drugmaker AbbVie's new lawsuit challenging HRSA's 340B patient definition, including the history of the agency's definition and what the legal outcome could mean for the 340B program's future.

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In this episode, 340B Report Publisher and CEO Ted Slafsky, Associate Editors and Senior Writers Shannon Young and Will Newton and 340B Report's national correspondent Luke Zarzecki break down the latest in 340B news, including 340B stakeholder reactions to a provider hearing in the U.S. House and ongoing discussion over a 2027 fiscal year (FY) federal spending package that could include language blocking 340B rebates. The team also discusses major updates in the states, including a newly enacted first-of-its-kind 340B law in the Pacific Northwest, a controversial effort to kill a 340B bill in the Midwest and a closer look into state prescription drug affordability boards (PDABs).

Key Topics Covered:

Capitol Hill Update

Shannon and Luke discuss a recent House Energy & Commerce (E&C) Health Subcommittee hearing on providers' role in health care costs, which focused on the 340B program, among other things. Shannon breaks down what two of the witnesses had to say about the drug discount program. Luke highlights the questions key lawmakers asked witnesses, as well as how two senior Republican committee members called for 340B reforms and support for their 340B ACCESS Act, which has drawn major pushback from provider groups. Shannon also offers an update on the FY 2027 federal appropriations process taking shape on Capitol Hill, noting that a group of bipartisan House lawmakers is pushing to add language to the health spending bill that would block a 340B rebate model's implementation.

Key State Developments

Will discusses "the tale of two states," where high-profile 340B bills in Washington and Kansas faced very different outcomes. He also discusses two recent federal district court rulings in favor of state contract pharmacy laws, which continued a string of mostly favorable legal rulings for the states.

Deep Dive into PDABs

Luke discusses PDABs that are popping up across the states and their potential implications on the 340B program. At least 11 states have created a PDAB or a similar board tasked with addressing high drug prices, with some states granting that board to set upper payment limits on drugs. Luke shares why experts say PDABs could lead to lower 340B savings for covered entities, as well as other impacts on the drug supply chain.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. Proximity is the 340B revenue operations platform built to bring control back to your program. Proximity unifies and normalizes TPA, pharmacy, EHR, wholesaler and payer data into a single system—so issues can be identified, corrected and resolved across the full claim lifecycle. To learn more, reach out to [email protected]. We are very grateful to Proximity for its sponsorship.

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In this episode, 340B Report Publisher and CEO Ted Slafsky, Associate Editors and Senior Writers Shannon Young and Will Newton and 340B Report's national correspondent Luke Zarzecki break down the latest in 340B news, including a key U.S. House subcommittee's upcoming provider hearing and a leadership shakeup that could affect the bipartisan U.S. Senate 340B working group. The team also discusses reactions to another major drugmaker's plan to require 340B in-house pharmacy data reporting, major 340B related-developments in two federal court cases and divergent state 340B program bills on the cusp of becoming law.

Key Topics Covered:

Capitol Hill Update

Shannon and Luke discuss the latest 340B developments on Capitol Hill. Shannon previews the House Energy and Commerce (E&C) Health Subcommittee's March 18 hearing that will look at the role providers play in rising health care costs. She notes that while the hearing will not specifically focus on the 340B program, the issue is likely to arise with the American Hospital Association—which successfully blocked the Trump administration's 340B rebate pilot from taking effect—among those slated to testify. Shannon also highlights E&C Committee Chairman Brett Guthrie's (R-Ky.) reintroduction of a bill, which calls for a study of how value-based purchasing arrangements affect the 340B program. Luke talks about what the change in guard at the Department of Homeland Security could mean for the bipartisan 340B Senate working group, after President Donald Trump nominated U.S. Sen. Markwayne Mullin (R-Okla.) to take over for DHS Secretary Kristi Noem.

Claims Data Pushback

Will discusses Novo Nordisk's recent announcement that it plans to require covered entities to submit claims data for 340B utilization at in-house pharmacies in order to access 340B pricing. He explains why Novo's policy, which is similar to one Eli Lilly announced earlier this year, marks a significant expansion of reporting requirements. Meanwhile, Luke breaks down what provider groups and pharmaceutical stakeholders have said about the new requirements, and the actions they have taken in response to them.

Key Court Rulings

Shannon, Will and Ted discuss two recent federal court rulings that have major 340B implications. Shannon shares how a Washington D.C. federal district court's order striking down the Health Resources and Services Administration's (HRSA) contentious 340B hospital offsite clinic registration policy is a major win for hospitals. Ted provides historical context on the case and why hospitals sued HRSA over the policy. Will discusses the federal government's latest amicus briefs backing drugmakers in legal challenges to state 340B contract pharmacy access laws, and how the unexpected move could potentially impact ongoing litigation.

State Legislative Activity

Will discusses Washington's state 340B contract pharmacy access legislation, which also includes both provider and drugmaker reporting requirements, that's awaiting action from Gov. Bob Ferguson (D). He also dives into Virginia's unsuccessful efforts to pass contract pharmacy access legislation after lawmakers amended an earlier contract pharmacy bill to replace it with a work study group. Ted explains why he was surprised that Virginia did not enact a 340B contract pharmacy access law despite early momentum in the state capitol and a newly elected governor who has been a longtime 340B advocate.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. This week's episode is sponsored by CompassRx, the premier AI services platform built exclusively for 340B. Harnessing pharmacy and AI expertise, CompassRx helps maximize 340B savings and operational efficiency. Visit CompassRx.com to learn more. We are very grateful to CompassRx for its sponsorship.

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In this episode, 340B Report Publisher and CEO Ted Slafsky, Associate Editors and Senior Writers Shannon Young and Will Newton and Luke Zarzecki, 340B Report's national correspondent, break down the latest in 340B news, including the Trump administration's high-profile entrance into the fight over state 340B contract pharmacy access laws. The team also discusses updates in the federal government's consideration of a potential new 340B rebate pilot, President Donald Trump's recent calls to codify most-favored nation (MFN) pricing agreements and the 340B Coalition's winter conference and National Association of Community Health Centers' (NACHC) Policy & Issues Forum.

Key Topics Covered:

Contract Pharmacy Restrictions Fight Heats Up

Will discusses the Trump administration's unexpected move to file amicus briefs supporting two drugmaker legal challenges to state 340B contract pharmacy access laws in Colorado and Rhode Island. He explains that most federal court rulings on contract pharmacy access laws have sided with the states, noting it is unclear to what extent the federal government's briefs will affect this trend. Will also notes that two U.S. Justice Department lawyers who signed the briefs previously represented drugmakers in drug pricing litigation, including one who served as a drugmaker's counsel in cases on 340B contract pharmacy use and 340B rebates.

Rebate Model Update

Luke, Shannon and Will discuss the latest developments in the federal government's consideration of a potential new 340B rebate model after court action halted the initial pilot from taking effect. They break down the latest regulatory actions surrounding that effort, including the White House's Office of Management and Budget's review of a prerule and the Health Resources and Services Administration's (HRSA) subsequent issuance of a request for information and an information collection request—and how stakeholders have responded to them. Will offers insights into what HRSA's possible new rebate model could look like based off of these documents.

MFN Codification Push

Shannon highlights the Trump administration's recent push to codify MFN principles into federal law, including the president's State of Union call for Congress to pass such legislation and Centers for Medicare and Medicaid Services Administrator Mehmet Oz's similar comments during a Pharmaceutical Research and Manufacturers of America (PhRMA) forum. She notes pushback such efforts have garnered from PhRMA, which has instead urged lawmakers to focus on reforming pharmacy benefit managers and the 340B program.

Conference Recaps

Will shares his key takeaways from the Winter 340B Coalition Conference in San Diego, including provider concerns with manufacturer actions they argue are threatening the 340B program. He also discusses health policy experts' takes on the program, including what to expect from Congress and the Trump administration in the coming months. Luke discusses HRSA Administrator Tom Engels' comments at NACHC's forum.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. This episode is sponsored by RxParadigm. RxParadigm's mission is to cultivate innovative approaches and technologies that promote transparency and authenticity, leading to enhanced outcomes, reduced overall healthcare costs and effective 340B program administration. We are very grateful to RxParadigm for its sponsorship.

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In this episode, 340B Report Publisher and CEO Ted Slafsky, Associate Editors and Senior Writers Shannon Young and Will Newton and Luke Zarzecki, 340B Report's new national correspondent, break down the latest in 340B news, including 340B legislative developments on Capitol Hill and statehouses—and the role of dark money campaigns trying to shape the message. The team also discusses the Health Resources and Services Administration's major decision to formally withdraw its 340B rebate model pilot and what that could mean for the future of drugmaker-backed efforts to pursue 340B rebates. Key Topics Covered:

Capitol Hill Happenings Shannon, Luke and Will highlight the latest 340B-related happenings in Congress. Shannon discusses a new bipartisan U.S. House bill that aims to prevent federally qualified health centers from being included in any 340B rebate models and previews a yet-to-be introduced bill that would expand similar protections to other 340B covered entities, but not major hospitals. Luke provides an update on the bipartisan U.S. Senate group working on the SUSTAIN 340B Act, including what the final legislation could look like and the reported issues stalling its introduction. Shannon also offers a recap of the recently enacted federal spending package and how it's expected to affect 340B stakeholders. Meanwhile, Will discusses Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy's (R-La.) recent inquiries into 340B prime vendor Apexus as part of his broader probe into the 340B program.

Rebate Model Update Will discusses the federal government's recent filing formally withdrawing its controversial 340B rebate pilot proposal and agreeing to new procedural guardrails if it attempts to implement a different 340B rebate model in the future. He then details the hospital lawsuit that led federal courts to block implementation of the 340B rebate pilot before it took effect on Jan. 1. Will also discusses what the outcome of this litigation could mean for the future of 340B rebates.

States Eye 340B Bills Will shares new developments from statehouses in Illinois, Michigan, Kansas and Virginia, where lawmakers are considering 340B contract pharmacy access legislation, 340B provider reporting bills—or both. He also breaks down 340B Report's recent coverage of the tactics of new dark multiple new money efforts opposing 340B contract pharmacy legislation in multiple states.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. This episode is sponsored by VytlOne. As the only independent provider of integrated pharmacy solutions, VytlOne leads the way in partnering with hospitals, health systems and health centers to unlock pharmacy revenue, strengthen local care, and reinvest in communities. We are very grateful to VytlOne for its sponsorship.

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In this episode, Associate Editors and Senior Writers Shannon Young and Will Newton join Luke Zarzecki, 340B Report's new national correspondent, in breaking down the latest in 340B news, including the Department of Health and Human Services' (HHS) move to officially drop its appeal in a case that halted the 340B rebate pilot program and a new federal spending bill that includes funding for key departments overseeing the 340B program, as well as for community health centers. They also discuss new drugmaker 340B contract pharmacy and maximum fair price (MFP) policies, and Luke introduces himself.

Key Topics Covered:

Rebate Case Update

Will provides the latest on the 340B rebate debate, including HHS' decision to drop its appeal of a Maine federal judge's injunction halting the agency's 340B rebate pilot program. That means HHS still cannot implement its 340B rebate pilot as originally planned. But, as Will notes, it does not mean the broader debate over 340B rebates is settled. He shares that attorneys who have represented both 340B providers and the drug industry do not expect drugmakers or HHS to abandon their efforts to pursue 340B rebate models.

Federal Funding Package

Shannon and Luke break down a new bipartisan congressional health care package and what it could mean for the 340B program. Shannon discusses a U.S. House-approved spending bill and how much it allocated for key agencies that oversee the 340B program. She also details the highly anticipated funding figures for community health centers, which are largely funded by the federal government, and notes that it doesn't include a Trump administration proposal to move 340B program oversight from the Health Resources and Services Administration to the Centers for Medicare and Medicaid Services. Luke discusses the pharmacy benefit manager (PBM) reform provisions included in the legislation and their 340B implications. Shannon also notes that congressional leaders, who authored the appropriations bill, signaled concerns with the 340B rebate pilot program and requested an update from HRSA within one month in a bipartisan document released in conjunction with the spending package.

Drugmaker Policies

Will and Shannon discuss recent drugmaker policy developments. Will details Eli Lilly's new policy that would require all covered entities to submit claims data on 340B utilization at in-house pharmacies in a major shift that drew strong provider backlash. Shannon discusses Johnson & Johnson's interim plan to address "deduplication" between 340B discounts and the MFP without the 340B rebate pilot.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. This episode is sponsored by Pillr Health. Pillr is a leading provider of innovative solutions designed to optimize and streamline pharmacy operations with a focus on enhancing efficiency, reducing costs and improving patient outcomes, particularly within the 340B program. We are very grateful to Pillr Health for its sponsorship.

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In this episode, 340B Report Publisher and CEO Ted Slafsky joins Associate Editors and Senior Writers Shannon Young and Will Newton in breaking down the latest in 340B news, including a Maine federal judge's ruling that halted the government's 340B rebate model pilot rollout—and subsequent appeals court actions. They also discuss what 340B stakeholders can expect from statehouses and Congress on the legislative front in 2026.

Key Topics Covered:

Rebate Pilot Paused

Shannon, Will and Ted provide an overview of the American Hospital Association's lawsuit challenging the Department of Health and Human Services and Health Resources Administration's 340B rebate model pilot program, which was set to begin on Jan. 1. Shannon breaks down the Dec. 19 oral arguments held in Portland, Maine, that she covered, while Will discusses the judge's decision to temporarily halt the program and the government's efforts to appeal the ruling. Ted offers perspectives on how the litigation could unfold in the coming months and its implications.

Actions in Another 340B Rebate Case

Will provides an update on separate 340B rebate-related litigation before a Washington, D.C. federal appeals court. He explains why this case, which deals with broader legal questions about statutory authority over 340B rebates, is different from the hospital lawsuit in Maine, which is an administrative law case dealing specifically with the government's 340B rebate pilot.

2026 Legislative Agenda

Shannon discusses what 340B stakeholders can expect to see on Capitol Hill in 2026, including U.S. Rep. Brett Guthrie's (R-Ky.) recent comments about prescription drug policy reforms at an early January GOP retreat. Will breaks down the latest 340B legislative activity in multiple statehouses, including the first contract pharmacy access bills of 2026 in Washington and Florida, as well as the growing number of provider reporting bills expected in the coming year.

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This week's episode is sponsored by Verity Solutions. Verity's innovative, award-winning 340B program management solutions are designed to optimize your 340B pharmacy spend and maximize your pharmacy supply chain savings. We are very grateful to Verity Solutions for its sponsorship.

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In this episode, 340B Report Publisher and CEO Ted Slafsky joins Associate Editors and Senior Writers Shannon Young and Will Newton breaking down the latest in 340B news, including a new hospital lawsuit aiming to block the Health Resources and Services Administration's (HRSA) 340B rebate pilot, HRSA's recent webinar about that program, key regulatory updates on Medicare negotiated drug prices and a finalized hospital outpatient rule with significant implications for 340B hospitals and other stakeholders.

Key Topics Covered:

Hospitals Continue to Oppose Rebate Pilot

Will breaks down a hospital group's new lawsuit urging a Maine federal district court to block HRSA from implementing its 340B rebate pilot ahead of its Jan. 1, 2026 launch. He also provides an update on separate 340B rebate litigation before a Washington, D.C. federal appeals court. Shannon highlights a new letter from a different national hospital group urging HRSA to address key concerns with the pilot.

Technical Issues Disrupt HRSA's Rebate Webinar

Will explains the technical issues that hampered HRSA's highly anticipated Dec. 4 webinar on its 340B rebate pilot program, preventing many stakeholders from joining. He then shares details of the second half of HRSA's webinar that 340B Report was able to access and notes 340B Report will provide additional coverage of the full webinar once it becomes available.

CMS Lists New Negotiated Medicare Prices, Finalizes OPPPS Rule

Shannon breaks down the Centers for Medicare and Medicaid Services' (CMS) late-November release of the "maximum fair price" (MFP) it will pay for 15 high-cost Medicare Part D drugs starting in 2027, and how those negotiated prices are expected to compare to the drugs' 340B ceiling prices. She and Ted also discuss 340B provider advocates' concerns with CMS' finalized 2026 Hospital Outpatient Prospective Payment System (OPPS) rule, which includes a Medicare drugs acquisition cost survey and plan to accelerate outpatient payment cuts to offset previous 340B hospital lump sum repayments.

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This week's episode is sponsored by PharmaForce. PharmaForce is the only third party administrator composed entirely of experienced 340B professionals developing uniquely flexible technology solutions for covered entities and pharmacies of every size. We are very grateful to PharmaForce for its sponsorship.

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In this episode, 340B Report Associate Editors and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including the Health Resources and Services Administration's (HRSA) approval of the final drugmaker 340B rebate pilot plan; oral arguments in a key federal court case centered on 340B rebates; and Kalderos' official entrance into the 340B contract pharmacy claims clearinghouse space.

Key Topics Covered:

Final Rebate Pilot Model Plans Approved, Additional Details Unveiled

Will provides an in-depth look at HRSA's recent approval of Novartis' 340B rebate plan for Entresto—the final drug eligible for the upcoming pilot program. He also explains provider concerns about the pilot's rollout—including how manufacturers and their vendor defined the claims data field "340B ID"—and HRSA's response seeking to quell those concerns.

Appeals Court Hears Oral Arguments in Rebate Case

Will discusses oral arguments he attended at a Washington, D.C., federal appeals court that could shape the future of 340B rebates, including HRSA's rebate pilot. Attorneys for the drug industry, the federal government and trade group 340B Health debated who—if anyone—has authority to decide whether drugmakers can offer 340B pricing through a rebate. Will notes that all three sides faced tough questioning from the judges, who appeared well-versed in the nuances of the 340B program.

1st Drugmaker Transitions to Kalderos' Truzo Platform

Shannon breaks down the significance of drugmaker Alkermes' recent decision to transition its 340B contract pharmacy policy administration from Second Sight Solutions' 340B ESP platform to Kalderos' Truzo clearinghouse—making it the first drug manufacturer to do so. She also discusses the pushback the Alkermes' short timeline for the shift, which will go live Dec. 1, drew from 340B provider advocates.

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This week's episode is sponsored by RxParadigm. RxParadigm's mission is to cultivate innovative approaches and technologies that promote transparency and authenticity, leading to enhanced outcomes, reduced overall healthcare costs, and effective 340B program administration. We are very grateful to RxParadigm for its sponsorship.

Subscribe to 340B Report with a Special Discount

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In this episode, 340B Report Publisher and CEO Ted Slafsky and Associate Editors and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including the Health Resources and Services Administration's (HRSA) recent approval of drugmaker 340B rebate pilot plans—and the reactions they sparked; major court actions affecting Oklahoma and Colorado's 340B contract pharmacy access laws; and what Abigail Spanberger's (D) Virginia gubernatorial win could mean for 340B policy in that state.

Key Topics Covered:

Rebate Pilot Model Plans Approved, Unveiled

Will provides an in-depth look at the manufacturer rebate pilot plans that HRSA approved, as well as provider frustrations over the pilot's rollout. Shannon breaks down the contrasting reactions to HRSA's plan approvals. 340B providers panned the move and the drug industry embraced it, urging that the model be expanded. She also teases a Dec. 15 340B Report subscriber-only webinar that will focus on the rebate pilot model's implementation.

Federal Courts Block Oklahoma's Contract Pharmacy Law, Back Colorado's

Will discusses a pair of conflicting federal district court rulings on 340B contract pharmacy access laws in two states. One judge blocked Oklahoma from enforcing its law while the drug industry litigation plays out, while a different judge denied AbbVie's bid to block enforcement of Colorado's statute. Despite the Oklahoma federal court's ruling, Shannon notes that some drugmakers are exempting covered entities in that state from their contract pharmacy restrictions.

Virginia's Gubernatorial Election Implications

Shannon breaks down how Spanberger's recent gubernatorial win could bolster advocates' efforts to enact 340B contract pharmacy protections in Virginia. She and Ted discuss Spanberger's leadership on 340B issues in Congress and how the Democrat made prescription drug pricing a key tenet of her 2025 campaign for governor. They also compare Spanberger's actions on 340B to outgoing Gov. Glenn Youngkin (R), who vetoed a widely supported, bipartisan 340B contract pharmacy access bill in 2024 after pressure from a dark-money group.

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This week's episode is sponsored by VytlOne. As the only independent provider of integrated pharmacy solutions, VytlOne leads the way in partnering with hospitals, health systems and health centers to unlock pharmacy revenue, strengthen local care, and reinvest in communities. We are very grateful to VytlOne for its sponsorship.

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