Episode 20: Reconciliation Bill’s 340B Impact, CMS’ Big 340B Proposals and Rebate Update

In this episode, 340B Report Publisher & CEO Ted Slafsky and 340B Report Associate Editor and Senior Writers Shannon Young and Will Newton break down the latest 340B news, including key developments in Washington D.C., a federal 340B rebate court case and the ongoing lobbying effort of the White House’s Office of Management and Budget over a potential rebate model. Ted closes the episode with a touching tribute to his late mentor David Gergen.

Key Topics Covered:

Reconciliation Bill Becomes Law, Key Congressional Subpanel Updates Leaders 

Shannon and Will discuss the recent enactment of the GOP-backed reconciliation bill, known as the “Big Beautiful Bill,” including what its massive health spending cuts over the next decade could mean for 340B providers. Shannon highlights how 340B-related provisions stripped from the wide-ranging spending legislation have been reintroduced as part of a large bipartisan standalone bill focused on the Pharmacy Benefit Manager industry. And Ted discusses recent leadership changes on the House Energy and Commerce Health Subcommittee following U.S. Rep. Buddy Carter’s (R-Ga.) decision to step down as chair as he runs for U.S. Senate.

CMS Proposes Rules With Major 340B Implications

Shannon and Will break down how two new Centers for Medicare and Medicaid Services (CMS) proposed rules would affect the 340B program. Shannon offers an overview of CMS’ Outpatient Prospective Payment System (OPPS) draft rule and its significant implications for the 340B community. It contains controversial provisions to accelerate hospital outpatient payment cuts to offset previous 340B hospital lump sum repayments, as well as plans to survey hospital acquisition costs for certain outpatient medications. Next, Will discusses CMS’ proposal to establish, for the first time, claims-based approaches to identifying 340B claims billed to Medicare Part D.

340B Rebate Model Debates Heats Up

Will discusses the latest in drug industry efforts to implement controversial 340B rebate models. Four drugmakers are currently appealing a pair of lower courts’ rebate rulings, while dozens of program stakeholders—including drugmakers, providers and technology vendors—are meeting with federal officials in an effort to sway highly anticipated federal 340B rebate guidance.

Tribute to David Gergen

Ted offers a touching tribute to David Gergen, his first mentor and boss out of college. Gergen was a senior adviser to four U.S. presidents and a highly influential editor and political commentator. Ted reflects on his inspiring career and shares his thoughts on his mentorship.

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In this episode, 340B Report Associate Editor and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including key developments in a federal 340B rebate model court case, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s latest remarks on the Trump administration’s efforts to lower prescription drug prices and two New England states’ embrace of new 340B contract pharmacy access and provider reporting laws.

Key Topics Covered:

Appeals Court Expedites Schedule in 340B Rebate Case 

Will recaps recent developments in the drug industry efforts to convert upfront 340B discounts to post-purchase rebate models. After a federal district court in Washington, D.C. ruled that drugmakers cannot implement 340B rebates without HHS approval, multiple drug companies appealed. Meanwhile, hospital trade group 340B Health filed a cross-appeal arguing that the court should have ruled that the 340B statute “categorically prohibits” rebates. While those appeals play out, stakeholders are also meeting with HHS about the agency’s 340B rebate guidance, which is not yet public pending regulatory review.

RFK Jr. Touts Administration’s Drug Pricing Plans, Key Lawmaker Talks 340B

Shannon breaks down Kennedy’s recent appearance before the House Energy and Commerce Committee’s Health Subcommittee to testify on President Donald Trump’s budget proposal. While the HHS secretary did touch on the budget’s controversial plan to shift 340B oversight within the agency, Shannon notes that he touted the administration’s efforts to lower prescription drug prices through recent executive actions and endorsed pharmacy benefit manager reform efforts. She discusses how U.S. Rep. Diana Harshbarger (R-Tenn.) briefly floated the potential for renegotiated “340B contracts” during her exchange with Kennedy—comments which some 340B advocates criticized as a misunderstanding of the 340B program’s structure. Will provides an update on another drug pricing executive order.

New England States Embrace Contract Pharmacy Access, Provider Reporting Laws 

Will provides an update on Maine’s recent enactment of a contract pharmacy access and reporting law. Shannon notes that Rhode Island is on the cusp of signing similar legislation into law. With 20 states now having enacted contract pharmacy protections, Will breaks down the latest trends in state 340B legislation. He discusses the increasing number of states that have passed bills that contain both contract pharmacy access and reporting provisions in 2025. 

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Episode 18: Impending Rebate Guidance, Possible 340B Move from HRSA to CMS & Oklahoma’s Veto Override

In this episode, 340B Report Publisher and CEO Ted Slafsky, Associate Editors and Senior Writers Shannon Young and Will Newton and National Correspondent Bella Czajkowski break down the latest in 340B news, including the U.S. Department of Health and Human Services’ (HHS) submission of 340B rebate guidance for regulatory review, a proposal to shift 340B oversight to the Centers for Medicare & Medicaid Services (CMS), U.S. Sen. Bill Cassidy’s (R-La.) latest comments on 340B and Oklahoma's 340B contract pharmacy legislation veto override.

In This Episode: 

Rebate Updates 

Will provides an update on the latest surrounding drugmakers’ attempts to convert upfront 340B discounts to a post-purchase rebate model. He discusses HHS’ June 1 submission of proposed 340B rebate guidance to the Office of Management and Budget, which will remain confidential throughout the review. Meanwhile, drugmakers Novartis and Bristol Myers Squibb filed an emergency motion to expedite their legal challenge to a ruling that affirms the government’s authority to pre-approve 340B rebate models—citing looming compliance deadlines under the Inflation Reduction Act.

A Proposed Shift to CMS and Other Federal Happenings 

Shannon and Ted break down President Donald Trump’s full HHS budget request that calls for moving the Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA), which oversees the 340B program, to CMS. They discuss the differences between the formal proposal and a version included in a leaked document, as well as 340B stakeholders’ reaction to such a move. Shannon and Ted also discuss key federal players on 340B, including Cassidy’s latest remarks on potential congressional reform plans and the return to the private sector of Katie Miller, a Trump adviser tied to a dark-money group running anti-340B ads in various states.

The State of the States 

Will recaps Oklahoma’s path to enacting a contract pharmacy access law, which included a gubernatorial veto and legislative override. He and Bella discuss the latest state-level action on 340B bills, as well as how drugmakers have responded to Tennessee's unique contract pharmacy access law.

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In this episode, 340B Report Publisher and CEO Ted Slafsky and Associate Editor and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including a major federal court ruling on drugmaker 340B rebate models, Health and Human Services (HHS) Secretary Robert F Kennedy Jr.’s first public comments on the 340B program and the Oklahoma governor’s decision to veto a widely supported contract pharmacy access bill.

Key Topics Covered:

Court Upholds HHS’ Right to Pre-Approve 340B Rebates

Will recaps the latest developments in a key 340B rebate lawsuit, including a recent opinion from the Washington D.C. U.S. District Court that rejected drugmakers’ claims that HHS acted unlawfully by requiring pre-approval of their 340B rebate proposals. He dives into the implications of the ruling, which doesn’t rule out the possibility of drugmaker rebates in the future, what it means for stakeholders and how key 340B players responded. 

RFK Jr. Offers 1st Public Comments on 340B, Trump Issues Drug Pricing EO 

Shannon breaks down Kennedy’s first public comments on the 340B program, which came during his recent testimony before House and Senate subcommittees. She and Ted discuss how the HHS secretary’s comments about the program largely reflect drug industry talking points, as well as the pushback the comments drew from 340B providers. Shannon also offers an update on budget reconciliation talks and discusses President Donald Trump’s new “most-favored nation” drug pricing executive order. She and Ted note the challenges the White House could face in advancing efforts to lower drug prices.

Oklahoma Governor Vetoes Contract Pharmacy Bill Following Dark-Money Campaign

Will provides an update on Oklahoma’s efforts to pass contract pharmacy access legislation after Gov. Kevin (R) vetoed a bill, which cleared the legislature with widespread support. Will discusses the role that misleading dark-money ads may have played in the governor’s decision, and how GOP lawmakers, who were the lead sponsors of the 340B legislation, are pushing to override that veto.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. RxParadigm sponsored this week’s episode. 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.

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In this episode, 340B Report Publisher and CEO Ted Slafsky, Associate Editor and Senior Writers Shannon Young and Will Newton and National Correspondent Bella Czajkowski break down the latest in 340B news, including developments in two major 340B lawsuits, new state contract pharmacy access laws with unique twists and developments on health funding negotiations and drug pricing policy talks in Washington, D.C.

Key Topics Covered:

Courts Hear Arguments in 340B Rebate, Antitrust Lawsuits Will recaps the latest developments in a key 340B rebate lawsuit, including recent oral arguments in which the drug industry argued it doesn’t need federal approval to institute rebate models. HHS has told the drug manufacturers that they are not allowed to unilaterally implement a rebate model and a hospital group has intervened to oppose the use of rebates.  The judge grilled attorneys representing both the drug industry and the Department of Health and Human Services (HHS). HHS later committed to issuing guidance on a rebate model—and what conditions, if any, they could be permitted—within the next few weeks.

Bella recaps the recent oral arguments in a 340B antitrust case against four major insulin manufacturers. Ted and Bella discuss the significant implications of this case for 340B covered entities, should the appeals court side with the two health centers that have accused drugmakers of colluding on contract pharmacy restrictions.

More States Advance Contract Pharmacy Bills

Will provides an overview of recent contract pharmacy access bill developments in Oklahoma, Colorado and Hawaii. He notes some of the unique provisions contained in those bills, such as new reporting requirements for providers.

Drug Pricing Talks Loom Large

Shannon breaks down the latest developments on Capitol Hill as congressional Republicans work to wrap up wide-ranging spending legislation, which calls for $880 billion in health spending cuts that are largely expected to target Medicaid. The White House has proposed tying Medicaid drug prices to the prices paid in other affluent countries—a policy which has drawn pushback from both the drug industry and provider advocates. Ted recalls a similar initiative President Donald Trump pursued in his first term to tie dozens of Medicare Part B drugs prices to their international equivalents. Shannon also discusses new federal drug pricing legislation and Trump’s HHS budget blueprint.

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In this episode, 340B Report Publisher & CEO Ted Slafsky joins Associate Editors and Senior Writers Shannon Young and Will Newton and National Correspondent Bella Czajkowski to break down the latest developments in the 340B space. The team discusses Senate HELP Committee Chair Bill Cassidy’s (R-La.) high-profile report on the 340B program, an executive order sparking concerns among providers, reactions to potential pharmaceutical tariffs and important state 340B bills in Indiana and Tennessee.

Key Topics Covered:

Senate Report Calls for Congressional 340B Reform

Sen. Cassidy unveiled the long-awaited findings of his two-year investigation into the 340B program with a 200-page report that criticized multiple 340B providers and called for significant congressional 340B reform that echoes many drug industry policy asks. Shannon and Ted discuss the implications of the report and stakeholder reactions to it, as well as the latest on a separate bipartisan Senate 340B legislative effort that’s expected to be more provider friendly. 

Executive Order and Tariffs Spark Concerns

Will Newton breaks down President Donald Trump’s (R) recent executive order that attempts to revive a controversial rule requiring health centers to pass all 340B savings on insulin and EpiPens directly to certain low-income patients. The order also calls for a survey on hospital acquisition costs—the likely precursor to an attempt to reduce Medicare Part B payments to 340B hospitals. Providers have raised alarm bells over both proposals. Bella discusses the administration’s proposed tariffs on pharmaceuticals and why both drugmakers and provider advocates are warning that they could be problematic for the pharmaceutical supply and patients.

State 340B Bills in Indiana and Tennessee

Will breaks down a 340B hospital reporting bill in Indiana and a contract pharmacy bill in Tennessee that are both likely to soon become law. Tennessee’s unique bill grandfathers in existing drugmaker 340B restrictions but requires the “winners-only” contract pharmacy model that’s popular among providers. 

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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 Pillr Health, a company known for its 340B solutions that emphasize transparency, integrity, and ease of use for covered entities. Visit PillrHealth.com to learn more.

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In this episode, 340B Report Associate Editors and Senior Writers Shannon Young and Will Newton and National Correspondent Bella Czajkowski break down the latest in 340B news, including the latest states to enact contract pharmacy access laws, updates in key lawsuits and new U.S. Department of Health and Human Services (HHS) restructuring efforts.

Key Topics Covered:

New State Contract Pharmacy Access Laws Will highlights new contract pharmacy access laws enacted in Nebraska and Utah, including when they take effect and how their respective state governors approached the legislation. He also briefly discusses New Mexico’s newly enacted contract pharmacy access law, which does not take effect until 2026 and is the only enacted state contract pharmacy protection statute that only applies to health centers.

Key Updates in Drug Industry Lawsuits and State Enforcement Action Will also breaks down a Minnesota federal district judge’s order to dismiss two drug industry lawsuits challenging that state’s contract pharmacy access law. The judge ruled that the drugmakers had no legal standing to sue the state over its contract pharmacy law since Minnesota’s law—unlike most other existing state contract pharmacy protection statutes—has no enforcement mechanism. Meanwhile, in Arkansas, a state official recently ordered AstraZeneca to restore access to 340B drugs at all contract pharmacy locations. AstraZeneca had been the only major manufacturer not to comply with Arkansas’ first-in-the-nation contract pharmacy access law after a federal appeals court panel unanimously upheld the statute in March 2024.

A New CMS Leader and HHS Restructuring

Shannon and Bella provide an update on 340B-related activity at the federal level. Bella discusses the U.S. Senate’s recent confirmation of Mehmet Oz as the new administrator of the Centers for Medicare and Medicaid Services (CMS). Shannon highlights the recent restructuring at HHS and rumored efforts to move the 340B program into CMS. 

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Each episode is brought to you by one of our great Ultra Diamond sponsors. Verity Solutions sponsored this week’s episode. 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 for its sponsorship.

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In this episode, the Inside 340B Report team dives into a flurry of activity at the state and federal levels. Publisher and CEO Ted Slafsky and Associate Editor/Senior Writers Shannon Young and Will Newton break down the unprecedented wave of state-level 340B contract pharmacy access and provider reporting bills, explore key federal movements, including the latest on the bipartisan U.S. Senate working group behind the SUSTAIN 340B Act, and provide an update on 340B rebate litigation.

Key Topics Covered:

State Legislative Activity Heats Up The team discusses the recent surge in legislative action on state 340B bills as more than 25 states have introduced contract pharmacy access bills in 2025. South Dakota and Utah recently enacted contract pharmacy laws in 2025, joining eight other states that passed similar bills in previous years, while bills in New Mexico and North Dakota are awaiting action from their state governors. Will also highlights several state bills that would place a range of reporting requirements—and in some cases significant restrictions—on 340B providers.

Federal Legislative Developments and Bipartisan Efforts Shannon provides updates on the latest developments on the 340B front in Washington, D.C., including the new members of the bipartisan group of six senators working on 340B overhaul legislation known as the SUSTAIN 340B Act. She and Ted also highlight other federal bills that could resurface this session, including the provider-supported 340B PATIENTS Act and drug industry-backed 340B ACCESS Act. The team also provides an update on Mehmet Oz’s nomination to lead the Centers for Medicare & Medicaid Services (CMS), focusing on a new Washington Post story that highlighted 340B Report’s previous reporting on his undisclosed ties to ZorroRx, a health benefits company that partners with 340B hospitals. Despite facing new ethics concerns, Oz has not drawn much scrutiny from lawmakers during the confirmation process over his 340B ties or stance on the program—a shift from previous nominees.

Rebate Litigation Developments Will explains recent developments in ongoing lawsuits that pharmaceutical giants, like Johnson & Johnson and Eli Lilly, have filed against the federal Health Resources and Services Administration (HRSA) in their attempts to unilaterally impose 340B rebate models. Notably, in a series of recent court filings, President Donald Trump’s (R) administration has chosen to continue to defend HRSA’s long-standing position that drugmakers cannot implement 340B rebate models without explicit agency approval, offering some relief to the 340B provider community.

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In this episode of Inside 340B Report, Ted Slafsky, Will Newton and Bella Czajkowski explore the latest developments in the 340B world at both the state and federal levels. They cover the progress of contract pharmacy access bills across the country—including a breaking news development—plus dark money efforts to oppose the legislation. They also break down key updates in drugmaker rebate lawsuits and provide an update on federal budget talks including major cuts expected for the Medicaid program and where we may be headed on the 340B program.

Key Topics Covered:

Contract Pharmacy Bills Progress, Despite Resistance                                                                           Will summarizes recent key votes on state contract pharmacy access bills and provider reporting legislation. He also breaks the news that South Dakota became the first state in 2025 to enact contract pharmacy protections after hearing from the governor’s office mid-recording. Meanwhile, Bella highlights the tactics of dark money efforts to oppose contract pharmacy legislation through misleading ads, noting that many of the efforts appear to be backfiring.

Drugmaker Rebate Litigation Heats Up                                                                                                        The team discusses five drugmakers’ ongoing legal efforts to implement 340B rebate models without approval from the Health Resources and Services Administration. Bella and Will explain the significance of the recent decision allowing the hospital advocacy group 340B Health and two of its member hospitals to intervene in four of those cases, all while other major provider advocacy groups have filed amicus briefs opposing the rebate models.

Budget Talks and the Looming Federal Shutdown                                                                                     With crucial budget negotiations unfolding in Congress, Ted breaks down the potential impact of proposed healthcare funding cuts totaling $880 billion over the next decade. These cuts could have significant effects on Medicaid, directly affecting 340B providers and the patients they serve. Ted notes that 340B stakeholders should keep a close eye on Capitol Hill as budget battles continue, especially given the possibility of a government shutdown.  He also talks about the leaders of key committees with jurisdiction over the 340B program and what that could mean for 340B stakeholders.

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Each episode is brought to you by one of our great Ultra Diamond sponsors. 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're grateful to PharmaForce for making this episode possible.

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In this episode of Inside 340B Report, Ted Slafsky, Shannon Young, Will Newton and Bella Czajkowski discuss what may be a record-breaking year for state contract pharmacy access legislation with more than 20 states having already introduced such bills in 2025. On the federal front, the U.S. House's budget blueprint targeting $880 billion in health spending cuts over the next decade has raised alarm bells among providers over potential significant Medicaid reductions. Finally, Ted and Shannon share takeaways from last week’s 340B Coalition Winter Conference in San Diego, where these topics and others were center stage.

Key Topics Covered:

State Legislative Surge and Legal Developments As of Feb. 28, at least 21 states had introduced new contract pharmacy access bills. Ted and Bella discuss the significance of major states like California, Texas and New York joining the fray with their own 340B access bill proposals. Will also discusses several of the states that have advanced their contract pharmacy bills, before joining Ted and Bella to provide updates on critical legal battles unfolding in states that have already passed contract pharmacy access laws, including Missouri, Kansas and West Virginia. 

Budget Blueprint and Medicaid Concerns In Washington, D.C., the House recently passed a budget framework that calls for $880 billion in health spending cuts over the next decade. Shannon discusses the potential implications for Medicaid funding and how these budgetary moves might indirectly impact the 340B program. 

340B Coalition Conference Insights Shannon and Ted break down the key issues that dominated the 340B Coalition’s recent Winter Conference, including the status of three key federal 340B bills, new scrutiny U.S. Sen. Bill Cassidy (R-La.) could bring to the 340B program as the new HELP Committee chairman and how a Washington D.C. dark-money group’s campaign targeting 340B access bills could play out at statehouses.

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Pillr Health sponsored this week’s episode. Pillr Health is a leading provider of innovative solutions designed to optimize and streamline pharmacy operations. It focuses on enhancing efficiency, reducing costs and improving patient outcomes, particularly within the 340B program and beyond. We are very grateful to Pillr Health for its sponsorship.

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