Inside 340B Report

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 Senate Health, Education, Labor and Pensions (HELP) Committee's recent hearing on 340B, key takeaways from the 340B Grantees Fall Conference in Atlanta and 340B Report's recent webinar on the Health Resources and Services Administration's (HRSA) 340B rebate pilot and where we may be headed next on that controversial proposal.

Key Topics Covered:

Senate HELP Committee Mixes 340B Criticisms and Support

Shannon and Will provide an in-depth look at the Senate HELP Committee's Oct. 23 hearing on the 340B program, which occurred despite an ongoing federal government shutdown. Shannon discusses the dark money anti-340B campaign now underway in Washington, D.C., and how many provider advocates were pleasantly surprised about how the hearing went. Will explains that while HELP Committee Chair Bill Cassidy (R-La.) reiterated familiar 340B criticisms, many lawmakers from both parties defended the program's importance to providers. He also notes that the hearing often veered off topic, with many Democrats criticizing the government shutdown and health care cuts.

Ted also discusses the growing momentum for a bipartisan group of senators' draft bill, the SUSTAIN 340B Act. He notes that multiple lawmakers expressed support for that effort, including longtime 340B critic Cassidy. Ted also shares insights into the status of the SUSTAIN Act and what might be included in the legislation.

Takeaways from 340B Grantees Conference in Atlanta and Industry Conference in NYC

Ted and Will discuss their recent trip to Atlanta for the 340B Grantees Fall Conference, where they each moderated panels. Will discusses his panel on state 340B legislative activity and shares providers' concerns that drugmakers could use the 340B program as a bargaining chip in negotiations with the Trump administration on things like direct-to-consumer drug pricing and pharmaceutical tariffs. Ted discusses continued provider concerns with the HRSA's 340B rebate pilot proposal and shares insights on potential 340B negotiations with the Trump administration, which he heard at a separate conference in New York City that had a strong drug industry presence.

340B Report's Rebate Pilot Webinar and Rumblings

Shannon highlights 340B Report's recent subscriber-only webinar on HRSA's 340B rebate pilot proposal, which focused on key implementation concerns and included a lively debate on the rebate proposal's merits. Ted also shares what he is hearing about the status of the rebate model.

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This week's 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 and Associate Editors and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including the ongoing federal government shutdown's impact on 340B operations, the latest in the 340B rebate debate and a large drugmaker's move to tighten 340B restrictions on certain hospitals that it believes are not complying with the company's current contract pharmacy policy.

Key Topics Covered:

Federal Government Shutdown Could Affect 340B Program Operations

Shannon explains how the federal government shutdown has led to furloughs at the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs—and what that could mean for stakeholders if the shutdown drags on. She also discusses how the shutdown could impact a key upcoming deadline in HRSA's 340B rebate pilot program. Meanwhile, Ted shares his thoughts on politically-charged language about the shutdown that appeared on HRSA's website and the shutdown's real world effects on the HRSA staff and other federal workers.

340B Rebate Pilot Concerns and Upcoming Exclusive 340B Report Webinar

Will discusses 340B stakeholders' continued implementation concerns with HRSA's controversial 340B rebate pilot program, including potentially significant financial and administrative burdens for providers. Will and Ted also preview 340B Report's exclusive, subscriber-only webinar on the biggest implementation questions for 340B stakeholders, which will take place on Oct. 15 and include a panel of experts from across the 340B supply chain.

Pfizer Tightens 340B Restrictions, Makes Headlines with 'MFN' Move

Shannon discusses Pfizer's recent move informing certain 340B hospitals that they could lose their approved one contract pharmacy exemption registered with industry vendor 340B ESP as of Nov. 1. She also explains Pfizer's headline-grabbing move to offer its drugs to Medicaid at a "most favored nation" price and launch a direct-to-consumer prescription drug platform. Shannon discusses why industry observers don't think it will have as significant an impact as it has been heralded by the White House and Pfizer executives. And why some stakeholders view those moves as undermining the drug industry's arguments that 340B drives higher drug prices.

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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 and Associate Editors and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including one drugmaker's removal of medications from the 340B and Medicaid Drug Rebate programs, recent developments in key 340B drug industry lawsuits and dark money groups' efforts to block Michigan's 340B contract pharmacy and reporting bill.

Key Topics Covered:

Bausch Health Pulls Drugs From 340B, Medicaid Rebate Programs

Shannon discusses Bausch Health's recent decision to remove drugs from the 340B and Medicaid rebate programs effective Oct. 1. She notes that while the terminations will affect hundreds of products associated with many of Bausch Health's national drug codes for 340B-eligible drugs, it's unclear whether Bausch will fully remove itself from the 340B program. Attorneys, however, have suggested that drugmakers can't "pick and choose." Ted discusses providers' responses to the forthcoming terminations, including their concerns about the move's financial implications, patient access to medications and whether other drugmakers will follow suit.

Two More Federal Courts Side With States on Contract Pharmacy Protections

Will explains the implications of two recent major federal court rulings in favor of state 340B contract pharmacy access laws. The U.S. 5th Circuit Court of Appeals denied AbbVie's bid to block enforcement of Mississippi's law, reaffirming a lower court's decision. Shortly thereafter, a federal district court in Maine denied AbbVie and Novartis' efforts to halt Maine's law, allowing the statute to take effect as scheduled.

Michigan's Contract Pharmacy and Reporting Bill Comes Under Fire

Will also discusses a recent Michigan House hearing over a contract pharmacy access bill with reporting requirements for hospitals and manufacturers. Providers strongly supported the bill, while the drug industry and two dark money groups heavily opposed it. The hearing came amid an ongoing feud between the Michigan House speaker and the leader of the state's hospital association. It also came six months after the state Senate easily passed a similar measure.

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This week's episode is sponsored by Plenful. Plenful is the leading AI workflow automation platform transforming how healthcare teams work. Built to empower operators and the patients they serve, Plenful enables healthcare organizations to scale operations with speed, precision, and intelligence. We are very grateful to Plenful for its sponsorship.

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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 1,000-plus public comments on the Health Resources and Services Administration's (HRSA) 340B rebate pilot proposal, the 340B ACCESS Act's reintroduction in Congress and a new Congressional Budget Office (CBO) report on 340B program growth, which has drawn criticism from provider advocates. Shannon and Will also provide updates on oral arguments in key federal cases that recently went before appeals court judges.

Key Topics Covered:

More than 1,000 Stakeholders Weigh-in on HRSA's 340B Rebate Pilot Proposal

Will discusses the more than 1,200 stakeholder comments HRSA received over its contentious 340B rebate pilot proposal. He explains why hundreds of 340B providers urged the agency to abandon the rebate pilot altogether and discusses the drug industry's push to expand the pilot to more drugs. Will also breaks down stakeholders' concerns with the one-week turnaround between the comment due date and manufacturers' deadline to submit rebate proposals.

CBO Report and ACCESS Act Reintroduction Take Center Stage on Capitol Hill

Shannon breaks down the latest version of the 340B ACCESS Act, a controversial 340B overhaul bill which two key House GOP lawmakers reintroduced on Sept. 10. She discusses how the National Association of Community Health Centers has backed off from supporting the measure, which contains many of the provisions included in the May 2024 original version that providers advocates have vocally opposed. Shannon notes that the bill's reintroduction came one day after the nonpartisan CBO released a report on 340B program growth. Ted highlights provider advocates' criticisms of the report and why they believe it misses the mark.

Appeals Courts Hear Arguments in Key 340B-Related Cases

Will breaks down a trio of oral arguments that recently took place in federal appeals courts over drug industry challenges to state 340B contract pharmacy access laws. The hearings centered on whether the 340B statute's silence on drug delivery allows states to pass contract pharmacy access measures, and the judges asked tough questions of all parties. Shannon provides an update on recent oral arguments in a 5th Circuit Court of Appeals case surrounding a Centers for Medicare and Medicaid Services rule which could affect some hospitals' 340B program eligibility. A group of Texas hospitals have challenged the rule. A Texas federal District Court in 2024 declared it "unlawful" and halted its enforcement. HHS appealed the decision.

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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.

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Listen to our newest podcast 340B Leaders Upfront

We encourage you to check out 340B Report's new business area podcast, 340B Leaders Upfront, formerly 340B 360°, hosted by Anna Mangum. In the latest episode, Anna interviews two of the leaders of Plenful, an AI service provider company that is providing very cost-effective and highly beneficial services for the 340B provider community.

In this episode, Ted Slafsky, publisher and CEO of 340B Report, and Will Newton, associate editor and senior writer at 340B Report, break down the latest in 340B news, including concerns over the Health Resources and Services Administration's (HRSA) controversial 340B rebate pilot program and a new hospital Medicare reclassification trend that is alarming some rural health advocates. Next, they're joined by Colleen Meiman, a senior policy advisor to state primary care associations, to discuss the incredible life and legacy of Sue Veer, a nationally recognized 340B advocate and educator who passed away last week.

Key Topics Covered:

HRSA Posts Rebate FAQ, Federal Court Extends Rebate Appeal Deadlines

Will discusses HRSA's recently published FAQ that clarifies parts of its contentious 340B rebate pilot program. Then, he explains why a major hospital trade group is urging the agency to abandon the rebate pilot altogether. Will also shares recent updates in the drug industry's litigation challenging HRSA's authority to pre-approve rebates.

Rural Health Advocates Alarmed by Hospital Reclassification Trend

Will discusses an emerging trend in which some large urban hospitals are reclassifying as rural under the Medicare program. This gives them access to benefits designed for rural providers, including higher Medicare payments and a lower 340B eligibility threshold. Will explains why some rural health advocates are concerned this could deplete rural resources and bring negative scrutiny to the 340B program. Ted also discusses the myriad financial challenges hospitals are facing, including recently enacted steep Medicaid cuts that could threaten 340B eligibility for many.

A Tribute to the Life and Legacy of 340B Champion Sue Veer

Special guest Colleen Meiman joins the team to mourn the loss of the late Sue Veer and honor her incredible legacy as a nationally respected 340B program advocate and educator. Colleen shares the incredibly powerful story of why Sue began her career in health care, as well as her close personal relationship with Sue. Next, Ted and Colleen discuss Sue's omnipresence in the 340B space, including her various roles with national provider organizations and reputation as a "straight shooter" respected by all sides of the 340B debate., Colleen also shares a few fun stories about Sue unbeknownst to many.

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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. Visit RxParadigm to learn more.

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Listen to our newest podcast 340B Leaders Upfront

We encourage you to check out 340B Report's new business area podcast, 340B Leaders Upfront, formerly 340B 360°, hosted by Anna Mangum. In the latest episode, Anna interviews two of the leaders of Plenful, an AI service provider company that is providing very cost-effective and highly beneficial services for the 340B provider community.

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 updates to the comment deadline on the Health Resources and Services Administration's (HRSA) 340B rebate guidance—and why 340B stakeholders say the agency's timeline is not long enough. They also reflect on the implications of a major ruling in an antitrust lawsuit that two health centers filed against drug manufacturers, which were among the first companies to impose 340B contract pharmacy restrictions. The team also discusses new 340B enrollment requirements for sexually transmitted disease (STD) clinics. And Will breaks down a new 340B Report analysis that raises questions about the controversial alliance between the National Association of Community Health Centers (NACHC) and Pharmaceutical Research and Manufacturers of America (PhRMA).

Key Topics Covered:

HRSA Extends Rebate Pilot Comment Period and HHS Touts Model Shannon offers a recap on HRSA's proposed 340B rebate pilot program, including which drugs would qualify and when manufacturers can deny claims. She discusses a legal filing in which the Health and Human Services (HHS) Department touts its rebate model pilot plan, and she highlights HRSA's recent deadline extension for public comments on the proposal. Ted notes 340B providers' concerns with the rebate model, and why they're asking the agency to extend its consideration timeline for such proposals.

Antitrust Case Ruling Sets Stage for Future Litigation Shannon highlights a recent federal appeals court ruling that 340B provider attorneys argue could open the door for future 340B-related lawsuits against drug manufacturers. The U.S. 2nd Circuit Court of Appeals overturned a lower court decision, unanimously ruling that an antitrust class action lawsuit can continue in a lower court. Two community health centers allege in the lawsuit that four major drugmakers illegally colluded to deny 340B pricing on insulin and other diabetes medicines through contract pharmacy restrictions. Ted discusses the legal background surrounding the case and its potential importance.

STD Clinic Lawsuits and New Eligibility Requirements Will breaks down multiple lawsuits related to the 340B eligibility of a Nevada-based STD clinic, including multiple sites that HRSA terminated and later reinstated. Shannon notes that a new HRSA proposal would require STD clinics and other 340B covered entities to submit new or more complete information to enroll in or be re-certified in the 340B program. The proposal came just weeks after Office of Pharmacy Affairs (OPA) Director Chantelle Britton hinted at changes affecting STD clinics.

Analysis Raises Questions about ASAP 340B Alliance Will discusses his recent analysis of the 340B reform alliance, called ASAP 340B, between the NACHC and PhRMA. Since the two groups formed their unlikely alliance in March 2023, the number of PhRMA member companies that have placed 340B restrictions on health centers has more than doubled—raising questions over how much the alliance has actually benefited NACHC members. Will also breaks down how NACHC's public posture on the alliance has appeared to shift, even as ASAP 340B continues its advocacy efforts and NACHC continues to be listed as one of its founding members.

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This week's episode is sponsored by VytlOne, 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. Visit VytlOne to learn more.

Subscribe to 340B Report with a Special Discount

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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 the Health Resources and Services Administration's (HRSA) highly anticipated release of proposed 340B rebate guidance—and the significant concerns it garnered from 340B stakeholders. They also reflect on the 340B Coalition's recent summer conference and Capitol Hill lobbying efforts.

Key Topics Covered:

HRSA Releases 340B Rebate Model Guidance

Will discusses the details of HRSA's proposed 340B rebate pilot program, including which drugs would qualify and when manufacturers would be able to deny claims. Though HRSA's proposed 340B rebate pilot, which stakeholders will have 30 days to comment on, is narrower in scope than what had been proposed by various drug makers, it still would mark a dramatic shift to a program that has operated using an upfront discount since its inception more than 30 years ago.

Stakeholders Raise Concerns on Proposed 340B Rebate Pilot Proposal

Shannon breaks down how key 340B stakeholders initially responded to HRSA's rebate guidance, including concerns raised by both providers and the drug industry. She notes that hospital groups quickly expressed their opposition to efforts to implement a 340B rebate model, arguing it marks a major departure from how the program's been run and could hurt their financial ability to provide services to low-income patients. Health center groups have not yet weighed in with 340B Report. The drug industry, meanwhile, contends that HRSA's proposal doesn't go far enough and is needed to address what they say are continued challenges in addressing duplicate discounts, Shannon adds.

Key Takeaways from the 340B Coalition's Summer Conference

Shannon recaps the 340B Coalition's recent summer conference in National Harbor, Md., including keynote speeches from 340B Health leaders and HRSA's Office of Pharmacy Affairs Director Chantelle Britton. Shannon notes that 340B reform and PBM reform efforts are likely to remain hot topics in Washington, D.C., despite the post-reconciliation budget lull on Capitol Hill. Will discusses covering the fourth annual "Defend 340B" march on Capitol Hill, which took place after the conference and was unaffiliated with the 340B Coalition. He also discusses competing lobbying efforts from two trade groups that took place that week.

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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 Pillr Health to learn more.

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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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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.

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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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Each episode is brought to you by one of our great Ultra Diamond sponsors. CompassRx sponsored this week's episode. CompassRx is the premier AI-services platform built exclusively for 340B covered entities. We are very grateful to CompassRx for its sponsorship.

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

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