Episode 23: 340B Rebate Update, Hospital Reclassification Trend and a Tribute to the Late Sue Veer

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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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.

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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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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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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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We’re offering a special discount for podcast listeners. 340B Report is the indispensable source for news and intelligence on the 340B program. First-time subscribers may subscribe now using coupon code PODCAST25. Not ready to subscribe? Sign up for a 15-day free trial.

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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Each episode is brought to you by one of our great Ultra Diamond sponsors. Maxor sponsored this week’s episode. From specialty pharmacies to comprehensive pharmacy management, Maxor optimizes the pharmacy experience for patients and partners. We are very grateful to Maxor for its sponsorship.

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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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We’re offering a special discount for podcast listeners. 340B Report is the indispensable source for news and intelligence on the 340B program. First-time subscribers may subscribe now using coupon code PODCAST25. Not ready to subscribe? Sign up for a 15-day free trial.