340B Insight

After months of litigation in a federal district court, a key decision recently came out in the legal fight over 340B drug rebates. 340B Health Vice President of Legal and Policy Amanda Nagrotsky updates us on the development.Court deals a blow to drugmakersD.C. district court judge Dabney Friedrich ruled on May 15 that manufacturers cannot unilaterally implement rebate models for 340B, agreeing with the Health Resources & Services Administration (HRSA) that the agency effectively has preapproval authority over rebates. In her decision, the judge cited early results from a 340B Health survey finding that shifting 340B to a rebate model would divert significant hospital resources from patient care. Drugmakers have already appealed the ruling.Some bright spots for drugmakers in this decisionAlthough the decision largely went against pharmaceutical companies, the judge ruled that the 340B statute does not categorically prohibit rebates, leaving the door open for government approvals of rebates. The judge also agreed with drugmakers' assertions that HRSA should consider how rebate models could improve 340B compliance and how requiring the sharing of data through rebates could aid in drug company audits of covered entities.Will HRSA stop all rebates from proceeding?Despite this decision, the legal fight over rebates isn't over yet. The judge found that, for three of the manufacturers in these cases, HRSA has yet to issue final decisions with respect to their proposed rebate models. In the case of Sanofi, the judge found that HRSA failed to adequately explain the legal basis for rejecting the drugmaker's rebate model, and she directed the agency to reconsider its decision and explain whether and how it would violate the 340B statute. HRSA sent rebate guidance to the White House for approval earlier this month, though as of recording this episode it was not known what that guidance would say.ResourcesRead Our Analysis of the First Federal Court Decision on Rebates340B Health Continues Court Fight Against Rebates

More than a third of patients released from the hospital never fill their discharge prescriptions, but “meds-to-beds” programs can help improve that statistic. That is the approach Renown Health in Reno, Nev., took with the help of its 340B savings. Renown Vice President of Pharmacy Services Adam Porath joins us to describe how this meds-to-beds program improves patient care.Hospital readmissions down, patient convenience upRenown Health's 340B-funded program offers medication to patients who are being discharged from the hospital, either through bedside delivery, pneumatic tube, or a unique discharge lounge. The effort began as a pilot for Medicaid patients in 2016, and it demonstrated patients in the program were 25% less likely to be readmitted to the hospital once discharged. These health improvements plus the added convenience of medication access for patients convinced the system to expand the program.340B pricing to patients who cannot payPorath says Renown Health refers patients who cannot afford discharge medications to its social services team, which can authorize providing the drugs to those patients at the 340B-discounted rate. The team also will work with patients to see if they qualify for coverage such as Medicaid or other programs to reduce their out-of-pocket costs. Porath said Renown's meds-to-beds program provides drugs free of charge to about 30 patients per month.The keys to successRenown Health's meds-to-beds program has been a success, with more than 80% of eligible patients participating as of the end of 2024. The hospital expanded the services to all patients and started operating it 24/7 in April 2024. Porath said the keys to success include regular reporting to stakeholders and innovations to handle a large volume of patients discharging at once. Such changes allow all parties to stay in the loop with the development of the program and to celebrate successes as they occur.ResourcesRead Our Analysis of the First Federal Court Decision on RebatesSecond Federal Judge Allows 340B Health, Member Hospitals To Intervene in Rebate Lawsuit

Big potential changes to how 340B operates plus heightened interest in both new protections and new restrictions for covered entities means there is much to keep track of in the 340B world. 340B Health CEO Maureen Testoni joins us to make sense of recent developments in the nation's courts and beyond.Rebates Get Their Day in Court340B Health, two member hospitals, and the government met drug companies in court in late April to challenge drugmaker attempts to replace 340B discounts with rebates. Testoni says the judge cited potentially devastating consequences to hospitals if rebates proceeded but also had probing questions for the government on how it is working to address drugmaker compliance concerns. The Dept. of Health and Human Services is set to release guidance by early June on the rebate issue, and the court's decision could come out soon.The White House Proposes 340B Big Oversight Shift A leaked copy of the Trump administration's latest budget proposal includes a plan to move the Office of Pharmacy Affairs (OPA) from the Health Resources & Services Administration to the Centers for Medicare & Medicaid Services. Testoni says the oversight shift is concerning because of a stark difference between the purpose of 340B and the operations of Medicare and Medicaid. CMS also imposed years of Medicare payment cuts to 340B hospitals that the U.S. Supreme Court eventually overturned.340B Protections, Mandates Take Center StageStates continue enacting laws to protect hospital access to 340B pricing, but they also are moving forward with reporting mandates and proposals to define how hospitals should use their savings. Testoni said reporting and use-of-savings mandates lead to misdirected views on the purpose of 340B, which goes far beyond direct patient care and cost assistance. On Capitol Hill, a report from a long-running investigation of 340B recently came out, contributing to the debate over possible new restrictions.ResourcesFederal Government Signals Upcoming Guidance on 340B Rebate Models Amid Legal ChallengesBrief Your Leaders on White House Plans for Major 340B ChangesNebraska Is 12th State To Enact Contract Pharmacy ProtectionsIndiana Becomes Fifth State To Mandate 340B Reports From HospitalsKey Senator Concludes 340B Investigation, Calls for Major ReformsNew 340B Health Research340B Impact Profiles

The ancillary outpatient sites known as 340B child sites serve as important places for patients to access the drugs and care they need. There are crucial steps involved in effectively onboarding potential child sites as well as ongoing processes involved with maintaining the parent hospital's partnership with those sites. University Hospitals Cleveland Medical Center  340B Pharmacy Manager Joe Moss joins us to shed light on this process and the potential problems to be on the lookout for.How is a 340B child site onboarded?Moss says the first big step to identifying potential sites is to work with a hospital's finance, revenue, pharmacy, and legal departments to evaluate a site. The team looks at Medicare cost reports and trial balances to ensure they are eligible for 340B. As part of the process, they also use electronic medical record and retail data to identify potential clinic areas based on their patient volumes.A 340B child site is registered. Now what?The work is not over once a child site has been registered in 340B. UH has a program it calls the “340B Concierge Program,” which aims to provide comprehensive, ongoing support and guidance to a given child site. The program offers additional education and information in such areas as procurement processes, the appropriate ways to handle drug transfers, and miscellaneous licensing issues.Onboarding requires relationships and a close eye on complianceMoss says that hospitals onboarding a child site should establish and maintain close ties with the site to prevent issues with 340B compliance. This can involve being the first line for any pharmacy issues the site staff might be having, holding frank conversations with clinic management when necessary, and inviting staff to observe mock audits so they can learn more about what goes into maintaining 340B compliance.Resources:Trump Executive Order Could Revive Medicare 340B Cuts

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

Artificial intelligence continues to impact industries, including pharmacy and 340B. As hospitals and health systems consider adopting AI, we spoke with Kristin Chupka, the 340B program system director for Dartmouth Health, who shares her experience launching this initiative there and considerations for entities seeking to do the same.  AI, automation, and how they can support 340BChupka distinguishes that AI is like a machine learning and making decisions depending on what it is taught. Automation, although similar to AI, does not make decisions. Both can systematize processes and with the help of guardrails, enable pharmacists to dedicate more time to patient care. Opportunities and considerations The novelty of AI promises an opportunity for 340B teams that can consider and correct its potential pitfalls. Chupka explains that as with any emerging technology, it is best to start slowly, teach the algorithm, and consistently check in to ensure accuracy and ethical considerations. This approach can limit errors and inspire confidence as time goes on. What entities can learn from Dartmouth Health? The Dartmouth Health team has explored how AI can help with budgeting, modeling, and auditing, always double-checking work to avoid errors. Because a fully staffed team is required for this, Chupka reassures that AI has not affected staffing. If anything, Chupka says AI is a tool to assist in compliance. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org. Resources:340B Health, Member Hospitals Ask Court To Throw Out Drugmaker Rebate Lawsuits)

Hospital clinical pharmacies play a key role in ensuring patients are taking medications effectively and supporting other providers who are managing their care. Mark Riggle, the assistant chief pharmacy officer at UC Davis Health, explains how 340B helps make this direct care and ancillary support possible.Clinical pharmacies are a bridge between providers and patientsRiggle says clinical pharmacy teams serve as drug experts that can help teach patients about potential side effects and how to take their medications properly. But these teams also can take the lead on supporting other providers on refills, prior authorizations, financial assistance, and more. That allows the other providers to focus less on those processes and more on providing medical care to the patients. In-house pharmacies can improve patient care and generate revenueUsing an in-house clinical pharmacy has benefits for both patients and the hospital. Riggle notes that keeping prescriptions and pharmacy support in-house can enable hospitals to keep better track of patients' health and identify if there are issues or questions with certain medications. At the same time, it generates revenue and 340B savings that support even more hospital services and improve patient health outcomes even more.Ramping up clinical pharmacy services and overcoming barriers can take timeRiggle says expanding clinical pharmacy initiatives at UC Davis Health has come with some challenges. It took years to roll out a refill program for all the providers who needed that support, and achieving success with a prior authorization program involved an evaluation of workflows to improve efficiency. But he noted that hospital pharmacists can present a value proposition to their leaders for how investing in 340B-supported clinical pharmacy services can be worth it to improve care quality and provider satisfaction.ResourcesFederal Judge Allows 340B Health, Member Hospitals To Intervene in Rebate Lawsuits

The legal fight over drugmakers' push to impose 340B rebates is heating up, with five lawsuits pending in a federal court in Washington, D.C. Recently, 340B Health joined with two of its member hospitals in asking the court to intervene as defendants to stop these rebates from taking effect. Genesis HealthCare System based in Ohio is one of those hospitals. Shona Carr, the director of 340B and ambulatory pharmacies at Genesis, breaks down how rebate models would create financial challenges for hospitals that would hamper their patient care initiatives.Carrying and Compliance CostsEach drugmaker's push to impose rebates would incur new drug purchasing and compliance expenses for covered entities. Bristol-Myers Squibb's rebate policy alone would cost Genesis HealthCare System an additional $400,000 per month in drug spend if it applied to all BMS drugs. If 340B rebate models became the norm for all drugmakers, Carr estimates Genesis would pay an additional $5.2 million per month in upfront costs. Those figures do not include additional hundreds of thousands of dollars in annual staffing expenses to process rebate claims and challenge denials.Effects on Patient Care and SupportImposing 340B rebates could force Genesis HealthCare System to scale back or discontinue its patient assistance program, according to Carr. But 340B savings do not just go towards direct patient help with drug costs at the hospital. The financial impact of rebates also could affect other community programs and free services, such as patient transportation, meds-to-beds, health screenings, and a paramedicine program.Advice for Other HospitalsCarr says every covered entity that has not already done so should begin reviewing drugmaker rebate policies and working with their 340B third-party administrators to estimate potential costs. She says this involves entities asking bigger questions: Would rebate policies require additional 340B staffing? Does senior leadership understand the potential impact of these changes? What 340B-funded programs might be at risk?Resources:340B Health Seeks To Intervene in All Drugmaker Rebate LawsuitsDeclaration of Shona Carr in Support of Motion To Intervene

In what has become an annual tradition for the podcast, we consulted with 340B Health's expert staff to answer our listeners' most pressing 340B questions. As an uncertain and busy year starts for the world of 340B, we want to prepare you by covering your queries about the efforts by drug companies to impose 340B rebates, proposed federal and state legislation on 340B, how Inflation Reduction Act implementation will affect 340B, and more.340B Rebate Lawsuits Heat UpSo far, five drug companies have sued the Health Resources & Services Administration to challenge HRSA's rejections of their backend rebate proposals. 340B Health Vice President of Legal and Policy Amanda Nagrotsky notes that a rebate model would harm 340B hospitals through delayed access to 340B savings and potentially denials of legitimate rebate claims based on drugmaker interpretations of 340B rules. We recorded this episode just before 340B Health filed a motion to intervene as a defendant in the Johnson & Johnson (J&J) rebate lawsuit against HRSA.Lawmakers Eye Ways To Protect or Cut 340BThe new year means a new Congress and the start of new state legislative sessions. 340B Health Senior Vice President of Government Relations Tom O'Donnell notes that members of Congress have floated potential reductions in what the federal government pays for 340B drugs to help fund new spending priorities outside of health care, though it is unclear how seriously they are considering those options. 340B Health Vice President of Legal and Policy Greg Doggett reports that several states are considering new contract pharmacy or payment nondiscrimination protections for 340B hospitals, but others have introduced proposed new mandates for covered entities. Price Caps Will Apply to More Medicare DrugsThe list of drugs eligible for Medicare price caps will grow to 25 starting in 2027 under the Inflation Reduction Act, which will have implications for 340B savings on those drugs. 340B Health Research and Policy Analytics Manager Claudia Escue notes that popular weight loss and diabetes drugs like Ozempic and Wegovy have made the price cap list because of how much they cost Medicare. 340B Health is tracking how these price caps might lower 340B savings and have submitted letters to Medicare officials to represent other hospital concerns about the implementation of the IRA.Resources:340B Health Files Motion To Intervene in J&J Rebate LawsuitOption To Cut Commercial Pay Rates for 340B Drugs Is on Draft Congressional Budget “Menu”Medicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings340B Coalition Winter Conference Registration 

A Minnesota requirement for covered entities to submit data on the costs they pay and the payments they receive for 340B drugs yielded its first annual report this past November. Today's guest, Minnesota Hospital Association Director of State Government Relations Danny Ackert, tells us why the report's findings don't tell the whole story.The Context for the Dollars The first Minnesota report concluded that covered entities received a net of $630 million in payments for 340B drugs in 2023 and paid $120 million to contract pharmacies and third-party administrators. But Ackert notes the figures do not account for what entities would have paid for drugs at non-340B prices, nor what pharmacy administrative costs they would have had if they did not have access to 340B.Where the Money GoesAckert notes that the report does not spell out how hospitals in the state use their 340B savings to stretch resources and provide more care and support to patients. He notes that Minnesota hospitals spend about $15 billion a year providing care. They also face an annual shortfall of about $1.8 billion from Medicare and Medicaid underpayments, a figure that does not even account for charity care, bad debt, and other unreimbursed hospital spending. Some rural hospitals in the state rely on 340B savings just to stay open.What Other States Can LearnAlthough submitting data for the report and countering misconceptions about its findings have been challenging for Minnesota hospitals, Ackert also notes that it has given them an opportunity to educate policymakers about 340B. By learning more about the report and following the state's example, hospitals in other states considering reporting mandates can put themselves in a position to explain to lawmakers why 340B is so vital.Resources:Minnesota 340B Covered Entity ReportEpisode 89: How New 340B Reporting Requirements Are Affecting Hospitals (February 2024)340B Medicare Hospital Pay Cuts Floated as an Option for Congress

Earlier this year, the Health Resources & Services Administration took a strong stance against drug giant Johnson & Johnson's plan for a proposed 340B rebate model, but the fight over rebates is far from over. 340B Health President and CEO Maureen Testoni joins us to discuss how the company is taking the issue to federal court and how they are not the only drugmaker doing so.J&J Sues HRSA Over RebatesJ&J is arguing in court that HRSA lacks the authority to block a 340B rebate model. Such a model would allow individual drug companies effectively to impose their own rules on 340B drug purchases. These rules would curtail the number of drugs a company would offer a 340B discount on and reduce the number of patients that would be deemed 340B-eligible.Other Drugmakers Pushing RebatesBristol Myers Squibb and Eli Lilly also sued HRSA, claiming the agency does not have the authority to stop a rebate model. Sanofi has not yet filed suit but is saying it will impose its rebate scheme in early January. The Sanofi model raises significant concerns not just because of the imminent effective date but because it would impose far more stringent restrictions on 340B eligibility than HRSA ever has.State Contract Pharmacy Laws Rack Up More WinsIn another 340B issue before the federal courts, state contract pharmacy protections continue obtaining key litigation wins. Several district courts and one appeals court have upheld state laws designed to protect covered entity access to 340B pricing through community and specialty contract pharmacies.Resources:Brief Your Leadership on Drugmaker Rebate SchemesThe Wall Street Journal: “The Economic Imperative of Protecting 340B”Register for the 340B Coalition Winter Conference

What Does the GOP Trifecta Mean for 340B?In January, Republicans will achieve what's known as a governing trifecta – taking control of the executive branch combined with GOP majorities in both the U.S. House and Senate. How will this new dynamic affect the 340B world? We discuss what is ahead with McDermott+ vice presidents Rodney Whitlock, a former Republican legislative staffer, and Debbie Curtis, a former Democratic legislative staffer.Capitol Hill Shakeups and New FacesSeveral 340B champions are set to leave Congress through retirement or new appointments, including Reps. Elise Stefanik and Abigail Spanberger as well as Sens. Debbie Stabenow and Ben Cardin. But this provides an opportunity to speak to newly elected lawmakers to express the value of 340B and what it means for their constituents.Preparing for 340B OversightThe new Congress could bring oversight hearings and other opportunities for 340B critics to speak out. Although 340B has faced and surmounted challenges before, this will require getting back to core advocacy efforts designed to protect the program.Trump's Second TermHow the second Trump administration will fill key roles and the decisions they make on health policy issues could impact 340B. The implementation of Inflation Reduction Act drug pricing provisions also will affect 340B and could lead to discussions about additional changes to the program.Resources:Create or Update Your 340B Impact ProfileRead Our Analysis of J&J's Legal Arguments for 340B RebatesLilly, Kalderos Press Federal Court for Ability To Impose Rebates

The focus of attention on cancer care most often goes to the curative treatments required to put cancer into remission, but what do cancer survivors need after that point to fully recover and lead their best possible lives? We discuss that question and how 340B can help answer it with guests Sarah Loschiavo and Ellen Morris-White, two nurse practitioners with UConn Health based in Farmington, Conn.Survivorship Care at a Crucial TimeUConn Health's Cancer Survivorship Program is led by advanced practice registered nurses who provide comprehensive care and support to cancer patients starting three to six months after their curative cancer treatments are complete. With the help of 340B funding, the multidisciplinary program is broad in scope, including referrals to meet cancer survivors' physical, psychosocial, spiritual, and financial needs. The goal is to keep patients on the road to recovery and to continue screening for any cancer recurrence or secondary cancers that could occur.340B Is Key To Covering Costs UConn Health covers the costs of its survivorship care, and low-income patients can receive additional financial assistance for their ongoing cancer therapies through this program. 340B funding is essential to making that happen. Over time, the program is expected to decrease health care costs by avoiding hospital readmissions and cancer recurrences. Building Out Best PracticesEvidence on survivorship care models is lacking, but UConn Health has worked on research that could provide some best practices for other institutions. Although there is no one-size-fits-all approach for hospitals, they can use elements of the nurse practitioner-led, interdisciplinary model to meet cancer patients' needs months and even years after curative treatment. Resources: UConn Health Cancer Survivorship ProgramDesigning, Implementing, and Evaluating an Interprofessional Survivorship Model of Care in an Academic Cancer Center

The 340B drug pricing program is crucial for safety-net hospitals and other providers that care for patients in need, especially those whom traditionally have been underserved by the broader health system. We speak with Dr. Tony Jackson, assistant vice president for pharmacy services at Scripps Health in San Diego, for his views on why 340B is “all about health equity.”340B Helps Serve the UnderservedJackson stresses the variety of services and support that 340B funding enables at Scripps Health. Because of 340B, Scripps can serve large populations of patients in the area who are homeless, lack health coverage, and are dealing with higher rates of chronic illness and disease. It does so in part through partnerships with community health centers and other community groups on outreach to those populations. Restrictions to 340B Threaten Patient Care340B savings help support vital Scripps services that include emergency department care, access to specialists, discharge and maintenance medications, and community health benefits such as disease screenings. Jackson notes that drug company restrictions on access to those savings threaten such services and risk creating health care deserts in the area.Representation and Advocacy MatterJackson is part of the Association of Black Health-System Pharmacists (ABHP), which works to increase Black representation in the pharmacy field with the goal of improving underserved patients' trust in pharmacists and access to needed care. He notes how ABHP leaders have advocated for 340B with the understanding of how important it is to the pursuit of health care equity.Resources340B Health Equity Report 2023Black Pharmacists Stand as Advocates in Support of 340B Access to CareSenate Letter to HHS on Rebates

Within the past few weeks, drugmaker Johnson & Johnson went head-to-head with 340B hospitals and the federal government over the company's plan to stop paying upfront 340B discounts on two of its top-selling drugs. 340B Health Senior Counsel Amanda Nagrotsky joins us to explain how that conflict played out.HRSA Warns Johnson & Johnson of Strong Punitive ActionsIn letters to J&J, the Health Resources & Services Administration (HRSA) warned the drugmaker that replacing 340B rebates with discounts only would be allowed if approved by the Health and Human Services (HHS) secretary. HRSA gave the company until the end of September to announce that it was going to walk away from its plan or face both civil monetary penalties and the termination of its pharmaceutical pricing agreement (PPA). Nagrotsky said the threat to end the PPA was unprecedented, noting that it would cause the company to lose access to Medicaid and Medicare Part B coverage for all its drugs.Johnson & Johnson Backs Down Under PressureJ&J announced at the end of September that it would walk back its plan to implement rebates in mid-October, bowing to pressure from federal health officials and a bipartisan group of nearly 200 members of Congress who opposed the J&J strategy. The company maintained that it disagreed with HRSA's reasoning and noted that it was reserving all legal rights with respect to rebates. That stance indicates the company is likely to continue its push to implement rebates.The Battle Against Rebates ContinuesDespite the win for hospitals on the J&J rebate scheme, efforts from the drug industry to change the 340B discount structure continue. Drug industry consultant Kalderos is part of ongoing litigation in a federal court in Washington, D.C., over the right to impose rebates. HRSA's references to the concept of HHS approval of rebate proposals also leaves open the door for companies to seek federal consent for such a model.Resources340B Hospitals Prevail on J&J Rebate Plans, But Fight Is Not OverBipartisan U.S House Letter to HHS, Sept. 27 HRSA Letter to Johnson & Johnson, Sept. 27J&J Response to HRSA, Sept. 30

A renewed push by a drugmaker to fundamentally transform 340B has the potential to cause major problems for 340B hospitals if allowed to take effect. 340B Health President and CEO Maureen Testoni joins us to explain the controversial 340B rebate issue and to cover some of the other recent developments in the 340B world. A Plan To Replace Upfront Discounts With Rebates For years, drugmakers have been pushing unsuccessfully for approval to turn 340B from an upfront discount program into a back-end rebate program. But recently, Johnson & Johnson announced it would unilaterally proceed with plans to stop selling two of its drugs at the discounted price for certain hospitals. Maureen explains the reaction of the government, hospitals, and others and outlines the potential next steps in the advocacy against such a harmful change. More Legislative Action on Capitol Hill Recently, Sen. Peter Welch of Vermont introduced legislation to make access to 340B through contract pharmacies a very clear part of statute and to prohibit manufacturers from imposing conditions on 340B pricing. It is one of several 340B bills pending on Capitol Hill, which also include a potential Medicaid payment reporting requirement for 340B hospitals. Maureen notes that although Congress does not have much time left to legislate this year, it is possible 340B will be part of the action during a lame-duck session after the elections. Court Action Continues on State 340B Laws Although two federal appeals courts recently ruled that the 340B statute does not categorically prohibit drugmaker conditions on 340B pricing, several states have moved to impose their own such prohibitions. Drug companies are suing to block these laws, but so far courts have denied these attempts. Maureen notes that 340B Health and other organizations continue to file friend of the court briefs in support of these state laws. Resources1. HRSA Threatens Johnson & Johnson With Sanctions Over Rebate Plans2. HRSA Letter to J&J 

The 340B drug pricing program is designed to give hospitals the flexibility to use their savings toward the types of patient care and support that their communities need the most. How does that work for hospitals that decide to use their access to 340B to provide the discounts directly to patients who cannot afford their drugs? Paul Orth, 340B program manager at University Health Kansas City Truman Medical Center, sits down with us to discuss how his health system's direct drug savings program is helping both uninsured and underinsured patients.How the program worksOrth says his system's direct savings program is built into the system that prescribes medication electronically from its clinics and its hospitals' electronic medical records system. When the prescriptions that generate from those visits are sent to a system pharmacy, 340B eligibility codes are attached that allows the pharmacy to know that they are eligible to receive the drugs at the 340B-discounted price plus a dispensing fee.Underinsured patients also benefitOrth says University Health describes its direct savings model as an uninsured program because that describes the key patient population that benefits from receiving the 340B price. But that assistance also is available for underinsured patients who otherwise would be expected to pay more in prescription drug copays than the 340B price. Drugmaker restrictions are a barrierOrth says this program is the difference between patients receiving a needed medication and going without one, which prevents hospital readmissions and emergency department visits. But he also notes that drug company restrictions limiting 340B pricing to a single contract pharmacy are negatively affecting the program, ultimately adding another barrier for access to care. Resources:340B Health Urges HRSA To Block J&J Plan To Replace 340B Discounts With RebatesJ&J Implements 340B Rebate Model Despite HRSA Opposition340B Health Equity Report 2023

This marks the time of year when 340B hospitals complete the recertification process to maintain their eligibility for 340B. But why is this recertification needed, and what do hospitals need to know before undergoing recertification? Steven Miller, the vice president of pharmacy services for 340B Health, describes what is at stake when it comes to hospitals completing recertification every year. Failure to do so could take a hospital months to correct and cost it millions of dollars – resources that the hospital could be using towards services for patients who need help the most.The key playersMiller says the hospital's authorizing official (AO) and primary contact (PC) are two of the most important figures for recertification. These individuals will be key to verifying and submitting information to the government during the process, and there are important rules governing their roles and responsibilities.Preparing for recertificationMiller says hospitals should have their “ducks in a row” and be ready to undergo recertification as soon as the period begins. This involves having the necessary staff involved, having required documentation on hand, and being prepared to respond quickly to any inquiries from the Health Resources & Services Administration (HRSA).Hospital best practicesMiller has tips for hospitals that want to navigate the recertification process efficiently and accurately. This includes advice on ensuring all the information in the HRSA Office of Pharmacy Affairs Information System is correct, fixing any discrepancies that could lead to future audit findings, and documenting needed changes to make sure they take effect.Resources:340B Health Registration and Recertification Resource340B Health Webinar Archive340B Health Equity Report 2023

Artificial intelligence is a hot topic in 2024. Discussions about AI in health care continue to grow, including about the potential for such technology to improve care and save lives. What role might AI play in the 340B world? We speak with WVU Medicine Enterprise 340B Program Coordinator Elizabeth Gibson to learn how one health system is exploring this potential.What Can a 340B “Bot” Do?Gibson's team uses artificial intelligence to improve its 340B internal auditing processes. What they call “the bot” can streamline the process by pulling data from the health system's electronic medical records system and automating the administrative tasks required to set up an audit. The bot also can make the process more effective by increasing the number of audited claims and flagging potential problem areas. She noted this makes the team more prepared for the data they must collect for external 340B audits as well.Lessons Learned During ImplementationGibson said installing the bot for 340B use was a very “trial and error” approach, though the team was able to make quick changes to fix any issues they encountered. She said one of the biggest growing pains of the AI-based system was the time needed to make the tool operational. She also notes the bot may be clunkier than a product they would have purchased through an outside vendor because it is designed to allow the team to customize and modify as needed.Opening Eyes to the Benefits of AutomationGibson said this new tool has led to her team re-evaluating other 340B processes that they can automate, even if that does not involve AI. WVU also is considering potential bots that will look specifically at Medicaid claims and help conduct retail audits. She urged health systems to consider the concept of automation more broadly than AI, bots, and machine learning, as collaborating with other departments that can share automation skills could help improve overall 340B processes.

We have released several episodes in recent months in which we have discussed federal and state legislative efforts on 340B. But what does it take to get 340B protections through a state legislature and to the governor's desk? In this episode, we speak with Ryan Cross, vice president of governmental affairs with Franciscan Missionaries of Our Lady Health System, based in Baton Rouge, La. This system operates 10 hospitals in Louisiana and Mississippi. Both states recently enacted contract pharmacy protection laws. Ryan says there were three factors involved with getting these state protections over the legislative finish line:Relationships — Ryan says the relationships 340B advocates formed with other hospitals, lawmakers, and public policy staff contributed to their successes at the state level. The first time to discuss 340B with these individuals cannot be when a bill is going up for consideration, much less when stakeholders are on defense and trying to explain the importance of 340B in the wake of legislation that would harm covered entities.Messaging — Ryan explains how the messaging that resonated in the states during the 340B contract pharmacy debate focused on how big pharma is trying to take money away from not-for-profit hospitals and drive it to out-of-state shareholders. By emphasizing the variety of patient programs and support that are possible because of 340B without making it a referendum on the federal program at large, that case mostly sells itself.Grassroots — Ryan notes that there are roughly 18,000 members of his health system across Louisiana and Mississippi. These are physicians, nurses, pharmacy techs, and other health care professionals with representatives that they can contact. Knowing when to deploy these grassroots supporters to make phone calls and send emails is important, because that can get attention and results when timed well.Resources:Missouri Becomes Eighth State To Enact Contract Pharmacy Protections

While significant 340B actions have happened at the federal level, state legislatures also have made big moves in the world of 340B so far this year. We are joined by Amanda Sellers Smith, 340B Health's legal counsel, to explain more.More states ban drug company restrictions on 340B contract pharmaciesFollowing the lead of Arkansas and Louisiana, five additional states have enacted contract pharmacy protection laws so far this year. Some states enacted standalone contract pharmacy laws, while others paired these laws with PBM non-discrimination bills. Another bill is with the governor in Missouri after passing the state legislature.Court battles continue despite early wins for state 340B lawsThe pharmaceutical industry continues to fight state 340B protection laws in federal courts, with most challenges focusing on whether federal 340B law preempts such state laws. So far, none of those lawsuits have succeeded, with one federal district court and one federal appeals court rejecting the preemption arguments.More states consider requiring 340B hospital savings dataLast year, Maine, Minnesota, and Washington enacted 340B reporting laws at the state level. And while no additional reporting packages have passed out of state legislatures so far this year, several considered doing so, and Minnesota added even more requirements for hospitals. These reporting requirements add burdens to covered entities and raise concerns about how states will use this information in the future.Resources:Mississippi Court Rejects Drug Industry Calls To Block Contract Pharmacy Protections340B Health State Policy and Advocacy Resource Center

The world of 340B has seen significant developments on the state and national levels in recent months. A second federal appeals court decision on 340B contract pharmacies came down in recent weeks, a new bill in Congress threatens to impose significant restrictions on hospital participation in 340B program, and more states move to protect covered entities from drugmaker restrictions. To understand these new developments, 340B Health President and CEO Maureen Testoni joins us to explain more. A second federal appeals court rules for drug companies In May, the D.C. Circuit Court of Appeals ruled that the 340B statute does not categorically prohibit drug manufacturers from imposing their own conditions on 340B. However, the court did note that manufacturers cannot impose a condition that effectively prevents a covered entity from purchasing a particular drug at the 340B price. This raises the importance of entities demonstrating situations in which they are cut off from all 340B access to a drug. Another appeals court based in Chicago has yet to issue a decision in its 340B contract pharmacy case. More states ban 340B restrictions as the industry increases state lobbying efforts  So far this year, Kansas, Maryland, Minnesota, Mississippi, and West Virginia have joined Arkansas and Louisiana in enacting laws to prohibit contract pharmacy restrictions on covered entities. But the pharmaceutical industry has become much more active in opposing ongoing legislative efforts in other states. A “dark money” group also has been running ads opposing these state bills by accusing covered entities of laundering taxpayer money to subsidize care for undocumented immigrants. New pharma-backed bill in Congress would slash 340B hospital eligibility U.S. House lawmakers recently introduced a bill known as the 340B ACCESS Act. The legislation is backed by the Pharmaceutical Research & Manufacturers of America (PhRMA) and the National Association of Community Health Centers (NACHC). It would impose significant restrictions on 340B hospital eligibility and access to savings, including by restricting 340B usage for insured patients and tying participation in the 340B program directly to levels of charity care. Resources: 1.      Statement on New Federal Legislation To Restrict 340B Hospital Eligibility2.      Statement on D.C. Circuit Appeals Court Decision on Drug Companies' 340B Restrictions3.      Report: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients4.      House Energy and Commerce Oversight and Investigations Subcommittee Hearing on 340B June 4

The finalized 340B administrative dispute resolution (ADR) rule is set to go into effect on June 18 and will create a process to settle certain disputes between covered entities and drug manufacturers. But what should covered entities know about this process before it launches? Jason Reddish, a 340B expert with the Powers Pyles Sutter & Verville health care practice group, joins us to discuss.How the ADR is intended to workJason notes that the ADR will use a panel of government officials to arbitrate certain types of disputes between covered entities and manufacturers. This process can allow covered entities to bring complaints against manufacturers for overcharging, and it can allow manufacturers to bring complaints against previously audited covered entities relating to allegations of diversion or duplicate discounts. The panel collects evidence from both sides and issues a binding decision in the dispute.The pros and cons of the final ruleJason says there are aspects of the final rule that are favorable to covered entities and some areas they might find lacking. The panels will be able to hear a wider range of complaints against drug companies, will have lower barriers to entry, and will avoid potential conflicts of interest in choosing their members. But they also will be able to take up to a year to issue decisions, will not be required to publish their findings, and will be able to hear certain controversial cases about alleged duplicate discounts.Having offensive and defensive strategiesJason recommends that covered entities be prepared for navigating the ADR process as both the filer of a complaint and as the subject of a complaint. Both parties must engage in good-faith efforts to resolve the dispute and drugmakers cannot file a complaint against a covered entity without conducting an approved audit first, so an ADR complaint should not come as a surprise to either party. Entities should consult legal counsel before making decisions related to any dispute.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources:Final Administrative Dispute Resolution (ADR) Rule Adopts Several 340B Health RecommendationsReport: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients

Hospitals throughout the U.S. use their 340B savings in innovative ways to care for their patients in need. In some cases, they can take that care outside the walls of the hospital to meet patients where they learn, live, and play. We speak with Heather Armstrong with Comanche County Medical Center in central Texas to tell us how her health system invests 340B savings into innovative approaches to community care.Improving student health on campusSince the end of 2022, Comanche County Medical Center has been operating a school campus-based program that pairs onsite diagnostic equipment with telehealth visits to keep students and staff healthy without requiring families to miss school and work. The program has decreased absenteeism and enabled faster recoveries for the patients it serves.Putting community care on wheelsComanche County Medical Center has a fully equipped mobile van clinic that it can deploy wherever the community needs care. By bringing the clinic to food drives, sporting events, and areas affected by wildfires, the center has been able to provide many more residents with preventive services, medications, and other vital care that they otherwise would not have accessed.Expanding the reach through pharmacy partnersThe community pharmacies that Comanche County Medical Center partners with, combined with prescription delivery services, has greatly expanded the numbers of patients whom the center can connect to needed prescription drugs. But drugmaker restrictions on contract pharmacies has had substantial negative impacts on that access and has affected the center's plans for health services growth.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources:Court-Backed Arkansas Contract Pharmacy Law Prompts Enforcement Action, More Drugmaker Retreats

340B savings can help hospitals and other covered entities better serve patients and improve their health outcomes. But how can these entities make the best use of 340B funds for their institutions? We sat down with Matt Webber, director of pharmacy business at Novant Health based in North Carolina, to learn more.340B optimization strategies One way that Novant Health optimized its 340B program was through a multidisciplinary team that includes data analysts and auditors. Matt says that while this team prioritizes compliance above all else, it also can focus on technology and data to increase 340B efficiency and to find opportunities to increase patient access to the drugs and care they need.  How 340B optimization helps patientsNovant Health was able to use their 340B optimization team to find cases in which patients receive a prescription from the hospital but use a non-contracted pharmacy to fill their medication. The team found out where this was occurring and used the information to expand their contract pharmacy footprint and better meet patients' needs where they are.The complexity of optimizingMatt says health systems can encounter numerous systemic challenges in pursuing 340B optimization, including navigating individuals' choice, rising drug costs for patients, and complex reimbursement issues. Still, Novant's optimization efforts are paying off for patients by measurably improving their health outcomes and connecting them to more affordable drugs and care.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources:Mississippi Bans Drugmakers' Contract Pharmacy RestrictionsHRSA Issues Final Rule on Changes to Administrative Dispute Resolution (ADR) Process

The 340B community has seen major activity on several fronts since the start of 2024 – the introduction of new legislation on Capitol Hill, movement on legislation in the states, and key developments in the courts. 340B Health President and CEO Maureen Testoni returns to the show to help us make sense of these developments and how they might affect stakeholders.Federal bills could help covered entities but also limit 340B's scope One new bill introduced in the House of Representatives would restore access for covered entities to 340B pricing through their community and specialty pharmacies, as well as protecting access to discounted pricing at in-house pharmacies. The bill would tackle drug company restrictions that have been in place for nearly four years by authorizing the government to impose civil monetary penalties for drug companies that cut off this access.But another draft bill under discussion in the U.S. Senate could have more mixed effects on covered entities. The Senate legislation would address the community and specialty pharmacy dispute, but it also could include additional provisions that would limit hospital eligibility for 340B and the types of patients that could receive 340B drugs. 340B Health was among the many stakeholder groups that submitted comments on the Senate bill discussion draft.Major ruling by federal court is a big win for 340B advocatesThe U.S. Court of Appeals for the Eighth Circuit recently ruled in favor of an Arkansas law that protects covered entity access to 340B discounts through specialty and community pharmacies. The pharmaceutical industry had sued to try to block the law in Arkansas as well as a similar law that Louisiana recently enacted. The decision will apply to any additional states within the Eighth Circuit jurisdiction that might enact their own 340B protections. Other federal appeals courts hearing drug industry challenges also will take note of this decision when considering those lawsuits.West Virginia becomes the third state to protect 340B pharmacy accessThe West Virginia governor recently signed into law a new 340B law that closely resembles the statute on the books in Louisiana. 340B hospitals in the state had worked closely with state lawmakers to advocate for the measure and drive it toward enactment. More than 20 states are considering such legislation during their current legislative sessions, so the number of states with 340B pharmacy access laws on the books could grow before the end of the year. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.ResourcesHouse Bill Would End Drugmakers' 340B Contract Pharmacy RestrictionsLearn How Stakeholders Weighed in on Draft Senate 340B BillFederal Appeals Court Upholds Arkansas Contract Pharmacy LawWest Virginia Bans Drugmakers' Contract Pharmacy Restrictions

One of the most important elements of 340B compliance is preventing duplicate discounts. Ensuring there are no duplicate discounts is high on the list of compliance concerns for covered entities, and it is one of the major items that 340B auditors look for. But how do these entities ensure they stay compliant? On this episode, we speak to Melissa Bruce, an ACE-certified compliance analyst for the 340B Programs Team at UNC Health in North Carolina, to learn more. Compliance factors can vary state by stateMelissa notes that it is important for covered entities to think through the duplicate discount compliance requirements in their home state, especially if their health system treats many patients from across state borders. A border state, a community that attracts tourists, or a college town are examples of areas in which providers can face different requirements depending on Medicaid rules for the states where those patients reside.Ensuring compliance can be complexEnsuring duplicate discount compliance can be complex, especially if a provider has multiple child sites. How does a health system establish a carve-in or carve-out list? Melissa explains that some entities can have manual workflows that involve individuals reviewing Medicaid dispenses, understanding EHRs, and using spreadsheet skills to keep drug purchases compliant. But given the complexity that UNC Health faced under this method, the health system took a different approach.Workflow automation can increase reliability and instill trustUNC Health decided to use an automated workflow approach to streamline manual duplicate discount prevention tasks. The team is rolling out the automation to other locations after finding that it improved accuracy and confidence in the process. Melissa notes that each health system will need to determine whether such an automated process makes sense for them.Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources:New Federal Legislation Would End Drug Company Restrictions on 340BMatsui Introduces Legislation To Protect 340B Drug Pricing ProgramFederal Appeals Court Upholds Arkansas Contract Pharmacy Law

340B hospitals can register certain outpatient locations with the Health Resources & Services Administration (HRSA) as 340B child sites, which allows them to use 340B drugs. HRSA recently announced some changes to how it had been determining this eligibility during the COVID-19 public health emergency. How have these changes affected 340B hospitals, particularly those that had planned new child sites under the previous policy? For the answers to this question and more, we spoke to Chuck Stubbs, a 340B pharmacist with Intermountain Health based in Salt Lake City. How new hospital child sites gain 340B eligibilityChuck explains that 340B child sites are outpatient departments that are not on the main hospital campus but are fully integrated with the hospital parent site. To start using 340B drugs at a new child site, the location must appear on a filed Medicare cost report with associated costs and charges and then be registered with the HRSA Office of Pharmacy Affairs Information System (OPAIS).What changed during the pandemicPrior to the COVID-19 pandemic, the process to start using 340B drugs at a new child site could involve up to nearly two years. Chuck notes that during the pandemic, HRSA indicated that child sites that had not yet been registered could begin using 340B drugs right away if they were for eligible patients. Hospitals believed that shift in policy would be permanent.Where things stand nowThe COVID-era child site eligibility changes did not last. In October 2023, HRSA ended what it called a temporary flexibility, citing the termination of the public health emergency in May 2023. Although HRSA granted a grace period for hospitals to come into compliance, that did not provide protections for planned child sites that had not yet been using 340B drugs. Chuck explains how this affected one of Intermountain's planned sites, and he shares advice for hospitals that are in similar situations.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources:HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period

The Health Resources & Services Administration audits 200 covered entities each year for compliance with 340B rules. We speak with Mark Capuano, senior director of the corporate pharmacy 340B program at New York City Health and Hospitals, about what hospitals should expect when they find out they will be going through a 340B audit.How a hospital can prepare for a 340B auditAuditors typically will ask to schedule a pre-site visit call and will provide a data request list for the information the auditor is seeking. Mark says it is important to provide this information in a timely, accurate and concise way, and to make sure you inform key stakeholders at your organization so you can get the subject matter experts involved. He also recommends doing test runs of the audit ahead of time.What a hospital should expect on the day of an auditOn the day of an audit, the auditor will trace a sample to see how a 340B drug goes from drugmaker to pharmacy to patient. The auditor will assess whether the hospital is following its 340B policies and procedures to make sure the drug went to an eligible patient and does not involve a duplicate discount. Mark says the process can be very stressful but that it also provides an opportunity to reframe the audit to showcase the great work of your hospital.What hospitals should do if they receive audit findingsIf HRSA issues a finding, the hospital must draft and implement a corrective action plan. Mark recommends bringing in legal counsel and 340B consultants to review this document. After HRSA approves the CAP, the hospital will demonstrate to the agency that it is in place to ensure compliance going forward.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources:HRSA 340B Program Integrity Website

340B sits at an intersection where federal programs and state agencies come together. Maine, Minnesota, and Washington recently enacted new laws requiring hospitals to report 340B information to the states each year. What should health systems know about these new requirements? We speak with Danny Ackert, the director of state government relations at the Minnesota Hospital Association, to learn more about what these requirements look like in his state and what hospitals might expect in other states considering such reporting.What Minnesota's reporting law requiresDanny explains that Minnesota's new reporting law requires 10 aggregated categories of information that hospitals and other covered entities must submit starting this April. Individual hospitals' reports will not be made public, but an aggregated report due in November will be made available to the state legislature and the public.Adjusting to an unprecedented systemMinnesota's new 340B requirements mandate an entirely new reporting system that the 340B program has not been trained to. These new requirements will affect 340B operations for small and large hospitals alike. Advocacy advice for hospitals in other statesDanny urges covered entities in other states that might be considering reporting to be speaking up on 340B now. He says talking about 340B can seem complicated because it involves pharmacy benefits, discounts and acquisitions, costs, savings, and more, but it is important for legislators to be educated on how it works.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.ResourcesSenate 340B Bipartisan Working Group Discussion DraftStatement on Senate 340B Bipartisan Working Group Discussion DraftSenators Developing 340B Bill Seek More Feedback on Contract Pharmacy, Patient Definition, Child Sites

We are returning to a popular episode format we aired early last year, when we consulted with 340B Health's expert staff to answer your most pertinent 340B questions. As we start another busy year for 340B, we help you prepare for the action by answering your questions about the Genesis court decision, 340B activity in state legislatures, Medicare Part B repayments, and more. Patient Definition After the Genesis Decision One listener wonders how the recent Genesis court decision might affect 340B patient definition issues. We discuss the implications, the status of HRSA's 1996 patient definition guidelines, and expectations for covered entities in the wake of this decision. Federal and State 340B ActionIn response to listeners' question, we discuss how 340B might come up on Capitol Hill and in state legislatures this year. After a busy first half of the 118th Congress for 340B, we discuss how the election year may influence issues on Capitol Hill and how lawmakers in numerous statehouses are already considering changes to 340B in their states. Timing of Repayments for Medicare CutsListeners inquire about upcoming Medicare Part B repayments, an increase in manufacturer overcharges for 340B drugs, last year's HRSA 340B audit findings, and the expected effects of the government's Medicare drug price-setting program under the Inflation Reduction Act. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.ResourcesHRSA Stresses Federal Court Decision on Patient Definition Only Applies to Genesis FQHC Implications of Genesis Decision on 340B Patient Definition WebinarState Policy and Advocacy Resource Center Analysis of the Medicare 340B Pay Cut RemedyHRSA Program Integrity WebsiteInflation Reduction Act: Assessing Financial and Operational Challenges Webinar 

Episode Description:The 340B drug pricing program can produce significant savings that hospitals can invest in more equitable care for underserved patients. What are some of the best ways for hospitals to use their savings in the pursuit of greater health equity? We sit down with Danielle McPherson, the executive director of managed care contracting and operations with Mercy Health, to discuss how one Mercy hospital uses 340B savings to close health care gaps in the St. Louis area. Danielle provides practical advice for how other hospitals can take their own integrated, collaborative, and formalized approaches to 340B and health equity.Investing in preventive and primary careMercy Hospital St. Louis invests significant 340B funding into primary and preventive care for patients who face barriers to accessing that care. These include maternal and child care for underserved patients, a clinic partnership in one of the lowest-income areas in the North City of St. Louis, and a mobile mammography van for patients who lack transportation. Improving substance use disorder and behavioral health treatmentMercy Hospital St. Louis found that significant portions of their patient population suffer from behavioral health problems and substance use disorders regardless of their insurance status. In response, the hospital invested more than a million dollars into an emergency department-based screening and therapy initiative and a health network partnership to support patients with the most complex needs.Helping patients with their drug costsMercy Hospital St. Louis found too many patients face health inequities because of the high costs of prescription drugs to treat their chronic diseases. The hospital uses millions in 340B savings to offset drug costs through infusion centers and specialty pharmacies as well as through a partnership with Dispensary of Hope to provide free drugs to patients.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.ResourcesReport: 340B Hospitals Advancing Health EquityTakeda Becomes 29th Drugmaker To Impose Restrictions on Use of Contract PharmaciesHouse Approves 340B Medicaid Spread Reporting RequirementHRSA Manufacturer Notices to Covered Entities

The past several months have seen several major developments in the world of 340B drug pricing. 340B Health President and CEO Maureen Testoni returns to the show to break down some of the most important recent 340B stories.Landmark Federal Court Ruling on Patient DefinitionIn November, a federal court in South Carolina ruled against the Health Resources & Services Administration for an unpublished interpretation of 340B patient definition guidelines the agency had been using in audits of covered entities. Maureen explains the implications of this ruling, which could extend far beyond the long-running dispute between HRSA and community health center Genesis Healthcare.HRSA Notice Officially Limits Use of 340B in New Hospital ClinicsHRSA also released a new notice in October clarifying that new hospital clinics cannot use 340B until they appear on a filed Medicare cost report and are registered – a process that could take up to nearly two years. Maureen describes a transition period for certain hospitals to come into compliance with the policy, continued advocacy for changes to the restrictions, and a new hospital lawsuit over the issue.Repayments Coming for 340B Medicare Payment CutsHospitals affected by unlawful Medicare payment cuts from 2018-2022 are set to receive direct lump-sum payments by early 2024 under a final rule the Centers for Medicare & Medicaid Services issued in November. Maureen goes over the repayments and discusses lingering concerns about how CMS is implementing the plan.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org. Resources Federal Court Issues Decision Against HRSA Limitation on “Patient” HRSA Facing Hospital Lawsuit Over Child Site Eligibility Policy Read 340B Health's Analysis of the Medicare 340B Pay Cut Remedy West Virginia Journal: A Health Care Policy We Can All Support Zanesville Times Recorder: Drug Pricing Program Is Critical for Patient Care Los Angeles Sentinel: Black Pharmacists Stand as Advocates in Support of 340B Access to Care The Washington Informer: Holy Cross Health, Maryland, Laser-Focused on Achieving Health Equity Through 340B Drug Discounts

In July, Karen Bowling became the new chair of the 340B Health Board of Directors. The West Virginia native is the president and CEO of Princeton Community Hospital and executive vice president of government affairs for West Virginia University Health System (WVU Medicine). In this episode, Bowling discusses her clinical and leadership experience, her 340B advocacy and communications work, and her advice for getting hospital and health system leaders engaged on 340B. Connecting 340B to PatientsBowling has spent decades working in health care since starting her career as an emergency department nurse in a small rural hospital in West Virginia's Wyoming County. Now that she is a regional and national 340B leader, she has a keen understanding of how 340B connects to the patient care mission. She explains how to use that knowledge to engage with the C-suite on these issues.Promoting 340B Advocacy EffortsAs a government relations professional, Bowling knows how crucial it is to advocate for 340B with state and federal lawmakers. She describes how to make and maintain connections with policymakers who play a major role in determining 340B's future.Telling the 340B StoryBowling urges hospitals to communicate about how they use 340B to help patients in need, including through opinion pieces, media briefings, and community events. She recently wrote an op-ed for West Virginia's The State Journal on the benefits of 340B and the harm caused by attempts to limit these benefits.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources Federal Court Rules HRSA Is Unlawfully Restricting Patients Who Qualify for 340B Read Our Full Analysis of the Medicare 340B Pay Cut Remedy HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period West Virginia State Journal: A Health Care Policy We Can All Support

This week we are joined by Amanda Sellers Smith, legal counsel for 340B Health. Amanda tracks and responds to 340B state legislative and regulatory actions. She discusses recent developments in state-based legislation, including 340B reporting requirements, nondiscrimination prohibitions, and bans on drugmaker restrictions. She also looks ahead to what hospitals and their government relations departments can expect in 2024. Before the interview, we give an update on a set of unprecedented changes to a major drugmaker's restrictive contact pharmacy policy, and we share the news that four of the five drugmakers that HRSA audited last fiscal year for 340B compliance received findings for overcharging covered entities. 340B Nondiscrimination LawsAmanda shares with us the importance of protecting 340B from discriminatory practices by pharmacy benefit managers (PBMs) and other payers when it comes to reimbursing providers for 340B drugs. More than half of the states have enacted such laws, including California, whose law will affect many providers and patients. Protecting Access to Contract Pharmacies Amanda discusses two states that have implemented laws against drugmaker restrictions on drugs dispensed at community and specialty pharmacies. Arkansas enacted its law in 2021 and Louisiana did so earlier this year, leading some drugmakers to suspend their restrictive policies in both states. However, the pharmaceutical industry is challenging these laws in federal courts, where the legal process can take years to play out. Hospital Reporting and Looking Ahead to 2024Amanda explains an increased interest in 340B hospital reporting requirements, with states such as Maine and Minnesota enacting new laws and Connecticut, Indiana, and Virginia considering legislation. As hospitals and their government relations team prepare for the 2024 session, she explains how 340B Health is monitoring legislation and supporting our members in their advocacy efforts. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources 340B Health Analyzes Potential Implications of Unprecedented Provisions in BMS Contract Pharmacy Policy Update HRSA Issues Findings for a Fourth Drugmaker Audit in FY 2023

Centralized distribution models can help health systems streamline day-to-day operations, including mitigating drug shortages, and maximizing contract compliance and efficiency. Jake Olson, 340B pharmacy manager at Froedtert Memorial Lutheran Hospital in Milwaukee, Wisconsin, joins us to discuss how centralized distribution models have operationalized Froedtert's 340B program. Mitigating Drug ShortagesInventory optimizing helps ensure organizations meet their resource demands. Jake discusses minimizing repetitions within an organization's entities by centralizing supply ordering to a single location. For Froedtert, this means purchasing bulk drugs to one large warehouse and then redistributing among hospitals. Contract ComplianceFroedtert's 60,000 square foot drug distribution warehouse is centrally located in Milwaukee. There, Jake works alongside Froedtert's contract manager, a set up that simplifies in-person communication regarding the complex factors of compliance, negotiation, and management. The process boosts speed, efficiency, and clarity among the team. Patient CareJake and Froedtert consider centralized distribution models essential for improving patient care. While Jake's model may not suit every health system, he believes organizations can adapt distribution methods to their unique needs, simplifying vendor, client, and inventory management for better efficiency and improved patient care. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340BHealth.org.

Several key developments in 340B-related legislation and regulation have occurred in recent weeks, and more are expected this fall. In this episode, Maureen Testoni returns to the show to give her updates on where 340B stands in Congress, in state legislatures, and with the administration.State LegislationTestoni notes how states such as Arkansas and Louisiana are leading the way on expanding protections for 340B, leading to changes in drugmaker behavior and lawsuits in federal courts.Federal LegislationThe House and Senate have been considering legislative language that would negatively impact. 340B. Testoni notes how lawmakers have backed away from some of the more harmful provisions but that advocates are remaining vigilant.Federal RegulationTestoni outlines a plan from the administration to pay back 340B hospitals for unlawful Medicare payment cuts. Advocates have submitted comments in favor of the repayment plan but in opposition to a related proposal to claw back other Medicare hospital funds.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org. 

340B compliance is essential to the integrity and success of the program, and data management across hospital departments is an essential element of compliance. By implementing data crosswalks, 340B hospitals can achieve greater program compliance and optimization. Anja Wilkinson, 340B program manager at St. Francis Health System in Tulsa, Okla., joins us to speak about best practices for 340B crosswalks and how interdepartmental coordination is key to maximizing the benefits of 340B.Before the interview, we give an update on the projected effects on the 340B program of the first 10 Medicare Part D drugs subject to caps starting in 2026 under the Inflation Reduction Act and the negative effects of the Stop Drug Shortages Act if it is passed into law as currently drafted. Types of CrosswalksAnja speaks to the different kinds of data crosswalks involving national drug codes, charge description masters, and electronic medical records, that are involved with mapping data from department to department. She stresses the importance of maintaining good contacts with hospital facilities management to stay aware of departmental changes. Interdepartmental SupportExperts on each of these crosswalks within hospitals must be able to rely on each other to further their understanding of each portion of the data. Anja talks about the significance of mapping data correctly for potential federal audits and expounds on the different players who should become involved in the process.340B Is Not Just PharmacyAnja speaks about the importance of ensuring that all hospital members understand how they should engage with the 340B program within their roles. She also gives advice on where hospitals can turn if they need help from outside sources on setting up crosswalks. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org. Resources Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 House Drug Shortage Bill Would Provide Windfall to Drugmakers While Harming 340B Hospitals 340B Coalition Winter 2024 Conference Call for Speakers

The Inflation Reduction Act (IRA) was enacted last year, and it includes a significant drug pricing component that will affect 340B savings on some of the drugs that cost the most for Medicare. In this episode, we are joined by Meetali Desai, director of pharmacy business services at UMass Memorial Medical Center, to discuss the impact of the IRA on 340B hospitals and health systems.Uncovering the Effects of the Inflation Reduction Act. The IRA will result in unique changes to 340B hospitals and health systems. Meetali discusses how the changes will roll out, how the drug pricing component might affect 340B savings, and how hospitals can prepare for the changes.Examining the Decrease in Medicare Reimbursements for 340B Hospitals. The IRA introduces a new maximum fair price (MFP) set by Medicare for select drugs. Meetali explains how this will create a smaller margin between the 340B price and the Medicare reimbursement amount, how that difference might affect a hospital's bottom line, and how administrators can project how that will affect their hospitals.Modeling the Impact of the IRA. How can organizations respond to the changes the IRA might bring? Meetali explains how hospitals can simulate the real-world effects of the IRA on their operations through modeling and how this can better place them to make informed decisions about how to navigate these effects.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.ResourcesMerck Relaxes Contract Pharmacy Restrictions in Two StatesHHS Issues First Findings for Drugmaker Audit in FY 2023

It's that time of year again when your 340B hospital must go through the annual 340B recertification process. 340B Health's vice president of pharmacy services Steven Miller joins us to discuss what 340B covered entities need to know about recertification and how to recertify without any errors. How the Recertification Process WorksSteve explains the step-by-step process for covered entities to confirm and validate the accuracy of their information and ensure they are still eligible for 340B. Eligibility Criteria for HospitalsSteve discusses the criteria covered entities must meet to qualify for recertification and how they can ensure their official information reflects that eligibility.Recertification Best Practices and ResourcesSteve shares his best practices for recertification, including common error hospitals must avoid, and explains how 340B Health can help member hospitals during this process.Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources 340B Health Responds to Senate Request for Information on 340B 340B Health RFI Response 340B Health Member Webinar Archive

Cindy Williams has critical advice for anyone wanting to start a career in 340B and pharmacy. Cindy is the vice president and chief pharmacy officer at Riverside Health System in Virginia. In this episode, she walks us through her 340B professional journey over the last three decades, from her initial dreams of having a career in health care to a leadership position that also involves managing a 340B program. She gives advice on building key relationships and driving impactful change in the industry. Before the interview, we provide updates on a newly proposed federal rule on repayments to 340B hospitals for past Medicare cuts.Starting a Career in Health Care Cindy shares valuable lessons for aspiring pharmacy professionals gleaned from decades of experience from her early interest in pharmacy during high school to her current role at Riverside. She advises how such professionals can invest in training and professional development to gain competency in 340B. Managing a 340B ProgramCindy shares best practices for how to manage a 340B program effectively by maximizing its value while maintaining compliance, and she stresses the importance of establishing key connections that are both internal and external. Advocating for 340B and Pharmacy Issues Cindy shares how she made time in her career for participation in advocacy, explains why this activity is critical, and gives practical steps for how 340B professionals can start contributing to such efforts. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Proposed Rule Statement on CMS Proposed Remedy for Unlawful 340B Medicare Payment Cuts

Specialty pharmacy trends have evolved significantly in recent years and even in the past few months. In this episode, Tim Paine, a specialty pharmacy expert who now heads up EPU Healthcare Consulting, dives into specialty pharmacy and its connection to the 340B program. Building off his decades of experience in pharmaceuticals and pharmacy, Tim discusses the high costs of specialty drugs, the crucial role of 340B discounts, and the challenges hospitals face navigating this ecosystem. Before the interview, we update listeners on the latest development in the ongoing 340B contract pharmacy issue.Challenges for Hospitals in Managing Specialty Drug CostsManaging costs in a hospital setting, particularly specialty drug costs, is challenging. Tim shares how hospital administrators can address various factors to keep costs in check and ensure smooth operation.Role of 340B Discounts in the Specialty Drug MarketTim highlights the value of the 340B discounts and how they can support hospitals while also highlighting how limited distribution drug networks and the influence of PBMs can further complicate cost management.Continued Growth of BiosimilarsTim discusses the biosimilar market, where it stands in the specialty pharmacy landscape, and how we can expect it to grow in the coming years. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources Astellas is Company No. 24 to Impose Contract Pharmacy Restrictions 340B Health Contract Pharmacy Resources

An increase in drug companies restricting 340B discounts and Capitol Hill action on 340B legislation are among several key recent developments that 340B professionals need to be aware of. In this episode, Maureen Testoni, president and CEO of 340B Health, discusses this activity and what it means for the 340B community.Drug Company Restrictions on Contract PharmaciesMaureen shares her concerns about the increasing restrictions, their effects on hospital access to 340B discounts, and expected court decisions regarding manufacturers setting these limits.340B Legislation in Congress and the StatesMaureen provides insights into some critical legislation that affects 340B providers, including federal and state legislation to require data reporting from 340B hospitals.HRSA Policy ChangesThe end of the COVID-19 public health emergency created uncertainty about the Health Resources & Services Administration (HRSA) policy on the use of 340B in new hospital child sites. Maureen explains how hospitals are seeking clarity on the issue and how they should proceed in the meantime. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.

340B hospitals must navigate the challenging world of pharmacy supply chain management, in which they must balance budget constraints while providing high-quality care to all their patients. In this episode, we explore best practices for how hospitals can manage the 340B pharmacy supply chain. Our guest is Ashley Covert, system director of pharmacy supply chain and contracting at Dartmouth Health. Before the interview, we give an update on two problematic bills approved by the House Energy and Commerce Committee that would have adverse effects on 340B hospitals if they were to become law.Pharmacy Supply Chain's Growing ProminenceThe pandemic spotlighted supply chain management and its influence on health care delivery and patient care. Ashley emphasizes how hospital pharmacy leaders can ensure the efficient management of their supply chains and the timely provision of patient care by staying informed and actively engaged with industry developments.Hospital Access to MedicationsSupply chain challenges often are exacerbated by factors such as global manufacturing problems and staffing shortages. Ashley gives strategies that leaders can adopt to overcome these obstacles and ensure patients have access to medication.Leveraging Data and AnalyticsAshley explains how pharmacy leaders can optimize their budgets and prepare for potential disruptions more effectively by adopting a data-driven approach to managing the pharmacy supply chain. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.ResourcesJoint Statement from National Hospital and Pharmacist Associations on Harmful House 340B LegislationHouse Committee Approves Problematic 340B Reporting Legislation340B Coalition Summer Conference Registration

Several of the drug companies restricting 340B discounts on drugs dispensed at contract pharmacies have created policies that say they will restore the 340B prices if covered entities submit patient claims data. In this episode, we dive deeper into these claims submission conditions with Jesse Breidenbach, vice president of pharmacy at Sanford Health and a member of the 340B Health Board of Directors. Jesse shares best practices for navigating the challenges when drug manufacturers demand claims data.Before the interview, we give an update on a drug company placing additional restrictions on its 340B pricing and recap a recent 340B advocacy event on Capitol Hill.The Impact of Drug Company RestrictionsThe restriction of 340B discounts has had a substantial financial impact on Sanford Health. Jesse shares how these restrictions have made it more difficult for Sanford to obtain 340B savings and use them to provide care to its patients.Making the Decision to Submit Claims DataResponding to companies whose policies require submitting patient claims data requires critical decision-making by hospitals. Jesse explains what is involved in submitting the data, how to decide if submitting is a viable option, and what steps hospital 340B teams need to take to prepare their data submissions.What Happens After Claims Are Submitted?Jesse explains how quickly discounts might be restored after submitting the claims, how consistently drug companies are keeping the 340B pricing in place, and the challenges hospitals face when dealing with discrepancies between claims. Resources 340B Health Contract Pharmacy Infographic Bayer Is Latest Company to Tighten 340B Restrictions 340B Health Hill Day Features Advocacy for Introducing Contract Pharmacy Bill 340B Coalition Summer Conference 2023 Registration

A recent report from 340B Health includes data on how drug company restrictions on 340B hospital partnerships with community and specialty contract pharmacies have taken a toll on the health care safety net and the patients who rely on it. On this episode, we speak with the report's author, 340B Health Vice President of Research and Policy Analytics Caroline Steinberg, to walk through the findings and discuss what they mean for 340B hospitals and their patients. Before the interview, we provide a news update on a federal appeals court case regarding a 340B non-discrimination law in Arkansas.  The Data Behind the ReportCaroline discusses the primary data sources for the report, including data from the federal government and survey results from 340B Health members. Tip of the Iceberg The report breaks down the amount of savings stripped from the health care safety net in 2021 from the five companies restricting 340B discounts for all of that year. Caroline uses this information to project the billions of dollars in annual lost 340B savings from the contract pharmacy restrictions. She also describes the patterns she found in the types of drugs that drugmakers are restricting. The Toll on Patient Care340B hospital survey data in the report uncovers how lost 340B savings from drug company restrictions affects patients' access to services and their ability to obtain discounts on medications through contract pharmacies. Caroline discusses results from the survey that shed light on how drug company demands for patient claims data are diverting resources from patient care. She also shares individual stories from the report of harm to patient care. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.Resources  340B Health, AHA, Arkansas Hospital Association Urge Federal Appeals Court to Uphold State Law Protecting 340B Community Pharmacies 340B Health Spring 2023 Report on Contract Pharmacy Restrictions  340B Health Spring 2023 Contract Pharmacy Report Infographic  340B Coalition Summer Conference 2023 Registration  

340B contributes vital resources toward the pursuit of health equity for historically underserved communities. As we recognize National Minority Health Month, we speak with Fatimah Muhammad, director of 340B pharmaceutical services and drug replacement at Saint Peter's University Hospital in New Brunswick, N.J. Fatimah discusses how her hospital uses 340B to address maternal health disparities, including support for a birth center to improve maternal health outcomes. Before the interview, we provide news updates on new 340B legislation in Congress and changes to drug company contract pharmacy policies. Causes of Maternal Health Disparities Fatimah shares data demonstrating disparities in maternal health outcomes and discusses the role that social determinants of health play in health disparities. The Saint Peter's Approach to Maternal HealthSaint Peter's University Hospital created a birth center that has adopted a midwifery model of care. Fatimah discusses how the birth center incorporates doulas into patient care and how it approaches high-risk pregnancies. She also notes that the birth center cares for all patients no matter their health insurance status.340B's Role in Maternal Health Saint Peter's has used its 340B savings to provide maternal health services and expand its family health center. The hospital's plans for continuing to support maternal health include creating a food pantry for mothers and families who are experiencing food insecurity.  Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.Resources  340B Health Statement on the Protect 340B Act to Ban Discriminatory Payment Policies  Novartis Is Latest in String Of Companies Tightening 340B Restrictions  340B Health Contract Pharmacy Dispute Resources for Members  National Minority Health Month 

340B helps health systems and hospitals stretch their resources and provide more services to patients in need. This makes 340B important to a hospital or health system leadership team's ability to plan how it will deliver care. In this episode, we speak with Matthew Perry, president and CEO of Genesis Healthcare System in Zanesville, Ohio. Matt shares his perspective about 340B and how 340B professionals can best engage with their hospital CEO. Prior to the interview, we share findings from a new 340B Health report about the effects of drug company 340B contract pharmacy restrictions on patient care. Economic ChallengesMany hospital CEOs face economic challenges in their organization. Matt shares the value that 340B leaders provide to help hospitals have the resources they need to meet their patient care mission. How to Engage Hospital CEOs in 340B Operations and Advocacy Matt provides best practices for how 340B professionals can best educate the CEO about 340B to help the CEO strategize how to use 340B savings to grow and sustain services for patients in need. He also discusses why 340B hospital CEOs should become engaged in program advocacy. Connecting 340B Professionals to the C-suite Matt describes how he and his leadership team support 340B program leadership and established an organizational structure for communication with the health system's 340B program leader. He also shares advice for 340B professionals who are interested in a health system C-suite career path. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.Resources  340B Health March 2023 Report on Drug Company 340B Contract Pharmacy Restrictions  Joint Statement from National Hospital and Pharmacist Associations on PhRMA-led Proposal to Restrict 340B Eligibility Matt Perry Op-ed about 340B Providing Stability for Hospitals Amid the COVID-19 Pandemic 

340B compliance is a critical requirement for hospitals participating in the program, and one of the ways 340B hospitals maintain compliance is through conducting internal audits. For this episode, we speak with Tristan Greer, 340B program business manager at Catholic Health in Buffalo, N.Y. Tristan has significant experience conducting 340B internal audits at the health system, and she shares several best practices for a successful internal audit. Before the interview, we provide a news update on how drug manufacturers are pursuing legislative changes to 340B and some of the responses to that proposal. The Benefits of Internal Audits Internal audits help 340B covered entities stay in compliance. Tristan outlines the internal audit process her health system uses and how this supports the overall compliance effort. She also explains how the internal audit process has changed over time. What HRSA Expects from Internal AuditsTristan discusses what HRSA expects hospitals to share about their 340B internal audits. Staying Organized During Internal Audits Tristan shares her approach to accomplishing a successful internal audit, including which materials her hospital gathers for the process. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you'd like us to cover in this podcast, email us at podcast@340bhealth.org.Resources  340B Health Statement on PhRMA Proposal to Reduce Safety-Net Hospital Participation in 340B Rep. Doris Matsui Statement on Proposal to Change 340B Program  PhRMA Unveils More Details About Proposed 340B Hospital Eligibility Cuts  340B Coalition Winter Conference  

State policymakers have increased the attention they are paying to 340B. In this episode, we hear from 340B state advocacy expert Abby Reale. Abby is director of government and external affairs with Mountain Health Network in West Virginia. The state has been a leader in protecting 340B, and she shares how her health system worked with other hospitals and provider organizations to advocate for the first 340B non-discrimination law in the nation. Prior to the interview, we provide a news update about a drug company that is imposing the pharmaceutical industry's most restrictive limits on 340B pricing.  Why You Need to Pay Attention to State Health Policy  Abby discusses the power states have to regulate health care. Advocating for a 340B Non-Discrimination Law Abby details the steps her hospital and other provider organizations took to help state legislators understand the need to stop payer and pharmacy benefit manager (PBM) payment discrimination against 340B providers. She also explains the work advocates sometimes need to do to ensure laws are enforced. Joining 340B State Advocacy Efforts Abby shares how 340B professionals can join advocacy efforts in their states and how advocacy differs between the state and federal levels. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.Resources  Statement on New Johnson & Johnson Restrictions on 340B Access  Contract Pharmacy Dispute Resources for 340B Health Members 340B Coalition Winter Conference 

Health information technology (IT) is intertwined with 340B operations and compliance. So how can hospitals and health systems manage IT while keeping 340B in mind? To find out, we hear from Robert Owens, director of pharmacy enterprise shared services at Atrium Health. Bob is a pharmacy health IT expert, and he shares how the technology intersects with 340B. He also shares insights to ensure strong 340B operations and compliance when undergoing an electronic health records (EHR) system conversion. Before the interview, we provide an update on two more drug companies restricting 340B discounts.  IT's Intersection With 340B OperationsBob discusses the different types of IT systems providing data that are important for closely monitoring your 340B program, including electronic health records, automated dispensing cabinets, and IV workflow software. He emphasizes the importance of the 340B team members becoming experts on 340B data. EHR ConversionsBob explains how EHR system conversions affect 340B operations and compliance. He walks through the steps his team took before and during one of its conversions and points out the potential pitfalls to avoid.  Strategies for Managing NDCs An EHR conversion means 340B professionals need to be aware of potential NDC challenges that go along with it. Bob shares some questions 340B professionals should ask about charging and administration practices when planning for a change in EHR systems. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.Resources  List of Drugmaker 340B Restrictions Grows in Wake of Court Decision  340B Insight Episode 67: Maureen Testoni's Outlook for 340B in 2023 340B Coalition 2023 Winter Conference