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This week, we are joined by Coletta Barrett, vice president of mission at Our Lady of the Lake Regional Medical Center. Our Lady of the Lake (OLOL) is using its 340B savings to pursue health equity initiatives. Coletta shares best practices and provides inspiration for how 340B professionals can work toward eliminating health disparities in their hospitals and communities. Before the interview, we share updates on a new 340B Health survey report demonstrating the harm to hospitals and patients of drug company restrictions on discounts for drugs dispensed at community and specialty contract pharmacies.  How 340B Savings Help Hospitals Pursue Health Equity OLOL has used 340B savings to expand services to underserved areas in Baton Rouge, La. Coletta gives examples on how the health system is investing those resources into expanding access to care for the uninsured and underinsured.  Collecting Data to Address Health Disparities Coletta gives advice on how hospitals can collect, analyze, and apply data to address health disparities in their communities. She explains how such data enabled OLOL to determine that it needed to open another emergency room, bring social workers into certain departments, and establish more relationship-based care.  Partnering With Others to Address Social Determinants of Health OLOL recognized that food insecurity and lack of access to COVID vaccines were negatively affecting its community. Coletta explains how the health system partnered with established community-based organizations and trusted resources to reach underserved areas. 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.  Episode Resources: 340B Health Survey Report: Financial Losses from Drug Companies’ 340B Restrictions Have More Than Doubled Since the End of 2021 Joint Statement from Leading HIV/AIDS and Viral Hepatitis Advocates Regarding Manufacturer Action on the 340B Drug Pricing Program 340B Coalition Summer Conference 2022 

This week, we are joined by Laurie Chiumento, director of federal relations and healthcare policy at UR Medicine, the health system for the University of Rochester in New York. Laurie is an expert on how health systems and hospitals can advocate and promote their legislative priorities to members of Congress. She shares advice to hospitals that are preparing to speak with their elected officials about 340B issues or are considering doing so. She also discusses advocacy days in D.C., opportunities to host elected officials for visits to your hospital, and the 2022 midterm elections. Before the interview, we provide an update on the 340B community pharmacy dispute court cases.  Work with the Government Relations Team  Government relations teams advocate to federal, state, and local elected officials. Laurie explains how her team builds relationships with members of Congress on 340B and other issues of importance to her health system. She also emphasizes the important advocacy role 340B professionals have when partnering with their hospital’s government relations team.  Participate in 340B Health Hill Days  Laurie shares how participating in 340B Health Hill Days are crucial for effective advocacy and describes how to engage in these events. The relationships hospitals build during these events enable hospitals to have ongoing communications with their elected leaders. For example, one of her biggest success stories stems from the regular communication she has with the congressional staff working for her members of Congress.  Host Your Members of Congress at Your Hospital  One important advocacy strategy is to host members of Congress at your hospital. Laurie provides an overview of the process to hosting a lawmaker and why these visits are beneficial for advocacy.   Prepare for Midterm Elections This November elections will take place for the entire U.S. House of Representatives and a third of the U.S. Senate. It is likely that there will be many new leaders elected to Congress. Laurie discusses the importance of preparing to educate these new members about 340B. She also explains the role of political action committees (PACs) in advocacy.  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 Community Pharmacy Legal Battle Moves to Next Stage 340B Coalition Summer Conference 2022  340B Health Advocacy Toolkit 

This week, we are joined by Steven Miller, vice president of pharmacy services at 340B Health. April 1 was the third anniversary of the federal 340B ceiling price website’s launch. Steve discusses how this database has become an invaluable tool for 340B drug pricing transparency. Before the interview, our news update shares how HRSA escalated enforcement actions against one of the companies restricting 340B discounts. The update also notes the release of 340B Health’s 2021 annual survey report on how hospitals are using their savings.   How the Ceiling Price Website Operates The drug price database requires drug companies to submit pricing information to HRSA that is then used to calculate 340B ceiling prices for each eligible drug. This makes the website the source of truth. Steve explains who can access the website, the data elements that drug companies submit to HRSA, and the timeline for this process. He also shares the types of analysis that hospitals can do using the ceiling price information.  What to Do When Your Hospital Is Overcharged Steve recommends how often an authorized official or primary contact at a hospital should check the ceiling price website and what to do if they believe the hospital has been overcharged. Filing overcharge reports are critical to keeping drug companies accountable.  The Impact of the Ceiling Price Website  In its three years, the ceiling price website has increased 340B drug pricing transparency. Steve recaps the trends in recent years’ overcharge reports and HRSA audits of drug companies, estimates how much covered entities are overcharged, and shares examples of how the database has become essential for drug manufacturer accountability and the protection of covered entities’ 340B savings. 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  Boehringer Ingelheim Referred for Penalties for Continued Violations of Federal Law of 340B Pricing 340B Health Member Survey Report 2021   340B Transparency Efforts Uncovering More Drug Company Overcharges

This week, we are joined for the latest in our regular check-ins with 340B Health President and CEO Maureen Testoni. Maureen analyzes the top issues in 340B that occurred in the early months of 2022. These include updates on the 340B community pharmacy dispute and a new law that protects 340B eligibility for hospitals serving on the front lines of the COVID-19 pandemic.  Drug Company 340B Restriction Trends  There now are 16 companies restricting 340B discounts to safety-net hospitals on drugs dispensed at community pharmacies. Maureen shares updates and in-depth analysis on the three main trends she is seeing in these restrictive 340B policies.  How 340B Health and Hospitals are Working to Restore Discounts  Maureen summarizes the decisions courts have made on the community pharmacy dispute and what will happen next in the legal process. She explains how 340B Health is responding to all the developments and what 340B hospitals should do to help move this issue toward a resolution.   Protecting 340B Hospitals from Losing Eligibility President Biden recently signed into law legislation protecting 340B hospitals from losing eligibility for the program due to the COVID-19 pandemic. Maureen describes the changes in patient demographics some hospitals have seen during the public health emergency, the advocacy efforts that made the law possible, and the details hospitals need to know about the law’s implementation.    New HRSA Leadership  In the past few months, the Health Resources & Services Administration (HRSA), which oversees the 340B program, had two new leaders join its team. Maureen discusses what this change in leadership means for 340B.  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  Additional Resources on 340B Community Pharmacy Dispute  340B Health Template to Protest Drug Companies Patient Claims Data Demands  HRSA Attestation Form for Reinstatement into the 340B Drug Pricing Program  Upcoming 340B Health Webinars 

This week, we are joined by Paul Mollo, national director of medication outcomes disparity at Ascension. Paul discusses what skills and professional backgrounds hospitals consider when building a team to operate their 340B programs and ensure compliance. He also shares overall 340B staffing trends. Before the interview, our news update covers the appointment of a new HRSA Office of Pharmacy Affairs director.  340B Team Structure  Paul explains how Ascension’s 340B team is structured at the national, regional, and local levels, as well as staffing models at other 340B hospitals. Under his leadership, Ascension has created a method for determining when the 340B team is sufficiently staffed.  The Skills 340B Professionals Need  Paul discusses the importance of hiring 340B professionals who are mission-oriented and come from a variety of career and educational backgrounds. He emphasizes the importance of building a 340B team where individuals complement each other’s strengths.  The Future of 340B Staffing  340B teams have changed since the start of the program. Paul shares how 340B teams have evolved to incorporate technology, and he analyzes what the next big trend in 340B staffing will be. 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 New Director of HRSA Office of Pharmacy Affairs 340B Health Letter to HHS Leadership on March 1 Regarding Contract Pharmacy Claims Data Submission Concerns  340B Health Letter to AbbVie CEO Regarding Contract Pharmacy Restrictions  340B Health Letter to Bristol Myers Squibb CEO Regarding Contract Pharmacy Restrictions 

This week, we are joined by Emily Cook, partner at McDermott Will & Emery LLP. At the 340B Coalition Winter Conference, Emily spoke on a new panel about the importance of 340B professionals understanding compliance issues related to 340B that are not covered by the 340B statute. We hear from her about that session, including the process for preparing for government inquiries and the need for hospitals to self-disclose government overpayments. Before the interview, we provide updates on multiple developments in the 340B contract pharmacy dispute. Working with the Legal and Compliance Department  Emily explains the expertise that legal counsel brings to meeting compliance required tied to the 340B statute. She also discusses what expertise is needed to form the ideal compliance team.    Legal and Compliance Issues Related to 340B  Emily discusses the types of compliance obligations that are not covered by the 340B statute, including issues associated with Medicaid and Medicare billing requirements.   Trends in 340B Compliance States are becoming more interested in 340B drug payments, including at least one state that is requiring self-audits from 340B hospitals. Emily speaks about the increased focus on overpayments of federal and state funds, how 340B hospitals should prepare for inquiries, and how these inquiries are different from HRSA audit requests.  The Inquiry and Self-Disclosure Process  Emily shares her insights on what a 340B professional should do if they receive an inquiry notice, what the process of resolving an inquiry or a self-disclosure entails, and the potential penalties for noncompliance.   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 Disputes Court Decision on 340B Contract Pharmacies in Favor of AstraZeneca GlaxoSmithKline Contract Pharmacy Conditions Follow Familiar Playbook 

This week, we are joined by Lauren Aronson, executive director for the Campaign for Sustainable Drug Pricing (CSRxP). CSRxP is a coalition of health care leaders, including providers, hospitals, patients, and health plans, that monitors drug pricing developments and promotes bipartisan solutions to lower U.S. drug prices. Lauren discusses recent alarming drug pricing trends, the role 340B plays in the drug pricing debate, and expectations for drug pricing legislation in 2022. Before the interview, we give an update on the 340B contract pharmacy dispute.  Trends in Drug Pricing CSRxP was formed in response to a hepatitis C drug that hit the market at an exorbitant price. Lauren shares how high drug prices affect all aspects of health care, notes the drugmakers that already have raised their prices in 2022, and outlines CSRxP’s key principles for addressing drug pricing problems.  340B’s Impact on Drug Pricing Lauren explains how 340B provides critical value to the nation because it enables hospitals, providers, and patients to access drugs at affordable prices. She comments on CSRxP’s concerns about drug companies attempting to defend their restrictions on 340B pricing in federal courts.  Steps to Lower Drug Prices  Drug pricing is one issue on which there is consistent bipartisan agreement. Lauren explains the need for coordination among federal government regulatory agencies to confront drug pricing issues. She also recaps what Congress has done in recent years to address drug prices and where drug pricing legislation might lead in 2022. 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  Pfizer Contract Pharmacy Restrictions Target Xeljanz, Oncology Drugs In Limited Distribution Network  CSRxP: Big Pharma’s Business-As-Usual Approach to January Price Hikes Underscores Urgency For Rx Solutions  CMS Proposes Narrowly Covering Controversial Alzheimer's Drug Aduhelm for Patients In Clinical Trials U.S. House of Representatives Oversight Committee Drug Pricing Investigation 

This week, we are joined by Leslie Pires, director of specialty pharmacy and 340B for Care New England Health System in Rhode Island. Leslie successfully helped start Care New England’s first specialty pharmacy. She shares what 340B hospitals need to know about opening a specialty pharmacy, how to gain accreditation, and how to remain compliant with 340B. Before the interview, we update our listeners on a 12th drug company that has imposed restrictions on 340B pricing for drugs dispensed at community pharmacies as well as a new bipartisan letter from Congress to HHS about the increasing number of drug companies restricting program discounts.  How to Build a Specialty Pharmacy 340B hospital-owned specialty pharmacies are becoming more common. Leslie explains the planning process for opening a specialty pharmacy and what to expect once it is open. She shares how Care New England built its specialty pharmacy in less than a year. She also provides insights on the challenges hospitals face, especially when it comes to payer and drug access.   The Intersection Between Specialty Pharmacy and 340B There are elements to operating specialty pharmacies that create unique challenges to remain 340B-compliant such as access to limited distribution drugs. Leslie explains how Care New England has used technology to help with compliance and how they used 340B savings to provide a patient with access to lifesaving drugs. The Importance of the Accreditation Process Leslie explains why it’s critical for hospital-owned specialty pharmacies to be accredited, what is needed for the accreditation process, and which organizations can accredit specialty pharmacies.  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  Statement on Bristol Myers Squibb Restricting 340B Discounts Through Community-Based Pharmacies  Bipartisan Congressional Letter to the Department of Health and Human Services Regarding the 340B Community Pharmacy Dispute

This week, we are joined by Dr. Ellen Eaton, an assistant professor and infectious disease specialist at the University of Alabama at Birmingham. Dr. Eaton works at UAB Medicine’s 1917 Clinic, a Ryan White HIV/AIDS clinic that relies on 340B savings to treat its patients. She discusses how the health system’s clinic has partnered with local community housing organizations to provide temporary housing support to patients with unstable housing to improve their medication adherence and overall health outcomes. Before the interview, we bring our listeners up to speed on a big update in the 340B community pharmacy dispute that occurred right at the end of 2021.  Addressing Social Determinants of Health Social determinants of health such as housing insecurity are a significant barrier to patients with HIV adhering to their medication schedules and in turn decreasing their viral loads. Dr. Eaton explains how the 1917 clinic connects patients with temporary housing resources and essential items, and she discusses the expansion of the program to include job and financial skills training to ensure patients can obtain housing for themselves in the future.  340B Savings Create a Robust Safety Net  340B savings have been critical to the operation of 1917 Clinic’s temporary housing initiative. Dr. Eaton discusses how the clinic reached out to HRSA for guidance when developing the program to ensure 340B compliance. She also shares data from the program on improved patient health outcomes and the story of one patient whose life has been changed by participating in the temporary housing initiative.  Ending the HIV/AIDs Epidemic There are many similarities between the HIV epidemic and others such as the hepatitis C epidemic. Innovative solutions focusing on social determinants of health, such as telehealth and the provision of taxi vouchers to attend medical appointments, enable patients to have greater access to care and lower disease transmission.   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  More Court Battles Ahead for 340B in 2022 A Hospital Community United Against Threats to 340B CDC: HIV Prevention in the United States: Mobilizing to End the Epidemic 

This week, we are joined again by 340B Health President and CEO Maureen Testoni. Maureen discusses and analyzes major developments for the 340B program that occurred this fall. These include updates on the community pharmacy dispute, legislation on drug pricing, and the U.S. Supreme Court hearing arguments on Medicare pay cuts to 340B hospitals.  Court Decisions in the 340B Community Pharmacy Dispute   More drug companies in recent months have announced plans to restrict 340B pricing on drugs dispensed at community pharmacies. Maureen discusses that development, recaps multiple court decisions affecting the dispute, and describes how 340B Health and the administration are responding to the new developments.  How Hospitals Can Be Heard Maureen discusses immediate advocacy actions 340B hospitals should take to ensure their voices are heard and to help the government escalate its enforcement.  The Latest on Capitol Hill   Congress is considering drug pricing legislation that could impact 340B savings. Maureen also gives updates on legislation to protect 340B eligibility during the COVID-19 public health emergency.   340B on the U.S. Supreme Court Docket   Maureen provides her analysis of oral arguments before the U.S. Supreme Court in a case to determine whether Medicare officials have the authority to impose Medicare cuts on 340B hospitals.  This is our final episode of 2021. 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  340B Hospital Sign-On Letter to the Department of Health & Human Services Statement on Amgen Restricting 340B Discounts Through Community-Based Pharmacies  Under Pressure, Clovis Oncology Backs Off 340B Rebate Model Supreme Court Case Oral Argument on Medicare Cuts to 340B Hospitals 340B Coalition Winter Conference 2022 

November is American Diabetes Month. To explore how 340B supports care for patients living with diabetes, we speak with Salem Health’s Riley Protz, pharmacy inventory and 340B program manager, and AJ Sowles, manager of ambulatory care clinical pharmacy services. Riley and AJ discuss Salem Health’s use of 340B savings to create a medication management clinic that is helping improve the health outcomes of patients living with diabetes. Before the interview, we share exciting news about 340B Insight, recap several recent federal court decisions in the 340B community pharmacy dispute, and provide an update on Medicare payment cuts to 340B hospitals in 2022.  The Challenges in Diabetes Patient Care Management Salem Health is in the Willamette Valley region of Oregon and serves a community with a higher prevalence of diabetes patients in comparison to the rest of the state. Riley and AJ discuss how treatments have become more complex and how COVID-19 has caused people to delay care needed to manage their conditions.  340B Savings Support Diabetes Care   To meet these challenges, Salem Health is using its 340B savings to operate a medication management clinic that supports diabetes care management. Riley and AJ discuss how the clinic was launched during the pandemic, how the teams collaborate with each other, and how health providers refer patients to the clinic. AJ also shares data demonstrating that the clinic has improved patient health outcomes.  Challenges Creating the Clinic  Riley notes that the eight drug companies denying 340B discounts to Salem Health and other safety-net providers on drugs dispensed at community pharmacies have made it more challenging to launch, operate, and expand the clinic’s services. This is in large part because many of the drugs affected by the drug company restrictions are diabetes medications.  The Future of the Medication Management Clinic Riley and AJ explain how 340B savings in the future will help them expand care and support to more patients, including through discounts on diabetes drugs and other medications to patients in need who cannot afford them.  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 Insight’s Excellence in Communication Award  Conflicting Court Decisions Prolong Dispute Over 340B Contract Pharmacies Statement on Medicare Payment Cuts to 340B Hospitals in 2022 Report: Meeting Varied Community Needs with 340B Savings 

Nov. 4, 2021, is the 29th anniversary of the 340B drug pricing program. To celebrate how 340B has benefited patients, we are joined by Jennifer Gallagher, lead pharmacy technician at Parkview Medical Center in Pueblo, Colo. Jennifer is not only a provider, she also is a patient whose health care journey has repeatedly intersected with the 340B program. She shares her story of how the 340B program has provided her access to the care she has needed to manage multiple health challenges. Before the interview, we answer a listener's question about HRSA audits of drug companies participating in 340B. From Pharmacy Technician to 340B Patient As a pharmacy technician, Jennifer was familiar with the 340B program, but she came to understand its benefits more fully when she became a patient at Parkview. Jennifer discusses the major medical events she has experienced.  How 340B Supports Comprehensive Care Throughout her health care journey, Jennifer witnessed how the 340B program helped Parkview offer comprehensive care to her and the community. She shares how 340B savings enabled Parkview to open an outpatient pharmacy and a cardiac rehab program that assisted her in receiving proper medication and care management. That support for her recovery enabled her to return to working full time. She also provides an update on how her health is today. Becoming a 340B Advocate Jennifer’s health care experiences and 340B’s important role in her care have influenced her approach as a pharmacy technician. She explains how these experiences prompted her to become an advocate and share her story with policymakers in Washington. 340B’s Importance to Pueblo  Pueblo is a rural community, with most of Parkview’s patients covered by Medicaid or Medicare. Without Parkview providing the services that 340B helps fund, patients often would have to travel long distances for their care. Jennifer believes that without the services she received at Parkview, she would have struggled to return to work full time and contribute to her community.  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  Jennifer Gallagher Faces of 340B Video Profile  340B Health’s Faces of 340B Series  HRSA FY21 Manufacturer Audit Results 340B Coalition 2022 Winter Conference 

This week, we are joined again by Scott Milner, senior director of pharmacy, business development, purchasing, 340B, and infusion services at St. Luke’s Health System in Idaho. We had spoken with Scott in January about the initial distribution of COVID-19 vaccines, and we reconnected with him to hear about how St. Luke’s has responded to a recent surge in COVID cases from the Delta variant and its effect on 340B program management. Redeploying Care for COVID-19 Patients It’s been more than 18 months since the COVID-19 pandemic began, and Scott discusses the new treatments providers have advanced and how St. Luke’s is working to accommodate the surge in patients by adding more resources and redeploying teams. This includes setting up monoclonal antibody clinics for COVID patients. He also explains how the Delta variant affects the ability to manage care for patients with chronic conditions. Responding to the 340B Community Pharmacy Dispute  The need to redeploy teams has included St. Luke’s reassigning members of its 340B team to assist in the COVID-19 response. As a result, Scott describes how some drug company denials of 340B discounts on drugs dispensed at community pharmacies has been harder for St. Luke’s to overcome. He also explains the health system’s efforts to continue partnerships with independently owned community pharmacies despite the drug companies’ actions.  Reaching More Patients with COVID-19 Vaccines  To distribute the COVID-19 vaccine effectively, St. Luke's developed strategies to make the vaccines more accessible for historically underserved communities. Scott shares how St. Luke’s has been delivering vaccines through mobile clinics and shares examples about how he’s responded to concerns about COVID-19 vaccines. 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 Insight Episode 19: 340B Hospitals Are COVID Vaccine Leaders (January 2021)

This week, we are joined by Amanda Nagrotsky, 340B Health’s legal counsel. Child sites are a key component of how hospitals reach more patients and provide more health care services. Amanda discusses what hospitals need to know about registering child sites, including eligibility requirements, registration timelines, required documents, and what resources are available to help them navigate the process.Before the interview, we give an update on HRSA taking an enforcement action against another drug company who has refused to provide 340B discounts when drugs are dispensed at community pharmacies.   Eligibility Requirements for 340B Child Sites. Amanda describes lists the eligibility requirements for a hospital’s offsite facility to participate in 340B and explains why the Health Resources & Services Administration (HRSA) requires the registration of child site facilities for 340B compliance. The types of offsite facilities that need to register has changed over the years. The Timeline for Child Site Registration. Historically, it often has taken a long time to complete child site registration. Amanda describes the timeline and how recent policy clarifications have enabled child sites to become eligible for 340B much faster.  How Hospitals Can Prepare for Registration. Amanda discusses some of the challenges 340B hospitals face registering child sites, shares which documents hospitals must prepare, and what the penalties are for making mistakes during the registration process. 340B Health also has several resources for hospitals to use as they prepare for registration.  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 October 4, 2021 Letter to Boehringer Ingeleheim  HHS Takes Vital Next Step Toward Ending 340B Pricing Denials 340B Insight Episode 35 with Maureen Testoni 340B Health Policy Guides  

This week, we are joined by Maureen Testoni, 340B Health’s president and CEO. The Health Resources & Services Administration (HRSA) made a major announcement recently regarding drug companies that are denying 340B discounts on drugs dispensed at community pharmacies. Maureen analyzes the news and discusses what comes next on this issue. She also catches us up on several other important 340B developments from during the summer.  HRSA Refers Six Drug Companies for Possible Fines  HRSA recently referred the first six drug manufacturers that imposed 340B pricing restrictions to the Health and Human Services Office of Inspector General (HHS OIG). Maureen explains what this step in the enforcement process means, what the OIG will do next, how the drug companies are responding, and what covered entities should do about two companies that were not included.     The Drug Companies’ Motivation to Deny 340B Discounts  340B Health recently released a report about how the 340B community pharmacy dispute has affected diabetes drugs. Maureen recaps the report’s findings and how it uncovers the drug companies’ likely motivation for sidestepping the 340B statute.  Drug Pricing Legislation and 340B  Congress is working on legislation to lower drug prices. Lawmakers also have introduced bipartisan legislation that would prevent certain discriminatory pricing behavior against 340B providers. Maureen explains what potential federal bills could mean for 340B. COVID-19 Concerns Continue The COVID-19 pandemic has prompted concerns that some hospitals could become ineligible for the 340B program. Maureen explains how 340B Health is working with Congress on legislation to ensure protection for these hospitals.  U.S. Supreme Court Takes 340B Case  This fall, the U.S. Supreme Court will hear a case regarding Medicare drug payment cuts to many 340B hospitals that have been in place since 2018. Maureen discusses the case and why the administration should not wait to hear the court’s decision to stop the cuts.    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  Six Drug Companies Referred for Penalties for Continued Violations of Federal Law on 340B Pricing  Report: The Impact on Diabetes of Restrictions on 340B Community Pharmacies  New 340B Health Video Explains 340B Community Pharmacy Dispute Momentum Grows to End Medicare Cuts for 340B Hospitals Maureen Testoni Participates in STAT Event About the Future of 340B 

This week, we are joined by Sumona Das Gupta, assistant director of pharmacy audit and compliance at University of Washington Medical Center and Harborview Medical Center. As part of the UW Medicine health system, the hospitals operate in the first region of the U.S. that experienced community transmission of COVID-19 last year. Sumona discusses how her hospitals quickly expanded their telehealth capacity to serve patients, how this transformation impacted their 340B program operations and compliance, and the benefits telehealth brings to both patients and providers.  Telehealth Before and During the COVID-19 Pandemic  Sumona explains how her medical centers began building a foundation for telehealth prior to the pandemic to reach underserved communities. Before the pandemic, limitations on telehealth existed. However, the pandemic brought changes in policy and technology regarding telehealth. She shares how the medical centers quickly adapted to these changes and what strategies they used to expand their telehealth capabilities.  Addressing 340B Policies and Procedures for Telehealth Sumona shares how telehealth visits remained eligible for 340B and how her system updated its 340B policies and procedures to reflect telehealth implementation and ensure 340B compliance. This was aided by the Health Resources & Services Administration’s public health emergency flexibilities for 340B providers.   The Benefits and Challenges of Telehealth  Telehealth has widened the ability for patients to access care, even across state lines, while keeping everyone safe. Sumona shares how to help prepare patients for a telehealth visit, the strategies used to help patients feel connected with practitioners during telehealth visits, and the overall satisfaction patients are experiencing with telehealth. She also discusses how telehealth might not work for every patient.  Telehealth is Here to Stay  Sumona previews what is ahead for telehealth post pandemic and how 340B savings can help further expand the access to care that telehealth provides.  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 Online Platform for Commenting on CMS’s Proposed Medicare Part B Cuts for 2022 340B Health Webinar Slides: Telemedicine Use By 340B Hospitals (May 2020) UW Medicine 

This week, we are joined by Tim Maurice, chief financial officer for UC Davis Health. Tim discusses how hospital finance teams support 340B and how they work together with hospital departments to provide the resources for health care services that patients need. Prior to the interview, we share a news update on an eighth drug manufacturer that plans to deny 340B discounts on drugs dispensed at community pharmacies.  How Health System Finances Have Changed Over the Years Health system finances have drastically changed over the years. Tim shares how UC Davis has responded to these changes, explains the financial challenges caused by COVID-19, and discusses how 340B eases the financial burden for safety-net hospitals both during a public health emergency and in regular times.    Finance Departments Support Improved Patient Care Finance departments ensure that providers and patients receive adequate resources. Tim explains how this responsibility is constantly focused on improving patient care. The CFO’s office collaborates with hospital departments to determine which services the community needs. Tim provides an example of this at UC Davis and what providers who have a new idea for a health care service should do to collaborate with the finance department to develop a robust plan that takes 340B into consideration.    Participating in Associations  Tim is a member of 340B Health’s Board of Directors, a member of the California Association of Public Hospitals and Health Systems board and is in a leadership role with America’s Essential Hospitals.  He explains how becoming active in associations helps 340B professionals in their own careers and in advocating for the health care safety net.   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  Merck Plan to Withhold 340B Discounts Adds to Threat to Diabetes Patients Hospital and Pharmacist Groups Urge Court to Reject United Therapeutics’ Arguments in Community Pharmacy Case  340B Health Upcoming Webinars  Tim Maurice Bio 

This week, we are joined by Nan Kempadoo, 340B internal auditor for Memorial Healthcare System in Hollywood, Fla. Nan is a certified pharmacy technician who spoke on the pharmacy technician roundtable at last month’s 340B Coalition Summer Conference. She discusses how pharmacy techs play an important role in the operations and compliance of 340B hospitals and notes the growing number of career opportunities available to them in 340B. Before the interview, we give an update on a seventh drug company that has refused 340B discounts to safety-net providers when drugs are dispensed at community pharmacies as well as how members of Congress are responding to the continuing dispute.  The Role Pharmacy Techs Play in 340B Nan shares how she first became a pharmacy tech and progressed to becoming a 340B internal auditor. Pharmacy techs’ experience equips them to take on 340B program management and auditing. Nan describes the roles pharmacy techs can take on, both on and off the 340B team, and how tech positions have evolved.  Resources for 340B Newcomers Nan shares what resources were most helpful when she first began her role in 340B. These resources provided basic insight into how the 340B program works. Nan also shares how she realized the importance of developing soft skills after she started working with the program. She gives advice to pharmacy techs who are starting their careers in 340B.  Hospital Training on 340B  Internal training also is critical for the professional development of pharmacy techs. Nan’s health system uses a combination of internal resources, presentations, and in-person site visits to help their teams learn more about 340B operations and compliance as well as how they use 340B savings to support their community.  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  Boehringer Ingelheim Cuts Off 340B Contract Pharmacies Statement on U.S. House Amendment in Support of Ending Drug Company Attacks on 340B  340B Insight Episode 31: Preparing for 340B Recertification Memorial Healthcare System  

This week, we are joined by Steven Miller, vice president of pharmacy services at 340B Health. The Health Resources & Services Administration (HRSA) recently announced that annual 340B recertification for hospitals will begin on Aug. 16, 2021. Steve discusses what 340B hospitals need to know about preparing for recertification and avoiding common errors during the process. Prior to the interview, we provide news updates on the Centers for Medicare & Medicaid Services proposing to continue Medicare Part B cuts to many 340B hospitals and new legislation introduced in Congress to protect 340B hospitals from discriminatory payment rules by pharmacy benefit managers and health insurers.  The Purpose of Recertification 340B hospitals must go through the recertification process to confirm and validate the accuracy of their information and ensure they comply with all program requirements. Steve recommends that 340B hospitals begin getting into the habit of preparing for recertification as soon as they qualify for the program and look at their policies and procedures to confirm they align with the 340B statute.  The Recertification Steps Steve explains the steps of the recertification process. He stresses the importance of reviewing information for the parent hospital first and then any child sites. The hospital will need to review the qualification information to confirm that the information on the most recent Medicare cost report matches with the information in OPAIS. If the information does not match, the hospital can make the changes in the recertification task and upload the supporting documentation. Steve also explains the Medicaid Exclusion File and why it is a critical component to recertification. Best Practices For 340B Hospitals Recertifying Steve shares common errors made when recertifying. The most common error is the authorizing official (AO) not checking every single qualification requirement. These include DSH percentage and Medicare cost report filing date. Steve recommends having both the primary contact and the AO review the information separately to ensure accuracy. He also encourages checking to ensure everything in OPAIS is saved correctly and taking screenshots of each screen in case the information does not save.  Resources For 340B Recertification Members of 340B Health have access to several resources to prepare for recertification and registration. Members can reach out to 340B Health to set up a technical assistance call with a 340B Health staff expert. Steve also recommends members attend a webinar on Aug. 12, 2021, that will review the recertification process and highlight any new changes for this 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 would like us to cover in this podcast, email us at podcast@340bhealth.org. Resources  1. 340B Health Statement on Proposed Medicare Payment Cuts to 340B Hospitals In 2022 2. 340B Health Statement on the Bipartisan Protect 340B Act to Stop Discriminatory Actions by PBMs and Insurers 3. 340B Health Member Resources on Program Registration and Recertification  4. 340B Health Webinar on Recertification on Aug. 12, 2021

This week, we are joined by Bryan Jackson, chief administrative officer at Jefferson Regional Medical Center in Arkansas. Bryan discusses why he advocates for 340B at the federal and state levels, explains how to prepare for and participate in advocacy meetings with policymakers and their staff, and shares his advocacy success stories. Prior to the interview, our news segment discusses how a seventh drug company is threatening to start denying 340B discounts on drugs dispensed at community pharmacies and how the U.S. Supreme Court will be hearing a 340B-related case during its next term.  Why to Advocate for 340B Jefferson Regional Medical Center (JRMC) is an independent, community-based hospital that treats patients in southeast Arkansas, many of whom experience socioeconomic challenges. While Bryan is not a full-time government relations staff member, he wanted to support his community’s needs, so he decided to devote time advocating to protect 340B at both the state and federal levels. Bryan discusses the time involved in preparing for advocacy meetings such as a 340B Health Hill Day, and he explains how to have efficient communications when speaking with busy policymakers and their staff.  The Key to 340B Advocacy Success  Bryan discusses the 340B issues he has recently advocated for with policymakers. At the federal level this includes asking members of Congress to support legislation that protects hospitals from losing eligibility for 340B during the COVID-19 public health emergency. Members of the Arkansas congressional delegation have responded with support for the legislation. At the state level, the efforts of Bryan and other Arkansas hospital advocates have resulted in the enactment of a law to stop drug companies from refusing 340B discounts to safety-net providers on drugs dispensed at community pharmacies. Bryan then explains why a big key to their success is building relationships with policymakers and their staff.   The Tool to Use When Advocating for 340B   When meeting with policymakers, Bryan recommends always using an Impact Profile that demonstrates how 340B has benefited the community the hospital serves. He says that all members of Congress are interested in helping their constituents, and it is a win for policymakers when they can share with the voters who elected them that they are supporting a program such as 340B that is positive for the community. The Impact Profile also ensures that hospital leadership understands 340B’s worth and encourages them to become involved in advocacy efforts. Bryan explains the importance of hospital leadership joining in advocacy efforts for 340B to demonstrate to policymakers that 340B is a priority to the entire hospital. Bryan says that sharing with policymakers how critical 340B is to the health of the hospital, how it provides critical resources to the communities that they serve, and how it does not cost taxpayer dollars is a winning message.  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 Calls on Boehringer Ingelheim to Withdraw Threat to Deny Drug Discounts to Safety-Net Hospitals  U.S. Department of Health & Human Services Federal Court Motion Shares Harm to Patients from Drug Company Refusals to Provide 340B Discounts on Drugs Dispensed at Community Pharmacies 340B Insight Episode 27 With Anne Webster  340B Health Statement on U.S. Supreme Court Order In 340B Medicare Cuts Lawsuit  340B Coalition 2021 Summer Conference