340B Insight

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 [email protected].

Resources 

1. 340B Health Statement on New Director of HRSA Office of Pharmacy Affairs
2. 340B Health Letter to HHS Leadership on March 1 Regarding Contract Pharmacy Claims Data Submission Concerns 
3. 340B Health Letter to AbbVie CEO Regarding Contract Pharmacy Restrictions 
4. 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 [email protected].

Resources 

1. HRSA Disputes Court Decision on 340B Contract Pharmacies in Favor of AstraZeneca
2. 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 [email protected].

Resources 

1. Pfizer Contract Pharmacy Restrictions Target Xeljanz, Oncology Drugs In Limited Distribution Network 
2. CSRxP: Big Pharma’s Business-As-Usual Approach to January Price Hikes Underscores Urgency For Rx Solutions 
3. CMS Proposes Narrowly Covering Controversial Alzheimer's Drug Aduhelm for Patients In Clinical Trials
4. 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 [email protected].

Resources 

1. Statement on Bristol Myers Squibb Restricting 340B Discounts Through Community-Based Pharmacies 
2. 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 [email protected].

Resources 

1. More Court Battles Ahead for 340B in 2022
2. A Hospital Community United Against Threats to 340B
3. 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 [email protected].

Resources 

1. 340B Hospital Sign-On Letter to the Department of Health & Human Services
2. Statement on Amgen Restricting 340B Discounts Through Community-Based Pharmacies 
3. Under Pressure, Clovis Oncology Backs Off 340B Rebate Model
4. Supreme Court Case Oral Argument on Medicare Cuts to 340B Hospitals
5. 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 [email protected].

Resources 

1. 340B Insight’s Excellence in Communication Award 
2. Conflicting Court Decisions Prolong Dispute Over 340B Contract Pharmacies
3. Statement on Medicare Payment Cuts to 340B Hospitals in 2022
4. 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 [email protected].

Resources 

1. Jennifer Gallagher Faces of 340B Video Profile 
2. 340B Health’s Faces of 340B Series 
3. HRSA FY21 Manufacturer Audit Results
4. 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 [email protected].

Resources 

1. 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 [email protected].

Resources 

1. HRSA October 4, 2021 Letter to Boehringer Ingeleheim 
2. HHS Takes Vital Next Step Toward Ending 340B Pricing Denials
3. 340B Insight Episode 35 with Maureen Testoni
4. 340B Health Policy Guides