340B Insight

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 Patients

Bowling 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 Efforts

As 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 Story

Bowling 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 [email protected].

Resources

1. Federal Court Rules HRSA Is Unlawfully Restricting Patients Who Qualify for 340B
2. Read Our Full Analysis of the Medicare 340B Pay Cut Remedy
3. HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period
4. 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 Laws

Amanda 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 2024

Amanda 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 [email protected].

Resources

1. 340B Health Analyzes Potential Implications of Unprecedented Provisions in BMS Contract Pharmacy Policy Update
2. 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 Shortages

Inventory 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 Compliance

Froedtert’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 Care

Jake 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 [email protected].

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 Legislation

Testoni 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 Legislation

The 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 Regulation

Testoni 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 [email protected]. 

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 Crosswalks

Anja 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 Support

Experts 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 Pharmacy

Anja 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 [email protected]. 

Resources

1. Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026
2. House Drug Shortage Bill Would Provide Windfall to Drugmakers While Harming 340B Hospitals
3. 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 [email protected].

Resources

Merck Relaxes Contract Pharmacy Restrictions in Two States

HHS 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 Works

Steve 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 Hospitals

Steve 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 Resources

Steve 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 [email protected].

Resources

1. 340B Health Responds to Senate Request for Information on 340B
2. 340B Health RFI Response
3. 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 Program

Cindy 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 [email protected].

Resources

1. Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Proposed Rule
2. 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 Costs
Managing 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 Market
Tim 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 Biosimilars
Tim 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 [email protected].

Resources

1. Astellas is Company No. 24 to Impose Contract Pharmacy Restrictions
2. 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 Pharmacies
Maureen 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 States
Maureen provides insights into some critical legislation that affects 340B providers, including federal and state legislation to require data reporting from 340B hospitals.

HRSA Policy Changes
The 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 [email protected].