The Power of 340B Crosswalks

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 audit

Auditors 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 audit

On 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 findings

If 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:

1. 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 requires

Danny 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 system

Minnesota’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 states

Danny 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.

Resources

1. Senate 340B Bipartisan Working Group Discussion Draft
2. Statement on Senate 340B Bipartisan Working Group Discussion Draft
3. Senators 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 Action

In 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 Cuts

Listeners 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.

Resources

1. HRSA Stresses Federal Court Decision on Patient Definition Only Applies to Genesis FQHC 
2. Implications of Genesis Decision on 340B Patient Definition Webinar
3. State Policy and Advocacy Resource Center 
4. Analysis of the Medicare 340B Pay Cut Remedy
5. HRSA Program Integrity Website
6. Inflation 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 care

Mercy 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 treatment

Mercy 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 costs

Mercy 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.

Resources

1. Report: 340B Hospitals Advancing Health Equity
2. Takeda Becomes 29th Drugmaker To Impose Restrictions on Use of Contract Pharmacies
3. House Approves 340B Medicaid Spread Reporting Requirement
4. HRSA 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 Definition

In 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 Clinics

HRSA 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 Cuts

Hospitals 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

1. Federal Court Issues Decision Against HRSA Limitation on “Patient”
2. HRSA Facing Hospital Lawsuit Over Child Site Eligibility Policy
3. Read 340B Health’s Analysis of the Medicare 340B Pay Cut Remedy
4. West Virginia Journal: A Health Care Policy We Can All Support
5. Zanesville Times Recorder: Drug Pricing Program Is Critical for Patient Care
6. Los Angeles Sentinel: Black Pharmacists Stand as Advocates in Support of 340B Access to Care
7. 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 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 podcast@340bhealth.org.

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 podcast@340bhealth.org.

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 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 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 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 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 podcast@340bhealth.org. 

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