340B Insight

It’s that time of year again to make sure your health system or hospital has everything it needs for the 340B recertification period. 340B Health Vice President of Pharmacy Services Steven Miller returns to the podcast to discuss what is new this year for the recertification process, go over the recertification steps, and provide best practices to recertify without any errors. 

What’s New for Recertification 

Steve shares the dates that recertification will take place this year and two significant changes from recent years that hospitals need to know. 

The Recertification Process

Steve explains the step-by-step process hospitals must go through to confirm and validate the accuracy of their information and submit to the Health Resources & Services Administration. 

Eligibility Criteria for Recertification

Steve discusses the specific criteria hospitals must meet to qualify for recertification, the importance of the Medicare cost report and the Medicaid Exclusion File for recertification, and when hospitals need to start preparing for recertification. 

Best Practices and Resources 

Steve shares common errors, recommendations, and best practices for recertification. He also lists resources 340B Health members can use to prepare for recertification and registration, including 340B Health’s upcoming webinar. 

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. Report: 340B DSH Hospitals Increased Uncompensated Care in 2020 Despite Significant Financial Stress
2. Report: 340B Hospitals Provide Care for High Percentages of Historically Underserved Patients 
3. 340B Health Webinars for Members 
4. 340B Health 340B Registration and Recertification Resources 

Inventory management is a major responsibility for many 340B professionals. Today, we’re joined by Melissa Antonopoulos, senior 340B internal auditor at Memorial Healthcare System, to learn more. She discusses the intersection of 340B and inventory management and goes over practices for ensuring hospitals and their patients have the medications they need. In our news segment, we cover a new letter on contract pharmacy from Congress to the Department of Health and Human Services and new developments on Medicare payments for 340B drugs. 

The Relationship between Inventory Management and 340B

Melissa explains why hospitals need adequate pharmacy inventory, how 340B affects the inventory budget, and how covered entities remain compliant with 340B when ordering medications. She also discusses the many resources available to 340B professionals both inside and outside of their hospitals. 

Preventing Drug Shortages

Drug shortage concerns are a significant challenge for a hospital pharmacy. Melissa shares how hospital pharmacies can work across departments to mitigate a drug shortage before it affects patients.

The Role of Electronic Health Record Data 

Melissa discusses how electronic health record data supports inventory management, including through tools such as barcode scanning, to better serve patients. She also describes a recent medication dispensing project at her health system. 

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. U.S. House of Representatives Letter to HHS Regarding the 340B Contract Pharmacy Dispute
2. CMS Plans to End 340B Medicare Pay Cuts 
3. 340B Coalition Summer Conference 2022 

Many 340B hospital professionals want to know how to operate an efficient specialty pharmacy that improves patient health outcomes. This week, we are joined by Betty Fang, director of ambulatory, specialty, and retail pharmacy at AdventHealth Great Lakes Region, formerly part of AMITA Health. Betty discusses how she helped lead a team that embedded specialty pharmacists into an oncology clinic. The team researched how the initiative improved patient health outcomes and increased 340B savings to reinvest in patient care. Before the interview, we provide several news updates on the contract pharmacy dispute and the release of 340B Health’s second annual health equity report. 

The Importance of Specialty Medications 

Betty explains the types of diseases that specialty medications treat and how 340B savings help hospitals provide these specialty drugs.

Embedding Specialty Pharmacists into Clinics

Betty shares how her health system placed specialty pharmacy staff directly into the oncology clinic. She also describes her research to measure the initiative’s success.  

Increasing 340B Savings to Invest in Patient Care 

Embedding specialty pharmacists into a clinic helps the pharmacy have better visibility into the process of connecting patients to their prescriptions. Betty’s research found this boosted the amount of 340B savings the health system could obtain to help support more patient care. She also analyzes the challenges of embedding specialty pharmacists into clinics and what the next trend in specialty pharmacy might 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 and Hospital Associations’ Amicus Briefs in Federal Appeals Courts Regarding the Contract Pharmacy Dispute 
2. 340B Health Statement on Bausch Health Restricting 340B Discounts Through Community-Based Pharmacies 
3. 340B Health Statement on HRSA Enforcement Letter to UCB Regarding Contract Pharmacy Restrictions 
4. 340B Health’s Second Annual Health Equity Report 
5. SP Onc PharmDs Bolster 340B, New Med Access
6. 340B Coalition Summer Conference 2022 

The U.S. Supreme Court issued a major decision earlier this month regarding Medicare Part B cuts for 340B drugs. We’re joined by Amanda Nagrotsky, senior counsel for 340B Health to understand what implications this decision holds for 340B hospitals.  

This Decision was Years in the Making Amanda provides important background on the Medicare Part B cuts and the different court cases that led to the U.S. Supreme Court deciding the case. 

An Important Victory for 340B Hospitals Amanda discusses the unanimous court decision in favor of 340B hospitals, whether the decision could affect payers other than Medicare, and other highlights from the court’s 14-page decision.

Next Steps Several key questions remain following the Supreme Court’s decision. Amanda analyzes what the decision could mean for future Medicare Part B payment rates for 340B drugs, the process for determining repayment to 340B hospitals, and what 340B hospitals should do now as we wait for next steps to develop.

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. U.S. House of Representatives 340B Special Order Hour Full Video 
2. Congressional Champions Stand Up to Defend 340B
3. U.S. Supreme Court Decision on Medicare Part B Cuts for 340B Drugs
4. U.S. Supreme Court Backs 340B Hospitals by Striking Down Medicare Cuts
5. 340B Health Outpatient Prospective Payment System (OPPS) Resource Center 

This week, we are joined by Bhupinder Kaur, business analyst and 340B coordinator with NorthBay Healthcare Group in California. Bhupinder presented at the 340B Coalition 2021 Winter Conference on data analysis and shares with us important information that 340B professionals need to know about best practices. Before the interview, we highlight a recently published op-ed on the critical role of 340B savings during the height of the COVID-19 pandemic.

A Day in the Life of a 340B Analyst

Bhupinder shares her path to becoming a 340B analyst, the changing nature of her work, and the types of projects an analyst works on. 

The Challenges with Configuring 340B Data 

When it comes to audit and compliance work, there are instances where data is difficult to obtain. Bhupinder explains how to work with third-party administrators (TPAs), key tools to use, and the importance of working across departments in your hospital or health system. She also shares tips for using the 340B quarterly price file and applying data analysis to the 340B recertification process. 

Financial Analyses Demonstrate 340B’s Value  

Hospital executive leaders use business data to make key decisions. Bhupinder discusses what decisions data can influence, the analysis hospital leadership requests most often, and how her work supports hospital efforts to communicate how they use their 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 [email protected].

Resources 

1. The 340B drug-pricing program, a critical MetroHealth patient lifeline, is under threat: Sherrie D. Williams
2. 340B Coalition Summer Conference 2022 Registration 

It’s our 50th episode! This week we are joined by Amanda Sellers Smith, legal counsel for 340B Health. Amanda is responsible for tracking and responding to 340B state legislative and regulatory actions. Even though 340B is a federal program, its close relationship with state Medicaid programs often keeps it on the agendas of state lawmakers and health officials. Amanda discusses what listeners need to know about recent 340B activity in the states. Before the interview, we give an update on recent briefs to appeals courts that are considering cases about the contract pharmacy dispute, and we note that another drug company has received an official violation letter from HRSA for its 340B restrictions. 

More States Protecting 340B Providers

Amanda shares what legislation states have been enacting into law that impacts 340B providers, including 340B nondiscrimination legislation. She also discusses legal challenges against some states’ nondiscrimination laws and how 340B hospitals are working to protect those laws. 

340B’s Relationship to State Medicaid Programs.

States heavily focus on Medicaid and sometimes pursue policies that can negatively impact 340B. Amanda explains what these problematic policies are and how safety-net hospitals can keep an eye on Medicaid action in their states.

Tips for 340B Hospital Advocacy

Amanda reviews the resources and guidance that 340B Health can provide member hospitals looking to become more involved in state-level advocacy. She also provides advice for dealing with state legislatures that is different than advocacy efforts with the federal legislature.

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]. 

Episode Resources:

1. 340B Health State Policy and Advocacy Resource Center
2. Five Hospital Associations Urge Appeals Courts to Back 340B Enforcement
3. HHS Brief to the U.S. Court of Appeals for the Third Circuit
4. HHS Brief to the U.S. Court of Appeals for the District of Columbia Circuit
5. HRSA Violation Letter to Merck

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 [email protected]. 

Episode Resources:

1. 340B Health Survey Report: Financial Losses from Drug Companies’ 340B Restrictions Have More Than Doubled Since the End of 2021
2. Joint Statement from Leading HIV/AIDS and Viral Hepatitis Advocates Regarding Manufacturer Action on the 340B Drug Pricing Program
3. 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 [email protected].

Resources 

1. 340B Community Pharmacy Legal Battle Moves to Next Stage
2. 340B Coalition Summer Conference 2022 
3. 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 [email protected].

Resources 

1. Boehringer Ingelheim Referred for Penalties for Continued Violations of Federal Law of 340B Pricing
2. 340B Health Member Survey Report 2021  
3. 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 [email protected].

Resources 

1. Additional Resources on 340B Community Pharmacy Dispute 
2. 340B Health Template to Protest Drug Companies Patient Claims Data Demands 
3. HRSA Attestation Form for Reinstatement into the 340B Drug Pricing Program 
4. Upcoming 340B Health Webinars