340B Insight: Recent Episodes
340B Health
340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.
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 podcast@340bhealth.org.
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 podcast@340bhealth.org.
Resources
- 340B Health Responds to Senate Request for Information on 340B
- 340B Health RFI Response
- 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 podcast@340bhealth.org.
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 CostsManaging 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 MarketTim 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 BiosimilarsTim 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 podcast@340bhealth.org.
Resources
- Astellas is Company No. 24 to Impose Contract Pharmacy Restrictions
- 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 PharmaciesMaureen 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 StatesMaureen provides insights into some critical legislation that affects 340B providers, including federal and state legislation to require data reporting from 340B hospitals.
HRSA Policy ChangesThe 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 podcast@340bhealth.org.
Nov. 17 is National Rural Health Day, which is an opportunity to celebrate the importance of rural hospitals to patients living in remote communities. We are joined by Karen McCombs, 340B program manager for Wills Memorial Hospital in Georgia. Karen shares her tips for managing her critical access hospital’s 340B program in a compliant and efficient manner to support patient care initiatives. Before the interview, we provide updates on the 2023 Medicare payment rate for 340B drugs and on the status of 340B contract pharmacy litigation pending in federal appeals courts.
Where Everyone Knows Your Name
Karen provides her perspective on the unique elements of working in a rural hospital and discusses her hospital’s extensive history in its community.
Filling in the Gaps
Karen explains how 340B savings help her hospital offset its costs to help ensure the hospital remains open for the community. She describes one of Wills Memorial’s greatest 340B success stories and shares how the hospital has used 340B to support all its patients.
Advice for Rural Hospitals
Rural hospitals often have smaller staffs. Karen discusses how she is the only employee at her hospital whose sole focus is 340B. She shares her framework, “Build, Research, Audit, Ask” as a model professionals can deploy to operate a successful 340B program.
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 topics you’d like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- CMS Rule Provides Clarity on 2023 Pay Rates and Modifiers but Puts Off Remedies for Past Cuts
- Appeals Court Judge Suggests HHS Might Need to Fine Drugmaker Before Lawsuit Over 340B Pricing Refusals Can Proceed
- HRSA Events for National Rural Health Day
- 340B Insight Episode 61: Congressman Henry Waxman Reflects on 30 Years of 340B
On Nov. 4, 1992, President George H.W. Bush signed the 340B drug pricing program into law. To celebrate 30 years of 340B, we speak on today’s episode with former Congressman Henry Waxman, who was one of the principal architects of the 340B program. Congressman Waxman served in Congress for 40 years from 1975-2015. During part of that time, he chaired the influential U.S. House Energy & Commerce Committee and U.S. House Government & Oversight Committee.
Chairman Waxman shares why Congress created 340B, explains the need for a strong health care safety net, discusses 340B’s achievements, and remarks on why the program is just as important today as it was 30 years ago.
Supporting the Health care Safety Net
Chairman Waxman prioritized building and protecting the health care safety net throughout his time in Congress. He discusses why this was a priority for him. He also explains the origins of the bipartisan legislation that created 340B.
340B’s Legacy
Throughout its history, 340B has had bipartisan support. Chairman Waxman shares his perspective on the major developments for 340B over its three decades and whether 340B has achieved what he envisioned when he wrote the law.
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
- Chairman Henry Waxman’s Bio
- Section 340B of the Public Health Service Act
- 340B Health Statement on Final Medicare 2023 OPPS Rule
- Merck Referred for Penalties for Refusal to Follow Federal Law on 340B Pricing
- HRSA Directs AbbVie and Amgen to Restore 340B Pricing to Safety-net Hospitals
When Hennepin Medical Center saw that some of their patients were frequently visiting the emergency department for all their health care needs, they recognized how vital it was to find a better way to care for them. Our guest this week is Christene Jolowsky, senior director of pharmacy at Hennepin Healthcare. Christene shares how Hennepin has used 340B savings to operate a coordinated care clinic that meets the health and social needs of their patients. Prior to the interview, we provide news updates on the restoration of full Medicare payment rates for 340B drugs and details about another drug company that is attempting to block the federal government from requiring 340B discounts on drugs dispensed at contract pharmacies.
A One-Stop Shop for Care
Chris shares how the coordinated care clinic determines which patients are eligible for its services. She then describes a typical patient experience at the clinic and how this experience meets the clinic’s mission to provide comprehensive care. This includes addressing social determinants of health such as transportation and food insecurity.
Keys to the Clinic’s Success
Many patients come into the clinic with distrust of the medical system and providers. Chris explains how Hennepin’s providers build trust with patients and provide personalized care.
The Role of 340B
340B savings have supported every aspect of the coordinated care clinic. Chris discusses how the clinic’s presence has reduced emergency department visits and shares a story of how the clinic significantly reduced the number of prescribed medications for one of its 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
- Medicare 340B Payment Cut Ending for the Remainder of 2022
- UCB Sues HHS Over 340B Contract Pharmacy Violation Letter
- Report on Hennepin Healthcare’s Coordinated Clinic: 340B Hospitals Are Directing Savings Toward Their Communities’ Unique Needs
All this year we are reflecting on the approaching 30th anniversary of the 340B program and celebrating the patient care successes the program has enabled over the past three decades. This week, we are joined by Andrew Lowe, clinical director of pharmacy at Arrowhead Regional Medical Center in California. Arrowhead has participated in 340B since the first days that hospitals were eligible for the program. Andy has had a front-row seat the entire time to see the difference 340B has made in the lives of patients in need and the health care safety net’s ability to care for them. He shares how Arrowhead navigated health care in a pre-340B world and what the program has allowed his hospital to accomplish in patient care over the past 30 years. Prior to the interview, we share several news updates on new developments on Medicare cuts for 340B drugs, the release of new 340B research, and more.
The Ability to Serve More Patients
Arrowhead was one of the first hospitals to participate in 340B. Andy shares about the challenges the hospital had faced when caring for low-income patients prior to 340B and what changed once the hospital started receiving 340B discounts.
Improved Patient Health Outcomes
With its 340B savings, Arrowhead expanded treatment programs to more patients. Andy discusses how the hospital used 340B savings to help fund hepatitis C and cancer treatment services and how patient health outcomes have improved.
Advice to Other 340B Professionals
Andy has nearly 30 years of experience in 340B, so we had to ask him his most important piece of advice to other professionals operating their hospitals’ 340B programs. Andy also shares how his career brought him to the world of safety-net hospitals and 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
- Report: 340B DSH Hospitals Serve Higher Share of Patients with Low Incomes
- Report Infographic: 340B DSH Hospitals Serve Higher Share of Patients with Low Incomes
- Federal Judge Reiterates that Medicare 340B Cuts Must End Immediately
Bipartisan Letter from Senators Joe Manchin and Mike Braun to HHS Regarding the 340B Contract Pharmacy Dispute
It has been an eventful summer for 340B, and we are checking in this week with 340B Health President and CEO Maureen Testoni to hear her analysis on the top 340B developments. Maureen provides updates on issues that include the contract pharmacy dispute, Medicare payment cuts, and the new drug pricing law. She also shares a preview of what may occur in the fall.
340B Contract Pharmacy Dispute Continues
The number of companies currently restricting 340B discounts has grown. Maureen discusses the impact of these unlawful restrictions on 340B hospitals and patient care, how Congress is responding to advocacy efforts, and where the issue stands in the courts. She also explains how 340B Health is taking a multi-pronged approach to address the dispute.
Progress Toward Ending Medicare Cuts
The U.S. Supreme Court decided in June that Medicare cuts for 340B drugs that have been in place since 2018 are unlawful. Maureen recaps how the Centers for Medicare & Medicaid Services (CMS) has responded to the court’s decision and predicts when hospitals might expect to be repaid for the cuts they received.
New Drug Pricing Law
Major federal drug pricing legislation became law in August, and the new law will have significant ramifications that are difficult to predict. Maureen describes the key drug pricing provisions and what they could mean for 340B.
Celebrating 340B’s Big Upcoming Anniversary
Maureen shares her key takeaways from the 340B Coalition Summer Conference. Amid the challenges covered entities face, she believes it is important to recognize the 30th anniversary of the 340B program in November by celebrating the difference 340B has made in patients’ lives.
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
- Survey Results: Contract Pharmacy Restrictions Represent Growing Threat to 340B Hospitals and Patients
- Hospitals Say Medicare Must End 340B Cuts, Repay Harmed Facilities
- Research Shows 340B Meeting Its Mission
- Maureen Testoni’s 340B Coalition Summer Conference 2022 Recap Blog Post
- Upcoming 340B Health Webinars
Drug shortages occurring throughout the U.S. health system can lead to delays for patients receiving the medications they need. 340B hospitals face unique challenges with avoiding and managing drug shortages. We are joined by Cescilly Smith-Jenkins, 340B program director at Ascension Wisconsin, to find out how 340B hospitals can address shortage problems effectively.
Why Drug Shortages Happen
There are several factors behind drug shortages. Cescilly explains how drug shortages are affected by other supply shortages, outlines drug shortage trends in the U.S., and notes which drugs are most prone to being in short supply.
340B Challenges to Managing Shortages
340B compliance adds additional complexity to drug shortages. Cescilly discusses how regulatory policies create challenges for avoiding shortages on 340B-eligible drugs. She also shares an example of how her health system overcame a recent drug shortage.
Approaches to Stay Ahead of Shortages
Cescilly has a unique way to think about 340B that can help hospitals operate their program in a way that stays ahead of drug shortages. She also explains risks that can occur when the 340B team is unaware of hospital operational changes, and she provides practical tips on maintaining communications with key stakeholders.
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
- Annual Hospital Recertification Closes Sept. 19
- 340B Insight Episode 55: Are You Ready for 340B Recertification?
Pharmacy technicians play key roles in hospital 340B program operations, but pharmacy technician staffing shortages are occurring in hospitals throughout the nation. We’re joined by Dr. Tyffani Wingfield with the American Society of Health-System Pharmacists (ASHP) to discuss how the shortages are affecting hospitals, the pharmacy technician workforce, and 340B. Tyffani also shares potential solutions. Before the interview, we discuss recently enacted federal drug pricing legislation and the start of the annual 340B hospital recertification process.
Factors Contributing to the Pharmacy Tech Shortage
Pharmacy technician vacancy rates are high. Tyffani shares results from a pair of ASHP surveys that provide insights into the most prominent challenges hospitals face in recruiting and retaining technicians as well as potential solutions.
How Pharmacy Tech Shortages Affect Hospitals
Tyffani explains the vital roles pharmacy technicians fill, the strain on the health care system when there aren’t enough technicians, and how hospital organization structures can be modified to support techs. She also provides advice for how pharmacy technicians can have a satisfying career.
What the Pharmacy Tech Shortage Means for 340B
The staffing shortage has affected technicians operating 340B programs and pharmacy services. Tyffani describes how the staffing shortage affects 340B professionals in their day-to-day work.
Check out all of our episodes on the340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting ourhomepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- Medicare Drug Price Negotiation Bill Becomes Law
- 340B Health Webinar: Inflation Reduction Act Drug Pricing Provisions and 340B
- 340B Insight Episode 55: Are You Ready for 340B Recertification?
- ASHP’s Executive Summary for the Pharmacy Technician Shortage Survey Findings
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 podcast@340bhealth.org.
Resources
- Report: 340B DSH Hospitals Increased Uncompensated Care in 2020 Despite Significant Financial Stress
- Report: 340B Hospitals Provide Care for High Percentages of Historically Underserved Patients
- 340B Health Webinars for Members
- 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 podcast@340bhealth.org.
Resources
- U.S. House of Representatives Letter to HHS Regarding the 340B Contract Pharmacy Dispute
- CMS Plans to End 340B Medicare Pay Cuts
- 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 podcast@340bhealth.org.
Resources
- 340B Health and Hospital Associations’ Amicus Briefs in Federal Appeals Courts Regarding the Contract Pharmacy Dispute
- 340B Health Statement on Bausch Health Restricting 340B Discounts Through Community-Based Pharmacies
- 340B Health Statement on HRSA Enforcement Letter to UCB Regarding Contract Pharmacy Restrictions
- 340B Health’s Second Annual Health Equity Report
- SP Onc PharmDs Bolster 340B, New Med Access
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 podcast@340bhealth.org.
Resources
- U.S. House of Representatives 340B Special Order Hour Full Video
- Congressional Champions Stand Up to Defend 340B
- U.S. Supreme Court Decision on Medicare Part B Cuts for 340B Drugs
- U.S. Supreme Court Backs 340B Hospitals by Striking Down Medicare Cuts
- 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 podcast@340bhealth.org.
Resources
- The 340B drug-pricing program, a critical MetroHealth patient lifeline, is under threat: Sherrie D. Williams
- 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 podcast@340bhealth.org.
Episode Resources:
- 340B Health State Policy and Advocacy Resource Center
- Five Hospital Associations Urge Appeals Courts to Back 340B Enforcement
- HHS Brief to the U.S. Court of Appeals for the Third Circuit
- HHS Brief to the U.S. Court of Appeals for the District of Columbia Circuit
- 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 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 the340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting ourhomepage. 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
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340B Health Statement on Proposed Medicare Payment Cuts to 340B Hospitals In 2022
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340B Health Statement on the Bipartisan Protect 340B Act to Stop Discriminatory Actions by PBMs and Insurers
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340B Health Member Resources on Program Registration and Recertification
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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
This week, we are joined by 340B Health President and CEO Maureen Testoni. Maureen provides analysis of the most recent developments regarding the 340B contract pharmacy dispute and what’s next in the efforts to resolve the matter. Before our conversation, we share the findings of a recently released 340B Health report that demonstrates how 340B hospitals are treating large percentages of patients who often are underserved by the broader health care system.
HRSA’s Letters to Drug Companies
On May 17, HRSA sent letters to the six drug companies that have refused to provide 340B discounts to safety-net hospitals and other providers on drugs dispensed at community pharmacies. The letters require the drug companies restore the discounts and repay all overcharges.
Drug Companies’ Response to HRSA
After receiving letters from HRSA, the drug companies went to federal court to prevent HRSA from enforcing the 340B statute. The drug companies had already been challenging a December 2020 advisory opinion from the Health and Human Services (HHS) General Counsel that said that drug companies must provide 340B discounts on drugs dispensed at community pharmacies. Following a federal court decision in one of the cases challenging the advisory opinion, HHS chose to withdraw the advisory opinion. Maureen explains that HHS has said it does not need the advisory opinion to continue with the steps it needs to take to enforce the 340B statute.
HRSA’s Next Steps
Maureen explains that HRSA can refer the drug companies’ actions to the HHS Office of the Inspector General (OIG). The OIG can impose civil monetary penalty fines on the drug companies. These fines can be imposed when drug companies knowingly and intentionally overcharge covered entities. The fines can be $6,000 dollars per overcharge. However, Maureen shares that drug companies are putting up a strong fight and that it will take time for this issue to be resolved.
Next Steps for 340B Hospitals
340B hospitals are waiting to be paid current and past refusals of 340B discounts. The refusals limit their ability to provide services for low-income and rural patients. Maureen recommends that hospitals continue sharing examples of the damage drug company refusals to provide 340B discounts is doing to patient care. Maureen says this type of advocacy led to HRSA issuing the May 17 enforcement letters to the drug companies and is needed to keep the pressure on the drug companies. She also invites listeners to attend the 340B Coalition Summer Conference in July to hear from top 340B experts and key officials regarding the contract pharmacy issue.
340B Health Continues the Fight
340B Health is active in the litigation processes in various states. The organization is filing friend-of-the-court briefs describing the effects the drug companies’ actions have on covered entities and their patients and addressing incorrect information in drug companies’ briefs on how the contract pharmacy system works. Maureen shares that 340B supporters are fighting a strong fight and that the Department of Justice has shown strong support for providers and what the 340B statute requires. Maureen credits HRSA leadership and Secretary Becerra for HHS’ recent actions and the many patient and provider groups as well as members of Congress who have advocated for the drug companies to restore the discounts.
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 would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- New 340B Health Report on the Comparison of Medicare Beneficiaries Treated in 340B Hospitals, Non-340B Hospitals, and Independent Physician Offices
- New Federal 340B Order Is Major Step Toward Restoring Drug Discounts
- 340B Health Statement on Withdrawal of HHS Advisory Opinion on 340B Community Pharmacies
- The Human Toll of Drug Company Restrictions on 340B
- 2021 340B Coalition Summer Conference
This week, we are joined by Kyle Robb, a state policy and advocacy associate for the American Society of Health System Pharmacists (ASHP). Kyle discusses the rise in payer-mandated white bagging, why hospital pharmacists are concerned about the trend, and how health providers and patients are affected by this model. Before the interview, our news update covers the critical step the Health Resources & Services Administration (HRSA) recently took to enforce the law on drug companies that have refused discounts to 340B covered entities when drugs are dispensed at contract pharmacies.
The Differences Between White Bagging, Brown Bagging, and Clear Bagging.
Kyle explains that clinician-administered drugs typically are distributed under the “buy-and-bill” model, where the provider purchases the drugs, administers them to the patient, and bills the health insurance plan. Under the white-bagging model, the drug is purchased through a specialty pharmacy affiliated with the insurance plan, shipped via common carrier to the hospital or clinic location, and reimbursed via the pharmacy benefit, not the medical benefit. Brown-bagged drugs are purchased through the affiliated pharmacy and reimbursed under the pharmacy benefit as well, but those are mailed directly to the patient, who must bring the drugs to their clinic appointments. Clear bagging describes a situation in which the drug is purchased and distributed by a pharmacy under common ownership with the administering facility.
The Harm That Payer-Mandated White Bagging Can Cause.
White bagging adds external entities into the patient care process, creating more complexity in patient care coordination. Kyle explains that when facilities receive white-bagged drugs, they have no access to the drug pedigree information or to the same security protocols they have when receiving drugs from their wholesale partners. White bagging also can disrupt the administering facility’s ability to make “just-in-time” treatment decisions, can delay hospital discharges, and can cause unnecessary hospital admissions if a patient cannot receive their drug in time. Drug shortages, delivery delays, and mishandled shipments also can result in serious patient safety concerns.
White Bagging’s Impact On 340B Discounts and Covered Entities.
340B covered entities do not receive 340B discounts on white-bagged drugs, as the drug is purchased through plan-affiliated pharmacies and not through the administering facilities’ wholesale partners. Kyle explains that in addition to these lost savings, hospitals can incur additional costs, as they must store, segregate, and prepare the drugs for specified patients prior to administration without additional reimbursement. White bagging consumes additional hospital resources and can lead to more medication waste.
Payers’ Rationales for White-Bagging Mandates.
Payers believe white bagging saves them money. However, ASHP argues that the money is not saved but rather shifted to the providers. Payers can reduce their net drug costs by capturing more reimbursements through vertically integrated, plan-owned specialty pharmacies and pharmacy benefit managers (PBMs).
How ASHP Is Addressing Payer-Mandated White Bagging.
ASHP’s position is that white bagging never should be forced on facilities and always should be a choice for the provider and patient to use in limited circumstances when patient safety can be ensured. Kyle shares that his association is advocating against the payer-mandated white bagging model at both the federal and state levels. It is urging the Food & Drug Administration (FDA) to require that administering facilities have access to drug pedigree information on white-bagged drugs. ASHP also is engaging with state legislatures and state boards of pharmacy on settling legal questions about which entity is responsible for white-bagged drugs that are mishandled. ASHP is working with states to pass patient-choice protections to prohibit insurance companies from forcing white bagging and is advocating to ban the unsafe practice of brown bagging.
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 would like us to cover in this podcast, email us at podcast@340BHealth.org.
Resources
- 340B Health statement on HRSA May 17 letters to drug companies
- 340B Health member update on contract pharmacy court case
- ASHP statement on payer-mandated white bagging
It is the one-year anniversary of 340B Insight, and this week we are joined by Anne Webster, a nurse practitioner for UnityPoint Health Methodist in Peoria, Ill. Anne discusses how drug company restrictions on 340B pricing on drugs dispensed at community pharmacies have directly affected her patients living with diabetes and their ability to access the insulin and other medications they need to manage their conditions. Please note that the episode was recorded prior to the Health Resources & Services Administration (HRSA) announcing on May 17, 2021, that drug companies refusing 340B discounts to safety-net hospitals and providers on drugs dispensed at community pharmacies are in violation of the law and that they must offer 340B pricing and pay refunds. We will discuss this news in future episodes.
340B Increases Patient Access to Insulin
Anne works in an endocrinology clinic, and her patients are living with complex cases of type 1 and type 2 diabetes. Her patients usually have several comorbidities and are underinsured. As one of the few 340B providers in the area, her clinic treats patients who travel up to two hours one way to receive care from Anne and access the insulin they need at the community pharmacy on the hospital campus. Through the community pharmacy partnership, Anne’s uninsured and underinsured patients were accessing highly concentrated insulin, reducing the frequency of injections per day. She explains that 340B pricing has helped patients obtain high-quality insulin and other medications at a price they could only afford with a discount. Anne says her uninsured and underinsured patients saved $1.2 million in out-of-pocket expenses per year by receiving their medications at UnityPoint Health Methodist’s community pharmacy.
Patients Are Losing Access to Insulin and Other Medications
After drug company refusals to provide 340B discounts on drugs dispensed at community pharmacies, Anne had to switch patients to lower-quality, less-concentrated insulin. This resulted in patients with worse glycemic control who were injecting a large volume of fluid under their skin, which can lead to health complications. Anne’s patients were very upset about the changes to their insulin and other medications. The insulin they often had to switch to must be injected through a vial and syringe setup. This is challenging for patients with vision and dexterity problems.
Higher Costs for Patients
In addition to taking insulin that is ill-suited for them, patients had higher costs due to the inability to access insulin at the community pharmacy. Anne shares that through the community pharmacy partnership, patients could access a month’s supply of insulin for less than $40. The insulin they often switched to can cost them up to $150 per month out of pocket.
Patient Stories
Anne also explains the stress the drug manufacturers’ actions have placed on her patients. She shares the stories of two patients who are living with diabetes and fall into the Medicare coverage gap. The first patient, a retired factory worker, has had his insulin prescription switched multiple times over the past year. The first time was when Eli Lilly refused to provide 340B discounts and the second time was when Novo Nordisk followed suit. Even though he since has gained access to insulin through a drug company patient assistance program, this took a long time. During that process, he experienced significant stress from the uncertainty about whether he could access the insulin he needs. The second patient is a retired police officer. He was accessing a medication from AstraZeneca for blood sugar and weight control that reduced the amount of insulin he needed. AstraZeneca’s decision to refuse 340B pricing on drugs dispensed at community pharmacies resulted in the patient losing access to the drug for a long time until a patient assistance program decided it would cover it.
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 would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- 340B Health and Allied Organizations Brief in AstraZeneca vs. HHS Federal Court Case About HHS Advisory Opinion Regarding 340B Community Pharmacies
- HHS Brief in AstraZeneca vs. HHS Federal Court Case About HHS Advisory Opinion Regarding 340B Community Pharmacies
- More States Acting To Protect 340B Safety-Net Hospitals
- Rising Insulin Prices Impact Patients’ Diabetes Management, Holistic Wellness
- Episode One: HRSA’s OPA Response to COVID-19 with Rear Admiral Krista Pedley– May 18, 2020
This week we are joined by Sean Dickson, director of health policy for West Health Policy Center. Sean is an expert on the U.S drug system and focuses on policies that reduce prescription drug costs. Sean discusses why drug prices are so high, his research on how 340B fits into the drug pricing policy conversation and affects overall drug pricing, and what approaches policymakers can take to curb high drug prices. Before the interview, our news update shares developments on drug pricing bills recently introduced in Congress and how a group of hospital and pharmacy organizations, including 340B Health, wrote to HHS Secretary Xavier Becerra about what the department can do to stop drug manufacturers from refusing 340B discounts on drugs dispensed at community pharmacies.
Why Drug Prices Are High
Sean explains that the U.S. health care system allows drug manufacturers to choose prices, and manufacturers choose the most profit-maximizing price for each drug that they can achieve. The prices do not reflect the cost of research and development or even the drug’s therapeutic benefits. Sean provides more details on what factors affect the manufacturer’s choice, including which types of payers – commercial or government – will be providing drug coverage to the patients taking the drug.
340B Puts Downward Pressure on Drug Prices
While some have argued that 340B causes higher drug list prices, Sean discusses how his research on drug pricing demonstrates the opposite. In one of his studies, Sean examined why new hepatitis C drugs were coming to market with lower list prices than their competitors. He found it was more profitable for drug manufacturers to reduce list prices for hepatitis C drugs, which often are provided through 340B covered entities, and reduce the manufacturers’ 340B and PBM obligations. This demonstrated that 340B discounts can lead to lower list prices.
Research on the 340B Inflation Penalty
Under 340B, inflation penalties kick in when a manufacturer raises their prices at a pace greater than the inflation rate. Sean found in recently published research that these inflation penalties slow the growth of drug prices when a drug has a large percentage of its sales to 340B covered entities. The 340B program has been a model policymakers can look to when considering whether to expand the inflation penalties to the broader drug market. Sean further explains that if 340B ever were cut back, manufacturers likely would take larger price increases year-over-year, which would pass down to Medicare beneficiaries and could lead to seniors not adhering to their medication regimens due to the higher costs.
Research Best Practices
For listeners interested in conducting their own drug pricing and 340B research, Sean shares that there are plenty of quality data available publicly for examining drug spending and 340B’s role in the marketplace. For example, the Medicare prescriber utilization file is accessible for free and is a great place for researchers to start. This has been the starting point for many of Sean’s own research projects.
Approaches to Slowing Drug Costs
Sean recaps three areas policymakers can implement to curb drug prices. The first is capping drug price growth, possibly at the rate of inflation. However, this won’t stop new drugs from coming onto the market at high prices. To address this, new drugs could be priced under domestic reference pricing, which is basing the price on the historic costs of similar drugs, adjusted for the rate of inflation. Finally, Medicare or commercial entities could be authorized to negotiate with manufacturers directly.
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 would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- Hospital and Pharmacy Groups Seek Action on Drug Company Violations of 340B Law
- HHS Considering Alternatives to ADR to Enforce 340B Statute on Contract Pharmacies
- Sean Dickson Research Article: Estimated Changes in Manufacturer and Health Care Organization Revenue Following List Price Reductions for Hepatitis C Treatments
- Sean Dickson Research Article: Association Between the Percentage of US Drug Sales Subject to Inflation Penalties and the Extent of Drug Price Increases
- Upcoming 340B Health Webinars
This week we are joined by Maureen Testoni, 340B Health’s president and CEO. Maureen provides her expert analysis on the top 340B developments from the first quarter of 2021. The conversation includes the latest on drug manufacturers denying 340B discounts on drugs dispensed at community pharmacies, attempts to turn 340B into a rebate program, and payers and pharmacy benefit managers making mandatory changes to their claims processes. Maureen also shares positive recent developments on advocating for 340B.
Updates on the Community Pharmacy Issue
The Department of Health and Human Services (HHS) has indicated that drug manufacturers are violating the law when they refuse to provide 340B discounts on drugs dispensed at community pharmacies. Maureen explains that she is encouraged by new HHS Secretary Xavier Becerra’s statements in support of 340B but that advocacy needs to continue on this issue to ensure the secretary and the department move forward with enforcing the 340B statute. One factor is the 340B administrative dispute resolution (ADR) process. The ADR process was created to resolve individual disputes between covered entities and manufacturers. However, because HHS has made it clear through an advisory opinion and in other court filings that drug manufacturers are violating the law, Maureen believes that the community pharmacy issue is not appropriate for the ADR process. ADR panels have not yet been appointed, and they will take longer to resolve the issue. Meanwhile, hospitals will continue losing 340B discounts every day. Maureen recommends that hospitals file overcharge notices with the Health Resources & Services Administration (HRSA) to demonstrate the harm caused by these restrictions and continue documenting all losses when refused 340B discounts. Hospitals also should continue contacting their members of Congress to ask them to reach out to the new administration on this issue.
Attempts to Turn 340B Into A Rebate Model
Maureen explains that while no concrete action has taken place, Kalderos, a drug manufacturer consultant, is marketing a new rebate system where 340B discounts are not provided when the drug is purchased but are later given as a rebate. This would result in higher upfront costs and would put covered entities at risk for a loss of access to 340B savings should the manufacturer not grant the rebate. 340B always has operated as an upfront discount per the direction of HHS, so 340B Health is advocating that HHS prevent this proposal from moving forward, Maureen explains.
Payers and PBMs Making Mandatory Changes to Claims Processes
Express Scripts recently notified 340B hospitals that they want providers to identify which claims are 340B. The company says this can be done either by placing a modifier on the claim when dispensing the drug or retroactively by using a transaction known as N1. While Express Scripts has said they are not planning to reduce reimbursements, Maureen explains that it is concerning that the company gives no clear reason why 340B drug claims must be identified and treated differently than non-340B drugs. 340B Health and the 340B Coalition, representing 340B providers at different types of covered entities, have written to Express Scripts about the concerns with this issue. 340B Health also has been communicating concerns about the policy to members of Congress.
Separately, Humana has notified 340B hospitals about plans to reimburse hospitals less for 340B drugs than non-340B drugs, which undermines the intent for safety-net hospitals to provide more care to low-income and rural populations through 340B savings.
Positive Developments on Advocacy
Maureen discusses 340B Health’s recent Virtual Hill Day, which included more than 300 individuals from 340B Health member hospitals meeting with more than 250 congressional offices. 340B Health members focused on all the issues Maureen analyzed earlier in the episode, including Medicare Part B cuts to 340B hospitals and DSH hospitals losing 340B eligibility due to the pandemic. 340B Health members shared Impact Profiles about their 340B savings and how they use them. Maureen also gives a preview of what to expect at the 340B Coalition Summer Conference in July.
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 would like us to cover in this podcast, please email us at podcast@340bhealth.org.
Resources
- New York Delays Medicaid Pharmacy Benefit Transfer for at Least Two Years
- Stop 340B Cuts – Drug Manufacturers Are Refusing to Provide Required 340B Discounts
- Express Scripts Granting Extensions on 340B Claims ID Mandate
- 340B Health Virtual Hill Day Video
- 340B Coalition 2021 Summer Conference
April is National Cancer Control Month, and this week we are joined by Dr. Gerold Bepler, president and CEO at the Barbara Ann Karmanos Cancer Institute in Detroit. Dr. Bepler discusses the unique role cancer centers play in preventing and treating cancer, the importance of 340B to Karmanos and its patients, how Karmanos is addressing racial and ethnic disparities in cancer treatment, and the partnership it has formed to expand access to cancer research and treatment in rural communities. Before the interview, we recap 340B Health’s recent virtual Hill Day.
The Karmanos Comprehensive Approach to Cancer Research and Treatment
The Karmanos Cancer Institute is one of 51 National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers. Karmanos has a comprehensive integrated organization that conducts research to evaluate how cancer grows and progresses, develops new targets, provides access to new drugs, and leverages early detection and prevention programs. Karmanos also has developed a genetic counseling program and a clinical trial program. Dr. Bepler shares that 15-20% of Karmanos patients are uninsured or underinsured and another third rely on Medicare.
340B Is Improving Access to Cancer Treatment
Karmanos’s main Detroit location is a disproportionate share hospital (DSH). 340B helps it to purchase highly effective cancer drugs that often can be $10,000-$15,000 per month. Dr. Bepler explains that Karmanos has established a specialty pharmacy that uses 340B savings to provide direct financial assistance to help patients in need cover the gap between what their insurer pays and the cost of the medication to the patient. In 2020, Karmanos provided $1.7 million in patient assistance through this specialty pharmacy. 340B also helps fund follow-up support that Karmanos pharmacists provide patients on the medications they need for their cancer treatment.
Ongoing 340B Issues Affect Cancer Treatment
Drug manufacturers’ refusals to provide 340B discounts on drugs dispensed at community pharmacies have had a detrimental effect on cancer patients. Karmanos has had to help some rural patients find alternative medications to replace the ones they have lost access to, and this risks a reduction in medication adherence. Dr. Bepler also discusses how cancer and rural hospitals are unable to access 340B discounts on orphan drugs when they are used for off-label purposes or to treat common conditions.
How Cancer Centers Advocate for 340B
Karmanos collaborates with several associations to advocate for 340B, including the Association of American Cancer Institutes (AACI). Dr. Bepler discusses that it is critical to be part of a larger organization that has power to affect and understand legislative action regarding 340B compliance.
Addressing Disparities in Cancer Prevention and Treatment
Dr. Bepler explains that different racial and ethnic groups have unique risks in developing cancer and that cancer may behave in different ways biologically. Karmanos conducts research to understand these biological differences and investigate if they require new drug development. Karmanos also has established an Office of Cancer Health Equity and Community Engagement to communicate directly with community leaders and understand the priorities of the communities it serves. They then match these needs to the development of screening, treatment, and early detection programs to reduce cancer risk and improve outcomes for diagnosed patients.
Bringing World-Class Cancer Research and Treatment to Rural Communities
Because NCI-Designated Comprehensive Cancer Centers are usually in metropolitan areas, more effort is required to reach rural patients with the latest treatments. Karmanos partnered with McLaren Health, a community-based health network. They work together to improve the quality of cancer care in rural communities and provide expedited access to newer treatments. Dr. Bepler shares that quality of care has improved and enrollment in clinical trials has increased five-fold in recent years in the rural communities they serve together.
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 would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- 340B Health Virtual Hill Day Video
- 340B Health’s Staffing 340B Webinar
This week we are joined by Amanda Sellers Smith, the assistant counsel for 340B Health. While 340B is a federal program, it is intertwined with Medicaid and states’ oversight of the health care marketplace. Amanda discusses how states are protecting 340B covered entities from discriminatory reimbursement, why changes to state Medicaid policy can affect 340B in multiple ways, and how listeners can advocate for 340B at the state level. Before the interview with Amanda, we recap the results of the newly released 340B Health annual survey of 340B hospitals.
How States Can Protect 340B Hospitals
Some pharmacy benefit managers (PBMs) have attempted to cut reimbursement for covered entities on 340B drugs. This ignores the intent of 340B drug pricing to enable covered entities to buy drugs at a discounted price and be reimbursed at the regular reimbursement rate. However, the 340B statute does not protect against PBMs making discriminatory reimbursements. Some states, including Utah, Ohio, Montana, and West Virginia, have passed anti-discriminatory laws. Regarding the ongoing issue of drug manufacturers’ refusals to provide 340B discounts on drugs dispensed at community pharmacies, Amanda explained that state officials can serve as key, high-profile advocates to the federal government.
The Intersection of 340B and Medicaid
The intersection of Medicaid and 340B policy has become the most significant 340B policymaking area in states. Congress decided that when a drug is purchased at the 340B price, the drug is not subject to the Medicaid rebate. This leads to debate on whether covered entities or states should receive the benefit.
States want the financial benefit of Medicaid drug rebates, and some states transfer the pharmacy benefit from Medicaid managed care into Medicaid fee-for-service. This transfer ties reimbursement to actual acquisition costs, and 340B covered entities no longer can negotiate the higher Medicaid reimbursement rate. This is happening in states such as California and New York. Other states are choosing a single PBM to administer the Medicaid managed care program. These policies are not focused on 340B, but covered entities in Ohio and other states have shared concerns with state policymakers that a single PBM for Medicaid managed care means the PBM has the power to set reimbursement at a rate that results in cuts to 340B savings. Another major trend is the use of mandatory carve-outs, where the state declares certain or all 340B drugs to be ineligible for Medicaid patients. Examples of states pursuing these policies include South Dakota, Massachusetts, and Louisiana.
How to Advocate at the State Level
Amanda recommends providers demonstrate to state lawmakers why the 340B drug pricing should remain with covered entities. Every state’s legislature operates differently, but advocacy work can be done through sharing how 340B savings are aligned with program intent and are used to benefit the community. It also is important to engage with local media, state Medicaid agencies, and anyone in charge of state-level advocacy within a covered entity.
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 would like us to cover in this podcast, email us at podcast@340bhalth.org.
Resources
- 2020 340B Health Annual Survey Report
This week we are joined by Dr. John Carlo, CEO of Prism Health North Texas. Prism Health is a Ryan White Clinic, which are grantees of the Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS program. They provide care to patients at risk of or living with HIV/AIDS and are one of 16 types of 340B covered entities. John discusses 340B’s role in Prism Health’s ability to care for patients, how Ryan White Clinics work together with 340B hospitals, how they are serving patients during the pandemic, and the latest innovations in HIV care. Before the interview, we share important updates related to drug company denials of 340B discounts to covered entities that partner with community pharmacies.
How 340B Savings Help Ryan White Clinics Serve Patients
Prism Health’s primary focus is on providing care and effective treatment for uninsured or underinsured patients at risk of or living with HIV/AIDS. As a Ryan White Clinic, Prism Health receives federal funding through the HRSA Ryan White HIV/AIDS program. John shares that this funding is not sufficient to cover the increasing number of people who need access to services. HIV medications are expensive, and the 340B program enables clinics to purchase more medications for uninsured and underinsured patients. The 340B savings also enable Prism Health to provide wraparound services including transportation access, case management, and behavioral health services.
Ryan White Clinics and 340B Hospitals Working Together
John describes Ryan White Clinics as part of a “medical neighborhood” for underserved patients along with 340B hospitals and other covered entities. Ryan White Clinics partner with 340B hospitals to ensure their patients have access to tertiary care, specialty care, diagnostics, and imaging, which are resources Ryan White Clinics do not have. In turn, 340B hospitals will refer patients who come to the hospital with HIV-related medical complications to Ryan White Clinics to maintain primary care services after they are discharged.
Drug Manufacturers’ Denial Of 340B Discounts and the Impact on HIV/AIDS Patients
John shares that drug manufacturer denials of 340B discounts to covered entities when drugs are dispensed at community pharmacies have a detrimental effect on care delivery for patients. The manufacturers have threatened to stop providing the discounts to Prism Health, which relies on community pharmacy partnerships because many of its patients are not local and live in rural areas. John explains how this decision from drug manufacturers risks access to prescription drugs for uninsured and underinsured patients and harms patient care.
The Effects of the COVID-19 Pandemic on HIV Care
Due to the pandemic, fewer patients are going to Prism Health to receive care and access needed medications. This can lead to a higher risk of patients contracting HIV and patients living with HIV experiencing disease progression or transmitting the disease to others. John discusses how Prism Health’s case management team takes several steps to provide outreach to patients who are missing appointments and prescription pickups, including having mobile teams go into neighborhoods and working with partners in housing and homelessness. The additional time and resources spent to accomplish this is another example of why 340B savings are needed to augment government grant funding.
Preventing HIV And the Future OF HIV/AIDS Care
Prism Health also works with patients who are at risk of HIV through pre-exposure prophylaxis (PrEP). Under the Ryan White Act, grant funds only can be used to provide care for someone living with HIV, so 340B is critical for supporting access to PrEP. John shares that Prism Health has used 340B savings to launch a program that provides PrEP to patients with sexually transmitted diseases, because these patients are at higher risk for HIV. John says ending the HIV/AIDS epidemic this decade is possible but will take substantial commitment, resources, and funding to support HIV/AIDS prevention and continued care for patients living with the disease.
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 would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- HHS Response to Eli Lilly Motion for Preliminary Injunction Regarding Administrative Dispute Resolution
- Statement on Court Dismissal of 340B Community Pharmacy Lawsuit
- Majority of U.S. House Backs Efforts to Protect 340B from Unlawful Drug Company Actions
- Prism Health North Texas
- 340B Coalition Winter Conference
This week we continue our two-part series focused on how 340B hospitals are pursuing health equity. In our recently released Health Equity Report, 340B Health profiled nine hospitals working to eliminate health disparities in their communities. Today, we continue sharing the stories of three hospitals from that report. For this episode, we are broadcasting from our virtual booth in the exhibit hall at the 340B Coalition Winter Conference that started Feb. 16 and will run through Feb. 24.
After we recorded this episode, a federal judge granted the government’s motion to dismiss a joint lawsuit that 340B Health and other plaintiffs had filed over drug company refusals to offer 340B pricing on drugs dispensed at community pharmacies. Read our statement about the decision, and we will provide additional analysis of the decision in upcoming episodes.
We sit down this week with health equity leaders from each of the three hospitals: Rukiya Curvey Johnson, director of community health and engagement at Rush University System for Health in Chicago; Dr. Cheryl Clark, director of health equity, research and intervention at Brigham and Women’s Hospital’s Center for Community Health and Health Equity in Boston; and Greta Todd, executive director of diversity inclusion and community affairs at St. Louis Children’s Hospital.
How Data Collection Identifies Disparities
Rush implemented a data-driven approach to identify health disparities within Chicago communities. Curvey Johnson explains how Rush uses assessments and metrics to determine priorities and progression of strategies. Dr. Clark shares how data were critical for Brigham and Women's Hospital in addressing disparities in the COVID-19 pandemic. Data informed the hospital more about the diversity within their community. To ensure culturally appropriate conversations, they purchased technology that enabled providers to communicate with patients in their preferred languages.
Setting Measurable Goals Supported with Data
With the use of timely data, 340B hospitals are setting goals relevant to their communities. Rush uses their data to help reduce the life expectancy gap in specific Chicago neighborhoods by focusing on education, access to care, and resources for managing chronic disease. Todd explains how St. Louis Children’s Hospital used data from employee engagement surveys to create a safe, inclusive environment for Black nurses in the hospital workforce.
Learning Cultural Competency
One way St. Louis Children’s Hospital pursues health equity is with cultural competency training for the hospital workforce, including senior leadership. Todd believes that cultural competency can help providers better understand and communicate with patients of diverse backgrounds. Todd shares stories of how unconscious bias can affect care for patients of color and the important role the hospital supply chain has in addressing disparities.
Collaboration and Courage Is Necessary to Overcome Health Equity Challenges
Curvey Johnson explains that pursuing health equity is hard work and must involve senior leadership. Collaboration with local and national organizations also is crucial for eliminating racial and ethnic disparities in health care.
Dr. Clark says providers need to collect more data to better understand the needs of people with disabilities as well as individuals with different sexual orientations and gender identities.”
Todd recommends that those working to pursue health equity ground themselves in the data that support this mission to demonstrate to stakeholders why it is critical to eliminate disparities.
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 would like us to cover in this podcast, email us at podcast@340bhealth.org.
Resources
- 340B Insight Episode 20: Pursuing Health Equity
- 340B Health Equity Report
- 340B Health Equity Report Infographic
- 340B Health Webinar: The ADR Final Rule & Its Implications for Hospitals
- 2021 340B Coalition Winter Conference
This week, we begin a two-part series focused on how 340B hospitals are pursuing health equity. The COVID-19 pandemic has spotlighted the significant racial and ethnic disparities in health care and patient health outcomes. Today, we focus on three hospitals featured in 340B Health’s recently released health equity report and hear more about how they’re working to eliminate health disparities in their communities. Before we launch into the episode, we answer a member question about the many lawsuits that have been filed related to disputes over 340B contract pharmacies.
We sit down with representatives from three hospitals: Dr. Cheryl Clark, director of health equity, research and intervention at Brigham and Women’s Hospital; Rukiya Curvey Johnson, director of community health and engagement at Rush University System for Health in Chicago; Julia Bassett, manager of health and community benefit at Rush; and Greta Todd, executive director of diversity inclusion and community affairs at St. Louis Children’s Hospital.
Why Health Equity Matters
340B hospitals are integral elements in the movement to reduce health disparities in the U.S. Dr. Clark explains why health equity is essential and defines the concept as the ability for all people to reach their optimal health without barriers such as reduced access to care and lack of affordability. Curvey Johnson discusses that 340B hospitals serve vulnerable, underinsured, and uninsured populations and should be part of a multi-sector collaboration to address health equity. Todd references health care’s core mission to “do no harm” and affirms that all hospitals should be working to prevent the harm of health disparities.
COVID-19’s Disproportionate Effect on People of Color
African Americans and Hispanic people experience higher infection rates and deaths from COVID-19. Brigham and Women’s Hospital acted on this by creating the COVID-19 Equity, Diversity and Community Health Response team. The team’s efforts included ensuring equity in participation for the hospital’s remdesivir research trial. Dr. Clark believes recruiting clinicians and staff from diverse backgrounds to create trustworthy, culturally sensitive environments was critical to ensuring that trial participants represented the same patient demographics as the community Brigham and Women’s serves.
The Connection Between Health Equity and Social Determinants
Identifying and addressing social determinants are critical to the pursuit of health equity. Brigham and Women’s Hospital participates in the Massachusetts Accountable Care Organization, serving patients with public insurance. As part of its participation, the hospital places a strong focus on the need to screen patients for social determinants and then connect them to needed services. Brigham and Women’s implemented best practices during the pandemic that it learned prior to COVID-19, including by screening for social determinants at COVID testing sites. Rush University System for Health screens patients for food insecurity and uses some of their 340B savings to deliver healthy meals to community members. St. Louis Children’s is using mobile pediatric units to remove barriers to transportation that make it difficult for families to travel to clinics for services that include hearing and vision screenings, immunizations, asthma treatment, diabetes services, and dental care.
Stay tuned for our next episode as we explore other key trends in 340B Health’s new equity report.
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 would like us to cover in this podcast, email us at podcast@340BHealth.org.
Resources
- 340B Health Equity Report
- 340B Health Equity Report Infographic
- 340B Health Manufacturer Updates Page
- Stop 340B Cuts
- 2021 340B Coalition Winter Conference
This week we are joined by Scott Milner, senior director of pharmacy, business development, purchasing, 340B, and infusion services at St. Luke’s Health System in Idaho. Scott shares his personal experiences on how the health system has been finding ways to overcome COVID-19 vaccine distribution challenges and describes how the effort has become a personal mission for him. Prior to the interview, we discuss in our news update segment how drug companies are suing HHS in response to the department’s advisory opinion on 340B contract pharmacies. When we recorded the episode, three companies had filed such lawsuits. Since then, a fourth company also has gone to court over the issue.
Preparing for the COVID-19 Vaccine
Scott shares his and his colleagues’ reactions to the exciting moment when they received the news that the vaccine had arrived at the hospital. To be prepared for the first delivery, decisions were made quickly without knowing full details about the vaccines. St. Luke’s acquired extra needles and syringes in case they were not provided with the doses. After learning what temperatures were needed to store vaccines, they purchased ultra-low freezers and ensured they had enough generator power. Preparation occurred while the hospital continued making pharmacy decisions to support the treatment of COVID-19 patients.
Overcoming Distribution Challenges
St. Luke's must track who is first eligible to receive the vaccine and ensure all eligible patients who request a dose receive it. They monitor this by using appointments. The initial vaccine deliveries were delayed in arriving due to the holiday season, so when St. Luke’s received the first shipment, they immediately enlisted their medevac helicopters to deliver the vaccines to their other locations throughout the state. Scott also noted the extra hours hospital staff and volunteers have worked as being key to smooth operation of the vaccine clinics.
Ensuring No Community is Overlooked
St. Luke’s has critical access facilities, a sole community hospital, and disproportionate share hospitals in Idaho. Scott explains that they treat many uninsured and underinsured patients, many of whom work several part-time jobs. The 340B assist program allows the system to provide 1,800 patients with access to medication cost assistance. St. Luke’s also has been working with remote rural communities with smaller numbers of patients and staff and limited access to equipment and storage space to grant them access to the optimal amount of COVID-19 treatments and vaccines.
One COVID-19 Vaccine Side Effect is Hope
Scott shares a personal story of why working on vaccine distribution is so meaningful to him and why he is eager to educate and support people who are uncertain about receiving the vaccine. He believes the most important “side effect” of COVID-19 vaccines is hope.
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 would like us to cover in this podcast, email us at podcast@340BHealth.org.
Resources
- 340B Health Analysis of Drug Manufacturers’ Lawsuits Against HHS
- 340B Insight Episode 14: The Biden Administration, New Congress, and 340B
- Scott Milner’s Video of the Phone Call Announcing the Arrival of the COVID-19 Vaccine
- Faces of 340B: St. Luke’s Health Patient Kathleen Cavanagh
- 340B Health Advocacy Webinar: A New Congress and Administration. What Does This Mean for 340B?
- 340B Coalition 2021 Winter Conference
This week we are joined by Steven Miller, vice president of pharmacy services at 340B Health. Steve discusses Health Resources & Services Administration (HRSA) audits of 340B hospitals and shares practical advice for how hospitals can best prepare, including the resources that are available to them. Prior to the interview, we provide a major news update you might have missed during the holiday season on the ongoing 340B contract pharmacy issue.
HRSA Audits 101
In 2015, HRSA started auditing 200 covered entities each fiscal year, with 155 of those covered entities being 340B hospitals. HRSA uses an algorithm to determine 90% of the covered entities to audit. The more 340B purchases, child sites, and contract pharmacies an entity has, the more likely they are to be audited. The other 10% of audits focus on complaints from 340B stakeholders or on covered entities that had previous audit findings. Steve explains that auditors are usually pharmacists and have an in-depth knowledge of the 340B program.
Data Are Important
Steve explains that hospitals must have a clear understanding of their data and how they connect between departments and relate to 340B eligibility. Software resources, third-party vendors, and split-billing tools can help hospitals monitor these data. It is important for the data to be clean and well-organized.
Following Policies and Procedures
HRSA also will assess if covered entities are following their institutional policies and procedures. This is because the policies and procedures are considered the standard for any aspect of compliance that is not explicitly addressed in the 340B statute. The policies and procedures should be aligned with HRSA enforcement.
Internal Auditing vs. External Auditing
340B hospital staff conduct internal audits to ensure their data systems’ logic and filters are working as they should. HRSA expects hospitals to review their own systems and data routinely. Internal auditing can be biased, because the staff works in 340B operations and thus can accidentally miss how the system is working. That is why external auditing allows the hospital to obtain a more objective report. Steve explains that this can reassure the hospital, especially in addressing problems that might not be found in the internal review. Steve suggests hospitals conduct internal reviews weekly or monthly and external audits once a year.
Resources for Preparing for Audits
340B Health has policy guides, compliance resources, and audit trends for hospitals to use in preparation for an audit. Steve encourages 340B Health members to contact 340B Health when they learn of an upcoming audit for a technical assistance call. 340B hospitals also should reference the website of the HRSA Office of Pharmacy Affairs (OPA). The HRSA Prime Vendor also provides additional resources.
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 would like us to cover in this podcast, email us at podcast@340BHealth.org.
Resources
- Office of the HHS General Counsel’s Advisory Opinion on Contract Pharmacies Under the 340B Program
- 340B Health and National Hospital and Pharmacists’ Organizations Lawsuit against HHS
- www.stop340bcuts.org
- 340B Health Compliance Resources
- 340B Coalition 2021 Winter Conference
In our final episode of 2020, we are joined by Maureen Testoni, the president and CEO of 340B Health. Our episode follows up last week’s bonus episode on 340B Health’s recent joint lawsuit against the Department of Health and Human Services regarding drug manufacturers’ refusals to provide 340B discounts when drugs are dispensed at community-based contract pharmacies. Maureen provides additional analysis on the issue and discusses her concerns with how some drug companies are attempting to change 340B into a rebate program. She also discusses the role 340B has played in helping hospitals respond to the COVID-19 pandemic this year.
340B Savings Help Hospitals Fight COVID-19
340B hospitals are using 340B savings during the pandemic to expand care to patients through telehealth and enhanced medication therapy management services. Maureen shares stories of hospitals throughout the country that have expanded services to reach more chronically ill patients in need or to secure the additional beds they need to care for COVID-19 patients. HRSA’s extended flexibilities to 340B are key in helping hospitals provide more services and avoid drug shortages.
Steps Hospitals Should Take When Drug Companies Refuse to Provide 340B Pricing
If drug manufacturers overcharge or refuse to provide 340B discounts to covered entities on drugs dispensed to contract pharmacies, Maureen strongly recommends the affected hospitals file notices of overcharge with HRSA to start the process of enforcement. Advocacy outreach to the new administration and new Congress also will be necessary for educating policymakers about 340B and the threats to the program posed by drug manufacturers not following the statute.
Manufacturers Attempt to Convert 340B Into Rebate Program
Maureen shares her concerns about drug companies working to convert 340B into a rebate program. She says a rebate process would make it very expensive for covered entities to access 340B savings, as they would have to pay for the drugs at the higher wholesale acquisition cost. With this model, manufacturers also potentially could deny the rebate, and there would be no clear process for hospitals to appeal. 340B Health has communicated its concerns about drug manufacturers converting 340B into a rebate program to HHS and has urged the agency to block such a move. Nearly half the members of the House of Representatives sent a letter to HHS expressing its concerns about the issue. Maureen also recommends 340B hospitals review with their counsel the terms and conditions presented by any drug manufacturers asking them to participate in a rebate program.
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:
- BONUS 340B INSIGHT EPISODE: TAKING THE 340B CASE TO COURT
- Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals Of 340B Discounts
- State Attorneys General Letter to HHS Regarding Drug Manufacturer Denials of 340B Discounts
- Nearly Half of U.S. House of Representative Oppose Move to Convert 340B Into a Rebate Program
- 340B Health Webinar: 340B & the Courts: How Lawsuits Shape 340B Enforcement
This week we have a breaking news bonus episode of 340B Insight. 340B Health President and CEO Maureen Testoni joins us to discuss the filing of a lawsuit against the Department of Health & Human Services with four other national hospital organizations, a national pharmacist’s organization, and three individual 340B hospitals, seeking to halt drug companies’ refusals to provide 340B discounts to hospitals on covered drugs dispensed at community-based contract pharmacies.
Manufacturers’ Actions are Unlawful A group of major drug companies have taken unilateral actions to refuse to provide 340B pricing, and the federal government has failed to act to enforce the law. As a result, 340B Health, four other national hospital organizations, a pharmacist organization, and three individual 340B hospitals have filed a lawsuit in the U.S. District Court for the Northern District of California.
What the Lawsuit Asks the Court to Do 340B Health and the other joint plaintiffs will demonstrate to the court that HHS has the authority and the responsibility to enforce the 340B statute to protect safety-net hospitals and patients. The lawsuit asks the court to order HHS to require drug manufacturers to provide 340B pricing on covered drugs dispensed to community-based contract pharmacies and refund to 340B hospitals the money that they lost because of the manufacturers’ actions. The complaint also asked for an order requiring HHS to refer the matter to the Office of the Inspector General for potential civil penalties.
Could a New Administration Affect the Case? Maureen says 340B Health will be educating the incoming Biden administration about the matter of drug manufacturers not complying with the 340B statute. The issue could be resolved quickly if the next HHS Secretary enforces the 340B statute, which would result in drug manufacturers having to provide 340B discounts again when drugs are dispensed at community-based contract pharmacies.
Tune in Next Week for More Analysis Maureen will join us again next week for our final podcast episode of 2020 to provide additional analysis of what comes next in responding to drug companies continued attacks on 340B as well as other issues that have affected 340B hospitals in 2020.
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
- Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals Of 340B Discounts
This week we are joined by Danielle Sestito, system director for the 340B program at Northwell Health in New York. Northwell Health is New York’s largest health system and was one of the systems most affected by the initial COVID-19 outbreak last spring. Danielle shares how Northwell responded to the initial outbreak and how it has prepared for a resurgence. She also discusses how the health system has avoided drug shortages while maintaining 340B compliance and the importance of HRSA’s 340B regulatory flexibilities during the public health emergency. Prior to the interview, we share updates on how some of the Trump administration’s final health care actions could affect 340B.
Clinical Challenges in the Pharmacy
During Northwell’s treatment of 3,500 inpatients for COVID-19 in April, providers grappled with the lack of evidence-based therapeutics and FDA-approved medications. Danielle shares how Northwell responded by developing a clinical guidelines committee and expanding clinical privileges to pharmacists, both of which resulted in improved patient health outcomes.
The Scramble to Purchase Drugs
Like all providers, Northwell was tasked with creating processes to ensure they avoided drug shortages. HRSA’s regulatory flexibilities for the 340B program allowed hospitals to purchase drugs at 340B pricing for new surge locations if they maintained program eligibility. In certain cases, drugs also could be purchased via GPO accounts, something that could not be possible prior to the pandemic. Thanks to the best practices they implemented, Northwell has avoided drug shortages.
340B Supporting Patients Under Financial Duress
Danielle explains that 340B savings are critical for helping patients during the pandemic. 340B enables Northwell to offer medication therapy management services, including follow-up calls, to ensure patients are adhering to their medications. The need for these programs has increased during the pandemic. Northwell also provides discounts on medications to qualified patients who have become uninsured or have low incomes.
Lessons Learned
Pharmacists need a very calculated approach in preparing for the winter COVID-19 surge. Danielle recommends frequent calls with drug procurement buyers and pharmacy directors in outlining plans for purchasing drugs, as well as constant communication with buyers on how many COVID and vented patients are in the hospital. Leveraging data analytics and estimating the run rates of drugs is crucial to avoid drug shortages. Danielle also discusses how Northwell is preparing for distribution of COVID-19 vaccines.
Telemedicine is Here to Stay
Danielle praises the role telemedicine and mail-order pharmacies have played in helping patients with chronic diseases access health care services and medications. Hospitals still will receive 340B credit for telemedicine visits if the visit meets 340B eligibility standards. Mail-order pharmacies will help patients with chronic diseases access medications even it they cannot leave their homes due to the pandemic or other health challenges.
Check out all of our episodes on the340B 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
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Most Favored Nation Pricing Could Trigger 340B Medicare Rate Cuts Starting in 2022
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Final PBM Rebate Rule Has Uncertain 340B Implications
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United Therapeutics is Fifth Drug Maker to Restrict 340B Contract Pharmacy
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Northwell Health
This week, we speak with Rodney Whitlock, former legislative staffer for Republicans on Capitol Hill and Jeremy Sharp, a former Capitol Hill and executive branch staffer for Democrats. Rodney and Jeremy discuss with 340B Health’s Kathryn DiBitetto how the incoming Biden administration and new Congress might affect the 340B program. The conversation also discusses what the congressional lame-duck session before the end of the year will mean for 340B and how hospital advocates should be preparing for the new administration and new Congress. Prior to the interview, we share news updates, including a bipartisan House of Representatives letter to HHS Secretary Alex Azar regarding pharmaceutical company attempts to turn 340B into a rebate program.
Congress’s Lame-Duck Session and 340B: While it’s not likely there will be new legislation affecting 340B before 2021, Jeremy and Rodney advise 340B professionals to be watchful. Congress has many issues it must resolve in roughly 20 days, including government funding, extension of certain health programs, and a potential COVID-19 stimulus package.
President-Elect Biden’s Potential Approach to 340B: Safety-net hospitals are highly relevant in some of President-Elect Biden’s priorities — including controlling the pandemic, increasing access to and affordability of health care, and achieving racial justice and equality.Jeremy speculates that the Biden administration will be less friendly to the pharmaceutical industry. He believes the Biden administration is going to view drug manufacturers’ attacks on 340B contract pharmacies and manufacturers’ attempts to turn 340B into a rebate program as the pharmaceutical industry trying to write its own rules to avoid the law. Still, 340B advocates will need to educate the administration on these issues.
What will Happen to the 340B Medicare Part B Cuts? After the Trump administration’s Medicare Part B cuts to 340B hospitals, a new administration could make changes, but Rodney emphasizes that would take time. As it considers the Medicare Part B cuts, the Biden administration also will be focused on Medicare’s impending solvency date and how all payment policies must be considered with that in mind.
The Future of Drug Pricing Policy: Major drug pricing legislation will face an uphill battle passing through a potentially divided Congress in the event that Democrats control the House and Republicans maintain control of the Senate. Still, with the addition of new congressional committee leaders and with the Biden administration having some options to act on its own, Rodney and Jeremy say that some action on the issue could occur.
Advice for Advocating to the New Congress: Advocacy and outreach to new members of Congress and new congressional staff will be crucial. These new members of Congress and their staffs need to learn about 340B and how it helps safety-net hospitals fulfill their mission.
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
- House of Representatives Letter to HHS Secretary Alex Azar Regarding 340B Rebate Model
- Statement Regarding Novartis Cutting Off Access to 340B Pricing Through Community- based Pharmacies
- The Health Policy Breakroom
- 340B Twitter Chat
For this episode of 340B Insight we speak with Alan Morgan, CEO of the National Rural Health Association. Alan previews National Rural Health Day on November 19, discusses how rural hospitals are faring during the COVID-19 pandemic, the future of rural hospitals, the role of 340B to help hospitals stay afloat, and why drug manufacturers attacks on contract pharmacies are detrimental to rural hospitals and their patients. In our news segment prior to the interview, we recap how Novartis has become the fourth drug manufacturer to block 340B discounts when drugs are dispensed at some contract pharmacies. We also celebrate the 340B program’s anniversary.
National Rural Health Day National Rural Health Day is November 19. On this day, the rural health community comes together to celebrate the importance of rural health. It is a great reminder of what’s working in health care for these communities. NRHA asks folks to promote the positive stories on social media and other digital platforms.
340B Keeps Rural Hospitals Afloat With 48% of rural hospitals operating at a loss back in the first week of April, many of these health care providers were struggling to stay afloat. Recent research from 340B Health found that more than 75% of rural hospitals depend on 340B savings to keep their doors open.
Rural Hospitals During the Pandemic A rise in COVID-19 cases has forced hospitals to stop scheduling elective and other non-emergency procedures, which account for 70-75% of revenue for rural hospitals. As a result, many of these facilities do not have the capacity or resources to manage the new surge of cases sweeping the nation. However, these hospitals have responded by collaborating and networking with peer hospitals to share supplies and efficiently transfer patients to facilities with additional resources.
Innovations That Have Helped Rural Hospitals Alan touches on the benefits and advances in telehealth, which have been critical and will continue even after the pandemic ends. He discusses the positive effects of rural hospitals and their CEOs reaching out to and communicating with their communities about the pandemic and public health.
Drug Manufacturers’ Attacks on Contract Pharmacies Affect Rural Hospitals and their Patients Drug manufacturers are refusing to provide discounts to 340B hospitals when drugs are dispensed at contract pharmacies. Alan says this is terrible for rural hospitals and their patients. In many communities, rural patients rely on contract pharmacies to receive their medications and other pharmacy services. The drug manufacturers’ actions put this at risk as well as the ability for rural hospitals to access their 340B savings. As a result of the pandemic, many people are moving to more rural areas and need access to care in these communities. This is why NRHA is advocating for rural hospitals to provide outpatient services, keep open a 24/7 emergency department, and use telehealth, while eliminating the requirement for inpatient beds.
Episode Resources:
1.340B Health Statement Regarding Novartis Cutting Off Access to 340B Pricing Through Community-based Pharmacies
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Letter to HHS Secretary Alex Azar from More than 60 Advocacy Organizations for Patients and Social Justice
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340B Health President and CEO Maureen Testoni’s 340B Anniversary Video Message
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National Rural Health Day
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340B Health Webinar: What the 2020 Election Means for 340B
In this episode, we speak with Julie Clements, Director of Health and Clinical Affairs at the University of California Office of Federal Government Relations. Clements details why advocating for 340B is critical, how health care professionals can engage in advocacy, and how advocacy has changed during the COVID-19 pandemic.
The Importance of Health Care Professionals Advocating For 340B: Clements discusses how important it is for those who work with the 340B program every day, such as pharmacists and other health care professionals, to provide their first-hand experiences to policymakers on how beneficial 340B is to patients. She and her government relations colleagues partner with health care providers and other health system colleagues, such as communications professionals, to share how University of California is a good steward of the program. Health care providers advocating directly about the program to policymakers is the best way for them to understand how the 340B program works.
Educating Policymakers on 340B: Julie discusses how one of the greatest advocacy challenges is helping policymakers understand how 340B works. A couple of years ago, University of California had one of its chief pharmacists testify on Capitol Hill to educate policymakers about the program and answer their questions. The chief pharmacist discussed how safety-net hospitals rely on 340B and how they use their program savings. Julie heard positive feedback about the testimony the chief pharmacist provided and how it helped members of Congress understand 340B better.
Workarounds During COVID-19: Advocacy days also have been productive opportunities to share information to policymakers in D.C. The temporary halt to in-person events drastically altered how advocacy is done. Clements shares that one upside is the ease of setting up virtual meetings to allow for quick one-on-one conversations with members of Congress and their staff rather than long trips to and from Washington D.C. Virtual meetings also provide more opportunities for C-suite executives to participate.
Drug Manufacturers Refuse to Provide 340B Discounts: One of the biggest challenges 340B currently faces is drug manufacturers refusing or threatening to refuse 340B discounts when drugs are dispensed at community pharmacies. Julie said that the timing of the drug manufacturers’ actions is unconscionable considering the ongoing COVID-19 pandemic. The University of California is responding to these actions by continuing to demonstrate to policymakers how the health system is using 340B as Congress intended.
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 Comment Letter to CMS Regarding Proposed 2021 Medicare Part B Cuts
- Webinar: What the 2020 Election Means for 340B
- UC Health
In this episode, we spoke with Dr. Jessica Tilton, the clinical coordinator for the University of Illinois Health Medication Therapy Management Clinic and a clinical assistant professor in the Department of Pharmacy Practice at the University of Illinois at Chicago College of Pharmacy. Jessica discusses the research she and her colleagues have conducted that demonstrates how the clinic is measurably improving patient health outcomes. Prior to the interview, we provide news updates on additional drug manufacturers refusing to provide 340B discounts and the Centers for Medicare and Medicaid Services reviewing comment letters regarding its proposals to make deep Medicare Part B cuts in 2021.
Improving Medication Adherence: The majority of the MTM clinic’s patients are on more than 10 medications and struggle with medication adherence. Jessica and her colleagues spend 60 minutes the first time a patient comes to the clinic evaluating the medications the patient has at home and comparing this to the medications the patient has been prescribed and indicates they are taking. Following the appointment, patients can pick up their medications all at once since the clinic is embedded within the pharmacy.
Disease State Management: Once a patient’s medication adherence challenges are addressed, the clinic’s pharmacists are working with patients on disease state management, primarily for diabetes, hypertension, and asthma. For instance, a patient with blood pressure of 200/150 can be managed weekly in the clinic until their blood pressure is under control, rather than through the emergency department.
340B Savings Create a Robust Clinic: Jessica says that 340B savings enable the Medication Therapy Management clinic to care for many more patients than it otherwise could without this financial support.
Conducting 340B Research: The Medication Therapy Management clinic partnered with the Department of Health Systems, Outcomes, and Policies to conduct its own 340B research to measure how much patients’ health outcomes were improving. The research focused on patients with diabetes and hypertension. The research found that the MTM clinic reduces A1C hemoglobin levels by an average of 0.63% and systolic blood pressure by 8.2 ml. Using modeling, the research also found the decrease in blood pressure reduced cardiovascular events by 10 and increased life years for the cohort of 200 patients by 4.5 life years. Costs to insurers were reduced by $500,000.
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 Statement Regarding AstraZeneca and Sanofi Refusing to Provide 340B Discounts for Drugs Dispensed at Community Pharmacies
- 340B Health Comment Letter to CMS Regarding Proposed Medicare Part B Cuts to 340B Hospitals for 2021
- Webinar: State Policies Impacting 340B Year-In-Review
- University of Illinois Health Medication Management Clinic
- 340B Health Research
340B Health Celebrates American Pharmacists Month
In this episode, we speak with Caroline Steinberg, Vice President of Research and Policy Analytics at 340B Health, about research into the 340B program. For more information about 340B Health’s research, you can review the research page on our website. Before the interview, our news segment covers the latest updates on proposed Medicare cuts to 340B hospitals and 340B Health’s Virtual Hill Day last week.
The Role of Research: Research is vital for educating policymakers about the 340B program to help ensure continuing support for the program. Research also helps demonstrate that the program is vital for safety-net institutions. For example, one study revealed that 60% of uncompensated care is provided by 340B hospitals, even though 340B hospitals are only about 40% of all hospitals. Verifiable data helps combat misinformation the policymakers hear from opponents of the program.
Research Demonstrates 340B’s Importance to Medicaid: The most recent 340B Health research study found that 75% of all hospital care provided to Medicaid patients is provided by 340B hospitals. Partly because of serving a high percentage of Medicaid patients, 340B hospitals have negative margins on average.
340B Hospital Surveys Are Key: 340B Health’s surveys of member hospitals are critical for gauging the impact of policy changes and sharing that information with policymakers. For example, as policymakers continue to discuss drug manufacturer efforts to cut back on providing discounts when drugs are dispensed at contract pharmacies, 340B Health has found that 57% of 340B savings for critical access hospitals come from community pharmacy relationships.
Outside Studies Support 340B’s Value: A recent Medicare Payment Advisory Commission report concluded there was no consistent pattern of higher or lower drug spending between 340B hospitals compared to non-340B hospitals. MedPAC also found that 340B hospitals provide more services to low-income patients, disabled Medicare beneficiaries, and younger patients and that these patient characteristics tend to be linked to higher spending on cancer treatment. Caroline says the research demonstrates that drug company price increases, especially on new drugs, drove prices higher, not the 340B program.
Meanwhile, a new study published this month in the Journal of the American Medical Association authored by an independent policy researcher found that drugs with a higher proportion of sales through the 340B program had a lower rate of price increases.
340B Hospitals Should Conduct Their Own Research: Caroline shares that 340B hospitals have opportunities to conduct their own research. To start a research project, 340B hospitals should determine how 340B savings fund specific programs and then see if they already have data available to gauge the impact of these programs. 340B Health also has launched a grant program to help hospitals conduct their own research.
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:
- Association Between the Percentage of US Drug Sales Subject to Inflation Penalties and the Extent of Drug Price Increases
- 340B Health Templates for Commenting on Proposed 2021 CMS Medicare Cuts
- 340B Health Compilation Research Brief
- MedPAC Report to Congress on 340B
- 340B Health Webinar: Update on Manufacturer Developments
In this episode, we spoke with Nicole Shoquist, Chief Pharmacy Officer for JPS Health Network in Fort Worth, Texas. Nicole described the importance of 340B in meeting the needs of patients experiencing homelessness. Nicole describes JPS’s innovative response to care for these patients during the height of the pandemic that included telehealth and new ways to help patients receive their prescriptions. Prior to the interview, our news update segment provides an update on drug manufacturers refusing to offer 340B pricing when drugs are dispensed at community pharmacies.
340B Savings Stretch Scarce Resources: Prior to COVID-19, JPS Health Network offered primary and some specialty care for the homeless population in Fort Worth, including a mobile van, hepatitis C and HIV clinics, and nurse practitioners in shelters. Nicole emphasized the importance of 340B in making these service offerings possible.
Shelter-in-Place and the Homeless Community: When Fort Worth and Tarrant County issued stay-home orders, regional homeless shelters closed, leaving their residents without access to medical clinics or a place to receive prescriptions. The city then made its Civic Center available to several hundred residents without shelter, and JPS made health care services normally accessed at its clinics and a mobile van available at the Civic Center.
Meeting the Challenge with Innovation: In addition to expanding its care offerings to the Civic Center, JPS installed iPads and phones in private areas there so that residents could take advantage of telehealth offerings. In addition, JPS initiated prescription delivery to the Civic Center.
Maintaining 340B Compliance: JPS worked to ensure it remained complaint with 340B as it delivered care both to patients it had an existing relationship with as well as first-time patients. In some cases, prescriptions were not eligible for 340B due to program eligibility rules.
Best Practices and Silver Linings: The pandemic has led to JPS discovering new best practices for serving a community of underserved patients that can be hard to reach. JPS found that delivering patients their medications rather than asking patients to come to the pharmacy led to improved medication adherence rates and lower hemoglobin A1C and blood pressure levels. As a result, Nicole says many of these best practices are continuing even though the Civic Center shelter operations have closed.
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
- 1,100 + Hospitals Letter to Secretary Alex Azar Urges HHS to Halt Attempts to Undermine the 340B Drug Pricing Program
- 7 Groups Representing Hospitals Letter to Secretary Alex Azar Asking to Enforce 340B Rules
- Drug Manufacturer Updates for Members
- Webinar: Medicare Part B Drug Payment Cuts to 340B Hospitals
- JPS Health Network
In this episode we speak with Maureen Testoni, President and CEO for 340B Health, on new 340B policy developments in recent weeks that include a major court decision and drug manufacturer challenges to 340B contract pharmacies. Prior to the interview, we answer a member question on changes this year to the 340B hospital recertification process.
Some key takeaways from the conversation with Testoni include:
Court Decision Upholds CMS Medicare Part B Cuts: Since 2018, The Centers for Medicare & Medicaid Services (CMS) has cut payments by nearly 30% to many 340B hospitals. Testoni explains how the D.C. Circuit Court of Appeals for the District of Columbia has overturned a lower court decision and has ruled that the government has the authority to continue with the cuts. Testoni shared potential next steps in the case.
CMS Proposes Steeper Medicare Part B Cuts for 2021: Following the D.C. Circuit Court of Appeals decision to allow CMS Medicare Part B cuts to hospitals, Testoni analyzed how CMS’ proposed 2021 Medicare Outpatient Perspective Payment Systems rule could result in an even steeper cut for 340B hospitals. She explained how 340B Health plans to work with members to respond.
Recent Actions by Pharmaceutical Companies: Several drug companies are refusing or threatening to not provide 340B pricing on drugs that will be distributed at a contract pharmacy. Two of these companies are asking 340B covered entities for claims data to be shared with them. Testoni says that these actions violate the 340B statute and that requests for claims data create multiple challenges for covered entities. She also gives insight to what 340B hospitals should do when manufacturers ask for claims data or do not offer 340B pricing on medications purchased for distribution at a contract pharmacy.
Progress on Protecting 340B Hospitals During the Pandemic: For 340B hospitals whose program eligibility is determined by their DSH adjustment percentage, there is concern that changes in payor mix during the COVID-19 pandemic puts them at risk for losing program eligibility. Testoni provides updates on two new bills in Congress that have been introduced to address this problem.
Check out all of our episodes on the 340B Insight podcast website. You can also 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 Recertification Webinar
- U.S. Court of Appeals Decision on CMS Medicare Part B Cuts to 340B Hospitals
- CMS 2021 Proposed Outpatient Prospective Payment System Rule
- Bipartisan Bill Would Protect 340B Status During Emergency
In this episode, we spoke with Dr. Jewel Younge, Clinical Pharmacist at the University of Illinois Hospital & Health Sciences System (UI Health) and Clinical Assistant Professor at the University of Illinois Chicago College of Pharmacy. We invited Jewel on the podcast after she participated in a panel discussion on health care inequalities during the 340B Coalition Virtual Summer Conference in late July. At the start of the episode, we discussed several news updates including a new presidential executive order regarding the 340B program.
Some key takeaways from the conversation with Jewel Younge include:
Jewel’s Path to Pharmacy: Jewel took a nontraditional path to become a pharmacist. Originally the Chair of the Visual and Performing Arts Department at Olive-Harvey College, Jewel sought to expand her horizons by taking chemistry courses. After years of learning and training, she is now a practicing pharmacist and assistant professor at the University of Illinois Chicago College of Pharmacy.
COVID-19 Highlights Health Disparities in the US: Jewel shared data pointing to race and age disparities during the COVID-19 pandemic in Chicago. She notes that the Black and Latinx communities have experienced higher positivity rates and deaths, while deaths for people over the age of 60 are disproportionately high.
Busting Myths: Jewel emphasizes that communities that lack trust in health care systems are suffering from “COVID-19 myths.” For example, many are skeptical that the costs of seeking hospital care for medical conditions during the pandemic outweigh the benefits. She calls on health care professionals to improve outreach and build relationships with these communities.
340B’s Role in Addressing Health Disparities: UI Health provides more than $27 million per year in uncompensated care and has more than $19 million in 340B savings, which in turn is invested in pharmacy services, a medication assistance program, and other services that enhance patient care. Jewel said, “That's really what 340B is all about. Taking a small benefit and turning it into a massive reward for as many people as possible.”
Closing patient care gaps that perpetuate health care disparities in the U.S. will require input and action from safety-net providers. We are fortunate to have leaders such as Jewel who are leading the way toward progress.
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:
- President Trump Signs Executive Order on 340B
- Statement on Congresswoman Doris Matsui and Congressman Chris Stewart on Bipartisan House Legislation to Protect 340B During COVID-19
- Report: The Role of Hospitals in Serving Medicaid and Low-Income Medicare Patients (and accompanying infographic)
- University of Illinois Hospital & Health Sciences System
In this episode, we speak with Sarah Dodson, the 340B Program Director at Ascension Via Christi, the largest health care provider in Kansas. Sarah talks about her work with the Community Cares Clinic, which provides comprehensive and hands-on care for vulnerable patients.
It’s also been a busy news month for 340B. In our news update segment, we discuss a drug manufacturer’s unprecedented new policy for refusing 340B pricing on one of its drugs to a covered entity that will be distributing that drug through a contract pharmacy. We also discuss new, bipartisan pro-340B legislation that has been introduced in the U.S. Senate.
A Collaborative Approach for Patients: Community Cares Clinic is one of five services offered by Ascension Via Christi that work together to address the barriers and other challenges to patient health care.
Hands-On Health Care Services: The Community Cares Clinic is a nurse practitioner house-call model that sends nurse practitioners to the homes of patients with COPD or heart failure once per month or more frequently if needed. The service also includes access to a 24/7 telephone line for patients to speak with a nurse practitioner from the program. This helps a patient’s care team understand factors affecting patients outside of the hospital setting. With more knowledge about a patient’s lifestyle and environment, health care providers can offer personalized and targeted care. These efforts in tandem with other models of care have resulted in significant reductions in avoidable hospital admissions over the past few years.
The Role of 340B in the Community Cares Clinic: The savings generated by Ascension Via Christi’s 340B participation support the Community Cares Clinic, as well as the other four model services with which it partners.
Replicating the Community Cares Clinic Model: Other hospitals looking to start programs like Community Cares should first identify key barriers for their patients such as the inability to leave their home for care. Hospitals should develop programs that address these barriers when providing services to their 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 answer on the podcast, email us at podcast@340BHealth.org.
Episode Resources:
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340B Health Member Alert on Eli Lilly’s Contract Pharmacy Plan
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Bipartisan Bill Would Protect 340B Status During Emergency
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Ascension Via Christi Community Cares Clinic
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340B Coalition Virtual Summer Conference
In this episode of 340B Insight we speak with Chuck Beams, executive director of pharmacy services, business development, and government relations at East Alabama Medical Center (EAMC), about how the 340B program helps EAMC serve its rural community. We also provide 340B news updates regarding the CMS Medicare Part B cuts to 340B hospitals and new 340B research.
A Diverse Patient Population: EAMC is located in Opelika, Alabama, and serves 11 counties, totaling a population of nearly half a million. Although it is located near Auburn University, it serves many underserved, rural patients who live in nearby communities.
Support Center Amid Natural Disasters: In March 2019, eastern Alabama experienced a devastating tornado that left 23 people dead. In the aftermath, EAMC held the community together with its emergency medical response and social services such as discounted medical bills.
Using 340B Savings to Serve the Underserved: EAMC is one of a dwindling number of hospitals in the area. The 340B program is a key reason why EAMC has survived. Chuck’s team has leveraged 340B savings to provide uncompensated care to uninsured and low-income patients, a meds-to-beds program to ensure patients have the medications they need at discharge, mobile health services, and access to pharmacists in the emergency department,.
The Importance of Advocating for 340B: Chuck shares the importance of advocating for the program at both the federal and state levels to ensure policymakers understand the value it brings to patients and the rural hospitals that care for them.
Check out all of our episodes on the 340B Insight podcast website. You can also 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 OPPS Resource Center
- Research Brief: 340B HOSPITALS TREAT A LARGER PERCENTAGE OF CANCER PATIENTS IN UNDERSERVED POPULATIONS
- Faces of 340B: Chuck Beams
- East Alabama Medical Center
In this episode, we speak with Tracy Gilmore, 340B specialist at Labette Health in Parsons, Kansas. Tracy discusses her hospital’s experience responding to COVID-19 in a rural community and highlights the lifesaving impact of 340B on Labette Health and its patients.
A Strong Hospital for the Local Community: Labette County faces numerous challenges, including high poverty rates and childhood hunger. Amid these challenges, Labette Health is a staple of the community providing excellent service for Labette and patients from neighboring counties.
Robust Response and Sacrifices During COVID-19: Labette Health has treated dozens of COVID-19 cases, with some indications at the start of the pandemic that the outbreak could become much more severe. In response, Labette Health obtained extra beds, waived all patient out-of-pocket payments in March, and issued public service announcements on social distancing and hygiene to the local community.
340B Provides Financial Support: Tracy emphasized that 340B funds have been critical in keeping the hospital financially afloat amid the substantial actions taken in response to COVID-19. As the only source of constant income throughout this pandemic, 340B helped Labette Health to staff additional beds and continue providing excellent care to its patients.
Strength of the Community: Hospital administrators, doctors, and nurses made incredible sacrifices for the patients and local community that included taking pay cuts, working through high-stress circumstances, and providing extra services directly to the community. The community has taken note. Local citizens recently participated in a socially distant parade to honor health care workers.
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.
Episode Resources:
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HRSA Offsite Clinic Eligibility Rule Change
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340B Health COVID-19 Resource Center
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340B Health COVID Conversations Webinar
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340B Coalition Virtual Summer Conference
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Labette Health
In this episode, we speak with Mike Bonck, Manager of Pharmaceutical Services for CHI Franciscan Health (CHIFH) in Tacoma, Washington, about the impact of COVID-19 on the US health care system. CHIFH is a system with four DSH hospitals, one rural referral center, and one critical access hospital that participate in the 340B program.
Tacoma is one of the most significantly affected regions of the U.S., having experienced a major surge of COVID-19 cases in March and April. CHIFH was one of the first hospital systems in the U.S. to face the enormous challenge of responding to COVID-19. Mike offers his perspective on the impact of the novel coronavirus on hospitals, staff, and patients. Some major takeaways include:
Planning, Communication, and Support: Hospitals overwhelmed by COVID-19 face severe equipment and drug shortages. Other major complications include scheduling surgeries and establishing new visitation policies. To address these challenges, hospitals must engage in meticulous planning, system-wide communication, and support for health care employees.
Financial Challenges: COVID-19 has severely threatened the financial health of U.S. hospitals. Federal stimulus money for hospitals through the CARES Act is helping but likely insufficient. As such, it will take a concerted effort to recover from COVID-19, from both a public health and financial health perspective.
Impact of the 340B Program: The 340B program has mitigated CHIFH’s financial challenges, helping the hospital continue to provide critical health services to low-income and underserved patients.
340B Regulatory Flexibility: Policies adopted by the Health Resources & Services Administration to provide greater flexibility to 340B hospitals have helped and should be made permanent.
Long-Term Impact of COVID-19: Innovations such as telemedicine will improve and expand health care in the long term. However, the U.S. health system faces more immediate challenges of caring for the millions of Americans who are newly unemployed and without insurance coverage.
Check out all our episodes on the 340B Insight podcast website. You can also stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover on our podcast, email us at podcast@340bhealth.org.
Episode Resources:
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340B Health COVID-19 Resource Center
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340B Health OPPS Resource Center
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Sen. Ben Sasse’s press release on rural health legislation
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340B Coalition Virtual Summer Conference
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CHI Franciscan
In this episode, we speak with our President and CEO, Maureen Testoni, about the impact of COVID-19 on the 340B program. Maureen has been leading 340B Health since April 2018 and previously served as the Senior Vice President and General Counsel for the organization.
Maureen discusses several key issues for the 340B community amid the uncertainty of the COVID-19 pandemic. Some key discussion topics include:
1.HRSA’s Response to COVID-19: HRSA has provided flexibility for hospitals on 340B drug purchases, registration of new hospital clinics, and telemedicine. However, there are additional steps HRSA should take to help hospitals provide continued care for their low-income patients during the pandemic.
2. 340B Health Advocacy: 340B Health is conducting outreach to HRSA, HHS Secretary Alex Azar, and members of Congress about enacting regulatory and legislative flexibility in the 340B program to ensure it is responsive to a rapidly changing health care environment. 340B Health also created an online COVID-19 Resource Center for its members (see link below).
3. CMS Survey: CMS is surveying many 340B hospitals related to their drug acquisition costs. This survey is part of the agency’s effort to cut Medicare Part B payments to most 340B hospitals.
4. Medicaid Cuts: 340B is closely following legislative proposals in Congress that would reduce Medicaid reimbursements to 340B hospitals.
5. Health System Trends: Maureen highlights recent trends in the health care world that affect 340B, such as transitions to outpatient care and the emergence of new drugs that replace invasive procedures.
Check out all of our episodes on the 340B Insight podcast website. You can also 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 the podcast, email us at podcast@340bhealth.org.
Episode Resources:
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340B Health COVID-19 Resource Center
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340B Health OPPS Resource Center
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340B Health’s Statement Regarding Bipartisan Efforts to Protect 340B Hospitals During COVID-19 (May 8, 2020)
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340B Health’s Statement Regarding Federal Flexibility for Hospitals Amid COVID-19 Response (March 20, 2020)
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340B Health’s Statement Regarding White House Approval of 340B Medicare Drug Cost Survey (April 24, 2020)
340B Insight is a podcast hosted by 340B Health that provides its members and supporters with timely news updates and discussion around the 340B drug pricing program.
This inaugural episode includes news updates on the Centers for Medicare and Medicaid Services going ahead with a controversial survey of 340B hospitals, and lawmakers on Capitol Hill asking congressional leaders to protect 340B during the COVID-19 pandemic.
In the feature interview for this episode, the President and CEO of 340B Health, Maureen Testoni, speaks with Rear Admiral Krista M. Pedley, the Director of the Office of Pharmacy Affairs (OPA) in the Health Resources & Services Administration (HRSA). OPA administers the 340B drug pricing program, which requires drug manufacturers to provide outpatient drugs to eligible safety-net providers at reduced prices.
During the interview, Rear Admiral Pedley offers numerous insights into critical 340B issues, including:
- HRSA Provides Flexibility During the COVID-19 Pandemic: HRSA is offering certain flexibilities for covered entities to ensure that they can remain focused on patient care during the pandemic. For example, it will conduct remote 340B audits for the next several months.
- HRSA Has Limited Enforcement Powers During Audits: HRSA can only enforce 340B guidance if it discovers a clear and direct violation of the 340B statute. As such, HRSA states that it has limited capacity to broadly enforce 340B guidance.
- The New 340B Ceiling Price Website Improves Transparency: Last year, HRSA launched the new 340B ceiling price website, which has improved transparency and communications with external stakeholders in relation to price reporting and price comparisons.
- Eligible 340B Participants Must Continue to Document and Track Activities: Rear Admiral Pedley urges all 340B participants to document how they follow HRSA guidance in their policies and procedures and to keep auditable records of what makes them eligible to participate. It is also critical that 340B participants have a system in place to track every purchase of a 340B drug to an eligible patient.
- HRSA Finds Common Ground Between All Stakeholders: Rear Admiral Pedley highlights her role in listening to all sides of the 340B ecosystem to help find common ground and a sustainable path forward on reduced drug pricing.
340B Health expresses our gratitude to Rear Admiral Pedley for more than 10 years of dedication to the 340B program. Under her leadership, the 340B program continues to improve in its role as a vital health care safety net to patients in the U.S.
Check out all of our episodes on the 340B Insight podcast website. You can also stay updated on all 340B Health news and information by visiting our homepage.
Episode Resources:
HRSA OPA website
340B Health COVID-19 Resource Center
340B Health OPPS Resource Center
340B Health press release on Reps. Matsui-Stewart letter
Maureen Testoni op-ed about the 340B ceiling price website
Rear Admiral Krista Pedley’s Bio
Rear Admiral Krista M. Pedley is the Director of the Office of Pharmacy Affairs (OPA) in the Healthcare System Bureau, Health Resources & Services Administration (HRSA). Her office administers the 340B drug pricing program, through which more than 700 drug manufacturers provide discounted outpatient drugs to more than 46,700 hospitals and clinics, and more than 24,500 pharmacies purchase more than $24 billion in 340B drugs annually. The 340B program spans HHS and focuses on drug pricing transparency and reducing the cost of medications for the country’s most vulnerable safety-net patient populations.
RADM Pedley began her career as a pharmacist with the United States Public Health Service in May 2000. She was assigned to the Food and Drug Administration, Office of Generic Drugs, as a Project Manager for Bioequivalence and then as Medical Affairs Coordinator reviewing topical drug protocol design. After five years, RADM Pedley transferred to HRSA and then the Office of the Secretary of Health and Human Services, where she served as Senior Public Health Analyst for the National Bioterrorism Hospital Preparedness Program (NBHPP). In 2007, RADM Pedley began working with OPA, where she led a national collaborative that focused on integrating clinical pharmacy services into primary care to improve the health of patients with multiple chronic conditions. She then became the Director of OPA in July 2010 and was promoted to Rear Admiral and Assistant Surgeon General in February 2020.
RADM Pedley received her Doctor of Pharmacy degree at the University of Pittsburgh in 2000 and her Master of Science in Engineering Management and Systems Engineering, with a Concentration in Crisis, Emergency and Risk Management, from The George Washington University in 2008. She is also a 2011 graduate of the Public Health Leadership Institute (PHLI) Scholar Program.
RADM Pedley has participated in numerous deployments, including Hurricanes Frances, Ivan, Isabel, and Katrina as well as the Presidential Inauguration in 2005. RADM Pedley was also a contributor on the Report to the Surgeon General on Clinical Pharmacy and co-author on PHS Pharmacy Prevention Strategy.
RADM Pedley is the recipient of numerous awards, including an Exceptional Promotion to Captain in 2015, the Meritorious Service Medal in 2018, the PHS Commendation Medal in 2012, 2009, 2005, and the APhA Foundation Pinnacle Award in 2016 and 2011.
Welcome to 340B Insight! Hosted by 340B Health, the nation’s leading advocate for hospitals participating in the 340B drug pricing program. 340B Insight features the latest news, expert interviews, and answers to your questions. Learn about the ways 340B hospitals use program savings, demonstrate patient health improvements, respond to public health emergencies, and more.