show episodes
 
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.
 
Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly c ...
 
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show series
 
On episode 24, Dr. Ross M. Ramsey, MD, President & CEO of Scheurer Health, gives listeners an inside look at working in one of Michigan’s rural hospitals as both a clinician and leader. Ramsey, who grew up in the region before attending medical school at Michigan State University, explains the care model and culture that sets rural hospitals like S…
 
We often receive listener questions about 340B issues and developments that affect professionals in the 340B world. In this episode, we open the listener virtual mailbag and answer some of your questions with help from our 340B Health staff experts. Some of the questions we tackle include queries about mitigating 340B contract pharmacy restrictions…
 
In this episode, Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statute. They analyze the Wheeling Hospital case and the Catholic Medical Center case and discuss key takeaways from the cases as they relate to the False Claims Act.…
 
Providing care beyond hospital walls is a growing trend for 340B hospitals. One service that health systems provide outside of the hospital setting is home infusion care. On our first episode of 2023, we are joined by David Klinger and Seth Gazes from Geisinger Health to hear how 340B hospitals can establish home infusion care and the 340B consider…
 
340B professionals are not the only hospital staff who need to know about 340B. That is why it is important that 340B professionals educate their colleagues about the program and what it means for clinical care and patient care operations. For our final episode of the year, 340B professional Ryan Atherton joins us to share the strategies he has dep…
 
In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B hospital reimbursement cuts, the agency’s proposed rule with respect to hospital outpatient reimbursement, and some considerations…
 
The recent election results have implications for the future of U.S. health policy and the 340B program. Health policy experts Debbie Curtis and Rodney Whitlock join us this week to discuss how the new Congress will affect 340B and how individuals can best engage in educating and advocating for the program. Debbie and Rodney are vice presidents at …
 
In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline. Using a recent letter from several health care providers and other stakeholders to the Office of the National Coordinator for Health IT (ONC) that outlines concerns related to the Information Blocking regulations, Gina and Stephen…
 
In this episode, Darlene Davis, Andrew Ruskin, and Lauren Norris Donahue review data that is now available in light of the hospital price transparency rule. They discuss the recent increase in compliance among hospitals, benefits of hospital price transparency data, antitrust considerations, and suggestions for hospitals to implement guidelines for…
 
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 efficien…
 
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 chair…
 
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 …
 
On this episode, Laura Appel, executive vice president of Government Relations and Public Policy at the MHA, discusses the upcoming general election, which will set the stage for critical healthcare decisions for Michigan and the nation in the years ahead. Appel explains how voting directly impacts healthcare and outlines details on this year’s can…
 
On this episode, MHA CEO Brian Peters is joined by T. Anthony Denton, J.D., MHSA, senior vice president and CEO of University of Michigan Health – Michigan Medicine, and 2022-2023 Chair of the MHA Board of Trustees. The two explore priorities for the new program year along with efforts underway to address workforce challenges, improve health equity…
 
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 th…
 
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs i…
 
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 occu…
 
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 pr…
 
In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised publication regarding cybersecurity. They highlight how this resource incorporates NIST security lessons from other industries and maps the guidance to compliance requirements under the HIPAA Security…
 
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 workfo…
 
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 …
 
In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the Health Resources and Services Administration’s definition of a 340B eligible patient in light of recent developments in the 340B P…
 
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 the…
 
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…
 
In this episode, Gabriel Scott and Darlene Davis analyze the private payor rates reporting requirements under the Protecting Access to Medicare Act. They discuss the type of entities required to report, potential penalties for failing to report, and provide some suggestions for how to initiate the reporting process.…
 
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 cu…
 
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 rec…
 
We're always more interested in ASCO presentations that focus on spending and prices than we are about the next great breakthrough -- we're stay-in-your-line types -- so we were excited to see new research quantifying the impact of oral oncology medicines on overall spending and out-of-pocket spending. It turns out that both of those types of spend…
 
On this episode, Lucy Ciaramitaro of the MHA interviews Karen Cheeseman, Chief Executive Officer of Mackinac Straits Health System and Leah Heffernan, retail pharmacy director, to explain the 340B drug pricing program; specifically what it is, and how it benefits Michigan's rural communities.You can help protect 340B by heading to the MHA Legislati…
 
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 hea…
 
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 h…
 
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…
 
In this episode, Myla Reizen, John Lawrence, and Bobby Higdon analyze the increase in governmental scrutiny around laboratory investigations and enforcement. They discuss the Eliminating Kickbacks Recovery Act (EKRA), trends in enforcement surrounding Operation Double Helix, guidance for medical labs, and the importance of outside counsel for compl…
 
On this episode, Lucy Ciaramitaro of the MHA is joined by Wright Lassiter, President and CEO of Henry Ford Health, to discuss the social determinants of health - what they are, why they matter and how understanding them can help us achieve better health outcomes. As President and CEO, Lassiter oversees the $7 billion integrated health system compri…
 
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 enfor…
 
In this episode, Steven Pine and Gary Qualls discuss the arbitration provision under the federal No Surprises Act, controversy around the qualifying payment amount (QPA), a recent decision in a Texas federal court that impacts the QPA, and new developments around the independent dispute resolution process.…
 
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 …
 
In this episode, Lou Patalano, Jacqueline Hoffman, and Spencer Hamer discuss employment law and the health care sector. They give a review of highlights from 2021, as well as developments that will impact employment law and the health care sector in 2022, including vaccine mandates, non-competes, and diversity, equity and inclusion.…
 
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 a…
 
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 prepari…
 
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 al…
 
Andrew Ruskin and Gabriel Scott discuss how Centers for Medicare & Medicaid Services (CMS) has recently promulgated rules implementing the provisions of the Consolidated Appropriations Act that affect a very large number of community hospitals. Specifically, due to CMS’s interpretation of Medicare graduate medical education reimbursement rules, man…
 
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 wit…
 
On this episode of the MiCare Champion Cast, Michael Leonard, MD, partner at Safe & Reliable Healthcare, shares his personal experience falling severely ill to COVID-19 in 2020. Leonard, who spent a total of 59 days in the hospital, gives a close-up look at what it was like as a tenured, perfectly healthy physician to become a critically ill COVID-…
 
While Jan. 1 means sleeping off a campagne-induced hangover for many, for drug-price wonks, it means an opportunity to look at price-change behavior in the pharmaceutical market, as January is traditionally the month where most list-priceadjustments happen. Antonio Ciaccia from 46Brooklyn and 3Axis Advisors, looks as closely at the data as anyone -…
 
Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the health care sector. They define what qualifies under HIPAA as a protected health information breach, discuss the importance of outside counsel in security incidents, review the timeline of reporting a breach to the…
 
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 communi…
 
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