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340B Unscripted

SpendMend Pharmacy

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Pharmacists and healthcare industry leaders Rob ‘Hoopi’ Nahoopii PharmD, MS, ACE and Greg Wilson PharmD, BCPS, ACE dive deeply into the complicated and contentious 340B Program as well as other pressing Pharmacy matters. Special guests and industry experts pop in frequently to add insights from all sides of the discussion. If you serve in the pharmacy sector, this podcast is a must-listen!
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Being Well Informed discusses trending topics such as police reform, book banning intensified, the Emmett Till Alert App, new and upcoming authors, the Anne Arundel County NAACP Greenbook, judicial reform, long term care insurance, cryptocurrency scams, Maryland Lynching Memorial Project, Education in a Pandemic, and much more. The program, hosted by Claudia Barber, is designed to educate the audience on these trending topics.
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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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In this episode, Greg and Rob continue to provide insights on the HRSA data request list. DRL #8 is self-disclosure documentation and DRL #9 is Medicaid billing information, which includes providing details regarding your CE’s listing on the Medicaid Exclusion File, as well as sample billing claim forms for physician-administered drugs and billing …
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We delve into the discussion of renaming the Key Bridge in Baltimore, Maryland to the Parren J. Mitchell Bridge. Caucus of African American Leader Elder Charles James joins us for a lively discussion on what others are saying about the renaming of this bridge and also the Choptank River Bridge to honor the legacy of the late Gloria Richardson, one …
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Pastor Troy Barnett shares more about Saturday, June 1, 2024 at 2 pm at the Reginal Lewis Museum in Baltimore, Maryland. Parts I and II of the Legacy of Apostle Leroy H. Cannady, Sr. will be shared for all to see. Being Well Informed is an educational podcast designed to educate listeners of current topics. It is aired on You Tube, iHeart Radio, Ap…
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In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine and other remote models has become heavily adopted: Corporate Practice of Medicine, or “CPOM.” As more and more health care c…
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In this episode, SpendMend colleagues Jasmine and Megan provide some grantee CE perspectives concerning the HRSA DRL. They have so much great insight, we are breaking this conversation up into two parts. Stay tuned for Part 2 next week! In the intro, Rob and Greg discuss thoughts around responding to manufacturer 340B inquiries.…
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In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The Department of Health and Human Servi…
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In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The Department of Health and Human Servi…
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In this episode, Rob and Greg catch up on a cluster of developments in the 340B space, including updates to manufacturer contract pharmacy restrictions, thoughts on a federal appellate court ruling on Arkansas' contract pharmacy law, a preliminary take on the 340B PATIENTS Act recently introduced by Rep. Doris Matsui (D-CA), and an update on ongoin…
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In this episode, Greg and Rob continue reviewing data solicited by HRSA during an audit. DRL #5 is purchasing documentation, including a list of accounts, sample invoices, and 340B purchase order details. This ends up being a labor-intensive section to complete for HRSA, especially for larger organizations with a variety of purchasing practices. DR…
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In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA’s final…
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In this episode, Greg and Rob are once again joined by SpendMend team member Riley Protz, to catch up on the current state of ongoing manufacturer restrictions on 340B contract pharmacy operations, as well as to offer insights on various mitigation strategies, like the opportunity for grantee CEs to make associated site contract pharmacy designatio…
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In this episode, Greg and Rob continue their review of items from the HRSA audit data request list (DRL). They’ll cover DRL #4, the provider list, as well as DRL #6, contract pharmacy documentation. Don’t worry – they’ll come back to DRL #5 (purchasing documentation) in an upcoming episode! In the intro, Rob shares a few insights from the recent 34…
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We discuss the expected and unexpected things that happen when losing a spouse. Elder Valerie Watson of Transformation Church of Jesus Christ, Baltimore shares details of what it is like and how life has changed for her. Listeners are given an in depth view of how your relationship with family changes. Being Well Informed airs weekly on all major p…
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Reparation grants are here in Maryland, thanks to the hard work of the Episcopal Diocese of Maryland. The Episcopal Diocese of Maryland began with $1 million dollars in seed money. Now grants opportunities are available. The deadline is February 24, 2024. The call for reparations is not ignored. Our guest Rev. R. Callender shares with us where this…
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In this episode, Greg and Rob continue to cover the HRSA data request list, focusing this week on DRL item #3, probably the most complex of all of the sections – 340B universe data. They’ll talk about tips for organizing your 340B utilization data for an HRSA audit, and share insights regarding what the HRSA audit experience might be like when revi…
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Being Well Informed discusses Author Patricia A. Turner's book, Trash Talk: Anti-Obamalore and Race in the 21st Century. The author also headed the Arthur Ashe Legacy Project at UCLA. We delve into why former President Obama is still the target of conspiracy theories. The book covers the time period 2004 through 2022, the year of publication. Being…
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In Episode 36, Greg and Rob provide updates on recent 340B news around state legislation, manufacturer restrictions, and HRSA's decision to not appeal the Genesis case court ruling. They also provide insight and thoughts around the HRSA data request list item 2, the covered entity eligibility documentation. Also, if you are at 340B Winter Coalition…
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In this episode, Greg and Rob are joined by Spendmend colleague Cat Eriksen (16:11) to discuss the importance of self-auditing as part of a 340B covered entity’s overall compliance strategy. They’ll talk about HRSA standards around self-auditing, how some hospitals and clinics struggle to prioritize this effort, and why seeking external support to …
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In this episode, Rob and Greg share thoughts from the recent federal court ruling on the Genesis v Becerra case, which focuses on patient definition. Additionally, they catch up on manufacturer restriction changes and some developments from recent Senate HELP Committee 340B inquiries. If you are attending the ASHP Clinical Midyear meeting in Anahei…
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This episode is the first part of a series of recordings we are putting together to review the HRSA data request list (DRL). Rob and Greg discuss DRL item #1 – 340B Policies and Procedures. They’ll review the types of operations that HRSA expects to see outlined in a covered entity’s 340B policies and share some insights into how to manage these do…
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In this episode, Rob is pitted against ChatGPT to answer 340B-related FAQs, including topics like child site registration, GPO prohibition, and HRSA audit findings (17:29). In the intro, Greg and Rob catch up on revised contract pharmacy restrictions and thoughts on recent manufacturer inquiries that 340B entities have been receiving. Email us ques…
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In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.…
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Rich Bucher, one of the co-founders of Turnkey Pharmacy Solutions, makes a long-awaited appearance on the podcast with Greg and Rob. Rich and Rob share anecdotes from their early days getting involved in external 340B support (23:26). Rich also shares some thoughts on 340B topics like GPO Prohibition mitigation strategies (39:13), what to make of t…
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In this episode, Greg and Rob are joined by healthcare attorney Jeff Davis, to discuss how the Medicare drug pricing provisions in the IRA will impact 340B providers. They’ll go over CMS billing modifier requirements (15:27), share opinions on the financial impact covered entities might experience (38:02), and how various legal challenges to the IR…
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Rob and Greg continue their conversation with health care attorney and 340B expert Emily Cook (21:05). They discuss thoughts on the CMS Medicare Part B remedy, provide some commentary on the Inflation Reduction Act (IRA) and its intersection with 340B covered entities, and address an issue that could impact hospital DSH eligibility in the future. I…
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In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agency initiative to help create security tools to protect the US health care system from cyberattacks.
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Rob and Greg are joined by Emily Cook (20:15), an attorney in the health care and 340B space. They discuss a number of 340B topics, including ongoing manufacturer restrictions of contract pharmacies (24:52) as well as legal challenges to HRSA’s patient definition (42:16). This is part one of a two-part series, so look for a future podcast episode w…
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Steven H. Wilson, former Republican Central Committee Chair of Howard County, Maryland is our guest to discuss the direction of the Republican Party in Maryland. A recent editorial in the Baltimore Sunpapers was captioned, "The Republican Party Should Stand for More Than Conspiracy Theories and Banning Schoolbooks." We learn more about the Moms for…
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In this episode, Darlene Davis, Leah Richardson, and Andrew Ruskin unravel CMS’s proposed rule for the remedy for Medicare payments for drugs purchased under the 340B Program and reimbursed as hospital outpatient services. The discussion includes background of the unlawful 340B drug reimbursement policy, as well as CMS’s proposed remedy. They also …
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Aiden shares the 340B questions sent in by our listeners, and there are some good ones. Questions include opening an in-house retail pharmacy, CAR-T therapy, continuum of care and 190 clinics, the IRA, and a couple of other fun ones. On our one-year anniversary, we want to thank everyone for listening and for all the encouragement we have received.…
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Our guest, Robert Stubblefield discusses the challenging work of the Bethesda African American Cemetery Coalition. Updates are provided on the court battle that ensues in Maryland. Being Well Informed airs on iHeart Radio, Apple Podcasts, Google Podcasts, Podvine, Podbean, Amazon music and on many other major platforms. #renamekeybridge…
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Rob and Greg continue to unpack all the great information gathered from the 2023 340B Coalition Summer Conference in Washington D.C. They chat with coworkers, clients, and friends in the 340B community to share insights from sessions at the Conference. Guests include SpendMend colleagues Jennifer Hagen (16:54) and Shakita Carter (38:12), as well as…
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Why is the process or system for granting parole broken? We explore changes that need to be made. Justice Policy Institute describes Maryland's parole process as fraught with challenges. We give the answer to the question, "Why?" Our guest, Willie Hamilton works with No Struggle No Success and tells us more about what lawmakers can do to change the…
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In this episode, Alexander Chu and Ashley Davis review the end of the continuous Medicaid enrollment condition as a result of the Consolidated Appropriations Act, 2023. They discuss potential impacts of the disenrollment process for health care providers and provide helpful tips for health systems to navigate this change.…
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Greg and Rob break down the ins and outs of the Medicare Cost Report and the dos and don'ts of child site registrations. They also provide an update on contract pharmacy manufacturer restrictions and information on the upcoming 340B Coalition Conference. We also hear from our Producer Aiden and provide the secret password for your free 340B Unscrip…
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In this episode, Greg and Rob talk about an important 340B Program compliance element – preventing Medicaid duplicate discounts. They discuss the importance of maintaining the Medicaid Exclusion File (MEF), challenges with managing state-specific billing requirements, and strategies for managing out-of-state Medicaid. In the intro, the guys review …
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In this episode, Greg and Rob discuss a recent publication regarding how 340B Program participation may impact the degree of biosimilar utilization. Additionally, the guys recap recent legislative proposals with 340B impact that were advanced by the House Energy & Commerce Committee. Article citation: Health Affairs 42, NO. 5 (2023): 632–641…
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In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical trials, as well as notable planning considerations and regulatory requirements for both the industry sponsors and the academic medi…
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In this episode, Rob and Greg discuss an interesting piece of 340B history – the Morford letter (25:31). Rob shares his understanding of the origins of the letter and contemporary application of the letter as it relates to the recent debate around the 340B-eligible patient definition. But first, the guys catch up on 340B news, including: -A reminde…
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In this episode, Rob and Greg are joined by guest Ted Slafsky, of 340B Report and Wexford Solutions (13:20). Ted shares his thoughts on the ongoing contract pharmacy impasse, updates on legislative developments coming out of D.C., and highlights some of the emerging advocacy groups as the debate over 340B Program reform heats up. But first, Greg an…
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US Congressman Kweisi Mfume stopped by to share about legislation (House Bill 727) both he and US Senator Ben Cardin introduced to preserve African American history and culture. The legislation would create a 12 person National Council to advise the National Endowment for the Humanities on how to amplify, strengthen teaching and learning in schools…
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This week, Rob and Greg connected with Vacheria Keys, Director of Policy & Regulatory Affairs at NACHC. Vacheria will talk about her role at NACHC and how the health centers she represents have been impacted by a number of ongoing 340B developments (23:05). She’ll also share her thoughts on where things may go in terms of ongoing litigation related…
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What are the highlights of collecting Social Security? What simple steps should I take to maximize receiving benefits. If I buy a car after collecting Social Security and choose to pay using a pension account, how will that impact my Social Security? These and more questions are answered in this podcast with Jake Serfas of Copper Creek Wealth. Visi…
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