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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Ep 43 | Getting to Know the HRSA DRL – DRL 8 Self-Disclosure Documentation and DRL 9 Medicaid Billing Information
51:10
51:10
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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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Renaming the Key Bridge in Baltimore, Maryland and Choptank River Bridge in Cambridge, Maryland
29:15
29:15
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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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Ep 42 | Getting to Know the HRSA DRL – Grantee Considerations Part 2
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44:43
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SpendMend colleagues Jasmine and Megan continue their conversation providing some grantee CE perspectives concerning the HRSA DRL.By SpendMend Pharmacy
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Bishop Troy Barnett, The Legacy of Apostle Leroy H. Cannady, Part II
25:48
25:48
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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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Corporate Practice of Medicine: New Relevance in a Changing World
28:55
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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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Ep 42 | Getting to Know the HRSA DRL – Grantee Considerations Part 1
48:48
48:48
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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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Health System Cybersecurity Risks: Part Two
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22:49
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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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Health System Cybersecurity Risks: Part One
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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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Ep 40 | Getting to Know the HRSA DRL: DRL 5 Purchasing Documentation and DRL 7 Entity-Owned Pharmacy Documentation
48:20
48:20
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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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Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast
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15:54
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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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Ep 39 | A Revisit of Ongoing Contract Pharmacy Restrictions
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32:39
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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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Ep 38 | Getting to Know the HRSA DRL: DRL 4 Provider List and DRL 6 Contract Pharmacy Documentation
1:04:50
1:04:50
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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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Losing a Spouse. What Next? Guest: Elder Valerie Watson
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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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Reparations Now; Reparation Grants are Here in Maryland; Guest Rev. R. Callender
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25:47
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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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Ep 37 | Getting to Know HRSA DRL: Part 3 - 340B Universe Data
1:06:51
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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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Trash Talk: Anti-Obamalore and Race in the 21st Century: Guest Professor Patricia A. Turner
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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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Ep 36 | Getting to Know HRSA DRL: Part 2 - CE Eligibility Documentation
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43:32
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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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Ep 35 | Top 10 Developments in 340B for 2023
1:05:01
1:05:01
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For our last episode of 2023, Greg and Rob reviewed hot topics impacting 340B covered entities from the past year.By SpendMend Pharmacy
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Ep 34 | Maintaining 340B Compliance: The Importance of Self-Auditing
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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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Ep 33 | Thoughts on the Genesis v. Becerra Court Ruling
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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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Ep 32 | Getting to Know the HRSA DRL: Part 1 – Policies & Procedures
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58:56
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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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Bonus Ep 2 | HRSA Notice Addressing 340B Registration Requirements
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24:47
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In this bonus episode, Rob and Greg review the HRSA notice published on October 27 that addresses the immediate use of 340B drugs in unregistered locations and some hospital considerations in response to the update.By SpendMend Pharmacy
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Ep 31 | Answering 340B FAQs - Rob vs. ChatGPT
1:02:37
1:02:37
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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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FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors
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15:05
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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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Ep 30 | Turnkey Pharmacy Solutions, Whiteboards & 340B Stuff
1:07:46
1:07:46
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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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Ep 29 | The Intersection Between the Inflation Reduction Act (IRA) & 340B – Conversation with Jeff Davis
1:09:11
1:09:11
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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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Ep 28 | 340B Conversation with Emily Cook - Part 2
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50:13
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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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Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations
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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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Ep 27 | 340B Conversation with Emily Cook - Part 1
1:08:21
1:08:21
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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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The Republican Party, Is it More Than Conspiracy Theories and Book Banning?
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27:24
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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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Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement
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17:45
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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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Ep 26 | First Year Anniversary of the 340B Unscripted Podcast - Q & A Session
1:05:31
1:05:31
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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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Descecration of Slave Cemeteries in Bethesda, Maryland
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28:51
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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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Ep 25 | 340B Coalition Summer Conference Recap - Part 2
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1:33:30
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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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Parolees. Changes Needed to the Existing Parole System in Maryland; Guest is Willie Hamilton
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24:02
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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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Ep 24 | 340B Coalition Summer Conference Recap
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Greg and Rob share highlights from the 340B Coalition Conference in DC. Topics covered include proposed CMS repayment for affected hospitals, Inflation Reduction Act updates, legislative updates, and other worthy conference discussions.By SpendMend Pharmacy
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The End of Continuous Medicaid Enrollment—What Health Systems Should Know
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5:51
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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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Ep 23 | 340B and the Medicare Cost Report
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57:38
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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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Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?
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In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers have experienced in navigating the new regulatory flexibilities for value-based arrangements announced in 2020.
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Ep 22 | Maintaining 340B Compliance: Medicaid Duplicate Discount Prevention
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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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Ep 21 | Thoughts on 340B & Biosimilar Uptake
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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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Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials
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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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Ep 20 | 340B History Lesson – The Morford Letter
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54:16
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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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Bonus Ep 1 | New 340B Location Qualification and FAQ 4301 Update
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16:39
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Greg and Rob provide a quick update on FAQ 4301 and where we are with HRSA removing language around the immediate use of new 340B locations.By SpendMend Pharmacy
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Ep 19 | 340B D.C. Update – Conversation with Ted Slafsky
1:09:27
1:09:27
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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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New Federal Legislation Pushing Back Against Book Banning; Congressman Kweisi Mfume - National Council of African American History and Culture Act of 2023
24:18
24:18
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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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Ep 18 | 340B Program Reform – A Conversation with NACHC
1:11:32
1:11:32
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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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Collecting Social Security Benefits; What I Need to Know; Guest Jacob Serfas
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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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