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.
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 ongoing litigation between hospitals and HRSA over child site eligibility guidance. Email us at 340BUnscripted@spendmend.com with comments, questions, or to...
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. DRL #7 is an entity-owned pharmacy documentation, which includes demonstrating ownership of pharmacies that are dispensing 340B drugs but are not regist...
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 designations in 340B ESP. If you have questions about this topic or have other topics that you want us to address on the podcast, email us at 340BUnscripted@spe...
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 340B Coalition Winter Meeting in San Diego, and then the guys catch up on some 340B related news. They’ll share a quick reminder on grantee 340B annual ...
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 reviewing this data. In the intro, the guys catch up on state-level 340B legislative updates, discuss CMS’s upcoming process for Medicare Part B repayment...
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, make sure to come see the team at Booth 611.
For our last episode of 2023, Greg and Rob reviewed hot topics impacting 340B covered entities from the past year.
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 address self-auditing needs might be a good approach for some. But first, the guys share additional thoughts on the recent Genesis case. SpendMend is ...
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 Anaheim, make sure to stop by booth 1500 to see us!
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 documents. HRSA audit readiness and a detailed overview of the DRL will be the subject of our next SpendMend Pharmacy Webinar in December 2023. Look for...
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.
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 questions, comments, or suggested podcast topics at 340BUnscripted@spendmend.com !
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 the FAQ 4301 developments earlier this year (49:58) and opinions on recent state-enacted laws addressing contract pharmacy provisions (57:49). In the i...
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 IRA by the pharma industry may play out (56:29). They also add some insights around CMS’s proposed Part B payment remedy (1:01:03). In the intro, Rob ca...
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. In the intro, Greg and Rob are joined by SpendMend colleague Jennifer Hagen and catch up on recent 340B developments, including updates on manufacturer...
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 with more conversation among Rob, Greg, and Emily. In the intro, the guys catch up on some news and noteworthy 340B items, including drug shortage legi...
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.
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 340B hospital experts Erin Leigh (47:12), Nan Kempadoo (1:00:14) and Pooja Shah (1:14:08). Submit your questions for Rob and Greg here: https://ww2.s...
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.
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 Unscripted t-shirt at the conference.
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 updates to manufacturer restrictions for contract pharmacies and share anecdotes from recent HRSA audit experiences.
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
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 reminder of 340B protections offered under the 2022 Consolidated Appropriations Act (i.e., DSH attestation) -Legislative updates from the House E&C healt...
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.
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 and Rob discuss upcoming recertification for grantee-covered entities and debate what the end of the COVID-19 Public Health Emergency means for 340B cov...
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 to contract pharmacy restrictions and patient definition (30:29). Finally, Vacheria and the guys will chat about NACHC’s 340B advocacy efforts, s...
Rob is back from San Diego, and he and Greg have a lot to catch up on, including a recap of notable events and sessions from the 340B Coalition 2023 Winter Conference (27:37). But first, They’ll discuss recent changes to manufacturer-related contract pharmacy restrictions (1:03), share insights from recent Congressional hearings where 340B has been a focus (13:42), discuss recent OPAIS changes (20:43) and talk about the impact hospitals might expect with the phase-out of continuous Medicaid cove...
In this episode, Rob and Greg dissect some of the finer details of the ASAP 340B policy principles. They’ll address the merits of proposed reform around topics like patient definition, hospital and child site eligibility, contract pharmacy provisions, and 340B savings transparency, among other targeted policy areas. Also, with the 340B Coalition Winter Conference right around the corner, the guys highlight sessions and presentations (41:08) featuring SpendMend clients and 340B friends that you w...
