340B Unscripted

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 claim screenshots for retail dispenses.

In the intro, they recap state-level 340B l...

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.

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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. DRL #7 is an entity-owned pharmacy documentation, which includes demonstrating ownershi...

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 ...

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 ...

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 upda...

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 sh...

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...

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-en...

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 C...

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...

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 ...