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 registered as contract pharmacies.

In the intro, the guys catch up on new manufacturer restrictions in the contract pharmacy space and share thoughts on other items in the news, including the Change Healthcare cyberattack and a political ad recently published targeting the 340B Program.

Contact us at [email protected] if you have any questions or comments on what we’ve discussed, or have a topic that you think we should address on the podcast!

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 [email protected].

Pharmacy technicians and Pharmacists looking for CE credits?  Please register to attend our upcoming webinar: https://attendee.gotowebinar.com/register/8340831873822502743?source=340BUnscripted

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 recertification (starting now through 2/26/2024) and describe communication HRSA has been sending to hospitals that were granted eligibility extensions last year under the Consolidated Appropriations Act. Finally, they’ll discuss some developments from the Senate “Gang of 6” and their newly released 340B legislative draft and request for information on 340B Program reform.

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 repayments, and talk about a new Medicaid rebate policy change that might impact 340B providers in the future.

We are at the 340B Coalition Winter Conference in San Diego this week!  Stop by and see the team at booth 611!

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 at ASHP Midyear, stop by and see some members of our team at Booth 1500.

Also, don’t forget to register for our next webinar: https://attendee.gotowebinar.com/register/6765415327956894816?source=340B+Unscripted

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 more information on registering for this webinar on our social media pages.

Have a suggested podcast topic?  Email us at [email protected] with your ideas.

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.