340B Unscripted

In this episode, Greg and Rob are joined by a new SpendMend team member – Nick Gnadt – to discuss considerations around the use of alternate distribution models (ADMs) in the 340B space. They discuss some of the practical considerations around implementing ADM, where there may be operational or regulatory challenges, and what the long-term outlook is for this more novel strategy.

In the intro, the guys recap a flurry of updates in contract pharmacy restrictions, and discuss a communication posted on OPA’s website that foreshadows what might be an increasing number of HRSA audit reports released over the next few months that have findings of non-compliance.

Catch us at 340B Coalition Summer Conference July 8th - 10th in National Harbor. We will be at booth 717! 

In this episode, Greg and Rob welcome back health care attorney Jeff Davis to catch up on the latest draft guidance published by CMS to address IRA-mandated Medicare drug pricing provisions and impact to 340B providers (15:25).   Additionally, they chat about the 340B ACCESS Act, a new piece of draft legislation introduced in the House with sweeping 340B Program reform considerations (41:28).

In this episode, Greg and Rob are joined by healthcare attorney Ross Marguiles to discuss how a Supreme Court ruling on litigation in the fishing industry could have a major impact on the healthcare landscape.  Ross provides background on Chevron deference, a 40-year judicial doctrine that allows courts to defer ruling to federal administrative agencies, and ponders what the ripple effects could be to the 340B community if SCOTUS overturns this long-standing rule.

In the intro, the guys catch up on state-level contract pharmacy legislation and share thoughts on some recent data published around the 340B Program.

In this episode, SpendMend colleague Matt Parker joins Greg and Rob (14:00) to discuss pharmacotherapy services, and how pharmacist-driven care can help promote improved health outcomes in a community, as well as how these services might intersect with a covered entity’s 340B Program. They highlight the clinical and financial benefits that these services can provide, map out a typical workflow for how these services might be executed, and share thoughts on both operational and regulatory challenges that might be encountered when getting started.

In the intro, Rob and Greg briefly discuss some 340B news, including the recently published Administrative Dispute Resolution (ADR) Final Rule.

Register for our webinar on Tuesday, May 14th at 2 PM ET/11 AM PT, which offers pharmacist and pharmacy technician CE credits! https://attendee.gotowebinar.com/register/1001816060425009246?source=340BUnscripted

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 legislation, discuss ongoing uncertainty around Medicare Advantage & Part B underpayment remedies, and also note some recent data published on drug shortages.

Rob and other folks from our team will be attending Asembia in Las Vegas from April 29 – May 2.  Reach out to us if you want to connect there! Email us at [email protected]

Also, save the date for our next webinar, which will be on May 14, 2024 – We’ll be sharing tips on what covered entities should be doing to effectively self-audit their 340B Program operations!

SpendMend colleagues Jasmine and Megan continue their conversation providing some grantee CE perspectives concerning the HRSA DRL. 

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 [email protected] with comments, questions, or topic suggestions!

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