340B Unscripted

In this episode, Rob and Greg are joined by guest Andy Ruskin, healthcare attorney and government payer expert from K&L Gates. They’ll be discussing the 2026 CMS OPPS Final Rule, focusing on the provision related to the ODACS, or Outpatient Drug Acquisition Cost Survey. They’ll review the statutory landscape surrounding the survey, recap past attempts by CMS to lower 340B hospital reimbursement, and discuss considerations for h...

In this episode, Greg and Rob share some initial reactions around the recent judicial activity affecting HRSA's 340B rebate model. They'll discuss thoughts on the federal court ruling that halted the rebate model from going into effect, and also debate what the fallout could be for manufacturers and covered entities given the lack of a regulated deduplication process for MFP and 340B prices. They'll also discuss some of the prelimi...

In this episode, Greg and Rob recap key developments in the 340B space from 2025.  They’ll discuss the flurry of activity in recent months related to 340B rebates, project the impact of the OBBB on DSH hospitals, share insights from HRSA audit trends over the last year, and offer commentary on one of the few high points for 340B providers this year – state legislative activity. Also, Rob offers a heartfelt pep talk for 340B folks a...

In this episode, Greg and Rob catch up on some clarifications gained around the upcoming 340B rebate model, including purchasing requirements and developments with select chain retail pharmacies updating their policies. Additionally, they discuss the CMS CY2026 OPPS final rule that was just published, including potential implications for 340B hospitals.

CMS Hospital Drug Acquisition Cost Survey Info: https://www.cms.gov/medicare/pa...

In this episode, Greg and Rob share initial reactions to the HRSA update on 340B rebate model implementation. They’ll review the communication provided by HRSA on October 30th on their website, as well as discuss some of the manufacturer letters published on October 31st, that formally communicate rebate policies to 340B stakeholders.

HRSA 340B Rebate Website: https://www.hrsa.gov/opa/340b-model-pilot-program

Beacon Manufacturer ...

In this episode, Greg and Rob chat about what the government shutdown might mean for 340B Program oversight in the short-term. They’ll also discuss a flurry of developments from manufacturers recently. Specifically, they’ll highlight efforts to promote more direct-to-consumer (DTC) pathways for obtaining medications, all related to a recent Trump Administration executive order calling for “most favored nation (MFN)” pricing for dru...

In this episode, Greg and Rob are joined by SpendMend colleague Heather Lynch, to talk about how H.R.1 (i.e. One Big Beautiful Bill Act, or OBBBA) could impact 340B covered entities in the long run. They’ll discuss how federal Medicaid cuts projected from the bill could influence a trend in lower average DSH% for some hospitals, threatening 340B Program eligibility. They’ll also have a conversation about things hospitals should con...

In this episode, Greg and Rob review recent changes made to the HRSA Audit Data Request List (DRL). They also discuss some of the comments provided by the public to HRSA regarding potential 340B rebate models, debate a recent change to a manufacturer’s contract pharmacy restrictions, and highlight some communication that has gone out to hospitals regarding a proposed CMS 340B drug acquisition cost survey expected in CY26.

SpendMend...

In this episode, Greg and Rob discuss tips for completing the annual 340B hospital recertification process, which is occurring now through early September. They also recap a recent notice in the Federal Register that signals HRSA’s intent on modifying some elements of OPAIS and the 340B enrollment/registration/recertification process. The guys also can’t help themselves and wrap up with another debate around impending 340B rebate c...

This week’s episode is a short one but a good one. Rob is out on vacation, so Greg is joined by SpendMend colleague Sabrina Allen to discuss the recent policy changes impacting FQHCs related to a Trump Administration executive order from earlier this year that address insulin and injectable epinephrine 340B pricing provisions.

SpendMend is at Booth #413 this week at the 340B Coalition Summer Conference in National Harbor, MD. Come ...

In this episode, Greg and Rob welcome back Ted Slafsky to recap what the first six months of 2025 have brought to the 340B landscape. They’ll talk about where we are at with 340B rebate model action, discuss how federal agency reorganization efforts could impact 340B regulatory oversight, recap state legislative wins for 340B providers and debate how Congress may address the call for 340B Program reform later in the year.

Come catc...

In this episode, Greg and Rob catch up on developments in the 340B space. They chat about new information provided by CMS for pharmacies related to the Medicare Drug Price Negotiation Program (some helpful links are below). Also, they debate about what might be coming with the widely anticipated 340B rebate model guidance.

CMS Medicare Transaction Facilitator (MTF) User Guide: https://www.cms.gov/files/document/negotiation-program-...

In this episode, Greg and Rob are joined by guest Peggy Tighe, healthcare attorney and government relations specialist. They catch up on lots of contemporary issues impacting 340B providers, including state legislative activity (19:44), the recent Trump Administration’s executive order on drug pricing (30:02), Senator Cassidy’s 340B investigation report (43:20), and movement in 340B rebate litigation (52:00).   Also, listen for Dav...

In this week’s episode, Greg and Rob are joined by colleague Heidi Larson to recap lots of questions that came out of a recent SpendMend webinar focused on 340B location issues. They’ll address issues like what is considered onsite vs. offsite for the purposes of OPAIS registration, when newly registered locations are eligible to use 340B and a variety of other issues pertaining to how entities need to address their locations from ...

In this episode, Rob and Greg review tips and tricks for maintaining a covered entity’s registration on the OPAIS database. Failure to keep an up-to-date and accurate listing on OPAIS can result in audit findings, and may warrant a corrective action plan with HRSA. The guys will cover some of the common compliance pitfalls with keeping an accurate record on this website. Megan from the team chimes in, too, with some tips for grante...