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340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.
Narration [00:00:04]:
Welcome to 340B Insight from 340B Health.
David Glendinning [00:00:12]:
Hello from Washington, D.C. and welcome back to 340B Insight, the premier podcast about the 340B drug pricing program. I'm your host David Glendinning with 340B Health. Our guest for this episode is Joe Moss, the 340B pharmacy manager at University Hospital's Cleveland Medical Center. Joe was a presenter at a workshop that preceded this year's 340B Coalition winter conference where he spoke about onboarding 340B child sites. We met up with him after that workshop concluded to learn more about the process behind getting a new child site up and running. But before we hear that interview, let's do a quick recap of some of the Latest news about 340B. President Trump recently ordered his administration to conduct a survey of hospitals outpatient drug acquisition costs and propose a plan to set Medicare payments based on those costs.
David Glendinning [00:01:18]:
This could lead to the return of Medicare pay cuts to 340B hospitals, which the US Supreme Court deemed unlawful because the Administration had not conducted such a survey beforehand. The order directs the Health and Human Services Secretary to publish a plan within 180 days for conducting the hospital outpatient drug acquisition survey. Following the conclusion of that survey, the order says the HHS Secretary, quote, shall consider and propose any appropriate adjustments that would align Medicare payments with the cost of acquisition, end quote, for those outpatient drugs. This could result in the Administration paying rates for 340B drugs that are as low as acquisition cost. However, under federal budget neutrality rules, Medicare may use any savings it retains on 340B drugs to raise rates for non drug services at 340B and non 340B hospitals. The provision is among several items that would affect 340B covered entities in a new White House Executive order aimed at lowering drug costs, 340B Health members can read more details about these developments by visiting the show Notes and now for our feature interview with Joe Moss with University Hospitals. Joe has significant experience in identifying potential 340B clinic sites within his health system and bringing those clinics into the fold as child sites so he knows how important it is for a health system to have an onboarding plan for those sites as well as a plan for after they come on board. We chatted more about those important processes after he shared his expertise with the pre conference workshop attendees.
David Glendinning [00:03:11]:
Here's that conversation.
David Glendinning [00:03:13]:
I am sitting here with Joe Moss, the 340B pharmacy manager at University Hospital's Cleveland Medical center, and we're speaking at the 340B Coalition winter conference, and it is during the ice cream social. So, Joe, special thanks for being here. We'll get through this interview and then we can go crush some gelato. Welcome to 340B Insight.
Joe Moss [00:03:34]:
Thank you for having me.
David Glendinning [00:03:36]:
Please start by telling us a little bit about university hospital's health system and the patients you serve there.
Joe Moss [00:03:42]:
University hospital's health system was founded in 1866 as a nonprofit entity. We currently have 23 hospitals across Northeast Ohio. We're the largest primary care network in the region. We have 50 plus health centers, freestanding urgent cares, convenient care centers, and surgery centers. We also have six facilities that provide behavioral health care, elder care, home care, rehabilitation, and integrative care. We're the second largest employer in Northeast Ohio and we have six 340B covered entities. We currently have 3400 active research studies going on, and we are a top funded research program in the nation.
David Glendinning [00:04:24]:
All right, great. Thanks for running through that. So, you know, Joe, I don't often have the opportunity to go to many of the conference sessions while I'm here, But I was able to attend your session in which you spoke about 340B child sites, and that's what we're here to speak about today. So for those who are newer to 340B, please explain what a 340B child site is.
Joe Moss [00:04:49]:
A child site is basically an ancillary outpatient site that is typically not located on the main hospital campus. So the hospital is called a parent and the clinic or the other site is called the child site.
David Glendinning [00:05:04]:
Okay, great. So now we're up to speed on on the concept and we're here to speak specifically about bringing such child sites on board. Tell me, why have an onboarding process in the first place?
Joe Moss [00:05:18]:
The reason they have an onboarding process is to simplify the registration of the new child site on the opace database to ensure that we have the correct data collected. In addition, it allows for better preparation for new site onboarding process with 340B compliance and audit readiness. And we also want to start building good relationships between the parent and the child site staff that we need in the future.
David Glendinning [00:05:40]:
Okay, that certainly makes sense to me and I think will resonate with hospitals that maybe already have their own child sites for those who don't and are going to be going through it for the first time. How does child site onboarding start?
Joe Moss [00:05:54]:
Sure. The first big step is to identify potential sites by determining if they're eligible for 340B. We typically work with our Finance department using the Medicare cost report and trial balance as a start. We work with various other teams as well to obtain cost center information so that we could look them up on those documents. And we also use EMR and retail data to identify potential clinics areas to bring them on to 340B, just to know what their volume is.
David Glendinning [00:06:22]:
It seems like there are a bunch of key issues to consider and keep track of in that process. So who needs to be involved with the enrollment process? I'm thinking in particular about the staff at a hospital that would be brought on for these processes.
Joe Moss [00:06:38]:
Yeah, the typical staff is finance. We have revenue, pharmacy, legal, 10 times. We have government relations join as well. We have our legal partners join and everybody's involved. Everybody brings a different aspect to the registration and identification of a child site that could potentially be eligible for 340B.
David Glendinning [00:06:56]:
And after the site is officially on board, so to speak, once the site's registered up and running in 340B, what happens then?
Joe Moss [00:07:06]:
Great question. We have developed a maintenance process to provide ongoing and comprehensive and guidance to that site. We look at that child site as it's brand new. It's due to the 340B program. We know that the staff needs additional education going forward. There's always questions about the procurement processes, understanding what they can and cannot do for drug transfers. Work with us for drug transfers between eligible 340B sites. We call that program 340B Concierge Program.
Joe Moss [00:07:35]:
And it's really to make that child site as if they really belong part of the program.
David Glendinning [00:07:41]:
All right, the 340B concierge program. I'm picturing a sharply dressed and helpful person at a hotel. Although in this case, I would imagine the helpful part may be more appropriate. So for this concierge program that you do have, what kind of support are you providing your 340B clinics on initial.
Joe Moss [00:08:03]:
When registered, we start them with an onboarding education component to understand what 340B is, the mechanics of 340B, what's expected to maintain compliance within that clinic. We also provide annual education going forward for that clinic staff and everybody else involved in the 340B program. At university hospitals, typically at clinics, we encounter physicians, nurses, and business managers who are new to 340B. We just make sure that they're. We're answering their questions. In addition, we provide ongoing procurement management for issues with licensing, issues that come up with board licenses and things like that. Anytime there's a drug shortage, how to help them mitigate that problem to get the Medications they need, helping with any transfers to 340B, other child sites with a parent hospital, and any type of invoicing issues that occur. In addition, we provide an ongoing monthly program where we email the clinic manager and just to discuss 340 issues that we've identified, identify anything that they have that's new for us.
Joe Moss [00:09:00]:
We have ad hoc meetings as needed with those with them as well to keep them moving. We review all their data for dispensations and purchases. We're always looking for data inconsistencies. We invite them to come to our mock audits and participate in HRSA audits as well. It gives them a 360 view of the 340B program at university Hospitals.
David Glendinning [00:09:20]:
Okay, so you brought up mock audits there as one of the items that you help with through this concierge level support. Can you walk me through that a little bit more? What does a mock audit look like and how does that look to a child site that you're working with?
Joe Moss [00:09:34]:
Mock audit starts out with the university hospital hiring an external consulting group to come in to review us annually. We review the HRSA data request list that's currently used by HRSA and it covers areas for policy, procedure, your eligibility requirements. It's requesting your data to claims for both hospital mixed use child sites, anything related to contract pharmacies as well. We're collecting government documents that we file on behalf of the irs part of eligibility. We look at all Medicaid in state Medicaid and out of state Medicaid. We're audited on modifier uses as well. If your contract pharmacy relationship, at least in the state of Ohio, those are carved out, meaning we don't bill Medicaid for those type of claims. It's an ongoing process.
Joe Moss [00:10:20]:
I think it's eye enlightening to a clinic who has never sat through one to see all the mechanics that goes in to verify all the eligibility requirements for a clinic to be in the 340B program. Of course, we also have other interested parties. We have pharmacy at the table, typically legal, department finance, your authorizing official, your primary contact person as well. We have credentialing folks in there to cover anything to do with provider credentialing, employees, employees, contractual relationships. So it's a lot going on when you have a mock audit. It's busy.
David Glendinning [00:10:52]:
Yeah. I'm wondering in particular about all of the potential items to stay vigilant about. We're always Interested in the 340B compliance side of it because of how important that is. So what are some of the potential issues that hospitals might encounter with their child sites?
Joe Moss [00:11:09]:
Yeah, potential issues that a child site could encounter is one of them is bind on incorrect account type. Depending on your organization, you could be subject to WAC, GPO and 340B pricing just to make sure that they're carrying those drugs in the proper accounts at the time of purchase. In addition, the child site could have a legacy account that was active prior to being converted over a 340B eligible clinic that they may access drugs from which may not be compliant with 340B programs. We always keep an eye on that as well. In addition, there are times when you may or may not be notified that a clinic has relocated moved, and we would have to update their OPACE records and re review their 340B eligibility as well. In addition, you could even lose eligibility if a site has closed and we have to remove it from the OPACE record.
David Glendinning [00:11:57]:
All right, a lot to think about. Joe, I really appreciate the University Hospital's perspective on all of this. I know all of those in the room for your presentation did as well. For those who weren't there, for those who were not able to make it, I'm curious as to what tips you might have for them. So what advice would you have for other hospitals on their own child site onboarding?
Joe Moss [00:12:19]:
Yeah, make sure you establish relationships with that clinic from the start and maintain that going forward to Prevent issues with 340B compliance. And always try to be the first line clinical pharmacy, prescription drug purchasing questions or issues that they come forward with that they're identified as well. And constantly identify and resolve potential compliance issues and have a frank conversation needed with the clinic management and upstream management.
David Glendinning [00:12:44]:
All right. And if you need a concierge, they should know who to call, right?
Joe Moss [00:12:47]:
They do.
David Glendinning [00:12:49]:
Joe, thank you again for doing double duty on this particular topic. We enjoyed having you here. And let's go get some ice cream.
Joe Moss [00:12:57]:
You got it. Let's do it.
David Glendinning [00:12:59]:
Our thanks again to Joe Moss for taking the time to share his 340B child site onboarding philosophy with the 340B community and for foregoing the ice cream social to spread the word more widely with our audience. Please let us know how you approach the important task of bringing new child sites into your 340B family. You can contact us at podcast@340bhealth.org we will be back in a few weeks with our next episode and we look forward to being with you again soon. In the meantime, as always, thanks for listening and be well.
Joe Moss [00:13:36]:
Thanks for listening to 340B Insight. Subscribe and rate us on Apple Podcasts, Google Play, Spotify, or wherever you listen to podcasts. For more information, visit our website at 340bpodcast.org. You can also follow us on Twitter @340Bhealth and submit a question or idea to the show by emailing us at podcast@340bhealth.org.