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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 Karen Famoso, Enterprise Director of 340B at WVU Medicine in West Virginia. Many of the patients in the communities that WVU Medicine served live in rural areas of West Virginia, where transportation and income barriers can make it difficult for patients to access important health screenings. That's why the health system found an innovative way to bring those screenings to the patients where they live with the help of 340B funding. We wanted to learn more about how 340B can help support such mobile health initiatives. But first, let's do a quick recap of some of the Latest news about 340B.
David Glendinning [00:01:11]:
The Health Resources and Services Administration has closed the submission window for its comments on its proposed 340B rebate pilot program, as well as for proposals from drug companies seeking to participate in the pilot. HRSA recently announced it would permit drug companies to propose rebate models limited to the 10 drugs that will be subject to Medicare price caps beginning in 2026. Under the rebate pilot, drug makers may require some or all covered entities to purchase the 10 drugs at wholesale acquisition cost or another commercial price, submit claims data to the companies or their vendor, and receive rebates reflecting the difference between the purchase price and the 340B ceiling price. HRSA collected comments on the proposed pilot for more than 1,000 stakeholders, including 340B Health. Our comment letter notes our position that the 340B statute does not authorize HRSA to approve rebate models for 340B. We argue that the pilot would increase costs for covered entities and and divert critical resources from patient care without a reasoned explanation from HRSA for why it is abandoning 340B's long standing upfront discount model. We also propose several changes to the pilot in the event HRSA approves one or more of the rebate plans that drug makers have submitted. You can visit the Show Notes to read the full letter.
David Glendinning [00:02:38]:
You can also visit the Show Notes to learn more about how federal courts continue to largely uphold state laws pro protecting covered entity access to 340B drugs through contract pharmacies. One of these latest wins comes from the U.S. court of Appeals for the 5th Circuit. That decision rejected constitutional challenges that the drug company Abbvie brought against a Mississippi law banning drug maker restrictions on delivery of 340B drugs to contract pharmacies in the state. This is the second federal appeals court to decide in favor of a state where with a contract pharmacy protection law. The court issuing the newest decision is still considering challenges to the Mississippi law from additional drug makers as well as drug maker challenges to a similar law in Louisiana. 340B Health had joined the American Hospital association, the Mississippi Hospital association, the Rural Hospital alliance, and the American Society of Health System Pharmacists on an appeals court brief in defense of the Mississippi law. And we remain closely involved with all the litigation over state contract pharmacy laws.
David Glendinning [00:03:53]:
And now for our feature interview with WVU Medicine's Karen Famoso. The combination of high cancer rates, low incomes, and difficulties accessing health screenings mean too many West Virginians do not receive a cancer diagnosis and until they are in the late stages of the disease. So Karen's health system determined it had to bring more of those screenings outside the four walls of the hospital and well into some of the more remote areas of the state. That meant using 340B funding to help put those screenings on wheels, some very large wheels, as it would turn out. We met up with Karen at the 340B Coalition Summer Conference to learn more. Here's that conversation.
David Glendinning [00:04:35]:
I am speaking with Karen Famoso, who is enterprise director of 340B at WVU Medicine in West Virginia. Karen, welcome to 340B Insight. Thanks for being here.
Karen Famoso [00:04:47]:
Thank you for having me.
David Glendinning [00:04:49]:
So we're here Speaking during the 340B Coalition Summer Conference, and today you and I are going to be speaking about WVU Medicine's mobile cancer screening initiatives, which, as we'll find out, has a. Has a pretty important 340B element to it. So before we get into that, could.
David Glendinning [00:05:08]:
You please tell us a little bit.
David Glendinning [00:05:09]:
About WVU Medicine and the patients you serve?
Karen Famoso [00:05:13]:
Absolutely. So WVU Medicine is one of the largest systems in the state of West Virginia. We have 24 hospitals total, and of that 22 are 340B covered entities. We have 19 distinct 340B ID numbers and comprise of 8 dish hospitals, 8 critical access hospitals, 1 rural referral center, and soon to have 1 sole community hospital. Our health system serves a whole array of patients. West Virginia is a poor state, so we tend to have 19% poverty rate and median income of $44,000. Our citizens tend to be unhealthy. We rank first in the nation in obesity and cardiovascular disease and also the highest smoking rate in the country.
Karen Famoso [00:06:04]:
But we also have a high percentage of diabetes and cancer within our citizens in our state. So the 340B program is vital to all of our hospitals since we service a high population of Medicare and Medicaid patients and patients that are underserved.
David Glendinning [00:06:24]:
You're actually the second Karen from WVU Health that we've had on the program. We also had our immediate past board chair, Karen Bolling, back in 2023, speaking about engaging your leadership with 340B. So certainly your system is well known to the program and to our organization. You got in. I think you started talking about this a bit. Little, little bit. But why is there a need for mobile cancer screenings from your health system?
Karen Famoso [00:06:53]:
We have one of the highest cancer rates and breast cancer and lung cancer tend to be some of the highest proportions of cancer within the state. So it was identified that there was a need for mobile screenings because one of the social determinants of care is in West Virginia is travel. West Virginia, being a rural state, has windy roads, small population sections, and sometimes it's just difficult to get to care. There's thousands of patients that live within 30 miles away from a primary care and with the poverty rate of our state, sometimes it's impossible for patients to seek out care because. Because it's hard to get there. So we are taking the care to the patients and screening for breast cancer and lung cancer. Bonnie's Bus and Lucas Lung screening Unit are part of WVU Cancer Institute mobile cancer screening program. It's focused on bringing cancer prevention services to the underserved communities throughout our state.
David Glendinning [00:08:02]:
Yeah, and so I understand on the breast cancer screening screening front, we have Bonnie's Bus, which if I'm getting my notes correct, launched in 2009. We have Lucas on the lung cancer side which launched in 2021. So let's start with Bonnie's Bus, if we could. What are the screenings that you provide residents through that mobile clinic?
Karen Famoso [00:08:23]:
So Bonnie's Bus is a mobile mammography unit that travels throughout our state into our small care areas that have limited access to care. It provides mammograms to people in our state who fall within the screening guidelines. And it is named after and was initially funded by the family of one of a patient whose first name was Bonnie. Their family got together and made a donation to support this program because her cancer was not diagnosed in an early enough time because of limited access to screenings. So this is how Bonnie's Bus started. Lucas is a lung cancer screening and Lucas is actually a full size trailer. So it's very large and it Winds through our roads on our states and sometimes has a difficult time getting to those small rural areas. But Lucas stands for lung cancer cancer screening.
Karen Famoso [00:09:23]:
And it is much bigger than what Bonnie's Bus is. But it provides low dose CT scans to the people within meeting the screening guidelines.
David Glendinning [00:09:33]:
And recently the New York Times had a feature on Lucas that I saw. We'll be sure to put a link to that story into the show notes and I encourage all of our listeners to read that story and also to see the photos because seeing this nearly 70,000 pound tractor trailer kind of rolling into these towns on, as you mentioned, some pretty precarious roads sometimes. It's a really impressive operation, impressive looking clinic. And of course you're very closely involved. You know, I'm sure there's a whole team that is involved with Bonnie's Bus and with Lucas. And you are more on the 340B side. And so how does 340B play a role in enabling these mobile screenings services to operate?
Karen Famoso [00:10:15]:
Like with 340B is so important to every hospital in our state. But this technology is an expensive technology and it doesn't include just the bus itself, but also the staffing and the operation operationalizing the unit. We do accept insurance, but we also never turn away a patient. So if they cannot pay, you know, they're still screened regardless. And that's the method of care. With wvu also, we treat all patients regardless of their ability to pay. The mobile screening units are funded through grants and donations, but they would not be able to operate without some of the funding that we obtained through our 340B program for Bonnie's bus and Lucas. Last year in 2024, we had an overall operating loss of almost 400,000.
Karen Famoso [00:11:07]:
The fact that it is the 340B savings that allows West Virginia University Hospitals to maintain, even though we have a narrow margin, allows us to continue with our mission. And without the 340B savings, WVU's financial position wouldn't allow us for such an investment in the mission focused programs like Bonnie's Bus and Lucas.
David Glendinning [00:11:28]:
And could you just speak a little bit more about those screening guidelines you mentioned? There were for both of these clinics. Who are the patients who are eligible to receive these scans for Bonnie's Bus?
Karen Famoso [00:11:40]:
The patients that are 40 and over are eligible for mammographies and screenings using the Bonnie Bus service. But also for Lucas, if there's a history of smoking, Those greater than 50 to 80 are eligible for screening in Lucas.
David Glendinning [00:11:58]:
And that is great to hear that you serve everyone who Falls within those guidelines, regardless of their ability to pay. I can see where the 340B element comes into that. Okay, so Bonnie's bus still going strong after more than 15 years at this point. And Lucas looks like it'll be coming up on its fifth anniversary before very long. So clearly there must be some success going on here that you keep this going. What have the results been from these screening initiatives? How has it worked out for patients?
Karen Famoso [00:12:27]:
We've had more than 37,000 screenings through Bonnie's Bus and Lucas, and both have identified over 250 cancers and the patients who might not otherwise have known. It's best to find a cancer early. If it's found in stage one or two, it's more easily treated. Once you get to stage four, it's more difficult and the outcomes aren't as positive.
David Glendinning [00:12:52]:
Yeah, that is excellent. More than 250 people who might not have known, as you said about that cancer before catching it earlier. That certainly is a great success. What happens next in that, you know, hopefully rare but sadly possible scenario in which the patients receive a positive result from one of these screenings.
Karen Famoso [00:13:13]:
So if a patient receives a positive response, response or result due to these screenings, they'll reach out to the patient, give them the information, and set them up with a referral to see a provider that they can seek treatment through. If during the screening for Lucas, they also will have smoking cessation recommendations and will refer those patients, patients out as well for smoking cessation programs.
David Glendinning [00:13:44]:
Okay, so it seems like these screenings are intended to be the first step, not the last step, in that patient's health journey. I'm excited to see where, what roads WVU medicine might be going down next. So what are the plans? What might the future hold for these mobile screening initiatives?
Karen Famoso [00:14:03]:
Definitely will continue the mobile screening initiatives, but we're also excited to say that Bonnie's bus number two is in the works and it is in development, and we could find it on the roads in 2026.
David Glendinning [00:14:18]:
That's great. Already gained national and now, you know, potentially international attention. That's excellent, Karen. This has been such an amazing story of how 340B helps fund healthcare not only outside the forest walls of the hospital, but, well, down those country roads that you mentioned before. So thank you so much for sharing that with me.
Karen Famoso [00:14:39]:
Okay, thank you for having me.
David Glendinning [00:14:42]:
Our thanks again to Karen Famoso for sharing such an important and heartwarming patient health success story with our listeners. We hope the impressive sight of WVU Medicine's tractor trailer rolling into town and bringing the hope of better health with it can serve as an inspiration for how other health systems can use their 340B funding to bring life saving care to the patients who need it most. If you have a 340B funded care innovation to share, we would love to hear about it and consider featuring it on the show. You can email us at podcastree40bhealth.org we will be back in a few weeks with our next episode. In the meantime, as always, thanks for listening and be well.
Narration [00:15:25]:
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.